Clinical research involving human beings on hold
Although Costa Rica has been involved in clinical research for several years, currently it is revising its clinical trial legislation and the approval of new trials is on hold. In the meantime countries such as Guatemala, Panama and the Dominican Republic are starting more relevant participation in clinical research, opening private research sites using investigators trained in the US.
In Costa Rica, clinical research rights are constitutionally protected. These rights are recognised in Articles 28 and 89 of the Political Constitution, and support freedom of research and private initiatives directed to scientific and artistic progress. Nonetheless, this freedom of research will be allowed only if the rights to life, health and human dignity of those involved in clinical research are protected.
Notwithstanding the above, on January 27, 2010, the Constitutional Chamber of the country’s Supreme Court ruled in favour of an action brought by a former congressman, leaving the legal framework that regulated clinical research in Costa Rica without force, namely, Executive Decree No. 31078-S (Regulations for Research involving Human Beings) of March 5, 2003 and the Regulations for Clinical Investigation in the Health Care Services of the Costa Rican Social Security Administration of January 16, 2003.
The Constitutional Chamber ruled and established that the two existing legal bodies are against the constitution and argued that the rights to life and human dignity have to be regulated by means of law instead of regulations.
"Costa Rica is not benefiting from investment in research and development and the value this brings to communities, such as access to the latest knowledge and technology."
Since then, the Ministry of Health has had to discontinue more than 100 investigations, which were then resumed with the aim of not compromising the health of patients. It has impeded new researches until the issuance of the respective legislation. As a consequence, Costa Rica is not benefiting from investment in research and development and the value this brings to communities, such as access to the latest knowledge and technology.
Since the Constitutional Chamber requires the enactment of a law for the continuation of clinical research, the Ministry of Health presented to the Congress a bill (no. 17.777) which includes not only the regulations for clinical research but also specific sections on issues concerning the authorisation for the storage of stem cells, with restrictions on their use in treatments to fight diseases.
A diverse group of stakeholders (industry, government, academia, patient advocates, physicians, and regulators) provided their input to the bill to produce an advance regulatory legislation.
On February 24, 2011 with the unanimous support of the eight congressmen present, the Permanent Commission on Social Aairs ruled positively on bill 17.777. The bill aims to ensure and protect the rights to life, health and human dignity of those involved in clinical research, without neglecting the freedom of research and scientific experimentation, all within a regulatory framework of human research.
The bill was printed in the Official Gazette on March 15 of 2011 and the discussion of the project is in its final stage and close to the first voting session. It is of critical importance that this ruling comes into force to foster greater private sector science and technology investment.
This will in turn make the economy more competitive and productive, creating high quality, knowledge jobs with high earnings, providing the means to reach a higher standard of living and enhanced quality of life. Costa Rica’s government should have as a priority creating an investment environment that gives incentives to the private sector to compete against other regions in the fields of innovative products, services and technologies.
