EFPIA Transparency Guidelines: Reporting Payments in Europe

In a recent update from the international law firm Fulbright & Jaworski, through its soon-to-be new firm Norton Fulbright (now Norton Rose), the law firm discussed the disclosure of payments to healthcare practitioners in the United Kingdom (UK).

The UK pharmaceutical industry has started publicly disclosing aggregate data on payments to healthcare practitioners (HCPs) and consulting on establishing a public register to disclose individual payments from 2016 onwards.

As we previously noted, payments from the pharmaceutical industry working with HCPs have been estimated to be around £40 million for 2012 in the United Kingdom.

“Collaborative working between HCPs and pharmaceutical companies has long been a positive driver for advancements in patient care and the progress of modern medicine. However, concerns have been raised around ethics and transparency. As a result, there has been a global shift towards greater transparency of financial relationships, with approaches ranging from legislation in the United States of America to self-regulation in the United Kingdom,” the alert notes.

Background

On June 24th, 2010, the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the research based pharmaceutical industry in Europe and comprises national associations and leading companies as members, made a public commitment to work towards greater transparency and ethical behavior within an industry framework of self regulation.

“EFPIA’s commitment reflects the objectives of the European Commission’s Corporate Social Responsibility (CSR) initiatives.” On September 24, 2010, the Commission emphasized the importance of facilitating discussion on the ethics and transparency of the pharmaceutical sector in particular. As a result of these CSR initiatives, on October 25, 2011, a Commission communication “A renewed EU strategy 2011-14 for Corporate Social Responsibility” was made to the European Parliament, Council, the European Economic and Social Committee and the Committee of the Regions.

“The Commission’s strategy provides that the development of CSR should be led by enterprises themselves and recognizes that self or co-regulation processes, for example industry codes of conduct, can be an effective means of ensuring responsible business conduct. It was considered that public authorities should play a supporting role in the development of an appropriate approach through a mix of voluntary policy measures and, where necessary, complementary regulation.” The strategy led to the creation of a platform for the pharmaceutical industry “whose ultimate goal is to establish reciprocal relations between all stakeholders that are based on mutual trust and led by transparency.”

On November 6, 2012, the platform’s steering group approved a “List of Guiding Principles Promoting Good Governance in the Pharmaceutical Sector” (Guiding Principles). A commitment was made in the Guiding Principles to working together with all stakeholders to set out a clear approach to full transparency of financial transactions and other declarations of interest.

EFPIA’s codes of practice

“EFPIA supports the Commission’s initiatives on CSR and has identified that one of the most important relationships that the pharmaceutical industry has is with HCPs. A number of EFPIA’s codes of practice, setting out minimum standards applicable to member companies and affiliates that have agreed to be bound already,” contain transparency provisions relating to:

• encouraged disclosure of information about donations, grants or benefits in kind made to healthcare organisations (HCOs) that are comprised of HCPs and/or that provide healthcare or conduct research; and
  
• details of the patient organisations which receive, directly or indirectly, any financial support including a list of names and amounts.
  

To ensure greater transparency in relation to the nature and extent of relationships with HCPs, “EFPIA is developing a new code of practice regarding transfers of value from pharmaceutical companies to HCPs/HCOs (Disclosure Code) and preparing further amendments to its HCP code of practice.” The new and amended codes, the alert explains, “will be made publicly available after formal approval by the EFPIA General Assembly in June 2013.” The proposed framework for the codes or practice was presented on January 17, 2013 by the Deputy Director General of EFPIA at the annual conference of the International Pharmaceutical Congress Advisory Association (IPCAA), a membership organization focusing on medical congress management.

The IPCAA presentation states that the Board of EFPIA had decided in the context of the Commission’s initiatives and the Guiding Principles that from 2016 all members will declare all financial relations with individual HCPs and HCOs relating to:

• donations and grants;
  
• sponsorships, events and hospitality; and
  
• fees for service and consultancy,
  

“but disclose only aggregate data in relation to transfers of value associated with research and development (for example, pre-clinical studies, clinical trials and observational studies).”

“It is expected by EFPIA that companies will each generate their own databases declaring relevant financial relationships, with the Disclosure Code framing the disclosure process. According to the stated timetable, member associations must transpose the provisions into national codes by December 31, 2013.”

“EFPIA’s codes of practice also require compliance with the national code of the country in which a company is located and the national code of the country in which it is undertaking relevant promotion or interaction. These national codes may extend further than EFPIA’s minimum standards that must be adopted in member associations’ national codes. In the event of conflict the more restrictive provisions will apply.”

“In the UK the control of interactions between companies and HCPs is based on a long established system of self-regulation. The Association of the British Pharmaceutical Industry Code of Practice (ABPI Code) sets the standards for promotion of prescription medicines to HCPs in the UK. It also applies to a number of areas that are non-promotional. It is a condition of membership of the ABPI to abide by the ABPI Code and most other companies operating in the UK which are not members have given their formal agreement to abide by the ABPI Code and accept the jurisdiction of the Prescription Medicines Code of Practice Authority (PMCPA), the arms length self-regulatory body responsible for administering and publishing details of cases considered under the ABPI Code.”

“The requirements of the ABPI Code extend beyond relevant legal requirements and are drawn up in consultation with the British Medical Association (BMA), the Royal College of Nursing (RCN), the Royal Pharmaceutical Society (RPS) and the Medicines and Healthcare products Regulatory Agency (MHRA). This system of self-regulation, which is seen as the first means of dealing with complaints, is also underpinned and supported by the MHRA acting as the competent authority responsible for administering medicines law in the UK, further details of which are set out in:

• a Memorandum of Understanding between the MHRA, ABPI and PMCPA; and
  
• the MHRA’s Blue Guide which includes guidance on the law relevant to advertising and promotion of medicines to HCPs in the UK and other matters not covered by the memorandum such as advertising over-the counter medicines to the public.”
  

Amendments to the ABPI Code

“Changes in the 2011 ABPI Code in relation to interactions with HCOs and HCPs introduced a number of transparency provisions which took effect in 2012 and 2013. These changes provide that pharmaceutical companies must make disclosures in relation to:

• details of donations and grants to HCOs
  (clause 18.6);
  
• financial details of sponsorship of HCPs and administrative staff in relation to attendance at meetings organized by third parties
  (clause 19.4); and
  
• details of fees paid to consultants, directly or indirectly, for certain services or market research but not including payments associated with research and development work
  (clauses 20.2, 20.3, and 20.4).”
  

Other transparency changes made to the ABPI Code in 2012 relate to payments to patient organisations, requiring pharmaceutical companies also to disclose from 2013:

• details of the patient organizations which receive, directly or indirectly, any financial support including a list of names and amounts
  (clause 23.7); and
  
• details of contracted services from patient organisations, a list of names and the total amounts paid
  

The ABPI has confirmed the commitment of the pharmaceutical industry in the UK to disclose certain payments to HCPs at an individual level across Europe by 2016 for payments made in 2015 onwards.

In the move towards this level of disclosure, in January 2013 the Ethical Standards in Health and Life Sciences Group (ESHLSG), a multi stakeholder industry group which includes as members the ABPI, BMA, RCN and RPS and represents the pharmaceutical, medical device and diagnostic sectors, launched a public consultation on how this can be achieved. The consultation is open until the end of April 2013 and ESHLSG will publish a report on the results during 2013.

The consultation is intended to establish whether there is support in principle for a publicly available, single, searchable system for disclosure of payments such as:

• fees for consultancy services;
  
• financial sponsorship for attendance at independent medical education meetings; and
  
• payments received for research and development activity.
  

It is proposed that this system would be inclusive of all companies working in healthcare and would be delivered by HCPs and industry in partnership.