ENVI is lead committee
The European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) discussed the amendments to the draft report by MEP Soledad Cabézon Ruiz (ES/S-D) on the proposal for a Regulation on Health Technology Assessment (HTA) before the parliamentary summer break.
The key points of discussion were:
Particularly controversial is the Commission’s proposal that it should be compulsory for Member States to use joint clinical assessments of health technologies at EU level in their national evaluations, while banning them from conducting any assessment of the same health technologies themselves. MEPs are critical of this proposal, as are many Member States, and are calling for more flexibility for Member States. While there must be a certain degree of obligation, it should also be possible to carry out additional assessments at national level.
There is also disagreement as to whether medical devices should be covered by a European HTA. In its proposal, the Commission has put forward that both centrally authorised medicinal products and certain medical devices should undergo a joint EU assessment. The members of the ENVI Committee are divided in their opinions. The compromise emerging in the European Parliament is that there should be a common European assessment for medical devices only if various criteria are met, for example if a certain number of Member States carry out national HTA assessments of the medical device.
What will happen after the summer break?
The Committee on Industry, Research and Energy (ITRE) will discuss its proposed amendments on 3 September. Although the Industrial Committee had called for an exemption for medical devices at the beginning of the debate, ITRE Committee rapporteur Lieve Wierinck (BE/ALDE) has now presented a number of compromise amendments, including the assessment of certain medical devices.
The Committee on the Internal Market and Consumer Protection (IMCO) already adopted its opinion on the proposal for a Regulation on 12 July.
ENVI rapporteur, Cabézon Ruiz, has summarised the positions taken so far by the various committees so that Parliament can reach a consensus in the foreseeable future.
The ENVI Committee’s vote on the draft report is scheduled for 13 September 2018. The European Parliament plenary is expected to vote in October 2018.