ESMO provided feedback to the public consultation on the EU draft Implementing Act that sets out the procedural rules for cooperation, in the form of exchange of information, with the European Medicines Agency (EMA) in the context of the joint work under the EU’s HTA Regulation. ESMO’s full response can be accessed here.
In its feedback, ESMO welcomed the draft Implementing Act - published by the European Commission in June 2024 - and raised the following:
- The rules on the exchange of information should be aimed at maximising the annual number of Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs) for cancer treatments, whilst avoiding delays in the assessments and the implementation of HTAs, especially in situations of unmet need. This while keeping up with the rapid and volatile pace of innovation in the oncology field and facilitating sufficient assessments for all novel cancer treatments;
- The provisions concerning the information exchange related to the planning and forecast of JCAs and JSCs should allow for a continuous flow of information, rather than only providing the information once each year;
- Given that engagement with individual experts - including healthcare professionals - is a key condition for conducting the assessments in an appropriate and robust manner, the Implementing Act should allow for the involvement of sufficient qualified experts in both JCAs and JSCs for cancer treatments, especially concerning treatments for rare cancers for which there tend to be significantly fewer relevant experts available.
The HTA Regulation - set to enter into application in January 2025 - will reinforce cooperation on HTA between the Member States of the EU. Ahead of the entry into application of the EU legislation, six Implementing Acts will be launched to facilitate the implementation of the Regulation. The Implementing Act on cooperation with the EMA is the 3rd Act, with the remaining three still to be published in the second half of 2024.
ESMO stands ready to collaborate with the EU institutions on the development of the Implementing Act, aiming to achieve a successful implementation of the HTA Regulation.