Farmaindustria’s director general, Juan Yermo, stresses that this regulation is more demanding in terms of procedure and deadlines, and that this requires centres with sufficient resources and infrastructure to prevent researchers from wasting time on administrative activities.
Juan Antonio Da Silva, president of the Spanish Cystic Fibrosis Federation (FEFQ); Juan Estévez, head of the Clinical Trials Area of the Department of Medicines for Human Use of the Spanish Agency for Medicines and Health Products (Aemps); Mencía de Lemus, member of the Committee for Advanced Therapies of the European Medicines Agency (EMA), and Juan Yermo, director general of Farmaindustria.
31 January 2023 marked the start of the implementation of the new European Clinical Trials Regulation, which harmonises the submission, assessment and monitoring processes for clinical trials in the region, with the aim of speeding them up and, consequently, getting new, effective and safe medicines to the people who need them sooner.
This milestone opens up a range of opportunities for all those involved in the development of biomedical research and especially for patients, for whom clinical trials are a source of hope when a treatment to cure or palliate their disease is not yet available. “We are facing a real opportunity to support clinical trials in order to turn the European Union (EU) into a hub for clinical research, to promote the development of quality, safe and effective medicines and to better integrate this research into the European health system,” said the director general of Farmaindustria, Juan Yermo, on Thursday at the 7th Congress of Patients’ Organisations, which is being held these days in Madrid and organised by the Platform of Patients’ Organisations (POP).
However, he continued, “this regulation is more demanding in terms of procedure and deadlines, and this requires hospitals to have highly qualified teams trained in the entire clinical research process, as well as being equipped with the necessary resources and infrastructure to prevent researchers from having to waste time on administrative activities”.
Spain was the first EU country to adopt the new European regulation, with Royal Decree 1090/2015, which has had a direct impact in terms of gaining an advantage over other Member States. This has meant that 58% of the clinical trials launched last year in Spain (almost twice as many as 20 years ago) now correspond to the early stages of research, phases I and II, which means that patients can access promising therapies even earlier.
Likewise, clinical trials in the paediatric population have been increasing since 2016 to exceed 160 in 2022, according to data from the Spanish Clinical Trials Register (REEC). The same is happening with research in rare diseases. A total of 924 clinical trials were approved in 2022, of which approximately 25% focus on rare diseases.
Spain has consolidated its leadership in clinical trials in recent years and can confidently face new challenges, such as the implementation of this new European Clinical Trials Regulation. “Trials not only offer new hope for patients, but also have very positive economic consequences for healthcare systems,” stressed Yermo. They attract funding from the sponsoring pharmaceutical companies to the participating centres, “as well as savings for the NHS”. In addition, they add reputation, experience and knowledge to the healthcare professionals who carry them out, placing them at the scientific forefront, which they can apply in their healthcare work.
In addition to these benefits, there is the challenge of involving the patient in the entire clinical trial process. “The steps that have been taken so far are of great value, but we must not stop, because we have great challenges ahead, such as encouraging the inclusion in trials of more diverse population groups, training and information for patients in biomedical research, as well as explaining to society the value of sharing and reusing data, with ethical and legal guarantees, to make research more efficient. Patients must also be involved in the design of informed consent forms, which are complex, lengthy and not always easy to understand,” Yermo said.
To address these issues, he pointed out the need to promote networked clinical research, as well as decentralisation initiatives, “on which we are already working with the Aemps”, and digitisation.
Finally, Yermo pointed out that this regulation is part of a larger strategy, which includes other important measures such as the development of the European Health Data Space or the revision of pharmaceutical legislation. Currently, only 22% of new treatments originate in Europe, while 47% come from the United States. This loss of European competitiveness compared to other markets that have shown greater growth has a direct implication for citizens, as “they are exposed to less access to new medicines or the possibility of participating in innovative clinical trials”, he explained. “Let us not miss the opportunity to continue to make Spain a benchmark country in clinical trials. And to do research with patients and not just for patients, which is how we have been working for years in the pharmaceutical industry”.
The director general of Farmaindustria shared a discussion with Juan Estévez, head of the Clinical Trials Area of the Department of Medicines for Human Use of the Spanish Agency for Medicines and Health Products (Aemps); Mencía de Lemus, member of the Committee for Advanced Therapies of the European Medicines Agency (EMA), and Juan Antonio Da Silva, president of the Spanish Federation of Cystic Fibrosis (FEFQ).