Managing experts’ conflicts of interest in the EU Joint Clinical Assessment

Ariana Gentilini and Iva Parnanova, Research Associate at LUISS and member of BridgeGap

BMJ Open (2024)

https://doi.org/10.1136/bmjopen-2024-091777

The article evaluates the EU’s 2024 Implementing Regulation (IR) on managing conflicts of interest (COIs) in health technology assessment (HTA). It introduces EU-wide COI management for experts, requiring annual declarations of financial and non-financial interests. Based on French guidelines, the IR raises concerns about expert diversity, organizational COIs, and financial disclosure clarity.

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. The authors 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 the potential over-representation of experts from a small number of countries, lack of guidance on organizational COIs, and ambiguities in how the size of financial interests are disclosed. Unclear resource allocation for enforcement could also hinder compliance.

Although, 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.

COIs decision matrix for individual experts

Source: Gentilini and Parvanova (2024)

This is an open access article distributed under the terms of the Creative Commons CC BY 4.0 license, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.