Lorraine Williamson
Spain has quietly become Europe’s clinical-trials workhorse. In 2025 alone, Spain authorised 962 clinical trials through AEMPS, according to the Spanish Register of Clinical Studies (REec).
Yet for patients, the headline success can feel oddly distant. “Spain clinical trials access” is the uncomfortable phrase behind the celebration: after a medicine is approved at the EU level, it can still take well over 600 days on average to be incorporated into Spain’s public system, according to clinical research leaders cited by El Español.
At a glance
-
Clinical trials authorised in 2025:
962 -
Multinational trials authorised:
758 -
Reported average wait to access after EMA approval:
600+ days -
R&D spend as a share of GDP (Spain, 2024):
1.50%
A research powerhouse, but not a patient fast lane
Spain’s trial numbers are not a statistical quirk. Regulators point to a mature ecosystem: a large, capable hospital network, experienced investigators, and strong recruitment performance across a wide range of therapeutic areas.
Oncology dominates the pipeline. AEMPS says it authorised 378 oncology trials in 2025—around 40% of the national total—while immune, nervous system and cardiovascular conditions follow at a distance.
This is the part Spain does well: attracting global projects, running them reliably, and generating the evidence that underpins new medicines.
Why “tested here” does not mean “treated here”
The access gap begins after the science. Once the European Medicines Agency (EMA) grants marketing authorisation, countries must still decide pricing, reimbursement and real-world use. In Spain, that pathway is widely described by researchers as heavy on paperwork, slow negotiation, and vulnerable to delays across multiple decision points.
European industry analysis backs the broader pattern: patients in Northern and Western Europe often gain access within roughly 100–200 days, while patients in Southern and Eastern Europe can wait 600–1000 days for the same innovations.
In Spain’s case, El Español reports that the post-EMA timeline is typically stretched by (1) national assessment and positioning work and (2) pricing and funding negotiations—followed, in practice, by further friction as implementation plays out across autonomous communities.
The funding imbalance underneath the success story
There is another structural tension: who pays for the research?
Farmaindustria has repeatedly highlighted that more than eight in ten clinical trials in Spain are promoted by the pharmaceutical industry, with public-sector, investigator-led studies making up a much smaller slice.
Researchers quoted by El Español argue that this leaves promising local ideas stranded unless industry picks them up—and that long-term strength depends on Spain investing more consistently in its own science base.
On the national balance sheet, the direction of travel is upwards, but still modest by the standards of Europe’s biggest R&D spenders. Spain’s official statistics office (INE) put internal R&D expenditure at 1.50% of GDP in 2024.
Workloads, insecurity and the “invisible” cost of leadership
Trial leadership also has a human price tag. Voices in the sector warn that research careers can be unstable, with postdoctoral staff moving from project to project without secure long-term posts.
Clinicians face a different squeeze. El Español cites experts who say doctors in the public system may only have a small fraction of their working time formally protected for research, pushing trial tasks into evenings and weekends.
A system can hit record numbers and still burn through its people. That is a fragile way to stay on top.
The real-world consequences for patients
Spain’s position as a leading trial site should, in theory, bring earlier exposure to cutting-edge treatments. In practice, participation is uneven and limited to those who meet strict eligibility criteria and live near trial centres.
For everyone else, the wait begins after approval. El Español reports that nearly 30% of innovative medicines approved by the EMA never reach Spain’s national health system, and that many of those that do arrive with restrictions.
This is where the frustration becomes personal: patients help generate the evidence, but do not reliably see the benefit at the pharmacy counter.
What could change in 2026
No serious voice argues for weaker safety standards. The debate is about proportionality: how to protect patients while removing delays that add no clinical value.
Across Europe, the “root cause” analyses of access delays tend to converge on practical reforms—simpler, faster reimbursement pathways; clearer value assessment; and better alignment between national decisions and regional implementation.
In Spain, the most realistic pressure points are:
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Streamlining assessment and reimbursement steps
so decisions do not stall between agencies and committees. -
More stable public investment
to increase investigator-led research and reduce overdependence on commercial sponsors. -
Protected research time for clinicians
, so trial delivery does not rely on unpaid overtime. -
Faster, more consistent implementation across autonomous communities
, so access does not vary by postcode.
Spain has already proved it can be fast and reliable when the goal is to run trials at scale. The next test is whether it can be equally serious about getting the resulting medicines into routine care, before “leader in research” becomes a slogan patients no longer trust.
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