Inter-institutional negotiations on health technology assessment are not about to begin. The Council of the EU has still not adopted a general approach on this issue, which lays the foundations for permanent and viable European cooperation in the joint clinical evaluation of new medicines and medical devices. The Romanian Presidency is moving towards a progress report.
As a reminder, this draft regulation, presented at the beginning of 2018, introduces "common clinical evaluations" to determine the added value of a new medicinal product or certain new medical devices in order to help Member States take decisions on pricing and reimbursement (see EUROPE 11951/6). However, while the European Parliament has been ready to enter into negotiations since mid-February, the process is blocked in the Council of the EU (see EUROPE 12194/25).
Opaque negotiations at Council level
Overall, the discussions have been going on for a year and a half in total opacity. According to our information, the Austrian Presidency had tried to submit a draft compromise to the Member States in November 2018, but had failed to reach a qualified majority of Member States.
And for good reason, France and Germany are totally opposed to a binding common evaluation mechanism. In the autumn of 2018, six health ministers (French, German, Polish, Spanish, Czech and Bulgarian) even co-signed a letter summarising their concerns. In this letter, the delegations oppose common clinical evaluations that are binding, both in terms of participation and use of results. They also reject the way in which the coordination group operates, which is called upon to take decisions by a simple majority, and recommend qualified majority voting limited to questions of methodology.
Faced with the blockage of these ‘large countries’, the Romanian Presidency has adopted a more cautious approach: instead of tackling the core of the proposal, it has chosen to limit itself to more scientific issues, such as joint scientific consultations (section 2) or the identification of emerging technologies ('horizon scanning' - section 3).
What is the future for this proposal?
Negotiations are expected to continue in the Council of the EU in the coming months. The Romanian Presidency is expected to present a progress report in June, while the next Finnish Presidency could, at best, reach a general approach. However, this is not an easy task. In any case, meetings of no less than six working groups are planned for the next 6 months.
For its part, the European Parliament will be dissolved as the European elections approach. Its negotiating position on health technology assessments should continue, given the broad support it received in the Health Committee (40 votes in favour, 3 against and 2 abstentions). As a reminder, the report by Soledad Cabezón Ruiz (S&D, Spain) supports mandatory joint clinical evaluations, stressing that any additional analysis should be "justified and proportionate" and notified to the Commission and the coordination group.
The proposed regulation can be found at: https://bit.ly/2HlTu4T. (Original version in French by Sophie Petitjean)