The EU Council of Health Ministers of the Member States of the European Union, which will take place on 9 December, will be structured around two ministerial discussions, one on health as an essential component of the economy of well-being and the other on the EU's pharmaceutical policy. No legislative documents or conclusions are expected.
The meeting is not without interest, however. It will be a first opportunity to hear the views of the new Health Commissioner, Stella Kyriakides, and will also provide an opportunity to learn more about the EU Council's work on health technology assessment.
Progress report on HTA
The discussions are indeed particularly opaque on this draft regulation which introduces "joint clinical assessments" (JCAs) to determine the added value of a medicinal product or some of the most innovative in vitro medical devices (see EUROPE 11951/6). As we have recently noted, at this stage, only a discussion paper and a progress report, as well as a legal opinion, have been published by the EU Council (see EUROPE 12376/14).
Finland, which was no exception during its rotating Presidency, despite its commitments to transparency, will end its Presidency here with a new progress report. It is reported that in recent months, work in the EU Council has focused on joint clinical assessments (Articles 5 to 9 of the proposal). "Several [delegations] agreed that there is a need for a stepwise approach, successively increasing the number of health technologies that are subject to Joint Clinical Assessment (HTA), with each step lasting 2 to 3 years. In this way, the number of JCA to be carried out by the Coordination Group will be relatively small in the beginning, about 10 health technologies per year, and grow at a steady pace until the full capacity is reached", the report says. There does not seem to be a consensus on the issue of mandatory participation of Member States in assessments according to a closed list of medicines. As regards the obligation for Member States to take over the conclusions of the assessments on their own account, the Finnish Presidency notes that "the States' obligations have been reduced, but the obligation to examine joint clinical evaluations in the HTA process at national level has been maintained". It added:" While many delegations agree with these principles, it is necessary to refine the text".
According to our information, no minister is expected to speak at the round table, so as not to threaten the negotiations, we were told. [progress report: http://bit.ly/33RkbFc ]
Two debates
In the absence of a legislative file, two discussions remain on the ministers' agenda. In the first, on health as a factor of well-being, the Presidency intends to focus on mental health, healthy ageing and the digital transformation of health and social services. It will ask delegations what actions are needed and how Member States and the Commission could work towards the creation of a European health data area.
On the second debate, the EU's pharmaceutical policy, the rotating Presidency will be based on a working document already detailed in our columns (see EUROPE 12378/10). Among the questions it submitted to delegations, one asked about the need to "use EU legislative measures to require back-up production capacities, earlier notification of interruptions and stronger measures to ensure continuity of supply". This, knowing - as Helsinki notes - that one of the reasons for shortages and supply disruptions is that the supply chain for medicines has become longer, more complex and more fragmented, with companies producing a significant proportion of medicines outside the EU.
Also noteworthy was a working lunch on how to strengthen the role of the EU and its Member States in global health. (Original version in French by Sophie Petitjean)