The pharmaceutical industry with activity in Spain has intensified its efforts in clinical research in recent years, and has increased its investments in this area by 121% since 2004 to reach 662 million euros, according to the latest data of the BEST Project of excellence in clinical research of Pharmaindustry.
This has been one of the key factors that explain why Spain has become one of the countries in Europe with better conditions to develop clinical trials of new medicines, to the point that Spanish doctors and researchers are already participating in one of each three of these studies that are carried out in Europe.
This was explained by the head of the Innovative Medicines Platform, Amelia Martín Uranga, at the Innova Health Congress, which is being held these days in Madrid. “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 ”, explained the representative of Farmaindustria.
The investment in R&D of the pharmaceutical industry in Spain (amounting to 1,147 million euros per year if, together with clinical research, other chapters such as basic research, genetics or pharmacovigilance are included) also have a dynamic effect for the whole of the research tissue and the health system. Not in vain almost half of the funds invested in clinical research go to projects that are carried out in collaboration with hospitals, universities and other public and private research centers.
The keys to success in R&D
There are several factors that explain that Spain has become in recent years one of the most important countries to develop clinical trials, such as 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 patient organizations increasingly involved.
Nor should we forget another essential factor, and thanks to the collaboration between the different agents that participate in biomedical R&D, together with the favorable legal framework, it has been possible to reduce the implementation deadlines of 30% clinical trials in the last 15 years, going from 191 days in 2004 to 132 in 2017.
As regards the legislation, the fact that Spain was the first country in the European Union to incorporate the new clinical trial regulations has been key to simplifying procedures, reducing deadlines and increasing trials in early stages, that require higher levels of complexity and are already 52% of the total. The regulations have also been very important to favor the research of the pharmaceutical industry in rare diseases (which already accounts for 20% of the total) and in the pediatric population (15%).
“All these elements allow us to have the best basis on which to continue growing in the future and turn our country into a reference in clinical research in the new era of personalized precision medicine, which will undoubtedly change the way we understand the medicine, ”said Amelia Martín.
In this sense, those responsible for the BEST Project are currently working on the development of the 2019-2020 Action Plan, which in the field of clinical research seeks to apply benchmarking criteria [best practices] and encourage collaboration with the different participating agents. Likewise, the Plan includes the development of a new Data Protection Code regarding clinical research, as well as the creation of working groups to promote clinical trials in early phases.
In Distefar we believe that it is a reality that the pharmaceutical industry in Spain has intensified its efforts in clinical research in a very relevant way in recent years, and has increased its investments in this area.