Securing Europe’s Health Sovereignty: From Innovation to Outcomes

Health sovereignty today is not defined by physical control alone: stockpiles, warehouses or emergency reserves. Those still matter, but the real test for Europe is whether it can be the place that discovers and develops the next generation of life-changing medicines, or the place that waits and hopes for them to come from elsewhere.

Now, more than ever, health sovereignty, industrial competitiveness and economic growth are not separate agendas. They are the mutually reinforcing building blocks of a more secure health future for European citizens. If innovation, manufacturing and access shift elsewhere, Europe’s sovereignty is constrained.

Europe is losing ground – fast.

In a world where capital, talent and scientific leadership are increasingly mobile, Europe risks falling behind faster-moving competitors. The United States and China are not just investing more, they are moving faster, scaling quicker and evolving policies in line with scientific advancement. In life sciences, speed is strategy.

The numbers tell a stark story. Over the past two decades, Europe’s share of global pharmaceutical R&D has fallen from around 41% to just over 30%. In 2024, the United States produced 25 new medicines, China – 28. Europe delivered just 18 – and fewer than ten originated in the EU27. China, meanwhile, has grown its pharmaceutical R&D five times faster than Europe and overtook it in new medicine launches in 2023.

Because Europe’s world-class science base – its researchers, hospitals and universities – is no longer enough on its own. Innovation follows ecosystems, not just excellence. It flows to places that combine scientific strength with speed, scale and predictability across regulation, clinical trials, intellectual property and market realities. Too often, Europe offers the science, but not the ecosystem.

If nothing changes, Europe risks becoming what policymakers quietly fear but rarely say out loud – a third-wave consumer market for breakthrough medicines, where innovation arrives late, at higher cost, or not at all.

The consequences are already visible. Over 40% of medicines launched in the United States in the past five years are still not available in Europe. And when they do arrive, it takes 597 days on average to access them. Too often, access is defined by national evaluation and pricing policies that prioritise cost containment well-above clinical outcomes or their wider economic and social potential.

For patients, this is not abstract. It means waiting longer, getting treated later, or missing out entirely. For economies, it means higher downstream healthcare costs, more hospitalisations, lower workforce participation and weaker long-term growth. Put simply – when patients fall behind, economies do, too.

This trajectory is not inevitable. It is the result of policy choices – and it can be reversed.

We are living through a golden age of medical innovation. From genomics and precision medicine to AI-enabled diagnostics and data-driven care, the science is advancing at unprecedented speed. The question is whether Europe will lead—or follow.

Answering that question requires a fundamental reset in how Europe thinks about health.

Health is not a drain on public finances. It is a driver of economic strength, resilience and security.

The pharmaceutical sector alone invests over €55 billion annually in R&D in Europe and supports more than 2.5 million jobs. More broadly, a healthy population underpins productivity and fiscal stability. Underinvest in health today, and you pay for it – many times over -tomorrow.

This is why spending on innovative medicines and modern health systems should be recognised for what they are – growth-enhancing investment. Embedding this principle in the EU’s New Economic Governance Framework and the European Semester would be a decisive step toward aligning fiscal policy with long-term competitiveness.

Europe must also modernise how care is delivered.

Europe is ageing fast. With it comes a surge in chronic disease just as the healthcare workforce is shrinking. Demand for healthcare is rising sharply while capacity is falling — and demographics mean we will not simply grow our way out of the gap. Fewer workers will be supporting more patients, putting unprecedented strain on health systems.

Shifting from acute, hospital-centred care to prevention, early diagnosis, precision medicine and integrated care is not just a clinical imperative – it is an economic one. Healthier populations are more productive, more resilient and less costly to support. Investing in prevention and better care is, ultimately, an investment in Europe’s competitiveness and growth.

Here is the paradox at the heart of Europe’s health debate: we often treat innovation as a cost pressure, when, in reality, it is one of a very limited number of policy options available to secure Europe’s future.

Medicines that prevent disease progression, avoid hospitalisation and keep people in the workforce are not expenses to be minimised. 

Still, no single reform will be enough. Europe’s challenge is systemic – and so must be its response.

The Biotech Act is a strong start

At EU level, the proposed Biotech Act is an opportunity to move from rhetoric to reality. It acknowledges that Europe needs an ecosystem that works end-to-end: from laboratory to factory to patient. The task now is execution – fast, coordinated and ambitious.

Done right, the Biotech Act can cut through fragmentation and outpace others on clinical trials and incentives to invest and manufacture in Europe. And make no mistake: clinical trials are not just a scientific question; they are a competitiveness issue. Companies go where systems move fastest. Today, Europe is losing that race.

Equally critical is a globally competitive framework for intellectual property and innovation rewards. If Europe wants to attract and keep high-value R&D, it must send a clear signal – medical research will be recognised, protected and rewarded.

Herein lies the key test of EU ambition. The Act is a strong start — but it must close a real and widening gap. Today, commercial trials in the US launch in roughly half the time it takes in the EU. At best, the Act now would reduce that difference to a few months. The proposed SPC reward, meanwhile, would apply to only a small fraction of new medicines.

Policymakers should not question if it goes too far – but if it goes far enough to keep Europe in the global race.

Brussels cannot do this alone.

Health sovereignty is ultimately decided in national capitals and local health systems. It is Member States that determine how quickly transformative therapies reach patients.

Faster regulatory approvals mean little if medicines are then rejected at national level for “immature” data or endpoints accepted everywhere else. Reform at EU level cannot be offset by hesitation on the ground.

The same is true for clinical trials. The Biotech Act’s reforms will not recover Europe’s lost share in clinical trials if medicines are not launched here. Or if national bottlenecks on ethics assessment, trial site contracts and patient consent erase any speed gains agreed in Brussels.

And in a world of tariffs on medicines, incentives to manufacture in Europe must be matched by an uptake of the medicines produced. Otherwise, the cost of exporting to markets that move faster and buy more remains way too high.

Member States must meet EU reform with national policy. They must ensure their systems are ready for innovation. Slow, fragmented reimbursement and market access processes mean that European patients still wait longer than those elsewhere. Even when made available, few countries truly realise the value of innovation. Without the right diagnostics, workforce skills, care pathways and data infrastructure, the most advanced medicines won’t treat the right patient at the right time.

This is where coordination matters most. Without aligned action between EU institutions and national governments, Europe risks having world-leading science and second-rate patient outcomes.

There are tools available. Innovative funding models, public-private partnerships and EU-level investment instruments can help crowd in private capital and anchor key capabilities in Europe. But they must be deployed at scale and with urgency.

Because this is the bottom line – a competitive investment environment is not a gift to industry, it is a condition for sovereignty.

The choice is still ours. But the window is closing.

Europe can continue on its current path: managing decline, importing medical breakthroughs and accepting a second or third-tier role in medicines that will tackle the health challenges of the century.

Or it can act decisively to reset its approach.

That means treating health as a strategic investment, not a sunk cost. It means implementing the Biotech Act with speed and ambition. It means fixing access so that innovation reaches every European patient, not just some.

In healthcare sovereignty, leadership belongs to those who move first.

Europe must decide if it wants to set the pace or follow it.