Embedding Effective Patient Involvement in EU Joint Clinical Assessments

EU Joint Clinical Assessments (JCAs) for oncology went live in 2025, yet patient input remains confined to brief reactions to a near-final scope and a draft report. This “back-loaded” model risks tokenism by overlooking essential patient insights on outcomes, comparators and context. This Issue Panel convenes the Coordination Group, a national HTA agency, and regional patient advocates to debate a no-delay, high-value roadmap. A real-time poll will gauge audience confidence in today’s model before panellists outline the following: • Map the current regulatory touch-points for patient involvement and highlight clear opportunities for effective and timely patient engagement • Showcase specific oncology and rare-disease cases where early patient insight has already reshaped regulatory and national HTA. Stress-test four upgrade options: 1. Standing EU patient-led PICO survey to capture priority outcomes and feed scoping consolidation before the draft scope is written. 2. Compulsory lay summaries of both the manufacturer dossier and the JCA report—produced in plain language and all EU languages—to widen meaningful participation. 3. Patient co-authorship of contextual domains (unmet need, treatment acceptability, lived experience) so interpretations reflect real-world priorities. 4. NICE-style Patient/Carer involvement policy: NICE involves patients and carers through various channels and guided by comprehensive strategy. Panellists will rank each option against timelines and legal boundaries, then invite the audience to vote on priorities for the Regulation’s 2026 review clause.