The European Parliament confirmed on Thursday 8 July its negotiating position on the revision of the mandate of the European Medicines Agency (EMA). MEPs overwhelmingly supported (587 votes in favour, 28 against, 81 abstentions) the report by Socialist Nicolás González Casares (Spain) on the subject.
The text differs little from the one voted on in the parliamentary committee (see EUROPE 12752/15). In particular, Parliament added an article detailing the penalties, “including financial”, applicable in cases where marketing authorisation holders, medical device manufacturers, and other entities involved in the prevention of shortages of medicines fail to comply with their obligations in this respect—obligations set out in Articles 10 and 24 of the future regulation. This possibility has not been considered by the EU Council at this stage (see EUROPE 12741/7).
Finally, notwithstanding the Commissioner for Health, Parliament will ask for a one-year delay in the launch of the steering group on medical device shortages. It also intends to negotiate the creation of a European database on medicines supply (see EUROPE 12757/2). The amendments tabled by the EPP on this subject were all rejected.
A first interinstitutional meeting (trilogue) on this file will take place before the summer break, at the end of July, a diplomatic source confirmed to EUROPE.
See Parliament’s position: https://bit.ly/3yzz131 (Original version in French by Agathe Cherki)