Do European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020

This study shows that while European regulatory measures targeting UMNs often trigger corresponding actions in Belgium, this alignment does not necessarily shorten the time from regulatory submission to reimbursement. Lacking submission for reimbursement by pharmaceutical companies appears to be the most frequent reason for absent reimbursement in Belgium. European policy initiatives promoting timely market entry across member states could be crucial for improving patient access.

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Publication Details

Journal
BMJ Open
Published
2025-01-01
DOI
https://doi.org/10.1136/bmjopen-2024-091361
Citations
1
Primary Topic
Pharmaceutical Economics and Policy
Type
article
Field-Weighted Citation Impact
3.13

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article

Do European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020

Liese Barbier, Steffen Fieuws, Zilke Claessens, Isabelle Huys et al.
1 citations
BMJ Open
Pharmaceutical Economics and Policy
3.13
article

Do European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020

Liese Barbier, Steffen Fieuws, Zilke Claessens, Isabelle Huys, Joël Daems
article en
1 citations

Abstract

This study shows that while European regulatory measures targeting UMNs often trigger corresponding actions in Belgium, this alignment does not necessarily shorten the time from regulatory submission to reimbursement. Lacking submission for reimbursement by pharmaceutical companies appears to be the most frequent reason for absent reimbursement in Belgium. European policy initiatives promoting timely market entry across member states could be crucial for improving patient access.

BMJ OpenVol. 15(1)
Rijksinstituut voor Ziekte- en Invaliditeitsverzekering (BE), KU Leuven (BE)
Bill and Melinda Gates Foundation, University of Dundee, European Federation of Pharmaceutical Industries and Associations, European Commission, KU Leuven, Innovative Medicines Initiative, Institut National d'assurance Maladie-Invalidité
Partnerships for the goals
Openalex Percentile: Top 10%
Pharmaceutical Economics and Policy
3.13
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