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    Approval of the “Biomedical Research Regulation” Greatly Benefits Costa Rica

    Giving the country a privileged access to new treatments and also new sources of financing

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    With the new Biomedical Research Regulations, Costa Rica has all the potential to become a world leader in carrying out these studies. Not only does it position the country, but it also becomes an alternative to provide patients with new and modern treatments.

    “There are people whose diseases evolve beyond the possible treatments offered in today’s medicine. By having a portfolio of research projects implemented in the country, it may be that there studies give patients hope of finding a treatment that today do not exist,” said Román Macaya, executive president of the Costa Rican Social Security (CCSS).

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    Generating strategic agreements

    “At the same time, with the regulation, it gives the possibility of generating strategic agreements with laboratories of excellence, for certain scientific fields or more specific diseases, this would not only give Costa Rican patients access to medicines, but could also mean a new source of income for the CCSS”, he added

    “The Fund will be able to keep an eye on which are the most costly diseases or which today do not have very good treatment options, seeking to innovate and participate on research in a strategic way to try to bring and develop treatments for these patient populations, some related to rare diseases, others in more common diseases,” explained Macaya.

    Costa Rica at the forefront

    Before this regulation, the Fund was already doing this type of research, such as those currently being carried out with equine plasma to treat COVID-19; But the approval of the regulation that comes is to make this process more fluid.

    The Fund submitted this regulation to public consultation, after its publication on November 20, giving a period of ten working days to receive observations. After this process and assessment of the proposals, the regulations were submitted for final approval, last Thursday, by the Board of Directors of the CCSS.

    This regulation, made up of 12 chapters and 85 articles, establishes the general provisions that regulate the processes of formulation, review, approval, authorization, execution, monitoring, evaluation and dissemination of the results of biomedical research carried out in the CCSS.

    A great opportunity in clinical research

    Costa Rica has a great opportunity in clinical research sponsored by pharmaceutical houses. 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.

    “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 fro m innovative diagnostic and therapeutic alternatives, the health authorities stated”.

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