Managing experts’ conflicts of interest in the EU Joint Clinical Assessment
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Author(s)
Gentilini, Arianna
Parvanova, Iva
Type
Journal Article
Abstract
Objective This article critically evaluates the European Commission’s 2024 Implementing Regulation (IR) on conflicts of interest (COIs) management for stakeholders in the European Union (EU) Joint Clinical Assessment (JCA), with a focus on individual experts such as clinicians and patient representatives.
Key findings The IR is the first EU-level framework to assess COIs in the context of health technology assessment (HTA). The regulation requires experts involved in the JCA to submit annual declarations of interest for both financial and non-financial interests and presents a matrix on whether these conflicts should disqualify them from participating in the joint work. We compared the IR to COIs-management approaches from other European national HTA bodies and found that the IR is closely modelled after the French guidelines. Concerns include potential over-representation of experts from a small number of countries, lack of guidance on organisational COIs, and ambiguities in how the size of financial interests are disclosed. Unclear resource allocation for enforcement could also hinder compliance.
Conclusions The IR marks progress in EU-wide HTA collaboration, but improvements in transparency, expert diversity, and comprehensive COIs management are needed to ensure impartiality in the JCA process.
Key findings The IR is the first EU-level framework to assess COIs in the context of health technology assessment (HTA). The regulation requires experts involved in the JCA to submit annual declarations of interest for both financial and non-financial interests and presents a matrix on whether these conflicts should disqualify them from participating in the joint work. We compared the IR to COIs-management approaches from other European national HTA bodies and found that the IR is closely modelled after the French guidelines. Concerns include potential over-representation of experts from a small number of countries, lack of guidance on organisational COIs, and ambiguities in how the size of financial interests are disclosed. Unclear resource allocation for enforcement could also hinder compliance.
Conclusions The IR marks progress in EU-wide HTA collaboration, but improvements in transparency, expert diversity, and comprehensive COIs management are needed to ensure impartiality in the JCA process.
Date Issued
2024-11
Date Acceptance
2024-10-14
Citation
BMJ Open, 2024, 14 (11)
ISSN
2044-6055
Publisher
BMJ
Journal / Book Title
BMJ Open
Volume
14
Issue
11
Copyright Statement
© Author(s) (or their
employer(s)) 2024. Re-use
permitted under CC BY.
Published by BMJ.
employer(s)) 2024. Re-use
permitted under CC BY.
Published by BMJ.
License URL
Identifier
http://dx.doi.org/10.1136/bmjopen-2024-091777
Publication Status
Published
Article Number
e091777
Date Publish Online
2024-11-18