EU Commission clarifies REC position in draft Clinical Trials Regulation

At the final session of the DIA EuroMeeting in Amsterdam, earlier this week, Stefan Fuhring of the pharmaceuticals unit at the European Commission clarified the view of the Commission with regard to the position of Research Ethics Committees (RECs) in the draft Clinical Trials Regulation that is currently being discussed in the European Parliament.

In his presentation, he confirmed that the proposed Regulation does not exclude RECs and does not limit their scope to national, cultural or site issues. The proposed process will see each concerned Member States (MSs) make a single decision on all aspects of the study. Article 9 of the draft states that a REC opinion must be taken into account, but Mr Fuhring said that the Commission ultimately “doesn’t care” how aspects of that decision are divided up within each MS. The diversity of organisations and processes for ethics review in each MS, in the view of the Commission, make its harmonisation impossible and unnecessary for the proposed system to work.

In the same session, Greet Musch of the AFMPS (Belgian Competent Authority, CA) presented how some aspects of an application might be considered with the CA taking the lead and the REC able to comment, with the pattern reversed for other aspects. She also pointed out that ongoing discussions had highlighted the desire for the Declaration of Helsinki to be explicitly mentioned in the text of the Regulation, and for more to be done to facilitate cooperation of REC systems across the EU.

Earlier in the meeting, Mr Fuhring had “disagreed in the strongest possible terms” with a presentation by Anna Hallersten of SFL Regulatory Affairs and Scientific Communications, which had presented comments made by ethicists in several MSs to the draft Regulation, questioning the lack of direct mention of RECs and expressing concern that RECs and processes around ethics review might be sidelined or excluded from the new Regulation. The session chair diplomatically reminded Mr Fuhring “not to shoot the messenger”. However, it was clear from the public comments compiled in Ms Hallersten’s presentation that this concern was genuinely felt, at least until the points were clarified in Mr Fuhring’s presentation later in the day.

Two reports will be published by Committees of the European Parliament over the next few weeks, with a first reading and vote in the full Parliament scheduled for June 2013.