Historically, Europe has been a global powerhouse for life sciences and biotechnology. Our world-class research institutions, highly skilled healthcare professionals and strong scientific base have resulted in countless breakthroughs that improve patients' lives.
But lately, when it comes to translating discovering into meaningful innovation, there’s an issue: When sponsors decide where to conduct global clinical trials, investment is increasingly flowing out of Europe and into regions like the U.S. and China.
This is an important challenge for Europe to take seriously because clinical trials are the gateway to innovation. They determine where investment flows, where patients gain early access to cutting-edge therapies, and where future manufacturing and research capabilities are built. If Europe wants to address our competitiveness challenges, clinical research must be at the heart of the agenda.
This is an important challenge for Europe to take seriously because clinical trials are the gateway to innovation
The good news is that the EU has already taken several positive steps. The Clinical Trials Regulation and the Clinical Trials Information System (CTIS) have improved coordination and created a stronger foundation for multinational studies. However, these changes boil down to marginal optimisation and are not enough to address the systemic issues that are driving investment out of the region.
The heart of the clinical trials challenge
Fundamentally, Europe’s clinical trial problem stems from a lack of cohesiveness. Sponsors face different interpretations across Member States, divergent ethical review processes, operational inefficiencies, and unnecessary complexity when conducting multinational trials. Put another way, while the rules may be European, the experience of implementing them often remains national.
The result is slower timelines, reduced predictability and greater administrative burden compared with other parts of the world.
The Biotech Act as a solution
The Biotech Act can play a transformative role in addressing this lack of cohesion. But rather than treating clinical trial reforms as a collection of technical adjustments, the Act should provide the framework for a flagship EU Clinical Trials Competitiveness Initiative.
Europe can maintain its commitment to patient safety, scientific rigour and public confidence while creating a more efficient and integrated system
Such an initiative would recognise that improving Europe's clinical trial environment is one of the most direct ways to strengthen the continent's attractiveness for biotechnology investment and innovation. To maximize its impact, the Act should focus on three things:
-
First, speed: Europe should strengthen coordination across Member States and empower EU-level mechanisms to drive greater convergence in scientific assessments and implementation. A stronger and more consistent framework would reduce duplication and help sponsors navigate multinational studies more efficiently.
-
Second, predictability: Europe should work towards a more harmonised approach to ethics review. Ethical oversight is essential for patient trust and safety, but differing interpretations across countries create avoidable delays without necessarily improving protections.
-
Third, simplicity: Europe should embrace a risk-based and innovation-friendly approach to emerging technologies. For instance, artificial intelligence has the potential to improve protocol design, patient recruitment and data analysis across the clinical trial lifecycle. As AI-enabled research tools become a competitive differentiator globally, Europe should ensure that its regulatory framework enables responsible adoption rather than creating unnecessary barriers to innovation.
Historically, Europe has been a global powerhouse for life sciences and biotechnology
Crucially, none of this requires lower standards. Europe can maintain its commitment to patient safety, scientific rigour and public confidence while creating a more efficient and integrated system.
The global competition for biotechnology investment is intensifying. The question is not whether Europe can generate scientific breakthroughs; it clearly can. It is whether Europe can provide the regulatory environment that allows those breakthroughs to be developed, tested and scaled here.
Sign up to The Parliament's weekly newsletter
Every Friday our editorial team goes behind the headlines to offer insight and analysis on the key stories driving the EU agenda. Subscribe for free here.