From 1 July 2016 pharmaceutical companies that are members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) will begin publishing 2015 data on payments or “transfers of value” to healthcare professionals, organisations and hospitals. The voluntary EFPIA code introduces a significant new level of public scrutiny regarding pharmaceutical companies’ relationship with healthcare professionals across a total of 33 European countries. By highlighting potential anomalies and allowing public scrutiny of detailed information, the code could facilitate greater transparency and cost-efficiency within healthcare systems, as well as serve to reduce conflicts of interest in cases involving suspicious contributions.
The EFPIA code will pave the way for a new era for the European pharmaceutical sector. But there is undeniable caution within some quarters of the industry that, unless handled properly, the first wave of data releases may have a negative impact in terms of causing public misconceptions and controversial media headlines.
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Data collection and communication of the analysis pose a significant challenge for the industry
Drug companies have had several years to prepare for the new transparency-based rules and some of the larger pharmaceutical companies gained valuable experience complying with so-called “sunshine” laws in the United States and Australia. Even so, there are concerns small numbers of medium-sized firms may struggle to meet the initial data disclosure deadline in four months time.
At present the disclosure requirements are on a voluntary basis; although, long-term, the European Federation of Pharmaceutical Industries and Associations (EFPIA) code is likely to become legally binding. In fact, rather than heading-off mandatory legislation in Europe, the implementation of the EFPIA code will probably spur European authorities to require data disclosures on their own terms.
There is a growing need for the industry to try to manage public expectations in terms of the uniformity and depth of information that can be expected across all 33 European countries. The likelihood is that the information on “transfers of value” will have a high degree of country-to-country and regional variation. Several countries already have stringent national legislation in place covering 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 (above a value of EUR10). On the other hand, a number of European countries have not implemented such strong governance systems and, at least during the initial years of EFPIA data releases, may struggle to achieve a 100% compliance rate. This situation should improve incrementally. However, data discrepancies and inaccuracies are anticipated, given that each of the 33 countries can interpret the EFPIA code slightly differently.
Another problem that is likely to emerge is that the majority of pharmaceutical covered by the EFPIA code will disclose information through company websites. Only firms based in Belgium, the Czech Republic, Denmark, France, Ireland, Portugal the Netherlands, Russia and the United Kingdom are expected to disclose the payment information data through a central portal. In some cases this will inevitably make accessing and interpreting the data more challenging for the public. This feature of the data release is hardly ideal and could tarnish the goal of promoting public confidence in the pharmaceutical industry’s relationships and influence with healthcare professionals in Europe.
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By GlobalDataDisclosure of personal data referring to healthcare professionals directly can also require consent in certain countries under data protection directives (including the UK, Austria, Greece, Hungary, Luxembourg, and Switzerland). Denmark, France, Portugal and the Netherland do not require consent. Elsewhere, in the event consent is withheld, healthcare professionals’ names may have to be anonymised, which could in turn draw public criticism through no fault of the pharmaceutical company in question. The problem is likely to be particularly prevalent in Poland, Spain and Italy but may recede as healthcare professionals become more familiar with the system in years to come.
Pharmaceutical companies that are members of the EFPIA will be obliged to disclose financial relationships, including research grants, consultancy fees, gifts, and speakers fees. This is likely to draw closer public scrutiny and in the short term may lead to a potentially negative media focus that drowns out the benefits of the pharmaceutical industry’s relationships with healthcare professionals in Europe. Notably, the publication of similar data in the US resulted in a dent to public confidence in drug companies. Time will tell whether a similar pattern establishes itself in a European context. In a limited set of circumstances where a company is deemed not to have fully disclosed all relevant data at its disposal, under the terms of the EFPIA code, a fine and censure may be imposed.
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European Federation of Pharmaceutical Industries and Associations