The Member State Coordination Group on Health Technology Assessment (HTACG) has introduced three templates for patient, carer and clinician input into Joint Clinical Assessments (JCAs). Published on 14 September, the templates cover two points where external expertise can influence the assessment: definition of the assessment scope and review of the draft JCA report.
The EU HTA Regulation and its implementing rules already require patients and clinical experts to be involved in JCA. Selected experts can comment on the assessment scope and the revised draft assessment and summary reports. The September measure standardises how that existing participation route works in practice.
Separate scoping templates are now available for patients and carers and for clinical experts. A third common form allows patients, carers and clinicians to comment on the draft JCA report. The Commission gives selected experts seven days to provide written input at each of these stages.
Input during scoping can influence the PICO questions that determine the populations, interventions, comparators and outcomes addressed by the assessment and therefore the evidence requested from the developer. Patient experience can help test whether proposed outcomes and comparators reflect lived experience, while clinicians can bring current treatment pathways and practice variation into the assessment.
Using common templates should make these contributions more systematic and easier for assessors to incorporate consistently. Structured questions also encourage contributors to explain and support their observations, strengthening the robustness and traceability of expert input. For developers, this may make stakeholder influence on JCA scope more predictable while sharpening the clinical questions and uncertainties that the dossier must address.
Source: European Commission, Directorate-General for Health and Food Safety
Link: Three new templates to support the written input of patients, carers and clinicians in joint clinical assessments
Date: 14 September 2026
Source: European Commission
Link: Commission Implementing Regulation EU 2024/1381 of 23 May 2024 laying down procedural rules for joint clinical assessments of medicinal products
Date: 24 May 2024
