Europe’s health ambition is returning to the political agenda. With a focus on clinical trials, biotechnology and cardiovascular health, the Health Package signals Brussels’ intent to prioritize innovation, research and prevention as pillars of Europe’s competitiveness and resilience.
But for many patients, one reality remains unchanged: access to innovative medicines remains too slow.
Today, European patients are waiting longer than ever to access new medicines, and the trend is moving in the wrong direction. The latest data from EFPIA’s WAIT indicator shows that the average wait time in Europe has increased to 597 days, 19 days longer than in 2025, and 93 days more compared with 2019.
This is not a failure of scientific capability or innovation in Europe. This region continues to produce world-class science, attract research and pioneer advanced therapies. The challenge, and opportunity, lies in how access pathways, reimbursement processes and healthcare infrastructure are designed and connected.
Today, European patients are waiting longer than ever to access new medicines, and the trend is moving in the wrong direction.
The ambition is clear, but patients will ultimately judge Europe’s health agenda on one question: does innovation reach people fast enough to make a difference in their lives?
Why “Access from Day 1” deserves serious debate
Scientific leadership alone cannot benefit patients. If Europe is serious about improving access to medicines, we must be willing to ask a more fundamental question: are our regulatory, reimbursement and healthcare frameworks truly aligned around bringing innovation to patients quickly and equitably?
The European Medicines Agency delivers rigorous, globally respected scientific assessments. But patients do not experience “regulatory approval”; they experience access to treatment.
Today, in the European Union, only around 28 percent of centrally approved medicines are fully available to patients through public healthcare systems, with an additional 17 percent available under restricted conditions.
Why? Because after approval, medicines enter a fragmented landscape of national negotiations, reimbursement decisions, administrative procedures and budget discussions. The result is predictable: delays, divergence and unequal access across Europe.
The gap between regulatory approval and real-world patient access has become a test for Europe’s health ambitions. Europe will only improve access outcomes if all parts of the ecosystem move faster, more coherently and together.
The gap between regulatory approval and real-world patient access has become a test for Europe’s health ambitions.
This is why an “Access from Day 1” approach deserves serious consideration — a pragmatic model that would allow patients access to medicines immediately following regulatory approval, while reimbursement and value assessments continue in parallel.
This is not about lowering scientific standards or ignoring budget realities. Europe’s rigorous evaluation processes must remain fully intact. The objective is to reduce avoidable delay by designing smarter, more coordinated pathways between approval, assessment and access.
With the right safeguards, governance and investment by member states, such an approach could accelerate patient access, reduce inequity across countries and strengthen Europe’s overall health ecosystem.
Encouragingly, elements of these models already exist in parts of Europe. In countries such as Germany, around 93 percent of EU-approved medicines become rapidly available to patients. No single system is perfect, but Europe already has examples from which it can learn and build.
Access is a shared ambition. And a shared responsibility
Too often, access is framed as a tension between industry and payers. In reality, patient access to innovation depends on a far more interconnected ecosystem.
Patients themselves contribute to innovation by participating in clinical trials, often without the certainty of personal benefit. Healthcare professionals and hospitals develop the expertise, infrastructure and care pathways required to safely deliver increasingly advanced therapies. Public institutions assess value, define reimbursement conditions and ensure sustainability of healthcare systems.
When delays occur, they are rarely the result of a single actor or decision. More often, they reflect misalignment across the broader ecosystem.
Meaningfully reducing delays across Europe will require shared commitment around several principles:
—A common ambition for patient access from day one following regulatory approval.
—Predictable and timely access pathways, so availability is not dependent on prolonged national procedures or administrative variation.
—Recognition of innovation as a long-term investment in health outcomes and system sustainability, allowing reimbursement and value assessment to progress in parallel where appropriate.
—Greater system readiness, including alignment of infrastructure, workforce planning and healthcare delivery models to support advanced therapies safely and efficiently.
When innovation outpaces readiness, patients pay the price
Radioligand therapy (RLT) demonstrates both Europe’s scientific leadership and the operational challenges that increasingly accompany advanced medicines.
As innovation advances faster than system readiness, patients face delay — even when the science already exists.
These therapies require highly specialized diagnostics, multidisciplinary expertise, dedicated infrastructure, secure isotope supply chains and coordinated regulation. They sit at the intersection of medicines regulation and radioprotection frameworks that were never designed for therapies of this complexity.
As innovation advances faster than system readiness, patients face delay — even when the science already exists.
This is an important lesson for Europe’s broader health agenda. Scientific breakthroughs alone are not enough. Innovation only matters if healthcare systems are organized to deliver it at scale and in time for patients who need it.
The political test ahead
Europe knows how to innovate. The question is whether it is willing to design its systems around timely patient access.
The next phase of Europe’s health agenda must ensure that innovation is translated into timely and equitable patient access across the region.
Because in the end, approval is not what patients experience.
Access is.
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- The sponsor is European Federation of Pharmaceutical Industries and Associations (EFPIA).
- The entity ultimately controlling the sponsor is European Federation of Pharmaceutical Industries and Associations (EFPIA).
This article is linked to the EU pharmaceutical regulation and innovation policy.
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