Joint scientific consultation with HTA bodies is an early consultation on evidence planning for a medicinal product, involving the EMA and the Member States’ Coordination Group for Health Technology Assessment. It brings together regulatory and HTA perspectives in a coordinated procedure. The aim is for the development programme to generate robust data both for a potential marketing authorisation and for subsequent national benefit assessments and reimbursement decisions.
Context of the HTA Regulation
Regulation (EU) 2021/2282 on health technology assessment establishes an EU framework for cooperation between Member States in the field of HTA. It includes, among other things, joint clinical assessments and joint scientific consultations. The Member States’ HTA Coordination Group is supported by the European Commission. The EMA works with this Coordination Group, provides the necessary information, and in doing so safeguards the distinct responsibilities of regulatory authorities and HTA bodies.
HTA considers medical, economic, social and ethical issues related to health technologies. For medicinal products, national HTA bodies may use the evidence, among other things, to inform decisions on reimbursement and pricing. Joint consultation takes place earlier: it is intended to identify at an early stage which data questions are relevant from both a regulatory and an HTA perspective, without pre-empting the later decisions of the competent bodies.
Objective of the procedure and participation
For medicinal products, the EMA and the HTA Coordination Group conduct parallel joint scientific consultations with a synchronised process. The consultation may address questions on the baseline evidence for a marketing authorisation application, the evidence for reimbursement decisions, and post-authorisation data generation. It therefore provides a shared discussion framework for the development plan, while regulatory and HTA assessments remain within their respective areas of responsibility.
In practice, the focus is often on study populations, comparator therapies, patient-relevant endpoints, duration of follow-up, and the handling of uncertainty. The consultation does not allow for a single uniform requirement for all Member States, as subsequent HTA decisions are taken within the respective national frameworks. However, it can help avoid situations where key evidence questions only become apparent after completion of the pivotal authorisation studies and can then be addressed only with substantial additional effort.
Distinction from purely regulatory scientific advice
The EMA’s general scientific advice focuses on the investigations required to substantiate the quality, safety and efficacy of a medicinal product. Joint scientific consultation broadens the perspective to include the requirements of the participating HTA bodies. It is therefore not merely duplicated EMA advice, but a coordinated consultation across multiple decision-making contexts with different legal mandates.
Joint scientific consultation is also neither a marketing authorisation decision nor a joint clinical assessment. A marketing authorisation is decided only after submission and scientific assessment of a complete application. A joint clinical assessment is a separate HTA instrument. The consultation takes place before these assessments and provides recommendations on evidence generation without replacing the subsequent benefit assessment or a reimbursement decision.
In this way, joint consultation promotes an appropriate division of labour without blurring responsibilities. The EMA advises from a regulatory perspective, and the participating HTA bodies advise based on their evidence and assessment logic. Recommendations may differ in their substantive focus; they are not merged into a single market or reimbursement decision. However, developers have the opportunity to discuss early on with the relevant bodies any open assumptions regarding comparator therapy, endpoints and evidence transferability.
Participation does not relieve developers of the need to continuously analyse national requirements. It provides a structured early consultation, while subsequent evidence assessment, reimbursement and pricing remain within the respective remits.
The consultation remains confidential and procedure-specific.
Relevance for clinical trials
For clinical trials, joint consultation can shape the planning of comparator arms, endpoints, subgroups and follow-up periods. Development programmes must align regulatory benefit–risk requirements and the comparability of evidence relevant for HTA as far as possible. This does not lower the requirements of individual authorities and does not guarantee a positive assessment. However, it makes it easier to identify divergent questions early and to prioritise data generation in a transparent manner.
Full-service CROs such as Mediconomics provide support through study strategy, biostatistics, medical writing, regulatory affairs and project management. This includes analysing evidence gaps, preparing a joint briefing document, formulating targeted consultation questions, and translating feedback into protocols, statistical analysis plans, patient-relevance concepts and realistic plans for post-authorisation data collection.
Frequently Asked Questions (FAQ)
Does joint scientific consultation decide on a marketing authorisation?
No. It provides advice on evidence planning prior to submission; the marketing authorisation is assessed in a separate procedure.
Does it replace a national HTA assessment?
No. National HTA and reimbursement decisions remain the responsibility of the competent bodies and their respective legal frameworks.
How does it differ from the EMA’s Scientific Advice?
It additionally incorporates the HTA perspective, whereas purely regulatory advice is geared to the requirements of the marketing authorisation assessment.
Regulatory References
- Regulation (EU) 2021/2282 – establishes the EU framework for health technology assessment.
- Regulation (EU) 2021/2282, Articles 16 to 21 – governs joint scientific consultations for medicinal products.
- Regulation (EU) 2021/2282, Articles 7 to 15 – governs joint clinical assessments for delineation purposes.
- Regulation (EC) No 726/2004, Article 57 – describes the EMA’s tasks in scientific advice.
