More than eight out of 10 clinical trials in Spain are promoted by the pharmaceutical industry.
Our country is the leader in Europe with 930 clinical studies authorised in 2024.
22% of research to find new drugs is aimed at rare diseases and increasingly uses advanced therapies.
R&D is one of the pillars of the recently approved Strategy for the Pharmaceutical Industry in Spain, on which pharmaceutical companies are working together with the Government.
Farmaindustria.es
In recent years, Spain has progressed to become a European leader in the conduct of clinical trials. Last year, the Spanish Agency for Medicines and Health Products (AEMPS) authorised 930 research studies on new medicines. These figures are far higher than in the years prior to the pandemic, when the number increased due to the large amount of research on Covid-19. In 2024, Spain was also the country that coordinated the most multinational studies (770), 28% of all those approved in Europe.
Farmaindustria.es
Behind this success are to a large extent the innovative pharmaceutical companies based in Spain, represented by Farmaindustria, which are behind more than eight out of every 10 clinical trials. ‘The close collaboration over the years between all the agents involved, public and private, has been and must be the basis for success in biomedical research, which we must now maintain by responding to new challenges. These include clinical research in primary care and conducting trials in a network of hospitals in the same Autonomous Community, but we must also work to extend the network to hospitals in different Autonomous Communities, and thus reach a greater number of patients,’ explains Amelia Martín Uranga, Director of Clinical and Translational Research at Farmaindustria.
Farmaindustria.es
As reflected in data from the Spanish Clinical Trials Register (REEC), 37.6% of the trials involved drugs intended to treat some type of cancer. After oncology, the areas with the highest number of trials were diseases of the immune system (8.6%) and the nervous system (7%).
Last year, Spain was also the leader in advanced therapy drug research – with 52 trials – and continues to focus on rare diseases, with 22% of all research.
Another of this year’s successes has been the implementation of the fast-track procedure for phase I trials of advanced therapies or those seeking treatment for a disease with no therapeutic alternative, thus shortening the start-up time. ‘In addition, it is important to continue working so that this fast-track procedure can be applied to all types of phase I clinical trials launched in our country. Currently, there is strong competition between Australia, the US, Canada, Belgium and Germany to attract first-in-human trials due to their accelerated authorisation procedures, and Spain should be in the same league,’ says Martín Uranga.
The Spanish leadership, confirmed by REEC with its 2024 data, was already on the table in the recent international study Evaluating the clinical trial ecosystem in Europe, prepared by Iqvia for Efpia and Vaccines Europe, which placed Spain as a success story and an example of good practice in the context of a Europe affected by the loss of competitiveness. ‘R&D is one of the pillars of the Pharmaceutical Industry Strategy recently approved by the Government’, says Martín Uranga, “we need a strong regulatory environment, but at the same time we need to simplify some of the processes, reduce bureaucracy and streamline the management of clinical research both in Spain and Europe, in line with the Draghi Report to boost competitiveness and continue strengthening the innovation ecosystem that promotes the industry, which ultimately results in improved health and well-being of patients”.
It is important to remember that leadership in clinical trials is based on the collaboration of healthcare professionals, patients, the pharmaceutical industry, the healthcare system and a proactive regulatory agency that engages in dialogue. In recent years, Member States have had to adapt and implement the new Clinical Trials Regulation, something in which Spain has been a pioneer.
Juan Estévez, head of the Clinical Trials Division of the AEMPS, explains that ‘2024 has once again been a really good year for clinical research with medicines, and therefore for patients, who will continue to be able to choose real therapeutic alternatives. The AEMPS is proud to consolidate its position as a benchmark in the European environment, leading the coordinated evaluations between member states, and also being the Agency that has authorised the most clinical trials in the past year. The commitment of the pharmaceutical industry is undoubtedly one of the fundamental pillars to achieve these numbers, with more than 80% of the trials authorised in 2024 being promoted by commercial sponsors. Despite the challenges faced with the new European regulation, Spain is a benchmark in terms of its infrastructure and healthcare expertise, and the Agency will continue to work to streamline and facilitate as much as possible the conduct of new research in our country, exploring attractive alternatives within the regulatory framework for clinical trials’.
Innovative pharmaceutical companies have been increasing their investment in R&D in Spain for years, with almost 1.4 billion in 2022, of which 834 million were allocated entirely to clinical trials. In the last decade, this investment has grown by more than 74%, from 479 million in 2012. Much of the research underway in Spain is among the 10 key areas for advancing biomedical innovation published in Iqvia’s recent report for the Federation of the European Pharmaceutical Industry.
