A seat at the table: what the EU HTA reforms really ask of patient involvement

In January 2025, the way new medicines are assessed across Europe changed. A year and a half on, that change is real, but its full impact has yet to be felt.

Under the EU’s Health Technology Assessment (HTA) Regulation, there is now a shared, Europe-wide approach to assessing how well a new medicine works, instead of each country conducting its own separate clinical assessment. The aim is to streamline processes, reducing duplication and helping patients gain faster, more equitable access to innovative treatments across Europe.

That process involves a single Joint Clinical Assessment, carried out once for all member states. This currently applies to new cancer medicines and advanced therapies. Orphan medicines (rare disease medicines) will follow in 2028, with all centrally authorised medicines included by 2030. Most therapy areas haven’t felt the impact yet, which means that, for many people reading this, the change is still coming.

The structural change gets most of the attention. But the more interesting shift is who now has a seat at the table. Patients can contribute to assessments, helping to shape what is examined and bringing lived experience into discussions about value and benefit.

The question this blog series asks, though, is whether having a seat at the table is the same as being heard. It usually isn’t – and because the rollout is only part-way through, there is still time to get it right.

So, what actually changed?

Two new processes are worth knowing by name:

1. The Joint Clinical Assessment (JCA) is a shared review of a medicine’s clinical evidence: does it work, and how well, compared with relevant existing treatment options? It’s completed once at EU level and made available to every national body, so they’re not all repeating the same clinical analysis
2. The Joint Scientific Consultation (JSC) happens earlier during the planning stage of development. It’s a chance for developers to get advice on their evidence-generation plans, including which outcomes to measure, before key clinical studies are completed

Two boundaries matter.

First, scope. For now, the JCA applies only to new cancer medicines and advanced therapies, with orphan medicines joining in 2028 and all centrally authorised medicines by 2030.

Second, remit. The JCA looks only at clinical evidence. It doesn’t set prices, and it doesn’t decide what a health system will reimburse or fund. Those economic and market access decisions remain the responsibility of individual member states. So, the EU layer informs the national conversation; it doesn’t replace it.

Where do patients fit in?

Patient involvement isn’t a nice-to-have bolted onto the edge of this. It’s written into the process. Patients and clinical experts can help shape the scope of an assessment, including the populations it covers, the comparators it considers, and the outcomes it treats as relevant. Through the JSC process, patients can influence what evidence gets collected in the first place. In many ways, that's the point where their input can have the greatest impact.

Why a seat isn’t yet a voice

Giving patients a place in the process is a vital first step. But ensuring their contribution shapes decisions is another matter. Why? Because:

• Timelines are tight. Patient input is often requested within narrow windows, as assessments run alongside fast-paced regulatory processes
• Many of the organisations expected to contribute are small, volunteer-led charities, now being asked to engage at European level as well as within their own national systems
• The language is highly technical – scope, comparators, relative effectiveness – and not everyone invited into the process has the support needed to navigate it confidently
• A single EU assessment must satisfy many countries at once, increasing both the complexity of the discussion and the range of perspectives and evidence needs that patients are asked to consider

None of that is a reason to step back. But it is a reminder that involving patients and hearing patients are not quite the same thing. Without the right support and opportunities to contribute, there is a risk that involvement becomes something that’s done, rather than something that makes a difference. A seat filled, not a voice listened to.

So what does ‘doing it well’ look like?

The reforms have set a place for patients. The work is making sure that, by the time each therapy area's turn comes, someone they recognise and trust is actually sitting in it.

For the many fields not yet in scope, the time to build meaningful patient involvement is now, before the assessment arrives, not after.

That gap between having a seat at the table and being heard is what the rest of this series is about. We’ll start with the outcomes themselves – what patients actually value, and how often that differs from what assessments prioritise and measure. We’ll look at timing, and why the earliest conversation matters more than the loudest. We’ll explore who’s equipped to take part, and what real support for patient organisations looks like, including how to help without putting words in anyone’s mouth. And we’ll finish where transparency should, with making the results understandable to the people they matter to most.

Because having a seat at the table is only the beginning.

Ready to talk?

Helping patients, and the organisations that represent them, play a meaningful role in how medicines are assessed is the work. If you’re preparing for the EU HTA process, whether your therapy area is already in scope or still to come, and thinking about how to involve patients in a way that genuinely shapes the conversation, let’s talk.

References

EUR-Lex. Regulation (EU) 2021/2282 on health technology assessment (HTA Regulation). 12 January 2025. Available here. (Accessed July 2026).

European Union. Implementation of the Regulation on health technology assessment. 2024. Available here. (Accessed July 2026).

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