EU HTA Publication Digest: Legal implications of joint clinical assessments under the EU HTA regulation

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. 

In a recent publication, Xander et al. examined the legal implications of Joint Clinical Assessments under the EU HTA Regulation, focusing on PICO (population, intervention, comparator, and outcomes) disparities across Member States and conflict-of-interest management in expert involvement. The authors found that JCA reports are not legally binding at the national level. As a result, differences in evidence requirements across Member States may persist, creating a need for additional justification and increasing legal uncertainty. These differences may also lead to parallel national assessment efforts. 

The authors conclude that robust scoping and a strong focus on scientific excellence in JCAs will be essential. This could help reduce duplication, streamline national HTA procedures, and prevent delays in patient access.

Access the full-text article here.