Negotiators from the European Parliament and the Council of the European Union continued their interinstitutional negotiations (trilogue) on Monday 31 May over a draft regulation that will establish common clinical evaluations (see EUROPE 11951/6).
This meeting, which took place after a month of work having been done on a technical level, allowed co-legislators to make progress on two central points of the future regulation – Articles 7 and 8 – over which the two European institutions are making fundamentally opposing demands.
Article 7 provides a framework for the implementation of a list that will identify health technologies that have been assessed at European level. Among other things, it puts in place the provision for a final verification to be carried out by the European Commission and gives responsibility to the Commission to list the assessed technologies.
The article, which was relatively unamended by MEPs, was nevertheless completely removed from the EU Council’s position, since they do not want a binding European evaluation mechanism.
The same issue applies to Article 8, which deals with the use at national level of clinical evaluation reports that were produced at European level.
MEPs require Member States to use these reports in their national assessments and to not duplicate on an individual basis what would have already been done at the level of the EU27. Member States, on the other hand, would like to simply “give due consideration” to the information available at European level, so that this “does not affect their competence” and does not prevent them from “drawing conclusions” over the clinical added value of a health technology.
There is still no compromise yet on these two elements, but there is “progress” confirmed a European source to EUROPE on Tuesday 1 June.
Monday’s negotiating session also provided an opportunity to have an exchange over the main political points and to approve the work done upstream on a technical level.
The negotiators “decided to continue the technical discussions in order to prepare for the next and hopefully last trilogue, already scheduled for 21 June”, the same EU source added. (Original version in French by Agathe Cherki)