Clinical Trials at the Heart of EU’s Competitiveness: Delivering on the Promise of the EU Biotech Act

EU’s life sciences sector is at a turning point. While the region continues to generate world-class science, it is increasingly struggling to translate that excellence into innovation, investment, and timely patient benefit. The challenge is not scientific capability, but whether the EU’s systems can operate at the speed and scale required in a highly competitive global environment.

Clinical trials sit at the centre of this challenge. They are not only a key step in the development of new medicines, but also a decisive factor in where innovation happens. Over the past decade, the European Economic Area’s share of global clinical trials has declined from 22% to 12%¹, as activity has shifted to regions offering faster approvals, greater predictability, and more scalable systems. In a global environment where trial placement is a competitive decision, speed matters: faster timelines enable earlier data generation, earlier investment decisions, and ultimately faster patient access.

For companies like Pfizer, having submitted nearly 230 clinical trials applications under the EU’s Clinical Trials Regulation since 2022, the efficiency and predictability of the clinical trials framework directly influence where future research is conducted. 

It is in this context that the EU Biotech Act comes at a moment of strategic urgency. It reflects a growing recognition that restoring EU’s competitiveness will require more than incremental improvements: it will require a system capable of acting at scale. The intention to create a more harmonised, streamlined and science-based clinical trials framework is therefore a welcome and necessary improvement.

Indeed, important challenges remain. Despite progress under the Clinical Trials Regulation, the system continues to be characterised by fragmentation, comparatively slower timelines, and operational inefficiencies. A single EU application still results in multiple national decisions, and we often encounter misalignment between regulatory and ethical assessments, duplicative requests for information, and inconsistent interpretation across Member States. These structural issues continue to delay trial initiation and reduce EU’s attractiveness as a location for clinical research.

Addressing these shortcomings is critical, as other regions continue to move faster and operate at greater scale. For example, in China, late development trial recruitment often runs 2-5 times faster than US and EU benchmarks, thanks to large and concentrated patient pools, well-resourced sites, and maturing clinical capabilities. In 2025, China launched a nationwide 30-day fast-track review process² for innovative drug clinical trials. Ultimately, without further efforts to reduce fragmentation and improve predictability, the EU risks missing out on the scientific, economic, and patient benefits that clinical research can deliver.

In this context, the EU Biotech Act is a strong step forward, not because it offers all the solutions, but because it signals what kind of clinical trials environment the EU wants to have: one which values safety, speed, efficiency and predictability. 

The proposal introduces tangible measures for improving the clinical trials framework, including: 

• Shortening approval timelines for multinational trials from 106 to 75 days. This is essential if the EU wants to regain attractiveness as a location for clinical research. Importantly, this is exactly what patients need and what Pfizer has been delivering. Pfizer has pioneered patient-centric trial designs, integrated real-world data, and embraced digital innovation to accelerate timelines without compromising safety. During the COVID-19 pandemic, we moved from concept to authorisation of an mRNA vaccine in record time.
• Removing the additional 50-day assessment period for ATMPs. This will accelerate access to potentially transformative therapies without compromising the rigour of the review. 

• Enabling faster processing of substantial modifications, including parallel handling. Currently, the system prevents sponsors from submitting new changes while a substantial modification is already under assessment, forcing sequential submissions. This improvement removes that constraint.
• Coordinated assessment for combined studies. The increasing need to develop in vitro diagnostic medical devices alongside new medicinal products is currently delaying trial initiation due to separate evaluations and timelines. Streamlining and combining these assessments would enable personalised treatments to reach patients more quickly.
• Strengthened EMA support for multi-country trials. By enabling more integrated EU-wide coordination, simplified procedures, and targeted scientific guidance, the EU Biotech Act will accelerate the setup and conduct of multi-country trials across Member States.

The commercial logic behind these reforms is already visible elsewhere. When Pfizer entered a licensing agreement with 3SBio, one of the key factors was that 3SBio had been able to advance multiple clinical trials efficiently and generate positive interim Phase II results — progress made possible by a regulatory environment that supported accelerated development. It was the quality and pace of the clinical programme, enabled by the jurisdiction, that made the asset an attractive partner. This is precisely the virtuous cycle that well-functioning clinical frameworks can create: faster development builds confidence, which draws in global partners and capital³.

The EU is not yet able to replicate that dynamic at scale. While improvements enhance coordination, the system remains structurally fragmented. Final approval decisions continue to be taken at national level, leaving scope for divergence and unpredictability.

If the EU is to fully restore its competitiveness, a more ambitious step should be considered, moving toward a model where core scientific and ethical assessments are conducted once at EU level, ensuring greater consistency, speed, and scalability.

EFPIA’s “One Vision”⁴ provides a clear direction for such an evolution. A truly integrated system based on “one system, one governance” would combine a connected digital ecosystem with a more coordinated and strategically led regulatory framework. This would enable seamless data flow, reduce duplication, and ensure more consistent decision-making across the EU while preserving Member States’ roles where appropriate. Anchoring the Biotech Act in this vision would help ensure that EU builds not just a coordinated system, but a globally competitive one.

Finally, regulatory reform alone is not sufficient. Accelerating the path from research to authorization only delivers its full value if the medicines that result can reach patients – without being delayed by fragmented or under-resourced processes. This makes the access environment as strategically important as the clinical trials framework. As highlighted by EFPIA’s Director General Nathalie Moll⁵, Europe’s longstanding emphasis on cost containment has constrained its ability to attract investment and translate scientific excellence into patient benefit. Rebalancing how medicines are being valued – recognizing not just their price but their broader economic and societal contribution – is the necessary complement to everything the EU Biotech Act sets out to achieve on the clinical trials side. 

The EU Biotech Act arrives at a defining moment. The EU still possesses the ingredients of a world-leading life sciences ecosystem — scientific depth, skilled talent, industrial infrastructure, and a large and diverse patient population. What it has lacked is a system capable of converting those assets into competitive speed and scale. The Biotech Act is a meaningful step toward that conversion.

But the step must not become the destination. The reforms outlined here — faster timelines, reduced fragmentation, better coordination — matter because of what they unlock: earlier patient access, stronger investment signals, and a more competitive position in the global race for clinical research. Sustaining that momentum will require the EU to go further: toward a genuine EU model of core scientific and ethical assessments, and toward an access environment that rewards innovation rather than simply containing its cost. The prize is an EU where clinical trials are not a last resort for sponsors, but a first choice — because the system is fast, predictable, and built for the science of today.

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1 The economic impact of industry clinical trials across Europe, EFPIA, available at: https://www.efpia.eu/media/zdzg0bey/the-economic-impact-of-industry-clinical-trials-across-europe.pdf  

2 National Medicinal Products Administration, Policy Interpretation of the Announcement on Optimizing of the Review and Approval Process for Clinical Trials of Innovative Drugs, available at: https://english.nmpa.gov.cn/2025-10/14/c_1138493.htm?utm 

3 Pfizer completes licensing Agreement with 3SBio, Pfizer, available at: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-completes-licensing-agreement-3sbio 

4 EFPIA’s ONE Vision: Unlocking Europe’s Regulatory Innovation for Faster Patient Access, available at: https://efpia.eu/media/rigluns1/efpia_one-vision.pdf

5 Europe must rethink how it values medicines, says EFPIA chief, Euractiv, available at: https://www.euractiv.com/interview/europe-must-rethink-how-it-values-medicines-says-efpia-chief/