The Heads of HTA Agencies Group (HAG) met in Copenhagen, Denmark, on November 4th 2025 for its 14th meeting. The meeting, with more than 60 participants from 35 member agencies, was hosted by the Danish Medicines Agency (DKMA).
During the meeting, there were in-depth discussions on the evaluation of the Health Technology Assessment Regulation (EU HTAR) scheduled for early 2028. The discussions laid the foundations for the collation of HTA bodies’ perspectives on the assessment process provided for in Article 31 of the HTAR and on the potential role of the HAG in this process. A working group (HTAR Evaluation Working Group) was set up with the aim of promoting a coordinated approach to the reporting requirements and operational procedures for Member States. This Working Group will support the proactive participation of HTA bodies in the evaluation of the EU HTAR and will promote a fit-for-purpose framework for that evaluation.
The HAG also discussed the transformation of the EU legislative landscape, with significant implications for health systems, pharmaceutical regulation and health technology assessment (HTA), such as the EU Pharmaceutical Legislation, the Critical Medicines Act, the targeted evaluation of the MDR/IVDR, the Biotech Act, the Artificial Intelligence Regulation and other horizontal legislation. These EU legislations and strategic developments are reshaping the regulatory environment for medicinal products, medical devices and health technologies and introducing new demands and dimensions to Health Technology Assessment, including environmental impact, supply chain resilience, and innovation incentives and access. The members of the HAG decided to create the EU Legislation and Strategic Developments Working Group to monitor and analyse EU legislative and strategic developments with potential impact and interplay with the EU HTAR and to promote the involvement of HTA bodies in EU policy dialogues.
The members of the HAG discussed the latest developments and actions related to the implementation of the HTAR. The European Commission, represented by Maya Mathews, DG SANTE, and the HTA Coordination Group, through the Chair Roisin Adams, provided updates on ongoing and future key-activities, including on the ongoing joint clinical assessments and for the first joint scientific consultations (find more here). The members of the HAG highlighted the importance of reinforcing and promoting joint work on communication, to raise awareness among relevant stakeholders – decision-makers, payers, patients, healthcare professionals and institutions – on the importance of HTA and the use of HTA outcomes in informed decisions. Marcus Guardian, from the Brussels Centre for Collaboration in Health (BCCH), shared developments from the HTA Framework Contract Consortium (FWC) and Marco Marchetti, AGENAS, provided updates on the HAG-INSIGHT Consortium for capacity-building, both initiatives endorsed and supported by the HAG.
The HAG members elected their new leadership team during its meeting in Copenhagen. Trygve Ottersen, Director General of the Norwegian Medical Products Agency (NOMA), has been elected Chair, while Lionel Collet, President of the Haute Autorité de Santé (HAS) in France and Thomas Kaiser, Director of the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany, will serve as Vice-Chairs. During the handover of the chairpersonship, Rui Santos Ivo (HAG Chair 2021–2025) and Agneta Karlsson (HAG Vice-Chair 2023–2025) were recognised by the Group for their contributions to the development of the network and the consolidation of health technology assessment in Europe.
The next face-to-face HAG meeting will be in Paphos Cyprus, on the 28th and 29th of May 2026.
