Régimen de responsabilidad aplicable a los daños derivados de ensayos clínicos en Colombia : breves reflexiones y propuestas para su delimitación

Abstract

In Latin America, Colombia is one of the countries with the highest numbers of clinical trials being carried out. Despite the importance of the country in the clinical research scenario, there is little regulation that, at the national level, deals with the possible adverse consequences of this activity and the applicable liability regime. This article aims, first of all, to briefly outline the main characteristics of clinical trials, focusing on those that involve the application of molecules or drugs and highlighting the actors who take part in said trials. Subsequently,; Colombian regulations will be critically examined, specifically those referring to liability for damages derived from clinical trials; and a contrast will be made with the regulation of some countries in this matter. Finally, some reflections will be proposed aimed at the coherent structuring of a civil liability regime applicable to damages derived from clinical trials.