Paving the road for a successful EU HTA Reform implementation

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.

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Publication Details

Journal
Global & Regional Health Technology Assessment
Published
2025-08-29
DOI
https://doi.org/10.33393/grhta.2025.3502
Citations
2
Primary Topic
Health Systems, Economic Evaluations, Quality of Life
Type
article
Field-Weighted Citation Impact
6.26
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article

Paving the road for a successful EU HTA Reform implementation

Johan L. Severens, P.L. Canonico, Oriol Solà-Morales, Iga Lipska et al.
2 citations
Global & Regional Health Technology Assessment
Health Systems, Economic Evaluations, Quality of Life
6.26
article

Paving the road for a successful EU HTA Reform implementation

Johan L. Severens, P.L. Canonico, Oriol Solà-Morales, Iga Lipska, Claudio Jommi, H. Altmann, François Meyer, Andrew Dillon
article en
2 citations

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.

Global & Regional Health Technology AssessmentVol. 12(1)
Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT), Cwm Taf University Health Board (GB), Universitat Internacional de Catalunya (ES), Fundació Privada Centre CIM (ES), Court of Appeal (TH), Independent Age (GB), The Hague Centre for Strategic Studies (NL), Oldham Council (GB)
Openalex Percentile: Top 4%
Health Systems, Economic Evaluations, Quality of Life
6.26
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