EHDS can help Europe regain competitiveness in clinical trials.

Clinical trials give patients earlier access to new therapies, build clinical capabilities and generate high-value investment. Europe’s declining global share is therefore a challenge far beyond the pharmaceutical industry.

Europe has a strong base — but is losing ground

Between 2013 and 2023, the number of clinical trials worldwide rose by 38%, while Europe’s global share fell from 22% to 12%. Trial starts in the EEA declined from 2,424 to 1,978. China, by contrast, increased its share from 8% to 29%.

€35.7 billion in value each year

Frontier Economics estimates that industry-sponsored trials generate €35.7 billion in annual Gross Value Added across the EEA: €21.7 billion from research activity, €3.6 billion from R&D spillovers and €10.4 billion from workforce productivity. The activity supports more than 165,000 jobs.

Poland already benefits — and can gain more

The annual economic impact in Poland is estimated at €1.683 billion. A scenario restoring European trial activity to the 2013 level could add another €420.7 million per year and around 710 jobs.

+€420.7mPotential additional annual impact for Poland under a 25% increase in European trial activity.

Where does EHDS fit?

A well-implemented EHDS can improve data discovery, study feasibility, site selection and secure analysis across borders. Common metadata, permits and Secure Processing Environments can reduce uncertainty without weakening patient protection.

EHDS is not an automatic advantage

Regulation alone will not accelerate trials. Europe also needs effective health data access bodies, predictable permit procedures, high-quality data, real interoperability and public trust. The report models scenarios rather than guaranteed outcomes.

From compliance to competitiveness

The strategic question is not only how to implement EHDS lawfully, but how to use it to keep more research, innovation and patient benefit in Europe. Open, auditable and reusable infrastructure is central to that transition.