The introduction of the EU Joint Scientific Consultation (EU JSC) brings new opportunities and challenges for health technology developers seeking market access advice. Inbeeo consultant Lucy Forrester outlines how EU JSC compares to local advice and whether it’s right for your product.
EU JSC or Local Advice? What’s Best for Your Needs?
A randomised clinical trial against the standard of care (SoC) in a country is the gold standard for evidence generation. This trial should be long enough to demonstrate the treatment’s effect and should use a primary endpoint the country considers relevant. Meeting this standard often poses a significant challenge.
Different markets have different flexibility for accepting alternative design options. With limited resources, health technology developers (HTDs) must make decisions about how to optimise their clinical trial design. They must ensure it meet the needs of as many markets as possible.
HTD market access teams can seek advice on the perception of a trial design before finalising their evidence generation plans.
Informal advice
HTDs can informally seek advice through proxy payers (former HTA advisors now independent consultants) or specialist local health economists. Alternatively, HTDs can interview advisors from multiple countries or hold a roundtable discussion to review the trial design. Informal advice provides a quick turnaround, with no obligation to follow the advice. The drawback is that the advice reflects the “best guess” of former payers rather than how the current administration might perceive the trial at the time of reimbursement.
Informal advice provides a quick turnaround, with no obligation to follow the advice. The drawback is that the advice reflects the “best guess” of former payers rather than how the current administration might perceive the trial at the time of reimbursement.
Formal advice
HTDs must request formal scientific advice to ask questions directly to the HTA body. A representative of the HTA body provides this advice. This allows the HTD to more accurately assess the impact of trial design decisions on market access. The drawback is that formal advice often takes longer than informal routes. It also demands a significant investment (both time and money) in developing a briefing book and preparing for the engagement. Formal scientific advice also obligates the company to either follow the recommendations or justify why it chose not to.
Until recently, HTDs could access single-country advice in France (Haute Autorité de santé – HAS), Germany (Federal Joint Committee – G-BA), UK (National Insitutes of Health and Care Excellence – NICE), Italy (Italian Medicines Agency – AIFA), Sweden (Dental and Pharmaceutical Benefits Agency – TLV), Denmark (Danish Medicines Council – DMC), Norway (Norwegian Institute of Public Health – NIPH) and Canada (Canadian Drugs Agency – CDA). HTDs could also seek parallel advice from UK-Canada (NICE-CDA).
So, what are the EU JSC changes as of 2025?
The EU HTA regulation came into force on 12 January 2025. It requires products applying for EU Marketing Authorisation (MA) to submit an EU Joint Clinical Assessment (JCA). The EU HTA regulation is designed to harmonise and streamline HTA across EU member states. The EU JCA aims to reduce duplication, standardise HTA outcomes and methods, and speed up patient access across the EU.
Eligibility for this process rolls out in phases. From January 2025, oncology products and ATMPs become the first eligible group. Orphan products enter the process in 2028, followed by all new medical products in 2030. Offered alongside this process is EU JSC (Joint Scientific Consultation). The EU JSC allows HTDs to engage with the HTA Coordination Group (HTACG) around their evidence package at the EU-level. HTDs can also seek parallel advice from the European Medicines Agency (EMA) (Parallel HTACG/EMA JSC).
What’s the catch?
This exciting opportunity allows HTDs to seek advice at the EU level—and, for now, it is free of charge. However, there are some considerations before proceeding with EU JSC:
- Limited availability: In 2025, the EU will offer a maximum of 10 advice slots for advice (5-7 for medical products, 1-3 for medical devices). This is expected to increase in the coming years. However, demand for this engagement will likely exceed the number of slots, meaning HTDs should be ready early to apply. Before securing a slot, HTDs will need to complete a significant amount of preparatory work. HTDs will likely need to complete preparatory work for EU JSC ‘at risk’.
- Additional resourcing requirements: Pursuing EU-level advice will require additional resources, as it is an extra advice procedure on top of any local advice. HTDs will need to weigh up whether the benefits of seeking EU-wide advice justify the extra resources required.
- Confidentiality concerns: HTDs must include outcomes of JSCs within EU JCA submissions, along with any justifications for deviations. HTDs will need to weigh up whether this could pose a risk to their global market access strategy.
A summary
The EU JCA and EU JSC are still in their early stages. We’ll begin to understand the impact of EU JCA on local access in member states when the first JCA reports become available. These are expected early 2026. It will take even longer to gauge whether EU JSC provides detailed enough feedback to support EU-wide market access. This will only become clear after HTDs have gone through both EU JSC and a successful EU JCA. Since EU JSC informs evidence generation planning and requires preparation, it will only be relevant to products submitting after 2027.
What action can HTDs take now?
- Develop a decision framework to guide EU JSC decisions. This includes a risk-benefit assessment that outlines the pros and cons of seeking JSC as well as formal advice.
- Integrate EU JSC considerations into any existing internal scientific advice decision framework.
- Engage cross-functional teams early in the EU JSC decision-making process
- Coordinate closely between regulatory and access teams when pursuing Parallel EMA/HTACG advice.
Considering EU JSC or formal advice for your product? At Inbeeo, we help our clients navigate both informal and formal advice channels while establishing structured decision frameworks to guide their approach. Get in touch with one of our experts today!