The Portuguese Presidency of the Council of the EU is going for broke on the draft regulation on health technology assessments (see EUROPE 12679/11). Despite the continuing blockages, Lisbon will seek, on Wednesday 24 March, a negotiating mandate from the Member States’ Committee of Permanent Representatives (Coreper).
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).
In total, the Portuguese Presidency explains, 39 technical meetings have been held since the proposal was presented in January 2018. The last meeting, which took place on 19 February, failed to reach agreement despite broad support from delegations (according to a footnote, three delegations indicated difficulties with parts of the text). According to the Portuguese Health Minister, Marta Temido, who spoke at the Health Council of the EU on 16 March, the difficulties today are more political than technical.
Voting procedures, the main open question
It is in this context that the item was put on the agenda of Coreper. The Presidency recognises that two issues remain problematic on this text, now that the issue of the non-binding aspect of clinical evaluations has been resolved (see EUROPE 12649/4). This concerns, on the one hand, the voting arrangements for adopting decisions when unanimity cannot be reached in the coordination group (Article 3(4)) and, on the other hand, the arrangements for validation of joint clinical evaluation reports by the coordination group (Article 6d).
Lisbon suggests a number of ways to address these issues. On Article 3(4), it suggests either a two-thirds majority of Member States or a qualified majority. On Article 6d, it recalled that some of the Member States felt that validation should be by consensus, as this is a scientific report and all divergent opinions will be joined. Other states prefer to introduce a voting system when consensus cannot be reached in order to avoid blockages. The Presidency therefore proposes to aim for adoption by consensus, while stressing that the lack of consensus should not prevent the adoption of the evaluation report, as divergent opinions will be attached to the report.
Link to the draft mandate: http://bit.ly/3cWfSz7 and http://bit.ly/2Qx90kd (Original version in French by Sophie Petitjean)