[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]. / 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”.

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 year period during which any adverse event is assumed to have 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 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, 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.

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” / 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 year period during which any adverse event is assumed to have 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 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, 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.

[Health care reform in Chile: 2005 to 2009]. / El plan AUGE: 2005 al 2009.

Five years ago Chile implemented a Health Care Reform to reduce the great inequalities in health care provision that affects the low- income, high-risk segment of its population. A universal care plan ("AUGE") was designed to make medical coverage available to all Chilean citizens suffering from one of a specified, growing list of diseases (66 at present time). The diseases are prioritized by the Ministry of Health and its inclusion in the plan is revised periodically by an Advisory Committee according to four cardinal criteria: burden of disease, effectiveness of treatment, specific capacity of the health system and financial costs. The plan is funded by the state and enforced by law through a set of four specific guarantees: access, opportunity, quality and financial protection. This paper reviews the origin and development of the reform, the benefits and drawbacks of the application of the specific guarantees and the perception of the public regarding its strengths and weaknesses.

El plan AUGE: 2005 al 2009 / Health care reform in Chile: 2005 to 2009

Five years ago Chile implemented a Health Care Reform to reduce the great inequalities in health care provision that affects the low- income, high-risk segment of its population. A universal care plan ("AUGE") was designed to make medical coverage available to all Chilean citizens suffering from one of a specifed, growing list of diseases (66 at present time). The diseases are prioritized by the Ministry of Health and its inclusion in the plan is revised periodically by an Advisory Committee according to four cardinal criteria: burden of disease, effectiveness of treatment, specific capacity of the health system and financial costs. The plan is funded by the state and enforced by law through a set of four specific guarantees: access, opportunity, quality and financial protection. This paper reviews the origin and development of the reform, the benefits and drawbacks of the application of the specific guarantees and the perception of the public regarding its strengths and weaknesses.