ESMO provided feedback to the public consultation on the draft Implementing Act, issued by the European Commission on 1 October 2024, that lays down the procedural rules for Joint Scientific Consultations (JSCs) on medicinal products. The full ESMO response can be accessed here.
The Society welcomes the draft text, clearly specifying the processes for JSCs, and - with a view on further improving the proposal - highlights the importance of:
- Maximising the amount of JSCs that are to be conducted to the greatest possible extent, whilst keeping up with the rapid and volatile pace of innovation in the oncology field;
- Empowering the Member State Coordination Group on HTA (HTACG) to issue additional request periods for JSCs for the current year when this can help achieve the aims of the Health Technology Assessment (HTA) Regulation;
- Ensuring a robust involvement of oncologists and cancer specialists in the conduct of JSCs for cancer therapies.
The HTA Regulation is European Union (EU) legislation, set to enter into application in January 2025, that establishes a new permanent EU framework for collaboration on HTA. A key aspect of the new legislation is the introduction of Joint Clinical Assessments (JCAs) which are assessments of clinical aspects of novel medicines that can be considered for use in HTA at the national level.
JSCs will aim to support the preparation for JCAs by allowing health technology developers to obtain guidance from the HTACG on the information, data, analyses and other evidence that is likely to be required from clinical studies for the JCA.
The implementing legislation on JSCs is the fourth of a total of six Implementing Acts - to be adopted ahead of January 2025 - that will support the implementation of the HTA Regulation.
ESMO stands ready to collaborate with the HTACG, the European Commission and all stakeholders to ensure that the HTA Regulation improves access to innovative treatments and delivers meaningful benefits to patients with cancer.
For further information, please contact: publicpolicy@esmo.org