EU innovation gap demands regulatory science excellence centres

The European Union is falling behind in the global innovation race, and a new proposal published in the journal Nature argues that the bloc urgently needs dedicated regulatory science excellence centres to fix that. The idea is straightforward but ambitious: create specialised hubs that bridge the gap between cutting-edge research and the regulatory frameworks needed to get new technologies safely to market.

Why the EU keeps losing ground

Europe has no shortage of brilliant researchers. What it lacks is speed. New therapies, AI-driven diagnostics, advanced materials — these innovations often spend years trapped in regulatory uncertainty before reaching consumers or industries. The United States and China don’t have that problem to the same degree. The FDA in America has invested heavily in regulatory science as a discipline in its own right, with dedicated funding streams and institutional expertise. The EU hasn’t matched that investment.

The Nature proposal points to a structural problem. European regulatory agencies are stretched thin, often relying on scientific expertise that’s fragmented across 27 member states. That’s not a criticism of individual scientists — it’s a systems failure.

What the proposed centres would actually do

The recommended excellence centres wouldn’t just be advisory bodies collecting dust on shelves. They’d actively develop the scientific methods, data standards, and analytical tools that regulators need to evaluate genuinely novel technologies. Think gene therapies, personalised medicine, or next-generation battery chemistries — areas where existing regulatory playbooks simply don’t apply.

Each centre would focus on a specific domain, with dedicated funding potentially running into the tens of millions of euros annually per hub. They’d operate independently but feed directly into the work of agencies like the European Medicines Agency and the European Chemicals Agency.

“Building regulatory science capacity isn’t optional if Europe wants to remain a competitive destination for innovation investment,” said a senior policy adviser familiar with the proposal.

The political and funding hurdles

But getting this off the ground won’t be easy. The EU’s research budget under Horizon Europe is already oversubscribed. Convincing member states to back a new institutional structure — with all the bureaucratic negotiation that entails — is a genuine challenge. And some critics worry that adding more bodies to the European regulatory ecosystem could slow things down further rather than speed them up.

Still, the momentum is building. The European Commission has signalled interest in strengthening regulatory science as part of its broader competitiveness agenda, following the stark warnings in Mario Draghi’s 2024 report on European economic decline.

What comes next

The proposal is likely to feed into ongoing discussions about the EU’s next long-term budget cycle, which begins in 2028. That gives policymakers roughly three years to design a workable model.

And the clock is ticking. Every year without this infrastructure is another year that promising European research either stalls at the regulatory gate or gets commercialised elsewhere. The centres concept isn’t a silver bullet — but right now, it might be the most practical one on the table.