EFA has responded to 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 medicinal products for human use. In its 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.
At the end of October 2024, EFA responded to the European Commission’s HTA stakeholder consultation on the fourth implementing regulation of the EU HTA Regulation. This implementing regulation improves the cooperation between the national and regional HTA bodies, the European Commission, the European Medicines Agency (EMA), heath technology developers (companies) and individual patient experts. The HTAR gives the European Commission the role of secretariat to the EMA’s Coordination Group, known as the HTA Secretariat. The Coordination Group also has a Subgroup dedicated to processing JSCs. The HTA Secretariat, working with the JSC Subgroup, oversees the inclusion of these experts in consultations, presenting a key opportunity for patient involvement in HTA processes within the EU.
Barriers for patient involvement in EU JSCs
EFA welcomed the proposal’s intentions to improve patient expert involvement from the earliest stages of the JSC process. However, EFA raised concerns over the interpretations of conflict of interest within this implementing regulation, which could limit patient involvement. EFA recommended that managing conflicts of interest should be built on trust, not suspicion, fostering a system that values civil society and prioritises the inclusion of the patient experience.
EFA appreciated the role of the HTA secretariat in simplifying the JSC process for selecting individual experts but pointed out that the proposal does not fully embrace the unique, often volunteer nature of patient experts. Many patients face disproportionate challenges compared to other experts in complying with the administrative and procedural requirements in these processes and this is where patient organisations can have a useful role, if that role is recognised and supported.
Digital and procedural barriers
EFA noted that the proposal lacks support structures for patients with varying levels of digital literacy, which could impede digital participation. This is why we encouraged the HTA Coordination Group and European Commission HTA Secretariat to define onboarding paths and appoint dedicated staff to guide patients’ experts in overcoming procedural and digital barriers. We also highlighted the importance of adapting processes to support the health needs of patient participants, ensuring meaningful and accessible involvement.
In addition, EFA urged that time commitments, compensation and administrative support be explicitly introduced in the Implementing Regulation, with details provided at the start of each expert selection procedure.
Recognising the role of patient organisations in JSC
EFA highly welcomed Article 11 on consulting stakeholders and we encourage the Commission to explicitly recognise the role of patient organisations in JSCs. EFA encouraged the HTA Secretariat and the EMA to apply the same procedures such as desk support, guidance, and compensation for stakeholders involved in JSC processes to enhance engagement and equity.
Transparency and Member State obligations for JSC reports
EFA pushed for Member States to have access to information on the implementation of JSCs, to improve access to medicinal products in Europe. Unlike the HTAR, the current draft regulation does not require the publication of anonymised, aggregated information on JSCs in the annual reports of the Coordination Group.
For a full understanding of the JSC process, EFA requested the HTA Secretariat makes these reports available with translations in all EU languages on the HTA IT platform, which was set up by the European Commission under the HTAR in order to facilitate the secure exchange of information between the EMA’s Coordination Group and its subgroups with companies and experts. Publication of these reports would allow Member States to refer to shared insights and set precedents, promoting equal patient access to treatments.
You may find EFA’s full reply to the consultation here.