Why Europe should strive to increase its clinical trials

The pharmaceutical sector is the engine room that drives clinical trial activity and the benefits that go way beyond patient care. Clinical research delivers significant economic growth, and the European Union has the potential to deliver so much more.

That’s why it’s good news that the European Medicines Agency (EMA), alongside the European Commission and Heads of Medicines Agencies (HMA), have set a new target for increasing clinical trials in the EU. The 11.1 percent target should bring an additional 500 multinational trials over five years.

A new report by Frontier Economics, published in February by EFPIA, analyzed this target. It will produce an extra 35,000 clinical trial places for people in Europe, who will be able to access treatments that may otherwise have been unavailable. The economic impact is estimated to be around €4 billion. It’s certainly a good first step toward turning around a decade of decline.

Spain, where Almirall is based, has shown what is possible when the right conditions are in place. In 2023 it overtook Germany as the country with the most clinical trial starts across Europe. In just ten years, our industry investment in clinical trials in Spain has risen at an average annual rate of 5.7 percent, climbing from €479 million in 2012 to €834 million in 2022. The successful and timely implementation of the EU’s Clinical Trials Regulation (CTR) and effective collaborations and improvements to the Spanish healthcare system have made this possible. However, unlike Spain, the EU overall has been slow to deliver the simplifications and incentives needed to compete in attracting clinical trials. Other countries have implemented policies that are successful at attracting clinical research. Patients in the United States and China, for example, now see the benefit of significantly increased trial places, whereas Europe has lost 60,000 trial places in the past decade.

This is why the EU must implement policies urgently to bring our clinical trial ecosystem on a par with China and the US.

Particularly worrying is the trend for advanced therapeutics such as cell and gene therapy trials. China’s share has soared to 42 percent, while Europe’s has fallen from 25 percent to just 10 percent.

Our ask of policymakers is clear: we need streamlined processes to bring more clinical trials to Europe. The current fragmented national procedures must be replaced with a single, harmonized system for clinical trial authorization. Multi-country clinical trials are especially critical, enabling medicine developers in Europe to scale their efforts and compete with global leaders, however, regulatory fragmentation and operational complexity continue to make the EU a less attractive location for conducting clinical research.

Uniformly implementing the CTR across all member states and optimizing the Clinical Trials Information System will be critical for success, alongside efficient multi-country trial processes, including coordinated ethics reviews and cross-border patient participation. 

In recent months EU policymakers have started to realize the potential impact of the EU’s worrying trends. Alongside the EMA target, the Biotech Act pledges to harmonize and speed up the EUs regulatory system — this is undoubtedly a positive step.

Could Europe be more ambitious?

To highlight the real opportunity to be competitive in clinical trials, EFPIA’s report models two further, more ambitious scenarios that have the potential to take Europe to a completely different level supporting clinical trials, provide early access to developmental treatments and drive economic value.

The second scenario would increase trials by 25 percent, taking the EU back to 2013 levels. This would see 79,000 extra patients enrolled in trials, delivering economic benefits of €9 billion and supporting an extra 41,000 jobs. This would be a sign that Europe has taken action to address its current relegation to the second tier in clinical research. It would reflect our collective desire and ambition to reclaim some of the opportunities with clinical trials that have been lost recently.

Under a third scenario, the analysis in the report considers the rate of growth in clinical trials in China and North America since 2013. Matching that level of activity would mean doubling clinical trials in Europe. That path would offer an economic boost of €18 billion per year; 82,000 new jobs and 158,000 more clinical trial places for patients.

Importantly, the efforts and investment needed to achieve this third and most impactful scenario are modest, but the results and impact would be very significant, putting Europe firmly on the map in the increasingly competitive landscape of life sciences innovation.  It would also signal something even more important: Europe once again has the chance to become an innovation leader in health, the place where science moves rapidly from ideas to therapies. A clear focus on policy changes to make it more efficient to place clinical trials in Europe would see our hospitals at the forefront of innovation, clinicians trained on tomorrow’s treatments today and patients able to access new therapies without leaving the continent.

As an industry, we support the EMA’s target. But should we be more ambitious for Europe. Yes, I am convinced we can achieve more if we create the right conditions and Europe´s policymakers act now and with a sense of urgency.

Disclaimer

POLITICAL ADVERTISEMENT

• The sponsor is European Federation of Pharmaceutical Industries and Associations (EFPIA).
• The entity ultimately controlling the sponsor is European Federation of Pharmaceutical Industries and Associations (EFPIA).
• This article is linked to the EU Biotech Act.

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