In October, the European Parliament is expected to give its position on the draft regulation for joint health technology assessments (HTA). Three questions still need to be resolved: the binding or voluntary aspect of cooperation, including medical devices and the coordination group's decision-making process. This was all brought out during the public-health committee (ENVI) debate on Monday 9 July.
It should be recalled that the draft regulation introduces “joint health assessments” in order to evaluate the added value of a new medicine or certain new medical devices, in an effort to help the member states make decisions on pricing and reimbursement (see EUROPE 11951).
The Council held an initial orientation debate on 22 June (see EUROPE 12047). At Parliament, the two committees for the opinion are due to reach a position this week: the industry committee on 10 July and the internal market committee on 12 July. The votes by the lead ENVI committee is expected for 13 September next.
Examination of ENVI committee amendments
In total, 529 amendments have been submitted to the draft report by Soledad Cabezón Ruiz (S&D, Spain). The rapporteur presented some of the possible compromises envisaged and indicated that “these amendments do not bring any substantial modifications”. Ms Cabezón Ruiz is therefore looking at the possibility of maintaining the binding character of joint health assessment for new medicines.
MEPs, however, are still examining a formulation that should grant sufficient flexibility on this article but which appears the most controversial. Therefore, Ms Cabezón Ruiz mentioned “specific criteria in the national context” and Pieter Liese (EPP, Germany) suggested a “reasoned opt-out system”. Gesine Meissner (ALDE, Germany) indicated that her group defended subsidiarity but supported European level harmonisation where it made sense.
On the other sensitive issue, medical devices, MEPs are shifting towards “total voluntary exclusion” of compulsory assessments. Françoise Grossetête (EPP, France) defended “assessments on a voluntary basis alone or in certain specific cases".
Given the way the discussions went, the European Commission emphasised that its proposal did not include all medical devices. Its representative explained that “Our proposal is based on consultation with the pharmaceutical sector. It is based on a gradual approach that concentrates on a limited number of devices (high risk devices) during the first few years. Article 19 also allows for voluntary cooperation in collaborative assessments of medical devices”.
Finally, on the last sensitive question, namely, the way in which the coordination group makes its decisions, Ms Cabezón Ruiz is proposing to introduce a two-tier rule rather than simple majority voting. Pieter Liese, however, is opposed to this and would prefer the qualified majority rule. (Original version in French by Sophie Petitjean)