Declaración de la Academia Chilena de Medicina sobre el Título V de la Ley 20.850 (Ley Ricarte Soto) y su proyecto de reglamento “De los ensayos clínicos de productos farmacéuticos y elementos de uso médico

Resumen

In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850 which became effective in November 2015. A bylaw of this law - under discussion by the Senate – includes the regulation of clinical trials, posing main complex issues that will endanger front-line clinical research in Chile: 1. The exclusive and mandatory control bestowed to the Institute of Public Health during all stages of the trials and the surveillance of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2.The 10 year period after the appearance of any adverse event in which it is assumed it has been caused by the medication or devise evaluated by the trial, unless the contrary is proven in a judicial process; 3. Individuals submitted to the trials are entitled to free post trial access to the treatment received during the study, financed by the trial supporting entities and as long as the drug or devise is considered to be useful. While agreeing with the need to have a National Registry of Clinical Trials, we predict that the critical issues in the bylaw will lead to difficulties and unnecessary judicial processes, thus limiting clinicians’ interest in performing research. We propose that the bylaw should be modified in order to exclude responsibilities for events associated with the natural evolution of the medical condition, with patients’ ageing or with comorbidities and clinical events considered unpredictable when the protocol was accepted. We recommend that the free post trial access should be a joint decision involving the patient and his attending physician, taking into consideration the risks and burdens to which the volunteer has been exposed, or the vital hazard posed by discontinuation of treatment under study until this has been approved and becomes available in the national market.