The Member State Coordination Group on Health Technology Assessment (HTACG) convened its 18th meeting on 12 February 2026 to transition the European Union (EU) health technology assessment framework from its foundational phase into a period of active system management. The Directorate-General for Health and Food Safety (DG SANTE) marked the conclusion of the first year of application of Regulation (EU) 2021/2282 by calling for greater execution discipline across the joint clinical assessment (JCA) cycle.
This shift in institutional focus prioritises the refinement of horizon-scanning capabilities to support national planning. The HTACG requested the Subgroup for the identification of Emerging Health Technologies (EHT) to expand its reporting beyond immediate product identification. Future reports will address broader trends in innovative therapeutic areas and provide long-term estimates for orphan medicinal products. This forecasting provides the evidentiary base for the annual work programme and helps Member States allocate resources as more niche therapies enter the mandatory JCA scope.
Coordinators also formalised the timeline for the inaugural selection of medical devices and in vitro diagnostic medical devices for joint clinical assessment under Article 7(4) of the Regulation. Following a request from the European Commission, the HTACG confirmed it would adopt quarterly selection recommendations, with the first proposal scheduled for June 2026. While officials noted that all health technology developers met the initial deadlines for medicinal product dossiers, the group is now focused on maintaining throughput.
The group is developing mitigating measures to prevent the discontinuation of assessments. This strategy involves providing targeted support to developers – especially small and medium enterprises (SME) – to ensure dossier robustness for subsequent national appraisal. Representatives from Greece and Spain presented domestic reforms designed to embed these EU-level outputs directly into their domestic reimbursement processes. These efforts signify a move toward a more predictable and interventionist assessment environment.
The HTACG adopted its first annual report covering the 2025 activity period, which the European Commission will publish on its website. The next hybrid meeting is scheduled for 22 June 2026 in Brussels, immediately followed by the Stakeholder Network meeting.
Source: European Commission
Link: Flash report - 18th Meeting of the Member State Coordination Group on HTA
Date: 12 February 2026
