Negotiators from the European Parliament and the Council of the EU will meet again on Monday 21 June to try to reach an agreement on the draft regulation on health technology assessment (HTA) - a proposal to establish clinical assessments at European level (see EUROPE 11951/6).
Meeting in Luxembourg earlier this week, health ministers hinted that the aim remains to complete the dossier on this occasion, before Portugal hands over the Presidency of the EU Council to Slovenia.
However, as a final meeting at technical level opened on Friday 18 June, some difficulties remained - in particular relating to Article 8 of the future regulation, EUROPE has learned.
This article will regulate the way in which clinical evaluation reports carried out at European level are to be used in the Member States.
However, the latter refuse to be forced to implement the reports in question. The MEPs, for their part, do not see the point of allowing the Member States to repeat by themselves what would have been done by the EU-27. On Friday, therefore, it was still necessary to find a satisfactory formulation for both parties.
The other persistent disagreements are said to have been settled on the whole. These disagreements mainly concerned Articles 5 and 7 of the draft Regulation.
On Article 5, relating to the scope, the last details to be settled primarily concerned the time period to be respected between the market authorisation of a medicinal product and its clinical evaluation.
Article 7 - framing the creation of a list of assessed health technologies - had been deleted in the EU Council’s mandate (see EUROPE 12685/21). But the article that replaced it, on the “finalisation of the Joint Clinical assessment” (Article 6d), allowed work towards a consensus. (Original version in French by Agathe Cherki)