The EU Clinical Trials Regulation (CTR) aimed to boost Europe’s position in clinical research. However, there is a growing recognition among policymakers, regulators and innovative companies that a new approach is needed if we are to become more competitive. This welcome shift must be rapidly translated into meaningful change. To stem the flow of clinical trials from Europe to other regions of the world, positive signals and actions are needed.

The forthcoming EU Biotech Act will be a chance to deliver lasting change, reclaiming Europe’s place as a global leader in life sciences innovation. In the meantime, EFPIA is actively engaging with decision-makers, regulators and others to find ways that we can urgently address the challenges.

We have set out a range of concrete proposals designed to strengthen the clinical research ecosystem. These include surgical changes to the CTR, simplification and modernisation of the Clinical Trials Information System (CTIS), and the implementation of a core dossier model.

Good for patients, good for Europe

Despite a 38% increase in clinical trials globally over the past decade, Europe's share of global clinical trials has dropped from 22% in 2013 to 12% in 2023. This translates to 60,000 fewer clinical trial places for Europeans.

Clinical trials offer patients early access to new medicines, often five to ten years before they are launched. In some instances, notably in rare diseases, trials can provide patients with a treatment option when there are no others available.

Research makes an important financial contribution to our hospitals, delivering estimated savings and revenue of between €1 billion and 1.5 billion annually for health systems in the EU. Trials can also help our research hospitals attract the best scientists and healthcare professionals. In 2023, research-based pharmaceutical companies invested approximately €50 billion in R&D in Europe.

Europe provides many advantages for conducting clinical trials, such as strong centres of excellence, leading clinical investigators, high quality data and fast recruitment of patients. However, companies must consider a wide range of factors when deciding where to conduct clinical research in their global development programmes, including the timeline and complexity of the clinical trial approval process, especially for multi-national trials, and the openness to innovative trial designs.

How to tackle fragmentation  

Fragmentation and overly complex approval processes are Europe’s primary obstacles when attracting trials. To stay competitive, Europe must act as a unified region with simplified and harmonised processes supported by policies that attract global research investments.

We urge Member States to implement the EU Clinical Trials Regulation uniformly - avoiding national layers that complicate trial conduct. Simplified processes for multi-country trials, Ethics Committee coordination, and harmonised faster approvals are essential. Reducing approval timelines to 60 days supported by reliance mechanisms would ensure streamlined operations.

Further, CTIS lacks the flexibility needed to simplify processes. Immediate modernisation is required to create a user-friendly, reliable system that supports CTR’s goals without hindering innovation.

Cross-border trial access is another crucial area. Patients should have flexible options to join trials anywhere in Europe. An EU legal framework for cross-border participation would ease administrative, logistical, and financial burdens for patients and investigators.

Time for action

Despite these challenges, we are encouraged by the growing sense of urgency among decision-makers and their openness to working with EFPIA and other key stakeholders to make Europe more competitive. It is vital that positive signals from those in leadership positions are reflected at all levels of the clinical research and regulatory system.

Many of the changes we need, including greater flexibility in how the CTIS operates, reducing approval times to 60 days and a shift to a ‘core dossier’ model for clinical trial submission documents, can be achieved swiftly without legislative changes. This means implementation is possible within one to two years with the right commitment from policy makers, regulators and stakeholders. 

Globally, we are operating at a time of uncertainty. However, ongoing initiatives such as the ACT-EU and the EU Biotech Act offer an opportunity for serious improvements to European competitiveness in clinical research. We are committed to our common goal and are here to support the change and drive positive impact for patients in Europe. 

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Discover more on the EFPIA clinical trials webpage.