Source: www.20minutos.es
Our country is one of the best conditions to host biomedical and pharmaceutical research projects, both national and international.
In 1886, scientists Oskar Minkowski and Josef Mering discovered the importance of the pancreas as a gland that controlled blood glucose, a fact that laid the groundwork to boost the treatment of diabetes. In the 60s, the microbiologist Maurice Hilleman developed a series of vaccines to deal with such significant diseases as measles, hepatitis A, chickenpox or meningitis, which saved tens of millions of lives since then. In 2011, the first immunotherapeutic drug was approved to treat a metastatic melanoma, thus opening the door to a therapy that has already reduced the risk of death from cancer by up to 30%.
These are just some of the arguments that justifiably justify the importance of biomedical research and how clinical trials, preclinical studies and galenic research -related to medicines- are fundamental for the advancement of current medicine and for the improvement of World population health. Identifying the symptoms of a medical condition or finding the right treatment or drug to fight it further strengthens the health system and represents a growth engine for the society of the future.
And Spain is a reference for this: in the last fifteen years, our country has positioned itself as one of the best conditions to host biomedical and pharmaceutical R&D projects, both national and international. Thus, a third of clinical trials conducted in Europe have Spanish participation and for some companies our country is the second option to conduct these studies, only behind the United States.
This is largely due to the existing facility in terms of legal issues – such as the Royal Decree of Clinical Trials of 2016, which reduces the deadlines for starting projects by up to 30%, according to 2018 data – and the momentum of the pharmaceutical industry, which, according to Farmaindustria, in 2017 contributed 662 million euros of investment to the realization of clinical trials in Spain, doubling the 2005 figure and maintaining a sustained increase of 7% per year.
This investment in research and development, also carried out in collaboration with hospitals and public and private centers, has thus become the main dynamic of the research fabric in Spain, generating knowledge and an increase in qualified employment in the sector (7.1% in the last thirteen years).
HOW IS THE INVESTMENT IN CLINICAL RESEARCH DISTRIBUTED?
Clinical trials address four phases: phase I, which determines the mode of action of the new drug in humans and absorbs 14.5% of the investment in clinical research; and phase II, with 21.5% of the investment, which analyzes its efficacy and safety and is the most complex from the research point of view, since it allows patients access to new therapies. On the other hand, phase III compares the safety and efficacy of the new treatment and is the one with the highest percentage of investment, with 54.6%. Finally, phase IV, which are the tests that are carried out after the drug has been approved, which represents 9.4% of the resources allocated.
The cost of clinical research carried out by the pharmaceutical industry has increased at an average rate of 4.9% in the last 10 years.
THE FUTURE OF THE SECTOR
Since 2004, more than 7,000 trials with innovative drugs have been promoted in Spain. The BEST project, a strategic initiative to foster excellence in clinical research driven by the pharmaceutical industry; the European Innovative Medicines Initiative (IMI); or the Farma-Biotech program, which connects researchers with pharmaceutical companies, are just a few examples of the industry’s commitment to the research and development of new medicines, both in the private and public spheres. Before such a promising situation, and given The recent development of gene and cell therapies and the growing understanding of biochemical and physiological phenomena, as well as the identification of new therapeutic targets, Spain not only becomes an international attraction for R&D, but also highlights the keys to being at the forefront of precision medicine. Faced with such a promising situation, and given the recent development of gene and cell therapies and the growing understanding of biochemical and physiological phenomena, as well as the identification of new therapeutic targets, Spain not only becomes a pole of international attraction for R&D, it highlights the keys to being at the forefront of precision medicine.
In order to continue advancing and consolidating this position, the involvement of all agents (public administrations, healthcare professionals, pharmaceutical industry and patients) and facing the great challenges that this development poses: the revolution in biotechnology through new molecular therapies is essential. , genetic and cellular, that are transforming the treatment of the disease; the digitization; a greater investment in public health (now it represents 6% of GDP in Spain, while the European average stands at 7%); address a structural change in the financing and reimbursement model of the new medicines, and banish the arguments that the new drugs harm the health system.
Spain is already a benchmark for biomedical research and in Distefar we are proud to contribute to it.