Clinical research involving human beings on hold


María del Pilar López and Esteban Monge

Clinical trials using human beings are an essential part of the approval of new drugs and biologics.

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.

Costa Rica, Life sciences, IP, Ministry of Health,