Incentives for Brazilian health biotech

By Luiz A B Castro1¹ & Allan Kardec Barros ²
Published: Nature Biotechnology volume 27 number 4 april 2009
Figure 1 Camila and Tinho—two genetically modified goats developed in the laboratory of Vicente Freitas at the State University of Ceara to express G-CSF in milk as part of an experiment aiming to reduce child mortality due to neonatal diarrhea in the Northeast of Brazil.

The Feature article in last June’s issue¹ provides a commendable analysis of the Brazilian health biotech industry and its growing pains. Over the past three years, one of us (L.A.B.C.) has served as a secretary for the Ministry of Science and Technology in Brazil and has been part of the public sector’s continuous efforts to promote consolidation of this important area of industrial research for our society; indeed, many of the solutions proposed by Rahim Rezaie et al. are already in the process of being implemented. We would like to comment on two important challenges to Brazilian health biotech not mentioned in the Rezaie et al. article: first, the slow pace of development of health biotech compared with other biotech applications; and second, the importance of validated examples demonstrating the relevance of health biotech to the health needs of the local population.

Since Brazil introduced the Innovation Law in 2006, the levels of private investment in the innovative health biotech sector have been somewhat disappointing. Part of the problem is that innovation remains a relatively expensive and resource-intensive endeavor compared with other types of enterprises, such as the manufacture of generics. What’s more, regulation of recombinant technology in Brazil and its use in the production of new medicines also poses significant challenges to companies in the region. Indeed, genetic engineering and its oversight has been a center for controversy in Brazil as far back as 1995, soon after commercialization of genetically modified organisms was authorized in the US. While products of genetic engineering began to be disseminated worldwide, internal polarization prevented Brazil from participating in this process².

Although the controversy affects all areas of biotech, thus far transgenic crops have continued to flourish in Brazil (although much larger multinational agrochemical companies drive agbiotech development rather than smaller, entrepreneurial biotech companies typical of the health biotech sector). Moreover, the health biotech sector has continued to wrestle with perception issues (a worldwide problem not limited only to Brazil); often, one reads in the press that the gene revolution has failed to reach the problems of the poor³.

In recent years, work has been under way in Brazil to demonstrate the power of genetic engineering in providing solutions to important social problems.

For example, child mortality in the Northeast of the country is moving down but it is still twice the country’s average. A symbolic example is the state of Alagoas, which has an infant mortality rate of 50 deaths/1,000 births (in Africa it is above 100/1,000). This brings us to the RENORBIO—The Northeast Biotechnology Network effort—which was the subject of a short article in Nature last year⁴. As part of this network, we recently funded a project to show how products derived from genetically modified organisms can reduce child mortality. In this project, two goats expressing granulocyte colony– stimulating factor (G-CSF) provide a proof of concept (Fig. 1), which will provide a foundation for future efforts to produce transgenic animals expressing lysozyme and lactoferrin in collaboration with scientists at the University of California, Davis. This is where we want to go: developing animals that express in their milk proteins that neutralize enteropathogenic bacteria.

A new law that encourages the use of the Brazilian biodiversity in the discovery and production of new phytotherapies may also boost health biotech. Recent results5 have shown that 50% of all the drugs currently in the pharmaceutical pipeline derive from natural products. Even so, only two of these drugs originated from Brazil. In this regard, we believe that it is only by aggregating value to biodiversity in the Amazon forest that we can prevent deforestation. We are also currently working on a project within RENORBIO that aims to demonstrate that a product derived from a tree provides more value in one year than the tree would if converted into lumber and lost forever. The new law, which will soon go to the Brazilian Congress, provides support and benefits to those that collect, characterize and conserve in situ species to be used as drugs. For example, they will receive royalties and participate in the profits from commercialization, access to technology transfer, co-authorship in intellectual property and investments in R&D.

It provides the kind of ‘bioprospectors’ rights’ originally proposed 12 years ago6. We believe that these new incentives to private investment can galvanize Brazilian life science entrepreneurship. Together with validated examples of biotech applications that provide tangible solutions to real health problems, these incentives can provide the momentum needed to spur further development of the health biotech sector in Brazil.