Sample collected at a sperm bank Credit: Photo Stock

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Free Rein for Biobanks
By Emilio Godoy

Collections of human biological material, such as embryos, semen, blood cells and body tissue, are multiplying in a context of largely unregulated operations.

MEXICO CITY, Aug 11 (Tierramérica).- Four years ago, when Guillermo Soberón – one of the most recognized scientists in Mexico – became a grandfather, the newborn’s parents received a letter requesting a donation of biological material to be used for medical research.

Petitions of this kind reflect the multiplication 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 investigation is advancing quickly, and has made evident (the need for) an appropriate legal framework,” said Carlos Romeo, director of the Law and 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 organized as a technical unit with criteria for quality, order and purpose, according to Agustín Zapata, an expert with the Carlos III Health Institute of Madrid.

In order to seek ways to formulate laws, the LatinBanks project emerged, a study of the legal and social implications of biobanks in Latin America, and which 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 optimizing the legal structures, organization and forms of participation.”

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 public and private biobanks, for clinical and scientific research, physician Salvador Bergel, Argentine member of the LatinBanks project, told Tierramérica.

“So far they are guided according to 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, biobanks are just getting started in Costa Rica.

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 utilized without authorization.

The effectiveness of biobanks implies standardizing the protocols they employ, adopting appropriate methods for coding 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,” attorney Emilssen González de Cancino, director of the genetics and law research center at the private Externado University of Colombia, told Tierramérica.

“Prohibiting new processes means losing opportunities for progress,” said Cancino, who is driving a two-year study that began eight months ago.

The European Union adopted in 1995 a slate of standards of protection of physical persons, respect for personal data and circulation, and, since 2005, the Protocol to the Convention on Human Rights and Biomedicine has been in effect.

“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 utilize samples from blood, skin, brain tissue or bone marrow to investigate diseases like cancer and Alzheimer’s, and 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, which work under their own norms, which demonstrates that there is much yet to be done in the biological material field 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 nor for bone marrow samples.

In Colombia, the research under way shows that biobanks are found primarily in university institutions and they follow some of the regulations of the Constitution, but it is medical ethics the provide most of the current labor framework.

“It’s obvious that we have to apply the norms on informed consent for collecting samples, the norms that mention confidentiality of the data that emerge from those samples, and everything involved in the research of humans, but there are not yet specific laws in Colombia,” said Cancino.

The ultimate goal of LatinBanks, according to Romeo, is to reach the national legislations in order to create common ground, but which is based on the needs and characteristics of each country.

Another important question involves the economic benefits derived from donated biomaterials and from its scientific exploitation. 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 standardized guidelines between Europe and Latin America.

In Colombia, research is advancing slowly, but without ignoring existing studies. “The discussions lead more and more towards bioethics,” said Cancino.

* With reporting by Myriam B. Moneo (San José), Helda Martínez (Bogotá) and Marcela Valente (Buenos Aires).