ABPI CODE OF PRACTICE

FOR THE PHARMACEUTICAL

INDUSTRY

2021
 ABPI CODE OF PRACTICE
for the
PHARMACEUTICAL INDUSTRY 2021
together with the

PRESCRIPTION MEDICINES
CODE OF PRACTICE AUTHORITY
Constitution and Procedure

This edition of the Code of Practice comes into operation on 1 July 2021. There is no transition period other than for companies wishing to continue
with ongoing Medical and Educational Goods and Services where there is a transition period until 31 December 2021 as set out in the supplementary
information to Clause 23. The template for disclosure agreed for the 2021 Code should be used to submit the 2021 data to Disclosure UK in 2022.
 THE PRESCRIPTION MEDICINES
CODE OF PRACTICE AUTHORITY
The Prescription Medicines Code of Practice Authority (PMCPA) was established by the Association of the British Pharmaceutical
Industry (ABPI) in 1993 to operate the Code of Practice for the Pharmaceutical Industry independently of the Association itself.

Complaints should be submitted to the Director of the Prescription Medicines Code of Practice Authority, 7th Floor, Southside, 105
Victoria Street, London SW1E 6QT, telephone 020 7747 8880, email [email protected].

Complaints made under the Code are considered by the Code of Practice Panel and, where required, by the Code of Practice
Appeal Board. Reports on cases are published by the Authority and are available on request and on the Authority's website
www.pmcpa.org.uk.

The PMCPA is a division of the ABPI which is a company limited by guarantee registered in England and Wales, No 09826787.
Registered office: 7th Floor, Southside, 105 Victoria Street, London SW1E 6QT.

© Copyright 2021
Association of the British Pharmaceutical Industry.

02
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Contents
2021 CODE AND 2019 CODE CLAUSES COMPARED YELLOW SECTION – INTERACTIONS WITH HEALTH
....................................................................................................... 04 PROFESSIONALS, OTHER RELEVANT DECISION MAKERS,
HEALTHCARE ORGANISATIONS, PATIENT ORGANISATIONS
ABPI PRINCIPLES AND THE PUBLIC, INCLUDING PATIENTS AND JOURNALISTS
....................................................................................................... 05
CLAUSES 23–25
ABPI CODE OF PRACTICE FOR THE PHARMACEUTICAL Clause 23: Donations and Grants. . ............................................... 39
INDUSTRY INTRODUCTION Clause 24: Contracted Services .................................................... 41
....................................................................................................... 06 Clause 25: Relationships with Health Professionals, Other
Relevant Decision Makers, Healthcare Organisations
GREY SECTION – OVERARCHING REQUIREMENTS and Patient Organisations . . .......................................................... 43
CLAUSES 1–10
PINK SECTION – SPECIFIC REQUIREMENTS FOR
INTERACTIONS WITH THE PUBLIC, INCLUDING PATIENTS
Clause 1: Scope of the Code and Definition of Certain Terms. . .... 08
Obligations and Responsibilities AND JOURNALISTS, AND PATIENT ORGANISATIONS
Clause 2: Upholding Confidence in the Industry............................ 11
CLAUSES 26–27
Clause 3: Obligations...................................................................... 11
Clause 4: Responsibilities .............................................................. 13 Clause 26: Relations with the Public, Including
Patients and Journalists................................................................. 44
Quality Standards Clause 27: Relationships with Patient Organisations................... 47
Clause 5: High Standards and Suitability. . ..................................... 14
Clause 6: Information, Claims, Comparisons TEAL SECTION – ANNUAL DISCLOSURE REQUIREMENTS
and Disparagement........................................................................ 14
Clause 7: Use of Quotations.......................................................... 16 CLAUSES 28–31
Clause 8: Certification and Examination....................................... 16 Clause 28: Annual Disclosure of Transfers of Value to
Clause 9: Training........................................................................... 18 Health Professionals, Other Relevant Decision Makers
and Healthcare Organisations...................................................... 48
Clause 10: Events/Meetings and Hospitality. . ............................... 20
Clause 29: Annual Disclosure of Contracted Services,
Donations, Grants and Sponsorship (including in relation
BLUE SECTION – PROMOTION TO HEALTH PROFESSIONALS to events/meetings) Provided to Patient Organisations .............. 49
AND OTHER RELEVANT DECISION MAKERS Clause 30: Annual Disclosure of Contracted Services
CLAUSES 11–17 Provided by the Public, Including Patients and Journalists........... 49
Clause 31: Timings, Duration and Retention
Clause 11: Marketing Authorisation and Temporary of Disclosure Information. . ............................................................. 50
Supply Authorisation..................................................................... 24
Clause 12: Prescribing Information and Other PRESCRIPTION MEDICINES CODE OF PRACTICE
Obligatory Information.................................................................. 25
Clause 13: Abbreviated Advertisements.. ....................................... 27
AUTHORITY CONSTITUTION AND PROCEDURE
Clause 14: Information, Claims and Comparisons........................ 29 ........................................................................................................ 51
Clause 15: High Standards, Format and Suitability....................... 30 GUIDELINES ON COMPANY PROCEDURES
Clause 16: Material and Distribution. . ........................................... 30 RELATING TO THE ABPI CODE OF PRACTICE
Clause 17: Representatives............................................................. 31
...................................................................................................... 64
GREEN SECTION – INTERACTIONS WITH HEALTH
LEGISLATION, OTHER CODES AND GUIDELINES
PROFESSIONALS, OTHER RELEVANT DECISION MAKERS
....................................................................................................... 65
AND HEALTHCARE ORGANISATIONS
CLAUSES 18–22
In the Code of Practice, guidance on the interpretation of the Code
Clause 18: Information, Claims and Comparisons........................ 33 appears as supplementary information to the text against a pale
Clause 19: Prohibition on Inducements and Inappropriate coloured background.
Payments and the Provision of Items to Health Professionals
and Other Relevant Decision Makers. . .......................................... 33
Clause 20: Collaborative Working with Organisations. . ............... 35
Clause 21: Provision of Medicines and Samples ........................... 37
Clause 22: Non-Interventional Studies of Marketed Medicines . . . 38

03
 2021 CODE AND 2019 CODE
CLAUSES COMPARED
The table below provides a comparison of the 2021 Code clauses to the relevant 2019 Code clauses, to support familiarisation with
the changes. The numbers in brackets beside each clause or supplementary information throughout the 2021 Code are those from
the 2019 Code.

2021 Code Clauses 2019 Code Clauses

Grey Section – Overarching Requirements
Clause 1 Scope of the Code and Definition of Certain Terms 1.1, 28.2, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 1.10, 13.2, 17 SI, 23.2 SI, 24.1 SI, 27.1
Obligations and Responsibilities
Clause 2 Upholding Confidence in the Industry 2
Clause 3 Obligations 1.11, 1.12, 3.1, 12.1, 26.1, 29
Clause 4 Responsibilities 13.1, 13.3, 24.1, 25.1, 25.2, 26.5, 27.7, 27.8
Quality Standards
Clause 5 High Standards and Suitability 9.1, 9.2, 9.3, 9.7, 9.10, 11.1, 28.6
Clause 6 Information, Claims, Comparisons and Disparagement 7.2, 7.4, 7.8, 7.9, 7.11, 8.1, 8.2
Clause 7 Use of Quotations 10.2, 10.3
Clause 8 Certification and Examination 14.1, 14.2, 14.3, 14.4, 14.5, 14.6
Clause 9 Training 15.1, 16.1, 16.2, 16.3, 16.4
Clause 10 Events/Meetings and Hospitality 18.1 SI, 18.3, 18.3 SI, 22.1, 22.1 SI, 22.2, 22.3, 22.4, 22.5, 24.2, 27.3
Blue Section – Promotion to Health Professionals and Other Relevant Decision Makers
Clause 11 Marketing Authorisation and Temporary Supply Authorisation 3.1, 3.2
Clause 12 Prescribing Information and Other Obligatory Information 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 4.10
Clause 13 Abbreviated Advertisements 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9
Clause 14 Information, Claims and Comparisons 6.2, 7.3, 7.6, 7.7, 7.10
Clause 15 High Standards, Format and Suitability 9.4, 9.5, 9.6, 9.8, 9.9, 12.1
Clause 16 Material and Distribution 10.1, 11.2, 11.3, 28.1, 28.4
Clause 17 Representatives 15.1, 15.2, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9, 15.10
Green Section – Interactions with Health Professionals, Other Relevant Decision Makers and Healthcare Organisations
Clause 18 Information, Claims and Comparisons 7.1, 7.5
Clause 19 Prohibition on Inducements and Inappropriate Payments and 18.1, 18.2
the Provision of Items to Health Professionals and Other Relevant
Decision Makers
Clause 20 Collaborative Working with Organisations 20, 24.2
Clause 21 Provision of Medicines and Samples 17.1, 17.2, 17.3, 17.4, 17.5, 17.6, 17.7, 17.8, 17.9, 17.10
Clause 22 Non-Interventional Studies of Marketed Medicines 13.4
Yellow Section – Interactions with Health Professionals, Other Relevant Decision Makers, Healthcare Organisations, Patient Organisations and the Public,
Including Patients and Journalists
Clause 23 Donations and Grants MEGS in the form of Donations and Grants in 19.1, 19.2
Clause 24 Contracted Services 21, 23.1, 23.2, 23.3, 23.4 (27.8 incorporated)
Clause 25 Relationships with Health Professionals, Other Relevant Decision Makers, 27.4, 27.5, 27.9, 12.2
Healthcare Organisations and Patient Organisations
Pink Section – Specific Requirements for Interactions with the Public, Including Patients and Journalists, and Patient Organisations
Clause 26 Relations with the Public, Including Patients and Journalists 18.2 SI, 26.1, 26.2, 26.3, 26.4
Clause 27 Relationships with Patient Organisations 27.1, 27.2, 27.3, 27.5, 27.6
Teal Section – Annual Disclosure Requirements
Clause 28 Annual Disclosure of Transfers of Value to Health Professionals, Other 24.1, 24.2, 24.7, 24.8, 24.9, 24.10
Relevant Decision Makers and Healthcare Organisations
Clause 29 Annual Public Disclosure of Contracted Services, Donations, Grants and EFPIA Requirement, 27.7, 27.8
Sponsorship Provided to Patient Organisations
Clause 30 Annual Public Disclosure of Contracted Services Provided by the Public, ABPI Requirement
Including Patients and Journalists
Clause 31 Timings, Duration and Retention of Disclosure Information 24.4, 24.5, 24.6

04
ABPI PRINCIPLES
The following principles for pharmaceutical companies are seen Ethical relationships with stakeholders are critical to our
by the ABPI as key to how we operate as an industry and build mission of helping patients, guiding the appropriate use of our
trust and enhance our reputation. Companies are expected to medicines and ensuring the appropriate and timely exchange
implement and work to embed these into their organisation. of scientific information.

Patients are at the heart of our industry. We aspire to ensure that An important guide for such ethical relationships is adherence
everything we do will ultimately benefit patients. Our primary to the ABPI Code of Practice which, among other things, sets
contribution to society is to research and develop high quality the standards and drives an ethical culture in the industry. This
medicines and to encourage their appropriate and rational use. is delivered through self-regulation. Our industry, and the
Patient safety is paramount. individuals within it, are committed to supporting that culture,
working within both the letter and the spirit of the ABPI Code
and all relevant laws and regulations.

In adhering to the ABPI Code, we follow four key principles:

Principles developed by the ABPI Some examples of how we demonstrate the principle in our behaviour

1. W
 e are committed to benefiting PATIENTS • We promote only within the terms of the marketing authorisation.
and ensuring patient safety by operating in a • We do not advertise prescription only medicines to the public (other than vaccination
professional, ethical and transparent manner campaigns approved by the health ministers).
to ensure the appropriate and rational use of
• While our activities can encourage members of the public to seek treatment, they must
medicines and to support the provision of high
not promote the use of a specific prescription only medicine.
quality healthcare. All interactions with patients
and other stakeholders must comply with all • We ensure that all information is accurate, fair and balanced.
applicable laws and regulations. • We act promptly when advised of adverse events and encourage the use of the MHRA
Yellow Card Scheme to support patient safety.

2. W
 e act with INTEGRITY and commit to engaging • We are accountable for the activities of both our staff and third party providers.
in relationships which are responsible, professional, • We do not offer any improper payments, benefits, inducements, or anything of value
ethical and transparent. We ensure that all our to influence actions or decisions, obtain or retain business, or otherwise secure any
communications are appropriate, accurate, improper advantage, either directly or indirectly, to any individual, organisation
factual, fair, balanced, up-to-date, not misleading, or stakeholder.
capable of substantiation and reflect the available
evidence, and that all other activities are
appropriate and reasonable and of the
highest standards.

3. W
 e are committed to ensuring that • We disclose certain transfers of value to health professionals, other relevant decision
TRANSPARENCY is respected. We are open makers, healthcare organisations, institutions etc and payments made to patient
about our activities and interactions with all organisations and the public, including patients and journalists.
stakeholders and encourage our stakeholders to • We publish details of ongoing and completed clinical trials via relevant databases
act with the same openness. and registries.
• We do not disguise promotion.
• Company involvement in all materials and activities is made clear from the outset.
4. We interact with all our stakeholders with • We recognise and seek to balance the needs of patients, health professionals and the
RESPECT. We are committed to approaching our public, taking into account the environment within which the industry operates and the
stakeholders in an open and constructive manner statutory controls governing medicines.
and with mutual respect. • We value the importance of independent decision-making by all those we
interact with.

05
 ABPI CODE OF PRACTICE FOR THE
PHARMACEUTICAL INDUSTRY INTRODUCTION
Promoting Appropriate Use of Medicines and seeks to achieve a balance between the needs of patients,
The pharmaceutical industry in the United Kingdom is committed health professionals and the public, bearing in mind the political
to benefiting patients by operating in a professional, ethical and and social environment within which the industry operates and
transparent manner to ensure the appropriate use of medicines and the statutory controls governing medicines. The availability
support the provision of high quality healthcare. This commitment of accurate, up-to-date information is vital to the safety of
applies to all with whom the industry interacts. To demonstrate this patients and the appropriate use of medicines. Pharmaceutical
commitment over 60 years ago, in October 1958, the Association companies must ensure that enquiries about their medicines are
of the British Pharmaceutical Industry (ABPI), which represents the answered appropriately in a timely manner.
UK industry, decided that certain activities should be covered in
Strong support is given to the Code by the industry with all
detail and thus agreed the first ABPI Code of Practice. The Code
companies devoting considerable resources to ensure that their
covers the promotion of medicines for prescribing to both health
activities comply with it. Any complaint made against a company
professionals and other relevant decision makers. It also includes
under the Code is regarded as a serious matter both by that
requirements for interactions with health professionals. In addition,
company and by the industry as a whole. Sanctions are applied
it sets standards for the provision of information about prescription
against a company ruled in breach of the Code.
only medicines to the public and patients, including patient
organisations. Companies must ensure that all relevant personnel are
appropriately trained in the requirements of the Code and must
In addition to the Code, there is extensive UK and European
have robust operating procedures under which all materials and
law relating to the promotion of medicines. Following the UK
activities covered by the Code are reviewed to ensure compliance
departure from the EU, certain European law still applies in the
both with the Code and with the appropriate legal requirements.
UK, for example, in Northern Ireland. The Code reflects and
extends beyond the relevant UK law. The Code incorporates the principles set out in:
The aim of the Code is to ensure that the promotion of medicines • the International Federation of Pharmaceutical Manufacturers
to health professionals and other relevant decision makers is and Associations' (IFPMA) Code of Practice
carried out within a robust framework to support high quality • the European Federation of Pharmaceutical Industries and
patient care. As well as covering promotional material, it controls Associations' (EFPIA) Code of Practice
samples, meetings, promotional aids, outcome or risk sharing • the World Health Organisation's Ethical Criteria for Medicinal
agreements, patient access schemes, collaborative working Drug Promotion
between the industry and healthcare organisations, including
• Directive 2001/83/EC on the Community Code relating to
joint working between the pharmaceutical industry and the NHS,
medicinal products for human use, as amended by Directive
the conduct of non-interventional studies, the use of health
2004/27/EC
professionals and other relevant decision makers as consultants
and transfers of value to health professionals, other relevant • the Human Medicines Regulations 2012 (2012 No. 1916),
decision makers and healthcare organisations. The Code also as amended.
sets standards relating to the provision of information to patients The Code covers the industry's activities only. However, those
and the public as well as relationships with patient organisations. interacting with industry as individuals or organisations also
The industry considers that provided the requirements of the have a responsibility to ensure that their interactions comply with
Code are met, working with patients and patient organisations relevant legal requirements and are asked to follow the Code
can bring significant public health benefits. These requirements where relevant and not make requests that are not in accordance
also apply to working with all user groups, such as disability with the Code. Most of those interacting with the industry,
associations, relative and carer associations and consumer other than patients, are covered by a selection of professional
associations. There are disclosure requirements for interactions codes and guidance. For example, the General Medical Council
with patient organisations and contracted services by patient Ethics guidance for doctors, the General Pharmaceutical
organisations and individuals representing patient organisations Council's Standards for pharmacy professionals and the Nursing
and certain contracted services provided by members of the & Midwifery Council's professional standards of practice and
public, including patients and journalists. behaviour for nurses and midwives.
In summary, companies must ensure that their materials are In a joint statement, the chief executives of statutory regulators of
appropriate, factual, fair and capable of substantiation and that health and care professionals (which refers to individuals regulated
all other activities are appropriate and reasonable. by one of nine regulators overseen by the Professional Standards
Authority, including those referred to above) expect health and
Ensuring High Standards social care professionals to 'Ensure their professional judgement
The detailed provisions in the Code are to ensure that
is not compromised by personal, financial or commercial interests,
pharmaceutical companies operate in a responsible, ethical and
incentives, targets or similar measures' and to 'Refuse all but the
professional manner. Whilst the industry has a legitimate right to
most trivial gifts, favours or hospitality, if accepting them could be
promote medicines to health professionals, the Code recognises

06 CODE OF PRACTICE
interpreted as an attempt to gain preferential treatment or would The PMCPA also provides informal guidance about the Code and
contravene your professional code of practice'. its operation.
Patient organisations are likely to be covered by Charity Commission Promoting Health
rules as well as their own codes. The pharmaceutical industry takes The commitment of the pharmaceutical industry to bringing high
note of all relevant codes and guidance as well as the ABPI Code. quality and effective medicines and vaccines to patients supports
the UK's health and economy.
Transparency
The industry recognises that transparency is an important means Pharmaceutical companies invest over £4.5bn a year in researching
of building and maintaining confidence. The operation of the and developing new products, for the benefit of patients.
Code, including the complaints procedure, is a demonstration of
the industry's commitment to transparency as are the requirement The Association of the British Pharmaceutical
to declare pharmaceutical company involvement in activities Industry and its Code of Practice
and materials and the publication of detailed reports of cases The Association of the British Pharmaceutical Industry exists to
considered under the Code. The industry's global agreement make the UK the best place in the world to research, develop and
to disclose certain clinical trial data is another example of the use new medicines. It represents companies of all sizes which
industry's commitment to transparency. Companies also have invest in discovering the medicines of the future.
to publish the summary details and results of non-interventional
The ABPI represents companies which supply more than 80% of
studies as well as the monetary value of certain support to
all branded medicines used by the NHS and are researching and
patient organisations.
developing the majority of the current medicines pipeline.
Other transparency changes, effective in 2012 and 2013, included
The Code has been regularly revised since its inception in
disclosure of the total amount of fees paid to consultants
1958 and is drawn up in consultation with the British Medical
for certain services and the total amounts paid to sponsor
Association, the Royal Pharmaceutical Society, the Royal College
attendance at meetings organised by third parties. As set out
of Nursing, the Medicines and Healthcare products Regulatory
in the 2014 Code, starting in 2015 transparency was extended in
Agency of the Department of Health, the Competition and
relation to disclosure of fees and sponsorship provided to health
Markets Authority and the Serious Fraud Office. Anyone is
professionals, other relevant decision makers and healthcare
welcome to send suggestions for amendments or additions
organisations, including naming the recipients in many instances.
to the Code to the PMCPA.
The Code requires disclosure of donations, grants and
It is a condition of membership of the ABPI to abide by the
sponsorship to patient organisations and when contracting
Code in both the spirit and the letter. The Code applies to both
with patient organisations or individuals representing patient
members and affiliate members of the ABPI. Companies which
organisations to provide services for companies. Certain
are not members of the ABPI may give their formal agreement to
contracted services provided by the public, including patients and
abide by the Code and accept the jurisdiction of the PMCPA, and
journalists, will also now be disclosed on an annual basis; this will
over sixty have done so. Thus the Code is accepted by virtually all
start with 2022 data to be disclosed by 30 June 2023.
pharmaceutical companies operating in the UK.
Sanctions
In each case where a breach of the Code is ruled, the company
Administering the Code of Practice
The Code is administered by the PMCPA, which is responsible
concerned must give an undertaking that the practice in question
for the provision of advice, guidance and training on the Code
has ceased forthwith and that all possible steps have been taken
as well as for the complaints procedure. The PMCPA operates
to avoid a similar breach in the future. An undertaking must be
independently of the ABPI itself. The relationship between the
accompanied by details of the action taken to implement the ruling.
PMCPA and the ABPI is set out in a protocol of agreement.
At the conclusion of a case, a detailed case report is published.
Financial information about the PMCPA is published in its
Additional sanctions are imposed in serious cases. These can include: annual report.
• the audit of a company's procedures to comply with the Code, PMCPA publications can all be found on its website,
followed by the possibility of a requirement for the pre-vetting www.pmcpa.org.uk, or are supplied on request.
of future material
Complaints under the Code are considered by the Code of
• recovery of material from those to whom it has been given
Practice Panel and, where required, by the Code of Practice
• the issue of a corrective statement Appeal Board. Reports on completed cases are published by
• a public reprimand the PMCPA on its website. The PMCPA also publishes a list of
• advertising in the medical, pharmaceutical and nursing press of ongoing cases on its website.
brief details of cases in which companies were ruled in breach
of Clause 2 of the Code, were required to issue a corrective How to Complain
statement or were the subject of a public reprimand Complaints should be submitted to the Director of the Prescription
Medicines Code of Practice Authority, 7th Floor, Southside, 105
• suspension or expulsion from the ABPI.
Victoria Street, London, SW1E 6QT, telephone: 020 7747 8880,
Monitoring of Activities and Guidance email: [email protected].
The Prescription Medicines Code of Practice Authority (PMCPA)
arranges for advertising and meetings to be regularly monitored.

CODE OF PRACTICE 07
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Overarching Requirements
CLAUSE 1 SCOPE OF THE CODE AND DEFINITION OF CERTAIN TERMS

Clause 1 1.6 (24.1 SI) 'Europe' comprises those countries that are within
Scope of the Code and Definition of Certain Terms the European Union and other countries with a trade
association that is a member of the European Federation
1.1 (1.1) This Code applies to the promotion of medicines to of Pharmaceutical Industries and Associations (EFPIA).
members of the United Kingdom (UK) health professions
and to other relevant decision makers. For the purposes of 1.7 'Events' includes all professional, promotional, scientific
the application of the Code, the UK includes the Channel and educational meetings, congresses, conferences,
Islands and the Isle of Man. The Code also applies to a symposia, and other similar events (including, but not
number of areas which are non-promotional, including limited to, advisory board meetings, visits to research
information made available to the public about prescription or manufacturing facilities, and planning, training
only medicines. It does not apply to the promotion of or investigator meetings for clinical trials and non-
over-the-counter (OTC) medicines to members of the interventional studies) organised or sponsored by or on
health professions when the object of that promotion is to behalf of a company (further examples can be found in
encourage their purchase by members of the public. the supplementary information to Clause 10.1).

1.2 (28.2) Information or promotional material about medicines 1.8 (1.9) 'Healthcare organisation' means either a healthcare,
which is placed on the internet outside the UK will be medical or scientific association or organisation such as
regarded as coming within the scope of the Code, if it was a hospital, clinic, foundation, university or other teaching
placed there by: institution or learned society whose business address, place
of incorporation or primary place of operation is in Europe
• a UK company/with a UK company's authority, or
or an organisation through which one or more health
• an affiliate of a UK company, or with the authority of professionals or other relevant decision makers
such a company, and it makes specific reference to the provide services.
availability or use of the medicine in the UK.
If a healthcare organisation consists of only one health
1.3 'Collaborative working' refers to pharmaceutical companies professional or other relevant decision maker, then it would
working with other organisations to deliver initiatives which be subject to the requirements in the Code regarding
either enhance patient care or are for the benefit of patients individual health professionals.
or alternatively benefit the National Health Service (NHS)
and, as a minimum, maintain patient care. Further details 1.9 (1.4) 'Health professional' includes any member of the
are given in Clause 20. medical, dental, pharmacy or nursing profession and
any other person who in the course of their professional
1.4 'Contribution to costs related to events' in relation to activities may administer, prescribe, purchase, recommend
the disclosure of transfers of value means providing or or supply a medicine. In relation to the annual disclosure
covering the costs of travel, accommodation and/or of transfers of value (Clause 28), the term also includes any
registration fees to support the attendance of an individual employee of a pharmaceutical company whose primary
to an event organised or created by a company and/or occupation is that of a practising health professional.
independent organisation. When providing sponsorship
of events/meetings to organisations, associations etc such 1.10 'Hospitality' is limited to travel, subsistence (food and drink),
contributions may include costs for subsistence (food accommodation and genuine registration fees extended in
and drink). connection with events/meetings.

1.5 'Donations and grants' collectively mean providing funds, 1.11 (1.3) 'Medicine' means any branded or unbranded
benefits-in-kind or services freely given for the purpose of medicine intended for use in humans which requires
supporting healthcare, scientific research or education, with a marketing authorisation.
no consequent obligation on the recipient organisation,
institution and the like to provide goods or services to 1.12 (13.2) 'Non-interventional study' is defined as a study of a
the benefit of the pharmaceutical company in return. marketed medicine where the medicine is prescribed in the
Donations and grants to individuals are prohibited. usual manner in accordance with the terms of its marketing
authorisation. The assignment of the patient to a particular
In general, donations are physical items, services or benefits- therapeutic strategy is not decided by a study protocol
in-kind which may be offered or requested. Grants are the but falls within current practice, and the prescription of
provision of funds. the medicine is clearly separated from the decision to
include the patient in the study. No additional diagnostic
or monitoring procedures are applied to the patients, and
epidemiological methods are used for the analysis
of collected data.

08 CODE OF PRACTICE – CLAUSES 1–10 Clause numbers in brackets refer to the 2019 Code of Practice.
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

1.13 (1.5) 'Other relevant decision maker' particularly includes • information supplied by pharmaceutical companies
someone with an NHS role who could influence in any way to national public organisations such as the National
the administration, consumption, prescription, purchase, Institute for Health and Care Excellence (NICE), the All
recommendation, sale, supply or use of any medicine but Wales Medicines Strategy Group (AWMSG) and the
who is not a health professional. Scottish Medicines Consortium (SMC) is exempt from the
Code provided the information is factual, accurate and
1.14 (1.6) 'Over-the-counter medicine' (OTC) means a medicine not misleading
or particular pack of medicine which is primarily advertised
• measures or trade practices relating to prices, margins
to the public for use in self-medication.
or discounts which were in regular use by a significant
1.15 (27.1) 'Patient organisation' means an organisation proportion of the pharmaceutical industry on
mainly comprising of patients and/or caregivers or any 1 January 1993
user organisation such as a disability organisation, carer • summaries of product characteristics
or relative organisation and consumer organisation that • European public assessment reports
represents and/or supports the needs of patients
• UK public assessment reports
and/or caregivers.
• risk minimisation material approved by the Medicines
1.16 'Individuals representing patient organisations' means a and Healthcare products Regulatory Agency (MHRA)
person who is mandated to represent and express the views • the labelling on medicines and accompanying package
of a patient organisation. leaflets insofar as they are not promotional for the
medicines concerned; the contents of labels and package
1.17 (1.2) 'Promotion' means any activity undertaken by a
leaflets are covered by regulations
pharmaceutical company or with its authority which promotes
the administration, consumption, prescription, purchase, • information relating to human health or diseases provided
recommendation, sale, supply or use of its medicines. there is no direct or indirect reference to specific medicines.

It includes: 1.18 (1.8) 'Promotional aid' means a non-monetary item given for
a promotional purpose. Promotional aids may be given to
• journal and direct mail advertising
health professionals and other relevant decision makers only
• the activities of representatives, including any electronic in accordance with Clause 10.4. Health professionals may,
or printed material used by them however, be provided with items which are to be passed on
• the supply of samples to patients in accordance with Clause 19.2.
• the provision of inducements to prescribe, supply,
1.19 (1.7) 'Representative' means a representative calling on
administer, recommend, buy or sell medicines by the
members of the health professions and other relevant
gift, offer or promise of any benefit or bonus, whether in
decision makers in relation to the promotion of medicines.
money or in-kind
• the provision of hospitality for promotional purposes 1.20 (23.2 SI) 'Research and development transfers of value'
• the sponsorship of promotional events/meetings means, for the purposes of disclosure, transfers of value to
health professionals or healthcare organisations related to
• the sponsorship of scientific events/meetings, including
the planning or conduct of:
payment of travelling and accommodation expenses in
connection therewith i. non-clinical studies (as defined in the OECD Principles
on Good Laboratory Practice)
• all other promotion.
ii. clinical trials (as defined in Regulation 536/2014)
It does not include: iii. non-interventional studies that are prospective in nature
• replies made in response to unsolicited individual enquiries and that involve the collection of patient data from or
from members of the health professions or other relevant on behalf of individual or groups of health professionals
decision makers or in response to specific communications specifically for the study.
from them whether of enquiry or comment, including
letters published in professional journals, but only if they 1.21 (17 SI) 'Sample' means a small supply of a medicine
relate solely to the subject matter of the letter or enquiry, provided to health professionals so that they may familiarise
are accurate and do not mislead and are not promotional themselves with it and acquire experience in dealing with
in nature it. A sample of a medicine may be provided only to a health
professional qualified to prescribe that particular medicine.
• factual, accurate, informative announcements and
reference material concerning licensed medicines and 1.22 A company can provide sponsorship for an activity to
relating, for example, to pack changes, adverse reaction certain organisations. 'Sponsorship' means a contribution,
warnings, trade catalogues and price lists, provided they financial or otherwise, in whole or in part provided by or
include no product claims on behalf of a company, towards an activity (including an
• price lists relating to unlicensed medicines, provided they event/meeting or material) performed, organised, created
include no product claims and they make clear that the etc by a healthcare organisation, patient organisation or
products are unlicensed other independent organisation.

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1.23 A company can provide support for individual health

professionals or other relevant decision makers to attend The Code does not apply to the promotion of over-the-counter
events/meetings. 'Support' in this context is the provision (OTC) medicines to members of the health professions when
of a financial contribution, in whole or in part, whether paid the object of that promotion is to encourage their purchase
directly or indirectly to individual health professionals or by members of the public as specified in Clause 1.1. Thus, for
other relevant decision makers to attend events/meetings. example, an advertisement to doctors for an OTC medicine
does not come within the scope of the Code if its purpose
1.24 'Third party' means a legal person/entity or individual that is to encourage doctors to recommend the purchase of the
represents a company or interacts with other parties on medicine by patients. Where the advertisement is designed
behalf of a company or relating to a company's medicine, to encourage doctors to prescribe the medicine, then it comes
such as distributors, wholesalers, consultants, contract within the scope of the Code.
research organisations, professional congress organisers,
contracted sales forces, market research companies, Advertisements for OTC medicines to pharmacists are outside
advertising agencies, media buyers, providers of services the scope of the Code. Advertisements to pharmacists for
related to events, public relations services, non-clinical other medicines come within the scope of the Code.
services, non-interventional studies management services etc. Companies should be aware that if a non-promotional item
is used for a promotional purpose, it would come within
Companies are responsible under the Code for the acts and
the definition of promotion. If an item which is covered by
omissions of their third parties which come within the scope
regulations such as the summary of product characteristics
of the Code, even if they act contrary to the instructions
(SPC) or a patient information leaflet which is included in
which they have been given.
the pack (PIL) (excluded from the definition of promotion in
1.25 (1.10) 'Transfer of value' means a direct or indirect transfer of Clause 1.17) is used for a promotional purpose, then it would
value, whether in cash, in-kind or otherwise, made, whether come within the scope of the Code.
for promotional purposes or otherwise, in connection with Clause 1.1 Journals with an International Distribution
the development or sale of medicines. A direct transfer of The Code applies to the advertising of medicines in
value is one made directly by a company for the benefit of professional journals which are produced in the UK and/or
a recipient. An indirect transfer of value is one made on intended for a UK audience. The identification of the country
behalf of a company for the benefit of a recipient or in which a journal is 'produced' is based on factors such as
through an intermediate and where the company knows where it is compiled and edited, and for printed journals,
or can identify the recipient that will benefit from the where it is typeset, printed and bound, rather than on factors
transfer of value. such as the location of the head office of the publisher.
The following are not transfers of value for the purposes of
the Code: International journals which are produced in English in
the UK are subject to the Code even if only a small
• transfers of value that are solely related to OTC medicines
proportion of their circulation is to a UK audience.
• ordinary course purchases and sales of medicines by It is helpful in these circumstances to indicate that the
and between a company and a health professional or information in the advertisement is consistent with the
a healthcare organisation UK marketing authorisation.
• samples of medicines provided in accordance with Clause 21
It should be noted that the Medicines and Healthcare
• transfers of value provided in accordance with Clauses products Regulatory Agency's (MHRA's) guidance
10.4, 10.5 and 19.2 'Advertising and Promotion of Medicines in the UK', The Blue
• subsistence provided to health professionals and other Guide, differs from the above by advising that advertising
relevant decision makers in accordance with Clause 10.1. material in professional journals intended primarily for
circulation in the UK, whether or not in the English
language, must comply with UK legislation and with the UK
marketing authorisation for the product.
Clause 1 Supplementary Information In addition, where a journal is produced in the UK but
intended for distribution solely to overseas countries, local
Clause 1.1 Scope of the Code requirements and/or the requirements of the International
The Code applies to the promotion of medicines to members Federation of Pharmaceutical Manufacturers and Associations'
of the health professions and to other relevant decision (IFPMA) Code of Practice should be borne in mind.
makers as specified in Clause 1.1. This includes promotion
at events/meetings for UK residents held outside the UK. It Clause 1.1 Advertising to the Public and Advertising OTC
also applies to promotion to UK health professionals and Medicines to Health Professionals
other relevant decision makers at international events/ The promotion of medicines to the public for self-medication
meetings held outside the UK, except that the promotional is covered by the Consumer Code of the Proprietary
material distributed at such events/meetings will need to Association of Great Britain (PAGB) (www.pagb.co.uk).
comply with local requirements. Information on applicability The PAGB also has a Professional Code which applies to
of codes can be found in the supplementary information to advertising involving OTC medicines aimed wholly or mainly
Clause 3.4. at persons qualified to prescribe or supply and people

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working for them, where the object of the advertising is to Clause 1.17 (1.2) Terms of Trade
influence sales and/or recommendations to the public. See supplementary information to Clause 19.1.
Clause 1.1 Promotion to Other Relevant Decision Makers Clause 1.17 (1.2) Price Lists for Unlicensed Medicines
Particular attention is drawn to Clause 5.6. Price lists for unlicensed medicines which include no product
claims and make clear that the products are unlicensed can
Clause 1.17 (1.2) Replies Intended for Use in Response to be sent to health professionals and other relevant decision
Individual Enquiries makers at reasonable intervals or in response to enquiries.
An unsolicited enquiry is one without any prompting from They must not be used proactively in a manner which could
the company. In answering any unsolicited enquiry, a be seen to be promoting unlicensed medicines, such as by
company can offer to provide further information. If the displaying them on exhibition stands.
enquirer subsequently requests additional information, this
can be provided and would be exempt from the Code as Clause 1.17 (1.2) Risk Minimisation Plans and Material
long as the additional information met the requirements of As part of the marketing authorisation process,
the exemption. A solicited enquiry would be one where a companies can be required to have risk minimisation
company invites or prompts a person to make a request. plans and material approved by the MHRA as part of the
For example, material offering further information to readers company's pharmacovigilance obligations. Such approved
would be soliciting a request for that information and documentation can be delivered by a representative or
placing documents on exhibition stands amounts to an included on a company website without being considered to
invitation to take them; neither can take the benefit of be promotion of the medicine to which it refers.
this exemption.

Replies intended for use in response to enquiries which

are received on a regular basis may be drafted in advance
provided that they are used only when they directly and
solely relate to the particular enquiry. Documents must not
look like promotional material.

Overarching Requirements
CLAUSES 2-4 OBLIGATIONS AND RESPONSIBILITIES

Clause 2 Clause 3
Upholding Confidence in the Industry Obligations
Activities or materials must never be such as to bring discredit 3.1 (3.1) A medicine must not be promoted prior to the grant of
upon, or reduce confidence in, the pharmaceutical industry. the marketing authorisation which permits its sale or supply.

3.2 (26.1) Prescription only medicines must not be advertised to

Clause 2 Supplementary Information the public. This prohibition does not apply to vaccination
and other campaigns carried out by companies and
A ruling of a breach of this clause is a sign of particular approved by the health ministers.
censure and is reserved for such circumstances.
3.3 (29) When an undertaking has been given in relation to a
Examples of activities that are likely to be in breach of ruling under the Code, the company concerned must ensure
Clause 2 include prejudicing patient safety and/or public that it complies with that undertaking.
health, excessive hospitality, inducements to prescribe,
unacceptable payments, inadequate action leading to a 3.4 (1.11) Companies must comply with all applicable codes,
breach of undertaking, promotion prior to the grant of a laws and regulations to which they are subject.
marketing authorisation, conduct of company employees/
3.5 Gifts for personal benefit (such as sporting or
agents that falls short of competent care and multiple/
entertainment tickets, social courtesy gifts) are prohibited
cumulative breaches of a similar and serious nature in the
and must not be given, either directly or indirectly, to any
same therapeutic area within a short period of time.
individual health professional, other relevant decision maker
or individual associated with a healthcare organisation or
patient organisation.

Providing or offering cash, cash equivalents or the provision

of services that confer a personal benefit to the recipient
is prohibited.

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3.6 (12.1) Materials and activities must not be disguised promotion.

The information provided must not:
3.7 (1.12) Each company must appoint a senior employee to vi. be promotional in style – product logos should be
be responsible for ensuring that the company meets the avoided but company logos may be used; the brand
requirements of the Code. name of the product may be included in moderation but
it should not be stylised or used to excess
Clause 3 Supplementary Information vii. include mock up drafts of either summaries of product
characteristics or package leaflets.
Clause 3.1 (3) Marketing Authorisation If requested, further information may be supplied or
The legitimate exchange of medical and scientific a presentation made.
information during the development of a medicine is not
prohibited, provided that any such information or activity Clauses 3.1 and 3.2 (New) Temporary Authorisation for
does not constitute promotion which is prohibited under this Sale or Supply without a Marketing Authorisation
or any other clause. In response to certain types of public health emergency, under
UK law, the licensing authority may temporarily authorise
Clause 3.1 (3.1) Advance Notification of New Products the sale or supply of a medicine without a marketing
or Product Changes Which May Significantly Affect authorisation. This might apply to medicines without
Expenditure UK marketing authorisations or indications without UK
NHS organisations and others involved in the purchase of marketing authorisations. The campaign must be approved
medicines need to estimate their likely budgets in advance, by the health ministers and all other relevant requirements
so there is a need for them to receive advance information of the Code will apply. In relation to advertising to health
about the introduction of new medicines or changes to professionals and other relevant decision makers, further
existing medicines which may significantly affect their information is given in Clause 11.3 and its supplementary
level of expenditure, including that which might arise from information. In relation to advertising to the public, further
changes in the patient pathway and/or service delivery. information is given in Clause 26.1 and its supplementary
information. Companies should contact the Medicines
When this information is required, the medicines concerned
and Healthcare products Regulatory Agency (MHRA) for
(or the changes to them) will not be the subject of
information regarding approval of materials and activities.
marketing authorisations (although applications will often
have been made) and it would be in breach of the Code Clause 3.2 (26.1) Advertising of Medicines to the Public
for them to be promoted. Companies wishing to provide The advertising of prescription only medicines to the
advance notification must ensure that information is also public is also prohibited by the relevant regulations
provided wherever possible for inclusion in national horizon relating to advertising.
scanning databases. Non-promotional information can be
provided as advance notification, but it must: The promotion of over-the-counter (OTC) medicines to
the public for self-medication purposes is covered by the
i. relate to a product which:
Consumer Code of the Proprietary Association of Great
• contains a new active substance, or Britain (PAGB).
• contains an active substance prepared in a new way,
Clause 3.4 (1.11) Applicability of Codes
such as by the use of biotechnology, or
Compliance with all applicable codes, laws and regulations
• is to have a significant addition to the existing range to which a pharmaceutical company is subject is particularly
of authorised indications, or relevant when activities/materials involve more than one
• is to have a novel and innovative means country or when a company based in one country is
of administration involved in activities in another country.
ii. only be directed to those responsible for making policy
Activities carried out and materials used by a
decisions on budgets and not those only expected
pharmaceutical company located in a European country
to prescribe
must comply with the national code of that European
iii. state whether or not a new medicine or a change country as well as the national code of the country in which
to an existing medicine is the subject of a UK the activities take place or the materials are used.
marketing authorisation
iv. state the likely cost or savings and budgetary Activities carried out and materials used in a European
implications which must be such that they will country by a pharmaceutical company located in a country
significantly change the organisation's likely expenditure other than a European country must comply with the
(the budgetary implication might include the need for European Federation of Pharmaceutical Industries and
service redesign) Associations (EFPIA) Code as well as the national code
of the country in which the activities are carried out and
v. be factual and limited to that sufficient to provide
materials are used. For example, a company located in
an adequate but succinct account of the product's
the UK carrying out an activity outside the UK but within
properties; other products should only be mentioned
Europe, such as in France, must comply with the UK Code
to put the new product or indication into context in the
and the French Code regardless of whether or not UK
therapeutic area concerned.

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4.4 (27.7 and 27.8) Companies must document and publicly

health professionals or other relevant decision makers are disclose annually donations and grants whether financial,
involved. Conversely, a company located in France carrying non-financial or a benefit-in-kind, and sponsorship (including
out an activity in the UK must comply with the ABPI Code in relation to events/meetings) made to patient organisations.
regardless of whether or not UK health professionals or other
relevant decision makers are involved. Details of the various Fees and expenses for the provision of contracted services,
codes can be found at www.efpia.eu or www.ifpma.org. including those performed by individuals representing
patient organisations, which should be paid to patient
The term 'company' means any legal entity that organises organisations must also be publicly disclosed annually as set
or sponsors promotion which takes place within Europe, out in Clause 29.
whether such entity be a parent company (eg the
headquarters, principal office, or controlling company of a 4.5 (New Clause) Companies must document and publicly
commercial enterprise), subsidiary company or any other disclose annually fees and expenses made to individual
form of enterprise or organisation. members of the public, including patients and journalists, for
the provision of contracted services performed as set out in
In the event of a conflict of requirements, the more restrictive Clause 30.
requirements would apply. There is a potential exception
with regard to the limits for subsistence set in European 4.6 (13.1) Companies must disclose details of clinical trials in
countries where the national association is a member of accordance with the Joint Position on the Disclosure of
EFPIA and thus covered by the EFPIA Code as referred to in Clinical Trial Information via Clinical Trial Registries and
the supplementary information to Clause 10.7. Databases and the Joint Position on the Publication of
Clinical Trial Results in the Scientific Literature. Companies
All international events, that is to say events that take place must include on the home page of their website information
outside the responsible pharmaceutical company's home as to where details of their clinical trials can be found.
country, must be notified in advance to any relevant local
subsidiary or local advice taken. 4.7 (13.3) Companies must publish the summary details and
results of non-interventional studies of marketed medicines
Companies must take reasonable steps to ensure that any in a manner consistent with their parallel obligations with
other parties that they commission to design, implement or respect to clinical trials.
engage in activities covered by the Code but which do not
act on behalf of the company, and are therefore not covered 4.8 (26.5) Companies are responsible for information about
by Clause 1.17, for example, joint ventures or licensees, their products which is issued by their agencies, eg
comply with the Code. communications, advertising etc.

Clause 3.7 (1.12) Responsible Person

There is an assumption that the responsible person is the Clause 4 Supplementary Information
managing director or chief executive or equivalent unless other
formal arrangements have been made within the company. Clauses 4.1 and 4.2 (25.1 and 25.2) Scientific Service
Companies can have one scientific service in charge of
both responsibilities or separate services with clearly
delineated duties.
Clause 4 Clause 4.6 (13.1) Details of Clinical Trials
Responsibilities This clause requires the provision of details about ongoing
clinical trials (which must be registered within 21 days of
4.1 (25.1) Companies must have a scientific service to compile
initiation of patient enrolment) and the results of completed
and collate all information received from any source about
trials for medicines licensed for use and commercially
the medicines which they market.
available in at least one country.
4.2 (25.2) Companies must have a scientific service to deal with
Further information can be found in the current Joint
the approval and supervision of non-interventional studies.
Position on the Disclosure of Clinical Trial Information via
This scientific service must include a registered medical
Clinical Trial Registries and Databases and the current Joint
practitioner or a pharmacist registered in the UK who will be
Position on the Publication of Clinical Trial Results in the
responsible for the oversight of non-interventional studies
Scientific Literature, both at www.ifpma.org/resource-centre/
(including the review of any responsibilities relating to such
clinical-trials-position-papers/.
studies, particularly those given to representatives) and
certification of the protocol. Details about clinical trials must be limited to factual and
non-promotional information. Such information must not
4.3 (24.1) Companies must document and publicly disclose
constitute promotion to health professionals, other relevant
certain transfers of value made directly or indirectly to
decision makers or the public.
health professionals, other relevant decision makers and
healthcare organisations located in Europe as set out in
Clause 28. This includes any employee of a pharmaceutical
company whose primary occupation is that of a practising
health professional.

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Overarching Requirements
CLAUSES 5-10 QUALITY STANDARDS

Clause 5
These include:
High Standards and Suitability
• the display of naked or partially naked people for the
5.1 (9.1) High standards must be maintained at all times. purpose of attracting attention to the material or the use
of sexual imagery for that purpose
5.2 (9.2) All material and activities must recognise the special
• 'teaser' communication/advertising whereby material is
nature of medicines and respect the professional standing
intended to 'tease' the recipient by eliciting an interest in
or otherwise of the audience to which they are directed and
something which will be following or will be available at a
must not be likely to cause offence.
later date without providing any actual information about it.
5.3 (9.3) The name or photograph of a member of a health Care should be taken with language, use of abbreviations
profession must not be used in any way that is contrary to etc and the use of emojis and the like.
the conventions of that profession.
Clause 5.5 (9.10) Declaration of Involvement
5.4 (9.7) Extremes of format, size or cost of material must be The wording of the declaration of involvement must be
avoided. Informational or educational materials must be unambiguous so that readers are immediately able to
inexpensive, directly relevant to the practice of medicine or understand the extent of the company's involvement and
pharmacy and directly beneficial to the care of patients. influence. This is particularly important when companies are
involved in the production of material which is circulated
5.5 (9.10) Material relating to medicines and their uses, whether by an otherwise wholly independent party, such as
promotional or not, and information relating to human supplements to health professional journals.
health or diseases which is sponsored by a pharmaceutical
company or in which a pharmaceutical company has any The declaration of sponsorship must be sufficiently
other involvement, must clearly indicate the role of that prominent to ensure that readers of sponsored material are
pharmaceutical company. aware of it at the outset.

The only exception to this is market research material if Clause 5.7 (28.6) Sites Linked via Company Sites
it is such that the name of the company involved is not Sites linked via company sites are not necessarily covered by
required to be stated; then the material must state that it is the Code.
sponsored by a pharmaceutical company.

5.6 (11.1) Material should only be provided or made available to

those groups of people whose need for or interest in it can
reasonably be assumed. Material should be tailored to the Clause 6
audience to whom it is directed. Information, Claims, Comparisons and Disparagement
5.7 (28.6) It should be made clear when a user is leaving any Clauses 14 and 18 may also be relevant.
of the company's websites or websites sponsored by the
company or is being directed to a website which is not that 6.1 (7.2) Information, claims and comparisons must be accurate,
of the company. balanced, fair, objective and unambiguous and must be
based on an up-to-date evaluation of all the evidence and
reflect that evidence clearly. They must not mislead either
Clause 5 Supplementary Information directly or by implication, by distortion, exaggeration or
undue emphasis.
Clauses 5.1 and 5.2 (9.1 and 9.2) High Standards
and Suitability Material must be sufficiently complete to enable recipients
The special nature of medicines and the audience to which to form their own opinion of the therapeutic value of
the information is directed require that the standards set for the medicine.
information about medicines are higher than those which
might be acceptable for general commodity communications 6.2 (7.4) Any information, claim or comparison must be capable
and advertising. of substantiation.

It follows, therefore, that certain types, styles and methods Companies must provide substantiation, following a request
of communication, even where they might be acceptable for it as set out in Clauses 14.3 and 18.2. In addition, when
for products other than medicines, are unacceptable. data from a clinical trial is used, companies must ensure
that where necessary, that trial has been registered and the
results disclosed in accordance with Clause 4.6.

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6.3 (7.8) All artwork, including illustrations, graphs and tables,

must conform to the letter and spirit of the Code and, when • economic evaluation of medicines. Any claim involving the
taken from published studies, a reference must be given. economic evaluation of a medicine must be borne out by
Graphs and tables must be presented in such a way as to the data available and not exaggerate its significance. To
give a clear, fair, balanced view of the matters with which be acceptable as the basis of claims, the assumptions made
they deal and must not be included unless they are relevant in an economic evaluation must be clinically appropriate
to the claims or comparisons being made. and consistent with the marketing authorisation
• emerging clinical or scientific opinions which have
6.4 (7.9) Information and claims about adverse reactions must not been resolved in favour of one generally accepted
reflect available evidence or be capable of substantiation viewpoint must be referred to in a balanced manner
by clinical experience. It must not be stated that a product
• hanging comparisons whereby a medicine is described as
has no adverse reactions, toxic hazards or risks of addiction
being better or stronger or suchlike without stating that
or dependency. The word 'safe' must not be used
with which it is compared must not be made
without qualification.
• price comparisons as with any comparison, must be
6.5 (7.11) The word 'new' must not be used to describe any accurate, fair and must not mislead. Valid comparisons
product or presentation which has been generally available, can only be made where like is compared with like. It
or any therapeutic indication which has been promoted, for follows, therefore, that a price comparison should be
more than twelve months in the UK. made on the basis of the equivalent dosage requirement
for the same indications
6.6 (8.1) The medicines, products and activities of other
• statistical information, claims and comparisons must
pharmaceutical companies must not be disparaged.
have a sound statistical basis. Differences which do not
6.7 (8.2) The health professions and the clinical and scientific reach statistical significance must not be presented in
opinions of health professionals must not be disparaged. such a way as to mislead.

Instances have occurred where claims have been based on

published papers in which the arithmetic and/or statistical
Clause 6 Supplementary Information
methodology was incorrect. Accordingly, before statistical
Clauses 14 and 18 may also be relevant. information is included in material, it must have been
subjected to statistical appraisal.
Clause 6.1 (7) General
The application of this clause is not limited to information or Clause 6.3 (7.8) Artwork, Illustrations, Graphs and Tables
claims of a medical or scientific nature. It includes, among Care must be taken to ensure that artwork does not mislead
other things, information or claims relating to pricing and as to the nature of a medicine or any claim or comparison
market share. and that it does not detract from any warnings or contra-
indications. For example, anatomical drawings used to
It should be borne in mind that claims in material must show results from a study must not exaggerate those results
be capable of standing alone as regards accuracy etc. and depictions of children should not be used in relation to
In general, claims should not be qualified by the use of products not authorised for use in children in any way which
footnotes and the like. might encourage such use.
Clause 6.1 (7.2) Information, Claims and Comparisons Particular care should be taken with graphs and tables
The following are areas where particular care should be to ensure that they do not mislead, for example, by being
taken by companies: incomplete or by the use of suppressed zeros or unusual
• claims for superior potency in relation to weight are scales. Differences which do not reach statistical significance
generally meaningless and best avoided unless they can must not be presented in such a way as to mislead.
be linked with some practical advantage, for example,
reduction in adverse reactions or cost of effective dosage Graphs and tables must be adequately labelled so that the
information presented can be readily understood. When
• data derived from in vitro studies, studies in healthy taken from published studies, the source of the artwork must
volunteers and in animals must not be used in a way that be given (see also Clause 14.2). If a graph, table or suchlike is
misleads as to its significance. The extrapolation of such taken from a published study, it must be faithfully reproduced
data to the clinical situation should only be made where except where modification is needed in order to comply with
there is data to show that it is of direct relevance the Code. In such circumstances, it must be clearly stated
and significance that the material has been modified. Any such adaptation
• absolute risk and relative risk. Referring only to relative must not distort or mislead as to the significance of that
risk, especially with regard to risk reduction, can make graph, table etc. Care should be taken not to mislead when
a medicine appear more effective than it actually is. expressing data as percentages; patient numbers should be
In order to assess the clinical impact of an outcome, the included wherever possible. It should also be noted that if
reader also needs to know the absolute risk involved. a table, graph etc in a paper is unacceptable in terms of the
In that regard, relative risk should never be referred to requirements of the Code because, for example, it gives a
without also referring to the absolute risk. Absolute risk visually misleading impression as to the data shown, then it
can be referred to in isolation must not be used or reproduced in material.

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8.2 (14.2) All events/meetings involving travel outside the

Clause 6.4 (7.9) Use of the Word 'Safe' UK, unless the company's only involvement is to support
The restrictions on the word 'safe' apply equally to a speaker to present at the meeting, must be certified in
grammatical derivatives such as 'safety'. For example, advance as set out in Clause 8.1 or by an appropriately
'demonstrated safety' or 'proven safety' are prohibited under qualified person signatory (AQP signatory). That person
this clause. does not need to be either a registered medical
practitioner or a pharmacist registered in the UK.

8.3 (14.3) The following must be certified in advance in a

manner similar to that provided for by Clause 8.1:
Clause 7
• educational material for the public or patients issued by
Use of Quotations companies which relates to diseases or medicines but is
7.1 (10.2) Quotations from medical and scientific literature not intended as promotion for those medicines
or from personal communications must be faithfully • material relating to working with patient organisations as
reproduced, accurately reflect the meaning and current described in Clause 27 and its supplementary information
views of the author and otherwise comply with the Code. • material relating to collaborative working as described in
The precise source of the quotation must be identified. Clause 20 and its supplementary information
7.2 (10.3) Quotations relating to medicines taken from public • material and items for patient support whether provided
broadcasts, for example, on radio and television, and from directly to patients or to health professionals to be passed
private occasions, such as medical conferences or symposia, on to patients as described in Clauses 19.2, 26.3 and
must not be used without the formal permission of the speaker. associated supplementary information
• the written agreement for donations and grants,
including where relevant internal company and service
Clause 7 Supplementary Information provider instructions as described in Clause 23 and its
supplementary information
Clause 7.1 (10.2) Quotations
Any quotation chosen by a company for use in material • (25.2) protocols relating to non-interventional studies.
must comply with the requirements of the Code itself. For 8.4 (14.4) The names of those nominated as signatories as set
example, to quote from a paper which stated that a certain out in Clauses 8.1 and 8.2, together with their qualifications,
medicine was 'safe and effective' would not be acceptable must be notified in advance to the Advertising Standards
even if it was an accurate reflection of the meaning of the and Outreach Unit, Vigilance and Risk Management
author of the paper, as it is prohibited under Clause 6.4 to of Medicines Division of the Medicines and Healthcare
state without qualification that a medicine is safe. Care products Regulatory Agency (MHRA), and to the Prescription
should be taken in quoting from any study or the like to Medicines Code of Practice Authority (PMCPA). Changes in
ensure that it does not mislead as to its overall significance. the names of nominees must be promptly notified.
Quotations can only be adapted or modified in order to 8.5 (14.5) The certificate for promotional material must certify
comply with the Code. In such circumstances, it must be that the signatory has examined the final form of the
clearly stated that the quotation has been amended. material to ensure that in their belief it is:
If there is any doubt as to the current view of an author, • in accordance with the requirements of the relevant
companies should check with the author prior to its use. regulations relating to advertising and this Code
• not inconsistent with the marketing authorisation
and the summary of product characteristics
• a fair and truthful presentation of the facts about
Clause 8 the medicine.
Certification and Examination
The certificate for material covered by Clause 8.3 above
8.1 (14.1) Promotional material must not be issued unless its must certify that the signatory has examined the final form
final form, to which no subsequent amendments will be of the material to ensure that in their belief it complies with
made, has been certified by one person on behalf of the the Code.
company in the manner provided for by this clause, subject
Material which is still in use must be recertified at intervals
to the provisions of the supplementary information to this
of no more than two years to ensure that it continues to
clause where relevant. This person must be a registered
conform with the relevant regulations relating to advertising
medical practitioner or a pharmacist registered in the UK or
and the Code.
alternatively, in the case of a product for dental use only, a
UK registered dentist.

The person certifying on behalf of the company must not

be the person responsible for developing or drawing up
the material.

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The certificate for events/meetings involving travel outside

the UK must certify that the signatory has examined all material is available, including reproductions of any graphs,
the proposed arrangements and that, in their belief, they tables and the like that appear in it. In the event of a
are in accordance with the relevant regulations relating to complaint, a copy of the written material will be requested.
advertising and the Code. Alternatively, companies may certify material on interactive
systems by means of producing an electronic copy, for
8.6 (14.6) Companies must preserve certificates. Material in example, on a CD-ROM or data stick, if the electronic copy is
the form certified and information indicating the persons to write protected and unable to be changed.
whom it was addressed, the method of dissemination and
the date of first dissemination must also be preserved. In See also the supplementary information to Clause 11
relation to certificates for events/meetings involving travel regarding the certification of promotional material to be used
outside the UK, details of the programme, the venue, the at international conferences.
reasons for using the venue, the audience, the anticipated
Clause 8.1 (14.1) Certifying Dynamic Content
and actual costs and the nature of the hospitality and the
When certifying dynamic content such as websites etc care
like must also be preserved.
must be taken to ensure the dynamic content meets the
Companies must preserve certificates and the relevant requirements of the Code as a standalone item. As the final
accompanying information for not less than three years form is not static, consideration needs to be given to the
after the final use of the material or the date of the event/ context in which it appears but each possible combination
meeting and produce them on request from the MHRA or does not need to be certified.
the PMCPA.
Clause 8.1 (14.1) Qualifications for Signatories
In deciding whether a person can be a nominated signatory,
account should be taken of product knowledge, relevant
Clause 8 Supplementary Information experience both within and outside the industry, length of
service and seniority. In addition, signatories must have an
Clause 8.1 (14.1) Certification
up-to-date, detailed knowledge of the Code. The registered
An acceptable way to comply with Clause 8.1 is for the final
medical practitioner should be capable of being registered
proof to be certified, but this is not obligatory provided
in the UK without the need for additional tests of medical/
that that which is certified is in its final form to which no
clinical knowledge.
subsequent amendments will be made. Companies may
use validated electronic signatures for certifying material. Clause 8.1 (14.1) Joint Ventures and Co-Promotion
Paper or electronic copies of certificates and the final form In a joint venture in which a third party provides a service
of material etc must be preserved in order to comply with on behalf of a number of pharmaceutical companies, the
Clause 8.6. pharmaceutical companies involved are responsible for any
activity carried out by that third party on their behalf.
All promotional material must be certified in this way, including
audio and audiovisual material, promotional material on It follows, therefore, that the pharmaceutical companies
databases, interactive data systems and the internet and involved should be aware of all aspects of the service carried
relevant representatives' briefing materials. Promotional aids out on their behalf and take this into account when certifying
must also be certified – although not strictly promotional the material or activity involved. Similarly, if two or more
material, they are used for a promotional purpose. pharmaceutical companies organise a joint event/meeting,
each company should ensure that the arrangements for the
Companies should be aware that if they use a non-
event/meeting are acceptable.
promotional item for a promotional purpose, it would need to
be certified. Under co-promotion arrangements or other arrangements
where companies work together, such as collaborative
When certifying material where the final form is to be printed,
working projects, the companies concerned can agree to
companies can certify the final electronic version of the item
have only one final signatory to certify on behalf of all the
to which no subsequent amendments will be made. When
companies. This must all be agreed beforehand and the
such material is printed, the company must ensure that the
MHRA and the PMCPA must be informed in advance who
printed material cannot be used until the item has been
the signatory will be. In the event of a complaint about
examined and signed in its final form to ensure it accurately
material certified in this way, each company involved in the
reflects the content and presentation certified electronically.
project/activity would be responsible under the Code.
In such circumstances, the material will have a certificate
and a declaration approving the final form and both must Clause 8.2 (14.2) Events/Meetings Involving Travel Outside
be preserved as they form the certification of the item. The the UK
examination of the printed form can be carried out by a UK companies have responsibilities under the Code for
signatory, an appropriately qualified person signatory (AQP events/meetings which they organise and when UK
signatory) or an appropriately qualified person (AQP). delegates are supported and/or UK speakers are contracted
to go to events/meetings outside the UK. Clauses 24, 28, 29,
In certifying audio and audiovisual material and promotional
30 and 31 in relation to disclosure of transfers of value will
material on databases, interactive systems and the internet,
also need to be followed.
companies must ensure that a written transcript of the

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When certifying arrangements for events/meetings which Clause 8.4 (14.4) Notification of Signatories
involve travel outside the UK, all the relevant documents and The names and qualifications of signatories and changes
arrangements must be considered, including the programme, to them should be notified to the MHRA by email to
the venue, the reasons for using that venue, the intended [email protected]. The PMCPA can
audience, the anticipated cost and the nature of the be notified by completing the nominated signatory form
hospitality and the like. which can be found at www.pmcpa.org.uk. The names and
qualifications to be sent to the MHRA and PMCPA are those
If the company's only involvement is to support a speaker to of the registered medical practitioner or the pharmacist
present at the event/meeting and there is no pharmaceutical registered in the UK or, if the product is for dental use only,
company involvement with the event/meeting at all, for a UK registered dentist as set out in Clause 8.1 and the AQP
example, a learned society event/meeting, then neither signatory as set out in Clause 8.2.
certification nor examination is required.
Clause 8.6 (14.6) Retention of Documentation
Clause 8.2 (14.2) Presentations by UK Speakers at Events/ The MHRA is entitled to request details of an advertisement,
Meetings Held Outside the UK including particulars as to the content and form of the
When a pharmaceutical company based outside the UK advertisement, the method of dissemination and the date of
arranges via a UK company for a UK speaker to present first dissemination, and such a request is not subject to any
at an event/meeting to be held outside the UK, then time limit. This does not apply to the certificates themselves
that speaker's presentation materials do not need to be in respect of which the three year limit in Clause 8.6 is
certified or examined by the UK, provided there are no UK applicable. There is further information in the MHRA
delegates and the UK company has no role whatsoever in Blue Guide.
relation to the event/meeting or the presentation. In such
circumstances, the event/meeting arrangements, in as much
as they apply to the UK speaker, will not have to be certified
or examined.

Clause 8.2 (14.2) Qualifications for those who Certify

Clause 9
Events/Meetings Involving Travel Outside the UK Training
In deciding whether someone other than a registered
9.1 (16.1) All relevant personnel, including representatives, and
medical practitioner or a pharmacist registered in the UK is
members of staff, and others retained by way of contract,
appropriately qualified to certify events/meetings involving
concerned in any way with the preparation or approval
travel outside the UK (AQP signatory), account should be
of material or activities covered by the Code must be
taken of relevant experience both within and outside the
fully conversant with the Code and the relevant laws
industry, length of service and seniority. In addition, such a
and regulations.
person must have an up-to-date and detailed knowledge of
the Code. 9.2 (16.2) All personnel (and others retained by way of contract)
must be fully conversant with pharmacovigilance requirements
Clauses 8.1 and 8.2 Appropriately Qualified Persons
relevant to their work, and this must be documented.
It is possible for a company to have different individuals who
would act as an AQP for examination depending on their 9.3 (15.1) Representatives must be given adequate training
skill sets and the material and activities etc being examined. and have sufficient scientific knowledge to enable them to
For example, an individual with proof reading skills could provide full and accurate information about the medicines
examine and sign the final form of printed material which has which they promote.
been certified electronically as set out in the supplementary
information to Clause 8.1. It is unlikely that this AQP would 9.4 (16.3) Representatives must take an appropriate
also have the necessary skills to examine market research examination within their first year of employment as a
material to ensure it does not contravene the Code as set representative and must pass it within two years of starting
out under the supplementary information to Clause 8.3. such employment. To be acceptable, an appropriate
examination must have been accredited to at least Level 3
Clause 8.3 (14.3) Examination of Other Material or its equivalent by an external awarding body recognised
Material issued by companies which is not required to be by Ofqual.
certified under the Code should be examined by a signatory
or an AQP, who needs not be a signatory, to ensure that An appropriate examination for medical representatives is
it does not contravene the Code or the relevant statutory one that requires a broad understanding of body systems,
requirements. Such material might include corporate diseases and treatments, the development of new medicines
advertising, press releases, market research material, and the structure and function of the NHS and of the
financial information to inform shareholders, the Stock pharmaceutical industry. Such an examination must be at
Exchange and the like, and written responses from medical the level of a Diploma (equivalent to at least 480 hours Total
information departments or similar to unsolicited enquiries Qualification Time).
from the public etc.
An appropriate examination for generic sales
representatives is one that requires a broad understanding

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of body systems and the structure and function of the NHS

and of the pharmaceutical industry. Such an examination A candidate who has taken part of an ABPI examination
must be at the level of a Certificate (equivalent to at least who wishes to transfer to a new provider will have to take
330 hours Total Qualification Time). the whole of the new provider's examination. Similarly, a
candidate who has taken part of an alternative provider's
An appropriate examination can be either the relevant ABPI examination who wishes to transfer to an ABPI examination
examination (for medical or generic sales representatives) or will have to take the whole of that examination. This will
an examination of at least the same standard which covers not apply if it can be demonstrated that the units already
similar content and learning material as the corresponding passed are equivalent to those of the new provider.
ABPI examination.
Clause 9.4 (16.3) Information from Examination Provider
9.5 (16.4) Details of the numbers of representatives who have A company must ensure that its examination provider would
passed an examination, together with the examination respond to requests for information from the PMCPA.
status of others, must be provided to the PMCPA on request.
Clause 9.4 (16.3) Time Allowed to Pass an Examination
Prior to passing an appropriate examination, representatives
Clause 9 Supplementary Information may be engaged in such employment for no more than two
years, whether continuous or otherwise and irrespective of
Clause 9.1 (16.1) Training whether with one company or with more than one company.
Extensive in-house training on the Code is carried out by A representative cannot, for example, work eighteen months
companies and by the PMCPA. In addition, the PMCPA runs with one company and eighteen months with another and
seminars on the Code which are open to all companies and so on, thus avoiding an examination. Maternity or paternity
personnel from advertising agencies, public relations agencies leave does not count towards the specified time periods.
and the like which act for the pharmaceutical industry. Details
of these seminars can be obtained from the PMCPA. In the event of extenuating circumstances, such as
prolonged illness or no or inadequate opportunity to take
Clause 9.4 (16.3) Representatives Examinations an appropriate examination, the Director of the PMCPA
The ABPI offers two examinations, and further details may agree to the continued employment of a person as a
can be obtained from the ABPI. representative past the end of the two year period, subject
Examinations may also be offered by other providers. A to the representative passing an appropriate examination
company using an examination provider other than the ABPI within a reasonable time.
must be able to demonstrate that its examinations are at Similarly, in the event of failure to take an appropriate
least equivalent to those offered by the ABPI. The syllabus examination within the first year, the Director may agree
studied should be mapped to and meet the requirements to an extension, subject to the representative taking an
in the published ABPI standards. The assessment must be examination within a reasonable time.
under invigilated examination conditions.
An application for an extension should be made on a form
The ABPI Medical Representatives Examination is
available from the PMCPA. It should preferably be made by
appropriate for representatives whose duties comprise or
the company rather than the representative.
include one or both of:
• calling upon doctors and/or dentists and/or Service as a representative prior to 1 January 2006 by
other prescribers persons who were exempt from taking the appropriate
• the promotion of medicines on the basis of, among examination by virtue of Clause 16.4 of the 2003 edition
other things, their particular therapeutic properties. of the Code does not count towards the two year limit
on employment as a representative prior to passing the
The ABPI Generic Sales Representatives Examination is appropriate examination.
appropriate for representatives who promote medicines
primarily on the basis of price, quality and availability to Clause 9.4 (New) Extensions to the Time Allowed to Pass
non-prescribers. an Examination as a Result of the COVID-19 Pandemic
In addition to the information for extensions set out
Persons who have passed the ABPI Medical Representatives above, further arrangements were put in place as the ABPI
Examination or similar whose duties change to those specified examination was not available between 13 March 2020 and
for generic sales representatives do not need to take another 30 September 2020 due to the impact of the COVID-19
examination. However, persons who have passed the ABPI pandemic, and as a consequence, certain representatives
Generic Sales Representatives Examination or similar whose could not meet the time periods for taking and/or passing
duties change to those specified for medical representatives the examination as required by the Code. Extensions have
must take an appropriate examination within one year of their been granted during 2020 when requested. Everyone's
change of duties and pass it within two years. circumstances are different and will need to be taken into
account. Companies should make every effort to comply
Clause 9.4 (16.3) Accredited Examinations
with the spirit of the Code and ensure that representatives
Representatives commencing such employment on or after
take and pass the appropriate examination as soon
1 October 2014 must take an accredited examination. The
as possible.
unaccredited examination ceased on 31 December 2015.

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An examination is now available online. In order to assist, two months to add to their time period. Representatives
the following arrangements for all affected representatives who returned to work in 2020 anytime after 31 October
were put in place in late 2020 and are set out below. will not have an extension in relation to the cancellation
of the examination. Representatives making use of these
Representatives who started work as a representative additional months do not need to contact the PMCPA for an
for the first time from 1 July 2020 extension but must ensure that their employers are informed
For representatives who were employed as a representative and a record is kept.
for the first time from 1 July 2020, the time periods as set out
in the Code will apply. Extensions in addition to those set out above
There may be some representatives who might need longer
Representatives who worked as representatives during 2019 extensions than those referred to above. This is most likely
and have continued to work as representatives in 2020 to apply to those whose time periods completed around
For those representatives working as such in 2019 and February/March 2020. Applications should be made to the
whose one year or two year time periods include any time PMCPA in the usual way.
between 13 March 2020 and 31 October 2020, these eight
months will not count towards their time period for taking
and passing the examination. Representatives making use
of these additional eight months do not need to contact Clause 10
the PMCPA for an extension but must ensure that their Events/Meetings and Hospitality
employers are informed and a record is kept.
10.1 (22.1) Pharmaceutical companies may hold, sponsor or
Representatives who started their first role as a support delegates to attend a wide range of events/
representative between 1 January 2020 and 30 June 2020 meetings, providing such events/meetings meet the
For representatives who were employed as a representative requirements of the Code. This may include support
in their first role anytime from 1 January 2020 to 30 of health professionals not known to the company via
June 2020, the relevant months they worked when the a healthcare organisation by way of registration fees,
examination was not available will not count towards accommodation and travel.
their time period. For example, a representative starting
Companies must not provide hospitality to health
in January 2020 will have eight months to add to the time
professionals, other relevant decision makers etc except in
period to take the examination for the first time, ie they
association with scientific meetings, promotional meetings,
must take the examination by September 2021 and pass it
scientific congresses and other such meetings and training.
by September 2022. A representative starting in February
or March 2020 will also have eight months to add to the The content and arrangements for any event or meeting
time period to take the examination for the first time. A must also, to the extent relevant to the particular event/
representative starting in April 2020 will have seven months meeting, fulfil the following criteria:
to add to their time period, and a representative starting in • the event/meeting must have a clear educational content;
June 2020 will have five months to add to their time period. it should be the programme that attracts delegates to
A representative starting in such a role for the first time attend and not the associated hospitality or venue
in July 2020 will not have an extension in relation to the
cancellation of the examination. Representatives making • the content must be appropriate and relevant to attendees
use of these additional months do not need to contact • the venue must be appropriate and conducive to the
the PMCPA for an extension but must ensure that their main purpose of the event/meeting; lavish, extravagant or
employers are informed and a record is kept. deluxe venues must not be used
• any associated subsistence (food and drink),
Representatives who were previously employed as a accommodation and travel costs must be strictly limited
representative and who returned to such a role in anytime to the main purpose of the event/meeting, must be of
between 1 January and 31 October 2020 following a gap secondary consideration and must be appropriate and
in service (for example, due to a change of role, career not out of proportion to the occasion (see Clause 10.7)
break, parental leave)
For representatives who have been employed as a • companies must not sponsor, support or organise
representative and returned to work as a representative in entertainment (such as sporting or leisure activities, etc)
2020 (perhaps after a career break, maternity leave, etc), • any hospitality provided must not extend to an
including during the time the examination was not available accompanying person unless that person qualifies as a
(between 13 March 2020 and 30 September 2020), then the proper delegate or participant at the meeting in their own
relevant months they worked when the examination was not right. In exceptional cases of established clear health
available will not count towards their time period for taking needs of the delegate (eg disability or injury), similar
and passing the examination. For example, a representative hospitality may be provided for an accompanying person.
restarting such work in January 2020 will have eight months
10.2 (New Clause, previously 22.1 SI) No payment may be offered
to add to their time period, a representative restarting in
or paid to individuals to compensate merely for the time
April 2020 will have seven months to add to their time period
spent in attending events/meetings.
and a representative restarting in September 2020 will have

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10.3 (New Clause and part of Clause 27.3) Sponsorship of 10.11 (New Clause and part of Clause 24.2) Companies must
patient organisations (including individuals representing publicly disclose annually financial details for contributions
patient organisations to attend events/meetings) must have to costs related to events/meetings (sponsorship) paid
a written agreement in place setting out what has been to healthcare organisations, patient organisations or
agreed including, where possible, a breakdown of agreed organisations managing an event/meeting on their behalf.
costs. (The requirements for the written agreement are set This may include support of health professionals not known
out in Clause 27.2.) to the company via the healthcare organisation by way of
registration fees, accommodation and travel.
10.4 (18.3) Attendees of company organised events/meetings
may be provided with inexpensive pens, pencils and Contracts for sponsorship of individuals representing patient
notepads when required for use at those events/meetings. organisations to attend events/meetings should be made
They must not bear the name of any medicine or any with the patient organisation and disclosed against the
information about medicines but may bear the name of the patient organisation as set out in Clause 29.
company providing them. No individual attendee should
receive more than one pen or pencil or one notepad.
Clause 10 Supplementary Information
The total cost to the donor company of all such items
provided to an individual attending an event/meeting must Clause 10.1 (22.1) Events/Meetings and Hospitality
not exceed £6, excluding VAT. The perceived value to the In determining whether any event/meeting is acceptable or
recipient must be similar. not, consideration must also be given to the educational
programme, overall cost, facilities offered by the venue,
10.5 (18.3 SI) Pens/pencils and notepads provided in conference nature of the audience, subsistence provided and the like.
bags at independently organised meetings must not include
the name of the donor company, the name of any medicine Clause 10.1 (22.1) Types of Events/Meetings
or any information about medicines. Events/meetings range from small lunchtime audiovisual
presentations in a group practice; hospital meetings
The total cost to the donor company of all such items and events/meetings at postgraduate education
provided to an individual attending an event/meeting must centres; advisory board meetings; visits to research and
not exceed £6, excluding VAT. The perceived value to the manufacturing facilities; planning, training and investigator
recipient must be similar. meetings for clinical trials and non-interventional studies;
Pens/pencils and notepads must not be given out from launch events/meetings for new products; management
exhibition stands. training courses; patient support group meetings;
and satellite symposia through to large international
10.6 (18.1 SI) Quizzes which are intended to gauge attendees' events/meetings organised by independent bodies with
understanding of the subject matter of a meeting are sponsorship from pharmaceutical companies.
acceptable provided that such quizzes are non-promotional
and genuine tests of skill or knowledge; they must respect The hospitality costs involved in events/meetings must not
the professional standing or otherwise of the audience and exceed that level which the recipients would normally adopt
no prizes can be offered. To be acceptable, a quiz must form when paying for themselves.
part of the meeting's formal proceedings. Quizzes must not Companies should only offer or provide economy air travel
be conducted from or on exhibition stands. to delegates attending events/meetings. Delegates may
The use of competitions, quizzes and suchlike are organise and pay at their own expense the genuine cost of
unacceptable methods of promotion. an upgrade. For flights that are scheduled to take longer
than six hours, companies may pay for an upgrade from
10.7 (22.2) The cost of any subsistence (food and drink) provided economy to premium economy or similar.
must not exceed £75 per person, excluding VAT and gratuities.
Administrative staff may be invited to events/meetings
10.8 (22.3) Payments may not be made to doctors, groups of where appropriate. For example, receptionists might be
doctors, or to other prescribers, either directly or indirectly, invited to an event/meeting in a general practice when the
for rental for rooms to be used for events/meetings. subject matter is related to practice administration.

10.9 (22.4) When events/meetings are sponsored by A useful criterion in determining whether the arrangements
pharmaceutical companies, that fact must be disclosed in for any event/meeting are acceptable is to apply the
all the material relating to the events/meetings and in any question 'Would you and your company be willing to have
published proceedings. The declaration of sponsorship must these arrangements generally known?' The impression that
be sufficiently prominent to ensure that readers are aware of is created by the arrangements for any event/meeting must
it at the outset. always be kept in mind.

10.10 (22.5) Companies must publicly disclose annually financial Clause 10.1 (22.1) Events/Meetings held Outside the UK
details of support of UK health professionals and other Events/meetings organised by pharmaceutical companies
relevant decision makers in relation to attendance at which involve UK health professionals at venues outside the
events/meetings. UK are not necessarily unacceptable. There have, however,

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to be valid and cogent reasons for holding the event/ those referred to above) expect health and social care
meeting at such venues. These are that most of the invitees professionals to 'Ensure their professional judgement is not
are from outside the UK and, given their countries of origin, compromised by personal, financial or commercial interests,
it makes greater logistical sense to hold the event/meeting incentives, targets or similar measures' and to 'Refuse all
outside the UK or, given the location of the relevant resource but the most trivial gifts, favours or hospitality, if accepting
or expertise that is the object or subject matter of the event/ them could be interpreted as an attempt to gain preferential
meeting, it makes greater logistical sense to hold the event/ treatment or would contravene your professional code
meeting outside the UK. Consideration should be given to of practice'.
the use of technology to avoid travel outside the UK, eg
webinars, virtual meetings. Clause 10.1 (22.1) Continuing Professional Development
(CPD) Meetings and Courses
Clause 10.1 (22.1) Events/Meetings Organised by Affiliates The provisions of this and all other relevant clauses in the
Outside the UK Code apply equally to meetings and courses organised
Companies should remind their affiliates outside the UK or sponsored by pharmaceutical companies which are
that the ABPI Code must be complied with if UK health CPD approved. The fact that a meeting or course has
professionals attend events/meetings which they organise, CPD approval does not mean that the arrangements are
regardless of whether such events/meetings occur in the automatically acceptable under the Code. The relevant
UK or abroad. provisions of the Code and, in particular, those relating to
hospitality, must be observed.
Clause 10.1 (22.1) Certification and Examination
of Events/Meetings Clause 10.4 (18.3) Pens/Pencils and Notepads
Pharmaceutical companies must ensure that all events/ Pens/pencils and notepads are the only items that can
meetings which are planned are examined to see that they be provided to health professionals and other relevant
comply with the Code. Companies must have a written decision makers for them to keep and then only at bona
document that sets out their policies on events/meetings fide meetings. They cannot be provided, for example, by
and hospitality and the associated allowable expenditure. representatives when calling upon health professionals.
In addition, events/meetings which involve travel outside the
UK must be certified as set out in Clause 8.2. Clause 10.7 (22.2) Maximum Cost of Subsistence
The maximum of £75 plus VAT and gratuities is appropriate
Clause 10.1 (22.1) Health Professionals' Standards only in very exceptional circumstances, such as a dinner at
of Conduct a residential meeting for senior consultants or a dinner at
The General Medical Council (GMC) is the regulatory a learned society conference with substantial educational
body for doctors and is responsible for giving guidance on content. The cost of subsistence (food and drink) should
standards of professional conduct and on medical ethics. normally be well below this figure. The requirements
In its guidance, the GMC advises that 'You must not allow relating to hospitality in Clause 10.1 and its supplementary
any interests you may have to affect the way you prescribe information still apply.
for, treat, refer or commission services for patients' and
'You must not ask for or accept from patients, colleagues or The maximum of £75 plus VAT and gratuities (or local
others any inducement, gift or hospitality that may affect equivalent) does not apply when an event/meeting is held
or be seen to affect the way you prescribe for, treat or refer outside the UK in a European country where the national
patients or commission services for patients. You must not association is a member of EFPIA and thus covered by the
offer these inducements'. EFPIA Code. In such circumstances, the limits in the host
country code would apply. Information can be found at
The General Pharmaceutical Council is the regulatory body www.efpia.eu.
for pharmacists and pharmacy technicians. The Council's
Standards for pharmacy professionals includes that they Clause 10.8 (22.3) Payment of Room Rental
must use their professional judgement and must behave This provision does not preclude the payment of room rental
in a professional manner. They are expected to 'declare to postgraduate medical centres and the like.
any personal or professional interests and manage
Payment of room rental to doctors or groups of doctors or
these professionally'.
to other prescribers is not permissible even if such payment
The Code of the Nursing & Midwifery Council, Professional is made to equipment funds or patients' comforts funds and
standards of practice and behaviour for nurses and the like or to charities or companies.
midwives, states 'You must act with honesty and integrity in
Clause 10.9 (22.4) Sponsorship and Reports
any financial dealings you have with everyone you have a
of Events/Meetings
professional relationship with, including people in your care'.
Attention is drawn to Clause 5.5 which requires that all
In a joint statement, the chief executives of statutory material relating to medicines and their uses, whether
regulators of health and care professionals (which refers promotional or not, which is sponsored by a pharmaceutical
to individuals regulated by one of nine regulators overseen company must clearly indicate that it has been sponsored by
by the Professional Standards Authority, including the company.

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Where companies are involved in the sponsorship and/or

distribution of reports on events/meetings or symposia, etc
these reports may constitute promotional material and thus
be fully subject to the requirements of the Code.

Clause 10.10 (22.5) Support of Individual Health

Professionals/Other Relevant Decision Makers to
attend Events/Meetings
Disclosure of this information must be carried out in
accordance with Clause 28.

The information required by Clause 10.10 must be publicly

disclosed annually in respect of support for attendance
at events/meetings whether paid directly, indirectly or via
another party. Support in this context includes registration
fees and the costs of accommodation and travel, both inside
and outside the UK.

The information which must be disclosed comprises

registration fees and the costs of accommodation and travel,
both inside and outside the UK. The name of each recipient
and the associated transfer of value for that recipient must
be given.

Where a transfer of value is made to a health professional

or other relevant decision maker indirectly via a healthcare
organisation, institution or other party, such a transfer
should be disclosed once only, preferably as being a transfer
to the health professional or other relevant decision maker.

Clause 10.11 (New) Sponsorship to Healthcare

Organisations, Institutions and other Organisations
Disclosure of this information must be carried out in
accordance with Clause 28.

Sponsorship in this context includes registration fees and the

costs of accommodation and travel, both inside and outside
the UK, whether paid directly or indirectly. If, when providing
sponsorship to a healthcare organisation, institution or
other organisation in relation to their own event, a company
contributes towards the overall cost of subsistence (food
and drink), then this must be included in the disclosure of
the cost of the sponsorship to the healthcare organisation,
institution or other organisation.

Clause numbers in brackets refer to the 2019 Code of Practice. CLAUSES 1–10 – CODE OF PRACTICE 23
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Promotion to Health Professionals

and Other Relevant Decision Makers
CLAUSES 11–17

Clause 11
The display and provision of promotional material for such
Marketing Authorisation and Temporary medicines is permitted at international events/meetings in
Supply Authorisation the UK provided that the following conditions are met:
11.1 (3.1) A medicine must not be promoted prior to the grant of • the event/meeting must be truly international, of high
the marketing authorisation which permits its sale or supply scientific standing and with a significant proportion of
subject to the provisions of Clause 11.3 below. the attendees from countries outside the UK in which the
product is licensed
11.2 (3.2) The promotion of a medicine must be in accordance • the medicine or indication must be relevant and
with the terms of its marketing authorisation and must not be proportional to the purpose of the event/meeting
inconsistent with the particulars listed in its summary of product
• promotional material for a medicine or indication that
characteristics subject to the provisions of Clause 11.3 below.
does not have a UK marketing authorisation must be
11.3 (New Clause) A medicine with a temporary supply clearly and prominently labelled to that effect
authorisation must not be promoted unless it is part of a • in relation to an unlicensed indication, UK approved
campaign that has been approved by the health ministers. prescribing information must be readily available for a
medicine authorised in the UK even though it will not refer
to the unlicensed indication
Clause 11 Supplementary Information
• the names must be given of countries in which the
Clause 11.1 (3) Conditional Marketing Authorisation medicine or indication is authorised which must include at
If a medicine has been granted a conditional marketing least one major developed country; and it must be stated
authorisation then it can be promoted in accordance with the that registration conditions differ from country to country
terms of that licence and is considered to meet the definition • the material is certified in accordance with Clause 8, except
of a medicine. Material should clearly state at the outset that that the signatories need certify only that in their belief,
the medicine has a conditional marketing authorisation. the material is a fair and truthful presentation of the facts
Relevant information should be added wherever possible to about the medicine.
national horizon scanning databases. Clause 11.2 (3.2) Unauthorised Indications
Clause 11.1 (3) Early Access to Medicines Scheme (EAMS) The promotion of indications not covered by the marketing
Medicines that are approved under the EAMS meet one authorisation for a medicine is prohibited.
of the following two conditions. Either the medicine does
Clause 11.3 (New) Temporary Authorisation for Sale or
not have a marketing authorisation or the medicine has
Supply Without a Marketing Authorisation
a marketing authorisation but no licence for the specific
In response to certain types of public health emergency, under
indication. Medicines or indications that are approved for
UK law, the licensing authority may temporarily authorise
EAMS must therefore not be promoted.
the sale or supply of a medicine without a marketing
Relevant information should be added wherever possible to authorisation. This might apply to medicines without UK
national horizon scanning databases. marketing authorisations or indications without UK marketing
authorisations. The campaign must be approved by the
Clause 11.1 (3) Compassionate Use health ministers, and all relevant requirements of the Code
Companies may provide an unlicensed medicine or a medicine will apply. If there is no marketing authorisation, then the
for use in an unlicensed indication on a compassionate use requirement for inclusion of the marketing authorisation
basis for those with an unmet medical need. Such availability number in the prescribing information will not apply.
is for companies to decide in line with relevant requirements. If The name and address of the holder of the temporary
the medicine does not have a relevant marketing authorisation, authorisation or the business name and address of the part
then it cannot be promoted. of the holder's business that is responsible for its sale or
Clause 11.1 (3) Promotion at International Events/Meetings supply must be given in addition to the name and address
Promotion at international events/meetings held in the UK of the marketing authorisation holder where there is one.
may, on occasion, pose certain problems with regard to Companies should contact the MHRA for information
medicines or indications for medicines which do not have regarding approval of materials and activities.
a marketing authorisation in the UK although they are so
authorised in another major industrialised country.

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Clause 12 The summary of product characteristics may be provided

Prescribing Information and Other instead of i-viii above.
Obligatory Information If the summary of product characteristics is not used, then
the information specified above in relation to iv, v and vi
12.1 (4.1) The prescribing information listed in Clause 12.2
which is required to be included in advertisements, must
must be provided in a clear and legible manner in all
be placed in such a position in the advertisement that its
promotional material for a medicine except for abbreviated
relationship to the claims and indications for the product
advertisements (see Clause 13). The prescribing information
can be appreciated by the reader.
must be positioned for ease of reference and must not be
presented in a manner such that the reader has to turn the 12.3 (4.3) The non-proprietary name of the medicine or a list
material round in order to read it, for example, by providing of the active ingredients using approved names where
it diagonally or around the page borders. The prescribing such exist must appear immediately adjacent to the most
information must form part of the promotional material and prominent display of the brand name in bold type of a size
must not be separate from it. such that a lower case 'x' is no less than 2mm in height
or in type of such a size that the non-proprietary name
12.2 (4.2) The prescribing information consists of the following:
or list of active ingredients occupies a total area no less
• the legal classification of the product than that taken up by the brand name. For electronic
• the cost (excluding VAT) of either a specified package advertisements, the non-proprietary name of the medicine
of the medicine to which the advertisement relates, or a or the list of active ingredients, as required by Clause 12.3,
specified quantity or recommended daily dose, calculated must appear immediately adjacent to the brand name at
by reference to any specified package of the product, its first appearance in a size such that the information is
except in the case of advertisements in journals printed in easily readable.
the UK which have more than 15 per cent of their circulation
outside the UK and audiovisual advertisements and 12.4 (4.4) In digital material such as advertisements in electronic
prescribing information provided in association with them journals, emails, electronic detail aids and suchlike, the
prescribing information as required by Clause 12.1 may be
• and
provided either:
i. the name of the medicine (which may be either a brand
• by inclusion in the digital material itself, or
name or a non-proprietary name)
• by way of a clear, and prominent, direct, single click link.
ii. a quantitative list of the active ingredients, using approved
names where such exist, or other non-proprietary names; 12.5 (4.5) In audiovisual material and in interactive data systems,
alternatively, the non-proprietary name of the product if it is the prescribing information may be provided either:
the subject of an accepted monograph
• by way of a document which is made available to all
iii. at least one authorised indication for use consistent persons to whom the material is shown or sent, or
with the summary of product characteristics
• by inclusion on the audiovisual recording or in the
iv. a succinct statement of the information in the summary interactive data system itself.
of product characteristics relating to the dosage and
When the prescribing information is included in an
method of use relevant to the indications quoted in the
interactive data system, instructions for accessing it must be
advertisement and, where not otherwise obvious, the
clearly displayed.
route of administration
v. a succinct statement of common adverse reactions likely 12.6 (4.6) Promotional material provided on the internet must
to be encountered in clinical practice, serious adverse include a clear prominent statement as to where the
reactions and precautions and contra-indications prescribing information can be found.
relevant to the indications in the advertisement, giving,
in an abbreviated form, the substance of the relevant 12.7 (4.7) In a printed journal advertisement the prescribing
information in the summary of product characteristics, information must appear on at least one of the pages. The
together with a statement that prescribers should pages where the prescribing information is not visible must
consult the summary of product characteristics in include a reference on the outer edge of the page as to
relation to other adverse reactions where the prescribing information can be found in a type
size such that a lower case 'x' is no less than 2mm in height.
vi. any warning issued by the Medicines Commission, the
Commission on Human Medicines, the Committee on 12.8 (4.8) Promotional material other than advertisements in
Safety of Medicines or the licensing authority, which is professional publications must include the date on which
required to be included in advertisements the promotional material was created or last revised.
vii. the number of the relevant marketing authorisation and
12.9 (4.9) All promotional material must include the prominent
the name and address of the holder of the authorisation
statement 'Adverse events should be reported. Reporting
or the name and address of the part of the business
forms and information can be found at [website address
responsible for its sale or supply
which links directly to the MHRA Yellow Card site].
viii. the date the prescribing information was drawn up Adverse events should also be reported to [relevant
or last revised. pharmaceutical company]'.

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12.10 (4.10) When required by the licensing authority, all

promotional material must clearly show an inverted black therefore, that the information must be given in a clear and
equilateral triangle to denote that additional monitoring is legible manner which assists readability.
required in relation to adverse reactions. The symbol should
Clause 12.1 (4.1) Prescribing Information on Printed Material
always be black, and its size should normally be not less
and Reference to Online Current Regulatory Documents
than 5mm per side but with a smaller size of 3mm per side
In addition to including prescribing information, companies
for A5 size advertisements and a larger size of
are encouraged to include references on printed materials to
7.5mm per side for A3 size advertisements.
an online resource where the current regulatory documents
The symbol should appear once and be located adjacent for each medicine promoted can be found.
to the most prominent display of the name of the product.
Clauses 12.1 and 12.8 (4.1 and 4.8) Date of Prescribing
No written explanation of the symbol is necessary. Information and Promotional Material
If the summary of product characteristics is not used, then
Digital communications are also covered by this requirement, the date that the prescribing information was last drawn up
and the black triangle symbol should be located adjacent or last revised must be included (Clause 12.2 viii).
to the first mention of the product as this is likely to be
considered the most prominent display of the name of the In addition, promotional material (other than journal
product. The size must be such that it is easily noticed. advertising) must include the date that the material as a
whole, ie the copy plus the prescribing information, was
created or last revised.
Clause 12 Supplementary Information Clause 12.1 (4.1) Advertisements in Electronic Journals
Clause 12 Arrangements for Changes to the Marketing The first part of an advertisement in an electronic
Authorisation Number and the Marketing Authorisation journal, such as the banner, is often the only part of the
Holder Name and Address Following Changes Resulting advertisement that is seen by readers. It must therefore
from the UK Leaving the EU include a clear, prominent statement as to where the
For the period from 1 January 2021 until 1 January 2023, a prescribing information can be found. This should be in the
complaint that the prescribing information for a previously form of a prominent, direct, single click link. The first part is
centrally approved medicine does not have the new marketing often linked to other parts and in such circumstances, the
authorisation number or any new marketing authorisation linked parts will be considered as one advertisement.
holder's name and address as required by Clause 12.2 (vii) If the first part mentions the product name, then this is the
will not be considered to be in breach of that clause and most prominent display of the brand name, and so the
potentially any other relevant clause provided that: non-proprietary name of the medicine or a list of the active
• other changes to the prescribing information have not ingredients using approved names where such exist must
been needed appear immediately adjacent to it in a size such that the
• the prescribing information includes the previous information is easily readable. If the product is one that is
information about the marketing authorisation required to show an inverted black equilateral triangle on its
number and promotional material then that symbol must appear adjacent
• any new marketing authorisation holder can be contacted to the product name (see Clause 12.10). The size must be
via the address given in the prescribing information. such that it would not be easily overlooked. The requirement
of Clause 15.6 that promotional material and activities must
This will also apply to medicines (other than those centrally not be disguised should also be borne in mind.
approved) if the marketing authorisation numbers and
marketing authorisation holder name and address are Clause 12.1 (4.1) Advertisements for Devices
changed from 1 January 2021 as a result of the departure of Where an advertisement relates to the merits of a device
the UK from the EU. used for administering medicines, such as an inhaler, which
is supplied containing a variety of medicines, the prescribing
Clause 12.1 (4.1) Prescribing Information and Summaries information for one only need be given if the advertisement
of Product Characteristics makes no reference to any particular medicine. However,
Each promotional item for a medicine must be able to if particular medicines are referred to, then the prescribing
stand alone. For example, when a promotional letter on a information for each must be provided.
medicine is sent in the same envelope as a brochure about
the same medicine, each item has to include the prescribing Clause 12.1 (4.1) Prescribing Information at Exhibitions
information. It does not suffice to have the prescribing The prescribing information for medicines promoted on
information on only one of the items. The inclusion of a posters and exhibition panels at events/meetings must
separate summary of product characteristics is not sufficient either be provided on the posters or panels themselves or
to conform with the provisions of this clause. must be available at the company stand. If the prescribing
information is made available at the company stand, this
Clause 12.1 (4.1) Legibility of Prescribing Information should be referred to on the posters or panels.
The prescribing information is the essential information
which must be provided in promotional material. It follows,

26 CODE OF PRACTICE – CLAUSES 11–17 Clause numbers in brackets refer to the 2019 Code of Practice.
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Clause 12.2 (4.2) Use of the Summary of In the event that the website address required in Clause
Product Characteristics 12.9 is changed by the Medicines and Healthcare products
The Code defines prescribing information to consist of three Regulatory Agency (MHRA), companies must use the new
parts: the legal classification, the cost and other elements address within one year of the change.
(listed as i-viii) in Clause 12.2. Where space in printed
material is not an issue, elements i-viii can be provided Clause 12.10 (4.10) Black Triangle Symbol
by reproducing the summary of product characteristics. The black triangle symbol is also required on summaries
With an electronic advertisement, elements i-viii could of product characteristics and on package leaflets. The
be provided by a prominent, direct single click link to the size of the black triangle on these documents has to be
summary of product characteristics (Clause 12.4 and its proportionate to the font size of the subsequent text with
supplementary information). It would not be acceptable a minimum length of 5mm per side. Obligatory explanatory
to provide a website address for the summary of product wording is also required on these documents.
characteristics on printed material as a means of meeting
the requirements to provide elements i-viii.

Clause 12.3 (4.3) Non-Proprietary Name

'Immediately adjacent to…' means immediately before, after, Clause 13
above or below. Abbreviated Advertisements
In a promotional letter, the most prominent display of the 13.1 (5.1) Abbreviated advertisements are exempt from the
brand name will usually be that in the letter itself, rather requirement to include prescribing information for the
than that in prescribing information provided on the reverse advertised medicine, provided that they are limited in size
of the letter. and content as set out in this clause.
Clause 12.4 (4.4) Use of Links for Prescribing Information 13.2 (5.2) Abbreviated advertisements may only appear in
When digital material includes a link to prescribing professional publications, ie publications sent or delivered
information on another website, then such a link should wholly or mainly to members of the health professions and/
only be included for use when the material is generally or other relevant decision makers. A loose insert in such a
expected to be viewed online, for example, advertisements publication cannot be an abbreviated advertisement.
in electronic journals, emails or electronic detail aids when
used remotely and the like. This is to ensure that at the time Abbreviated advertisements may contain only the
of reading, the link is active and will provide readers with information specified in Clauses 13.4, 13.5, 13.6, 13.7 and 13.8.
the necessary information. When material is more likely to
Abbreviated advertisements are not permitted in audiovisual
be viewed offline, such as electronic detail aids to be used
material or in interactive data systems or on the internet,
by representatives when visiting health professionals, then
including journals on the internet.
the requisite information must be provided as part of the item
itself or as a link that does not require the reader to be online. 13.3 (5.3) Abbreviated advertisements must be no larger than
420 square centimetres in size.
Clause 12.5 (4.5) Prescribing Information
on Audiovisual Material 13.4 (5.4) Abbreviated advertisements must provide the following
Where prescribing information is shown on audiovisual information in a clear and legible manner:
material as part of the recording, it must be of sufficient
• the name of the medicine (which may be either a brand
clarity and duration so that it is easily readable. The
name or a non-proprietary name)
prescribing information must be an integral part of the
promotional content and must appear with it. It is not • the non-proprietary name of the medicine or a list of the
acceptable for the promotional content and the prescribing active ingredients using approved names where such exist
information to be separated by any other material. • at least one indication for use consistent with the
summary of product characteristics
Clause 12.8 (4.8) Date Created or Last Revised
• the legal classification of the product
This is in addition to the requirement in Clause 12.2 that the
date of the prescribing information be included. • any warning issued by the Medicines Commission, the
Commission on Human Medicines, the Committee on
Clause 12.8 (4.8) Dates on Loose Inserts Safety of Medicines or the licensing authority which is
A loose insert is not regarded for this purpose as appearing required to be included in advertisements
in the professional publication with which it is sent and must • the name and address of the marketing authorisation
therefore bear the date on which it was created or last revised. holder or the name and address of the part of the
business responsible for the medicine's sale or supply
Clause 12.9 (4.9) Adverse Event Reporting
A telephone number or email address for the relevant • the statement: 'Information about this product, including
department of the company may be included. Text is more adverse reactions, precautions, contra-indications and
likely to be deemed to be prominent if it is presented in a method of use can be found at [the address of the
larger type size than that used for the prescribing information. website referred to below]' and state that prescribers

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are recommended to consult the summary of product

characteristics before prescribing. Clause 13 Supplementary Information
The website referred to above must provide either: Clause 13.2 (5.2) Professional Publications
• the information set out in Clauses 12.2 and 12.3 (except Abbreviated advertisements are largely restricted to journals
that the non-proprietary name of the medicine or the and other such professional publications sent or delivered
list of active ingredients, as required by Clause 12.3, must wholly or mainly to members of the health professions etc. A
appear immediately adjacent to the most prominent promotional mailing or leavepiece cannot be an abbreviated
display of the brand name in a size such that the advertisement and an abbreviated advertisement cannot
information is easily readable and information about cost, appear as part of another promotional item, such as in a
as required by Clause 12.2, need not be included on the brochure consisting of a full advertisement for another of
website where the abbreviated advertisement appears the company's medicines.
only in journals printed in the UK which have more than 15
per cent of their circulation outside the UK), or The prescribing information must be made available for any
advertisement for a medicine appearing on audiovisual
• the summary of product characteristics.
material or in an interactive data system or on the internet,
13.5 (5.5) The non-proprietary name of the medicine or a list including online journals, as such advertisements cannot be
of the active ingredients using approved names where deemed abbreviated advertisements.
such exist must appear immediately adjacent to the most
Clauses 13.4, 13.5, 13.6, 13.7, 13.8 and 13.9 (5.4, 5.5, 5.6,
prominent display of the brand name in bold type of a size
5.7, 5.8 and 5.9) Permitted Information
such that a lower case 'x' is no less than 2mm in height or
The contents of abbreviated advertisements are restricted
in type of such a size that the non-proprietary name or list
as set out in Clauses 13.4, 13.5, 13.6, 13.7, 13.8 and 13.9 and
of active ingredients occupies a total area no less than that
the following information should not therefore be included in
taken up by the brand name.
abbreviated advertisements:
13.6 (5.6) Abbreviated advertisements must include the • dosage particulars
prominent statement 'Adverse events should be reported. • details of pack sizes
Reporting forms and information can be found at [website
• cost.
address which links directly to the MHRA Yellow Card
site]. Adverse events should also be reported to [relevant There may be exceptions to the above if the information
pharmaceutical company]'. provided, for example, the cost of the medicine or the
frequency of its dosage or its availability as a patient pack, is
13.7 (5.7) When required by the licensing authority, abbreviated
given as the reason why the medicine is recommended for the
advertisements must clearly show an inverted black
indication or indications referred to in the advertisement.
equilateral triangle to denote that additional monitoring is
required in relation to adverse reactions. Artwork used in abbreviated advertisements must not convey
any information about a medicine which is additional to that
It should be borne in mind that abbreviated advertisements
permitted under Clauses 13.4, 13.5, 13.6, 13.7, 13.8 and 13.9.
must be no larger than 420 square centimetres in size. In
abbreviated advertisements of no more than 310.8 square Telephone numbers may be included in abbreviated
centimetres (A5), each side of the triangle should be no advertisements.
less than 3mm. In abbreviated advertisements larger than
A5 (but no larger than 420 square centimetres) each Clause 13.5 (5.5) Non-Proprietary Name
side should be no less than 5mm. The other relevant 'Immediately adjacent to…' means immediately before, after,
requirements of Clause 12.10 apply equally to the use of the above or below.
black triangle symbol on abbreviated advertisements.
Clause 13.6 (5.6) Adverse Event Reporting
13.8 (5.8) Abbreviated advertisements may contain a concise In the event that the website address given in Clause 13.6
statement consistent with the summary of product is changed by the MHRA, companies must use the new
characteristics, giving the reason why the medicine is address within one year of the change.
recommended for the indication or indications given.

13.9 (5.9) Marketing authorisation numbers and references must

not be included in abbreviated advertisements.

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Clause 14
Information, Claims and Comparisons Clause 14 Supplementary Information
Clauses 6 and 18 may also be relevant.
Clauses 6 and 18 may also be relevant.
Clause 14.1 (7.3) Comparisons
14.1 (7.3) A comparison is only permitted in promotional material if:
The Code does not preclude the use of other companies'
• it is not misleading brand names when making comparisons.
• medicines or services for the same needs or intended for
the same purpose are compared Comparisons with other products are usually made to show
an advantage of the advertised product over its comparator.
• one or more material, relevant, substantiable and
Provided that such critical references to another company's
representative features are compared
products are accurate, balanced, fair etc and can be
• no confusion is created between the medicine advertised substantiated, they are acceptable under the Code.
and that of a competitor or between the advertiser's
trademarks, brand names, other distinguishing marks Clause 14.2 (7.6) References
and those of a competitor The references referred to are those to published material,
• the trademarks, brand names, other distinguishing marks, including the use of quotations, tables, graphs and artwork.
medicines, services, activities or circumstances of a
Clause 14.4 (7.10) Superlatives
competitor are not discredited or denigrated
Superlatives are grammatical expressions which denote the
• no unfair advantage is taken of the reputation of a highest quality or degree, such as best, strongest, widest
trademark, brand name or other distinguishing marks etc. A claim that a product was 'the best' treatment for a
of a competitor particular condition, for example, could not be substantiated
• medicines or services are not presented as imitations or as there are too many variables to enable such a sweeping
replicas of goods or services bearing a competitor's claim to be proven. The use of a superlative is acceptable
trademark or brand name. only if it can be substantiated as a simple statement of fact
which can be very clearly demonstrated, such as that a
14.2 (7.6) When promotional material refers to published studies, particular medicine is the most widely prescribed in the UK
clear references must be given. for a certain condition, provided that this is not presented in
a way which misleads as to its significance.
14.3 (7.7) When promotional material refers to data on file, the
relevant part of that data must be provided as soon as Clause 14.4 (7.10) Use of the Words 'The' and 'Unique'
possible, and certainly within ten working days, in response In certain circumstances, 'the' can imply a special merit,
to a request from a health professional or other relevant quality or property for a medicine which is unacceptable
decision maker. under this clause if it cannot be substantiated. For example,
a claim that a product is 'The analgesic' implies that it is, in
14.4 (7.10) Promotion must encourage the rational use of a
effect, the best and might not be acceptable.
medicine by presenting it objectively and without
exaggerating its properties. Exaggerated or all-embracing Similarly, care needs to be taken with the use of 'unique'.
claims must not be made and superlatives must not be used Although 'unique' may sometimes be used to describe some
except for those limited circumstances where they relate to clearly defined special feature of a medicine, often it may
a clear fact about a medicine. Claims should not imply that simply imply a general superiority. In such instances, it is not
a medicine or an active ingredient has some special merit, possible to substantiate the claim as the claim itself is so
quality or property unless this can be substantiated. ill defined.
14.5 (6.2) None of the individual screens or pages etc of a multi Clause 14.4 (7.10) Benefit/Risk Profile
screen/page advertisement must be false or misleading The benefit/risk profile of a medicine must be presented in
when read in isolation. such a way as to comply with the Code. Particular attention
should also be paid to Clauses 6.1 and 6.4.

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 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Clause 15
When a company pays for or otherwise secures or arranges
High Standards, Format and Suitability the publication of promotional material in journals, such
15.1 (9.4) Promotional material must not imitate the devices, material must not resemble independent editorial matter.
copy, slogans or general layout adopted by other companies Care must be taken with company sponsored reports of
in a way that is likely to mislead or confuse. events/meetings and the like to ensure that they are not
disguised promotion. Sponsorship must be declared in
15.2 (9.5) Promotional material must not include any reference to accordance with Clause 5.5.
the Commission on Human Medicines, the Medicines and
Healthcare products Regulatory Agency (MHRA) or the
licensing authority, unless this is specifically required by the
licensing authority.
Clause 16
15.3 (9.6) Reproductions of official documents must not be used Material and Distribution
for promotional purposes unless permission has been given
in writing by the appropriate body. 16.1 (28.1) Promotional material about prescription only
medicines directed to a UK audience which is provided on
15.4 (9.8) Postcards, other exposed mailings, envelopes or the internet must comply with all relevant requirements of
wrappers must not carry matter which might be regarded as the Code.
advertising to the public, contrary to Clause 26.1.
16.2 (28.4) A medicine covered by Clause 16.1 may be advertised
15.5 (9.9) The telephone, text messages, email, faxes, automated in a relevant, independently produced electronic journal
calling systems and other digital communications must not intended for health professionals or other relevant decision
be used for promotional purposes, except with the prior makers which can be accessed by members of the public.
permission of the recipient.
16.3 (11.2) Restraint must be exercised on the frequency
15.6 (12.1) Promotional material and activities must not be disguised. of distribution and on the volume of promotional
material distributed.

Clause 15 Supplementary Information 16.4 (11.3) Mailing lists must be kept up-to-date. Requests to be
removed from promotional mailing lists must be complied
Clause 15.2 (9.5) MHRA Drug Safety Update with promptly and no name may be restored except at the
Where factual safety information given in promotional addressee's request or with their permission.
material is based on advice in the MHRA Drug Safety Update,
the information can be referenced to that publication. 16.5 (10.1) Reprints of articles in journals must not be provided
proactively unless the articles have been peer reviewed.
Clause 15.5 (9.9) Unsubscribing to Emails
Where permission to use emails for promotional purposes
has been given by a recipient, each email sent should inform
the recipient as to how to unsubscribe from such emails. Clause 16 Supplementary Information

Clause 15.5 (9.9) Responding to Emails Clause 16.1 (28.1) Website Access
An unsolicited enquiry which includes an email address Unless access to promotional material about prescription
can be responded to by email without specific permission, only medicines is limited to health professionals and other
consent to do so being implied in such circumstances. There relevant decision makers, a pharmaceutical company
is no need to inform recipients as to how to unsubscribe to website or a company sponsored website must provide
an email response to an enquiry. information for the public as well as promotion to health
professionals with the sections for each target audience
Clause 15.5 (9.9) Remote Detailing clearly separated and the intended audience identified. This
When promotion is carried out remotely, such as by telephone is to avoid the public needing to access material for health
call, web chat or other online calls, prior permission from the professionals unless they choose to. The MHRA Blue Guide
recipient must be obtained in advance or at the start of the states that the public should not be encouraged to access
contact or call. In setting up the contact or call, full details material which is not intended for them.
must be given of the company the caller will represent, their
role and the purpose of the call. Arrangements made to Clause 16.2 (28.4) Advertisements in Electronic Journals
discuss a specific product should be adhered to. The MHRA Blue Guide states that each page of an
advertisement for a prescription only medicine should be
Clause 15.6 (12.1) Disguised Promotional Material clearly labelled as intended for health professionals.
Promotional material sent in the guise of personal
communications is inappropriate. Promotional material Clause 16.3 (11.2) Frequency of Distribution
must not imply that the contents are non-promotional, for The style of materials is relevant to their acceptability and
example, that the contents provide information relating criticism of their frequency is most likely to arise when their
to safety. The identity of the responsible pharmaceutical informational content is limited.
company must be obvious.

30 CODE OF PRACTICE – CLAUSES 11–17 Clause numbers in brackets refer to the 2019 Code of Practice.
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Briefing material must not advocate, either directly or

Emails can only be sent with the prior permission of indirectly, any course of action which would be likely to lead
the recipient. to a breach of the Code. Companies must prepare detailed
briefing material for medical representatives on the technical
Clause 16.5 (10.1) Provision of Reprints
aspects of each medicine which they will promote. A copy
The proactive provision of a reprint of an article about
of such material must be made available to the Medicines
a medicine constitutes promotion of that medicine and
Healthcare products Regulatory Agency (MHRA) and the
all relevant requirements of the Code must therefore
PMCPA on request.
be observed. Particular attention must be paid to the
requirements of Clauses 12.1 and 12.2. 17.10 (15.10) Companies are responsible for the activities of
their representatives if these are within the scope of
When providing a reprint of an article about a medicine, it
their employment even if they are acting contrary to the
should be accompanied by prescribing information.
instructions which they have been given.

Clause 17 Supplementary Information

Clause 17
Clause 17 (15) Representatives
Representatives
All provisions in the Code relating to the need for accuracy,
17.1 (15.1) Representatives must be given adequate training balance, fairness, good taste etc apply equally to oral
and have sufficient scientific knowledge to enable them to representations as well as to printed and electronic material.
provide full and accurate information about the medicines Representatives must not make claims or comparisons which
which they promote. are in any way inaccurate, misleading, disparaging, in poor
taste etc, or which are outside the terms of the marketing
17.2 (15.2) Representatives must maintain a high standard of authorisation for the medicine or are inconsistent with the
ethical conduct in the discharge of their duties and comply summary of product characteristics. Indications for which
with all relevant requirements of the Code. the medicine does not have a marketing authorisation must
not be promoted.
17.3 (15.3) Representatives must not employ any inducement or
subterfuge to gain an interview. No fee should be paid or Clause 17 (15) Contract Representatives
offered for the grant of an interview. Companies employing or using contract representatives
are responsible for their conduct and must ensure that
17.4 (15.4) Representatives must ensure that the frequency,
they comply with the provisions of this and all other
timing and duration of calls on health professionals and
relevant clauses in the Code, and in particular the training
other relevant decision makers in hospitals, the NHS and
requirements under Clause 9.
other organisations, together with the manner in which
they are made, do not cause inconvenience. The wishes of Clause 17.3 (15.3) Hospitality and Payments for
individuals on whom representatives want to call and the Events/Meetings
arrangements in force at any particular establishment must Events/meetings organised for groups of doctors, other
be observed. When briefing representatives, companies health professionals and/or other relevant decision makers
should distinguish between expected call rates and which are wholly or mainly of a social or sporting nature
expected contact rates. are unacceptable.
17.5 (15.5) In an interview, or when seeking an appointment for Representatives organising events/meetings are permitted
one, representatives must at the outset take reasonable to provide appropriate hospitality and/or to meet any
steps to ensure that they do not mislead as to their identity reasonable, actual costs which may have been incurred.
or that of the company they represent. For example, if the subsistence (food and drink) has been
organised and paid for by a medical practice, the cost may
17.6 (15.6) Representatives must, without delay, forward any
be reimbursed as long as it is reasonable in relation to what
information which they receive in relation to the use of
was provided and the subsistence itself was appropriate for
their company's medicines, particularly reports of adverse
the occasion. The requirements of Clause 10 apply.
reactions, to the scientific service referred to in Clause 4.1.
Donations instead of hospitality are unacceptable as they
17.7 (15.7) Representatives must be paid a fixed, basic salary and
are inducements for the purpose of holding an event/
any addition proportional to sales of medicines must not
meeting. If subsistence is not required at an event/meeting,
constitute an undue proportion of their remuneration.
there is no obligation or right to provide some benefit of an
17.8 (15.8) Representatives must provide, or have available to equivalent value.
provide if requested, a copy of the summary of product
Clause 17.3 (15.3) Items Delivered by Representatives
characteristics for each medicine which they are to promote.
Reply paid cards which refer to representatives delivering
17.9 (15.9) Representatives' briefing material must comply with items to health professionals or other relevant decision
the relevant requirements of the Code and, in particular, is makers should explain that there is no obligation to grant the
subject to the certification requirements of Clause 8. representative an interview when the items are delivered.

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This is to avoid the impression that there is such an obligation, Clause 17.8 (15.8) Provision of the Summary of
which would be contrary to Clause 17.3, which prohibits the Product Characteristics
use of any inducement or subterfuge to gain an interview. An electronic copy of the summary of product characteristics
can be provided. If discussion on a medicine is initiated
Clause 17.3 (15.3) Health Professionals' Standards by the person or persons on whom a representative calls,
of Conduct the representative is not obliged to have available the
The General Medical Council, the General Pharmaceutical information on that medicine referred to in this clause.
Council and the Nursing & Midwifery Council set out
requirements for doctors, pharmacists, pharmacy Clause 17.9 (15.9) Briefing Material
technicians, nurses and midwives. Further details are given The briefing material referred to in this clause includes the
in the supplementary information to Clause 10.1. training material used to instruct representatives about a
medicine and the instructions given to them as to how the
Clause 17.4 (15.4) Frequency and Manner of Calls product should be promoted.
on Doctors and Other Prescribers
The number of calls made on doctors and other prescribers
and the intervals between successive visits are relevant to
the determination of frequency.

Companies should arrange that the frequency of visits does

not cause inconvenience. The number of calls made on a
doctor or other prescriber by a representative each year
should not normally exceed three on average. This does
not include the following which may be additional to those
three visits:
• attendance at group events/meetings, including
audiovisual presentations and the like
• a visit which is requested by a doctor or other prescriber or
a call which is made in order to respond to a specific enquiry
• a visit to follow up a report of an adverse reaction.

Representatives must always endeavour to treat prescribers'

and others' time with respect and give them no cause to
believe that their time might have been wasted. If for any
unavoidable reasons, an appointment cannot be kept, the
longest possible notice must be given.

When briefing representatives companies should distinguish

clearly between expected call rates and expected contact
rates. Contacts include those at group events/meetings,
visits requested by doctors or other prescribers, visits in
response to specific enquiries and visits to follow up adverse
reaction reports. Targets must be realistic and not such that
representatives breach the Code in order to meet them.

32 CODE OF PRACTICE – CLAUSES 11–17 Clause numbers in brackets refer to the 2019 Code of Practice.
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Interactions with Health Professionals,

Other Relevant Decision Makers and
Healthcare Organisations
CLAUSES 18–22

Clause 18
Clause 19.1 (18.1) Payments to Contracted Individuals
Information, Claims and Comparisons Any payment to an individual for an activity that is ruled
Clauses 6 and 14 may also be relevant. in breach of Clause 24 and/or Clause 25.4 is likely to be
viewed as an unacceptable payment and thus in breach
18.1 (7.1) Upon reasonable request, a company must promptly of Clause 19.1.
provide health professionals and other relevant decision
makers with accurate and relevant information about the Clause 19.1 (18.1) Terms of Trade
medicines which the company markets. Measures or trade practices relating to prices, margins
and discounts which were in regular use by a significant
18.2 (7.5) Substantiation for any information, claim or comparison proportion of the pharmaceutical industry on 1 January
must be provided as soon as possible, and certainly within ten 1993 are outside the scope of the Code (see Clause 1.17)
working days, at the request of health professionals or other and are excluded from the provisions of this clause. Other
relevant decision makers. The validity of indications approved trade practices are subject to the Code. The terms 'prices',
in the marketing authorisation can be substantiated by 'margins' and 'discounts' are primarily financial terms.
provision of the summary of product characteristics.
Schemes which enable health professionals to obtain
Clause 19 personal benefits, for example gift vouchers for high
Prohibition on Inducements and Inappropriate street stores, in relation to the purchase of medicines are
unacceptable even if they are presented as alternatives to
Payments and the Provision of Items to Health financial discounts.
Professionals and Other Relevant Decision Makers
Clause 19.1 (18.1) Package Deals
19.1 (18.1) No gift, pecuniary advantage or benefit may be Clause 19.1 does not prevent the offer of package deals
supplied, offered or promised to health professionals or which are commercial arrangements whereby the purchase
to other relevant decision makers in connection with the of a particular medicine is linked to the provision of certain
promotion of medicines or as an inducement to prescribe, associated benefits as part of the purchase price, such as
supply, administer, recommend, buy or sell any medicine, apparatus for administration, the provision of training on its
subject to the provisions of Clauses 10.4 and 19.2. use or the services of a nurse to administer it. Transfers of
value made in the course of these package deals would need
19.2 (18.2) Health professionals may be provided with materials
to be disclosed in accordance with Clause 28. The transaction
and items for patient support which are to be passed on
as a whole must be fair and reasonable and the associated
to patients, the details of which must be appropriately
benefits must be relevant to the medicine involved.
documented and certified in advance as required by Clause 8.3.
Clause 1.25 exempts package deals solely relating to
The items provided must be inexpensive and directly benefit
ordinary course purchases and sales of medicines from the
patient care. They may bear the name of the company
requirement to disclose transfers of value.
providing them but must not be product branded, unless
the name of the medicine is essential for the correct use of Companies can provide genetic testing or other biomarkers/
the item by the patient. Items must not be given out from specific testing in relation to the rational use of its medicines.
exhibition stands. They must not be given to administrative
staff unless they are to be passed on to a health professional. Where the use of a medicine requires specific testing prior to
prescription, companies can arrange to provide such testing
as a package deal even when the outcome of the testing does
Clause 19 Supplementary Information not support the use of the medicine in some of those tested.

Clause 19.1 (18.1) Health Professionals' Standards Clause 19.1 (18.1) Outcome or Risk Sharing Agreements
of Conduct Clause 19.1 does not preclude the use of outcome or
For information on health professionals' standards of conduct risk sharing agreements where a full or partial refund
refer to the supplementary information to Clause 10.1. of the price paid for a medicine, or some other form
of recompense, is due if the outcome of the use of the

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 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

medicine in a patient fails to meet certain criteria. That is Clause 26 and its supplementary information. A story book
to say, its therapeutic effect does not meet expectations. for young patients about a product or a disease could be
Clear criteria as to when a refund or other recompense provided for relevant patients.
would be due must be settled in advance and set out in
the agreement. Any refund or recompense must always Clause 19.1 (18.1) Data Storage Devices
go to the relevant NHS or other organisation and never to Clause 19.1 does not preclude the provision to health
individual health professionals or practices etc. professionals and other relevant decision makers of
inexpensive data storage devices such as memory sticks
Clause 19.1 (18.1) Patient Access Schemes and the like which bear educational or promotional material
Patient access schemes are acceptable in principle under compliant with the Code, provided that their storage capacity
the Code but they must be carried out in a manner is commensurate with the amount of data to be provided.
compatible with its requirements.
Clause 19.1 (18.1) Textbooks
The 2014 Pharmaceutical Price Regulation Scheme described Textbooks must not be given to individual health
patient access schemes as schemes proposed by a professionals or other relevant decision makers as
pharmaceutical company and agreed with the Department of promotional aids. In appropriate circumstances,
Health (with input from the National Institute for Health and independently produced medical/educational publications
Care Excellence) in order to improve the cost-effectiveness of such as textbooks could be given for health professionals
a medicine and enable patients to receive access to cost- and other relevant decision makers to use in accordance
effective, innovative medicines. Corresponding arrangements with Clause 23.1, Donations and Grants, but they must not
applied in the devolved nations. be given to individuals.

The 2019 Voluntary Scheme for Branded Medicines Pricing Clause 19.1 (18.1) Long Term or Permanent Loan
and Access (VPAS) also refers to the Department of The requirements of Clause 23 cannot be avoided by
Health and Social Services, the ABPI and NHS England providing health professionals or practices etc with items on
understanding of the benefits that clinically and long term or permanent loan.
cost-effective medicines can bring and refers to patient
access schemes in relation to commercial flexibilities Clause 19.2 (18.2) Items for Patient Support
offered by the health service in England. VPAS states that Although items which are to be passed on to patients
the scheme represents an opportunity to further expand may not be given out from exhibition stands, they may be
the commercial flexibility offered by the health service in exhibited and demonstrated on stands and requests for
England. The governments of Scotland, Wales and Northern them accepted for later delivery.
Ireland may agree similar arrangements.
Items for patient support may be provided to health
Clause 19.1 (18.1) Promotional Aids professionals by representatives during the course of a
A promotional aid is defined as a non-monetary item given promotional call and representatives may deliver such items
for a promotional purpose. Promotional aids may be given when they are requested by health professionals. Examples
to health professionals and other relevant decision makers of items which might be acceptable include a peak flow meter
only in accordance with Clause 10.4. Health professionals as part of a scheme for patients to regularly record readings
may, however, be provided with items which are to be or a pedometer as part of a scheme to encourage exercise.
passed on to patients in accordance with Clause 19.2.
Provided that they have been appropriately documented
Items for the personal benefit of health professionals or other and certified in advance as required by Clause 8.3, items
relevant decision makers must not be offered or provided. for patient support which allow patients to gain experience
in using their medicines whilst under the supervision of a
Coffee mugs, stationery, computer accessories, diaries, health professional, may be made available for the use of
calendars and the like and items for use in the home or car health professionals even though they are not to be passed
are not acceptable. Items for use with patients in the clinic, on to patients for them to keep. Examples include inhalation
surgery or treatment room etc, such as surgical gloves, nail devices (with no active ingredient) and devices intended to
brushes, tongue depressors, tissues and the like, are also not assist patients to learn how to self-inject.
acceptable. Toys and puzzles intended for children to play
with while waiting must not be provided. An 'inexpensive' item for patient support means one that
has cost the donor company no more than £10, excluding
Advertisements for prescription medicines must not VAT. The perceived value to the health professional and the
appear on any items, such as diaries and desk pads, which patient must be similar.
pharmaceutical companies could not themselves give.
Information regarding material and items made available
Literature such as leaflets and booklets about medicines and directly to patients is set out in Clause 26 and its
their uses, which is intended for patients, can be provided supplementary information.
to health professionals for them to pass on. They are not
considered to be promotional aids but they must comply
with the relevant requirements of the Code, in particular

34 CODE OF PRACTICE – CLAUSES 18–22 Clause numbers in brackets refer to the 2019 Code of Practice.
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Clause 20 It must be clear in the documentation that the project is a

(New Clause and part of Clause 20) joint working project and account must be taken of relevant
best practice guidance on joint working between the
Collaborative Working with Organisations NHS, the pharmaceutical industry and other relevant
20.1 Collaborative working which either enhances patient commercial organisations.
care or is for the benefit of patients or alternatively
20.5 (24.2) Transfers of value made by companies in connection
benefits the NHS and, as a minimum, maintains patient
with collaborative working must be publicly disclosed annually.
care is acceptable providing it is carried out in a manner
compatible with the Code. Collaborative working is
generally between one or more pharmaceutical companies,
healthcare organisations and other organisations. Joint
Clause 20 Supplementary Information
working is a limited form of collaborative working as set Clause 20 Medical and Educational Goods and Services
out in Clause 20.4. which Comply with Clause 19 of the 2019 ABPI Code,
Including their Transition under the 2021 ABPI Code
20.2 Collaborative working, including its implementation, must
Medical and educational goods and services (MEGS)
have and be able to demonstrate the pooling of skills,
provided under Clause 19 of the 2019 Code are likely to fall
experience and/or resources from all of the parties involved
under donations in Clause 23 or collaborative working in
for the joint development and implementation of patient
Clause 20 of the 2021 Code. Companies wishing to continue
and/or healthcare centred projects. There must be a shared
with ongoing MEGS from 1 July 2021 can do so until 31
commitment to successful delivery from all parties, and each
December 2021 under the 2021 Code without the need for
party must make a significant contribution.
them to be reclassified as either a donation or collaborative
20.3 In addition to Clause 20.2, collaborative working must: working and comply with any new requirements as a result
• enhance patient care or be for the benefit of patients, or of this change. Thus there is a six month transition period
alternatively benefit the NHS and, as a minimum, maintain for MEGS.
patient care If the collaborative working involves services, then the
• not constitute an inducement to health professionals supplementary information to Clause 23 Donations and
or other relevant decision makers to prescribe, supply, Grants should be considered.
recommend, buy or sell a medicine
Clause 20 Collaborative Working with Organisations
• be carried out in an open and transparent manner
Collaborative working between the pharmaceutical industry,
• be prospective in nature healthcare organisations and others must be conducted in
• be documented with a formal written agreement which is an open and transparent manner and must either enhance
kept on record patient care or be for the benefit of patients or, alternatively,
• have a summary of the collaborative working agreement benefit the NHS and, as a minimum, maintain patient care. It
publicly available before arrangements are implemented. is expected that the arrangements will also benefit the NHS
and the pharmaceutical company or companies involved.
Material relating to collaborative working must be certified, Treatments, when mentioned, must be in line with nationally
including the summary of the collaborative working accepted clinical guidance where such exists. Collaborative
agreement. The collaborative working agreement does working differs from the situation where pharmaceutical
not need to be certified. Only the final documents etc for companies provide funds in the form of a grant for a specific
any collaborative working project need be certified. All event or programme.
documents etc used during the development of the project
should be of the same standard as certified material, but Collaborative working between the pharmaceutical
there is no requirement to certify such material. Material industry, healthcare organisations and others may, in
used in the delivery of the collaborative working project addition, involve working with a patient organisation. In
must also meet the requirements of Clause 8.3, for example, such circumstances, the arrangements for the patient
educational material for the public or patients which organisation involvement must comply with Clause 27 and is
relates to diseases or medicines used during the delivery of likely to be a contracted service, as set out in Clause 27.5.
collaborative working must be certified. Collaborative working is acceptable in principle provided
All collaborative working should adhere to all relevant that it is carried out in a manner compatible with the Code.
policies, including NHS policies. Collaborative working must not constitute an inducement
to health professionals or other relevant decision makers to
20.4 (New Clause and part of Clause 20) Joint working between prescribe, supply, recommend, buy or sell any medicine. It
one or more pharmaceutical companies and the NHS and must, therefore, always be ensured that none of the benefits
others which is patient centred and always benefits patients of any collaborative working project go to these individuals
is an acceptable form of collaborative working, providing it is or their practices. If the collaborative working is a joint
carried out in a manner compatible with Clause 20 and other working project and there are benefits which are due to the
relevant requirements of the Code. NHS, these must go to an NHS or similar organisation.

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The use of a particular medicine of a company party to a Clause 20.4 (20) Joint Working as a Form
collaborative working agreement is not prohibited provided of Collaborative Working
all parties are satisfied that the use of the medicine is Joint working as defined by the Department of Health and
appropriate and that the requirements for collaborative first introduced in the Code in 2008 is a form of collaborative
working are met. working as set out in Clause 20.
Resources provided by the company to deliver the The Department of Health defines joint working between the
collaborative working project must be relevant and the NHS and the pharmaceutical industry as situations where,
agreement as a whole must be fair and reasonable. Any for the benefit of patients, one or more pharmaceutical
resources provided by the company must themselves companies and the NHS pool skills, experience and/or
contribute to either patient care or healthcare. resources for the joint development and implementation
of patient centred projects and share a commitment for
The written agreement should cover the following points:
successful delivery. Each party must make a significant
• the name of the collaborative working project, the parties contribution and the outcomes must be measured.
to the agreement, the date and the term of the agreement Treatments, when mentioned, must be in line with nationally
• the expected benefits for patients, the population or user accepted clinical guidance where such exists.
groups, the NHS, pharmaceutical company and other
organisation(s) as applicable; benefits should always be In addition to the certification requirements set out in Clause
stated first, and outcomes should be measured 20.3, the joint working project initiation document must also
be certified.
• an outline of the financial arrangements
• the roles and responsibilities of the NHS, the The Department of Health has issued best practice
pharmaceutical company and other organisations and guidance on joint working between the NHS and
how the success of the project will be measured, when pharmaceutical industry and other relevant commercial
and by whom; all aspects of input should be included organisations. The ABPI has produced guidance notes
• the planned publication of any data or outcomes on joint working between pharmaceutical companies
and the NHS and others for the benefit of patients with
• if a pharmaceutical company enters into a collaborative
separate guidance for England, Scotland and Wales. When
working agreement on the basis that its product is already
considering joint working, companies should take account of
included in an appropriate place on the local formulary,
the applicable guidance.
a clear reference to this should be included in the
collaborative working agreement so that all the parties Collaborative working which relies on benefiting the NHS
are clear as to what has been agreed and maintaining patient care will not meet the requirements
• contingency arrangements to cover possible unforeseen for a joint working project.
circumstances such as changes to summaries of
product characteristics and updated clinical guidance; Clause 20.5 (24.2) Disclosure
agreements should include a dispute resolution The information required by Clause 20.5 as to transfers of
clause and disengagement/exit criteria, including an value must be publicly disclosed annually, giving in each case
acknowledgement by the parties that the project might the financial amount or value and the name of the recipient.
need to be amended or stopped if a breach of the Code
Companies must ensure that the amount spent on
is ruled
collaborative working projects is made public irrespective of
• publication by the company of a summary of the whether the value is transferred to a healthcare organisation
collaborative working agreement, for example, on a etc or some other funding model is used. Disclosure must be
clearly defined website or section of a website, such as carried out in accordance with Clause 28.
on the company's or companies' websites; the healthcare
organisation(s) and other parties involved in the
collaboration should also be encouraged to publish this
• outcomes should be published by all parties as soon as
possible and usually within six months of the project's
completion, so that other NHS organisations and others
can learn from and potentially replicate the initiative.
Companies should publish the outcomes on their websites.
Collaborative working should be distinguished from
straightforward sales where medicines are simply sold and
there are no accompanying goods and services etc and
from package deals and outcome or risk sharing agreements
as defined in the supplementary information to Clause 19.1.

36 CODE OF PRACTICE – CLAUSES 18–22 Clause numbers in brackets refer to the 2019 Code of Practice.
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Clause 21 21.10 (17.10) Samples must not be provided simply as an

Provision of Medicines and Samples inducement to prescribe, supply, administer, recommend,
buy or sell any medicine. Samples must not be given for the
21.1 (17.1) Samples of a product may be provided only to a health sole purpose of treating patients.
professional qualified to prescribe that product. They must
not be provided to other relevant decision makers.
Clause 21 Supplementary Information
21.2 (17.2) No more than four samples of a particular medicine
may be provided to an individual health professional during Clause 21.1 (17) Samples
the course of a year. A small sample which is provided only for identification or
similar purposes and which is not intended to be used in
Samples of a particular medicine may be provided to a treatment may be provided to any health professional but is
health professional for no longer than two years after that otherwise subject to the requirements of Clause 21.
health professional first requested samples of it.
Titration packs, free goods and bonus stock provided to
Notwithstanding the above, when a new medicine is pharmacists and others are not samples. This is because
marketed which is an extension of an existing product, they are not for the purposes described in Clause 1.21.
samples of that new medicine can be provided as above.
A 'new medicine' in this context is a product for which a new Titration packs are packs containing various strengths of
marketing authorisation has been granted, either following a medicine for the purpose of establishing a patient on an
the initial application or following an extension application effective dose.
for a new indication that includes new strengths and/
or dosage forms. Extension of a marketing authorisation The supply of a product which is not a medicine because it
to include additional strengths and/or dosage forms for does not contain the active ingredient normally present is
existing indications or to include additional pack sizes is not not regarded as the supply of a sample.
regarded as leading to a new medicine.
Clause 21.1 (17) Starter Packs
21.3 (17.3) Samples may only be supplied in response to written The provision of starter packs is not permitted. Starter packs
requests which have been signed and dated. An electronic were small packs designed to provide sufficient medicine
signature is acceptable. All signed and dated written for a primary care prescriber to initiate treatment in such
requests for samples should be retained for not less than circumstances as a call out in the night.
one year.
Clause 21.3 (17.3) Sample Requests
21.4 (17.4) A sample of a medicine must be no larger than the This clause does not preclude the provision of a pre-printed
smallest presentation of the medicine on the market in the UK. sample request form bearing the name of the product for
signing and dating by the applicant.
21.5 (17.5) Each sample must be marked 'free medical sample – not
for resale' or words to that effect and must be accompanied Clause 21.7 (17.7) Control and Accountability
by a copy of the summary of product characteristics. Companies should ensure that their systems of control,
quality and accountability relating to medicines held by
21.6 (17.6) The provision of samples is not permitted for any representatives cover such matters as the security of
medicine which contains a substance listed in any of delivery to them, the security of medicines held by them, the
Schedules I, II or IV to the Narcotic Drugs Convention audit of stocks held by them, including expiry dates, and the
(where the medicine is not a preparation listed in return to the companies of medicines no longer to be held
Schedule III to that Convention) or a substance listed in by representatives.
any of Schedules I to IV to the Psychotropic Substances
Convention (where the medicine is not a preparation which Samples distributed by representatives must be handed
may be exempted from measures of control in accordance direct to the health professionals requesting them or
with Paragraphs 2 and 3 of Article 3 of that Convention). persons authorised to receive them on their behalf. The
provision of medicines and samples in hospitals must comply
21.7 (17.7) Companies must have adequate systems of control with individual hospital requirements.
and accountability for samples which they distribute and
for all medicines handled by representatives. Systems must
clearly establish, for each health professional, the number of
samples supplied in accordance with Clause 21.2.

21.8 (17.8) Medicines which are sent by post must be packed so

as to be reasonably secure against being opened by young
children. No unsolicited medicine must be sent through
the post.

21.9 (17.9) Medicines may not be sold or supplied to members of

the public for promotional purposes.

Clause numbers in brackets refer to the 2019 Code of Practice. CLAUSES 18–22 – CODE OF PRACTICE 37
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Clause 22 • representatives may only be involved in an administrative

Non-Interventional Studies of Marketed Medicines capacity and such involvement must be supervised by the
company's scientific service which will also ensure that the
22.1 (13.4) Non-interventional studies that are prospective in representatives are adequately trained for the role; such
nature and involve the collection of patient data must be involvement must not be linked to the promotion of
conducted for a scientific purpose. They must comply with any medicine.
the following criteria:
22.2 To the extent applicable, companies are encouraged
• there must be a written study plan (observational plan/
to comply with Clause 22.1 for all other types of non-
protocol) and written contracts between the health
interventional studies, including epidemiological studies and
professionals and/or the healthcare organisations,
registries and other studies that are retrospective in nature.
institutes, academic faculties etc where the study will
take place and the pharmaceutical company sponsoring 22.3 Companies must publish the summary details and results
the study, which specify the nature of the services to be of non-interventional studies of marketed medicines in
provided and the payment for those services a manner consistent with their parallel obligations with
• in countries where ethics committees are prepared to respect to clinical trials, as set out in Clause 4.6.
review such studies, the study protocol must be submitted
to the ethics committee for review
• any remuneration must be reasonable and reflect the fair Clause 22 Supplementary Information
market value of the work
Clause 22 (13.4) Other Studies
• the study must not constitute an inducement to prescribe, All non-interventional studies, including epidemiological
supply, administer, recommend, buy or sell any medicine studies and registries and other studies that are
• the company's scientific service must certify the protocol retrospective in nature are subject to Clause 24.3.
and supervise the conduct of the study
• the study results must be analysed and summaries
made available within a reasonable period of time to the
company's scientific service, which shall maintain records
of such reports; the summary report should be sent to
health professionals who participated in the study. If the
study results are important for the assessment of benefit/
risk, the summary report should be immediately forwarded
to the relevant competent authority

38 CODE OF PRACTICE – CLAUSES 18–22 Clause numbers in brackets refer to the 2019 Code of Practice.
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Interactions with Health Professionals,

Other Relevant Decision Makers, Healthcare
Organisations, Patient Organisations and the
Public, Including Patients and Journalists
CLAUSES 23–25

Clause 23
Donations and Grants Clause 23 Supplementary Information
Clause 23 Medical and Educational Goods and Services
23.1 Donations and grants are funds, benefits-in-kind or services
which Comply with Clause 19 of the 2019 ABPI Code,
freely given for the purpose of supporting healthcare,
Including their Transition under the 2021 ABPI Code
scientific research or education, with no consequent
Medical and educational goods and services (MEGS)
obligation on the recipient organisation, institution and
provided under Clause 19 of the 2019 Code are likely to
the like to provide goods or services to the benefit of the
fall under donations in Clause 23 or collaborative working
pharmaceutical company in return. Donations and grants
in Clause 20 of the 2021 Code. Companies wishing to
to individuals are prohibited.
continue with ongoing MEGS from 1 July 2021 can do
In general, donations are physical items, services or benefits- so until 31 December 2021 under the 2021 Code without
in-kind which may be offered or requested. Grants are the the need for them to be reclassified as either a donation
provision of funds. or as collaborative working and comply with any new
requirements as a result of this change. Thus there is a six
23.2 (19.1 and 19.2) Donations and grants to healthcare month transition period for MEGS.
organisations, patient organisations or other organisations
are only allowed if they: Clause 23 (19.1) Donations and Grants
• are made for the purpose of supporting healthcare, Clause 19.1 does not prevent the provision of donations and
scientific research or education grants. They must not be provided to individuals.
• do not constitute an inducement to recommend The requirement in Clause 23.2 that donations must not
and/or prescribe, purchase, supply, sell or administer bear the name of any medicine does not apply where the
specific medicines donation is an independently produced textbook or journal
• are prospective in nature which includes as part of its texts the names of medicines.
• do not bear the name of any medicine – although they
Donations as a good or service may bear a corporate name.
may bear the name of the company providing them.
The involvement of a pharmaceutical company in such
In addition: activities must be made clear to those receiving a service.
In addition, the involvement of a pharmaceutical company
• there must be a written agreement in place for each
in any services should be made clear to patients. Such
donation or grant. The arrangements for the written
involvement should also be clear in any associated materials
agreement for donations and grants to patient
for patients. Clause 5.5 would apply.
organisations are set out in Clause 27.2 and for other
organisations in the supplementary information to Companies should be clear regarding the role of staff in
Clause 23.2 the provision of donations and grants, particularly the role
• the written agreement, and where relevant, internal of representatives. Companies should consider using staff
company and service provider instructions must be other than representatives. If companies decide to use
certified in advance as set out in Clause 8.3 representatives in relation to donations and grants, then this
• all information relating to the donation or grant should be should be in accordance with the principles set out below:
kept on record by the company i. the acceptability of the role of representatives will
• donations and grants must be publicly disclosed annually depend on the nature of the donation or grant and the
as set out in Clauses 28 and 29. method of provision
ii. representatives may introduce a donation or no more
Company involvement should be made clear for donations than a call for grant applications by means of a brief
and grants to the extent possible. description and/or delivering materials but may not

Clause numbers in brackets refer to the 2019 Code of Practice. CLAUSES 23–25 – CODE OF PRACTICE 39
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

instigate a detailed discussion about the donation or x. service providers must abide by the principle set out
grant at the same time as a call or contact at which in Clause 17.5 that in an interview, or when seeking an
products are promoted appointment, reasonable steps must be taken to ensure
iii. if representatives provide, deliver or demonstrate a that they do not mislead as to their identity
donation or grant, then this must not be linked in any or that of the sponsoring pharmaceutical company
way to the promotion of products. In order to comply xi. a recipient of a service must be provided with sufficient
with this, the representative must not carry out both written information to avoid misunderstandings as
activities at the same call or contact to what the recipient has agreed. The identity of the
iv. if, during a promotional call or contact by a sponsoring pharmaceutical company must be given
representative, a change in medication to one of the xii. any material designed for use in relation to the
company's products is agreed, the representative may provision of a service must be non-promotional. It
not then offer a donation or grant to facilitate the is not acceptable for such materials to promote the
change in medication as this would be seen as a way administration, consumption, prescription, purchase,
for the company to ensure that the agreed change recommendation, sale, supply or use of the sponsoring
would in fact be made. company's medicines. Nor is it acceptable for materials
to criticise competitor products as this might be seen as
In addition, companies should consider the following in promotional
relation to donations in the form of a service:
xiii. material relating to the provision of a service, such as
v. the nature of the service provider and the person internal instructions, external instructions, the written
associated with the provision of the service is important, information for recipients and other material, must be
ie is the service provider a suitably qualified person, certified as required by Clause 8.3
such as a health professional? If the service requires
xiv. a copy of the materials must be made available to the
patient contact, for example, either directly or by
PMCPA on request
identification of patients from patient records and the
like, then representatives must not be involved. Only a xv. companies are recommended to inform relevant NHS or
suitably qualified person, such as a health professional, other organisations of their activities where appropriate.
not employed as a representative, may undertake This is particularly recommended where companies
activities relating to patient contact and/or are proposing to provide a service which would have
patient identification budgetary implications for the parties involved.
vi. neither the company nor its representatives may be Clause 23 (19.1) Switch and Therapy Review Programmes
given access to data/records that could identify, or Clauses 19.1 and 23.1 prohibit switch services paid for or
could be linked to, particular patients facilitated directly or indirectly by a pharmaceutical company
vii. health professionals involved in the delivery of services whereby a patient's medicine is simply changed to another.
are required to adhere to all relevant professional For example, it would be unacceptable if patients on
standards of conduct (see supplementary information medicine A were changed to medicine B, without any clinical
to Clause 10.1). There should be no promotion of assessment, at the expense of a pharmaceutical company
specific products by those health professionals promoting either or both medicines. It would be acceptable
viii. the remuneration of those not employed as for a company to promote a simple switch from one
representatives but who are engaged to deliver a product to another but not to assist a health professional in
service as service providers must not be linked to implementing that switch even by means of a third party.
sales in any particular territory or place or to sales
A therapeutic review is different to a switch service. A
of a specific product or products and, in particular,
therapeutic review which aims to ensure that patients
may not include a bonus scheme linked to such sales.
receive optimal treatment following a clinical assessment is a
Bonus schemes linked to a company's overall national
legitimate activity for a pharmaceutical company to support
performance, or to the level of service provided, may
and/or assist. The result of such clinical assessments might
be acceptable
require, among other things, possible changes of treatment
ix. service providers must operate to detailed written including changes of dose or medicine or cessation of
instructions provided by the company. These should treatment. A genuine therapeutic review should include
be similar to the briefing material for representatives a comprehensive range of relevant treatment choices,
as referred to in Clause 17.9. The written instructions including non-medicinal choices, for the health professional
should set out the role of the service provider and and should not be limited to the medicines of the sponsoring
should cover patient confidentiality issues. Instructions pharmaceutical company. The decision to change or
on how the recipients are to be informed etc should be commence treatment must be made for each individual
included. The written instructions must not advocate, patient by the prescriber and every decision to change an
either directly or indirectly, any course of action which individual patient's treatment must be documented with
would be likely to lead to a breach of the Code evidence that it was made on rational grounds.

40 CODE OF PRACTICE – CLAUSES 23–25 Clause numbers in brackets refer to the 2019 Code of Practice.
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

• a written contract or agreement must be agreed in

Clause 23.2 Written Agreements advance of the commencement of the services which
Clause 27.2 sets out the arrangements for patient specifies the nature of the services to be provided and the
organisations. The written agreement for donations basis for payment of those services
and grants to other organisations should include:
• a legitimate need for the services must be clearly identified
• description of the donation or grant and documented in advance of requesting the services
• objective of the donation or grant. How it will support and entering into arrangements
healthcare, scientific research or education must also • the criteria for selection must be directly related to the
be included identified need and the persons responsible for selection
• the names of the organisations/parties involved and their must have the expertise necessary to evaluate whether
respective roles the particular contracted individuals and/or organisations
• the type of activity and the nature of the company's meet those criteria
contribution • the number of contracted individuals and/or organisations
• the time frame retained and the extent of the service must not be greater
than the number reasonably necessary to achieve the
• the amount of funding and/or a description of indirect/
identified need
non-financial, in-kind donation and the nature of that
donation. Where possible a full breakdown of costs • the contracting company must maintain records concerning,
should be included and make appropriate use of, the services provided
• a statement that all parties are fully aware that the • the hiring of the contracted party to provide the relevant
donation or grant must be clearly acknowledged and service must not be an inducement to prescribe, supply,
apparent from the start administer, recommend, buy or sell any medicine
• the signatories to the agreement • the remuneration for the services must be reasonable
and reflect the fair market value of the services provided.
• the date of the agreement.
Token consultancy arrangements must not be used to
Clause 23.2 (19.2) Annual Disclosure of Donations justify compensating the contracted party
and Grants • in their written contracts or agreements, companies
Company support of individuals to attend events/meetings must include provisions regarding the obligation of the
is covered by Clause 10. individual to:
Details of each donation or grant (transfer of value) must - declare that they are a contracted individual to the
be publicly disclosed annually, giving in each case the company whenever they write or speak in public about
financial amount or value and the name of the recipient a matter that is the subject of the agreement or any
institution, organisation or association. Companies are also other issue relating to that company
encouraged to ask recipients to make such funding public. - similarly, companies that employ, on a part-time basis,
Where applicable, fees and expenses should be disclosed health professionals who are still practising their
separately. Disclosure must be carried out in accordance profession, must ensure that such persons are obliged
with Clauses 28 and 29. to declare their employment arrangement with the
company whenever they write or speak in public about
a matter that is the subject of the employment or any
other issue relating to that company.

Clause 24 24.3 (21) Contracts between companies and health professionals,

other relevant decision makers or their employers on their
Contracted Services behalf, healthcare organisations, patient organisations,
24.1 Health professionals, other relevant decision makers or individuals representing patient organisations, and members
their employers on their behalf, healthcare organisations, of the public, including patients and journalists under which
patient organisations, individuals representing patient they provide any type of service (not otherwise covered by
organisations, and members of the public, including patients the Code) to companies are allowed providing such services:
and journalists, may be used as consultants and advisors, • are provided for the purpose of supporting healthcare,
whether in groups or individually, for services such as research or education; and
speaking at and chairing meetings, involvement in medical/ • do not constitute an inducement to recommend
scientific studies, clinical trials or training services, writing and/or, prescribe, purchase, supply, sell or administer
articles and/or publications, participation at advisory board a specific medicine.
meetings, and participation in market research where such
participation may involve remuneration and/or hospitality. 24.4 (23.2) Pharmaceutical companies must publicly disclose
annually details of the fees and expenses paid to UK
24.2 (23.1 and 27.8) The arrangements which cover genuine individuals, organisations etc for contracted services such as
consultancy or other services must, to the extent relevant chairing and speaking at meetings, assistance with training
to the particular arrangement, fulfil all the following criteria: and participation in advisory boards etc. Such disclosure

Clause numbers in brackets refer to the 2019 Code of Practice. CLAUSES 23–25 – CODE OF PRACTICE 41
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

includes payments in relation to research and development

work, including the conduct of clinical trials. disease or medicine. Providing advice with regard to the
design of clinical trials would be an included contracted
24.5 (23.3) In addition to the information required to be service whereas being a participant in a clinical trial
made public by Clause 24.4, companies must publicly would not.
disclose annually details of payments made to contracted
individuals in relation to market research (unless the The transparency of contracted services with members of
company concerned does not know the identities of those the public, including patients and journalists, is the next step
participating in the market research). in evolving disclosures made by pharmaceutical companies.
The arrangements are similar to those used when disclosure
24.6 (23.4 and part of Clause 27.8) Fees, expenses and the like for health professionals was introduced. The introduction
due to contracted individuals/organisations in relation to of requirements for contracted services with the public,
Clauses 24.3, 24.4 and 24.5 must be disclosed. including patients and journalists, was thought necessary
following publication of the EFPIA document 'Working
The relevant disclosure requirements are: together with patients – principles for remunerating
• fees and expenses paid for contracted services between patients, patient organisation representatives and carers
companies and institutions, organisations or associations for work undertaken with the pharmaceutical industry'
of health professionals in June 2019.
• fees and expenses paid for contracted services to health
Clause 24.1 (23.1) Contracted Individuals
professionals and other relevant decision makers, or to
The relevant provisions of Clause 10 apply to contracted
their employers on their behalf
individuals' attendance at events/meetings.
• the disclosure for contracted services provided by each
patient organisation must include: Clause 24.5 (23.3) Annual Disclosure of Transfers
- the total amount paid per patient organisation per of Value of Market Research
calendar year, including a description of the services Clause 24.5 relates only to market research using contracted
provided that is sufficiently complete to enable the reader individuals where the pharmaceutical company knows the
to understand the nature of the services provided without identity of the contracted individuals. This is because the
the necessity to divulge confidential information focus of the requirements concerning transparency is on
areas where there are direct relationships between the
- fees and expenses should be disclosed separately
parties and that is not so where the company does not
• the disclosure for contracted services provided by know the identity of the participants.
members of the public, including patients and journalists,
must include: Clause 24.6 (23.2) Annual Disclosure of Transfers of Value
- the total number of members of the public contracted to UK Health Professionals and Other Relevant Decision
to perform services, the total amount paid to members Makers or their Employers on their Behalf
of the public per calendar year and a description of the Disclosure must be carried out in accordance with Clause 28.
types of services provided that is sufficiently complete
The information which must be disclosed is the total amount
to enable the reader to understand the nature of the
paid in a calendar year to each contracted individual who
services provided without the necessity to divulge
is a health professional or other relevant decision maker
confidential information
and has provided services. Companies may of course give
- a breakdown of the total payments to each group of greater detail, for example, by giving separate figures for
individuals, ie the public, patients and journalists, without different categories of service.
the necessity to divulge confidential information.
The names of these contracted individuals must be disclosed
In addition, companies should disclose fees and expenses except in relation to payments in relation to research and
separately. development work, including clinical trials, as defined below,
where disclosure should be on an aggregate basis.
Contracts for UK individuals representing patient
organisations should be made with the patient organisation Fees and expenses should be disclosed separately.
and disclosed against the patient organisation as set out in
Clause 29. Clause 24.6 (23.2) Annual Disclosure of Transfers of
Value in Relation to Contracted Services Provided by
Patient Organisations or Individuals Representing
Clause 24 Supplementary Information Patient Organisations
Disclosure must be carried out in accordance with Clause 29.
Clause 24.1 Contracted Services with Members
of the Public, Including Patients and Journalists A payment to an individual representing a patient
Only certain services provided by members of the public, organisation should be disclosed as a payment to that
including patients and journalists, are covered by the Code; patient organisation. This means that the contract should
others are clearly outside the scope of the Code. The also be with the patient organisation.
services covered by the Code generally relate to healthcare,

42 CODE OF PRACTICE – CLAUSES 23–25 Clause numbers in brackets refer to the 2019 Code of Practice.
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Clause 25
The information which must be disclosed is the total amount
paid per patient organisation over the reporting period and Relationships with Health Professionals, Other
a description of the services provided that is sufficiently Relevant Decision Makers, Healthcare Organisations
complete to enable the reader to understand the nature and Patient Organisations
of the services provided without the necessity to divulge
confidential information. This information should include 25.1 (27.4) No company may require that it be the sole funder
contracted services provided by individuals representing or sponsor of a healthcare organisation or patient
patient organisations. organisation or any of its programmes.

Fees and expenses should be disclosed separately. 25.2 (27.5) A company must not make public use of a healthcare
organisation or patient organisation's logo and/or
Clause 24.6 (23.2) Annual Disclosure of Transfers of proprietary material without the organisation's written
Value in Relation to Contracted Services by Members agreement. In seeking such permission, the specific purpose
of the Public, Including Patients and Journalists and the way in which the logo and/or proprietary material
Disclosure must be carried out in accordance with Clauses will be used must be clearly stated.
30 and 31.
25.3 (27.9) Companies must ensure that all sponsorship is
The information which must be disclosed is the total amount clearly acknowledged from the outset. The wording of
paid to members of the UK public over the reporting the declaration of sponsorship must be unambiguous and
period, including the number of individuals contracted accurately reflect the extent of the company's involvement
and a description of the types of services provided that is and influence over the material.
sufficiently complete to enable the reader to understand
the nature of the services provided without the necessity to 25.4 (12.2) Market research activities, clinical assessments,
divulge confidential information. post-marketing surveillance and experience programmes,
post-authorisation studies (including those that are
Companies should provide a breakdown of the total retrospective in nature), and the like must not be disguised
payments to each group of individuals, ie the public, promotion. They must be conducted with a primarily
patients and journalists, without the necessity to divulge scientific or educational purpose.
confidential information.

Fees and expenses should be disclosed separately.

Clause 25 Supplementary Information
Clause 24.6 (23.2) Annual Disclosure of Transfers
Clause 25.2 (27.5) Use of Healthcare or Patient
of Value of Research and Development
Organisation Logos or Material
For the purpose of disclosure, research and development
Even with the organisation's permission, the use of its logo or
transfers of value are transfers of value to health
material must not be such as to otherwise breach the Code.
professionals or healthcare organisations related to the
planning or conduct of: Clause 25.4 (12.2) Market Research
i. non-clinical studies (as defined in the OECD Principles Market research is the collection and analysis of information
on Good Laboratory Practice) and must be unbiased and non-promotional. The use
ii. clinical trials (as defined in Regulation 536/2014) to which the statistics or information is put may be
promotional. The two phases must be kept distinct.
iii. non-interventional studies that are prospective in
nature and that involve the collection of patient data Attention is drawn to the Legal & Ethical Guidelines for
from or on behalf of individual or groups of health Healthcare Market Research produced by the British
professionals specifically for the study. Healthcare Business Intelligence Association.
Costs that are subsidiary to these activities can be included
in the aggregate amount. Market research material should be examined to ensure
that it does not contravene the Code.

Where market research is carried out by an agency on behalf

of a pharmaceutical company, the agency must reveal the
name of its client to the PMCPA when requested to do so.
When commissioning market research, a company must take
steps to ensure that its identity would be made known to the
PMCPA should a request for that information be made.

Clause numbers in brackets refer to the 2019 Code of Practice. CLAUSES 23–25 – CODE OF PRACTICE 43
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Specific Requirements for Interactions with

the Public, Including Patients and Journalists,
and Patient Organisations
CLAUSES 26–27

Clause 26 'This medicine is subject to additional monitoring. This

Relations with the Public, Including Patients will allow quick identification of new safety information.
You can help by reporting any side effects you may get.
and Journalists See [a website address which links directly to the MHRA
26.1 (26.1) Prescription only medicines must not be advertised Yellow Card site] for how to report side effects.'
to the public. This prohibition does not apply to vaccination
26.5 (26.4) Requests from individual members of the public for
and other campaigns carried out by companies and
advice on personal medical matters must be refused and
approved by the health ministers.
the enquirer recommended to consult their own doctor,
26.2 (26.2) Information about prescription only medicines which or other prescriber or other health professional.
is made available to the public either directly or indirectly
must be factual and presented in a balanced way. It must
not raise unfounded hopes of successful treatment or be Clause 26 Supplementary Information
misleading with respect to the safety of the product.
Attention is drawn to other relevant clauses of the Code, in
Statements must not be made for the purpose of particular, the quality standards Clauses 5 to 10, including
encouraging members of the public to ask their health meetings organised for or attended by members of the
professional to prescribe a specific prescription only medicine. public, patients, journalists and patient organisations which
must comply with Clause 10.
26.3 (18.2 SI) Items for patient support made available to
patients, for example, by completing a request card In the event of a complaint which relates to the provisions of
enclosed with a medicine, should be inexpensive, related to this clause, companies will be asked to provide copies of any
either the condition under treatment or general health, and information supplied, including copies of any relevant press
must be appropriately documented and certified in advance releases and the like. This information will be assessed to
as required by Clause 8.3. Care must be taken that any determine whether it fulfils the requirements of this clause.
such activity meets all the requirements of the Code and in
Clause 26.1 (New) Vaccination and Other Campaigns
particular Clause 26.4.
Approved by the Health Ministers
Companies cannot run or sponsor competitions or quizzes Further information regarding temporary supply
for patients if prizes are offered. authorisations is given in the supplementary information
to Clauses 3.1 and 3.2. Where the campaign for the public
26.4 (26.3) Any material which relates to a medicine and which is is approved by the health ministers all other relevant
intended for patients taking that medicine must include the requirements of the Code will apply. In addition, such
statement below or a similar one: campaigns should include a general reference to the
'Reporting of side effects If you get any side effects, talk reporting of side effects as it is unlikely that the requirements
to your doctor, pharmacist or nurse. This includes any of Clause 26.4 will apply as the relevant material is not
possible side effects not listed in the package leaflet. You intended for patients taking a particular medicine.
can also report side effects directly via the Yellow Card
Scheme at [a website address which links directly to the Clause 26.2 (26.2) Information to the Public
MHRA Yellow Card site]. This clause allows for the provision of non-promotional
information about prescription only medicines to the public
 y reporting side effects, you can help provide more
B either in response to a direct enquiry from an individual,
information on the safety of this medicine.' including enquiries from journalists, or by dissemination of
such information via press conferences, press announcements,
When the material relates to a medicine which is subject to television and radio reports, public relations activities etc.
additional monitoring, an inverted black equilateral triangle It also includes reference information made available by
must be included on it together with the statement below or companies on their websites or otherwise as a resource for
a similar one: members of the public and information provided by means
of posters distributed for display in surgery waiting rooms etc.

44 CODE OF PRACTICE – CLAUSES 26–27 Clause numbers in brackets refer to the 2019 Code of Practice.
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Companies should take particular care if they use social media. Public assessment reports (European or UK), summaries
of product characteristics and package leaflets may be
Any information so provided must observe the principles set provided to members of the public on request.
out in this clause; that is, it should be factual, balanced and
must not encourage members of the public to ask their doctors The Media: It is good practice to reference the summary of
or other prescribers to prescribe a specific prescription product characteristics with a press release or press pack
only medicine. It must not constitute the advertising of relating to a medicine. Companies should also consider
prescription only medicines to the public prohibited under including references to other credible sources of information
Clause 26.1. The provisions of Clause 26.5 must be observed if about a condition or a medicine.
an enquiry is from an individual member of the public.
Particular care must be taken in responding to approaches
Information to the public falls into one of three categories from the media to ensure that the provisions of this clause
depending on its purpose, how it is supplied and how the are upheld.
public is made aware of the information.
Attention is drawn to the Blue Guide Appendix: Reporting to
Proactive information is supplied to the public without the public on medicines: Advice for journalists and patient
a direct request. This includes booklets on diseases and/ organisations produced by the Medicines and Healthcare
or medicines supplied directly or via a health professional, products Regulatory Agency (MHRA).
press releases, briefings, conferences, mailings to patient
organisations and disease awareness information. Individuals Prescribed Medicines: Information about
medicines already prescribed for patients may be provided
Reference information is intended to provide a proactively, reactively or as reference information. It could
comprehensive, up-to-date resource that companies also be supplied to health professionals to pass on to those
should make available on their websites or by way of a link patients to whom the medicine has already been prescribed.
from their website or by some other means. The primary Such material must be factual and non-promotional and
purpose of reference information is to be a library resource clearly state the intended audience.
for members of the public giving information relating
to prescription only medicines which have marketing Items for patients or for use by patients are covered in
authorisations. Such information must not be presented in Clauses 19.2 and 26.3 and their supplementary information.
such a way as to be promotional in nature. Pharmaceutical
Disease Awareness or Public Health Campaigns can
companies are not obliged to provide reference information
be conducted by a company provided that the purpose
but it is considered good practice to provide as a minimum
is to encourage members of the public to seek treatment
the regulatory information comprising the:
for their symptoms while in no way promoting the use of
• summary of product characteristics (SPC) a specific medicine. The use of brand or non-proprietary
• the patient information leaflet which is included in the names and/or restricting the range of treatments described
pack (PIL) in the campaign might be likely to lead to the use of a
• and the public assessment report (PAR) (UK or European) specific medicine. Particular care must be taken where the
where such a document exists. company's product, even though not named, is the only
medicine relevant to the disease or symptoms in question.
Reference information may also include:
• registration studies used for marketing authorisation Information on disease awareness campaigns may be
applications and variations and any other studies proactive, reactive or reference information depending on
published or not including those referred to in the circumstances. Attention is drawn to the Blue Guide
the SPC, PIL, EPAR or UKPAR or available on clinical Appendix: Disease Awareness Campaign Guidelines
trial databases produced by the MHRA.
• material supplied for health technology assessments to Further information is available in Clauses 19.2 and 26.3 and
bodies such as the National Institute for Health and Care its supplementary information.
Excellence (NICE), the All Wales Medicines Strategy Group
(AWMSG) and the Scottish Medicines Consortium (SMC) Clause 26.2 (28.1) Website Access
A pharmaceutical company website or a company
• medicine guides where available
sponsored website providing information for the public as
• information about diseases well as promotion to health professionals must have the
• information about specific medicines. sections for each target audience clearly separated and
the intended audience identified. This is to avoid the public
Where companies decide to make reference information needing to access material for health professionals unless
available, this must represent fairly the current body of they choose to. The MHRA Blue Guide states that the
evidence relating to a medicine and its benefit/risk profile. public should not be encouraged to access material which is
Reactive information is supplied to the public in response not intended for them.
to a direct request and must be limited to that information
necessary to respond to the request.

Clause numbers in brackets refer to the 2019 Code of Practice. CLAUSES 26–27 – CODE OF PRACTICE 45
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Clause 26.2 (28.5) MHRA Guidance In the event that the website address given in Clause 26.4
The MHRA Blue Guide states that the public should not need is changed by the MHRA, companies must use the new
to access non-UK websites or non-UK parts of websites to address within one year of the change.
obtain basic information about a company's products, such as
package leaflets, summaries of product characteristics, public Clause 26.4 (26.3) Black Triangle Symbol
assessment reports and other non-promotional material. Details of the black triangle symbol can be found in the
It is good practice for each page of a company website to supplementary information to Clause 12.10.
include a statement identifying the intended audience.
Clause 26.5 (26.4) Requests for Information
Clause 26.2 (26.2) Financial Information or Advice on Personal Medical Matters
Information made available in order to inform shareholders, This clause prohibits the provision of advice on personal
the Stock Exchange and the like by way of annual reports medical matters to individual members of the public
and announcements etc may relate to both existing requesting it. This is to ensure that companies do not
medicines and those not yet marketed. Such information intervene in the patient/doctor or patient/prescriber
must be non-promotional, accurate, presented in a factual relationship by offering advice or information which properly
and balanced way and not misleading, taking into account should be in the domain of the doctor or other prescriber.
the information needs of the target audience. Business
Pharmaceutical companies can provide information
press releases should identify the business importance of
appropriate to support the use of medicines and enhance
the information and should only be aimed at the intended
patient welfare. Emergency advice, for example, action
financial and investment audience.
needed in the event of an overdose, can be provided.
Clause 26.2 (26.2) Information to Current Other information may also be given, including information
or Prospective Employees on medicines prescribed for the enquirer, provided that it
Information about pharmaceutical companies provided to complies with the requirements of Clauses 26.1 and 26.2 and
current or prospective employees may relate to both existing does not impinge on the principle behind this clause. For
medicines and those not yet marketed. Such information example, answering requests from members of the public as
must be factual and presented in a balanced way. to whether a particular medicine contains sucrose or some
other ingredient, or whether the medicine should be taken
Clause 26.2 (26.2) Certification of Information before or after a meal, is acceptable. Particular care needs
In general, information on medicines made available under to be taken with regard to enquiries relating to adverse
this clause must be certified in advance as required by reactions, the indications for a medicine and suchlike.
Clause 8.3. There are exceptions such as for responses from
medical information departments or similar to unsolicited Requests from members of the public must be handled
enquiries from the public, which should be examined as set carefully and a company should refer the enquirer to other
out in the supplementary information to Clause 8.3. sources where appropriate. These might include health
professionals, NHS websites, NHS 111, their equivalents in the
Clause 26.2 (26.2) Health Technology Assessments devolved nations and patient organisations etc.
Companies may supply information to relevant patient
A request from a patient for information may in some
organisations, the public or patients in relation to forthcoming
instances be more appropriately handled by passing the
health technology assessments by public national
information to the patient's doctor or other prescriber for
organisations such as NICE, AWMSG or SMC, provided the
discussion with them rather than providing the information
information is accurate, not misleading, not promotional in
direct to the patient concerned. This should not be done
nature and otherwise complies with Clause 26.2.
without the patient's consent.
Clause 26.3 (18.2 SI) Items for Patient Support
An 'inexpensive' item for patient support means one that
has cost the donor company no more than £10, excluding
VAT. The perceived value to the health professional and the
patient must be similar. Such items may bear the name of a
medicine and/or information about medicines only if such
detail is essential for the proper use of the item by patients.

Clause 26.4 (26.3) Obligatory Wording

The obligatory wording required corresponds to that
required for package leaflets by the European Quality
Review of Documents Group which updated the
requirements in The Human Medicines Regulations 2012.
If the suggested wording is not used, the same meaning
must be conveyed.

46 CODE OF PRACTICE – CLAUSES 26–27 Clause numbers in brackets refer to the 2019 Code of Practice.
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Clause 27 Donations, grants and sponsorships (including in relation to

Relationships with Patient Organisations events/meetings) must be publicly disclosed annually as set
out in Clause 29.
27.1 (27.1) When pharmaceutical companies interact with patient
organisations or any user organisations such as disability 27.3 (27.2) When providing donations, grants or sponsorship
organisations, carer or relative organisations and consumer (including in relation to events/meetings) to patient
organisations, companies must: organisations, companies must ensure:
• respect the independence of the organisations • they comply with the prohibition on advertising
prescription only medicines to the public
• assure the independence of the organisations, in terms of
their political judgement, policies and activities • that the involvement of the company is made clear and
that all of the arrangements comply with the Code.
• ensure relationships are based on mutual respect, with the
This includes the need to declare the provision, and the
views and decisions of each partner having equal value
wording of the declaration must accurately reflect the
• not promote or request the promotion of a particular nature of the company's involvement.
prescription only medicine
• ensure the objectives and scope are transparent and 27.4 (27.6) A company must not seek to influence the text of
support provided by companies must always be clearly patient organisation material in a manner favourable to
acknowledged. its own commercial interests. This does not preclude a
company from correcting factual inaccuracies.
27.2 (27.3) When companies provide donations, grants or
sponsorship (including in relation to events/meetings) to 27.5 (New Clause and part of Clause 27.5) Companies
patient organisations as set out in Clauses 23.2 and 10, can contract with patient organisations or individuals
companies must have a written agreement in place for each representing patient organisations under which they
donation, grant or sponsorship setting out exactly what has provide any type of service to companies providing these
been provided. comply with Clause 24. Companies must publicly disclose
annually fees and expenses paid to patient organisations
The written agreement must include: as set out in Clause 29. In their written contracts with
• a description of the donation, grant or sponsorship patient organisations, companies are strongly encouraged
to include provisions regarding an obligation of the patient
• the objective of the donation, grant or sponsorship,
organisations to declare that they have provided paid
including how it will support healthcare, scientific research
services to the company whenever those concerned write
or education
or speak in public about a matter that is the subject of the
• the names of the organisations/parties involved agreement or any other issue relating to that company.
(pharmaceutical company, patient organisations and any
other parties) and their respective roles Where companies contract with individuals representing
• the type of activity and the nature of the company's patient organisations to provide services, such contracts
contribution (eg donation, grant, sponsorship of a specific should be made with the patient organisation, and payment
meeting or publication etc) should be disclosed as a payment to the patient organisation.
• the time frame
• the amount of funding and/or a description of indirect/
Clause 27 Supplementary Information
non-financial, in-kind donation and the nature of that
donation (eg the donation of agency time or free training Clause 27.3 (27.2) Purpose of Materials and Activities
courses). Where possible, a full breakdown of costs Companies should take into account the purpose of materials
should be included and/or activities. The purpose of information supplied to a
• a statement that all parties are fully aware that the donation, patient organisation must be made clear. For example, there
grant or sponsorship must be clearly acknowledged and is a difference between providing information to be supplied
apparent from the start to the members of a patient organisation and providing
• the signatories to the agreement background information to enable a patient organisation to
respond to a health technology assessment or similar.
• the date of the agreement.
Clause 27.4 (27.6) Contributing to Patient
This written agreement must be certified as set out in Clause
Organisation Material
8.3. A company must ensure that any materials, activities
At the request of patient organisations, companies may
etc resulting from working with patient organisations are
contribute to the drafting of patient organisation materials
also certified where these are covered in Clause 8.3.
from a fair and balanced and scientific perspective.

Clause numbers in brackets refer to the 2019 Code of Practice. CLAUSES 26–27 – CODE OF PRACTICE 47
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Annual Disclosure Requirements

CLAUSES 28–31

Clause 28 28.5 (24.9) Where recipients of transfers of value cannot be

Annual Disclosure of Transfers of Value to Health identified for legal reasons, the amount attributable to such
transfers must be disclosed on an aggregate basis. The
Professionals, Other Relevant Decision Makers and number of recipients involved must be stated together with
Healthcare Organisations the percentage of all recipients that they represent and the
28.1 (24.1) Companies must document and publicly disclose aggregate amount attributable to transfers of value to
annually certain transfers of value made directly or indirectly such recipients.
to health professionals, other relevant decision makers and 28.6 (24.10) Each company providing transfers of value must
healthcare organisations located in Europe. This includes publish a note summarising the methodologies used by it
any employee of a pharmaceutical company whose primary in preparing the disclosures and identifying each category
occupation is that of a practising health professional. of transfer of value. The note, including a general summary
28.2 (24.2) The transfers of value covered by Clause 28.1 are: and/or country specific considerations, must describe the
recognition methodologies applied and should include the
• collaborative working, including joint working, in treatment of multi-year contracts, VAT and other tax aspects,
accordance with Clause 20 currency aspects and other issues relating to the timing and
• donations and grants provided to healthcare amount of transfers of value for the purposes of this Code.
organisations, institutions and other organisations in
accordance with Clause 23
• fees and expenses paid for contracted services between Clauses 28, 29 and 30 Supplementary Information
companies and institutions, organisations or associations
of health professionals, in accordance with Clause 24.6 (24.1) Lawful Disclosure
• support of attendance by health professionals and other Companies must ensure that they have appropriate
relevant decision makers at events/meetings whether paid arrangements in place to lawfully disclose information about
directly, indirectly or via another party in accordance with transfers of value and that recipients are aware of the
Clause 10.10 process for disclosure.
• fees and expenses paid for contracted services to health (24.1) Transfers of Value
professionals and other relevant decision makers, or to their Disclosure is required even if the payments etc are made by
employers on their behalf, in relation to Clause 24.6 overseas affiliates, head offices in the UK or overseas and
• sponsorship, including contributions to costs related to UK-based offices.
events/meetings paid to healthcare organisations or to
organisations managing events on their behalf, which
may include support of health professionals not known to
the company via the healthcare organisation by way of Clause 28 Supplementary Information
registration fees, accommodation and travel, in accordance
with Clause 10.11. Clause 28.1 (24.1) Mode of Disclosure for Health
Professionals, Other Relevant Decision Makers and
28.3 (24.7) Different categories of transfers of value to individual Healthcare Organisations
health professionals or other relevant decision makers can be There is a central platform for disclosure in the UK which
aggregated on a category by category basis, provided that companies must use. The template to be used is available
itemised disclosure would be made available upon request to from the PMCPA website www.pmcpa.org.uk.
the relevant recipient or the relevant authorities. Payments to
healthcare organisations are required to be disclosed on a per Clause 28.2 (24.2) Further Information
activity basis. The clauses of the Code noted in Clause 28.2 should be
consulted for further information about the requirements. In
28.4 (24.8) Where a transfer of value is made to an individual addition, the requirements of Clauses 10.1 and 10.10 should
health professional or other relevant decision maker indirectly be borne in mind in relation to meetings.
via a healthcare organisation, such a transfer should be
disclosed once only, preferably as being a transfer to the Clause 28.2 (24.2) Disclosure of Contributions to Costs
individual concerned. Related to Events/Meetings
If when providing sponsorship to a healthcare organisation,
institution, other organisation etc in relation to their own
event, a company contributes towards the overall cost of
subsistence (food and drink), then this must be included

48 CODE OF PRACTICE – CLAUSES 28–31 Clause numbers in brackets refer to the 2019 Code of Practice.
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

The disclosure for contracted services provided by each patient

in the disclosure of the cost of the sponsorship to the organisation, in accordance with Clause 24, must include:
healthcare organisation, institution, other organisation etc.
• the total amount paid per patient organisation per
Where a company supports individual health professionals
calendar year including a description of the services
or other relevant decision makers (directly or indirectly) to
provided that is sufficiently complete to enable the reader
attend events/meetings, there is no requirement to disclose
to understand the nature of the services provided without
subsistence (food and drink) as in Clause 10.1.
the necessity to divulge confidential information
Clause 28.5 (24.9) Disclosure of Transfers of Value to • fees and expenses should be disclosed separately.
Individual Health Professionals and Other Relevant
Decision Makers
If an individual health professional or other relevant decision Clause 29 Supplementary Information
maker receives a number of transfers of value from a
company and decides not to agree to disclosure of one Clause 29.1 (27.7) Further Information
or more of those transfers of value, then that company An indication of the patient organisation's total income
can disclose all of that individual's transfers of value in its and/or the company's support as a percentage of
aggregate amount. the patient organisation's total income may be given.
Companies are encouraged to be prepared to make
available up-to-date information about such activities at
any time in response to enquiries.

Clause 29 A template to disclose the information required in relation to

Annual Disclosure of Contracted Services, Donations, patient organisations is available from the PMCPA website
www.pmcpa.org.uk. The use of this template is optional.
Grants and Sponsorship (including in relation to
events/meetings) Provided to Patient Organisations
29.1 (New Clause) Companies must make publicly available
annually, a list of patient organisations to which it provides Clause 30
donations, grants or sponsorship (including in relation
Annual Disclosure of Contracted Services Provided by
to events/meetings) or with whom it has engaged to
provide contracted services over the reporting period. This the Public, Including Patients and Journalists
information must be disclosed on the company website 30.1 (New Clause) Companies must make publicly available
either on a national or European level. Each reporting annually details of the fees for certain contracted services
period shall cover a full calendar year. paid to members of the UK public, including patients and
Each company must include a note of methodologies used journalists. These services include speaking at meetings,
by it in preparing the disclosures and identifying support assistance with training, writing articles and/or publications,
and contracted services provided. participating in advisory boards, advising on the design etc
of clinical trials and participating in market research where
29.2 (New Clause and part of Clauses 27.7 and 27.8) such participation involves remuneration and/or travel.
The disclosure for the provision of donations, grants or
sponsorship (including in relation to events/meetings) to a The disclosure for contracted services provided by members
patient organisation must include: of the public, in accordance with Clause 24, must include:
• the monetary value of each financial contribution (grant • the total number of members of the public, including
or sponsorship) to include a description that is sufficiently patients and journalists contracted to perform services
complete to enable the reader to understand the nature and the total amount paid per calendar year, and a
of that support or the arrangements in accordance with description of the types of services provided that is
Clauses 23 and 10 sufficiently complete to enable the reader to understand
the nature of the services provided without the necessity
• the monetary value for each non-financial and/or indirect to divulge confidential information
support (donation); the published information must
also include a clear description of each donation that is • companies should provide a breakdown of the total
sufficiently complete to enable the reader to understand payments to each group of individuals, ie the public,
the nature of the support or the arrangements. If the patients and journalists without the necessity to divulge
non-financial and/or indirect support (donation) cannot confidential information
be assigned a meaningful monetary value, the published • fees and expenses should be disclosed separately.
information must describe clearly the non-monetary value
Each company must include a note summarising the
that the organisation receives that is sufficiently complete
methodologies used by it in preparing the disclosures and
to enable the reader to understand the nature of the
identifying support and services provided.
support or the arrangements in accordance with Clause 23.

Clause numbers in brackets refer to the 2019 Code of Practice. CLAUSES 28–31 – CODE OF PRACTICE 49
 CONTENTS CLAUSES 1–10 CLAUSES 11–17 CLAUSES 18–22 CLAUSES 23–25 CLAUSES 26–27 CLAUSES 28–31

Clause 31
Clause 30 Supplementary Information Timings, Duration and Retention of
Clause 30 (New) Disclosure of Contracted Services Disclosure Information
Provided by the Public, Including Patients and Journalists
The arrangements for such services should meet the 31.1 (24.4) Disclosures must be made annually in respect of each
requirements of Clause 24. calendar year and must be in the first six months after the
end of the calendar year in which the transfers of value/
Disclosure must be in the first six months in the calendar payments were made.
year following that in which the payments were made. The
information which must be disclosed is the total amount paid 31.2 (24.5) The information disclosed must remain in the
in a calendar year to the public, including individual patients, public domain for at least three years from the time of first
journalists and members of the public who have provided disclosure.
services. The total number of individuals must be given. The 31.3 (24.6) Companies must document all disclosures and
names of the individuals need not be disclosed. Companies retain the records for at least five years after the end of
may, of course, give greater detail, for example, by giving the calendar year to which they relate.
separate figures for different categories of service or by
providing details of the maximum and minimum payments etc.

A template to disclose the information required in relation

to the public etc is available from the PMCPA website Clause 31 Supplementary Information
www.pmcpa.org.uk. The use of this template is optional.
Clause 31.1 (New) Date of Implementation for Disclosure
All reasonable steps should be taken by companies to of Contracted Services Provided by the Public, Including
similarly disclose their best estimates of fees paid to UK Patients and Journalists
individuals by overseas affiliates, head offices in the UK or The information required by Clause 30 must be publicly
overseas and UK-based European offices. disclosed annually in respect of transfers of value made in
2022 and each calendar year thereafter.

50 CODE OF PRACTICE – CLAUSES 28–31 Clause numbers in brackets refer to the 2019 Code of Practice.
PRESCRIPTION MEDICINES
CODE OF PRACTICE AUTHORITY
CONSTITUTION AND PROCEDURE

Introduction........................................................................................................... 52

STRUCTURE AND RESPONSIBILITIES

1 Prescription Medicines Code of Practice Authority..................................... 53
2 Code of Practice Panel – Constitution and Procedure................................ 53
3 Code of Practice Appeal Board – Constitution. . .......................................... 53
4 Code of Practice Appeal Board – Procedure. . .............................................. 55

COMPLAINTS PROCEDURE
5 Action on Complaints.................................................................................... 56
6 Complaints Arising from Media Criticism. . .................................................... 57
7 Code of Practice Panel – Rulings.................................................................. 57
8 Code of Practice Panel – Reports
to the Code of Practice Appeal Board. . ........................................................ 59
9 Action on Complaints about Safety from the
Medicines and Healthcare products Regulatory Agency.. ........................... 59
10 Code of Practice Appeal Board – Rulings.................................................... 59
11 Reports to the Code of Practice Appeal Board. . ..........................................60
12 Code of Practice Appeal Board – Reports to the ABPI Board. . ...................60

13 Case Reports................................................................................................... 61

GENERAL PROVISIONS
14 Time Periods for Responding to Matters under the Code............................ 62
15 Withdrawal of Complaints and Notices of Appeal.. ..................................... 62
16 Code of Practice Levy and Charges. . ............................................................ 62
17 Scrutiny. . ......................................................................................................... 62
18 Provision of Advice and Assistance with Conciliation................................. 63
19 Amendments to the Code of Practice
and Constitution and Procedure................................................................... 63
20 Annual Report. . .............................................................................................. 63

PMCPA CONSTITUTION AND PROCEDURE 51

 Introduction to the PMCPA Constitution and Procedure
OPERATIVE ON 1 JANUARY 2019

The Code of Practice for the Pharmaceutical Industry is All complaints are judged on the evidence provided by the parties.
administered by the Prescription Medicines Code of Practice The weight to be attached to any evidence may be adversely
Authority. The Authority is responsible for the provision of advice, affected if the source is anonymous and thus in some instances it
guidance and training on the Code as well as for the complaints will not be possible for such a complaint to proceed.
procedure. It is also responsible for arranging for conciliation
between companies when requested to do so and for arranging Complaints made under the Code are considered by the Code
for the scrutiny of advertising and meetings on a regular basis. of Practice Panel and, where required, by the Code of Practice
Appeal Board. Reports on cases are published by the Authority
The Authority is not an investigatory body as such. It asks the and are available on request and on the Authority's website
respondent company for a complete response and may ask www.pmcpa.org.uk.
the parties to a case for further information in order to clarify
the issues. It is essentially an adversarial process in which the Complaints should be submitted to the Director of the Prescription
evidence to be taken into account comes from the complainant Medicines Code of Practice Authority, 7th Floor, Southside, 105
and the respondent company, though the Authority can seek Victoria Street, London SW1E 6QT, telephone 020-7747 8880, email
evidence from third parties where necessary. A complainant [email protected].
has the burden of proving their complaint on the balance of
probabilities. The system is designed so that both parties can
participate fully in the process. Although anonymous complaints
are accepted, it is preferable if complainants from outside the
industry provide a name, contact details and relevant information
about their interests in the matter of complaint. The names of
individuals complaining from outside the pharmaceutical industry
are kept confidential. In exceptional cases it may be necessary for
a company to know the identity of the complainant so that the
matter can be properly investigated. Even in these instances,
the name of the complainant is only disclosed with the
complainant's permission.

52 PMCPA CONSTITUTION AND PROCEDURE

Structure and Responsibilities

1 Prescription Medicines Code of Practice Authority 2 Code of Practice Panel – Constitution and Procedure
1.1 The Prescription Medicines Code of Practice Authority (the 2.1 The Panel consists of the members of the Authority and
'Authority') is responsible for the administration of the Code meets as business requires to consider complaints made
of Practice for the Pharmaceutical Industry (the 'Code') under the Code.
including the provision of advice, guidance and training on
the Code. It is also responsible for arranging for conciliation The member of the Authority who acted as case preparation
between companies when requested to do so and for manager for a particular case must not participate when the
arranging for the scrutiny of advertising and meetings on a Panel considers it or be present when it does so.
regular basis. The parties have no right to appear or be represented before
the Panel.
1.2 The Authority also administers the complaints procedure by
which complaints made under the Code are considered by 2.2 Two members of the Authority form a quorum for a meeting
the Code of Practice Panel (the 'Panel') and, where required, of the Panel. Decisions are made by majority voting. The
by the Code of Practice Appeal Board (the 'Appeal Board'). Director or, in his/her absence, the Deputy Director or, in
his/her absence, one of the Managers, acts as Chair of the
1.3 The Authority is appointed by and reports to the Board Panel and has both an original and a casting vote.
of the Association of the British Pharmaceutical Industry
(ABPI) (the 'ABPI Board') and consists of the Director, If necessary the Director or in his/her absence the Deputy
Deputy Director and two Managers. Director, may co-opt an appropriate person to be a member
of the Panel. The Director should seek the agreement of
Notwithstanding the above, the Director reports to the the Chair of the Appeal Board prior to any co-option.
Appeal Board for guidance on the interpretation of the The list of persons approved for co-option is drawn up
Code and the operation of the complaints procedure and to following procedures similar to those in place for appointing
the President of the ABPI (or, at the President's discretion, the Authority.
the Vice President of the ABPI) for administrative purposes.
Rulings are made on the basis that a complainant has the
In the absence of the Director, the Deputy Director is burden of proving their complaint on the balance
authorized to act on his/her behalf. In the absence of of probabilities.
the Director and Deputy Director, one of the Managers is
authorized to act on the Director's behalf. 2.3 The Director may obtain expert assistance in any field.
Expert advisors who are consulted may be invited to attend
1.4 To facilitate the complaints procedure by ensuring that the a meeting of the Panel but have no voting rights.
requisite information is available, the Director may request
copies of any relevant material from a pharmaceutical 3 Code of Practice Appeal Board – Constitution
company, including copies of the certificates authorizing 3.1 Vacancies for independent members of the Appeal Board,
any such material and copies of relevant briefing material including the Chair, are advertised in appropriate journals
for representatives. and/or the national press.
1.5 The Director may consult the Appeal Board upon any The Appeal Board and its Chair are appointed by the
matter concerning the Code or its administration. ABPI Board. The appointment of independent members
to the Appeal Board, including the Chair, is made following
consultation with the Medicines and Healthcare products
Regulatory Agency.

3.2 The Appeal Board comprises:

• an independent, legally qualified Chair
• three independent registered medical practitioners
appointed following consultation with the British Medical
Association, one with recent experience as a general
practitioner and one with recent experience as a hospital
consultant treating patients
• one independent registered pharmacist appointed following
consultation with the Royal Pharmaceutical Society

PMCPA CONSTITUTION AND PROCEDURE 53

 Complaint to Prescription
Medicines Code of
Practice Authority

Code of Practice Panel

Can report Companies

to Appeal Board

Complainant Advised Respondent Advised

of Ruling of Ruling

Accepted Appealed Appealed Accepted

Code of Practice
Appeal Board

Can Report Companies to

ABPI Board

ABPI Board

54 PMCPA CONSTITUTION AND PROCEDURE

 • one independent registered nurse prescriber appointed members of the Appeal Board, or who are on a list of
following consultation with the Royal College of Nursing persons approved for co-option to the Appeal Board, so
• one independent member representative of the interests as to enable a quorum to be achieved. The list of persons
of patients approved for co-option is drawn up following procedures
similar to those for appointing members of the Appeal
• one member from an independent body involved in
Board. No one may be co-opted in relation to any case in
providing information on medicines
which he/she has acted as a referee in accordance with
• one independent lay member Paragraphs 5.1, 5.2, 5.3, 7.2, 7.4, 7.5 and 7.6 below.
• four registered medical practitioners who are medical
directors or senior executives of pharmaceutical companies 4.3 Decisions are made by majority voting. The Chair has both
an original and a casting vote.
• four directors or senior executives of pharmaceutical
companies. Rulings are made on the basis that a complainant has
One of the members from pharmaceutical companies may the burden of proving their complaint on the balance
be retired, provided that the initial appointment is made of probabilities.
within one year of the date of retirement.
4.4 If a member of the Appeal Board is concerned in a case
3.3 The Chair of the Appeal Board is appointed for a term of either as complainant or respondent, that member does not
five years which may be renewed. receive copies of the papers circulated in connection with
the case and is required to withdraw from the Appeal Board
Members of the Appeal Board are each appointed for a during its consideration.
term of three years. Members may be reappointed but may
serve for no more than two consecutive terms. In exceptional The complainant and the respondent are advised in
circumstances the Chair may nominate a member who advance of the membership of the Appeal Board, including
has served two terms for reappointment for a third term. potential co-optees, and asked if they have any objections
A member of the Appeal Board who has served two or, to particular members and the grounds for such objections.
following the Chair's nomination, three consecutive terms of Any member in respect of whom there are valid objections
service is eligible for reappointment after a minimum interval must withdraw from the Appeal Board during consideration
of one year. of the case. The Chair determines whether objections
are valid.
3.4 The Director is responsible for providing appropriate
administrative support to the Appeal Board including the Members of the Appeal Board must declare any other
provision of case papers. interest in a case prior to its consideration. Having
consulted the representatives of the parties (if present), the
The Director, Deputy Director and the two Managers of the Chair determines whether it is appropriate for a particular
Authority may be present as observers at a meeting of the member to remain for the consideration of the case.
Appeal Board during the consideration of an appeal or a
report under Paragraph 11 below only at the invitation of 4.5 The Chair may obtain expert assistance in any field. Expert
the Chair and with the agreement of the party or parties advisors may be invited to attend a meeting of the Appeal
involved in the appeal or report in question. Board but have no voting rights.

4 Code of Practice Appeal Board – Procedure 4.6 When an appeal is considered by the Appeal Board, both
4.1 The Appeal Board meets as business requires to consider the complainant and the respondent company are entitled
appeals under the Code and any other matter which relates to appear or be represented.
to the Code. The Appeal Board receives reports on all The first presentation in relation to a ruling which is
complaints which have been submitted under the Code and appealed is made by the appellant.
details of the action taken on them.
A company may not be represented before the Appeal Board
4.2 The Chair and seven members of the Appeal Board by a representative who is also a member of the Appeal
constitute a quorum. Four of those present, in addition to Board except with the consent of the Chair. Such consent
the Chair, must be independent members, at least one of may be given only if the member of the Appeal Board can
whom must be a registered medical practitioner, and there satisfy the Chair that no other person within his/her company
must also be present three members from pharmaceutical can properly represent it in the case in question.
companies, at least one of whom must be a registered
medical practitioner. 4.7 Where an appeal is brought which is concerned with an
issue of fact between a complainant and the company
For the consideration of any particular case, or a report concerned which cannot be properly resolved without the
under Paragraph 11 below, independent members, including oral evidence of the persons directly involved, the Chair may
the Chair, must be in a majority. invite such persons to attend and give evidence.
In the event that a quorum cannot be attained for the
consideration of a case because of the number of members
barred under Paragraph 4.4 below, or for any other reason,
the Chair may co-opt appropriate persons who are former

PMCPA CONSTITUTION AND PROCEDURE 55

 Complaints Procedure

5 Action on Complaints To assist companies in ensuring that a complete response

5.1 When the Director receives information from which it is submitted the case preparation manager may suggest
appears that a company (being either a member of the relevant supporting material to be supplied. It is nonetheless
ABPI or a company which, although not a member, has the responsibility of the respondent to ensure that a
agreed to comply with the Code and accept the jurisdiction full response is submitted. If the complainant is not a
of the Authority) may have contravened the Code, the pharmaceutical company, the case preparation manager
Director must assign a member of the Authority (who may may suggest the clauses of the Code to be addressed.
be the Director) to be the case preparation manager to
If a complaint is received about a company other than one
process the matter and, if appropriate, prepare case papers
of those referred to in Paragraph 5.1 above, it is invited by
for the Panel.
the case preparation manager to agree to comply with the
The case preparation manager must not divulge to other Code and accept the jurisdiction of the Authority (unless it
members of the Authority details of matters being processed has previously declined to do so). In the absence of such
until the formal case papers are provided to the Panel for agreement, the complaint is not proceeded with and the
consideration as provided for in Paragraph 5.5 below. complainant is advised to refer the matter to the Medicines
and Healthcare products Regulatory Agency.
The Director is responsible for ensuring that the preparation
of a case and the adjudication of it are carried out by Unless the information is disclosed in the complaint, a
different members of the Authority and must take steps to complainant other than a pharmaceutical company is
make certain that this separation is maintained in the event asked whether or not they have any commercial, financial
of absences of those involved. or other interest in the matter of complaint or in the
company concerned, such as whether the complainant
The Director may delegate to a case preparation is an employee or ex-employee, or in a competitor.
manager one or more of his/her responsibilities under
this Constitution and Procedure when he/she considers it Such interests will be disclosed to the respondent company
appropriate and necessary to do so. and will normally be included in the case report.

The case preparation manager: If a complaint concerns a matter closely similar to one which
has been the subject of a previous adjudication, it may be
• determines whether a case should go before the Panel
allowed to proceed at the discretion of the Director if new
• may invite evidence from third parties when considered to evidence is adduced by the complainant or if the passage
be appropriate even though the primary responsibility for of time or a change in circumstances raises doubts as to
the provision of evidence lies with the parties to a case whether the same decision would be made in respect of
• may delay processing a complaint if the facts are essentially the current complaint. The Director should normally allow
similar to those before an external forum, such as an a complaint to proceed if it covers matters similar to those
employment tribunal; this does not apply to matters before in a decision of the Panel where no breach of the Code
the Medicines and Healthcare products Regulatory Agency was ruled and which was not the subject of appeal to the
• may amalgamate a complaint with an ongoing complaint Appeal Board.
or complaints where two or more complaints are based on If a complainant does not accept a decision of the Director
essentially the same evidence. that a complaint should not be proceeded with because a
When a complaint is delayed or amalgamated, as similar complaint has been adjudicated upon previously and
above, the complainant may appeal against the delay or nothing has changed in the meantime, then the matter is
amalgamation to an independent referee identified by the referred to an independent referee identified by the Director
Director and the Chair of the Appeal Board, for example a and the Chair of the Appeal Board, for example a former
former independent member of the Appeal Board, for his/ independent member of the Appeal Board, for his/her
her determination which is final. determination which is final.
If, in the view of the Director, a complaint does not show that
5.2 The managing director or chief executive or equivalent of
there may have been a breach of the Code, the complainant
the company concerned is requested to provide a complete
will be so advised. If the complainant does not accept that
response to the matters of complaint.
view, the matter is referred to an independent referee
identified by the Director and the Chair of the Appeal Board,
for example a former independent member of the Appeal
Board, for his/her determination which is final.

56 PMCPA CONSTITUTION AND PROCEDURE

5.3 When the complaint is from a pharmaceutical company, the The author of the article, or the editor where no author is
complaint must be signed or authorized in writing by the named, is treated as the complainant.
company's managing director or chief executive or equivalent
and must state those clauses of the Code which are alleged The author, or editor, is asked if they want to be involved in
to have been breached. the case and whether they have any additional information
to submit. The consequences of not being involved (no
A complaint from a pharmaceutical company will be right of appeal and no right to comment on a respondent's
accepted only if the Director is satisfied that the company appeal or the proposed text of the case report) must
concerned has previously informed the company alleged to be explained in writing. If the author or editor declines
have breached the Code that it proposed to make a formal involvement, this is stated in the case report.
complaint and offered inter-company dialogue at a senior
level in an attempt to resolve the matter, but that this offer 6.2 A published letter from which it appears that a company
was refused or dialogue proved unsuccessful. A formal may have breached the Code is dealt with as a complaint
statement detailing the actions taken must be provided. with the author being treated as the complainant. The
This requirement does not apply where the allegation is that procedure set out in Paragraph 6.1 above will be followed.
a company has failed to comply with an undertaking that
7 Code of Practice Panel – Rulings
it has given and is in breach of Clause 29 of the 2019 Code
(Clause 3.3 of the 2021 Code). 7.1 Where the Panel rules that there is a breach of the Code,
the complainant and the respondent company are so
If, in the view of the Director, that condition has not advised in writing and are given the reasons for the decision.
been met, the complainant shall be so advised. If the
complainant does not accept that view, the matter is If the material or activity at issue is considered by the Panel
referred to an independent referee identified by the Director to be likely to prejudice public health and/or patient safety,
and the Chair of the Appeal Board, for example a former and/or it represents a serious breach of the Code, the Panel
independent member of the Appeal Board, for his/her must decide whether, if there is subsequently an appeal by
determination which is final. the respondent company, it would be required to suspend
the use of the material or activity pending the final outcome
Attention is drawn to the availability of conciliation prior to of the case. If suspension would be required, the company
making a complaint as referred to in Paragraph 18.2 below. must be so notified when it is advised of the Panel's ruling of
Information about conciliation is available from the Director. a breach of the Code.
5.4 Upon receipt of a complaint, the company concerned has The respondent company has five working days to provide
ten working days in which to submit its comments in writing. a written undertaking that the activity or use of the
material in question and any similar material (if not already
5.5 When the respondent company's response is received, the discontinued or no longer in use) will cease forthwith
case preparation manager must determine whether there and that all possible steps will be taken to avoid a similar
is a prima facie case to answer under the Code. If, in the breach of the Code in the future. This undertaking must
view of the case preparation manager, no prima facie case be signed by the managing director or chief executive or
has been established, the complainant and the respondent equivalent of the company or with his/her authority and
company are so advised. If the complainant does not must be accompanied by details of the actions taken by the
accept that view, the matter is referred to the Code of company to implement the undertaking, including the date
Practice Panel to determine whether or not there has been on which the material was finally used or appeared and/or
a breach of the Code. If the complainant submits further the last date on which the activity took place.
evidence, then the respondent company shall be invited
to comment on that further evidence before the matter is In exceptional circumstances, an extension in the time
referred to the Panel. allowed in which to respond may be granted at the discretion
of the Director in accordance with Paragraph 14 below.
5.6 When a company advises the Authority that it may have
breached the Code, the Director will treat the matter as a The company must also pay within twenty working days an
complaint. The company's response is invited. The case administrative charge based on the number of matters ruled
preparation manager may suggest the clauses of the in breach of the Code.
Code to be addressed. When the response is received the
procedure under Paragraph 5.5 above will be followed. 7.2 Where the Panel rules that there is no breach of the Code,
the complainant and the respondent company are so
5.7 The parties must be notified that a case has been referred advised in writing and are given the reasons for the decision.
to the Panel. Where the complaint is from a pharmaceutical company,
the complainant must pay within twenty working days an
6 Complaints Arising from Media Criticism administrative charge based on the number of matters
6.1 When it appears to the Director from media reports (other alleged and ruled not to be in breach of the Code.
than letters to the editor of a publication) that a company
may have breached the Code, the matter is treated as
a complaint.

PMCPA CONSTITUTION AND PROCEDURE 57

 When advised of the outcome, the complainant will be sent In the event that the respondent company objects to certain
a copy of the comments and enclosures submitted by the of its comments being made available to the complainant
respondent company in relation to the complaint. If the on the grounds of confidentiality, and the matter cannot
respondent company objects to this because it regards part be settled by the Director, then it will be referred to an
of the material as being confidential, and the matter cannot independent referee identified by the Director and the Chair
be settled by the Director, then it will be referred to an of the Appeal Board, for example a former independent
independent referee identified by the Director and the Chair member of the Appeal Board, who will determine whether
of the Appeal Board, for example a former independent those particular comments can be included in the evidence
member of the Appeal Board, for his/her determination which goes before the Appeal Board. The referee's decision
which is final. is final.

7.3 The complainant or the respondent company may appeal 7.5 Where an appeal is lodged by the respondent company,
against a ruling of the Panel to the Appeal Board. Appeals the complainant has five working days to comment on the
must be accompanied by reasons as to why the Panel's reasons given by the respondent company for the appeal
ruling is not accepted. These reasons will be circulated to and these comments will be circulated to the respondent
the Appeal Board. company and the Appeal Board.

Notice of appeal must be given within five working days of Relevant material previously submitted to the Panel is
notification of the Panel's ruling and the appeal must be provided to the Appeal Board. All additional material which
lodged within ten days of notification of the Panel's ruling. the complainant and the respondent company want the
Appeal Board to consider must be submitted in writing with
If the Panel has so required in accordance with Paragraph the appeal or with the complainant's comments on the
7.1 above, where the respondent company gives notice of reasons given by the respondent company for the appeal.
appeal it must, within five working days of notification of the No new material may be introduced when the appeal is
Panel's ruling, suspend the use of the promotional material heard by the Appeal Board.
or activity at issue, pending the final outcome of the case, and
must notify the Authority that such action has been taken. In the event that the respondent company objects to
certain details of its appeal being made available to the
If the respondent company accepts one or more of the complainant on the grounds of confidentiality, and the
Panel's rulings of breaches of the Code, but appeals one matter cannot be settled by the Director, then it will be
or more other such rulings, then within five working days referred to an independent referee identified by the Director
of notification of the Panel's rulings it must provide the and the Chair of the Appeal Board, for example a former
undertaking required by Paragraph 7.1 above in respect of independent member of the Appeal Board, who will
the ruling or rulings which it is not appealing. determine whether those particular details can be included
in the evidence which goes before the Appeal Board. The
In exceptional circumstances, an extension in the time
referee's decision is final.
allowed in which to respond may be granted at the discretion
of the Director in accordance with Paragraph 14 below. Where an appeal is lodged by the respondent company,
the complainant is sent a copy of the initial comments and
7.4 Where an appeal is lodged by the complainant, the
enclosures submitted by the respondent company in relation
respondent company has five working days to comment on
to the complaint. If the respondent company objects to this
the reasons given by the complainant for the appeal and
because it regards part of the material as being confidential,
these comments will be circulated to the Appeal Board.
and the matter cannot be settled by the Director, then it
The complainant has five working days to comment on the will be referred to an independent referee identified by the
respondent company's comments upon the reasons given by Director and the Chair of the Appeal Board, for example a
the complainant for the appeal and these comments will be former independent member of the Appeal Board, for his/
circulated to the respondent company and the Appeal Board. her determination which is final.

Relevant material previously submitted to the Panel is 7.6 Where the Panel rules no breach of the Code because it
provided to the Appeal Board. All additional material which considers the matter of complaint is not within the scope of
the complainant and the respondent company want the the Code the complainant and the respondent company are
Appeal Board to consider must be submitted in writing with so advised in writing.
the appeal, with the respondent company's comments on
When advised of the outcome, the complainant will be sent
the reasons given by the complainant for the appeal or with
a copy of the comments and enclosures submitted by the
the complainant's comments on the respondent company's
respondent company in relation to the complaint. If the
comments on the reasons given by the complainant for
respondent company objects to this because it regards part
the appeal. No new material may be introduced when the
of the material as being confidential, and the matter cannot
appeal is heard by the Appeal Board.
be settled by the Director, then it will be referred to an
independent referee identified by the Director and the Chair

58 PMCPA CONSTITUTION AND PROCEDURE

 of the Appeal Board, for example a former independent 9 Action on Complaints about Safety from the Medicines
member of the Appeal Board, for his/her determination and Healthcare products Regulatory Agency
which is final. 9.1 In the event of the Medicines and Healthcare products
The complainant may appeal against the Panel's ruling Regulatory Agency making a complaint which relates to the
to an independent referee identified by the Director and safety or proper use of a medicine, and requesting that an
the Chair of the Appeal Board, for example a former advertisement be withdrawn, the respondent company has
independent member of the Appeal Board, for his/ five working days to respond with its comments.
her determination which is final. An appeal must be 9.2 If the Panel upholds the complaint, the company is required
accompanied by reasons as to why the Panel's ruling is not to suspend the advertisement or practice forthwith pending
accepted. These reasons will be provided to the referee. the final outcome of the case.
The appeal must be lodged within ten working days of
notification of the ruling of the Panel. 10 Code of Practice Appeal Board – Rulings
The respondent company has five working days to comment 10.1 Where the Appeal Board rules that there is no breach of
on the reasons given by the complainant for the appeal and the Code, the complainant and the respondent company
these comments will be provided to the referee. are so advised in writing and are given the reasons for
the decision.
The complainant has five working days to comment on the
respondent company's comments upon the reasons given Where a complainant pharmaceutical company appeals
by the complainant for the appeal and these comments will and the Appeal Board upholds the ruling that there is
be provided to the respondent company and the referee. no breach of the Code, the complainant pharmaceutical
company must pay within twenty working days an
In the event that the respondent company objects to certain administrative charge based on the number of matters
of its comments being made available to the complainant taken to appeal on which no breach is ruled.
on the grounds of confidentiality, and the matter cannot be
settled by the Director, then the referee must decide whether Where a respondent company appeals and the Appeal
he/she can take those comments into consideration when Board rules that there is no breach of the Code, the
making his/her determination. complainant pharmaceutical company must pay within
twenty working days an administrative charge based on
In such an appeal, the referee must consider no more than the number of matters taken to appeal on which no breach
whether or not the matter of complaint is within the scope is ruled.
of the Code.
10.2 Where the Appeal Board rules that there is a breach of the
If the referee determines that the matter is not within the Code, the respondent company is so advised in writing
scope of the Code the complainant and the respondent and is given the reasons for the decision. The respondent
company are so advised in writing. company then has five working days to provide a written
undertaking providing relevant information as specified in
If the referee determines that the matter is within the scope Paragraph 7.1 above.
of the Code the complainant and the respondent company
are so advised in writing. The case is referred back to the The company must also pay within twenty working days an
Panel for it to be considered on its merits and the procedure administrative charge based on the number of matters ruled
in Paragraph 5.5 above will be followed. in breach of the Code.

No administrative charges apply in relation to proceedings 10.3 Where the Appeal Board rules that there is a breach of the
under Paragraph 7.6 and there will be no case reports. Code, it may require the company to take steps to recover
items given in connection with the promotion of a medicine
8 Code of Practice Panel – Reports to the Code of or non-promotional items provided to health professionals
Practice Appeal Board and members of the public and the like. Written details of
8.1 Failure to comply with the procedures set out in Paragraphs the action taken must be provided to the Appeal Board.
5 and 7 above will be reported to the Appeal Board.
10.4 Where the Appeal Board rules that there is a breach of the
8.2 The Panel may also report to the Appeal Board any Code, it may require an audit of the company's procedures
company whose conduct in relation to the Code, or in relation to the Code to be carried out by the Authority
in relation to a particular case before it, or because it and, following that audit, decide whether to impose
repeatedly breaches the Code such that it raises concerns requirements on the company concerned to improve its
about the company's procedures, warrants consideration procedures in relation to the Code. These could include
by the Appeal Board. Such a report to the Appeal Board a further audit and/or a requirement that promotional
may be made notwithstanding the fact that a company has material be submitted to the Authority for pre-vetting for a
provided an undertaking requested by the Panel. specified period. The Authority must arrange for material

PMCPA CONSTITUTION AND PROCEDURE 59

 submitted for pre-vetting to be examined for compliance • require the company to issue a corrective statement;
with the Code but it cannot approve such material. details of the proposed content and mode and timing
All of the costs of pre-vetting must be met by the of dissemination of the corrective statement must be
company concerned. provided to the Appeal Board for approval prior to use
• require the company to take steps to recover items given
The Appeal Board may also require an audit if a company
in connection with the promotion of a medicine or non-
repeatedly breaches the Code.
promotional items provided to health professionals and
10.5 Where the Appeal Board rules that there is a breach of the members of the public and the like; written details of the
Code, it may reprimand the company and publish details of action taken must be provided to the Appeal Board.
that reprimand. 11.4 Where a company not in membership of the ABPI fails to
comply with the procedures set out in Paragraphs 5, 7, 9 or
10.6 Where the Appeal Board rules that there is a breach of 10 above and indicates that it no longer wishes to accept
the Code, it may require the company to issue a corrective the jurisdiction of the Authority, the Appeal Board may
statement. Details of the proposed content and mode and decide to remove the company from the list of non member
timing of dissemination of the corrective statement must be companies which have agreed to comply with the Code and
provided to the Appeal Board for approval prior to use. advise the Medicines and Healthcare products Regulatory
Agency that responsibility for that company under the Code
11 Reports to the Code of Practice Appeal Board
can no longer be accepted.
11.1 Where the Panel reports a company to the Appeal Board
under the provisions of Paragraphs 8.1 and 8.2 above, or The ABPI Board must be advised that such action
where the Panel reports the failure of a company to comply has been taken.
with the procedure set out in Paragraph 9 above, or where
the Authority reports the failure of a company to comply 12 Code of Practice Appeal Board – Reports to the
with the procedures set out in Paragraph 10 above, the ABPI Board
procedures set out below shall apply. These procedures 12.1 Where the Appeal Board considers that the conduct of a
also apply if the Appeal Board, having received a report company in relation to the Code or a particular case before
on a case completed at the Panel level, in accordance with it warrants such action, it may report the company to the
Paragraph 4.1 above, considers that additional sanctions ABPI Board. Such a report may be made notwithstanding
may be appropriate. the fact that the company has provided an undertaking
requested by either the Panel or the Appeal Board.
11.2 The company concerned is provided with a copy of the
report prior to its consideration and is entitled to have a 12.2 Where such a report is made to the ABPI Board, the ABPI
representative or representatives appear before the Appeal Board may suspend or expel the company from the ABPI.
Board to state the company's case.
In the case of a company not in membership of the ABPI,
A company may not be represented before the Appeal the ABPI Board may remove the company from the list
Board by a representative who is also a member of the of non member companies which have agreed to comply
Appeal Board except with the consent of the Chair. Such with the Code and advise the Medicines and Healthcare
consent may be given only if the member of the Appeal products Regulatory Agency that responsibility for that
Board can satisfy the Chair that no other person within company under the Code can no longer be accepted.
his/her company can properly represent it in the matter
in question. To assist it in deciding whether to suspend or expel a
company or, in the case of a company not in membership
11.3 The Appeal Board may: of the ABPI, to remove the company from the list of non
• reprimand the company and publish details member companies which have agreed to comply with
of that reprimand the Code, the ABPI Board may require an audit of the
• require an audit of the company's procedures in relation to company's procedures in relation to the Code to be
the Code to be carried out by the Authority and, following carried out by the Authority.
that audit, decide whether to impose requirements on the 12.3 If a member of the ABPI Board is concerned in a case
company concerned to improve its procedures in relation which has led to the report, as either complainant or
to the Code; these could include a further audit and/ respondent, that member does not receive a copy of the
or a requirement that promotional material be submitted report and is required to withdraw from the ABPI Board
to the Authority for pre-vetting for a specified period; during its consideration.
the Authority must arrange for material submitted for
pre-vetting to be examined for compliance with the Code The company concerned is advised in advance of the
but it cannot approve such material; all of the costs of pre- membership of the ABPI Board and asked if it has any
vetting must be met by the company concerned objections to particular members and the grounds for such

60 PMCPA CONSTITUTION AND PROCEDURE

 objections. Any member in respect of whom there are Medical Association, the Royal Pharmaceutical Society, the
valid objections must withdraw from the ABPI Board during Royal College of Nursing and the Editors of the BMJ, The
consideration of the report. The President (or Chair of the Pharmaceutical Journal and the Nursing Standard. Copies
ABPI Board in the absence of the President) determines are also available to anyone on request.
whether objections are valid.
13.6 In addition to the printed reports, full case reports appear
Members of the ABPI Board must declare any other interest on the Authority's website. The website also carries
in a report prior to its consideration. Having consulted the brief details of all complaints which are currently under
company representative(s) (if present), the President consideration but not yet resolved and the texts and
(or Chair of the ABPI Board in the absence of the President) modes of dissemination of any corrective statements that
determines whether it is appropriate for a particular member companies have been required to issue during the previous
to remain for the consideration of the report. twelve months. The Authority's website also carries interim
case reports in respect of cases where publication of the
12.4 Where a report is made to the ABPI Board under Paragraph final report is delayed because either the Appeal Board or
12.1 above, the company concerned is provided with a copy the ABPI Board has required an audit of the respondent
of the report prior to its consideration and is entitled to have company's procedures in relation to the Code.
a representative or representatives appear before the
ABPI Board to state the company's case. Access to the Authority's website is unrestricted.

13 Case Reports 13.7 Following publication of the relevant case reports, the
13.1 At the conclusion of any case under the Code, the Authority advertises in the medical, pharmaceutical and
complainant is advised of the outcome and a report is nursing press brief details of cases in which companies
published summarising the details of the case. were ruled in breach of Clause 2 of the Code, were required
to issue a corrective statement or were the subject of a
13.2 The respondent company and the medicine concerned public reprimand. Such advertisements also appear on the
are named in the report. Authority's website. The companies concerned are required
to contribute to the cost of the press advertisements.
In a case where the complaint was initiated by a company
or by an organisation or official body, that company or
organisation or official body is named in the report. The
information given must not, however, be such as to identify
any individual.

Where expert assistance has been obtained by either the

Panel or the Appeal Board, the report will include the name
and qualifications of the expert concerned.

Where a company has been required to issue a corrective

statement, the report will reproduce its text and provide
details of how the corrective statement was disseminated.

13.3 A copy of the report on a case is sent to both the

complainant and the respondent company prior to
publication. Any amendments to the report suggested by
these parties are considered by the Director, consulting with
the other party where appropriate. If either party does not
accept the Director's decision as to whether or not a report
should be amended, the matter is referred to the Chair of
the Appeal Board for his/her decision which is final.

13.4 Copies of all case reports are submitted to the Appeal

Board prior to publication. Copies of the reports are sent to
the ABPI Board for information following publication.

13.5 Full case reports in printed form are published each quarter
by the Authority.

Copies of the reports are sent to the Medicines and

Healthcare products Regulatory Agency, the Competition
and Markets Authority, the Serious Fraud Office, the British

PMCPA CONSTITUTION AND PROCEDURE 61

 General Provisions

14 Time Periods for Responding to Matters under 16.3 Where two or more companies are ruled in breach of the
the Code Code in relation to a matter involving co-promotion, each
The number of working days within which companies company will be separately liable to pay any administrative
or complainants must respond to enquiries etc from the charge which is payable.
Authority, as referred to in the above procedures, is counted 16.4 Where a company advises the Authority that it may have
from the date of receipt of the notification in question. breached the Code, and it is subsequently ruled in breach,
An extension in time to respond to such notifications may be any administrative charge payable will be one half of that
granted at the discretion of the Director. which would otherwise have been due.

16.5 The number of administrative charges which apply in a case

15 Withdrawal of Complaints and Notices of Appeal
is determined by the Director. If a company does not agree
15.1 A complaint may be withdrawn by a complainant with the with the Director's decision, the matter is referred to the
consent of the respondent company up until such time as Chair of the Appeal Board for his/her decision which is final.
the respondent company's comments on the complaint
have been received by the Authority, but not thereafter. 16.6 Failure to pay any of the charges provided for by this
paragraph must be reported by the Director to the Appeal
15.2 Notice of appeal may be withdrawn by a complainant with Board or the ABPI Board as appropriate.
the consent of the respondent company at any time but if
notice is given by a complainant company after the papers 17 Scrutiny
relating to its appeal have been circulated to the Appeal 17.1 The Authority arranges for the scrutiny of samples of
Board, then the higher administrative charge will be payable. advertisements, detail aids, leavepieces, other promotional
15.3 Notice of appeal may be withdrawn by a respondent items and meetings on a continuing basis in relation to the
company at any time but if notice is given after the papers requirements of the Code.
relating to its appeal have been circulated to the Appeal Members of the Authority must not carry out scrutiny.
Board, then the higher administrative charge will be payable.
To facilitate such scrutiny, the Director may request relevant
16 Code of Practice Levy and Charges material from pharmaceutical companies, including copies
16.1 An annual Code of Practice levy is paid by members of the of the certificates authorizing such material, and companies
ABPI. The levy together with the administrative charges must respond to such requests within ten working days.
referred to in Paragraphs 7 and 10 above, the charges for
audits carried out in accordance with Paragraphs 10.4, 11.3 17.2 Where a possible breach of the Code is identified under
and 12.2 above and the contributions to the cost of press this procedure by the scrutineer, the company concerned is
advertisements referred to in Paragraph 13.7 above are requested to comment in writing within ten working days of
determined by the ABPI Board subject to approval at a receipt of the notification.
General Meeting of the ABPI by a simple majority of those 17.3 If the company accepts that there is a breach of the Code,
present and voting. the company is requested to provide an undertaking
16.2 Administrative charges are payable only by pharmaceutical providing the information specified in Paragraph 7.1
companies and companies are liable for such charges above. No administrative charge will be payable in these
whether they are members of the ABPI or not. circumstances and there will be no case report on the
matter in question.
There are two levels of administrative charge.
17.4 If the company does not accept that there is a breach of the
The lower level is payable by a company which accepts Code and, having considered the company's comments, the
either a ruling of the Panel that it was in breach of the Code scrutineer decides that there is no case to answer under the
or a rejection by the Panel of its allegation against another Code, then the procedure is brought to a close. There will be
company. The lower level is also payable by a complainant no case report on the matter in question.
company if a ruling of the Panel that there was a breach
of the Code is subsequently overturned by the Appeal 17.5 If the company does not accept that there is a breach of the
Board and by a respondent company if a ruling of the Code but, having considered the company's comments, the
Panel that there was no breach of the Code is subsequently scrutineer considers that a case has been established, the
overturned by the Appeal Board. matter will be dealt with as a complaint.
The higher level is paid by a company which unsuccessfully
appeals a ruling of the Panel.

62 PMCPA CONSTITUTION AND PROCEDURE

18 Provision of Advice and Assistance with Conciliation 20 Annual Report
18.1 The Authority is willing and able to provide informal An annual report of the Authority is published each year
guidance and advice in relation to the requirements of the with the approval of the Appeal Board. This report includes
Code and, where appropriate, may seek the views of the details of the work of the Authority, the Panel and the
Appeal Board. Appeal Board during the year and provides a list of all
companies ruled in breach of the Code during the year
18.2 Companies wishing to seek the assistance of a conciliator which specifically identifies those ruled to have breached
with the view to reaching agreement on inter-company Clause 2.
differences about promotion may contact the Director for
advice and assistance.

19 Amendments to the Code of Practice and

Constitution and Procedure
19.1 The Code and this Constitution and Procedure may be
amended by a simple majority of those present and voting
at a General Meeting of the ABPI.

Notwithstanding the above, where a proposal to amend the

Code or this Constitution and Procedure arises solely from
the ABPI's obligation to comply with any code promulgated
by the European Federation of Pharmaceutical Industries
and Associations (EFPIA), then the ABPI Board may decide
that formal approval at an ABPI General Meeting is not
necessary. ABPI member companies must nonetheless be
consulted in relation to the proposed texts of the changes.

19.2 The views of the Authority and the Appeal Board

must be sought on any proposal to amend the Code
or this Constitution and Procedure. The views of the
Medicines and Healthcare products Regulatory Agency,
the Competition and Markets Authority, the Serious
Fraud Office, the British Medical Association, the Royal
Pharmaceutical Society and the Royal College of Nursing
must also be invited.

Notwithstanding the above, where the ABPI Board has

decided, in accordance with Paragraph 19.1 above, that
formal approval of the proposal at an ABPI General Meeting
is not necessary, then the bodies referred to above need
only be informed of the changes which are to be made.

19.3 The Authority and the Appeal Board may, in the light of
their experience, make recommendations for amendment of
the Code and this Constitution and Procedure.

PMCPA CONSTITUTION AND PROCEDURE 63

 GUIDELINES ON COMPANY PROCEDURES
RELATING TO THE ABPI CODE OF PRACTICE
FOR THE PHARMACEUTICAL INDUSTRY
It is important for companies to have policies and standard The guidelines, which are published on the PMCPA website, are
operating procedures (SOPs) to communicate corporate regarded as best practice and should be adapted to fit in with
standards, expectations and behaviour. These might be a mixture the arrangements at any particular company. Paragraphs 10.4,
of global, regional and local SOPs. Company documents should 11.3 and 12.2 of the Constitution and Procedure for the PMCPA
support compliance, ensure consistency, manage risk and provide variously authorise the Code of Practice Appeal Board or the
a platform for continuous improvement. It should be clear and ABPI Board to require an audit of a company's procedures in
apparent to all staff which requirements are relevant to their role. relation to the ABPI Code to be carried out by the PMCPA.
These policies and SOPs are minimum requirements which should During such audits, the PMCPA will review a company's policies
be adapted to fit the arrangements at a particular company. The and SOPs and their implementation, including but not limited to
introduction of the new ABPI Principles should also be reflected those relating to the Code. A company's website may also be
where appropriate. The PMCPA will not adjudicate on the reviewed and should be up-to-date and accurate at all times. It
ABPI Principles. is likely that an audit would also include a discussion about the
company's implementation of the ABPI Principles.
Companies' Code related policies and procedures should be in
line with the ABPI Code requirements, but of course, companies The guidelines do not cover all aspects of the Code and are
are fully entitled to have policies and procedures that impose thus no substitute for a detailed study of the Code as a whole,
higher standards than the ABPI Code. The ABPI Code reflects including the supplementary information.
and extends beyond relevant UK legislation and ensures that the
ABPI meets its commitments to implement other codes, such as
the IFPMA and EFPIA Codes.

64 CODE OF PRACTICE
LEGISLATION, OTHER CODES AND GUIDELINES
Legislation Guidelines
The Human Medicines Regulations 2012 as amended Advertising and Promotion of Medicines in the UK (2020) – The
2012 No. 1916 Blue Guide (Medicines and Healthcare products Regulatory
Agency). It includes Disease Awareness Campaign Guidelines
The Human Medicines (Amendment) (No. 2) Regulations and Medicines which are promoted for use during pregnancy –
2014 No. 1878 Guidance for the pharmaceutical industry
The Consumer Protection from Unfair Trading Regulations 2008 Best practice guidance on joint working between the NHS and
2008 No. 1277 the pharmaceutical industry and other relevant commercial
organisations (Department of Health)
Directive 2001/83/EC on the Community Code relating to
medicinal products for human use, as amended by Directive Moving beyond sponsorship: interactive toolkit for joint working
2004/27/EC between the NHS and the pharmaceutical industry (Department
of Health/ABPI)
Bribery Act 2010
ABPI Guidance notes on joint working between pharmaceutical
Data Protection Act 2018
companies and the NHS and others for the benefit of patients,
Other Codes March 2009
International Joint Position on the Disclosure of Clinical Trial Information
IFPMA Code of Practice (International Federation of via Clinical Trial Registries and Databases 2009
Pharmaceutical Manufacturers and Associations) (www.ifpma.org/resources/position-papers)

EFPIA Code of Practice (European Federation of Pharmaceutical Joint Position on the Publication of Clinical Trial Results
Industries and Associations) in the Scientific Literature 2010
(www.ifpma.org/resources/position-papers)
WHO Ethical Criteria for Medicinal Drug Promotion, Geneva 1988
(World Health Organisation) The Legal & Ethical Guidelines for Healthcare Market Research
(British Healthcare Business Intelligence Association)
IPCAA International Healthcare Congress Guidelines
(International Pharmaceutical Congress Advisory Association) PMCPA GUIDANCE is available at www.pmcpa.org.uk

United Kingdom
The UK Code of Non-broadcast Advertising and Direct &
Promotional Marketing (Committee of Advertising Practice/
Advertising Standards Authority)

Codes of Practice for Advertising Over-the-Counter Medicines

– the PAGB Consumer Code and the PAGB Professional Code
(Proprietary Association of Great Britain – PAGB)

BMA 'Medical ethics today' (British Medical Association)

General Medical Council 'Ethical guidance for doctors'

General Pharmaceutical Council 'Standards

for pharmacy professionals'

Nursing & Midwifery Council 'Professional standards of behaviour

for nurses, midwives and nursing associates'

NHS England Standards of Business Conduct Policy, 2019

NHS Managing Conflicts of Interest: Revised statutory guidance

for CCGs [Clinical Commissioning Groups] 2017

Joint Statement from the chief executives of statutory regulators

of health and care professionals

CODE OF PRACTICE 65