Managing experts’ conflicts of interest in the EU joint clinical assessment

Gentilini, Arianna and Parvanonva, Iva (2024) Managing experts’ conflicts of interest in the EU joint clinical assessment. BMJ Open. ISSN 2044-6055 (In Press)

Text (Communication BMJOpen_vAccepted_Arianna Gentilini) - Accepted Version Pending embargo until 1 January 2100. Download (248kB)

Abstract

Objective This article critically evaluates the European Commission’s 2024 Implementing Act (IA) on conflicts of interest management for stakeholders in the EU Joint Clinical Assessment (JCA), with a focus on individual experts such as clinicians and patient representatives. Key findings The IA is the first EU-level framework to assess conflicts of interest (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 IA to COI-management approaches from other European national HTA bodies and found that the IA is closely modelled after the French guidelines. Concerns include potential overrepresentation of experts from a small number of countries, lack of guidance on organisational COIs, and ambiguities in disclosure thresholds. Unclear resource allocation for enforcement could also hinder compliance. Conclusions The IA marks progress in EU-wide HTA collaboration, but improvements in transparency, expert diversity, and comprehensive COI management are needed to ensure impartiality in the JCA process.

Item Type:	Article
Additional Information:	© 2024 The Author(s)
Divisions:	Health Policy
Subjects:	R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine T Technology
Date Deposited:	21 Oct 2024 09:51
Last Modified:	01 Nov 2024 10:27
URI:	http://eprints.lse.ac.uk/id/eprint/125806

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