Abstract
Mexico is an attractive country for clinical trials, but almost 30 years after adopting the General Health Act and the Regulations of the General Health Act for Health Research (RLGSIS) the people of Mexico lack the certainty that their rights as participants in clinical research are being fully protected.
Mexico, like other Latin American countries, faces many social and economic problems. Although access to health services is a constitutional right, there is great inequity in access to medical care, and a high percentage of the population is not able to obtain needed medications. It is easy to understand that patients welcome the opportunity to participate in a trial to freely access the needed drug without fully understanding the risks and obligations that it entails. Serious flaws exist in the informed consent process, and the consent forms themselves are frequently not understandable by most of the Mexican population.
This chapter examines the number and characteristics of the trials, the flows of the regulatory system and the weaknesses of the regulatory agency COFEPRIS. The discussion of the research ethics committees shows the limited role that they play in protecting trial participants and the quality of the data obtained.
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Notes
- 1.
The country of Mexico is made up of 31 states and the Federal District (DF – Distrito Federal).
- 2.
The Coordinating Commission is a highly reputable administrative unit within the Federal Ministry of Health. Its purpose is to coordinate medical and hospital services to reduce the complications of rare illnesses. It brings together highly specialized human resources, equipped with advanced technology, who work in very expensive and specialized centers. Its scope includes 12 National Institutes of Health, which focus on conducting scientific health research, training qualified health personnel, and providing specialized medical services; six Regional Specialty Hospitals and six Federal Referral Hospitals are located in Mexico City and surrounding states.
- 3.
In addition to the IMSS, a number of labor unions have their own social security schemes that include health facilities for their beneficiaries. Among these, the most important are the union of state workers and the union of PEMEX, the national oil company.
- 4.
These functions have recently been changed.
- 5.
General Health Council, Ministry of Health, Subsecretary of Innovation and Quality, Directorate General of Quality and Health Education, Coordinating Commission of National Institutes of Health and Specialty Hospitals, representatives of 11 National Institutes of Health, Mexico General Hospital, Dr. Manuel Gea González General Hospital, Federico Gómez Children’s Hospital of Mexico, Juárez Hospital of Mexico, National Medical Arbitration Commission, National Health Council, Institute of Security and Social Services for State Employees (ISSSTE), National Defense Ministry, National Institute of Statistics, Geography and Informatics, Ministry of Public Education, Directorate General of University Higher Education of the Subsecretary of Higher Education, National Council of Science and Technology, National Autonomous University of Mexico, National Polytechnic Institute, National School of Medicine and Homeopathy, Anahuac University, La Salle University, Mexican Foundation for Health (not-for-profit organization), National Association of Private Hospitals (not-for-profit organization), National Chamber of the Pharmaceutical Industry (not-for-profit organization), Angeles de Las Lomas Hospital (Anonymous Society of Variable Capital), Cowdray American British Hospital (not-for-profit organization), Medical South Hospital (Anonymous Society of Variable Capital), Spanish Benevolent Society (not-for-profit organization).
- 6.
The ethics committees often are identified with different names in different institutions: ethics committee, committee for research ethics, bioethics committee, etc.
- 7.
In addition to the private for profit committees mentioned we can add: Comité de Ética Independiente en Investigacíon Científica, Paracelso, Eicla and Cecype.
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Annex 1
Annex 1
Letter from COFEPRIS to the National Cancer Institute explaining the new system of approval of research protocols
Translation of the body of the letter (written on September 3, 2009):
This letter will notify you that the Federal Commission for Protection Against Health Risks has appointed Dr. Omar Francisco Carrasco Ortega as its representative to the Committee for Research and Ethics of the National Cancer Institute.
The nomination of Dr. Omar Francisco Carrasco Ortega indicates the participation of COFEPRIS in the procedure to authorize protocols by the said Committee, by which means, when the Committee for Research and Ethics of the National Cancer Institute authorizes a protocol, simultaneous authorization is granted by the Federal Commission and it is therefore not necessary to conduct an additional review with this office.
I thank you for your valuable interest in participating in the research and development of methods to assure the quality of the services, which the Federal Government provides for the population.
(Signed)
Gustavo A. Olaiz Fernández
Commissioner of Health Authorization
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Verástegui, E., Váldez-Martínez, E. (2014). Ethical Guidelines for Clinical Trials in Mexico: Theory and Practice. In: Homedes, N., Ugalde, A. (eds) Clinical Trials in Latin America: Where Ethics and Business Clash. Research Ethics Forum, vol 2. Springer, Cham. https://doi.org/10.1007/978-3-319-01363-3_10
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