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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”
#
Comité de Estudio y Redacción:
Gloria López S.*
,
***
,
Gloria Valdés S.**
,
****,
Emilio Roessler B.**
,
***** y Vicente Valdivieso D.**
,
****
Declaration of the Chilean Academy of Medicine of Law 20.850
“On clinical trials of pharmaceutical products and medical devices”
and of the bylaw that will regulate its application
In Chile, high cost treatments required by selected medical conditions are financed by the State,
according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing
complex issues that will endanger local interest in front-line research: 1. The exclusive and mandatory
control bestowed to the Institute of Public Health during all stages of the trials and also the surveillance
of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2.The 10
years period during which any adverse event is assumed to have been caused by the medication or de-
vice 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 device is considered to be useful. While agreeing
with the need to have a National Registry of Clinical Trials, we predict that the mentioned critical issues
in the bylaw will lead to difficulties and unnecessary judicial processes, thus limiting clinicians’ interest
in performing research. We propose to modify the bylaw, excluding responsibilities on events associated
with the natural evolution of the medical condition, or 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 the attending physician, taking
in consideration that the volunteer has been exposed to risks and burdens, or when discontinuation of
treatment entails a vital risk until the treatment under study has been approved and becomes available
in the national market.
Key words:
Clinical trials as topic; Clinical trials data monitoring committees; Drugs, investiga-
tional; Jurisprudence; Public Health.
Documento aprobado por unanimidad, por Miembros de la Academia, el 22 de diciembre de 2016.
#
Este documento se ha publicado simultáneamente en Revista Médica de Chile, Revista Chilena de Enfermedades Res-
piratorias y Revista Chilena de Infectología por la relevancia de su contenido y la conveniencia de ampliar su acceso a
los lectores.
* Miembro de la Academia y Presidenta del Comité.
** Miembros de la Academia.
*** Facultad de Medicina, Campus Norte, Universidad de Chile.
**** Facultad de Medicina, Pontificia Universidad Católica de Chile.
***** Facultad de Medicina, Clínica Alemana de Santiago-Universidad del Desarrollo.
Rev Chil Enferm Respir 2016; 32: 244-250
ÉTICA MÉDICA