- Funding Programme
- Year
- 2023
Supporting the successful implementation of the Regulation UE 2021/2282 on Health Technology Assessment by HAS
The European Commission aimed to assist the French Haute Autorité de Santé (HAS) in implementing the EU regulation 2021/2282 on health technology assessment. The project provided support in understanding compliance, training staff, optimizing processes, and establishing continuous evaluation mechanisms, through a three-phase approach including diagnosis, implementation, and final reporting.
Context
Health Technology Assessment (HTA) is a multidisciplinary process that evaluates the value of health technologies to inform evidence-based decision-making in healthcare. The EU Regulation 2021/2282, effective from January 2025, creates a sustainable framework for conducting part of HTA at EU level, reducing duplication and enhancing cooperation between Member States. The project supported HAS in adapting to this regulation, which centralizes clinical assessments at the EU level but maintains national authority over reimbursement decisions. Funded by the EU's Technical Support Instrument, the project required procedural adaptations, training, and system updates for the HAS.
Support delivered
The project supported HAS in its preparation for the applicability of the EU regulation on health technology assessment. The project unfolded in a three-phase methodology: initial analysis, strategic implementation planning, and finalization, ensuring a seamless transition to the new European procedures. Activities involved developing comprehensive documentation to help HAS agents understand and implement EU Regulation 2021/2282 procedures. Reference materials were updated to align with EU standards, ensuring consistency and compliance. Targeted training was provided to equip staff with the skills needed for these changes. Webinars and informational materials facilitated external communication. Performance indicators were set, and a change management plan was crafted. These efforts aimed to enhance efficiency and cooperation across Member States.
Results achieved
The project effectively aligned HAS with the new EU regulation on health technology assessment by providing organizational, procedural, and technical support. The project developed new guidance documentation, updated documentation, and provided role-specific training for HAS departments, addressing challenges like increased workload, language transitions, and new procedures. This initiative enhanced HAS's ability to collaborate at the European level, ensuring compliance and efficient communication. A comprehensive communication strategy was executed, and a final report captured the project's outcomes and good practices, setting a foundation for future endeavours.
More about the project
You can read the documents related to the project here: