Emilio Godoy* – Tierramérica
MEXICO CITY, Aug 15 2008 (IPS) – Four years ago, when Guillermo Soberón one of Mexico s most prominent scientists became a grandfather, the newborn s parents received a letter requesting a donation of biological material to be used for medical research.
Sample collected at a sperm bank. Credit: Photo Stock
Requests of this kind reflect the mushrooming of biobanks banks that collect human biological material in Latin America, whether public or private, almost all of which operate without any specific legislation for their regulation.
Scientific research is advancing quickly, and has made evident the need for an appropriate legal framework, said Carlos Romeo, director of the Law and the Human Genome inter-university group, sponsored by the BBVA Foundation, the Diputación Foral de Bizkaia and the Spanish universities of Deusto and Basque Country.
A biobank is a not-for-profit entity that holds a collection of biological samples intended for biomedical diagnosis or research, and is organised as a technical unit that follows criteria for quality, organisation and purpose, according to Agustín Zapata, an expert with the Carlos III Health Institute of Madrid.
The LatinBanks project, a study of the legal and social implications of biobanks in Latin America, emerged to study the creation of laws. The initiative is the result of cooperation amongst the European Union, Argentina, Brazil, Chile, Colombia, Costa Rica and Mexico.
One of the aims is to elaborate proposals for optimising the legal structures and forms of organisation and participation with respect to biobanks.
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In Mexico, Article 6 of the constitution guarantees protection of data, and the Penal Code in Mexico City protects genetic information. Medical information is covered in broad terms by the General Law on Health.
In Argentina, there are public and private biobanks, for clinical and scientific research, physician Salvador Bergel, an Argentine member of the LatinBanks project, told Tierramérica.
So far they have followed administrative regulations established by the National Institute for Excision and Implants, which coordinates and monitors donations and transplants of organs, tissue and cells, he said.
In Brazil, the Biosafety Law, approved in 2005, refers to embryonic cells, but does not include management of samples or protection of personal data.
Meanwhile, in Costa Rica, biobanks are just getting started.
Carlos Valerio, representative of Costa Rica s Association of Medical law, said in a Tierramérica interview that there are sets of biological samples that were taken for very specific purposes and are not used for any purpose besides the one for which they were collected.
The risk of operating without regulations is, according to experts, that the confidentiality of the donors may not be respected or that the samples may be utilised without authorisation.
Ensuring the effective use of biobanks implies standardising the protocols they employ, adopting appropriate methods for codifying and identifying samples, obtaining informed consent from donors and hiring qualified medical staff.
In other Latin American countries, standards seem to be more lax. I m a supporter of first thinking about stimulating research and letting it be, before controlling it, attorney Emilssen González de Cancino, director of the genetics and law research centre at the private Externado University of Colombia, told Tierramérica.
Prohibiting new processes means losing opportunities for progress, said González de Cancino, who is coordinating a two-year study that began eight months ago.
In 1995, the European Union adopted a slate of standards for protection of physical persons and respect for personal data and circulation. In addition, the Protocol to the Convention on Human Rights and Biomedicine has been in effect since 2005.
In the last few years, interest in biological research with human material has developed very quickly, because of the implications it could have, said Romeo, one of the leading experts in the field.
According to a survey by the Institute of Juridical Investigations (IIJ) of the National Autonomous University of Mexico, in that country there are 38 biological banks operating in 51 public medical institutions.
Of the 38, 14 said they utilise blood, skin, brain tissue or bone marrow samples to carry out research on diseases like cancer and Alzheimer s, and that they conduct biomedical analyses. Furthermore, 12 said they have systems to protect patient confidentiality, one admitted it had no such protections, and the rest did not respond.
We are starting from zero because in Mexico there are no precedents in this area, said IIJ researcher Ingrid Brena.
Valerio cited the example of the efforts of the Health Ministry and the University of Costa Rica, that work under their own norms, which demonstrates that there is much yet to be done in the field of biological material in this Central American country, where there is only the private Provida, which collects umbilical cord blood.
The samples collected so far are derived from blood. Costa Rica has no cell banks for assisted reproduction or for bone marrow samples.
In Colombia, biobanks are found primarily in university institutions and they follow guidelines based on the Constitution, but it is medical ethics standards that provide the framework for the work that is currently being carried out.
It s obvious that we have to apply the standards on informed consent for the collection of samples, norms on confidentiality of the data that emerge from those samples, and standards for research on humans in general, but there are no specific laws as of yet in Colombia, said González de Cancino.
The ultimate goal of LatinBanks, according to Romeo, is to give rise to national laws that are based on common ground, but that also apply to the needs and characteristics of each country.
Another important question involves the economic benefits derived from donated biomaterial and from scientific uses of such material. Many experts believe that, since donation is voluntary, the benefits should go to the community.
Valerio notes that Costa Rica is trying to make a contribution towards better regulation of areas like ownership of biological samples and their storage. He predicts that through LatinBanks the members will formulate standardised guidelines that are in line with those of Europe.
In Colombia, research is advancing slowly, but without ignoring existing studies. The discussions lead more and more towards bioethics, said González de Cancino.
(*With additional reporting by Myriam B. Moneo in San José, Helda Martínez in Bogotá and Marcela Valente in Buenos Aires. Originally published by Latin American newspapers that are part of the Tierramérica network. Tierramérica is a specialised news service produced by IPS with the backing of the United Nations Development Programme, United Nations Environment Programme and the World Bank.)