Second implementing act for the EU HTA Regulation details rules on conflicts of interest

Swiftly following adoption of the first implementing act, the second act outlining procedural rules for assessing and managing conflicts of interest is now open for consultation. 

With the new EU HTA procedure starting in January 2025, the European Commission is moving full steam ahead in detailing expectations for industry and national HTA authorities regarding joint clinical assessments (JCA) and joint scientific consultations (JSC). On May 23, 2024, the EC adopted the first implementing act, outlining procedural rules, templates, and timelines for JCA of medicines under the EU HTA Regulation. They have now launched a public consultation on the second act concerning the management of conflicts of interest, ending June 26, 2024.  

Commenting on LinkedIn, Roisin Adams, Head of HTA Strategy and External Engagement, National centre for Pharmacoeconomics, Ireland and elected Chair of the Member State Coordination Group on HTA (HTACG) stressed the significance of this act:  

“This is very important document putting this matter into a legislative framework for the first time. It details the rules on conflict of interest for committee representatives and experts (e.g. patients, clinical experts.) All of this is designed to maintain the independence, impartiality and transparency of the EU HTA process.”

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Key details 

Establishing stringent procedural rules for managing conflicts of interest in HTA ensures that assessments remain objective, transparent and trustworthy. This second act, “Health technology assessment – procedural rules for assessing and managing conflicts of interest” includes rules for managing conflicts of interest for participants such as HTACG representatives, assessors, patients, and clinical experts. It consists of a main text detailing conflict management, and two annexes: a declaration of interest (DOI) template and an overview of participation exclusions based on declared interests. DOI regarding industry interactions in the last 3–5 years are required, with most DOIs made public and assessed within 15 days; DOIs for patient experts will not be made public.  

Any participant with a perceived conflict of interest and ‘deemed incompatible with the participation in the joint work’ will be excluded, including clinical experts with strategic advisory or consultancy roles in the industry. As several experts have noted, this strikes concern in the field of rare diseases, where the limited number of clinical experts makes it difficult to find individuals without such conflicts, adding to the other challenges rare disease companies may face. 

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Next steps 

If the timeline for the first act is followed, the second implementing act is expected to be adopted by the EC in July 2024. Four more acts are to follow, covering information exchange with the European Medicines Agency (EMA), JSC of medicinal products, and JCA/JSC of medical devices and in vitro diagnostic medical devices. Industry and HTA bodies are waiting with bated breath for the final details of these acts in order to ensure their readiness ahead of the first JCA procedures starting next year.