In 1996 the Brazilian Congress and the Federal Government concluded an enduring five year debate on patents by adopting a new patent law. Late in 1995, the Access to Genetic Resources Bill was proposed in the Senate, which will deepen the debate regarding the implementation of the Convention on Biological Diversity (CBD).

1996 is not only an important year for Brazilian biopolitics because of the patent law and the access bill. A few other bills are being discussed as well, such as the Cultivar Bill, a bill concerning the establishment of a National System of Conservation Units, the proposed legislation regarding a National System of Management of Water Resources and River Basins, and the Statute of Indigenous Societies. Although most of these bills were already proposed to the Congress before 1996, in the first half of this year the prospects of concrete legislation increased. However, due to the approaching local elections the attention of national politicians might turn away from national politics. Therefore it is too early to predict the outcomes of the current debates on the different aspects of Brazilian politics in biotechnology. The proposed bills, however, are likely to contribute to an improved Brazilian awareness over the issue and highlight the challenges of implementing the CBD.

Patent law
On May 14, 1996, the Brazilian President Fernando Henrique Cardoso of the centrist social democratic party signed a new patent law which was approved by the Congress on April 9, 1996. The adoption was preceded by a five year debate which started in 1991 when former President Fernando Collor de Mello of the neo-liberal party sent a concept bill to the Congress to prove his administration’s adherence to the international community and to the USA in particular. After Brazil ratified the GATT, including the agreement on the Trade Related Aspects of Intellectual Property Rights (TRIPS), the current administration of Cardoso reiterated the necessity for adopting the proposed patent legislation to confirm its position as a reliable international trading partner. The hour of the sanctioning ceremony of the law was therefore carefully chosen by President Cardoso so it would provide immediate international media coverage.
Passage of the legislation has been delayed because of intense lobbying by opponents, including non-governmental organizations and members of the scientific community on the one hand, and proponents like national and transnational pharmaceutical and biotechnology industries on the other. The opponents tried to avoid the patenting of life and were against a very broad recognition of the ‘pipeline’ article in the patent law; the proponents including the government clearly favoured the permanence of both aspects in the bill. The Congress approved these two most hotly debated articles of the new patent law separately on April 10, 1996.

Pipeline article
The pipeline article provides for the recognition of two kinds of patents: (1) patents on processes and products that are already on the international market and that have been granted patents outside Brazil before the enforcement of the Brazilian law. The recognition of such a patent is for the period remaining from the date the patent has first been granted outside Brazil; (2) Patents that have been granted on processes and products in another country, but that are not yet on the international market, meaning that they still are in the final research phase. With regard to the latter, an exception is made for Brazilian serious and effective research and investment in the areas of chemicals, pharmaceuticals and food products. Consequently, all fundamental Brazilian biotechnological research not yet directly linked to the development of a particular product or process in one of these three specific areas has become excluded from this exception. In this sense the pipeline provisions will have a serious effect on the Brazilian biotechnology sector.

Patents on life
With regard to the patentability of life, different interpretations of the law exist. Articles 10 and 18, which deal with this issue, state that it is not possible to patent natural biological processes and (the whole or any part of) living beings or biological material as found in nature. This includes the genome and germplasm, even if they are isolated in laboratories. The provision in article 18.III, however, makes an exception for micro-organisms provided that they fulfil the three requirements for patentability: novelty, inventive activity and industrial application. Confusion about the different interpretations of the law starts with the explanatory paragraph of article 18, because it defines transgenic micro-organisms, while in the article itself the term transgenic micro-organisms is never used. Therefore it remains unclear if the exception only applies to transgenic micro-organisms or to micro-organisms in general.
Because of the ambivalence within the law of what micro-organisms really are, at least three different interpretations are possible. The restricted interpretation is that only transgenic micro-organisms such as bacteria, are patentable. The second, broader interpretation is that micro-organisms, in this case referring to isolated and auto-reproductive plant or animal cells, once they are genetically engineered, are subject to patentability. This interpretation can be considered as a subtle inclusion of patentability of plants and animals. Thirdly, there is also the possibility, referred to in the articles 42 and 43, in which genes from micro-organisms, in the strict sense, are introduced in plants or animals, which leads both to the patentability of the processes and of the resulting transgenic plants and animals, known as virtual patents. The latter two interpretations result in a wider possibility of patenting life than the TRIPS agreement requires. Although Brazil should only have to comply with the TRIPS requirements within the required five year period starting at the moment of signature of the treaty, it did so within a year and a half.
In order to understand the lack of clarity that remains within the law it is important to take into consideration the Brazilian legislative process. The law under discussion is not always the main focus of the political process. There is room for lobbying and bargaining, and sometimes the approval or rejection of one law  is related to that of another or related to the distribution of certain political benefits. David Hathaway, a committed opponent of the patenting of life, states that most of the representatives and senators hardly understand the implications of the patent law and followed their leaders’ opinion. The lobbying of civil groups opposing the patenting of life has led to a restriction of articles 10 and 18, which before had an even broader application. However, they did not succeed in obtaining a clear and uniform regulation concerning the patentability of micro-organisms .
The existing gaps within the law are a result of intense lobbying of mostly transnational private sector interests, and of Brazilian neo-liberal politicians. According to Senator Fernando Bezerra, a member of the conservative neo-liberal party and one of the leading figures among the proponents of the patent law, both the pipeline regulations and the patentability of micro-organisms will not have a serious effect on Brazil’s research capacity since the areas of chemicals, pharmaceuticals and food products are excluded, and the patent law does not go beyond the terms of the TRIPS agreement.  It is clear that the opponents of the law do not agree with his point of view. However, only the actual impementation of the law and the forthcoming judicial decisions will demonstrate the difficulties of its intepretation and its consequences for the Brazilian biotechnology sector.

Access to Genetic Resources Bill
The Access to Genetic Resources Bill is an attempt to develop a regulatory mechanism for access to genetic resources and to enable Brazil to exercise its sovereign rights over its biological resources in accordance with the CBD. Although the current proposal is still being discussed, it eventually should lead to a comprehensive access law. The initiative for the Access to Genetic Resources Bill was taken by Senator Marina Silva, representative of the labour party in the State of Acre, Amazon Region. Together with the Brazilian CBD’s focal point, the General Coordinating Office on Biological Diversity (COBIO) of the Ministry of the Environment, Water Resources and the Legal Amazon, the National Research Center for Genetic Resources and Biotechnology (CENARGEN), and a few environmental NGOs, the senator will organize a preparatory workshop in August 1996 and subsequently a series of four public hearings in major cities around the country, trying to gather support from society as well as from other senators for approving an improved version of the bill.
The proposed bill is an attempt to implement parts of the CBD, and is inspired by the Colombian Proposal on the Regulation of the Protection, Conservation and Use of Biological Diversity and Genetic Resources, which deals with the complex issue of adapting the Colombian national law to the CBD. Already criticism of the proposal has been expressed. Firstly, it is noted that it only deals with access to genetic resources from the provider country point of view, which may be correct from the Colombian perspective, but not from the Brazilian perspective considering the country’s rather large dependency on exotic genetic resources for its own agriculture.
Secondly, the subjects of technology transfer and the national capacity building (technical, scientific, institutional and managerial) in the field of conservation and utilization of biological resources are barely mentioned.
Thirdly, the relatively new theme of ‘collective intellectual property rights’, which refers to the recognition of indigenous and traditional knowledge about biological resources, is a crucial element of the bill, however it does not give any provision of how to regulate and operationalize these rights. A clear answer to questions that arise  from recognizing and implementing collective intellectual property rights has yet to be formulated.
Finally, the crucial question of benefit sharing still needs more refinement. If this issue is not properly regulated, then the access bill will fail in implementing the CBD.
Gisela S. de Alencar*/Marco C. van der Ree**

* Legislative Aide of The House of Representatives, Praça dos Três Poderes, Câmara dos Deputados, Anexo III, gab. 46, Brasília - DF, Brazil, 70160-900. Fax (+55) 61 318 2112; E-mail gisela@cdsid.com.br
** Associate Researcher of the Institute for Society, Population and Nature (Instituto Sociedade, População e Natureza - ISPN), Caixa Postal 9944, Brasília - DF, Brazil, 70001-970. Fax (+55) 61 321 6333; E-mail ispn@ax.apc.org.br

Sources
Fernando Bezerra (1996), "Patentes: Um Assunto Complexo". Folha de São Paulo, April 12, p.3.

Câmara dos Deputados (1996), Avulso do Projeto de Lei. No. 824-G, de 1991. Brazil.

Lyle Glowka, et al (1994), A guide to the Convention on Biological Diversity. Gland, Switzerland: IUCN. <>Senado Federal (1995), Projeto de Lei do Senado. No.306, de 1995. Brazil.

David Hathaway (1996), Patentes: Lei Promulgada por FHC. E-mail message, May 26, AS-PTA, Nova Friburgo. Brazil.

Personal communications with Senator Marina Silva (labour party) and Lídio Coradin (vice-coordinator of COBIO).