How Joint Scientific Consultations under the EU HTA Regulation impact your technology

A Structural Shift in Evidence Generation for Medicines and Medical Technologies

The implementation of the EU Health Technology Assessment Regulation (HTAR, 2021/2282) marks a fundamental transition in how clinical and economic evidence is generated, interpreted, and ultimately translated into reimbursement decisions across Europe. Among its most consequential instruments is the introduction of Joint Scientific Consultations (JSCs) – a mechanism that, while framed as advisory, represents a critical inflexion point in the lifecycle of medicinal products, medical devices, and in vitro diagnostics.

Between 1 and 29 April 2026, developers of medicines, medical devices, and IVDs can submit requests for JSCs coordinated by the European Commission, working with the HTA Coordination Group and national HTA bodies. These consultations precede the formal Joint Clinical Assessment (JCA) and are designed to align evidence generation strategies with anticipated HTA expectations at EU level. However, to interpret JSCs merely as a procedural step would be to misunderstand their scientific and strategic significance.

From fragmentation to structured convergence

Historically, European HTA has been characterised by fragmentation. National agencies – such as HAS in France, IQWiG in Germany, and others – have adopted heterogeneous methodological approaches, particularly regarding comparator selection, endpoint hierarchy, acceptance of real‑world evidence (RWE), and integration of organisational or system‑level outcomes. This fragmentation has imposed a substantial burden on developers, often necessitating parallel evidence-generation strategies and resulting in inefficiencies, delays, and inconsistent reimbursement outcomes.

The HTAR introduces a coordinated framework for Joint Clinical Assessments, in which clinical evidence will be evaluated centrally at EU level, initially for oncology medicines and ATMPs and progressively extending to orphan drugs, other centrally authorised medicines, and high‑risk devices. JSCs serve as the upstream mechanism through which developers in biotech, pharma, MedTech, and IVD can align their evidence generation strategies with this emerging evaluative architecture. In effect, JSCs represent the transition from post hoc evaluation to prospective evidentiary alignment.

Scientific purpose of JSCs: beyond advisory dialogue

At a technical level, JSCs provide structured input on:

Study design (randomised vs pragmatic vs observational)
Target population definition and subgroups
Comparator appropriateness
Endpoint selection and hierarchy
Statistical considerations and evidentiary robustness

Yet their deeper function lies in shaping the PICO framework – Population, Intervention, Comparator, Outcomes – that will underpin subsequent HTA evaluations. The PICO construct is not merely descriptive; it is determinative. It defines:

What constitutes relevant clinical benefit
Which comparators are considered valid benchmarks
Which outcomes are decision‑driving versus supportive
How uncertainty is interpreted within the assessment

By engaging in JSCs, developers are not simply receiving guidance; they are participating in the co‑construction of the evidentiary lens through which their technology will be judged. https://odelletechnology.com/the-eu-hta-regulation-and-the-future-of-reimbursement-in-europe/

Implications for evidence generation in MedTech, IVD, biotech and pharma

The implications are particularly profound for medical devices and in vitro diagnostics, where traditional hierarchies of evidence – dominated by randomised controlled trials (RCTs) – are often misaligned with real‑world clinical practice. For biotech and pharma assets entering early JCA waves (oncology, ATMPs and, later, orphan indications), JSCs provide a structured forum to test assumptions about comparators, lines of therapy, endpoints, and the role of pragmatic or hybrid designs alongside pivotal RCTs.

JSCs create a formalised pathway to legitimise alternative evidentiary approaches, including:

Pragmatic and adaptive trial designs
Real‑world evidence derived from routine clinical use
Before–after implementation studies
Diagnostic accuracy studies linked to clinical decision impact
Pathway‑level analyses incorporating organisational and workflow outcomes

For diagnostic technologies, especially those addressing antimicrobial resistance (AMR), oncology, or critical care pathways, this is transformative. It enables the elevation of endpoints such as:

Time to appropriate therapy
Reduction in inappropriate antibiotic prescribing
Avoidance of invasive procedures
Impact on hospital length of stay and resource utilisation

These are not surrogate endpoints; they are system‑relevant outcomes that directly interface with payer decision‑making and health‑system performance.

Comparator selection as a scientific and economic variable

One of the most critical – and frequently underestimated – dimensions of JSCs is comparator definition. In HTA, the comparator is not a neutral reference point; it is a structural determinant of perceived value. An inappropriate comparator can:

Dilute apparent treatment effect
Misrepresent clinical practice
Obscure economic benefit

JSCs provide a unique opportunity to justify comparator selection based on real‑world treatment patterns, clinical heterogeneity, variability in guideline adherence, and the limitations of existing standards of care. From a methodological standpoint, this aligns with increasing recognition within HTA science that contextual validity is as important as internal validity.

Reframing endpoints: from efficacy to decision impact

A further scientific evolution enabled by JSCs is the reframing of endpoints. Traditional efficacy endpoints – while necessary – are often insufficient to capture the value of complex interventions, particularly diagnostics, digital health technologies, and workflow‑modifying devices. JSCs allow for the incorporation of endpoints that reflect:

Clinical decision modification
Downstream treatment optimisation
System efficiency and capacity release
Patient pathway acceleration

This aligns with broader methodological shifts towards value‑based healthcare and health‑system performance metrics, where the unit of analysis extends beyond the individual patient to the system as a whole.

JSCs as a pre‑HTA experimental design space

Conceptually, JSCs can be understood as a form of pre‑HTA experimental design environment. They enable developers to:

Test the acceptability of evidentiary approaches
Identify potential sources of methodological challenge
Refine study designs before resource‑intensive implementation
Reduce the probability of negative or inconclusive HTA outcomes

In this sense, JSCs function analogously to protocol optimisation in clinical research, but with the added dimension of payer and policy alignment.

Operational considerations: the briefing document as a proto‑dossier

Following acceptance of a JSC request, developers must submit a detailed briefing document via the HTA IT Platform, using templates specific to medicinal products, medical devices, or IVDs. This document is not merely administrative; it represents a proto‑HTA dossier, incorporating:

Clinical rationale and unmet need
Proposed study designs and methodologies
Target populations and subgroups
Comparator justification
Endpoint selection and hierarchy
Preliminary considerations of clinical and system impact

The scientific quality of this document is critical. It must demonstrate not only methodological rigour but also conceptual coherence, a clear articulation of how the proposed evidence will support future HTA evaluation under the HTAR framework.

Strategic implications: designing the conditions of acceptance

The introduction of JSCs signals a broader shift in HTA philosophy – from retrospective judgement to prospective alignment. For developers, this creates a new strategic imperative: evidence generation is no longer solely a scientific exercise; it is a designed interaction with the future decision‑making framework.

Technologies that engage early and effectively with JSCs are positioned to:

Reduce evidentiary uncertainty
Accelerate time to reimbursement
Achieve more favourable pricing outcomes
Strengthen investor confidence through clearer regulatory and reimbursement pathways

Conversely, failure to engage risks the generation of evidence that is scientifically robust but misaligned with HTA expectations, resulting in delayed or suboptimal access.

Joint Scientific Consultations under the HTAR should not be viewed as optional advisory interactions. They represent a foundational architectural layer in the European market access landscape. Scientifically, they formalise the integration of clinical research design with health‑system evaluation. Strategically, they offer developers the opportunity to shape the criteria by which their technologies will be assessed.

In a healthcare environment increasingly defined by constrained resources, methodological scrutiny, and demand for demonstrable value, JSCs are not simply a regulatory innovation – they are a mechanism through which evidence, economics, and policy converge.

Joint Scientific Consultations under the EU HTA Regulation

Q1. What are Joint Scientific Consultations (JSCs) under the EU HTA Regulation?

Under the EU Health Technology Assessment Regulation (HTAR, 2021/2282), Joint Scientific Consultations (JSCs) are EU‑level scientific advice procedures that allow health technology developers to discuss their development plans with HTA bodies before generating the full evidence package. They focus on the information and evidence needs for a future Joint Clinical Assessment (JCA), covering both medicinal products and certain medical devices and in vitro diagnostics.

JSCs are formally “advisory,” but functionally they are the first structured interaction where a product becomes visible to the EU payer and HTA system. Done well, they shift the JCA from a high‑risk judgement to a confirmation exercise.

Q2. Why is this a structural shift for evidence generation in Europe?

Historically, evidence strategies were built around a small number of influential national HTA bodies (e.g. HAS, IQWiG, NICE), each with different preferences on comparators, endpoints, and real‑world evidence. HTAR introduces an EU‑level architecture where JCAs for selected technologies sit “on top” of national processes and progressively cover oncology, ATMPs, orphan drugs, other centrally authorised medicines and high‑risk devices.

JSCs are upstream of this joint assessment: they enable prospective alignment on what “good evidence” will mean at EU level, instead of developers discovering misalignment only at the time of HTA submission. That makes evidence generation both more centralised and more path‑dependent.

Q3. Who can apply for JSCs, and when?

Health technology developers (HTDs) of:

Medicinal products that will fall under JCA (starting with oncology medicines and ATMPs in 2025, then orphan medicines in 2028, and eventually all centrally authorised medicines)
Selected high‑risk medical devices and IVDs that will be subject to joint work

may request a JSC while their pivotal clinical studies or investigations are still in the planning or early design phase.

In 2026, the European Commission has opened several request periods; the current 1–29 April 2026 window is open to medicinal products and medical devices, with briefing document deadlines tied to consultation slots on 6 July, 31 August, and 28 September 2026. Requests must be submitted via the HTA IT Platform before the end of the request period, and registration on the platform can take several days.

Q4. How do JSCs change evidence strategy for biotech and pharma?

For biotech and pharma, especially in oncology and ATMPs, JSCs provide a venue to discuss:

Choice of comparator regimen and line of therapy
Positioning versus evolving standard of care
Clinically meaningful endpoints (e.g. OS vs PFS, MRD, QoL)
Role of pragmatic / hybrid designs alongside pivotal RCTs
Subgroup and biomarker strategies

Because JSCs are linked to future JCA requirements, the feedback shapes not only study design but also how uncertainty will later be interpreted across multiple Member States. This makes JSC participation a strategic tool to reduce the risk that a strong regulatory package is viewed as weak or irrelevant by HTA bodies.

Q5. How do JSCs affect evidence generation for MedTech and IVDs?

For medical devices and IVDs, where classic RCTs are often impractical or poorly aligned with real‑world use, JSCs create a formal route to validate alternative evidence approaches:

Pragmatic and adaptive trial designs
Real‑world evidence (registries, routine practice data)
Before–after implementation studies
Diagnostic accuracy studies linked to changes in clinical decision‑making
Pathway‑level and organisational outcomes (workflow, capacity, ICU or bed‑days)

Developers can use JSCs to argue for endpoints such as time to appropriate therapy, reduction in inappropriate antibiotic use, avoidance of invasive procedures, and impact on length of stay – all of which are highly relevant to payers and system performance but are often absent from traditional efficacy‑focused designs.

Q6. What is the role of comparator selection in a JSC?

Comparator choice is one of the most strategically sensitive elements of any HTA, and JSCs are the moment to “lock” the logic around it. An unrealistic or unfavourable comparator can dilute apparent benefit, misrepresent real practice, and obscure economic value.

During a JSC, developers can justify comparator selection based on:

Real‑world treatment patterns and pathway variation
Clinical heterogeneity and local practice
Guideline adherence (and its limits)
Weaknesses of existing standard of care

This shifts comparator definition from a post‑hoc point of contention to a prospectively debated and documented scientific choice.

Q7. How do JSCs help reframe endpoints beyond simple efficacy?

JSCs allow a broader set of endpoints to be discussed and positioned as decision‑relevant, particularly for diagnostics and system‑level interventions:

Clinical decision modification (e.g. treatment changes driven by test results)
Downstream treatment optimisation and avoidance of low‑value care
System efficiency and capacity release (e.g. ICU avoidance, reduced length of stay)
Patient pathway acceleration and time to appropriate therapy

Aligning on these endpoints at JSC stage supports HTAs that are more consistent with value‑based healthcare and health‑system performance metrics, rather than narrowly focused on traditional clinical outcomes.

Q8. How should we think about JSCs as a “design space” rather than just advice?

Conceptually, JSCs are a pre‑HTA experimental design environment. Companies can:

Test acceptability of their evidence plan
Identify methodological “red flags” early
Adjust sample size, comparators, and endpoints before committing major resources
Better align with what future JCAs and national HTAs will consider “sufficient”

This moves evidence generation from a unilateral scientific plan to a negotiated architecture between developers and HTA bodies, before irreversible investments are made.

Q9. What are the key operational steps and documents?

Operationally, a JSC includes:

Eligibility and planning – confirming that the technology falls within the scope of joint work and that key studies are still in planning.
Request submission – via the HTA IT Platform within the stated request period (e.g. by 29 April 2026 for the current window).
Briefing document – a structured, detailed document submitted by the relevant deadline (e.g. 6 July, 31 August, or 28 September 2026), following HTACG templates for medicinal products, medical devices, or IVDs.
Consultation meeting(s) – an EU‑level discussion with HTA bodies based on the briefing package.
Written advice – non‑binding but highly influential feedback on evidence plans.

The briefing document acts as a proto‑HTA dossier: it must describe the unmet need, target populations and subgroups, proposed study designs, comparators, endpoints, and anticipated clinical and system impact.

Q10. How do JSCs interact with national HTAs and reimbursement?

JSCs are specifically designed to support the future JCA, which is then used by Member States in their national HTA, pricing and reimbursement processes. They do not replace national economic evaluations or pricing decisions, but they shape the shared clinical evidence base that all countries will see.

A well‑aligned JSC can:

Reduce clinical uncertainty that might otherwise slow or fragment national decisions
Make economic modelling more straightforward and consistent across countries
Strengthen the credibility of the overall value proposition at both EU and national levels

Conversely, a weak or misaligned evidence strategy – especially if it ignored the opportunity for JSC – can lead to broad scepticism in the JCA and simultaneous downstream challenges in multiple markets.

Q11. What are the main strategic risks of not using JSCs?

For serious assets, especially those in early JCA waves or with complex evidence needs, not using JSCs creates several risks:

Generating evidence that is scientifically strong but misaligned with HTA expectations
Facing avoidable disputes over comparators or endpoints at JCA stage
Delayed or negative HTA opinions in multiple markets simultaneously
Weaker pricing power due to unresolved uncertainty
Reduced investor confidence, given unclear EU market‑access trajectory

JSCs do not guarantee a positive outcome, but they materially reduce the chance of “strategic misfire” in evidence generation.

Q12. How does this relate to Odelle Technology’s earlier HTAR analysis?

In your earlier article, “The EU HTA Regulation and the Future of Reimbursement in Europe,” you describe the overall architecture of HTAR, the staged implementation of JCAs, and the continued sovereignty of national reimbursement systems. This JSC‑focused piece should be positioned as a deep‑dive extension of that work, showing how companies can move from understanding the regulation to actively designing within it.

Together, the two articles offer a macro view (HTAR architecture and timelines) and a micro view (JSC as the pre‑HTA design space for evidence and market‑access strategy).

References and further reading

European Commission – Joint Scientific Consultations (overview, procedures, HTA IT Platform)
https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-scientific-consultations_en
European Commission / HaDEA – New opportunity to apply for JSCs (request period 1–29 April 2026)
https://hadea.ec.europa.eu/news/health-technology-assessment-new-opportunity-apply-joint-scientific-consultations-2026-04-09_en
European Commission – FAQ on joint HTA work under HTAR
https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/opportunities-patients-carers-and-clinical-experts_en
HTACG – Guidance for Joint Scientific Consultations (medicinal products / medical devices / IVDs)
(PDF links from Commission JSC guidance page)
Odelle Technology – The EU HTA Regulation and the Future of Reimbursement in Europe
https://odelletechnology.com/the-eu-hta-regulation-and-the-future-of-reimbursement-in-europe/
Remap Consulting – Leveraging Joint Scientific Consultations to maximise market access
https://remapconsulting.com/hta/joint-scientific-consultation/leveraging-joint-scientific-consultations/
YouTube – Joint Scientific Consultation – Key Steps, Timing & Strategy
https://www.youtube.com/watch?v=r5R-C7z_ZZw