Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative

National pricing and reimbursement agencies face growing challenges with complex health technologies, prompting European policy advancements. Beneluxa is a cross-country collaboration involving Belgium, the Netherlands, Luxemburg, Austria, and Ireland that aims to address sustainable access to medic...

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Main Authors: Zilke Claessens, Michiel Lammens, Liese Barbier, Isabelle Huys
Format: Article
Language:English
Published: MDPI AG 2024-07-01
Series:Journal of Market Access & Health Policy
Subjects:
Online Access:https://www.mdpi.com/2001-6689/12/3/12
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author Zilke Claessens
Michiel Lammens
Liese Barbier
Isabelle Huys
author_facet Zilke Claessens
Michiel Lammens
Liese Barbier
Isabelle Huys
author_sort Zilke Claessens
collection DOAJ
description National pricing and reimbursement agencies face growing challenges with complex health technologies, prompting European policy advancements. Beneluxa is a cross-country collaboration involving Belgium, the Netherlands, Luxemburg, Austria, and Ireland that aims to address sustainable access to medicines. In view of the soon-to-be-implemented EU HTA Regulation, insights and experiences from stakeholders with Beneluxa cross-country collaboration could provide possible transferable learnings. Therefore, this research aims to (i) identify the opportunities and challenges faced by Beneluxa, (ii) gather insights from stakeholders, namely (possible) applicants and policymakers, within and beyond Beneluxa on the initiative and broader cross-country collaboration principles, and (iii) transfer these insights into learnings and recommendations in anticipation of the full implementation of the new HTA Regulation. Fifteen semi-structured interviews were conducted with industry and European HTA/policy stakeholders. The principal challenges discussed by stakeholders encompass hesitancy from the industry toward Beneluxa assessments, which were attributed to procedural and timeline uncertainties, legislative framework ambiguity, and challenges in terms of industry’s internal organization. Another challenge highlighted is the resource-intensive nature of the procedure due to diverse approaches among member states. In addition, industry stakeholders mentioned limited communication and procedural complexity. Despite challenges, both stakeholder groups recognized important opportunities for cross-country collaboration. Transferable insights for future cross-country collaboration include transparent communication, clear legislative embedding, internal industry restructuring to facilitate joint HTAs, and member state support for conducting collaborative assessments. The study underscores diverging views among stakeholders on cross-country collaboration’s potential to support HTA and the market access of complex health technologies. While acknowledging benefits, there still are challenges, including industry hesitancy, emphasizing the need for transparent communication and clear guidance in the evolving EU HTA landscape.
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spelling doaj-art-095fb859f18c4019a284c0368f75b13a2025-08-20T03:55:28ZengMDPI AGJournal of Market Access & Health Policy2001-66892024-07-0112314415710.3390/jmahp12030012Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa InitiativeZilke Claessens0Michiel Lammens1Liese Barbier2Isabelle Huys3Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, BelgiumDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, BelgiumDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, BelgiumDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, BelgiumNational pricing and reimbursement agencies face growing challenges with complex health technologies, prompting European policy advancements. Beneluxa is a cross-country collaboration involving Belgium, the Netherlands, Luxemburg, Austria, and Ireland that aims to address sustainable access to medicines. In view of the soon-to-be-implemented EU HTA Regulation, insights and experiences from stakeholders with Beneluxa cross-country collaboration could provide possible transferable learnings. Therefore, this research aims to (i) identify the opportunities and challenges faced by Beneluxa, (ii) gather insights from stakeholders, namely (possible) applicants and policymakers, within and beyond Beneluxa on the initiative and broader cross-country collaboration principles, and (iii) transfer these insights into learnings and recommendations in anticipation of the full implementation of the new HTA Regulation. Fifteen semi-structured interviews were conducted with industry and European HTA/policy stakeholders. The principal challenges discussed by stakeholders encompass hesitancy from the industry toward Beneluxa assessments, which were attributed to procedural and timeline uncertainties, legislative framework ambiguity, and challenges in terms of industry’s internal organization. Another challenge highlighted is the resource-intensive nature of the procedure due to diverse approaches among member states. In addition, industry stakeholders mentioned limited communication and procedural complexity. Despite challenges, both stakeholder groups recognized important opportunities for cross-country collaboration. Transferable insights for future cross-country collaboration include transparent communication, clear legislative embedding, internal industry restructuring to facilitate joint HTAs, and member state support for conducting collaborative assessments. The study underscores diverging views among stakeholders on cross-country collaboration’s potential to support HTA and the market access of complex health technologies. While acknowledging benefits, there still are challenges, including industry hesitancy, emphasizing the need for transparent communication and clear guidance in the evolving EU HTA landscape.https://www.mdpi.com/2001-6689/12/3/12Beneluxa initiativecross-country collaborationhealth technology assessmentInternational Horizon Scanningpricing and reimbursementEU HTA Regulation
spellingShingle Zilke Claessens
Michiel Lammens
Liese Barbier
Isabelle Huys
Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative
Journal of Market Access & Health Policy
Beneluxa initiative
cross-country collaboration
health technology assessment
International Horizon Scanning
pricing and reimbursement
EU HTA Regulation
title Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative
title_full Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative
title_fullStr Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative
title_full_unstemmed Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative
title_short Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative
title_sort opportunities and challenges in cross country collaboration insights from the beneluxa initiative
topic Beneluxa initiative
cross-country collaboration
health technology assessment
International Horizon Scanning
pricing and reimbursement
EU HTA Regulation
url https://www.mdpi.com/2001-6689/12/3/12
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AT michiellammens opportunitiesandchallengesincrosscountrycollaborationinsightsfromthebeneluxainitiative
AT liesebarbier opportunitiesandchallengesincrosscountrycollaborationinsightsfromthebeneluxainitiative
AT isabellehuys opportunitiesandchallengesincrosscountrycollaborationinsightsfromthebeneluxainitiative