Comparing harmonization in medicines regulation and health technology assessment in Europe: lessons for the EU HTA regulation.

Abstract

Objectives: The European Union (EU) has long pursued harmonization in medicines regulation and, more recently, in health technology assessment (HTA). The European Medicines Agency (EMA) and the EU HTA Regulation (EU HTAR) represent key milestones in these respective trajectories. This study compares the harmonization trajectories of EU medicines regulation and EU HTA to identify lessons relevant for EU HTAR implementation.

Methods: We used a multi-method qualitative approach combining a narrative literature review with online focus groups involving eighteen regulatory and policy experts. The review explored the historical development of harmonization in both policy areas. The focus-group analysis examined perspectives on collaboration, harmonization dynamics, and implementation.

Results: Both policy areas moved from national arrangements and voluntary cooperation toward more formal EU-level structures. Medicines regulation developed earlier and resulted in more centralized procedures and binding EU-wide authorization decisions. EU HTA retains greater national responsibility for value judgments, pricing, and reimbursement. The two areas also differ in the scope and standardization of assessments. In both trajectories, harmonization was shaped by trust, willingness to collaborate, capacity differences, and legal and procedural contexts. Participants emphasized the importance of stepwise implementation, work sharing, and sustained dialogue, while anticipating variation in national JCA uptake and impact.

Conclusions: Experience from EU medicines regulation highlights the importance of building trust and adapting collaboration to differences in national maturity and priorities. Harmonization should develop gradually through learning and refinement across diverse legal and procedural contexts. These lessons may support EU HTAR implementation and further development.