Jim Murray: The EU, transparency, and access to clinical trial results

jim_murrayHow is the EU involved in transparency and access to clinical trial results? Many readers will know this already, but perhaps not all. For obvious reasons, health professionals have tended to focus on the national and they might not all appreciate the strength of the “side-wind” blowing from the EU.

The EU was formed on the basis of a common market, an area of free movement of people, capital, and goods, and in this context “goods” included pharmaceuticals. Thus the EU has competence, within limits, to make laws coordinating or “harmonising” rules on the authorisation of medicines and clinical trials, and to set up the European Medicines Agency.  Without at least some common rules there cannot be a common market in pharmaceuticals.

This partly explains why the industry division (now DG Enterprise) of the European Commission was given responsibility for pharmaceuticals—one industrial product among many for which a single market would be developed.  The same DG was also responsible for promoting the European pharmaceutical industry, and it showed. A major communication on medicines policy in 2008 was entitled, “Safe, Innovative, and Accessible Medicines: a renewed vision for the Pharmaceutical Sector” (my emphasis).

In 2010, at last, responsibility for medicines was passed to the general directorate for health and consumers, DG Sanco.  Unfortunately, the mind-set in DG Sanco does not appear to me to be very different, so far, from that of their predecessors in enterprise, apart perhaps from consulting more widely. There were no signs of new thinking in the DG Sanco management plans and roadmaps for 2011 and 2012.  The proposed revision of the Clinical Trials Directive was justified on the grounds of reducing unnecessary administrative burdens, a key (and valid) industry demand, but DG Sanco has shown little or no acknowledgement of any need to improve the quality, transparency, and rigour of the science and evidence base for medicines policy. Among senior officials,  I can detect no sense of “ownership” of such issues as publication bias, access to clinical trials results, authorship, and the like.

The European Parliament and the European Medicines Agency have tried to move forward on transparency, but DG Sanco seems to be lagging behind. It is not clear if they will support the parliament’s initiative on transparency and they do not appear to have little enthusiasm for the efforts of the European Medicines Agency either.

Competing interests: I declare that that I have read and understood the BMJ Group policy on declaration of interests and I have no relevant interests to declare.

Jim Murray is a former director of BEUC the European Consumers Organisation, having previously been the first director of the Office of Consumer Affairs and Fair Trade in Ireland. He writes here in a personal capacity. During his time with BEUC, he was a founder and one time president of the Transatlantic Consumer Dialogue. Currently he is a member of the European Commission’s High Level Group on Administrative Burdens, and president of the European Foundation for Financial Inclusion.