New EU president Juncker has taken the responsibility for the regulation of medicines away from the health department and handed it to the industry department. This means that the section of the European Commission with oversight for the European Medicines Agency (EMA) will no longer be DG SANCO (the Health and Consumers Directorate General) and will now be DG Enterprise.
Síle Lane, Director of Campaigns, Sense about Science and co-founder of AllTrials:
In the last year, the EMA has taken steps to proactively publish clinical study reports. President Juncker must show that this commitment to clinical trial transparency will not slip following the move of medicines regulations from Health to Enterprise.
When I was negotiating the transparency laws for clinical trial results, it was DG Enterprise that wanted to water the rules down. Now they will be overseeing the European Medicines Agency as it implements the transparency regime, which is frankly concerning. Following the breast implant scandal people expect stronger regulation of medical devices, regulation that protects patients. Clearly medical devices should be the responsibility of the Heath Commissioner. This was a bad decision from President Juncker, I hope he will quickly come to his senses and rectify it.
Policies on pharmaceuticals and medical devices should be designed to promote and protect public health, but DG Enterprise is mandated to promote the competitiveness of these industries, not the health of consumers.
Update 13th October 2014: EurActiv reports that responsibility for the EMA is set to remain with the health department (DG-SANCO).