Brazil tried to lead the world in sustainable use of biodiversity over the last decades. It attracted the whole world for the RIO 92 summit and Eco 92. The most prominent authorities worldwide came to Rio and a host of countries signed the Biological Diversity Convention (BDC). The goal of the convention is the sustainable use of biological diversity and the fair and equitable sharing of benefits derived from the use of genetic resources, through the appropriate access to genetic resources and transfer of relevant technologies, taking into account all rights over these resources and technologies, and by means of appropriate funding – this is all in the first article of BDC.

More than two decades later, we unfortunately have to consider that the Convention failed to accomplish its first goal: conservation of the world biodiversity. Brazil fortunately did not lead this destruction but we must acknowledge that in the last three decades an area larger than Germany was devastated in the Amazon. Asia and Africa are even more drastic examples.

Also, the BDC never accomplished the equitable sharing of benefits derived from the use of genetic resources. This is mostly because benefits are protected by patents and there is no appropriate funding to assure technology transfer. Thus, I would have to say, unfortunately, that BDC was a big failure overall. But for Brazil? For Brazil it is even worse, because the principles advocated by the Convention were intended to be folded into national law, and this did not happen. These principles stated that one country could not benefit from the biodiverse richness of another without financial compensation. This is difficult because negotiations between countries in the subject of intellctual property rights are complex and results are hard to achieve.

In Brazil, the attempt to incorporate the principles of the BDC into law failed because sharing of benefits had to be exercised between scientists and indigenous people, and thus these actors had to deal with contracts in place before the benefits were known. The law (Provisional Measure 2186, 2001) concentrated the power for regulating access to genetic resources in the hands of the Ministry of Environment. It also created a council called CGEN (Conselho de Gestão do Patrimonio Genético) that controls the access to genetic resources in the worst way possible, and when Marina Silva was the Minister of Environment, she created an institution called Chico Mendes. A third actor in the process is IBAMA, which should be subordinated to the Minister of the Environment but in practical terms it is not.

The result is that all these actors did not work together and caused chaos. CGEN admitted that it does not know how to exercise the Provisional Measure, but continuously sued companies and scientists. It’s interesting to note that not one pharmaceutical product has been produced from Brazilian biodiversity (ACHEFLAN is the only exception, and it caused the company ACHE to be sued by CGEN). If one works at the Butantan Institute, home to a tremendous snake collection, and one wants to develop a pharmaceutical product from a snake poison, one must get an authorization from Instituto Chico Mendes. These authorizations take forever to be issued. Elibio Rech, a scientist from EMBRAPA, was sued because he wanted to work with spider genes encoding for important proteins. He was treated as if the spiders were going to disappear from the environment because of his experiments.

So what is the future of Brazil, the most biodiverse country in the world? A recent attempt to build a new law to replace the MP proposed by the government resulted in a version that is worse than the current. The CGEN is still there, and the control of genetic resources will be retained by the Ministry of Environment, even though there is opposition.

Attempts by scientist to go beyond science into technologies or products might still be possible. The Labor Party proposal lost and the “substitutive” won; the next step is that the “substitutive” will move to the Senate. It is still possible that some improvement will be introduced in the substitutive and improve the context greatly. Time will tell.

Luiz Antonio Barreto de Castro

Genetic engineering started in the early seventies. It was called then Recombinant DNA Technology. The first successful experiment in genetic engineering was performed by Herbert Boyer, who expressed the insulin gene in Escherichia coli. Over the last four decades, the pharmaceutical industry has grown into a multi-billion-dollar sector, and in agriculture, more than 170 million hectares have been cultivated with genetically modified plants.

This occurred because the National Institutes of Health established very early on rules to assure the safety of the work done with this nascent technology. This after the Asilomar Conference that took place in San Diego, 1975, asked for a moratorium on use of the technology, fearing that use of virus vectors might harm humans. While there have been a few lethal cases in the pharmaceutical area due to viral vectors, there have been none in agriculture, and no harm to the environment.

In Brazil the development of biotechnology, as we call it today, flourished in agribusiness, to the benefit of six major corporations: Monsanto, Bayer, Syngenta, BASF, Dupont/Pioneer and Dow. Together these companies are responsible for the cultivation of more than 40 million hectares of GM crops in Brazil, second in the world only to the United States. This is about 20% of the total grain production in Brazil and about 22% of the whole Gm crop production in the world.

Yet we cannot say the same with respect to the pharmaceutical sector, where large corporations do not invest in Brazil. We have never produced one blockbuster molecule locally, we have never registered one molecule at the FDA, and we do not have a large-scale  infrastructure to work with gene expression in bacteria, yeast or Chinese hamster ovary (CHO) cells. Brazil simply does not innovate in the pharmaceutical sector. We import, formulate and sell drugs. Every year we buy from foreign countries billions of dollars of drugs to satisfy our demand.

In this blog I’ve said that we have to change paradigms, and build a competitive pharmaceutical industry in Brazil. Is this important for financial reasons only? Of course not. It is absolutely necessary for each country to have a strong pharmaceutical industry, but the benefits of biotech have not yet reached the poor. It needs to, and this is possible if we begin to express genes in plants. To our advantage, we can already express genes from any organism in other organisms, including plants and the milk of mammals. It can be done.

The question is, Who will benefit from it? In Brazil, agribusiness properties – which are quite large, more than 300 hectares apiece – take up 76% of the entire agricultural land. This group received last year US$40 billion to finance their crops.

Family farmers have property that occupies the other 24% of agricultural land, though their plots can be as small as 20 hectares. This family group received US$6.4 billion last year, and with this money produced most of the food consumed in Brazil.

The food produced by family farmers corresponds to close to 40% of the revenues coming from agriculture in Brazil; the large properties produce 60% (that group also produces feed for local animal consumption and commodities, mostly for export). So US$6.4 billion generates 40% of the agricultural product for consumption as food, and US$40 billion generates 60% of the agricultural products for food animal consumption and also commodities, mostly to be exported.

Our proposal is to take biotechnology to some of the family farmers to add value to their products, while expressing molecules for the pharmaceutical sector to strengthen this industry.

Luiz Antonio Barreto de Castro

The efforts to develop biotechnology in Brazil now exceed three decades. It began in Brazil at almost the same time as the recombinant DNA technology, which became publicly known early in the ’70s, when Herbert Boyer expressed the insulin gene in E.coli.

A couple of scientists in Brazil repeated this experiment almost at the same time, and the interest in this area came to the agenda of a public company called EMBRAPA, which was founded in the ’70s to work with agricultural research in Brazil.

I’ve written an e-Book (made available by Bentham Sciences), covering almost two years of my experience in the pharmaceutical area, related to biotechnology. This was all new to me, since I worked all my professional life in agriculture. Since the ’80s, I’ve been building a platform to train young scientists in plant genetic engineering and molecular biology, hoping to incorporate this nascent technology into EMBRAPA’s plant breeding efforts. This work took place at The National Center for Genetic Resources and Biotechnology (CENARGEN) and added to the efforts of a dozen excellent geneticists.

The soybean revolution in Brazil was brought about by Romeu Kihl; aluminum-resistant corn developed for the acidic, cerrado soil was created by Ricardo Magnavacca; and the foundations of maize breeding had been previously done by the late Ernesto Paterniani. Also, Eleuzio Curvello produced cotton, and Alcides Carvalho, coffee, for 52 years of his life. Dalmo Giacometti and Silvio Moreira, citrus. Marcilio Dias and Hiroshi Ikuta are the fathers of the vegetable genetics; Raul Moreira tackled banana; Ady Raul da Silva, wheat; and Frederico Menezes Veiga, sugarcane.

Through all this, plant breeding has continuously built cultivars to feed our seed industry. High-tech seeds and low-cost farming practices were the result of seed laws and plant breeder’s law in Brazil. The end result is that Brazil can competitively produce nearly 200 million tons of grain because it is cheap for the farmer.

Brazil tried to follow the growth of commercial biology. In the ’90s, Brazil introduced protections for intellectual property around genetics, but that effort was not sufficient, and thus Brazil suffered through rampant inflation for decades even as it invested in biotechnology.

I’ve written this e-book now because Brazil has emerged financially and now has more opportunities in biotech than previously. The book is intended for those who want to know some of the history of biotech in Brazil, and to ponder the power of this technology and the opportunities we now have in our hands. Brazil may become a relevant actor in this area internationally, taking advantage of some circumstances here that are not available in other countries, particularly our biodiversity.

The e-Book describes adjustments that must be made to assure the success of our investments, particularly to the laws and regulatory framework. The book investigates the immense possibilities of agbiotech in Brazil, partly because the mechanisms of public private interactions are well designed and in operation. The public perception in Brazil and many other countries has turned against genetic engineering for political and ideological reasons: when the first engineered soybean resistant to glyphosate was released commercially a campaign against transgenic plants prevented the application of this technology in agriculture for almost a decade in Brazil. However, the world adopted recombinant DNA technology in the pharmaceutical area and most products utilized internationally by the public in this industry (including Brazil) are genetically engineered.

This is a perception problem that that has to be faced globally, particularly in Europe. The only solution is to focus biotech on the issues surrounding poverty (discussed in one of the e-book’s chapters). In the pharmaceutical industry in Brazil the context is quite different. Brazil lags behind many developed and emerging countries, and does not have an equivalent to EMBRAPA in the public pharmaceutical area.

The pharmaceutical area is growing, however (in 2011, up 14%), because the market is a demanding one. But it is growing without innovation. There are initiatives that pull large, nationally funded companies together as consortia, and which propose biosimilars for monoclonal antibodies with expiring patents, but there is no innovation as an initiative. Brazil has no contract manufacturing organization, and not one cGMP-facility (the first one will be inaugurated by Cristalia this year).

Because of this, Brazil cannot scale up its pharmaceutical products, nor can it properly conduct the clinical studies needed for registration at ANVISA. Brazil has never produced a block buster or registered a pharmaceutical product at the FDA. Large corporations in general do not invest in Brazil, claiming Brazil’s patent laws are not adequate. And finally, Brazil has no risk capital funds (Burrill & Co is a solitary actor).

There is movement in the right direction, however. The government is supplying loans for biotech projects, allowing repayment in 10 to 15 years, with subsidized interest and the absence of capital payment for 3 to 5 years. Also, the federal government and private sector are funding scholarships to train 100,000 students in the next five years at all levels from high school to PhD . This is great news, but there are many more problems that need to be resolved in the coming decade.

Many discussions on these topics in the e-book were first published on this blog, and can be found here. The published e-book can be found at here or here.

Luiz Antonio Barreto de Castro