European Commission Publishes Joint Clinical Assessment Templates for Patient and Clinician Input

The European Commission has published three new joint clinical assessment templates that formalise written input from patients, carers and clinicians in EU Joint Clinical Assessments (JCA). Posted by the Directorate-General for Health and Food Safety on 14 September 2026, the questionnaires were developed after consultation with organisations in the HTA Stakeholder Network. The PDF files are dated 10 September 2026 and appear in English only.

The package does not create a new right of participation. It operationalises the articles of Regulation (EU) 2021/2282 that already require patient, carer and clinician involvement, and it locks that involvement onto two points in the assessment: the consolidated scope proposal, before the PICO questions are frozen, and the draft report, before publication.

What the joint clinical assessment templates cover

Two 13-page scoping templates, one for patients and carers and one for clinical experts, carry the code JCA-MP-202X and sit at the consolidated assessment scope proposal stage. A two-page joint comment form, coded JCA-MX-20XX, covers review of the draft JCA report and its standalone summary. The MP prefix marks medicinal-product assessments, while MX is the shared report-review sheet used by both expert types.

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None of the three files is a live PDF form. Respondents download the questionnaire, complete it offline, and upload it to a numbered folder under Shared documents on the HTA IT Platform. The patient and carer template spends its first nine pages on onboarding rather than questions, with a short abbreviation list, a glossary that separates subgroup from subpopulation, a plain-language definition of JCA, and a worked hypertension PICO with model answers.

Where they sit in the JCA cycle

Individuals are nominated by a national or EU-level patient or clinician organisation, or by a national HTA body. The Secretariat vets a Declaration of Interest and CV, and the JCA Subgroup selects against therapeutic relevance, geographic diversity and conflict rules. Selected experts sign confidentiality papers through the Brussels Centre for Collaboration in Health, and compensation follows Commission expert rules at EUR 450 for a full day and EUR 225 for a half day. All work is in English, and the written window at both stages is seven calendar days.

Scoping and report comments are published in Appendix A of the final JCA report. Patient and carer text is anonymised; clinician names are collected and carry no such promise. The clinical expert template also states, more bluntly than the patient file, that the consolidated proposal reflects the needs of all EU and EEA Member States, not any single Member State’s evidence needs.

What each template asks

The prompts are more operational than the label patient input usually implies. On population, respondents are asked whether the description is clear and specific and whether elderly, young adult, early-symptom and socio-economically disadvantaged groups are visible. On comparator, whether the list reflects standard practice and which option best matches patient need, with invasiveness, convenience, administration burden, travel and monitoring named as tests. On outcomes, whether the endpoints match what patients value, with quality of life, functional status, symptom burden, long-term effects, survivorship and late toxicity explicitly invited. On subgroups, whether the cuts the Subgroup will force the company to make are the ones that matter in real life.

The intervention itself cannot be changed. It is the EMA-claimed technology, and the respondent may only describe how the intervention reshapes population, comparator or outcomes. The Commission states this twice, clearly, and the clinician file applies the same lock to name and posology. The clinician questionnaire asks for concise, practice-based input on whether the proposed populations, comparators, outcomes and subgroups reflect clinical care, and it collects name, professional-society affiliation and medical specialty.

What works and what will create friction

Timing is the strongest part of the package. Commenting after Member States have tabled national PICOs but before the scope is frozen and sent to the company is the only moment patient and clinician views can still change the evidence request. The patient file also refuses to let lived experience stay a free essay, mapping it onto P, C, O and subgroups instead, which is how input survives contact with an HTA methodologist. Comparators may be procedures, watchful waiting or individualised bundles rather than only rival brands, a point that matters for advanced therapies and some oncology sequences.

The friction is structural. The seven-day window leaves little time for a patient to read a multi-PICO scope, take advice and write in English, and the English-only working language filters who can complete the form despite geographic diversity being a selection criterion. Patients are anonymised while clinicians are named, which will shape how candid hospital specialists are about off-label standard of care and poor comparators. The templates are silent on how the Subgroup treats expert input that contradicts a Member State PICO; made available and discussed is not a decision rule. The patient template’s section 4.5 still addresses the clinical expert, an almost certain copy-paste error, and the two-page report form offers no structured prompt on certainty of evidence, missing indirect comparisons, or whether the assessors’ narrative matches practice. The scoping files are coded for medicinal products, so a device-specific variant is not in this package even though high-risk device JCAs begin in 2026.

What this means for dossier teams

JCA remains shared clinical input rather than a shared reimbursement decision, and these templates do not change that. They do change the information environment around the PICO lock and the public report. For developers, expert scoping comments are an early-warning system for extra comparators, extra subgroups and missing patient-relevant endpoints, and once the scope is final those items become dossier obligations. Companies should not lobby selected individual experts; conflict-of-interest rules and the public Appendix A make that improper and visible, and the legitimate channel is the company dossier and any earlier joint scientific consultation.

The practical steps follow from the template design. Map the patient and clinician organisations most likely to be asked to nominate experts for each asset approaching JCA. Stress-test the draft company PICO set against the exact prompt lists, especially administration burden, access and identifiable subgroups. Pre-build evidence for the endpoints the patient template names, health-related quality of life, function, symptom burden, survivorship and late toxicity, even when they are not the regulatory primary. And assign one person to harvest Appendix A from each published JCA to log whether expert comments changed PICOs, outcomes, subgroups or only the narrative.

Source: European Commission, Three new templates to support the written input of patients, carers and clinicians in joint clinical assessments, 14 September 2026.