Advances in Occupational Health in Guatemala.

Occupational health in Guatemala has come a long way. In 1958, the first Regulation of Occupational Health by the Guatemalan Social Security Institute was published. There wasn´t another Directive in the country regarding this issue until the year 2000, when the National Council for Occupational Safety and Health was created. In 2014, it published the Governmental Agreement 229-2014 Occupational Health and Safety Regulations, which came into force on September 8th, 2015. Nowadays there are other institutions that care about this topic. Some of these institutions promote occupational health training through courses, workshops, seminars, etc., but there is not a formal education program yet. There are some other institutions, such as the National Institute of Statistics, which generates information concerning employment, unemployment, characteristics, composition, structure, and functioning of the labor market through surveys. And finally, there are other institutions like the Health, Labor and Environment Program of Central America SALTRA, which promotes investigation in this topic, generates information as well as endorses training regarding occupational safety as an important issue in the country.

[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.

[Diagnosis of the productive capacity of the IMSS regarding health technologies]. / Diagnóstico de la capacidad productiva del IMSS para la generación de tecnologías en salud.

OBJECTIVE: To quantify the production capacity and performance in research and technological developments of the Mexican Social Security Institute (IMSS). MATERIAL AND METHODS: We identified and analyzed information of the legislation, human and financial resources, and infrastructure addressed for research and technological development of IMSS. We analyzed whether the information on the legal framework contained key features to boost research and technological development. Information on the human, financial, and infrastructure resources were obtained from official sources. The research productivity was identified by a bibliometric analysis in 2014; productivity in technological developments was identified by intellectual products. RESULTS: The legal framework of the IMSS has several areas for improvement to boost research and technological development, especially the guidelines for technology transfer. The IMSS has 438 researchers, 39 research units, and a budget of US$ 37.4 million for research and technological development. The rate of articles published per 10 researchers was 4.8; while rate patients was 1.8. CONCLUSIONS: The IMSS has a great potential to translate research into technological developments, it is only necessary to make some changes to the legal framework.

Organization of a tumor bank: the experience of the National Cancer Institute of Mexico.

A tumor bank (TB) is an ordered collection of neoplastic samples, normal tissue, and/or fluids preserved under optimal conditions, as well as storing patients' clinical information. The objective of this article is to outline the planning and logistics necessary for the functioning of the Instituto Nacional de Cancerología (INCan) TB in Mexico City. For the planning and logistics of a TB, several technical, legal, medical, structural, and physical aspects were considered, which can be grouped under four headings: (1) design and structure, (2) equipping the area and informatics, (3) ethical-legal aspects, and (4) sample collection, preservation, and quality control. One crucial element of interinstitutional interest will be the transfer of these concepts to the different oncological centers, integrating in this manner a network that enables the exploration of the different pathologies from therapeutic, epidemiological, and molecular points of view.

[Stewardship of public health surveillance in the health system in Colombia: a case study]. / Rectoría de la vigilancia en salud pública en el sistema de seguridad social en salud de Colombia: estudio de casos.

INTRODUCTION: With the reform of the Colombian health system in 1993, public health surveillance continued to be a governmental responsibility under the stewardship of the Ministry of Social Protection along with state and local health authorities. OBJECTIVE: The effectiveness of the development and organization of state and municipality public health surveillance programs will be studied as they have evolved under the general social security system in Colombia. MATERIALS AND METHODS: Qualitative study and case-study method are applied to several institutions as they function in 5 states and 11 counties, ten years after the health system reforms. RESULTS: Public health authorities have reduced resources for providing advice, technical assistance, supervision and control of the process of the public health surveillance. Weaknesses in administrative control are common. Quantity and quality of human resources, as well as, staffing and financial resources are inadequate to meet the responsibilities that have been assigned to each state and county. The public health surveillance has prioritized the notification and registration of cases, and the strength of development of particular areas occasionally has been subject to the particular interests of officials in charge, particularly in the public hospitals. Little commitment or interest is shown by mayors, insurance companies, and institutions providing health services that are supposed to be involved with monitoring. A lack of cross-institutional collaboration is apparent in the development of health services surveillance. CONCLUSION: The implementation of public health surveillance at state and local levels is weak due to problems with the governmental stewardship. These weaknesses are manifested in the lack of regulation, financing and control of the health system.