22 January 2025
On 21 January 2025, the European Health and Digital Executive Agency (HaDEA) signed a new Framework contract (FWC) to support joint clinical assessments and joint scientific consultations under Regulation (EU) 2021/2282 on Health Technology Assessment (HTAR) with a consortium of HTA bodies representing 21 EU countries.
The consortium, led by the Belgian INAMI-RIZIV (Institut national d’assurance maladie-invalidité – Rijksinstituut voor ziekte- en invaliditeitsverzekering), will conduct joint clinical assessments and joint scientific consultations. The contract will last for 48 months, for a total financial support of €35 million under the EU4Health programme.
This signature marks a milestone, following the application of the HTAR on 12 January 2025. The Regulation provides an EU framework for the assessment of health technologies, such as medicines and medical devices, by fostering collaboration and coordination between EU countries. This will help national authorities to make more timely and informed decisions on the pricing and reimbursement of health technologies and streamline the procedure for health technology developers.
In line with the HTAR, HTA bodies will be mandated by the Member State Coordination Group on HTA to assess the relative clinical effectiveness and safety of new medicines, and of certain high-risk medical devices and in-vitro medical devices. Joint scientific consultations requested by technology developers are also within the scope of this framework contract and EU financing of the joint work will be ensured through it.
In a pioneer effort, the European Commission and EU countries have put together a systematic, transparent and multi-stakeholders’ mechanism to speed up patients’ access to innovative technologies. This aims to strengthen the quality of HTA across the EU, ensure its efficiency and secure the long-term sustainability of HTA cooperation in the EU.
Relevant links
- New EU rules on Health Technology Assessment
- Implementation of the Regulation on health technology assessment
Background
EU4Health is the fourth and largest of the EU health programs. The EU4Health program goes beyond an ambitious response to the COVID-19 crisis to address the resilience of European healthcare systems. The program provides funding to national authorities, health organisations and other bodies through grants and public procurement, contributing to a healthier Europe.
HaDEA manages the vast majority of the total EU4Health budget and implements the program by managing calls for proposals and tenders from 2021 to 2027.
Source – HaDEA