The EU Joint Clinical Assessment (JCA) is one of the most significant changes to hit market access in years.
Under Regulation (EU) 2021/2282, new medicines will go through a single EU-level clinical assessment before Member States make their national pricing and reimbursement decisions.
This is already rolling out:
- Oncology and ATMPs from 2025
- Orphan drugs from January 2028
For rare disease companies, this shift isn’t just technical — it has real consequences for timelines, evidence strategy and launch planning.
What Is the EU Joint Clinical Assessment (JCA)?
The JCA is part of the new EU HTA Regulation designed to create one joint clinical assessment across the EU, rather than multiple national assessments.
The assessment will focus on clinical effectiveness and will feed into national HTA and pricing processes.
This means companies can no longer rely on staggered national timelines — the EU-level assessment sets the pace.
Who Is Affected and When?
- 2025: Oncology and ATMP products enter the scope of the JCA.
- 2028: Orphan drugs and rare disease therapies are included.
- Transitional phase: Sponsors need to prepare evidence earlier than before.
Once PICO scoping is locked in, there’s no going back to fix evidence gaps.
Why This Matters for Smaller and Mid-Sized Sponsors
Unlike large pharma, many rare disease sponsors don’t have big regulatory or patient engagement infrastructures.
More often than not, Market Access, Regulatory or Medical teams have to manage these requirements on top of everything else.
And that matters because:
- Timelines are tight.
- PICO scoping happens earlier.
- Patient evidence is now part of the core JCA evidence set.
- Missed windows = launch delays and potential pricing consequences.
Patient Experience Data Is Now Core Evidence
The EMA Reflection Paper (September 2025) confirms it:
Patient experience data is no longer an optional “nice to have.” It’s core evidence in the JCA context.
If this work is left too late:
- Patient input can’t be integrated meaningfully.
- Evidence becomes patchy and hard to defend.
- PICO scoping closes off options.
This is particularly tough for smaller teams with no dedicated patient engagement function — but the responsibility still lands somewhere.
When to Act
If you’re waiting for Phase III or submission, you’re already behind.
Patient evidence and access planning need to start well before PICO scoping to avoid gaps that can’t be fixed later.
This is not a policy footnote. It’s an operational pressure point that can make or break your launch trajectory.
Practical Steps to Prepare for JCA
- Map your evidence early.
Start aligning your clinical package with likely PICO scenarios well ahead of formal timelines. - Engage ERNs and patient groups early.
Real-world experience from patient communities strengthens the relevance and credibility of your evidence base. - Build structured, traceable patient evidence.
EMA expects structure and transparency — not anecdotes. - Consider early Joint Scientific Consultations.
This is a smart way to align expectations before the formal JCA clock starts. - Assign clear ownership.
If there’s no patient engagement team, ensure Market Access, Regulatory or Medical know who’s accountable for evidence planning.
References
- Regulation (EU) 2021/2282 on Health Technology Assessment
- European Commission JCA Implementation Documents
- EMA Reflection Paper on Patient Experience Data (September 2025)
- HTA Coordination Group (HTACG) Guidance on PICO Scoping
(All references are official public sources.)
Final Word
The EU JCA isn’t on the horizon anymore — it’s here.
And for rare disease sponsors, early preparation is the difference between hitting timelines and losing ground.
If you don’t have a patient engagement function, the responsibility doesn’t go away — it just makes structured, early action even more critical.
Learn how the RAREready™ 100-Day Sprint can help build that foundation early.
[Link to RAREready Sprint / Playbook page]
FAQ
Q: What is the EU JCA?
A: JCA stands for Joint Clinical Assessment. It’s a new EU process that delivers a single clinical assessment for new medicines at EU level.
Q: When will JCA apply to orphan drugs?
A: Orphan drugs enter the scope of JCA from January 2028.
Q: Will JCA replace national HTA processes?
A: No. JCA provides the clinical assessment, but pricing and reimbursement remain national.
Q: Why is patient evidence so important?
A: EMA confirms patient experience data is core evidence for JCA. If evidence isn’t structured early, you can’t fix gaps later.
Q: Who is responsible for patient evidence if we don’t have a patient engagement team?
A: Responsibility typically falls to Market Access, Regulatory or Medical functions — and needs to be planned early.