Human Health Related Biotechnology In Brazil

Brazil has an area of 8,547,403 square kilometres and a population of 152 million inhabitants, 80% of them living in urban areas. Brazilian GNP, in 1996, reached US$ 750 billion, 12% corresponding to agriculture and cattle. The country invests in science and technology roughly 0.8% of the GNP, corresponding to US$ 6 billion. Of this total, 70% to 80% is governmental funding.

Presently the country experiments with fundamental structural and political reforms. A process of privatising some of the biggest state-owned companies and opening up commercial frontiers to international trade is ongoing. After 1994, a successful economic plan has reduced the huge previous levels of inflation of 2,000% a year to less than 10% a year. It is expected that these changes will have a positive impact on endogenous science and technology development.

During the 1980s, Latin American and the Caribbean countries contributed scientific papers published in international journals that were estimated by several authors to comprise 1—2% of all scientific publications in the world (Martínez-Palomo and Sepúlveda, 1989, Polanco, 1990, Pellegrini Filho, 1993). Notwithstanding the small budgets allocated to science and technology, efforts made since the 1980s have intensified scientific activity in the health field at the regional level. In the group of countries formed by Argentina, Brazil, Chile, Mexico and Venezuela, which produce approximately 90% of the scientific papers originated in the Latin America region, Brazil contributes more than 30% of this total.

It is estimated that Brazil has 4 researchers for every 10 thousands inhabitants, a very low proportion compared to the situation observed in the developed countries of 40 researchers for 10 thousands inhabitants.

Nevertheless, Brazil shows a concentration of research in biological areas and a considerable capability in biomedical science. Nearly 26% of its researchers operate in biological and health areas. This statement is relevant, taking in to account that a large proportion of the Brazilian health necessities constitutes strategic targets for health-related modern biotechnology. These goals include vaccines, sera, anti-toxins, biological reagents, drugs, medicinal plants and pesticides.

In a previous paper this author has already argued that the extent to which Brazil has been contributing to the international pool of advances in biomedical field during the last hundred years is underestimated (Marques, 1996a). Among the nearly thirty new infectious diseases described world-wide, in the last two decades, three of them were identified by or with the strong participation of Brazilian biomedical scientists: Brazilian purpuric fever caused by the Haemophilus aegyptius, first described in 1984; Sabiá virus hemorrhagic fever, first described in 1990; Rocio virus encephalitis, first described in 1975 (Lederberg et al, 1992). Still, the industrial production of some of the main Brazilian public institutes like the Oswaldo Cruz Foundation, created in 1900, and the Butantan Institute, created in 1889, currently provides the internal market requirements for vaccines against measles, serum-type A/C meningococcal meningitis, yellow fever, and other biologic substances applicable to human and animal health.

The utilisation of modern biotechnology methods is now a reality in the country and vaccines against hepatitis B and yellow fever via recombinant DNA are foreseen in both the aforementioned institutions. Regarding diagnostic products, it is estimated that in the medium term, the Brazilian biotechnology research institutes will be manufacturing reagents for Chagas disease using DNA probe techniques and for Schistosomiasis, Leishmaniasis and Malaria, using monoclonal antibodies.

We know that in developed countries most health-related industrial biotechnology occurs in the private sector, being conducted by highly specialised small to medium-sized firms in combination with large pharmaceutical corporations. This contrasts with the framework currently observed in Brazil, where in the three last decades, investments in biotechnology R&D and industrial production have been largely the responsibility of federal government.

Brazil contributes to approximately 40% of patents issued in Latin America, most of this total pertaining to biological areas. Nevertheless, the great majority of patent rights granted in Brazil belong to foreign entrepreneurial groups, especially from the USA. Brazilian governmental institutions (universities and research institutes) are allowed to obtain patents; nonetheless, patents are not well understood by the local scientific community, which operates on a principle of communal possession of research results rather than private ownership. Recent developments in the regulatory framework for biotechnology have at least partly changed this situation. Brazilian scientists are becoming less indifferent to intellectual property rights and the main universities and research institutes are introducing internal rules regarding the ownership of research results.

Transfer of technologies applicable to the field of health from developed countries to the country has been a prime concern. Strategies for achieving such a transfer, involving the integrated actions of international agencies and national government, have included incentives to promote co-operation between Brazilian universities and research centres and groups of the developed countries.

Since the 1980s Brazil has been an active participant in a number of biomedical programs and initiatives of multilateral agencies. These include the World Health Organization (WHO) Special Program for Research and Training in Tropical Diseases (Tropical Disease Research—TDR); the United Nations Development Program (UNDP) / UNESCO / UNIDO Regional Biotechnology Program for Latin America and the Caribbean; the Pan American Health Organization (PAHO) Program for the Regional Development of Biotechnology as Applied to Health; the PAHO / WHO Expanded Program on Immunization (EPI); and PAHO's Regional System of Vaccines (SIREVA).

Brazil was an active participant of the two main multilateral agreements for the debate on patenting of human genetic materials: the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Convention on Biological Diversity.

According to the Biodiversity Convention, the expression biological resources comprises genetic resources, organisms or parts of them, populations and any other biotic-component of ecosystems, with real or potential utility or value for humankind. The capacity of modern biotechnology to identify and incorporate biological resources into commercial products has led to the growing importance placed by Brazil on its own rich biological resources. Brazil is the most important Latin America country with respect to the number of mammal species, reptiles and amphibians. At the world level, in terms of biodiversity Brazil is ranked the first in amphibians, the third in birds and the fourth in mammals and reptiles.

One important issue raised at the United Nations Conference on Environment and Development, held, in 1992, in Rio de Janeiro, was the debate over the risk of private and foreign appropriation of Brazilian biological resources, particularly the rain forest genome, which would impede local R&D and manufacturing in the field of medicinal plants. In the Brazilian Amazon, there are 55 thousands species of plants. Regarding the status of the Earth's living resources, Brazilian ecosystems comprise more then 10% of the nearly 1.4 million life species described by universal science. At the present time, patents are not issued for higher life forms in Brazil; nevertheless, patents are issued for engineered micro-organisms.

Since the 80s, the main concern in Brazil about patenting biotechnology has been the possible impact on national efforts to research and develop new drugs for prevention, diagnosis and therapy of diseases such as Malaria and Chagas. Brazil, like most developing countries, considers that the advanced technologies are a critical tool for its development strategies, considering its position in the international market.

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