The European Federation of Pharmaceutical Industries and Associations (EFPIA) deadline for full disclosure of transfer-of-value payments to healthcare professionals and healthcare organisations will take effect from 30 June 2016.
Implications | The EFPIA disclosure code is due to come into force from 30 June. The first set of data releases on transfer-of value-payments from pharmaceutical companies to healthcare professionals and organisations in Europe will refer to 2015. |
Outlook | Proponents have welcomed the EFPIA code as positive in terms of increasing public awareness and broadening citizen access to information. The large-scale data disclosure is likely to increase the level of public scrutiny regarding collaboration activities, and relationships between research-based pharmaceutical firms, healthcare organisations, and doctors. |
From 30 June 2016, a new voluntary European Federation of Pharmaceutical Industries and Associations (EFPIA) disclosure code governing the transfer-of-value payments made by pharmaceutical companies to healthcare professionals and organisations in Europe will come into effect. The self-regulation code will be applied on a Europe-wide basis (across 33 countries), and will include both monetary payments and payments in kind. EFPIA members will be obliged to disclose information on research grants, consultancy fees, gifts, and speaker fees (including for education-related conferences), as well as payments made to healthcare professionals for attendance at conferences (such as travel and accommodation expenses), although it must be noted that such payments are not evidence of any wrongdoing.
In certain cases, a special derogation is in place allowing pharmaceutical companies to provide aggregate and anonymised information (assuming that healthcare professionals withhold consent to be named). Disclosure of personal data referring to healthcare professionals directly requires consent in certain countries under data protection directives (including the United Kingdom, Austria, Greece, Hungary, Luxembourg, and Switzerland). Denmark, France, Portugal, and the Netherlands do not require consent.
The initial quality of information will likely be subject to a high degree of country-to-country and regional variation. Several countries already employ stringent national legislation governing the disclosure of payments; these include Denmark, Estonia, Greece, Latvia, Lithuania, Portugal, Romania, the Netherlands, and Slovenia, among others. France also has a well-instituted system for disclosing payments through the May 2013 "Le Loi Bertrand" legislation, requiring all gifts to medical professionals to be documented. Conversely, a number of European countries do not have such strongly enforced governance systems and, at least during the initial years of EFPIA data releases, may struggle to achieve 100% compliance rates. This situation should improve incrementally; however, data discrepancies and inaccuracies are anticipated, particularly since it is possible for individual countries to each utilise a slightly different interpretation of the EFPIA code.
In the majority of cases information will disclosed on company websites, potentially rendering the interpretation of data more challenging for the public. Elsewhere, firms based in Belgium, the Czech Republic, Denmark, France, Ireland, Portugal, the Netherlands, Russia, and the United Kingdom are expected to disclose information data through a central portal.
By highlighting potential payment anomalies and allowing public scrutiny of detailed information, the EFPIA code holds the potential to facilitate greater transparency and cost-efficiency within healthcare systems, as well as serving to reduce conflicts of interest.
Outlook and implications
The transparency-based rules will usher a new era for the European pharmaceutical sector, whereby participating companies are obliged to publish information annually covering transfer-of-value payments to healthcare professionals and organisations. Future 12-month data releases must be issued prior to an end-of-June deadline each year. Compliance with the code will impose a heavy burden on some smaller and medium-sized pharmaceutical companies; the majority of larger pharmaceutical players are sufficiently experienced in complying with similar regulations in the United States and Austria for this to pose fewer challenges. At present, the EFPIA's data-disclosure requirements are on a voluntary basis. However, in the longer term, the EFPIA code is likely to become legally binding; this would bring benefits for the pharmaceutical sector, holding the possibility of mitigating the threat of potentially mandatory EU legislation.
The EFPIA code has the potential to increase public confidence in the transparency of the European pharmaceutical and medical-device industry. However, there is a risk that a small number of firms could face complaints related to alleged conflicts of interest: limited sanctions can be imposed (such as a fine or censure) for violations of the EFPIA code.
The EFPIA code will mark the first comprehensive public disclosure of financial transactions in Europe between the industry and physicians, pharmacies, hospitals, research organisations, and patient groups, among other organisations. The unprecedentedly detailed view of industry payments is therefore regarded by the majority of healthcare stakeholders in Europe as a valuable bid to increase transparency and accountability.