Adopted by the EFPIA Statutory General Assembly of 24 June 2013, and requiring implementation in national codes by 31 December 2013 - FINAL EDITED VERSION Following General Assembly Approval
Healthcare professionals and healthcare organisations with whom they work provide the pharmaceutical industry with valuable, independent and expert knowledge derived from their clinical and management experience. This expertise makes an important contribution to the industry’s efforts to improve the quality of patient care, with benefits for individuals and society at large. Healthcare professionals and healthcare organisations should be fairly compensated for the legitimate expertise and services they provide to the industry.
Prescription medicines developed by the industry are complex products designed to address the needs of patients and educating healthcare professionals about medicines and the diseases they treat benefits patients. The pharmaceutical industry can provide a legitimate forum for the education of healthcare professionals and the exchange of knowledge among healthcare professionals and industry.
EFPIA believes that interactions between the pharmaceutical industry and healthcare professionals have a profound and positive influence on the quality of patient treatment and the value of future research. At the same time, the integrity of the decision of a healthcare professional to prescribe a medicine is one of the pillars of the healthcare system. EFPIA recognises that interactions between the industry and healthcare professionals can create the potential for conflicts of interest. Consequently, professional and industry associations, including EFPIA and its member associations, have adopted codes and guidelines 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 demands of the society. In particular, there is a growing expectation that interactions between corporations and society are not only conducted with integrity but are also transparent. Following the EU Commission initiative on Ethics & Transparency in the pharmaceutical sector, a multi-stakeholders’ platform – including, among others, EFPIA – has adopted a “List of Guiding Principles Promoting Good Governance in the Pharmaceutical Sector” (the “Guiding Principles”).
In line with these “Guiding Principles”, EFPIA believes that it is critical to the future success of the pharmaceutical industry to respond to society’s heightened expectations. EFPIA has therefore decided that its existing Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals (the “HCP Code”) and Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations (the “PO Code”) should be supplemented by requirements for detailed disclosure regarding the nature and scale of the interactions between the industry and healthcare professionals and organisations. EFPIA hopes that, by taking this step, it can enable public scrutiny and understanding of these relationships and thus contribute to the confidence of stakeholders in the pharmaceutical industry.
EFPIA believes that the interest of patients and other stakeholders in the transparency of these interactions is compelling. EFPIA recognises that disclosure can raise data privacy concerns and seeks to work with healthcare professionals to ensure that these concerns are addressed. EFPIA nonetheless believes that transparency can be achieved without sacrificing the legitimate privacy interests of healthcare professionals and legislation should not therefore impose excessive restrictions on disclosure by the industry.
The following Code provides for disclosures of transfers of value to healthcare professionals, whether directly or indirectly. When deciding how a transfer of value should be disclosed, companies should, wherever possible, identify and publish at the individual healthcare professional (rather than healthcare organisation) level, as long as this can be achieved with accuracy, consistency and compliance with applicable law.
The following code imposes obligations to disclose transfers of value to healthcare professionals and healthcare organisations commencing with reporting in 2016 in respect of transfers of value for the calendar year 2015. The provisions of this Code shall be implemented by EFPIA’s member associations in a manner consistent with applicable competition and data protection laws and regulations and all other applicable legal requirements.
This Code governs disclosures regarding certain interactions with HCPs and HCOs. It is intended that this Code shall apply to interactions with HCPs and HCOs to the same extent as the existing HCP Code and PO Code (1). Therefore, this Code applies to Member Companies, including:
This Code sets out the minimum standards which EFPIA considers must apply to all EFPIA Member Associations in all member states. All EFPIA Member Associations will be required to transpose this Code 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 national law or regulation.
Where an EFPIA Member Association has determined that this Code cannot be implemented in full due to national law or regulation, such EFPIA Member Association will not be in breach of its obligations under this Code if the deviation from this Code is no broader than necessary to comply with such national law or regulation and if it clearly documents the legal issues limiting full implementation. It is understood that if there is an inconsistency between this Code and the applicable law or regulation to which a Member Company is subject which would make adherence to this Code not reasonably possible, the Member Company must comply with such law or regulation and such lack of adherence shall not constitute a breach of this Code.
Member Companies shall be bound by the relevant EFPIA Member Association’s code in each country in Europe in which they operate (whether directly or through its relevant subsidiary). If an EFPIA Member Association where a Member Company operates fails to transpose this Code into its national code by the relevant deadline, such Member Company will be required to comply with this Code. If a Member Company is not a member of the EFPIA Member Association in any given country in Europe, it agrees, as a consequence of its membership in EFPIA (either directly or through its relevant subsidiary), to be bound by that EFPIA Member Association’s code (including any applicable sanctions that may be imposed under such code).
Non-member associations and companies that decide to voluntarily implement this Code shall require that each of their respective members, affiliates and subsidiaries, as applicable, comply with all of the provisions of this Code.
Section 1.01. General Obligation. Subject to the terms of this Code, each Member Company shall document and disclose Transfers of Value it makes, directly or indirectly, to or for the benefit of a Recipient, as described in more detail in Article 3.
Section 1.02. Excluded Disclosures. Without limitation, Transfers of Value that (i) are solely related to over-the-counter medicines; (ii) are not listed in Article 3 of this Code, such as items of medical utility (governed by Article 9 of the EFPIA HCP Code), meals and drinks (governed by Article 10, especially Section 10.05 of the EFPIA HCP Code), medical samples (governed by Article 16 of the HCP Code); or (iii) are part of ordinary course purchases and sales of Medicinal Products by and between a Member Company and an HCP (such as a pharmacist) or an HCO do not fall within the scope of the disclosure obligation described in Section 1.01.
Section 1.03. Schedules. Each of the attached Schedules forms part of this Code. Definitions of capitalised terms are included in Schedule 1 to ensure consistent understanding of such terms.
Section 2.01. Annual Disclosure Cycle. Disclosures shall be made on an annual basis and each reporting period shall cover a full calendar year (the “Reporting Period”). The first Reporting Period shall be the calendar year 2015.
Section 2.02. Time of Disclosure. Disclosures shall be made by each Member Company within 6 months after the end of the relevant Reporting Period and the information disclosed shall be required to remain in the public domain for a minimum of 3 years after the time such information is first disclosed in accordance with Section 2.04, unless, in each case, (i) a shorter period is required under applicable national data privacy or other laws or regulations, or (ii) the Recipient’s consent relating to a specific disclosure, if required by applicable national law or regulation, has been revoked.
Section 2.03. Template. Subject to Section 2.04(ii), for consistency purposes, disclosures pursuant to this Code will be made using a structure set forth in Schedule 2 for reference, reflecting the requirements of this Code.
Section 2.04. Platform of Disclosure. Disclosures can be made in either of the following ways, provided that they are unrestricted and publicly available:
Section 2.05. Applicable National Code. Disclosures shall be made pursuant to the national code of the country where the Recipient has its physical 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 physical address, the Member Company shall disclose such Transfer of Value in a manner consistent with the national code to which the Recipient is subject.
Section 2.06. Language of Disclosure. Disclosures shall be made in the language(s) prescribed in the national code by the relevant Member Association. Member Companies are encouraged to make disclosures in English in addition to the mandatory disclosures in the local language (if other than English).
Section2.07. Documentation and Retention of Records. Each Member Company shall document all Transfers of Value required to be disclosed pursuant to Section 1.01 and maintain the relevant records of the disclosures made under this Code for a minimum of 5 years after the end of the relevant Reporting Period, unless a shorter period is required under applicable national data privacy or other laws or regulations.
Section 3.01. Individual Disclosure. Except as expressly provided by this Code, Transfers of Value shall be disclosed on an individual basis. Each Member Company shall disclose, on an individual basis for each clearly identifiable Recipient, the amounts attributable to Transfers of Value to such Recipient in each Reporting Period which can be reasonably allocated to one of the categories set out below. Such Transfers of Value may be aggregated on a category-by-category basis, provided that itemised disclosure shall be made available upon request to (i) the relevant Recipient, and/or (ii) the relevant authorities.
For Transfers of Value to an 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 11 of the HCP Code).
Contribution to costs related to Events. Contribution to costs related to Events, through HCOs or third parties, including sponsorship to HCPs to attend Events, such as:
Sponsorship 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 of the EFPIA HCP Code).
Fees for Service and Consultancy. Transfers of Value resulting from or related to contracts between Member Companies and institutions, organisations or associations of HCPs under which such institutions, organisations or associations 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 Transfers of Value relating to expenses agreed in the written agreement covering the activity will be disclosed as two separate amounts.
For Transfers of Value to an HCP:
Contribution to costs related to Events. Contribution to costs related to
Events, such as:
Registration fees; and
Travel and accommodation (to the extent governed by Article 10
of the EFPIA HCP Code).
Fees for Service and Consultancy. Transfers of Value 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 Transfers of Value relating to expenses agreed in the written agreement covering the activity will be disclosed as two separate amounts.
Section3.02. Aggregate Disclosure. For Transfers of Value where certain information, which can be otherwise reasonably allocated to one of the categories set forth in Section 3.01, cannot be disclosed on an individual basis for legal reasons, a Member Company shall disclose the amounts attributable to such Transfers of Value in each Reporting Period on an aggregate basis. Such aggregate disclosure shall identify, for each category, (i) the number of Recipients covered by such disclosure, on an absolute basis and as a percentage of all Recipients, and (ii) the aggregate amount attributable to Transfers of Value to such Recipients.
Section3.03. Non Duplication. Where a Transfer of Value required to be disclosed pursuant to Section 3.01 or 3.02 is made to an individual HCP indirectly via an HCO, such Transfer of Value shall only be required to be disclosed once. To the extent possible, such disclosure shall be made on an individual HCP named basis pursuant to Section 3.01(2).
Section 3.04. Research and Development Transfers of Value. Research and Development Transfers of Value in each Reporting Period shall 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.
Section 3.05. Methodology. Each Member Company shall publish a note summarising the methodologies used by it in preparing the disclosures and identifying Transfers of Value for each category described in Section 3.01. The note, including a general summary and/or country specific considerations, shall describe the recognition methodologies applied, and should include the treatment of multi-year contracts, VAT and other tax aspects, currency aspects and other issues related to the timing and amount of Transfers of Value for purposes of this Code, as applicable.
Section 4.01. Enforcement through Member Associations. Each Member Association shall adopt Implementation and Procedure Rules (as set forth in more detail in Schedule 3), 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 of sanctions in a manner consistent with applicable data protection, competition and other applicable laws and regulations (3).
Section 4.02. Transposition in Member Associations’ Codes. Each Member Association shall transpose the provisions of this Code into its national code by 31 December 2013. This Code 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 Code shall not be deemed to constitute deviations from this Code.
Section 4.03. Disclosure Requirements Different from this Code. Any proposal to transpose this Code into a national code, or to amend any provision transposing this Code, that requires disclosures different from those required under this Code, 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 General Assembly shall be asked to confirm consistency with this Code, following an EFPIA Board decision after consultation with the EFPIA Codes Committee. Member Companies abiding by such Member Associations’ codes as confirmed by the EFPIA General Assembly shall not be considered to have failed to meet their obligations under this Code.
If the applicable national law or regulation, the relevant national code or other industry self-regulation prescribes equivalent or more stringent disclosure requirements, the relevant Member Company shall comply with such equivalent or more stringent requirements in a manner as consistent as possible with the substantive disclosure requirements of this Code.
Section 4.04. Sanctions. Each Member Association should include in its code provisions governing the imposition of sanctions for violations of its code. Sanctions should be proportionate to the nature of the infringement, have a deterrent effect and take account of repeated offences of a similar nature or patterns of different offences. A combination of publication and fines will generally be considered to be the most effective sanction; however, each Member Association may use any other appropriate sanction to enforce its 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 or fines are not permitted due to applicable legal, regulatory or fiscal requirements, Member Associations should impose the best alternative effective sanction.
Section 4.05. Reporting. The EFPIA Codes Committee shall produce at least annually reports summarising:
(i) the transposition by Member Associations of this Code into their national codes (such report to be produced by 31 March 2014, which date is three months after the deadline for the transposition of this Code by Member Associations and prior to the 2014 General Assembly so as to allow sufficient time to remedy inadequate or incomplete transposition by any Member Association); and
(ii) once this Code has been transposed into national codes and disclosures are made for the first time in 2016 (no later than 30 June 2016), activities related to this Code (first such report to be produced in September 2016).
Section5.01. 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 Schedule 3 attached to this Code.
Section 5.02. Amendments to the Code. The EFPIA Codes Committee shall regularly review this Code and any guidance issued regarding compliance with this Code.
Any proposed amendments to the Code will be submitted for the EFPIA Board decision and the EFPIA General Assembly ratification. Proposed amendments to this Code shall be reviewed by the Codes Committee following consultation with the EFPIA membership and the relevant EFPIA committees.
Donations and Grants
Donations and Grants, collectively, means those donations and grants (either cash or benefits in kind) within the scope of Article 11 of the HCP Code.
All promotional, scientific or professional meetings, congresses, conferences, symposia, and other similar events (including, but not limited to, advisory board meetings, visits to research or manufacturing facilities, and planning, training or investigator meetings for clinical trials and non-interventional studies) (each, an “Event”) organised or sponsored by or on behalf of a company. (Article 10 of the HCP Code).
Any legal person (i) that is a healthcare, medical or scientific 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 patient organisations within the scope of the EFPIA PO Code) whose business address, place of incorporation or primary place of operation is in Europe or (ii) through which one or more HCPs provide services.
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 or her professional activities, may prescribe, purchase, supply, recommend or administer a medicinal product and whose primary practice, principal professional address or place of incorporation is in Europe. For the avoidance of doubt, the definition of HCP includes: (i) any official or employee of a government agency or other organisation (whether in the public or private sector) that may prescribe, purchase, supply 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.
EFPIA Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals, adopted by the EFPIA Board on 5 July 2007 and ratified by the EFPIA Statutory General Assembly on 19 June 2008, amended on 14 June 2011, and as further amended on 24 June 2013, and as may be amended, supplemented or modified from time to time.
Medicinal Products as used in the EFPIA HCP/HCO Disclosure Code has the meaning set forth in Article 1 of the Directive 2001/83/EC, including: medicinal products, immunological medicinal products, radiopharmaceuticals, medicinal products derived from human blood or human plasma, for which a marketing authorisation has been delivered in application of Directive 2001/83/EC.
Collectively, the national Member Associations or their constituent members, as the context may require, and bound by the EFPIA codes of practice, including the EFPIA HCP Code, the EFPIA PO Code and the EFPIA HCP/HCO Disclosure Code.
Collectively, “corporate members” (as defined in the HCP Code) of EFPIA, their respective parent companies, if different, subsidiary companies (irrespective of whether a subsidiary is a company or such other form of enterprise or organisation) and any companies affiliated with corporate members or their subsidiaries
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 – shall be deemed to constitute a single company, and is as such committed to compliance with the EFPIA Codes.
EFPIA Code of Practice on Relationships between Pharmaceutical Industry and Patient Organisations, adopted in 2007 and as amended by the General Assembly on 14 June 2011, and as may be amended, supplemented or modified from time to time.
Any HCP or HCO as applicable, in each case, whose primary practice, principal professional address or place of incorporation is in Europe.
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 Directive 2001/20/EC); 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).
Transfers of Value
Direct and indirect transfers of value, whether in cash, in kind or otherwise, made, whether for promotional purposes or otherwise, in connection with the development and sale of prescription-only Medicinal Products exclusively for human use. Direct transfers of value are those made directly by a Member Company for the benefit of a Recipient. Indirect transfers of value are those made on behalf of a Member Company for the benefit of 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.
This version approved by the Board will be submitted to General Assembly ratification on 6 June 2014.
The Implementation and Procedure Rules set out below establish the framework for the implementation of the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations (the “Code”), the processing of complaints and the enforcement of sanctions ordered by Member Associations.
SECTION 1. Member Association Implementation
Each Member Association is required to:
establish national procedures to receive and process complaints, to determine sanctions to be ordered 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 non-industry chairman and, besides any industry members, membership from other stakeholders;
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
prepare, 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 applicable year.
SECTION 2. EFPIA Codes Committee Implementation and Key Tasks
The EFPIA Codes Committee shall assist Member Associations to comply with their obligations under Section 1 above:
The EFPIA Codes Committee will be composed of all the national code secretaries, who will elect a chair among their peers, assisted by one person from the EFPIA staff.
As a key part of its role of assisting Member Associations in their national code compliance activities, the EFPIA Codes Committee shall monitor the adoption of national codes. The EFPIA Codes Committee will not participate in the adjudication of any individual complaint under any national code.
In order to promote the Code and to encourage best practice among Member Associations, the EFPIA Codes Committee will, at least annually, invite Member Associations and company representatives to participate in a meeting at which the participants will be encouraged to share their respective relevant experiences relating to the Code. Any conclusions from the meeting shall be summarised in the Annual Codes Report (referred to under (e) of this Section 2 below) and, if appropriate, be presented to the EFPIA Board.
The EFPIA Codes Committee shall publish an Annual Code Report which will summarise the work 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 Section 1(c) above.
On an annual basis, the EFPIA Codes Committee shall: (i) advise the EFPIA Board of its work and operations and the work and operations of the Member Associations, as summarised in the Member Association’s annual reports; and (ii) review with the EFPIA Board any additional recommendations to improve the Code with a view towards increasing transparency and openness within the pharmaceutical industry and among Member Associations and companies.
SECTION 3. Reception of Complaints
Complaints may be lodged either with a Member Association or with EFPIA. Adjudication of complaints shall be a matter solely for the Member Associations.
Complaints received by EFPIA shall be processed as follows:
EFPIA will forward any complaints it receives (without considering their admissibility or commenting upon them) to the relevant Member Association(s).
EFPIA will send an acknowledgement of receipt to the complainant, indicating the relevant Member Association(s) to which the complaint has been sent for processing and adjudication.
In addition, upon receipt by EFPIA of multiple external complaints (i.e. several complaints on the same or similar matter(s) lodged from outside the industry against several subsidiaries of any company), EFPIA will communicate these complaints to the Member Association either of the parent company or of the European subsidiary designated by the parent company.
SECTION 4. Processing of Complaints and Sanctions by Member Associations
Member Associations shall ensure that industry and non-industry complaints are processed in the same manner, without regard to who made the complaint.
Complaints will be processed at the national level using the procedures established by the relevant Member Association(s) pursuant to Section 1(a) above. Each Member Association’s national body shall take decisions and order any sanctions on the basis of the national code in force in its country.
Where a complaint fails to establish a prima facie case for a violation of the applicable national 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.
Each Member Association should establish effective procedures for appeals against the initial decisions made by its national body at the national level.
Member Associations shall ensure, to the extent permissible, that any final decision taken in an individual case shall be published in its entirety or, where only selected details are published, including a level of detail that takes into account the seriousness and/or persistence of the breach as follows:
(i) in cases of a serious/repeated breach, the company name(s) should be published together with details of the case;
(ii) in cases of a minor breach, or where there is no breach, publication of the details of the case may exclude the company name(s).
Member Associations or national disciplinary bodies are encouraged to publish summaries in English of cases that have precedential value and are of international interest (keeping in mind that cases resulting in the finding of a breach as well as those where no breach is found to have occurred may each have such value and/or interest).