Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder Interviews Article Swipe
Zilke Claessens
,
G Beirne
,
Catherine Decouttere
,
Nico Vandaele
,
Liese Barbier
,
Isabelle Huys
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1007/s43441-025-00855-2
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1007/s43441-025-00855-2
Introduction During the COVID-19 pandemic, regulatory and market access actions were taken to expedite the market entry of COVID-19 medicines. This study aims to (i) capture multi-stakeholder views on these actions, and (ii) provide recommendations for future-proofing routine and health-emergency frameworks. Methods Semi-structured interviews were conducted with policy makers/advisors (i.e. regulators, HTA assessors, and payers), and pharmaceutical industry representatives across Europe to elicit their perspectives on marketing authorisation and market access practices during the COVID-19 pandemic. Interviews were transcribed ad verbatim and transcripts analysed via the thematic framework method. Results The interviews ( n = 16) resulted in an overview of stakeholder-perceived benefits and limitations for four key regulatory advice or authorisation procedures (i.e. emergency task force, rapid scientific advice, rolling review, conditional marketing authorisation) and one market access procedure (i.e. joint procurement) applied during the COVID-19 pandemic. Highlighted benefits of the procedures relate to a reduction in timelines, enhanced collaboration and alignment, procedural flexibilities, and often a combination of these. Challenges are linked to inefficient allocation of time and resources for both industry representatives and policymakers/advisors and decreased transparency in certain procedures. In addition, several recommendations for the optimisation of both the routine and health-emergency healthcare framework were proposed. Emphasis is placed on the need for enhanced interaction and alignment between industry representatives and policymakers/advisors but also within stakeholder groups, development of more pragmatic and flexible procedures, and application of clear and transparent eligibility criteria for facilitating actions. Conclusion This study provides an overview of the perceptions from regulatory, and market access practices during COVID-19, highlighting how these experiences can inform regulatory and market access practices both in routine times and during health emergencies. Taking stock of stakeholder reflections and lessons learned are valuable for improving preparedness and responsiveness in future health crises.
Related Topics
Concepts
Coronavirus disease 2019 (COVID-19)
Pandemic
Stakeholder
Pharmacy
European union
2019-20 coronavirus outbreak
Business
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Public relations
Political science
Medicine
Virology
Family medicine
Disease
Outbreak
Infectious disease (medical specialty)
Economic policy
Pathology
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1007/s43441-025-00855-2
- https://link.springer.com/content/pdf/10.1007/s43441-025-00855-2.pdf
- OA Status
- hybrid
- References
- 20
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4414038826
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4414038826Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1007/s43441-025-00855-2Digital Object Identifier
- Title
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Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder InterviewsWork title
- Type
-
articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2025Year of publication
- Publication date
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2025-09-06Full publication date if available
- Authors
-
Zilke Claessens, G Beirne, Catherine Decouttere, Nico Vandaele, Liese Barbier, Isabelle HuysList of authors in order
- Landing page
-
https://doi.org/10.1007/s43441-025-00855-2Publisher landing page
- PDF URL
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https://link.springer.com/content/pdf/10.1007/s43441-025-00855-2.pdfDirect link to full text PDF
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YesWhether a free full text is available
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hybridOpen access status per OpenAlex
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https://link.springer.com/content/pdf/10.1007/s43441-025-00855-2.pdfDirect OA link when available
- Concepts
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Coronavirus disease 2019 (COVID-19), Pandemic, Stakeholder, Pharmacy, European union, 2019-20 coronavirus outbreak, Business, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Public relations, Political science, Medicine, Virology, Family medicine, Disease, Outbreak, Infectious disease (medical specialty), Economic policy, PathologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
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20Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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