How joint scientific consultation works
Joint scientific consultations (JSCs) are run by the Member State Coordination Group on HTA (HTACG) under Regulation (EU) 2021/2282, which applies from 12 January 2025. Their purpose, in Article 16, is to exchange information with health technology developers on development plans, so that the evidence generated meets the likely requirements of a later joint clinical assessment (JCA). The advice covers study design, comparators, interventions, health outcomes and patient populations. Each consultation includes a meeting and ends with an outcome document containing the scientific recommendations.[1, 2]
Within the HTACG, a JSC subgroup appoints an assessor and a co-assessor from different Member States. They draft the outcome document; other subgroup members may comment and add Member State-specific recommendations; and patients, clinical experts and other relevant experts may give input. After the meeting with the developer, the assessor finalises the draft, the HTACG approves it, and the Commission sends it to the developer at the latest 10 working days after finalisation. Commission Implementing Regulation (EU) 2024/3169 of 18 December 2024 sets the detailed procedural rules for JSCs on medicinal products for human use.
Eligibility and selection
A product is eligible if it is likely to be the subject of a JCA under Article 7(1) and its clinical studies or investigations are still at the planning stage. For devices, the call covers class IIb and III medical devices and class D in vitro diagnostics.
Capacity is limited. The HTACG announced up to 10 JSCs for 2025, with capacity to increase in later years. Where eligible requests exceed the slots available, Article 17 sets the selection criteria:
- unmet medical need
- first in class
- potential impact on patients, public health or health care systems
- significant cross-border dimension
- major Union-wide added value
- Union clinical research priorities
The HTACG notifies developers within 15 working days after the end of each request period, and gives reasons for any refusal. A request should therefore make the case against these criteria explicitly, not leave the reviewers to infer it.
Request periods and the briefing document
Requests can be made only during the request periods published by the HTACG, through the HTA IT platform. Access to the platform is requested from the Commission's HTA secretariat, and can take a few days. The request uses the Commission's template; the briefing document follows later on separate templates for HTA-only and parallel EMA/HTA consultations on medicines.
For the autumn 2026 request period (23 September to 21 October 2026), the published slots have briefing document deadlines of 11 January, 8 February and 15 March 2027, with discussion meetings in the weeks of 12 April, 10 May and 7 June 2027. In other words, the briefing document is due roughly three months after the request period closes, and the meeting follows about three months later. That timetable has to fit the protocol finalisation date of the pivotal trial, or the advice arrives too late to use.
Parallel consultation with the EMA
A developer of a medicinal product may ask for the JSC to run in parallel with EMA scientific advice, and must submit the EMA request at the same time. Article 16(5) requires parallel consultations to involve the exchange of information and synchronised timing, while keeping the remits of the HTACG and the EMA separate. The outputs stay separate too: the EMA issues a scientific advice letter, and the HTA bodies issue the outcome document.[3]
The parallel route is useful when regulatory and HTA needs may diverge, for example on the control arm, an endpoint that matters to payers but not to the marketing authorisation, or the length of follow-up needed for a cost-effectiveness model.
Status, confidentiality and the link to JCA
The outcome document has no legal effect for Member States, the HTACG or the developer, and does not prejudice a later JCA of the same product. It is advice, not a commitment. For medicinal products, the Regulation also directs that the draft recommendations should, where appropriate, advise directly comparative, randomised, blinded studies with a control group.
Information shared in a JSC goes through the secure HTA IT platform, and the Regulation provides that it is disclosed to third parties only after a confidentiality agreement. What is published is limited to anonymised, aggregated, non-confidential summaries in HTACG annual reports and on the platform's public page. Where a JSC has taken place, the assessor and co-assessor for the later JCA must be different people, unless the HTACG approves an exception for lack of expertise.
The practical link is the PICO. At JCA scoping, Member States set out the populations, comparators and outcomes they need, often more than one. A JSC is the earliest chance to see how far those needs diverge and to design the trial, or the plan for indirect treatment comparisons, accordingly.
What we deliver
- Go or no-go assessment: is a JSC worth a request, and in which period, given your protocol timelines
- Request drafting that addresses the Article 17 selection criteria
- PICO simulation across Member States to identify the comparators and outcomes most likely to be requested
- Question framing and the briefing document, in the HTA-only or parallel EMA/HTA template
- Evidence context: systematic literature reviews of the treatment landscape and feasibility of indirect comparisons
- Meeting preparation and rehearsal
- Translating the outcome document into the evidence plan and the later JCA dossier
What to get right
- Timing: request advice while the protocol can still change, so the advice can shape it.
- Specific questions: state your proposal and ask whether it is acceptable, and if not, what would be.
- Several comparators: Member States use different standards of care, so show how you will handle comparators you cannot include in the trial.
- Advice as guidance: it is not binding, and evidence needs can evolve before JCA.
- National needs: Member State-specific recommendations can matter as much as the joint view.
Why Evidaxia
We have developed EU JCA dossiers for several companies, including PICO scoping, indirect treatment comparisons and network meta-analyses, so we prepare a JSC with the later assessment already in view. Hasan Bari, our Founder and Managing Director, is a clinician and health economist and former NICE HTA Technical Lead and Analyst, used to reading evidence plans as an assessor does.
References
- Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. Official Journal of the European Union. 2021 Dec 22;L458:1-32. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32021R2282
- European Commission. Joint scientific consultations [Internet]. Brussels: European Commission; [date unknown] [cited 2026 Oct]. Available from: https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-scientific-consultations_en
- European Medicines Agency. Parallel scientific advice [Internet]. Amsterdam: European Medicines Agency; [date unknown] [cited 2026 Oct]. Available from: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance/parallel-scientific-advice-special-development-aspects-or-product-types
Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.