The Council of the EU adopted, on Tuesday 15 June, its position for the negotiations with the European Parliament on the draft regulation aimed at reinforcing the role of the European Medicines Agency (EMA).
This initiative will allow the EMA to better anticipate possible shortages of medicinal products and ensure their timely development. The aim is to improve the EU’s capacity to respond to health emergencies.
In this respect, the Commission suggested the creation of two ‘Steering Groups’ within the Agency - one dedicated to shortages of medicinal products, the other to shortages of medical devices - as well as a task force for emergency situations.
The latter will meet only in the event of a public health emergency and will then have the main task of facilitating clinical trials. The Steering Groups may need to meet more regularly, for example in anticipation of a health risk. They will be responsible, among other things, for drawing up lists of medicinal products and medical devices considered necessary to respond to a public health emergency.
Some changes were made in the text approved by the EU Council on the functioning of these three future formations, some of which reflect the desire of Member States to retain control over the management of medicinal products.
Thus, while the Commission proposed that the EMA should chair the two steering groups, the Member States opted - after several discussions on the subject (see EUROPE 12718/3, 12733/25) - for a shared chairmanship between the Agency and “a representative of a Member State”.
Data and funding
In addition, the Member States have added two articles to the initial proposal which, the EU Council explains, will make it possible to “clarify the provisions” concerning the financing of the initiative and data protection.
On the first point, they specify that it will be up to the Agency to remunerate the activities carried out by the Member States’ experts involved in the Steering Group’s activities, through the national authorities.
On data protection, States require that in the absence of an adequacy decision or appropriate safeguards, confidential information may still be exchanged with third country regulators “where necessary for the prevention of a serious threat to public health”.
While negotiations in the EU Council have been relatively quick on this text, they appear to have more difficulty on the other two associated regulations (see EUROPE 12600/24).
Work on these texts on the ECDC mandate and cross-border health threats will resume under the Slovenian Presidency.
Welcoming the progress made, Health Commissioner Stella Kyriakidès called on Member States to move faster and overcome national differences in order to achieve rapid adoption of the regulations.
For the EU Council’s position on EMA: https://bit.ly/3cK1f2y (Original version in French by Agathe Cherki)