The EU Council working group on “Pharmaceuticals and Medical Devices” continued on Tuesday 11 May its examination of the legislative package presented by the European Commission last November (see EUROPE 12600/24), with a view to better preventing future health crises.
The discussions on Tuesday focused on the proposed revision of the regulation establishing the European Centre for Disease Prevention and Control (ECDC), in order to strengthen the mandate of the ECDC.
The working group discussed a first draft compromise, dated 7 May, which made relatively few changes to the original draft revision.
One of these changes relates in particular to the EU Health Task Force, which the ECDC could deploy in the event of a health crisis, “to assist local responses to outbreaks of diseases”. This would include setting up missions in the Member States, as well as in third countries.
The EU Council’s draft compromise suggests that a “permanent” task force should be established, so that the ECDC can “maintain” its capacity to carry out such missions.
Other changes include the reintroduction of the provision—deleted by the Commission—that the candidate nominated by the ECDC Management Board to head the institution must be invited “to make a statement before the European Parliament and to answer questions” from MEPs.
Finally, several amendments presented in this draft compromise reflect a desire to involve Member States even more in the work of the ECDC. They require, for example, that the latter involve the “national focal points for surveillance” in the preparation of risk assessments.
The paper also suggests that ECDC should develop rules of procedure for such risk assessments, “especially regarding the involvement of experts to ensure independency and representativeness of Member States expertise”.
With regard to the collection of data by the ECDC, the draft compromise also recommends “seeking the expertise and guidance of the Member States” for a proper understanding of the health data made available, as well as their limitations and the national context.
See the draft compromise: https://bit.ly/3w1xxNx
European Medicines Agency
The EU Council’s desire to ensure that a number of prerogatives remain in the hands of the Member States is also reflected in the EU Council’s draft compromise on the second part of this legislative package, namely the proposal for a Regulation “on a strengthened role for the European Medicines Agency (EMA)” (see EUROPE 12700/17).
The draft compromise, of which EUROPE has obtained a copy, is dated 30 April and was reviewed by the EU Council working group on 4 May.
In particular, it states in its recitals that “all decisions on clinical trial applications should remain within the remit of the Member States concerned where the trials are to be conducted”.
The draft also requires that the future Medicines Steering Group—which the Commission suggests be set up—be chaired by the EMA “and co-chaired by a representative of a Member State”. The same applies to the Steering Group on Medical Devices.
The document is further punctuated by the phrases “without prejudice to the tasks of the Member States” and “in collaboration with the Member States”. (Original version in French by Agathe Cherki)