EU Regulation on HTA enters a new phase and the Trilogue started

Posted on 05.05.2021

The Portuguese EU presidency accelerated the discussion and reached an agreement on a compromise text reflecting the Council’s (Member States) views. Also, the European Parliament voted positive to start the Trilogue which kicked of 26th of April 2021.

Ahead of the Trilogue negotiations, MedTech Europe put forward three recommendations to guide Trilogue discussions on regulating medical technologies joint clinical assessments. This to facilitate the selection on the best options of the views expressed by European Parliament and Council to be carry forward in the final regulation supportive of the accessibility of innovation in Europe.

These recommendations are:

  • Have predictable joint clinical assessments for selected medical technologies;
  • Ensure the new EU HTA framework does not interfere with regulatory assessments conducted on medical technologies;
  • Secure a pre-defined and clear purpose on how clinical assessment reports will be used.

For more details, please click here.