Hostname: page-component-586b7cd67f-rcrh6 Total loading time: 0 Render date: 2024-11-28T17:16:39.623Z Has data issue: false hasContentIssue false

Mexican Regulation of Biobanks

Published online by Cambridge University Press:  01 January 2021

Abstract

Biobank-based research in Mexico is mostly governed by research and data protection laws. There is no direct mention of biobanks in either statutory or regulatory law besides a requirement that the Federal Ministry of Health and a Mexican institution devoted to scientific research approve the transfer of biological materials outside of Mexico for population genetics research purposes. Such requirements are the basis of Genomic Sovereignty in Mexico, but such requirements have not prevented international collaboration. In addition, Mexican law singles out genetic research in informed consent provisions, but it does not specify whether all biobank-based research is genetic research. In order to facilitate international collaboration on biobank-based research, Mexico should directly address biobanking in its laws, building on the research framework and data protection framework already in place.

Type
Symposium Articles
Copyright
Copyright © American Society of Law, Medicine & Ethics 2016

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Linares, F. Navarrete, The Indigenous People of Mexico, CDI, 2008, at 8, available at <http://www.cdi.gob.mx/dmdocuments/monografia_nacional_pueblos_indigenas_mexico.pdf> (last visited February 10, 2016).+(last+visited+February+10,+2016).>Google Scholar
INEGI, Census of Population and Housing 2010, available at <http://www.inegi.org.mx/sistemas/olap/proyectos/bd/consulta.asp?p=17118&c=27769&s=est#> (last visited February 10, 2016).+(last+visited+February+10,+2016).>Google Scholar
Promulgated on February 5, 1917.Google Scholar
Every six years for the President of the Republic and the members of the Senate and every three for the members of the Chamber of Representatives.Google Scholar
Promulgated on February 5, 1917.Google Scholar
Constitutional Reform Act published in the Diario Oficial de la Federación [Federal Official Journal] on February 3, 1983.Google Scholar
Published in the Diario Oficial de la Federación on February 7, 1984.Google Scholar
IMSS: Instituto Mexicano del Seguro Social (Mexican Institute of Social Security); ISSSTE: Instituto de Seguridad Social y Servicios Sociales de los Trabajadores del Estado (Institute of Social Security and Social Services for the Public Servants); PEMEX: Petróleos Mexicanos (Mexico’s State owned Oil Company); and SEDENA: Secretaría de la Defensa Nacional (Ministry of National Defense).Google Scholar
Article 2, Section III of the Law of the National Institutes of Health, published in the Diario Oficial de la Federación on May 26, 2000.Google Scholar
Published in the Diario Oficial de la Federación on February 7, 1984.Google Scholar
According to Article 314 of the General Health Law, the following terms are defined as:Google Scholar
See Pereira, D. Vasconcelos, Giora, M. L. Garbarino, De Oliveira Mattos Graner, R., Pettorossi, J. C. Imparato and Navarro, N. Pérez, “Banco de dientes: una alternativa para la rehabilitación de dientes temporales anterosuperiores,” Revista Cubana de Estomatología, 34, no. 2 (July-December, 1997).Google Scholar
Cf. Roche Institute, Guía Práctica para la Utilización de Muestras Biológicas en Investigación Biomédica Spain, 2004, at 15 and 16, available at <http://contenidos.institutoroche.es/pdf/guia/pdf_completo.pdf> (last visited February 10, 2016).+(last+visited+February+10,+2016).>Google Scholar
See García, N. Doménech and Purriños, N. Cal, “Biobancos y su importancia en el ámbito clínico y científico en relación con la investigación biomédica en España,” Reumatología Clínica 10, no. 5 (2014): 304-308, available at <http://www.reumatologiaclinica.org/es/biobancos-su-importancia-el-ambito/articulo/90340763/> (last visited February 10, 2016).Google Scholar
Cf. Europe Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research, Gottweis, H. and Kaye, J., et al., Report: Biobanks for a Challenge for Governance, European Union Commission, 2012, at 13, available at <http://www.coe.int/t/dg3/healthbioethic/Activities/10_Biobanks/biobanks_for_Europe.pdf> (last visited February 10, 2016).Google Scholar
Published in the Diario Oficial de la Federación on February 7, 1984.Google Scholar
Please note that ‘Bis’ is a prefix or suffix designating the second instance of a thing. It is commonly used within the context of legislative drafting when an amendment is aimed to include a new article, paragraph or fraction after another one that already exists, in order to avoid renumbering an entire law.Google Scholar
For purposes of the General Health Act, the term population genomic study shall be understood to mean a study aiming to analyze one or more genetic markers in unrelated individuals, describing the genomic structure of a determined population, identifying an ethnic group or identifying genes associated with a trait, disease or drug response.Google Scholar
Article 100.-Research in humans will be developed pursuant to the following basis:Google Scholar
The Slim Initiative for Genomic Medicine (SIGMA) is an unprecedented alliance aimed at ensuring that Latin Americans, particularly Mexicans, benefit from the genomic revolution with actions such as: promoting a broader access to genomic medicine in Mexico and Latin America, supporting research programs focused on health issues that are specially relevant to one region, and using the distinctive genetic characteristics of the population, as well as strengthening the capacity of genomic research in Mexico through the training of scientists and supporting the development of diagnostic methods and genomic treatments in Latin America. This alliance has brought together several organizations, among which the more prominent are the Carlos Slim Foundation, the Broad Institute of MIT and Harvard, and the National Institute of Genomic Medicine — all of which share a commitment to transform human health. The efforts are carried out in coordination with scientists from other Mexican institutions, such as the UNAM and the National Institute of Medical Sciences and Nutrition Salvador Zubirán.Google Scholar
Published in the Diario Oficial de la Federación on February 20, 1985.Google Scholar
Published in the Diario Oficial de la Federación on March 26, 2014.Google Scholar
Currently, the RLGS-mCSDOTCSH only regulates blood banks and plasma banks.Google Scholar
Published in the Diario Oficial de la Federación on January 6, 1987.Google Scholar
NOM-012-SSA3-2012, published in the Diario Oficial de la Federación on January 4, 2013. See <http://dof.gob.mx/nota_detalle.php?codigo=5284148&fecha=04/01/2013> (last visited September, 2015).+(last+visited+September,+2015).>Google Scholar
Comisión Nacional de Bioética, Guía Nacional para la Integración y el Funcionamiento de los Comités de Ética en Investigación, 3rd ed., 2012, available at <www.conbioetica-mexico.salud.gob.mx/descargas/pdf/registrocomites/Guia_CEI.pdf> (last visited September, 2015).+(last+visited+September,+2015).>Google Scholar
Published in the Diario Oficial de la Federación on June 11, 2003.Google Scholar
Thesis: VI.1o.C.88 C. Ninth Period, Collegiate Circuit Courts, Isolated Thesis (Civil), Weekly Judicial Publication of the Federation and Gazette thereof Volume XXIV, August, 2006, at 2317, Record 174388.Google Scholar
Thesis: 1st./J. 17/2003. Ninth Period. First Chamber, Jurisprudence (Civil): Weekly Judicial Publication of the Federation and Gazette thereof Volume XVII, April 2003, at 88, Record 184431.Google Scholar
Published in the Diario Oficial de la Federación on May 4, 2015.Google Scholar
The Federal Law of Transparency and Access to Public Government Information was published in the Diario Oficial de la Federación on June 11, 2002, and its Regulations was published on June 11, 2003.Google Scholar
The Federal Law on the Protection of Personal Data held by Private Individuals was published in the Diario Oficial de la Federación on July 5, 2010. Its regulations were published on December 21, 2011.Google Scholar
Published in the Diario Oficial de la Federación on October 30, 2013.Google Scholar
Global Alliance for Genomics and Health, available at <http://genomicsandhealth.org/> (last visited February 10, 2016).+(last+visited+February+10,+2016).>Google Scholar
Added to the General Health Law by the Decree through which Section IX Bis is added to Article 3; added a Fifth Title Bis and its Single Chapter on Human Genome; and Article 421 Ter, published in the Official Gazette on November 16, 2011.Google Scholar
The term informed consent shall be understood as the written agreement by which the research subject or, when appropriate, their legal representative authorizes their participation in the research, with full knowledge of the nature of the procedures and risks to which they shall be subjected, being able to choose freely and without coercion (Article 20 RLGS-mIS).Google Scholar
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General Assembly in Helsinki, Finland, in June, 1964, last reviewed at the 64th WMA General Assembly in October, 2013, available at <http://www.wma.net/es/30publications/10policies/b3/> (last visited February 10, 2016).+(last+visited+February+10,+2016).>Google Scholar
See Hudson, K., “Genomics, Health Care, and Society,” New England Journal of Medicine 365, no. 11 (2011): 1033-1041; M. Mello and L. Wolfe, “The Havasupai Indian Tribe Case–Lessons for Research Involving Stored Biological Samples,” New England Journal of Medicine 363, no. 3 (2010): 204-207; K. S. Steinsbek, B. K. Myskja, and B. Solberg, “Broad Consent versus Dynamic Consent in Biobank Research: Is Passive Participation an Ethical Problem?” European Journal of Human Genetics 21, no. 9 (2013): 897–902.Google Scholar
Health On the Net Foundation, “List of Rare Diseases,” available at <https://www.hon.ch/HONselect/RareDiseases/index_sp.html> (last visited February 10, 2016).+(last+visited+February+10,+2016).>Google Scholar
Published in the Diario Oficial de la Federación on October 31, 2012.Google Scholar
Secretaría de Salud/Comisión Nacional de Bioética, “Guía nacional para la integración y el funcionamiento de los Comités de Ética en Investigación,” available at <http://www.conbioetica-mexico.salud.gob.mx/descargas/pdf/registrocomites/Guia_CEI.pdf> (last visited February 10, 2016).+(last+visited+February+10,+2016).>Google Scholar
Published in the Diario Oficial de la Federación on October 15, 2012.Google Scholar