EFA has responded to a consultation on the EU Health Technology Assessment Regulation (HTAR) draft implementing regulation that determines the process for selecting and involving individual patient experts in joint scientific consultations (JSC) on medical devices and in-vitro medical devices. In our response, EFA advocates for better guidance for patient experts in JSCs and for stronger recognition and involvement of patients’ organisations at all stages of the JSC process.
Barriers for individual patient involvement in JSC processes on medical devices
EFA welcomed the draft implementing Regulation’s aim to improve individual experts’ involvement in the JSC process and involve them as early as possible.
We called for onboarding paths for patients in the JSC process. The European Commission should embrace the volunteer nature of patients, who may need extra support in fulfilling the administrative and procedural requirements.
As with the implementing Regulation on JSCs for medicines, EFA is concerned about patients’ assessment of declarations of interests, and asked to further outline conflict of interest for medical devices. EFA also called for further outlining the compensation of patients in the JSC process.
Selection of patients’ organisations in JSC on medical devices
EFA welcomed the possibility for the JSC on medical devices process to take place in parallel with the ‘expert panel’ consultation. EFA highly welcomed article 12 , which allows the JSC Subgroup to being able to consult stakeholder organisations at any time during the JSC process and encouraged the Commission to explicitly recognise the role of patient organisations in the procedures. Patients’ organisations play a crucial role in providing an aggregated perspective of the patient community and in providing evidence-based information that accurately reflects the burden of the disease and the value of treatment, especially in cases where symptoms and their impact vary widely.
EFA welcomed the proposal’s approach to protecting personal data, and agreed with article 13, whereby patients should not be obliged to disclose their identity to the companies.
Finally, while HTA is carried out by the national authorities of the Member States, there currently is no EU-level agency dedicated to assessing the implementation of the HTAR. EFA encouraged the establishment of an EU agency dedicated to medical devices and in vitro medical devices.
The HTAR is set to apply in all Member States from 12 January 2025 onwards. By 31 March 2025, the European Medicine Agency’s (EMA) Coordination Group will set at least one request period for JSC on medical devices for 2025.
You may find EFA’s full reply to the consultation here.