Biopolicy Journal Pontificia Universidad Católica de Valparaíso ISSN: 1363-2450 Vol. 2, Num. 1, 1997

Biosafety in Biotechnology: Current Gaps in Brazilian Regulation relating to Cloning

Leila Macedo Oda; Bernardo E. Corre Soares; Telma A. de O. Cardoso

Fundacao Oswaldo Cruz, Av. Brasil, 4036, sl. 715 Departamento de Estudos em Ciencia e Tecnologia 21040-361 Manguinhos, Rio de Janeiro, Brazil. Fax: 55- 021-2609944 Tel: 55-021-2605979
E-mail: oda@dcc001.cict.fiocruz

Received March 1997
Revision accepted August 26th 1997
Published September 1st 1997

Code Number: PY97007
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At present biotechnology is a fast growing and important technology for mankind, mainly in medicine, and with increasing impact On agriculture, food and bioremediation. Outstanding achievements in these fields have been made by genetic engineering and the utilization of biotechnologies is considered to be a very promising branch of science in developing countries economy. However, these advances have raised some apprehension in society which is often now faced with new ethical issues. The speed of development of scientific knowledge places new challenges to be overcome everyday in the field of science regulation.

Researchers from the Roslin Institute in Scotland recently developed the clone of a sheep from a udder cell (3,13). The technique used was the extraction of DNA from a non-fertilized egg, its fusion with an udder cell followed by implantation of the fused cell in the sheep's uterus. The Nature editorial (8) states that cloning, like all advancements in science, must be used responsibly. Most countries have no regulations for cloning animals, but there may be regulations which prohibit the cloning of humans. If there are legal doubts, the matter should be resolved quickly and legislation brought in. Safety regulations should guarantee safe research, being the result of consensus between regulators and scientists, and considering the attitude of the public.

With the main advances of genetic engineering and recombinant DNA/RNA technology, new international guidelines were introduced in order to strengthen biosafety principles, widening some of them to include the bioethical issues of these technologies. Accordingly, the European Union (EU) has defined in directives 219/90 and 220/90 (5,6) the main measures to be taken into account for the use of genetic engineering techniques, aiming at the reassurance and protection of human health and the environment. Also the United Nations Environment Programme (UNEP), has recently published the 'International Technical Guidelines for Safety in Biotechnology' (12) with the main purpose of ensuring a similar set of guidelines or regulations for the safe use of biotechnology for all parties to the Convention on Biological Diversity.

Even in developing countries such technologies advance more rapidly than development of a regulatory framework, demanding constant review on the law of each country regarding this subject. Brazil is the first member country of MERCOSUL (Southern Zone Commerce and Trade Union) to issue a specific law for the regulation of biotechnological processes using recombinant DNA technology. It is essential that like Brazil, other MERCOSUL countries set up biotechnology regulation policies in order not to hamper the transfer of technologies in this field to their countries. The overwhelming majority of these countries do not have active regulatory or monitoring procedures, mainly due to lack of defining continuous specific policies in this field, strengthening systems and often inadequate institutional capacity. As an emerging country IN the use of modern biotechnology, Brazil has followed the international discussions related to the regulation of these technologies (9,10), particularly in the field of agriculture and health.

Recently, Brazil has set up its Biosafety Law (Law n. 8974 of 5 January 1995) that deals with the use and application of genetic engineering techniques. As in the two directives from the EU, techniques of mutagenesis, formation and use of animal hybridoma somatic cells, cellular fusion including protoplasm of plant cells that may be produced by traditional growth methods, and the self-cloning of non-pathogenic organisms being processed in a natural manner, are excluded in Brazilian law. Brazilian regulation clearly forbids the use of human germinal cells in genetic engineering experiments, but does not make reference to the use of human somatic cells or to biological procedures not using DNA/RNA recombinant technology (1,11). Therefore, genetic handling of human germinal cells or radical in vivo intervention in human genetic material is forbidden in Brazil, unless used for medical treatment.

Despite having set up the Brazilian Biosafety Law, there is no legal control with regard to the cloning of superior organisms. Governmental scientific authorities are now seeking a closer definition on which genetic experiments, besides those using DNA/RNA technologies, may be considered within the regulatory scope of the law. The use of technical terms should be explained, such as 'germinal cell' whether originally germinal or a cell that starts acting as germinal, as in the Scottish sheep experiment. These issues would then be addressed in legal tools, which would complement the present law. However, such regulation must not be too restrictive , being careful not to delay or block important medical advances such as gene therapy.

As in other countries, there is a legal loophole in Brazilian regulation with regard to the control of advanced technologies. The law states that these procedures should be previously validated by the National Technical Biosafety Committee (CTNBio) according to the risk level of the organism involved. As with the European validation system, Brazil set up a specialized decision group, where specialists in the field may discuss the matter with representatives of the respective ministries or governmental associations. This committee is responsible for biosafety matters relating to protection of the environment and the population and is currently working on regulations for human genetic manipulation and cloning, given the urgency of recent developments in gene technology.

Besides the present biosafety regulation, the Brazilian National Health Council of the Ministry of Health has also issued Act n. 196, that refers to safety procedures to be followed in research with human beings (2,4). Nevertheless, this Act neither deals with law endorsement nor with liability issues. It is also worth quoting Law n. 8501 of 1992, which deals with the use of corpses for scientific matters, as well as Law n. 8489 of 1992 that regulates the withdrawal of tissues, organs and other parts of human body for experimental or humanitarian purposes (11). However, neither of these laws include cloning procedures within their scope.

The analysis of biosafety regulations in Brazil and in Europe shows that although there is an agreement concerning the need for biotechnology validation, the absence of detected problems in the use of recombinant DNA technology has led to a greater flexibility on the criteria set for product evaluations. Brazil has formulated national validation rules only in the beginning of 1995 and was able to compare the advantages of such technologies in other countries, therefore preparing a modern legislation in accordance with the international market. However, countries currently gaining the technical ability to carry out work with molecular techniques, face policy difficulties to implement regulatory mechanisms.

The control of biosafety regulation in Brazil demands a definition of each specific technology, since there is a delay between the coming into force of the law and its implementation. Control issues are also subject to pressures, mainly from industry and the constant changes in governmental authorities, which may influence the regulation system. Another drawback to a suitable regulation control is the lack of training and capacity-building in biosafety questions, as well as sponsoring mechanisms from international institutions, as for example the UNEP (United Nations Environment Programme) and the WHO (World Health Organization). Evaluation of biotechnology's public perception may also be a limit to the development of the law. The country needs a system that listens to the community's ideas, similar to the 'Eurobarometer' which records public opinion on biotechnology in Europe (7). This would be important as an indicator to the National Technical Biosafety Committee and to the industry on the proper release of genetic products into the environment.

The boundaries opened by the advances in molecular biology enable the creation of new life forms, pointing to a social, moral and ethical responsibility of the scientist and leaders of society to think deeply about science's rights over nature and its biodiversity. On the other hand, the deepening of scientific knowledge and technological evolution require a thorough review of concepts and the development of ethical thresholds for these experiments (9). Any advancement in science must be in accordance with the regulation system of the country, but a law can only be effective when it meets the real demands of society and if there is a political commitment from the policy makers to be operative, considering the well- being of mankind.

References

[1] Brasil. Lei 8974 de 05 de janeiro de 1995. Estabelece o uso das normas tecnicas de engenharia genetica e liberacao no meio ambiente de organismos geneticamente modificados, autoriza o Poder Executivo a criar, no ambito da Presidencia da Repeblica, a Comissao Tecnica Nacional de Biosseguranca, e da outras providencias. Diario, Oficial [da Republica Federativado Brasil], Brasilia, v. 133, n. 5, p. 337-346, Secao I.

[2] Brasil. Ministerio da Saude. Conselho Nacional de Saude. Resolucao n_ 196 de 10 de outubro de 1996. Aprovacao das normas de pesquisa em saude. Informe Epidemiologico do SUS, v. 5, n.2, p.3-15.

[3] Campbell, K.H.S., McWhir, J., Ritchie, W.A. & Wilmut, I. (1996). Sheep cloned by nuclear transfer from a cultured cell line. Nature, 380: 64-66.

[4] Conselho das Organizacoes Internacionais das Ciencias Medicas & Organizacao Mundial de Saude (1995). Diretrizes eticas internacionais para pesquisas biomedicas envolvendo seres humanos. Bioetica, 3(2): 95-136.

[5] European Union (1990). Directiva del Consejo. Relativa a la utilizacion confinada de microorganismos modificados geneticamente. Diario Oficial de las Comunidades Europeas, 219: 1-14.

[6] European Union (1990). Directiva del Consejo. Sobre la liberacion intencional en el medio ambiente de organismos modificados geneticamente. Diario Oficial de las Comunidades Europeas, 22: 15-27.

[7] Kinderlerer, J. (1995) Public Perception of Biotechnology. Doc. n. University of Sheffield Law School, UK. Personal Communication.

[8] Masood, E. (1997). Cloning technique reveals legal loophole. Nature, 385: 573-574.

[9] Morel, C.M., Emerick, M. C. & Oda, L.M., (1995). Biosseguranca: Uma Nova Ciencia?, Anais da 47a Reuniao Anual da SBPC, v.1: 25-26.

[10] Oda, L.M. (1995). Lei de Biosseguranca: como fiscalizar?. Jornal da Ciencia Hoje, 08/09/95.

[11] Oda, L.M. (editor-1996). Biosafety of Transgenic Organisms in Human Health Products, p.127. Maio Grafica Ed., Rio de Janeiro, Brasil.

[12] United Nations Environment Programme (1996). International Technical Guidelines for Safety in Biotechnology, p. 31. Nairobi, Kenya.

[13] Wilmut,I., Schnieke, A.E., McWhir, J.,Kind, A.J. & Campbell, K.H.S. (1997). Viable offspring derived from fetal and adult mammalian cells. Nature, 385: 810-813.

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