How Regulatory–HTA Convergence Is Reshaping European Market Access
Across Europe, 2025 accelerated a shift from sequential regulatory and access steps to more connected process through the Joint Clinical Assessment. Regulatory approvals, and clinical portion of HTA evaluation are now more tightly linked, which has the potential to bring the evidence expectations closer together as well. In Trinity’s webinar ”Around the World in Market Access 2026: Global Trends Life Sciences Leaders Need to Watch,” the section on the European market focused on how joint clinical assessment (JCA) and parallel regulatory–HTA activity will change planning for market access in 2026 and beyond.
What Changed in Europe in 2025
Historically, regulators and HTA bodies acted as two separate checkpoints. Regulators focused on benefit–risk in the context of disease, while HTA bodies evaluated comparative benefit versus existing options and, in many countries, economic value as well. That separation often meant long gaps between marketing authorization and broad access for patients.
After years planning and piloting, in 2025, EU JCA evaluations formally started. Thirteen assessments are now underway, with the first JCA reports expected in the second quarter of 2026. At the same time, the UK signaled that parallel reviews between MHRA and NICE are expected to become the standard approach, allowing earlier and more coordinated engagement on both regulatory and HTA questions. During the webinar, the US Commissioner’s National Priority Voucher (CNPV) pilot program was also highlighted as a fully regulatory initiative with goals that include improving affordability, underscoring how access considerations are increasingly influencing regulatory priorities.
What We Will Learn From JCA
JCA raises important questions for manufacturers planning launches in Europe. A central concern is how the HTA Coordination Group will prioritize PICOs, defined as patient, intervention, comparator, and outcomes, across EU member states. Member states can propose different comparators, populations, and endpoints, so the final PICO set could be broad and complex.
Over the next year, companies will be watching to understand:
- How many PICOs are included and how diverse comparator requests are across member states
- How regulatory and HTA stakeholders interact when assessments are written in parallel and whether questions from one side shape thinking on the other
- How member states respond when EMA approval and JCA report release happen at roughly the same time and how they incorporate JCA into national negotiations
Unlike EMA decisions, which are generally accepted across the region, JCA is not yet expected to be binding at the same level. However, its influence may grow over time if member states find the outputs useful and credible.
How Manufacturers Should Prepare
To succeed under JCA, manufacturers need closer collaboration between regulatory, access, and evidence teams. The old model, where access teams ramped up after regulatory submission, is no longer sufficient.
Practical steps include:
- Incorporate access feedback earlier, so pivotal trials reflect both regulatory and HTA needs
- Simulate and prioritize PICOs, based on what different member states are likely to request, and decide where to respond
- Reflect prioritized PICOs in the value proposition and global evidence plan
- Seek joint scientific advice, when possible, to understand how EMA and the HTA Coordination Group may interact for a given product
JCA currently applies to oncology products and ATMPs, with orphan drugs coming soon in 2028, and all products expected to be in scope by 2030. That timeline reinforces the need to adjust planning now rather than wait for more case studies.
What Manufacturers Should Do Next
European market access is moving toward a world where regulatory decisions, HTA outcomes, and launch timing are more tightly intertwined. Companies need to plan for JCA requirements, prepare for parallel regulatory–HTA questions, and align internal teams around a shared, PICO-aware evidence strategy.
To explore these themes in more detail, watch the replay of “Around the World in Market Access 2026: Global Trends Life Sciences Leaders Need to Watch.” Our third annual State of Global Market Access white paper, which expands on what was shared in the webinar, will be released soon, and you can sign up to receive it by visiting TrinityLifeSciences.com. Other blogs summarize the US, China, and Latin America/MENA sections of the webinar.
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Author: Ismail Ismailoglu