Analysis highlights regulatory pathways and stakeholder engagement issues among Member States, suggesting solutions.
The article explores the challenges and opportunities presented by the implementation of the EU Health Technology Assessment Regulation (EU HTAR). It highlights the varying degrees of readiness among Member States (MSs) and the perceived concerns regarding loss of sovereignty. The discussion emphasizes the importance of national preparedness, reducing bureaucratic inefficiencies, and fostering transparent communication amongstakeholders. The article also underlines the critical role of Joint Scientific Consultation (JSC) in optimizing regulatory and HTA processes, advocating for an expansion of JSC slots and selection criteria. Moreover, it calls forgreater involvement of clinicians and patient advocacy organizations to enhance trust and facilitate effectiveimplementation. Ultimately, the article argues that strengthening collaboration, optimizing regulatory pathways,and ensuring comprehensive stakeholder engagement are key to realizing the full potential of the EU HTAR andimproving patient access to innovative medicines across Europe.
No takes yet. Share an insight, caveat, or question.
Severens et al. (2025) studied this question.