The EFPIA Disclosure Code:

Your Questions Answered

Working together: why do the pharmaceutical industry and healthcare

professionals work together?

1 Why does industry pay health professionals to provide services?

Collaboration between industry and healthcare professionals benefits patients. It is a relationship that has de-
livered numerous innovative medicines and changed the way many diseases impact on our lives. Industry and
health professionals collaborate in a range of activities from clinical research, sharing best clinical practice and
exchanging information on how new medicines fit into the patient pathway.

2 What services to health professionals does the industry provide?

As the primary point of contact with patients, healthcare professionals offer invaluable and expert knowledge on
patient outcomes and management of diseases. This plays a crucial role in informing the pharmaceutical indus-
try’s efforts to improve patient care, treatment options and patient outcomes.

Health professionals also may be paid to contribute to medical education meetings. Sharing information and best
practice on state-of-the-art treatments is a driver of better healthcare and improving patient outcomes.

As with any professional group providing services it is fair and appropriate to remunerate healthcare professionals
for their time and expertise.

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European Pharmaceutical Industry The EFPIA Disclosure Code: Your Questions Answered

About the EFPIA Disclosure Code

3 What is the EFPIA Disclosure Code?

The EFPIA Disclosure Code is a code of conduct that requires all EFPIA member companies and companies that
are members of EFPIA member associations to disclose transfers of value to HCPs and healthcare organisations
(HCOs). Under the Code, EFPIA member companies will have to disclose the names of healthcare professionals
and organisations that have received payments or other transfers of value from them. They will also have to dis-
close – by HCP or HCO – the total amounts of value transferred, by type of activity, which could consist of, for
instance, a grant to an HCO, a consultancy fee for speaking, payment for travel, or registration fees to attend a
medical education congress.

The first disclosures will be made by 30 June 2016, for payments made in 2015. This information will be pub-
lished on a public platform, which could be on the company’s own website or in some countries, a central plat-
form combing data from different companies.

4 Why is EFPIA introducing the public disclosure of payments to health professionals?

Collaboration between industry and health professionals benefits patients. It is a relationship that has delivered
numerous innovative medicines and changed the way many diseases impact on our lives. Industry and health pro-
fessionals collaborate in a range of activities from clinical research, sharing best clinical practice and exchanging
information on how new medicines fit in to the patient pathway. Bringing greater transparency to this, already
well-regulated, vital relationship is about strengthening the basis for collaboration in the future. Society has
increasingly high expectations for transparency, none more so than in healthcare. We want to ensure we meet
those expectations going forward.

5 Which countries does the EFPIA Disclosure Code cover?

The EFPIA Code covers the 33 countries within its membership (see www.efpia.eu), EU, EEA and EFTA countries
and beyond, as well as countries that decide to voluntarily abide by the Code - it covers the geographical area
from Portugal to Russia, from Turkey to Iceland, and from Greece to Scandinavian countries.

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European Pharmaceutical Industry The EFPIA Disclosure Code: Your Questions Answered

6 What types of payments will be disclosed?

Companies will disclose payments made to health professionals such as sponsorship to attend meetings, speaker
fees, consultancy and advisory boards.

More specifically, donations and grants (to organisations only; grants and donations are not allowed to individual
healthcare professionals under the EFPIA Code), coverage of costs to participate in events (including registration
fees, travel and accommodation), fees-for-service & consultancy, where a contract is in place for activities such as
speaking at, or chairing meetings, attending advisory boards and media consultancy and research & development
transfers of value, which are disclosed in aggregate.

7 Will the new system cover all payments to healthcare professionals at an individual level?

No. Payments made for research and development activities will be disclosed in aggregate. For the purposes of
the Code, these activities are defined as transfers of value to HCPs or HCOs related to the planning or conduct of:

• non-clinical studies (as defined in OECD Principles on Good Lab-

oratory Practice);
• clinical trials (as defined in Directive 2001/20/EC); or
• non-interventional studies that are prospective in nature and
that involve the collection of patient data from or on behalf of indi-
vidual, or groups of, HCPs specifically for the study (Section 15.01
of the HCP Code).

Meals and drinks will not be disclosed, but a threshold has been ap-
plied in each country, limiting hospitality under a certain value. The
Code does not require items of medical value, information and edu-
cational materials designed for patients, samples and activities solely
relating to over the counter medicines, to be disclosed.

8 Why are payments made for research and development not included in the disclosures?

The EFPIA Disclosure Code focuses on transfers of value for attending educational meetings and for the provision
of services, such as speaking at events or attending advisory boards. This is a significant step in bringing greater
transparency to the relationship between industry and the health professional community.

It is worth noting that research and development, and in particular clinical trials, are subject to transparency leg-
islation under the EU Clinical Trial Regulation (2001/20) and the European Medicines Agency Transparency Policy
(Policy 0070). The names of investigators working on industry-sponsored trials will be publicly disclosed in the
Clinical Study Reports published by the EMA.

Company spending on research and development will be disclosed in aggregate.

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European Pharmaceutical Industry The EFPIA Disclosure Code: Your Questions Answered

9 Why are meals and drinks not included in the disclosures?

Very often these transfers of value are for small amounts such as a coffee or sandwich. Disclosing these small
transactions would place a disproportionate administrative burden on industry and HCPs, for little value. Instead,
a threshold has been applied in each country, limiting hospitality under a certain amount. These amounts are
outlined in country national codes of practice.

10 How does the new system work?

Payments made to health professionals are recorded throughout the

year and publically disclosed by the 30 June, of the following year. The
first disclosures will be made by 30 June 2016, for payments made in
2015.

11 How will payments be disclosed?

In the majority of countries in Europe, payments will be disclosed on

company websites. In countries such as France and Denmark, national
legislation requires disclosure on a central platform.

Belgium, Ireland, Portugal, Russia, the Netherlands, Czech Republic

and the UK have opted to make disclosures on a central, online platform in each country, through self-regulation,
often in partnership with stakeholders.

Denmark, Estonia, France, Greece, Latvia, Lithuania, Portugal, Romania, Serbia and Slovakia have either existing leg-
islation or legislation in development covering the disclosure of payments to health professionals.

Why are some countries disclosing payments through a central platform for disclosure
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and some just disclosing on company websites?

In some cases, such as in France or Denmark, disclosure of payments on a central platform is a legislative require-
ment. The decision to disclose payments on a central platform through self-regulation or co-regulation with the
healthcare professional community, such as in Belgium, Ireland, Portugal, Russia, the Netherlands, Czech Repub-
lic and the UK, is a national decision reflecting the differing stakeholder, technical and resource environments. In
the majority of countries in Europe, payments will be disclosed on company websites.

13 What is the definition of “healthcare professional” in the context of the EFPIA Disclosure Code?

The EFPIA Disclosure Code defines healthcare professionals as any member of the medical, dental, pharmacy or
nursing professions, or any other person who, in the course of his or her professional activities, may prescribe,
purchase, supply or administer a medicinal product.

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What do healthcare professionals and healthcare organisations need to do under the new system
of disclosure?

Healthcare professionals and healthcare organisations will be informed by the company or companies they work
with of the intent to disclose. In order for the disclosures to be made public, healthcare professionals and in the
case of Austria and Switzerland, healthcare organisations, need to give their consent for the information to be
made public. This usually will be managed through a clause in the contract between the healthcare professional/
healthcare organisation and the company.

If an HCP lives on one country but is paid to provide a service in another country,
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where will the payment be disclosed?

In order to make the system meaningful for patients and other interested parties, disclosures will be made in the
country where the HCP/HCOs holds their principal practice.

16 What consultation has there been with healthcare professionals about this initiative already?

EFPIA has reached out to the healthcare professional community in Europe at an early stage. 

A broad range of stakeholders, including several leading European healthcare professional representative organ-
isations, endorsed the Principles for Good Governance in the Pharmaceutical Sector. The principles, published in
2012, contain a section on transparency that requests stakeholders to “have, or develop, a policy on transparen-
cy regarding conditions under which professional relations in this area are made accessible to the public”.

EFPIA Member Associations have conducted a range of activities, consulting with healthcare professionals, on
the issue of disclosure such as surveys, consultations and meetings. EFPIA continues to engage with European
professional bodies on the issue and will be launching a social media platform to engage with individual health-
care professionals.

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European Pharmaceutical Industry The EFPIA Disclosure Code: Your Questions Answered

About Data Privacy

Will individual healthcare professionals need to give consent for information

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about their payments to be disclosed?

It depends where your principle place of work is.

The collection and use of personal data is subject to EU Directive 95/46. The Directive is transposed into data protec-
tion legislation in each country. The Directive means that companies, as the data processors, must comply with the
relevant data protection laws in each country. As part of these obligations, companies have the right to retain data
but there are strict rules around how data is obtained, recorded, stored, used and published. Where the publication
of data is deemed to be in the public interest, this can outweigh the individuals right to privacy and form a legiti-
mate basis for publication. This approach is being adopted in countries such as France, the Netherlands, Denmark,
Belgium and Slovakia.

Gaining an individual’s consent to process and publish their personal data is an alternative way that data proces-
sors can show that they are handling data fairly.
In order for it to be valid, any consent from healthcare professional must be:

• Freely given
• Specific
• Unambiguous
• The result of an informed decision

Where individual consent has been used as a basis for publication (rather than public interest), then healthcare
professionals will retain the right to refuse to disclose their information and will retain their right under the law
to seek a correction of mistakes or deletion of their information.

The process of obtaining consent will usually be managed through a clause in the contract between the health-
care professional/healthcare organisation and the company.

Bringing greater transparency to this, already well-regulated, vital relationship is about strengthening the basis for
collaboration in the future. Industry is being proactive, based on its commitment to this relationship. Our hope is that
health professionals will also recognise the benefits of greater transparency and grant consent to disclose the data.

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European Pharmaceutical Industry The EFPIA Disclosure Code: Your Questions Answered

What happens if an HCP refuses to give consent for information about their payments
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to be disclosed?

Where individual consent has been used as a basis for publication (rather than public interest) and healthcare
professionals do not grant consent to disclose payments, then the payments will be disclosed on an aggregate
basis. Each company will disclose the number of health professionals that did not grant consent and the total
amount paid to them.

However, bringing greater transparency to this, already well-regulated, vital relationship is about strengthening
the basis for collaboration in the future. Industry is being proactive, based on its commitment to this relationship.
Our hope is that health professionals will also recognise the benefits of greater transparency and grant consent
to disclose the data.

19 What happens if an HCP withdraws consent for their information to be disclosed?

Where individual consent has been used as a basis for publication (rather than public interest), then under data
protection legislation, when a healthcare professional withdraws their consent for the information to be pub-
licly disclosed, then the data controller (the company) is obligated to remove payments made to that individual
from the public domain. Instead the payments will be added to the aggregate total of payments made to health
professionals that have not given consent to disclose and this aggregate figure will be published along with the
number of healthcare professionals that did not give consent.

However, bringing greater transparency to this, already well-regulated, vital relationship is about strengthening
the basis for collaboration in the future. Industry is being proactive, based on its commitment to this relationship.
Our hope is that health professionals will also recognise the benefits of greater transparency and grant consent
to disclose the data.

20 What happens if an HCP does not agree with the payment information a company holds?

Healthcare professionals should contact the company. Where mistakes have been made or inaccurate data post-
ed, companies will revise the payment information once the correct figure has been agreed.

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Will companies refuse to work with health professionals that do not give their consent
to disclose payment information?

This is an individual company decision. Companies set their own policies and criteria for working with healthcare
professionals within the applicable legislative and regulatory frameworks.

If health professionals can refuse to grant their consent to disclose payment information,
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will the new system of disclosure really bring greater transparency?

We believe that a more open, transparent relationship is in the best interests of patients, healthcare professionals
and systems. Bringing greater transparency to this, already well-regulated, vital relationship is about strengthen-
ing the basis for collaboration in the future. Industry is being proactive based on its commitment to this relation-
ship. Our hope is that healthcare professionals will also recognise the benefits of greater transparency and grant
their consent to disclose the data.

23 Are you taking away HCPs’ rights to privacy?

Where public interest or national legislation has negated the need for individual consent, then the data will be
automatically published. Where individual consent is used as a basis for publication (rather than public interest),
health professionals retain the right to withhold their consent to disclose transfers of value or withdraw their con-
sent to disclose at anytime. However, we believe that a more open, transparent relationship is in the best interests
of patients, healthcare professionals and systems. Bringing greater transparency to this, already well-regulated,
vital relationship is about strengthening the basis for collaboration in the future. Industry is being proactive, based
on its commitment to this relationship. Our hope is that health professionals will also recognise the benefits of
greater transparency and where needed, grant consent to disclose the data.

Does this show that industry does not trust health professionals to manage conflicts
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of interest appropriately?

No, we believe that a more open, transparent relationship is in the best interests of patients, healthcare profession-
als and systems. Bringing greater transparency to this, already well-regulated, vital relationship is about strength-
ening the basis for collaboration in the future. Society has increasingly high expectations for transparency, none
more so than in healthcare. We want to ensure we meet those expectations going forward. We believe healthcare
professionals can manage their conflicts of interest, and transparency is an additional tool in this process.

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European Pharmaceutical Industry The EFPIA Disclosure Code: Your Questions Answered

General Information and Questions

25 Will the amounts disclosed vary between countries?

Yes, every healthcare system in Europe is different. Industry and HCP activity is shaped by different legislation,
self-regulation and guidance. There is also significant variation in resources, infrastructure, income and expertise
between countries.

For example the availability of funding for, and access to, medical education differs across Europe. Taking these
factors in to account, it is likely there will be some variation in the transfers of value to health professionals in
countries across Europe.

26 Does the number of HCPs giving their consent vary between countries?

Yes, the EFPIA Disclosure Code applies to HCPs across 33 countries, each with different cultural, socio-economic,
healthcare and regulatory environments. As a consequence, disclosure rates are likely to vary between countries.
Industry is keen to work with individual health professionals and their representative bodies to maximise the rates
for disclosure across Europe.

Bringing greater transparency to this, already well-regulated, vital relationship is about strengthening the basis for
collaboration in the future. Industry is being proactive, based on its commitment to this relationship. Our hope is that
health professionals will also recognise the benefits of greater transparency and grant consent to disclose the data.

27 Who can an HCP contact for more information or questions?

The first port of call for information is the pharmaceutical company a healthcare professional is working with.
For more general information on disclosure, healthcare professionals can contact the national association in the coun-
try they are working in. You can access a list of EFPIA member associations at www.efpia.eu/about-us/membership.
For information on disclosure from EFPIA please go to www.transparency.efpia.eu/downloads.

EFPIA Brussels Office

Leopold Plaza Building Rue du Trône 108
*
B-1050 Brussels Belgium
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Tel: + 32 (0)2 626 25 55 Fax: + 32 (0)2 626 25 66
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