Yesterday 28 October, MPE provided feedback, as part of a public consultation open to all categories of stakeholders, on the Implementing Regulation on joint scientific consultations on medicinal products for human use at Union level. This is the fourth implementing act (out of six planned to be adopted this year) paving the road for the application of the Health Technology Assessment (HTA) Regulation from January 2025.

Joint Scientific Consultations (JSCs) offer medicine developers the opportunity to obtain feedback from regulators and HTA bodies in Member States on the evidence needed to be submitted as part of subsequent HTA regulatory approvals. The JSC process as described in this implementing act offers opportunities for patient involvement including both patient experts as well as patient organisations.

In its feedback MPE welcomed the commitment to involve patients in conducting these consultations but drew attention to the lack of clarity concerning certain sections of the document. Specifically, MPE commented that:

• The same patient experts might be called to provide insights in parallel to both JSCs and the scientific advice on medicinal products by the European Medicines Agency (EMA). In this case it would be critical for the expert that both EMA and HTA Secretariat would be aware of this fact and ensure that the expert would have enough time to reply to both.
• A lack of time under strict timelines might also be an issue for patient organisations asked to provide input. Thus, these organisations would need to be informed of their potential involvement as early as possible.
• The strict approach to conflicts of interest under HTA Regulation might make the recruitment of patient experts for rare and ultra-rare diseases difficult. While there is a possibility of including patient experts with conflict of interests if no other experts will be identified, especially for rare diseases, this inclusion remains very much “exceptional” as well as vaguely described.
• To provide input all stakeholders will need to use the HTA IT Platform. While a secure dedicated platform for exchanging information is greatly welcomed, many patient experts might require training to learn how to use it properly, as well as additional training to understand the confidentiality requirements.

Previously this year MPE provided comments on the first implementing act supporting EU HTAR, focused on Joint Clinical Assessments, as well as on the second implementing act focused on conflicts of interest for representatives and individual experts (including patient experts).