For years, BEUC and many other organisations pressed for the transfer of responsibility for medicines from DG Enterprise to DG Sanco. It seemed wrong that one DG should combine responsibility for medicines with responsibility for promoting the European pharmaceutical industry. It was not, in my view, a question of impropriety but rather that it would be difficult for one DG to have a clear headed view of the two issues simultaneously. (I donâ€™t know of any national government where the regulation of medicines is the responsibility of the industry rather than the health ministry.)
We got our wish at the beginning of the current Commission (Barosso II).
We had been often told that the Commission worked as a college and that it did not really matter which DG had which tasks. I think it did matter. I think there would not have been so much transparency on clinical trials under the previous arrangement, with DG Enterprise in the lead.
Internally within the Commission DG Enterprise was opposed to the new provisions on transparency put forward by the Parliament. By some accounts, DG Sanco was not enthusiastic about these new provisions either but they did hold the line and agree to them eventually. I believe the outcome might have been different if DG Enterprise had been the lead DG here. It would have been difficult in that case for DG Sanco to change the Commission position.
Internally, DG Trade was also opposed to the transparency provisions on the grounds that they would create difficulties in the negotiations on TTIP. I think this was scandalous. It is one thing to argue against a proposal that is contrary to an existing agreement; it is quite another to argue pre-emptively that the EU should not make its own decision on medicines in case it might cause difficulties in future negotiations. This was to use, not an existing agreement but the possibility of a future agreement, to try to limit the EUâ€™s freedom to regulate now.
The European and US pharmaceutical industry associations were very much opposed to the transparency provisions in the revision of the clinical trials directive, as they are opposed to the new transparency policy of the European Medicines Agency. They will try to use the TTIP to roll back these provisions and policies. I will say more about this in my next blog. END