THE LEGAL MECHANISMS OF CITIZEN PARTICIPATION IN THE APPROVAL OF NEW THERAPIES IN COSTA RICA.

Abstract

This paper analyzes citizen participation for the approval of new therapies in Costa Rica legal system. Firstly, it makes a conceptualization about the role of patients in a healthy democracy. Costa Rican situation is contrasted with two reference agencies: the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA), based on the Modelo de Producción Social de la Salud and the legal and technical mechanisms for the approval of new therapies in Costa Rica, such are the Consejo Técnico de Inscripción de Medicamentos del Ministerio de Salud and the Comité Central de Farmacoterapia de la Caja Costarricense de Seguro Social. It is concluded that in Costa Rica there is no regulation that ensures citizen participation in the authorization processes of new therapies, and there is little transparency on decisions regarding health of the country's population.