This week MPE provided feedback on the draft of the fifth 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 12 January 2025. The fifth implementing act focuses on joint scientific consultations on medical devices and in vitro diagnostic medical devices at Union level. A medical device is, according to the World Health Organization (WHO), “any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.” In myeloma, for example, this would include all instruments and kits used to perform and analyse blood tests (such as serum free light chains), bone marrow biopsies or imaging tests (such as X-rays, or computed tomography (CT) scans).

Joint Scientific Consultations (JSCs) offer medical device 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 issues in the document:

• Challenging timelines: as the timelines are strictly set for both patient experts and patient organisations to provide input, the situation might prove particularly challenging for patient organisations with small teams and individual experts who will provide insights on the same product in the same timeframe to both HTA and the European Medicines Agency (EMA). In these cases, it would be critical that both the EMA and HTA Secretariat would be aware of this fact and ensure that patient organisations and individual experts would have enough time to reply.
• Handling of potential conflicts of interests: 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.
• Support for patient experts: while measures to support and prepare patients to be involved in HTA have been taken at the EU level (for example by funding training courses such as EUCAPA), MPE believes that more should be done on specific issues to support the involvement of patient experts. For example, the HTA Secretariat could ensure that patient experts understand the selection and engagement process, including the stipulations of the confidentiality agreement, and will be offered training on the use of the HTA IT Platform.
• Feedback to patients on their input: to improve patients’ contributions as well as building a better relationship between HTA bodies and patients, patient experts could greatly benefit from feedback on how their input was used.

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