Europe has no shortage of strategies for life sciences, personalised medicine, health data or advanced therapies. The real challenge is different. Across Europe, scientific advances continue to accelerate, investment is growing and policy ambitions are becoming increasingly clear. Yet patients still experience uneven access to innovation, clinical trials remain concentrated in a limited number of ecosystems, and many promising technologies struggle to move from research into routine care. The gap is no longer primarily scientific. It is operational. After working with 15 European regions, PRECISEU is reaching a simple conclusion: Europe does not need more ambition. It needs stronger implementation capacity. This insight sits at the centre of the upcoming high-level policy dialogue “PRECISEU with Choose Europe for Life Sciences”, taking place at the European Parliament on 4 June 2026.
The challenge is not only innovation. It is implementation capacity.
PRECISEU’s cross-regional work shows that the barriers to personalised medicine implementation are not one-dimensional. They rarely sit in only one part of the system.
Fragmented health data, unclear governance, slow or uncertain reimbursement, regulatory complexity, limited clinical readiness, weak coordination and insufficient innovation infrastructure often reinforce each other. The result is not one isolated bottleneck, but a chain of connected barriers that can slow down the adoption of advanced healthcare innovation. This is particularly visible in ATMPs and clinical trials. For ATMPs, scientific excellence is only one part of the equation. These therapies require specialised infrastructure, advanced diagnostics, manufacturing capacity, regulatory clarity, , hospital readiness, trained professionals and patient access models that can work in practice. For clinical trials, the challenge is also changing. Scientific quality remains essential, but Europe’s attractiveness increasingly depends on speed, predictability, recruitment capacity, diagnostics, data access and the ability of healthcare systems to deliver. The main challenge, therefore, is not only regulation. It is the lack of connected implementation capacity across data, diagnostics, reimbursement, clinical workflows, and regional coordination.
Ecosystem maturity is not only about science
One of the early lessons emerging from PRECISEU is that regional maturity in personalised medicine cannot be measured only by the presence of excellent research. More mature ecosystems tend to combine several capacities: university hospitals, specialised centres, advanced diagnostics, biobanks, health data infrastructures, clinical trial experience, innovation support mechanisms and stronger public-private collaboration. Less mature ecosystems often face a different starting point. They may struggle with basic infrastructure, fragmented data, limited national or regional strategy, fewer specialised sites and weaker coordination between healthcare, research, industry and public authorities.
This difference matters because personalised medicine is not implemented by research institutions alone. It needs an operational system able to absorb, test, finance, regulate and scale innovation. In other words, maturity is not only about having excellent science. It is about having the machinery that allows innovation to move from research into clinical practice, from pilot to adoption, and from isolated excellence to wider patient access. This is where regional ecosystems become critical. They are the level where infrastructure, clinical pathways, innovation support, procurement, reimbursement, patient engagement and policy implementation meet.
What regional evidence shows that EU-level policy can miss
European policy often assumes that regions can absorb innovation if funding, regulation or strategic frameworks are in place. PRECISEU’s regional perspective suggests that this assumption is too simple.
In practice, many regions still lack the local implementation conditions needed to make personalised medicine work. These include interoperable data systems, clear consent models, trained workforce, clinical pathways, diagnostics capacity, procurement models and incentives for hospitals to participate in innovation. These issues are not always visible from a national or EU-level perspective. They become clearer when looking at how innovation actually moves through regional ecosystems. Regions are where hospitals operate, where patients access care, where clinicians decide whether innovation can fit into workflows, where SMEs and industry partners test solutions, where data custodians manage access, and where public authorities try to align health, innovation and economic development priorities. This is why regions should not be seen only as delivery points for European policy. They are where Europe’s competitiveness in personalised medicine will be won or lost.
Four lessons emerging from PRECISEU
Four lessons are emerging consistently across PRECISEU regions. First, personalised medicine is not constrained by a single bottleneck. Data, diagnostics, reimbursement, regulation, workforce skills and clinical readiness are deeply interconnected. Weakness in one area often slows progress across the entire system.
Second, ecosystem maturity is determined less by scientific excellence alone and more by the ability to connect research, healthcare, industry, patients and public authorities around implementation.
Third, regions do not start from the same place. While some ecosystems are already addressing questions of ATMP scale-up, manufacturing and market access, others continue to face fundamental challenges related to healthcare system readiness, access to specialised treatment centres, manufacturing infrastructure, investment capacity, workforce competencies, and sustainable financing of high-cost therapies. A one-size-fits-all implementation model is unlikely to succeed.Fourth, Europe’s competitiveness increasingly depends on operational performance. Speed, predictability, recruitment capacity, access to diagnostics and hospital readiness are becoming as important as scientific excellence itself.
Clinical trials: Europe needs speed, predictability and delivery capacity
Clinical trials are a clear example of why implementation capacity matters. Across regional ecosystems, practical barriers can include fragmented infrastructure, slow patient recruitment, lack of specialised sites, administrative burden, insufficient incentives for clinicians, data access problems and weak hospital-industry collaboration. These barriers affect Europe’s ability to attract and deliver high-quality clinical research.
From the Swedish perspective, stakeholders have highlighted issues such as slow recruitment, difficulties in delivering promised patient numbers, and limited visible financial incentives in healthcare budgets and restricted access to companion diagnostics. These factors can make countries or regions less attractive for industry-sponsored trials. The lesson is relevant beyond one region. Clinical trial competitiveness is no longer only about scientific excellence. It is about whether an ecosystem can offer speed, predictability, recruitment capacity, diagnostics, data access and reliable delivery.
If Europe wants to remain competitive in clinical research, it needs stronger connections between hospitals, research infrastructures, industry, data systems, regulators, patients and regional authorities.
ATMPs require a full value-chain perspective
ATMPs are among the most promising areas of personalised medicine, because they offer highly targeted treatments with the potential to cure, rather than simply manage, disease but their implementation depends on a complex value chain. A region may have strong research capacity, but still lack the manufacturing infrastructure, logistics, regulatory support, reimbursement models or hospital readiness needed to bring advanced therapies closer to patients. This is why ATMP implementation cannot be reduced to one issue. It requires coordination across discovery, translation, manufacturing, clinical validation, regulation, reimbursement, hospital adoption and patient access.
Personalised medicine cannot be scaled through a one-size-fits-all model. It requires tailored implementation pathways that recognise where each ecosystem starts, what assets it already has, and what capacities it needs to build or connect.
From exchange of good practices to shared implementation capacity
Interregional collaboration is often described as an exchange of good practices. That remains useful, but PRECISEU’s work suggests that Europe needs to go further. The strongest opportunities for interregional collaboration are not limited to knowledge exchange. They include shared data models, joint clinical trial networks, coordinated patient recruitment, ATMP manufacturing and logistics capacity, regulatory learning, market readiness support, training, procurement alignment and reimbursement learning. For example, interregional reference networks for ultra-rare diseases or manufacturing hubs closer to clinical centres can help reduce access and logistics barriers. Similar approaches could support stronger cross-border clinical trial capacity or shared learning on health data governance.
The next step for Europe is to move from exchanging what works to building shared implementation capacity. This is where PRECISEU can add value. By connecting 28 partners from 15 European regions, the project can help identify barriers, compare capacities, mobilise stakeholders and translate regional insights into practical priorities for policy and implementation.
What PRECISEU brings into the European policy conversation
PRECISEU was created to connect regional innovation ecosystems and support the adoption of personalised medicine across Europe. Its role is not to replace existing European strategies, but to help make them more actionable at regional level.
The project brings a perspective that is both European and grounded in implementation. It shows that Europe does not only need more innovation pipelines. It needs stronger regional implementation engines. It shows that clinical trial attractiveness depends not only on research excellence, but also on speed, predictability and delivery capacity. It shows that ATMP adoption requires a full value-chain approach, from infrastructure and diagnostics to reimbursement and hospital readiness. It shows that regions are not passive recipients of policy, but active places where Europe’s life sciences competitiveness is shaped. And it shows that interregional collaboration should evolve from exchange of experience to shared capacity-building.
What Europe should do next
The lesson emerging from PRECISEU is straightforward. Europe’s future competitiveness in personalised medicine will not be determined only by where innovation is discovered. It will be determined by where innovation can be implemented. This means investing not only in research excellence, but also in data infrastructure, diagnostics, clinical trial capacity, workforce development, reimbursement readiness, regulatory learning and ecosystem coordination. It also means recognising regions as strategic assets rather than simple delivery mechanisms. Regions are where patients access care, where hospitals adopt innovation, where clinical trials are delivered and where implementation either succeeds or fails.
The next phase of European leadership in personalised medicine will not be won through better strategies alone. It will be won by building stronger implementation engines capable of turning scientific breakthroughs into patient benefit at scale. That is the perspective PRECISEU brings to the European policy conversation!
