Third EU HTA Regulation implementing act sets out rules on conflicts of interest

The new regulation mandates conflict-of-interest declarations in health technology assessments (HTAs), ensuring transparency, impartiality, and rigorous standards for unbiased healthcare evaluations.

On October 25, 2024, the European Commission adopted the third implementing act, Health technology assessment – procedural rules for assessing and managing conflicts of interest, under the EU HTA Regulation, setting out comprehensive rules for managing conflicts of interest in the EU’s HTA processes. This regulation outlines how conflicts of interest will be identified and managed to ensure independent and transparent assessments of new health technologies across the EU.

The regulation mandates that all participants in joint clinical assessments (JCAs) and joint scientific consultations (JSCs) must declare any interests that could affect impartiality. This group includes representatives from the Member State Coordination Group on Health Technology Assessment (HTACG), patients, clinical experts, and other relevant stakeholders. “To ensure a uniform approach regarding the interests to be declared,” the regulation states, “it is appropriate to set out rules on the content, format, and validity of the declaration of interests (DOI).” The declaration must be submitted via the HTA IT platform and be accompanied by a comprehensive curriculum vitae (CV) based on the Europass CV template.

This new framework aims to ensure that assessments remain free from bias; for instance, if any individual fails to submit an updated DOI or provide requested clarifications regarding declared interests, they will be restricted or excluded from joint work. The regulation highlights that such actions are necessary, “to ensure the robustness of the system of management of conflicts of interest and the highest standards of independence, impartiality, and transparency related to the joint work.”

The DOI, along with each participant's qualifications, will be made publicly accessible through the HTA IT platform, except for those submitted by patients. Clinical experts' DOIs will be available for one year after the completion of their joint work, while DOIs for representatives in the HTACG will remain accessible for the entire duration of their involvement.

Additionally, the Commission has the authority to exclude individuals from participation if they fail to declare relevant interests or if there is an inconsistency between their declared and actual interests. In cases where interests are deemed incompatible with the responsibilities of the HTA role, the regulation stipulates that, “the HTA secretariat shall invite the member of the Coordination Group or its subgroup to appoint another representative,” or ensure that the representative no longer participates in joint work until the conflict no longer exists.

The conflict-of-interest regulation is the third of six implementing acts required before the full application of the HTA Regulation on January 12, 2025. As the EU moves closer to this milestone, each new procedural framework further strengthens the foundations of EU-wide HTA efforts.