Joint Scientific Consultations (JSCs): What They Are and Who They Can Help
- Jul 8
- 16 min read
If you have spent any time navigating the EU Health Technology Assessment (HTA) landscape in 2025 or 2026, you will have encountered a question that stops many development teams in their tracks: how do we design a clinical trial that satisfies both the EMA for marketing authorisation and EU HTA bodies for the Joint Clinical Assessment — when their evidence requirements do not always align?
The answer, in regulatory terms, is the Joint Scientific Consultation (JSC) — one of the most strategically valuable yet chronically underused tools in the EU HTA Regulation. Established under Regulation (EU) 2021/2282, the JSC allows pharmaceutical companies, biotech developers, medical device manufacturers, SMEs, and academic institutions to receive formal, pan-European scientific guidance on their clinical development programmes before their pivotal trial protocol is locked. Critically, it is provided free of charge. Yet slots are scarce, awareness is uneven, and many developers are either applying too late or not at all.
This blog explains exactly what a JSC is, how it works, who can access it, who benefits most — and what the existence of the JSC means for anyone building a career in regulatory affairs and market access in 2026.
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The Problem That the JSC Was Designed to Solve
To understand why the JSC matters, it is necessary to understand the evidence problem at the heart of the EU HTA Regulation.
When the EU HTA Regulation came into force on 12 January 2025, it introduced Joint Clinical Assessments (JCAs) as the mandatory EU-wide evaluation of clinical evidence for new oncology medicines and Advanced Therapy Medicinal Products (ATMPs). From 2028, orphan medicines are included. By 2030, the scope extends to all new medicinal products.
A JCA assesses the relative clinical effectiveness of a new medicine — how it compares, in terms of patient outcomes, to the current standard of care. The assessment is conducted by the HTA Coordination Group (HTACG) using the PICO framework (Population, Intervention, Comparator, Outcomes), with input from HTA bodies across EU member states.
The problem is this: the evidence that satisfies the EMA for a marketing authorisation — typically demonstrating absolute safety and efficacy, often against placebo, in a controlled trial population — is frequently not the same evidence that HTA bodies need for a JCA. HTA bodies want to know: how does this medicine perform against the actual treatments that patients are currently receiving? What happens to outcomes that matter to patients and health systems — not just the primary endpoint chosen by the developer? Does the evidence apply to the specific sub-populations who will receive the medicine in clinical practice?
If a development team designs a trial exclusively around EMA requirements and only thinks about HTA evidence needs at the marketing authorisation stage, it is too late. The trial is done. The data that HTA bodies need — different comparators, different outcomes, different patient sub-groups — either exists or it does not. It cannot be retrospectively generated.
The JSC exists to prevent exactly this scenario, by bringing HTA bodies into the conversation about evidence generation before pivotal trial protocols are finalised.
What Exactly Is a Joint Scientific Consultation?
A Joint Scientific Consultation is a formal scientific advice procedure under the EU HTA Regulation, managed by the HTACG, in which health technology developers receive structured written guidance from multiple EU HTA bodies simultaneously on the evidence they will need for a future JCA.
It is, in essence, the HTA equivalent of EMA Scientific Advice — but focused on market access and reimbursement evidence rather than regulatory authorisation.
The JSC covers:
- Population (P): Which patient populations should the clinical programme focus on? How should sub-groups be defined? Are there specific populations where HTA bodies will expect dedicated evidence?
- Intervention (I): How is the medicine or device best characterised for HTA purposes? At what dose, in what combination, under what conditions of use?
- Comparator (C): What is the relevant standard of care — across different EU member states — against which the medicine should be compared? What if the standard of care differs between countries?
- Outcomes (O): Which clinical endpoints matter to HTA bodies? What patient-reported outcomes are relevant? How should surrogate endpoints be treated? What would constitute a meaningful clinical benefit?
- Study design: What trial design will generate evidence that is both credible for EMA and meaningful for HTA? Can indirect treatment comparisons fill evidence gaps, and if so, under what conditions?
- Real-world evidence: What role can real-world data play in supplementing RCT evidence for the JCA?
The output is formal written scientific advice, issued by the HTACG approximately two weeks after the consultation meeting, reflecting the consolidated positions of the participating HTA bodies.
How the JSC Process Works: Step by Step
Understanding the JSC process operationally is essential for any company planning to apply — or any regulatory professional advising on EU HTA strategy.
Step 1: Identify the Right Submission Window
JSC requests cannot be submitted at any time. The HTACG publishes designated submission periods in its Work Programme throughout the year. In 2026, the submission periods are:
Submission Period | Window |
Period 1 | 7 January – 4 February 2026 |
Period 2 | April 2026 |
Period 3 | June – July 2026 |
Period 4 | September – October 2026 |
Developers must register on the secure HTA IT Platform in advance and submit through that platform — not by email. Initial contact with the HTA Secretariat is required to gain platform access, and no commercially sensitive information should be shared in initial email enquiries.
Step 2: Prepare and Submit the Briefing Document
The core of the JSC submission is the briefing document — a structured scientific dossier that presents the developer's current evidence base, the proposed clinical development programme, and the specific questions the developer wants the HTACG to address.
The quality of the briefing document is critical. HTA bodies cannot give useful advice on poorly defined questions. The briefing document must be precise, scientifically robust, and internally consistent. Key deadlines for briefing documents in 2026 are set for April 7, May 4, and June 8.
Step 3: The Consultation Meeting
Following submission and review of the briefing document, a consultation meeting is held between the developer and the HTACG. This is a structured scientific dialogue — not a negotiation, not a presentation, but a genuine exchange in which HTA experts from multiple member states engage with the developer's evidence programme.
Developers can opt to align their JSC with EMA Scientific Advice — enabling a parallel joint meeting where both EMA and HTA bodies are present simultaneously. This parallel approach is widely considered the most efficient use of the JSC mechanism, as it ensures that regulatory and HTA requirements are addressed in a single, coordinated dialogue rather than two separate processes that may produce conflicting guidance.
Step 4: Written Scientific Advice
Approximately two weeks after the consultation meeting, the HTACG issues formal written scientific advice. This document reflects the consolidated positions of the participating HTA bodies on the questions raised in the briefing document.
Importantly, JSC outcomes are confidential — they are not automatically published or shared with other HTA bodies or member states beyond the process itself. This confidentiality is a feature for developers who do not want their evidence strategy exposed to competitors, but it has also been noted as a limitation in terms of building a shared understanding of precedent across the JCA system.
Who Can Apply for a JSC?
One of the most important — and most frequently misunderstood — aspects of the JSC is its accessibility. It is not reserved for large pharmaceutical companies. The regulation explicitly makes the JSC available to:
- Pharmaceutical companies of any size — large multinationals, mid-size biotechs, and small pharmaceutical companies
- Medical technology companies — manufacturers of high-risk medical devices and in-vitro diagnostics, albeit under a somewhat different process than medicinal products
- Small and medium-sized enterprises (SMEs) — the regulation and HTACG are explicitly aware that SMEs face disproportionate challenges navigating the EU HTA system, and the JSC is available to them on the same basis as larger organisations
- Academic institutions and researchers — where academic groups are developing health technologies, they can seek JSC guidance
Critically, the JSC is provided entirely free of charge. There is no consultation fee. For SMEs and academic groups that cannot afford country-by-country national HTA scientific advice across 10 or 15 member states, the JSC offers a uniquely accessible route to pan-European HTA guidance.
Eligibility Criteria
Not every product qualifies for a JSC. The HTACG prioritises applications from products that meet specific criteria, including:
- The product addresses a significant unmet medical need — existing treatments are absent, insufficient, or associated with serious adverse effects
- The product is likely to be subject to a JCA — i.e., it falls within the scope of the EU HTA Regulation's mandatory assessment categories
- The JSC would genuinely add value — the developer has not already obtained equivalent guidance through other means
- The product is at an appropriate stage of development — typically Phase 2/3 transition, before pivotal trial protocol lock
Products in oncology, ATMPs (gene and cell therapies), rare diseases, and high-risk medical devices tend to meet eligibility criteria most readily, reflecting both the JCA scope priorities and the genuine evidence complexity these product types present.
Who Benefits Most from a JSC?
The JSC is valuable for any developer navigating the EU HTA landscape — but it offers the most transformative strategic advantage to specific categories of developer who face the greatest evidence alignment challenges.
1. Advanced Therapy Medicinal Product (ATMP) Developers
ATMPs — gene therapies, cell therapies, and tissue-engineered products — face a structural evidence problem in the EU HTA system that the JSC is uniquely positioned to help address.
The clinical benefit of many ATMPs is long-term or potentially curative — but the data available at the point of marketing authorisation and JCA is inherently limited, because the therapies are new and patient follow-up is measured in years rather than decades. Standard HTA evidentiary frameworks — built around randomised controlled trials with active comparators and patient-relevant outcome measures — may simply not be achievable for rare diseases affecting small patient populations.
A coalition of 39 stakeholder organisations has formally called on the HTACG to modernise its evaluation approach for ATMPs, urging recognition of single-arm trials, natural history studies, and real-world data as legitimate evidence sources for JCA purposes. The JSC is the mechanism through which ATMP developers can engage directly with the HTACG about what evidence frameworks will be acceptable before they commit to a clinical development programme.
For an ATMP developer, a JSC could mean the difference between a JCA conducted on evidence the HTACG has pre-agreed is appropriate — and a JCA conducted on evidence the HTACG considers insufficient, with the downstream consequences for European market access that would follow.
2. Rare Disease Developers
Rare disease — particularly orphan medicine — development faces the same structural evidence challenge as ATMPs: small patient populations make large, randomised, multi-arm comparative trials practically or ethically impossible.
The JSC provides a structured opportunity for rare disease developers to establish, early in development, what evidence standards the HTACG will apply. Which statistical methods are acceptable? Can natural history data serve as a control arm? How should indirect treatment comparisons be conducted when no head-to-head trial data exists? What patient sub-populations need specific evidence, and is sub-group analysis feasible given the small overall trial population?
These are questions that, if left unanswered until the JCA stage, can result in assessments that neither reflect the genuine clinical value of a medicine nor serve the patients who need it.
Orphan medicines are included in JCA scope from 2028 — giving rare disease developers a defined window in which to seek JSC guidance and incorporate feedback into their clinical development programmes before the scope expansion hits.
3. Oncology Companies — Particularly US-Focused Biotechs
Oncology is the dominant area of JCA activity — accounting for 74% of health technology evaluations in the early JCA pipeline. It is also the area where the gap between FDA regulatory strategy and EU HTA strategy is most acute.
A recurring challenge documented in the EU HTA literature is the experience of US biotech companies that design their pivotal trials entirely around FDA requirements — optimising comparator selection, endpoint design, and patient populations for regulatory approval — and then discover at the EU HTA stage that none of these choices align with what European HTA bodies consider relevant.
The PICO complexity in oncology is formidable. The standard of care for a given cancer indication may differ significantly between Germany, France, Spain, and Eastern European member states. The same product may face entirely different comparators in different countries — potentially generating dozens of PICOs, some of which the trial simply was not designed to address.
A JSC, conducted before Phase 3 protocol lock, allows oncology developers to receive HTACG guidance on which comparators matter, which outcomes are weighted by HTA bodies, and how the evidence package should be structured to address the full PICO landscape across the EU. That guidance — incorporated into trial design — dramatically reduces the risk of evidence gaps at JCA stage.
4. Small and Medium-Sized Enterprises (SMEs)
For SMEs, the JSC's most valuable characteristic is its cost structure: free. National HTA scientific advice is available in most major EU member states — Germany (IQWiG), France (HAS), the Netherlands (ZIN), Sweden (TLV) — but conducting parallel consultations across multiple countries is expensive, time-consuming, and logistically demanding. The outputs may also be inconsistent, reflecting different national methodological preferences.
The JSC replaces all of that with a single, consolidated, pan-European dialogue at no cost. For an SME developing a potential breakthrough therapy for a rare condition, the JSC could provide strategic intelligence that would otherwise require hundreds of thousands of euros in individual national consultations — guidance that shapes clinical development before any money is spent generating evidence that may not meet EU HTA needs.
5. Medical Device Manufacturers
High-risk medical devices are increasingly being brought within the EU HTA framework, and the JSC pathway for devices is evolving in parallel with the medicinal product process. Evidence requirements for devices are more heterogeneous — randomised controlled trial data is often not available or ethically achievable, and real-world evidence plays a proportionally larger role.
The 2026 work programme reflects an increase in JCA and JSC activities for medical devices and IVDs, as the regulatory infrastructure for device assessments matures. Device manufacturers navigating this space will find the JSC an increasingly important tool for understanding what clinical evidence will satisfy the HTACG's requirements.
JSC vs Alternatives: An Honest Comparison
Given the scarcity of JSC slots — approximately 10 slots were available in 2025 — it is essential for developers to understand their options and how the JSC compares to alternative scientific advice mechanisms.
Advice Mechanism | Scope | Cost | Timing Flexibility | Slot Availability | Formal Output |
Joint Scientific Consultation (JSC) | Pan-EU, multi-HTA body | Free | Fixed submission windows | Very limited (~10/year in 2025) | Formal written advice (~2 weeks post-meeting) |
National HTA Scientific Advice (e.g., IQWiG, HAS, NICE) | Single country | Varies (often low/free) | More flexible | More flexible | Formal writen advice |
Parallel EMA-HTA Scientific Advice | Regulatory + HTA simultaneously | EMA fees apply | Fixed windows | Limited | Formal joint output |
Multi-country Advisory Boards | Flexible, expert-driven | Varies | Highly flexible | No slots needed | Informal; strategic insights |
HTACG Stakeholder Engagement | Thematic/policy level | Free | Periodic | Open | Policy recommendations only |
The honest assessment is that the JSC is the gold standard — but its scarcity means many developers will need to pursue complementary strategies:
- National HTA scientific advice from key markets (Germany, France) provides country-specific perspectives quickly and reliably, and should not be deprioritised simply because a JSC is being pursued
- Multi-country advisory boards — panels of clinical experts from multiple EU markets — provide valuable informal intelligence on clinical practice and comparator relevance that complements formal JSC guidance
- Parallel EMA-HTA advice is the most efficient mechanism when both regulatory and HTA questions need to be addressed in the same development cycle
The key strategic error is waiting for a JSC slot before making any evidence decisions. Developers who delay Phase 3 protocol lock indefinitely in hopes of obtaining a JSC may miss the optimal window for evidence generation entirely. National advice and advisory boards should be running in parallel to inform evidence strategy regardless of JSC status.
The Most Common JSC Mistakes — and How to Avoid Them
Industry experience with the early JSC process has already surfaced a clear pattern of avoidable errors:
❌ Applying too late: The JSC is only valuable if the advice can be acted upon — which means the trial protocol must not yet be locked. Companies that wait until Phase 3 is already underway before seeking a JSC gain insights they can no longer implement.
❌ Asking the wrong questions: JSC slots are too scarce to spend on questions where the answer is already known or predictable. Bold, genuinely uncertain strategic questions — particularly around comparators and outcomes in contentious areas — are where JSC guidance is most valuable.
❌ Insufficient internal alignment: Walking into a JSC without cross-functional alignment between clinical, regulatory, market access, and medical affairs teams is a wasted opportunity. The JSC is a strategic event that requires all relevant functions to have agreed their positions in advance.
❌ Treating confidential advice as a substitute for ongoing dialogue: JSC advice reflects the HTACG's position at a point in time, based on the evidence available. As the clinical programme evolves and new data emerges, the advice may need revisiting. A single JSC is not a guarantee of JCA success.
❌ Underestimating PICO complexity: Companies frequently underestimate how many distinct PICOs their product will face across different EU member states. Preparing a realistic PICO landscape analysis before the JSC briefing document is submitted is essential to asking the right questions.
What the JSC Means for Regulatory Affairs Professionals
The JSC is not just strategically important for pharmaceutical companies — it is reshaping the skill set demanded of regulatory affairs and market access professionals across the industry.
A New Type of Expertise in Demand
The regulatory affairs profession in 2026 is increasingly bifurcating. On one side are professionals who focus on product-lifecycle regulatory submissions — INDs, NDAs, MAAs, variations, post-market compliance. On the other — and this is the faster-growing side — are professionals who work at the interface of regulatory strategy and market access: understanding not just how to get a medicine approved, but how to build the evidence base that translates approval into actual patient access.
JSC strategy sits squarely in this second category. Companies seeking regulatory affairs professionals who can advise on JSC positioning, PICO modelling, evidence gap analysis, and the alignment of clinical development programmes with HTA requirements are encountering a significant talent shortage.
The Salary Landscape
The commercial value of this expertise is reflected in market compensation:
- Regulatory Science and Affairs professionals in pharmaceuticals and biotechnology are earning $80,000–$140,000 at experienced levels, with specialist market access roles frequently commanding premium compensation above these benchmarks
- Entry-level regulatory affairs roles range from $55,000–$85,000 in the US, with EU equivalents starting at €35,000–€50,000 and rising steeply with specialisation
- HEOR (Health Economics and Outcomes Research) specialists — whose work is directly relevant to JCA and JSC evidence strategies — are among the fastest-growing and highest-compensated profiles in European life sciences
- Projected job growth of 8% through 2030 in regulatory affairs, driven by increasing regulatory complexity and the expanding scope of the EU HTA system
- Life sciences recruitment specialists specifically identify regulatory strategists and market access professionals with hybrid capabilities as the most sought-after profile in EU hiring in 2026
Choosing the Right Training to Build These Skills
The skills required to work effectively in the EU HTA and JSC landscape — PICO analysis, evidence gap identification, dual regulatory-HTA strategy, RWE design, ATMP evidence frameworks — are specialist. They are not covered in a 6-hour online certification or a generic university course. And the market knows it.
What consistently distinguishes candidates who secure regulatory affairs roles from those who do not — as confirmed by hiring managers and regulatory affairs recruiters in 2026 — is demonstrable practical experience with real regulatory documents and processes. Academic knowledge without applied exposure does not translate into competitive candidacy in this market.
Key Takeaways
The Joint Scientific Consultation is one of the most consequential — and most underutilised — tools available to pharmaceutical and medical technology developers in the EU HTA landscape. Whether your organisation is a large pharmaceutical company, a fast-growing biotech, an ATMP developer, or an academic research institution, understanding and accessing the JSC effectively could determine not just the quality of your clinical evidence, but whether your product ultimately reaches patients across Europe.
For industry:
- ✅ Apply for JSC during Phase 2/3 transition — before pivotal trial protocol is locked. That is the only window in which advice can genuinely influence development
- ✅ Pursue parallel EMA-HTA scientific advice where feasible — address regulatory and HTA questions simultaneously to maximise efficiency
- ✅ Do not wait for a JSC slot to begin evidence strategy work — use national HTA scientific advice and multi-country advisory boards in parallel
- ✅ Prepare bold, genuinely uncertain questions — JSC advice is only valuable if it addresses real strategic decisions, not confirmations of what you already know
- ✅ Align your clinical, regulatory, and market access teams before the JSC — it is a cross-functional strategic event, not a regulatory affairs-only exercise
- ✅ Monitor the 2026 submission windows — if a JSC is part of your development strategy, the next slot may already be approaching
For regulatory and market access professionals:
- ✅ Understand the JSC as a distinct competency — it is not covered by traditional regulatory affairs training and represents a genuine career differentiator
- ✅ Develop fluency in PICO analysis — the foundational language of JCA and JSC strategy
- ✅ Build understanding of the EMA-HTA interface — the ability to navigate both simultaneously is where the most strategic and best-compensated roles in European regulatory affairs now sit
- ✅ Enter this market now — the EU HTA system is maturing, JSC activity is increasing, and the professionals who understand it deeply are in short supply
Build a Career at the Forefront of EU Regulatory Affairs and Market Access
The EU HTA Regulation and the JSC framework are creating a sustained demand for regulatory professionals who understand evidence strategy, market access science, and the increasingly complex interplay between EMA authorisation and EU HTA assessment. This is where regulatory affairs careers are growing — and where the most impactful work is being done.
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About the Author: Rabiea is an Honorary Associate Professor at UCL, former MHRA Health Authority reviewer, and CEO of Entry to Regulatory and Advanced Regulatory Consulting. After transitioning from retail pharmacy to regulatory affairs, she has dedicated her career to helping others make the same successful career change. Connect with her on LinkedIn for the latest regulatory affairs insights and career advice.
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