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.
To continue reading, you need a subscription to WIPR. Start a subscription to WIPR for £455.
In-house feature articles, the archive and expert comment require a paid subscription. Subscribe now.
Want to give it a try? We are offering a two week free trial to the WIPR website – register and select “Free Trial” to begin access to the full WIPR archive and read the latest news, features and expert comment. Begin your free trial here.
Is your 2 week free trial about to end? Upgrade to a 12 month subscription for £455 now.
If you have already subscribed please login.
If you have any technical issues please email tech support.
Costa Rica, Life sciences, IP, Ministry of Health,