The pharmaceutical industry is the engine room that drives clinical trials with benefits that go beyond patient care. Medical research provides significant economic growth, and the European Union has the potential to provide much more.
That is why it is good news that the European Medicines Agency (EMA), together with the European Commission and the Heads of Medicines Agencies (HMA), have set a new goal to increase clinical trials in the EU. The 11.1 percent target should result in an additional 500 international trials over five years.
A new report and Frontier Economics, published in February by EFPIA, analyzed this objective. It will provide more than 35,000 clinical trial places for people in Europe, who will have access to treatments that otherwise would not be available. The economic impact is estimated at around €4 billion. It is certainly a good first step towards reversing a decade of decline.
Patients in the United States
and China, for example, is now seeing the benefits of increased test sites, where Europe has lost 60,000 test locations in the last decade.
Spain, where Almirall is located, has shown what is possible when the right conditions are in place. In 2023 it overtook Germany as the country with the most clinical trials to start across Europe. In just ten years, our industry investment in clinical trials in Spain has increased at an average rate of 5.7 percent per year, rising from €479 million in 2012 to €834 million in 2022. The successful and timely implementation of the EU Clinical Trials Regulation (CTR) and good cooperation with the improvements of the Spanish healthcare system have made this possible. However, unlike Spain, the European Union as a whole has been slow to provide the necessary facilitations and incentives to compete in attracting clinical trials. Other countries have implemented policies that have been successful in attracting medical research. Patients in the United States and China, for example, are now seeing the benefits of increased trial sites, where Europe has lost out. 60,000 test locations in the last decade.
This is why the European Union must urgently implement policies to bring our medical ecosystem on par with China and the United States.
Of particular concern is the trend towards advanced treatments such as cell and gene therapy trials. Chinese stocks have risen to 42 percent, while European stocks have fallen from 25 percent to just 10 percent.
Our request to policy makers is clear: we need coordinated processes to bring more clinical trials to Europe. The current fragmented national procedures must be replaced by a single, harmonized system for the authorization of clinical trials. Multinational clinical trials are very important, enabling drug manufacturers in Europe to increase their efforts and compete with international leaders, however, regulatory fragmentation and operational complexity continue to make the EU a less attractive area for conducting clinical research.
Equitable implementation of the CTR in all member states and an improved Clinical Trials Information System will be critical to success, as well as multi-country trial processes, including coordinated ethical review and cross-border patient participation.
In recent months, EU policymakers have begun to recognize the potential implications of the EU’s worrying trend. In addition to the EMA’s goal, the Biotech Act promises to harmonize and speed up the EU’s regulatory framework – this is undoubtedly a positive step.
Could Europe be more ambitious?
To highlight the real opportunity to be a competitor in clinical trials, the EFPIA report is two more examples, ambitious events that have the potential to take Europe to a completely different level to support clinical trials, provide early access to development treatments and drive economic value.
The second scenario would increase trials by 25 percent, bringing the EU back to 2013 levels. This would see 79,000 additional patients enrolled in trials, generating economic benefits of €9 billion and supporting 41,000 additional jobs. This would be a sign that Europe has taken steps to address its current relegated status in clinical research. It may reflect our shared desire and willingness to reclaim some of the opportunities for clinical trials that have recently been lost.
Under the third scenario, the analysis in the report considers the growth rate in clinical trials in China and North America since 2013. Comparing that level of activity would mean a doubling of clinical trials in Europe. The route would generate an economic increase of €18 billion per year; 82,000 new jobs and 158,000 more clinical trial positions for patients.
A clear focus on policy changes to make it more efficient to conduct clinical trials in Europe could see our hospitals at the forefront of innovation, clinicians trained in the treatments of tomorrow and patients able to access new treatments without leaving the continent.
More importantly, the effort and investment required to achieve this third and high-impact scenario is moderate, but the results and impact will be significant, putting Europe on the map in the increasingly competitive landscape of life science innovation. It would also signal something more important: Europe once again has the chance to be a leader of innovation in health, a place where science is moving rapidly from ideas to treatment. A clear focus on policy changes to make it more efficient to conduct clinical trials in Europe could see our hospitals at the forefront of innovation, clinicians trained in the treatments of tomorrow and patients able to access new treatments without leaving the continent.
As an industry, we support the EMA’s goal. But we should be more ambitious for Europe. Yes, I am convinced that we can achieve more if we create the right conditions and European policy makers to act now and with a sense of urgency.
Disclaimer
POLITICAL ADVERTISEMENT
- Sponsor is the European Federation of Pharmaceutical Industries and Associations (EFPIA).
- Finally the entity that controls the sponsor is the European Federation of Pharmaceutical Industries and Associations (EFPIA).
- This article is linked to the Biotech Law of the European Union.
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