On Thursday 13 September, MEPs on the environment and public health committee supported the introduction of compulsory common clinical assessments in the future for medicines and medical devices.
They were speaking on a draft regulation unveiled in January 2018 by the European Commission, which establishes ‘common clinical assessments’ for discovering the value-added of new medicines or certain new medical devices, in order to help member states decide on questions of tariffs and reimbursement (see EUROPE 11951).
At the end of an expeditious vote (given the length of the voting list - 78 pages), the MEPs backed the outlines of the Commission’s proposal, even going as far as reinforcing certain aspects. They decided, for example, to amend the legal basis of the legislative proposal to add, in addition to Article 114 proposed by the European Commission (internal market), Article 168(4) (public health). They also multiply the references to the need of experts to be independent and they amend television-making process at the coordination group (responsible for common work). They stipulate that the coordination group must act by consensus or, and this is the new part, in the absence of consensus, by a two-thirds majority of the member states present (the Commission proposed a simple majority). They set the quorum for the group’s meetings at two-thirds of the group’s members.
Otherwise, the MEPs retain the Commission’s approach – highly criticised by the member states – in favour of the compulsory nature of the future assessment mechanism, stressing that any further analysis would have to be ‘justified and proportionate’ and notified to the European Commission and coordination group. To reassure the Council, they noted that the regulation should not interfere with the exclusive national competence of the member states for setting prices and reimbursement. The report by Soledad Cabezón Ruiz (S&D, Spain), as amended, adds that the clinical assessments made by the member states before the clinical application of the regulation should be pursued, unless the member states decide to interrupt them. It also stipulates that the EU should continue to support voluntary cooperation in assessing healthcare technologies among the member states in other domains, such as developing and implementing vaccination programmes and boosting the capacity of national healthcare technology assessment capabilities (HTA).
The report should be on the agenda of one of the next European Parliament plenaries. The issue may be discussed among the member states at the working group on pharma products and medical devices on 21 September. (Original version in French by Sophie Petitjean)