The HTA Regulation (HTAR) is fully applied as of 12 January 2025. This regulation establishes a new and permanent EU framework which will allow Member State HTA Agencies to increase their efficiency in assessing medicinal products and high-risk medical devices. Through joint clinical assessments and joint scientific consultations, this allows a unified approach to HTA that benefits patients and healthcare systems. The HTAR introduces a streamlined single EU-level submission dossier for joint clinical assessments in order to ensure pooling of resources at the EU level and strengthening the scientific quality of HTA across the EU, while avoiding duplication of assessments at national level.
Since 12 January, these new rules are applicable to new cancer medicines and advanced therapy medicinal products (ATMP). The HTAR will be incrementally applied until 2030, when it will be extended to all new medicinal products and selected high-risk medical devices.
This legislative innovation is further reinforced by the European Commission who are providing funding support to HTA Agencies implementing the regulation. For such purpose, the European Commission has awarded a framework contract to a consortium of 34 European HTA agencies.
The consortium tasked with the implementation of the framework contract was formed under the guidance of the Heads of the HTA Agencies Group (HAG); it includes the members of the “HTA Coordination Group” and is led by the “Belgian National Institute for Health and Disability Insurance” (RIZIV-INAMI).
With the signature of this framework contract on 22 January 2025, the final piece of the overall legislative and procedural framework is now in place. With this final step, a new era of high-quality collaboration, resource efficiency, transparency and faster and wider access to health technologies across the EU can begin.
The collaboration in HTA within Europe started in the mid-90s and has evolved significantly over the past three decades towards the harmonisation of methodologies and procedures that are now in place. The HTAR application starts a new era of EU HTA Collaboration. We want to thank everyone who has contributed to the journey to this point.
We wish the European Commission, the HTA Coordination Group, the Heads of HTA Agencies Group and the HTAR implementing consortium every success in this most important new way of collaboration!
