The equine plasma studies for treating COVID-19 and the one that evaluates whether some 2,000 people developed antibodies to that disease are two examples of biomedical research that the country is currently conducting.
These studies showed that Costa Rica has all the potential to become the leader in this area, agrees the Costa Rican Chamber of Health, the Central American and Caribbean Federation of Pharmaceutical Laboratories (Fedefarma) and the Social Security Fund (CCSS).
To strengthen this, the CCSS created the Biomedical Research regulation and has it in consultation period.
This document establishes the general provisions and includes regulations in terms of biomedical research in human beings, whether with drugs, medical devices or patient data.
In addition, it classifies research according to its source of funding and even talks about protection policies for those who participate in the studies.
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“It is of great relevance for us as a public health service provision system to have a regulatory framework to develop this activity that is of benefit to the institution and to patients, this regulation is based on national and international bioethical codes ”, commented Juan Carlos Esquivel, director of the Center for Strategic Development and Information on Health and Social Security (Cendeisss).
Said regulation is the first step for Costa Rica to aspire to have a “hub of Innovation and Life Sciences”, both the Chamber and Fedefarma acknowledge.
This is due to the fact that there are already positive factors to position itself, such as human talent, geographical location and investment climate.
“The situation caused by COVID-19 has made the need for biomedical research in the public sector more than evident, which allows patients to benefit from innovative diagnostic and therapeutic alternatives,” considers Victoria Brenes, executive director of Fedefarma.
In turn, she highlighted that the best health systems worldwide cover 16% of clinical studies and it is not because they had the resources to do so, but because the research has generated sufficient savings. That is why she considered it important that the Fund visualize that biomedical research will bring financial benefits, in addition to the impact on innovation to the health system.
“Costa Rica has a great opportunity in clinical research sponsored by pharmaceutical companies. They give us design and we produce it, but the country can participate in all the previous stages such as research, development and pre-commercialization of clinical studies, which are necessary stages in human beings before receiving approval from the regulatory authorities to commercialize them”, emphasized Massimo Manzi, executive president of the Chamber of Health.
Along the same lines, he considered that we have the task of reactivating and consolidating ourselves as a nation where biomedical research can be carried out, continuing to advance in the approval of the regulations for biomedical research in the institution and that the health authorities also authorize the so-called “first-in-humans” studies, which are very necessary in the presence of pandemics, and also issues related to studies on medical devices.