On 21 November 2025, CPE participated in the European Huntington Association (EHA) Workshop “Access to Future Therapies – How Can We Ensure Patient Involvement in HTA Procedures for HD Therapies?” in Prague, to share an overview of the new regulation and provide insights on its implementation from the cancer patient community’s perspective.
Understanding the Joint European Clinical Assessment Through the Patient Lens
CPE senior Policy Officer Josephine Mosset joined the workshop, aiming to share updates and best practices from the cancer patient community to help the Huntington community prepare for meaningful and effective future involvement in EU HTA processes. In the session “Joint European Clinical Assessment – how does it work from a patient organisation’s perspective?”, she provided an overview of the state of play of patient involvement in Joint Clinical Assessments (JCA) under the new EU HTA Regulation. She explained how the JCA provides a single EU-level report on the clinical effectiveness and safety of new medicines with the contribution of patients. The implementation of the EU HTA Regulation started with cancer medicines and ATMPs in 2025 and will expand to medical devices in 2026 and rare diseases in 2028 before becoming mandatory for all new therapies in 2030.
Drawing on CPE’s experience within the EU HTA Stakeholder Network, Josephine outlined how patients and carers are identified, selected, and involved in both JCAs and Joint Scientific Consultations (JSCs). She highlighted the rapid progress already underway: over 180 profiles of patients and clinicians have been collected, with more than 30 experts selected for involvement as of October 2025.
Yet, she also emphasised that meaningful involvement requires more than participation alone. It requires processes that value, integrate, and respond to patient insight.
Early Lessons From Patients: Progress, Gaps, and What Must Change
Josephine shared insights from CPE’s June 2025 survey, noting that previously identified gaps have improved, including clearer timelines, better guidance on patient roles, enhanced communication from the HTA Secretariat, and increased visibility and follow-up on how patient contributions are used.
She stressed that patients want to be true partners in the JCA process and outlined priority improvements: systematic involvement at all stages, clearer communication, realistic timelines, transparent feedback, and stronger capacity-building. These steps are essential to ensure patient perspectives genuinely shape fair and patient-centred assessments.
CPE’s Commitment to Strengthening Patient Involvement in EU HTA
CPE is committed to ensuring meaningful patient involvement in EU HTA processes by supporting patient experts, providing tools and training, and leading initiatives like the HTAi PCIG project. CPE calls for patient voices to be included in decision-making, promoting a more transparent, inclusive, and evidence-based HTA system.
