Introduction
The EU Health Technology Assessment (HTA) Regulation (EU 2021/2282) introduced Joint Clinical Assessments (JCAs) to harmonise clinical assessment across EU Member States and reduce duplication of clinical evidence requirements.1
The EU HTA Regulation establishes common obligations for national HTA bodies to give ‘due consideration’ to JCA reports and avoid duplication of clinical evidence requirements. However, countries retain discretion over how JCA is integrated into national HTA processes
As JCA implementation progresses, the extent of convergence in national HTA processes, timelines and evidence requirements remains uncertain
Authors: Julia Tokarska, BSc; Higia Vassoler, BSc, MSc; Evie Kenna, BSc
Objectives
The EU Health Technology Assessment Regulation (HTAR) introduced the Joint Clinical Assessments (JCAs) to support harmonisation of assessments across Member States. This research compares early national implementation across selected EU countries, identifying areas of convergence and divergence in JCA integration, scientific advice interaction, dossier requirements, and assessment processes.
Methods
A structured comparative policy review examined publicly available HTA-body, government and official sources published up to 10/06/2026. Eight countries were included: Germany, France, Italy, Spain, the Netherlands, Sweden, Poland and Hungary.
Data were extracted across four domains: legislative/procedural readiness, joint scientific consultation (JSC)-national advice interaction, JCA integration and timeline alignment. Findings were compared to identify patterns of convergence and divergence in national implementation approaches.
Conclusion
Early implementation suggests that HTAR is reducing duplication in clinical evidence submission but has not yet demonstrated full convergence of national clinical assessment approaches. National-level heterogeneity, despite EU harmonisation aims, creates a persisting layer of uncertainty for manufacturers seeking pan-European evidence planning, sustaining the need for early national advice and country-specific strategies.