On Wednesday 3 October, the European Parliament is due to adopt its negotiating position on health technology assessments. Given the debate organised at the beginning of the week, the result of the vote appears quite clear: MEPs are likely to support joint mandatory clinical assessments with certain exceptions for medical devices.
It should be recalled that the draft regulation introduces “joint clinical assessments” in an effort to the assess the value of a new medicine or new medical devices and help the member states make appropriate decisions with regard to pricing and reimbursement (see EUROPE 11951). At the Council, the Austrian Presidency has only planned a political debate during a ministerial meeting on 7 December. At the Parliament, however, work went relatively quickly, despite, we should point out, a vote for an opinion at the industry committee that was interrupted by a power cut.
Main changes
The plenary vote is mainly expected to be based on the amendments adopted on the substance of the subject during the environment and public health committee (ENVI) (see EUROPE 12095). It should be recalled that these amendments propose:
A quasi mandatory character of the assessments. ENVI’s position supports the Commission approach - subject to much criticism from the member states - in favour of a mandatory character of the future assessment mechanism and underlines that any additional analysis should be “appropriate and proportionate” as well as reported to the Commission and coordination group. During the plenary debate on 1 October, the rapporteur, Soledad Cabezón Ruiz (S&D, Spain) emphasised that “the compromise opens the door to voluntary cooperation such as in the precision medicine field".
Medical devices. The Commission proposed a limitation to the mandatory joint assessments for medicines that have received a marketing assessment as well as certain medical devices and in vitro devices. The amendments from the ENVI committee further restricts the scope of the medical devices affected, by adding the condition that the latter should be “considered as major innovations with a possibly significant impact on public health or healthcare systems”.
Legal basis. The ENVI position suggests an amendment to the legal basis of the legislative proposal by adding, in addition to article 114 proposed by the Commission (internal market), article 168(4) (public health). Soledad Cabezón Ruiz explained “The Commission retained article 114 from the internal market in an effort to avoid any duplication but this is not the most important objective. It is also necessary to improve the quality and effectiveness of the medicines”.
Other isolated amendments should also be put to a vote, such as those from the EPP, which propose a modification of the decision making rules at the coordination group in charge of joint work (by replacing simple majority voting by qualified majority voting). (Original version in French by Sophie Petitjean)