The EU Health Technology Assessment (HTA) Regulation (EU HTAR) entered into force in January 2022 and will be applied starting in January 2025. It aims to improve the availability of medicines and certain medical devices by establishing EU level joint clinical assessments and joint scientific consultations. It also sets rules for the involvement of patients, clinical experts and other relevant experts.

Following the first implementing act supporting EU HTAR, to which MPE provided detailed feedback in April 2024, the European Commission recently opened consultation on the second implementing act. The focus of this second implementing act is on procedural rules for assessing and managing conflicts of interest (CoI) for representatives and individual experts (including patient experts).

MPE provided feedback on the draft of the second implementing act, drawing attention to the overly strict approach to CoI which might lead to serious difficulties recruiting patient experts to participate in assessments and thus jeopardise patient involvement overall. Specifically, MPE commented that:

• The European Commission’s goal of actively involving patients not only in the regulation of new therapies but also in their development seems to come at odds with the CoI detailed in this implementing act
• In rare and ultra-rare diseases, there are often a limited number of patients with clinical and regulatory expertise in their disease area and are thus involved in a wide range of activities, many made possible with financial contributions from industry
• Current requirements for conflicts of interest as detailed in the second implementing act and accompanying Annex would thus disqualify the vast majority of patient experts in the area of rare and ultra-rare diseases from being involved in HTA assessments
• A key concern of MPE is that patients with the best available expertise will be left out of HTA assessments
• A flexible and pragmatic approach towards the CoI, one that balances the need to ensure transparency, impartiality and independence with the realities of patient expertise should be pursued

For more details on MPE’s comments please see here.