The ambassadors of the Member States to the European Union (Coreper) granted, on Wednesday 24 March, a negotiating mandate to the Portuguese Presidency of the EU Council on the draft ‘HTA’ regulation on health technology assessments. In order to reach this compromise, the Member States nevertheless decided not to decide on the issue of the voting modalities of the coordination group (see EUROPE 12684/5).
This step paves the way for negotiations with the European Parliament, which took a position on the text in February 2019 (see EUROPE 12095/12).
The draft regulation on health technology assessment, known as ‘HTA’, aims to pool the clinical assessments carried out by the Member States to determine the added value of a medicinal product or certain medical devices and thus help the Member States to decide on their specific pricing and reimbursement policies (see EUROPE 11951/6). It has been discussed since January 2018 by the Member States in total opacity.
Both the Parliament and the Council of the EU have retained the dual legal basis of health (Article 168) and the Internal market (Article 114).
However, they differ on whether joint clinical assessments are binding or voluntary. Where the Parliament wants this assessment mechanism to be binding, the EU Council wants Member States to remain free to draw their own value judgements and conclusions on the overall clinical added value of a health technology.
Regarding the remaining outstanding issues, Coreper opted for the Portuguese Presidency’s suggestion on Article 6d that the joint clinical assessment reports by the Coordination Group be adopted by consensus, bearing in mind that the lack of consensus should not prevent progress as divergent opinions will be attached to the report.
However, the Member States have not regulated Article 3(4) on the voting arrangements for adopting decisions where unanimity cannot be achieved in the Coordination Group, leaving the option of moving towards qualified majority or two-thirds majority of Member States.
Link to the draft mandate: http://bit.ly/3cWfSz7 (Original version in French by Sophie Petitjean)