By Anna Rzhevkina

Europe’s share of global clinical trials has slid from over 25% to 19.3% in the past decade, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) weighed down by rising international competition and a fragmented, uncoordinated approach. This trend persists despite robust public healthcare systems, highly qualified researchers, a large and diverse population, and academic centres of excellence.

Experts say reversing the decline demands stronger coordination among EU member states and centralised legislation procedures. “We are a long way from one regional ecosystem, but the building blocks are there,” Martin O'Kane, regional head, regulatory affairs EU policy & liaison at Novartis, told the conference Healthy competition: Can Europe regain its global edge in life sciences? hosted by Science|Business.

To foster collaboration between stakeholders, the European Commission has launched several initiatives, under the umbrella of the Accelerating Clinical Trials in the EU (ACT EU), designed to improve the clinical trials environment via harmonisation, innovation and collaboration with stakeholders. However, while many of these useful initiatives address urgent and immediate challenges, there remains a need for more profound structural and transformative change to secure Europe’s long-term competitiveness, O'Kane said.

The legislation is often interpreted differently in different EU Member States with duplication of effort during assessment, leading to prolonged approval timelines. The review of a clinical trial averages more than 110 days in Europe, compared with about 30 days in the U.S. or China, according to O'Kane. This disparity could be addressed by establishing a single set of rules with enhanced central coordination across all EU and EEA countries for processing clinical trial applications and with greater reliance on previously assessed core information.

The case for strategic autonomy

With the U.S. pushing to bring production back home, and China rapidly expanding its capabilities, it has become crucial for Europe to achieve strategic autonomy and reduce its dependency on other regions, the conference heard. “If we don't do something at the European level, in 10 years we’ll have an enormous lack of investments, an enormous gap in production facilities for innovative medicines in Europe, while the U.S. and China will have almost a complete monopoly,” Tomislav Sokol, a member of the European Parliament warned. “We cannot let that happen.”

To address these challenges, the European Parliament is advocating for greater central coordination of clinical trials from both regulatory and ethical perspectives, opening opportunities to all countries and patients across Europe.

Another key component of the EU’s strategy is joint procurement, which remains a top priority for most member states and the Parliament despite some industry scepticism. By pooling resources, Europe can negotiate better terms, improve efficiency, and ensure fairer access to essential medicines and trial infrastructure.

Policymakers are also pushing for stronger oversight of strategic projects at the European level to ensure investments are allocated optimally. Another important issue is stockpiling, as fragmented national reserves can create shortages in some member states while others remain oversupplied. “We want to create a common European system for the exchange of information, so that we know at the central level what the situation with stocks is in different member states,” Sokol said. “In case of shortages, medicines can then be reallocated from one country to another, ensuring continuity of care across Europe.”

Lack of clear positioning and incentives

Europe could also benefit from better defining and promoting its competitive advantages in clinical trials. The region benefits from large, publicly-supported healthcare systems and vast population-based data, yet its unique strengths remain underused. “I think we need to focus on what we want to achieve in the EU, not only on what others are doing or who the competition is,” said Marianne Pilgaard, CEO at Trial Nation. “In the current geopolitical climate, we need to make sure that we are resilient on our own.” She added that while common objectives exist, she worries about the speed of implementation.

Pilgaard stressed that clinical trials can represent a potentially life-saving opportunity for terminally ill patients, and should be viewed not as a separate activity, but as one of the treatment options available during a patient’s disease journey.

Moreover, incentives to stimulate research and accelerate clinical trials could be stronger, according to Clara Hellner, presidential advisor for life sciences at the Karolinska Institutet. “I don't see the push. In Sweden, for example, there's a lot of action towards this direction, but it's a bit slower, and it doesn't have the clear framework that the health data issue has,” Hellner said.

The lack of incentives and inconsistent rules for data sharing can also be barriers to attracting sponsors for clinical trials. To help address these issues, Maria Pilar Aguar Fernández, director for people: health & society at the European Commission’s research directorate, explained the Commission is aiming to establish a network of trusted investors around the European Innovation Council and bring them closer to industry.

Speakers also highlighted the importance of patient recruitment incentives, such as the new clinical trial map, which allows patients and healthcare professionals to identify trials taking place near them. It was lauded as a good example of the potential to increase access to clinical research in the EU.

While Europe’s strong foundations present an opportunity to build a globally competitive clinical trials ecosystem, experts stress that turning that potential into reality will require true collaboration across borders, sectors and stakeholders.