EFPIA CODE OF PRACTICE

www.efpia.eu

Adopted by the EFPIA Board on 22 March 2019, and ratified by the EFPIA
Statutory General Assembly of 27 June 2019

FINAL CONSOLIDATED VERSION 2019
Approved by the General Assembly of 27 June 2019
The EFPIA Code constitutes the collection of ethical rules agreed by EFPIA members
for the Promotion of Medicinal Products to HCPs and the interactions with HCPs, HCOs
and POs, with the intent of guaranteeing that these activities are conducted while
respecting the most stringent ethical principles of professionalism and responsibility.
This Code applies to all types of communication and interaction (traditional and digital).

TABLE OF CONTENTS
DEFINITIONS							 P. 05
PREAMBLE							 P. 09
INTRODUCTION							 P. 11
SCOPE OF THE EFPIA CODE						 P. 13
APPLICABILITY OF THE EFPIA CODE					 P. 15
CHAPTER 1
Article 1
Article 2
Article 3
Article 4
Article 5
Article 6
Article 7
Article 8
Article 9

PROMOTION OF POM TO HCPs				Marketing authorization
Information to be made available
Promotion and its substantiation
Use of quotations in Promotion
Acceptability of Promotion
Distribution of Promotion
Transparency of Promotion
Promotional information provided during international Events
Personal medical matters

CHAPTER 2
INTERACTIONS WITH HCPs, HCOs AND POs			
Article 10		Events and hospitality
Article 11		Prohibition of Gifts
Article 12		Donations and Grants to HCOs and POs
Article 13		Contribution to Cost of Events and Sponsorship
Article 14		Member Company funding
Article 15		Contracted services

P. 16

P. 19

CHAPTER 3
SPECIFIC REQUIREMENTS FOR INTERACTIONS WITH HCPs AND HCOs P. 23
Article 16		Lifelong Learning in Healthcare
Article 17		Informational or Educational Materials, Items of Medical Utility
Article 18		Non-Interventional Studies
Article 19		Medical Samples
Article 20		Member Company Staff
CHAPTER 4
SPECIFIC REQUIREMENTS FOR INTERACTIONS WITH POs
Article 21		Interactions with POs

P. 27

CHAPTER 5DISCLOSURE OF TRANSFERS OF VALUE FROM MEMBER COMPANIES P. 28
Article 22		Disclosure of ToVs to HCPs & HCOs and POs
Article 23		Disclosure of ToVs to HCPs and HCOs
Article 24		Disclosure of support and services provided to POs
CHAPTER 6
PROCEDURAL REQUIREMENTS				
P. 32
Article 25		Enforcement
Article 26		Amendments to, and guidance on compliance with, the EFPIA Code
Article 27		Awareness and education
Article 28		Implementation and procedure rules
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ANNEXES			
Annex A (binding)Annex B (binding)Annex C (binding)		Annex D (binding) 	Annex E (binding)

P. 36
Standardised disclosure template
EFPIA guidance
Guidance obligations for Member Associations under the EFPIA
Code
EFPIA standard operating procedure related to processingof complaints and questions submitted to EFPIA
EFPIA e4ethics rules and procedure

Non-binding annexes:
Annex 1 		EFPIA recommendation
Annex 2 		Principles for the use of digital channels
Annex 3 		EFPIA Guideline on a Quality Framework - Principles in Lifelong
			Learning in Healthcare

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DEFINITIONSDefinitions of capitalised terms are included to ensure their consistent understanding.
Applicable Codes:
p in the case of Promotion or interaction that is undertaken, sponsored or organised by oron behalf of, or with, a Member Company located within Europe, the Member Association
National Code of the country in which such Member Company is located; or (ii) in the caseof Promotion or interaction that is undertaken, sponsored or organised by or on behalf of, orwith, a Member Company located outside of Europe, the EFPIA Code; andp t he Member Association’s National Code of the country in which the Promotion or theinteraction takes place.
In case of international Event for which a Member Company sponsors the attendance of a
HCP, if any funding is provided to such HCP in accordance with the provisions of Article 13,
such funding is subject to the rules of the National Code where such HCP carries out his/her
profession, as opposed to those in which the international Event takes place.
In the event of a conflict between the provisions of the Applicable Codes set forth above, themore restrictive of the conflicting provisions must apply, except for the application of Section
10.05, where the monetary threshold set in the country where the event takes place (i.e. the“host country”) must prevail.
Contribution to Costs related to Events: is a support providing or covering the costs of meals,
travel, accommodation and/or registration fees to support the attendance of an individual HCP or
PO Representative to an Event organised or created by a Member Company and/or a Third Party.
Donations and Grants: collectively, mean providing funds, assets or services freely given forthe purpose of supporting healthcare, scientific research or education, with no consequent­obligation on the recipient to provide goods or services to the benefit of the donor in return.
European Federation of Pharmaceutical Industries and Associations (EFPIA): is the­representative body of the pharmaceutical industry in Europe.
EFPIA Code: The EFPIA Code of Practice, including those Annexes which are expressly mentioned
as binding and which form part of this Code.
Europe: includes those countries in which the EFPIA Member Associations’ National Codes apply1.
Events: All professional, promotional, scientific, educational meetings, congresses, conferences,
symposia, and other similar events (including, but not limited to, advisory board meetings, visits toresearch or manufacturing facilities, and planning, training or investigator meetings for clinical trials
and non-interventional studies) organised or sponsored by or on behalf of a Member Company.
1 - As of June 2019, these countries include: Austria, Belgium, Bosnia and Hezegovina, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, the Netherlands, North Macedonia, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia,
Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and the United Kingdom.

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Healthcare Organisation (HCO): any legal person/entity (i) that is a healthcare, medical orscientific association or organisation (irrespective of the legal or organisational form) such as a
hospital, clinic, foundation, university or other teaching institution or learned society (except
for POs within the scope of article 21) whose business address, place of incorporation or primaryplace of operation is in Europe or (ii) through which one or more HCPs provide services.
Healthcare Professional (HCP): any natural person that is a member of the medical, dental,
pharmacy or nursing professions or any other person who, in the course of his/her professional
activities, may prescribe, purchase, supply, recommend or administer a Medicinal Product andwhose primary practice, principal professional address or place of incorporation is in Europe.
For the purpose of this Code, the definition of HCPs includes: (i) any official or employee ofa government, agency or other organisation (whether in the public or private sector) thatmay prescribe, purchase, supply, recommend or administer Medicinal Products and (ii) any
employee of a Member Company whose primary occupation is that of a practising HCP, but
excludes (x) all other employees of a Member Company and (y) a wholesaler or distributor of
Medicinal Products.
Host Country Principle: refers to the primacy of the monetary threshold for a meal (food andbeverages) set by the relevant Member Association in its National Code.
The monetary threshold set in the country where the Event takes place must prevail.
Informational or Educational Material: constitutes inexpensive material directly relevant to
the practice of medicine or pharmacy and directly beneficial to the care of patients.
Item of Medical Utility: constitutes inexpensive item aimed directly at the education of HCPs
enhancing the provision of medical services and patient care and that do not offset routine
business practices of the HCPs.
Lifelong learning in healthcare: constitutes non-promotional education related to humanhealth and diseases.
Location: refers to the geographic place where the Event is organized (e.g. the city, town).
Medical Sales Representative: personnel employed by a Member Company or retained by
way of contract with Third Parties, who interact with HCPs and HCOs, in connection with thePromotion of Medicinal Products.
Medical Sample: has the meaning set forth in the Directive 2001/83/EC, namely sample ofMedicinal Product free of charge to persons qualified to prescribe or supply them so that they
can familiarize themselves with new products and acquire experience in dealing with them.
Medicinal Product: has the meaning set forth in Article 1 of the Directive 2001/83/EC, namely:(a) any substance or combination of substances presented as having properties for treating or
preventing disease in human beings; or (b) any substance or combination of substances which
may be used in or administered to human beings either with a view to restoring, correcting or
modifying physiological functions by exerting a pharmacological, immunological or metabolic
action, or to making a medical diagnosis.

6Member Association: as defined in the EFPIA Statutes, means an organisation representing
pharmaceutical manufacturers at national level whose members include, among others,
research-based companies. Collectively, the national Member Associations or their constituent
members, as the context may require, are bound by the EFPIA Code.
Member Company: as defined in the EFPIA Statutes, means research-based companies,
developing and manufacturing Medicinal Products in Europe for human use.
Member Company Staff: personnel employed by a Member Company or retained by way ofcontract with Third Parties, who are concerned with any matter covered by this Code.
National Code: The code of practice of a Member Association.
Non-Interventional Study (NIS): is a study where the Medicinal Product(s) is (are) prescribedin the usual manner in accordance with the terms of the marketing authorization. The
assignment of the patient to a particular therapeutic strategy is not decided in advance by atrial protocol but falls within current practice and the prescription of the Medicinal Product isclearly separated from the decision to include the patient in the study. No additional diagnostic
or monitoring procedures must be applied to the patients and epidemiological methods must
be used for the analysis of collected data2.
Patient Organisation (PO): non-for-profit legal person/entity (including the umbrellaorganisation to which it belongs), mainly composed of patients and/or caregivers, that
represents and/or supports the needs of patients and/or caregivers and which businessaddress, place of incorporation or primary place of operation is in Europe.
Patient Organisation Representative: is a person who is mandated to represent and express
the collective views of a PO on a specific issue or disease area3.
Personal Health Data: is any information related to the physical, mental health or to theinherited or acquired genetic characteristics of an identified or identifiable natural person,
including the provision of health care services, which reveal information about his or her
physiology or health status4.
Prescription-Only Medicines (POM): is a Medicinal Product that requires a medicalprescription issued by a professional person qualified to prescribe.
Promotion: includes any activity undertaken, organised or sponsored by a Member
Company, or with its authority, which promotes the prescription, supply, sale, administration,
recommendation or consumption of its Medicinal Product(s).
Recipient: any HCP or HCO or PO as applicable, in each case, whose primary practice, principal
professional address or place of incorporation is in Europe.

2 - Article 2 of the Directive 2001/20/EC
3 - EUPATI definition
4 - Definition based on the definitions of “personal data”, “genetic data” and “data concerning health” in Article 4 of GDPR

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Reporting Period: refers to the annual disclosure cycle and covers a full calendar year.
Research and Development Transfers of Value: Transfers of Value to HCPs or HCOs related
to the planning or conduct of (i) non-clinical studies (as defined in OECD Principles on Good
Laboratory Practice); (ii) clinical trials (as defined in Regulation 536/2014); or (iii) NIS that areprospective in nature and that involve the collection of patient data from or on behalf ofindividual, or groups of, HCPs specifically for the study.
Sponsorship: is a support provided by or on behalf of a Member Company, when permitted
by law, as a contribution to support an activity (including an Event) performed, organised or
created by a HCO, a PO or a Third Party.
Third Party: is a legal person/entity or individual that represents a Member Company orinteracts with other Third Parties on behalf of a Member Company or relating to the Member
Company’s Medicinal Product, such as distributors, wholesalers, consultants, contract researchorganisations, professional congress organisers, contracted sales forces, market researchcompanies, advertising agencies, providers of services related to events, public relations
services, non-clinical, non-interventional studies management services.
Transfers of Value (ToV): Direct and indirect ToV, whether in cash, in kind or otherwise, made,whether for promotional purposes or otherwise, in connection with the development and saleof POM exclusively for human use. Direct ToVs are those made directly by a Member Company
for the benefit of a Recipient. Indirect ToVs are those made on behalf of a Member Company
for the benefit of a Recipient, or those made through a Third Party and where the Member
Company knows or can identify the Recipient that will benefit from the Transfer of Value.
Venue: refers to the logistic place where the Event is organized (i.e. the hotel, the congress center).

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PREAMBLE
This document replaces previous codes issued by EFPIA, namely:
p E FPIA Code on the Promotion of Prescription-Only Medicines to, and Interactions with,
Healthcare Professionals (Final Consolidated Version approved by the General Assembly of June2014), which first came into effect in January 1992;
p E FPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient
Organisations (approved by the General Assembly of June 2011), which was first approved in
September 2007; andp E FPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare
Professionals and Healthcare Organisations (approved by the General Assembly of June 2014),
and which was first approved in June 2013.
ETHICAL PRINCIPLESAs pharmaceutical companies, we work in collaboration with various stakeholders including
HCPs, HCOs, POs and their Representatives, regulatory authorities, governments and the public
to improve health and quality of life.
We continuously invest in research and development to deliver new treatments for medical
needs and improving the quality of treatment.
As commercial organisations, we encourage competition and economic development tosustain investment and foster innovation.
We believe in what we do and know that there is somewhere a patient whose health andwellbeing is, directly or indirectly, dependent on our work.
We aim at creating an environment where our stakeholders and the general public, consider
pharmaceutical companies as trusted partners.
In addition to complying with extensive legal requirements (i.e. laws and regulations applicableto our industry such as pharmaceutical, competition, intellectual property and data protection
laws as well as anti-bribery and anti-corruption legislation), the pharmaceutical industry has
agreed to comply with additional standards in its self-regulatory codes and joint positions.
For EFPIA and its members, self-regulation means being fully committed to define, implement,comply with and enforce the highest ethical standards through EFPIA and National Codes,
where breaches are not tolerated.
Self-regulation includes the concept of continuous challenge for us to exceed society’s
expectations and openness regarding suggestions from others on how we might further
strengthen confidence in our industry and our behaviour.

9Stakeholders who share the values and principles enshrined in this self-regulation are invited toadhere to these rules and guidance5.
ETHOS
Our Ethos outlines the ethical principles that underpin the EFPIA Code and ​guide theindustry’s interactions with the healthcare and patient community.

5 - EFPIA Leadership statement on ethical practices – June 201010

INTRODUCTION
The EFPIA’s membership6 is composed of:p F ull members, including: (i) research-based pharmaceutical companies, developing andmanufacturing Medicinal Products in Europe for human use – called Member Companies; and(ii) those organisations representing pharmaceutical manufacturers at national level whose
members include, among others, research-based companies – called Member Associations.
pA ffiliate members, including: (i) companies specialising in particular fields of pharmaceuticalresearch and/or development or in new technologies of particular interest to thepharmaceutical industry – called “affiliate Member Company”; and (ii) organisations
representing research-based pharmaceutical companies at national level in Europe that havebeen granted the title of “affiliate Member Associations”.
pR esearch-based pharmaceutical companies operating in a particular segment of thepharmaceutical market that joint a specialised group within EFPIA: Vaccines Europe (VE).
Separate entities belonging to the same multinational company – which could be the parent
company (e.g. the headquarters, principal office, or controlling company of a commercial
enterprise), subsidiary company or any other form of enterprise or organisation – are deemed
to constitute a single company, and are as such committed to comply with the EFPIA Code.
EFPIA and its members7 are conscious of the importance of (i) providing accurate, fair andobjective information about Medicinal Products so that rational decisions can be made as
to their use, (ii) ensuring that interactions with HCPs, HCOs and POs, which are key to shareknowledge aiming to improve the quality of patient care, take place in an ethical manner and(iii) introducing greater transparency around the pharmaceutical industry’s interactions with
HCPs, HCOs and POs.
Chapters 1, 2 and 3 reflect the requirements of Council Directive 2001/83/EC, as amended,
relating to Medicinal Products, and fit into the general framework established by the Directive,
which recognises the role of voluntary control of advertising of Medicinal Products by selfregulatory bodies and recourse to such bodies when complaints arise.
EFPIA encourages competition among pharmaceutical companies. The EFPIA Code is notintended to restrain the Promotion of Medicinal Products to HCPs, or limit interactions with
HCPs, HCOs, and POs in a manner that is detrimental to fair competition. Instead, it seeks toensure that pharmaceutical companies conduct such Promotion and interactions in a truthfulmanner, avoiding deceptive practices and potential conflicts of interest with stakeholders, andin compliance with applicable laws and regulations.
The EFPIA Code thereby aims to foster an environment where the general public can be
confident that the choices regarding their Medicinal Products are being made on the basis of
the merits of each product and the healthcare needs of patients.

6 - Article 4 of EFPIA Statutes
7 - The updated list of EFPIA membership can be found on www.efpia.eu

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HCPs and HCOs provide the pharmaceutical industry with valuable, independent and expert
knowledge derived from their clinical and scientific experience. This expertise makes animportant contribution to the industry’s efforts to improve the quality of patient care, with
benefits for individuals and society at large. HCPs and HCOs should be fairly remunerated forthe legitimate expertise and services they provide to the industry.
EFPIA believes that interactions between Member Companies and HCPs have a profound andpositive influence on the quality of patient treatment and the value of future research. At thesame time, the integrity of the decision of a HCP to prescribe a Medicinal Product is one of thepillars of the healthcare system. EFPIA recognises that interactions between the industry and
HCPs/HCOs can create the potential for conflicts of interest. Consequently, professional andindustry associations, including EFPIA and its Member Associations, have adopted codes andguidelines to ensure that these interactions meet the high standards of integrity that patients,
governments and other stakeholders expect.
In order, to continue to be successful, self-regulation needs to respond to the evolving demandsof society. In particular, EFPIA recognises the growing expectation that interactions with society
are not only conducted with integrity but are also transparent.
In the same way, the pharmaceutical industry works with POs to learn from their knowledge
and experience of patient’s condition that is able to provide a true picture of what it is like tolive with a specific condition, how care is delivered, how that impacts on them, their careersand families and how medicines and other treatments can change their quality of life and meettheir needs.
POs have a key role in helping to shape, develop and define the outcomes that make themost difference to patients. Member Companies disclose the amounts provided to POs in theframework of these interactions.
EFPIA strongly supports public scrutiny and the understanding of these relationships anddisclosure contributes to the confidence of stakeholders in the pharmaceutical industry.
In relation to working with HCPs and HCOs, since the introduction of the EFPIA Disclosure Code,EFPIA has worked to encourage Member Companies to always look to disclose and to encourage
HCPs (and HCOs where relevant) to agree to individual disclosure. Member Companies will not
be criticized for over-disclosure.

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SCOPE OF THE EFPIA CODE
The EFPIA Code covers:pP romotion of POMs to HCPs,
p i nteractions between Member Companies and HCPs, HCOs and POs;pd
 isclosure of ToVs from Member Companies to HCPs, HCOs and POs; andpp rocedural requirements of the EFPIA Code.
Member Companies are responsible for the obligations imposed under any relevant Applicable
Code even if they commission a Third Party to design, implement or engage in activities
covered by the Applicable Code on their behalf. In addition, Member Companies must takereasonable steps to ensure that any other parties that they commission to design, implement
or engage in activities covered by the Applicable Code but that do not act on behalf of theMember Company (e.g. joint ventures, licensees) comply with Applicable Codes.
The EFPIA Code covers all methods of Promotion including, but not limited to, oral and written
promotional activities and communications, journal and direct mail advertising, the activities
of Medical Sales Representatives, the use of digital communications and channels, such as
websites and social media, the use of audio-visual systems such as films, video recordings,
data storage services and the like. It also covers the provision of Informational or Educational
Materials, Items of Medical Utility, hospitality in relation to Events and Medical Samples.
The EFPIA Code also covers interactions between Member Companies and HCPs and HCOs
including, but not limited to, those in the context of research or contractual arrangements(including certain aspects of clinical trials, non-interventional studies as well as consultancy
and advisory board). It also covers the interactions between Member Companies and POs.
The EFPIA Code is not intended to restrain or regulate activities directed towards thegeneral public which relate solely to non-prescription Medicinal Products. EFPIA, however,acknowledges that some Member Associations address these activities in their respective
National Codes, and encourages other Member Associations to do so, where appropriate.
The EFPIA Code does not cover the following:
p t he labelling of Medicinal Products and accompanying package leaflets, which are subject tothe provisions of Title V of the Directive 2001/83/EC;
p c orrespondence, possibly accompanied by material of a non-promotional nature, needed toanswer a specific question about a particular Medicinal Product;p f actual, informative announcements and reference material relating, for example, to packchanges, adverse-reaction warnings as part of general precautions, trade catalogues andprice lists, provided they include no product claims;
p a ctivities which relate solely to non-prescription Medicinal Products; orpn on-promotional, general information about Member Companies (such as information
directed to investors or to current/prospective employees), including financial data,
descriptions of research and development programmes, and regulatory developments
affecting a Member Company and its Medicinal Products.

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The following documents are attached to the EFPIA Code and are binding for EFPIA members:pA
 nnex A
Standardised Disclosure template;pA nnex B

EFPIA guidance;pA
 nnex C

Guidance obligations for Member Associations under the EFPIA Code; andpA
 nnex D 	EFPIA Standard Operating Procedure related to processing of complaints andquestions submitted to EFPIA;pA
 nnex E

EFPIA e4ethics rules and procedure.

Additional documents are developed to illustrate the provisions of the EFPIA Code and provide
explanations for a consistent implementation, such as the following:p E FPIA recommendation;p Principles for the use of digital channels;
p EFPIA Guideline on a Quality Framework - Principles in Lifelong Learning in Healthcare.

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APPLICABILITY OF THE EFPIA CODE
The EFPIA Code sets out the minimum standards which EFPIA considers must apply. In a mannercompatible with their respective national laws and regulations, Member Associations must, at aminimum, adopt in their National Codes provisions no less rigorous than the provisions containedin the EFPIA Code. Member Associations are encouraged to tailor their National Codes to adapt
to national conditions and to adopt additional provisions which might extend further than theminimum standards included in the EFPIA Code.
All Member Associations are required to implement the disclosure provisions into their National
Codes in full, except where its provisions are in conflict with applicable national laws or regulations,in which case deviations are allowed, but only to the extent necessary to comply with such nationallaw or regulation.
Promotion and interactions which take place within Europe must comply with applicable laws
and regulations. In addition, Promotion and interactions which take place within Europe must also
comply with Applicable Codes.
Member Companies must comply with any Applicable Codes and any laws and regulations
to which they are subject. All Member Companies must either (i) be a member of the Member
Association in each country where it conducts activities covered by the EFPIA Code (either directlyor through the relevant subsidiary) or (ii) agree in writing with each such Member Association thatit (or its relevant subsidiary) is bound by such Member Association’s National Code (including any
applicable sanctions that may be imposed there under).
Member Companies must be bound by the relevant National Code in each country in Europe inwhich they operate (whether directly or through its relevant subsidiary). If a Member Association
where a Member Company operates fails to transpose the EFPIA Code into its National Code by therelevant deadline, such Member Company will be required to comply with the EFPIA Code itself.
Non-member associations and companies that decide to voluntarily implement the EFPIA Codemust require that each of their respective members, affiliates and subsidiaries, as applicable,
comply with all provisions of the EFPIA Code.
To facilitate compliance with the Applicable Codes, each Member Association must establish
adequate procedures for ensuring that each of its member companies complies with therequirements of such National Code and any other National Code which may be applicable to its
conduct, even if the member company does not belong to the other Member Association. In orderto establish adequate procedures for ensuring compliance with the Applicable Codes, Member
Associations will be required, among other things, to establish appropriate complaint procedures
and sanctions for breaches of their respective codes. Additionally, all international Events and/or
activities as relevant must be notified to any relevant local subsidiary or, alternatively, local advice
must be taken.
The spirit, as well as the provisions of the EFPIA Code must be complied with. EFPIA also
encourages compliance with the letter and spirit of the provisions of the International Federationof Pharmaceutical Manufacturers and Associations (“IFPMA”) Code of Practice, where applicable.
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CHAPTER 1.
PROMOTION OF POM TO HCPs
ARTICLE 1 MARKETING AUTHORIZATION
Section 1.01. A Medicinal Product must not be promoted prior to the grant of the marketing
authorization allowing its sale or supply or outside of its approved indications.
Section 1.02. Promotion must be consistent with the particulars listed in the summary of
product characteristics of the relevant Medicinal Product.
ARTICLE 2 INFORMATION TO BE MADE AVAILABLE
Section 2.01. Subject to applicable national laws and regulations, all promotional materialmust include the following information clearly and legibly:pe ssential information consistent with the summary of product characteristics, specifying thedate on which such essential information was generated or last revised;p t he supply classification of the Medicinal Product; andpw
 hen appropriate, the selling price or indicative price of the various presentations and theconditions for reimbursement by social security bodies.
Section 2.02. Subject to applicable national laws and regulations, where an advertisement isintended only as a reminder, the requirements of Section 2.01 above need not be complied
with, provided that the advertisement includes no more than the name of the Medicinal
Product or its international non-proprietary name, where this exists, or the trademark.
ARTICLE 3 PROMOTION AND ITS SUBSTANTIATION
Section 3.01. Promotion must be accurate, balanced, fair, objective and sufficiently complete
to enable the HCP to form his/her own opinion of the therapeutic value of the Medicinal
Product concerned. It must be based on an up-to-date evaluation of all relevant evidence andreflect that evidence clearly. It must not mislead by distortion, exaggeration, undue emphasis,omission or in any other way.
Section 3.02. Promotion must be capable of substantiation which must be promptly provided
in response to reasonable requests from HCPs. In particular, promotional claims about sideeffects must reflect available evidence or be capable of substantiation by clinical experience.
Substantiation need not be provided, however, in relation to the validity of elements approvedin the marketing authorization.
Section 3.03. Promotion must encourage the rational use of Medicinal Products by presenting themobjectively and without exaggerating their properties. Claims must not imply that a Medicinal Product,
or an active ingredient, has some special merit, quality or property unless this can be substantiated.

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Section 3.04. When Promotion refers to published studies, clear references must be given.
Section 3.05. Any comparison made between different Medicinal Products must be based on
relevant and comparable aspects of the Medicinal Products. Comparative advertising must not
be misleading or disparaging.
Section 3.06. All artwork, including graphs, illustrations, photographs and tables taken frompublished studies included in promotional material must: (a) clearly indicate the precise
source(s) of the artwork; (b) be faithfully reproduced, except where adaptation or modificationis required in order to comply with any Applicable Code(s), in which case it must be clearlystated that the artwork has been adapted and/or modified.
Particular care must be taken to ensure that artwork included in Promotion does not mislead
about the nature of a Medicinal Product (for example, whether it is appropriate for use inchildren) or mislead about a claim or comparison (for example, by using incomplete or
statistically irrelevant information or unusual scales).
Section 3.07. The word “safe” must never be used to describe a Medicinal Product without
proper qualification.
Section 3.08. The word “new” must not be used to describe any Medicinal Product orpresentation which has been generally available or any therapeutic indication which has been
generally promoted, for more than one year.
Section 3.09. It must not be stated that a Medicinal Product has no side-effects, toxic hazards
or risks of addiction or dependency.
ARTICLE 4 USE OF QUOTATIONS IN PROMOTION
Quotations from medical and scientific literature or from personal communications must be
faithfully reproduced (except where adaptation or modification is required in order to comply
with any Applicable Code(s), in which case it must be clearly stated that the quotation has been
adapted and/or modified) and the precise sources identified.
ARTICLE 5 ACCEPTABILITY OF PROMOTIONMember Companies must maintain high ethical standards at all times. Promotion must: (a)never be such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry;(b) be of a nature which recognises the special nature of Medicinal Products and the professional
standing of the intended audience; and (c) not be likely to cause offence.
ARTICLE 6 DISTRIBUTION OF PROMOTION
Section 6.01. Promotion must only be directed at those HCPs whose need for, or interest in, theparticular information can reasonably be assumed.

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Section 6.02. Mailing lists must be kept up-to-date. Requests to be removed from mailing lists
must be complied with.
Section 6.03. Subject to applicable national laws and regulations, the use of faxes, e-mails,
automated calling systems, text messages and other digital communications for Promotion isprohibited except with the prior permission, or upon the request, of those who receive it.
ARTICLE 7 TRANSPARENCY OF PROMOTION
Section 7.01. Promotion must not be disguised.
Section 7.02. Clinical assessments, post-marketing surveillance and experience programmes
and post-authorization studies (including those that are retrospective in nature) must not be
disguised Promotion. Such assessments, programmes and studies must be conducted with a
primarily scientific or educational purpose.
Section 7.03. Where a Member Company pays for or otherwise secures or arranges the
publication of promotional material in journals, such promotional material must not resemble
independent editorial matter.
Section 7.04. Material relating to Medicinal Products and their uses, whether promotional innature or not, which is sponsored by a Member Company must clearly indicate that it has beensponsored by that Member Company.
ARTICLE 8 PROMOTIONAL INFORMATION PROVIDED DURING INTERNATIONAL EVENTS
Promotional information which appears on exhibition stands or is communicated toparticipants at international Events may, unless prohibited or otherwise regulated by local laws
and regulations, refer to Medicinal Products (or uses) which are not registered in the country
where the Event takes place, or which are registered under different conditions, as long as: (i)any such promotional material is accompanied by a suitable statement indicating the countries
in which the Medicinal Product is registered and makes clear that the Medicinal Product orindication is not registered locally, and (ii) any such promotional material which refers to
the prescribing information (indications, warnings etc.) authorized in a country or countries
where the Medicinal Product is registered must be accompanied by an explanatory statement
indicating that registration conditions differ internationally.
ARTICLE 9 PERSONAL MEDICAL MATTERS
In the case of requests from individual members of the general public for advice on personal
medical matters, the enquirer must be advised to consult a HCP.

18

CHAPTER 2.
INTERACTIONS WITH HCPs, HCOs AND POs
ARTICLE 10 EVENTS AND HOSPITALITY
Section 10.01. All Events must be held in “appropriate” Locations and Venues that are conduciveto the main purpose of the Event, avoiding those that are “renowned” for their entertainment
facilities or are “extravagant”.
Section 10.02. No Member Company may organise or sponsor an Event that takes placeoutside its home country unless:pm ost of the invitees are from outside of its home country and, given the countries of origin of
most of the invitees, it makes greater logistical sense to hold the Event in another country; orpg
 iven the location of the relevant resource or expertise that is the object or subject matter ofthe Event, it makes greater logistical sense to hold the Event in another country.
Section 10.03. Member Companies may only offer hospitality when such hospitality is“appropriate” and otherwise complies with the provisions of any Applicable Code(s).
Section 10.04. Hospitality extended in connection with Events must be limited to travel, meals,
accommodation and genuine registration fees.
Section 10.05. Member Companies must not provide or offer any meal (food and beverages)
to HCPs, HCOs’ members or POs’ Representatives, unless, in each case, the value of such meal
does not exceed the monetary threshold set by the relevant Member Association in its National
Code (following the “Host Country Principle”).
Section 10.06. Hospitality may only be extended to persons who qualify as participants in theirown right. In exceptional cases of established health needs (e.g. disability or injury), the travel,
meals, accommodation and genuine registration fee costs of an accompanying person can bereimbursed within the same parameters.
Section 10.07. All forms of hospitality offered to HCPs, HCOs’ members or POs’ Representatives
must be “reasonable” in level and strictly limited to the main purpose of the Event. As a generalrule, the hospitality provided must not exceed what those individuals would normally be
prepared to pay for themselves.
Section 10.08. Hospitality must not include sponsoring or organising entertainment events(e.g. sporting or leisure).
ARTICLE 11 PROHIBITION OF GIFTS
Section 11.01. Gifts for the personal benefit (such as sporting or entertainment tickets,
social courtesy gifts) of HCPs, HCOs’ members or POs’ Representatives (either directly or
indirectly) are prohibited.
19

Providing or offering cash, cash equivalents or personal services is also prohibited. For these
purposes, personal services are any type of service unrelated to the profession and that confer
a personal benefit to the Recipient.
Section 11.02. A promotional aid is a non-monetary item given for a promotional purpose (which
does not include promotional materials as defined in Chapter 1). Providing or offering them to
HCPs, HCOs’members or POs’ Representatives in relation to the promotion of POM is prohibited.
ARTICLE 12 DONATIONS AND GRANTS TO HCOs AND POs
Section 12.01. Donations and Grants (in cash or in kind or otherwise) to HCOs and/or POs
are only allowed if: (i) they are made for the purpose of supporting healthcare, research or
education; (ii) they are documented and kept on record by the donor/grantor; and (iii) they
do not constitute an inducement to recommend and/or prescribe, purchase, supply, sell oradminister specific Medicinal Products.
Section 12.02. Donations and Grants to individuals are not permitted. The Contribution to
Costs related to Events for HCPs to attend international Events is covered by Article 13.
ARTICLE 13 CONTRIBUTION TO COSTS RELATED TO EVENTS AND SPONSORSHIP
Section 13.01. Member Companies must comply with criteria governing the selection andsupport of HCPs or POs’ Representatives to attend Events as provided in, or in connection with,
any Applicable Code(s). No payment must be offered to compensate merely for the time spentby the HCP or PO’s Representative in attending Events.
Section 13.02. The public use of an HCO or PO´s logo and/or proprietary material by aMember Company requires written permission from that organisation. In seeking suchpermission, the specific purpose and the way the logo and/or proprietary material will be
used must be clearly stated.
Section 13.03. Member Companies must ensure that their Sponsorship to HCOs and POs isalways clearly acknowledged and apparent from the outset.
ARTICLE 14 MEMBER COMPANY FUNDINGNo Member Company may require that it be the sole funder or sponsor of a PO or HCO or anyof its programmes.
Member Companies welcome broad funding and sponsorship of POs and HCOs frommultiple sources.

20

ARTICLE 15 CONTRACTED SERVICES
Section 15.01. Contracts between Member Companies and HCPs, HCOs, POs or POs’
Representatives under which those provide any type of services to Member Companies (nototherwise covered by the Code) are only allowed if such services: (i) are provided for the purposeof supporting healthcare, research or education; and (ii) do not constitute an inducement torecommend and/or prescribe, purchase, supply, sell or administer specific Medicinal Products.
Section 15.02. It is permitted to contract HCPs or POs’ Representatives as consultants, whether
in groups or individually, for services such as speaking at and/or chairing meetings, involvement
in medical/scientific studies, clinical trials or training services, participation at advisory board
meetings, and participation in market research where such participation involves remuneration
and/or hospitality. The arrangements that cover these genuine consultancy or other services must,
to the extent relevant to the particular arrangement, fulfil all the following criteria:p a written contract is agreed in advance of the commencement of the services which specifies
the nature of the services to be provided and, subject to clause (g) below, the basis forpayment of those services;p  a legitimate need for the services has been clearly identified and documented in advance ofrequesting the services and entering into arrangements;
p  the criteria for selecting consultants are directly related to the identified need and thepersons responsible for selecting the consultants have the expertise necessary to evaluate
whether the particular consultant meets those criteria;p  the number of consultants retained and the extent of the service are not greater thanreasonably necessary to achieve the identified need;p  the contracting Member Company maintains records concerning, and makes appropriate
use of, the services provided by consultants;
p  the engagement of the consultant to provide the relevant service is not an inducement torecommend and/or prescribe, purchase, supply, sell or administer a particular Medicinal
Product;p  the remuneration for the services is reasonable and reflects the fair market value of theservices provided. In this regard, token consultancy arrangements must not be used to justify
compensating the HCPs or PO Representatives.
Section 15.03. In their written contracts with consultants, Member Companies are strongly
encouraged to include provisions regarding the obligation of the consultants to declare thatthey are consultants to the Member Company whenever they write or speak in public abouta matter that is the subject of the agreement or any other matter relating to that Member
Company.
Similarly, Member Companies that employ, on a part-time basis, HCPs that are still practising
their profession are strongly encouraged to ensure that such persons have an obligation to
declare their employment arrangements with the Member Company whenever they writeor speak in public about a matter that is the subject of the employment or any other matter
relating to that Member Company. The provisions of this Section 15.03 apply even though the21

EFPIA Code does not otherwise cover non-promotional, general information about Member
Companies (as discussed in the “Scope of the EFPIA Code” section).8
Section 15.04. Limited market research, such as one-off phone interviews or mail/e-mail/internet questionnaires are excluded from the scope of this Article 15, provided that the HCP,
HCO’s member or PO’s Representative is not consulted in a recurring manner (either withrespect to the frequency of calls generally or of calls relating to the same research) and that the
remuneration is minimal.
Section 15.05. If an HCP or a PO’s Representative attends an Event (an international Event orotherwise) in a consultant capacity the relevant provisions of Article 10 must apply.

8 - Companies are strongly encouraged to include such provisions in any contracts covered by this Section 15.03.

22

 HAPTER 3.
C
SPECIFIC REQUIREMENTS
FOR INTERACTIONS WITH HCPs AND HCOs
ARTICLE 16
LIFELONG LEARNING IN HEALTHCARE
Lifelong learning in healthcare (LLH) is aimed at increasing the scientific knowledge andcompetence of HCPs to enhance medical practice and improve patient outcome.
Member Companies can be engaged in or support different types of educational programs
but such activities must not constitute Promotion. These activities can be one of three types: 1)
Independent Medical Education i.e. conducted by an independent organisation and funded by
the industry; 2) programs that are developed in collaboration with another stakeholder; or 3)
pharmaceutical industry led LLH activities.
When funding Independent Medical Education or organizing LLH activities directly or incollaboration with third parties, Member Companies must ensure that their participation androle is clearly acknowledged and apparent from the outset.
LLH activities must have content that is fair, balanced and objective, designed to allow theexpression of diverse evidence-based science and fulfill unmet educational needs in healthcare.
This Article is complemented by a Guideline on a Quality Framework for LLH (Annex 3).
ARTICLE 17
INFORMATIONAL OR EDUCATIONAL MATERIALS AND ITEMS OF MEDICAL UTILITY
Section 17.01. The provision of Informational or Educational Materials is permitted provided
it is: (i) “inexpensive”; (ii) directly relevant to the practice of medicine or pharmacy; and (iii)
directly beneficial to the care of patients.
Section 17.02. Items of Medical Utility aimed directly at the education of HCPs and patient carecan be provided if they are “inexpensive” and do not offset routine business practices of those
who receive them.
Section 17.03. The nature of Informational or Educational Materials and Items of Medical Utility
considered may not constitute a circumvention of the prohibition on gifts defined under Article
11 of this Code. The transmission of such materials or items must not constitute an inducement
to recommend and/or prescribe, purchase, supply, sell or administer a Medicinal Product.
Section 17.04. Informational or Educational Materials and Items of Medical Utility can include
the Member Company name, but must not be product branded, unless the Medicinal Product’sname is essential for the correct use of the material or item by the patient.

23

ARTICLE 18 NON-INTERVENTIONAL STUDIES
Section 18.01. Non-Interventional Studies must be conducted with a primarily scientificpurpose and must not be disguised Promotion.
Section 18.02. Non-Interventional Studies that are prospective in nature and that involve thecollection of patient data from or on behalf of individual, or groups of, HCPs specifically for the
study must comply with all of the following criteria:
p There is a written study plan (observational plan/protocol);p In countries where ethics committees are prepared to review such studies, the study plan
must be submitted to the ethics committee for review;
p The study plan must be approved by the Member Company’s scientific service and the
conduct of the study must be supervised by the Member Company’s scientific service as
described in Section 20.01.a;
p The study results must be analysed by or on behalf of the contracting Member Company andsummaries thereof must be made available within a reasonable period of time to the Member
Company’s scientific service (as described in Section 20.01.a), which service must maintainrecords of such reports for a reasonable period of time. The Member Company must send
the summary report to all HCPs that participated in the study and must make the summary
report available to industry self-regulatory bodies and/or committees that are in charge ofsupervising or enforcing Applicable Codes upon their request. If the study shows results thatare important for the assessment of benefit-risk, the summary report must be immediately
forwarded to the relevant competent authority;9 andp Medical Sales Representatives may only be involved in an administrative capacity and such
involvement must be under the supervision of the Member Company’s scientific service
that will also ensure that the Medical Sales Representatives are adequately trained. Suchinvolvement must not be linked to the Promotion of any Medicinal Product.
Section 18.03. To the extent applicable, Member Companies are encouraged to comply with
Section 18.02 for all other types of NIS, including epidemiological studies and registries and otherstudies that are retrospective in nature. In any case, such studies are subject to Article 15.01.
ARTICLE 19 MEDICAL SAMPLES
Section 19.01. In principle, no Medical Samples should be given, except on an exceptional basis.
Medical Samples must not be given as an inducement to recommend and/or prescribe,purchase, supply, sell or administer specific Medicinal Products, and must not be given for thesole purpose of treating patients.
Medical Samples are provided to HCPs so that they may familiarise themselves with theMedicinal Product and acquire experience in dealing with them.
In accordance with national and/or EU laws and regulations, a limited number of Medical Samples
may be supplied on an exceptional basis and for a limited period. A reasonable interpretationof this provision is that each HCP should receive, per year, not more than 4 Medical Samples
9 - Member Companies are encouraged to publicly disclose the summary details and results of NIS in a manner that is
consistent with the parallel obligations with respect to clinical trials.

24

of a particular Medicinal Product he/she is qualified to prescribe for 2 years after the HCP first
requested samples of each particular Medicinal Product (i.e. the “4x2” standard).
In this context, a new Medicinal Product is a product for which a new marketing authorisation
has been granted, either following an initial marketing authorisation application or following
an extension application for new strengths/dosage forms that include a new indication.
Extensions of the marketing authorisation to additional strengths/dosage forms for existing indications
or pack sizes (number of units in the pack) cannot be considered as new Medicinal Product.
Without prejudice to the ban on medical sampling of Medicinal Product containing psychotropic
and narcotic substances, Medical Samples can only be given in response to a written requestfrom HCPs qualified to prescribe that particular Medicinal Product.
Written requests must be signed and dated by those who ask for the Medical Samples.
On an exceptional basis, Member Associations may allow, through additional guidance, alonger period than 2 years if required by local healthcare conditions.
Section 19.02. Member Companies must have adequate systems of control and accountability
for Medical Samples which they distribute and for all Medicinal Products handled by theirs
Medical Sales Representatives. This system must also clearly establish, for each HCP, the numberof Medical Samples supplied in application of the provisions in Section 19.01.
Section 19.03. Each Medical Sample must be no larger than the smallest presentation of thatparticular Medicinal Product in the relevant country.
Each Medical Sample must be marked “free medical sample – not for sale” or words to that
effect and must be accompanied by a copy of the summary of product characteristics.
ARTICLE 20 MEMBER COMPANY STAFF
Section 20.01. All Member Company staff must be fully conversant with the relevant
requirements of the Applicable Code(s) and laws and regulations.
p Each Member Company must establish a scientific service in charge of information about its
Medicinal Products and the approval and supervision of NIS. Member Companies are free todecide how best to establish such service(s) in accordance with this Section 20.01 (i.e. whether
there is one service in charge of both duties or separate services with clearly delineatedduties), taking into account their own resources and organisation. The scientific service must
include a medical doctor or, where appropriate, a pharmacist who will be responsible forapproving any promotional material before release. Such person must certify that he or she
has examined the final form of the promotional material and that in his or her belief it isin accordance with the requirements of the Applicable Code(s) and any relevant laws andregulations, is consistent with the summary of product characteristics and is a fair and truthfulpresentation of the facts about the Medicinal Product. In addition, the scientific service must
include a medical doctor or, where appropriate, a pharmacist, who will be responsible forthe oversight of any NIS (including the review of any responsibilities relating to such studies,particularly with respect to any responsibilities assumed by Medical Sales Representatives).
Such person must certify that he or she has examined the protocol relating to the NIS andthat in his or her belief it is in accordance with the requirements of the Applicable Code(s) andany relevant laws and regulations.

25p Each Member Company must appoint at least one senior employee who must be responsible
for supervising the Member Company and its subsidiaries to ensure that the standards of the
Applicable Code(s) are met.
Section 20.02. Each Member Company must ensure that its Medical Sales Representatives arefamiliar with the relevant requirements of the Applicable Code(s), and all applicable laws andregulations, and are adequately trained and have sufficient scientific knowledge to be able toprovide precise and complete information about the Medicinal Products they promote.
p Medical Sales Representatives must comply with all relevant requirements of the Applicable
Code(s), and all applicable laws and regulations, and Member Companies are responsible for
ensuring their compliance.
p Medical Sales Representatives must approach their duties responsibly and ethically.
p 
During each visit, and subject to applicable laws and regulations, Medical Sales
Representatives must give the persons visited, or have available for them, a summary of the
product characteristics for each Medicinal Product they present.
p Medical Sales Representatives must transmit to the scientific service of their companies
forthwith any information they receive in relation to the use of their company’s Medicinal
Products, particularly reports of side effects.
p Medical Sales Representatives must ensure that the frequency, timing and duration of visits
to HCPs, pharmacies, hospitals or other healthcare facilities, together with the manner inwhich they are made, do not cause inconvenience.
p Medical Sales Representatives must not use any inducement or subterfuge to gain aninterview. In an interview, or when seeking an appointment for an interview, Medical Sales
Representatives must, from the outset, take reasonable steps to ensure that they do not
mislead as to their identity or that of the Member Company they represent.

26

CHAPTER 4.
SPECIFIC REQUIREMENTS
FOR INTERACTIONS WITH POs
ARTICLE 21 INTERACTIONS WITH POs
Section 21.01. Member Companies must comply with the following principles that EFPIA,
together with pan-European POs, have subscribed to:p The independence of POs, in terms of their political judgement, policies and activities, must
be assured.
p A
 ll interactions between POs and Member Companies must be based on mutual respect, withthe views and decisions of each partner having equal value.
pM ember Companies must not request, nor shall POs undertake, the Promotion of a particular POM.
p The objectives and scope of any collaboration must be transparent. Financial and nonfinancial support provided by Member Companies must always be clearly acknowledged.
p Member Companies welcome broad funding of POs from multiple sources.
Section 21.02. EU and national laws and regulations prohibit the advertising of POM to thegeneral public.
Section 21.03. When Member Companies provide financial support, significant indirect
support and/or significant non-financial support to POs, they must have in place a writtenagreement. This must state the amount of funding and also the purpose (e.g. unrestricted grant,
specific meeting or publication, etc). It must also include a description of significant indirect
support (e.g. the donation of public relations agency´s time and the nature of its involvement)
and significant non-financial support.
Section 21.04. Member Companies must not influence the text of PO’s material they sponsor in amanner favourable to their own commercial interests. This does not preclude Member Companies
from correcting factual inaccuracies. In addition, at the request of POs, Member Companies may
contribute to the drafting of the text from a fair and balanced scientific perspective.

27

CHAPTER 5.
DISCLOSURE OF ToVs FROM MEMBERCOMPANIES
ARTICLE 22. DISCLOSURE OF ToVs TO HCPs, HCOs, AND POs
Section 22.01. Time of Disclosure
Disclosures must be made by each Member Company within 6 months after the end of therelevant Reporting Period and the information disclosed must be required to remain in the
public domain for a minimum of 3 years after the time such information is first disclosed unless,in each case, (i) a shorter period is required under applicable national laws or regulations, or (ii)the relevant data protection legal basis (e.g. the legitimate interest grounds, a legal duty or the
Recipient’s consent relating to a specific disclosure) is no longer applicable.
The common reporting period for publication of ToVs to Recipients is set during the time intervalfrom 20th to 30th June each year at the latest. Where a National Code provides a different timeinterval for its country, this must consistently apply to all disclosure obligations to Recipients.
ARTICLE 23. DISCLOSURE OF ToVs TO HCPs AND HCOs
Section 23.01. Rationale
The following article provides for disclosures of ToVs to HCPs and HCOs, whether directly or
indirectly. When deciding how a ToV must be disclosed, Member Companies should, wherever
possible, identify and publish at the individual HCP (rather than HCO) level, as long as this can beachieved with accuracy, consistency and in compliance with applicable laws and regulations.
Section 23.02. Implementation and deviations
This Article sets out the minimum standards which EFPIA considers must apply to all Member
Associations. All Member Associations must transpose this article into their National Codesin full, except where its provisions are in conflict with applicable national laws or regulations,in which case deviations are allowed, but only to the extent necessary to comply with suchnational law or regulation.
Where a Member Association has determined that this article cannot be implemented in full due
to national law or regulation, such Member Association will not be in breach of its obligations
under this article if such deviation is no broader than necessary to comply with such nationallaw or regulation and if it clearly documents the legal issues limiting the full implementation.
It is understood that if there is an inconsistency between this article and the applicable law or
regulation to which a Member Company is subject which would make adherence to this article
not reasonably possible, the Member Company must comply with such law or regulation andsuch lack of adherence will not constitute a breach of this article.
Section 23.03. Disclosure Obligation
General Obligation. Subject to the terms of this article, each Member Company must document
and disclose ToVs it makes, directly or indirectly, to or for the benefit of a Recipient, as describedin more detail in Article 23.05.

28

Excluded Disclosures. Without limitation, ToVs that (i) are solely related to over-the-counter
medicines; (ii) are not listed in Section 23.05 of this article, such as Items of Medical Utility(governed by Article 17), meals (governed by Article 10, especially Section 10.05), Medical
Samples (governed by Article 19); or (iii) are part of ordinary course purchases and sales ofMedicinal Products by and between a Member Company and a HCP (such as a pharmacist)or a HCO do not fall within the scope of the disclosure obligation described above in “General
Obligation”.
Section 23.04. Form of Disclosure
Annual Disclosure Cycle. Disclosures must be made on an annual basis and each Reporting
Period must cover a full calendar year.
Template. Subject to “Platform of Disclosure”, for consistency purposes, disclosures pursuant
to this article will be made using a structure set forth in Annex A for reference, reflecting therequirements of this article. Deviations from this template are only acceptable where legal
requirements justify that this article is not transposed in full – therefore, within a given country,
only one template must apply.
Platform of Disclosure. Disclosures can be made in either of the following ways, provided thatthey are unrestricted and publicly available:po n the relevant Member Company’s website in accordance with the section “Applicable
National Code”; orpo n a central platform, such as one provided by the relevant government, regulatory or
professional authority or body or a Member Association, provided that disclosures made on acentral platform developed at the initiative of Member Associations must be made, so far as
possible, using a structure set forth in Annex A for reference.
Applicable National Code. Disclosures must be made pursuant to the National Code of thecountry where the Recipient has its professional address. If a Member Company is not resident
or does not have a subsidiary or an affiliate in the country where the Recipient has its physicaladdress, the Member Company must disclose such ToV in a manner consistent with the relevant
National Code.
Language of Disclosure. Disclosures must be made in the language(s) prescribed in the
National Code by the relevant Member Association. Member Companies are encouraged tomake disclosures in English in addition to the mandatory disclosures in the local language (ifother than English).
Documentation and Retention of Records. Each Member Company must document all ToVs
required to be disclosed pursuant to Section 23.03 and maintain the relevant records of thedisclosures made under this article for a minimum of 5 years after the end of the relevant
Reporting Period, unless a shorter period is required under applicable national laws or
regulations.
Section 23.05. Individual and Aggregate Disclosure
Individual Disclosure. Except as expressly provided by this article, ToVs must be disclosed on an
individual basis. Each Member Company must disclose, on an individual basis for each clearly29

identifiable Recipient, the amounts attributable to ToVs to such Recipient in each Reporting
Period which can be reasonably allocated to one of the categories set out below. Such ToVs
may be aggregated on a category-by-category basis, provided that itemised disclosure must
be made available upon request to (i) the relevant Recipient, and/or (ii) the relevant authorities.
p For ToVs to a HCO, an amount related to any of the categories set forth below:
Donations and Grants. Donations and Grants to HCOs that support healthcare, including
donations and grants (either cash or benefits in kind) to institutions, organisations or
associations that are comprised of HCPs and/or that provide healthcare (governed by Article
12).
Contribution to costs related to Events. Contribution to costs related to Events, throughHCOs or Third Parties10, including support to HCPs to attend Events, such as:• Registration fees;• S ponsorship agreements with HCOs or with Third Parties appointed by an HCO to manage an
Event; and• Travel and accommodation (to the extent governed by Article 10).
Fees for Service and Consultancy. ToVs resulting from or related to contracts between
Member Companies and HCOs under which such HCOs provide any type of services to a
Member Company or any other type of funding not covered in the previous categories. Fees, on
the one hand, and on the other hand ToVs relating to expenses agreed in the written agreement
covering the activity will be disclosed as two separate amounts.
p For ToVs to a HCP:
Contribution to costs related to Events. Contribution to costs related to Events, such as:•R egistration fees; and• Travel and accommodation (to the extent governed by Article 10).
Fees for Service and Consultancy. ToVs resulting from or related to contracts between
Member Companies and HCPs under which such HCPs provide any type of services to a Member
Company or any other type of funding not covered in the previous categories. Fees, on the
one hand, and on the other hand ToVs relating to expenses agreed in the written agreement
covering the activity will be disclosed as two separate amounts.
Aggregate Disclosure. For ToVs where certain information, which can be otherwise reasonably
allocated to one of the categories set forth in Section 23.05, cannot be disclosed on an individual
basis for legal reasons, a Member Company must disclose the amounts attributable to such ToVsin each Reporting Period on an aggregate basis. Such aggregate disclosure must identify, for eachcategory, (i) the number of Recipients covered by such disclosure, on an absolute basis and as apercentage of all Recipients, and (ii) the aggregate amount attributable to ToVs to such Recipients.
Non duplication. Where a ToV required to be disclosed pursuant to Section 23.05 is made to anindividual HCP indirectly via a HCO, such ToV must only be required to be disclosed once. To theextent possible, such disclosure must be made on an individual HCP named basis pursuant to
Section 23.05.
10 - cf. Guidance of indirect ToVs through Third Parties – Support to/Sponsorship to Events through Professional Conference
Organisers in Annex B

30

Research and Development ToV. Research and Development ToVs in each Reporting Period
must be disclosed by each Member Company on an aggregate basis. Costs related to Events
that are clearly related to activities covered in this section can be included in the aggregate
amount under the “Research and Development Transfers of Value” category.
Methodology. Each Member Company must publish a note summarising the methodologies
used by it in preparing the disclosures and identifying ToVs for each category described in
Section 23.05. The note, including a general summary and/or country specific considerations,must describe the recognition methodologies applied, and should include the treatment ofmulti-year contracts, VAT and other tax aspects, currency aspects and other issues related to thetiming and amounts of ToVs for purposes of this article, as applicable.
ARTICLE 24. DISCLOSURE OF SUPPORT AND SERVICES PROVIDED TO POs
Each Member Company must disclose a list of POs to which it provides financial support and/or
significant indirect/non-financial support or with whom it has engaged to provide contracted
services for that Member Company.
This disclosure must include a description of the nature of the support or services provided thatis sufficiently complete to enable the average reader to form an understanding of the natureof the support or the arrangement without the necessity to divulge confidential information.
In addition to the name of the PO, the following elements must be included:p For support:• the monetary value of financial support and of invoiced costs.
• t he non-monetary benefit that the PO receives when the non-financial support cannot be
assigned to a meaningful monetary value.
p For contracted services: the total amount paid per PO over the Reporting Period.
This information must be disclosed on the Member Company website either on a national or
European level on an annual basis and each Reporting Period shall cover a full calendar year.
Methodology. Each Member Company must publish the methodologies used by it in preparing
the disclosures and identifying supports and services provided.

31 HAPTER 6.
C
PROCEDURAL REQUIREMENTS
ARTICLE 25. ENFORCEMENT
Section 25.01. Enforcement through Member Associations
Member Associations must, within current applicable laws and regulations enforce theprovisions of the EFPIA Code. In the event that a breach is established pursuant to theprocedures of its National Code, each Member Association shall require from the offending
company an immediate cessation of the offending activity and a signed undertaking by thecompany to prevent recurrence.
Each Member Association shall adopt Implementation and Procedure Rules (as set forth inmore detail in Article 28), which will be binding upon its members, and set forth the framework
for the implementation of this Code, the processing of complaints and the enforcement ofsanctions in a manner consistent with applicable data protection, competition and other laws
and regulations.
Section 25.02. Disclosure Requirements Different from those established in Article 23
This article sets out the minimum standards applicable to Member Associations, except where
it is in conflict with applicable national law or regulation, in which case deviations are allowed,
but only to the extent necessary to comply with such national law or regulation. Any provisions
contained in National Codes that embody higher standards than those of this article shall not
be deemed to constitute deviations from this article.
Any proposal to transpose Article 23 into a National Code, or to amend any provisiontransposing that article, that requires disclosures different from those required under thisarticle, shall be clearly and conspicuously so identified in the relevant Member Association’s
consultative process and any materials relating to such proposal. In such case, the EFPIA Board
shall be asked to confirm consistency with this article, following an EFPIA Board’s decision after
consultation with the EFPIA Codes Committee. Member Companies abiding by such National
Codes as confirmed by the EFPIA Board shall not be considered to have failed to meet their
obligations under this article.
If the applicable national law or regulation, the relevant national code or other industry selfregulation prescribes equivalent or more stringent disclosure requirements, the relevant
Member Company shall comply with such equivalent or more stringent requirements in amanner as consistent as possible with the substantive disclosure requirements of Article 23.
ARTICLE 26. AMENDMENTS TO, AND GUIDANCE REGARDING COMPLIANCE WITH,
THE EFPIA CODE
Section 26.01. Code Compliance
The EFPIA Codes Committee shall assist Member Associations to comply with their obligations
under this Code. The key tasks of the Committee are set forth in Article 28.

32Section 26.02. Amendments to the EFPIA CodeThe EFPIA Codes Committee shall regularly review this Code and any guidance issued regarding
compliance with this Code.
Any proposed amendments to the EFPIA Code will be submitted to the EFPIA Board for adecision and to the EFPIA General Assembly for ratification. Proposed amendments to thisEFPIA Code shall be reviewed by the Codes Committee following consultation with EFPIA
members and the relevant EFPIA committees.
ARTICLE 27. AWARENESS AND EDUCATION
Member Associations must, within current applicable laws and regulations facilitate companies’
awareness of and education about the EFPIA Code, including by providing guidance tocompanies in order to prevent breaches of the National Codes. Member Associations areencouraged to share their respective interpretations of the EFPIA Code through the regularmeetings organised by EFPIA (see Section 28.02) and through IFPMA.
ARTICLE 28. IMPLEMENTATION AND PROCEDURE RULES
The Implementation and Procedure Rules set forth herein establish the framework forthe implementation of the EFPIA Code, the processing of complaints and the initiation oradministration of sanctions by Member Associations.
Section 28.01. Member Association Implementation
Each Member Association is required to:p  Establish national procedures and structures to receive and process complaints, to determine
sanctions and to publish appropriate details regarding the same including, at a minimum,a national body of the Member Association that is designated to handle complaints andconsists of a non-industry chair and, besides any industry members, membership from otherstakeholders;p  Ensure that its National Code, together with its administrative procedures and other relevant
information, are easily accessible through, at a minimum, publication of its National Code on
its website; andp  Prepare, and provide to the EFPIA Codes Committee (defined below), an annual reportsummarizing the work undertaken by it in connection with the implementation, development
and enforcement of its National Code during the year.
Section 28.02. EFPIA Codes Committee Implementation and Key Tasks
The EFPIA Codes Committee must assist Member Associations to comply with their obligations
under Section 28.01 above.
p  The EFPIA Codes Committee is composed of all the national body secretaries, who will elect achair person among their peers, assisted by one person from the EFPIA staff.
p  As a key part of its role of assisting Member Associations in their National Code complianceactivities, the EFPIA Codes Committee must monitor the adoption of compliant National
Codes. The EFPIA Codes Committee will not participate in the adjudication of any individualcomplaint under any National Code.
33p  In order to promote the EFPIA Code and to share best practice, the EFPIA Codes Committee
must, at least annually, invite Member Associations and Member Companies representatives
to participate in a meeting at which the participants are encouraged to share their respective
relevant experiences relating to the EFPIA Code. Any conclusions from the meeting must besummarised in the annual code report (referred to under (e) below) and, if appropriate, bepresented to the EFPIA Board.
p  The EFPIA Codes Committee must publish an annual code report which summarizes thework and operations which have taken place in connection with the implementation,
development and enforcement of the various National Codes during the applicable year,
based on the country reports provided by the Member Associations pursuant to (c) above(such report shall be produced by 31 March, which date is prior to the General Assembly so
as to allow sufficient time to remedy inadequate or incomplete transposition by any Member
Association).
p  On an annual basis, the EFPIA Codes Committee must: (i) advise the EFPIA Board of its workand operations and the work and operations of the Member Associations, as summarized in
the Member Association annual reports; and (ii) review with the EFPIA Board any additional
recommendations to improve the EFPIA Code with a view towards increasing transparency
and openness within the pharmaceutical industry and among Member Associations andMember Companies.
Section 28.03. Reception of Complaints
Complaints may be lodged either with a Member Association or with EFPIA. Adjudication ofcomplaints must be a matter solely for the Member Associations.
Complaints received by EFPIA must be processed as follows:p  EFPIA must forward any complaints it receives (without considering their admissibility orcommenting upon them) to the relevant Member Association(s).
p  EFPIA must send an acknowledgement of receipt to the complainant, indicating the relevant
Member Association(s) to which the complaint has been sent for processing and decision.
p  In addition, upon receipt by EFPIA of multiple external complaints (i.e. several complaints on
the same or similar subjects lodged from outside the industry against several subsidiaries ofa single company), EFPIA must communicate these complaints to the Member Association
either of the parent company or of the EU subsidiary designated by the parent company.
Section 28.04. Processing of Complaints and Sanctions by Member Associations
p  Member Associations must ensure that all complaints, whether originating from within
the industry or not, are processed in the same manner, without regard to the origin of thecomplaint.
p C omplaints must be processed at national level through the procedures and structures
established by the Member Associations pursuant to Section 28.01. Each Member Association’s
national body must take decisions and pronounce any sanctions on the basis of the National
Code in force in its country.
p  Each Member Association must include in its National Code provisions governing theimposition of sanctions for violations of its National Code. Sanctions must be proportionate to
the nature of the infringement, have a deterrent effect and take account of repeated offencesof a similar nature or patterns of different offences. A combination of publication and fines is34generally considered to be the most effective sanction; however, each Member Association
may use any other appropriate sanction to enforce its National Code. Each Member
Association should consider any applicable legal, regulatory or fiscal requirements which
would affect the nature or extent of sanctions which may be imposed. Where publication orfines are not permitted due to applicable legal, regulatory or fiscal requirements, Member
Associations should impose the most effective alternative sanction.
p  Where a complaint fails to establish a prima facie case for a violation of an Applicable Code,such complaint shall be dismissed with respect to that National Code. Member Associations
may also provide that any complaint which pursues an entirely or predominantly commercial
interest shall be dismissed.
p E ach Member Association should establish effective procedures for appeals against the initialdecisions made by its national body. Such procedures and appeals should also take place atnational level.
p  National bodies shall ensure that any final decision taken in an individual case shall be
published in its entirety or, where only selected details are published, in a level of detail thatreflects the seriousness and/or recurrence of the breach as follows:• in cases of a serious/repeated breach, the company name(s) should be published together
with details of the case;• in cases of a minor breach, or where there is no breach, publication of the details of the casemay exclude the company name(s).
p  Member Associations or national bodies are encouraged to publish summaries in English
of cases that have precedential value and are of international interest (keeping in mind thatcases resulting in the finding of a breach as well as those where no breach is found to haveoccurred may each have such value and/or interest).
The process used by EFPIA is set out in a standard operating procedure (Annex D).

35

36

HCPs

HCOs

R&D

Country of Principal
Practice

Principal Practice
Address

Unique country
identifier OPTIONAL

Donations andGrants to HCOs
Sponsorshipagreements with
HCOs / third parties
appointed by HCOs
to manage an Event
Registration Fees

Travel &Accommodation

Contribution to costs of Events

Fees

Related expenses
agreed in the fee forservice orconsultancy
contract, including
travel &accommodation
relevant to thecontract

Fee for service and consultancy

N/A

etc.

N/A

N/A

N/A
Yearly amount

Yearly amount

Yearly amount
Yearly amount

Yearly amount

Yearly amount
Yearly amount

Yearly amount

Yearly amount

N/A% of the number of Recipients included in the aggreate disclosure in the total number, by category, ofRecipients disclosed
N/A

N/A

N/A

%

numberAggregate HCPs%

numberAggregate HCPs%

numberAggregate HCPs%

numberAggregate HCPs

Yearly amount

Yearly amount

Yearly amount

Yearly amountetc.

latest update: 27 June 2019Yearly amount

Yearly amount

Yearly amount

Yearly amount

Yearly amount

Yearly amount%number%numberAggregate HCOs%

numberAggregate HCOs

AGGREGATE DISCLOSURE

Aggregate HCOs

Transfers of Value re Research & Development as defined in the EFPIA Code of Practice% of the number of Recipients included in the aggreate disclosure in the total number, by category, ofRecipients disclosed

Number of Recipients in aggregate disclosure

Aggregate amount attributable to transfers of value to such Recipients

Yearly amountHCO 2

Yearly amount

Yearly amount

Yearly amount

Yearly amount

Yearly amount

Yearly amount%numberAggregate HCOs%

numberAggregate HCOs

OTHER, NOT INCLUDED ABOVE - where information cannot be disclosed on an individual basis for legal reasonsYearly amount

HCO 1

%

numberAggregate HCOs

Yearly amount

Yearly amount

Yearly amount

TOTAL AMOUNTINDIVIDUAL NAMED DISCLOSURE - one line per HCO (i.e. all transfers of value during a year for an individual HCO will be summed up: itemization should be available for the individual Recipient or public authorities' consultation only, as appropriate)

N/A

N/A

Number of Recipients in aggregate disclosure

Aggregate amount attributable to transfers of value to such Recipients

N/A

OTHER, NOT INCLUDED ABOVE - where information cannot be disclosed on an individual basis for legal reasons

N/A

Dr B

OPTIONAL

N/A

Optional

Optional

Optional

Optional

Optional

N/A

Optional

OptionalTOTAL
OPTIONAL

Date of publication: ………………..

INDIVIDUAL NAMED DISCLOSURE - one line per HCP (i.e. all transfers of value during a year for an individual HCP will be summed up: itemization should be available for the individual Recipient or public authorities' consultation only, as appropriate)

HCPs: City of
Principal Practice
HCOs: city whereregistered

Dr A

Full Name

ANNEX A - STANDARDISED DISCLOSURE TEMPLATE

ANNEX A (binding)Standardised disclosure template

ANNEX B (binding)
EFPIA guidance
GUIDANCE ON DISCLOSURE OF NON-INTERVENTIONAL STUDIES
BackgroundIn application of the EFPIA HCP/HCO Disclosure Code to exemption on individual reportingof ToVs relating to non-interventional studies (NIS) is limited to NIS that are prospective innature. The Code prescribes that retrospective NIS must be reported on an individual names
basis, in line with applicable codes.
Member Companies informed EFPIA that it was not always possible to distinguish ToVs relating
to prospective (included in the aggregated reporting of R&D ToVs) and retrospective (to bereported on an individual basis) NIS.
The Ethics & Compliance Committee (E&CC) had considered that definitions in the new EU Clinical
Trials Regulation 536/201411 could be used for reference when implementing the Disclosure
requirements, thus anticipating and align with the regulatory change that will eventually takeplace.
On 13th June 2017, EFPIA Board approved the Guidance on disclosure of all NIS on an individual
basis in case ToVs relating prospective and retrospective non-interventional studies cannot be
distinguished.
This Guidance provides a basis for distinguishing between prospective versus
retrospective NIS and aims at ensuring consistency in reporting of ToVs relating to NIS.
Relevant EFPIA Disclosure Code provision
Schedule 1: Definition of Terms
Research and Development Transfers of Value – Transfers of Value to HCPs or HCOs related to theplanning or conduct of (i) non-clinical studies (as defined in OECD Principles on Good Laboratory
Practice); (ii) clinical trials (as defined in Regulation N° 536/201412); or (iii) non-interventional
studies that are prospective in nature and that involve the collection of patient data from or on
behalf of individual, or groups of, HCPs specifically for the study (Section 15.01 of the HCP Code).
Guidance

11 - Application date of the new Clinical Trials Regulation 536/2014 is dependent on the development of the IT system “ EU
Clinical Trial Portal and Database”. At the moment, the “go-live date” is expected in second half of 2019. The effective
implementation date of the Regulation will not change definitions, these definitions are considered as an appropriate
reference for consistent implementation of provisions relating to the disclosure of ToVs relating to NIS.
12 - In the EFPIA HCP/HCO Disclosure Code, the definition of R&D ToVs refers to EU Directive 2001/20/EC on Clinical Trials.
This legal instrument is replaced by EU Regulation N°536/2014. The definition under the EFPIA HCP/HCO Disclosure
will refer to the update regulatory provisions.

37

Transfers of Value relating to non-interventional studies (NIS) that are not within the definitionof R&D ToVs under the EFPIA Disclosure Code must be reported on an individually named basis.
In this regard, prospective versus retrospective NIS will be considered following classificationin the table below:

PROSPECTIVE NISRETROSPECTIVE NISProspective cohort studies in which
the prescription of the medicine isindependent from the inclusionof the patient in the study

Purely observational database review
and/or research
Retrospective review of records where
all the events of interest have alreadyhappenedp e.g. case-control, cross-sectional, andpurely retrospective cohort studies

A retrospective study to which aprospective element is subsequently
introduced
Long-term extension studies with patient
follow up beyond trial protocol specified
time for observation and active collectionof additional data

Studies in which the prescriber later
becomes an
Investigator, but prescribing has alreadyoccurredp e .g. retrospective data collection fromindividual medical records at the site of
the investigator

For sake of clarity, activities not falling within the definition of R&D ToVs, including NIS that are notconducted to maintain a marketing authorisation (in application and following definitions of the“Clinical Trials” Regulation 536/2014), will be disclosed under “consultancy/fee-for-services”.
Member Companies are encouraged to include a comment in the Methodological Note, whereappropriate.
This Guidance will apply at the latest to 2018’s ToVs (reported in 2019).

38

DISCLOSURE OF INDIRECT TRANSFERS OF VALUES (ToVs) THROUGH THIRD PARTIESSUPPORT TO / SPONSORSHIP TO EVENTS THROUGH PROFESSIONAL CONFERENCE ORGANISERS (PCOS)
Background
Third parties13 provide support to Member Companies in a variety of capacities, impacting
more or less on the conduct of activities regulated by the EFPIA Code. Such activities would bereported as indirect Transfers of Values (ToVs) following provisions of the EFPIA Disclosure
Code. When Member Companies provide support / sponsorship to PCOs involved in theorganisation of scientific Events, it is understood that the Member Companies’ intention is toprovide support to HCPs/HCOs at arm’s length.
Indirect ToVs are those made on behalf of a Member Company for the benefit of a Recipient, or
ToVs through an intermediate and where the Member Company knows or can identify the HCP/HCO that will benefit from the ToV14.
In consideration of the multiple ways collaboration with third parties can be contracted, it
may not be straightforward to report in application of the EFPIA Disclosure Code in full. As thismay lead to underreporting of ToVs through third parties, further Guidance aims at providing
a consistent approach towards improved reporting wherever possible in compliance withapplicable law and regulations.
This Guidance clarifies reporting of Indirect ToVs to HCOs made through Professional
Congress Organiser (PCOs15).
In consideration of legal issues that may arise in the reporting of ToVs through Distributors onbehalf of a Member Company, reporting of such ToVs are not within scope of this Guidance.
Where appropriate, EFPIA may consider further Guidance for this category of (and othercategories of third parties involved in) ToVs.
Relevant EFPIA Disclosure Code provision
Section 3.01.1.bContribution to costs related to Events, through HCOs or third parties, including
sponsorship to HCPs to attend Events, must be disclosed individually under the name of theRecipient; such costs may relate to:pR egistration fees;p S ponsorship agreements with HCOs or with third parties appointed by an HCO to manage
an Event; andp Travel and accommodation (to the extent governed by Article 10 of the EFPIA HCP Code).

13 - Third parties are entities or individuals that represent a company in the market place or interact with other third parties
on behalf of a company or relating to the company’s product. Among others, these thirds parties can be distributors,
travel agents, consultants, contract research organisations. This Guidance applies to PCOs as third parties involved
in Events involving HCOs.
14 - Definition of an indirect ToV in EFPIA’s HCP/HCO Disclosure Code Schedule 1
15 - A PCO is a company/individual specialised in the organisation and management of congresses, conferences, seminars
and similar events (all “Events”). For the application of this Guidance, commercial companies involved in organisationof travel (travel agencies) or accommodation (hotels, banqueting functions in hotels, etc.) are not considered PCOs.

39

Schedule 1: Definitions
Indirect transfers of value are those made on behalf of a Member Company for the benefitof a Recipient, or transfers of value made through an intermediate and where the Member
Company knows or can identify the HCP/HCO that will benefit from the Transfer of Value.
Guidance
Contributions provided to Events through PCOs – that would therefore be the Recipient of theToVs – must be considered as indirect ToVs.
When a Member Company contributes to the costs related to Events through PCOs, thefollowing reporting approaches are considered compliant with EFPIA reporting requirements:pA
 ll ToVs to an HCO (either as Recipient or as Beneficiary) are reported in the relevant category
under the name of the HCO
p ToVs through PCOs are reported:•e ither in the name of benefitting HCO (through include the name of Recipient PCO), if notincluded in direct ToVs to the HCO;•o
 r in the name of Recipient PCO (to the benefit of include the name of benefitting HCO)
This Guidance applies whether PCOs organise Events on their own initiative, or at the requestof an HCO.
For further clarification, the attached table reviews scenarios of support / sponsorship to Events
through PCOs that may help in preparation of reporting according to this Guidance.
For good order, it is reminded that contribution to costs related to Events paid through third
parties to the benefit of individual HCPs that the Member Company knows, must be reported
on an individually named basis, as Indirect ToVs to HCPs.
Further recommendation
EFPIA recommend that Member Companies confirm support / sponsorship to Events throughPCOs in written agreements, and encourage them to include provisions relating to informationthat the PCOs must communicate to the Member Company to allow appropriate reporting of
ToVs following the EFPIA Disclosure Code.
The Member Companies are encouraged to describe the process followed to collect the
information in their Methodological Note, where it must also be stated that the full value ToVs
to the PCO will not constitute a benefit (in cash or in kind) to the HCO as the PCO may retain a“service fee”.
Additional Guidance adopted at national level or requested by national legal requirements may
complement this EFPIA Guidance (for such cases, Article 4.03 of EFPIA Disclosure Code applies).
This Guidance will apply at the latest to 2018’s ToVs (reported in 2019).

40

Additional Guidance on ToVs through PCOs
SUPPORT TO / SPONSORSHIP TO EVENTS THROUGH PROFESSIONAL CONFERENCE ORGANISERS (PCOS)
For further clarification, the table below reviews scenarios of support / sponsorship to Events
through PCOs, which may help in preparation of reporting according to this EFPIA Guidance.
Examples of possible scenarios in support of Events
These examples are offered to help Member Companies when preparing their disclosure
reports in the perspective of optimal reporting of Events which they sponsor / support

RECIPIENTPCO RECEIVING THE
TOVS

BENEFICIARYHCP/HCO BENEFITTINGDISCLOSURE

PCO on behalf of / incollaboration with a HCO

where the Member
Company knows the HCP/HCO benefitting

Individual disclosure
following guidance

PCO on behalf of / incollaboration with HCO

where the Member Company
does not known the HCP/HCO benefitting

Whilst disclosure on an
individual HCP/HCO named
basis, the Member Company
may consider disclosing under
the PCOs name with indicationof the specialty area

PCO with HCO ScientificCommittee

HCO(s) is (are) known
to the Member Company

Individual disclosure
following guidance

PCO with HCP ScientificCommittee

HCP(s) is (are) known
to the Member Company

Individual disclosure
following relevant EFPIAHCP/HCO Disclosure Codeprovisions

PCO developing /organising an Eventat its own initiative(independent event)where the Member
Company knows the HCP/HCO participating in the
Event

Individual disclosure
following guidance

PCO developing /organising an Event at its
own initiative (independent
event)

where the Member Company
does not know the HCP/HCO
participating in the Event

Whilst disclosure on an
individual HCP/HCO named
basis, the Member Company
may consider disclosing under
the PCOs name with indicationof the specialty area

Disclosures on an individual names basis are subject to appropriate consent; where such­consent cannot be secured, related ToVs will be disclosure in aggregate.

41

ANNEX C (binding)
Guidance obligations for Member Associations under the EFPIA Code
Member Companies must comply with any relevant guidance provided under this Annex or inconnection with any Applicable Code(s).
Article 10 Events and hospitality
Member Association must set a monetary threshold in its National Code, failing which EFPIA
will set such threshold in lieu of such Member Association.
Member Associations must provide guidance on the meaning of the term “reasonable”, as usedin the Article 10. Member Associations must also provide guidance on “appropriate”, “renowned”
and “extravagant” Venues, as used in the Article 10.
Article 17 Informational or Educational Materials and Items of Medical Utility
Member Associations must provide guidance on the meaning of the term “inexpensive”, asused in Article 17.

42

ANNEX D (binding)
EFPIA standard operating procedure related to processing of complaints andquestions submitted to EFPIA
IMPLEMENTATION & ENFORCEMENT OF CODES
Background
Organisations that are members of EFPIA – be it full or affiliate member, or member of a specialised
group, sign-off on Principles laid out in the EFPIA Charter. The Board may consider that non-compliancewith the EFPIA Principles jeopardises the attainment of the aims pursued by EFPIA, and may therefore
decide to exclude organisations that impede EFPIA’s general policy following the provisions laid downin the Statutes.
Under Principle 4, EFPIA members are required to implement high and transparent standards ofconduct in dealings with external stakeholders, including abiding by the rules of EFPIA including rules
laid down in the EFPIA Code.
In line with applicable codes, implementation and enforcement (including handling of complaints) is
entrusted to national disciplinary bodies. EFPIA’s role – with the support of the Codes Committee– is to ensure consistent implementation of the Codes.
The EFPIA Code provide for implementation and procedural rules for the processing of complaints
submitted under applicable codes in line with the EFPIA requirements, including:p t he EFPIA’s “Code of Practice on the Promotion of Medicines and Relationships with Healthcare
Professionals” (HCP Code);p t he “EFPIA Code on Relationships between the Pharmaceutical Industry and Patient Organisations”(PO Code); andp t he “EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare
Professionals and Healthcare Organisations” (Disclosure Code).
Under these Rules each member association is required to:pE stablish national procedures and structures to receive and process complaints, to determine
sanctions and to publish appropriate details regarding the same including, at a minimum, a national
body of the member association that is designated to handle complaints and consists of a nonindustry chair and, besides any industry members, membership from other stakeholders;p E nsure that its national code, together with its administrative procedures and other relevant
information, are easily accessible through, at a minimum, publication of its national code on its
website; andpP
 repare, and provide to the EFPIA Codes Committee, an annual report summarizing the work
undertaken by it in connection with the implementation, development and enforcement of its
national code during the year.

43This Standard Operating Procedure (SOP) clarifies processes for the follow-up ofcomplaints / questions submitted to EFPIA.
This SOP does not cover the process that should ensure that the EFPIA Code is transposed
into national codes, in line with national laws and regulations. This task is entrusted to theCodes Committee that reports yearly to the Board on issues arising from the transposition,
implementation and enforcement of applicable codes.
Relevant EFPIA Code Provision
The “Implementation and Procedure Rules” set forth in the EFPIA Code establish theframework for the implementation of Codes, the processing of complaints and the initiation oradministration of sanctions by member associations.
ANNEX A to the EFPIA Code is attached for reference.
STANDARD OPERATING PROCEDURES (SOP)
Enforcement and adjudication of complaints is been entrusted to Member Associations,
EFPIA’s role is to ensure consistent implementation of the EFPIA Code.
Complaints may be lodged either with a Member Association or with EFPIA. Adjudication ofcomplaints shall be a matter solely for the national associations.
The EFPIA Director General will appoint a Compliance Officer within the EFPIA Staff, who will
be mandated to ensure processes are followed and prepare responses to questions submitted
to EFPIA. In line with the EFPIA Code, the Compliance Officer will prepare recommendations to
the Board in collaboration with the Codes Committee.
The following sections establish procedural steps for matters that may arise when EFPIA is
involved in enforcement of codes. These procedural steps are to be read in conjunction with
the EFPIA Code, particularly the “Applicability of Codes” section and the responsibilities on
Member Associations for the “Implementation and Procedure Rules”.
Common procedure rules
Each attendee of an EFPIA meeting where matters covered by this SOP are to be considered,should ensure that relevant interests are disclosed to EFPIA before such a meeting.

44

A. COMPLAINTS16 RECEIVED BY EFPIA
Section 3 of the “Implementation & Procedural Rules” further provides that complaints
received by EFPIA shall be processed as follows:p  EFPIA will forward any complaints it receives (without considering their admissibility orcommenting upon them) to the relevant member association(s).
p E FPIA will send an acknowledgement of receipt to the complainant, indicating the relevant
national association(s) to which the complaint has been sent for processing and decision.
p I n addition, upon receipt by EFPIA of multiple external complaints (i.e. several complaints
onthe same or similar subjects lodged from outside the industry against several subsidiaries
of a single company), EFPIA will communicate these complaints to the national association
either of the parent company or of the EU subsidiary designated by the parent company.
Procedural Stepsp When a complaint is received by EFPIA, the Compliance Officer forwards it, within 10 working
days, to the relevant Member Association(s) for action under the Member Association(s)’sprocedure for dealing with complaints, and the complainant will be informed of which
Member Association(s) are responsible for dealing with the complaint;p S imultaneously, the Compliance Officer will inform, in writing, the responsible senior
employee17 of the company(ies) against which the complaint is made. If the complaint
involves a number of countries, EFPIA will forward the complaint to the Member Associationof the parent company and to the relevant company’s subsidiary(ies);p The Member Association(s) must acknowledge receipt of the complaint from EFPIA within 30
days following EFPIA’s communication;p The Member Association(s) should consider the complaint under its usual procedure,
including timelines. During the adjudication period, EFPIA will not intervene, neither will it
answer questions neither from the complainant nor from the Member Company(ies) involvedin the case;p When the Member Association(s) has(ve) completed its(their) consideration of the matter,
EFPIA must be so informed of the decision(s) made by the adjudication bodies, including,where appropriate, the sanction imposed. The Member Association(s) should provide updates
to EFPIA as the matter proceeds no later than 6 months after it receipt of the complaint, andsubsequently within each following quarter until a final decision is made on the compliant(within a reasonable timeframe);pA summary of decisions made on cases submitted to EFPIA will be published in EFPIA’s Codes
Activity Report – once the complaint has been concluded, the learnings might lead to further
discussion by the Codes Committee including enhancing code consistent implementation,
where relevant.

16 - EFPIA will consider as a complaint any concerns raised about an EFPIA Member Company for materials or activities
related to the EFPIA Code’s implementation and/or enforcement.
17 - Each Member Company must appoint at least one senior employee who shall be responsible for supervising thecompany and its subsidiaries to ensure that the standards of the Applicable Code(s) are met. See EFPIA Charter andSection 18.02 of the EFPIA HCP Code45

Throughout the complaint procedure (from receipt of the complaint at EFPIA to decision of
the competent adjudication bodies), EFPIA will not communicate with parties involved in thecomplaint within the limits of its involvement set out in the EFPIA Code and following theprocedural steps described in this SOP. In this context, communications within EFPIA will belimited to General Counsel and Compliance Officer; the Director General will be involved to theextent justified by the complaint.
B. MEMBER COMPANY REFUSING TO SUBMIT TO DECISIONS OF A NATIONAL CODEAUTHORITY
The “Applicability of Code” section in the EFPIA Code makes it clear that Member Companies
must comply with any applicable codes and any laws and regulations to which they are subject.
EFPIA member companies must:p E ither be a member of the Member Association in each country where it conducts activities
covered by the EFPIA Code (either directly or through the relevant subsidiary);pO r agree in writing with each such Member Association that it (or its relevant subsidiary) isbound by such Member Association’s code (including any applicable sanctions that may be
imposed thereafter).
There may be occasions where a Member Association is not able to achieve resolution of acomplaint concerning an EFPIA Member Company, for example, if that Member Company does
not accept a ruling or follow the agreed process. In such circumstances, EFPIA will need to be
informed and to decide what action should be taken bearing in mind the obligations of EFPIA
membership.
EFPIA will not consider the merits of the case – this is the role of the Member Associations.
The role of EFPIA is in relation to whether the Member Company is meeting its membership
obligations, and – where appropriate – to provide further clarification on interpretation of
the EFPIA Code, which will always need to be considered in conjunction with national laws,
regulation and codes.
Procedural Stepsp When a Member Association, following completion of the adjudication of a complaint
is unable to achieve resolution of a complaint concerning a EFPIA Member Company, theAssociation will inform EFPIA, indicating the reasons18 why it cannot achieve resolution of thecomplaint;p Within 10 working days of notification of the issue, EFPIA’s Compliance Officer will inform,in writing, the responsible senior employee19 of the Member Company concerned with theMember Association’s request for EFPIA’s intervention;

18 - For example: the Member Company concerned might not be a member of the Member Association in that country; orit might not accept a decision of that Member Association.
19 - Each Member Company must appoint at least one senior employee who shall be responsible for supervising thecompany and its subsidiaries to ensure that the standards of the Applicable Code(s) are met. See EFPIA Charter andSection 18.02 of the EFPIA HCP Code.

46

pB
 ased on the respondent Member Company’s comments (that should be provided to EFPIA
within 30 days of EFPIA’s request), EFPIA’s Compliance Officer will consult with the Codes
Committee Chairs to agree on follow-up actions that could be recommended. These actions
could be to report to the Codes Committee and/or to EFPIA Board. The Codes Committee
Chairs should agree on these actions within 60 days;pN
 o later than 120 days following the Member Association’s initial information, EFPIA will
inform the Member Company of steps that it is expected to take in accordance with its EFPIA
membership obligations;p Within 30 days, the Member Company should inform EFPIA of follow-up actions put in place,and the Member Association will confirm with EFPIA that the issue has been settled;p I f no response is received from the Member Company or the response is not adequate,
EFPIA will take the opinion of the Codes Committee on next steps to be taken. The Codes
Committee could decide on further action, such as reporting the matter to the EFPIA Board
that will decide on the recommended action that should be agreed.
C. MEMBER COMPANY NOT SUBMITTED TO APPLICABLE CODES
Member Companies that are not within the membership of EFPIA’s Member Associations incountries where they operate are expected to formalise their submission to applicable national
codes, including the sanction system.
Member Associations must ensure that the arrangements for application of national codes
cover any EFPIA Member Company when such company is not a member of the national
Member Association. Each Member Association must have a process to allow non-membersof that Member Association to agree to comply with their national code and to accept thejurisdiction of that Member Association’s adjudication body. However, Member Associations
must not oblige the EFPIA Member Company becoming a member of the Member Association.
The arrangements and conditions should be clear and transparent.
Scope and Applicability of EFPIA CodeThe EFPIA Code applies to activities relating to prescription-only medicines (POM) (whether
patented or off-patent, branded or generics). This is similar to the scope of the EU Pharma
Regulation20. The Code is applicable to all activities relating to POM and relationships with
Healthcare Professionals, Healthcare Organisations and Patient Organisations (as definedin the Code, and excluding commercial activities).
When joining EFPIA’s membership, a corporation commits to obligations described in the EFPIA
Charter, including inter alia:
p I mplement high and transparent standards of conduct in dealings with external
stakeholders, including:• Abiding by the rules of EFPIA including rules laid down in the EFPIA Code20 - DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community
code relating to medicinal products for human use.

47• Signing-off the national self-regulatory codes in all the countries where the Member
Company operates, and confirm that it is bound by such member association’s code(including any applicable sanctions that may be imposed there under);• E ach Member Company must appoint at least one senior employee who shall be
responsible for supervising the company and its subsidiaries to ensure that the standardsof the Applicable Code(s) are met.
For application of the EFPIA Code, the term “company” shall mean any legal entity that organises
or sponsors promotion, or engages in interactions with healthcare professionals covered by an
Applicable Code, which takes place within Europe, whether such entity be a parent company(e.g. the headquarters, principal office, or controlling company of a commercial enterprise),subsidiary company or any other form of enterprise or organisation.21
To ensure EFPIA Code’s applicability, implementation and enforcement is conducted in aconsistent manner, EFPIA – with the support of Member Associations – will continue to regularly
monitor Member Companies’ commitments to applicable national codes.
Procedural Stepsp When actions undertaken by a Member Association aiming at ensuring that an EFPIA
Member Company is subject to that Member Association’s national code are unsuccessful,
the Member Association will inform EFPIA, in writing, providing details of its actions and theMember Company’s response;p EFPIA will intervene directly when an EFPIA Member Company does not submit to thenational applicable codes and require that the Member Company formalises its adherence
to national applicable codes including their adjudication arrangements within 2 months of
EFPIA’s request;
p I f the EFPIA Member Company still does not agree to respond to EFPIA’s request to confirm
its adherence to applicable national codes (including submission to the national sanction
system), the Board will be informed;pA
 s part of its yearly review of code activities, the Codes Committee will provide an update on
the status of EFPIA Member Companies and their obligations under the EFPIA Code. Where
the Codes Committee establishes a pattern of non-adherence – i.e. a Member Company has
not agreed to be subject to national applicable codes in more than one country, or countries
where a majority of EFPIA Member Companies are not subject to the Member Association’scode – the Codes Committee will make proposals to address the situation and is likely torequest the Board’s intervention.
D. MEMBER ASSOCIATIONS IN DEFAULT OF ADOPTING ADEQUATE IMPLEMENTATION
AND PROCEDURAL RULES
Under the EFPIA Code, each Member Association is required to establish national procedures and structures
to receive and process complaints. The national body that is designated to handle complaints must consist ofa non-industry chairperson and, besides any industry members, membership from other stakeholders.
21 - See Section “Applicability of the Code” in the EFPIA Code.

48

Procedural stepsp When EFPIA establishes that a Member Association does not have the required national
procedures and body in place to receive and process complaints, it shared the elements
on which its assessment is based with the Member Association, with a request to provide awritten explanation within 30 days.
p If EFPIA maintains its view that the Member Association’s arrangements for implementationof its code are inconsistent with those required by the EFPIA Code, EFPIA will refer to theCodes Committee that will hear the Member Association at its next upcoming meeting.
p Within 30 days of the Codes Committee meeting, the Compliance Officer will submit a
remediation plan (approved by the Codes Committee Chairs) to the Member Association withthe deadline for implementation of proposed measures (which should not exceed 3 months).
p Where the Member Association fails to confirm the establishment of appropriate
implementation and procedure rules within the 3-month deadline, the Codes Committee will
escalate the case to the Board with a request for intervention.
E. QUESTIONS SUBMITTED TO EFPIA FOR CLARIFICATION OF CODE PROVISIONSThe EFPIA Code sets out the minimum standards which EFPIA considers must apply to all EFPIA
Member Companies in the countries where they operate. Member Associations will transpose
the EFPIA Code’s provisions into their national codes, in line with applicable law or regulation.
Member Associations may adopt stricter standards.
Member Companies shall be bound by the relevant EFPIA Member Association’s codein each country in Europe in which they operate (whether directly or through its relevant
operation in that country).
Deviations and Variations
Where provisions are in conflict with applicable national laws or regulations, deviations areallowed, but only to the extent necessary to comply with such national law or regulation.
Variations to the EFPIA Code include provisions that are stricter than the EFPIA Code. These
are often the consequence of code development over time and the value attached to selfregulation within the national context.
Clarification and interpretation of Code provisions
When questions are submitted to EFPIA, the Compliance Officer will provide clarification of
the EFPIA Code’s provisions, which are minimum standards that must apply in all countries
where EFPIA has a Member Association. However, such clarification / interpretation willoften need to be complemented by relevant Member Associations that would further clarify
specific rules applicable.

49

It should be noted that any clarification / interpretation provided cannot constitute a judgmentof compliance with applicable codes. Decisions regarding compliance / breaches are the sole
responsibility of national adjudications bodies.
When questions are submitted about the EFPIA Code, EFPIA will provide clarification, and –where applicable – may revert to the Member Association(s) concerned.
Procedural stepsp EFPIA will acknowledge receipt of a question submitted by a Member (either a company oran association) within 10 days;p When an EFPIA Member submits a question that goes beyond factual clarification of an
EFPIA Code provision, EFPIA’s Compliance Officer will draft an answer for review by the Codes
Committee Chairs and the Member Association of the country(ies) involved, who may want tocomplement. It is expected that input from Codes Committee Chairs and Member Associations
will not delay EFPIA’s response beyond 1 month following the date of the question;pWhere the Codes Committee Chairs would consider that the question must be submitted to
the full Codes Committee, EFPIA’s Compliance Officer will inform the author of the question.
In such case, the final response should however be sent no later than 3 months following thedate of the question;pAnswers that pertain to Codes interpretation with a broader scope will be summarized in the
yearly Codes Activities Report, and may be submitted as a Recommendation for Guidance tothe Board approval, enhancing consistent implementation of the EFPIA Code.
EFPIA will treat questions submitted with due confidentiality in regard of sensitivity of
information shared, considering that the Compliance Officer will keep General Counsel
informed of follow-up to any question relating to Codes submitted to EFPIA.

50

ANNEX E (binding)
EFPIA e4ethics rules and procedure
1. Background
Article 10 of the EFPIA Code defines the requirements applicable to pharmaceutical companies
when organising events (professional, promotional, scientific, educational meetings,
congresses, conferences) and/or providing hospitality during these events (paying for travel,
meals, accommodation and genuine registration fees).
In 2011, EFPIA coordinated the monitoring of European third-party organised events (withmore than 500 HCPs coming from 5 different countries in the scope of the EFPIA Code) bysetting up an on-line platform to pre-assess events (named e4ethics).
Through e4ethics, EFPIA helps ensure a consistent implementation of the EFPIA Codeprovisions, enhances compliance with the Code and allows collaboration with our stakeholders(e.g. learned societies, congress organisers). While an EFPIA member company needed to takeits individual decision to sponsor, participate or collaborate to an event, e4ethics provided an
independent reference to inform such a decision.
2. e4ethics decisions binding and mandatory assessments
Based on a recommendation of the EFPIA Codes Committee (CodCom) and Ethics & Compliance
Committee (E&CC), the EFPIA Board decided, in March 2020, to make the e4ethics platformbinding, meaning that sponsoring, participation or collaboration in an event that has not been
approved or has been qualified as non-compliant by e4ethics is considered as a potential
breach to the EFPIA Code which could be enforced by the competent national Code authorities.
In summary, this means that e4ethics decisions are binding for EFPIA Member Companies
and that Member Companies must verify that an e4ethics positive assessment is available.
3. Collaboration with MedTech Europe
In 2012, MedTech Europe, the European Association for Medical Devices, set up the Conference
Vetting System (CVS) as an independently managed system that checks the complianceof third-party educational events with MedTech Europe’s Code of Ethical Business Practiceand Mecomed’s Code of Business Practice. The outcome of the assessment determines theappropriateness for MedTech Europe and Mecomed member companies to provide financial
support to the events. The decisions rendered by the Compliance Officer are binding on
MedTech Europe and Mecomed members. This means that these members cannot provide
support to an event which is found to be non-compliant.
In March 2020, the EFPIA Board approved the collaboration with MedTech Europe in the field ofcongresses’ assessments. Therefore, e4ethics assessments will be integrated in CVS even if theassessments will be directed to two different websites: e4ethics and CVS. Based on the EFPIA
Board recommendation, a testing period of 6 months will be implemented and will start on 1st
January 2021. During this testing period, the binding effect of decisions and the mandatory
nature of assessments will be in force.
A. KEY ELEMENTS

Each platform keeps its identity and branding, meaning that each one would have its own page51

with relevant information, including specific user-friendly routing to the submission form, butboth pages will be hosted on www.ethicalmedtech.eu. An e4ethics banner will be added on
MedTech Europe website but decisions rendered by CVS Compliance Officers shall be posted onwhat will become the joint online calendar. Technical adjustment will have to be made within
the CVS software to allow profile separation, while keeping a shared history of knowledge andan optimisation of service level.
Common back end22: In the back end, all assessment requests will be received by MedTech
Europe Compliance Officers, which will become the Compliance Officers also for Pharma Events.
The scope of e4ethics will remain the same: European congresses, organised by a third
party, with 5 different countries in the scope of the EFPIA Code and more than 500 HCPs.
Virtual congresses are out-of-scope.
B. ALIGNMENT OF CRITERIA

The criteria applying to e4ethics will be aligned to those of CVS:p The submission for events assessment must be done proactively and online by the EFPIA
member companies or the congress organisers.
p The travel arrangements and meals & drinks threshold will no longer be part of the criteria
assessed. Therefore, the EFPIA Member Associations will not be consulted.
p S ubmission in e4ethics will be mandatory, i.e. EFPIA Member Companies need to verify thatan e4ethics positive assessment is available for the Event prior to being able to provide any
kind of support, from the first day of the pilot phase. The submission for such assessment canbe made by the Member Company or the Congress Organiser (HCO/PCO).
pB
 inding nature of all decisions rendered by e4ethics on the EFPIA members during and after
the pilot phase, meaning that an Event assessed as non-compliant cannot receive any form of
support from EFPIA members.
p Full MedTech Europe/EFPIA alignment on the approach and interpretation of the six
assessment criteria23, which means that there will not be a difference on how Pharma and
MedTech Events will be assessed.
C. IMPORTANT CONSIDERATIONS

The following considerations are important:p Decisions are rendered on the basis of the documents and information provided to the CVS
Compliance Officer via the online submission form. The CVS Compliance Officer does notindependently verify whether the information or documents are up to date.
pD ecisions do not consider, nor supplant national and local laws, regulations or professionaland company codes that may impose more stringent requirements upon members, HCPs,
HCOs or PCOs.
p The schedule and relevance of scientific programme sessions of an Event are reviewed, but
not their value or quality.
22 - For the IT project, were underlined the importance to build-in data analytics tools as well as necessity to transfer
historic data of e4ethics, to be used for later data analytics purposes.
23 - Event Programme - Geographic Location - Event Venue Facility – Hospitality - Event Registration Packages - Communication Support52

p The sole purpose of the vetting system is to assist corporate members in determining theappropriateness for member companies to provide support to an Event.
4. Procedure applicable to e4ethics
A. APPEAL

The assessments for e4ethics will follow the CVS process: the MedTech compliance panel will
be in charge of the appeal procedure for the assessments. An appeal of the CVS Compliance
Officer’s assessment is possible. The body responsible for reviewing such appeals is the
MedTech Europe Compliance Panel, given the value of having one single authority overseeing
the decision processes respectively pertaining to MedTech and Pharma Events.
An appeal may be filed by the Member Company or the Congress Organiser (HCO/PCO) with
the Compliance Panel provided that the following requirements are respected:
pA
 ppeals must be filed within a deadline of 10 days for Pre-Clearance and Regular Submissions
after the Compliance Officer’s assessment decision has been published on the joint online
calendar.
pA
 formal appeal needs to be addressed to the Chair of the Compliance Panel at cvs@
ethicalmedtech.eu
The Compliance Panel will endeavour to respond to appeals within 72 hours of receipt.
B. COMPLAINT RELATED TO AN EVENT

In case of a complaint related to a European congress (and not related to an assessment), the
EFPIA SOP is applicable (Annex D part A of the EFPIA Code). EFPIA will forward the complaint
to the relevant national Code authority. The final decision of the national Code authority will beshared with the MedTech compliance panel for information.
A. COMPLAINTS24 RECEIVED BY EFPIA
Section 3 of the “Implementation & Procedural Rules” further provides that complaints received by
EFPIA shall be processed as follows:p E FPIA will forward any complaints it receives (without considering their admissibility orcommenting upon them) to the relevant member association(s).
p E FPIA will send an acknowledgement of receipt to the complainant, indicating the relevant
national association(s) to which the complaint has been sent for processing and decision.
pn
 addition, upon receipt by EFPIA of multiple external complaints (i.e. several complaints on
the same or similar subjects lodged from outside the industry against several subsidiaries of asingle company), EFPIA will communicate these complaints to the national association eitherof the parent company or of the EU subsidiary designated by the parent company.

24 - EFPIA will consider as a complaint any concerns raised about an EFPIA Member Company for materials or activities
related to EFPIA Code’s implementation and/or enforcement.

53

Procedural Stepsp When a complaint is received by EFPIA, the EFPIA Compliance Officer forwards it, within
10 working days, to the relevant Member Association(s) for action under the Member
Association(s)’s procedure for dealing with complaints, and the complainant will be informedof which Member Association(s) are responsible for dealing with the complaint;p S imultaneously, the EFPIA Compliance Officer will inform, in writing, the responsible senior
employee25 of the company(ies) against which the complaint is made. If the complaint
involves a number of countries, EFPIA will forward the complaint to the Member Associationof the parent company and to the relevant company’s subsidiary(ies);p The Member Association(s) must acknowledge receipt of the complaint from EFPIA within 30
days following EFPIA’s communication;p The Member Association(s) should consider the complaint under its usual procedure,
including timelines. During the adjudication period, EFPIA will not intervene, neither will it
answer questions neither from the complainant nor from the Member Company(ies) involvedin the case;p When the Member Association(s) has(ve) completed its(their) consideration of the matter,
EFPIA must be so informed of the decision(s) made by the adjudication bodies, including,where appropriate, the sanction imposed. The Member Association(s) should provide updates
to EFPIA as the matter proceeds no later than 6 months after it receipt of the complaint, andsubsequently within each following quarter until a final decision is made on the compliant(within a reasonable timeframe);pA summary of decisions made on cases submitted to EFPIA will be published in EFPIA’s Codes
Activity Report – once the complaint has been concluded, the learnings might lead to further
discussion by the Codes Committee including enhancing code consistent implementation,
where relevant.
Throughout the complaint procedure (from receipt of the complaint at EFPIA to decision of
the competent adjudication bodies), EFPIA will not communicate with parties involved in thecomplaint within the limits of its involvement set out in the EFPIA Code and following theprocedural steps described in this SOP. In this context, communications within EFPIA will belimited to General Counsel and EFPIA Compliance Officer; the Director General will be involved
to the extent justified by the complaint.”

25 - Each Member Company must appoint at least one senior employee who shall be responsible for supervising thecompany and its subsidiaries to ensure that the standards of the Applicable Code(s) are met. See EFPIA Charter andSection 18.02 of the EFPIA HCP Code.

54

ANNEX 1
EFPIA recommendation
DISCLOSURE “GATEWAY” ON MEMBER ASSOCIATIONS WEBSITES
BackgroundIn application of the disclosure requirements, ToVs to HCPs / HCOs are published (in line withapplicable laws and regulations) in one of the following forms:
p on individual Member Companies websites;p through an Association platform operating as a “gateway” to individual companies websites;p on a multi-stakeholder platform;
p on a government platform.
Following disclosure in 2016, media have criticised poor access to the data, denouncing lackof transparency. On 14th July 2016 (i.e. only 2 weeks following public disclosure), Der Spiegel
provided access to all data disclosure by Member Companies in Germany, re-organising thedata in a full transparent way, using the searchable database constructed by Correctiv (aResearch Centre of Public Interest). In the months following, Correctiv provide access to asimilar database for Switzerland and Austria.
Similar platforms have been developed in Sweden and had been announced in Finland.
Against this trend, the Board supported the Codes Committee suggestion to take steps leadingfrom disclosure to transparency, as the pharma industry should take credit for its disclosure
initiative.
Relevant EFPIA Disclosure provisions
Section 23.04. Platform of Disclosure.
Disclosures can be made in either of the following ways, provided that they are unrestricted
and publicly available:po n the relevant Member Company’s website in accordance with Section “Applicable National
Code”; orp on a central platform, such as one provided by the relevant government, regulatory or
professional authority or body or a Member Association, provided that disclosures made ona central platform developed at the initiative of Member Associations shall be made, so far as
possible, using a structure set forth in Annex A for reference.
Recommendation
In countries where there is no central platform in place, Member Associations are encouraged
to provide access to individual Member Companies reporting in their country through a“Gateway” on the Association’s website as a way to improve access to information disclosed.
55

Each Member Association will frame the “Gateway” in consideration of the national context
and in line with application law and regulations, and in consideration of the Annex 3 Principles
for the use of digital channels. In this context, it is recommended to include a pop-up on therelevant Member Association webpage indicating that the visitor is being redirected to a
webpage that is not under the Member Association’s responsibility.
Each Member Association is expected to ask its member companies to provide the links to theirdisclosure reports.
It is expected that Member Associations take steps to operationalise the “Gateways” in time forthe upcoming disclosure period (June 2018).
Follow-up
The Codes Committee will check the follow-up that Member Associations will have given to thisrecommendation – a status report will be included in the 2018 Codes Report.
Based on learning, the Codes Committee may issue recommendation aiming at improving

56

transparency.
ANNEX 2
Principles for the use of digital channels
1. Principles applicable to all types of communication
COMPLIANCE WITH LAWS, REGULATIONS AND CODES OF PRACTICE

A digital channel is only a platform for communicating. Laws and regulations applicable toother platforms and media also apply to digital media. The content, target group and use of theplatform are relevant factors to determine applicable rules, not the media as such.
Therefore, the provisions of the Directive 2001/83/EC related to the Medicinal Products’
advertising and of the EFPIA Code of Practice apply to digital communication.
The processing of personal data must comply with applicable data protection regulations.
RESPONSIBILITY

Member Companies are responsible for all material disseminated via any digital channel that is
initiated, branded and/or sponsored by Member Companies, or any Third Party acting on theirbehalf, including promotion of Medicinal Products.
A Member Company owning the social media page or site is responsible for the content. E.g. any
mention of a Prescription-Only Medicine is likely to be considered promotion of that medicine
to the public and prohibited. Another example might be the use of social media directed to the
public to alert HCPs about the publication of a study on a Medicinal Product which is also likely
to be considered promotion of that Medicinal Product and therefore prohibited.
Member Companies may also have responsibilities when interacting on digital channels owned
by other companies or organisations.
Member Companies are also responsible for information disseminated by Member Company
staff who do so via their private social media channel including, a) when they can reasonably
be perceived as representing the Member Company, or b) if they are instructed, approved or
facilitated by the Member Company to do so. The Member Company should have internal
guidelines in place on how its staff should behave on digital channels including their own
personal account activities.
For digital channels owned by the Member Company, processes should be established tomonitor, moderate and/or delete any inappropriate comments in a timely manner to theextent permitted by the data protection regulations and applicable laws and codes. Member
Companies may need to have similar processes when using digital channels owned by othercompanies or organisations.
PHARMACOVIGILANCE

Member Companies should consider developing specific guidance for digital channels
and contacting their pharmacovigilance experts for specific projects in order to meet theirpharmacovigilance responsibilities including the obligation to record and report any adverse
effects that are discussed about their Medicinal Products.
57

TRANSPARENCY

Section 7.04 of the EFPIA Code of Practice requires Member Companies to clearly indicate
when they have sponsored a communication. Whenever a Member Company or an individual
or entity acting on behalf of a Member Company provides information on a digital channel,
it should clearly state the involvement of the Member Company, including but not limited todefining content, funding in part or in totality.
In addition, the transfers of values to HCPs, HCOs and POs are reportable under the disclosure
obligations as described in the EFPIA Code of Practice (Chapter 5).
When possible, the target audience of the channel should be clearly identified (e.g., HCPs andthe public, or a combination thereof ).
2. How to identify the allowed information for the different digital channels
It is important that the Member Company understands what content is appropriate for thedifferent digital channels and the respective audience. All laws and regulations in this regard
must be complied with in the same way as for other media.
Information included on a digital channel should be regularly updated and should clearly
display, for each page and/or item, as applicable, the most recent date as of which suchinformation was updated.
The following questions can be useful to assess risks associated with digital communication
and appropriateness of digital channel content, access, set-up and maintenance:p What is the objective of the communication (promote, inform, exchange)?
p What content will be made available on the digital channel?
◊ Is the content related to Medicinal Products?
◊ Is the content promotional or non-promotional?
◊ Is the content related to disease awareness?
◊ Is the content related to healthcare information e.g. in connection with diagnosis,
treatment education, dietary support◊ Is the role of the Member Company providing/developing the content clear?
p Who is the intended audience? e.g. public, HCPs or both
◊ Is verification of audience required?
◊ If yes, how?
p What is the channel standard set-up?
◊ Is the digital channel open to audience reaction such as sharing, commenting,58

exchanging?
◊ How is the information cascaded across the digital channels?
◊ Is the digital channel an open platform or for a closed audience?
◊ Are there limitations in content size? e.g. Twitter◊ Are there any community guidelines applicable? e.g. Facebook, YouTube◊ How is the information about the channel audience processed?
p How is the content reviewed, approved and maintained including by the Member Company?
3. EFPIA guidance for members for various digital channels
Below is a short description of the general use of different types of digital channels. When
deciding which digital channel to use and how to develop it, the principles set out above
should be taken into account.
The content published by a Member Company on each channel must be appropriate andaligned with relevant regulations, laws and codes including the EFPIA Code of Practice.
WEBSITES

Websites are classified as a channel that reaches the public, unless verification (e.g. pop-up for
identification, or password) is required to access the website e.g. to HCPs. Some websites may
include forums where the public can exchange or discuss topics.
Since many website visits are a result of using a search engine, keyword optimization has
become an important tool. Member Companies can use appropriate search optimization toensure that their websites are displayed high on the list of search results for relevant key words.
However, Member Companies need to ensure that the use of keyword optimization isappropriate for the intended audience. For example, optimized search through use of key
words directed to websites with therapy-oriented information for the public or websites aimed
at HCPs, where such websites can only be accessed by the authorized individuals.
Member Companies may sponsor website material to be produced by a Third Party in which
the role of the Member Company must be made clear. If the Member Company i) is initiating
the material, or the concept for it; ii) is influencing the content of the material in any way;iii) is selecting or directly paying the authors; then the Member Company is very likely to beliable for the contents of the website. If the reverse is true, and there is a strictly arm’s lengtharrangement with the Member Company just providing a grant, then the Member Company
may not be liable.
Member Companies should be confident about the choice of linked websites and that these do
not promote Prescription-Only Medicines to the public. If a Member Company includes website
addresses in an advertisement of a Prescription-Only Medicines to HCPs, the core principles
apply, of ensuring the content of those websites is appropriate.
SOCIAL MEDIA

In general, social media are digital channels that are considered to be aimed at the public.
Social media are websites or applications on which people can interact in social networks (e.g.
59Facebook, Twitter, Snapchat, LinkedIn, YouTube, Instagram). In most cases social media areused to reach or interact with the public. A social media platform can be an open channel forthe public or a closed channel for a targeted audience where verification of the audience isrequired before providing access.
BLOGS

The difference between a text on a website and on a blog is that a blog is usually owned andupdated by a person or a group of people who posts on the blog regularly.
A blog can be owned by the Member Company or the Member Company may engage(either through sponsorship or consultancy fees) the owner to write on a blog (such as “social
influencers”). In both cases, the blog should clearly state the involvement of the Member
Company.
Given that, by its very nature, a blog is for contributors to freely and spontaneously express
their personal views on a subject, Member Companies should not sponsor such blogs if they
were intended, or could reasonably be expected, to promote Prescription-Only Medicines andtheir uses.
PODCASTSA Member Company can have its own podcast which should follow the same rules as forwebsites.
A podcast can be downloaded from any podcast distributor. Core principles apply, of ensuring
the recipient is well defined and targeted and that content is appropriate. E.g. a podcast
promoting Prescription-Only Medicines should only be accessed by HCPs.
APPLICATIONS (APPS)

An application, usually referred to as an “app”, is to be downloaded on an electronic device (e.g.
smartphone, computer or tablet).
A Member Company can develop apps for the use of external stakeholders (e.g. HCPs, HCOs,
patients, payers), provided that they follow the same rules as for websites. Also, they should
consider potential regulatory requirements if the app fulfils the requirements for a medical
device. Core principles apply, including ensuring the audience is well defined and targeted.
An app can also be developed to improve compliance with a treatment method. If an app
targets a specific group (e.g. HCPs, patients, caregivers), it is important that only this group isoffered access to the app content.
WEBINARS

A webinar is an on-line event conducted via the internet and it can be either performed as a live
streaming event or as an on-demand service.
A Member Company can be the direct organiser of a webinar and/or use a Third Party facilitator
to run the event. The Member Company is responsible for these webinars including the content
and ensuring that the audience is well defined and targeted. Similar arrangements apply toThird Party webinars sponsored by Member Companies.
60Such webinars can be for the communication with external stakeholders (e.g. HCPs, HCOs,
patients, payers) provided, that they follow the same rules as for websites.
DIRECT CHANNELS

These are one-to-one or one-to-many channels, which are targeting selected recipients; theseare most commonly private, not visible to non-selected recipients; they could be replies onsocial media channels to an individual.
Member Companies should ensure they have the consent of the recipients to be in contact withthem, and the recipients should be able to stop receiving messages easily. Appropriateness ofthe frequency of contact should be borne in mind.
DISCUSSION FORUMS

If a Member Company facilitates a discussion forum on either a Third Party platform, or hosts a
forum on its own platform, the Member Company must be confident that they can moderate
the site such that the content complies with relevant regulations, laws and codes including
the EFPIA Code of Practice. The intended audience should be identified so that relevant
requirements are complied with. If discussion forums are used for market research, Member
Companies should ensure these are compliant with relevant legal and ethical guidelines.

61

ANNEX 3
EFPIA Guideline on a Quality Framework - Principles in Lifelong Learning in Healthcare
EXECUTIVE SUMMARY
Lifelong Learning is defined by the European Commission as ‘all learning activity undertaken
throughout life, with the aim of improving knowledge, skills, competences within a personal,
civic, social and/or employment related perspective ’. The pharmaceutical industry has alongstanding commitment to engaging and innovating in Lifelong Learning in Healthcare(LLH). This non-binding guideline for EFPIA Members Companies provides definition andstandards for quality, transparency and ethics in medical learning.
Adhering to the principles in this guideline, will assist the pharmaceutical industry to ensure
a disciplined approach to the funding and organisation of LLH and its continued contribution
to improved patient outcomes. Adherence to laws and regulations, and organizing up-todate, fair and balanced learning programmes remains essential to the development of quality
educational programmes. By implementing and/or maintaining this approach to LLH, thepharmaceutical industry agrees to formally incorporate educational principles of LLH, provide
transparency and facilitate working effectively with other stakeholders in healthcare.
Preamble
The purpose of this document is to provide a guideline for the implementation of EFPIA Code
Article 16. The guideline must be read with the requirements and spirit of the Code in mind andin accordance with applicable laws and regulations, in particular, the EU Directive 2001/83/EC
Titles VIII and VIIIa on information and advertising.
The intention of this guideline is to ensure that LLH by the pharmaceutical industry adheresto high ethical standards and robust educational principles with the ultimate common goal tobenefit patients.
LLH must not constitute promotion.
High scientific standards and the process of quality assurance for medical learning programmes
are required to maximize transparency, ensure quality, fair and balanced content, and mitigate
bias. The pharmaceutical industry strives to use educational principles which are based on,learner-centric engagement to advance the value and impact of learning.
The Value of the Pharmaceutical Industry in LLH
The pharmaceutical industry has a legitimate role among other stakeholders in providing
evidence to ensure innovations are used safely and in the appropriate patient populations.
To keep up with the speed and breadth of scientific and medical progress, different LLH
providers are needed for rapid diffusion of new evidence and innovations in healthcare. Given
that the pharmaceutical industry must ensure its medicines are used safely and in the right
populations, it provides important high quality and a complementary channel for LLH.
To facilitate a robust and practical learning experience with a fair and balanced presentationof evidence, the pharmaceutical industry often partners with leading and recognised experts.
62

The pharmaceutical industry is in constant dialogue with healthcare professionals at the global,
regional and local levels and may be in a position to identify and address learning needs that
may not be covered by other providers of LLH.
With its large geographic footprint, the pharmaceutical industry can provide opportunities foreducation to HCPs in countries with limited access to LLH offerings.
With innovation in therapeutic areas, the pharmaceutical industry is frequently at theforefront of the provision of LLH to assist and accelerate the translation of clinical research andother advancements into clinical practice.
Introduction
Multiple terms are used to describe learning and Continuous Professional Development(CPD). These vary across regions and countries and may or may not be associated with formal
accreditation. In the EFPIA Code Article 16 as well as in this document the term Lifelong Learning
in Healthcare (LLH) is used to describe non promotional educational activities led and/or
funded by the pharmaceutical industry and that fulfil unmet educational needs in healthcare.
LLH must not be to promote company products, devices or healthcare solutions, but totranslate evidence relevant for enhancing patient care into respective learning interventions
in disease areas. Company-driven, product only specific educational activities which promote
medicinal products are out of scope for this document. Such activities must comply with laws
and regulations for the promotion of medicines.
The following types of educational activities are covered by this guideline and have common
objectives, but differ as to the level of pharmaceutical industry involvement, ownership andfunding:1.

Independent Medical Education (IME), with or without Continuous Medical Education(CME) or Continuous Professional Development (CPD) accreditation. IME is conductedby an independent organisation without industry involvement or influence and can befunded by the pharmaceutical industry.
2. LLH programmes developed through collaboration or partnership of one or more
pharmaceutical company(ies) with professional societies, healthcare organizations,education providers, or other key stakeholders. The collaboration/partnership includes
a commitment to a definition of mutual relationships and goals; a jointly developed
structure and shared responsibility; mutual authority and accountability for success.
3. Pharmaceutical industry led LLH activities, which may address human health, and diseases-specific learning needs. These activities are organized by individual pharmaceuticalcompanies and may involve scientific committees, and/or independent scientific andprofessional organisations. Ownership, accountability and funding for these programmes
remains that of the pharmaceutical company.
Whatever the type of LLH, the pharmaceutical industry is committed to delivering andsupporting high-quality learning. The pharmaceutical industry expects other stakeholders, suchas IME providers, scientific committees, scientific organizations or professional associations toadhere to the following principles when receiving pharmaceutical industry support/funding63

for LLH.
Quality Framework
This document describes the following 3 elements:
1.
2.
3.

Ethical, transparent and responsible engagement;
Quality content: programmes and activities must not be promotional, either in content or
intent; andRobust processes: educational needs assessment, learning design and outcomesmeasurement.

Ethical, transparent and responsible engagement is mandatory for any LLH activity. Quality
content and robust processes are strongly recommended to meet the highest quality learning
standards and educational impact.
1. MANDATORY REQUIREMENTS: ETHICAL, TRANSPARENT, AND RESPONSIBLE ENGAGEMENT

Ethical, transparent and responsible engagement is the overarching and basic principle ofthe quality framework and is mandatory. It is supported by robust educational processes andquality content. It is the responsibility of the funding pharmaceutical company to ensure thescientific integrity of LLH activity.
The purpose of ethical, transparent and responsible engagement is to address the following
major considerations:•
Funding: Transparency regarding the reporting of funding and other value provided tothose delivering or receiving the education as per EFPIA Code Chapter 2 and 5•
Disclosure: Disclosure of interests and potential conflicts of interest for any activity typeof LLH by all party(ies) involved•
Intent: Transparency regarding intent, involvement, roles and responsibilities and natureof potential collaboration with external stakeholders (clinicians, medical associations/organizations)•
Data privacy: respect regulations (such as per GDPR)•
Compliance with pharmaceutical industry codes of practice [such as IFPMA, EFPIA], EUregulations and local applicable laws and regulations.
2. RECOMMENDED PRACTICES

2.1 Quality content
The objective of LLH is to increase the scientific knowledge and competence of HCPs toenhance medical practice and improve the overall patient and healthcare outcomes. Quality
content is the foundation of LLH.
To ensure high quality content is provided by pharmaceutical industry led and/or funded LLH
activities, the programmes must not be promotional, either in content or intent. They must notinclude product branding (trade name, logo, brand colours etc.), nor product claims.
It is recommended that a scientific committee formed of experts in the specific disease areas is64

responsible for developing the agenda/programme, selecting the faculty and guaranteeing thescientific integrity of the programme. With the exception of IME, members of pharmaceuticalindustry scientific/medical functions and therapeutic area specialists can be members ofscientific committees.
Companies should consider the following principles in order to ensure high quality content for
LLH programmes:•
Needs-based: needs may be identified through scientific literature review, by a scientificcommittee and/or a dedicated educational needs assessment - see Section 3.1•
Up to date, factual and of high scientific standard capable of substantiation: use of themost appropriate, current and evidence-based content relevant to current clinical practiceand standards•
Balanced and objective: provision of scientifically balanced perspectives on the subject
matter with involvement of independent scientific input when appropriate and allowing
time for scientific peer to peer exchange•
Incorporates multiple sources of scientific data•
Referenced: all content should be referenced so learners can assess the level of statisticaland clinical relevance of the content.
Different learning styles, the cultural differences of the audience and modes of delivery should
be considered to best meet the learning objectives. All components of the programme,
regardless of method, design or channel (digital, visual and practical) must give a clear, fair andbalanced view of the information/data they aim to convey and allow the expression of diverse
theories and recognised opinions.
2.2 Robust processes
To ensure high educational quality; a robust and standardized process is strongly recommended,
including:•
Educational needs assessment•
Learning design•
Outcomes assessment
Each pharmaceutical company will individualise their own educational processes. Examples
below are intended to assist companies in the design of their processes.
2.2.1. Educational needs assessment
A disciplined and accurate assessment of programme participants´ learning needs is arecommended initial step in planning educational activities and should ensure clarity on theselection criteria. Selection of delegates should be based on educational needs.
Needs can be classified as:•
Perceived needs; expressed and perceived by learners– e.g. a survey among HCPs
attending a specific LLH activity•
Expressed needs; expressed in action – e.g. a clinical centre’s need to understand new
guidelines in clinical practice•Normative needs; stated by experts•
Comparative needs; expressed in group comparison for instance between clinical65

institutions and their clinical practice.
An educational needs assessment should include input from multiple stakeholders in healthcare.
Methods for assessing learner´s needs can include reviewing literature, qualitative exploratory
research, surveys, input from experts and other stakeholders in healthcare, advisory boards andmultiple other data collection methods.
2.2.2. Learning design
The current healthcare ecosystem is undergoing a major transformation. This is driven by amore patient centric approach towards healthcare and vast improvements in technology. Thistransformation requires all stakeholders in the healthcare ecosystem to collaborate for LLH
processes to meet high educational standards.
A quality assurance framework26 may include a standardized process for learning designand should be part of a developed higher-level strategy that aims at increasing the scientificknowledge and competence of HCPs to enhance medical practice and improve patient andhealthcare outcomes.
Such processes could include an outcomes-based planning approach and should communicate
what LLH should achieve. The following steps may be used in education:
1.
2.
3.

Identify the intended outcomes based on educational needs (see needs assessment)
Agree on acceptable evidence e.g. discuss programme and faculty with scientificcommittee based on identified learning outcomes
Plan the learning experience

2.2.3. Outcomes measurement
To ensure continuous improvement in LLH, different approaches for measurement should
be used and outcomes used to improve future programmes. Measurements may apply todifferent learning or instructional design and delivery channels. Although objective measures
are preferred, subjective measures are used where the opinion of learners is sought, (e.g.
‘satisfaction’ or ‘relevance’).

26

Anderson et al, Moore et all, Michie et all66

Recommended bibliography
EFPIA Code of Practice: https://www.efpia.eu/relationships-code/the-efpia-code/
IFPMA Code Article 10 Support for Continuing Medical Education: https://www.ifpma.org/wpcontent/uploads/2018/09/IFPMA_Code_of_Practice_2019.pdf
IFPMA Note for guidance on Continuing Medical Education: https://www.ifpma.org/resourcecentre/ifpma-note-for-guidance-on-continuing-medical-education/
Framework for industry engagement and quality principles for industry-provided medical
education in Europe - Tamara Allen, Nina Donde, Eva Hofstädter-Thalmann, Sandra Keijser,
Veronique Moy, Jean-Jacques Murama, and Thomas Kellner - J Eur CME. 2017; 6(1): 1348876. Published online 2017 Jul 31. doi: 10.1080/21614083.2017.1348876: https://www.ncbi.nlm.nih.
gov/pmc/articles/PMC5843061/
Learning needs assessment: assessing the need – Grant J. - BMJ. 2002 Jan 19; 324(7330): 156–
159
Understanding Medical Education: Evidence, Theory, and Practice - Tim Swanwick - Chapter 7
on ‘quality’.
A Taxonomy for Learning, Teaching, and Assessing: A revision of Bloom’s Taxonomy of
Educational Objectives - Anderson L.W., Krathwohl D.R., Airasian P.W., Cruikshank K.A., Mayer
R.E., Pintrich P.R., Raths J., Wittrock M.C. (2001) – Pearson.
A conceptual framework for planning and assessing learning in continuing education activities
designed for clinicians in one profession and/or clinical teams - Moore DE Jr, Chappell K, Sherman
L, Vinayaga-Pavan M - Med Teach 2018 Sep;40(9):904-913. doi: 10.1080/0142159X.2018.1483578.
Epub 2018 Jul 28:
https://www.ncbi.nlm.nih.gov/pubmed/30058424
The behaviour change wheel: A new method for characterising and designing behaviourchange interventions – Susan Michie, Maartje M van Stralen, and Robert West - Implement Sci
2011; 6: 42. Published online 2011 Apr 23. doi: 10.1186/1748-5908-6-42:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3096582/
The Net Promoter Score (NPS) for Insight Into Client Experiences in Sexual and Reproductive
Health Clinics - Rebecca Koladycz, Gwendolyn Fernandez, Kate Gray, and Heidi Marriott
Glob Health Sci Pract. 2018 Oct 3; 6(3): 413–424. Published online 2018 Oct 3. Prepublished
online 2018 Aug 2. doi: 10.9745/GHSP-D-18-00068
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6172123/
Oxford Textbook of Medical Education – Walsh et al - pp74-85

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