Transparency risks “misuse of data” says commissioner due to oversee regulation of medicines in EU

Yesterday, the likely European Commissioner for industry who will oversee the regulation of medicines and the EMA said there are risks that need to be balanced with greater clinical trial transparency. MEPs have been questioning the candidates for the new European Commission and, if approved by MEPs, Elżbieta Bieńkowska will lead the industry department (DG ENTR).

The new president of the European Commission, Jean-Claude Juncker, recently moved the responsibility for the regulation of medicines from the health to the industry department. When asked whether this move would allow industry lobbying to affect drug regulations, Ms Bieńkowska said, “All my professional experience shows that I am lobbyist-proof. I’m absolutely lobbyist-proof”. Glenis Willmott MEP said, “It is disappointing Ms Bieńkowska didn’t answer directly whether or not she thinks pharmaceutical and medical devices should really be in the health commissioner’s portfolio.”

Ms Willmott also asked Ms Bieńkowska if she will ensure the EMA’s commitment to greater clinical transparency will continue. Ms Bieńkowska replied that clinical trial transparency is important for Europe; “however, you have to look at the other side and ensure there are adequate levels of safety when it comes to the potential misuse of data.” We’ve heard this claim before and we responded on our “Myths & Objections” page.

MEPs will vote to appoint the candidates to the European Commission on 22^nd October.

Update 13th October 2014: EurActiv reports that responsibility for the EMA is set to remain with the health department (DG-SANCO).