Clinical research in Spain seeks new impulses to maintain its leadership position in Europe

Farmaindustria advocates strengthening the role of the Spanish Agency for Medicines and Health Products (Aemps) to maintain the competitiveness of our country in biomedical R&D

The pharmaceutical industry has redoubled its research efforts in infrequent and pediatric diseases, as revealed in the jornada Future of Clinical Research in Spain ’conference, held today in Madrid


Spain has made great progress in recent years in biomedical research, and specifically in clinical research, to position itself among European countries with better conditions to host the development of clinical trials of new medicines. In fact, today up to one in three of the tests carried out in Europe already have Spanish participation. This leap in medical research has been possible largely thanks to the cooperation of the health system with the biopharmaceutical industry. However, from the research world the need to redesign new strategies to maintain and, where appropriate, strengthen Spain’s progress in this area in an international context of strong competition is detected. This was revealed on Wednesday in the Future conference in clinical research in Spain, organized by the Association of Medicine of the Pharmaceutical Industry (Amife) at the headquarters of the College of Physicians of Madrid, and in which Pharmaindustria has participated.

Specifically, the Association advocates to strengthen and increase the resources of the Spanish Agency for Medicines and Health Products (AEMPS), one of the key agents in maintaining the leadership position of our country in biomedical R&D. And, as Amelia Martín Uranga, head of the Innovative Pharmaceutical Industry Platform, pointed out, the average time to start a clinical trial in Spain has risen for the first time in the last year. “In the 2016-2018 period, the average time to start a clinical trial was 140 days, and it became 132 days at the end of 2018. Now, the data for the first half of 2019 indicate that this time Waiting has risen to 159 days, ”he said.

The deadlines for the implementation of clinical trials are a determining factor to achieve investments in this area and had also been significantly reduced after the entry into force of the new Royal Decree of Clinical Trials of 2015, which allowed Spain to adopt early new community regulations in this regard. In this regard, the representative of Farmaindustria highlighted the efforts of the centers to reduce the signing time of the contracts necessary to launch these trials, which has fallen for the first time below 90 days, from 109 days in the period 2016-2018 to 89 days in the first half of 2019.

Amelia Martín highlighted the reasons why Spain has become in recent years a power to develop clinical trials, thanks, he said, to the existence of a solid health system; the prestige of Spanish researchers and doctors; a well developed logistics and research infrastructure; a pioneering legislation on clinical research; administrations and an industry committed to R&D, and organizations of patients increasingly involved. “The commitment of the pharmaceutical industry for Spain as a destination for investments in clinical research has been clear and decided in recent years, and we have to do everything possible to maintain this trend because we are facing a historic opportunity for the whole of the country, ”he explained.

Bet on rare and pediatric diseases
The head of the Innovative Pharmaceutical Industry Platform recalled the commitment of the pharmaceutical industry to the investigation of new medicines in both rare diseases and pediatric age. Thus, he said that currently one in six clinical trials promoted in Spain by pharmaceutical companies already corresponds to drugs designated as orphans. These are figures obtained from the database of the BEST Project for the promotion of biomedical R&D promoted by Farmaindustria, a platform that monitors the research activity of 50 pharmaceutical companies, four cooperative research groups and 54 hospitals in the country.

As a result of these efforts of the innovative pharmaceutical sector, from the year 2000 to 2018, 164 new treatments have been approved in Europe against almost a hundred rare diseases, while before 2000 there were only eight treatments available against these pathologies, which in their together they affect 30 million people in Europe (one in 17), half of them children. A key factor in this progress was the approval, in 2000, of the European Orphan Medicines Regulation, which established incentives for its research, development and commercialization. “These regulations have also been very important to favor the research of the pharmaceutical industry in specific innovations for the pediatric population, which today already account for 15% of the total,” said Martin.

The objectives of the Action Plan for the year 2020 of the Innovative Medicines Platform have also advanced on the day. “Our commitment is to increase collaboration with all the agents involved in biomedical research, such as the Aemps, ethics committees, hospital managers, research foundations, patients and researchers, to respond to the new challenges posed by biomedical research, such as digitalization and new advanced therapies. ” At this point, the research of drugs with genetically modified organisms (GMOs), including new gene therapies such as CAR-T, has become especially important in recent years. “More and more drugs in experimental phase include GMO, and in fact this type of therapy is called to modify the course of diseases as different types of cancer that today have no cure, being a key piece of the so-called personalized medicine. These new medicines require an additional authorization from the Interministerial Council of Genetically Modified Organisms, so it is also vital to expedite the deadlines in their authorization, ”said the representative of Pharmaceuticals.

Annual appointment of biomedical research
This boost to clinical research in Spain will be one of the main issues that will be addressed at the next Annual Conference of the Biomedical Research Technology Platforms, which annually organizes the Spanish Technological Platform for Innovative Pharmaceutical Industry Drugs in collaboration with Fenin, Asebio and Nanomed , and that this edition will be held in Barcelona on March 9 and 10. It will also highlight the fundamental need to bring these advances to society and work to communicate the social impact of biomedical research in society as a whole. The provisional program and the registration form for the Conference are available both on the Pharmaindustrial website and on the Spanish Technological Platform for Innovative Medicines.

In Distefar we are proud that thanks to clinical trials, Spain has positioned itself as one of the best European countries for the development of these.

Private zoneHoja de Validación
Reembolso de Gastos