As the first EU Joint Clinical Assessment reports approach, national HTA systems across Europe are already adapting to a new era of coordinated clinical evaluation.
Understanding the Context of the EU JCA
The European Joint Clinical Assessment (JCA), launched in 2025 under Regulation (EU) 2021/2282 on Health Technology Assessment (HTA), represents a centralised approach to HTA processes across Europe. With the first public JCA assessment report expected to be published shortly, attention has increasingly shifted towards how the framework will operate in practice and whether it can achieve its intended objectives of reducing duplication and improving efficiency across European HTA systems.
For health technology developers (HTD), the report is expected to provide early insights into evolving evidence expectations and submission requirements within a more convergent HTA environment. For member states it may offer greater clarity regarding how harmonised European-level clinical assessments can be balanced against country-specific decision-making needs, particularly in relation to the breadth and complexity of PICO definitions and, when relevant, to the additional cost-effectiveness evidence.
HTA is currently conducted independently across Europe, with methodologies and requirements varying substantially due to differences in healthcare systems, institutional frameworks, evaluation criteria, and societal preferences. Against this fragmented landscape, the JCA aims to:
- Reduce duplication in HTA processes across EU member states;
- Strengthen HTA cooperation between EU member states;
- Improve the quality, consistency, and scientific robustness of HTA evaluations across the EU; and
- Support timely and equitable patient access to innovative technologies across the EU
Overview of the EU JCA Processes and Methods
Implementation of the HTAR began in 2022 and has been overseen by the Member State Coordination Group on Health Technology Assessment (HTACG). Since its establishment, the HTACG has developed methodological guidance and conducted pilot activities to support implementation of the Regulation (see published guidance documents). The HTAR became applicable in 2025 and will be phased in progressively according to the following timelines.
- From 2025: new active substances (NAS) in oncology, advanced therapy medicinal products (ATMPs), and selected high-risk medical devices
- From 2028: orphan (rare disease) medicines
- From 2030: all medicinal products
Unlike national HTA processes, the JCA is limited to the assessment of relative clinical effectiveness and safety at the European level. It does not cover economic evaluation, pricing, or reimbursement decisions, which remain the responsibility of individual member states. Consequently, HTDs will continue to engage in national submissions and negotiations for these aspects.
Prior to the JCA, HTDs may request a Joint Scientific Consultation (JSC), a voluntary regulatory-HTA dialogue, with the option of being conducted in parallel with scientific advice from the European Medicines Agency (EMA). This consultation is intended for technologies likely to undergo JCA and still in the clinical development phase. Its objective is to align evidence generation with both regulatory and HTA requirements at an early stage, thereby improving the relevance of evidence and efficiency of subsequent assessments.
The JCA process is initiated following submission of a marketing authorisation application to the EMA, after which the regulatory and HTA processes proceed in parallel (see Figure 1). The approach is intended to strengthen coordination between regulatory and HTA bodies at the European level.
Figure 1 Stages and timeline of the JCA and JSC process, integrated with the EMA regulatory process
Governance of the JCA is structured through the HTACG and its four subgroups:
- Joint Clinical Assessment (JCA);
- Joint Scientific Consultation (JSC);
- Identification of Emerging Health Technologies; and
- Methodological and Procedural Guidance.
The JCA and JSC subgroups play a central role in delivering assessments. For each technology, an assessor and co-assessor from different national HTA agencies are appointed, marking the formal initiation of the JCA process. The assessors are responsible for drafting and proposing the assessment scope, which defines the research question using the PICO (Population, Intervention, Comparator, Outcome) framework. The scope is intended to reflect the needs of all member states, with HTDs required to submit evidence aligned with the agreed PICOs. The assessors then conduct the assessment and finalise the JCA report.
Following endorsement by the HTACG and European Commission granting an MAA for the technology under assessment, member state authorities are required to report how JCA outputs are used within national HTA processes. This enables the European Commission to monitor uptake and implementation across member states.
To support the consistent implementation of the JCA framework across jurisdictions, a range of methodological guidance documents has been published, a selection of which is provided below.
Table 1 List of key HTACG methodological guidance documents
Early Insights: National Adaptation to the JCA
Several HTA agencies across Europe have already begun adapting their national guidance, submission requirements, and assessment processes in response to implementation of the EU JCA. In some jurisdictions, such as Germany and France, integration has been more explicit, including formal incorporation of JCA reports into national assessment procedures, reduced duplication of clinical evidence submissions, and increased alignment with EU-level dossier requirements. Other agencies have introduced more limited procedural adaptations or acknowledged how JCA outputs will be considered within future national processes.
Table 2 presents a selected overview of recent adaptations to HTA guidance and processes following implementation of the EU JCA since 2025. These examples are illustrative only and do not represent all EU Member States or HTA agencies currently adapting their frameworks in response to the HTAR.
Table 2 Examples of HTA agencies that recently adapted national guidance and processes following implementation of the EU JCA (since 2025)
| Agency | Nature of update | Type of update | Key JCA-related changes |
| AIFA (Italy) | Dossier guidance updates | Explicit integration | JSA and JSC acknowledgedFor technologies with an available JCA report, comparators must reflect Italian clinical practice Optional completion of clinical dossier sections (C.4-C.6) when a JCA report is available |
| DMC (Denmark) | Process guidance updates | Early procedural adaptation | HTDs must identify which submission components are covered by JCA reports Further updates anticipated |
| G-BA (Germany) | Rules of procedure and process changes | Explicit integration | JCA reports formally integrated into benefit assessments Cross-referencing to EU dossier evidence permitted to reduce duplicationAlignment with JCA guidance on comparator selection and outcome definitions |
| HAS (France) | National process and procedure updates | Explicit integration | Early scientific advice no longer available for JCA technologiesClinical data submitted at EU level do not need to be resubmitted nationally National assessment procedures are being adapted to avoid duplication with JCA outputs |
| NOMA (Norway) | National process updates | Early procedural adaptation | National working group established to adapt HTA process to the HTARUpdates made to clinical evidence (chapter 2) and health economic (chapter 3) dossier template |
| TLV (Sweden) | National process updates | Procedural alignment | JCA documentation must be included within P&R submissions JCA evidence must be considered nationally |
As specified in EU HTA Regulation 2021/2282, HTDs do not need to submit any information (data, evidence, analyses) at the national level, that has already been submitted at the EU level.
Abbreviations: AIFA, Italian Medicines Agency; DMC, Danish Medicines Council; G-BA, Federal Joint Committee; HAS, French National Authority for Health; HTAR, Regulation (EU) 2021/2282 on Health Technology Assessment; HTD, health technology developer; JCA, Joint Clinical Assessments; JSC, Joint Scientific Consultation; NOMA, Norwegian Medical Products Agency; P&R, pricing and reimbursement; TLV, Dental and Pharmaceutical Benefits Agency
Current and Emerging Challenges
Implementation of the JCA at both the European and national levels raises multiple operational, methodological, and governance challenges, many of which have been largely debated and may affect stakeholders differently. Below, we highlight key challenges from the perspective of HTA agencies and national implementation.
Heterogeneity and complexity of PICO definition. The breadth and complexity of PICO definitions present significant challenges, particularly in aligning assessment scope across member states. Variability in treatment availability, nationally licensed products or indications, and differences in clinical practice (including off-label uses of medicines) contribute to difficulties in narrowing comparator selection. Members of IQWiG have noted that approximately one-third of requested comparators are not available across all jurisdictions. As the number of PICOs increases, assessments may become increasingly complex, potentially diluting the clarity and interpretability of conclusions for national decision-making.
Early evidence requirements and lifecycle uncertainty. The parallel conduct of regulatory assessment and JCA means that assessments will generally put pressure towards generating comparative and HTA-relevant evidence earlier in clinical development. Alongside the breadth of PICOs, this creates additional challenges for lifecycle evidence generation, including uncertainty regarding responsibility for generating follow-up data following the initial assessment. The HTAR does not specify how such evidence should be generated, nor does it provide mechanisms to mandate further data collection. Consequently, national bodies may need to undertake post-hoc reassessments as additional evidence emerges, potentially reintroducing some of the inefficiencies the JCA seeks to reduce. This could partly be addressed in JSCs, if a life-cycle approach is taken and an approach to evidence generation stages is discussed and agreed.
Resource and operational capacity constraints. Delivering JCAs within compressed timelines will require substantial methodological and operational capacity from HTA agencies serving as assessors and co-assessors. Smaller agencies may face challenges related to staffing, expertise, and resource allocation, particularly as the number of assessments increases. Ensuring sustainable resourcing, appropriate technical support and guidance, and balanced participation across member states will therefore be important to maintaining assessment quality and consistency as well as timely delivery, particularly as national agencies continue adapting their legal and procedural frameworks to incorporate JCA outputs.
Current Outlook
Implementation of the EU JCA remains at an early stage and its ability to achieve its intended objectives has yet to be determined. To date, 15 JCAs have been initiated, with the HTACG’s Annual Work Programme 2026 indicating a substantial increase in future activity. The anticipated publication of the first JCA report, conducted by NCPE (Ireland) and IQWiG (Germany), will represent the first practical test of how JCA methodologies, evidence requirements, and assessment processes are implemented.As additional JCAs are completed and implemented nationally, greater clarity is likely to emerge regarding how JCA outputs are interpreted, incorporated into national decision-making, and whether the initiative can meaningfully reduce duplication and improve efficiency in European HTA.