MEDICINES AUSTRALIA

CODE OF CONDUCT
ANNUAL REPORT
2007/2008

Table of Contents
Foreword
Executive Summary
Transparency
Note of Explanation
Definitions
Committees and Secretariat
Code of Conduct Committee
Appeals Committee
Monitoring Committee
Code Secretariat

Meeting Schedules

Code of Conduct Committee

Appeals Committee
Monitoring Committee

Promoting understanding of the Code

Code Compliance Network

Code Education in Australia
Code & Education Event Report Websites
Continuing Education Program (CEP)

Complaints Process
Analysis of Complaints

Source of complaints
Complaint determinations
Sanctions & fines
Resolution timeframes
Alleged & actual breaches of the Code

Educational Event Reports

Overview
Review

Complaint Determinations

Summary
Outcomes of individual complaints

Monitoring Committee Reviews

Overview
Summary of materials & activities reviewed 2003 2008
Summary of materials & activities reviewed in 2008
Outcomes of review

Appendix 1

Table 1: Source of complaints 2007/2008

Table 2: Summary of determinations finalised from 2006/2007
Table 3: Complaints received in 2007/2008
Table 4: Summary of complaint determinations in 2007/2008
Table 5: Sanctions imposed on companies
Table 6: Fines imposed on companies
Table 7: Length of time to resolve complaints
Table 8: Summary of alleged & actual breaches of the Code

1
2
3
4
5
7
7
8
8
9
10
10
11
11
12
14

18
19
20
22
23
24
25
26
31
37
199
200
201
202
210
211
212
212
213
213
214
215

Foreword
In the past year there have been many issues of significance for the members
of Medicines Australia. One of these has been a substantial increase in the
transparency of our industry through the reporting of educational events.
I am therefore pleased to present the Medicines Australia
Code of Conduct Annual Report for 2007/2008. Medicines
Australia is committed to continuous and demonstrable
improvement in industry conduct associated with member
company engagement with our many stakeholders, and also
to achieving enhanced understanding of the Code of Conduct
to which we seek absolute compliance.
Following authorisation of Edition 15 of the Code in 2007, the
Board of Medicines Australia has overseen considerable
progress toward increased transparency, culminating in the
publication of the first set of educational event reports on the
Medicines Australia website on 28 March 2008.

We acknowledge that community expectations have changed over the past few years. There
is a greater demand for transparency and accountability for a range of industry sectors,
including the pharmaceutical industry.
Publication of the first, and subsequent, educational event reports, will better enable the
public to understand the pharmaceutical industrys role in medical education. The
pharmaceutical industry takes very seriously its responsibility to provide current, accurate and
balanced information to prescribers and other healthcare professionals, and welcomes
opportunities to provide transparent information to the community on its activities.
We are now posting on our website details of how we inform and educate doctors about new
medicines and the most appropriate way to use them. We are committed as an industry to
providing up to date information about medicines to healthcare professionals, usually in their
own time, after hours and on weekends. Publication of educational event reports will enable
the community to gain an appreciation of the commitment of the industry to providing high
quality education in a range of formats, including through support to other organisations in
their independent educational activities.
I would like to take this opportunity to congratulate our Chief Executive, Ian Chalmers, and the
Medicines Australia Secretariat, for their efforts in managing and improving the Code process.

Will Delaat
Chairman

Code of Conduct Annual Report 2007/2008

Executive Summary
As the Chairmans report outlines, Medicines Australia has set a global
precedent for the innovative industry by publishing the details of medical
educational events held or sponsored by its member companies.
The transparent reporting of industry-wide activity has been
fully embraced by the member companies of Medicines
Australia.
I am proud to say that the industry successfully met the
challenge of implementing educational event reporting,
satisfying the requirement of the Australian Competition
and Consumer Commission. I expect this again to be the
case as the second reporting period closes. Educational
event reporting is now business as usual for Medicines
Australia members.
This Code of Conduct Annual Report is presented to share
with you what we have learnt through the year, encourage
increased Code compliance by companies and provide
baseline data from which future improvements can be
measured.
Reporting educational events and the associated hospitality has provided our industry with an
opportunity to review our activities. As a result, we will be making some changes.
In July 2008 Medicines Australia will commence a review of Edition 15 of the Code. I urge all
stakeholders and interested parties to contribute views and recommendations to this
scheduled triennial review constructive criticisms, comments, observations and suggestions
for improvement are all welcome.
The independent members of the Code of Conduct, Appeals and Monitoring Committees
deserve our recognition and appreciation for their commitment to the Code of Conduct
process during 2007 and 2008. Their professional expertise and active participation in the
meetings helped to ensure Medicines Australias industry self regulatory regime remains one
of the best in the world.
Finally, I thank Deborah Monk, Heather Jones and Melissa Smith the Medicines Australia
Code Secretariat who work tirelessly to ensure these Committees are always supported and
resourced in a professional, impartial, responsive and timely manner.

Ian Chalmers
Chief Executive

Code of Conduct Annual Report 2007/2008

Transparency

As has been noted by the Medicines Australia Chairman in the Foreword to this Report, in
2007/2008 the industry has made significant advances in being more open and transparent
about its conduct in interacting with health professionals in the educational sphere.
The industry has rapidly and comprehensively responded to the Australian Competition and
Consumer Commissions (ACCC) requirement for greater transparency. The industry has
recognised that the community and the ACCC expect pharmaceutical companies to be more
transparent, and therefore accountable, for their conduct in all facets of their business.
Medicines Australia members have acknowledged that there have been concerns about
whether our interactions with health professionals are conducted without inappropriate
influence. We hope that through the educational event reporting the value and
appropriateness of these activities will be recognised and understood.
It has been extremely challenging for companies to gather the required information, and it
certainly has been a learning experience for every company during this first year of
educational event reporting. We expect to see continuous improvement in the detail, form
and rigour of reporting as this activity becomes embedded as part of the usual business of an
Australian pharmaceutical company.
43 companies submitted reports of their educational activities to Medicines Australia by the
required date of 14 January 2008. One of these companies, Alphapharm Pty Ltd, is not a
member of Medicines Australia. Its report addresses interactions with medical practitioners
but not with other health professionals. In the period 1 July to 31 December 2007, 14,633
events were held or sponsored by companies, of which approximately 22% were organised by
a third party organisation and sponsored by a pharmaceutical company.
While not a requirement of the ACCC, Medicines Australia decided to appoint an independent
expert to audit the educational events reported by member companies against the
requirements of the Code of Conduct. Following a competitive tender process, Medicines
Australia engaged Deloitte Touche Tohmatsu (Deloitte) as its independent auditor. Deloitte
analysed the full dataset for the first reporting period to identify any event that was an
exception to pre-determined test criteria.
The Monitoring Committee closely scrutinised the events identified by the independent auditor
-- approximately 5% of the 14,633 educational events reported to Medicines Australia -- and
after evaluating further information provided by each company, determined that 52 events
should be adjudicated by the Code of Conduct Committee. 24 of the 52 educational events
were determined to be in breach of the Code; six appeals were lodged and heard by the
Appeals Committee. Three appeals were upheld (that is, the events were finally determined
not to be in breach of the Code).
Therefore, a total of 21 events (0.14%) were finally determined to be in breach of the Code.
The detailed reports on all 52 matters relating to educational events, including the Appeals
Committees considerations, can be found in the Complaint Determinations section of this
report.
At the time of publishing this Code of Conduct Annual Report the second educational event
reporting period has closed and companies will submit their reports by 14 July 2008.
Medicines Australia has engaged Deloitte once again to audit the reported educational events
and we will be reporting in detail the outcomes of the audit and any events that are identified
by the Monitoring Committee as requiring adjudication by the Code Committee; as well as
placing every event reported to Medicines Australia on our website by the end of September
2008.
We welcome engagement with our stakeholders as we seek to meet and hopefully surpass
your expectations for a more open, communicative and valued industry partner as we
progress.

Code of Conduct Annual Report 2007/2008

Note of Explanation

The vast majority of pharmaceutical companies who interact with healthcare

professionals and the general public do so responsibly and ethically.
Nevertheless on occasion a potential breach of the Code is
identified and a complaint is filed with Medicines Australia.
This Annual Report essentially provides a detailed
description of all complaints received, the decisions made
by the Codes adjudication Committees and any sanctions
imposed.
Medicines Australia is not the adjudicator of complaints.
The role of the Code Secretariat is to provide the
administrative support to the independent Code of Conduct,
Appeals and Monitoring Committees.
The Code of Conduct and Appeals Committees enforce the
standards set by the Code by investigating and arbitrating
on complaints and, if a breach of the Code is found,
imposing sanctions.
The Monitoring Committee proactively monitors companies conduct and has been active
during 2007/2008 in reviewing educational events identified by the independent auditor as
potentially in breach of the Code.
The members of these Committees bring extensive experience in trade practices law, public
health, general practice, specialist medicine, consumer advocacy and evaluation of the utility
of drugs in a variety of research and clinical situations. The Committees review processes are
fair, rigorous and independent of Medicines Australia or its member companies.
The complaints process is open to any company, organisation or individual. Medicines
Australia does not charge a fee to make a complaint; however, there is a fee for a company to
lodge an appeal against the findings of the Code of Conduct Committee. This fee is not
applicable to non-industry complainants who may wish to appeal a decision.
Financial sanctions imposed by the Code of Conduct Committee are paid to Medicines
Australia and used for the following purposes:
defraying the costs of the complaints and audit process particularly, to support the Code
of Conduct, Appeals and Monitoring Committees;
providing independent facilitators to assist non-industry complainants;
providing education services free seminars and presentations for any stakeholders, at no
cost;
developing and distributing Code of Conduct booklets;
developing and producing resources to promote compliance with the Code; and
public dissemination of outcomes of all complaints on the Medicines Australia website.
In 2007/2008 Medicines Australia received 83 new complaints. A summary of all complaints
finalised in this period can be found on pages 31 - 36 of this report, with the detailed
discussion of each complaint from page 37.

Deborah Monk
Director, Innovation and Industry Policy

Code of Conduct Annual Report 2007/2008

Definitions

The definitions included in this list apply only to terms used in this Annual
Report. A more extensive glossary of terms is included in Edition 15 of the
Code of Conduct.
Accommodation means a company may provide a reasonable level of expenses to enable a
healthcare professional to attend the meeting.
Advertisement means any communication which promotes or discourages the use, sale or
supply of products (whether or not in conjunction with the supply of services, and whether or
not the communication identifies particular products or services).
Australian Approved Name means the active ingredients or chemical components of a
medicine.
Brand name has the same meaning as proprietary name which is the registered trade mark
of the therapeutic product or the unique name assigned to the product.
Brand name reminder (BNR) means such items of low monetary value which are intended to
remind healthcare professionals of the existence of a product.
Complainant means an individual, organisation or company who lodges a complaint under the
Code of Conduct.
Company event is an educational event organised by a pharmaceutical company for
healthcare professionals.
Congress is an extended educational meeting usually organised by a medical society or
college, university or other non-pharmaceutical company entity.
Consumers and the general public are persons other than healthcare professionals.
Consumer Medicine Information (CMI) is information about a medicine written by the
pharmaceutical company that makes the medicine. It is easy to understand and written for
consumers.
Entertainment means the provision of any diversion or amusement.
Guidelines means the current Code of Conduct Guidelines.
Healthcare professional (HCP) includes members of the medical, dental, pharmacy or nursing
professions and any other persons who, in the course of their professional activities, may
prescribe, supply or administer a medicine.
Hospitality means the provision of food and/or beverages.
Indications mean the registered therapeutic use of a medicine as approved by the Therapeutic
Goods Administration (TGA).
International congress means a congress held in Australia where a Society or College in an
overseas country is actively organising and has joint control over the conference with an
Australian Society or College.
IFPMA means International Federation of Pharmaceutical Manufacturers and Associations.
Medical representative means a person expressly employed by a company whose main
purpose is the promotion of the companys products to healthcare professionals.

Code of Conduct Annual Report 2007/2008

Member means a company holding membership of Medicines Australia.

Minor breach is a breach of the Code that has no safety implications to the patients well being
and will have no major effect on how the medical professional will prescribe the product.
Moderate breach is a breach of the Code that has no safety implications for a patients well
being but may have an impact on how the medical profession prescribes the product.
Non-member means a company who does not hold membership of Medicines Australia
PBS means the Pharmaceutical Benefits Scheme of the Commonwealth Department of
Health and Ageing.
Patient support program means a program run by a company, with or without involvement
from a health consumer organisation, with the aim of increasing patient compliance and
positive health outcomes.
Product familiarisation program (PFP) means a program run by the company with the aim of
allowing the medical profession to evaluate and become familiar with the product.
Product Information (PI) means a document submitted to the TGA which includes the
following information: description, pharmacology, clinical trials, indications, contraindications,
precautions, adverse reactions, dosage and administration.
Promotional material means any representation concerning the attributes of a product
conveyed by any means whatever for the purpose of encouraging the usage of a product.
Repeat of previous breach is where the same or a similar breach is repeated in the promotion
of a particular product of a company which has been found in breach
Starter pack means a quantity of a product supplied without cost to medical practitioners,
dentists and hospital pharmacists. Starter packs are also referred to as samples by
healthcare professionals.
Satellite meeting is a meeting held in conjunction with international or Australasian
Congresses.
Severe breach is a breach of the Code that will have safety implications to the patients well
being, and/or will have a major impact on how the medical profession will prescribe the
product and/or will have a significant commercial impact on the relevant market. A severe
breach of the Code will also be found for activities that bring discredit upon or reduce
confidence in the pharmaceutical industry.
Subject Company means a pharmaceutical company against whom a complaint under the
Code of Conduct has been lodged.
Symposium is a meeting between a number of experts in a particular field at which papers are
presented by specialists on particular subjects and discussed with participants. Symposia
may be organised by a pharmaceutical company as separate educational events or as
satellites to another congress or conference.
Therapeutic Goods Administration (TGA) is the Division of the Commonwealth Department of
Health and Ageing that is responsible for the regulation of therapeutic goods in Australia.
Trade pack means a package of a product which is sold by the company.

Code of Conduct Annual Report 2007/2008

Committees and Secretariat

The administration of the Code is supervised by the Code of Conduct

Committee. The Code of Conduct Committee has the power to make a
determination as to a breach of the Code, and impose sanctions. The right of
appeal is available to both the Complainant and Subject Company. An appeal
is heard by the Appeals Committee which has the power to confirm or
overturn the decision.
Committee Member Biographies

Brief biographies for all Code, Appeals and Monitoring Committee members are available on
the Medicines Australia website http://www.medicinesaustralia.com.au/pages/page96.asp

Code of Conduct Committee

Full Members (Voting rights)

Independent Lawyer (Chairman) selected from a panel of six trade practices lawyers

Australian General Practice Network (AGPN)

Australian Medical Association (AMA)
Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists
(ASCEPT)
Consumers Health Forum of Australia (CHF)
Royal Australasian College of Physicians (RACP)
Royal Australian College of General Practitioners (RACGP)
Therapeutic Goods Administration (TGA)
Medicines Australia Association Representatives (maximum 3)
Medicines Australia Medical/Scientific Directors (maximum 2)

Representatives nominated by:

Observers (No voting rights)

Medicines Australia member companies employees (maximum 2)

Observer nominated by Medicines Australia (maximum 1)

Advisors (No voting rights)

Secretary, Code of Conduct Committee

Medicines Australia officer responsible for Scientific and Technical Affairs
Medicines Australia Chief Executive Officer

Appeals Committee
Full Members (Voting rights)

Independent Lawyer (Chairman) selected from a panel of six trade practices lawyers

The College and/or Society associated with the therapeutic class of the product subject to
appeal
The target audience to which the activity was directed eg: AMA, RACGP, AGPN
Consumers Health Forum of Australia (CHF)
Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists
(ASCEPT)
Medicines Australia Association Representatives (maximum 2)
Medicines Australia Medical/Scientific Director (maximum 1)

Representatives nominated by:

Advisors (No voting rights)

Secretary, Code of Conduct Committee

Medicines Australia Chief Executive Officer or delegate

Code of Conduct Annual Report 2007/2008

The Monitoring Committee proactively monitors selected promotional material,

information available to the general public/patients and company activities.
The Monitoring Committee is empowered to seek further information from the
pharmaceutical company and where not satisfied with the explanation refer
the matter to the Code of Conduct Committee for a determination of a
potential breach of the Code.
Monitoring Committee
Permanent Members

Consultant with industry experience in marketing and knowledge of the Code of Conduct
(Chairman) selected from a panel of two people

Representatives nominated by:

Royal Australian College of General Practitioners (RACGP)

Australian Medical Association (AMA)
Consumers Health Forum of Australia (CHF)

Rotating Members

One representative of the College and/or Society from the therapeutic class being
reviewed
Medicines Australia Medical/Scientific Director (maximum 1)
Medicines Australia Marketing Director (maximum 1)

Advisors

Secretary, Code of Conduct Committee

Medicines Australia officer responsible for Scientific and Technical Affairs

Conflict of Interest

A person must not have a conflict of interest with the therapeutic area/s or company/ies
against which a complaint has been lodged or with the Complainant. This also extends to
financial or perceived bias with any of the matters being considered at the meeting which they
have been invited to attend.
In addition to the requirement to disclose a direct or indirect pecuniary interest in a matter
about to be considered in a meeting of any Committee, members should also disclose a
conflict of interest if a reasonable third party would conclude that there was a likelihood that a
member of the Committee may be influenced in reaching a decision by factors other than the
merits of the case.

Code Secretariat

The Code Secretariat at Medicines Australia means the staff within Medicines Australia with
responsibility for Code and related matters.

Ms Deborah Monk
Ms Heather Jones
Ms Melissa Smith

Director, Innovation and Industry Policy

Manager, Code of Conduct & Secretary, Code Committee
Code Administration Officer (Part time)

The Code Secretariat has responsibility for:

Providing advice to healthcare professionals, members of the general public,
pharmaceutical companies or agencies on Code related matters;
Providing educational seminars, training and briefings to companies and other
stakeholders; and
Providing the administrative support to the Code, Appeals and Monitoring Committees.

Code of Conduct Annual Report 2007/2008

Meeting Schedules
Code of Conduct Committee Meetings
Code of Conduct Committee meetings are held on the third Monday of each month. A list of
meeting dates is available from the Medicines Australia website at
http://www.medicinesaustralia.com.au/pages/page114.asp
A meeting of the Code Committee requires a quorum of six full members, two of which must
be representatives from Medicines Australia and one of which must be a representative of the
Australasian Society for Clinical Experimental Pharmacologists and Toxicologists (ASCEPT).
The Committee held 12 meetings in 2007/2008. As shown in Figure 1, the vast majority of
committee members attended all the meetings.

Figure 1: Code of Conduct Committee Meeting Attendance in 2007/2008

Base: All Permanent Members (n=8)

Chair (n=12)

Number of meetings attended

AGPN (n=10)
AMA (n=12)
ASCEPT (n=12)
CHF (n=12)
RACGP (n=12)
RACP (n=12)
TGA (n=12)
0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Attendance

Code of Conduct Annual Report 2007/2008

Appeals Committee Meetings

Appeals Committee meetings are organised on an as needs basis.
A meeting of the Appeals Committee requires a quorum of three full members, one of which
must be a representative from Medicines Australia. The Committee held 12 meetings in
2007/2008. As shown in Figure 2 , the vast majority of committee members attended all the
Appeals Committee meetings

Figure 2: Appeals Committee Meeting Attendance in 2007/2008

Number of meetings attended

Base: All Permanent Members (n=5)

Chair (n=12)

ASCEPT (n=12)

CHF (n=10)
GP Representative
(AGPN/AMA/RACGP) (n=12)
Specialist-relevant College or
Society (n=12)
0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Attendance

Monitoring Committee Meetings

Monitoring Committee meetings are held on the third Monday of each month. A list of meeting
dates is available from the Medicines Australia website at
http://www.medicinesaustralia.com.au/pages/page114.asp
There is no specified quorum for this Committee. The Committee held 11 meetings in
2007/2008. Please see page 200 for information on the reviews conducted during the year.

Code of Conduct Annual Report 2007/2008

10

Promoting Understanding
of the Code
Medicines Australia has continued to be an active member of the International
Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code
Compliance Network (CCN).
These gatherings present an important opportunity for collaborative communication and
education on ethical and policy issues at the international level. The CCN meetings provide
an occasion to hold an informed debate on the challenges and potential of self-regulation in
the field of ethical promotion of pharmaceutical medicines.
July 2007
Ms Deborah Monk, Director Innovation and Industry Policy was a speaker at the Asia Pacific
training seminar held in Singapore. This group is focusing on compliance issues within the
region and Medicines Australia is pleased to be able to demonstrate leadership in
implementation of self-regulation.
May 2008
Ms Monk and Ms Donna Edman, Executive Director Public Affairs, participated in the Fifth
CCN Conference in Montreal, presenting on Transparency and Accountability: Medicines
Australia Event Reports and the Compliance Continuum.

Code Education in Australia

As a service to pharmaceutical companies and organisations working with the industry

Medicines Australia provides free training and educational opportunities to aid understanding
of and compliance with the Code.
Informal advice on the Code
Many requests for informal guidance and advice on the Code were received in 2007/2008.
The written and verbal requests came from member and non-member companies, healthcare
professionals, consumer organisations, members of the public, the media and agencies
working in the healthcare sector (advertising, PR and event organisers).
Training on the Code
In 2007/2008 Medicines Australia staff participated in 57 training or education sessions with a
total audience of 1311 people (See Table A).
Table A: Code Education 2007/2008
Audience
Member Company

Number of events

Number of attendees

10

359

Non-member Company

15

External advertising & PR agencies, event

organisers, software producers

24

164

Healthcare professionals

Health Consumer Organisations

25

Australian briefings, seminars & conferences

14

649

International seminars & conferences

96

57

1311

Code of Conduct Annual Report 2007/2008

11

Medicines Australia Website

Code of Conduct
The Medicines Australia website is a useful source of information on the Code and related
activities. Figure 3 provides a detailed account of information downloaded from the Code
website during 2007/2008.

Figure 3: Web downloads in 2007/2008

Base: All downloads

100%
90%

8%

7%

13%

28%

80%

20%

49%

70%
60%

20%

34%

24%

20%

20%

25%

28%

50%

49%

25%

5%

41%

23%

50%
89%
40%
30%

83%
69%

21%

73%
63%

20%
10%

48%

74%

66%
49%

17%

0%

Code of Conduct Edition 15

Code of Conduct Reports
Code of Conduct Committee Meeting dates
Frequently Asked Questions
Complaints Submission Form

Code of Conduct Annual Report 2007/2008

Code Guidelines to Edition 15

Guidelines for Determining Code Sanctions
Committee Membership
Responding and lodging a complaint

12

Medicines Australia Website

Educational Event Reports
The July December 2007 Educational Event Reports were published on the Medicines
Australia website in March 2008. Figure 4 provides a detailed account of downloads from this
section of the website in the period March June 2008.
Figure 4: Downloads from Educational Event Reporting webpage
Base: All downloads from March 2008 to June 2008
100%
90%
80%

33%

70%

52%
65%

60%

70%

50%
5%

40%
39%

30%

5%

20%

5%

25%

10%
10%

7%

March,2008 (n=5837)

April,2008 (n=3401)

0%

14%

11%

May,2008 (n=2773)

June,2008 (n=2428)

Auditor's Report

Member Company Reports

Non-Member Company Reports

Glossary

Frequently Asked Questions

Code of Conduct

Media

Useful Links

Report
Auditors Report
Member Company Reports 30,000
Non-Member Company Reports
Glossary
Frequently Asked Questions
Code of Conduct
Media
Useful Links

Code of Conduct Annual Report 2007/2008

13

Continuing Education Program (CEP)

Medicines Australias Continuing Education Program (CEP) is designed to educate company
representatives to a recognised industry standard in order to provide healthcare professionals
with accurate, balanced information in an ethical manner that will enhance the quality use of
medicines.
The CEP is offered in distance learning and online modalities through UQ Health Insitu which
is the life long learning arm of the Centre for Health, Innovation and Solutions (CHIS). CHIS is
a centre of the University of Queenslands Faculty of Health Sciences. The course is tailored
for adult learning and designed to provide flexibility for participants in full time employment.
The CEP Programs are:
Program 1
The Medicines Australia Code of Conduct - ethical practices within the pharmaceutical
industry, including the obligations and practices of companies in their relationship with the
health care industry and the public;
Program 2
The Pharmaceutical Industry - the historic development of the industry, government regulatory
processes and the industry's role in the Australian health care system;
Program 3
An Introduction to Pharmacology - pharmacokinetics and pharmacodynamics, how drugs are
administered, transported through the body and absorbed;
Program 4
Understanding Product Information - an overview of the scientific, medical and therapeutic
information contained in Product Information, including how the information is structured to
comply with Therapeutic Goods Administration requirements; and
Program 5
Understanding Clinical Trials and Scientific Literature - a systematic approach to the analysis
of published clinical papers, including how clinical trials are designed and conducted, and the
four phases of clinical trials.
2008 saw the introduction of a new program Introduction to the Human Body. This program
introduces the student without prior knowledge of human biology to the foundational biological
principles of the human body and an introduction to medical terminology. This program is a
pre-requisite for An Introduction to Pharmacology.
For more information or enrolment
http://ma.healthinsitu.uq.edu.au

details,

please

visit

the

CEP

website

at

CEP Evaluation
Each person enrolled in the CEP is asked to complete an evaluation form. Medicines Australia
is pleased that the majority of students undertake this task with the overall satisfaction rate
over 98.2%.
Overall Student Satisfaction*

Exceeded expectations 33%

Met expectations 67%
Did not meet expectations 1.8%

*Totals may not add up to 100% due to rounding in the original data

Code of Conduct Annual Report 2007/2008

14

CEP Enrolments in 2007/2008

Figure 5 shows the number of enrolments in Semester 2, 2007. Please note some candidates
may be enrolled in more than one program in the Semester, for example Programs 1 and 2.

Figure 5: Semester 2, 2007 CEP Enrolments

Base: All enrolments in Semester 2, 2007 (n= 1529)

Program 1

478

Program 2

311

Program 3

266

Program 4

242

Program 5

232

100

200

300

400

500

600

Number of enrolments

Figure 6 shows the enrolments in Semester 1, 2008. Please note some candidates may be
enrolled in more than one program in the Semester, for example Programs 3 and 4).

Figure 6: Semester 1, 2008 CEP Enrolments

Base: All enrolments in Semester 1, 2008 (n= 1466)

Program 1

423

Program 2

310

Program 3

302

Program 4

225

Program 5

206

50

100

150

200

250

300

350

400

450

Number of enrolments

There were 99 enrolments in the new Human Biology program in Semester 1 2008.

Code of Conduct Annual Report 2007/2008

15

CEP Awards 2007

The CEP Awards for 2007 (students
enrolled between January and December
2007)
were
presented
at
the
AusPharma08 Conference in April 2008
by:
Professor Robert Hendy (left in photo)
Director, Health Insitu, University of
Queensland; and
Mr Will Delaat (right in photo), Chairman
Medicines Australia.

UQ Health Insitu Active Learning Prize

This prize is based on the level and quality of participation in group discussions and personal
reflections in online tutorials. The awards were presented by Professor Robert Hendy.
UQ Health Insitu Active Learning Prize Semester 1

Ms Iris Depaz GlaxoSmithKline Australia

UQ Health Insitu Active Learning Prize Semester 2

Ms Lisa Croker CSL

2007 CEP Certificate of Excellence

The winners of this award are the students who achieve the 10 highest aggregate marks for
the five programs (out of a possible total aggregate of 500). The awards were presented by Mr
Will Delaat.

Ms Tammy Alabakis Alphapharm

Ms Michelle Campbell GlaxoSmithKline
Ms Sinead Doran AstraZeneca
Ms Diane Gray Abbott Australasia
Ms Lisa Jenyns Bristol Myers Squibb
Ms Alana Joy AstraZeneca
Ms Emily McKneil AstraZeneca
Mr Andrew Moore Nycomed
Mrs Navneet Sehmi Bristol Myers Squibb
Ms Rebecca Wagemaker Schering Plough

2007 Code of Conduct Award

To be eligible for this award a student must achieve a final mark of 100% for the Code of
Conduct Program. From those achieving this outstanding result, the winner is determined by a
UQ panel through a review of learning log books and the candidates online participation. The
awards were presented by Mr Will Delaat.
The 2007 award was presented to two candidates who both achieved outstanding results and
participation.

Mr Adrian Desfontaines Merck Sharp & Dohme Australia

Mr Ryan Chang AstraZeneca

Code of Conduct Annual Report 2007/2008

16

2007 CEP Award Recipients at AusPharma08

BACK ROW: Ms Rebecca Wagemaker (Schering-Plough), Mr Andrew Moore (Nycomed),

Ms Emily McKneil (AZ), Professor Robert Hendy (Health Insitu), Mr Will Delaat (Chairman
Medicines Australia), Ms Tammy Alabakis (Alphapharm), Mr Ryan Chang (AZ),
Mr Adrian Desfontaines (MSD)
FRONT ROW: Ms Alana Joy (AZ), Ms Sinead Doran (AZ), Ms Michelle Campbell (GSK),
Ms Lisa Croker (CSL)

Code of Conduct Annual Report 2007/2008

17

Complaints Process
Rights

The rights of pharmaceutical companies, healthcare professionals and members of the

general public are recognised, including the right to lodge a complaint and the right to an
impartial decision. Where anonymity by a healthcare professional or member of the general
public to the pharmaceutical company has been requested, this will be respected. However,
anonymous complaints to the Secretariat will not be accepted.
The complaints process is free of charge.
A Complaints Submission Form for non-industry complainants can be found at:
http://www.medicinesaustralia.com.au/pages/page34.asp
Complainants and the Subject Company have the right to appeal a decision of the Code of
Conduct Committee. The appeals process is free of charge for non-industry appellants;
however a pharmaceutical company must lodge an appeal bond of $20,000 when lodging an
appeal.
Complaints and appeals are considered in a transparent, equitable, objective and unbiased
manner by the Code of Conduct and Appeals Committees. The complaints handling process
will reflect the principles of natural justice and procedural fairness.

Accessibility

The complaints process is readily accessible to pharmaceutical companies, healthcare

professionals and members of the general public. An Independent Facilitator is available to
assist non-industry complainants.
Where a complaint falls outside the jurisdiction of Medicines Australia the matter will be
referred to the most appropriate alternate body.

Timeframe

The complaints handling process will be responsive and target times for handling complaints
have been set down in the provisions of the Code of Conduct. The Complainant and Subject
Company will be informed of all decisions and provided with an extract of the minutes
pertaining to their particular complaint.

Reports

The outcomes of all finalised complaints are published on the Medicines Australia website in
quarterly and annual reports. Complaints where the activity is directed towards the general
public will be published on the Medicines Australia website within one month of the finalisation
of the complaint (the outcomes are also published in the next quarterly or annual report).

Where to find assistance

If you need any assistance understanding the complaints process or the Code, you can
contact Medicines Australia on 02 6122 8500 or via email at
[email protected]
Guidance documents:
Lodging a Complaint non-industry complainant
Responding to and lodging a complaint pharmaceutical industry
http://www.medicinesaustralia.com.au/pages/page34.asp

Code of Conduct Annual Report 2007/2008

18

Analysis of Complaints
This section of the Code Annual Report provides information on the source of
complaints, outcomes from the determination of complaints and sanctions
imposed by the Code of Conduct and Appeals Committees.
Source of Complaints

In 2007/2008 83 new complaints were received by Medicines Australia. As shown in Figure 7,

the majority of complaints received in 2007/2008 were submitted by the Medicines Australia
Monitoring Committee (64%, n=53). Nearly a quarter of the complaints were lodged by
Medicines Australia member companies (24%, n=20). 6% of complaints were submitted by
healthcare professionals [general practitioners (n=1), doctor in a hospital (n=1), and academic
(n=3)] and 5% of complaints were received from organisations such as the Therapeutic
Goods Administration (n=2), a hospital (n=1) and a consumer organisation (n=1). One
complaint was received from a company representative. (See Table 1 in Appendix 1 for
details)

Figure 7: Source of complaints 2007/2008

Base: All complaints (n=83)
Others (n=1)
Organisations (n=4)

Healthcare Professionals
(n=5)

Pharmaceutical Company
(n=20)

Medicines Australia
Monitoring Committee
(n=53)

Code of Conduct Annual Report 2007/2008

19

Complaint Determinations
Complaints carried forward from 2006/2007
Five complaints received in 2006/2007 were finalised in 2007/2008. As shown in Figure 8,
three out of the five complaints were found not in breach of the Code. One complaint was
found to be in breach of all aspects (n=1) and one complaint to be in breach of some aspects
(n=1) of the Code.

Figure 8: Complaints carried forward from 2006/2007 (n=5)

Where all aspects
of a complaint were
found to be in
breach (n=1), 20%

Where no aspects
of a complaint were
found to be in
breach (n=3), 60%

Where some
aspects of a
complaint were
found to be in
breach (n=1), 20%

Of the five complaints received in 2006/2007 and finalised in 2007/2008, one outcome was
appealed and referred to the Appeals Committee for a final determination. No aspects of the
appeal were upheld by the Appeals Committee; however the fine was reduced from $120,000
to $110,000 (See Table 2 in Appendix 1).

Code of Conduct Annual Report 2007/2008

20

Complaints received in 2007/2008

Of the 83 new complaints received by Medicines Australia, 75 complaints were considered in
2007/2008.
One (n=1) new complaint was referred back to the complainant for further
information (See Table 3 in Appendix 1).
Each complaint is usually made up of several different aspects, where the complainant
alleges that certain statements or claims in the materials or a companys conduct are in
breach of one or more sections of the Code. Each element of the complaint is considered and
a decision made. Thus, in many complaints there may be decisions where some aspects are
found in breach and other aspects not in breach.
Of the remaining 74 complaints, 71 were finalised in 2007/2008 (three complaints considered
by the Code of Conduct Committee late in 2007/2008 were deemed not finalised as the
complainants and Subject Companies had not had sufficient time to advise of any appeal). As
shown in Figure 9, nearly half of the complaints (48%) were found not in breach of the Code.
Of the 37 complaints found in breach, 34 were found in breach of some aspects (48%) and 3
complaints were found to be in breach of all aspects (4%) of the Code.

Figure 9: Complaints received and finalised in 2007/2008 (n=71)

Where all aspects
of a complaint were
found to be in
breach (n=3), 4%

Where no aspects
of a complaint were
found to be in
breach (n=34), 48%

Where some
aspects of a
complaint were
found to be in
breach (n=34), 48%

15% (n=11) of Code of Conduct Committee determinations pertaining to complaints received

in 2007/2008 were appealed. In the majority of cases (n=8) no aspects of an appeal were
upheld by the Appeals Committee. In three (n=3) cases, all aspects of an appeal were upheld
(See Table 4 in Appendix 1).

Code of Conduct Annual Report 2007/2008

21

Sanctions

Figure 10 provides a snapshot of sanctions imposed by the Code of Conduct and Appeals
Committees on companies found in breach of the Code. A financial penalty (fine) was the
most common sanction imposed on companies found in breach of the Code (See Table 5 in
Appendix 1).
Note that the requirement to withdraw and cease using materials/activity found in breach, can
only apply to materials that might otherwise be used again. It cannot be required for an activity
that has already taken place and is not continuing, such as an educational event.

Figure 10: Sanctions imposed by the Code and Appeals Committees on companies with
complaints found in breach and finalised in 2007/2008 (n=42)
Fines

Withdraw/cease using material/activity found in breach

Corrective Letter/Corrective Advertisement 1

Other (eg. Update internal review processes)

31

0
Complaints finalised from 2006/2007 (n=5)

10

15

20

25

30

35

Complaints received and finalised in 2007/2008 (n=37*)

The number of sanctions may not add up to the number of complaints as a single complaint could be in breach of multiple sections of
the Code and therefore could attract multiple sanctions.

Fines

Figure 11 shows the financial penalties imposed on companies found in breach of the Code.
One-third of all fines (n=11) were between $ 50,000 and $75,000 in 2007/2008 (See Table 6
in Appendix 1). In 2007/2008 the Code of Conduct Committee imposed two fines of $175,000
and $200,000 which are the highest fines so far imposed.

Figure 11: Fines imposed by the Code and Appeals Committees on companies with
complaints found in breach and finalised in 2007/2008 (n=33)
$150,000 - $200,000

$100,000 - $149,999

$75,000 - $99,999

$50,000 - $74,999

10

$25,000 - $49,999

$0 - $24,999

10

12

Number of Complaints

Complaints finalised from 2006/2007

Code of Conduct Annual Report 2007/2008

Complaints received and finalised in 2007/2008

22

Complaints Resolution Timeframe

Complaint resolution time is measured from the date a complaint is received at Medicines
Australia to the date of the Code of Conduct or Appeals Committee meeting. Most complaints
are lodged on, or close to, the cut off date for the next Code of Conduct Committee meeting. If
the cut-off date is missed by the complainant this extends the timeframe as the complaint is
referred to the next Code of Conduct Committee meeting.
As shown in Figure 12, the average time taken to resolve a complaint is 26 working days.
However, complaint resolution ranged from 16 working days (shortest) to 104 working days
(longest). Where a complaint is subject to appeal, the average time to resolve is increased to
55 working days (See Table 7 in Appendix 1).

Figure 12: Length of time to resolve all finalised complaints in 2007/2008

Base: All complaints finalised in 2007/2008 [n= 76 (5 from 2006/2007 and 71 in 2007/2008)]

Shortest time for all complaints

16

Average time for all complaints

26

Longest time for all complaints

104

Average time for all complaints not subject to

appeal

20

Average time for all complaints subject to appeal

55

20

40

60

80

100

120

Time (working days)

Code of Conduct Annual Report 2007/2008

23

Alleged and actual breaches of Code Sections 2007/2008

In 2007/2008 there were 304 separate allegations of a breach of the Code in the 71
complaints finalised by the Code of Conduct Committee. Nearly one-third of the allegations
were found to be in breach (32%, n=102). Figure 13 provides a snapshot of the alleged and
actual breaches by sections of the Code.
Around one-third of all alleged breaches related to either Section 10 (37%, n=112) or Section
6 (35%, n=107) of the Code. Just over one-fifth of all alleged breaches related to Section 1
(22%, n=66) of the Code (See Table 8 in Appendix 1).

Figure 13: Alleged and actual breaches of Code Sections 2007/2008

Base: All complaints finalised in 2007/2008 (n=71)

Section 12 1
Section 10

20

Section 9

92

Section 8
Section 7
Section 6

81

26

Section 5
Section 4 2
Section 3

5 1

Section 2
Section 1

36
0

10

20

30
30

40

50

60

70

80

90

100

110

120

Alleged Breaches (numbers)

Breach

Code of Conduct Annual Report 2007/2008

No Breach

24

Educational Event Reports

In June 2007, the Australian Competition Tribunal handed down its decision in
relation to the Australian Competition and Consumer Commissions condition
applying to the 15th edition of the Medicines Australia Code of Conduct.
The condition required detailed disclosure of every education event conducted by, or
sponsored by, Medicines Australia member companies. Companies were required to report
on a six-monthly basis:
July December, with company reports required by 14 January and publication on the
Medicines Australia website by 31 March
January June, with company reports required by 14 July and publication on the
Medicines Australia website by 30 September

Review of Educational Event Reports (July December 2007)

Reports received by Medicines Australia
42 member company reports
& I non-member company report

Reports provided to Deloitte

Used forensic accounting techniques and self
organising maps to analyse the data

Educational events which exceeded the

thresholds were forwarded to the Monitoring
Committee for review

The Monitoring Committee reviewed the reported

events and made recommendations on each
issue/matter

Review and take no further action

Review & request further information from the

company

Review additional
material and take no
further action

Outcomes Summary
14,633 educational events were reported for
the six months ending 31 December 2007
221 international events 48 sponsored and
173 organised by a company
14, 412 events held in Australia 3,136
sponsored and 11,276 organised by the
company
951 events forwarded to the Monitoring
Committee
Requests for further information in relation to
312 events
52 events forwarded to the Code of Conduct
Committee
21 events found in breach of the Code
6 appeals 3 upheld

Code of Conduct Annual Report 2007/2008

Review additional
material and forward to
the Code Committee
as a formal complaint
matter dealt with via
the normal process

Complaints considered
by the Code
Committee 52
Outcomes provided in
this report

Appeals considered by
the Appeals
Committee 6
Outcomes provided in
this report

25

Review of Educational
Event Reports

Prior to considering the 52 educational event complaints, members of the

Code of Conduct Committee deliberated on a range of issues that may
influence the decision making process. This discussion should be read in
association with the determinations in relation to the events forwarded to the
Code of Conduct Committee (See list of complaints on pages 31 - 36)
Professional expectations, standards and scrutiny
The Committee put forward a number of views in relation to the appropriate level of hospitality
for healthcare professionals when attending educational events and the expectations of the
healthcare professionals.
Members commented that what physicians think is reasonable may not necessarily match the
general publics perception of what is reasonable.
All members of the Committee were cognisant of the busy schedule of Australian healthcare
professionals, whether general practitioners or specialists. Members agreed that it is
important that all healthcare professionals maintain their professional development and keep
up to date with current research and development, changes in clinical management and have
the opportunity to discuss case studies and patient management with their colleagues.
Members were of the view that while the type of education provided and the needs may differ,
continuing professional education is equally important for all healthcare professionals,
including solo GPs, rural doctors and specialists.
Members commented that the transparency of interactions between pharmaceutical
companies and healthcare professionals is the driver for the educational event reporting and
all companies must ensure that internal company policies and procedures regarding Code
compliance with the Code are developed and adhered to.
Members debated whether Medicines Australia should set a maximum level of expenditure on
hospitality provided per attendee at an educational event. However members concluded that
the Committees task is to interpret the Code of Conduct as it stands, which does not include
any monetary limits. Further, the proportionality between hospitality and education provided
and how this would be perceived by an independent external observer is primarily important.
Members made the following comments:
The vast majority of educational events provided by companies provide quality education;
Healthcare professionals attend events in their own time, often coming directly from their
workplace (hospital or practice) to the educational event or giving up time with their
families or limited recreational time;
It is not reasonable to expect a person who has been working since the morning to attend,
and actively participate and learn, at an event which concludes at 9.00pm without
refreshments. It is acceptable to provide food and beverages prior to, or during an
evening educational event or during a multi-day event.
Natural breaks during an event, for example lunch or dinner, create opportunities for
interaction between attendees. This interaction is most commonly related to the practice
of medicine; and
Healthcare professionals are not captive learners and if an educational program and
learning environment do not suit their needs they will not attend events. Healthcare
professionals often choose educational events that fill an educational need. They are
often hostile or disparaging to events that are promoting a companys products.

Code of Conduct Annual Report 2007/2008

26

Overall, members confirmed that it is acceptable to fund educational events but any
associated hospitality should not be excessive or extravagant. Members discussed the
meaning or interpretations by various audiences of what is excessive, extravagant or lavish.
The Collins dictionary definition of extravagant means spending money excessively or
immodestly; going beyond usual bounds; unrestrained; ostentatious; showy; exorbitant in
price; overpriced.
As discussed in other sections of the minutes, many factors should be taken into
consideration when evaluating the components of an educational event:
Appropriateness of the venue whether it is conducive to education and learning;
Duration and quality of the educational component;
Cost of food and beverages appropriate balance with educational component; and
Other costs, for example accommodation number of nights accommodation appropriate
and necessary to achieve the educational objective.
Public perception of educational events
The Committee accepted that the public acceptability of the costs associated with an
educational event may be at odds with the views of healthcare professionals. However,
members were also of the view that the majority of patients would want their doctor to be well
informed and up to date with current medical knowledge and the range of available treatment
options.
In considering what is an appropriate level of hospitality a member of the public earning the
basic wage would probably form the view that a meal that cost $120 per head was
extravagant as this would equate to a significant portion of their weekly income. However
other members of the public may also accept that the audience at these events are
professionals and it was acceptable to provide hospitality costing $120 per head if they were
being educated appropriately. What is appropriate will always be subjective.
The Committee was aware that decisions made at this meeting may not meet expectations of
some members of the public. Members agreed that public perception does matter and the
industry cant ignore this. However each case before the Committee must be considered on its
merits and against a range of factors.
Influence
The Committee discussed what constitutes the fundamental mischief potentially arising from
companies holding or sponsoring educational events that should be avoided. The most
important outcome should be that, when a healthcare professional prescribes a medicine, the
decision is based on the clinical evidence and made in the best interest of the patient. There
should not be anything in a prescribers mind other than the potential benefit of a medicine for
a patient. If a benefit (hospitality etc) provided by a company is of such significance that it will
influence a doctor to make an inappropriate or harmful decision for a patient, this would be
inappropriate.
Members understood that healthcare professionals will access information from a range of
sources, including competing pharmaceutical companies and independent third parties or
medical publications. Several members of the Committee questioned whether influence is
always negative. If balanced and appropriate information is provided to healthcare
professionals they will continue to make informed and appropriate prescribing decisions for
patients.
Members were of the view that the intent of the Australian Competition Tribunal (ACT) and the
Australian Competition and Consumer Commission (ACCC) requirements for reporting of the
details of educational events was that greater transparency would expose any inappropriate
influence of health professionals through the provision of hospitality and other benefits and
lead to positive changes in industry conduct.

Code of Conduct Annual Report 2007/2008

27

Hospitality
Definitions
The Code of Conduct defines hospitality as the provision of food and/or beverages.
The ACCC and ACT intended hospitality to include the provision of food and beverages,
travel, accommodation and entertainment, which are required to be disclosed in the event
report table.
What must be reported by a company?
Description of the function, including duration of the educational component
Name of the venue
Professional status of the attendee
Hospitality provided
Total cost of the hospitality
Number of attendees
Total cost of the function
Sections of the Code relevant to hospitality
The Monitoring Committee asked that companies respond to the educational event complaints
under the following sections of the Code. Not all sections were applicable to all complaints.

6.2

Hospitality

6.2.1

Any hospitality provided by companies either directly or by sponsorship or assistance

to the organisers of educational meetings, must be secondary to the educational
purpose.

6.2.2

For educational meetings directly organised by, and the responsibility of companies,
all hospitality must be consistent with the professional standing of the delegates.
Meals provided at an educational meeting should not be extravagant or exceed
standards which would meet professional and community scrutiny. No entertainment
should be provided.

6.6

Venue Selection

10.2

Educational meetings organised by or the responsibility of companies must be held in

venues suitable for the attainment of the primary objective of enhancing medical
knowledge and the quality use of medicines in Australia. The choice of venue must
be able to successfully withstand public and professional scrutiny and conform to
professional and community standards of ethics and good taste.

Hospitality

Any hospitality offered by companies to healthcare professionals must be secondary

to the educational content, provided in an environment that enhances education and
learning and reflect the professional standing of the audience. The venue and
location at which a company provides hospitality to healthcare professionals must be
conducive to education and learning and must not be chosen for its leisure or
recreational facilities. Meals provided by companies at an educational meeting
should not be extravagant or exceed standards which would meet professional and
community scrutiny.
A company must not subsidise or pay for the costs of family or companions of
attendees at educational meetings.

Taxes, surcharges, gratuities and other costs

Members were of the view that the intent of the ACT decision and the ACCC was to focus on
the actual benefits provided to a healthcare professional.
The Committee was aware of the difficulties in comparing costs between companies. The
Committee decided that the most appropriate comparison was the cost excluding taxes and
other service costs.

Code of Conduct Annual Report 2007/2008

28

Within Australia reportable costs are exclusive of GST. When providing hospitality in a country
outside Australia the applicable taxes and surcharges vary and can add more than 20 percent
to the cost. Hospitality should be judged taking into consideration the value to recipients, not
just by the monetary cost. Members also commented that following the finalisation of these
complaints further guidance should be provided to all companies.
Number of attendees
Members noted that there was some discrepancy in the interpretation of the number of
attendees to be stated in the educational event reports. Some companies had advised that the
cost per head for hospitality appeared higher because there had been no shows. The
Committee agreed that it would review complaints on the basis of costs attributed to the
confirmed number of attendees (that is, the number of health professionals who had advised
the company that they would be attending). This would allow the most appropriate
assessment of the cost and the most appropriate way to compare events.
Food and/or beverage costs
All members were of the view that the cost of food and beverages per head should not be
considered in isolation and concurred that it was not appropriate to apply fixed limits to the
cost of hospitality provided. There are many elements to each complaint about an educational
event and each event should be considered on its merits, which includes a range of factors
such as the purpose of the event, the quality of the presenter and the materials as well as the
duration of the educational component would be taken into consideration.
While acknowledging the suggestion that the industry should set a firm limit on expenditure for
food and beverages at an educational event, the Committee reaffirmed the view that
hospitality should not be considered in isolation. It was also noted that there will be a
difference in cost between an individual or small private group eating at a restaurant/hotel and
that charged to a pharmaceutical company holding a conference or large event at the same
venue. Companies are regularly charged for room hire, alternate menu plating and other
surcharges which increase the cost per head. For example, while the actual cost of food and
beverages per head (which is the benefit to the healthcare professional) might be $80.00, the
cost per head charged to a company including the other charges may increase to $100.00.
Members also noted that costs around Australia will vary and costs attributed to international
events will vary greatly depending on the country and exchange rate at the time.
Accommodation
Members noted that the cost of hotel accommodation within Australia will depend on the city
or town and what other events might be held at the same time. In the case of major
international conferences where a large number of people from around the world attend
(some conferences have 11,000 delegates), hotels in the city will increase their room rates
significantly from the regularly advertised price per night, and the cost can rise substantially in
response to demand as the date of the event becomes closer. The Committee also noted that
the cost of a hotel room in Europe is often significantly higher than in Australia and
accommodation costs will vary from country to country.
Quality of Education
Members were unanimous in their comments that educational events held or sponsored by a
pharmaceutical company must provide a high standard of education and support the quality
use of medicines. The quality of educational events may vary between international and local
events.
Duration of educational component and accommodation and/or travel
The Committee debated what is a reasonable number of nights accommodation to be
provided in relation to the duration of an educational event? Members expressed the view
that this must be considered on the basis of the location, time required to travel to the venue
and the place of origin of attendees.
Where the educational component for a weekend meeting is scheduled only in the morning
session on each day of the event, several members of the Committee recommended that
companies should consider starting later on the first day of the event and allow less free time

Code of Conduct Annual Report 2007/2008

29

in the afternoon. This would enable the majority of attendees to fly in on the morning of the
first day rather than the night before and therefore would not require accommodation.
Members also commented that the Monitoring Committee had reviewed invitations on an
annual basis since 2003 and provided advice to companies, particularly on the hours of
education expected for weekend events.

Code of Conduct Annual Report 2007/2008

30

Complaint Determinations
Table 2: Code of Conduct Complaints July 2007 June 2008

This table provides a summary of each complaint finalised in 2007/2008. To view the detailed
report on each complaint please click on the complaint number.
Information on the provisions of the Code (Sections) can be accessed at:
http://www.medicinesaustralia.com.au/pages/page16.asp
Complaint
Number

Subject
Company

Material
Activity

Product

Complainant

Outcome
(Sections of the
Code where one
or more
breaches found)

Complaints received in 2006/2007 and finalised in 2007/2008

870
AstraZeneca
Information to
the general
public

Choice

No Breach 9.4

N/A

871

GSKA

Media release

Roche

No Breach 12.1.1

N/A

872

Roche

Media releases

GSKA

Following appeal:
Breach 1.1,
1.3.1, 9.2.1,
9.2.4, 9.3, 9.4

Tykerb

Sanction

Following appeal:
Remove media
releases from
website
Fine $110,000

No Breach 1.5,
9.6, 9.6.1, 9.6.4,
9.10
GSKA no breach
12.3
873

GSKA

Promotional
material

Seretide

AstraZeneca

Breach 1.1, 1.2.2,

1.3, 1.7

874

Mundipharma

Information and
promotional
material
provided at an
education event

Norspan

Healthcare
professional
(GP)

No Breach 1.1,
1.3, 1.3.1

TGA

Breach 1.3, 3.3.1,

3.4.2, 9.6, 9.6.3

Complaints received and finalised in 2007/2008

875
Device
Device News
Penthrox
Technologies
and Device
Technologies
website

876

Schering
Plough

Promotional
material

Olmetec

No Breach 10.8

AstraZeneca

Breach 1.1, 1.3

No Breach 10.8

877

Sanofiaventis

Promotional
material

Actonel

Merck Sharp
& Dohme
(Australia)

Following appeal:
Breach 1.2.2, 1.3
No Breach 1.2.1,
1.7

878

Novartis

Promotional
material

Femara

Code of Conduct Annual Report 2007/2008

AstraZeneca

No Breach 1.2.2,
1.3

Withdraw item
Corrective letter
Fine $50,000
N/A

Withdraw item
Corrective letter to
recipients of
newsletter and
place on website
Withdraw item
Corrective letter
and advertisement
Amend Minimum
PI and consider
amending CMI
Following appeal:
Withdraw item
Corrective letter
Fine $80,000
N/A

31

Complaint
Number

Subject
Company

Material
Activity

Product

Complainant

879

GSKA

Promotional
material

Seretide

Pfizer &
Boehringer
Ingelheim

Outcome
(Sections of the
Code where one
or more
breaches found)
Following appeal:
Breach 1.3
Preamble to 3,
3.1.1.3

Sanction

Following appeal:
Withdraw item
Fine $50,000

No Breach 1.2.2
880

Novartis

promotional
brochure

Famvir

Healthcare
professional
(GP)

No Breach 1.1,
1.2, 1.3

881

Hospira

Promotional
material

Eligard

AstraZeneca

Following appeal:
Breach 1.1, 1.2,
1.3, 1.7

Following appeal:
Withdraw item
Corrective letter
Fine $50,000

882

Allergan

Allergan Event

Botox/
Juvederm

Monitoring
Committee

Breach 6.2.2,
10.2, 10.8

Fine $175,000

N/A

No Breach 6.2.1,
6.6
883

AstraZeneca

Promotional
material

Crestor

Pfizer

Repeat Breach
1.3, 1.7

884

Orphan
Australia

Promotional
Material

Tetrabenzine

Healthcare
professional
(hospital
doctor)

Considered by
Code of Conduct
Committee and
referred back to
the complainant
for further
information

885

Eli Lilly

Dear healthcare
provider letter

Actos

GSKA

Breach 1.10, 3.3

No Breach 1.1,
1.3, 1.7

Fine $80,000
Company had
undertaken to
send a corrective
letter
N/A

Company had
already sent
corrective letter
No further
corrective action
required

886

Pfizer

Promotional
Material

Lipitor

AstraZeneca

Following appeal:
Breach 1.1, 1.2,
1.3, 1.5, 1.7

Following appeal:
Fine $50,000

887

Boehringer
Ingelheim

Promotional
Material

Micardis

AstraZeneca

Breach 1.3.1

Withdraw item
Fine $25,000

No Breach 10.5
888

Allergan

Promotional
material

Lumigan

Pfizer

No Breach 1.1,
1.2.2, 1.3, 1.3.1,
1.5, 1.7

889

Abbott

Promotional
material

Reductil

iNova

Breach 1.3, 1.2.2

N/A

Withdraw items
Fine $10,000

No Breach 1.7
890

Abbott

Educational
Event

Abbott
Educational
Event AB-200

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

891

Amgen

Educational
Event

Amgen
Educational
Event AM-217

Monitoring
Committee

Breach 6.2.1,
6.2.2, 10.2

N/A

Fine $10,000

No Breach 10.8

Code of Conduct Annual Report 2007/2008

32

Complaint
Number

Subject
Company

Material
Activity

Product

Complainant

Outcome
(Sections of the
Code where one
or more
breaches found)
No Breach 6.2.1,
6.2.2, 10.2, 10.8

Sanction

892

Abbott

Educational
Event

Abbott
Educational
Event AB-87

Monitoring
Committee

893

Alcon

Educational
Event

Alcon
Educational
Event AL-22

Monitoring
Committee

Following appeal:
No Breach 6.2.1,
6.2.2, 10.2, 10.8

Following appeal:
N/A

894

Allergan

Educational
Event

Allergan
Educational
Event AG-105

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

895

Allergan

Educational
Event

Allergan
Educational
Event AG-90

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

896

Amgen

Educational
Event

Amgen
Educational
Event AM-79

Monitoring
Committee

Following appeal:
Breach 6.2.2

N/A

Following appeal:
Fine $50,000

No Breach 6.2.1,
10.2, 10.8
897

CSL

Educational
Event

CSL
Educational
Event CSL-75

Monitoring
Committee

Breach 6.2.2,
10.2

Fine $50,000

No Breach 6.2.1,
10.8
898

Amgen

Educational
Event

Amgen
Educational
Event AM-270

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

899

AstraZeneca

Educational
Event

AstraZeneca
Educational
Event AZ-454

Monitoring
Committee

Following appeal:
Breach 6.2.1,
6.2.2

N/A

Following appeal:
Fine $10,000

No Breach 10.2,
10.8
900

901

Baxter

Biogen

Educational
Event

Educational
Event

Baxter
Educational
Event BX-73

Monitoring
Committee

Biogen
Educational
Event BIO-9

Monitoring
Committee

Breach 10.3

Fine $35,000

No Breach 6.2.1,
6.2.2, 10.2, 10.8
Breach 6.2.1,
10.2

Fine $10,000

No Breach 6.2.2,
10.8
902

903

904

905

CSL

GSKA

GSKA

Servier

Educational
Event

Educational
Event

Educational
Event

Educational
Event

CSL
Educational
Event CSL-98

Monitoring
Committee

GlaxoSmithKline
Educational
Event GSK-308

Monitoring
Committee

GlaxoSmithKline
Educational
Event GSK-690

Monitoring
Committee

Servier
Educational
Event SV-154

Monitoring
Committee

Breach 6.2.2

Fine $40,000

No Breach 6.2.1,
10.2, 10.8
Breach 10.2

Fine $20,000

No Breach 6.2.1,
6.2.2, 10.8
Breach 6.2.1

Fine $100,000

No Breach 6.2.2,
10.2, 10.8
Breach 6.2.1,
6.2.2, 10.2

Fine $20,000

No Breach 10.8

Code of Conduct Annual Report 2007/2008

33

Complaint
Number

Subject
Company

Material
Activity

Product

Complainant

906

GSK

Educational
Event

GlaxoSmithKline
Educational
Event GSK-691

Monitoring
Committee

Outcome
(Sections of the
Code where one
or more
breaches found)
Breach 6.2.1

Sanction

Fine $90,000

No Breach 6.2.2,
10.2, 10.8

907

Solvay

Educational
Event

Solvay
Educational
Event SOL-6

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

908

Octapharma

Promotional
material

Octagam

CSL

Breach 1.1, 1.2.2,

1.3, 9.7
No Breach 1.3.1,
9.10

N/A

Withdraw
materials
Corrective letter
Fine $50,000

No Finding 1.2.2,
1.5, 9.5.7
Corrective letter
Provide new
procedures &
evidence
implementation of
compliance
procedures
Fine $200,000

909

Pfizer

Representatives'
Conduct

Pfizer Conduct

AstraZeneca

Breach 1.1, 1.2,

1.3, 1.7, 4.3, 4.4,
10.5.2, 10.8

910

Ipsen

Educational
Event

Ipsen
Educational
Event IP-44

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

911

Merck Sharp
& Dohme

Educational
Event

Merck Sharp &

Dohme
Educational
Event MSD-417

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

912

Novartis

Educational
Event

Novartis
Educational
Event NO-651

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

913

Novo Nordisk

Educational
Event

Novo Nordisk
Educational
Event NN-125

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

914

Nycomed

Educational
Event

Nycomed
Educational
Event NY-49

Monitoring
Committee

Following appeal:
Breach 6.2.1,
10.2

Following appeal:
Fine $35,000

No Breach 6.2.2,
10.8
915

Nycomed

Educational
Event

Nycomed
Educational
Event NY-76

Monitoring
Committee

Breach 6.2.1,
10.2

Fine $60,000

No Breach 6.2.2,
10.8
916

Pfizer

Educational
Event

Pfizer
Educational
Event PF-229

Monitoring
Committee

Following appeal:
No Breach 6.2.1,
6.2.2, 6.6, 10.2,
10.8

Following appeal:
N/A

917

Pfizer

Educational
Event

Pfizer
Educational
Event PF-965

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

918

Pfizer

Educational
Event

Pfizer
Educational
Event PF-93

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

Code of Conduct Annual Report 2007/2008

34

Complaint
Number

Subject
Company

Material
Activity

Product

Complainant

Sanction

Monitoring
Committee

Outcome
(Sections of the
Code where one
or more
breaches found)
No Breach 6.2.1,
6.2.2, 10.2, 10.8

919

Pfizer

Educational
Event

Pfizer
Educational
Event PF-624

920

Pfizer

Educational
Event

Pfizer
Educational
Event PF-1155

Monitoring
Committee

Breach 6.2.2,
10.2

Fine $20,000

N/A

No Breach 6.2.1,
10.8
921

Pharmion

Educational
Event

Pharmion
Educational
Event PM-11

Monitoring
Committee

Breach 6.2.1,
10.2

Fine $25,000

No Breach 6.2.2,
10.8
922

Roche

Educational
Event

Roche
Educational
Event RO-181

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

923

Roche

Educational
Event

Roche
Educational
Event RO-68

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

924

sanofiaventis

Educational
Event

sanofi-aventis
Educational
Event SA-518

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

925

sanofiaventis

Educational
Event

sanofi-aventis
Educational
Event SA-983

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

926

sanofiaventis

Educational
Event

sanofi-aventis
Educational
Event SA-1026

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

927

sanofiaventis

Educational
Event

sanofi-aventis
Educational
Event SA-859

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

928

sanofiaventis

Educational
Event

sanofi-aventis
Educational
Event SA-949

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

929

sanofiaventis

Educational
Event

sanofi-aventis
Educational
Event SA-1012

Monitoring
Committee

Following appeal:
No Breach 6.2.1,
6.2.2, 10.2, 10.8

Following appeal:
N/A

930

sanofiaventis

Educational
Event

sanofi-aventis
Educational
Event SA-872

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

931

sanofiaventis

Educational
Event

sanofi-aventis
Educational
Event SA-extra2

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

932

sanofiaventis

Educational
Event

sanofi-aventis
Educational
Event SAextra14

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

933

sanofiaventis

Educational
Event

sanofi-aventis
Educational
Event SAextra19

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

Code of Conduct Annual Report 2007/2008

35

Complaint
Number

Subject
Company

Material
Activity

Product

Complainant

934

sanofiaventis

Educational
Event

sanofi-aventis
Educational
Event SAextra29

Monitoring
Committee

935

Servier

Educational
Event

Servier
Educational
Event SV-128

Monitoring
Committee

Outcome
(Sections of the
Code where one
or more
breaches found)
No Breach 6.2.1,
6.2.2, 10.2, 10.3,
10.8

Sanction

Breach 6.2.1,
10.2

Fine $60,000

N/A

No Breach 6.2.2,
10.8
936

Servier

Educational
Event

Servier
Educational
Event SV-428

Monitoring
Committee

Breach 6.2.1,
10.2

Fine $50,000

No Breach 6.2.2,
10.8
937

Servier

Educational
Event

Servier
Educational
Event SV-493

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

938

Solvay

Educational
Event

Solvay
Educational
Event SOL-9

Monitoring
Committee

Breach 6.2.1,
10.2

N/A

Fine $20,000

No Breach 6.2.2,
10.8
939

Solvay

Educational
Event

Solvay
Educational
Event SOL-28

Monitoring
Committee

Breach 6.2.1,
6.2.2, 10.2

Fine $80,.000

No Breach 10.8
940

941

Wyeth

Ipsen

Educational
Event

Educational
Event

Wyeth
Educational
Event WY-310

Monitoring
Committee

Ipsen
Educational
Event IP-131

Monitoring
Committee

Breach 10.2

Fine $35,000

No Breach 6.2.1,
6.2.2, 10.8
Breach 6.2.1,
6.2.2, 10.2

Fine $30,000

No Breach 10.8
942

Ipsen

Educational
Event

Ipsen
Educational
Event IP-21

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

943

Amgen

Educational
Event

Amgen
Educational
Event AM-303

Monitoring
Committee

No Breach 6.2.1,
6.2.2, 10.2, 10.8

N/A

944

AstraZeneca

Promotional
Material

Heartburn &
reflux products

TGA

No Breach 9.4,
9.5, 9.6

N/A

945

Schering
Plough

Promotional
Material

Olmetec

AstraZeneca

Breach 12.1

946

CSL

Promotional
Material

Influenza
Vaccine

HCP
(academic)

No Breach 1.1,
1.3, 9.4, 9.5

Code of Conduct Annual Report 2007/2008

Publish corrective
advertisement
Fine $50,000
N/A

36

AstraZeneca Heartburn
Campaign (870)
Subject Company: AstraZeneca
Complainant: CHOICE
Product: N/A
Complaint
The complainant stated that information
about heartburn available to the general
public encouraged consumers to visit the
AstraZeneca website www.heartburn.com.au.
While the website does not name a drug it
does mention several classes of drugs for
heartburn which can only be prescribed by
a
doctor,
including
H2-receptor
antagonists and proton pump inhibitors as
well as antacids. The complainant
maintained that this was a form of direct to
consumer advertising and therefore in
breach of the Code.
Sections of the Code
Materials alleged to be in breach of the
following Sections of the Code:
9.4 Promotion to the general public
Response
AstraZeneca denied that the information
available to the general public was
encouraging a patient to seek a specific
prescription only medicine. The website
did not name a prescription medicine and
mentioned several classes of drug for
heartburn which can be prescribed by a
doctor. AstraZeneca asserted that the
website contained a large amount of
helpful information about heartburn, its
management and treatment as well as
links to helpful websites such as the
Gastroenterological Society of Australias
website.
Code Committee determination
In a unanimous decision the Code
Committee found no breach of Section 9.4
of the Code.
Consideration of the complaint
The Committee noted that Section 9.4
states: Prescription products may be

promoted only to healthcare professionals.

Any information provided to members of
the general public must be educational.
Any activity directed towards the general
public which encourages a patient to seek
a prescription for a specific prescriptiononly medicine is prohibited.

Code of Conduct Annual Report 2007/2008

It was also noted that the Code requires

pharmaceutical companies to identify
within disease state awareness material
(both electronic and print) that the
information is prepared by an identified
company. It would be considered to be
misleading if a company did not make this
information available to a reader or viewer.
The Committee reviewed the information
available on the www.heartburn.com.au
website which was referred to on the
poster that gave rise to the complaint.
Members were of the view that the
information on the website was informative
and balanced. It was noted that the site
included information on lifestyle issues and
dietary tips before any reference to
medications and recommended that
readers discuss their condition with their
doctor, which was appropriate. Members
were also of the view that it is legitimate to
make reference to all the therapeutic
classes, both non- prescription and
prescription, which are used to treat the
condition. The website did not include the
name of any particular medicine and did
not compare or recommend any specific
treatment.
The Committee was of the view that a
patient would not link this website with any
specific medicine. If a patient asked their
doctor for the medicine that is supplied by
AstraZeneca as the provider of the
website, it would be the role of the
healthcare professional to firstly assess
whether the patient did have reflux,
secondly whether they required any
medication and if this was considered
necessary which treatment was most
appropriate for the particular patient.
Healthcare professional members of the
Committee noted that there is a
hierarchical treatment approach for reflux
patients
which
were
discussed
appropriately in the materials.
The Committee did caution that it may not
be possible for a pharmaceutical company
to conduct a disease awareness campaign
where there was only one available
treatment for the medical condition where
the campaigns message was to
recommend to readers to talk to your
doctor or ask your doctor as this could
lead to a patient effectively asking for a
prescription for a specific medicine.

37

In a unanimous decision the Committee

found no breach of Section 9.4 of the Code
in relation to the heartburn information
supplied by AstraZeneca.

Code of Conduct Annual Report 2007/2008

38

Tykerb (871)
Subject Company: GlaxoSmithKline
Australia (GSKA)
Complainant: Roche Pharmaceuticals
(Roche)
Product: Tykerb
Complaint
Roche alleged a repeat breach of the
Code in relation to complaint Tykerb (867)
and a breach of Section 12.1.1. Roche
stated that GSKA had again provided
material to a public media outlet and had
therefore failed to comply with the sanction
imposed by the Code Committee.
Sections of the Code
Materials alleged to be in breach of the
following Section of the Code:
12.1.1 Sanctions
Response
GSKA stated that it had not issued any
media releases since the ruling made by
the Code of Conduct Committee on 16
April 2007 in relation to Tykerb (867).
Four media articles on Tykerb were
published/broadcast in Adelaide on 7 May
2007. A GSKA spokesperson had
provided information in response to a
specific request by the Adelaide
Advertisers health writer. GSKA had no
knowledge of, and did not provide any
materials to, the other broadcasters or
publishers.

In relation to the information on the Tykerb

Expanded Access Program, it was noted
that the program was authorised under the
TGA Clinical Trial Notification (CTN)
Scheme and had been subject to approval
by the relevant ethics committees.
However members noted that information
provided to the media by GSKA would not
have been part of any ethics approval
process. Members also commented that
the drive for patient recruitment through
the media could also have been initiated
by the trial centres keen for additional
patients. This was not considered to be a
negative aspect; however companies must
be careful when providing information
about clinical trials to the general public.
Members did not raise any issues with the
provided text for the recorded 1800number automated message.
Radio and Television Broadcasts (3)
The Committee was of the view that there
was no evidence that GSKA had been
responsible for or provided any information
to the journalists responsible for these
media stories.
Members commented that there is no
evidence that GSKA is continuing to
promote Tykerb and expected that GSKA
had also instructed the PR agency working
on their behalf not to engage in any further
such activities.
By a unanimous decision, the Committee
did not find a breach of Section 12.1.1 of
the Code.

Code Committee determination

The Committee found no breach of
Section 12.1.1 of the Code.
Consideration of the complaint
The Committee noted GSKAs statement
that it had not issued any media releases
following the ruling of the Code of Conduct
Committee at the 16 April 2007 meeting.
GSKA response to Adelaide Advertiser
The Committee reviewed the written
materials tendered by GSKA that had
been provided to the Adelaide Advertiser
health writer. Members were of the view
that it was acceptable for GSKA to
respond to a request from health writer
and did not consider the materials
provided by GSKA to be in breach of the
Code.

Code of Conduct Annual Report 2007/2008

39

Roche Media Releases (872)

Subject Company: Roche Products
Complainant: GlaxoSmithKline Australia
(GSKA)
Product: Not applicable
Complaint
GSKA alleged that Roche had made
available in Australia over 20 media
releases which promoted either unregistered
products or unregistered indications for
registered products. GSKA alleged that
Roche had made these media releases
available both directly to the general public
via the company website and indirectly
through the lay media with the purpose of
publication of media articles and promotion
of prescription products to the general
public.
Sections of the Code
Materials alleged to be in breach of the
following Sections of the Code:
1.1 Responsibility
1.3.1 Unapproved products and
indications
1.5 Unqualified superlatives
9.2 Product Specific Media Statements
(including 9.2.1, 9.2.2 and 9.2.3)
9.3 General Media Articles
9.4 Promotion to the general public
9.6 Use of the Internet (including 9.6.4)
9.10 Discredit to and reduction of
confidence in the Industry
Response
Roche responded that the complaint was
unfounded, retrospective and had not
followed due process. Roche alleged that
the complaint was an abuse of the
complaint process and was frivolous and
vexatious and therefore in breach of
Section 12.3 of the Code.
Code of Conduct and Appeals Committee
determinations
In unanimous decisions the Code
Committee found breaches of the Code in
relation to three media releases:
Media Release #17 dated 12 December
2006 (Considered under Edition 15 of the
Code)
Breach of Sections 1.1, 9.2.1, 9.3 and 9.4
of the Code (Decision confirmed by the
Appeals Committee)

Code of Conduct Annual Report 2007/2008

Sanctions
Remove from any public access website
and not issue the media release again in
the same or similar form
Fine $20,000 (Fine amended to $30,000
by the Appeals Committee)
Media Release #20 dated 20 October
2005 (Considered under Edition 14 of the
Code)
Breach of Sections 1.1, 1.3.1, 9.2.1, 9.2.4,
9.3 and 9.4 of the Code (Decision
confirmed by the Appeals Committee)
Sanctions
Remove from any public access website
and not issue the media release again in
the same or similar form
Fine $60,000 (Fine amended to $40,000
by the Appeals Committee)
Media Release #21 dated 18 May 2005
(Considered under Edition 14 of the Code)
Breach of Sections 1.1, 9.2.1, 9.3 and 9.4
of the Code
No breach of Section 9.10 of the Code
(Decision confirmed by the Appeals
Committee)
Sanctions
Remove from any public access website
and not issue the media release again in
the same or similar form
Fine $40,000 (Decision confirmed by the
Appeals Committee)
The Committee did not find any breach of
the Code in relation to media releases
numbered 1-16, 18 or 19 as submitted in
the complaint.
In a unanimous decision the Committee
found no breach by GSKA of Section 12.3
of the Code.

Code of Conduct Committee

Consideration of the complaint
The Committee considered several
general issues raised by Roche and GSKA
in relation to Section 9.2 of the Code.

Do provisions under Section 1 of the Code

apply to complaints pertaining to Section
9.2?
Members were of the view that irrespective
of the medium, that is hard copy,
electronic format, computer based,
website or available through a media
release, it is the responsibility of a
company to ensure that the content of all

40

materials produced and/or distributed by it

or on its behalf are balanced, factual,
correct and not misleading to a reader,
whether intended for a healthcare
professional, patient or general public
audience. It was therefore the Committees
opinion that a complaint in relation to a
media release may also be subject to a
complaint under provisions such as
Sections 1.1 and 1.3 of the Code. This
does not mean, however, that Section 9.2
should be interpreted as if it contained
language that it does not. In particular, the
reference in Section 1.3.1 to unapproved
indications should not be imported into
Section 9.2.

Does Section 9.2 apply to media activity to

communicate or respond to landmark
studies in non approved products and
landmark studies for approved products in
new indications?

Members were of the view that the

requirements of Section 9.2 do not permit
media releases relating to unapproved
products. Contrary to GSKAs suggested
interpretation, Section 9.2 regulates the
circumstances
under
which
media
releases
relating
to
non-approved
indications may be made. The provisions
apply whether a company is proactively
distributing a media release about a nonapproved indication or whether a company
is responding to a question about a
landmark clinical trial. Any communication
must also be considered on the basis of
the representation of the outcomes of the
study that it refers to - that is, it must be
current, accurate, balanced and must not
be promotional.

Does the Code hold Australian companies

responsible for the content of their parent
companys global media/news releases?

Whilst noting that the Australian company

is not responsible for the content of parent
company media releases, members were
of the view that it is the manner in which
such a global release is used or distributed
within Australia that is considered in
reviewing a complaint under the Code,
including whether the Australian company
actively distributed the global media
release in Australia and whether the
Australian company directed Australian
healthcare professionals to view a new
media release on the parent company
website.
On the evidence provided to it, the
Committee formed the view that Roche

Code of Conduct Annual Report 2007/2008

had not promoted the global releases to

Australian healthcare professionals nor to
the general public, although the media
releases could be accessed through the
Roche Australia website through a link,
Global News, to the parent company
website. Members noted that Roche had
included a statement on the Australian
website in accordance with Section 9.6.4
advising visitors, prior to leaving the Roche
Australia website, that

The information that you are about to be

referred to may not comply with the
Australian regulatory environment and that
you should refer to the CMI for products to
fully understand the terms of a products
registration in Australia; and that the intent
of providing this material is informational
and not as advice; and any information
provided by this source should be
discussed with the readers healthcare
professional and does not replace their
advice.
Please see our CMI/PI Download Centre
News from the global Roche Group can be
found at the following location.
http://www.roche.com/med-cor
In relation to the global media releases
numbered 1-16, 18 and 19, the Committee
did not find any breach of the Code as
members accepted that Roche had not
promoted or distributed the releases within
Australia.
Global Media Release #1 dated 22
February 2007 (Edition 15)
No breach of Sections 1.1, 1.3.1, 9.2.1,
9.3, 9.4, 9.6, 9.6.1 or 9.6.4
Global Media Release #2 dated 24
January 2007 (Edition 15)
No breach of Sections 1.1, 1.3.1, 9.2.1,
9.3, 9.4, 9.6, 9.6.1 and 9.6.4
Global Media Release #3 dated 12
December 2006 (Edition 15)
No breach of Sections 1.1, 1.3.1, 9.2.1,
9.3, 9.4, 9.6, 9.6.1 and 9.6.4
Global Media Release #4 dated 11
December 2006 (Edition 15)
No breach of Sections 1.1, 1.3.1, 1.5,
9.2.1, 9.3, 9.4, 9.6, 9.6.1 and 9.6.4
Global Media Release #5 dated 20
November 2006 (Edition 14)
No breach of Sections 1.1, 1.3.1, 1.5,
9.2.1, 9.3, 9.4, 9.6, 9.6.1 and 9.6.4

41

Global Media Release #6 dated 2 October

2006 (Edition 14)
No breach of Sections 1.1, 1.3.1, 9.2.1,
9.3, 9.4, 9.6, 9.6.1 and 9.6.4

Global Media Release #19 dated 13

October 2006 (Edition 14)
No breach of Sections 1.1, 1.3.1, 9.2.1, 9.3
and 9.4

Global Media Release #7 dated 31 July

2006 (Edition 14)
No breach of Sections 1.1, 1.3.1, 1.5,
9.2.1, 9.3, 9.4, 9.6, 9.6.1 and 9.6.4

In relation to the media releases #17, 20

and 21 dated 12 December 2006, 20
October 2005 and 18 May 2005
respectively
the
Committee
found
breaches of the Code as members were of
the view that Roche Australia had
distributed the releases within Australia
and the releases did not comply with the
provisions of the Code.

Global Media Release #8 dated 17 July

2006 (Edition 14)
No breach of Sections 1.1, 1.3.1, 9.2.1,
9.3, 9.4, 9.6, 9.6.1 and 9.6.4
Global Media Release #9 dated 27 June
2006 (Edition 14)
No breach of Sections 1.1, 9.2.1, 9.4, 9.6,
9.6.1 and 9.6.4
Global Media Release #10 dated 22 June
2006 (Edition 14)
No breach of Sections 1.1, 1.3.1, 9.2.1,
9.3, 9.4, 9.6, 9.6.1 and 9.6.4
Global Media Release #11 dated 3 June
2006 (Edition 14)
No breach of Sections 1.1, 9.2.1, 9.3, 9.4,
9.6, 9.6.1 and 9.6.4
Global Media Release #12 dated 29 May
2006 (Edition 14)
No breach of Sections 1.1, 1.3.1, 9.2.1,
9.3, 9.4, 9.6, 9.6.1 and 9.6.4
Global Media Release #13 dated 6 April
2006 (Edition 14)
No breach of Sections 1.1, 1.3.1, 1.5,
9.2.1, 9.3, 9.4, 9.6, 9.6.1 and 9.6.4
Global Media Release #14 dated 26 April
2007 (Edition 15)
No breach of Sections 1.1, 9.2.1, 9.3 and
9.4
Global Media Release #15 dated 22
January 2007 (Edition 15)
No breach of Sections 1.1, 1.3.1, 1.5,
9.2.1, 9.3 and 9.4
Global Media Release #16 dated 14
December 2006 (Edition 15)
No breach of Sections 1.1, 1.3.1, 9.2.1, 9.3
and 9.4
Global Media Release #18 dated 12
November 2006 (Edition 14)
No breach of Sections 1.1, 1.3.1, 9.2.1, 9.3
and 9.4

Media Release #17 (12 December 2006

considered under Edition 15 of the Code)
Some members commented that the
media release referred to the results of a
clinical trial and there is no evidence that
the trial was a landmark study. Members
also commented that irrespective of
whether it was a landmark study the
release concerned a specific medicine and
was promotional through the use of terms
such as give hope to thousands,
results represent a major advance in the
treatment, definitive proof, has
revolutionised, and major milestone; and
did not provide a balanced perspective of
the product by omitting information in
relation
to
the
precautions,
contraindications, warnings etc. Whilst
there was a link to the CMI provided in the
footnotes in the media release, the Code
requires that the information about the
products precautions, adverse reactions
contraindications etc must be included in
the media release. The Committee was
also of the view that statements such as
those identified above may encourage a
patient to seek to be prescribed the
specific prescription-only medicine. The
Committee noted that the media release
directed members of the general public to
talk to your healthcare professional. The
media release was found in breach of
Sections 9.2.1 and 9.4 of the Code.
The Committee considered that the
purpose of the media release was to
encourage publication of general media
articles. However in the absence of
objective evidence that Roche had taken
any action to initiate a general media
article other than by issuing the media
release subject to complaint, it found no
breach of Section 9.3 of the Code.
The Committee found the media release to
be in breach of Section 1.1 of the Code

Code of Conduct Annual Report 2007/2008

42

because, by the omission of information

about the precautions, side effects,
warnings and contraindications associated
with the product, it was not balanced
Roche has a responsibility to ensure that
any media release by it or on its behalf is
balanced and is not promotional.
Sanctions
Having found a number of breaches of the
Code the Committee considered an
appropriate sanction.
The Committee determined that Roche
should:
Remove the media release from any
public access website and not issue the
media release again in the same or
similar form
Pay a fine of $20,000
Media Release #20 (20 October 2005
considered under Edition 14 of the Code)
The Committee noted that while the
release was issued by the Australian New
Zealand Breast Cancer Trials Group
(ANZBCTG), Roche had funded the
development and distribution of the media
release by ANZBCTG in association with a
PR company, although Roche had stated
that it did not have any input into the
content of the release.
Members expressed the view that if a
media release was genuinely independent
of a pharmaceutical company there would
be no connection with the company that is
the sponsor of the product.
The
Committee considered that although
Roche had not had editorial control over
the media release, nor any input into the
content, it had funded the logistics for the
issue of the media release in the
knowledge that the ANZBCTG intended
issuing the release about the particular
clinical trial results. Roche therefore had
some responsibility for the media release.
The Committee noted that Roche had
stated in the response column in its
tabulated response that it had not taken
any action to initiate a general media
article other than by issuing the media
release subject to complaint (emphasis
added), which was understood by the
Committee to be an admission by Roche
that it had issued the release. In any
event, a majority of the Committee was of
the view that Roche was responsible for
ensuring this release was balanced with
regard to its product as the release had
been funded by Roche.

Code of Conduct Annual Report 2007/2008

The Committee agreed with the arguments

proposed by GSKA that the media release
was promoting an unapproved use of
Herceptin and was therefore in breach of
Section 1.3.l. As the media release had
been issued to the general media and
included a number of promotional
statements as had been identified by
GSKA, the media release was found to
promote Herceptin to members of the
general public and was therefore in breach
of Section 9.4 of the Code.
The Committee agreed that Roche had
been responsible for the initiation of a
media release about an unapproved use of
a product and was therefore in breach of
Section 9.2.1 of the Code. A majority of
the Committee determined that Roche was
in breach of Section 9.2.4 of the Code
because the media release was issued by
ANZBCTG, with the assistance of a PR
agency, and the release was funded by
Roche, and did not comply with the Code.
For similar reasons to those found in
relation to media release #17, the
omission of information about the risks
associated with Herceptin (precautions,
contraindications,
side
effects
and
warnings) resulted in a lack of balance.
The media release was therefore in breach
of Section 1.1 of the Code.
The Committee considered that the
purpose of the media release was to
encourage publication of general media
articles. However in the absence of
objective evidence that Roche had taken
any action to initiate a general media
article other than by issuing the media
release subject to complaint, it found no
breach of Section 9.3 of the Code.
Sanctions
Having found a number of breaches of the
Code the Committee considered an
appropriate sanction.
The Committee determined that Roche
should:
Remove the media release from any
public access website and not issue it
again in the same or similar form
Pay a fine of $60,000
In determining that a higher fine should be
applied in relation to media release # 20,
the Committee considered that Roche had
used a third party to communicate
promotional information about its product

43

to the general public and had failed to

exercise
adequate
control
over
organisations it had funded, in the
knowledge that the funding provided was
going to be used to issue a general media
statement that would be favourable to its
product.
Media Release #21 (18 May 2005
considered under Edition 14 of the Code)
Roche had stated that media release #21
was a parent company global release that
was provided by Roche to a public website
designed to provide information about
medical treatments to consumers, the
Virtual Cancer Centre. Members were of
the view that Roche Australia could have
responded to the enquiry for information
about studies released at the ASCO
meeting otherwise than by simply
providing the parent company media
release concerning a non approved
indication for a particular prescription
medicine. In responding to the request
Roche could have provided information
that was balanced and not promotional
that complied with the Code.
For the same reasons as applied in
relation to media releases #17 and #20,
the Committee found that the supply of the
global media release to the Virtual Cancer
Centre for publication on its Australian
website was a breach of Sections 1.1
(failure to provide balanced information),
9.2.1 (supply of a media release that is not
balanced and which is promotional for a
non approved use of a product) and 9.4
(promotion to the general public) of the
Code as the company had a responsibility
to ensure the information released in
Australia is balanced and not promotional.
The Committee also considered that
Roche had failed to provide appropriate
educational material in response to a
request and therefore was in breach of
Section 9.3 of the Code.
Sanctions
Having found a number of breaches of the
Code the Committee considered an
appropriate sanction.
The Committee determined that Roche
should:
Remove the media release from any
public access website and not issue it
again in the same or similar form
Pay a fine of $40,000

14)/9.10 (Edition 15) of the Code.

Members were of the view that of the 21
media releases alleged to be in breach of
the Code, findings of a breach had been
found in relation to only three releases and
that further guidance to companies and
future Code of Conduct and Appeals
Committees was required in relation to
Sections 9.2 and 9.3 of the Code.
The Committee discussed whether Code
of Conduct Committee or Medicines
Australia should set a time limit for the
lodgment of complaints as numerous
releases subject to this complaint were
released in 2005. This matter will be
discussed at a subsequent meeting and
forwarded to the Code Review Panel for
consideration when the Code is next
revised.
The Committee considered the allegation
by Roche that this complaint was an abuse
of the complaints process and was
frivolous and vexatious. By a majority
decision the Committee determined that
GSKA should be asked to show cause why
the Committee should not impose a fine
for abuse of the Code of Conduct.
The Committee also considered the
allegation from Roche that it had been
denied procedural fairness by GSKA in the
processing of the complaint.
The
Committee determined that since the last
meeting of the Committee Roche had had
the opportunity to provide and had
provided a full defense to the allegations
and had been afforded sufficient time to
recover its position if any procedural
disadvantage had actually occurred.

Appeals Committee
Roche appeal
Roche lodged an appeal against some of
the decisions of the Code Committee.
Roche stated that the core issue was
whether the reference to an unapproved
indication is prohibited in media releases
concerning major developments such as
landmark studies concerning approved
products. The central issue in the appeal is
the correct interpretation and application of
Sections 9.2 and 9.3 to media releases
and how they relate to Section 1 of the
Code.

In a majority decision the Committee did

not find a breach of Section 9.8 (Edition

Code of Conduct Annual Report 2007/2008

44

GSKA response to appeal

GSKA argued that each of the breaches
found by the Code Committee should be
upheld by the Appeals Committee. The
sanctions imposed as a result of those
findings are reasonable based on other
similar decisions by the Committee.
Consideration of the appeal
The following summarises the main points
presented by Roche representatives in
favour of its appeal:
Roche appealed all findings of breach of
the Code in relation to media releases
numbered 17, 20 and 21 in the complaint
and the sanctions imposed, which Roche
interpreted as being reflective of the
number of breaches found.
All three media released were issued in
response to enquiries about key
international developments.
All three media releases were about
significant improvements in overall
survival in cancer outcomes with
clinical impact.
All qualify as landmark studies.
All properly fall within the example in the
Explanatory Notes for Section 9.
All studies referenced in the media
releases were Phase III studies Level II
evidence
(NHMRC
hierarchy
of
evidence).
Media releases #17 and #21 related to
approved indications for the two
medicines non-Hodgkins Lymphoma
and metastatic breast cancer.
Release #20 related to a study that was
the basis for approval of new indications
for adjuvant breast cancer treatment.
Roche
considers
the
information
provided was accurate, balanced,
appropriate in the circumstances, and
was about study results and not
promotional of a product.
Roche considered the most pertinent
Section of the Code relevant to the media
releases was Section 9: Relationship with
the General Public. Under this section,
industry may provide information about
medicines and studies, as long as proper
standards are observed, which are
documented
in
Section 9.
The
Explanatory
Note
identifies
key
developments including landmark studies
as an exceptional circumstance in terms of
section 9.2

Code of Conduct Annual Report 2007/2008

In relation to proper interpretation of

Section 9.2.1:
Media releases are permitted to
announce a new product or major
indication approval for medicines
available in Australia.
Such releases must include the
products
precautions,
adverse
reactions, warnings, contraindications
and interactions.
However, the releases in question were
not announcing availability of new
products or indications, so Section 9.2
doesnt apply, in Roches opinion, and also
do not fall under Sections 9.3 or 9.4.
Roche argued that if 9.2 did apply to a
media release about a study, this would
mean that the release would have to
include
warnings,
precautions,
contraindications etc about every drug in
the study, which, in their view, is
unreasonable.
Roche did not agree that it is the intention
of the Explanatory Notes to Section 9.2, in
specifically allowing a media statement
about a key development such as a
landmark study, to then have such a
release condemned as a breach of Section
9.4 that prohibits product promotion to the
general public.
Roche did not agree that Section 1 should
be applied to these media releases.
The principles in Section 1 are only
relevant to promotional and medical
claims about products.
The releases were not about product
specific
promotional
claims
and
therefore do not fall under Section 1 or
1.3.1 of the Code.
Roche referred to the requirement in
Section 9.2.1 that a media release must be
in
language
that
reflects
current
community standards. In support of their
position that the language was not
promotional Roche stated that the
language used in the media releases was
consistent with that used by:
investigators and collaborative groups
independent clinical experts
the media
other companies
when publicizing positive study results.
Roche cited statements from several
sources as evidence to support their
position that the language in the media
releases was consistent with language
45

used to describe the impact of the studies

in the clinical arena, an internationally
renowned expert oncologist; a New
England Journal of Medicine (NEJM)
editorial and the high level of media
interest in the study results.
In relation to the Australian New Zealand
Breast
Cancer
Treatment
Group
(ANZBCTG) media release (#20), that
Group had initiated the request for
sponsorship from Roche for the media
release. The release related to a US study
which was not sponsored by Roche
Australia.
There was no pre-existing
relationship with ANZBCTG in relation to
the NEJM publication.
ANZBCTGs
interest was not in promoting a particular
product but was to promote its involvement
in important international studies, the value
of patients participating in clinical trials,
and positive clinical outcomes for patients.
Roche referred to statements in the media
release which were found to be
promotional of Roches product, which
Roche considered were about the study
concerned, not the product.
Roche considered that the finding of
breaches for the ANZBCTG release as
though the Treatment Group was acting as
an agency for Roche was contrary to the
fact that Roche had no involvement in the
media release. The release contained
statements by a third party about study
results which had been wrongly interpreted
as company promotion of an unapproved
indication, despite the Code stating that
landmark studies can involve new
indications. Roche further objected to the
$60,000 sanction imposed for ANZBCTGs
language, which is higher than that
imposed for a breach where a company
was directly publicising an unapproved
product (Complaint 867).
In relation to media release #17, Roche
explained that survival rates for patients
with non-Hodgkins Lymphoma (NHL)
have not changed for decades. The study
referred to in the media release was the
earliest study to show significant overall
survival benefit of treatment with rituximab
first line in follicular NHL. Information
about the study which was presented at
the American Society of Haematology
(ASH) meeting was requested by a
number of Australian organisations,
including the Leukaemia Foundation
Australia and Lymphoma Support and
Research Association. Media release #17

Code of Conduct Annual Report 2007/2008

was placed on the Roche Australia

website in a password protected area
accessible by healthcare professionals
and a patient already prescribed rituximab
and was issued to the media.
Roche maintained that the positive
statements identified by the Code
Committee as the basis for finding the
media release in breach of the Code relate
to results of the study, not the drug itself.
Roche did not agree that the media
release was product promotional.
In relation to media release # 21, which
appeared on the Virtual Cancer Centre
(VCC) website, Roche had provided the
global release to the VCC, and in hindsight
recognised that it would have been
preferable to only provide information
about the study.
In defence of the
conduct, the release was from May 2005;
the release provided information about the
reported study which was factual and not
misleading and related to an approved
indication for the medicine.
Roche
considered that there would be minimal
consequences for patients because the
medicine can only be prescribed by a
specialist medical practitioner.
In relation to sanctions, Roche submitted
that the penalties were too severe and
should be substantially moderated.
Positive language in the media releases is
about the studies, not the products. Some
releases raised in the complaint were
more than two years old and no complaints
had been raised in that time. Roche had
no information or advice that the releases
were not acceptable. If it had been aware,
Roche would have changed its conduct.
The sanction of $120,000 is inconsistent
with that imposed in complaint 867 for
which GSKA had been found in breach for
publicising an unapproved product.
The Code Committee erred in stating
breaches of Section 9.3 of the Code were
found when determining the sanctions.
The following summarises the main points
presented by GSKA representatives:
Media releases are common. GSKA has
identified 30 media releases issued by 8
companies in the two-year period to March
2007.
21 referred to an unapproved
product or indication; 16 were issued by a
single company.

46

GSKA noted that the Code Committee has

considered 3 complaints about media
releases in 2007 (867, 871, 872). The
Code Committee had recognised some
potential
interpretive
inconsistencies
between provisions of the Code and the
Explanatory Notes in Sections 9.2 and 9.3.
The Committee had endeavoured in great
detail to clarify interpretation of the Code
to provide assistance to companies in
complying with the Code and had referred
these differences to the next Code Review
Panel. The Committee had confirmed that
the provisions of the Code take
precedence over the Explanatory Notes.
In its consideration of Complaint 867, the
Code Committee made clear that media
releases about unapproved products are
not acceptable and cannot be initiated by a
pharmaceutical company; releases cannot
have promotional content and must be
balanced through provision of information
on
side
effects,
precautions,
contraindications etc.
The Code
Committee can only respond to evidence
presented to it on the actual content of
media releases.
In complaint 871, there was media
coverage in the absence of a media
release; the complaint dealt with
responding to media enquiries.
GSKA noted that in the current complaint
(872), in relation to eighteen media
releases, which were all global media
releases only available on a global
company website, the Code Committee
had determined that an Australian
subsidiary has no responsibility unless
such releases are distributed by the
company in Australia.
GSKA agreed with the Code Committee
that media release #17 was in breach of
the Code. GSKA considers that study
results are the basis for all promotional
claims that a company makes. Thus it
cannot be argued that information about
study
results
cannot
be
product
promotional.
For media release #20,
GSKA agreed that a pharmaceutical
company has responsibility for media
releases issued by a third party
organisation or agencies that it has
sponsored to undertake that activity. The
ANZBCTG
release
promoted
an
unapproved indication of a registered
product to the general public. Media
release #21 included promotional content

Code of Conduct Annual Report 2007/2008

for an unapproved indication of a

registered product. Consideration of this
release highlighted what should be an
appropriate response to media enquiries.
GSKA concluded that Sections 1 and 9 of
the Code are fundamental to what can and
cannot
be
promoted
to
health
professionals and the general public.
Section 9 deals with companies
relationship with the general public,
highlighting a higher onus of responsibility
and a higher standard for provision of
balanced information. GSKA proposed
that the decisions of the Code Committee
in Complaints 867, 871 and 872 have
substantially increased clarity about
Sections 1 and 9.
GSKA considered that the Code
Committees decisions in relation to
complaint 872 provide an appropriate
framework for companies in relation to
media releases. Therefore, the decisions
in complaint 872 should be confirmed and
the appeal should be rejected.
The
sanctions imposed are based on relevant
precedents and are appropriate.
Following GSKAs presentation the
Appeals Committee sought clarification on
several matters:
The Chairman invited Roche to further
elaborate on its argument that the Code
Committee cannot find a breach of two
sections of the Code in relation to media
releases and why Roche considered that a
media release was not subject to Section 1
of the Code.
GSKA representatives responded that
Roche had interpreted the Code
Committee reasoning to be that because
the precautions, contraindications etc had
not been included in the media releases
they were in breach of 9.2 and that the
releases were therefore not balanced and
in breach of Section 1.1.
Roche
considered that the statements in the
media releases were about clinical studies,
were fair, factual, balanced and were not
promotional statements. The Chairman
responded that Section 9 is a narrower
prohibition on conduct than Section 1, but
both can apply to media releases.
A Committee member questioned Roche
about the appropriate interpretation of
different contexts in which information
about study results is discussed. He noted
that some of the media releases related to

47

study results discussed at a conference

but not published at the time. Sometimes
what is presented at a conference is more
positive than the subsequently published
paper following peer review, which is the
reason the Code does not accept abstracts
and posters as the sole basis to support
claims.
There is also a different
interpretive
context
between
an
investigator
presenting
results
to
professional
colleagues
and
communicating the results to the general
public, noting that a lay person would not
share the same understanding as a
learned audience. Roche responded that
the minutes of the Code Committee record
particular phrases from the media releases
out of context and concluded they were
promotional. Roche maintained that the
language in the media releases was to
describe the studies, not the products.
The releases were not found to be
inaccurate, or to have misled physicians.
Roche considered that the language used
in the media releases is consistent with
that used in presenting results at a
conference.
The Chairman questioned Roche about
the terms of Section 9 as it applies to the
media releases.
He proposed that
Sections 9.2 and 9.3 should be interpreted
as a prohibition on certain conduct in
relation to media releases and identifies a
distinction between what may be initiated
by companies and when companies may
only respond to an enquiry. It could be
said that media releases are initiating
communication. Roche responded that in
each case the company was responding
people in different organisations and
groups had asked Roche to respond to
information about major issues that arose
at ASH or the American Society of Clinical
Oncology (ASCO) meetings.
Roche
stated that if the Australian media want to
publish a story they will seek an opinion
from an expert. The Chairman suggested
that there are ways of responding to a
request for information other than issuing a
media release.
Roche then made its concluding remarks.
Roche noted that it shared the perspective
with GSKA that there had been lack of
clarity in the Code, which is the reference
point for decisions on the acceptability of
certain conduct. Roche believed it had
made a reasonable interpretation of what
was acceptable. The complaints referred
to by GSKA had all occurred since

Code of Conduct Annual Report 2007/2008

February 2007 none of that information

was available to Roche when the media
releases were issued.
Roche believed that the Code Committee
had made subjective interpretations of
language in the media releases and
concluded that certain statements were
promotional. Studies that were the subject
of the media releases included reference
to unapproved indications, but the Code, in
Roches view, recognised that information
on unapproved uses was valid.
The releases posed no threats to patient
safety Roche believed that patients with
cancer cant demand a prescription for
MabThera or Herceptin on the basis of a
media release or media story. The impact
of the releases doesnt warrant the
sanctions imposed.
The GSKA and Roche representatives left
the meeting following these presentations.
The Committee unanimously agreed that
Section 1 of the Code does apply to media
releases it is broader than Section 9, but
does apply.
The Committee considered Section 9.2 of
the Code. It considered that the section
provides clear language that media
releases must be current, accurate
balanced and must not be promotional.
The explanatory notes to Section 9 are for
guidance and do not override these
requirements of Section 9.2. The
Committee determined that the three
media releases in question were product
specific and promotional. It did not accept
Roches argument that the releases were
solely about clinical studies.
The
language used in the media releases was
promotional of the products concerned.
In relation to media release #20, issued by
the ANZBCTG, whilst it was written by a
third
party,
Roche
had
provided
sponsorship for the production and issue
of the release and therefore must take
responsibility for the release. Roche had
been aware that the release was to be
produced and its subject matter, although
Roche had not exercised editorial control,
and had funded the ANZBCTG for the
specific purpose of issuing the media
release. The Committee considered that
Roche had an ultimate responsibility for
the fact that a media release had been
issued. In forming its opinion the Appeals

48

Committee did not rely on the statement in

the Code Committee minutes that it
understood that Roche had also issued the
media release itself. Nonetheless, the
Committee determined that Roche had
responsibility for the media release.
The Committee reviewed the release and
confirmed its view that the media release
was about the product, Herceptin, not
solely about the study published in the
NEJM and was promotional.
The
Committee also noted that the NEJM
publication of the study refers to adverse
effects such as cardiotoxicity, which was
not mentioned in the media release. The
Committee also did not accept Roches
assertion that members of the public with
breast cancer would not ask their doctor to
prescribe the drug for them after reading
media articles. Consumers may not have
the same capacity as a health professional
to interpret study results.
The Appeals Committee considered that
the media releases were promotional.
They included statements from key opinion
leaders conveying positive attributes of
particular medicines arising from clinical
studies. The Committee noted that there
is a difference between comments in a
peer reviewed publication and positive
statements by commentators included in a
media release. It further noted that further
interpretation of study results presented at
a scientific conference often occurs during
the peer review process prior to
publication.
Any response to an enquiry about
information about recent clinical studies
needs to be confined to being a reflection
of the trial itself and put into context of
existing information about the medicine
used in the trial to provide appropriate
balancing information, such as the
precautions, warnings, contraindications
etc.
Publication of a media release
containing third party commentary is not
regarded as the company responding to
an enquiry but is rather drawing attention
to that third partys response to an issue,
and can be regarded as promotional.
The Appeals Committee concluded that
Roche had not persuaded it that the Code
Committee had erred in its findings. The
Appeals
Committee
confirmed
the
determinations of the Code of Conduct
Committee in relation to all three media
releases (#17, #20 and #21).

Code of Conduct Annual Report 2007/2008

The Appeals Committee advised that an

appropriate disclaimer of a website page
that links to a global website which may
not comply with Australian Code of
Conduct
requirements
should
be
maintained. It should be clear to a reader
that the information available from the
linked page may not comply with
Australian requirements. It would also be
beneficial to provide a further notice on the
global webpage.
Sanctions
Having not upheld the appeal the Appeals
Committee considered the sanctions
imposed by the Code of Conduct
Committee.
Media Release #17 dated 12 December
2006 (Considered under Edition 15 of the
Code)
Remove from any public access website
over which Roche Australia has control
and not issue the media release again in
the same or similar form.
Fine amended to $30,000. In increasing
the fine from $20,000 to $30,000 the
Committee determined that the language
contained in the media release was
more culpable than the other two media
releases. The activity was also more
recent than releases #20 and #21.
Media Release #20 dated 20 October
2005 (Considered under Edition 14 of the
Code)
Remove from any public access website
over which Roche Australia has control
and not issue the media release again in
the same or similar form. Endeavour to
remove the media release from any
other website that makes it available to
the public.
Fine amended to $40,000. In reducing
the fine from $60,000 the Committee
considered that whilst the issues subject
to complaint were essentially the same
as the other two media releases, the
involvement of a third party in issuing the
media release justified a higher fine than
that imposed in relation to media release
#17.
Media Release #21 dated 18 May 2005
(Considered under Edition 14 of the Code)
Remove from any public access website
over which Roche Australia has control
and not issue the media release again in
the same or similar form. Endeavour to
remove the media release from any

49

other website that makes it available to

the public.
Fine retained at $40,000. The Appeals
Committee determined that whilst the
issues subject to complaint were
essentially the same as the other two
media releases, the breach was broader,
including Section 9.3 of the Code.
Further, there was no lack of clarity in
relation to the requirements of Section
9.3, as has been suggested in relation to
Section 9.2. Roche should have been
more clearly aware of their obligations.
In determining the sanctions, the Appeals
Committee specifically stated that the
sanctions were not applied simply because
there were multiple breaches of the Code
found, but on the basis of the totality of the
conduct. The penalties applied are lower
than might otherwise have been imposed
because at the time the conduct occurred
Roche could not have been aware of
recent decisions of the Code of Conduct
Committee for other complaints which
would have provided further guidance
regarding appropriate and acceptable
conduct with respect to media releases.
The Appeals Committee confirmed that
Section 9.2 applies to both unapproved
products and unapproved indications for
approved products.
Code Committee consideration of a
potential breach of Section 12.3
The substantive issues in relation to the
complaint by GSKA pertaining to Roche
Media Releases 872 had been dealt with
by preceding Code of Conduct and
Appeals Committees and were not for
further consideration.
The Committee considered the response
from GSKA to the question whether it had
engaged in vexatious conduct. GSKA had
expressed surprise to be asked to respond
to the breach of Section 12.3 of the Code.
GSKA had stated that the outcome from
the Tykerb complaint (complaint 867) in
their view had set a precedent for
interpretation of the Code in relation to the
publication of media releases. Having
received the minutes pertaining to Tykerb
867, GSKA lodged the complaint against
Roche in relation to its media releases to
seek further clarification on this matter.
GSKA also drew attention to the fact that
the Code of Conduct and Appeals
Committees had supported GSKAs views
in relation to three Roche media

Code of Conduct Annual Report 2007/2008

statements released in Australia, with

substantial financial sanctions being
imposed by the Code of Conduct
Committee and confirmed with minor
amendment by the Appeals Committee.
The Committee considered the Oxford
dictionary definitions of vexatious and
frivolous and also noted that GSKA had
identified five ways in which a complaint
may give rise to concerns that it is
vexatious.

Vexation - Causing vexation (annoying,

irritating, distressing) and lacking sufficient
grounds for action and seeking only to
annoy defendant
Frivolous not serious, shallow, silly,
trifling
Members were unanimous in their view
that the complaint was not frivolous.
The Committee also noted GSKAs
assertion that the issue of media releases
is important for pharmaceutical companies
and for the Code of Conduct. GSKA had
submitted that they had accepted the
decision of the Code Committee in relation
to complaint 867 and had not appealed the
decision. As a result of the consideration
of complaints Tykerb 867, Tykerb 871 and
Roche Media Releases 872 the intent and
effect of Section 9 of the Code is now
much clearer.
The Committee commented that in relation
to intercompany dialogue, there had been
interactions between GSKA and Roche;
however
it
appeared
there
were
fundamental and unresolvable differences
between them. Some members were of
the view that there appeared to have been
faults on both sides and the matter of
vexatious conduct by GSKA, although
raised by Roche seemed to lack support.
Members commented that it was difficult to
prove intent by GSKA. The Committee
noted the e-mail on 1 August 2007 from
GSKA to Code of Conduct Secretary,
which accompanied the revised complaint.
This
correspondence
provided
a
contemporaneous
view
of
GSKAs
intention in submitting the complaint; that
is, to clarify interpretation of the Code,
which is consistent with its response to the
question of a breach of Section 12.3.
In relation to the amount of information
submitted by GSKA in its complaint and

50

whether this was burdensome on Roche,

the Committee noted that the July Code of
Conduct Committee had requested further
information from GSKA and the Secretariat
had proposed to GSKA that it set out the
revised complaint in a table, identifying
each media release alleged to be in
breach of the Code, the sections of the
Code and the reasons supporting the
allegations of breach of the Code. It was
noted that GSKA had a legitimate right to
complain, even though the complaint
material was substantial. It is not unusual
for a complainant to allege breaches of a
number of different sections of the Code
for a particular activity.
In summarising its reasoning, members
agreed that companies have a legitimate
right to complain, however they must
follow the processes set out in the Code
and Guidelines. There were faults by both
GSKA and Roche in the intercompany
dialogue process and more genuine efforts
could have been made to resolve the
differences between the companies. In
considering the importance of clarifying the
use of media releases pertaining to
prescription
medicines
(whether
unapproved products or unapproved
indications) members were of the view that
the three complaints (867, 871 and 872)
and the appeal in relation to 872 have
resulted in a greater clarity for companies
of what is permissible under the Code
Whilst the 872 complaint had been
voluminous, GSKA had been invited by the
Secretariat to reformulate its complaint in a
detailed tabular form.
In a unanimous decision the Committee
found no breach of Section 12.3 of the
Code by GSKA.

Code of Conduct Annual Report 2007/2008

51

Seretide (873)

Claim 2
Graph titled Inspiratory flow rate with the
claim Accuhaler is the only asthma dry
powder inhaler to deliver consistent dosing
even at low inspiratory flow rates with
transparent
overlay
information
on
Symbicort Turbuhaler.

Subject Company: GlaxoSmithKline

Australia (GSKA)
Complainant: AstraZeneca
Product: Seretide
Complaint
The complainant alleged that the Seretide
detail aid contained several claims that are
not consistent with the body of evidence
and the key findings of the referenced
study stand in direct contrast to the claims.

Issue 1: Excel Study

manipulation of data by GSK

alleged

Claim 1
However, there was a significant
difference in the rate of moderate to
severe exacerbations over time, in favour
of Seretide, in the last two months
(p=0.006)
Claim 2
New evidence: the benefits of Seretides
long lasting control and graph entitled
Number
of
Moderate
to
Severe
Exacerbations
Claim 3
57% lower rate of moderate to severe
exacerbations with Seretide
Claim 4
Seretide is .significantly superior to
[Symbicort] in reducing the rate of
moderate/severe
exacerbations
with
regular, stable dose treatment together
with the EXCEL Claims
Sections of the Code
Material alleged to be in breach of the
following Sections of the Code:
1.3 Nature and Availability of Claims
1.2.2 Level of Substantiating Data
1.3 False or Misleading Claims
1.7 Comparative Statements

Issue 2 Asthma control

inspiratory flow rate

relating

to

Claim 1
Accuhaler for long lasting control in an
award winning device

Code of Conduct Annual Report 2007/2008

Sections of the Code

Material alleged to be in breach of the
following Sections of the Code:
1.1 Nature and Availability of Claims
1.2.2 Level of Substantiating Data
1.3 False or Misleading Claims
1.7 Comparative Statements
Response
GSKA stated that the sales aid subject to
complaint was not in breach of the Code
as it has relied on the appropriate body of
evidence and correctly presented the data
contained in the relevant peer reviewed
publications.
Code Committee determination
The Code Committee unanimously found
breaches of Sections 1.1, 1.2.2, 1.3 and
1.7 of the Code in relation to all claims
under both Issues 1 and 2 of the
complaint.
Sanctions
Take immediate action for the prompt
withdrawal of the Detail Aid and permit
that no further appearance of the item in
its current form or in a manner that
conveys the same or similar meaning.
Corrective
letter
to
all
general
practitioners and respiratory physicians
who had been detailed with the item
found in breach.
Fine of $50,000
Consideration of the complaint

Issue 1: Excel Study

manipulation of data by GSK

alleged

Claim 1
However, there was a significant
difference in the rate of moderate to
severe exacerbations over time, in favour
of Seretide, in the last two months
(p=0.006)
Claim 2
New evidence: the benefits of Seretides
long lasting control and graph entitled
Number
of
Moderate
to
Severe
Exacerbations

52

Claim 3
57% lower rate of moderate to severe
exacerbations with Seretide
Claim 4
Seretide is .significantly superior to
[Symbicort] in reducing the rate of
moderate/severe
exacerbations
with
regular, stable dose treatment together
with the EXCEL Claims
Members of the Committee were of the
view that the graph adapted from the R.
Dahl et al Study (the Excel study)
depicting the number of moderate to
severe exacerbations placed undue
emphasis on this subgroup of the study
without adequately explaining the primary
endpoints which found that the mean rate

of all exacerbations over 24 weeks was

similar in both treatment groups
/fluticasone
propionate
[salmeterol
combination
(SFC)
and
formoterol/budesonide
combination
(FBC)]. It was not sufficiently clear to a

reader that the number of moderate to

severe exacerbations related to 10% of
subjects treated with Seretide and 11% of
subjects treated with Symbicort who had
moderate
to
severe
exacerbations
throughout the study period. The lower
rate of moderate to severe exacerbations
with Seretide was obtained from a post
hoc subgroup analysis and was not a predetermined study endpoint.
The
Committee noted that the summary of the
study in the published reference described
the further post hoc analyses that were
conducted. The Committee noted that the
primary endpoint was not stated in the
tabulation describing the Excel study on
the page opposite the graph; only in the
text under the table.
The Committee considered the clinical
relevance of the numerical imbalance
between the treatment groups with respect
to the number of moderate or severe
exacerbations in the Excel study. Whilst
the difference was just statistically
significant in the final eight weeks of the
study, the Committee questioned the
clinical relevance.
The Committee
considered that the numerical difference
observed in the study should have been
regarded as hypothesis generating rather
than a sound basis for making a major
claim of superiority of Seretide over
Symbicort. The Committee considered
that the referenced data was inadequate
as the basis for the claims.

Code of Conduct Annual Report 2007/2008

The Committee also expressed concern at

the conflation in the promotional material
of the statistical data represented in Table
2 and Figure 3 in the Dahl et al paper,
which gave the adjusted mean rate of
exacerbations per year, with the
representation of Figure 2 of the Dahl
paper which was the cumulative number of
exacerbations.
The figure of 57%
reduction in the rate of exacerbations was
not derived from the cumulative number of
moderate/severe exacerbations but rather
from the adjusted mean rate per year for
moderate/severe exacerbations.
Members also commented that as this
material was being detailed to general
practitioners the definitions of moderate
and severe as used in the study should
have been stated in the promotional
material as the study definitions were not
necessarily the same interpretations as
Australian practitioners would use.
Members were of the view that by
substituting the word is into the claim in
place of the study outcome statement
which used was makes a generalisation
of the study data which is not appropriate.
(Use of Seretide is .significantly
superior instead of the stated conclusion
SFC was found)
The Committee concluded unanimously
that the claims and associated graphical
representation of data from the Excel
study on pages 7 and 8 of the detail aid
were unbalanced, misleading and made
an unfair comparison with Symbicort. The
data were inadequate, being a post-hoc
secondary analysis of a sub-group of
questionable clinical significance, on which
to basis a major comparative claim. Lack
of qualifiers makes this table and claim
misleading and was in breach of Sections
1.1, 1.2.2, 1.3 and 1.7 of the Code.

Issue 2 Asthma control

inspiratory flow rate

relating

to

Claim 1
Accuhaler for long lasting control in an
award winning device
Claim 2
Graph titled Inspiratory flow rate with the
claim Accuhaler is the only asthma dry
powder inhaler to deliver consistent dosing
even at low inspiratory flow rates with
transparent
overlay
information
on
Symbicort Turbuhaler.

53

Members of the Committee expressed

concern that one reference was a 1998
abstract (in-house company information)
that had never been published providing
the Seretide Accuhaler data and this was
used to make comparisons with data
generated in 2004 for Symbicort. Whilst
noting the qualifying statement that the
graphs were adapted from two separate in
vitro studies, members were of the view
that the comparison on a single graph was
inappropriate as the evidence for Seretide
was of inadequate quality, being an
abstract of an unpublished in-house study,
on which to base a comparative claim.
Also, the clinical relevance of the in vitro
data has not been established. The claim
for long-lasting control was not relevant to
the data presented in the graph, which
only related to dose delivered at different
inspiratory flow rates. Members concluded
that
the
graph
was
misleading,
unbalanced, and the substantiating data
was selective and inadequate. It made an
unfair
comparison
with
Symbicort
Turbuhaler.
Members also commented that because
the Accuhaler device is award winning as
a technological achievement, this does not
constitute an endorsement of the clinical
outcome of its use with a medicine.
The Committee found a breach of Sections
1.1, 1.2.2, 1.3 and 1.7 of the Code in
relation to Claims 1 and 2 under Issue 2.

The Committee determined that GSKA

should:
Take immediate action for the prompt
withdrawal of the Detail Aid found in
breach of the Code and advise medical
representatives
that
no
further
appearance of any item in its current
form or in a manner that conveys the
same of similar meaning is permitted.
Send a corrective letter to all general
practitioners and respiratory physicians
who had been detailed with the item
found in breach. The letter should
communicate to recipients that the
promotional material for Seretide had
been found in breach of the Code.
On the basis of the primary endpoints in
the Excel study no significant difference
had been found between Symbicort
Turbuhaler and Seretide Accuhaler.
Claims for superiority of Seretide over
Symbicort had been found in breach of
the Code because they could not be
adequately substantiated.
The promotional material had included
claims regarding dose delivery at
different inspiratory flow rates that were
based on selective data that could not
be substantiated.
Pay a fine of $50,000. In imposing this
fine the Committee stated that it had
taken into account the requirement for a
corrective letter as well.

Members were of the view that this was a

moderate breach and whilst there was no
potential for patient harm there was the
potential for having an effect on how the
medical profession will prescribe the
product.
The Committee also commented that
GSKA should take more care when
preparing detail aids or leave behind
materials for healthcare professionals.
Poor quality information does not enhance
the image of the industry and whilst there
was no allegation of a breach of Section
10.8 members were concerned that the
level of information and education in this
item could reduce confidence in the
industry.
Sanctions
Having found several breaches of the
Code, the Committee considered an
appropriate sanction.

Code of Conduct Annual Report 2007/2008

54

Norspan (874)
Subject Company: Mundipharma
Complainant: Healthcare professional
Product: Norspan
Complaint
The complainant expressed concern at the
marketing of Norpsan by Mundipharma to
general practitioners. It was alleged that at
an
education
evening
hosted
by
Mundipharma the case study used gave
misleading advice to GPs and the company
was misrepresenting the true indications of
Norspan and other opioid products. The
Complainant also alleged that insufficient
attention had been given to the risks and
management of long-term dependency, side
effects and problems of withdrawing from
the medication.
Sections of the Code
The Secretariat had asked Mundipharma
to respond to the complaint with regard to
the following Sections of the Code:
1.1 Nature and availability of claims
1.3 False and misleading claims
1.3.1 Unapproved products and
indications
Response
Mundipharma
maintained
that
all
information and medical claims presented
to doctors in the Continuing Medical
Education (CME) meeting were balanced,
accurate and fully supported by the
Norspan Product Information. Further, the
material presented at the CME meeting
was consistent with the approved
indication for Norspan.
Code Committee determination
In a majority decision the Code Committee
found no breach of Sections 1.1, 1.3 or
1.3.1 of the Code.
Consideration of the complaint
The
Committee
commented
that
healthcare professionals will consider the
evidence for using a particular medicine
from a range of sources. This will include
the Product Information (PI), published
studies and information provided at an
educational event. The Committee also
noted that the meeting in question was an
educational activity accredited by the
Royal Australian College of General
Practitioners (RACGP) and the Australian

Code of Conduct Annual Report 2007/2008

College of Rural and Remote Medicine

(ACRRM) Total CPD points: 4 (Group 2).
The Committee noted the attendees
comments in the evaluation questionnaires
that they had benefited from attending the
meeting with 93% considering the
presentation to be sufficiently evidence
based.
Members also commented that it is the
responsibility of a treating doctor to use a
medicine in accordance with the PI and to
make decisions on each patients specific
needs.
Members noted that the case
study referred to by the complainant was
consistent with subjects included in the
pivotal Phase III study reported in the
Norspan PI.
The majority of members were of the view
that the presentation used at the CME
meeting provided sufficient scientific
evidence and information to enable a
prescriber to make an informed decision.
Members also noted that Mundipharmas
response stated that issues such a weight
management and diet were part of the
management plan. The presenter, who
had provided a letter to Mundipharma
summarising
the
content
of
his
presentation, had emphasised to the
audience that opiods are not first line
therapy for patients and that a trial of
opiates should be instituted to determine a
patients
response,
particularly
in
improvement of function before committing
to long term use and that ongoing
monitoring if response to the opiates in
both pain relief and improvement of
function, is paramount.
However, a few members were of the view
that the moderators handbook and power
point presentation were not totally
balanced. The potential side effects for
Norspan were not emphasised whereas
there was considerable attention given to
the side effects of non-steroidal antiinflammatory drugs (NSAIDs) and there
was no recommendation to institute weight
loss measures for the case study subject
who was obese. However, the Committee
noted that these issues had not been
specifically raised by the complainant and
Mundipharma had not had the opportunity
to respond to them.
The Committee noted that the adverse
effects in patients who had been
prescribed Norspan reported by the
complainant were all listed in the Product

55

Information, which had been included in

the reading material for participants in the
CME meeting. It was also noted that one
report of side effects provided by the
complainant noted that the patient had
been commenced on 10 microgram
Norspan
patches
whereas
the
recommended starting dose is 5
micrograms.
By a majority decision the Committee
concluded that there was no breach of
Sections 1.1, 1.3 and 1.3.1 of the Code.
Whilst some members of the Committee
had some concerns that the slide
presentation and printed material were not
completely balanced, the correspondence
from the presenter, which had reported the
points he had emphasised in his
presentation, was one of the factors that
mitigated the Committees concerns in this
particular instance.

Code of Conduct Annual Report 2007/2008

56

Penthrox (875)
Subject Company: Device Technologies
Complainant: Therapeutic Goods
Administration (TGA)
Product: Penthrox
Complaint
The complainant alleged that an article in
Device News March 2007, published by
Device Technologies, promoted the
analgesic methoxyflurane rather than the
device which it purports to promote and
there was no reference to the side effects
from methoxyflurane and no Product
Information had been included.
The
complainant further stated that when the
website was consulted, which required no
password and therefore was freely
accessible to the public, there was no CMI
available and the article was promotional
in tone and promoted unapproved
indications. The complainant alleged that
the behaviour is likely to bring the industry
into discredit.
Sections of the Code
Materials alleged to be in breach of the
following Sections of the Code:
1.3 False or Misleading Claims
3.3.1 Printed Promotional Material
3.4.2 Mailings
9.6 Use of the Internet
9.6.3 Use of the Internet
10.8 Discredit to, and reduction of
confidence in the Industry
Response
Device Technologies acknowledged the
validity of a number of aspects of the
complaint and advised that it had taken
immediate corrective actions to ensure
compliance with the Code by removing all
internet advertising for Penthrox. As the
majority of products supplied by Device
Technologies are medical devices they
were not as familiar with requirements for
advertising a medicine or the Medicines
Australia Code.
Device Technologies
maintained that the intention of the article
was to promote the device, but
acknowledged that the content may have
been poorly constructed leading to
possible misinterpretation. However there
was no intention to bring discredit to the
industry.

Code of Conduct Annual Report 2007/2008

Code Committee determination

In a unanimous decision the Committee
found a breach of Sections 1.3, 3.3.1,
3.4.2, 9.6 and 9.6.3 of the Code.
No breach of Section 10.8 of the Code was
found.
Sanctions
Withdraw material found in breach from
the website
Corrective letter to all recipients of the
newsletter and to place this corrective
letter on the website where the
newsletter appears
Consideration of the complaint
The Committee noted that this complaint
was in relation to an article promoting a
prescription medicine and the medicine
delivery device. Members were of the view
that a company that markets any
therapeutic good should be aware of the
Therapeutic Goods Advertising Code and
applicable
industry
Codes
of
Conduct/Practice. However the Committee
noted that Device Technologies had
immediately undertaken corrective action
on being advised of the complaint. The
company had implemented new polices in
relation to approval processes within the
organisation and in providing training to all
staff in the area of compliance with
advertising requirements.
Members were of the view that the article
was in breach of Sections 1.3, 3.3.1, 3.4.2,
9.6 and 9.6.3 of the Code as it contained
promotional statements in relation to a
prescription medicine that could be
accessed by members of the general
public on the internet and was not
balanced in terms of communicating the
precautions, side effects, interactions with
other medicines etc.
Members were
particularly concerned that the article
claimed that the medicine has no known
side effects and provides safe and
effective pain relief whereas the medicine
is a potent inhalational anaesthetic with
well known risks. The Product Information
includes a number of precautions and
contraindications and also a warning to
health workers who are regularly exposed
to patients using Penthrox inhalers.
Sanctions
Having found a number of breaches of the
Code the Committee considered an
appropriate sanction.

57

Although this medicine is only available in

restricted circumstances, the information
provided to health practitioners should be
corrected. The Committee determined
that Device Technologies must distribute a
corrective letter that highlights the side
effect section of the Product Information to
all recipients of the Device News (March
2007) and in addition that Device
Technologies
should
publish
this
corrective letter on the website where the
newsletters can be found. The content of
this corrective letter must be approved by
the Committee prior to publication and
distribution.

Code of Conduct Annual Report 2007/2008

58

Olmetec (876)
Subject Company: Schering-Plough
Complainant: AstraZeneca
Product: Olmetec

Amend
the
Minimum
Product
Information as was proposed in
intercompany dialogue.
Consider amending the CMI to more
closely reflect the dosage described in
the Product Information in relation to the
elderly and special populations.

Complaint
The complainant alleged that two
important pieces of information were not
included in a promotional item for Olmetec.
These are the omission of the
recommended starting dose for the elderly
which is 10mg and that the 10mg tablets
are not PBS listed and are not currently
available in Australia. AstraZeneca stated
that this omission of relevant dosage
information is misleading to prescribers
and
exposes
elderly
patients
to
unnecessary safety risk and is therefore a
severe breach of the Code.

Consideration of the complaint

The Committee noted that there had been
considerable intercompany dialogue and
that the two companies had resolved the
majority of the issues originally subject to
complaint. The Committee congratulated
both companies on the manner in which
this was undertaken.

Sections of the Code

Materials alleged to be in breach of the
following Sections of the Code:
1.1 Responsibility
1.3 False or Misleading Claims
10.8 Discredit to, and reduction of
confidence in the Industry

In relation to the concern that whilst the

10mg dose in the elderly and people with
renal insufficiency was approved in
Australia, a 10mg tablet was not currently
available, Members noted the advice from
Schering-Plough that the inclusion of a
statement in the Product Information that
10mg is not currently available in Australia
had been accepted by the TGA and
Schering-Plough.

Response
Schering-Plough rejected the allegations.
It stated that information on the 10mg
dosage had not been included because
this strength is not available in Australia
and that a starting dose of 20mg in the
elderly does not represent a significant
safety risk. The materials included the
Minimum Product Information and the list
of precautions including use in the elderly,
enabling prescribers to be well informed
and avoid safety issues.
Code Committee determination
In a unanimous decision the Committee
found a breach of Sections 1.1 and 1.3 of
the Code.
No breach of Section 10.8 was found.
Sanctions
Withdraw materials found in breach.
Corrective letter to all healthcare
professionals detailed with the item
Corrective
advertisement
to
be
published in the same journals as the
advertisement found in breach

Code of Conduct Annual Report 2007/2008

Members noted the offers by ScheringPlough to amend the Minimum Product

Information and provide the full Product
Information to all healthcare professionals
being detailed with Olmetec.

The Committee reviewed the Product

Information for specific references to the
elderly:
Page 8 Use in the elderly; and
Page 13 Dosage and Administration
Special Populations Elderly where a
lower starting dose of 10mg once daily is
recommended.
The Committee also reviewed the
Minimum Product Information included on
the advertisement and noted that it did not
include any reference to a recommended
starting dose of 10mg in the elderly.
Rather it stated that The dose of
olmesartan medoxomil should not exceed
20mg daily..
Members were of the view that use of
medicines by the elderly is a matter that
must be taken seriously and advertised
appropriately. The principles of the quality
use of medicines require that only
medicines that are scored for cutting or
breaking can be recommended for use at a
reduced dosage. Olmetec is not scored.
Therefore it would not be appropriate for a

59

healthcare professional to tell a patient to

cut the 20mg Olmetec tablet in half
because the 10mg dose was not available
in Australia. It was also noted that many
elderly patients may have difficulty cutting
a tablet even if it was scored.

The Committee did not impose a fine as

there had been considerable attempts to
resolve the complaint and amend the
information during intercompany dialogue.

Having reviewed the literature and based

on the knowledge of the healthcare
professionals members, the Committee
accepted that as many as 65%-70% of
patients with hypertension will be elderly.
The Committee considered that the
Olmetec promotional material should make
it clear to a prescriber that the
recommended starting dose for the elderly
is 10mg and include clear advice that
10mg is currently not available in Australia.
The Committee was of the view that
although it is acceptable for a company to
promote a specific dose or formulation to
healthcare professionals, the content of
any advertisement or leave behind must
be consistent with the Product Information
and where there is a specific reference to
a different starting dose for a particular
population such as the elderly this should
be included in the Minimum Product
Information and on the item. The omission
of this information was misleading and
unbalanced and was therefore in breach of
Sections 1.1 and 1.3 of the Code. The
Committee did not consider that the issues
would bring the industry into disrepute and
noted that Schering-Plough had made
significant
endeavours
to
propose
amendments that would have corrected
the breaches.
Sanctions
Having found the materials in breach of
the Code the Committee considered an
appropriate sanction.
The Committee determined that ScheringPlough should:
Withdraw the materials found in breach
Send a corrective letter to all healthcare
professionals detailed with the leave
behind
Publish a corrective advertisement in the
same journals as the advertisement
found in breach
Amend
the
Minimum
Product
Information as was proposed in
intercompany dialogue
Consider amending the CMI to more
closely reflect the dosage described in
the Product Information in relation to the
elderly and special populations

Code of Conduct Annual Report 2007/2008

60

Actonel (877)
Subject Company: sanofi-aventis
Complainant: Merck Sharp & Dohme
(Australia) [MSDA]
Product: Actonel
Complaint
The complainant alleged that a sanofiaventis detail aid failed to make
appropriate disclosure of the limitations of
the data presented and made significant
claims of superiority based on a
retrospective observational study.
Sections of the Code
Materials alleged to be in breach of the
following Sections of the Code:
1.2.1 Provision of Substantiating Data
1.2.2 Level of Substantiating Data
1.3 False of Misleading Claims
1.7 Comparative Statements
Response
Sanofi-aventis denied any breach of the
Code and responded that the data were
taken from the REAL study which is a
robust study with rigorous methodological
design that includes full methodological
explanations of any potential bias within
the published results and can withstand
scrutiny in this regard. Sanofi-aventis
argued that it would be inappropriate to
dismiss the data simply because it was an
observational study.
Code Committee and Appeals Committee
determinations
There were three matters before the
Committee that had not been resolved
through intercompany dialogue.
In relation to the unresolved item 3.1 in the
complaint the Committee found a breach
of Section 1.3 of the Code by unanimous
decision. (Decision confirmed by the
Appeals Committee)
In relation to the unresolved item 3.5 in the
complaint the Committee found a breach
of Section 1.3 of the Code by unanimous
decision. (Decision confirmed by the
Appeals Committee)
In relation to the unresolved item 3.8 in the
complaint the Committee found a breach
of Sections 1.2.2 and 1.3 of the Code by

Code of Conduct Annual Report 2007/2008

unanimous decision. (Decision confirmed

by the Appeals Committee)
Sanctions
Withdraw materials found in breach
Fine of $100,000 (Fine amended to
$80,000 by the Appeals Committee)
Corrective letter to all General
Practitioners

Code of Conduct Committee

Consideration of the complaint
The Committee noted that many of the
issues raised in the original complaint had
been resolved during intercompany
dialogue and only three matters remained
unresolved that had been referred to the
Committee. However the Committee
expressed some reservations about what
was agreed to by both parties and the
allegations by sanofi-aventis that MSDA
had later rescinded their agreement.
Item 3.1 in complaint - Graphs
representing non vertebral data for
Fosamax (Alendronate) and Actonel
Members were concerned that the graphs
had been adapted from the data in the
studies and did not provide a healthcare
professional with any information about the
different patient populations or trial
designs. Members also commented that a
healthcare professional may not be aware
of whether the evidence was the best
available data for both products or had
been selectively chosen to highlight a
difference which is not consistent with the
body of evidence.
The Committee found a breach of Section
1.3 of the Code because the graphs on
sequential pages of the detail aid were
presented in a manner that invites
comparison and suggested that the two
studies are directly comparable. It was not
clear to a reader that the two studies were
not head to head comparisons nor that the
patient populations and trial designs were
different. The presentation was therefore
misleading.
Item 3.5 in the complaint Actonel
reduces the risk of hip fracture by 60% in
women with established osteoporosis
The Committee considered that the graph
depicted a selected sub-set of the study
population elderly women with confirmed
osteoporosis identified by having a
vertebral fracture at baseline but it was
not clear to a reader that the results

61

depicted did not reflect the total study

population. The graph did not include
confidence intervals which would assist a
reader to appropriately interpret the
information appropriately. In creating
figures using data adapted from a
published paper companies must ensure
they accurately reflect the findings and
include sufficient information to enable
correct interpretation such as confidence
intervals. Some members were of the view
that if a company truly wanted to provide
accurate information it would have
included the actual table from the
published
study.
Members
also
commented that the claims under the
graph did not accurately reflect the study
outcomes and generalised the results from
a particular subset of subjects as though
they were representative of the total study
population, which was misleading.
The Committee found a breach of Section
1.3 of the Code as the information was
misleading as it did not fully or accurately
reflect the outcomes of the referenced
study which stated that Risedronate

significantly reduces the risk of hip

fractures among elderly women with
confirmed osteoporosis but not among
elderly women selected primarily on the
basis of risk factors other than low bone
mineral density. It was noted that the

study population consisted of 5445 women

between 70 and 79 and 3886 women aged
at least 80 years who met a defined
criteria. The results depicted in the graph
did not represent the full study population
of over 9,000 women.

Item 3.8 in the complaint REAL study quote, claims and statements based on
the results of the REAL Study
The Committee was of the view that there
was some risk in using the REAL study as
the basis for making high level
comparative claims that imply Risedronate
is superior to Alendronate in all
circumstances. There is insufficient
information presented to healthcare
professionals in the detail aid to allow
them to make an informed decision of the
true comparison between products. Whilst
the REAL study provided some favourable
comparison for Actonel, the Committee
noted that at least one editorial (Ferrari et
al) suggested the REAL study was not
consistent with randomised controlled
trials which had shown comparable
efficacy between Actonel and Fosamax.

Code of Conduct Annual Report 2007/2008

The Committee found a breach of Sections

1.2.2 and 1.3 of the Code.
Sanctions
Having found a number of breaches of the
Code the Committee considered an
appropriate sanction. The Committee
considered that this was a moderate
breach of the Code that was likely to have
an effect on how the medical profession
would prescribe the product.
The Committee determined that sanofiaventis should:
Withdraw the Detail Aid found in breach
Send a corrective letter to all General
Practitioners informing them that at
present there are inadequate data to
differentiate between risedronate and
alendronate.
The content of this
corrective letter must be approved by the
Committee prior to distribution.
Pay a fine of $100,000

Appeals Committee
Sanofi-aventis appeal
Sanofi-aventis lodged an appeal against
some of the Code Committees findings.
Sanofi-aventis considered that there had
been inconsistencies between the specific
complaints lodged by MSDA and the basis
of the Code Committees rulings. In the
companys view the Committee did not
appreciate that the comparative claims for
the efficacy of Actonel all related
specifically to fracture risk reduction within
the first 12 months. Additionally, sanofiaventis argued that the sanctions were too
great for a moderate breach and appeared
inconsistent with other decisions. It also
claimed that the Committee had not taken
into account that the detail aid was
withdrawn to implement all changes that
were agreed as recorded in the
intercompany dialogue minutes.
Sanofi-aventis stated that it would be
inappropriate to dismiss the REAL study
merely on the basis that it was an
observational study and that MSDA should
not rely on a generic allegation that
observational studies are insufficient to
support comparative claims. The study
had dealt with the potential for
confounding bias and is consistent with the
body of evidence.
Sanofi-aventis
considered
that
the
presentation of the graphs from the
individual randomised controlled trials was

62

clear and presented in a manner that

avoided any confusion or suggestion that
they were directly comparative. Sanofiaventis also stated that the claims are an
accurate reflection of the REAL Study and
consistent with the body of evidence.
MSDA response to appeal
MSDA stated that the use of the REAL
Study results as a basis for significant
claims of superiority was not justified. The
limitations
of
this
retrospective
observational study do not permit the
claims to be made, especially when they
are not consistent with the randomised
controlled trials.
MSDA also responded that it had not been
aware that the detail aid was no longer
being used because the letter from sanofiaventis informing them of its withdrawal
was received after the complaint had been
lodged.
The fact that it had been
withdrawn did not remedy that the breach
had already occurred. MSDA further stated
that the fine imposed by the Committee
was within the range available to them.
Consideration of the appeal
The following outlines the appeal
presentation made by sanofiaventis:
Some of the Committees rationale and
findings were inconsistent with the
claims being made and supporting
evidence provided.
The promotional piece specifically
promotes the early (6 months) reduction
in fracture risk with risedronate in post
menopausal women, but the Code
Committee minutes did not record this
critical element to understanding the
context of the promotion.
The promotional piece specifically
highlights this distinguishing effect of
risedronate through comparison with
alendronate
utilising
randomised
controlled trials (RCTs) and an
observational study.
The graphs pertaining to non-vertebral
data for alendronate and risedronate
were on separate pages, were clearly
annotated as each being against
placebo controls and contained a brief
description of the study under the graph
with references. The presentation would
not lead a healthcare professional into
believing that the graphs represented a
head to head comparison.
The Code does not prohibit comparison
between non-head to head data.

Code of Conduct Annual Report 2007/2008

The Code Committee had found that the

REAL study was not consistent with the
body of evidence.
Sanofi-aventis
contended that the detail aid represents
the combined data from the pivotal
RCTs for each of the drugs for reduction
of risk of fracture at 6 months. The
validity of these data had not been
questioned by MSDA.
sanofi-aventis
was
not
claiming
superiority for risedronate in all
circumstances, only superior fracture
risk reduction at 6 months, which was
the context of the promotional piece as a
whole.
sanofi-aventis had agreed to modify the
title of the graph presenting the REAL
study data in intercompany dialogue.
The Code does not prohibit use of
observational studies as supportive
evidence.
The REAL study was described in the
detail aid as complements RCT in early
fracture risk reduction. The claims were
consistent with the RCTs; the body of
evidence for this endpoint.
In relation to the graph presenting
results from the Hip Intervention
Program (HIP) study, the associated
claim accurately reflects the authors
conclusion for the relevant predefined
subpopulation of patients.
Other patients enrolled were outside the
approved indications. The claim based
on the sub-population analysis is
relevant to the approved indications and
PBS listings.
There is sufficient information provided
with the graph for a healthcare
professional
to
understand
the
implications of the data:
Graph includes description of
subgroup
Graph includes the n-value of
subgroup
However, given the potential for the
reference to the full study population
under the graph, 9000 to be
misleading, sanofi-aventis agreed to
the changes as stated in the minutes of
the teleconference with MSDA dated 31
May 2007. Sanofi-aventis considered
the matter resolved prior to lodgement
of the complaint.
Sanofi-aventis summarised the appeal as
follows:
Appeal relates to a number of critical
flaws in the findings of the Code
Committee, specifically:

63

The data referenced in the detail

aid support the specific claim that
risedronate has demonstrated a
fracture risk reduction benefit at 6
months whereas alendronate has
not.
This specific claim is entirely
consistent with the body of
evidence.
The data representation provides
adequate information to enable
correct
interpretation
by
professionally trained clinicians.
Nevertheless
sanofi-aventis
appreciates potential interpretative
concerns with the representation
of the data and agreed to
implement
mutually
agreed
resolutions.
Sanofi-aventis
questions
the
Committees findings and the
justification for the sanction
imposed.

The following outlines the presentation in

response to the appeal by MSDA:
The detail aid:
As a whole failed to adequately
disclose the limitations of the
results from the REAL study.
Significant medical claims for
superiority of risedronate were
made on the basis of data from a
study that was inadequate in
design to support these claims.
There was insufficient information
in the detail aid to allow an
informed decision regarding the
true comparison of efficacy
between the two products.
The fact that the graphs on non-vertebral
fracture risk were on sequential pages
doesnt mean that a comparison
between risedronate and alendronate
wasnt invited. The detail aid invited
comparison by:
Identical presentation of the
risedronate
and
alendronate
graphs
Colour, format, font etc identical
Presented on sequential pages easily switch between one graph
to the next
Headings invite comparison
Footnotes beneath the graphs were
inadequate to inform a reader of
important differences between the
studies such that they are not directly
comparable

different
patient
populations and study designs.

Code of Conduct Annual Report 2007/2008

The study referenced in the alendronate

graph used 5mg for two years and then
increased to 10mg dose. This dosage
regimen is not optimal to study the onset
of effect in fracture risk reduction and
was therefore not a fair comparison.
HIP study graph
In relation to the HIP study, the graph
displaying 60% relative risk reduction
appeared under a general heading about
hip fractures, with a dot point below that
refers to the full study population.
The qualifying statement below the
graph was inadequate in size, but this
was resolved in intercompany dialogue.
There was a 28% relative risk reduction
in the total study population; 60%
reduction was seen in a sub-population
who had a fracture a baseline. It is
inevitable that a different patient
population
will
achieve
different
outcomes.
The presentation of the HIP data was not
full or accurate.
The REAL study data do not meet Code
requirements for unequivocal and
highest
quality
evidence
to
substantiate claims.
Efficacy results from the retrospective,
observational REAL study were not
consistent with RCT data.
Design and other specific limitations of
REAL study mean that the study cannot
demonstrate whether there are real
differences in efficacy between the two
drugs.
Insufficient information was included in
detail aid to allow informed decision of
true comparison between treatments.
In a commentary on the REAL study,
Ferrari and Rizzoli stated this

observational study (REAL) by design

cannot demonstrate whether there are
real differences in efficacy between the
two drugs. However it might suggest that
to reproduce drug efficacy, as
demonstrated in RCTs, in real life, full
adherence to treatment is required.

In closing comments, the sanofi-aventis

representatives made the following points:
The detail aid highlights differences with
respect to early fracture risk reduction, at
6 months and twelve months. It does
not claim overall superior efficacy of
Actonel.
There are agreed limitations of
observational studies; the detail aid

64

seeks to communicate the trends shown

by the body evidence.
The
MSDA
and
sanofi-aventis
representatives left the meeting following
these presentations.
Appeals Committee members considered
the referenced data for both alendronate
and risedronate and were of the view that
both were effective treatments for
osteoporosis however there was no data
that supported the view that one treatment
was more effective overall than the other.
The Committee noted sanofi-aventis
argument that the detail aid should be
considered in the context of claims about
early reduction of fracture risk with
Actonel. It was noted that whilst there is
evidence that risedronate reduces the risk
of non-vertebral fractures after six months
treatment in an appropriately selected
group of patients, there is currently no
evidence that this is also the case for
alendronate.
The Committee was of the view that
although not every page of the detail aid
made a direct comparison between
alendronate and risedronate, the overall
inference was there; the inclusion of the
data for a competitor product invites the
comparison between the two products. It
was also noted that the headings on each
page added to the comparative nature of
the piece. Direct comparisons between
alendronate and risedronate were made
on three pages of the detail aid.
The Appeals Committee considered each
aspect of the sanofi-aventis appeal.
Item 3.1 in complaint - Graphs
representing non vertebral fracture data for
Alendronate and Actonel
The Appeals Committee accepted that the
graphs pertaining to non-vertebral fracture
data for alendronate and risedronate were
on separate pages and were annotated
with either alendronate vs placebo and
risedronate vs placebo. There was a brief
description of the relevant studies and
references, which should not lead a
healthcare professional to the view that the
graphs represented a head to head
comparison. On this point the Appeals
Committee differed from the Code
Committee.
However
the
Appeals
Committee
remained of the view that the presentation

Code of Conduct Annual Report 2007/2008

of the data on alendronate and linking the

information with that for risedronate
through headings and claims was clearly
intended to invite comparison, which in this
case was misleading. The referenced
studies were different patient populations
and trial designs; it was not clear to a
reader that in the alendronate study
patients were initiated on a low dose of
5mg and switched to 10mg after two years.
It was further noted there was a trend in
the meta-analysis to reflect a greater effect
with higher dosing of alendronate. The
inferred comparison between alendronate
and Actonel was therefore not fair and was
misleading.
The Appeals Committee did not uphold the
appeal in relation to the breach of Section
1.3 of the Code.
Item 3.5 in the complaint Actonel
reduces the risk of hip fracture by 60% in
women with established osteoporosis
The Appeals Committee did not uphold the
appeal in relation to the breach of Section
1.3 of the Code for the reasons set out by
the Code of Conduct Committee. The
Appeals Committee noted that sanofiaventis had agreed to amend and clarify
this claim.
Item 3.8 in the complaint REAL study quote, claims and statements based on
the results of the REAL Study
The Appeals Committee accepted that the
REAL study was appropriately conducted.
Nevertheless the two patient populations
those treated with alendronate and those
with risedronate were not directly
comparable at baseline, which is a
limitation of the study data. This limitation
would not be apparent to a reader and had
not been clearly communicated in the
detail aid. The Appeals Committee did not
uphold the appeal in relation to the breach
of Sections 1.2.2 and 1.3 of the Code for
the reasons set out by the Code of
Conduct Committee.
Sanctions
Having not upheld the appeal, the Appeals
Committee considered whether the
sanctions determined by the Code of
Conduct Committee were appropriate.
The Committee considered that this was a
moderate breach of the Code that was
likely to have an effect on how the medical
profession would prescribe the product.

65

The Committee determined that sanofiaventis should:

Withdraw the Detail Aid found in breach
and allow no further appearance of the
graphs and claims found in breach of the
Code in the same or similar form.
Send a corrective letter to all General
Practitioners who had been detailed with
the item found in breach of the Code,
informing them that at present there are
inadequate data to differentiate between
risedronate and alendronate.
The
content of this corrective letter must be
approved by the Committee prior to
distribution.
Pay a fine of $80,000. The Appeals
Committee reduced the fine, which was
at the upper limit of fines although the
breach was considered moderate, after
consideration of sanctions applied to
breaches of a similar nature.

Code of Conduct Annual Report 2007/2008

66

Femara (878)

Consideration of the complaint

The Committee noted the extensive
negotiation
and
dialogue
between
AstraZeneca and Novartis and that there
had been a similar complaint considered in
New Zealand.

Subject Company: Novartis

Pharmaceuticals (Novartis)
Complainant: AstraZeneca
Product: Femara
Complaint
AstraZeneca
alleged
that
Novartis
promotion of Femara used only a 26-month
analysis of the BIG 1-98 study when a 51month analysis had also been published,
resulting in inaccurate promotional items
due to the omission of information reflecting
the most current data available.
The second aspect of the complaint related
to the outcome measure Time to Distant
Recurrence (TTDR) which is identified as an
exploratory endpoint in the BIG 1-98
publication, whereas in the Femara Product
Information the endpoint is stated as Distant
Disease Free Survival (DDFS) and
described as a secondary endpoint of the
trial.
Sections of the Code
Materials alleged to be in breach of the
following Sections of the Code:
1.2.2 Level of Substantiating Data
1.3 False and Misleading Claims
Response
Novartis had responded that they believe
that the Primary Code Analysis of the BIG
1-98 trial is the first and only complete
analysis and remains the reference data
set for promotional items for letrozole
(Femara).
In relation to the terminology for the
endpoint, Novartis was of the view that
whether it is defined as additional or
secondary is immaterial when they have
undergone regulatory scrutiny and are
accepted by the clinical community as
being highly relevant.
Code Committee determination

Issue 1: Continued promotion of the Breast

International Group (BIG) 1-98 26-month
analysis without any reference to the 51month analysis
No breach of Section 1.3 of the Code

Issue 2: Use
Recurrence

of

Time

to

Distant

No breach of Section 1.2.2 of the Code

Code of Conduct Annual Report 2007/2008

The Committee reviewed the Breast

Cancer International Group (BIG) 1-98
Study first publication and subsequent
analysis. The study is a randomised,
phase 3, double blind trial that compared
five years of treatment with various
adjuvant endocrine therapy regimens in
post menopausal women with hormone
receptor-positive breast cancer. Subjects
were randomised to receive either:
Letrozole
Letrozole followed by tamoxifen
Tamoxifen
Tamoxifen followed by letrozole
Two analyses of the BIG 1-98 study have
been published:

New England Journal of Medicine (NEJM),

29 December, 2005
This analysis, referred to as the Primary
Core Analysis, compared the two groups
assigned to receive letrozole alone
(letrozole alone and letrozole prior to
switching to tamoxifen) with the two
groups assigned to receive tamoxifen
alone (tamoxifen alone and tamoxifen
prior to switching to letrozole) for the first
two years of the study.
Outcomes for subjects in the two
sequential-treatment
groups
were
included up to the time that treatments
were switched at two years.

Journal of Clinical Oncology (JCO), 2

January 2007
This second analysis of the data included
only those subjects in the letrozole-only
and tamoxifen-only arms of the study, i.e.
excluding the two arms where subjects
would switch to the alternative treatment.
The authors stated that they had
conducted this analysis to assist other
investigators who may wish to perform
meta-analyses of these data. The authors
had also stated that the primary analysis
published in the NEJM may unduly overrepresent early events.
The second
published analysis was limited to patients
randomly assigned to continuous therapy
arms, so the number of subjects included
in this analysis was lower than the total
group in the trial, and included protocoldefined updated results.
The second

67

analysis had not been submitted to the

FDA or TGA because Novartis did not
have access to these data and was
therefore not included in the Femara
Product Information.

statement with the BIG 1-98 results that

these results are definitive in real time but
further analyses have been planned and
will resolve the potential early event bias
identified by the investigators.

The Committee noted that the Primary

Core Analysis was the basis on which
letrozole was registered in Australia. It was
also noted that further analyses had been
planned by the study investigators. The
JCO analysis at 51-months was one of the
additional analyses. In considering the
complaint Members commented that the
results from the JCO analysis were
supportive of the primary core analysis.

Issue 2: Use of
Recurrence (TTDR)

Issue 1: Continued promotion of the Breast

International Group (BIG) 1-98 26-month
analysis without any reference to the 51month analysis

Members commented that the issue to be

considered is whether the 51-month data
is materially or substantially different to the
primary core analysis which could
potentially make the Femara promotional
materials misleading. The Committee was
of the view that the use of the primary core
analysis as substantiating data for the
promotional items was not misleading as
the 2007 JCO analysis was essentially
confirmatory of the primary core analysis
and because the claims were supported by
the Product Information.
The NEJM
analysis was a primary core analysis
performed in accordance with the protocol.
The Committee did not agree with
AstraZenecas assertion that the JCO
analysis was a further interim analysis,
following the analyses performed by the
Data Safety Monitoring Board, described
in the protocol, when 24% of events and
67% of events had been accrued. The
JCO
was
an
additional
analysis
documented
as
a
late
protocol
amendment, for the reasons stated by the
investigators noted above.
The JCO
published analysis is not materially or
substantially different to the primary
analysis published in the NEJM.
The Committee unanimously found no
breach of Section 1.3 of the Code.
Members commented that it takes a long
time to collect and analyse data in breast
cancer trials, however accrued evidence
can be reported in real time. Some
members suggested that it may be useful
in the future to include an explanatory

Code of Conduct Annual Report 2007/2008

Time

to

Distant

The Committee noted AstraZenecas

statement that in the BIG 1-98 publications
TTDR is listed as an exploratory endpoint,
however
in
the
Femara
Product
Information it is identified as Distant
Disease Free Survival (DDFS) and a
secondary endpoint.
The Committee noted that AstraZeneca
and Novartis agreed on the importance
and clinical validity of distant cancer
recurrence which indicates a worse
prognosis than local recurrence of breast
cancer. Members also noted that Novartis
was currently seeking clarification from the
IBCSG on this matter.
The Committee noted that the measure of
TTDR was not included in the original
study protocol but was added to the
statistical analysis plan as being an
important emerging measure for the future.
Members noted that the TGA had
accepted the term DDFS, which is
essentially the same as TTDR and
reflected the same statistical data
published in the results. There was very
little difference between TTDR and DDFS
and DDFS had been accepted by TGA.
Novartis should be able to use this
endpoint in its promotional material.
However members were also aware that
there had been discussion within the FDA
that the use of DDFS is not specific to
breast cancer as there could be other
causes of death in the breast cancer study
patients.
Members considered that AstraZenecas
arguments concerning whether this was an
exploratory or secondary endpoint were
not sustainable. This is an endpoint that
emerged as relevant during the study, and
the analysis was done carefully and
properly and described in the change to
the statistical analysis.
One member
suggested that if future advertisements
refer to risk of distant recurrence that it
might assist interpretation of the data by
also presenting the primary outcome
measure in all advertisements, and making

68

it clear that the DDFS is a measure of

events not a time measure.
The Committee unanimously found no
breach of Section 1.2.2 of the Code in
relation to use of the DDFS endpoint in the
Femara promotional material.

Code of Conduct Annual Report 2007/2008

69

Seretide (879)

3 and Section 3.1.1.3 of the Code. (No

appeal)

Subject Company: GlaxoSmithKline

Australia (GSKA)

Sanction
Withdraw material found in breach
Pay a fine of $50,000

Complainants: Boehringer Ingelheim &

Pfizer Australia (Pfizer)
Product: Seretide
Complaint
The complainants alleged that GSKA had
not provided adequate references to
substantiate the claim Add Seretide
COPD to slow disease progression
(COPD is chronic obstructive pulmonary
disease) and that the claims in relation to
the PBS listing for Seretide for COPD were
misleading.
Sections of the Code
Materials alleged to be in breach of the
following Section of the Code:
1.2.2 Level of Substantiating Data
1.3 False and Misleading Claims
Preamble to Section 3, Promotional
Material
3.1.1.3 Primary Advertisement
Response
GSKA stated that it had relied on an
appropriate body of evidence and correctly
represented the data from the relevant
peer-reviewed publications. In relation to
the PBS listing claim, GSKA stated that a
reader would be sufficiently alerted to the
restricted benefit listing for Seretide.
Code of Conduct and Appeals Committee
determinations

Add Seretide COPD to slow disease

progression
By a unanimous decision the Committee
found no breach of Sections 1.2.2 or 1.3 of
the Code (Decision confirmed by the
Appeals Committee)

We are now PBS listed for COPD and

Seretide is now listed for COPD

By a majority decision the Committee

found a breach of Section 1.3 of the Code.
By a unanimous decision the Committee
found no breach of the preamble to
Section 3 of the Code. (No appeal)

No PBS information on the advertisement

flap

By a unanimous decision the Committee

found a breach of the preamble to Section

Code of Conduct Annual Report 2007/2008

Code of Conduct Committee

Consideration of the complaint
The Committee considered the chronology
of events and key issues in relation to this
complaint:

Jones & Agusti 2006

Questions the reliability of 1977 study on

change in FEV1 (forced expiratory
volume in one second) as the sole
measure of COPD progression.
Offers a list of several indices and
recommends use of several measures of
disease progression rather than one.

TORCH Study published in February 2007

in the New England Journal of Medicine
(NEJM)

Three year study in COPD of all cause

mortality
Included a number of measures
including:
Quality of Life (QoL): St George's
Respiratory
Questionnaire
(SGRQ)
Number of exacerbations
FEV1

Letters to the Editor of the NEJM after the

publication of TORCH, 24 May 2007
P J Barnes: rate of decline in FEV1
significant
P Calverley, the primary author of
TORCH study, responded: rate
decline in lung function could not
inferred from the spirometric data in
TORCH study.

not
the
of
be
the

Data on rate of decline

Abstract of the analysis of the TORCH

data presented at American Thoracic
Society (ATS) May 2007.
Poster of the analysis of the TORCH
data presented at European Respiratory
Society (ERS).
Further analysis of the TORCH data has
been completed and presented at ERS,
which showed that the rate of decline in
FEV1
does
change
with
the
salmeterol/fluticasone
propionate
combination this now supersedes the

70

previous statements on the rate of

decline.

27 July 2007 advertisement subject to

complaint published
3 August 2007 complaint from Boehringer
Ingelheim & Pfizer sent to GSK
17 August 2007 GSK wrote to Boehringer
Ingelheim/Pfizer with a proposal about
including a combination of indices in the
Seretide COPD advertisements

improvements in QoL
improvement in exacerbations
improvements in lung function over
time
reduction in inflammation

27 August 2007 teleconference between

Boehringer Ingelheim, Pfizer and GSKA

Agreement achieved on indices of

disease progression
Disagreed that there is sufficient
evidence (rate of declines in FEV1)

17 September 2007 complaint submitted

to MA
Indices of positive impact on COPD
progression available for Seretide from
TORCH study
Exacerbations: statistically significant
QoL: statistically significant
FEV1: statistically significant at end of
study (rate not included in first
publication subsequently shown to be
statistically significant)
Indices of inflammation (Barnes 2006)

Complaint 1: Add Seretide COPD to slow

disease progression

Members were of the view that having

reviewed the studies provided by the
parties to the complaint, there is evidence
to support the concept that more than one
marker should be taken into account when
considering
the
rate
of
disease
progression in COPD. Members stated
that collectively the references supported
the claim.
While agreeing that the broad scope and
measures of outcomes were valid in
disease progression and QoL some
members were of the view that there could
be more qualification and explanation
within the body of the advertisement and
more comprehensive referencing. The
Committee noted that the references to

Code of Conduct Annual Report 2007/2008

support the claim listed in the

advertisement were the Seretide Product
Information, the TORCH study (Calverley
et al NEJM) and Barnes (2006). The
further analysis of the TORCH data
presented at the ERS was not included as
a reference. However, the TORCH study
did demonstrate statistical improvements
in FEV1, exacerbation rates and QoL
measures. In a unanimous decision the
Committee found no breach of Sections
1.2.2 and 1.3 of the Code

We are now PBS listed for COPD and

Seretide is now listed for COPD
Members were of the view that while
mandatory PBS box appeared on
second page of the advertisement,
statements We are now PBS listed

the
the
the

for
COPD and Seretide is now listed for
COPD in large font on the front page gave
the impression that Seretide was PBS
listed for all COPD patients, without
qualification. Members commented that
while it may be reasonable to expect a
reader to turn the page, is was misleading
to not have qualified or referenced the very
large and bold statements to ensure a
reader would be directed to a statement on
the same page which advised that the
restricted PBS benefit was for a discrete
subgroup of COPD patients.

In a majority decision the Committee found

a breach of Section 1.3 of the Code and in
a unanimous decision the Committee
found no breach of the preamble to
Section 3 of the Code.

No PBS information of the advertisement

flap

Having reviewed the advertisement

subject to complaint in the form it
appeared (Australian Doctor 27 July first
page inserted after page 8 with flap after
page 56) members determined that the
item should be treated as two
advertisements, the first comprising the
two full-sized pages appearing after page
8 and the second comprising the flap
page appearing after page 56.
The
Committee noted that GSKA had not been
able to provide any evidence that it had
requested Australian Doctor to publish the
advertisement as a centrefold.
The
Committee commented that a company
should be able to provide evidence of
instructions for publications, for example
the date of publication and positioning in
the publication.

71

The Committee considered that the

information on the flap advertisement
should
have
complied
with
all
requirements for an advertisement,
including the PBS information, as it was
separate from the other advertisement
which contained the mandatory PBS
information.
In a unanimous decision the Committee
found a breach of the preamble to Section
3 and Section 1.3 of the Code.
Sanction
Having found several breaches of the
Code, the Committee considered an
appropriate sanction.
The Committee
considered that this constituted a
moderate breach of the Code. Whilst
there was no suggestion of major patient
safety issues, the use of a broad statement
pertaining to PBS reimbursement for
COPD without adequate qualification may
influence prescribers in their choice of
product for those patients whose COPD is
less likely to benefit.
The Committee determined that GSKA
should:
Take immediate action to cease using
the advertisements found in breach of
the Code and not use them again in the
same or similar form unless they fully
comply with the Code.
Pay a fine of $50,000
The
Committee
considered
and
determined that there was no requirement
for corrective action.

Appeals Committee
Boehringer Ingelheim/Pfizer appeal
An appeal was lodged by the complainants
Boehringer Ingelheim and Pfizer against
the decision of the Code Committee to find
no breach in relation to the claim Add

Seretide COPD to slow disease

progression .Boehringer Ingelheim and

Pfizer stated that their complaint had

insufficiently emphasized the importance
and significance to the market of this claim
and had inadequately described the
appropriate context in which to assess the
claim and this may have contributed to the
Committee arriving at, what the companies
believe is, an incorrect decision.
Boehringer Ingelheim and Pfizer believe
that to substantiate the claim slows
disease progression GSKA must provide
evidence that Seretide slows deterioration

Code of Conduct Annual Report 2007/2008

in the lung function measure FEV1

(Forced Expiratory Volume in one second)
GSKA response to the appeal
GSKA stated that Boehringer Ingelheim
/Pfizer had had ample opportunity to
present the context and emphasis in their
argument to GSKA in intercompany
dialogue and the Code of Conduct
Committee. GSKA also maintained that
Boehringer Ingelheim/Pfizer had not
provided any new information or
demonstrated an error in the Code of
Conduct Committees process to warrant
this appeal. GSKA stated that the
promotional material and claims were
consistent with current local and
international
evidence-based
COPD
treatment guidelines.
Consideration of the appeal
The following summarises the Boehringer
Ingelheim appeal as presented:
Boehringer
Ingelheim
and
Pfizer
consider that the Code Committee erred
in not adequately considering the
magnitude of the claim Add Seretide
COPD to slow disease progression,
which is a significant and new claim with
respect to COPD and is not supported
by evidence or the Product Information
(PI).
COPD indication for Seretide is For the
symptomatic treatment of patients with
severe COPD (FEV1<50% predicted
normal) and a history of repeated
exacerbations, who have significant
symptoms despite regular beta 2 agonist
bronchodilator therapy.
The claim is in breach of Section 1.2.2
because there is no unequivocal or
highest level of evidence to support the
claim and therefore the claim is also
false and misleading and in breach of
Section 1.3.
The PI includes no indication for
slowing of disease progression; the
COPD indication is only for symptomatic
treatment.
The TORCH study is a very big and
important long term COPD study
Primary outcome was difference in
all cause mortality for the
comparison
between
the
combination regimen and placebo
(which
did
not
achieve
conventional levels of statistical
significance).
Secondary outcomes
frequency
of
COPD
exacerbations

72

 Health status according to St

Georges
Respiratory
questionnaire
Other outcomes
COPD related mortality
On treatment mortality
Severe COPD exacerbations
Clinic
post-bronchodilator
FEV1 (which is not equivalent
to rate of decline in FEV1)
TORCH
does
not
address
disease progression focus was
on mortality.
Statistical analysis of TORCH
does not support the claim that the
treatment reduces mortality.
In relation to the other reference for the
claim, Barnes et al (American Journal of
Respiratory and Critical Care Medicine,
2006):
It was a proof-of-principle study to
ascertain whether inhaled therapy
can modify inflammation in
COPD.
Methodology included bronchial
biopsies and induced sputum from
140 subjects.
Conclusion: The combination of
salmeterol
and
fluticasone
propionate has a broad spectrum
of anti-inflammatory effects in both
current and former smokers with
COPD.
It does not address COPD disease
progression and does not support
the claim.
In making the claim that Seretide slows
disease progression, GSKA is in breach
of:
Code Section 1.2.2 Level of
substantiating data as none of the
references (the Seretide PI,
Calverley 2007, Barnes 2006)
address disease progression
Code Section 1.3 False or
misleading claims
Current Australian and global
evidence-based
COPD
treatment guidelines - only
smoking cessation has been
shown to slow disease
progression.
Under
current
regulatory
guidelines, trials specifically
designed to investigate rate of
decline in FEV1 are needed to
claim slowing of disease
progression.

Code of Conduct Annual Report 2007/2008

The following is a summary of the expert

evidence presented:
A graph was referenced from an article
by Fletcher and Peto in the British
Medical Journal, June 1977 describing
the natural decline in lung function
measured by FEV1.
The Holy Grail of COPD Research is to
modify the rate of decline of lung
function as measured by FEV1. Whilst
there have been multiple randomised
clinical trials attempting to prove an
intervention changes the rate of decline,
these have only been able to shift the
curve to the right (indicating delayed
onset of decline) but the rate of decline
remains unaffected.
The results of various trials were
discussed:
Effects of Budesonide on mild
COPD rate of decline the same
ISOLDE Trial in more severe
COPD no difference in rate of
decline
Pooled Analysis of seven studies
on FEV1 rate of decline no
difference
TORCH Study
There is no analysis in the
published study of the rate of
decline in FEV1.
The further data analysis of postbronchodilator FEV1 showed the
rate of decline was significantly
different with Seretide but is only
in abstract, has not received peer
review or been published.
This result is at variance with other
studies.
The methodology behind the
further analysis was not described
in the TORCH publication.
Quality control of spirometry such
as calibration of instruments,
performance of test, has not been
described or published; this is
particularly important because the
study was of 6112 patients in 444
centres in 42 countries.
Is the FEV1 the appropriate measure of
disease progression?
Conventionally and universally
accepted as the measure of
progression.
Jones and Augusti (2006) suggest
rate of decline of FEV1 or health
status but the rate of decline in
health status is known to be less
with fluticasone since ISOLDE
study (2000), yet there has been
no change to the guidelines that

73

state that only smoking cessation

is effective in changing the rate of
decline in lung function.
Patient centred outcomes (TDI,
exercise capacity, health status)
are accepted as measures of
treatment effect but not of disease
progression.
The published TORCH study does not
support a claim for the study
medications to slow progression of
COPD.
There are a number of abstracts with
data to demonstrate an effect of drugs
on disease progression but these need
to be peer reviewed before they can lead
to the claim that the Holy Grail has been
found.
The following summarises the GSKA
response to the appeal:
GSKA do not agree that an error in the
Code Committees process or outcome
has occurred.
Boehringer Ingelheim/Pfizer has had
ample opportunity to present their case
in the original complaint.
GSKA does not believe that the
complainant
placing
insufficient
emphasis
on
the
claim
and
inadequately describing the appropriate
context equates to altering medical
validity of data presented.
No new information has been provided
by Boehringer Ingelheim /Pfizer.
The
Code
Committee
Members
unanimously found the claim not in
breach.
There is evidence to support the concept
that more than one marker should be
taken into account when considering the
rate of disease progression in COPD.
Members of the Code of Conduct
Committee stated that collectively the
references supported the claim.
Boehringer Ingelheim/Pfizer maintain
that rate of decline in FEV1 is the only
relevant measure of COPD disease
progression.
GSKAs claim is consistent with local
and
international,
evidence-based
treatment guidelines
GOLD
COPD-X (Australasian)
International guidelines recognise the
need for multiple disease indices
including:
Inflammation
Exacerbations
Quality of life

Code of Conduct Annual Report 2007/2008

Lung Function
International GOLD guidelines support
the use of multiple disease markers as
indicators of disease progression:
with
COPD
are
Patients

heterogeneous in terms of their

clinical
presentation,
comorbidities,
underlying
lung
pathology, disease severity, and
rate of disease progression. Thus
it is highly unlikely that a single
measure can accurately assess
the severity of COPD, predict
patient prognosis, and evaluate
the effectiveness of therapy,
thereby measuring all dimensions
of the disease.
Since inflammation is a feature of
COPD, it follows that antiinflammatory therapies may have
clinical benefit in controlling
symptoms,
preventing
exacerbations, and slowing the
progression of the disease
(GOLD Guidelines 2005).

Jones and Agusti recognised the need

for multiple markers of disease
progression: The concept of a single
global marker has the attraction of
simplicity and convenience but may not
be appropriate to a complex, multicomponent disorder such as COPD
(Jones & Agusti 2005).
The 2007 GOLD Guidelines recognise
several markers of disease progression
"....neither bronchodilator nor oral
glucocorticosteriod reversibility testing
predicts disease progression, whether
judged by decline in FEV1, deterioration
of health status, or frequency of
exacerbations......"(GOLD
Guidelines
2007).
Boehringer
Ingelheim/Pfizer
had
questioned the validity of the TORCH
study as supporting evidence for
changing the rate of decline in lung
function
and
questioned
the
methodology for assessing FEV1 in
TORCH.
TORCH is the largest and most
comprehensive study of COPD.
It
compared combination therapy and
monotherapy with long acting beta
agonist and inhaled corticosteroids
versus placebo. TORCH showed
statistically significant advantages for
Seretide in health status, frequency of
exacerbations, use of oral steroids, and probably most importantly clinically
protection against a decline in lung
function. Change in rate of decline in

74

FEV1 can be obtained from the TORCH

data; the quality control on spirometry
was adequate.
The further analysis of TORCH for FEV1
rate of decline is being peer reviewed for
publication.
There is a body of evidence that
supports having more than one marker
of COPD disease progression.
GSKA maintained their original position
regarding this claim - that it is supported
by the body of evidence including local
and international guidelines.
Following questions in relation to the
spirometry measurements in the TORCH
study, it was stated that there were 26,000
spirometric observations available for the
analysis. Spirometers were calibrated
according
to
the
manufacturers
recommendations and a calibration log
was kept. Lung function data were
reviewed centrally during the study and
queried if values differed significantly in
consecutive visits. The standard deviation
of the FEV1 measurements was
comparable to that of previous studies
where spirometry was performed using
more vigorous quality control. With 26,000
observations any error would be balanced
out.
A Member of the Appeals Committee
questioned the Boehringer Ingelheim
representatives
concerning
their
interpretation of the primary outcome in
the TORCH study (all-cause mortality),
which very nearly reached statistical
significance at a p-value of 0.052. The
response was that TORCH probably did
show a real change in mortality rate
despite not achieving conventional levels
of statistical significance, but that in his
opinion this is not the same as disease
progression.
An opinion was put forward that it is
appropriate to measure treatment effects
from a patient-centred perspective,
recognising that these effects do not
always correlate well with changes in
FEV1.
However, in his opinion the
measure of disease progression in COPD
is universally regarded to be measured by
change in FEV1.
The Boehringer Ingelheim and GSKA
representatives left the meeting following
these presentations.

Code of Conduct Annual Report 2007/2008

The Committee considered the primary

audience for this item, which was
published in Australian Doctor, how a
general practitioner would view the claim
slows disease progression, and how the
interpretation of such a claim might impact
prescribing of the product. Members
considered that the academic or clinical
researchers view of slows disease
progression may differ from that of a
general practitioner, and also from that of
a
specialist
respiratory
physician.
Healthcare professional members of the
Committee took the view that slows
disease progression could mean, to the
target audience, delaying the onset of
worsening of a disease or death, rather
than necessarily a slowing of the rate of
decline of an organs function. Some
members also commented that if an
individual patients FEV1 measurement
remained at the same level but the patient
reported fewer exacerbations, an increase
in normal activity levels and better ability to
perform day to day tasks, improved sleep,
or less breathlessness they would
consider these effects to indicate delayed
or slowed disease progression. Members
considered that a GP would be unlikely to
rely solely on FEV1 measurements as the
indicator of COPD disease progression.
Members discussed the additional analysis
of change in FEV1 from the TORCH data,
which has not been published in a peer
reviewed journal. It was noted that an
abstract may not be used as the sole
supporting evidence for a claim but can be
used as a secondary reference to support
other evidence.
The abstract of the
additional analysis of decline in FEV1 had
not been referenced in the advertisement.
Members expressed caution about
reliance on the unpublished additional
analysis to support the claim if FEV1 was
the only measure of disease progression.
Members were of the view that, on
balance, there is sufficient evidence taken
in its entirety to support the notion that
more than one marker could be taken into
account when considering the rate of
disease progression in COPD, not just
change in FEV1.
In considering the
published TORCH study as an example,
some members of the Appeals Committee
expressed their concern in principle about
companies making promotional claims
based on analyses of secondary endpoints
from a study for which the primary
endpoint did not reach conventional levels

75

of statistical significance. In this particular

case, however, Members agreed with the
Code of Conduct Committee that the claim
in question was also supported by the
broad balance of evidence, including the
Barnes et al study, for which the primary
endpoint was reduction in inflammation,
the TORCH study secondary endpoints
and the Seretide Product Information.

progression claim that was offered during

intercompany dialogue and review the
referencing used to support the claim, as
recommended by the Code Committee.

Members considered that the claim was

not inconsistent with the Product
Information, although Seretide is not
specifically indicated for slowing COPD
disease progression.
The Appeals Committee agreed with the
decision and reasoning by the Code of
Conduct Committee that collectively the
cited references supported the claim:

While agreeing that the broad scope and

measures of outcomes were valid in
disease progression and QoL some
members were of the view that there could
be more qualification and explanation
within the body of the advertisement and
more comprehensive referencing. The
Committee noted that the references to
support the claim listed in the
advertisement were the Seretide Product
Information, the TORCH study (Calverley
et al NEJM) and Barnes (2006). The
further analysis of the TORCH data
presented at the ERS was not included as
a reference. However, the TORCH study
did demonstrate statistical improvements
in FEV1, exacerbation rates and QoL
measures. In a unanimous decision the
Committee found no breach of Sections
1.2.2 and 1.3 of the Code.
The Committee also considered that many
COPD Guidelines take a broader view of
disease progression than only considering
FEV1. Further, the claim would be read in
the context of the statement above the
claim reducing inflammation decreases

exacerbations and helps to slow disease

progression.

The Appeals Committee did not uphold the

appeal and as such the claim slows
disease progression was determined to
be not in breach of Sections 1.2.2 and 1.3
of the Code.
The
Appeals
Committee
strongly
recommended
that
GSKA
should
immediately implement inclusion of the
qualifying statement with the disease

Code of Conduct Annual Report 2007/2008

76

Famvir (880)
Subject Company: Novartis
Pharmaceuticals
Complainant: Healthcare Professional
Product: Famvir
Complaint
The complainant alleged that that a
brochure for Famvir was misleading as it
ignored symptomatic treatment as a
reasonable option for cold sores and it
ignored low level near infra red light
treatment as a scientifically tested,
effective and safer approach to the
treatment of herpes labialis.
Sections of the Code
Materials alleged to be in breach of the
following Sections of the Code:
1.1 Responsibility
1.2 Substantiating Data
1.3 False and Misleading Claims
Response
Novartis stated that the content of the
promotional material for Famvir was
balanced,
accurate,
correct,
not
misleading and fully supported by the
product information, current published
literature and the current treatment
guidelines. Novartis also noted that low
level near infra red light therapy has not
been approved by the TGA for the
treatment of cold sores.

Claim 1: until now sufferers have only

had topical anti-viral creams from their
pharmacist to rely on

not a benign illness and is highly

contagious and can lead to serious illness.
Famvir is indicated for the treatment of
recurrent herpes labialis (cold sores) in
immunocompetent adult patients. It is also
indicated in immunocompromised patients
for the treatment and suppression of
recurrent herpes simplex. Members noted
that the Product Information for Famvir
and the clinical evidence supported the
use of Famvir for the treatment of herpes
labialis. However some members were of
the view that the statement until now

sufferers have only had topical anti-viral

creams from their pharmacist to rely on

could have better communicated that the

reference
was
only
to
approved
pharmacologic treatments.
In relation to the assertion by the
complainant that Novartis had ignored the
use of low level near infra red (NIR) light
therapy, the Committee noted that this
treatment has not been approved by the
Therapeutic Goods Administration (TGA)
for the treatment of cold sores. Members
were also of the view that little evidence
had been presented to demonstrate the
safety and efficacy of NIR light therapy.
The reference cited by the complainant
was a small study that just reached
statistical significance. Further, there was
doubt expressed regarding the general
availability of this therapy to general
practitioners.
By a unanimous decision, the Committee
found no breach of Sections 1.1, 1.2 or 1.3
of the Code for the reasons outlined
above.

It ignores symptomatic treatment as a

reasonable approach to, in most cases,
a relatively benign condition
It ignores low level near infra red light
therapy as a scientifically tested
effective, available and arguably safer
approach to treatment of herpes labialis
Code Committee determination
In a unanimous decision the Committee
found no breach of Sections 1.1, 1.2 or 1.3
of the Code.
Consideration of the complaint
Members noted that Herpes labialis or cold
sores are caused by herpes simplex virus
type 1 (HSV-1) and whilst a cold sore may
be considered simple, HSV infection is

Code of Conduct Annual Report 2007/2008

77

Eligard (881)
Subject Company: Hospira
Complainant: AstraZeneca
Product: Eligard
Complaint
AstraZeneca asserted that the claims
made in relation to Eligard were
misleading and would have an impact on
clinical practice. AstraZeneca also stated
that the claims of clinical relevance and
subsequent benefits to patients have not
been evaluated and any claims should be
in line with the highest levels of clinical
evidence.

Claim 1 A testosterone level of <20ng/dL

(equal to bilateral orchidectomy) should be
the target for LHRH agonists
Sections of the Code
Materials alleged to be in breach of the
following Sections of the Code:
1.1 Level of Substantiating Data
1.2 Substantiating Data
1.3 False and Misleading Claims
1.7 Comparative Statements

Claim 2 Eligard appears to be the only

LHRH agonist currently available able to
achieve castrate levels below the
testosterone level of 20ng/dl in most
patients. Implied claim of better outcomes
with Eligard
Sections of the Code
Materials alleged to be in breach of the
following Sections of the Code:
1.1 Level of Substantiating Data
1.2 Substantiating Data
1.3 False and Misleading Claims
1.7 Comparative Statements
Response
Hospira stated that it had not defined a
new suppression target for LHRH
agonists; however they brought the serum
testosterone (ST) level of 20ng/dL to the
attention of Australian physicians. Hospira
also maintained that the statements were
representative of the latest scientific
evidence from reputed urologists and
published in peer reviewed urological
journals.

Code of Conduct Annual Report 2007/2008

Code of Conduct and Appeals Committee

determinations

Claim 1

In a unanimous decision the Committee

found a breach of Sections 1.1, 1.2 and
1.3 of the Code and no breach of Section
1.7 of the Code. (Decision confirmed by
the Appeals Committee)

Claim 2

In a unanimous decision the Committee

found a breach of Sections 1.1, 1.2, 1.3
and 1.7 of the Code. (Decision confirmed
by the Appeals Committee)
Sanction
The Appeals Committee revised the
level of breach from moderate to severe
to moderate.
Withdraw the materials found in breach
of the Code
Pay a fine of $75,000 (Fine amended to
$50,000 by the Appeals Committee)
Send a corrective letter to all healthcare
professionals
detailed
with
the
promotional items found in breach
(Decision confirmed by the Appeals
Committee)

Code of Conduct Committee

Consideration of the complaint

Claim 1 A testosterone level of <20ng/dL

(equal to bilateral orchidectomy) should be
the target for LHRH agonists

Members noted that there has been

improvement in testosterone assay
technologies with improved sensitivity
since 1995. It was further noted that there
is some debate on what should be the
accepted testosterone level which is
equivalent to surgical castration and there
does not appear to be a consensus on
what this level should be. Also, the
relationship
between
the
absolute
testosterone level, which is a surrogate
marker, and clinical outcome has not been
established.
The Eligard Product
Information (PI) and some consensus
Guidelines
state
that
adequate
testosterone suppression is defined as
<50ng/ml.
Members noted the use of the word
should (generally defined as must,
ought or have to) in the claim might
convey a meaning to healthcare
professionals that there is high level of
evidence to support the claim. The
Committee considered the level of
evidence to support the claim and was of

78

the view that physician opinion (Level 5

evidence), the lowest level of evidence
and particularly that it was obtained at a
company sponsored event, was not
sufficient to support a claim.
The Committee accepted that lowering
testosterone levels to levels equivalent to
surgical castration was appropriate, but
there was no evidence that lowering the
levels below those recommended in
product information i.e. <50ng/ml, made a
difference to clinical outcomes of patients.
Further, members noted that it was not
usual practice to measure testosterone
levels in prostate cancer.
The Committee was of the view that whilst
there may have been some support at a
consensus meeting for aiming for a lower
testosterone level, there was insufficient
evidence of appropriate quality to support
a promotional claim for a new clinical
target using this surrogate indicator. A
change in a clinical target that is a
surrogate of a disease outcome should be
supported by the highest level of evidence,
not just the highest level of evidence
available (in this case Level 5).
The
material could have been better worded to
provide advice on serum testosterone
levels rather than make claims that cannot
be substantiated.
In a unanimous decision the Committee
found a breach of Sections 1.1, 1.2 and
1.3 of the Code because the statement
was not balanced, was not supported by
all the body of evidence, and was not a
conclusive position supported by the
highest level of evidence. No breach of
Section 1.7 of the Code was found
because the Committee did not consider
that Claim 1 was a comparative statement.

Claim 2: Eligard appears to be the only

LHRH agonist currently available able to
achieve castrate levels below the
testosterone level of 20ng/dL in most
patients

The Committee was of the view that

Hospira was seeking to position Eligard as
a new clinical comparator for LHRH
agonists in terms of testosterone
suppression. Overall the claim implies a
comparison between Eligard and other
LHRH agonists, which was inaccurate and
misleading for physicians who are treating
prostate cancer.

Code of Conduct Annual Report 2007/2008

The Committee considered Hospiras

assertion that it had never claimed that
Eligard reduces serum testosterone below
20ng/dL in all patients and did not claim
clinical superiority to other LHRH agonists.
Whilst the statement might be a direct
quotation from the conclusions of a clinical
paper, a pharmaceutical company must
accept responsibility for the accuracy and
balance of the statement in its promotional
material. Members concluded that the use
of appears and the only was not
appropriate as no evidence had been
provided to support the implication of
better clinical outcomes with lower
testosterone levels from Eligard.
Members were of the view that the highest
level of evidence should always be
provided to healthcare professionals and
in this case the supporting evidence
Hospira had provided is not of a sufficient
quality and the relevance to clinical
outcomes is not documented.
In a unanimous decision the Committee
found a breach of Sections 1.1, 1.2, 1.3
and 1.7 of the Code.

Implied claim of better outcomes with

Eligard.

The Committee noted Hospiras comments

that AstraZeneca had introduced this as a
new aspect to the complaint that had not
been raised as part of intercompany
dialogue. The Committee determined that
the implied claim of superiority of Eligard
effectively followed on from Claim 2 and
was not therefore separately considered.
The Committee determined that the
implied claim of better outcomes with
Eligard was appropriately dealt with as
part of Claim 2.
Sanctions
The Committee determined that this was a
moderate to severe breach of the Code.
Members stated that there was no
potential for patient harm but the
information may have an impact on the
way the product is prescribed.
Having found several breaches of the
Code the Committee determined that
Hospira should:
Withdraw the materials found in breach
of the Code
Pay a fine of $75,000
Send a corrective letter to all healthcare
professionals detailed with the items
found in breach

79

Appeals Committee
Hospira appeal
Hospira lodged an appeal stating that it
had acted to inform the market of
directional change in the interests of
improved clinical practice and that this is
consistent with the Code of Conduct.
Hospira also re-iterated that at no time did
it state or imply that a serum testosterone
level of 20ng/dL made a difference to
clinical outcomes. Hospira also noted that
it was acknowledged that evidence from
expert consensus meetings was not
absolute and that the promotional material
made no implied comparisons with other
products.
AstraZeneca response to Hospira appeal
AstraZeneca argued that robust debate
does not equate to evidence and that only
clinical trial data can conclusively
determine hypotheses for new target
testosterone levels and provide guidance
for clinical management. AstraZeneca also
stated that the promotional item did imply
that a greater clinical benefit might be
achieved with Eligard when compared to
other drugs in this class.

Consideration of the appeal

The Chairman sought clarification from the
Hospira representatives as to whether they
were appealing all decisions of the Code
of Conduct Committee, as this was not
clear in the appeal submission. It was
stated that Hospira was appealing the
decisions in relation to all breaches of the
Code.
The following summarises the Hospira
appeal presented by the Hospira
representative.
Both claims 1 and 2 can be defended by
the highest levels of evidence.
In relation to claim 1, surgical castration
is still considered the gold standard for
androgen deprivation therapy, against
which all other treatments are rated.
LHRH agonists (chemical castration)
have shown equivalent efficacy to
orchidectomy (surgical castration) (Level
1A evidence).
The historical level for testosterone was
arbitrarily set at <50ng/dL by the US
FDA in the 1980s on the basis of assays
available at the time, but techniques
have changed.
Studies post-orchidectomy have shown
testosterone levels less than or equal to
20ng/dL from surgical castration. As
Code of Conduct Annual Report 2007/2008

tests improved, the body of recent LHRH

evidence indicates the target has
tightened with studies reporting efficacy
at testosterone levels 20ng/dL.
AstraZeneca Global endorses this on its
website and promotes 20ng/dL as the
target.
The deduction is that the gold standard
is
surgical
castration;
chemical
castration should approximate surgical
as much as possible; the goal of
chemical castration (with LHRHs) should
be 20ng/dL.
Hospira did not infer in the Eligard
promotional material any clinical benefit
or risk from the lower testosterone target
this was a claim made by AstraZeneca.
Regarding the level of evidence to
support the claim, the American Urologic
Association meeting in San Antonio,
Texas, in May 2005 reviewed the
evidence.
9 experts ( 9 professors from 7
countries) received the latest 20
randomised controlled trials prior
to discussions
These discussions were then taken up at
the 6th International Consultation on
New Developments in Prostate Cancer
and Prostate Diseases in Paris, France,
in June 2005.
400 delegates considered using
an interactive voting system
to give their own opinions.
Experts and delegates agreed that
a testosterone level of 20ng/dL
is optimal (64% of experts).
This was not the view of a sole
physician, and is not level 5
evidence. Whilst it was not a
systematic review, it is level 1 or 2
evidence.
This was not a company sponsored
event; only the publication of the findings
was sponsored.
Hospira asserted that Claim 1 is
supported by the body of evidence.
In relation to Claim 2, no health outcome
benefit was stated or implied by Hospira.
The claim is a quote from a peerreviewed publication of a systematic
review of 55 clinical papers. There is no
other evidence to refute the claim.
Hospira was and is willing to not use the
claim if AstraZeneca could provide
evidence to refute it.
AstraZeneca would only provide mean
data relating to suppression of
testosterone levels to less than 20ng/dL.

80

 To assess this, all testosterone level

outliers must be assessed, not mean
data which can hide such subjects.
The AstraZeneca data showed that even
with mean values, Zoladex achieved but
did not maintain testosterone <20ng/dL
at week 8 and 52. AstraZeneca has now
changed its demands of Hospira and
contend that the onus is on Hospira to
demonstrate clinical superiority. Hospira
did not assert clinical superiority.
The two Eligard detail pieces subject to
complaint were provided to urologists,
not general practitioners or consumers.
The Code Committee found no potential
for patient harm exists therefore Hospira
questions why this was determined to be
a moderate to severe breach. Hospira
asserted that the level of fine was
disproportionately high in considering
the criteria for determining sanctions.
Intercompany
dialogue
was
inappropriately
terminated
by
AstraZeneca without notice and the
complaint submitted to Medicines
Australia.

the

The company representative provided a

brief explanation of the mechanism of
action of LHRH agonists.
The main issue is that claim 1 suggests
a new testosterone target for Australian
physicians, but the references used to
support the claim do not definitively
assert 20ng/dL as a new target.
There is no agreed consensus amongst
prostate cancer guidelines.
Introduction of a new testosterone level
reflects advances in measurement
technology, not advances in therapy.
20ng/dL is not a new target for LHRH
agonists it is merely a new lower limit in
the definition of testosterone levels
achieved
with
bilateral
orchidectomy/surgical castration.
As
only the assay technologies have
improved, not the agents lowering
testosterone, using the word target is
misleading physicians in believing that
therapies should demonstrate they can
achieve this target rather than stating
that LHRH agonists get testosterone to
orchidectomy levels which are now
considered by some to be as low as
20ng/dL.
The claim is not supported by relevant
consensus guidelines, particularly:

The
following
summarises
AstraZeneca response to the appeal.

Code of Conduct Annual Report 2007/2008

the European Association of

Urology (EAU) Guidelines 2007 do
not define an orchidectomy
testosterone value;
2007 National Comprehensive
Cancer
Network
(NCCN)
Guidelines state that inadequate
testosterone
suppression
is
defined as > 50ng/dL;
2004 ASCO Guidelines state that
orchidectomy is defined as
<10ng/dL.
Hospira has stated that the issue of
testosterone target level is currently
being deliberated in American and
European conferences debate does not
equal evidence and cannot be used to
support a claim.
The Eligard Product Information defines
testosterone castrate threshold as
50ng/dL.
Main reference used in support of
Hospiras argument is the Zlotta 2005
paper, which also states that 26% of
delegates never measure testosterone
regularly and 50% only if there is a
prostate specific antigen (PSA) rise.
In relation to Claim 2, AZ asserted that it
was not factual and was disparaging to
other LHRH agonists.
LHRH
agonists
all have same
mechanism of action; consensus
guidelines do not distinguish between
LHRH agonists.
Hospira is using testosterone levels to
create a new clinical comparator for
LHRH agonists.
Using testosterone levels to compare
LHRH agonists is disparaging because
not all have been tested equally.
All LHRH agonists have same
mechanism of action; all accepted and
registered by TGA as equivalent to
surgical
castration/bilateral
orchidectomy, defined as <50ng/dL.
The lowest possible level of testosterone
achieved with surgical orchidectomy is
not defined; important that LHRH
agonists reach the upper testosterone
threshold definition of orchidectomy.
Advances in measuring testosterone
levels does not mean that one LHRH
agonist is superior to the rest.
Claims 1 and 2 together create an
implied clinically meaningful difference
between LHRH agonists and that Eligard
is the superior agent.
There is no evidence to support Eligards
implied superiority of clinical benefit; a

81

lack of evidence to refute this claim is

not adequate substantiating evidence.
Hospiras promotion in claim 1 of a new
lower target level for testosterone, that is
said to be
equal
to bilateral
orchidectomy which is recognised by
clinicians as the gold standard, followed
by claim 2 that Eligard is the only agent
able to achieve this level, is implying that
Eligard is the new gold standard.
Use of the words should be the target
implies that the new lower testosterone
level is somehow better, which could be
interpreted by physicians as providing a
larger clinically meaningful difference.
There is no evidence for a clinical benefit
in prostate cancer patients who achieve
50ng/dL versus 20ng/dL.
AstraZeneca provided a timeline for
intercompany dialogue in relation to this
complaint and noted that a number of
issues had been resolved but the two
main issues had not been. AstraZeneca
did not agree that intercompany dialogue
had been prematurely truncated.
AstraZeneca agreed with the breaches
found by the Committee and with the
sanctions imposed by the Committee
which adequately reflect the severity of
the breaches.

Following questions from members of the

Committee Hospira provided these
responses:
The claims in question reflect shifting
knowledge about target testosterone
levels in prostate cancer treatment. New
standards are being set by leading
urologists in the field following review of
the current data.
Treatment Guidelines are not always up
to date with new evidence.
The evidence supports that surgical
castration
means
achieving
a
testosterone level of 20ng/dL.
If
surgical castration sets the gold
standard of 20ng/dL then chemical
treatments should also aim to meet that
level.
Following questions from members of the
Committee AstraZeneca provided these
responses:
Information on the AstraZeneca global
website does not reflect promotion to
Australian healthcare professionals.
AstraZeneca does not promote a
testosterone target of 20ng/dL in
Australia for its product Zoladex.

Code of Conduct Annual Report 2007/2008

Sufficient time had been allowed for

intercompany dialogue. Hospira had
stalled the process by asking for
evidence of the AstraZeneca Managing
Directors endorsement of the complaint.
The
AstraZeneca
and
Hospira
representatives left the meeting following
these presentations.
Members commented that an overarching
rule is that a company must only promote
within the Australian approved PI. Before
a claim can be made on the basis of new
evidence that is outside the current PI, the
new evidence should be submitted to the
Therapeutic Goods Administration for
evaluation and inclusion in the PI.
While having no issues with the comments
and debate within the international urology
community in relation to matters such as
the target testosterone level in prostate
cancer patients, and acknowledging that
this is how new Guidelines will be
developed, the Appeals Committee reiterated that an Australian pharmaceutical
company must not promote a product
outside the PI. While the information used
by Hospira may be correct and may in the
future be supported by unequivocal
published evidence, the claims as
presented in the Hospira promotional
items subject to complaint are in breach of
the Code because they cannot be
adequately substantiated.
The Appeals Committee concurred with
the Code Committee that technological
advances to testosterone assay technique
have made the measurements more
sensitive. Members also agreed with the
Code Committee that there was no
evidence that the lower testosterone level
made any difference to clinical outcomes
or patient longevity.
While agreeing that if surgical castration is
the gold standard chemical treatments
should try and match the same
suppression of testosterone, any claim
made by a company must not be
misleading or imply benefits that have not
been established. It would be acceptable
for opinions from the consensus meetings
at which target testosterone levels were
discussed to be presented at a scientific
forum, for example at a urology
conference, but not used in company
promotional material as substantiation for
claims.

82

While noting Hospiras comments that the

promotional materials did not imply any
clinical benefit resulting from lower
testosterone levels, members were of the
view that the association between the two
claims in the promotional items did imply
that a clinical benefit from lower
testosterone levels achieved with Eligard
compared with other LHRH agonists,
which could not be substantiated.
Members considered that claim 2 is clearly
comparative.
The Appeals Committee discussed the
relationship between the testosterone
level, which is a surrogate marker, and
clinical outcomes. The claim that the
target testosterone should be less than
20ng/dL implies that there may be a
clinical benefit. The Eligard PI and some
consensus Guidelines state that adequate
testosterone suppression is defined as
<50ng/dL. The Appeals Committee agreed
with the Code Committee findings that
lowering testosterone to levels equivalent
to surgical castration was appropriate, but
there was no evidence that suppressing
testosterone to below that recommended
in product information i.e. below 50ng/dL
made a difference to clinical outcomes for
patients.

was no potential for patient harm as a

result of the claims, the level should be
revised from moderate to severe to
moderate because the claims may have
some impact on how the product is
prescribed.
Sanctions
Having
considered
the
information
provided by both companies the Appeals
Committee
imposed
the
following
sanctions:
The severity of the breach should be
reduced from moderate severe to
moderate.
The fine of $75,000 should be reduced
to $50,000
The requirement for a corrective letter
was confirmed. The corrective letter
must be sent to all urologists in Australia
and any other health professional who
received or was detailed using the item
found in breach
Withdraw the materials found in breach
of the Code

Irrespective of where research into the

treatment of prostate cancer is heading,
the claims for Eligard, even though they
were only directed to specialists in the
field, could not be supported by the
appropriate level of evidence.
In a unanimous decision the Appeals
Committee did not uphold the appeal in
relation to Claims 1 or 2 and concurred
with the findings of the Code of Conduct
Committee:

Claim 1: A testosterone level of <20ng/dL

(equal to bilateral orchidectomy) should be
the target for LHRH agonists
A breach of Sections 1.1, 1.2 and 1.3 of
the Code.

Claim 2 Eligard appears to be the only

LHRH agonist currently available able to
achieve castrate levels below the
testosterone level of 20ng/dL in most
patients

A breach of Sections 1.1, 1.2, 1.3 and

1.7 of the Code.
The Appeals Committee discussed the
level of breach. In consideration that there

Code of Conduct Annual Report 2007/2008

83

Allergan Event (882)

Subject Company: Allergan Australia
(Allergan)
Complainant: Medicines Australia
Monitoring Committee
Products: Botox and Juvederm
Complaint
Following the Monitoring Committee
review of invitations to company initiated
and sponsored educational events the
Committee had sought some clarification
in relation to the Allergan event held on 23
and 24 February 2007.
Having reviewed the feedback the
Monitoring Committee was concerned that
the event may not comply with the
Medicines Australia Code of Conduct and
forwarded this matter to the Code of
Conduct Committee as a complaint for a
determination, in accordance with Section
14.4 of the Code.
Sections of the Code
Allergan had been invited to respond to
the referral to the Code of Conduct
Committee in relation to the following
Sections of the Code:
6.2 Hospitality
6.2.1
6.2.2
6.6 Venue Selection
10.2 Hospitality
10.8 Discredit to the industry
Response
Allergan stated that the one and a half
days of education provided at the event
was compliant with the Code and that the
hospitality was appropriate to the
professional standing of the audience, who
were
cosmetic
surgeons,
cosmetic
physicians,
plastic
surgeons
and
dermatologists.
Code Committee determination
In unanimous decisions the Committee
found a breach of Sections 6.2.2, 10.2 and
10.8 of the Code and no breach of
Sections 6.2.1 and 6.6 of the Code.
Sanction
Fine $175,000

Code of Conduct Annual Report 2007/2008

Consideration of the complaint

Section 6.2.1 Any hospitality provided by

companies
either
directly
or
by
sponsorship or assistance to the
organisers of educational meetings, must
be secondary to the educational purpose.
The Committee was of the view that the
primary purpose for the event was
education.
Members
reviewed
the
educational program which extended over
2 days and noted that there were
international and Australian presenters at
the scientific sessions. It was noted that
the dinner venue was not mentioned in the
invitation to the meeting and determined
that the educational purpose of the
meeting would have been the primary
focus for attendance. Members also noted
that all attendees at the dinner had also
been in attendance at the educational
event.
In a unanimous decision the Committee
did not find a breach of Section 6.2.1 of the
Code.

Section 6.2.2 For educational meetings

directly
organised
by,
and
the
responsibility of companies, all hospitality
must be consistent with the professional
standing of the delegates. Meals provided
at an educational meeting should not be
extravagant or exceed standards which
would meet professional and community
scrutiny. No entertainment should be
provided.
The Committee noted the venue and the
cost for the dinner.
In relation to Allergans assertion that there
were no other venues available to cater for
300 people on a Saturday evening,
members were of the view that with early
planning for such a sizeable event, a more
suitable venue and appropriate level of
hospitality could have been arranged.
Allergan had stated that the ballroom at
the meeting venue was able to hold an
event of this size; however, it was
considered that there were logistical
problems for the venue staff with setting up
for a dinner because the clinical program
concluded late in the afternoon on day
one. Some members commented that the
clinical program could have been held in
rooms other than the ballroom which
would have allowed for that venue to be
used. Further, there was a three hour

84

window between the close of the days

program and commencement of dinner,
which, in some members experience,
would normally be sufficient to reorganise
a large meeting room for a dinner.
Members also noted that many of the
alternative venues proposed for the event
were also highly prestigious and some of
the best restaurants in Sydney. Members
also expressed doubt about Allergans
criteria for venue selection as being one
within reasonable distance from the
meeting venue because a number of the
alternate locations were some distance
from the meeting venue.
However
members also noted that the proposed list
of alternate venues was not subject to
complaint and was not taken into
consideration in relation to determining
whether the hospitality actually provided
was in breach of the Code.

Committee did not find a breach of Section

6.6 of the Code.

The
Committee
considered
the
requirement of Section 6.2.2 of the Code
that hospitality be consistent with the
professional standing of the delegates.
Members were of the view that whilst it is
acceptable for members of a particular
group of healthcare professionals to avail
themselves of hospitality at this level,
when a pharmaceutical company is
providing hospitality in association with an
educational event the hospitality should
not be at the extravagant end of the scale,
as was the case for this event. Overall
Members considered the hospitality to be
inappropriately luxurious and extravagant
for a pharmaceutical company to provide
in association with an educational event.

Sanctions
The Committee noted that a breach of
Section 10.8 is considered to be a severe
breach. In determining an appropriate
sanction the Committee noted that the
previous decision in relation to complaint
835 had attracted a fine of $75,000.
Allergan should have been aware of
previous Code decisions in this area. The
Committee therefore determined that a
higher fine was appropriate and should
give a clear message to companies.

Section 10.2 Hospitality

For the same reasons as discussed in

relation to Section 6.2.2 of the Code, the
Committee unanimously found a breach of
Section 10.2.

Section 10.8

Members were of the view that an event

with this level of hospitality brought the
industry into disrepute. Allergan should
have been informed by a previous Code
Committee decision in relation to what was
considered to be extravagant hospitality
and the criticisms such conduct had
brought upon the industry and avoided
similar conduct.
The Committee
unanimously found a breach of Section
10.8 of the Code.

The Committee determined that Allergan

should pay a fine of $175,000 and should
not repeat the same conduct in association
with any further educational meetings.

The
Committee
also
took
into
consideration other wording in this section
of the Code - Meals provided at an
educational meeting should not be
extravagant or exceed standards which
would meet professional and community
scrutiny and commented that this event
was extravagant and in their view would
exceed the standards that would be
acceptable to the majority of healthcare
professionals or the community.
In a unanimous decision the Committee
found a breach of Section 6.2.2 of the
Code.

Section 6.6 Venue Selection

The Committee did not raise any concerns

in relation to the venue for the educational
sessions. In a unanimous decision the

Code of Conduct Annual Report 2007/2008

85

Crestor (883)
Subject Company: AstraZeneca
Complainant: Pfizer Australia (Pfizer)
Product: Crestor
Complaint
Pfizer alleged that at a Post Graduate
weekend event on 3-4 November 2007 a
trade display banner carrying claims
previously found in breach [Crestor (842)]
was prominently displayed to the 120
healthcare professionals in attendance.
Pfizer considered this to be a significant
repeat breach.
Sections of the Code
Promotional materials carried claims
previously found to be in breach of the
following Sections of the Code:
1.3 False and misleading claims
1.7 Comparative Statements
Response
AstraZeneca denied any deliberate
attempt to intentionally mislead healthcare
professionals through the use of claims
previously found to be in breach of the
Code. An internal investigation identified
that a breakdown in the companys
promotional material withdrawal procedure
had resulted in the inadvertent use of the
materials previously found in breach of the
Code.

safeguards relating to withdrawal and

recall of promotional materials.
Members also commented that it would
have
been
preferable
for
Pfizer
representatives to have raised the matter
with AstraZeneca representatives at the
educational meeting and ask that they
remove the offending material.
Such
action may have avoided healthcare
professionals being exposed to the claims
previously found in breach.
In a unanimous decision the Committee
found that the activity was a repeat breach
of the Code, as had been accepted by
AstraZeneca. The Committee noted that
AstraZeneca had provided a corrective
letter which will be sent to all attendees at
the weekend educational meeting where
the material was displayed.
Sanction
The Committee determined that a repeat
breach of the Code had occurred and
determined that AstraZeneca should pay a
fine of $80,000. The Committee did not
impose a corrective letter itself in
consideration that AstraZeneca had
volunteered that it would send a corrective
letter to all doctors in attendance at the
educational meeting.

Code Committee determination

In a unanimous decision the Committee
found a repeat breach had occurred
(Sections 1.3 and 1.7).
Sanction
Fine $80,000
Consideration of the complaint
The Committee expressed concern that
having been found in breach of the Code,
a company should take all possible action
to ensure materials are destroyed.
Members noted that following this incident
the AstraZeneca Managing Director had
sent a communication to all sales and
marketing staff and relevant medical staff
advising them of the circumstances and
reinforcing the companys commitment to
complying with the Code and the
importance of corporate compliance. In
addition, the companys procedures had
been amended to strengthen the

Code of Conduct Annual Report 2007/2008

86

Actos (885)

Code Committee determination

Part 1 Distinction of Promotional Material

Subject Company: Eli Lilly Australia (ELA)

In a unanimous decision the Committee

found a breach of Sections 1.10 and 3.3

Complainant: GlaxoSmithKline Australia

(GSKA)

Part 2 Misleading claims

cardiovascular outcomes

Product: Actos
Complaint
GSKA alleged that ELA had disguised
promotional material as a safety related
notification in a Dear Doctor safety letter
concerning Actos. GSKA argued that a
safety notification letter should not have
included comparative promotional claims.
Further it was alleged that the claims
relating to cardiovascular outcomes for
Actos were misleading and could not be
supported by clinical data and comparative
claims against Avandia were false and
misleading. GSKA argued that the letter
should be classified as promotional
material and had omitted mandatory
information required by the Code for such
materials.
Sections of the Code
Materials alleged to be in breach of the
following Section of the Code:
1.1 Responsibility
1.3 False or Misleading Claims
1.7 Comparative Statements
1.10 Distinction of Promotional Material
3.3 Printed Promotional Material
Response
Eli Lilly Australia (ELA) had responded that
the complaints made by GSKA were
unwarranted and denied that the letter was
in breach of the Code. ELA advised that a
second Dear Doctor letter had been
issued on 29 November 2007 which
included an explanatory paragraph
regarding Actos and its association with
congestive heart failure as proposed in
intercompany dialogue with GSKA. ELA
asserted that the letter of 6 August 2007,
subject to the complaint, had been
attempting to clarify confusion within the
medical community brought about by the
recent FDA review of myocardial infarction
events
associated
with
the
thiazolidinedione class of antidiabetic
agents, which had specifically focused on
Avandia and had resulted in the addition of
black box warning to the Product
Information for Avandia.

Code of Conduct Annual Report 2007/2008

regarding

In a majority decision the Committee

found no breach of Section 1.3 or 1.7

Part 3 Incorrect and misleading

comparative statements regarding lipids
and
Carotid Inter-Media Thickness (CIMT)

In a majority decision the Committee

found no breach of Sections 1.1, 1.3 or
1.7

Part 4 Underestimating risk of Congestive

Heart Failure (CHF) with Actos
In a majority decision the Committee
found no breach of Section1.3

The Committee determined that the

breaches in relation to failing to distinguish
the Dear Doctor letter as promotional
material were minor.
Sanction
By a majority decision the Committee did
not require a corrective letter, taking into
account that a second Dear Doctor letter
had been issued by Eli Lilly following
intercompany dialogue, and no fine was
imposed.
Consideration of the complaint

Part 1 Distinction of Promotional Material

The Committee noted that the Dear

Doctor safety letter was sent to healthcare
providers in response to widespread
perplexity in the medical community
regarding the incidence of myocardial
infarction in association with the
thiazolidinedione class of antidiabetic
medications following a review by the US
Food and Drug Administration (FDA). The
thiazolidinedione class includes Actos
(pioglitazone) and Avandia (rosiglitazone).
Members noted ELAs allegation that
GSKA was leading healthcare providers to
believe that myocardial infarction was a
class effect.
Members of the Committee queried
whether there are any Code of Conduct
Guidelines regarding the content and form
for Dear Doctor safety letters. Industry
representatives
on
the
Committee
commented that there is a general

87

understanding within the industry that

Dear Doctor safety letters should only
communicate important safety related
information and not be used for
promotional claims. Having been advised
by the Code Secretariat that there was no
formal guidance from Medicines Australia,
the Committee recommended that, in
consultation with industry, Medicines
Australia develop guidance on the
appropriate content of Dear Doctor safety
letters for inclusion in the Code of Conduct
Guidelines.
The Committee was of the view that ELA
was entitled to distribute a Dear Doctor
safety letter following the concerns raised
in relation to myocardial infarction and its
association with the thiazolidinedione
class of antidiabetic medications. The
Committee noted that overall the letter
contained useful information for a
prescriber; however, members expressed
some concerns in relation to the third
paragraph which stated Actos has a more
favourable effect on lipids compared to
rosiglitazone. While this may be correct,
members were of the view that
promotional claims should not be included
in a Dear Doctor safety letter and the
letter should focus on and provide clear
information about any safety issues of
importance to the medical community.
Because the letter included promotional
claims for Actos, it should be considered to
be printed promotional material which
requires the inclusion of a PBS disclosure
box and the Minimum Product Information
within the body of the item.
This
information was not included in the Dear
Doctor letter subject to complaint. The
Committee agreed with the complainant
that ELA had failed to clearly distinguish
the Dear Doctor letter as promotional
material and went beyond providing
updated safety information.
In a unanimous decision the Committee
found a breach of Sections 1.10 and 3.3 of
the Code.

Part 2 Provision of misleading claims

regarding cardiovascular outcomes

The majority of members of the Committee

were of the view that the letter contained a
range of information on cardiovascular
outcomes with Actos but did not claim that
pioglitazone (Actos) confers a decrease in
cardiovascular risk or in overall mortality.
A minority of members expressed some

Code of Conduct Annual Report 2007/2008

concern that the statement . these

studies do not provide definitive results
that Actos is associated with a decreased
risk of myocardial infarction; however,
there is no indication in the current body of
evidence to suggest an association with
Actos and a higher risk of myocardial
infarction was an attempt to imply a link
between Actos and its positive effects on
surrogate markers for atherosclerosis and
cardiovascular outcomes.
In a majority decision the Committee found
no breach of Section 1.3 of the Code.

Part 3 Provision of incorrect and

misleading
comparative
statements
regarding lipids and Carotid Inter-Media
Thickness (CIMT)

The majority of members were of the view

that the information was not necessarily
misleading; however, it would have been
preferable for ELA to include a range of
references rather than relying on a single
study as substantiating data.
In a majority decision the Committee found
no breach of Sections 1.1, 1.3 and 1.7. In
its majority decision against finding a
breach of the Code, the Committee noted
that this was a close decision and
expressed some reservations regarding
appropriate generalisation from surrogate
markers where important safety concerns
relate
to
clinical
outcomes
from
cardiovascular mortality.

Part 4 Underestimating risk of Congestive

Heart Failure (CHF) with Actos

Several members of the Committee were

concerned that ELA had distributed the
letter at a time when the company was in
negotiation with the Therapeutic Goods
Administration (TGA) in relation to
strengthening the Product Information for
Actos. While the letter may have been
current at the time it was issued, it may
have been preferable to wait until the
outcome of these negotiations. However,
other members of the Committee
commented that the length of time to
resolve the matters between the TGA and
ELA would not have been known at the
time and may have inappropriately
delayed ELA being able to communicate
with health professionals about the
possible safety concerns. The Committee
noted the amendments to the Actos
Product Information which did not include
a boxed warning as has been required for
Avandia.

88

Members also noted that ELA had

distributed a second Dear Doctor letter
regarding Actos and its association with
congestive
heart
failure
following
intercompany dialogue with GSKA.
In a majority decision the Committee found
no breach of Section 1.3 of the Code.
Sanctions
The Committee commented on the degree
of resolution achieved in intercompany
dialogue and noted that ELA had gone a
long way to meet GSKAs concerns in the
second Dear Doctor letter published in
November 2007. No breaches of the Code
had been found in relation to the
allegations
of
misleading
conduct.
Further, the Committee noted that no
specific guidance was currently available
from Medicines Australia concerning Dear
Doctor letters.
The Committee was of the view that no
further corrective action was required and
no fine was imposed. It noted that had
ELA not distributed the second Dear
Doctor letter a sanction may have been
imposed.

Code of Conduct Annual Report 2007/2008

89

Lipitor (886)

1.7. (Decision confirmed by the Appeals

Committee)

Subject Company: Pfizer Australia (Pfizer)

Issue 2 Routine promotion of Lipitor 80mg

to general practitioners irrespective of the
patient population

Complainant: AstraZeneca
Product: Lipitor
Complaint
AstraZeneca alleged that claims made by
Pfizer in relation to Lipitor were false and
misleading and cannot be substantiated by
the current body of evidence. The claim
that Lipitor reduces recurrent stroke risk by
16% was alleged to be in breach of the
Code because the referenced study was
designed to evaluate efficacy of Lipitor in
the secondary prevention of stroke, which
is outside the approved indications for
Lipitor in Australia. In addition, it was
alleged that Pfizer had been routinely
promoting to general practitioners the
80mg Lipitor dose, irrespective of a
patients cardiovascular risk profile, which
is not in accordance with the approved
Product Information.
Sections of the Code
Materials alleged to be in breach of the
following Section of the Code:
1.1 Responsibility
1.2 Substantiating Data
1.3 False of Misleading Claims
1.5 Unqualified Superlatives
1.7 Comparative Statements
Response
Pfizer stated that the issue of comparative
efficacy between Crestor and Lipitor
across the dosage range has been
extensively reviewed by Code and
Appeals Committees since late 2006.
Pfizer did not accept that the publication of
the POLARIS study (Leiter et al) was
sufficient
to
overturn
previous
interpretations of the data. Pfizer also
rejected AstraZenecas assertion that its
promotion
of
80mg
Lipitor
was
indiscriminate or that the promotion of the
SPARCL study is encouraging off label
use.
Pfizer alleged that several of
AstraZenecas complaints were vexatious.
Code of Conduct and Appeals Committee
determinations

Issue 1 Unsurpassed statin effects on

LDL-C

In a majority decision the Committee found

a breach of Sections 1.1, 1.2. 1.3, 1.5 and

Code of Conduct Annual Report 2007/2008

In a unanimous decision the Committee

found no breach of Sections 1.1 or 1.3 in
relation to the claims promoting initiation of
Lipitor at any dose.

In a majority decision the Committee found

no breach of Sections 1.1 or 1.3 in relation
to the claims to reduce cardiovascular risk
fast with intensive Lipitor therapy. (No
appeal)

Issue 3 SPARCL

In a majority decision the Committee found

no breach of Sections 1.1, 1.3, or 1.3.1.
(No appeal)

Issue 4 Tagline Power.

Confidence; Intensity

Evidence.

In a majority decision the Committee found

no breach of Section 1.5.
In a majority decision the Committee found
a breach of Sections 1.1 and 1.2.
(Decision confirmed by the Appeals
Committee)
Moderate breach
Sanction
Fine $50,000 (Decision confirmed by the
Appeals Committee)
In a majority decision, no corrective
letter was required

Code of Conduct Committee

Consideration of the complaint

Issue 1 Unsurpassed statin power to lower

LDL-C and TG

The Committee debated at length the

issue of what would be a sufficient body of
evidence to claim superior efficacy of one
statin over another. Members noted that
from a regulatory perspective a company
would be required to submit three double
blind randomised controlled trials and
another safety study when seeking
registration from the TGA. The Committee
considered that the use of unsurpassed
from a marketing or promotional
perspective would mean to a reader that a
product had the best qualities or most
favourable qualities; the promotional
claims using unsurpassed subject to this
complaint variously imply that there is no
other statin as powerful as Lipitor.

90

Members noted that the Crestor Product

Information had been amended since
previous complaints were considered in
relation to Lipitor and now include the
published
randomised
double-blind
POLARIS study (by Leiter et al) in addition
to the open label STELLAR study. The
POLARIS study was a very strong study in
high cardiovascular risk patients, which
showed superior LDL-C lowering efficacy
of rosuvastatin 40mg (Crestor) compared
with atorvastatin 80mg (Lipitor).
Members of the Committee were not
convinced that the current evidence was
adequate to support the claim that Lipitor
is unsurpassed and in a majority decision
found a breach of Sections 1.1, 1.2. 1.3,
1.5 and 1.7 of the Code.

Issue 2 Routine promotion of Lipitor 80mg

to general practitioners irrespective of the
patient population
The Committee referred to the Product
Information for Lipitor, which states inter
alia.

Lipitor can be administered within the

dosage range of 10 80mg/day as a
single dose. Therapy should be
individualised according to lipid levels
the recommended goal of therapy and
the patients response.

The majority of patients are controlled

with 10mg Lipitor once a day ..
While there were some reservations
expressed that patients should be initiated
on 80mg of Lipitor, members were of the
view that it is a correct statement that
Lipitor can be initiated at any dose.
However members also commented that
promotion should also support the quality
use of medicines and all promotional
material should be an accurate reflection
of appropriate medicine use within a
therapeutic area.
Some members
expressed the need for a more balanced
approach to indicate that not every patient
requires the higher dose of Lipitor at
initiation and that cardiovascular risk and
potential for side effects should be
considered.
The Committee discussed the particular
claims to reduce CV risk fast with
intensive Lipitor therapy, in dot point 2
under Issue 2 in the letter of complaint. It
was noted that the studies supporting this
claim are of different durations and there
was no clear indicator of what is fast.

Code of Conduct Annual Report 2007/2008

Further, statins have an approved

indication for hypercholesterolemia and
not to lower cardiovascular risk, although
the rationale for lowering cholesterol is to
reduce cardiovascular risk.
In a unanimous decision the Committee
found no breach of Sections 1.1 and 1.3 in
relation to the claims promoting initiation of
Lipitor at any dose. In a majority decision
the Committee found no breach of
Sections 1.1 or 1.3 in relation to the claims
to reduce cardiovascular risk fast with
intensive Lipitor therapy.

Issue 3 SPARCL
Lipitor 80mg reduces recurrent stroke risk
by 16% vs placebo in landmark SPARCL
trial [p=0.03]
The Committee noted the further
information submitted by AstraZeneca,
which was a Dear Doctor letter issued by
Pfizer in the UK providing information from
the post hoc analysis of the SPARCL study
and Pfizers further response to this
information. It was noted that the SPARCL
study post hoc analysis was included in
the Lipitor Product Information under the
heading Precautions - Haemorrhagic
stroke.
The Committee noted the National Heart
Foundation (NHF) Lipid Management
Guidelines statement that lipid treatment
is appropriate in the context of overall
risk and correspondence from the
Department of Health and Ageing to
Medicines Australia in 2003 that the
definition/interpretation
of
hypercholesterolaemia may depend on a
variety of factors including associated
morbidity. Members were of the view that
independent Guidelines are important;
however, companies must ensure they
promote products within their approved
indications.
Some members commented that the claim
Lipitor 80mg reduces recurrent stroke risk
by 16% vs placebo in landmark SPARCL
trial [p=0.03] was not qualified with
information that while the reduction in fatal
strokes was statistically significant there
was no difference between the placebo
and atorvastatin arms in recurrent nonfatal stroke [p=0.11].
The majority of members did not agree
that the claim relating to reduction of
recurrent stroke was promoting Lipitor
outside of the approved indications.

91

Hypercholesterolemia is understood in
terms of a patients overall risk factors as
well as the actual lipid levels.
The
approved indications for Lipitor include
reference to these risk factors, including
history of stroke or other cerebrovascular
disease.
In relation to the assertion by AstraZeneca
that the promotion was misleading, the
Committee noted that there was a
qualifying statement on the advertisement:

There was a higher incidence of

haemorrhagic stroke in the Lipitor
80mg group (n-55) compared with
placebo
(n=33).
Patients
with
haemorrhagic stoke on entry appeared
to be at increased risk for recurrent
haemorrhagic stroke (n=7 Lipitor 80mg
vs n=2 placebo; however the very
small
numbers
preclude
any
meaningful
conclusion
regarding
relative risks of statin treatment in this
population.

which is a paraphrase of the actual study

results that refer to small numbers. Some
members expressed the view that Pfizer
should not re-interpret study results, and
should accurately reflect the referenced
study. However, the majority of members
did not consider that this was sufficient to
find a breach of the Code but cautioned
that Pfizer should not use interpretive
comment when communicating study
findings.
In a majority decision the Committee found
no breach of Sections 1.1, 1.3, or 1.3.1 of
the Code.

Issue 4 Tagline Power.

Confidence; Intensity

Evidence.

The majority of members were of the view

that the tagline words were not unqualified
superlatives although some members
were of the view that together they did
imply a special merit or quality of Lipitor.
In a majority decision the Committee found
no breach of Section 1.5 of the Code.
The Committee was of the view that a
company has a responsibility to ensure
that claims, including taglines are qualified
where it would be misleading not to do so.
The majority of the Committee considered
that the tagline words were making claims
for Lipitor that had not been referenced or
substantiated. Members commented that
the word intensity was generally
meaningless
without
appropriate
explanation, substantiation or qualification.

Code of Conduct Annual Report 2007/2008

In a majority decision the Committee found

a breach of Sections 1.1 and 1.2 of the
Code.
Sanction
The Committee determined that the
breaches should be regarded as
moderate. Having found several breaches
of the Code the Committee determined
that Pfizer should pay a fine of $50,000
and withdraw all materials found in breach
of the Code.
In a majority decision the Committee
determined that as there were no safety
implications for patients resulting from the
advertisements, although the breaches
were moderate, no corrective letter was
required.
The Committee noted that Pfizer had
alleged that several of the complaints were
vexatious.
However, having found a
number of breaches of the Code, the
Committee determined that AstraZeneca
should not be required to respond to the
allegation of a breach of Section 12.3 of
the Code.

Appeals Committee
Pfizer appeal
Pfizer lodged an appeal in relation to two
matters (Issues 1 and 4) and the sanctions
imposed by the Code of Conduct
Committee.
Claims subject to appeal

Issue 1 Unsurpassed statin effects on

LDL-C
Issue 4 Tagline Power.
Confidence; Intensity

Evidence.

Pfizer believed that the Code of Conduct

Committee had erroneously interpreted the
definition of unsurpassed to mean that
Lipitor has the best qualities or most
favourable qualities rather than the more
common definition of not capable of being
improved on. Pfizer asserted that this
was always its intention when using this
claim.
Pfizer stated that the results of two TGAevaluated studies in the Crestor PI
comparing Crestor (40 mg) and Lipitor 80
mg (the highest doses approved in
Australia) show that one drug does not
surpass the other in its LDL-C lowering
capabilities. Pfizer maintained that this

92

supports the view that Lipitor 80 mg is not

surpassed by Crestor 40 mg (and vice
versa).
Pfizer also stated that the promotional
piece in question was withdrawn from
circulation on 25 June 2007 (3 months
before the complaint was received from
AstraZeneca).
Pfizer argued that the fine was
disproportionally large when compared to
the $80,000 fine imposed on AstraZeneca
for a repeat breach of the Code for Crestor
promotional material.
AstraZeneca response to the appeal
AstraZeneca supported the Code of
Conduct Committees view that from a
marketing or promotional perspective
unsurpassed would mean that a product
had the best qualities or most favourable
qualities; and variously imply that there is
no other statin as powerful as Lipitor.
AstraZeneca stated that the body of
evidence does not support Pfizers claims
in relation to the efficacy of Lipitor.
AstraZeneca also expressed the view that
the claims made by Pfizer for Lipitor, and
the tagline, are intended to influence a
prescriber to believe that there is no doubt
that there is no other statin as powerful
as Lipitor.
Consideration of the appeal
The following summarises
appeal.

the Pfizer

The timeline leading to the initial

complaint was outlined:
Unanimous Code of Conduct
Committee decision (complaint
842) that AstraZeneca cannot
claim superiority of Crestor over
Lipitor (October 2006)
Appeals
Committee
(842)
concluded that there was an
evolving body of evidence which
was not strong enough at this time
to support the strong claim that
Crestor is more effective than
other statins
Crestor Product Information (PI)
updated with Leiter et al. study
data in August 2007 (this data had
previously been reviewed as an
abstract in complaint 842)
Complaint 886 received by Pfizer
four weeks after Crestor PI
updated

Code of Conduct Annual Report 2007/2008

Use and definition of term unsurpassed

The Code of Conduct Committee
interpreted unsurpassed to mean
superiority this was incorrect and
it was not the intention of Pfizer to
infer superiority of Lipitor.
In the context of use of
unsurpassed
within
the
promotional
material,
unsurpassed meant equivalence.
As the Code of Conduct Committee
decision was not unanimous, this was
indicative of a mixed view on the
definition.
Crestor 40 mg (C40) and Lipitor 80 mg
(L80) have comparable efficacy in
lowering LDL.
Throughout this complaint, Pfizer
considers that AstraZeneca has been
attempting to position Crestor as
superior to Lipitor a position twice
rejected in complaint 842.
Efficacy comparisons of C40 and L80
differ in the two studies referenced in the
Crestor PI (Jones et al. and Leiter et al.),
with these data representing equivocal
results.
The PBAC has referenced-priced
Crestor to Lipitor, suggesting equivalent
efficacy.
It is necessary to evaluate the drugs
across the full range of their available
doses to accurately assess whether
superiority advantages exist.
Crestor and Lipitor do not have
comparable doses (Crestor doses are 5
mg, 10 mg, 20 mg, 40 mg daily and
Lipitor 10 mg, 20 mg, 40 mg, 80 mg
daily).
The TGA has required limitations for the
use of the highest dose of Crestor (40mg
-C40). The PI states that the usual
maximum dose is 20 mg and that 40 mg
should only be considered in patients
still at high cardiovascular risk and that
specialist
supervision
should
be
considered when the dose is titrated up
to 40 mg.
The breach found in relation to the use
of unsurpassed relates only to the
usage of the word, not the remainder of
the claim.
The publication of Leiter et al. does not
substantially change the body of
evidence.
The Law meta-analysis provides the
highest possible level of evidence for the
lipid lowering effect of Lipitor as it is a
meta-analysis of double blind placebo
controlled trials.

93

 Four of the five papers cited by

AstraZeneca do not have placebo
control arms, so the treatment effect
could have been underestimated. The
study with the placebo arm, (Amarenco
et al.), shows a 53% LDL reduction,
consistent with Law.
The promotional materials on which the
tagline or headline Power, Evidence,
Confidence
appears
are
fully
referenced.
The taglines will not mislead prescribers.
There are no safety implications for
patients arising from the claims subject
to complaint.
Intensity is part of the promotional copy
rather than a tagline. Pfizer stated that it
would be incorrect for the Appeals
Committee to rule on this term as a
tagline.
The fine of $50,000 for a moderate
breach is out of proportion to the
$80,000 fine levied on AstraZeneca for a
repeat breach (883).
The breaches were not made on a
unanimous basis and therefore should
be considered, at best, a minor breach.
Due to the potential for ambiguity Pfizer
is
no longer
using
the word
unsurpassed.
The
following
summarises
AstraZeneca response to the
appeal.

the
Pfizer

The reference by Pfizer to complaints

over the past 18 months is irrelevant to
the matters subject to appeal. The
appeal is not about AstraZeneca claims
or promotional materials.
The Code of Conduct Committee did
state that evidence concerning lipid
lowering agents is evolving.
The body of evidence comparing C40
and Lipitor 80mg (L80) clearly indicates
that C40 is more efficacious than L80
and consequently leaves an observer in
doubt about the claim for unsurpassed
efficacy of Lipitor.
Superiority claims should be based on
head-to-head comparisons.
Law et al. was published 5 years ago
and is outdated.
The Law analysis did not include any of
the five head to head comparative
studies which comprise the body of
evidence in this matter.
The studies included in the Law metaanalysis included only 1,700 patients on
Lipitor and 34 patients on C40.

Code of Conduct Annual Report 2007/2008

Five randomised clinical trials published

since Law et al involved 14,000 patients.
Data from the five head to head studies
do not support the 55% LDL-C treatment
effect claimed by Pfizer using Law et al.
The Crestor PI does not prohibit the use
of C40.
It provides guidance on
appropriate use and monitoring of
patients on the higher dose.
While Pfizer claim unsurpassed means
not capable of being improved on there
are
many
dictionary
definitions.
Readers, including members of the
Code Committee, will have a range of
interpretations of its meaning.
The use of the words Power, Evidence,
Confidence, Intensity do convey a
meaning to a reader when they appear
directly underneath the Lipitor name and
product logo and are intended to
associate these qualities with the
product.
The onus is on a company to leave a
reader in no doubt about the evidence.
This is not the case with the Lipitor
materials which give the impression of
superiority of Lipitor.
The Chairman thanked the representatives
from Pfizer and AstraZeneca and asked
that they leave the meeting to allow
members to adjudicate on the matters
before them.
Consideration of the appeal

Issue 1 Unsurpassed statin effects on

LDL-C

There was a majority view from the

Appeals Committee members that the
claim of unsurpassed could be interpreted
in many ways, even in the context of the
Lipitor promotional materials. The strict
literal
meaning
appeared
to
be
equivalence, despite some dictionary
definitions which referred to superiority.
However the majority of members were of
the view that, in the particular context of
this promotional
piece, the word
unsurpassed was capable of being
understood as conveying a message or
claim of superiority, and that there was
therefore sufficient ambiguity in the use of
unsurpassed to support the Code
Committees finding that the use of the
word was misleading.
Following lengthy discussion on the
evidence that was used to substantiate the
claims using the word unsurpassed,
members concluded that there is a
difference in the evidence that can be

94

used for claims of efficacy for a specific

product standing alone and that which is
required to support comparative claims.
Members were of the view that because
the word unsurpassed is inherently
comparative, the highest level of evidence
should be used as substantiating data.
The Appeals Committee confirmed the
decision of the Code of Conduct
Committee that the cited evidence was not
sufficient to support the claim that Lipitor is
unsurpassed and in a majority decision
found a breach of Sections 1.1, 1.2, 1.3,
1.5 and 1.7 of the Code.

Issue 4 Tagline Power.

Confidence; Intensity

Evidence.

Having taken note that the Lipitor tagline is

Power, Evidence, Confidence (without the
word intensity) the Appeals Committee
was of the view that the use of these
words involved an implied claim and
therefore
required
appropriate
substantiation. Members also commented
that the word intensity is meaningless
from a scientific viewpoint and did not
have a pharmacological meaning.
The Appeals Committee stated that the
tagline and/or use of the word intensity in
the context of promotional materials that
also implied superiority, combined to
provide a message of superiority which
could
not
be
substantiated.
The
Committee was not persuaded that the
tagline was to be seen as dissociated from
the promotional content of the item
complained of.
In a majority decision the Appeals
Committee confirmed the finding of a
breach of Sections 1.1 and 1.2 of the
Code.
Sanction
Having not upheld the appeal the
Committee
reviewed
the
sanctions
imposed by the Code of Conduct
Committee. Members considered the
arguments concerning the level of sanction
and agreed that the fine of $50,000 was
not disproportionate and should remain
and that materials containing words and
claims found to be in breach of the Code
should be withdrawn.

Code of Conduct Annual Report 2007/2008

95

Micardis (887)
Subject Company: Boehringer Ingelheim

Consideration of the complaint

Unsolicited dissemination of information

on ONTARGET and other clinical trials
involving off-label indications

Sections of the Code

Materials alleged to be in breach of the
following Section of the Code:
1.3.1
Unapproved
Products
and
Indications
10.5 Medical Literature/reprints

Members reviewed the large range of

promotional materials that provided
information on the ONTARGET program
and other clinical trials. Some members
were concerned that although it is
appropriate to provide information on
clinical trials to healthcare professionals,
there was a widespread campaign to
increase awareness of the ONTARGET
trial program.
Members discussed
whether the information about the various
trials, and particularly the ONTARGET
program, were promoting Micardis outside
its approved indications. Members noted
that just as there is an accepted
association between lipid lowering and
lowering cardiovascular risk, there is also
a well established association between
lowering blood pressure and reducing
cardiovascular and cerebrovascular risk.
Members did not agree that the
information about the Micardis clinical trial
program was promoting off-label use. The
information on the clinical trial design,
inclusion and exclusion criteria and
primary and secondary endpoints did not
make any claims for Micardis as no results
were available.

Response
Boehringer Ingelheim strongly denied the
allegations and asserted that AstraZeneca
had misrepresented the information in their
complaint. Boehringer Ingelheim regarded
the communication of information on the
landmark study ONTARGET Clinical
Program was consistent with the Code.
Boehringer Ingelheim stated that it had at
no time promoted Micardis for the
treatment of metabolic syndrome per se,
but had promoted Micardis for the
treatment of hypertension, including the
treatment of hypertension as a component
of metabolic syndrome.

In relation to the allegation of promotion of

Micardis
for
metabolic
syndrome,
members noted that metabolic syndrome
usually, but not always, includes
hypertension.
Most patients with
metabolic syndrome have hypertension;
for people who are not hypertensive it is
nevertheless preferable to lower blood
pressure.
A majority of members
considered that the information and
educational activities covering telmisartan
(Micardis) and its use in metabolic
syndrome were not promoting off-label
use, except as identified below in relation
to the Medical Information Request Form.

Code Committee determination

In a unanimous decision the Committee
found a breach of Section 1.3.1 in relation
to the Micardis Medical Information
Request Form. In a majority decision the
Committee found no breach of Section
10.5.1

By a majority decision, the Committee

found no breach of Section 10.5.1 in
relation to any of the materials submitted
with the complaint.

Complainant: AstraZeneca
Product: Micardis
Complaint
AstraZeneca alleged that Boehringer
Ingelheim was engaged in activities to
increase clinician awareness of off-label
data on Micardis that is likely to encourage
off-label use.
It was alleged that
Boehringer Ingelheim was promoting offlabel use of Micardis through unsolicited,
routine dissemination of clinical trials
information
involving
non-registered
indications of Micardis. AstraZeneca also
alleged that the promotion of Micardis was
an orchestrated campaign with the intent
to build a case to infer benefits exclusive
to Micardis for patients with the metabolic
syndrome.

Sanction
Fine $25,000 and withdraw item found
in breach

Code of Conduct Annual Report 2007/2008

Members raised concerns in relation to

one item only - the Medical Information
Request Form, which included the
following statements:

96

Boehringer Ingelheim is committed to the

safe and appropriate use of its products
and to the provision of relevant clinical
literature in response to your enquiries
about our products.
Micardis is indicated for the treatment of
hypertension. As such, the responsibility
for its use for other indications is that of the
prescriber.
I would like to receive information on the
effects of Micardis in:
Diabetic nephropathy
Heart Failure
Metabolic Syndrome
Renally impaired patients
I confirm that my request has not been
solicited
Members were of the view that a request
for information on unapproved indications
for a product should be initiated by the
healthcare professional rather then the
company providing a checklist which
includes unapproved indications from
which a healthcare professional can make
a selection.
The Committee unanimously found a
breach of Section 1.3.1 in relation to the
Medical Information Request Form only,
because it solicited health professionals to
request information on unapproved
indications for Micardis.
Sanction
Having found a breach of the Code in
relation to one item, which was considered
to be a minor breach, the Committee
determined to impose a fine of $25,000.
The item found in breach should be
withdrawn and Boehringer Ingelheim
should not permit further appearance of
the item in its current form or in a manner
that conveys the same or similar meaning.

Code of Conduct Annual Report 2007/2008

97

Lumigan (888)

CLAIM 2 Lumigan eye drops

Xalacom
equally
efficacious
monotherapy 24-hour mean IOP

Subject Company: Allergan Australia

(Allergan)

Breaches alleged of the following sections

of the Code:
1.1 Responsibility
1.2.2 Level of Substantiating Data
1.3 False or Misleading Claims
1.7 Comparative Statements

Complainant: Pfizer Australia (Pfizer)

Product: Lumigan
Complaint
Pfizer asserted that Allergan had failed to
ensure that data used to support
promotional claims met all requirements of
the Code of Conduct, particularly the
inclusion of data of sufficient detail and of
adequate quality to allow evaluation of the
validity of results.
Pfizer asserted that the two claims
constituted repeat breaches (of Lumigan
836) because the same equivalent efficacy
claim
is
used
without
adequate
substantiation.
Sections of the Code
Repeat breaches of
complaint:

Lumigan

and
in

836

CLAIM 1: A monotherapy as efficacious

as a combination treatment ensures you
have somewhere to go

Breaches alleged of the following sections

of the Code:
1.1 Responsibility
1.2.2 Level of Substantiating Data
1.3 False or Misleading Claims
1.7 Comparative Statements

Response
Allergan rejected the allegations that the
Lumigan promotional material was in
breach of the Code. Allergan maintained
that the previous complaint did not include
a head-to-head comparison whereas the
new material referred specifically to a new
head-to-head study.
Allergan alleged that Pfizers criticisms of
the promotional material were frivolous
and that Pfizer should be found in breach
of Section 12.3 of the Medicines Australia
Code of Conduct.
Code Committee determination
In a unanimous decision the Committee
found no breach of Sections 1.1, 1.2.2, 1.3
or 1.7. The Committee did not consider the
matter to be a repeat breach of the Code.

Code of Conduct Annual Report 2007/2008

Code Committee determination

In a unanimous decision the Committee
found no breach of Sections 1.1, 1.2.2, 1.3
or 1.7. The Committee did not consider the
matter to be a repeat breach of the Code.
New breaches:

CLAIM 3: A monotherapy as efficacious

as a combination treatment ensures you
have somewhere to go
Breaches alleged of the following sections
of the Code:
1.1 Responsibility
1.2.2 Level of Substantiating Data
1.3 False or Misleading Claims
1.7 Comparative Statements

Code Committee determination

In a unanimous decision the Committee
found no breach of Sections 1.1, 1.2.2, 1.3
or 1.7.

CLAIM 4: Monotherapy or Combination

therapy?
Breaches alleged of the following sections
of the Code:
1.1 Responsibility
1.2.2 Level of Substantiating Data
1.3.1
Unapproved
Products
and
Indications
1.7 Comparative Statements

Code Committee determination

In a unanimous decision the Committee
found no breach of Sections 1.1, 1.2.2,
1.3.1 or 1.7.

CLAIM 5: Sight above all else

Breaches alleged of the following sections

of the Code:
1.3 False or Misleading Claims
1.3.1
Unapproved
Products
and
Indications
1.5 Unqualified Superlatives
Code Committee determination
In a unanimous decision the Committee
found no breach of Sections 1.3, 1.3.1 or
1.5.

98

CLAIM 6: No significant differences seen

between treatment groups in any safety or
efficacy measure.
Breaches alleged of the following sections
of the Code:
1.1 Responsibility
1.2.2 Level of Substantiating Data
1.3 False and Misleading Claims
1.7 Comparative Statements

Code Committee determination

In a unanimous decision the Committee
found no breach of Sections 1.2, 1.2.2, 1.3
or 1.7.
Consideration of the complaint

CLAIM 1: A monotherapy as efficacious

as a combination treatment ensures you
have somewhere to go

The Committee noted that the Rossetti et

al study was a randomised, doublemasked (which is equivalent to doubleblind), multi centre clinical trial. The study
was published in Ophthalmology the
journal of the American Academy of
Ophthalmology. This publication is a highly
esteemed, specialty journal and has a
stringent peer review process with only
36% of submitted articles accepted for
publication. The Committee did not accept
that there were any issues with the
veracity of the trial or the journal as
alleged by Pfizer.
The primary outcome was to compare the
effect of bimataprost and the fixed
combination of latanoprost and timolol
(LTFC) on 24-hour mean intraocular
pressure (IOP) after patients are switched
from
a
non-fixed
combination
of
latanoprost and timolol. The hypothesis
was that bimataprost is not inferior to the
LTFC in lowering IOP. Rossetti et al
concluded that bimataprost was not
inferior to LTFC.
The Committee referred to the minutes of
the previous complaint (Lumigan 836) in
which the claim was found in breach
because there had been no published,
head to head evidence to substantiate the
claim that Lumigan and Xalacom were
equally efficacious. Members also noted
that in considering the Lumigan 836
appeal, the Appeals Committee had
commented that while the Rossetti study
was not published at the time of complaint
836, it did not mean it could not be used to
support claims in future promotional
material if the company considered the
published paper could support the claim.

Code of Conduct Annual Report 2007/2008

Having reviewed the analysis in the

Rossetti study, the Code of Conduct
Committee did not agree that there was
any evidence to support Pfizers
allegations in relation to the timing of
dosing compromising the study results or
that there was any potential selection bias
due to the non-inclusion of non-responders
to latanoprost or timolol. The patients
included in the study were all well
controlled on the non-fixed combination or
on monotherapy with either latanoprost or
timolol and eligible for dual therapy. The
latter group received a 6 week wash in
period with the non-fixed combination.
The Committee was of the view that there
was no evidence to suggest that the study
design would bias the results in favour of
Lumigan.
Members noted Pfizers assertion that the
confidence intervals were not included in
the study results. The methods section
noted that confidence interval calculation
was undertaken in the test of noninferiority.
The
Code
Committee
considered that as the study had been
peer
reviewed
and
accepted
for
publication it would be a reasonable
assumption that the authors had done as
stated in the methods section and
calculated the confidence intervals to test
the hypothesis.
In relation to Pfizers assertion that
equivalent efficacy requires stricter criteria
than no significant difference, the
Committee reviewed the description of the
data analysis in the Rosetti paper. The
statistical analysis of covariance for
whether there was a difference in mean
IOP after bimataprost and the LTFC was a
standard test and demonstrated noninferiority. The paper also described the
secondary analysis for superiority using a
two-tailed T-test which didnt find any
statistical superiority for bimataprost. The
Code Committee concluded that the
Rosetti paper provided an acceptably
stringent basis for demonstrating noninferiority and equivalent efficacy of
bimataprost when compared with LTFC.
In a unanimous decision the Committee
found no breach of Sections 1.1, 1.2.2, 1.3
or 1.7. The Committee did not consider the
claim to be a repeat breach of the Code.

99

CLAIM 2 Lumigan eye drops

Xalacom
equally
efficacious
monotherapy 24-hour mean IOP

and
in

See discussion in relation to Claim 1.

In a unanimous decision the Committee
found no breach of Sections 1.1, 1.2.2, 1.3
or 1.7. The Committee did not consider the
claim to be a repeat breach of the Code.

CLAIM 3: A monotherapy as efficacious

as a combination treatment ensures you
have somewhere to go

The Committee considered that the claim

was a little obscure, but did not consider
that the claim implied that patients should
be started or initiated on Lumigan,
although the approved indication for
Lumigan includes first line treatment of
raised IOP, but that it was another option.
The Committee was of the view that when
considered in the context of the whole
piece, the claim did not infer that it implied
equal efficacy to all combination therapies.
In a unanimous decision the Committee
found no breach of Sections 1.1, 1.2.2, 1.3
or 1.7.

CLAIM 4: Monotherapy or Combination

therapy?

The Committee noted Pfizers allegation

that the nature of this claim implied that
there is a choice in the treatment algorithm
for initiating therapy regarding Primary
Open Angle Glaucoma or Ocular
Hypertension. Members noted that this
item was provided to ophthalmologists
only. This audience would be familiar with
the guidelines for treating patients with
glaucoma. Members were of the view that
the detailing aid in dispute was offering an
alternative treatment when a patient may
not be responding satisfactorily to another
treatment.
In a unanimous decision the Committee
found no breach of Sections 1.1, 1.2.2,
1.3.1 or 1.7.

CLAIM 5: Sight, above all else

Members
discussed
whether
this
statement made a claim that was specific
to any aspect of Lumigans indications, a
comparison to other treatment options or
whether the specific placement of the
statement juxtaposed with the product
name and logo impacted on its meaning.
The Code Committee was of the view that
the preservation of sight would be the goal
of all ophthalmologists when treating any

Code of Conduct Annual Report 2007/2008

condition of the eye. Members were of the

view that this statement would not lead a
healthcare professional to the conclusion
that Lumigan was the only efficacious
treatment for glaucoma, or that Lumigan
was more effective at preserving sight that
any other treatment.
In the context of the Lumigan promotional
piece, where overall no claim was found in
breach of the Code and the claims were
consistent with the Rosetti et al paper, the
Committee determined that the statement
was not in breach of the Code. However,
in a different context use of the words
sight, above all else unreferenced or in
an unqualified way may raise some issues
with respect to the Code.
In a unanimous decision the Committee
found no breach of Sections 1.3, 1.3.1 or
1.5.

CLAIM 6: No significant differences seen

between treatment groups in any safety or
efficacy measure.

The Committee noted that the Rossetti

paper stated Although no severe local
side effect was observed at 12 weeks,
bimataprost-treated patients had more lid
changes
(9/101
vs
1/99),
more
conjunctival hyperaemia (25/101 vs 13/99)
and more corneal changes (14/101 vs
4/99) than patients treated with LTFC. No
significant difference from baseline in
either group or the groups was found.
The Committee reviewed Table 6 Local
Adverse Effects from the Rosetti et al
paper and noted that the study analysis
included the Fischers exact test for safety
variables. Claim 6 was consistent with the
study results. It was noted that the study
was not designed or powered to detect
differences in safety between treatments.
Some members stated that while there
appeared to be no statistically significant
difference between local adverse effects
from LTFC and bimataprost, the
frequencies of minor side effects were
numerically higher for bimataprost.
However again the Committee was of the
view that the statistical methods had been
peer reviewed and were deemed to be
accurately represented in the manuscript
as published. Nevertheless, a view was
expressed that it may be helpful to provide
the full statement from the Rosetti study in
information to ophthalmologists, although
this audience should be aware of this

100

detailed information in the respective

Product Information documents.
In a unanimous decision the Committee
found no breach of Sections 1.2, 1.2.2, 1.3
or 1.7.
Section 12.3 allegation
The Committee considered the allegation
by Allergan that the complaint was
frivolous and that Pfizer should be found in
breach of Section 12.3 of the Code of
Conduct. Some members did consider
that Pfizer was stretching the boundaries
of reasonable argument to challenge the
validity of the Rosetti et al study
publication to support the claims in the
Lumigan promotional piece and to assert
that Claims 1 and 2 were repeat breaches.
However, after further discussion the
Committee concluded that Pfizer should
not be required to show cause why the
Committee should not impose a fine for
abuse of the Code.

Code of Conduct Annual Report 2007/2008

101

Reductil (889)
Subject Company:
(Abbott)
Complainant:
(iNova)

iNova

Abbott

Australasia

Pharmaceuticals

Product: Reductil
Complaint
iNova had no dispute with the intent or
right of Abbott to inform healthcare
professionals about a price reduction for a
product. Rather, it was the execution of the
communication that, in iNovas opinion,
contained claims that are likely to lead to
an unfair competitive advantage for
Reductil.
iNova alleged that claims in the Reductil
promotional material are likely to mislead,
are unsubstantiated and often not
referenced. Furthermore, iNova proposed
that the price reduction claim within the
Reductil
promotional
material
is
misleading and inaccurate to doctors and
pharmacists by implication and omission.
iNova maintained that the promoted price
must be specific, clear, substantiated and
representative of the price to patient in the
market place.
Sections of the Code

Issue 1: Cost of Reductil cut by over 30%

Issue 2: Accompanying graphic showing
$120 being cut in half
Issue 3: From January 1, the price of
Reductil will be cut to below $85.00
advertised to doctors and From January
1, the price of Reductil will be cut to
$84.99 advertised to pharmacists
Materials alleged to be in breach of the
following Section of the Code:
1.3 False of Misleading Claims

Issue 4: Feel Full, Eat Less tagline

Materials alleged to be in breach of the
following Sections of the Code:
1.2.2 Level of Substantiating Data
1.3 False of Misleading Claims

Issue 5: More affordable therapy and

Proven weight loss therapy will be more
affordable

Code of Conduct Annual Report 2007/2008

Materials alleged to be in breach of the

following Sections of the Code:
1.3 False of Misleading Claims
1.7 Comparative Statements

Issue 6: Helping increase treatment

duration

Materials alleged to be in breach of the

following Sections of the Code:
1.3 False of Misleading Claims
1.7 Comparative Statements
Response
Abbott maintained that the promotional
pieces subject to complaint were designed
to communicate to physicians and
pharmacists a reduction in the price of
Reductil. Because Reductil is a private
prescription medication it does not have a
fixed price. Abbott argued that basing the
over 30% claim on the Arrow Private
Prescription model for Reductil would
provide a fair representation of the price
reduction. Abbott further argued that the
advertisements include a statement that
clearly indicated that the prices and
discounts quoted refer to recommended
dispensed price to patients.
Code Committee determination

Issue 1: Cost of Reductil cut by over 30%

By a majority decision the Committee

found no breach of Section 1.3 of the
Code.

Issue 2: Accompanying graphic showing

$120 being cut in half

In a unanimous decision the Committee

found no breach of Section 1.3 of the
Code.

Issue 3: From January 1, the price of

Reductil will be cut to below $85.00
advertised to doctors and From January
1, the price of Reductil will be cut to
$84.99 advertised to pharmacists
In a unanimous decision the Committee
found no breach of Section 1.3 of the Code

Issue 4: Feel Full, Eat Less tagline

By a majority decision the Committee

found a breach of Sections 1.2.2 and 1.3
of the Code.

Issue 5: More affordable therapy and

Proven weight loss therapy will be more
affordable
In a unanimous decision the Committee
found no breach of Sections 1.3 and 1.7 of
the Code.

102

Issue 6: Helping increase treatment

duration
In a majority decision the Committee found
a breach of Section 1.3 of the Code and in
a unanimous decision the Committee
found no breach of Section 1.7 of the
Code.
Sanctions
Withdraw claims found in breach of the
Code and do not use again in the same
manner or a manner which conveys the
same meaning
Pay a fine of $10,000
Consideration of the complaint
The Committee noted that the Code of
Conduct covers activities directed to
healthcare professionals who in the course
of their professional duties prescribe,
administer or supply a prescription
medicine; that is doctors, nurses, dentists
and pharmacists. Members accepted that
advertisements for prescription medicines
directed at pharmacists must comply with
the Medicines Australia Code of Conduct.

30%, members were of the view that the

image was not misleading.
In a unanimous decision the Committee
found no breach of Section 1.3 of the
Code.

Issue 3: From January 1, the price of

Reductil will be cut to below $85.00
advertised to doctors and From January
1, the price of Reductil will be cut to
$84.99 advertised to pharmacists

Healthcare
professionals
on
the
Committee commented that there is some
evidence that obesity is of particular
concern in lower socio-economic sectors
of the community and that patients are
price sensitive for weight reducing
products. Therefore it would be in the
interest of a patient for a prescriber to have
information to enable them to advise a
patient of the potential cost of this
treatment.
Members were of the view that the
advertisements only related to Reductil
and were not misleading.

Members also noted that Reductil is not a

PBS listed medicine and is available on a
private prescription for the management of
obesity.

In a unanimous decision the Committee

found no breach of Section 1.3 of the
Code.

Issue 1: Cost of Reductil cut by over 30%

Issue 4: Feel Full, Eat Less tagline

The Committee noted that there was a

statement qualifying the statement From
January 1, the price of Reductil will be cut
to below $85.00; that is Recommended
Retail Price may vary by pharmacy.
Members were of the view that there was
sufficient context provided in the
advertisement that the price reduction of
over 30% was a fair claim. However it
could have been clearer and the
Committee encouraged Abbott to include a
more detailed qualifying statement in
future advertisements. This statement
should indicate the basis of the 30% price
reduction when compared to what
original price.
By a majority decision the Committee
found no breach of Section 1.3 of the
Code.

Issue 2: Accompanying graphic showing

$120 being cut in half

In relation to the allegation that the graphic

gave the impression that the percentage of
the original price, as depicted by currency
valued at $120, being cut was greater than

Code of Conduct Annual Report 2007/2008

Members noted the difficulties created by

a simple unqualified feel full claim, in
terms of what it would be interpreted to
mean.
Members were concerned that it could be
open to a range of interpretations. Whilst
this was an issue in itself, given the
audience and the cited references, it was
considered that a more technical approach
was appropriate.
Members discussed the use of the terms
fullness and whether it meant the same
as satiety. The consensus being that they
were not likely interchangeable and less
likely to be so in a clinical setting. Having
reviewed the clinical papers members
determined that there was no unequivocal
evidence provided to support the Feel full
component of the tagline. The references
for the tagline were the Reductil Product
Information and a review article by Lean
(2001). However, the Product Information
only states that Reductil resulted in weight
loss, not a feeling of fullness.
The
Committee reviewed two papers cited by
Lean Hansel et al (1999) and Chapelot et

103

al (2000). The Hansen paper stated No

significant drug effect was found on either
satiety or fullness ratings. The paper by
Chapelot stated Analysis at each time
point revealed hunger scores were
significantly lower 240 minutes following
sibutramine (Reductil) than following
placebo. No difference at any other time
point was found. A similar trend was for
served gastric fullness, although this failed
to reach statistical significance. Therefore
it was considered there was not the
required level of evidence that could
support the claim that Reductil had a feel
full effect.
By a majority decision the Committee
found a breach of Sections 1.2.2 and 1.3
of the Code.

In a majority decision the Committee found

a breach of Section 1.3 of the Code and in
a unanimous decision the Committee
found no breach of Section 1.7 of the Code
Sanctions
Having found several breaches of the
Code the Committee considered what
sanction/s should be imposed.
The Committee determined that Abbott
should:
Withdraw all claims found in breach of
the Code and not use them again in the
same form or in a manner which
conveys the same or similar meaning
Pay a fine of $10,000

Issue 5: More affordable therapy and

Proven weight loss therapy will be more
affordable

Members were of the view that these

claims were not hanging comparatives
given the context. The advertisements
relate only to Reductil and there was no
inference of comparison with another
weight loss product. As previously stated,
a doctor would likely discuss the potential
cost of the treatment as it only available on
private script. If a treatment was more
affordable, a patient may be more likely to
be in a position to use the treatment, or to
use it longer, which was in line with the
product information.
In a unanimous decision the Committee
found no breach of Sections 1.3 and 1.7 of
the Code.

Issue 6: Helping increase treatment

duration
While it may be reasonable to assume that
because a treatment becomes cheaper a
patient may be more likely to continue
therapy, members were of the view that
there was no evidence to support the claim
that the price reduction will increase
treatment duration and it was therefore
misleading. The use of helping rather
than may help suggests that there is
evidence that lowering the price of
Reductil does have an effect on patients
staying on treatment, which could not be
substantiated. As previously stated all the
advertisements subject to complaint were
in relation to the costs for Reductil and
members did not consider the claim to be
comparative to another weight loss
treatment.

Code of Conduct Annual Report 2007/2008

104

Abbott Educational Event (890)

Description of function
including duration of the
educational content
delivered
1hr Presentation
Controversy and News
surrounding the active
Vitamin D in patients
with chronic kidney
disease: Treating SHPT
and Beyond

Venue

Professional status of
attendees

Hospitality
provided

Total cost
of
hospitality

Number of
attendees

Total cost
of function

Observatory
Hotel, Sydney
NSW

Multidisciplinary Team

Dinner:
Food &
beverages
for 26 plus
travel &
accommoda
tion for 7

8,176.00

24

10,567.00

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event the cost of
hospitality and cost of function columns were amended.

Subject Company: Abbott Australasia

(Abbott)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event AB-200
Complaint
The Monitoring Committee had asked that
Abbot provide a rationale for the
educational meeting and sponsorship of
interstate delegates and justification for the
accommodation at a cost of $339 per
night.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Abbott denied any breach of the Code.
Abbott responded that the visiting
Professor from the Harvard Medical
School was in Australia to present at an all
day Advisory Board meeting and had
extensive clinical experience with Vitamin
D receptor activator (VDRA) therapy in
both clinical trials and in clinical practice.
The Professor had agreed to follow this
with presentations to the broader renal
community in Australia. He was available
to present in Sydney and Melbourne but
not other capital cities. A decision was
therefore made to fly Queensland
physicians to the Sydney meeting.
Delegates from Queensland flew into
Sydney late in the afternoon and returned
the next morning. Only seven delegates

Code of Conduct Annual Report 2007/2008

were provided with accommodation. The

alternative would have been to find a
second speaker who could have presented
at an event in Brisbane. This decision
would have also incurred costs.
The educational component of the meeting
was 1 hour and 45 minutes.
Abbott considered the venue to be
professional and offered better rates than
other hotels available on this evening.
Code Committee determination
In a majority decision the Committee found
no breach of Sections 6.2.1, 6.2.2, 10.2
and 10.8 of the Code.
Consideration of the complaint
The majority of the Committee held the
view that there was justification for inviting
physicians to the meeting in Sydney given
the small number in Brisbane. The
Committee was also of the view that it is
important that healthcare professionals in
relatively small specialised fields have the
opportunity to interact with their peers and
avail themselves of presentations by
international speakers. A minority of the
Committee
considered
that
the
accommodation was not justified. These
members considered that it was irrelevant
that the speaker was not able to give
presentations in other cities; this was
insufficient justification for providing travel
and
accommodation
for
interstate
delegates for an evening presentation.
In a majority decision the Committee did
not find that the accommodation costs for
the seven interstate delegates at this
educational event were excessive and
found no breaches of the Code.

105

Amgen Educational Event (891)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total
cost of
function

Discussion of Amgen Clinical

Program Presented by
Haematologist Duration: 2
Hours

Hilton
Hotel,
Adelaide,
SA

Haematologists;
Oncologist

Dinner Food &

Beverage (With
Alcohol) 3 Courses

887.50

887.50

Subject Company: Amgen Australia

(Amgen)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event AM-217
Complaint
The Monitoring Committee had asked that
Amgen provide justification for the overall
cost of the hospitality provided at the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Amgen stated that it regretted that this
event fell short of its usual high standards
of company conduct. The event was
organised as a last minute request by the
visiting senior company representative.
The event focussed on early clinical
development and scientific programs and
as such contained commercial in
confidence information and no materials
were produced or distributed.
Amgen accepted that the food and
beverage cost of $201.71 was excessive
and inconsistent with the requirements of
the Code and Amgens own internal
operating guidelines and policies. Amgen
also stated that they are introducing an
Australia Information Pack to be provided
to individuals visiting Australia form
overseas offices of the global Amgen
group and holding staff refresher training
sessions on the obligations that arise
under the Code of Conduct related to the
provision of hospitality to healthcare
professionals. Amgen will also introduce a
business card size Hospitality Quick

Code of Conduct Annual Report 2007/2008

Reference Card identifying the companys

internal rules governing expenditure on
hospitality and supported activities.
Code Committee determination
In a unanimous decision the Committee
found a breach of Sections 6.2.1, 6.2.2
and 10.2 of the Code. In a majority
decision the Committee found no breach
of Section 10.8.
Sanction
By majority decision pay a fine of
$10,000
Consideration of the complaint
The Committee noted the admission by
Amgen, its expression of contrition and
measures to ensure future compliance
with the Code.
The Committee was
unanimously of the view that the hospitality
(cost of $201.71) provided to two
healthcare professionals was excessive
and in breach of the Code. There was no
evidence of proper educational purpose for
the meeting.
In a unanimous decision the Committee
found a breach of Sections 6.2.1, 6.2.2
and 10.2 of the Code. In a majority
decision the Committee found no breach
of Section 10.8.
Sanctions
Having found several breaches of the
Code the Committee considered what
sanction/s should be imposed.
The Committee determined that Amgen
should:
Pay a fine of $10,000

106

Abbott Educational Event (892)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of function

Inner Circle Symposium 3

Day Symposium with Lectures
& Workshops on
Rheumatology

Park Hyatt,
Parliament
Square
Melbourne
Vic

Rheumatology
Nurses &
Registrars

Accommodation,
Food & Beverages
X 2 Days For 80
Pax, Travel &
Transfers X 80 Pax,
Airfares X 68 Pax

119,545.00

80

182,273.00

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event the
hospitality column was expanded to provide additional breakdown of the hospitality components.

Subject Company: Abbott Australasia

(Abbott)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event AB-87
Complaint
The Monitoring Committee had asked that
Abbott provide justification for the cost of
the dinners held in association with the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry

Code Committee determination

In a unanimous decision the Committee
found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.
Consideration of the complaint
The Committee accepted that the
submitted information demonstrated there
had been significant educational content
provided during the event. The Committee
was of the view that the hospitality
provided was secondary to the educational
component and was not extravagant or
excessive and found no breaches of the
Code. In a unanimous decision the
Committee found no breach of any section
of the Code.

Response
Abbott denied any breach of the Code.
Abbott stated that the venue had been
selected following a review of venues in
Melbourne that met the criteria of having
suitable meeting facilities, reasonable
priced accommodation and not amidst the
CBD shopping or other inducements that
may distract delegates.
The event provided 10 hours education for
registrars and 8 hours of education for
nurses plus the inaugural meeting of
Rheumatology
Nurses
Education
Committee
(RNEC)
on
Saturday
afternoon.
Accommodation was provided for nonMelbourne delegates and dinners for the
two evenings cost $89.95 and $136.71 per
head.

Code of Conduct Annual Report 2007/2008

107

Alcon Educational Event (893)

Description of function
including duration of the
educational content delivered
Dinner In Association with
American Academy of
Ophthalmology Annual
Scientific Meeting

Venue

K-Pauls
Restaurant,
New
Orleans

Professional
status of
attendees
Ophthalmologists

Subject Company: Alcon Laboratories

(Australia) [Alcon]
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event AL-22
Complaint
The Monitoring Committee had asked that
Alcon provide justification for the cost of
the dinner provided in association with the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Alcon denied any breach of the Code.
Alcon stated that the company had
provided final invoices/statements in
relation to this event that were not
available at the time of reporting. The
actual value of the food and beverages
provided to the attendees calculated by
Alcon on the basis of the original booking
made and excluding service charges and
room hire (AUD$150.00) was lower than
what appears in the report (equivalent to
AUD$226.00). The reported cost included
a 20% agency fee and the private room
hire was included in the per head charge,
not as a separate fee.
The event was held in New Orleans, a city
which has seen increases in costs since
Hurricane Katrina because many venues
have not re-opened resulting in high
demand on open venues.

Code of Conduct Annual Report 2007/2008

Hospitality
provided
Three Course
Dinner with
Alcohol

Total cost
of
hospitality
6,784.55

Number
of
attendees
30

Code of Conduct and Appeals Committee

determination
In a unanimous decision the Code
Committee found a breach of Section 6.2.2
of the Code and no breach of Sections
6.2.1 and 10.2 of the Code. In a majority
decision no breach of Section 10.8 of the
Code was found. The finding of a breach
of Section 6.2.2 was overturned by the
Appeals Committee.
Sanction
The requirement to pay a fine of $50,000
was removed by the Appeals Committee

Code of Conduct Committee

Consideration of the complaint
The
Committee noted
the Alcon
information in relation to the actual value
of the food and beverages provided to
healthcare professionals. Due to lower
than expected attendees the original
negotiated cost of US$176 per person was
revised to US$210 per person inclusive of
notional room hire and agency fee. Whilst
accepting the high demand for hospitality
in New Orleans resulting from hurricane
Katrina, the Committee considered that the
hospitality provided was extravagant at a
cost of approximately AUD$235 per
person..
Alcon was not obliged to go ahead with the
dinner if the number of attendees resulted
in a cost that was excessive and would not
withstand public or professional scrutiny.
Alcon had not provided any evidence to
support its assertion that the agency fee
was 20% of the actual amount paid.
Members also noted that there was an
open premium bar for a period of three
hours.
The Committee was of the view that this
hospitality was extravagant and therefore
in breach of Section 6.2.2 of the Code. In a
unanimous decision the Committee found
no breach of Sections 6.2.1 and 10.2 of
the Code. In a majority decision no breach
of Section 10.8 of the Code was found.

108

Total cost
of function
6,784.55

Sanctions
Having found a breach of the Code the
Committee considered what sanction/s
should be imposed.
The Committee determined that Alcon
should:
Pay a fine of $50,000

Appeals Committee
Alcon appeal
Alcon lodged an appeal and provided
further information on the cost breakdown
for the event, obtained from the
independent agency through which the
restaurant booking was made and paid for.
This cost breakdown provided evidence of
taxes (9.75%), fixed gratuity (20%) and
agency fees (15%) which Alcon argued
should not be attributed to the cost per
head of the food and beverages provided
to attendees. Alcon maintained that the
actual benefit to the attendees should be
considered to be AUD $141.00 which
includes a 20% gratuity or AUD $117.53 if
all surcharges and gratuities are removed
from the cost per attendee.
Consideration of the appeal
Prior to reviewing the appeal materials
members of the Committee reviewed the
general discussion and outcomes from the
21 April 2008 Code of Conduct Committee
meeting at which the educational event
complaints referred by the Monitoring
Committee were considered.
Members noted the Code of Conduct
Committees comments that as Australian
events should be reported exclusive of
GST it was appropriate that taxes imposed
on events held in countries outside
Australia should also be excluded.
Members also discussed the imposition of
other costs, such as agency fees, which
did not provide attendees any additional
benefit and the compulsory gratuities
which are imposed for many overseas
events and which are outside the control of
the company.
In response to a question pertaining to the
jurisdiction of Medicines Australia over
events held in countries outside Australia,
the Secretariat advised that the Australian
Competition Tribunal and the ACCC
determination
required
a
member
company to report all events held or
sponsored by the Medicines Australia
Member Company. This has been

Code of Conduct Annual Report 2007/2008

interpreted to include hospitality provided

by Australian companies at international
educational events.
The following summarises the Alcon
appeal.
Alcon apologised for the reporting errors in
the costing information submitted to the
Monitoring and Code Committees. Further
detailed breakdowns of the costs had now
been obtained from the agency which
assisted in organising the event.
Overview of hospitality costs

Cost breakdown provided to the Code of

Conduct Committee

The initial reported hospitality cost of

US$210 (AUD$235) per head was
reviewed by the Code Committee and
found to be in breach of the Code.
Although incomplete documentation
was provided it has now been shown
that the hospitality cost of AUD$235
included a 9.75% state tax, 15%
agency fee and included a component
for room hire. There was also a 20%
fixed gratuity and a minimum
attendance guarantee.

Cost breakdown provided to the Appeals

Committee

Alcon stated that the correct hospitality

cost per head was US$126.00
(AUD$141.00 which included a 20%
fixed gratuity but excluded taxes) or
US$105.00 (AUD$117.53) if all
surcharges
and
gratuities
are
removed.

Overview of event

Audience

Australian
&
New
Zealand
Ophthalmologists
attending
the
American Academy of Ophthalmology
Annual
Meeting
(4183
health
professionals registered for this
meeting
although
approximately
12000 to 15000 were expected the
numbers were significantly lower than
the organisers predicted presumably
as it was held in New Orleans)

The venue

K-Pauls restaurant, which is known for

good quality southern style food.

Appropriateness of venue

Walking distance from the Convention

Centre

109

Hospitality costs

The hospitality cost should relate to

the actual cost of the benefit of food
and beverage provided to each
Ophthalmologist.
Alcon asserted that this was in
compliance with the Code.
The event did not provide a benefit of
significance
to
attending
Ophthalmologists.

Overall Alcon remained in control of the

event as is required by the Code at all
times.
Unusual issues that impacted on
hospitality costs
Alcons event occurred in conjunction
with a large medical conference which
means that venues were limited and in
high demand. Early bookings were
required to secure a chosen venue.
Venues were also less available due
to the continuing effects post hurricane
Katrina.
The restaurant charged a minimum
food and beverage cost per function
room to minimize their opportunity
cost.
There was a 20% fixed gratuity.
The hospitality cost included a 9.75%
state tax, a 15% agency management
fee and room rental. In order to
calculate the actual benefit received
by each Ophthalmologist these items
should be removed from any
calculated cost per head.
Hospitality cost per head

Initial contract was for an event in a Private

room for 60 attendees

Minimum food and beverage charge

was USD$7000.
Room size was intended for 60.
Hospitality cost per head calculated for
60 attendees was anticipated to be
USD$116.67*
(AUD$130.56)
excluding state tax (9.75%) and
management fee (15%) but including
room rental.
If the 20% fixed gratuity is included the
cost
would
be
USD$140.00
(AUD$156.04).

Due to a lower than expected number of

attendees at the event, Alcon sought to
renegotiate its contract with the restaurant
through the agency. The Committee was
informed that the contract with the
restaurant did not require the restaurant to

Code of Conduct Annual Report 2007/2008

revisit the quoted cost to Alcon. However,

the restaurant agreed to do this and the
event was moved from a private dining
room to a courtyard for 40 (30 actual
attendees on the night).
Minimum food and beverage charged
was USD$4200.
Room size was suitable for up to 40,
which was the minimum number for
which Alcon was charged for the
event.
Hospitality cost per head was
recalculated
for
40
attendees
USD$105.00 (AUD$117.50) excluding
state tax (9.75%) and agency
management fee (15%) but including
room rental.
If the 20% fixed gratuity is added this
cost
becomes
USD$126.00
(AUD$141.00).
This figure is well below AUD$235 per
head for which Alcon was found in
breach of the Code of Conduct.
When the number of attendees decreased
from 60 to 30 Alcon reviewed its options
carefully:
Canceling the event was NOT
considered an option as this would
inconvenience
the
remaining
attendees and Alcon would have
incurred a 100% cancellation fee.
Alcon re-negotiated with the restaurant
to conduct the event in a smaller
location.
The final hospitality cost was
USD$105 (AUD$117.53) inclusive of
the room rental or USD$126.00
(AUD$141.00) inclusive of the 20%
fixed gratuity and room rental. Both
these calculations exclude the state
tax (9.75%) and management fee
(15%).
Regarding the reference by the Code
of Conduct Committee to an Open
premium bar being provided, Alcon
suggested this term to be a marketing
tool. No spirits or cocktails were
offered; only beer, soft drinks and
middle range wines were served.
On the basis of the actual hospitality
benefit provided to the attendees and the
special circumstances associated with this
event, Alcon requested that the finding of a
breach of 6.2.2 be overturned and that the
fine be removed.
The Chairman thanked the Alcon
representatives and asked that they retire

110

from the meeting to allow the Committee

to make a determination on this matter.

fine of $50,000 imposed by the Code of

Conduct Committee.

Consideration of the appeal

The Appeals Committee was concerned
that Alcon had made several submissions
to the Monitoring and Code Committees
with various costs and it was only on
appeal that the company was able to
provide the finalised figures and an
explanation for the breakdown of all
components. Members were of the view
that
all
companies
should
have
appropriate documentation and a process
for identifying all detailed costs if asked to
respond to the Monitoring or Code
Committees. Members agreed that a
company is responsible for accurately
reporting all events and associated costs
in their educational event report to
Medicines
Australia.
The
Appeals
Committee was also cognisant of the
difficulties
many
companies
had
experienced in providing reports for the
first reporting period.
Medicines Australia has endeavoured to
provide companies with comprehensive
advice on completing and checking their
educational event reports.
Members were of the view that the venue
and use of a small courtyard at the
restaurant, a less formal location, for the
dinner held in association with the
American Academy of Ophthalmology
Annual
meeting
did
not
appear
extravagant. Members also commented
that fixed gratuities of 20% were standard
in the USA, particularly where there are
more than 8 attendees at a dinner. The
Committee also noted the advice on the
ongoing issues with restaurant closures in
New Orleans since hurricane Katrina.
Having cancelled the American Academy
of Ophthalmology meeting at the time of
the hurricane the academy had agreed to
hold a meeting in New Orleans as soon as
possible thereafter. New Orleans remained
short of venues and staff which has an
effect on all costs in the city.
Having noted the actual breakdown of
costs now provided by Alcon and
supported by documentation from the
agency, members were of the view that the
event at a per head cost of AUD$141.00
(including the 20% gratuity) was not
extravagant and determined that the
appeal by Alcon should be upheld. The
Committee also determined to remove the

Code of Conduct Annual Report 2007/2008

111

Allergan Educational Event (894)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

Dinner Held In Association with

the Australasian Academy of
Facial Plastics Oculoplastic
Conference

The
Observatory
Hotel,
Sydney

Specialist
Doctors in
the field of
Facial
Plastic
Surgery

3 Course Dinner And

Drinks

7,552.00

51

9102.00.
This was
inclusive
of a room
hire
charge
and
parking
fees.

Subject Company: Allergan Australia

(Allergan)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event AG-105
Complaint
The Monitoring Committee had asked that
Allergan provide justification for the cost of
the dinner in association with the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Allergan denied any breach of the Code.
Allergan stated that this dinner was part of
a two day educational conference
organised by the Australasian Association
of Facio Plastic Surgeons (AAFPS), held
at Sydney Hospital. Allergan had agreed to
sponsor the conference dinner at short
notice. The cost per head of the dinner
was $148 per head. This cost included a
special order for a Kosher meal, for which
the restaurant had to outsource the
preparation at a cost of $240.00.
Allergan stated that the venue for the
dinner had been chosen due to its
proximity to the hospital at which the
education was provided and its availability
to cater for dinner for 51 delegates.

Code of Conduct Annual Report 2007/2008

Code Committee determination

In a unanimous decision the Committee
found no breach of Sections 6.2.1, 10.2 of
the Code. In a majority decision the
Committee found no breach of Section
6.2.2 and 10.8 of the Code.
Consideration of the complaint
Many members of the Committee were of
the view that there are many venues closer
to the Sydney Hospital than the
Observatory Hotel, which is a higher cost
venue that could have been used for the
dinner. The Committee reiterated its view
that testimonials from attendees are not
persuasive.
Members were of the view that if a
company is asked to sponsor a dinner in
association with an educational event the
company must assure itself that the event
and the venue are appropriate and
consistent with the Code. A group of
healthcare professionals may organise
and pay for a dinner at a venue and cost of
their
choosing.
However,
if
a
pharmaceutical company sponsors a
dinner the company must ensure that it is
not extravagant or excessive.
The
Committee accepted that the primary
purpose of the meeting was educational
and the hospitality was secondary to this
purpose.
While acknowledging that the kosher meal
was expensive, excluding this cost the
cost per head for other attendees would
have been $146. Several members were
of the view that this cost bordered on being
extravagant. However, a majority of
members considered there was an
appropriate balance between the whole
day educational component and the
hospitality. By a majority decision the

112

Committee found no breach of Section

6.2.2 and 10.8 of the Code.
In a
unanimous decision the Committee found
no breach of Sections 6.2.1 and 10.2 of
the Code.

Code of Conduct Annual Report 2007/2008

113

Allergan Educational Event (895)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total
cost of
function

AACPDM 61st Annual

Meeting (Vancouver, Canada)
Australian Doctor Dinner. This
Dinner was Held Allergan for
Australian and New Zealand
Doctors who were attending
The AACPDM Meeting CPD
Points: 0

Diva at The
Met
Restaurant,
Vancouver

Paediatric
Rehabilitation
Specialists,
Physiotherapists,
Occupational
Therapists

3 Course Dinner &

Drinks

9,010.32

40

9,010.32

Subject Company: Allergan Australia

(Allergan)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event AG-90

the food and beverages were excluded,

the meal was not excessive for a dinner
held during a large educational event in
North America.
In a unanimous decision the Committee
found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.

Complaint
The Monitoring Committee had asked that
Allergan provide justification for the cost of
the dinner in association with the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Allergan denied any breach of the Code.
Allergan stated that the dinner was held in
association with the four day American
Academy
of
Cerebral
Palsy
and
Development Medicine Conference in
Vancouver. The dinner cost per head was
AUD$176.00 per head. This included a
21.6% service fee and other local tax
components which increased on the cost
of the dinner.
Code Committee determination
In a unanimous decision the Committee
found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.
Consideration of the complaint
The Committee acknowledged that the
various service fees, taxes and charges
may inflate the actual cost of the food and
beverages provided to the attending
healthcare professionals. Members were
of the view that if the charges additional to

Code of Conduct Annual Report 2007/2008

114

Amgen Educational Event (896)

Description of function
including duration of the
educational content
delivered

Venue

Professional
status of
attendees

Hospitality
provided

Total cost
of
hospitality

Number
of
attendees

Total cost of
function

Amgen Australia Director of

Pharmacy Symposium
Friday, 10th August And
Sunday, 12 August 2007
The Symposium is an
Annual Event now in its 15th
Year. The objective of the
Symposium is to provide the
forum for genuine education
on topics that are both
current and integral to best
practice by hospital
pharmacy Senior Managers.
The format includes didactic
presentations, panel
discussions, Q & A and
general interactive debate.
The agenda for the
Symposium Is developed by
an independent Steering
Committee of experienced
Hospital Pharmacists and
includes highly topical
clinical and management
issues of both general and
often more specific interest
to the majority of the
audience. The Steering
Committee this year
focused on molecular
genetics, drugs, targeting
and Therapeutic
Applications, Plus a session
on the important issue of
Work-Life balance. Duration
of education content over
weekend Event: Approx. 12
Hours

The
Intercontinental
Hotel, Sydney,
NSW

Directors of
Pharmacy

3 Course Dinner
(With Alcoholic
Beverages) X 2
Days Breakfast X
2 Days Morning
Tea X 2 Days
Lunch X 2 Days
Afternoon Tea X 1
Days
Accommodation:
For 82 X 2 Days
Travel: For 31
(Domestic
Economy Return
Airfares for
Delegates
Travelling from
Interstate to
Sydney);
Transfers (Food &
Beverage =
$27,432.18
Flights =
$20,207.14
Airport Transfers
= $4,397.75
Accommodation =
$21,320.00)

73,357.07

56

$127,676.63
(Includes
Hospitality,
Onsite Car
Parking,
Honorarium
Payments,
Promotional
Materials,
Event Agency
Fee,
Administration
Fees, Audio
Visual,
Meeting
Room Hire
And Misc.
Cost Items)

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event there was
additional information in relation to the education and hospitality components.

Subject Company: Amgen Australia

(Amgen)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event AM-79
Complaint
The Monitoring Committee had asked that
Amgen provide justification of the cost of
the dinner held on the second night during
the educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality

Code of Conduct Annual Report 2007/2008

10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Amgen denied any breach of the Code.
Amgen stated that this was an annual
event developed by an independent group
of directors of pharmacy from throughout
Australia and endorsed by the Society of
Hospital
Pharmacists
of
Australia.
Considerable advance planning for the
entire event was undertaken to ensure
compliance with the Code. There was 12
hours education provided to attendees.
The actual cost per head for the dinner on
the second night ($146.02) exceeded the
planned cost ($124.36) as there were

115

substantial delays between courses

resulting in greater consumption of
beverages per head (namely, water and
soft drink) far exceeding the planned cost.
The venue had also over catered for finger
food prior to the dinner.
Code of Conduct and Appeals Committee
determinations
In a unanimous decision the Committee
found a breach of Section 6.2.2 and no
breach of Sections 6.2.1 and 10.2 of the
Code. In a majority decision no breach of
Section 10.8 of the Code was found.
(Decision confirmed by the Appeals
Committee)
Sanction
Pay a fine of $50,000 (Decision
confirmed by the Appeals Committee)

Code of Conduct Committee

Consideration of the complaint
The Committee commented that the
complaint was not in relation to the length
or quality of the education provided. The
complaint pertains to the hospitality
provided by Amgen at the.
Having reviewed the information provided
on the actual costs for the dinner,
members noted that there was finger food
on arrival ($15.74 per head excluding
GST) and a three-course dinner (food and
beverages) at $130.28 per head excluding
GST. Although these two aspects were
quoted separately, it was provided at the
same function to the same group of
attendees. The cost of beverages was
$43.92 per person excluding GST. The
cost per head for the food and beverages
was considered to be extravagant
hospitality and therefore in breach of the
Code.
In a unanimous decision the Committee
found a breach of Section 6.2.2 and no
breach of Sections 6.2.1 and 10.2 of the
Code. In a majority decision no breach of
Section 10.8 of the Code was found.
Sanctions
Having found a breach of the Code the
Committee considered what sanction/s
should be imposed.
The Committee determined that Amgen
should:
Pay a fine of $50,000

Code of Conduct Annual Report 2007/2008

Appeals Committee
Amgen appeal
Amgen submitted that the finding of a
breach of the Code was incorrect and that
the Committee had misapplied the
principles set out in the General
discussion

Educational
Event
Complaints (from the 21 April 2008
meeting) and reached a conclusion that
was inconsistent with the spirit of the
Code.
Amgen stated that the venue was not
ostentatious and did not have any
restaurant hat rating. Amgen was of the
view that the Committee had considered
the cost of the food and beverages in
isolation without proper regard for the
education provided and the professional
standing of the audience. The increased
charges were the result of very
responsible service of food with alcohol
and higher than expected consumption of
non-alcoholic beverages.
Consideration of the appeal
The following summarises the Amgen
appeal:
Amgen takes the Code of Conduct
requirements in any country very
seriously within Australia and around
the world.
Amgen considers that the Directors of
Pharmacy Symposium was not in breach
of the Code. The educational content of
the Symposium was extensive, with
twelve hours of education over two days,
developed by the Directors of Pharmacy.
The program was accredited by the
Society of Hospital Pharmacists.
Education is important for the quality
healthcare provided to patients.
Amgen was proud to be associated with
this event and has sponsored it for 15
years.
Amgen did not promote any products at
the event but did provide a brief
presentation on the Amgen pipeline and
the complexity of new biotechnology
medicines.
The
hospitality
provided
was
commensurate with the professional
standing of the audience and was not
extravagant. The menu was moderate;
wine cost was at the low to medium
range; the venue was conducive to
discussion of the days events.
Amgen had engaged a third party
organizer to plan the event including the

116

dinner held on the second night of the

event which has been found in breach.
The planned cost was well within
Amgens internal guidelines that applied
at the time.
The was a difference between the
planned ($124) and actual ($146) costs
can be attributed to the following:
Venue over catering with respect to
the finger food.
Increased consumption of water and
soft drink due to the delay between
main course and dessert.
Wines were not high cost restaurant
prices $46 - $54 per bottle which
equates to a retail cost of $15 - $30
in a liquor store.
Planned beverage cost included
only 2 glasses of water at $8 per
head but actual consumption was
much higher.
Amgen considers the event passes both
public and professional scrutiny and
following the reporting of the event no
external objection to this event has been
raised.
The Code Committee has erred in its
finding by focusing on the amount
charged to Amgen rather than the actual
quality of the hospitality.
Amgen
referred to the dictionary meaning of
extravagant and argued that the
hospitality was by no means showy or
ostentatious. The event should not be
found in breach on the pure cost per
head for hospitality.
Following questions from the Committee
Amgen provided the following responses:
At the time of reporting the first round of
educational events Amgen had internal
guidelines
for
hospitality
and
recommended expenditure limits. Since
the publication of the events and the
outcomes from the Code of Conduct
Committee Amgen has developed a
revised policy that must be adhered to
by all staff.
A Committee member suggested it was
a subjective view that the higher cost
was due to the consumption of mineral
water. No documentary evidence had
been provided to support this. Amgen
referred to a letter from an attendee at
the dinner that states that the hospitality
was not excessive. A letter from the
CEO of the Society of Hospital
Pharmacists attests to the necessity of
the content of the Symposium.

Code of Conduct Annual Report 2007/2008

The Chairman thanked the Amgen

representatives and asked that they retire
from the meeting to allow the Appeals
Committee to consider the matter before
them.
The Committee did not raise any concerns
with the quality of the education provided
at the event. In relation to the restaurant
venue for the dinner, members were of the
view that it was not extravagant and was
not considered to be in breach of the
Code.
However members were concerned that
Amgen was not able to provide any
evidence, such as an invoice or receipt,
which would allow the Committee to
identify the breakdown in charges, for
example how much of the additional cost
could be attributed to water or soft drink or
any other element. The only evidence to
support the assertion that the additional
cost was due to higher consumption of
water and non-alcoholic beverages were
Amgens staff observations.
Planned cost - $124.36 per head
Actual cost - $146.02 per head
Difference of $21.66 (a 17% increase on
the planned cost)
The beverage bill was $43 per head
(30% of the overall cost per head).
The Committee noted that hospital
pharmacists are the gatekeepers of
medicines purchased within a hospital and
there is a benefit to a company with high
cost medicines to have interactions with
the Directors of Pharmacy.
The Committee was of the view that there
had been a considerable increase in cost,
above Amgens own internal policies at the
time, and Amgen should have ensured
that the finger food quote was adhered to
by the venue. Members remained of the
view that as there was no evidence that
the increase in cost could be attributed to
additional water and soft drink consumed.
The Committee can only consider the
overall cost of the hospitality and judge it
on the face value.
The explanation offered by Amgen did not
persuade the Committee that the Code
Committee had erred in its finding. The
Appeals Committee found the cost of $146
per head to be extravagant hospitality and
in breach of Section 6.2.2 of the Code.

117

Sanctions
Having not upheld the appeal the
Committee reviewed the sanction imposed
by the Code of Conduct Committee. The
Committee was of the view that the fine of
$50,000 should remain.

Code of Conduct Annual Report 2007/2008

118

CSL Educational Event (897)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total
cost of
function

28 Hour Congress/Symposium,
European Research
Organisation on Genital
Infection and Neoplasia.

Hotel De
Paris - Le
Grill;
Monaco

Sexual
Heath,
Gynaecology
Oncologists

Dinner with alcoholic

& non-alcoholic
drinks provided.

3,272.00

3,272.00

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event the cost of
hospitality and total cost of function columns were amended.

Subject Company: CSL

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event CSL-75
Complaint
The Monitoring Committee had asked that
CSL provide justification for the cost of the
dinner held in association with the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
CSL denied any breach of the Code. CSL
stated that the dinner was held in
association with the 3 day European
Research
Organisation
on
Genital
Infection and Neoplasia and the venue for
the dinner was selected by the conference
organisers with no input from CSL. The
nine attendees were all of high
professional standing, some of whom were
keynote speakers at the conference. The
use of a private room was ideal to facilitate
discussion of the conference and days
session.
CSL noted that the high cost of living in
Monaco and the relative weakness of the
Australian dollar, which made the
reportable cost in Australian dollars appear
much higher than what might be paid at a
restaurant in Australia.

Code of Conduct Annual Report 2007/2008

Code Committee determination

In a unanimous decision the Committee
found a breach of Sections 6.2.2 and 10.2
and no breach of Section 6.2.1. In a
majority decision the Committee found no
breach of Section 10.8 of the Code.
Sanction
Pay a fine of $50,000
Consideration of the complaint
While acknowledging that costs in
European cities and restaurants are higher
than Australia members were of the view
that a dinner at a cost equating to
AUD$273.00 per head was extravagant
hospitality, even in Europe, and in breach
of the Code.
Members commented that when using a
conference organiser to identify a venue in
an overseas location a company should
ensure that it provides some guidance on
the price range that would be acceptable
to ensure an appropriate level of
hospitality that is not extravagant and
would withstand public and professional
scrutiny.
In a unanimous decision the Committee
found a breach of Sections 6.2.2 and 10.2
and no breach of Section 6.2.1. In a
majority decision the Committee found no
breach of Section 10.8 of the Code.
Sanctions
Having found two breaches of the Code
the Committee considered what sanction/s
should be imposed.
The Committee determined that CSL
should:
Pay a fine of $50,000

119

Amgen Educational Event (898)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost of
function

Amgen Australia Dinner

Meetings held during the
American Society Of
Nephrology (ASN) Renal
Week Congress 2007, San
Francisco, USA Conference
Dates: Wednesday October
31st To Monday November 5th
2007 [The ASN Renal Week
Congress was held in San
Francisco, USA, October 31st
to November 5th 2007. The
ASN organized the Congress.
The duration of education
content of the event: 6 Day
Program]

Thursday
1st
November:
Campton
Place, San
Francisco,
California
Friday 2nd
November:
Jardinire
Restaurant,
San
Francisco,
California
Friday 2nd
November:
Foreign
Cinema,
San
Francisco,
California
Saturday
3rd
November:
The
Franciscan
Crab
Restaurant,
Francisco,
California

Renal
Physicians

3-Course Dinners
Including Alcohol X 4
Dinner Transfers X 4
Evenings Thursday
1st November:
Campton Place, 43
Delegates =
$5,425.39 Friday
2nd November:
Jardinire
Restaurant,43
Delegates =
$7,945.47 Friday
2nd November:
Foreign Cinema, 11
Delegates =
$1,474.57 Saturday
3rd November: The
Franciscan Crab
Restaurant, 98
Delegates =
$5,589.20 *Dinner
Transfers For 4 X
Dinners Above
$6,037.95

26,472.58

195

$26,472.58
Amgen was
Not
Responsible
For
Organising
The ASN
Congress
And
Therefore
Does Not
Know The
Cost Of
Doing So.

Subject Company: Amgen

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event AM-270
Complaint
The Monitoring Committee had asked that
Amgen provide justification for the cost of
the hospitality provided on nights 1 and 2
at the educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Amgen denied any breach of the Code.
Amgen stated that the dinner was held in
association with a four day global
educational
and
scientific
meeting
(American Society of Nephrology Renal
Week Congress) attended by 13,000

Code of Conduct Annual Report 2007/2008

healthcare professionals from around the

world. With an event of this size there is
considerable demand on hotels and
restaurants to accommodate the number
of conference delegates. Amgen spent
considerable time in planning and seeking
suitable venues. Amgen also stated that
the total costs do not reflect the hospitality
provided as in this case fixed gratuities
and service charges amounted to 46% of
the total costs for the dinners. The cost of
dinner on night 1 was AUD$210.21
($152.24 excluding surcharges and taxes)
and dinner on night 2 was AUD$194.46
($122.39 excluding the fixed gratuity; taxes
and surcharges are included in this figure).
Code Committee determination
In a unanimous decision the Committee
did not find a breach of Sections 6.2.1,
6.2.2, 10.2 or 10.8 of the Code.
Consideration of the complaint
The Committee noted that dinners
provided on nights 3 and 4 were less
expensive than those on nights 1 and 2.
As stated in the general discussion prior to
each event being considered, the
Committee was cognisant of the higher

120

costs of hospitality in Europe and North

America; issues arising from large
conferences being held in a city; and the
taxes and surcharges imposed. Although
the dinners on the first and second nights
of the conference were more expensive
than the dinners on the third and fourth
nights, the Committee did not consider that
any of the hospitality provided was
extravagant. The Committee noted the
heavy program of high quality education
provided at the Congress and considered
that there had been an appropriate
balance between education and hospitality
provided.
For these reasons the
Committee, in a unanimous decision did
not breach any breaches of the Code.

Code of Conduct Annual Report 2007/2008

121

AstraZeneca Educational Event (899)

Description of function including
duration of the educational
content delivered
Sponsorship of Journal Club 1
Hour Meeting 1 Hour
Educational Content

Venue

John Hunter
Hospital,
New
Lambton,
NSW

Professional
status of
attendees
Urologists
Allied
Health

Hospitality provided

Refreshments

Total cost
of
hospitality
1,023.65

Number
of
attendees
7

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event the venue
for the education and hospitality was amended.

Subject Company: AstraZeneca

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event AZ-454
Complaint
The Monitoring Committee had asked that
AstraZeneca provide information in
relation to the cost of the hospitality
provided at the educational event and the
rationale for the provision of this hospitality
in association with a journal club meeting.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
AstraZeneca denied any breach of the
Code. AstraZeneca responded that this
event was a sponsored educational dinner
meeting for the hospital department and
was held at the Newcastle Club. The
Department determined the educational
content and developed the presentation for
the meeting and invited the attendees. The
venue was selected in consultation with
AstraZeneca whose role was to arrange
logistics and to directly pay for the meal (at
a cost of $117.00 per head excluding GST)
at the conclusion of the meeting.
Code of Conduct and Appeals Committee
determinations
In a majority decision the Committee found
a breach of Section 6.2.2 of the Code and
no breach of Sections 6.2.1 and 10.8. In a
unanimous decision the Committee found
no breach of Section 10.2. (Decision
confirmed by the Appeals Committee)

Code of Conduct Annual Report 2007/2008

Sanction
Pay a fine of $10,000

Code of Conduct Committee

Consideration of the complaint
The Committee noted that AstraZeneca
had referred to this event as a journal club
meeting in its educational event report.
The event included a formal presentation
by a doctor from the hospital department
followed by discussion of development of
treatment guidelines for use in the
hospital. Some members questioned why
pharmaceutical companies are being
asked to pay for a dinner at a restaurant
for a departmental meeting which could be
conducted within the hospital. Members
also commented that journal clubs are
usually held within the hospital setting with
minimal hospitality.
In reviewing the invoice for the dinner
provided by AstraZeneca, members noted
that the actual cost per head was $129.70
(excluding GST and tip). Members also
commented that the selection of wine at
$85 a bottle was extravagant for an event
with a one hour educational component. A
majority of members considered that the
hospitality was secondary to the
educational purpose of the meeting.
In a majority decision the Committee found
a breach of Section 6.2.2 of the Code and
no breach of Sections 6.2.1 and 10.8. In a
unanimous decision the Committee found
no breach of Section 10.2.
Sanctions
Having found a breach of the Code the
Committee considered what sanction/s
should be imposed.
The
Committee
determined
AstraZeneca should:
Pay a fine of $10,000

that

122

Total cost
of
function
1,023.65

Appeals Committee
AstraZeneca appeal
AstraZeneca asserted that the hospitality
provided in association with the event was
not extravagant and should not be found in
breach of the Code.
AstraZeneca acknowledged some factual
errors in the original report of this event
and advised that this has been corrected.
The event was not held at the John Hunter
Hospital and it was not a journal club
meeting. The hospital department was
responsible for formulating the educational
content of the meeting as well as for
selecting and inviting the attendees, all of
whom were healthcare professionals
within the department. The meeting did
include a formal presentation and group
discussion.
Consideration of the appeal
The
following
summarises
the
AstraZeneca appeal:
Educational Event AZ-454 was a
sponsored educational meeting over
dinner for a medical Department in the
John Hunter Hospital in Newcastle. The
educational event was not a journal club
meeting.
The event was held at the Newcastle
Club which is 10 minutes walk from the
hospital.
The hospital department independently
formulated the educational content and
selected and invited attendees (all of
whom were healthcare professional
employees within the Department).
As a third party sponsorship, this
meeting
was
approved
by
the
AstraZeneca Medical Department prior
to any commitment to sponsor it.
There was a formal presentation by a
senior member of the Department of
approximately 1 hour duration. Group
discussion aimed at the development of
new treatment guidelines lasted for
approximately 1.5 hours.
The total
educational content was two and a half
hours.
Clinician availability required that the
meeting be held after work hours rather
than during the day.
It was not
logistically possible to bring catering into
the hospital after hours.
The Code Committee had commented
on the cost of wines consumed at the
event. However, there has been no
guidance from Medicines Australia in

Code of Conduct Annual Report 2007/2008

relation to the cost of alcohol. The cost

was within the total cost per head
guidelines of AstraZeneca.
There are no known precedents for
finding a breach on the basis of the
proportion of expenditure on food or
beverages.
AstraZeneca has made all best
endeavours to ensure no extravagance
in relation to hospitality at any of its
educational events.
AstraZeneca has had a total dollar limit
for hospitality, not broken down into food
and beverage costs.
Following this
decision there is now also internal
guidance in relation to the proportion
between beverages and food costs.
AstraZeneca asserted that it is confident
the event was not in breach of the Code
and had undertaken extensive actions to
ensure that none of its events could be
found in breach of the Code.
AstraZeneca has made a strong
commitment to implementation of
educational event disclosure with great
intent and detail. As a company it has a
strong history of compliance in relation
to meetings and hospitality.

Following questions from the Appeals

Committee AstraZeneca provided the
following responses:
There actual number of attendees at the
event was less than planned reduced
from 12 to 7, but this had a minimal
effect on the per head cost.
The previous AstraZeneca internal
hospitality limits have now been reduced
as a result of this decision. There have
also been more rigorous procedures
implemented by the company now the
company must make all arrangements
with
the
venue
and
company
representatives must order the wine.
When there are only a small number of
attendees it is usual policy to allow the
attendees to select from the menu rather
than have a set menu, which is more
common for larger groups.
AstraZeneca has no treatment for the
medical condition discussed at the
department meeting, but nevertheless
agreed to sponsor the hospitality at this
educational event.
The department was up-skilling and
developing treatment protocols
The Chairman thanked the AstraZeneca
representatives and asked that they retire
from the meeting to allow the Appeals

123

Committee to consider the matter before

them.
The Committee noted the amendments to
the original event report in terms of the
actual venue and accepted that the
meeting was not a journal club and the
actual expenditure per head was $117
(excluding GST and function and
American Express surcharges).
The Committee considered that a
company must take responsibility for the
hospitality for which it is paying. A
company must exert appropriate control
over its expenditure on hospitality,
including controlling the selection of
meeting venue, menu and beverages.
Members did note that AstraZeneca had
been diligent in amending their internal
policies and procedures as a result of the
Code Committee decision. However, the
Committee was concerned that in allowing
attendees to select wine at $85 per bottle
the company had not exercised sufficient
control over the overall expenditure and
these costs should be regarded as
extravagant. The hospitality provided was
not proportional to the educational purpose
of the meeting.

the choice of high cost wines was in

breach of Section 6.2.2 of the Code.
The Appeals Committee wished to
reinforce the view that companies must
continue to be transparent and provide
detailed
evidence
on
costs
and
breakdowns for individual components
where required by the Monitoring or Code
Committee.
Sanctions
Having not upheld the appeal the
Committee reviewed the sanction imposed
by the Code of Conduct Committee. The
Committee was of the view that the fine of
$10,000 should remain.

Some members of the Committee

remained concerned and questioned why
a pharmaceutical company should have
been asked to pay for their food and
beverages for a departmental meeting,
which could have been held within the
hospital.
The Committee commented on the
AstraZeneca assertion that Medicines
Australia had not provided any advice on
appropriate costs for beverages. Members
were of the view that the Code or
Guidelines should not have to provide
details on what is a reasonable cost for a
bottle of wine. Members also commented
that the review process by the Monitoring
and Code Committees was based on the
current wording in the Code which states
that hospitality should not be extravagant
and this is relevant to any items within the
food and beverages.
The Committee noted the breakdown of
the costs attributed to the function
surcharge, American Express fee and
GST and accepted that the cost per head
was $117.00. The Committee was of the
view that the hospitality cost, specifically

Code of Conduct Annual Report 2007/2008

124

Baxter Educational Event (900)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

Launch & Clinical Symposium

on Inhibitor Management.
Dinner with short presentation.
Clinical Symposium
3 X 1.5 Hr sessions.
3 X International Speakers.
1 X Amgen Speaker & 3 X
local clinician Speakers.

Park Hyatt
Hotel
Sydney

Haematologists,
Nurses

Food, Beverages,
Travel &
Accommodation

35,900.00

30

55,836.00

Subject Company: Baxter Healthcare

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event BX-73
Code of Conduct Committee Meeting
21 April 2008
Complaint from the Monitoring Committee
The Monitoring Committee had asked that
Baxter justify the overall cost of the
hospitality provided at the educational
event, including the welcome reception
and symposia dinner. Baxter was also
asked to identify the number of delegates
for whom accommodation was provided,
the rationale for the cost of the
accommodation and the necessity to
accommodate the delegates overnight in
light of the duration of education provided.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Baxter denied any breach of the Code.
Baxter stated that given the highly
specialised nature of this therapeutic area
(treatment of patients with haemophilia
and Factor VIII inhibitors) and the small
number of healthcare professionals
involved, it was not a cost effective option
to run the educational symposium in all
capital cities. The decision was taken to
organise one product launch in Sydney.
This event was of significant educational
value to the specialists and nurses from
Australia and New Zealand who
participated. Interstate and overseas

Code of Conduct Annual Report 2007/2008

delegates were flown in the night before in

order to attend the first session
commencing at 9.00am. The program
finished mid-afternoon and delegates left
that day. The original costs provided to
Medicines Australia also included staff
costs which should not have been included
therefore the actual benefit to the
attending healthcare professionals was
reduced.
Code Committee determination
The Committee had asked that Baxter
further respond to a potential breach of
Section 10.3 of the Code which pertains to
accommodation costs.
Consideration of the complaint
The Committee raised no objection to
holding one event for this small therapeutic
area. However members were of the view
that the cost of accommodation was too
high (ranging from $390 to $520 per night).
The Committee asked that the Code
Secretariat write to Baxter seeking a
response to Section 10.3 of the Code
which also pertains to the accommodation
expenses.
Code of Conduct Committee Meeting
19 May 2008
Additional response from Baxter
Baxter stated that a key factor in the higher
room rates was that the company had
entered into an initial agreement with the
hotel for a specific number of rooms based
on the initial estimates of attendance. Due
to the popularity of the event, delegate
numbers exceeded this expectation
requiring further rooms to be booked at a
higher daily rate.
Committee determination
In a unanimous decision the Committee
found a breach of Section 10.3 of the
Code.

125

Sanction
Pay a fine of $35,000
Consideration of the complaint
The Committee reviewed the information
provided to the Code of Conduct
Committee for the meeting on 21 April and
the additional response provided by Baxter
in relation to Section 10.3 of the Code.
Members
noted
that
the
original
submission stated that 17 Australian and
12 New Zealand healthcare professionals
had attended the educational event.
The Committee was of the view that a
company would need to plan a launch
meeting of this type at least three months
in advance and that it was unlikely that a
large number of busy haematologists and
specialist nurses would decide to attend at
the last minute. Members were of the view
that the additional information from Baxter
did not provide any justification for
accommodation ranging from $390 to
$510 per night and required the
Committee to conclude that proper
planning lead time would have given
Baxter better control over accommodation
costs. The Committee concluded that
these costs were excessive and in breach
of Section 10.3 of the Code.
It would appear that the entire Australian
delegation which was staying overnight
was on the higher rate and thus, according
to Baxters reply, would have been late
registrations. This does not seem to be
compatible with a launch meeting of a new
product in Australia which should be
possible to organise with sufficient lead
time to allow for lower priced rooms.
Sanctions
Having found a breach of the Code
members considered an appropriate
sanction.
The Committee determined that Baxter
should:
Pay a fine of $35,000

Code of Conduct Annual Report 2007/2008

126

Biogen Idec Educational Event (901)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total
cost of
function

1 Hour Clinical Educational

Presentation for Specialist
Physician with an interest in
Multiple Sclerosis

Establishment
Restaurant,
Sydney, NSW

Neurologists

Lunch With
Beverages

$600.98
Food and
Beverages:
$600.98

600.98

Subject Company: Biogen Idec Australia

(Biogen)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event BIO-9
Complaint from the Monitoring Committee
The Monitoring Committee had asked that
Biogen provide justification for the
sponsorship of this event, particularly
being a quarterly meeting of a college,
society or group, when there is no formal
agenda and the educational component
cannot be confirmed.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Biogen Idec denied any breach of the
Code. Biogen stated that the event report
as originally submitted to Medicines
Australia was incorrect. Biogen stated that
the event was a three hour meeting of the
Steering Committee of the Sydney
Neurophysicological Workshop Group,
held in the evening, in order to prepare two
neurophysiology workshops scheduled for
November 2007 and March 2008. As
Biogen was a principal sponsor of these
meetings the Steering Committee had
approached Biogen to provide sponsorship
of the Steering Committee meeting.
There was an informal agenda and three
case studies had been presented by the
Chairman to the Steering Committee for
discussion and consideration of their
suitability for the forthcoming meetings.
The dinner was served during the meeting.
The cost per head was $120.00.

Code of Conduct Annual Report 2007/2008

Code Committee determination

In a unanimous decision the Committee
found a breach of Sections 6.2.1 and 10.2
of the Code and in a majority decision no
breach of Sections 6.2.2 and 10.8 of the
Code.
Sanction
Pay a fine of $10,000
Consideration of the complaint
The Committee queried the choice of
venue, which is one of Sydneys premier
restaurants, and that there was no
evidence that the meeting was held in a
private room Biogen Idecs response
referred to the area being cordoned off.
Members also questioned the necessity for
a company to pay for the dinner of the
Steering Committee whilst members are
planning future meetings. While the
meeting was planning for upcoming
educational events, the Committee was
not convinced that there was a specific
educational component to this meeting.
Members were not confident that the
venue was conducive to education or that
the event could withstand public or
professional scrutiny. Weighing up the
balance
between
the
educational
component and the hospitality, the
Committee found that the hospitality was
extravagant for a limited educational
purpose; the hospitality was not secondary
to education. The event was therefore
found in breach of the Code.
In a unanimous decision the Committee
found a breach of Sections 6.2.1 and 10.2
of the Code and in a majority decision no
breach of Sections 6.2.2 and 10.8 of the
Code.
Sanctions
Having found two breaches of the Code
the Committee considered what sanction/s
should be imposed.
The Committee determined that Biogen
Idec should:
Pay a fine of $10,000

127

CSL Educational Event (902)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total
cost of
function

16 Hour Congress/Symposium
on Human Papillomavirus &
Update on Cervical Cancer.

The China
Club; China

Gynaecology
Oncologists,
Sexual Health
Physicians,
Immunologists

Dinner With Alcoholic

& Non-Alcoholic
Drinks Provided.

2,049.00

12

2,049.00

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event the
hospitality and cost columns were amended.

Subject Company: CSL

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event CSL-98
Complaint
The Monitoring Committee had asked that
CSL provide justification for the cost of
hospitality provided at the dinner in
association with this educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
CSL denied any breach of the Code. CSL
stated that the dinner was provided in
association with the six day International
Papillomavirus Societys 24th Annual
International Papillomavirus Conference
and Clinical Workshop in Beijing. CSL also
stated that Beijing is a rapidly developing
city with a cost of living comparable to
many of the major cities in the western
world. A recent survey ranked Beijing the
20th most expensive city, ahead of Sydney
which was ranked 21.
CSL stated it was acutely aware of the
variable hygiene standards and therefore
sought to choose a restaurant that could
demonstrate a high standard of hygiene to
reduce the risk of guests becoming ill
following the meal.
The cost per head was inclusive of an
integral charge for the use of a private
room. A significant proportion of the total
cost was drinks. As it is only safe to drink
Code of Conduct Annual Report 2007/2008

imported bottled water, the bill included 24

bottles of water. Taking all these factors
into consideration the dinner cost of AUD
$193.00 per head was not excessive.
Code Committee determination
In a unanimous decision the Committee
found a breach of Section 6.2.2 and no
breach of Sections 6.2.1 or 10.2 of the
Code. In a majority decision the
Committee found no breach of Section
10.8 of the Code.
Sanction
Pay a fine of $40,000
Consideration of the complaint
The Committee stated that the educational
event at which the hospitality was provided
was of high quality and this complaint did
not raise any issues with the educational
purpose.
Members noted the advice that in a world
ranking of city costs, Beijing is ranked next
above Sydney. Members were of the view
that a dinner at a cost of AUD$193 per
head would not be acceptable in Australia
and that this cost was also considered to
be excessive for a meal in Beijing.
The Committee considered the hospitality
to be extravagant and found a breach of
Section 6.2.1 of the Code. In a unanimous
decision the Committee found no breach
of Sections 6.2.1 or 10.2 of the Code and
in a majority decision no breach of Section
10.8 of the Code.
Sanctions
Having found a breach of the Code the
Committee considered what sanction
should be imposed.
The Committee determined that CSL
should:
Pay a fine of $40,000

128

GSK Educational Event (903)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of function

Breast Cancer Treatment

Launch Meeting. Weekend
Conference on new medication
for specialists. 6.25 Hours
Over 2 Days

Shangri-La
Hotel,
Sydney,
NSW

Oncologists

Accommodation,
Flights, Transfers,
Food And
Beverages, Off Site
Dinner, Dinner
Transfers, Parking

144,416.00

131

$160,592
(Includes
Venue
Hire,
AudioVisual Hire
and
materials
developed
specifically
for this
meeting)

Subject Company: GlaxoSmithKline

Australia (GSKA)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event GSK-308
Code of Conduct Committee Meeting
21 April 2008
Complaint from the Monitoring Committee
The Monitoring Committee asked that
GSKA provide justification for the overall
extent of the hospitality provided at the
educational event with respect to the
duration of the educational component and
the number of delegates for whom
accommodation was provided.
Sections of the Code:
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
GSKA denied any breach of the Code.
GSKA stated that the information originally
provided to Medicines Australia was
incorrect due to a communication error
between GSKA and the event organising
company. The figures provided to the
Code Committee have been reconciled
and reflect actual costs excluding GST.
The educational component was over six
hours and included the opportunity to meet
the international expert.

Code of Conduct Annual Report 2007/2008

Code Committee determination

In a majority decision the Committee found
no breach of Sections 6.2.1, 6.2.2, or 10.8
of the Code.
Consideration of the complaint
The Committee noted that while the
program extended over two days some of
the sessions were optional (including the
Sunday morning one hour session). While
finding no breach of the Code in relation to
the accommodation and hospitality
provided, members expressed concern
that the actual educational component was
bordering on being insufficient to justify
provision of two nights accommodation for
the majority of delegates.
Members were also concerned about the
supplementary fee payable by partners
who wished to attend the dinners did not
fully cover the cost of the dinner on the first
night. In reviewing the invitation and
comparing this to GSKAs statement of
costs for the dinner, the Committee was of
the view that the partner payment for the
Friday night was less than that required to
cover all costs. Section 10.2 of the Code
states a company must not pay for or
subsidise the costs attributable to partners
or family members.
The Committee asked that GSKA respond
to a possible breach of Section 10.2 of the
Code in relation to the partner payment for
the dinner on the first night of the
educational event.
Code of Conduct Committee Meeting
16 June 2008
Further response from GSKA
GSKA responded that a potential breach
of Section 10.2 may have occurred. If such
a breach did occur, it was inadvertent and

129

GSKA apologised to the Committee. All

meals were charged at $80 per head for
partners; however as the beverages were
on an as-consumed basis this cost was
not factored into the cost for partners. Only
one registrant took their partner to the
dinner concerned and there are no records
to show whether this person consumed
any beverages. GSKA are examining
options to ensure such a discrepancy does
not occur in the future.

In a majority decision the Committee

determined that GSKA should pay a fine of
$20,000.

Sections of the Code

10.2 Hospitality (partner payment)
Code Committee determination
In a unanimous decision the Committee
found a breach of Section 10.2 of the
Code.
Sanction
Pay a find of $20,000
Consideration of the complaint
The Committee noted the response from
GSKA and that there did not appear to be
a deliberate attempt to subsidise partner
costs. Members also noted that GSK was
reviewing its internal policies in relation to
the way in which partner costs are
charged.
While acknowledging that there was only
one partner in attendance, members were
of the view that as $80 per head had been
the advertised cost in the program, the
event could potentially have been attended
by a much larger number of partners.
The Committee was of the view that the
Code was quite clear that a company
could not pay for, or subsidise the costs of
a partner with respect to food and
beverages, accommodation or travel.
Members also referred to a previous
educational event complaint heard at the
21 April Code meeting in which a company
had been fined for subsidising partner
costs.
In a unanimous decision the Committee
found a breach of Section 10.2 of the
Code.
Sanction
Having found a breach of the Code the
Committee considered what sanction/s
should be imposed.

Code of Conduct Annual Report 2007/2008

130

GSK Educational Event (904)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of function

GOLD GP Meeting 2 Day

Diabetes Forum with
Presentation by International
Speaker. Educational Content
6 Hours

Novotel,
Darling
Harbour,
NSW

General
Practitioners

Accommodation,
Flights, Transfers,
Food And
Beverages, Off Site
Dinner, Parking

87,689.00

79

$102,970
(Includes
Venue
Hire,
AudioVisual Hire
and
materials
developed
specifically
for this
meeting)

Subject Company: GlaxoSmithKline

Australia (GSKA)

location by a morning flight were provided

with two nights accommodation.

Complainant: Medicines Australia

Monitoring Committee

Code of Conduct Committee determination

In a majority decision the Committee found
a breach of Section 6.2.1 of the Code. In a
unanimous decision the Committee found
no breach of Sections 6.2.2, 10.2 of the
Code. In a majority decision no breach of
Section 10.8 of the Code was found.

Event: Educational Event GSK-690

Complaint
The Monitoring Committee had asked that
GSKA provide justification for the overall
extent of the hospitality provided at the
educational event with respect to the
duration of the education provided and
provide detail on the accommodation
provided.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
GSKA denied any breach of the Code.
GSKA advised that the original costs
reported to Medicines Australia were
incorrect due to communication issues
with the event organising company. The
costs provided to the Code of Conduct
Committee are reconciled actual costs
excluding GST and staff costs.
The event was held nationally, rather than
regionally
to
accommodate
the
engagement of high quality speakers. The
program included lectures, expert panel Q
& A and workshops facilitated by
international and local experts in diabetes.
Delegates who could not travel to the

Code of Conduct Annual Report 2007/2008

Sanction
Pay a fine of $100,000
Consideration of the complaint
The Committee noted that while the event
was held over two days, less than five
hours of actual education was provided.
The education started after lunch on
Saturday and included only two hours of
education on Sunday morning. Members
were of the view that in order to justify
providing extended hospitality over a
weekend the educational component
should be greater than five hours.
The Committee stated that the complaint
was not in relation to the venue but the
hours of education with respect to the
hospitality (nights of accommodation and
meals and beverages), that is the balance
between education and hospitality.
Members noted that one attendee from
Queensland was provided with three
nights accommodation.
The Committee agreed that where it is not
possible for a delegate to fly to the venue
on the day in time for the start of the
meeting it was appropriate to provide
accommodation the night prior to the event
commencing. However, in this case the
presentations did not start until after lunch
on Saturday, therefore the Committee did
not accept the necessity to provide

131

accommodation for delegates on Friday

night. The Committee considered that
there was insufficient education to justify
the hospitality provided and found a
breach of Section 6.2.1 of the Code.
The Committee also noted that the dinner
was held at an entertainment venue.
In a majority decision the Committee
found a breach of Section 6.2.1 of the
Code. In a unanimous decision the
Committee found no breach of Sections
6.2.2 and 10.2 of the Code. In a majority
decision no breach of Section 10.8 of the
Code was found.
Sanctions
Having found a breach of the Code the
Committee considered what sanction/s
should be imposed.
The Committee determined that GSKA
should:
Pay a fine of $100,000

Code of Conduct Annual Report 2007/2008

132

Servier Educational Event (905)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

60 Min Presentation on
Osteoporosis Management.

Pier
Restaurant,
Rose Bay,
NSW

Specialist
Speaker &
GP's

Dinner, Non
Alcoholic & Alcoholic
Beverages

4,768.00

29

5,268.00

Subject Company: Servier Laboratories

(Australia) [Servier]
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event SV-154
Complaint
The Monitoring Committee had asked that
Servier provide the actual total cost of cost
of food and beverages and justification for
the costs.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Servier denied any breach of the Code.
Servier advised that an error had been
made when booking this event. The senior
manager
involved
was
of
the
understanding that the booking was made
for a meal to cost $90 per head plus
beverages, rather than $120 per head plus
beverages. Servier also advised that
several other events had been held at this
venue for the former cost. Servier stated
that the cost of this meal would have been
in contravention of Servier policy.

Consideration of the complaint

The Committee acknowledged that an
error had been admitted by the Servier
employee. However as the food and
beverages totalled $151 per head
(exclusive of GST) this was considered to
be extravagant hospitality. The Committee
considered that there was a lack of
proportion between the one hour
educational presentation and the provision
of hospitality which suggested the
hospitality was not secondary to the
education.
In a unanimous decision the Committee
found a breach of Sections 6.2.1, 6.2.2
and 10.2 of the Code. In a majority
decision the Committee found no breach
of Section 10.8 of the Code.
Sanctions
Having found several breaches of the
Code the Committee considered what
sanction/s should be imposed.
The Committee determined that Servier
should:
Pay a fine of $20,000

Code Committee determination

In a unanimous decision the Committee
found a breach of Sections 6.2.1, 6.2.2
and 10.2 of the Code. In a majority
decision the Committee found no breach
of Section 10.8 of the Code.
Sanctions
In a majority decision pay a fine of
$20,000

Code of Conduct Annual Report 2007/2008

133

GSK Educational Event (906)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of function

GOLD SPECIALIST Meeting

2 Day Diabetes Forum with
Presentation by International
Speaker. Educational
Content 5.5 Hours

Four
Points By
Sheraton,
Darling
Harbour,
NSW

Endocrinologists,
Cardiologists,
Epidemiologists

Accommodation,
Flights, Transfers,
Food and
Beverages, Off Site
Dinner, Dinner
Transfers, Parking

79,949.00

91

$93,244
(Includes
Venue
Hire,
AudioVisual Hire
And
Materials
Developed
Specifically
For This
Meeting)

Subject Company: GlaxoSmithKline

Australia (GSKA)

location by a morning flight were provided

with two nights accommodation.

Complainant: Medicines Australia

Monitoring Committee

Code Committee determination

In a majority decision the Committee found
a breach of Section 6.2.1 of the Code. In a
unanimous decision the Committee found
no breach of Sections 6.2.2 and 10.2 of
the Code. In a majority decision no breach
of Section 10.8 of the Code was found.

Event: Educational Event GSK-691

Complaint
The Monitoring Committee had asked that
GSKA provide justification for the overall
extent of the hospitality provided at the
educational event with respect to the
duration of the education provided and the
detail
on
the
accommodation
requirements.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
GSKA denied any breach of the Code.
GSKA advised that the original costs
reported to Medicines Australia were
incorrect due to communication issues
with the event organising company. The
costs provided to the Code of Conduct
Committee are reconciled actual costs
excluding GST and staff costs.
The event was held nationally, rather than
regionally
to
accommodate
the
engagement of high quality speakers. The
program included lectures, expert panel Q
& A and workshops facilitated by
international and local experts in diabetes.
Delegates who could not travel to the

Code of Conduct Annual Report 2007/2008

Sanction
Pay a fine of $90,000
Consideration of the complaint
The Committee noted that at this two day
event 6.5 hours of actual education was
provided. Members were of the view that
while this event had a more substantial
educational component than the GP
GOLD event (GSK-690 904) it was still
borderline as a weekend event. For this
event only one hour of education was
provided on Sunday morning, which
members
considered
was
small
justification for providing two nights
accommodation.
The Committee accepted that where it is
not possible for a delegate to fly into the
venue on the day of the meeting it was
appropriate to provide accommodation the
night prior to the event commencing.
However, in this instance the educational
sessions did not commence until 11.00
am, which would allow most delegates to
fly in that morning, other than those from
Western Australia.
The Committee stated that the complaint
was not in relation to the venue but the
quality and duration of education provided
with respect to the accommodation
provided. The Committee considered that
the program could have been structured in

134

a manner that would have necessitated

providing only one nights accommodation
and food and beverages.
The Committee considered that there was
insufficient education at the meeting to
justify the hospitality provided; that is there
was an inappropriate imbalance between
hospitality and the education and therefore
found a breach of Section 6.2.1 of the
Code.
In a majority decision the Committee found
a breach of Section 6.2.1 of the Code. In a
unanimous decision the Committee found
no breach of Sections 6.2.2 and 10.2 of
the Code. In a majority decision no breach
of Section 10.8 of the Code was found.
Sanctions
Having found a breach of the Code the
Committee considered what sanction/s
should be imposed.
The Committee determined that GSKA
should:
Pay a fine of $90,000

Code of Conduct Annual Report 2007/2008

135

Solvay Educational Event (907)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total
cost of
function

Presentation of New Data

from the FIELD Study

Shangri-La
Hotel,
Sydney,
NSW

Endocrinologists,
Cardiologists,
Renal
Physicians

Food & Beverage

4,568.60

30

6,068.60

Subject Company: Solvay

Pharmaceuticals (Solvay)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event SOL-6

Members accepted that the actual food

and beverage component was $116 per
head which was not considered to be
extravagant at the venue, which was an
appropriate venue for the event.
The Committee found no breach of any
sections of the Code.

Complaint
The Monitoring Committee had asked that
Solvay provide justification for the cost of
the food and beverages provided at this
event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Solvay denied any breach of the Code.
Solvay
stated
that
the
meeting
incorporated an educational component of
1.5 hours during which the new FIELD
Study results were presented by the
Principal Investigator. At the time the
meeting was booked there were 34 (not 30
as reported originally to Medicines
Australia) confirmed attendees at a total
cost of $134 per head. The costs reported
included dinner at $116 per head, parking
for 15 people and AV hire. On the night of
the meeting a wild storm hit Sydney and
only 13 physicians attended.
Code Committee determination
In a unanimous decision the Committee
found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.
Consideration of the complaint
The Committee considered that because
companies should report the confirmed
number of attendees, which is the number
paid for by the company, and the total cost
of the hospitality, no-shows should not
alter the cost per head for hospitality.

Code of Conduct Annual Report 2007/2008

136

Octagam (908)
Subject Company: Octapharma
Complainant: CSL
Product: Octagam
Complaint
CSLs complaint had been directed at the
promotion of the safety of Octagam and
the manner in which the rate of adverse
drug reactions (ADR) is claimed in
promotional pieces as well as conference
trade displays. The promotional pieces
alleged to be in breach of the Code were a
promotional brochure for Octagam, trade
displays at conferences in May and
November 2007 and the Octagam Patient
Information Leaflet. CSL asserted that the
claimed ADR rate of <0.4% is significantly
lower than ADR rates reported in clinical
studies with Octagam and is not consistent
with the literature on intravenous
immunoglobulin (IVIg) safety in general.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
1.1 Responsibility
1.2.2 Level of Substantiating Data
1.3 False of Misleading Claims
1.3.1 Unapproved indications
1.5 Unqualified superlatives
1.7 Comparative Statements
9.5.7 Patient education
9.7 Patient Aids
9.10 Discredit to and reduction of
confidence in the industry

Debes et al study. Octapharma stated it

had merely included a reprint of the Debes
study in a pocket at the back of the
brochure. In accordance with the Code,
published papers on tolerability of
Octagam (with varying ADR rates) are
referenced throughout the brochure to
allow a professional reader to evaluate the
validity of results and to form their own
opinion.
Code Committee determination
Octagam Liquid Harmony Brochure
In a unanimous decision the Committee
found a breach of Sections 1.1, 1.2.2 and
1.3 and by majority decision no breach of
Section 1.3.1 of the Code.
No finding was made in relation to Section
1.5 as this matter had not been raised
during intercompany dialogue.
Trade Displays
The Committee noted that the matter of
claims in trade displays had not been
raised in intercompany dialogue; however
it was noted that the trade displays
included the same tolerability claims used
in the Octagam brochure which were
found in breach of the Code.
Octagam Patient Information Leaflet
In a majority decision the Committee found
a breach of Sections 1.1, 1.3 and 9.7 and
no breach of Section 9.10 of the Code.
No finding was made in relation to
Sections 1.2.2 and 9.5.7 as these matters
had not been raised during intercompany
dialogue.

Response
Octapharma raised
a number of
procedural issues in relation to the CSL
complaint. Octapharma stated that the
most senior executive of CSL had had no
involvement in the intercompany dialogue
process;
issues
not
subject
to
intercompany dialogue had been included
in the complaint; and that certain matters
that
had
been
resolved
during
intercompany
dialogue
had
been
forwarded to the Code of Conduct
Committee in the complaint.

Sanctions
Withdraw all materials containing claims
found in breach of the Code
Send a corrective letter to all health
professionals or others who had been
detailed with or sent the items found in
breach
Pay a fine of $50,000

Octapharma contended that the Octagam

brochure subject to complaint accurately
represents Octagam as a member of the
class of IVIg products. Contrary to CSLs
assertion, Octapharma stated that it did
not make any safety claims based on the

Involvement of the most senior company

executive in intercompany dialogue
The Committee noted that the head of the
Bioplasma Division had signed the letter of
complaint and that the Medical &
Research Director had led the CSL team

Code of Conduct Annual Report 2007/2008

Consideration of the complaint

Prior to discussing the complaint members
of the Committee considered the
procedural issues raised by Octapharma.

137

during intercompany dialogue. Members

also noted that Appendix 1 of the Code,
Intercompany Dialogue Guidelines states
that there should be evidence of the
active involvement of the most senior
executive responsible for the companys
prescription medicines business in the
intercompany dialogue process. While
agreeing that the head of CSL Bioplasma
should
have
been
involved
in
intercompany dialogue, members were of
the view that as the General Manager had
authorised submission of the complaint the
consideration of the complaint should
proceed. Some members expressed a
view that the procedural matters raised by
Octapharma were obfuscatory.
No intercompany dialogue in relation to the
materials at trade displays
Octapharma asserted that there had been
no intercompany dialogue in relation to the
trade display material.
Members noted that the CSL statement
that the claims on the light box trade
displays at the Australasian Society of
Clinical Immunology and Allergy (ASCIA)
and Australian and New Zealand
Association of Neurologists (ANZAN)
conferences were the same as the
tolerability information presented in the
brochure subject to complaint.
The Committee resolved to deal with the
claims in the brochure subject to complaint
and then consider whether the same
claims appeared in the trade display light
boxes.
Patient information leaflet withdrawn
following
intercompany
dialogue
Octapharma asserted that CSL should not
have included the Octagam patient
information leaflet as part of the complaint
as the leaflet had been withdrawn from
circulation during intercompany dialogue.
The Committee discussed the process of
intercompany dialogue and resolution of
complaints in light of the Intercompany
Dialogue Guidelines in Appendix 1 of the
Code which state, inter alia:
Following the process of inter-company
dialogue,
companies
should
have
documented clearly the position of each
party, ie including offers on the part of the
Subject Company for resolution and
whether or not the Complainant is willing
to accept such offers. There should also

Code of Conduct Annual Report 2007/2008

be clear evidence of any corrective action

undertaken by the Subject Company as a
result of the inter-company dialogue.
Should the Complainant still wish to
progress the matter to Medicines Australia,
the complaint should be accompanied by
the consensus
minutes
and
any
subsequent correspondence relating to
offers for resolution and actions taken.
Some members of the Committee were
concerned that if a matter was resolved
during the intercompany dialogue process
then it should not form part of any
subsequent complaint unless the Subject
Company did not undertake the agreed
action.
The purpose of intercompany
dialogue is to encourage resolution
between companies.
However other
members were of the view that while a
company may agree to not use a claim or
material in the future, healthcare
professionals and, in this case, patients
will have been exposed to the incorrect
material and a complainant was entitled to
lodge a complaint about damage done
during the time the material was in use.
The Committee resolved to consider the
complaints
concerning
the
patient
information leaflet, which had been
distributed to patients prior to its
withdrawal, and consider the remedies
instituted by Octapharma if the material is
found in breach of the Code when
considering any sanctions.
Octagam Liquid Harmony Brochure
The Committee noted that the Octagam
Product Information (PI) does not assign
frequencies to any reported adverse
events, nor do the PIs for any other
registered Australian IVIg products.
Members were not convinced that there
was sufficient evidence to support the
implied claim that the tolerability of
Octagam was better than any other IVIg
product. Members noted that the the data
on file used to support the claim of
reported ADRs of less than 0.4% of
infusions for Octagam had been published
in
July
2007
in
the
journal
Pharmacoepidemilogy and Drug Safety in
a paper by Debes et al. Members were of
the view that it was not appropriate to
support a claim of tolerability with data on
file. Between the time of publication of the
brochure in March 2007 and the
publication of the Debes et al paper the
evidence to support the claim was not

138

easily accessible by readers who could

have been misled to believe that there
were significant differences in IVIg
products in relation to safety. It was noted
that the Debes et al study is an open
prospective observational cohort study
which is not at the highest level of
evidence.
Several
members
were
concerned that there was insufficient
information in the study about the data
collection it was unclear whether a case
report form had been submitted for every
patient and infusion delivered during the
study. Members considered that the
Debes et al study was inadequately
designed to form the basis of claims of a
lower incidence of ADRs. Members were
of the view that having reviewed the
studies provided by CSL and Octapharma
the body of evidence does not support a
claim of less than 0.4% adverse reactions
for Octagam.
In reviewing the Debes et al paper
members noted that the study included
patients being treated for indications not
approved in Australia. However members
were of the view that by including the
Debes et al study in the back pocket of the
Octagam brochure the company was not
promoting a non-approved indication.
In relation to the FDA letter to Octapharma
in 2005 criticising the use of unequalled
tolerability claim in relation to Octagam,
the
Committee
did
not
accept
Octapharmas assertion that the FDA letter
was not relevant to the complaint. The
Committee noted that the claim identified
in the FDA letter had been modified and
was not used in the materials subject to
complaint. However, the Committee noted
that the FDA was critical of the
methodology of the post-marketing study,
recently published as Debes et al.
In relation to the section on page 4 of the
brochure Tolerability of Octagam the
Australian
experience,
members
unanimously
agreed
that
it
was
inappropriate and misleading to use
adverse drug reactions spontaneously
reported to the company as data to
support a tolerability claim.
It is not
possible to infer incidence of adverse
reactions from spontaneously reported
data.

subject of intercompany dialogue the

Committee agreed that the allegation of a
breach of Section 1.5 of the Code,
unqualified superlatives, would not be
considered in this context. However,
members were of the view that had this
complaint been properly before the
Committee they would have been inclined
to a find it in breach.
In a unanimous decision the Committee
found that the tolerability claims identified
in the complaint contained in the brochure
were in breach of Sections 1.1, 1.2.2 and
1.3 and not in breach of Section 1.3.1 of
the Code.
Trade Displays
The Committee noted that the claims
appearing in light boxes at trade displays
had not been raised during intercompany
dialogue. However it was also noted that
the trade display materials included the
same claims pertaining to tolerability used
in the Octagam brochure, including the
claim of less than 0.4% rate of infusions
with adverse events related to Octagam
which were found to be in breach of the
Code.
Octagam Patient Information Leaflet
The Committee noted that the Patient
information leaflet had been withdrawn by
Octapharma effective from 14 December
2007. However several members of the
Committee expressed the view that
although it was no longer being used,
many patients had been exposed to the
messages contained in the leaflet which
gave a false impression of the level of
adverse reactions to Octagam. For the
reasons outlined above the Committee
found that the evidence did not support the
claim in relation to adverse reactions and
the message was misleading to patients.
In a majority decision the Committee found
a breach of Sections 1.1, 1.3 and 9.7 and
no breach of Section 9.10 of the Code.
No findings were made in relation to
allegations of a breach of Sections 1.2.2
and 9.5.7 as these matters had not been
subject to intercompany dialogue.
Sanctions
Having found several breaches of the
Code
the
Committee
considered
appropriate sanctions.

In acknowledging that the claim for the

outstanding characteristics of Octagam
on page 10 of the brochure was not the

Code of Conduct Annual Report 2007/2008

139

The
Committee
determined
that
Octapharma should:
Withdraw all materials containing the
claims found in breach of the Code and
not use them again in the same form or
in a manner which conveys the same or
similar meaning.
Send a corrective letter to all healthcare
professionals who had been detailed
with or sent the items found in breach.
The corrective letter shall be approved in
writing by the Chairman of the Code of
Conduct Committee. The letter must
convey that the published evidence does
not support the claims for Octagam of
superior tolerability and safety.
Pay a fine of $50,000. In imposing the
fine the Committee noted that the fine
might have been considerably higher if
the patient information leaflet had not
been withdrawn. The Committee noted
that whilst Octapharma had withdrawn
the leaflet, in its correspondence with
CSL there had been no acceptance of
the necessity to correct the leaflet.
Allegation of a breach of Section 12.3 of
the Code
Members of the Committee discussed in
detail the extent of intercompany dialogue
and actions by Octapharma in response to
the matters raised by CSL. As discussed
during the consideration of the complaints,
the majority of members were of the view
that while a company might agree to
withdraw
an
item,
healthcare
professionals, and in this case patients,
were exposed to a claim that was found to
be in breach of the Code. Issues raised
by CSL that had not been subject to
intercompany dialogue had not been
determined by the Committee, whereas
Octapharma had been found in breach in
relation to other issues that had been
discussed through intercompany dialogue.
The Committee concluded that the
allegation by Octapharma that CSL was in
breach of Section 12.3 was not sufficiently
made out.

Code of Conduct Annual Report 2007/2008

140

Pfizer Conduct (909)

Subject Company: Pfizer Australia (Pfizer)
Complainant: AstraZeneca
Product: Crestor
Complaint
AstraZeneca alleged serious misconduct
by Pfizer in relation to disparaging
behaviour by Pfizer representatives in
relation to Crestor.
AstraZeneca stated that a number of
geographically
dispersed
Pfizer
representatives had directed negative and
false representations regarding the renal
safety profile of Crestor to healthcare
professionals across New South Wales
and Queensland between April and
October 2007. AstraZeneca also alleged
that whilst Pfizer had given undertakings to
cease the conduct and prevent the alleged
behaviour from continuing, Pfizer has not
corrected the alleged damage that has
already occurred to industry stakeholders
including healthcare professionals.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
1.1 Responsibility
1.2 Substantiating Data
1.3 False and Misleading Claims
1.7 Comparative Statements
4.3 Company representatives
4.4 Company representatives
10.5 Medical literature/reprints
10.8 Discredit to and reduction of
confidence in the industry
Response
Pfizer
stated
that
AstraZenecas
allegations very significantly overstate
and exaggerated as to what occurred.
Pfizer accepted that some inappropriate
conduct, on the part of a relatively small
number of Pfizer sales representatives in
certain localities in New South Wales and
Queensland, had occurred over a few
months in 2007. However this conduct was
contrary to Pfizers instructions to its sales
force and was not intentionally misleading
in nature. Pfizer asserted that the conduct
did not have any significant effect on
AstraZeneca,
Crestor,
patients
or
healthcare professionals. Considerable
efforts to resolve the dispute regarding the
conduct had been made.

Code of Conduct Annual Report 2007/2008

Pfizer
expressed
concerns
about
AstraZenecas use of the Code process,
and its perceived intention to disparage
Pfizer through use of any corrective letter
issued by Pfizer, and requested the
Committee
to
consider
whether
AstraZeneca had engaged in abuse of the
Code as set out in Section 12.3 of the
Code.
Code of Conduct and Appeals Committee
determinations
In a unanimous decision the Committee
found a breach of Sections 1.1, 1.2, 1.3,
1.7, 4.3, 4.4, 10.5.2 and 10.8 of the Code.
(Decision confirmed by the Appeals
Committee)
Sanction
Send a corrective letter to all general
practitioners and pharmacists in NSW
and Queensland. The Corrective letter
must
state
that
some
Pfizer
representatives had been providing
misleading information on the renal
safety profile of Crestor and that there
was no difference in the safety profile
between Crestor and other statins. The
letter must also state that Pfizer had
been found in severe breach of the
relevant parts of the Code.
The
corrective letter must be approved in
writing by the Chairman of the Code
Committee. The text of the corrective
letter must be in a font of no less than 12
point. Medicines Australia must receive
documentary evidence of the distribution
of the corrective letter and the Secretary
of the Code Committee must be included
on the mailing list for the letter.
Pfizer must report to Medicines Australia
and the Committee its actions to ensure
compliance by its staff with all provisions
of the Code and provide evidence of
effective implementation of revised
compliance procedures in accordance
with Section 15 of the Code.
Pay a fine of $200,000

Code of Conduct Committee

Consideration of the complaint
The Committee noted that Pfizer had listed
a number of companies with which they
had been involved in a Code complaint
over the past 24 months and which they
considered should not be represented on a
Code of Conduct Committee considering a
complaint against Pfizer.

141

The Secretariat advised that it is difficult to

identify a company with which Pfizer does
not have a conflicting interest given the
number of medicines and the therapeutic
classes in which Pfizer is interested.
Given the nature of the complaint at hand
and therapeutic area, the Committee did
not agree there were sufficient grounds to
disqualify
any
of
the
company
representatives from participation in
determining this matter.
The Committee debated at length the
intersection between the legal actions
instituted by AstraZeneca and the Code of
Conduct process. Members noted that a
legal process external to the Code and the
Code of Conduct process can operate in
parallel. The Committee recognised that
companies have a choice of forum and
that these would vary depending on the
circumstances.
However, companies
should not use a parallel legal process as
leverage against another pharmaceutical
company.
The Chairman stated that there was no
constraint on a company taking legal
action after going through the Code
process. It was further noted that a
company is entitled to take proactive
action in the Federal Court to seek an
injunction to stop an activity that is
considered urgent or may lead to serious
risk for patients. The Committee also
commented that it is a positive reflection
on the industry Code that the vast majority
of complaints are dealt with effectively by
the Code of Conduct Committee without
need to resort to legal action. Following a
question from the Committee the
Chairman responded that the Federal
Court would not be improperly influenced
or bound by a decision of this Committee.
The Code of Conduct Committee has
relatively limited ability to discover
information compared to the court. The
Federal Court could access all relevant
documents and require sworn affidavits
from a range of parties and would make its
decision based on the evidence before the
court. This could result in a different
outcome to that of the Code of Conduct
Committee due to different evidence
available to the court.
While noting that there were differences in
the information provided by AstraZeneca
and Pfizer, the Committee was extremely
concerned that Pfizer representatives had
made negative and false representations

Code of Conduct Annual Report 2007/2008

in relation to the safety profile of Crestor.

Members commented that while the
evidence was only in relation to the actions
of nine Pfizer representatives in NSW and
Queensland, of greater concern was how
this information had been provided to the
representatives and a possible more
serious problem within the management of
Pfizer. The Committee accepted that it
was possible that the most senior
management were not aware of the
activities of all representatives, but there
evidently are management structural
issues at Pfizer that had allowed false and
disparaging
information
to
be
communicated about a competitor product.
In relation to the alleged renal safety
profile for Crestor, members commented
that the Product Information (PI) does not
include any evidence that the renal safety
profile is unacceptable or that the side
effects are more serious or frequent than
with any other statin.
The Committee also considered the
petition by Dr Sidney Wolfe to the FDA in
2005 in which he raised concerns with the
renal safety profile of Crestor. Members
noted that these concerns had been
refuted by the FDA. The Committee was
concerned that the Pfizer representatives
had misrepresented the issues raised by
Dr Wolfe and had not provided a complete
and accurate version of the FDA opinion.
In relation to the alleged representative
statements that Crestor had a similar
safety profile to that of Lipobay and may
be withdrawn from the market like Vioxx
and Prexige, members were of the view
that this was an extremely misleading
statement and could have an influence on
prescribing.
The Committee was of the view that the
actions of the nine representatives in NSW
and Queensland identified by Pfizer were
misleading, serious and likely to bring
discredit to the industry.
In a unanimous decision the Committee
agreed that the statements made by the
Pfizer representatives were misleading,
lacked supporting evidence and were
disparaging to Crestor. Members were
also of the view that Pfizer had failed in its
responsibilities to ensure that all company
representatives
possessed
sufficient
medical and technical knowledge to
present information about the companys
products in a correct accurate and

142

balanced manner and were cognisant of

all provisions of the Code. Pfizer had also
failed to ensure its representatives
maintain high standards of ethical conduct
and professionalism. In a unanimous
decision the Committee found Pfizer to be
in breach of Sections 1.1, 1.2, 1.3, 1.7, 4.3,
4.4 and 10.5.2 of the Code.

Medicines Australia in accordance with

Section 12.2 of the Code.
The
Committee concluded that the other
sanctions were sufficient, but would
consider referral to the Board under
Section 12.2 if there was any evidence
that the conduct found in breach
continued or was repeated.

The Committee was also of the view that

these actions had the potential to bring the
industry into disrepute and found a breach
of Section 10.8 of the Code.

Pfizer allegation of breach of Section 12.3

by AstraZeneca
The Committee was cognisant of the
potential legal aspects to this complaint
and that Pfizer may have felt restrained by
the potential for legal action. However
having found several breaches of the
Code, the Committee was of the view that
AstraZeneca should not be asked to
respond to the alleged breach of Section
12.3 of the Code.

Sanctions
Having found several breaches of the
Code, which members considered to be
severe, the Committee considered what
sanction/s should be imposed.
The Committee determined that Pfizer
should:
Send a corrective letter to all NSW and
Queensland general practitioners and
pharmacists. The Corrective letter must
state that some Pfizer representatives
had
been
providing
misleading
information on the renal safety profile of
Crestor and that there was no difference
in the safety profile between Crestor and
other statins. The letter must also state
that Pfizer had been found in severe
breach of the relevant parts of the Code.
The corrective letter must be approved
by the Chairman of the Code of Conduct
Committee and must be in a font size of
not less that 12. Medicines Australia
must receive documentary evidence of
the distribution of the corrective letter
and the Secretary of the Code
Committee must be included on the
mailing list for the letter. Members were
of the view that the letter should be
restricted to NSW and Queensland as
there was no evidence that the conduct
was more wide spread.
Pfizer must report to Medicines Australia
and the Committee its actions to ensure
compliance by its staff with all provisions
of the Code, in accordance with Section
15 of the Code, and provide evidence of
effective implementation of revised
compliance procedures.
Pay a fine of $200,000. Some
consideration was given to imposing
separate fines on each section of the
Code found to be in breach. Members
also considered whether this matter
should be referred to the Medicines
Australia Board for consideration of
suspension or expulsion of Pfizer from

Code of Conduct Annual Report 2007/2008

Appeals Committee
Pfizer appeal
Pfizer stated that it was appealing in order
to clarify and correct certain matters as
recorded in the Code of Conduct
Committee minutes and to obtain
acknowledgements that some of the
Committees conclusions were without
basis. Pfizer did not seek to appeal any of
the decisions of the Code of Conduct
Committee in respect of the breaches or
sanctions that the Code Committee
imposed.
AstraZeneca response to the appeal
AstraZeneca endorsed the decision of the
Code of Conduct Committee as reflected
in the minutes. AstraZeneca reiterated the
view that this was an extremely serious
complaint with false and misleading claims
directed at healthcare professionals.
Additionally, the effects of this conduct
were damaging to AstraZeneca.
Consideration of the appeal
Prior to the company representatives
joining the meeting to present the appeal,
the Appeals Committee reviewed the
written submissions from both parties.
Members noted that that AstraZeneca had
threatened legal action under the Trade
Practices Act to seek the immediate
cessation of the alleged misleading
conduct. The Committee was cognisant
that this may have placed Pfizer in a
difficult situation when trying to respond to
the issues subsequently raised by
AstraZeneca through the Code of Conduct
143

process. Following a question from a

member of the Committee, the Chairman
advised that if the matter was considered
by a court, the judge would have access to
more extensive and possibly robust
evidence than the Code and Appeals
Committees and would not be bound by
any decisions made outside the courts
jurisdiction.

The Chairman asked that members note

the request from AstraZeneca that no
restrictions be placed on the use of the
Pfizer corrective letter (and Pfizers
statement that any use by AstraZeneca be
restricted to NSW and QLD) in line with the
provisions of the Code following the
presentations
from
Pfizer
and
AstraZeneca.

The Chairman also noted that the Appeals

Committee did not have the jurisdiction to
amend the confirmed minutes of the Code
of Conduct Committee meeting. The
Appeals Committee may make comment
on any matters brought before it. The
minutes of a Code of Conduct or Appeals
Committee meeting are not a transcript,
but a summary of the discussion and
reasons for coming to a decision.

The company representatives from Pfizer

and AstraZeneca were invited to join the
meeting.

The Committee also noted that Pfizer had

only made an admission in relation to the
specific conduct of one representative in
Maryborough in Queensland. However
Pfizer had also conceded that the conduct
had involved nine representatives in NSW
and Queensland Pfizer had denied that
any of its representatives had visited any
of the healthcare professionals who had
made a statutory declaration in relation to
this matter.
Members noted the advice from the Pfizer
Sales Director to the sales force that

every statement and all modalities of

written material require approval from
medical and marketing otherwise we
cannot be assured that it is not a technical
breach of the Code. Getting caught could
result in a fine of up to $200,000. Best way
to avoid this is not to do it.
The Committee reviewed the actual
number of representatives involved in this
conduct as stated in the Pfizer written
appeal
and
AstraZenecas
written
response to the appeal:
4 of 28 QLD cardiovascular
representatives
5 of 53 NSW cardiovascular
representatives
Total of 9 out of 81 cardiovascular
representatives or 11% of the NSW &
Queensland Cardiovascular Sales Force
Pfizer had stated that nationally this was
9 out of approximately 300
representatives
The parties agreed that NSW and
Queensland probably represented about
50-60% of the Australian market.

Code of Conduct Annual Report 2007/2008

The following
appeal.

summarises

the

Pfizer

In presenting its appeal, Pfizer tabled and

discussed the following documents with
the Appeals Committee:
Chronology of events (from 14
November 2007 to 20 March 2008)
List of Actions Taken by Pfizer Australia
to Address Alleged Conduct (November
2007 to June 2008)
Basis for Appeal
Pfizer is not appealing the sanctions
imposed by the Committee and will
comply with them.
Pfizer is appealing the manner in which
the Committee reached some of its
decisions and recorded those decisions
in the Minutes.
The Committee failed to properly
analyse and take into account a number
of important facts contained in Pfizers
submissions and made a number of
comments without basis.
Specifically, Pfizer believed that the
Committee:
failed to adequately consider
Pfizers efforts to resolve the
dispute with AstraZeneca.
failed to properly take into account
Pfizers efforts to immediately stop
the alleged conduct and prevent it
from recurring.
unfairly speculated about what
caused
the
conduct,
citing
unsubstantiated
management
issues within Pfizer.
made generalised statements in
the
minutes
which
miscommunicate the extent of
findings.
Pfizer sought written acknowledgements
from the Appeals Committee that the
Committee should have considered
certain
matters
in
reaching
its

144

conclusions and should not have

speculated on other matters.
Pfizer considers that the publication of
the Code of Conduct Committee
minutes:
unfairly damages the reputation of
Pfizer, its management and
representatives
may be used improperly by
Pfizers competitors;
may reduce confidence in the
Code process, and
may of themselves bring the
industry into disrepute.
Pfizer addressed a number of issues
that it anticipated may be raised by
AstraZeneca in its presentation to the
Appeals Committee. AstraZeneca may:
Seek to reiterate, misrepresent
and exaggerate the extent of the
conduct that occurred. However,
the conduct occurred between
July and November 2007 and was
limited to only 9 representatives in
2 discrete Pfizer sales districts.
Say that the conduct resulted from
management issues within Pfizer
and talk about the need for
corporate governance at Pfizer.
However,
if
Corporate
Governance was problematic,
Pfizer would not have responded
as it did when the conduct was
brought to its attention.
Repeatedly say Pfizer gave no
evidence to contest AstraZenecas
position or did not provide
statutory declarations from its own
representatives. However, Pfizer
set
out
at
length
why
AstraZenecas submissions did
not establish many aspects of the
alleged conduct.
Seek
to
say
that
the
acknowledgements
Pfizer
is
seeking are unprecedented. This
is not accurate. Many Code
appeals have addressed errors in
the way in which the Code
Committee
reached
its
conclusions.
Argue the inter-company dialogue
process was unnecessarily drawn
out by Pfizer. It is Pfizers view that
AstraZeneca withheld details of
the alleged Pfizer conduct for
months and also used the threat of
litigation to manipulate its position
during the Code process.
Seek to have input into the
corrective letter that Pfizer has

Code of Conduct Annual Report 2007/2008

been asked to issue. AstraZeneca

is not the appellant in this matter.
In any such event, such input
would be unprecedented and
inappropriate.
Pfizer emphasised their position
Pfizer accepts the sanctions of the
Committee and will comply with
them.
Pfizer
is
simply
seeking
acknowledgements that the Code
Committee made some findings
and some statements about the
conduct that were without basis,
and these should be corrected in
the interests of preserving Pfizers
reputation, and the integrity of the
Code process and the broader
reputation of the industry.
Pfizer then provided more detailed
arguments in support of their appeal.
1. Failure to take into account extent of
efforts to resolve the dispute
The Committee failed to have adequate
regard to the significant attempts Pfizer
made to resolve the dispute before it
was referred to Medicines Australia.
Pfizer staff discussed the Chronology of
Events between 14 November 2007
and 20 March 2008.
Undertakings were given by Pfizer to
AstraZeneca on 10 December 2007.
Pfizer made the offer of issuing a
corrective letter on several occasions
before its internal investigations of the
alleged conduct were complete.
The Guidelines for determining Code
Sanctions explicitly list extent of dispute
resolution dialogue as a factor to be
considered.
Pfizer requested an acknowledgement:
of the extensive steps taken by it
to resolve the dispute with
AstraZeneca after it arose;
that the Committee should have
taken those steps into account
when determining sanctions.
2. Failure to take into account extent of
effort to prevent conduct recurring
The Code Committee appears to have
failed to have sufficient regard to
extensive steps taken by Pfizer to
ensure that the alleged conduct ceased
and to prevent the conduct from
recurring.
Pfizer staff referred in detail to the tabled
List of Actions Taken to Address
145

Alleged Conduct (between November

2007 and June 2008).
Pfizer requested an acknowledgement
from the Appeals Committee:
that Pfizer took immediate steps to
address the alleged conduct as
soon as it arose and to prevent it
from recurring;
that the Committee should have
taken this into account when
determining its sanctions against
Pfizer.
3. Speculation on Management Issues
within Pfizer Australia
The Code Committee inappropriately
linked the actions of 9 representatives to
a more serious problem within the
Management of Pfizer.
The Minutes state:

there evidently are management and

structural issues at Pfizer that allowed
false and disparaging information to be
communicated about a competitor
product (emphasis added).

There was no basis for Code Committee

to make these comments:
no
evidence
was
put
by
AstraZeneca to this effect;
Pfizers submissions stated that
conduct was contrary to its
instructions to its sales force. Ms
Glover referred to the statutory
declaration
from
the
Pfizer
Cardiovascular
Brand
Team
Leader,
which
described
instructions from Pfizer to the
cardiovascular
sales
representatives to avoid making
any disparaging comments about
Crestor, which appears not to
have been properly considered by
the Code Committee).
The Code Committees comments were
speculative and extremely damaging to
Pfizers
directors
and
senior
management.
Pfizer seeks an acknowledgement from
the Appeals Committee that the
reference to management issues within
Pfizer was mere speculation on the part
of the Committee and should not have
been made.
4. Comments on Safety profile
The Code Committee minutes state:

In relation to the alleged representative

statements that Crestor had a similar
safety profile to that of Lipobay and may
be withdrawn from the market like Vioxx
and Prexige, members of the Committee

Code of Conduct Annual Report 2007/2008

were of the view that this was an

extremely misleading statement and
could have an influence on prescribing

Pfizer considers that this suggests the

Committee
accepted
that
such
statements had in fact been made on a
number of occasions by Pfizer
representatives.
Pfizers
extensive
investigations
revealed
that
only
one
Pfizer
representative appears to have made a
statement
to
similar
effect
in
Maryborough. In its submissions to the
Code Committee Pfizer denied that such
representations
had
been
made
elsewhere based on its investigations.
The Committee appears not to have had
regard to this and has taken
AstraZenecas submissions on this point
at face value.
Pfizer requested the Appeals Committee
to acknowledge that such statements
were denied by Pfizer (except in the
case of Maryborough).
5. Breach of Section 4.4 of the Code
The Code Committee found Pfizer in
breach of section 4.4 and stated:

Pfizer had also failed to ensure its

representatives maintain high standards
of ethical conduct and professionalism.

The Committee acknowledged only 9

representatives were involved in NSW
and Queensland but the above
statement implies that Pfizer had failed
to maintain theses standards in respect
of all of its representatives. Pfizer is
concerned that this statement may be
taken out of context by its competitors.
Pfizer requests that the Appeals
Committee acknowledge and clarify that
the breach of Section 4.4 related to the
conduct of 9 representatives in 2
discrete Pfizer sales districts in NSW
and Queensland.
6. Failure to provide directions to AZ on
appropriate use of the corrective letter
In its submission to the Code Committee
Pfizer had requested that AstraZeneca
be directed as to how any corrective
letter should be used, specifically as
AstraZeneca
has
indicated
their
intention to use it, proactivelyin our
dealings with any HCP nationally (in an
e-mail from the AstraZeneca Managing
Director to the Pfizer Managing Director)
The Code Committee did not address
this issue.

146

 Whilst Pfizer is prepared to send a

corrective
letter
to
NSW
and
Queensland as sanctioned by the
Committee, AstraZeneca should be
directed not to use it outside these
states or as a tool to disparage Pfizer.
Pfizer requests the Appeals Committee
to provide directions to AstraZeneca to
this effect.
7. Statements Regarding Expulsion from
Medicines Australia
Pfizer believes it acted responsibly from
the moment it was first made aware of
the alleged conduct.
However, the Code Committee minutes
state Some consideration was given to

imposing separate fines on each section

of the Code found to be in breach and
that Members also considered whether
this matter should be referred to the
Medicines
Australia
Board
for
consideration of suspension or expulsion
from Medicines Australia.

These comments are particularly harsh

and set an inappropriate tone having
regard to the responsible manner in
which Pfizer acted to address the
conduct.
Pfizer requests the Appeals Committee
acknowledge
that
in
all
the
circumstances, it was inappropriate for
the Committee to have had this
discussion and record it in the minutes.

Summary of Pfizer Appeal

Pfizer is not challenging the sanctions
imposed by the Code Committee.
It is not challenging that the conduct that
did occur was wrong.
Pfizer is seeking acknowledgements that
the Code Committee was not entirely fair
in reaching its conclusions in that if failed
to take into account a number of
important issues raised by Pfizer in its
submissions, and made some general
and damaging statements without proper
justification.
Pfizer is also asking that directions be
given to AstraZeneca regarding use of
the corrective letter.
Pfizer
acted
responsibly
and
appropriately in seeking to address the
conduct that occurred as soon as it was
made aware of it. Pfizer considers it
does not deserve many of the
statements recorded in the minutes.
Pfizer requested the Appeals Committee
provide acknowledgements on the points
made in its presentation, to help

Code of Conduct Annual Report 2007/2008

preserve the reputation of Pfizer and its

staff, as well as that of the industry.
The
following
summarises
the
AstraZeneca response to the Pfizer
appeal:
AstraZeneca endorses the original Code
Committee minutes and decisions.
Pfizers appeal raises issues between it
and the Code Committee. Pfizer has not
challenged the findings and sanctions.
Pfizer has chosen not to provide any
evidence
disputing
AstraZenecas
account of the Pfizer conduct, which
should restrict what they can now argue
to the Appeals Committee.
The request to the Appeals Committee is
unprecedented to rewrite or alter the
minutes of the Code Committee. This
could not happen in a court.
The Pfizer conduct was serious, wrong,
misleading and damaging. It involved
widespread representatives in NSW and
Queensland making misrepresentations
about the renal safety profile of Crestor.
Three healthcare professionals provided
statutory declarations describing the
conduct. Numerous other healthcare
professionals reported the conduct to
AstraZeneca.
AstraZeneca
believes
the
Code
Committee did weigh up all the
evidence;
its
examination
was
systematic and rigorous.
Drawing
inferences is something that the Code
Committee was entitled to do having
considered all the evidence.
Pfizer has had opportunities to explain
and provide evidence about the conduct.
AstraZeneca provided 3 independent
statutory
declarations,
advice
of
additional reports to its representatives
and also is of the view that there is
further undiscovered conduct. Pfizer
chose to provide no evidence to the
Code Committee. Pfizer admitted that
11% of representatives (9 out of 81
representatives) who promote Lipitor in
NSW and QLD breached the Code.
No evidence from Pfizer means they
have no basis to challenge the
Committees decision.
The tables
presented by Pfizer in its response to the
complaint merely deny that the conduct
occurred, which is not evidence.
Pfizer has admitted in intercompany
dialogue on 19 February 2008 that the
conduct
has
raised
corporate
governance issues for Pfizer and was
very serious.

147

 Pfizer Management is responsible for its

employees actions.
Pfizers investigations led to admissions
of the conduct. These are serious and
extensive breaches.
AstraZeneca strenuously opposes any
direction about the dissemination of the
corrective letter this would be
inconsistent with the Code.
There
should be no change to the normal
approach to corrective letters.
Any concerns Pfizer has about
inappropriate use of the corrective letter
should be dealt with under the ordinary
industry channels; that is a formal code
complaint.
The Code Committee minutes are a
public document and seek to achieve a
remedial purpose.
The commentary
recorded in the Code Committee
minutes was appropriate to capture the
discussions with respect to the sanctions
that were discussed by the Committee.
The Code Committee needs to take a
strong stance to deter future conduct
and reinforce the requirements for all
companies to have good corporate
governance and compliance procedures.
Pfizers requests to the Appeals
Committee are inappropriate and
unwarranted.
Pfizer must be responsible for the
wrongful actions of its representatives.
The Chairman invited questions from the
Committee.
In response to a question from the
Committee, AstraZeneca staff explained
that the Public Citizen organisation in the
US had formed an opinion that the renal
safety of Crestor was unsatisfactory. In
response to its submission, the FDA had
fully analysed all the safety data for
Crestor and concluded that its safety
profile was at least equal to other statins
on the market. FDA had published this
analysis. AstraZeneca asserts that Pfizer
representatives had selectively and
misleadingly used this document by only
referring to the allegations by Public
Citizen and not the FDA conclusions,
which therefore misrepresented the renal
safety of Crestor.
Pfizer was asked how this conduct could
have occurred. Members commented that
they found it difficult to believe that nine
Pfizer representatives were independently
using the same incorrect information.
Pfizer replied that AstraZeneca were using

Code of Conduct Annual Report 2007/2008

the FDA review of Crestor safety and one

Pfizer representative had then used this
document together with the Public
Citizens submission to the FDA, which
alleged a serious toxicity profile for
Crestor, in their detailing of healthcare
professionals. This action was without the
approval of anyone in Pfizer management.
The documents subsequently were shared
amongst other representatives within two
discrete sales areas. Once Pfizer had
been advised by AstraZeneca that such
activity was being undertaken immediate
action was taken by Pfizer to stop it. Pfizer
has subsequently undertaken an extensive
investigation of the conduct by an external
legal team.
Pfizer also disputed that the statutory
declarations from health professionals in
the AstraZeneca submissions actually
prove that the Pfizer representatives made
the
statements.
These
are
the
recollections
of
the
healthcare
professionals some time after the event.
Pfizer also commented that the Code of
Conduct Committee had failed to take
these immediate actions by Pfizer into
account when making their determination.
The minutes of the Code of Conduct
Committee meeting are worded in such a
way that the Committee had accepted that
more extensive conduct had occurred than
actually occurred. Pfizer admits that on
only one occasion did a Pfizer
representative make statements as
alleged; there is no other evidence to
support the alleged statements in the NSW
pharmacists statutory declaration. The
Committee should have given weight to,
and acknowledged Pfizers attempts to
resolve this matter.
On being questioned as to why Pfizer were
appealing the wording of the minutes
rather than the decisions or sanctions,
Pfizer responded that it was not seeking
that the Code of Conduct Committee
minutes were altered but rather that the
Appeals Committee acknowledge a proper
reflection of what occurred.
This is the first time the Code of Conduct
Committee has imposed a fine of
$200,000 and referred in the minutes to
possible suspension or expulsion from
Medicines Australia, which was extremely
damaging to Pfizer and the industry. Pfizer
reiterated their concerns that the minutes
appear to be one-sided and give the
impression that the conduct was much

148

worse and extensive than it was. The use

of the misleading data was not systematic
and occurred in only two of 37 sales
territories within Australia. AstraZeneca
has asserted that there is further evidence
that the conduct was more widespread but
despite numerous requests from Pfizer this
has never been produced.

Board of Medicines Australia for possible

suspension or expulsion.

Pfizer considered that the Committees

decision was harsh and gave little weight
to what Pfizer had done to address the
issue or the immediacy of the actions
taken by the company. In relation to the
statement in intercompany dialogue
regarding corporate governance, Pfizer
absolutely takes corporate governance
extremely seriously and took action
immediately upon being informed of the
conduct.

The Chairman thanked the company

representatives for their input and asked
that they retire from the meeting to allow
the Appeals Committee to deliberate on
the matters before them.

Pfizer accepts that the conduct by a small

number of representatives was serious
and in breach of the Code and have taken
internal action to correct this. This
outcome has attracted the attention of the
Pfizer head office. Pfizer are prepared to
distribute the corrective letter as directed
and pay the fine. This appeal is about the
balance of the record of how Pfizer had
responded, which was not adequately
reflected in the minutes of the Code of
Conduct Committee meeting. Pfizer is also
seeking the Appeals Committee to place
restrictions on how AstraZeneca can use
the corrective letter and that it should not
be used outside NSW and QLD. The
breaches occurred in two of 37 sales
districts by 9 of a total of 81 cardiovascular
representatives within a broader sales
force of approximately 300.
AstraZeneca responded that the Pfizer
appeal should be rejected and the
decisions of the Code Committee be
endorsed.
Alteration of the Code
Committee
minutes
would
be
unprecedented.
AstraZeneca asserted that Pfizer had
chosen not to produce any evidence at all
through this process to support its
assertion of the limited scope of the
conduct. The decisions of the Committee
unanimously found eight breaches of the
Code and imposed the maximum sanction.
AstraZeneca also noted the seriousness
with which the Code of Conduct
Committee had considered this conduct
through the discussion about referral to the

Code of Conduct Annual Report 2007/2008

AstraZeneca noted that this was an

unusual case in that the corrective letter
referred
to
AstraZenecas
product
(Crestor) and not the Subject Companys
(Pfizers) product.

The Appeals Committee considered all of

the evidence submitted by AstraZeneca
and Pfizer to the Code of Conduct
Committee, as well as the written and oral
materials presented to the Appeals
Committee.
The Appeals Committee
concluded that it was open to the Code of
Conduct Committee to make the
comments it did in respect of the issues
raised by Pfizer on appeal. The minutes
reflect the seriousness with which the
Committee regarded the conduct.
In relation to the statement by the Code of
Conduct Committee - The Committee

accepted that it was possible that the most

senior management were not aware of the
activities of all representatives, but there
evidently are management structural
issues at Pfizer that had allowed false and
disparaging
information
to
be
communicated about
a competitor
product. - members noted that Pfizer

acknowledged that corporate governance

is taken very seriously [whether] in the
sales context or any context and acts
immediately to correct anomalies. The
Appeals Committee considered that given
the conduct involved 11% of the
cardiovascular sales force of Pfizer in
NSW & Queensland; it was open to the
Code Committee to make such a
statement.
Corporate
governance
practices extend across the entire
company
and
the
size
of
the
cardiovascular sales force involved
warranted these statements by the Code
Committee.
The Appeals Committee determined that
the sanctions imposed by the Code of
Conduct
Committee
reflected
the
seriousness with which the Code of
Conduct
Committee
observed
the
breaches. The Appeals Committee
acknowledged
that
Pfizer
gave

149

undertakings to AstraZeneca as early as

November 2007, and had attempted to
begin to resolve the dispute. However, the
decisions of the Code of Conduct
Committee and the sanctions imposed
indicate the seriousness of the breaches,
particularly noting it had involved 11% of
the relevant cardiovascular sales force.
Furthermore, based on the materials
before the Appeals Committee, the Code
of Conduct Committee had been within its
rights to make observational comments
about Pfizer in respect of Section 12.2 of
the Code.
The Appeals Committee determined not to
deviate from the practice of requiring any
corrective letter from Pfizer to be approved
by the chairs of the Appeals Committee
and Code of Conduct Committee without
reference to AstraZeneca in that process.
However, the concerns of AstraZeneca
with respect to the content of the corrective
letter were noted. Additionally the Appeals
Committee will not impose any restrictions
on how AstraZeneca uses the corrective
letter once it is in the public domain, noting
that it is open to Pfizer to pursue a
complaint in the usual manner if it
considers a breach of the Code has
occurred with respect to the use of that
letter by any member company.

Code of Conduct Annual Report 2007/2008

150

Ipsen Educational Event (910)

Description of function
including duration of the
educational content
delivered

Venue

Professional
status of
attendees

Hospitality
provided

Total cost of
hospitality

Number
of
attendees

Total cost
of function

Endocrinology Meeting,
Overseas Specialist Presentation 1hour

Four
Seasons
Hotel,
Sydney
NSW

Consultant
Endocrinologist,
Cardiologists,
Registrars and
Nurses

3 Course sit down

dinner

Total:$6838.4

42

Total:
$14126.90

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event additional
information on the hospitality components were provided.

Subject Company: Ipsen

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event IP-44
Complaint
The Monitoring Committee had asked that
Ipsen provide justification for the cost of
the food and beverages provided at this
event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Ipsen denied any breach of the Code.
Ipsen stated that the primary purpose of
this meeting was to provide an opportunity
for Australian healthcare professionals to
meet and listen to a world renowned
expert in the field of pituitary neoplasms,
growth hormone deficiency, acromegaly
and associated cardiac performance
issues.
Ipsen also raised concerns that the
Monitoring Committee had forwarded
matters to the Code of Conduct Committee
based on a numerical figure for hospitality
of which the company was not aware.

Code Committee determination

In a unanimous decision the Committee
did not find a breach of Sections 6.2.1,
6.2.2, 10.2 or 10.8 of the Code.
Consideration of the complaint
In response to the concern raised by Ipsen
about how the Monitoring Committee
analysed educational events, the Code
Committee commented that the data
provided to the Monitoring Committee by
the Independent Auditor, Deloitte, was
based on statistical analysis. Having
reviewed this data the Monitoring
Committee requested further information
from companies and made decisions that
certain events should be forwarded to the
Code
of
Conduct
Committee
for
adjudication. It was recognised that it is
not the role of the Monitoring Committee to
find breaches of the Code.
Members acknowledged that it was a
difficult process for companies to compile
the required information; however this
review by the Code of Conduct Committee
would not determine a monetary limit for
providing hospitality in association with
educational events.
The Committee
reiterated the earlier general discussion
that each event should be considered on
its merits.
The Committee accepted that in deducting
the cost of $16.50 per head for alternate
menu plating the hospitality provided at a
cost of $121 per person was not
extravagant and found no breaches of the
Code.

The cost per head included a $16.50

charge per head for alternate plating.
Excluding this charge the actual cost per
head of food and beverages was $121.00
per head.

Code of Conduct Annual Report 2007/2008

151

Merck Sharp & Dohme Educational Event (911)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

Advanced Trainee Weekend, 2

Days

Shangri-La
Hotel,
Sydney

GP

Morning/Afternoon
Tea, Lunch, 3 Course
Conf Dinner With
Alcohol,
Accommodation,
Travel, Parking,
Transfers

52,059.00

98

85,561.00

Subject Company: Merck Sharp & Dohme

(Australia) [MSDA]
Complainant: Medicines Australia
Monitoring Committee

In a majority decision the Committee

found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.

Event: Educational Event MSD-417

Complaint
The Monitoring Committee had asked that
MSDA provide justification for the
provision of two nights accommodation
with respect to the educational component
of the meeting.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
MSDA denied any breach of the Code.
MSDA stated that the educational content
of the event was delivered by 13
specialists, to 98 registrars and advanced
trainees. The educational component was
8.5 hours over two days, plus a 1.5 hour
presentation over dinner. 45 delegates
were provided with accommodation on the
first night and 46 on the second night.
Code Committee determination
In a majority decision the Committee
found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.
Consideration of the complaint
The Committee was of the view that the
educational component over the two days,
including the presentation during the
Saturday evening dinner, was sufficient to
justify two nights accommodation and
found no breach of the Code.

Code of Conduct Annual Report 2007/2008

152

Novartis Educational Event (912)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

10.5 Hour (2 Day)

International Age-Related
Macular Degeneration
Congress with Presentations
by Leading Retinal Specialists
from around the world on the
latest scientific innovations
and the practical challenges
of incorporating these new
advances into everyday
clinical practice.

Palacio De
Ferias Y
Congresos
De
Marbella,
Marbella,
Spain

Ophthalmologists

Business Class
Airfares for 6
People. 3 Nights
accommodation for
4 people and 2
nights
accommodation for
2 people. Breakfast
each morning, 1
Buffet Dinner, 2
Buffet Lunches and
3 Coffee Breaks for
each attendee.
Registration fee to
attend Congress.

65,958.00

68,358.00

Subject Company: Novartis

Pharmaceuticals (Novartis)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event NO-651
Complaint
The Monitoring Committee had asked that
Novartis provide a full breakdown of the
cost for all meals and accommodation
associated with this event.

Code Committee determination

In a majority decision the Committee found
no breach of Sections 6.2.1, 6.2.2, 10.2 or
10.8 of the Code.
Consideration of the complaint
Following its review of the detailed
information provided by Novartis, the
Committee was of the view that the
hospitality provided to the sponsored
delegates
was
not
excessive
or
extravagant and found no breach of the
Code.

Sections of the Code

Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Novartis denied any breach of the Code.
Novartis stated that the event was a major
scientific symposium of high standing, the
International
Age-Related
Macular
Degeneration Congress that attracted over
1,000 delegates from around the world.
Novartis sponsored six ophthalmologists to
attend this scientific meeting. The
accommodation was AUD$288.00 per
night and the two dinners were at a cost of
AUD$94.13 and AUD$104.95 per head.
Novartis
considered
the
hospitality
provided to be modest and consistent with
professional standards and therefore the
event was not in breach of the Code.

Code of Conduct Annual Report 2007/2008

153

Novo Nordisk Educational Event (913)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality
provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

Dinner Held in Association

with European Association for
the Study of Diabetes Annual
Meeting (EASD) 5 Day
Conference with Plenary
Sessions, Presentations and
Workshops.

Cristofori
Restaurant
Amsterdam
The
Netherlands

Endocrinologists
Diabetes
Educators
General
Physicians
Endocrine
Registrars
Nurses

3 Course Dinner
with Alcoholic and
Non Alcoholic
Drinks Provided
Private Room Hire
Coach Transfers to
and from Hotel for
49

13,556.94

49

13,556.94

Subject Company: Novo Nordisk

Pharmaceuticals (Novo Nordisk)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event NN-125
Complaint
The Monitoring Committee had asked that
Novo Nordisk provide justification for the
cost of the hospitality provided at the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry

Consideration of the complaint

The Committee noted that the costs
attributed to meals at overseas venues
included a range of taxes and charges. In
this case there was a 5% service fee plus
VAT on food (6%) and beverages (19%).
In Australia a company may report costs
which are GST exclusive. The Committee
considered that the menu and beverages
was not extravagant and was consistent
with a business meeting.
For these reasons the Committee found no
breaches of the Code.

Response
Novo Nordisk denied any breach of the
Code. Novo Nordisk stated that the dinner
was held in association with a major five
day international conference (European
Association for the Study of Diabetes
Annual Meeting) for 12,656 delegates. The
intent was to facilitate discussion after a
full day session at the conference and also
allow the Australian guests to interact with
principals from Novo Nordisk global. The
cost reported to Medicines Australia
included room hire, coach transfers,
agents fees and local taxes. The actual
food and beverage component was
AUD$173.80 (including service charges
and gratuities).
Code Committee determination
In a majority decision the Committee found
no breach of Sections 6.2.1, 6.2.2, 10.2 or
10.8 of the Code.

Code of Conduct Annual Report 2007/2008

154

Nycomed Educational Event (914)

Description of function including
duration of the educational content
delivered

Venue

Professional
status of
attendees

Hospitality
provided

Total cost
of
hospitality

Number of
attendees

Total cost
of
function

Weekend of GP Grand Rounds

Peppers, Leura. This was
organised in association with GP
Grand Rounds, an organisation of
physicians who supply educational
content and speakers for General
Practitioner Education. The focus
of this meeting was on
Gastroenterology.

Peppers
Fairmont
Resort,
Leura

General
practitioners

Accommodation
with breakfast
for 1 night for
120; Morning
tea, lunch,
afternoon tea &
dinner with
beverages for
120.

64,130.00

120

70,907.00

Subject Company: Nycomed

Complainant: Medicines Australia
Monitoring Committee

Sanction
By majority decision pay a fine of
$70,000 (Fine amended to $35,000 by
the Appeals Committee).

Event: Educational Event NY-49

Code of Conduct Committee

Complaint from the Monitoring Committee

The Monitoring Committee had asked that
Nycomed provide justification for a
weekend meeting with an educational
component of 3 hours and 30 minutes,
which was considered to be insufficient
education to be classified as a weekend
educational event with accommodation
provided.

Consideration of the complaint

The Committee noted the Code provision
that Any hospitality provided by

Sections of the Code

Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Nycomed denied any breach of the Code.
Nycomed stated that the education
provided at this event was of exceptional
quality and suitable for a weekend meeting
for busy GPs. All sessions generated
much interest and discussion. Nycomed
also stated that the hospitality was not
excessive for the quality of education
provided.
Code of Conduct and Appeals Committee
determinations
In a unanimous decision the Committee
found a breach of Sections 6.2.1 and 10.2
of the Code and no breach of Section
6.2.2. In a majority decision the Committee
found no breach of Section 10.8 of the
Code was found. (Decision confirmed by
the Appeals Committee)

Code of Conduct Annual Report 2007/2008

companies
either
directly
or
by
sponsorship or assistance to the
organisers of the educational meetings,
must be secondary to the educational
purpose. Members were of the view that it

was not acceptable for a company to

provide a weekend educational event with
only three and a half hours educational
content, (two hours and a half hours on
Saturday and one hour on Sunday). The
Committee particularly noted the short
video presentation session on Sunday
morning.
Whilst accepting that some
doctors work on Saturday mornings, which
is a rationale for starting the meeting in the
afternoon, the Committee commented that
there should be more extensive, good
quality education provided the next day to
justify
provision
of
overnight
accommodation.
The Committee determined that the
hospitality provided was not secondary to
the educational purpose.
There was
insufficient good quality education in
proportion to the provision of hospitality.
In a unanimous decision the Committee
found a breach of Sections 6.2.1 and 10.2
of the Code and no breach of Sections
6.2.2. In a majority decision no breach of
Section 10.8 of the Code was found.

155

Sanctions
Having found two breaches of the Code
the Committee considered what sanction/s
should be imposed.
The Committee determined that Nycomed
should:
Pay a fine of $70,000

Appeals Committee
Nycomed appeal
Nycomed argued that the event delivered
an
appropriate
balance
between
educational content (over 5 hours) and
hospitality. The delivery of the program on
Saturday afternoon and Sunday morning
enabled GPs from around NSW and the
ACT, including those with Saturday
morning practice, to attend.
Consideration of the appeal
The following summarises the Nycomed
appeal:
Nycomed Australia supports and
adheres to the Medicines Australia Code
of Conduct in principle, spirit and
practice.
During the reporting period 1 July -31
December 2007, Nycomed supported
166 Medical Educational Events. 7,982
Health Care professionals attended or
participated in Nycomed Educational
Events.
The significant majority of events were
related to the broad areas of
Gastroenterology
and
Respiratory
Diseases.
Nycomed is committed to providing a
high quality ongoing medical education
program to healthcare professionals in
order to enhance patient care.
120 delegates (GPs) attended the GP
Grand Rounds Pty Ltd event, sponsored
by Nycomed.
A team of 9 Specialists facilitated the
educational event. The equivalent event
was first run in 2005. The education is
case study based, which is preferred by
many GPs.
The Peppers Fairmont Resort, Leura
location was chosen for a number of
reasons:
The event was specifically held outside
Sydney and commenced at 2pm on
Saturday to facilitate attendance of GPs
from outside Central Sydney
More than 20% of delegates were from
rural NSW and ACT.

Code of Conduct Annual Report 2007/2008

Peppers Fairmont Resort has the

reputation of being a professional
conference centre with adequate
equipment and room for catering, and
ensured a level of privacy for the
sessions, which presented case studies.
Hospitality
provided
during
the
educational event consisted of 1 night
accommodation (including breakfast),
optional lunch on the day of arrival,
afternoon tea, dinner and morning tea on
the day of departure.
Hospitality provided was modest and
secondary to the educational purpose.
Although the duration of the educational
event is very important, factors such as
the educational content, the speakers
and the educational material also should
be taken into the consideration.
GP
Grand
Rounds
Educational
Programmes are highly valued and are
developed by doctors for doctors without
the influence of its sponsors.
Multidisciplinary clinical presentations
during the event generated intense
discussions
and
questions
from
attendees, which continued beyond the
programmed presentation time on both
days.
Saturdays program provided a rotation
of three concurrent sessions.
Sundays session was a combination of
6 short videos presenting unique
treatment situations. Each video was
followed by an in depth analysis and
discussion of the cases, moderated by
speakers.
The educational component was greater
than the times stated in the invitation,
and was actually in excess of five hours.
Educational content was highly relevant
to clinical practice, according to the
feedback survey conducted immediately
following the event (67% responded
definitely on this question)
The style of the meeting was suited to
GP learning styles according to the
feedback survey (71% responded
definitely on this question)
The cases presented point by point
allowed maximal audience interaction in
determining the particular diagnostic and
therapeutic challenges.
Group discussion highlighted some
regional
differences
in
patient
management.
Nycomed believes that the event did
comply with the Medicines Australia
Code of Conduct when viewed in its
entirety, rather than only on the basis of

156

a calculation of presentation times stated

on the invitation.
Nycomed asked the Appeals Committee
to recognise the aforementioned points
by upholding the appeal and dismissing
the complaint.
If the Appeals Committee agrees with
the Code of Conduct Committee that the
event was in breach, Nycomed
submitted that there should be a
reprimand only and no fine imposed.
If the Appeals Committee is not
prepared to sanction Nycomed with a
reprimand only, it submitted that any fine
should be substantially reduced from
that imposed by the Code of Conduct
Committee.
Following questions from the Committee
Nycomed
provided
the
following
responses:
Nycomed had no input into the
educational content of the meeting,
which was developed by GP Grand
Rounds Pty Ltd.
Peppers Fairmont Resort was chosen
because it was accessible to rural NSW
and ACT GPs. No travel costs were
paid for or subsidised by Nycomed.
The Program commenced at 2.00pm to
allow doctors who have Saturday
morning practice to attend.
While the invitation stated 3.5 hours
there was a great deal of discussion
following the case studies and Sunday
videos, which resulted in an overall
education duration of over 5 hours.
The Chairman thanked the Nycomed
representatives and asked that they retire
from the meeting to allow the Appeals
Committee to deliberate on the mater
before them.
Members were of the view that the venue
did offer appropriate educational facilities
and that a range of different educational
formats are appropriate and raised no
concerns with the use of case studies. It
was acknowledged that there was a
positive reaction to this format.
The Committee also noted that a venue
away from the attendees home town or
city can be more conducive to education
as delegates are more likely to remain
focussed on the education and have less
outside influences. Members also noted
that the attendees costs in driving to the
venue were not covered by the company.

Code of Conduct Annual Report 2007/2008

Members acknowledged that discussion

may have continued after the times set
out in the invitation; however they also
noted that because the delegates rotated
through three consecutive case study
sessions there would have been limited
capacity for extended discussion except
for following the third session at the end
of day one. There was only a short time
between the end of the afternoon session
and the dinner and according to the
program the Sunday session closed
immediately after the 10.00am 11.00am
videos. Notwithstanding the discussion
may have continued after the educational
sessions expected finish time, Nycomed
had planned and advertised three and a
half hours of education spread over the
two days.
The Committee noted that the educational
component was prepared by GP Ground
Rounds Pty Ltd; however Nycomed
should have required a longer educational
component in order to justify the overnight
accommodation provided. Members were
of the view that it would have been
possible to have a longer session on
Sunday. In the general discussion from
the April 2008 meeting, the Code of
Conduct Committee had put forward a
view that companies holding a weekend
event should have at least six hours of
education to justify providing a nights
accommodation and meals over two
days. This is consistent with advice from
the Monitoring Committee arising from its
review of invitations to educational
meetings over several years.
In making their decision to not uphold the
appeal the Committee reiterated the view
that it was not questioning the quality or
independence of the education that was
provided. Rather the decision reflected
that the duration of the educational
component, which was planned and
advertised as three and a half hours, was
inadequate to justify a weekend meeting
and associated accommodation.
The
Appeals Committee was not persuaded
that the hospitality was secondary to the
educational content.
The Committee
confirmed a finding of a breach of
Sections 6.2.1 and 10.2 of the Code.
Sanctions
Having not upheld the appeal the
Committee
reviewed
the
sanction
imposed by the Code of Conduct
Committee. Members were of the view

157

that the fine of $70,000 was excessive

when taking all the circumstances of the
meeting into account and determined that
the fine should be reduced to $35,000.

Code of Conduct Annual Report 2007/2008

158

Nycomed Educational Event (915)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality
provided

Total cost
of
hospitality

Number of
attendees

Total cost
of function

Full day practice

management program for
medical registrars.

Sofitel Hotel,
Gold Coast

Registrars

Accommodation
2 nights for 36;
Welcome
Cocktail;
Morning Tea,
Lunch,
Afternoon Tea
for 36, included
in delegate
package
Breakfast on 2
days; Travel for
36

43,261.00

36

69,850.00

Subject Company: Nycomed

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event NY-76
Complaint
The Monitoring Committee had asked that
Nycomed provide justification for a
weekend meeting with an educational
component of 5 hours and 30 minutes,
which was considered to be insufficient
education
to
justify
two
nights
accommodation.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Nycomed denied any breach of the Code.
Nycomed responded that accommodation
was provided on the Friday evening as the
education
session
on
Saturday
commenced at 9.00am and did not
conclude until 4.45pm which then required
accommodation on the Saturday evening.
Nycomed stated that a comprehensive
educational program was provided and
that it was not disproportionate to the
hospitality provided.
Code Committee determination
In a unanimous decision the Committee
found a breach of Sections 6.2.1 and 10.2
of the Code and no breach of Section
6.2.2. In a majority decision the Committee

Code of Conduct Annual Report 2007/2008

found no breach of Section 10.8 of the

Code.
Sanction
By majority decision - pay a fine of
$60,000.
Consideration of the complaint
The Committee noted that the actual
educational component was six hours with
the first educational session commencing
at 9.00am on Saturday and concluding at
4.45pm. There was no educational
component on Sunday.
The Committee commented that it would
be possible to spread the educational
component over two days, starting later on
Saturday and concluding by Sunday lunch.
If the agenda was spread over Saturday
afternoon and Sunday morning the
company should only be required to
provide one night of accommodation for
delegates who could travel to the Gold
Coast during the morning. Members were
of the view that it would be appropriate to
provide two nights accommodation for an
attendee coming from a location that did
not have flights arriving into the Gold
Coast on Saturday morning.
In this
instance two nights accommodation had
been provided for all delegates, including
those from Sydney and Brisbane.
The Committee recommended that
companies should be encouraged to
increase the educational component for
weekend or multi-day meetings to ensure
that hospitality is secondary to the
educational
purpose
and
therefore
meeting the requirements of Sections
6.2.1 and 10.2 of the Code.

159

In a unanimous decision the Committee

found a breach of Sections 6.2.1 and 10.2
of the Code and no breach of Section
6.2.2. In a majority decision the Committee
found no breach of Section 10.8 of the
Code.
Sanctions
Having found two breaches of the Code
the Committee considered what sanction/s
should be imposed.
The Committee determined that Nycomed
should:
Pay a fine of $60,000

Code of Conduct Annual Report 2007/2008

160

Pfizer Educational Event (916)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of function

Uroscience Forum - 3 Days

Sheraton
Noosa
Resort
Noosa
Heads,
NSW

Specialists

Accommodation,
Travel, Food &
Beverage

154,453.00

120

196,871.00

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event the cost of
hospitality and total cost of function columns were amended.

Subject Company: Pfizer Australia (Pfizer)

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event PF-229
Complaint
The Monitoring Committee had asked
Pfizer to provide justification for the choice
of the venue and the need to provide travel
for doctors to attend this venue. Pfizer was
also asked to provide information on the
number of doctors that required travel and
where they travelled from.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
6.6 Venue
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Pfizer denied any breach of the Code.
Pfizer advised the Code Committee that
the difference between the actual costs
incurred and the costs originally reported
to Medicines Australia were due to the
estimated costs being provided in the first
instance.
Pfizer stated that 58 attendees required
flights from Adelaide, Sydney, Melbourne,
Canberra, Launceston, Perth and Wagga
to the Sunshine Coast or Brisbane
Airports. The other 11 delegates did not
require flights.
The venue was selected because of its
conference facilities and its accessibility by
air.

Code of Conduct Annual Report 2007/2008

Code of Conduct and Appeals Committee

determinations
In a majority decision the Committee found
no breach of Sections 6.2.1 and 6.2.2 and
a breach of Sections 6.6 and 10.2 of the
Code. In a majority decision the
Committee found no breach of Section
10.8 of the Code. The Appeals Committee
upheld Pfizers appeal and found no
breach of the Code.
Sanction
Having found no breach of the Code the
requirement to pay a fine of $50,000 was
removed by the Appeals Committee.

Code of Conduct Committee

Consideration of the complaint
The Committee questioned why the
majority of attendees needed to be flown
to Noosa when a more central (to all
attendees) city location such as Brisbane
or Sydney could have been selected. Had
a more central location been used the
majority of attendees would have required
only one nights accommodation.
The Committee noted that delegates had
paid a registration fee of $180 to attend the
Uroscience Forum. Members considered
that the quality of the education provided
was acceptable.
The Committee determined that the
selection of the Noosa location for the
meeting was in breach of the Code. The
Committee stated that they did not find the
venue in breach of the Code for reason of
its name being a resort. The decision
pertained to the choice of a venue that was
remotely located to all attendees thereby
requiring more extensive hospitality
(meals, travel and accommodation) to be
provided, notwithstanding that delegates
had contributed a fee towards the cost of

161

the event. The venue apparently was

selected for its leisure and recreational
purpose. Members considered that the
rationale for selecting the venue could not
withstand public and professional scrutiny.
In a majority decision the Committee found
a breach of Sections 6.6 and 10.2 of the
Code.
In a majority decision the
Committee found no breach of Sections
6.2.1, 6.2.2 or 10.8 of the Code.
Sanctions
Having found two breaches of the Code
the Committee considered what sanction/s
should be imposed.

The Committee determined that Pfizer

should:
Pay a fine of $50,000

Appeals Committee
Pfizer appeal
Pfizer appealed on the basis that there
was a lack of clarity in the Code regarding
the choice of a venue with respect to the
location of attendees. This event had not
been found in breach of the code in terms
of the quality of the educational content,
the food and beverages provided or the
actual venue. Pfizer maintained that the
grounds upon which the Committee based
its decision to find breaches of Sections
6.6 and 10.2 were incorrect and/or based
on unproven assumptions.
Consideration of the appeal
The following summarises the Pfizer
appeal presented by:
The Uroscience Forum was organised
with an independent scientific organising
committee. The educational content and
target audience is agreed and then the
scientific organising committee is
responsible for the agenda. There was
an agreed budget with an estimated
number of attendees.
The program was developed by the
independent health professionals a
total of 9.5 hours of education was
provided, commencing on Friday
evening and concluding at 12.00pm on
Sunday.
The venue was chosen on the basis that
it had appropriate conference facilities
and reasonable access by air/road from
major centres.
200 invitations were sent out nationally
specifying program and venue. Pfizer
expected that Queensland health
Code of Conduct Annual Report 2007/2008

professionals would be well represented,

but in the end they were not as
numerous, but this was only known well
into event planning.
The location and venue was selected
before invitations were sent out (the
equivalent event has previously been
conducted in previous years in NSW and
Victoria).
Location was close to an airport that
received flights from around Australia
the same number of flights would have
been required if the venue had been in
Brisbane.
The venue was not extravagant Pfizer
is careful with venue selection and has a
global
policy
pertaining
to
the
interactions with health professionals.
This policy identifies the type of venues
that would not be acceptable.
The venue was no more expensive and
likely cheaper than major city locations.
Pfizer argued that if Noosa is deemed
unacceptable as a location for
pharmaceutical company educational
meetings, using the same logic the Gold
Coast would also be an unacceptable
location and all national meetings could
only be held on Brisbane, Sydney and
Melbourne. It would also exclude
Adelaide and Perth as the cost would be
excessive as the majority of health
professionals are based on the east
coast of Australia.
Such a decision would also prohibit the
use of Noose as a location for regional
or local meetings.
Two nights accommodation would have
been required regardless of the location
because of the length and structure of
the educational program.
There was no recreation or sporting
opportunities as there was little free time
with
the
Saturday
education
commencing at 8.00am and concluding
at 4.00pm. The Sunday education
session commenced at 9.00am and
concluded at 12.00pm.
There is no evidence that the location
was selected on the basis of sporting or
leisure facilities the statement in the
Code Committee minutes that the
location was apparently selected for its
leisure and recreational purpose was
purely speculative.
There are leisure and recreation
activities available near any venue in
Sydney, Brisbane, Gold Coast and
Hunter Valley.

162

 The finding is inconsistent as the Code

Committee did not find the venue in
breach of the Code.
Pfizer asserted that the educational
event should not be found in breach of
the Code.
Following questions form the Appeals
Committee Pfizer provided the following
responses:
Attendees paid a contribution of $180
towards the cost of the event.
When selecting a venue for a national
meeting Pfizer does not know in
advance the breakdown by state of final
attendees.
There is a budget for each event and
venues must meet the internal company
policy. Pfizer would not hold an
educational event at a venue that had a
golf course as part of the complex. The
venue for this educational event was in
the main street of Noosa and does not
have any recreational or leisure facilities
associated with it such as a golf course.
The Chairman thanked the Pfizer
representatives and asked that they retire
from the meeting to allow the Appeals
Committee to consider the matter before
them.
The Committee agreed that the venue had
appropriate conference facilities and does
not offer sporting or leisure activities. The
venue is a good hotel centrally located and
accessible to the local airport. Members
confirmed that the educational program
and duration were not in question the
program format was the same as
Uroscience Forums held in previous years
and was not developed specifically for the
Noosa location. Members also noted that
attendees had little opportunity to engage
in any sporting or leisure activity as it was
winter and there was little free time in the
program in day light hours.
However some members were of the view
that the public perception of Noosa as a
location was that is was for holidays and
recreational
opportunities.
Members
considered that this was an extremely
difficult issue because both the venue itself
and the location must be taken into
account. Some members were of the view
that it would be difficult to prohibit the use
of a particular town, city or locality for
national meetings. All members of the
Committee agreed that if the meeting had
been for Victorian doctors only it would

Code of Conduct Annual Report 2007/2008

have been inappropriate to take them to a

location in NSW or Queensland.
Members accepted that there are benefits
in selecting a venue that is away from the
workplace or home of many delegates as
they are free more likely to focus on the
business of the meeting. Members also
commented that an attendee equally could
leave an educational event in Sydney,
Melbourne or Brisbane to partake in
sporting and leisure activities at nearby
facilities.
Where the educational component can
justify the provision of travel and
accommodation,
the
Code
permits
companies to pay for travel and
accommodation costs of healthcare
professionals attending a company
educational event.
Some members raised the issue of the
attraction of particular meeting locations to
the partners of delegates. Members noted
the provisions of the Code that if a partner
wishes to accompany a healthcare
professional to an educational event it was
at their own cost. What the partner does
during the day must be entirely without
assistance or financial support of the
company organising the educational event.
The hotel chosen for the educational event
was not extravagant and had appropriate
conference facilities to support the
educational purpose.
By a majority decision, with the Chairman
exercising the casting vote, the Appeals
Committee upheld the appeal.
In
upholding this appeal the Appeals
Committee noted the view of some
members that the community perception of
Noosa as a holiday destination may not
meet some community expectations of an
appropriate
location
for
company
organised or sponsored educational
meetings. However, because the venue
itself does not offer or emphasise sporting
activities, such as golf; the educational
content was of high quality and extensive
in duration (9.5 hours); and it was a
national meeting where close access to an
airport receiving flights from around
Australia could be achieved the Committee
agreed in a majority decision to uphold the
appeal.
The Committee wished to emphasise that
this decision was specific to the particular

163

circumstances of the event in question.

Another event held in the same locality
might be found in breach of the Code.
Companies must be very diligent in their
rationale for choosing locations and
particular venues for educational meetings
to ensure that the choice can be justified
under the Code.
The Appeals Committee recommended
that further guidance be provided to
companies and that the Code Review
Committee considers clarification of
Sections 6 and 10 of the Code pertaining
to venues, travel and accommodation.
Sanctions
Having upheld the appeal the Committee
reviewed the sanction imposed by the
Code of Conduct Committee. The
Committee determined that the fine of
$50,000 should be removed as no
breaches of Sections 6.6 or 10.2 of the
Code had been found.

Code of Conduct Annual Report 2007/2008

164

Pfizer Educational Event (917)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

Cardiometabolic Risks & the

Role of Atypical Antipsychotics:
What is the Solution?, Evening
Meeting

The Westin
Hotel,
Sydney,
NSW

Various

Accommodation,
Meal / Drinks,

15,893.00

100

30,251.00

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event the cost of
hospitality and total cost of function columns were amended.

Subject Company: Pfizer Australia (Pfizer)

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event PF-965
Complaint from the Monitoring Committee
The Monitoring Committee had asked that
Pfizer provide justification for the cost of
accommodation provided at this event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry

Consideration of the complaint

The Committee raised no concerns with
the educational component of the meeting.
Members considered that it was important
for rural doctors to have the opportunity for
education and to hear international
speakers. Accommodation had only been
provided for the doctors from regional
locations. The majority of members were
of the view that the accommodation cost of
$340 per night was not excessive in this
instance and found no breaches of the
Code.

Response
Pfizer denied any breach of the Code.
Pfizer stated that accommodation was only
provided for 11 regional attendees. The
decision to invite country doctors was
made in light of the international standing
of the speakers. The availability of the
speakers was only known to Pfizer four
weeks in advance of the event. Pfizer then
arranged the meeting at the Westin Hotel
and was unable to negotiate a room rate of
less than $340 due to a number of factors:
Lack of advance notice;
The small number of rooms required;
and
The timing of the event being a Friday
one month before Christmas.
Code Committee determination
In a majority decision the Committee did
not find a breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.

Code of Conduct Annual Report 2007/2008

165

Pfizer Educational Event (918)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total
cost of
function

Ophthalmologists 2007
Update, 2 Hours, Evening
Meeting"

Sir
Stamford At
Circular
Quay,
Sydney,
NSW

Ophthalmologist

Meal / Drinks,

6,270.00

45

7,991.00

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event the cost of
hospitality and total cost of function columns were amended.

Subject Company: Pfizer Australia (Pfizer)

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event PF-93
Complaint
The Monitoring Committee asked that
Pfizer provide justification for the cost of
the dinner provided in association with the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry

Consideration of the complaint

The Committee reiterated that the
reporting requirement referred to the
confirmed attendees as this is what the
company is required to pay for. No-shows
should not affect the reporting of number
of attendees or hospitality costs.
The Committee accepted the evidence
provided by Pfizer to demonstrate that the
cost of the set dinner menu and beverages
was $107.00 per head. The Committee
did not consider that this was extravagant
hospitality and found no breach of the
Code.
In a unanimous decision the Committee
found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.

Response
Pfizer denied any breach of the Code.
Pfizer stated that the difference in the
figures provided in its event report to
Medicines Australia and the Code
Committee is that the original report
included estimated costs and the company
can now report on the final reconciled
costs.
The cost per head for the dinner appears
inflated because Pfizer had to pay for the
confirmed number of attendees not the
actual number of attendees. The total cost
also included a fee of $280 for alternate
plating (total cost) and parking.
Code Committee determination
In a unanimous decision the Committee
found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.

Code of Conduct Annual Report 2007/2008

166

Pfizer Educational Event (919)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total
cost of
function

Esc latest scientific and clinical

data

Messe
Wien
Congress
Centre
Vienna,
Austria

Specialists

Food & beverage

2,892.00

11

2,892.00

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event the cost of
hospitality and total cost of function columns were amended.

Subject Company: Pfizer Australia (Pfizer)

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event PF-624
Complaint
The Monitoring Committee had asked that
Pfizer provide justification for the cost of
the two dinners held in association with the
conference.

city in association with this event was not

excessive or extravagant and in a
unanimous decision found no breaches of
the Code.
However, members should be aware that
they are not absolved from responsibility
because a congress organiser has
recommended a venue. It is the
responsibility of the company to ensure
any agent is aware of the requirements of
the Code.

Sections of the Code

Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Pfizer denied any breach of the Code.
Pfizer stated that the dinners were
provided in association with the 6 day
2007 European Society of Cardiology
Annual Congress held in Vienna. Pfizer
commented that the first dinner at
AUD$175.78 per head and second dinner
at AUD$138.25 per head in central Vienna
restaurants were not excessive.
The
venues
were
chosen
on
the
recommendation of the congress organiser
and were not specifically chosen by Pfizer.
Code Committee determination
In a unanimous decision the Committee
found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.
Consideration of the complaint
The Committee was of the view that the
cost of the hospitality provided at the
identified restaurants in a major European

Code of Conduct Annual Report 2007/2008

167

Pfizer Educational Event (920)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

European Society for Sexual

Medicine - 4 Hours

Lisbon
Convention
Centre,
Spain

Specialists

Food & Beverage

6,008.00

30

6,008.00

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event the cost of
hospitality and total cost of function columns were amended.

Subject Company: Pfizer Australia (Pfizer)

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event PF-1155
Complaint
The Monitoring Committee had asked that
Pfizer provide justification for the cost of
the dinners held in association with the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Pfizer denied any breach of the Code.
Pfizer stated that the dinners were held in
association with the four day 2007
European Society for Sexual Medicine
(ESSM) annual congress in Lisbon. Pfizer
also stated that they are some differences
between the costs reported to the
Monitoring Committee and the actual costs
and Pfizer has since changed its approach
to the collection of data for event reporting.
The actual costs for the three dinners
provided at the educational meeting were:
Dinner 1: AUD$192
Dinner 2: AUD$123
Dinner 3: AUD$214 this cost was
incurred due to the restaurant charging
for 2 people who did not attend

decision no breach of Section 10.8 of the

Code was found.
Sanctions
Pay a fine of $20,000
Consideration of the complaint
The Committee acknowledged that costs
in European cities and restaurants may be
higher than Australia, however members
were of the view that a dinner at a cost of
AUD$214.00 per head was extravagant
even in Europe and in breach of the Code.
The Committee noted that the dinner was
for a small number of healthcare
professionals.
In a unanimous decision the Committee
found a breach of Sections 6.2.2 and 10.2
of the Code in relation to Dinner 3 and no
breach of Section 6.2.1. In a majority
decision no breach of Section 10.8 of the
Code was found.
Sanctions
Having found several breaches of the
Code the Committee considered what
sanction/s should be imposed.
The Committee determined that Pfizer
should:
Pay a fine of $20,000

Code Committee determination

In a unanimous decision the Committee
found a breach of Sections 6.2.2 and 10.2
of the Code in relation to Dinner 3 and no
breach of Section 6.2.1. In a majority

Code of Conduct Annual Report 2007/2008

168

Pharmion Educational Event (921)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of function

Pharmion Annual
Haematology Symposium
Discussing Treatment
Practices in Multiple Myeloma
and Myeldoysplatic Syndrome,
11.5 Hours over two Days
(Includes cost of
accommodation, AV,
Honorarium)

Westin
Hotel,
Melbourne,
Vic

Haematologists
And Hospital
Pharmacists

Dinner, Breakfast,
Lunch, Morning
And Afternoon
Teas, Dinner

88,557.00

53

162,781.00

Subject Company: Pharmion

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event PM-11
Complaint
The Monitoring Committee had asked that
Pharmion provide justification of the
provision of two nights accommodation
with respect to the hours of education
provided.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Pharmion denied any breach of the Code.
Pharmion stated that the educational
component was 7 hours over Friday
evening and Saturday. The primary
purpose was to provide an opportunity for
specialist to join their colleagues and
international experts to discuss key issues
surrounding current and future clinical
practice. Attendees were provided with two
nights accommodation as the event
commenced with a presentation at the
dinner on the Friday evening and
concluded at 5.00pm on Saturday. A
dinner was held on Saturday evening as it
was too late for all attendees to fly home.

Sanction
Pay a fine of $25,000
Consideration of the complaint
The Committee did not raise any concern
with the quality or duration of the
educational component of the meeting.
However members were of the view that if
the event concluded at 5.00pm on
Saturday and there was no educational
component on Sunday, attendees would
have had the capacity to depart from
Melbourne to most cities in Australia and
arrive at a reasonable time.
The Committee considered that the
hospitality provided was disproportionate
to the education provided. The second
night of accommodation was considered
unnecessary for the majority of delegates.
In a unanimous decision the Committee
found a breach of Sections 6.2.1 and 10.2
and no breach of Section 6.2.2.
In a
majority decision no breach of Section
10.8 of the Code was found.
Sanctions
Having found two breaches of the Code
the Committee considered what sanction/s
should be imposed.
The Committee determined that Pharmion
should:
Pay a fine of $25,000

Code Committee determination

In a unanimous decision the Committee
found a breach of Sections 6.2.1 and 10.2
and no breach of Section 6.2.2.
In a
majority decision no breach of Section
10.8 of the Code was found.

Code of Conduct Annual Report 2007/2008

169

Roche Educational Event (922)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

Path-B Meeting: Train The

Trainer 29-30 October 2007
Educational Content = 15 Hrs

Sheraton
On The
Park,
Sydney

Nurses

Accommodation,
Meals, Beverages,
Travel, Flights,
Transfers, Parking,
Conference Day
Package

21,425.00

18

23,850.00

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event the cost of
hospitality and total cost of function columns were amended.

Subject Company: Roche Products

(Roche)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event RO-181
Complaint
The Monitoring Committee had asked that
Roche provide justification for providing a
2-day course on presentation skills and the
relevance to the practice of nursing or
medicine.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Roche denied any breach of the Code.
Roche stated that the Progress And
Treatment in Hepatitis B Educational
meeting (PATH-B) was a tailored
educational programme for healthcare
professionals involved in the management
and support of chronic hepatitis B patients.
Teaching self-injection, managing acute
and chronic side effects and maintaining
patient compliance with regular injections
has become largely the responsibility of
clinic nursing staff. The program was
targeted towards the knowledge gaps
identified by the Path-B Committee. The
first day was dedicated to teaching the
participants the content of the program
and in keeping with a train-the-trainer
initiative the nurse educators were also
coached on communicating the content,
including presentation skills.

Code of Conduct Annual Report 2007/2008

Code Committee determination

In a unanimous decision the Committee
found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.
Consideration of the complaint
The Committee acknowledged that the
presentation skills sessions were only part
of the 2 day program for nurse educators.
Some
members
queried
why
a
pharmaceutical company should provide
training in presentation skills and
cautioned that there should be a clear
distinction between any product-specific
promotional message and genuine training
to nurses. One member of the Committee
expressed concern that some of the
information in the presentation may be
biased.
After further discussion the Committee
concluded that the educational purpose
was, on balance, consistent with the Code.
In a unanimous decision the Committee
found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.

170

Roche Educational Event (923)

Description of function
including duration of the
educational content
delivered

Venue

Professional status
of attendees

Hospitality
provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of function

Hepatitis Symposium &

Investigator Meeting 17th19th August 2007 Education
Content = 22hrs

Grant
Hyatt
Hotel
Melbourne

Gastroenterologist,
Hepatologists,
Virologists,
Nurses, Health
Professionals

Accommodation,
Meals,
Beverages,
Flights, Transfers,
Parking,
Conference Day
Package, Audio
Visual & Speaker
Honorariums

138,500.00

337

619,413.00

Following the Monitoring Committee review of educational event reports, companies were permitted to amend their
report to be placed on the Medicines Australia website, where genuine errors were identified. In this event the cost of
hospitality and total cost of function columns were amended.

Subject Company: Roche Products

(Roche)

review previous progress with research

projects.

Complainant: Medicines Australia

Monitoring Committee

The costs associated with dinner also

included room hire, a weekend surcharge
of $9.95 per head and $10.00 per head to
provide alternate plating. Excluding these
additional costs the actual cost per head
was $132.00.

Event: Educational Event RO-688

Complaint
The Monitoring Committee had asked that
Roche provide justification for the cost of
the dinner held in association with the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Roche denied any breach of the Code.
Roche stated that the dinner was held in
association with the two-day Hepatitis
Symposium, which is one of only two
annual meetings focussed on the
treatment of hepatitis in Australia. The
event
attracted
300
attendees

gastroenterologists,
hepatologists,
infectious disease specialists, virologists
and other healthcare professionals with a
special interest in hepatitis.

Code Committee determination

In a unanimous decision the Committee
found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.
Consideration of the complaint
The Committee noted the hospitality (food
and beverages actual cost) provided to the
healthcare professional cost $132.00 per
head and, balanced with the quality
educational program of 10 hours duration,
the event was not in breach of the Code.
In a unanimous decision the Committee
found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.

The dinner subject to complaint allowed

delegates to network with each other and
the international experts and also to
encourage the delegates in support of
local research by awarding annual
research grants and have the researchers

Code of Conduct Annual Report 2007/2008

171

sanofi-aventis Educational Event (924)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality
provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of function

12th World Conference on

Lung Cancer - 6 Days of
Education Session and
Symposiums

Coex
Convention
Centre, Seoul
Korea.
Accommodation
- Hotel
Renaissance

Oncologist

Flights, Transfers,
Accommodation,
3 Dinners,
Conference
Registration

161,537.52

19

161,537.52

Subject Company: sanofi-aventis

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event SA-518
Complaint
The Monitoring Committee had asked that
sanofi-aventis provide justification of the
cost of the hospitability provided in
association with the educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry

While not finding a breach of the Code in

relation to the provision of food and
beverages at the educational event, some
members of the Committee did have
concerns at the cost of accommodation at
$500
per
night.
Other
members
commented that finding accommodation in
a city during a major international meeting
with thousands of attendees will often
result in accommodation cost increasing in
response to demand, as was noted in the
general discussion at the commencement
of the meeting.

Response
Sanofi-aventis denied any breach of the
Code.
Sanofi-aventis stated that the
dinners were held in association with the 5
day World Conference on Lung Cancer.
The original costs reported included
translator fees and transfers and were
estimated costs. From now reconciled
accounts, the actual cost of the food and
beverages for the three dinners were
AUD$89.00, AUD$77.00 and AUD$98.00
per head. The accommodation was at a
rate of AUD$500.00 per night.
Code Committee determination
In a majority decision the Committee found
no breach of Sections 6.2.1, 6.2.2, 10.2 or
10.8 of the Code.
Consideration of the complaint
The Committee noted sanofi-aventis
advice and documentation supporting the
revised hospitality cost and accepted that
the hospitality was not extravagant and
was secondary to the education at the
event.

Code of Conduct Annual Report 2007/2008

172

sanofi-aventis Educational Events (925, 926, 927, 928, 929 & 930)

The sanofi-aventis complaints pertaining to PBS Reform meetings were considered together
Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality
provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of function

sanofi-aventis Educational Event 925

PBS Reforms Speaker Tour,
7.00pm - 10.00pm

National
Press Club,
Canberra,
ACT

Pharmacists

Conference
Registration including
3 Course Conference
Dinner

12,470.00

30

15,181.00

Pharmacists

Conference
Registration including
Dinner & Beverages

13,140.00

30

15,651.00

Pharmacists

Conference
Registration including
Conference Dinner

8,473.95

38

11,218.31

Pharmacists

Conference
Registration including
Conference Dinner

6,614.32

33

8,720.00

Pharmacists

Conference
Registration including
Dinner & Beverages

22,425.00

126

26,437.25

Pharmacists

Conference
Registration including
Conference Dinner

16,614.76

98

19,463.00

sanofi-aventis Educational Event 926

PBS Reforms Speaker Tour,
7.00pm - 10.00pm

Four Points
By Sheraton,
Geelong,
VIC

sanofi-aventis Educational Event 927

PBS Reforms Speaker Tour,
7.00pm - 10.00pm"

Surfers
Paradise
Marriott
Resort &
Spa. QLD

sanofi-aventis Educational Event 928

PBS Reforms Speaker Tour,
7.00pm - 10.00pm"

Novotel
Wollongong,
NSW

sanofi-aventis Educational Event 929

PBS Reforms Speaker Tour,
7.00pm - 10.00pm"

Langham
Hotel,
Melbourne,
VIC

sanofi-aventis Educational Event 930

PBS Reforms Speaker Tour,
7.00pm - 10.00pm"

Conrad
Treasury
Brisbane,
QLD

Subject Company: sanofi-aventis

Complainant: Medicines Australia
Monitoring Committee
Events: Educational Events SA-925 - 930
Complaint
The sanofi-aventis complaints pertaining to
PBS Reform meetings were considered
together
The Monitoring Committee had asked
sanofi-aventis to provide detail on how the
registration costs and hospitality costs
added up to the totals provided in the

Code of Conduct Annual Report 2007/2008

reports or in the further information

provided by the company.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Sanofi-aventis denied any breach of the
Code. Sanofi-aventis responded that it

173

had arranged a number of events in capital

cities and major regional centres for
pharmacists to attend a presentation from
the Pharmacy Guild of Australia explaining
major changes to the PBS system (known
as PBS Reform) and the impact that those
changes were likely to have on community
pharmacists, These changes have been
described as the most significant reforms
to the PBS in the past 50 years. More
scripts of sanofi-aventis products are
dispensed through pharmacy than any
other pharmaceutical company in Australia
which meant that sanofi-aventis had an
important role to play in the provision of
independent information to pharmacists.
The educational content of each meeting
was 2 hours.
Sanofi-aventis stated that the hospitality
costs reported to Medicines Australia
included costs pertaining to staff and
speakers,
such
as
fees
and
accommodation. The actual costs for the
food and beverages at each event were
$66.70, $105.00, $100.00, $88.00, $140
and $89.00. Sanofi-aventis argued that
these costs should not be considered
excessive. The dinner at the Langham
Hotel (Complaint 929 - $140.00 per head)
incurred a higher cost due to the difference
between confirmed and actual attendees.
Code of Conduct and Appeals Committee
determinations
Complaints 925, 926, 927, 928 & 930
No breach of Sections 6.2.1, 6.2.2, 10.2
or 10.8
Complaint 929
Breach of Section 6.2.1 and no breach of
Sections 6.2.2, 10.2 or 10.8. The finding
of a breach of the Code was overturned
by the Appeals Committee.
Sanction
Having found no breach of the Code the
Appeals Committee removed the
requirement to pay a fine of $50,000

Code of Conduct Committee

Consideration of the complaints
Some members of the Committee
questioned the motive behind sponsoring
the Pharmacy Guild to advise pharmacists
about PBS Reform. Members also noted
that the Guild received a $400 registration
fee for each attendee.

Code of Conduct Annual Report 2007/2008

The Committee was of the view that the

education provided at the PBS Reform
events
was
primarily
directed
at
pharmacists business and commercial
interests. Members commented that the
take away message from the events was
promotion of substitution for commercial
advantage to pharmacists. One slide was
encouraging pharmacists to do bulk deals
or buy bulk orders of sanofi-aventis
products
to
maximise
commercial
advantage from PBS Reforms. This was a
business advantage presentation to a
select group of pharmacists the invitation
stated exclusive information evening for
Pharma Future Members, which is a
sanofi-aventis program. There was no
education provided that would benefit
patient care.
The Committee considered the balance
between the educational content and the
hospitality provided at each of the six PBS
Reforms meetings. The cost of hospitality
provided varied considerably between
each event whereas the educational
content was the same.
The Committee debated what should be
an appropriate level of hospitality for such
events which had very limited education
value for patient care or management.
Some members of the Committee
considered that all the events should be
found in breach of the Code because they
considered it was unnecessary for a
pharmaceutical company to support this
type of education for pharmacists, arguing
that the provision of even modest
hospitality was disproportionate to the
value of the education.
In relation to complaints 925, 926, 927,
928 and 930 the Committee did not find a
breach of Sections 6.2.1, 6.2.2, 10.2 or
10.8 of the Code.
However, by a narrow majority the
Committee determined that based on the
balance between the educational content
and the cost of the hospitality, the event
held at the Langham Hotel in Melbourne
(complaint 929), at which hospitality at a
cost of $126 per person (excluding GST)
was provided, was in breach of Section
6.2.1 of the Code. No breach of Sections
6.2.2, 10.2 or 10.8 of the Code were found.

174

Sanctions
Having found a breach of the Code the
Committee considered what sanction/s
should be imposed.
The Committee determined that Sanofiaventis should:
Pay a fine of $50,000 in relation to
complaint 929

Appeals Committee
Sanofi-aventis appeal 929
In lodging their appeal in relation to
complaint 929 sanofi-aventis stated that
the Code of Conduct Committee had erred
in their decision and the minutes of the
decision contained factual errors. Sanofiaventis also stated that the needs of
pharmacists are very different than those
of a GP or specialist and believe that the
opinions contained in the minutes
demonstrate a lack of awareness of this.
Consideration of the appeal
The following summarises the sanofiaventis appeal:
Sanofi-aventis believe that the Code
Committee had erred in finding a breach
in relation to this educational event.
Sanofi-aventis disagreed that the
content of the PBS Reform meetings
was inconsistent with the Code
requirements for education. The Code
encompasses professional development
as part of education. Sanofi-aventis
referred to the Code Guidelines, Section
10 which state:

This section also relates to educational

meetings provided by companies
relating to practice and professional
development,
such
as
practice
management, communication skills and
conflict resolution

The Guidelines to the Code also refer to

the importance of providing information
about the PBS status of medicines:
In the lead up to the 2002 Federal
Budget, Medicines Australia discussed
with the government ways in which PBS
expenditure could be reduced by
ensuring prescribers were provided with
information regarding the PBS status of
medicines.
Sanofi-aventis
consider
that
the
educational value of the meetings was
unquestionable.
The content and
presentation at the PBS Reform
meetings
was
developed
and
coordinated by the President of the

Code of Conduct Annual Report 2007/2008

Pharmacy
Guild
of
Australia,
independently of sanofi-aventis. Sanofiaventis disputed the Code Committees
conclusion that no education had been
provided that would benefit patient care
or management.
This
directly
contradicts the judgement of the target
audience,
which
had
requested
education about the PBS reforms.
The President of the Guild had written to
the Appeals Committee expressing the
view that:
The Members of the (Code of Conduct)
Committee have failed to see that the
Federal
Government has placed
incentives in PBS Reform legislation for
pharmacists to influence practice change
Pharmacists need to know how the
PBS Reform arrangements were
structured.need to understand what
outcome the Federal Government was
trying to achieve.
It appears that the Code Committee had
judged the educational value as low;
however a number of companies are
running meetings on the PBS reforms.
The Pharmacy Guild of Australia
attendee advised that the Guild had
embarked on a roadshow of events to
educate pharmacists on the complexity
of the recent PBS changes and what
they mean for the business of pharmacy.
A minority view had been expressed by
the Code Committee that even minor
hospitality was disproportionate to the
educational value of the meetings.
Sanofi-aventis strongly disagreed with
this view.
12 PBS Reform events had been held
(of which 6 were considered by the Code
of Conduct Committee):
each identical in content, format,
presentation
differed only in venue and thus
cost
The venue for the event found in
breach of the Code is one that is
commonly
used
by
other
companies.
It is not an
extravagant hotel and is consistent
with the Code; it has not been
questioned for other educational
meetings held there.
5 PBS reform events were found
not in breach. The cost per head
of the next highest cost event was
$AUD119.00.
1 meeting was found in breach (at
a cost per head AUD$126.00).
sanofi-aventis questioned why $7

175

per head more should result in a

finding of a breach of the Code.
Sanofi-aventis asserted there were
factual errors made by the Code of
Conduct Committee that would have
influenced the Committees decision,
including
the
statement:
Members also noted that the Guild
received a $400 registration fee for each
attendee.
This is incorrect. There was no such
payment made to the Guild or
subsidised by sanofi-aventis. Sanofiaventis has no understanding of where
this incorrect impression might have
come from.
The Code Committee had also
incorrectly stated:
One
slide
was
encouraging
pharmacists to do bulk deals or buy bulk
orders of sanofi-aventis products to
maximise commercial advantage from
PBS reforms
This is incorrect the product referred to
in the slide concerned is not a sanofiaventis product.
Sanofi-aventis argued that the level of
sanction was excessive. The Code of
Conduct
Guidelines
state:

The principles for determining a

sanction should be transparent to both
the complainant and subject company.
Sanctions should be based upon clear
principles and applied in a predictable
and
consistent
manner
without
unnecessary rigidity

Based on previous published sanctions

a $50,000 fine is excessive and cannot
be justified.
This breach, if it is indeed a breach, by
definition would fall into the minor
category since:
clearly no safety implications to
the patients wellbeing
no effect on how the medical
profession will prescribe a product
this event would not bring the
industry into disrepute
there is no history of sanofiaventis breaching the Code with
respect to the provision of
hospitality
Many moderate or severe
breaches found in 2007 involving
false and misleading claims
attracted a sanction of less than
$50,000
Following questions from the Committee
sanofi-aventis provided the following
responses:

Code of Conduct Annual Report 2007/2008

The content of the PBS Reform

presentations was developed by the
Guild with no involvement from sanofiaventis.
Information on PBS reforms was
important because the reduction of
medicine prices on 1 August 2008 would
have a major impact on pharmacy
business and the continued supply of
medicines to patients.
The Guild does not have the financial
resources to fund such extensive
national education programs.
The business of running a pharmacy
should not be considered any different
from that of running a general practice.
The educational component of the PBS
Reform events was not promoting
sanofi-aventis commercial interests,
however, sanofi-aventis accepted that
there was an indirect commercial
interest for a pharmaceutical company to
ensure that pharmacists are aware of
the PBS reforms.
Sanofi-aventis
has
a
significant
pharmacy division more sanofi-aventis
product packs are sold in pharmacy than
any other company.
Surveys were conducted following the
PBS reform events with generally
positive feedback from attendees around
Australia
There was definitely no fee paid to the
Guild.
Sanofi-aventis covered the travel and
accommodation costs of the speaker,
but no other payment was made to the
Guild by sanofi-aventis.
The Chairman thanked the sanofi-aventis
and Pharmacy Guild representatives and
asked that they retire from the meeting to
allow the Appeals Committee to deliberate
on the matter before them.
The Committee referred to the minutes of
the Code of Conduct Committee meeting
which stated that a registration fee had
been paid. The Secretariat advised that
the Code Committee had been given this
advice following a review of a page on the
Guild website where pharmacists could
register for the PBS Reform events. As this
information could not be confirmed and
both the Guild representative present at
the Appeals Committee meeting and
sanofi-aventis staff denied that any
registration fee had been paid by sanofiaventis to the Guild, members were of the

176

view that the Code Committee had been in

error in this assumption.
The Committee also noted that the
medicines referred to in the presentation
were not sanofi-aventis products and that
this factual error should also be noted.
The Appeals Committee accepted the
independence of the development of the
educational content and its delivery.
Members noted the advice from sanofiaventis that the only venue that could seat
150 people and was available on the
scheduled night required a contract for a
minimum spend of $6,000 based on a
booking for 150. On the evening only 130
people attended. The Committee referred
to advice provided by Medicines Australia
that the number of attendees reported
should the confirmed attendees which the
company must pay for, not the actual
number this means that the cost per head
would not be inflated if some confirmed
delegates do not attend.
The cost breakdown for the food and
beverages component provided by sanofiaventis reflected a cost of $126.00 per
head. Members were of the view that this
was borderline for what is acceptable for a
pharmaceutical company to pay for food
and beverages.
However, members
accepted that a central city venue in
Melbourne or Sydney may have higher
costs than a regional venue with a smaller
number of attendees.
By a majority
decision, the Appeals Committee did not
find a breach of Section 6.2.1 of the Code.
Sanctions
Having upheld the appeal the Committee
reviewed the sanction imposed by the
Code of Conduct Committee. Having
found no breach of Section 6.2.1 of the
Code members were of the view that the
fine of $50,000 should be removed.

Code of Conduct Annual Report 2007/2008

177

sanofi-aventis Educational Event (931)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of function

Bipolar Disorder Scientific

Meeting Educational Content
1.5 Days

Sheraton
Brisbane

Psychiatrists

Flights, Transfers,
Accommodation
and all meals
including 2 dinners

$65,000.00

40

$65,000.00

Subject Company: sanofi-aventis

Complainant: Medicines Australia
Monitoring Committee

The Committee did not find a breach of

any sections of the Code.

Event: Educational Event SA-extra2

Complaint
The Monitoring Committee asked that
sanofi-aventis provide justification for the
cost of accommodation provided at this
event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Sanofi-aventis denied any breach of the
Code. Sanofi-aventis stated they provided
financial and organisational & logistical
support for this meeting. The agenda
topics were decided solely by the
Australian Society of Bipolar Disorder. The
educational content was 8 hours over
Saturday and Sunday. A review of the
invoice provided by the Brisbane Marriott
showed that accommodation was charged
at a rate of $235.00 per night.
Code Committee determination
In a majority decision the Committee did
not find a breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code.
Consideration of the complaint
The Committee noted the amended costs
pertaining to the accommodation rate per
night, and this is reflected in the invoice
from the hotel. The Committee was of the
view that the provision of accommodation
for the conference was not excessive or
extravagant at a cost of $235.00 per night.
The educational component was over
eight hours over two days, and was good
quality education.

Code of Conduct Annual Report 2007/2008

178

sanofi-aventis Educational Event (932)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of function

Presentation on "Reducing the

Impact Of Diabetes:
Management Strategies And
New Treatment Options".
International Speaker Tour
Presentation Time:7.3010.00pm

Hilton
Hotel,
Brisbane,
Qld

General
Practitioners

Dinner (Incl. F&B),

Accommodation for
7 Doctors

$6,300.00

35

$11,630.14

Subject Company: sanofi-aventis

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event SA-extra14

regional healthcare professionals in these

circumstances was not in breach of the
Code.
In a majority decision the Committee found
no breach of Sections 6.2.1, 6.2.2, 10.2 or
10.8 of the Code.

Complaint
The Monitoring Committee had asked that
Sanofi-aventis provide justification for the
provision and cost of accommodation.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Sanofi-aventis denied any breach of the
Code. Sanofi-aventis stated that the event
was part of a speaker tour by a renowned
international lecturer and speaker in
diabetes. Of the 22 general practitioners
present,
accommodation
was
only
provided to three attendees from regional
Queensland.
Sanofi-aventis
also
commented that these were the only
rooms available in the hotel (at a cost of
$386 per night (exclusive of GST)) where
the presentation was to be held and did
not consider that it should be necessary to
find accommodation at an alternate venue.
Code Committee determination
In a majority decision the Committee found
no breach of Sections 6.2.1, 6.2.2, 10.2 or
10.8 of the Code.
Consideration of the complaint
Whilst a minority of Committee members
were of the view that the accommodation
cost of $386 per night was excessive, the
majority of members accepted that the
provision of accommodation to three

Code of Conduct Annual Report 2007/2008

179

sanofi-aventis Educational Event (933)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

14th European Cancer

Conference - 5 Days of
Educational Sessions and
Symposiums (Third Party
Organised Conference)

CCIB
Convention
Centre,
Barcelona

Oncologists
And
Oncology
Nurses

Dinners and 1 Lunch

for Doctors

$3,058.44

25

$3,058.44

Subject Company: sanofi-aventis

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event SA-extra19
Complaint
The Monitoring Committee had asked that
sanofi-aventis justify the accommodation
costs provided to Australian healthcare
professionals attending the conference.

accommodation
cost
increasing
in
response to demand, as was noted in the
general discussion at the commencement
of the meeting.
In a majority decision the Committee found
no breach of Sections 6.2.1, 6.2.2, 10.2 or
10.8 of the Code.

Sections of the Code

Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Sanofi-aventis denied any breach of the
Code. Sanofi-aventis responded that the
accommodation was provided to four
attendees at the five day 14th European
Cancer Conference in Barcelona. Sanofiaventis commented that the cost of living
in European cities is higher than Australia
and, combined with the large number of
people attending costs; it would not be
unusual to pay $500 per night in a
reasonable quality hotel.
Code Committee determination
In a majority decision the Committee found
no breach of Sections 6.2.1, 6.2.2, 10.2 or
10.8 of the Code.
Consideration of the complaint
Whilst not finding a breach of the Code in
relation
to
the
provision
of
accommodation, some members of the
Committee did have concerns at the cost
of accommodation at $500 per night. Other
members
noted
that
finding
accommodation in a city during a major
international meeting with thousands of
attendees
will
often
result
in

Code of Conduct Annual Report 2007/2008

180

sanofi-aventis Educational Event (934)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

ECTRIMS (Independent)
Multiple Sclerosis Conference,
Educational Breakfast
Symposium with MS Expert

Prague,
Czech
Republic

Neurologists

Breakfast
Symposium & 3
Dinners

$3,000.00

60

$3,000.00

Subject Company: sanofi-aventis

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event SA-extra29
Code of Conduct Committee Meeting
21 April 2008
Complaint from the Monitoring Committee
The Monitoring Committee had asked
sanofi-aventis to provide justification for
the cost of accommodation provided to
attendees at this event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Sanofi-aventis denied any breach of the
Code. Sanofi-aventis responded that the
accommodation (rate of AUD$643 a night)
was provided to Australian attendees at
the four day Congress of European
Committee for Treatment and Research in
Multiple Sclerosis at the Marriott Hotel in
Prague. This hotel provides good
accommodation but is not lavish. Sanofiaventis
noted
that
prices
for
accommodation are at their highest levels
during these major conference events and
historically it has been found that it can be
difficult to obtain any more reasonable
accommodation
without
using
the
appointed
conference
agents.
The
accommodation rates were not negotiable
and corporate rates did not apply during
the conference. Costs that were directly
within the control of sanofi-aventis, such
as the dinners, are in line with costs that
would be expected in an Australian setting.

Code of Conduct Annual Report 2007/2008

Code Committee determination

The Committee remained concerned that
the cost of accommodation was higher
than the advertised conference hotel rates
and asked that sanofi-aventis respond to a
possible breach of Section 10.3 of the
Code.
Consideration of the complaint
Sanofi-aventis further response will be
considered at the next Committee
meeting.
Code of Conduct Committee Meeting
19 May 2008
Further information provided by sanofiaventis
Sanofi-aventis stated that the event was
organised
through
the
conference
appointed travel organiser. Requests had
been sent by Sanofi-aventis for bookings
at two venues, based on price and
convenient location to the congress. Both
of these hotels were fully booked, which
necessitated another hotel to be selected.
Sanofi-aventis asserted that the hotel
chosen (Marriott) is a mid-range five star
hotel which allowed easy access to the
congress venue. Other hotels of similar or
higher price involved additional transport
costs. The room rate included breakfast,
all taxes and a commission to the agent (it
is only possible to book via the agents for
large conferences). Sanofi-aventis also
stated that an equivalent room outside the
conference period was $425.00 per night
however during the conference the same
room was $643 per night.
Code Committee determination
In a majority decision the Committee found
no breach of Section 10.3 of the Code.
Consideration of the complaint
Members commented that companies
should know reasonably accurately how
many healthcare professionals would be
attending
the
congress
through
sponsorship
as
busy
healthcare

181

professionals do not usually make a last

minute decision to attend an international
event. A company should endeavour to
finalise attendees and make arrangements
many months in advance of the event in
order to (amongst other things) negotiate
more acceptable accommodation rates.
The Committee also noted that hotel room
rates
may
increase
during
large
conferences and it was in the best interest
of a company to plan in advance for
accommodation at a reasonable rate.
The Committee considered that it is not
acceptable to refer to responsibilities
delegated to an agent as a defence when
responding to a Code complaint. A
company must plan and provide clear
guidance to an agent about the type of
venue,
level
of
hospitality
or
accommodation. The Committee noted
that information had been provided by the
agent to sanofi-aventis about an
alternative hotel at a more reasonable
rate, and which was within one
underground
train
stop
from
the
conference venue.
However, the
Committee also noted that the rate for
accommodation provided by sanofi-aventis
was within the rate for the Category 1
hotel rooms organised by the overall
conference organiser,
In a majority decision the Committee found
no breach of Section 10.3 of the Code as
the
accommodation
provided
was
consistent with the rates set out in the
congress brochure. However members
had some discomfort about the level of
accommodation provided to Australian
healthcare professionals.

Code of Conduct Annual Report 2007/2008

182

Servier Educational Event (935)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

2 Day WA Physician's Clinical

Meeting. (5 Hours 45 Min
Education)

Quay
West,
Bunker
Bay, WA

GP,
Endocrinologists,
Country
Physician,
Cardiologist

Buffet Lunch X 1
Day, Non Alcoholic
Beverages
Provided. Dinner X
1 Night With
Alcoholic/NonAlcoholic
Beverages.
Accommodation X 2
Nights for 44,
including Breakfast
X 2 Days.

30,291.00

56

32,645.00

Subject Company: Servier Laboratories

(Australia) [Servier]
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event SV-128
Complaint
The Monitoring Committee had asked that
Servier provide justification for the
provision of two nights accommodation in
consideration
of
the
educational
component of the meeting.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Servier denied any breach of the Code.
Servier stated that the venue is popular for
both local and national medical meetings
as it provides good conference facilities in
an environment conducive to learning and
discussion and free from interruptions. The
location is 3 hours by car from Perth for
the majority of delegates. Servier asserted
that this is a significant advantage for the
meeting
in
removing
competing
distractions particularly physicians cannot
be on-call for Perth and Fremantle
hospitals, which enhances their ability to
focus on the academic program. Friday
evening dinner arrangements and travel
costs to and from the event were at the
cost of the attendee. Servier provided
modest hospitality at the Saturday evening
dinner. The program included five hours of
education.

Code of Conduct Annual Report 2007/2008

Code Committee determination

In a unanimous decision the Committee
found a breach of Sections 6.2.1 and 10.2
of the Code and no breach of Section
6.2.2. In a majority decision no breach of
Section 10.8 was found.
Sanction
Pay a fine of $60,000
Consideration of the complaint
The Committee was of the view that a
meeting of five hours duration (three
hours on Saturday morning and two hours
on Sunday morning) is not sufficient to
justify two nights accommodation. The
event could have commenced later on
Saturday, to allow delegates to travel
during the morning, and finished on
Sunday, thereby requiring only one
nights accommodation. The Committee
did not find that the use of the Bunker Bay
venue was a breach of the Code; it was
the balance between the educational
component and hospitality that members
considered to be in breach of the Code.
The Committee questioned the value of
testimonials provided by participants who
attend events that are under review.
In a unanimous decision the Committee
found a breach of Sections 6.2.1 and 10.2
of the Code and no breach of Section
6.2.2. In a majority decision no breach of
Section 10.8 was found.
Sanctions
Having found two breaches of the Code
the
Committee
considered
what
sanction/s should be imposed.
The Committee determined that Servier
should:
Pay a fine of $60,000

183

Servier Educational Event (936)

Description of function
including duration of the
educational content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

1 Day Meeting of NSW

Cardiologists

Lilianfels
Blue
Mountains
Resort,
NSW

Cardiologists
& Advanced
Trainees

2 X Dinners with Non

Alcoholic And
Alcoholic Beverages
Accommodation X 2
Nights for 58
Including 2 Breakfast
Morning Tea, Lunch
and Afternoon Tea X
1 Day For 64

56,604.00

64

60,342.00

Subject Company: Servier Laboratories

(Australia) [Servier]

Sanction
Pay a fine of $50,000

Complainant: Medicines Australia

Monitoring Committee

Consideration of the complaint

While not raising any concerns with the
quality of the education provided,
Committee members questioned why
Servier needed to provide two nights
accommodation
for
healthcare
professionals for the five hours and 20
mins of education provided (of which only
one and a half hours was provided on
Sunday morning). The company stated
that it is a 1.5 hour drive from Sydney to
the Blue Mountains. It would have been
possible to start the meeting slightly later
in the day on Saturday and move some
components of the program to Sunday,
finishing by midday. This programming
would then require only one nights
accommodation.

Event: Educational Event SV-428

Complaint from the Monitoring Committee
The Monitoring Committee had asked that
Servier provide justification for the
provision of two nights accommodation in
consideration
of
the
educational
component of the meeting.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Servier denied any breach of the Code.
Servier stated that the meeting was
organised to fill a need for a specific forum
for
interchange
between
NSW
cardiologists. A Committee of three senior
cardiologists independently plan the
academic program and invites speakers
and delegates. Serviers role has been to
provide funding and logistic support to
ensure success of the meeting. One of the
keys to success of this meeting is its
retreat aspect i.e. it offers a degree of
privacy and relative freedom from
interruptions (attendees cannot be on call
in Sydney).
Code Committee determination
In a unanimous decision the Committee
found a breach of Sections 6.2.1 and 10.2
of the Code and no breach of Section
6.2.2. In a majority decision no breach of
Section 10.8 of the Code was found.

Code of Conduct Annual Report 2007/2008

Whilst the scientific content of the meeting

had been developed independently from
the
company,
Servier
remained
responsible for ensuring there was an
appropriate balance between education
and hospitality provided and ensuring that
hospitality was secondary to the
education.
The Committee was of the view that the
duration of education did not warrant two
nights accommodation and found a
breach of Sections 6.2.1 and 10.2 of the
Code. No breach of Sections 6.2.2 or
10.8 was found.
Sanctions
Having found two breaches of the Code
the Committee considered what sanction/s
should be imposed.
The Committee determined that Servier
should:
Pay a fine of $50,000

184

Servier Educational Event (937)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

60 Min Presentation on Blood

Pressure Management for Type
2 Diabetes

Enoteca
Vino Bar,
Carlton
North VIC

Specialist
Speaker &
GP's

Dinner, Non
Alcoholic & Alcoholic
Beverages

1,836.00

13

2,836.00

Subject Company: Servier Laboratories

(Australia) [Servier]
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event SV-493
Complaint
The Monitoring Committee had asked that
Servier provide the total cost of food and
beverages and justification for the costs.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry

Consideration of the complaint

The Committee noted Serviers response
that the venue required confirmation 2
months forming advance of the event.
Many members were of the view that this
was unreasonable and that it put a
company in a difficult position when
reporting
actual
costs.
Members
commented that the number of attendees
in the educational event report should be
the confirmed number, as this is what a
company must pay for and reflects the
benefit to the healthcare professional.
In a majority decision the Committee found
no breach of Sections 6.2.1, 6.2.2, 10.2 or
10.8 of the Code.

Response
Servier denied any breach of the Code.
Servier stated that the event had been
planned 3-4 months in advance and the
venue required that the number of
attendees be confirmed (with a nonrefundable deposit) two months prior to the
event. Servier also stated that they had
held several other meetings on this topic
attracting an average of 20 people at each
event. For this reason Servier considered
it reasonable to confirm 20 attendees for
the event. Servier reported a total of 13
attendees when the actual costs paid for
by the company were for 20 confirmed
attendees, which resulted in a higher
hospitality cost per head reported. The
cost per head for the (actual, revised) 14
attendees was $112.00 per head.
Code Committee determination
In a majority decision the Committee found
no breach of Sections 6.2.1, 6.2.2, 10.2 or
10.8 of the Code.

Code of Conduct Annual Report 2007/2008

185

Solvay Educational Event (938)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

Lipid Modifying Therapies

Jonah's,
Whale
Beach,
NSW

GP's

Food & Beverage

4,550.00

33

6,750.00

Subject Company: Solvay

Pharmaceuticals (Solvay)

Sanction
Pay a fine of $20,000

Complainant: Medicines Australia

Monitoring Committee

Consideration of the complaint

The Committee noted that the information
provided in response to the complaint
pertaining to the cost of hospitality was
lower than the figure provided to the
Monitoring Committee by Solvay. The
Committee considered that because
companies should report the confirmed
number of attendees, which is the number
paid for by the company, and the total cost
of the hospitality, no-shows should not
alter the cost per head for hospitality.

Event: Educational Event SOL-9

Complaint
The Monitoring Committee asked that
Solvay provide justification for the cost of
the dinner held in association with the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Solvay denied any breach of the Code.

The Committee did not find the venue in

breach of the Code; however the
Committee questioned the rationale
behind the selection of a venue that is not
centrally located or easily accessible for
most attendees.
The venue is a
considerable distance from most of the
locations identified that the attendees
would have travelled from.

Solvay stated the invitation for this event

was sent to general practitioners in the
Northern Sydney, Upper North Shore,
Northern
Beaches,
Neutral
Bay,
Chatswood, Northbridge, Seaforth, Mona
Vale, Brookvale, Collaroy, Manly, Avalon
and Newport. The venue was chosen as it
was easily accessible to the GPs attending
and could cater for the proposed number
of attendees. The speaker was an eminent
specialist in patient lipid management who
discussed current research and thinking in
lipid modifying therapies. The educational
component was one hour and the cost was
$137.88 per head not $153.75 that was
originally reported.

The Committee considered that the

hospitality
was
extravagant
when
compared to the educational component
and was not secondary to the education
provided at the event, a one hour
presentation.

Code Committee determination

In a unanimous decision the Committee
found a breach of Sections 6.2.1 and 10.2
of the Code and no breach of Section
6.2.2. In a majority decision no breach of
Section 10.8 of the Code was found.

The Committee determined that Solvay

should:
Pay a fine of $20,000

Code of Conduct Annual Report 2007/2008

Members found the provision of hospitality

at the event to be in breach of Sections
6.2.1 and 10.2 of the Code. No breach of
Sections 6.2.2 or 10.8 was found.
Sanctions
Having found two breaches of the Code
the Committee considered what sanction/s
should be imposed.

186

Solvay Educational Event (939)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

Considerations when
Prescribing CCB's:
Hypertension Case Studies

Bunker Bay,
Busselton,
WA

GP

Food & Beverage

plus 19 Room Nights
accommodation for
18 delegates

8,189.00

18

9,374.00

Subject Company: Solvay

Pharmaceuticals (Solvay)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event SOL-28
Complaint
The Monitoring Committee had asked that
Solvay provide justification for the cost of
the food and beverages provided at this
event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Solvay denied any breach of the Code.
Solvay stated that the case studies
presented at the meeting were reflective of
the type of patient that would present to a
GP and were therefore directly relevant to
the primary care setting. Furthermore the
case studies were approved by the
RACGP as part of the QA&CPD Program.
Each case study was allocated 2
points/hour (Group 2). Total program 2
hours.
Solvay stated that the meeting was
organised to provide education to general
practitioners in the South West of Western
Australia. The venue was selected as it
was readily accessible to the GPs from
Albany and Margaret River. By the
meeting reply deadline only 2 GPs had
expressed an interest to attend. As a
deposit had been paid to the venue,
Solvay had decided to extend the invitation
to GPs in Perth.

Code of Conduct Annual Report 2007/2008

Code Committee determination

In a unanimous decision the Committee
found a breach of Sections 6.2.1, 6.2.2
and 10.2. In a majority decision no breach
of Section 10.8 of the Code was found.
Sanction
Pay a fine of $80,000
Consideration of the complaint
The Committee was of the view that the
event did not have sufficient educational
component (two hours duration) to justify
providing overnight accommodation for 17
attendees. While cognisant that the
company would have lost their deposit,
members questioned how this could
possibly justify the hospitality that was
provided. Members commented that it
would have been preferable for the
company to cancel the meeting if local
GPs were not interested in attending, if
this was the rationale for the event. The
Committee was also of the view that the
dinner which cost $217.00 per head was
extravagant hospitality. The Committee
considered that the hospitality provided to
delegates (dinner and accommodation)
was not secondary to the education
provided. The Committee found a breach
of Sections 6.2.1, 6.2.2 and 10.2 of the
Code.
Several members stated that the provision
of a weekend event at a location known for
its leisure and recreation facilities, with
only two hours education and the provision
of an extravagant dinner were likely to
bring the industry into disrepute. However,
by a majority decision the Committee
found no breach of Section 10.8 of the
Code.
Sanctions
Having found several breaches of the
Code the Committee considered what
sanction/s should be imposed.
The Committee determined that Solvay
should:
Pay a fine of $80,000

187

Wyeth Educational Event (940)

Description of function
including duration of the
educational content
delivered

Venue

Professional
status of
attendees

Hospitality
provided

Total cost of
hospitality

Number
of
attendees

Total cost
of function

2 Day Annual Biologics

Clinics Weekend
Symposium providing
Workshops, Presentations
and Clinical Studies on
Biologics 6 Hours of
Education

Four
Points
By
Sheraton
Hotel,
Sydney,
NSW

Rheumatologists
Dermatologists
Rheumatology
Nurses Joint
Care Staff
Consultant
Rheumatologists

Buffet Lunch (Hot

and Cold
Selection) with
Non Alcoholic
Beverages X 1
Day Afternoon
Tea (Biscuits,
Muffins, Fruit)
With Non
Alcoholic
Beverages X 1
Day 3 Course
Dinner with
Alcoholic/Non
Alcoholic
Beverages held
at the American
Club, Sydney
Accommodation
for 31 (1 Night)
Travel for 31

$29707
This Amount
Includes Lunch
(1 Day),
Afternoon Tea
(1 Day), Dinner
(1 Day),
Accommodation
for 31 (1 Night)
and travel for
31

31

$62107
This
Amount
includes
hospitality,
transport
costs,
external
contractor
fees,
invitations,
venue
hire, AV
hire

Subject Company: Wyeth Australia

(Wyeth)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event WY-310
Complaint
The Monitoring Committee had asked that
Wyeth provide justification for the provision
of
two
nights
accommodation
in
association with the educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Wyeth denied any breach of the Code.
Wyeth stated that there was a strong
educational component to the weekend
meeting (duration of education was 5.5
hours). One night of accommodation was
provided to 77% of delegates with 8
delegates being provided with an
additional night of accommodation as they
were flying from interstate or regional
areas.
Code Committee determination
In
relation
to
the
provision
of
accommodation by a majority decision the
Code of Conduct Annual Report 2007/2008

Committee found no breach of Sections

6.2.1, 6.2.2, 10.2 or 10.8 of the Code. The
Committee unanimously found a breach of
Section 10.2 of the Code in relation to the
part payment of the partner costs for
attending the dinner.
Sanction
Pay a fine of $35,000
Consideration of the complaint
The Committee was of the view that it was
acceptable to provide an additional night of
accommodation on the night preceding the
meeting for delegates who were unable to
fly into the city or town on the day of the
meeting. The majority of Committee
members considered that the education
provided was appropriate and acceptable.
However some members expressed some
concerns with some of the educational
content.
By a majority decision, the Committee
found no breach of Sections 6.2.1, 6.2.2,
10.2 or 10.8 of the Code in relation to the
provision of accommodation in association
with the event.
In reviewing the Wyeth response the
Committee noted that partners had been
invited to attend the dinner if they paid
$75.00 per head, however the actual cost
of the dinner was $122.00 per head.
Members noted that Section 10.2 of the
Code states that a company cannot pay for
or subsidise costs for partners or family

188

members. The Committee found a breach

of Section 10.2 of the Code in relation to
the subsidisation of partner costs in
attending the dinner.
Sanctions
Having found a breach of the Code the
Committee considered what sanction/s
should be imposed.
The Committee determined that Wyeth
should:
Pay a fine of $35,000

Code of Conduct Annual Report 2007/2008

189

Ipsen Educational Event (941)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

Sponsorship of large Cosmetic

Meeting. Presentation and
Display Stand. 1hr

Frasers
Restaurant,
Perth, WA

Cosmetic
Physicians,
Cosmetic
Surgeons,
Cosmetic
Nurses,
Practice
Nurses.

Food and Beverage

5,500.00

40

5,500.00

Subject Company: Ipsen

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event IP-131
Complaint
The Monitoring Committee had asked that
Ipsen provide justification for the cost of
the dinner in association with the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry
Response
Ipsen expressed concern that the
Committee would make a ruling in relation
to costs pertaining to hospitality based on
a numerical figure which has not been
communicated to the industry.
Ipsen denied any breach of the Code.
Ipsen stated it was not responsible for
organising the educational content of the
event or for inviting the attendees. The
organiser, who was the key presenter, had
selected the venue and menu as befitted
the audience. The sponsorship of $5,000
paid by Ipsen should have been
attributable to the whole event not just the
dinner. It had been anticipated that the
dinner would cost approximately $124 per
head, for 40 attendees however the actual
cost was $156 per head for 32 attendees.
Code Committee determination
In a unanimous decision the Committee
found a breach of Sections 6.2.1 and 10.2
and in a majority decision a breach of

Code of Conduct Annual Report 2007/2008

Section 6.2.2 of the Code. In a majority

decision the Committee found no breach
of Section 10.8 of the Code.
Sanction
Pay a fine of $30,000
Consideration of the complaint
In relation to Ipsens concerns that the
Code Committee should not find
companies in breach of the Code as there
is no monetary limit stated in the Code or
accompanying Guidelines, members were
of the view that this first review of
educational event reports by the
Monitoring and Code Committees would
assist member companies in determining
appropriate levels of hospitality. However,
as was noted in the general discussion
earlier in the meeting, a range of factors
must be taken into consideration when
determining
appropriate
hospitality
associated with educational events, not
just the cost. Further, companies are
expected to comply with all aspects of the
Code whether or not further guidance has
been
provided;
or
interpretations,
decisions or Committee rulings have been
made previously. The Committee noted
that the majority of companies had
developed internal policies and procedures
on what they consider are appropriate
costs.
The Committee was very concerned that
Ipsen had failed to exercise appropriate
control over the provision of hospitality
associated with this educational event.
The Committee did not accept the defence
that the company was not responsible for
organising the event or selecting the
venue and appropriate hospitality. It is the
responsibility of the sponsoring company
to fully understand how its sponsorship
funds will be expended and ensuring that
this is consistent with the Code.

190

Members also noted that at any event the

hospitality must be secondary to the
education. In this case the balance
between the educational component
(stated as 45-60 minutes with no agenda
to support this) and the cost of food and
beverages of $156.00 per head indicated
that the hospitality was not secondary to
the education. The Committee noted that
the absolute cost of the hospitality was not
the determining factor in their decision to
find this event in breach of the Code, but
rather the proportionality between the
education, which was limited, and the
hospitality, at an upmarket venue, and the
failure of the company to exercise
appropriate controls over its funding of the
educational event.
In a unanimous decision the Committee
found a breach of Sections 6.2.1 and 10.2
and in a majority decision a breach of
Section 6.2.2 of the Code.
The Committee debated at length whether
this event should be found in breach of
Section 10.8. Some members expressed
the view that this event was the opposite of
responsible education by pharmaceutical
companies and was very poor practice by
the company. However, in a majority
decision the Committee found no breach
of Section 10.8 of the Code.
Sanctions
Having found several breaches of the
Code the Committee considered what
sanction/s should be imposed.
The Committee determined that Ipsen
should:
Pay a fine of $30,000

Code of Conduct Annual Report 2007/2008

191

Ipsen Educational Event (942)

Description of function including
duration of the educational
content delivered

Venue

Professional
status of
attendees

Hospitality provided

Total cost
of
hospitality

Number
of
attendees

Total cost
of
function

Cosmetic Injection Training Duration: 2.5Hrs

Four
Seasons
Hotel,
Sydney
NSW

Cosmetic
Physicians

3 Course Meal
Including Beverages,
2 X Accommodation

8,298.00

56

10997.94
Includes
AV Car
Parking

Subject Company: Ipsen

Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event IP-21
Complaint
The Monitoring Committee had asked that
Ipsen provide justification for the cost of
the dinner in association with the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry

hours as stated in the event report. While

not questioning the quality of the speaker
or education provided, some members
were concerned that this cost was
bordering on being extravagant for one
hour of education. However, by a close
majority
decision
the
Committee
concluded that the education was the
primary purpose of the meeting and the
hospitality secondary.
In a unanimous decision the Committee
found no breach of Sections 6.2.2 and
10.2 of the Code. In a majority decision the
Committee found no breach of Section
6.2.1 and 10.8 of the Code.

Response
Ipsen expressed concern that the
Committee would make a ruling in relation
to costs pertaining to hospitality based on
a numerical figure which has not been
communicated to industry.
Ipsen denied any breach of the Code.
Ipsen stated that the speaker at the event
was of international renown and the
educational content of the event should
not be in question. The cost of food and
beverages ($137.00 per head) was not
excessive for this audience and should not
be found in breach of the Code.
Code Committee determination
In a unanimous decision the Committee
found no breach of Sections 6.2.2 and
10.2 of the Code. In a majority decision the
Committee found no breach of Section
6.2.1 and 10.8 of the Code.
Consideration of the complaint
The Committee noted that the actual
educational component of the event,
taking a generous interpretation of the
agenda, was one hour not two and a half

Code of Conduct Annual Report 2007/2008

192

Amgen Educational Event (943)

Description of function including
duration of the educational
content delivered

Venue

Professiona
l status of
attendees

Hospitality provided

Total cost
of
hospitality

Number of
attendees

Total cost of
function

Amgen Dinner Meeting held

during the American Society Of
Haematology 49th Annual
Meeting and Exposition (ASH)
[The American Society Of
Haematology 49th Annual
Meeting And Exposition (ASH)
was held In Atlanta, USA,
December 2007. The American
Society Of Haematology 49th
Annual Meeting and Exposition
is Organized by ASH. The
duration of education content of
the event: 4.5-Day Program]

The Capital
Grille
Restaurant,
Atlanta,
USA

Haematolog
ists

3-Course Dinner
Including Alcohol

1,469.32

$1,469.32
Amgen was
not
responsible
for organizing
the American
Society Of
Haematology
49th Annual
Meeting and
Exposition
and therefore
does not know
the cost of
doing so

Subject Company: Amgen Australia

(Amgen)
Complainant: Medicines Australia
Monitoring Committee
Event: Educational Event AM-303
Complaint
The Monitoring Committee had asked that
Amgen provide justification for the overall
cost of the hospitality provided at the
educational event.
Sections of the Code
Conduct alleged to be in breach of the
following Sections of the Code:
6.2.1 Hospitality
6.2.2 Hospitality
10.2 Hospitality
10.8 Discredit to and reduction of
confidence in the industry

AUD$160.85 per head, however the actual

cost per head excluding the no-shows and
taxes and surcharges was AUD$124.04.
Code Committee determination
In a unanimous decision the Committee
did not find a breach of Sections 6.2.1,
6.2.2, 10.2 or 10.8 of the Code.
Consideration of the complaint
As stated in the general discussion prior to
each event being considered, the
Committee was cognisant of the higher
costs of hospitality in Europe and North
America; issues arising from large
conferences being held in a city; and the
taxes and surcharges imposed.
The
Committee did not consider that the
hospitality provided in association with the
educational event was extravagant. For
these reasons the Committee did not find
any breaches of the Code in relation to this
event.

Response
Amgen denied any breach of the Code.
Amgen stated that the dinner was held in
association with a four day global
educational
and
scientific
meeting
(American Society of Haematology Annual
Meeting) attended by 21,000 healthcare
professionals from around the world. With
an event of this size there is considerable
demand on hotels and restaurants to
accommodate the number of conference
delegates. Amgen spent considerable time
in planning and seeking a suitable venue.
Amgen also stated that the total costs do
not reflect the hospitality provided as there
were four no-shows and a 20% gratuity
was imposed. The cost per head was
Code of Conduct Annual Report 2007/2008

193

AstraZeneca Heartburn
Campaign (944)
Subject Company: AstraZeneca
Complainant: referred by TGA
Product: Television advertisement and
Website Information
Complaint
The Therapeutic Goods Administration
had received an anonymous complaint
concerning advertising for the treatment of
heartburn and reflux, by the Subject
Company. As the material subject to
complaint did not fall within the TGA
Complaints Resolution Panels jurisdiction,
which
deals
with
non-prescription
medicines, the complaint was forwarded to
the Code of Conduct Committee for
consideration.
The anonymous Complainant expressed
concern that this advertising encouraged
consumers to see their doctor and request
products that treat heartburn, reflux etc. As
the advertising does not expressly mention
any specific product, the Complainant was
concerned that this was an attempt to
circumvent the Therapeutic Goods Acts
prohibition on advertising prescription
medicines to the general public. The
Complainant alleged that the television
commercial and website constituted
indirect
promotion
of
prescription
medications to the general public.
Sections of the Code
Materials alleged to be in breach of the
following Sections of the Code:
9.4 Promotion to the general public
9.5 Patient Education
9.6 Use of the Internet
Response
AstraZeneca stated that this complaint
(944) was conceptually the same as a
previous complaint (870). AstraZeneca
asserted that the complainant was under
the misconception that pharmaceutical
companies are not permitted to engage in
disease
awareness
campaigns.
AstraZeneca asserted that the Code
explicitly
permits
pharmaceutical
companies to engage in disease
awareness
campaigns,
including
encouraging patients to seek further
information or explanation from the
appropriate healthcare professional.

Code of Conduct Annual Report 2007/2008

AstraZeneca strongly denied that the

television
advertisement
or
the
heartburn.com.au website breached the
Code. AstraZeneca asserted that the
information provided does not promote a
specific prescription medicine and no
brand names had been mentioned in
either media of AstraZenecas product or
other companies products. AstraZeneca
further contended that this campaign was
educational in nature with a view to
enhancing
the
general
publics
appreciation of the risks of heartburn and
their
understanding
of
heartburn
management options.
Code Committee determination
In a unanimous decision the Committee
found no breach of Sections 9.4, 9.5 or 9.6
of the Code.
Consideration of the complaint
The Committee reviewed the television
commercial and website information. It
noted that no medicine brand name or
generic name was mentioned in either
media. The information provided about
heartburn, which is a common condition,
was general in nature, included reference
to all classes of medicine used to treat
heartburn and was not oriented towards
any particular product or class of
medicines.
The Committee noted that disease
awareness communication to the general
public is permitted under the Code of
Conduct. It was accepted that except for
the Code requirement that the sponsor
include the company name and contact
details
on
a
website
or
other
communication, a consumer would not
know who had provided the information.
The Committee noted that there was no
link to any AstraZeneca product but there
were links to independent and informative
websites such as the Gastroenterological
Society of Australia and www.quit.com.au
The general information about the
management of heartburn included
information on lifestyle tips and dietary
changes.
The Committee further noted that the
website included a helpful checklist and
both the website and the television
advertisement advised consumers to seek
further
advice
from
their
health
professional.

194

The Committee unanimously concluded

that the television advertisement and the
website did not encourage a member of
the general public to seek a prescription
for a specific prescription medicine and
was therefore not in breach of Section 9.4.
The website provided relevant and
balanced
educational
material
for
consumers and was consistent with the
use of the internet described in Section 9.6
of the Code. The Committee unanimously
found no breach of Section 9.5 or 9.6 of
the Code.

Code of Conduct Annual Report 2007/2008

195

Olmetec (945)
Subject Company: Schering-Plough
Complainant: AstraZeneca Pty Ltd
(AstraZeneca)
Product: Olmetec
Complaint
AstraZeneca alleged that Schering-Plough
had failed to comply with sanctions
regarding the promotion of Olmetec, as
imposed by the Code Committee at its
meeting on 20 August 2007. Sanctions
imposed by the Committee included
withdrawal of materials found in breach, a
corrective Dear Doctor letter, publication
of a corrective advertisement and changes
to materials in line with Schering-Ploughs
proposals made during intercompany
dialogue.
AstraZeneca asserted that ScheringPlough had not made the required
changes to the Olmetec advertising and
promotional materials. AstraZeneca stated
that a change had been made to the
Abridged Product Information included on
promotional items. However, in limiting
changes to the Minimum Product
Information AstraZeneca considered that
Schering Plough had failed to comply with
the sanctions.
Sections of the Code
Company alleged to be in breach of the
following Section of the Code:
12.1.2
Response
Schering-Plough responded that it had
complied with Section 12 of the Code in
that all promotional material was updated
as per the sanctions required by the Code
Committee in August 2007. ScheringPlough published retraction letters as
close as possible to the stipulated 30
calendar days required by the Code.
Schering-Plough conceded that retraction
letters had not been placed in two of six
journals due to an error by the media
agency, which Schering-Plough had not
been aware of until its investigation of the
complaint and expressed regret for this. To
ensure this does not happen again,
Schering Plough has updated its internal
processes and now requires that all
original versions of retraction letters be
sourced by marketing and undergo postCode of Conduct Annual Report 2007/2008

publication check by the Medical

Department. This will ensure that no future
errors occur internally or as a result of
misinformation provided by a media
agency.
Code Committee determination
In a unanimous decision the Committee
found a breach of Section 12.1.2 of the
Code.
Sanction
Publish the corrective advertisement in
Medical Observer and MIMS as
previously required
Pay a fine of $50,000
Consideration of the complaint
Prior to discussing the complaint members
reviewed the minutes and sanctions
imposed by the Committee in relation to
the Olmetec 876 complaint.

Extracts from the Olmetec 876 minutes

The Committee considered that the
Olmetec promotional material should
make it clear to a prescriber that the
recommended starting dose for the elderly
is 10mg and include clear advice that
10mg is currently not available in Australia.
The Committee also reviewed the
Minimum Product Information included on
the advertisement and noted that it did not
include any reference to a recommended
starting dose of 10mg in the elderly, rather
it stated that The dose of olmesartan
medoxomil should not exceed 20mg
daily..
The Committee was of the view that
although it is acceptable for a company to
promote a specific dose or formulation to
healthcare professionals, the content of
any advertisement or leave behind must
be consistent with the Product Information
and where there is a specific reference to
a different starting dose for a particular
population such as the elderly this should
be included in the Minimum Product
Information and on the item.
Sanctions
The Committee determined that Schering
Plough should:
Withdraw the materials found in breach
Send a corrective letter to all healthcare
professionals detailed with the leave
behind

196

 Publish a corrective advertisement in the

same journals as the advertisement

found in breach
Amend
the
Minimum
Product
Information as was proposed in
intercompany dialogue
Consider amending the CMI to more
closely reflect the dosage described in
the Product Information in relation to the
elderly and special populations.
In relation to the allegation that Schering
Plough had not made changes to the
Minimum Product Information and to the
promotional material members were of the
view that in the primary advertisement
provided to the Committee the bolded
amendment within the Minimum PI
Dosage: ..For elderly of volume
depleted patients or renal impairment
10mg daily recommended as a starting
dose. 10mg tables are not available. was
sufficiently clear to a reader and found no
breach of the Code. Members were also of
the view that there was a statement in the
secondary advertisement, where no
Minimum PI is required, 10mg dose not
available in Australia.
The Committee noted that its acceptance
of the changes to the Olmetec
advertisements was specific to those
presented to the Committee; other
advertisements must be judged on their
merit.

publication
of
advertisements.

the

corrective

In relation to the timeframe for publication

of corrective advertisements, they must be
published in the next issue of the
publication taking into account publication
cut-off dates.
As the corrective advertisement had not
been published in all journals as directed
by the Committee, in a unanimous
decision members found a breach of
Section 12.1.2 of the Code.
Sanctions
Having found a breach of the Code
members considered an appropriate
sanction. Section 12.1.2 of the Code
states that where corrective action has not
been undertaken as required within 30
days the Committee may impose a fine of
up to $50,000.
The Committee determined that Schering
Plough should:
Publish the corrective advertisement in
Medical Observer and MIMS within 30
days and provide Medicines Australia
with a copy of the actual journal
advertisement as published.
Pay a fine of $50,000

The Committee was concerned that

Schering-Plough had not published the
corrective advertisement in all publications
as directed in the previous sanctions.
Members questioned the media agencys
advice that Medical Observer had refused
to publish the retraction letter in the
approved format due to Australia Post
regulations. Members noted that the
corrective advertisement would generally
have been a single page bound within the
publication. The requirement to publish a
corrective letter, which would have been a
one or two page letter sent in the standard
post, is independent of the requirement to
publish a corrective advertisement. Whilst
the text of the corrective advertisement
must be the same as the corrective letter,
it is not required to be addressed Dear
Doctor; it should be headed Corrective
Advertisement. The Committee also
commented that a company should require
its agents to provide evidence of the

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197

Influenza Vaccine (946)

Subject Company: CSL
Complainant: Healthcare professional
Product: Influenza Vaccine
Complaint
The Complainant stated that the identified
brochure did not recommend that people
specifically take the CSL vaccine.
However the brochure did not say what
you can do it you do catch the flu, either
because you did not have the vaccine, or
because you experienced vaccine failure,
which is common. The complainant stated
that as a matter of public health, CSL
should include a paragraph telling people
about new anti viral drugs, what they are,
how they work and how they should be
used.
Sections of the Code
Materials alleged to be in breach of the
following Sections of the Code:
1.1 Level of Substantiating Data
1.3 False and Misleading Claims
9.4 Promotion to the General Public
9.5 Patient Education
Response
CSL stated that according to the Influenza
Specialist Group, influenza vaccination is
the primary, single most effective measure
to prevent infection and the complications
associated with influenza. CSL also noted
that the complainant is an advocate of
anti-viral medicines and he has publicly
stated his case to government that Tamiflu
should be made available over the counter
in pharmacies.

Members noted the statements from the

Influenza Specialist Group that influenza

vaccination is the primary, single most

effective measure to prevent infection and
complications association with influenza

and
the
Australian
Immunisation
Handbook (AIH) which states it is
important that the public is made aware of
the proven effectiveness of immunisation
to save lives and prevent serious disease.
The AIH recommends annual influenza
vaccination. Members also noted that
Fluvax (CSL influenza vaccine) was for the
prevention of influenza virus, Types A and
B while Tamiflu is indicated for the
treatment of influenza Types A and B.
The Committee was of the view that the
CSL brochure was educational and was
not advocating the use of any specific
prescription medicine; it advised a reader
to talk to their doctor.
Members commented it would be a breach
of the Code (and Therapeutic Goods Act)
for a company to compare medicines, as
had been suggested by the complainant,
or to suggest that a member of the general
public should ask for a specific medicine.
In a unanimous decision the Committee
found no breach of Sections 1.1, 1.3, 9.4
or 9.5 of the Code.

Code Committee determination

In a unanimous decision the Committee
found no breach of Sections 1.1, 1.3, 9.4
or 9.5 of the Code.
Consideration of the complaint
The Committee noted the complainants
interest and his work in the development of
the antiviral drug Tamiflu and his current
campaign to have Tamiflu available over
the counter. The Committee understood
the view put by the complainant that the
identified
brochure
should
contain
information about anti viral drugs and
influenza.

Code of Conduct Annual Report 2007/2008

198

Monitoring Committee
Reviews
The Monitoring Committee proactively reviews selected promotional materials
and activities on a regular and ongoing basis.
During each reporting period the Monitoring Committee reviews:
different types of promotional material for example advertisements, printed promotional
material, brand name reminders, across particular therapeutic classes for example
cardiovascular, respiratory and immunology;
plus other activities across all therapeutic classes for example websites, advertisements
in prescribing software, educational events.
The therapeutic classes are derived from the Therapeutic Class Index used by MIMS
Australia:
Alimentary System
Cardiovascular System
Central Nervous System
Analgesia
Musculoskeletal System
Endocrine and Metabolic Disorders
Genitourinary System
Infections and Infestations
Neoplastic Disorders
Immunology
Respiratory System
Ear, Nose and Oropharynx
Eye
Skin
Surgical Preparations
Contraceptive Agents
Member companies are required to provide copies of the requested promotional
material/educational material or activity for the three month period under review. Each
company must provide a signed verification statement confirming that all information
requested has been identified and submitted to the Monitoring Committee.
In 2007/2008 the Monitoring Committee reviewed the following materials and activities:

Company websites for the general public and patients (excluding corporate websites)
Advertisements in prescribing software
Invitations to educational meetings (this is in addition to the Educational Event
Reports)
Advertisements in the Central Nervous System therapeutic class
Printed promotional material in the Neoplastic Disorders therapeutic class
Educational Event Reports
Competitions in the Cardiovascular therapeutic class
Corporate websites

Code of Conduct Annual Report 2007/2008

199

Table B: Summary of materials and activities reviewed between 2003 & 2008
2003/2004

2004/2005

2005/2006

2006/2007

2007/2008

Invitations to
Educational
Meetings

Invitations to
Educational
Meetings

Invitations to
Educational
Meetings

Invitations to
Educational
Meetings

Invitations to
Educational
Meetings

Media
releases

Market
Research

Websites

Patient
Support
Programs

Patient
Websites

Brand Name
Reminders

Prescribing
software

Alimentary System
Cardiovascular System
Central Nervous System

Reviewed
2002/2003

Analgesia
Muscular Skeletal System

Reviewed
2002/2003

Endocrine & Metabolic Disorders

Genitourinary System
Infections & Infestations
Neoplastic Disorders
Immunology
Respiratory System
Allergic Disorders
Ear, Nose & Oropharynx
Eye
Skin
Surgical Preparations
Contraceptive Agents
Reviews across all therapeutic
classes

Patient
Education

Brand Name
Reminders

Competitions

Corporate
Websites
Competitions

Websites

Prescribing
Software
Educational
Event
Reports

For some therapeutic areas where no reviews have been conducted, the majority of products
are not prescription medicines. Therefore the therapeutic areas may not be relevant to
Medicines Australia member companies.

Code of Conduct Annual Report 2007/2008

200

Table C: Summary of materials and activities reviewed by the Monitoring

Committee in 2007/2008.

Therapeutic Class

Type of materials or
activitiy subject to
review

Number of
companies

Number of items

Number of meetings
to complete review

All therapeutic
classes

Company websites
available to the
general public &
patients*

26

103

1*

All therapeutic
classes

Advertisements in
prescribing software

10

25

All therapeutic
classes

Invitations to
educational
meetings

32

683

Central Nervous
System

Advertisements

36

Neoplastic Disorders

Printed Promotional
Material

13

234

All therapeutic
classes

Educational Event
Reports

42

951

Cardiovascular
System

Competitions

22

All therapeutic
classes

Corporate websites

33

33

2087

11

TOTAL
* Reviewed in 2006/2007 and finalised in 2007/2008 (1 meeting in 2006/2007 )

Code of Conduct Annual Report 2007/2008

201

Outcomes of the Monitoring

Committee review of materials
and activities
Company websites for the general public and patients
The Committee reviewed 103 websites. The Committee did not review corporate websites at
this meeting.
The websites reviewed were provided by the following companies:

Actelion
Alcon
Allergan
Altana
Amgen
AstraZeneca
Bayer Schering
Bristol Myers Squibb (BMS)
CSL
Eli Lilly Australia
GlaxoSmithKline (GSK)
Ipsen
Lundbeck

Merck Serono
Merck Sharp & Dohme (Australia)
Mundipharma
Novartis
Novo Nordisk
Organon
Sanofi Pasteur
Smith & Nephew
Pfizer
Roche
Solvay
UCB Pharma
Wyeth

The Monitoring Committee raised a number of general issues arising from the review of
websites.
General Issues

Company name and contact details

Members were of the view that a company controlled website should include the company
name and contact details. Section 3.8.5 of the Code states that where a company website
includes information about a product, the address and identity of the company should be
provided.

Passwords

Members stated that a company should not use the product name as a password to access
secure information. The purpose of a password is to provide a secure site and prohibit access
by an unauthorised person. Passwords or other forms of secure access to healthcare
professional only sites or patient support program sites may include the provider number for
healthcare professionals; product bar code numbers; ARTG number or a password that would
not be easily identifiable by a member of the general public.

Pack Shots

Members were of the view that a company should not include pack shots on a website
accessible to the general public this may be deemed advertising to the general public.

Code of Conduct Guidelines state:

Companies should not provide pack shots for publication/broadcast by the media. The TGA
has previously provided advice to the Pharmacy Board of NSW that a brochure for consumers
that includes pictorial representation of products is an advertisement.

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202

TGA Price Information Code of Practice (Applies to S3, 4 and 8 medicines)

Illustrations
Price information cannot be accompanied by, or located near, pictures, photographs of
illustrations of any medicines to which this Code applies.
It is not permissible to include packs shots as this makes it an advertisement and advertising
to the general public is prohibited.

Links to other sites

Members were of the view that links from disease state websites or patient support program
websites should only be to reputable sites providing non-promotional education relevant to
Australia. It was not appropriate to provide a link or series of links provided by a parent
company where these may be to sites that advertise prescription medicines or make
comparisons with other treatments. As the advertising of prescription medicines is prohibited
in Australia a company should not attempt to circumvent the Code or Commonwealth law.

Consumer Medicine Information (CMI)

The Committee noted that many companies were not using the correct wording for a CMI
must always be referred to as Consumer Medicine Information.

Accessing patient information

A member raised a concern that a company was charging a $50 fee for a patient to access
personal information held by the company. Some members were of the view that a company
should not charge a patient a fee - not a significant expense to a company but may be an
imposition to a patient. Another member indicated that it is possible to charge a fee for the
time taken to search for the data; however it is not permissible to charge for releasing this
information.

Use of find a clinic or find a healthcare professional

Following a complaint in 2006, Medicines Australia consulted with the AMA on the use of lists
of doctors names or clinics on a company website. Both the Code of Conduct Committee and
members of the AMA Therapeutics Committee were strongly of the view that this practice was
not acceptable. Healthcare professionals were of the view that the list can be seen as an
endorsement of a company or product. If a patient does not find their doctors name of the list
they may be misled into thinking that their doctor does not have an interest in the specialty
area eg childrens health or mens health. This may result in the patient presenting to an
unknown doctor for treatment. It was the view of both the Code Committee and the AMA that it
is acceptable for a company to include a link to an Australian College or Society which may
include a list of doctors or clinics on their site. This link could only be provided with the
express permission of that College or Society.
The Monitoring Committee sought further information from nine companies in relation to 12
websites. Following its review of company responses, the Monitoring Committee determined
that no websites should be forwarded to the Code of Conduct Committee for a determination
on a potential breach of the Code.

Advertisements in prescribing software

The Committee reviewed 23 advertisements and two items of patient education placed by
member companies in prescribing software which was available to healthcare professionals in
August 2007. The Committee did not review advertisements for information placed by nonmember companies or for non-prescription medicines.
The advertisements were placed by:
AstraZeneca
Boehringer Ingelheim
CSL
GlaxoSmithKline
Merck Sharp & Dohme (Australia)

Code of Conduct Annual Report 2007/2008

Merck Sharp & Dohme (Australia) &

Schering Plough
Novo Nordisk
Pfizer
Sanofi-aventis
Servier Laboratories

203

The Committee noted that in three advertisements the generic name was difficult to read.
Members were of the view that if companies wish to place advertisements in this small space
the content must be legible.
The Committee was pleased to note that there were no advertisements for prescription
medicines in the CMI section or with clinical tools which may be used with patients.
No advertisements were forwarded to the Code of Conduct Committee for a determination on
a potential breach of the Code.

Invitations

Prior to the Australian Competition Tribunal decision in relation to the Medicines Australia
appeal (in June 2007), the Monitoring Committee reviewed invitations to educational events
held in one month in 2007. The decision on the month was at the discretion of the Monitoring
Committee. This was an interim review prior to the reporting of educational events as set out
by the ACCC in its final determination on authorisation of Edition 15 of the Code.
The Monitoring Committee reviewed 683 invitations for events in the month of February 2007.
This review was conducted in September and October 2007.
Companies providing invitations:

Abbott Australasia
Actelion
Alcon Laboratories
Allergan
Amgen
AstraZeneca
Bayer Schering
Biogen Idec Australia
Boehringer Ingelheim
Bristol Myers Squibb (BMS)
CSL
Eli Lilly Australia
Gilead
GlaxoSmithKline (GSK)
iNova
Janssen Cilag

Lundbeck
Novartis
Novo Nordisk
Merck Serono
Merck Sharp & Dohme (Australia)
Mundipharma
Nycomed
Organon
Pfizer
Roche
Sanofi-aventis
Sanofi Pasteur
Schering Plough
Solvay
UCB Pharma
Wyeth

The Committee made a general observation that the general standard of invitations had
improved with the majority of companies including a greater level of information about the
educational component of the meeting.
Members noted that some companies were attributing Medicines Australia as prohibiting
certain activities. Companies should not misrepresent company policy as a Medicines
Australia policy. Activities that are prohibited under the Code of Conduct, for example
payment for partners travelling with a healthcare professional who is attending an educational
event, should be referenced to a statement such as In accordance with the Code of Conduct

for the prescription medicines industry in Australia any costs (for example travel or meals)
incurred by a partner/spouse travelling with a healthcare professional must not be paid for or
subsidised by the company.
Companies should review the educational component of a meeting which requires travel and
accommodation costs to be met by the company to ensure that the education is the primary
purpose of the event.

Having reviewed the invitations the Monitoring Committee requested further information from
12 companies. Having reviewed this additional information the Monitoring Committee
forwarded one event to the Code of Conduct Committee for a determination on a potential

Code of Conduct Annual Report 2007/2008

204

breach of the code. The outcomes of the Code of Conduct Committees determination in
relation to the Allergan Educational Event can be read at page 84 of this report.

Advertisements in the Central Nervous System therapeutic class

The Committee reviewed advertisements from seven member companies covering 10

medicines in this therapeutic class 36 advertisements.
Companies providing advertisements:

AstraZeneca
Eli Lilly Australia
Janssen Cilag
Pfizer Australia

Solvay Pharmaceuticals
UCB Pharma
Wyeth Australia

The Committee raised a number of issues that should be considered by all companies when
preparing promotional materials.
The mandatory text must not be in a narrow font which makes the information difficult to
read
The PBS dispensed price should be current if the price is changed, advertisements must
be updated
The Australian Approved Name must be included adjacent to the most prominent
presentation of the brand name as set out in Section 3.1.1.3(b)
Care should be taken when using referencing symbols which are very similar and in close
proximity, making it difficult to identify them easily, for example
The Committee also advised companies that materials provided to the Committee must be in
the original size, because a reduced size makes the content difficult to read.
The Committee sought feedback in relation to six advertisements. Following the review of
company responses, the Committee determined that no advertisements should be forwarded
to the Code of Conduct Committee for a determination on a potential breach of the Code.

Printed promotional material in the Neoplastic Disorders therapeutic class

The Committee reviewed 234 items of printed promotional material from 13 member
companies.
Companies providing items of printed promotional material:

Abbott Australasia
AstraZeneca
Bayer Australia
Bristol Myers Squibb
Eli Lilly Australia
GlaxoSmithKline Australia
Janssen Cilag

Merck Sharp & Dohme (Australia)

Novartis Pharmaceuticals
Pfizer Australia
Roche Products
Sanofi-aventis
Schering Plough

The Committee raised a number of issues that should be considered by all companies when
preparing promotional materials.

The Committee expressed concern that companies were making claims, often very
significant claims, and then qualifying them with a statement that results was not
statistically significant
Similarly with graphs or tables evidently comparing products, which are qualified with a
statement .the studies are not head-to-head and therefore cannot be used to make a
direct comparison. Members were of the view that this is misleading if they cant be
compared, dont use them!
Members also noted that many tables and graphs did not include a p-value.

Code of Conduct Annual Report 2007/2008

205

The Committee sought feedback in relation to materials from 3 companies (4 items).

Following the review of company responses the determined that no items should be
forwarded to the Code of Conduct Committee for a determination on a potential breach of the
Code.

Educational Event Reports

The decision of the Australian Competition Tribunal requires the Monitoring Committee to
conduct a review of the Educational Event Reports provided by the members at the end of
each financial year (three months selected at random for the preceding 12 month period), the
Board of Medicines Australia decided to proactively conduct a review of the July December
2007 reports. Under the provisions of the Code the Monitoring Committee is empowered to
request information concerning a particular event such as a copy of the invitation to the
meeting and a copy of any printed material provided to attendees.
Where the Monitoring Committee considers that the conduct of the member company with
regard to a meeting may breach the Code of Conduct, it can refer a report about the meeting
and the member companys response to the Code of Conduct Committee which, after giving
notice to the member company, may deal with it as though it were a complaint.
As set out on page 25 the Monitoring Committee reviewed 951 educational events. The
Committee requested further information in relation to 312 events. Having reviewed the
additional information the Monitoring Committee referred 52 events to the Code of Conduct
Committee for a determination on potential breaches of the Code of Conduct. The outcomes
of these events can be viewed on pages 31 - 36 of this report.
In considering the events before them, the Monitoring Committee provided the following
commentary.
The Medicines Australia Monitoring Committee, which includes healthcare professionals,
consumer and industry representatives, reviewed all educational events that had been
identified by the independent auditors (Deloitte) using forensic accounting and statistical
techniques.
Role of the Monitoring Committee
The role of the Monitoring Committee was to identify any potential breaches of the code. The
Monitoring Committee was empowered to request further information in relation to any event
and, if not satisfied with the companys response, to forward the event to the Code of Conduct
Committee for adjudication.
Review Process
The Monitoring Committee met three times during March 2008 to review the events identified
by the auditor. After the first of these three meetings the Monitoring Committee asked the
auditor to provide a further subset of events. The Monitoring Committee reviewed 951 events
in total, which is approximately 6% of the total dataset of 14,633 events.
During the Monitoring Committees review, it soon became clear that the level of detail
provided by companies varied considerably, although it complied with the requirements
stipulated by the Australian Competition Tribunal. In order to undertake the review of events,
the Monitoring Committee requested further details from companies. There were 312 events
for which further information was requested and provided by companies
.
Analysis of Data
Assessed initially on the cost of hospitality (meal costs, travel and accommodation); and the
quality and duration of medical education provided in proportion to the level of hospitality
provided
Where companies appeared to provide excessive hospitality in proportion to the education
provided, these events were referred back to companies to provide reasons as to why the
event should not be referred to the Medicines Australia Code of Conduct Committee.

Code of Conduct Annual Report 2007/2008

206

Upon reviewing the responses from companies, it was clear that many system, human and IT
errors had been made in compiling the event reports as companies tried to combine data sets
that had not been designed for this purpose. Following review of the further information and
explanation provided by companies, the majority of events appeared to comply with the Code
once the corrected expenditure and number of confirmed attendees was examined. Most
companies noted that they had reviewed or were reviewing their data collection processes in
order to make sure similar errors do not occur in the future.
Cost Guidance
The Committee agreed that all service fees should be considered as part of the cost of
provision of hospitality, but all taxes such as GST or taxes imposed in other countries should
be disregarded.
Education Component
Where accommodation was required, the Monitoring Committee suggested:
minimum of 8 hours education (education session times only) was generally
necessary to justify 2 nights of accommodation, but if delegates need to travel from
remote locations this should also be considered;
minimum of 5 hours education (education session times only) was generally
necessary to justify 1 night of accommodation; and
4 hours education was generally insufficient to justify any overnight accommodation
unless the attendee was from rural/remote region or interstate.
Venue Selection
The location for providing education was also discussed by the Monitoring Committee.
Members generally considered that location was irrelevant unless the rationale for choice of
location was not immediately obvious, based on the attendees origin and/or the specific
conference facilities.
In a majority decision the Monitoring Committee referred the event to the Code Committee on
the rationale that the significant majority of attendees had been provided travel from capital
cities both near and distant and it was considered that the popular holiday location was not
adequately justified in preference to a capital city location. The same holiday location had
been considered acceptable for a regional meeting for Queensland HCPs.
The Monitoring Committee referred 52 educational events to the Code of Conduct Committee
for deliberations. The outcomes of the Code of Conduct and Appeals Committees are
summarised on pages 31 - 36 of the Report.

Competitions in the Cardiovascular therapeutic class

The Committee reviewed 22 competitions from nine member companies.

Companies conducting competitions:

AstraZeneca
Bayer Schering
Boehringer Ingelheim
CSL
Merck Sharp & Dohme (Australia) &
Schering Plough

Pfizer
Sanofi-aventis
Servier
Solvay

The Committee noted a number of general issues in relation to the review of competitions.
Privacy Guidelines
Members noted that some competitions did not include a privacy statement and those that did
varied in the manner in which the statement was made. The Committee was of the view that
whenever a pharmaceutical company is collecting information from a healthcare professional,
a privacy statement on how that data may be used should be a mandatory inclusion. This
information, with possible examples should be included in the Code Guidelines.

Code of Conduct Annual Report 2007/2008

207

Competition/Printed Promotional Material

Members discussed when does a competition become a piece of printed promotional
material. The Committee was of the view that where promotional claims are made in a
competition the mandatory requirements for printed promotional material should also apply.
That is, the inclusion of the Minimum Product Information and PBS disclosure information.
Competition Results
One member of the Committee questioned whether companies should provide the winning
entries to ensure that the Terms & Conditions of the competition had been fulfilled. This
matter should be referred to the Code Review Panel for further guidance.
Market research and request for starter packs
The Committee was concerned that some companies had not heeded the advice from the
previous review of competitions. Market research, surveys or requests for starter packs
should not able to be confused with competitions.
Members were of the view that surveys and competitions should be kept quite separate, that
is, not on the same page; and that competitions should not ask the healthcare professional
whether they want samples of a product or which products they prescribe. Any request for
starter packs should not be linked to entry to a competition.
Distribution of competition prizes
The Committee re-iterated the view that receipt of a competition prize must not be dependent
on making an appointment with a company representative (page 22 Code Guidelines).
Members noted that a few competitions offered this as an option for delivery. A representative
may deliver a competition prize, that is, leave the prize at reception.
Level of difficulty of questions
Members of the Committee commented that there had been an improvement in the level of
difficulty of the questions and hoped that this level would be maintained or exceeded.
Competition Prizes
The Committee did not raise any issues in relation to prizes being offered in the competitions
reviewed.
The Committee requested a response from two companies in relation to two competitions. At
the time of publication this information has not yet been reviewed by the Monitoring
Committee. A final report will be included in the 2008/2009 Code Annual Report.

Australian Corporate Websites

The Committee reviewed 33 member company websites. Four of these companies did not
have an Australian website.
Company websites reviewed:

Abbott Australasia
Actelion
Alcon Laboratories
Allergan
Amgen
AstraZeneca
Baxter
Bayer
Biogen Idec Australia
Boehringer Ingelheim
Bristol Myers Squibb
Celgene
CSL
Eli Lilly Australia

Code of Conduct Annual Report 2007/2008

Genzyme
Gilead
GlaxoSmithKline
Ipsen
Janssen Cilag
Lundbeck
Merck Serono
Merck Sharp & Dohme (Australia)
Mundipharma
Novartis
Novo Nordisk
Nycomed
Pfizer
Roche

208

Sanofi-aventis
Schering Plough
Servier

Solvay
Wyeth

The Committee made a number of general comments in relation to company corporate

websites.
Use of disclaimers when leaving an Australian company site
The Committee noted that there were numerous versions of the recommended disclaimer as
set out in Section 9.6.4 of the Code.
Reference or linkages to other reputable information sources that provide valuable
educational information that would enhance a member of the general publics understanding
of a disease area. When making such a reference or linkage a clear screen displaying the
following statements must appear before the information can be accessed:
that the information a reader is about to be referred to may not comply with the Australian

regulatory environment and that readers should refer to the CMI for products to fully
understand the terms of a products registration in Australia;
that the intent of providing this material is informational and not as advice; and
any information provided by this source should be discussed with the readers healthcare
professional and does not replace their advice.

Members were of the view that a statement to the effect This website may not comply with
the Medicines Australia Code of Conduct is not appropriate.
Where a linkage is made to a third party site, whether through a list or within the text, it must
be clear that the reader is leaving the Australian company site.
Links to global homepages or sections of a global website
Members were of the view that it is acceptable to provide a link to a global company home
page; however an Australian company must not provide a link to a specific section of a global
site that may include advertising or promotional information. Similarly a company may include
a link from the Australian news or media release page to the global news page, however
companies must not include a link from the Australian news page to a specific media release
or news item on the global page that makes reference to a non-approved product or
indication.
Pack Shots
The Committee reiterated the view that a company must not include pack shots of their
medicines on their website. A company may include a list of their products available in
Australia plus a brief statement of the indications or a link to the CMI.
Consumer Medicine Information
The Committee recommended that where a company has a list of products and links to the
CMI, there should be a statement explaining what a CMI is. The Committee noted that the
correct term is Consumer Medicine Information. Members were of the view that companies
should refrain from using other terms as all stakeholders are trying to encourage awareness
of CMIs.
The Committee requested further information in relation to two websites. At the time of
publication this information has not yet been reviewed by the Monitoring Committee. A final
report will be included in the 2008/2009 Code Annual Report.

Code of Conduct Annual Report 2007/2008

209

Appendix 1
Analysis of Complaints Data - Tables
Table 1: Source of complaints 2007/2008
Complainant

Number of Complaints

Healthcare Professionals
General Practitioner

5
1

Doctor in a hospital

Physician/Specialist

Pharmacist
Nurse
Academic

0
0
3

Medicines Australia Monitoring

Committee

53

Pharmaceutical Company

20

Medicines Australia Member

Company

20

Non-member Company

Organisations

Therapeutic Goods Administration

Hospital

Consumer Organisation

Others
Company representative

1
1

Academic (non-healthcare
professional)

Total new complaints in 2007/2008

83

Code of Conduct Annual Report 2007/2008

210

Appeals

Complaints

Table 2: Summary of complaint determinations Complaints finalised from

2006/2007
Complaints finalised from 2006/2007

Number

Number of complaints received from 2006/2007

and finalised in 2007/2008

100%

Code of Conduct Committee Decision

100%

Where all aspects of a complaint were found to

be in breach

20%

Where some aspects of a complaint were found

to be in breach

20%

Where no aspects of a complaint were found to

be in breach

60%

Appeals relating to complaints finalised from

2006/2007

Number

Number of appeals pertaining to complaints held

over from 2006/2007 and finalised in 2007/2008

20%

Appeals Committee Decision

100%

Where all aspects of an appeal were upheld

0%

Where some aspects of an appeal were upheld

0%

Where no aspects of an appeal were upheld

100%

Code of Conduct Annual Report 2007/2008

211

Table 3: Complaints received by Medicines Australia in 2007/2008

Complaints received in 2007/2008

Number

Number of complaints received by Medicines Australia

83

100%

Complaints considered by the Code of Conduct Committee

71

85%

Complaints considered by the Code of Conduct Committee and

subject to appeal in 2008/2009 (not finalised)

4%

Complaint withdrawn

0%

Complaint referred to TGA

Complaint returned to complainant with request for further
information
Complaint received after cut off date for June Code meeting to
be heard in July 2008

0%

1%

10%

Complaints received and finalised in 2007/2008

Number

Complaints considered by the Code of Conduct

Committee

71

100%

4%

34

48%

34

48%

Number

11

100%

Where all aspects of an appeal were upheld

27%

Where some aspects of an appeal were upheld

0%

Where no aspect of an appeal was upheld

73%

Appeals

Complaints

Table 4: Complaints received and finalised in 2007/2008

Code of Conduct Committee Decision

Where all aspects of a complaint were found to
be in breach
Where some aspects of a complaint were found
to be in breach
Where no aspect of a complaint was found to be
in breach
Appeals relating to complaints received and
finalised 2007/2008
Number of appeals pertaining to complaints
received in 2007/2008

Code of Conduct Annual Report 2007/2008

212

Table 5: Sanctions imposed by the Code and Appeals Committees on

companies with complaints found in breach and finalised in 2007/2008
Sanctions*

Complaints finalised
from
2006/2007 (n=5)

Complaints received
and finalised in
2007/2008 (n=37**)

Withdraw/cease using
material/activity found in breach

Corrective Letter/Corrective
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Fines

31

Other (eg. Update internal review

processes)

* A single complaint could be in breach of multiple sections of the Code and therefore could attract multiple sanctions.
** Of the 71 complaints received and finalised in 2007/2008, 1 complaint was referred back to the complainant, 30
complaints were found to be not in breach of the Code. Of the 40 remaining complaints, 3 outcomes were appealed
and upheld by Appeals Committee that is, the finding of a breach/es of the Code was overturned to a determination
of no breach of the Code.

Table 6: Fines imposed by the Code and Appeals Committees on companies

with complaints found in breach and finalised in 2007/2008
Fines

Complaints finalised
from
2006/2007

Complaints received
and finalised in
2007/2008

$0 - $24,999

$25,000 - $49,999

$50,000 - $74,999

10

$75,000 - $99,999

$100,000 - $149,999

$150,000 - $200,000

Total value of fines

$160,000.00

$1,650,000.00

Code of Conduct Annual Report 2007/2008

213

Table 7: Length of time to resolve all finalised complaints in 2007/2008

Length of time to resolve
complaints

Number of working days

Shortest time for complaints

16

Longest time for complaints

104

Average time for all complaints

26

Average time for complaints

not subject to appeal

20

Average time for complaints subject

to appeal

55

Code of Conduct Annual Report 2007/2008

214

Table 8: Summary of Alleged and Actual Breaches of Code Sections

2007/2008
Section of
the Code
1.1
1.2
1.3
1.4
1.5
1.7
1.9
1.10
2.1
Preamble
to 3
3.1
3.3
3.4
3.5
3.12
4.1
4.2
4.3
4.4
4.8
5.1
5.3
5.9
6.1
6.2
6.3
6.4
6.6
6.8
7.1
8.2
9.2
9.3
9.4
9.5
9.6
9.7

Alleged

Breach

No Breach

15
13
25
0
3
9
0
1
0

8
8
14
0
1
4
0
1
0

7
5
11
0
2
5
0
0
0

1
2
1
0
0
0
0
1
1
0
0
0
0
0
106
0
0
1
0
0
0
0
0
2
3
3
1

1
2
1
0
0
0
0
1
1
0
0
0
0
0
26
0
0
0
0
0
0
0
0
0
0
2
1

0
0
0
0
0
0
0
0
0
0
0
0
0
0
80
0
0
1
0
0
0
0
0
2
3
1
0

Code of Conduct Annual Report 2007/2008

215

Section of
the Code
9.8
9.10
10
10.1
10.2
10.3
10.5
10.8
12.1
Total

Alleged

Breach

No Breach

0
1
0
0
54
1
2
55
1
304

0
0
0
0
17
0
1
2
1
93

0
1
0
0
37
1
1
53
0
211

Code of Conduct Annual Report 2007/2008

216