Paving the road for a successful EU HTA Reform implementation.

Abstract

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 among stakeholders. 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 for greater involvement of clinicians and patient advocacy organizations to enhance trust and facilitate effective implementation. 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 and improving patient access to innovative medicines across Europe.