ESMO responded to the public consultation on the draft Implementing Act - put forward by the European Commission in May 2024 - that sets the rules, procedures and templates for the management of conflicts of interest in the framework of the joint work under the HTA Regulation. ESMO’s full response can be accessed here.
In its feedback, ESMO overall welcomed the draft text and highlighted the importance of striking a right balance between the need for both transparency and expert engagement concerning Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs) for cancer treatments. The Society also urged to take into account the availability of suitable experts when measures are taken to address conflicts of interest, accommodate the volatile nature of the process of defining those specific interests that may constitute a conflict of interest, and limit unnecessary administrative burdens for involved individual experts.
The EU’s HTA Regulation was adopted in December 2021 and is set to enter into application in January 2025. This EU legislation establishes a permanent framework for collaboration on HTA at the EU level, with a key novelty being the introduction of JCAs which are assessments of clinical aspects of novel medicines that can be considered for use in HTA at the national level. The HTA Regulation also provides for JSCs which will allow for exchanges of information with health technology developers on their development plans for a new treatment.
Both processes will begin with cancer medicines and advanced therapies as from the start of the application of the legislation in January 2025.
The published Implementing Act on Conflicts of Interest is the second of a total of six Implementing Acts - to be launched ahead of January 2025 - that will facilitate the implementation of the HTA Regulation and set out in detail how the joint HTA processes are to be conducted. ESMO’s earlier response to the consultation on the first Implementing Act on JCAs for of Medicinal Products can be accessed here.
ESMO stands ready to collaborate with the EU institutions and all stakeholders on the development of the Implementing Acts and support the implementation of the HTA Regulation.
For further information, please contact: publicpolicy@esmo.org