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Bureaucratic maze

The Ministry of the Environment (MMA) has devised a new strategy to evaluate requests for licenses by researchers interested in collecting and studying species from Brazil

EDUARDO CESARThe year 2011 promises a new round in the dispute between scientists and environmentalists caused by the strict legislation regarding biopiracy. These laws were enacted to avoid the riches from Brazil’s biodiversity being diverted. The Ministry of the Environment (MMA) has devised a new strategy to evaluate requests for licenses by researchers interested in collecting and studying species. On one hand, the Ministry has promised to reduce the bureaucracy – allowing broader licenses to be granted. Furthermore, the Ministry has decided that other entities, such as the National Sanitation Surveillance Agency (Anvisa) and the Ministry of Agriculture – can grant these licenses, in addition to the Brazilian Institute of the Environment and Renewable Natural Resources (IBAMA) and the National Council of Scientific and Technical Development (CNPq). The bad news is that the MMA is also considering taking measures against the parties that do not comply with the biopiracy laws. This means that the researchers who have continued their research work in the last few years without complying strictly with the laws, have a reason to be worried. “So far, we have penalized researchers who did not comply with the laws, but had contacted us so that their status could be regularized. From now on, we will focus on the researchers who did not bother to request the licenses and the penalties will be much harsher”, warns Braulio Dias, secretary of Biodiversity and Forests of the MMA.

The decision of the MMA is expected to incite the perception of the researchers’ vulnerability, which becomes sharper every time a new penalty is announced – the last penalty was a R$ 21 million fine imposed on cosmetics company Natura, for the use of biodiversity without the due authorization. “The fine imposed on Natura has caused considerable concern among the members of the academic research community with access to genetic resources. If Natura, a corporation which had everything to lose by committing an infraction, was fined, you can imagine how the researchers feel”, says Roberto Berlinck, professor of the Chemistry Institute of São Carlos of the University of São Paulo (USP). Berlinck has followed the effects of the law ever since it became effective through a provisional measure in June 2000. This law establishes rules for access to the country’s genetic resources, to the traditional knowledge associated with such resources, and to the sharing of  benefits resulting from such exploitation. Right after the publication of the Provisional Measure, 10 years ago, Berlinck filed a request for authorization to collect species in different places. “It took seven years for my request to be granted. Of course it’s necessary to have laws that protect our biodiversity from being plundered, but the laws cannot be an obstacle to the work of scientists”, he says. He adds that lately he has seen some improvements in this respect. The main advance was that researchers will be able to request licenses not only from Ibama but currently also from the CNPq, which is linked to the Ministry of Science and Technology. “The license is granted quickly now, but refers only to the collection of specimens for basic studies. If there is any possibility of commercial applications, the request entails a much longer and more detailed process, as this includes the possibility of filing patents”, says Berlinck.

Life cycle
Natura was fined because the company did not want to wait for the outcome of the MMA’s  lengthy proceedings. According to the rule in effect, any access to species of Brazilian flora and fauna for research purposes depends on a previous authorization granted by the Council for the Management of Genetic Resources (CGEN), a board linked to the MMA. This board was also created by a governmental provisional measure, enacted in August 2001. Before a product is placed on the market, it is necessary to obtain the related authorization from the so-called provider (the government or a traditional or indigenous community) and enter into an agreement for the sharing of the benefits, which is the financial compensation for the holder of the biodiversity. Natura says that 100% of its products comply with the benefit sharing provision, but complains that it cannot afford to wait for two years for a research authorization to be granted by the CGEN. “Two years is the life cycle of a product in the market”, said Rodolfo Guttilla, director of corporate affairs and government relations at Natura. “The company pioneered the agreements in Brazil for the sharing of benefits with traditional communities. It also accounts for most of the requests for authorization for access to biodiversity in Brazil – 68% of these requests filed with the regulatory authorities come from Natura”, he states.

EDU_1496Eduardo CesarResearchers have also been fined for failing to comply with the law while trying to continue their research work. In 2006, professor Massuo Kato, of the Chemistry Institute of USP, was approached by Ibama authorities at the airport in the city of Belem, and was forbidden to board the return flight to São Paulo, because he was carrying leaves and thin branches of the Piper and Peperomia species which he had gathered at the Caxiuanã National Forest. The material had been legally collected by a botanist from the Museu Paraense Emílio Goeldi museum and the researchers mistakenly thought that the authorization to collect the samples also included the authorization to transport them. Kato is getting ready to request new licenses and is doing everything to comply strictly with the law. “We are making a point of interpreting the rules correctly so that our license requests for specimen collection are forwarded to the CNPq and to the System for Authorization and Information on Biodiversity (Sisbio) at the Ministry of the Environment” he says. “The process has been generally simplified and there is no longer any need for licenses for activities that involve basic research only”, he states. “On the other hand, Sisbio has still not been able to regularize the receipt of license reports already granted and those which have already expired”, he adds.

The requirement to obtain several licenses and the long time to get them makes research studies unfeasible, says professor Maria Fatima das Graças Fernandes da Silva, of the Natural Products Laboratory at the Federal University of São Carlos. She mentions a research study she is participating in, which entails eliminating pests that damage hardwoods such as cedar and mahogany, in the North of Brazil. “African cedar, which is resistant to an insect that attacks mahogany, was introduced into Brazil, but now the African cedar is being attacked by a fungus. We need to bring the damaged tree and the fungus to São Paulo, but this material will not be allowed to go beyond the airport”, she says. The problem is the absence of a license from Ibama to transport this material. “Ibama employees are always very helpful, but there is a bureaucratic problem which seems to be unsolvable. We have tried to solve this issue through the Brazilian Chemical Society (SBQ) for quite some time. We sent letters, voted on motions at congresses, but to very little effect. The license granted by the CNPq has helped to some extent, but questions are constantly being asked and it is not always possible to travel with a plant or an insect from one region to another”, she states.

The fear of being penalized is a secondary detail when one evaluates how the existing legislation jeopardizes research on biodiversity in Brazil. Vanderlan Bolzani, a professor at the Chemistry Institute of Araraquara of the State University of São Paulo (Unesp), draws attention to the paradox: by creating obstacles to the basic research studies conducted at universities and research institutes, the law is preventing in-depth studies on the micro molecular universe which could lead to information on whether some substances stemming from biodiversity have actual value. “The fact that some environmentalists and supervising authorities lack in-depth knowledge on biology, chemistry, and pharmacology leads to simplistic analyses of biodiversity and the erroneous impression  that the plants in Brazilian biomes are the source of alot of money – leaves represent dollars”, says Vanderlan. “In its basic state, biodiversity is not as valuable as so many people think. Nature is an inexhaustible source of forms of life, whose evolution, regulation and adaptation took hundreds of years, but Nature does not give anything away for free. We are the ones who have to understand Nature, study all of its aspects so that we can discover how it works and what it can offer us, or what we can copy from it”, the professor adds. She coordinates Bioprospecta, a program that focuses on the search for new molecules in nature that might be financially attractive. The program is included within the scope of the Biota-FAPESP program.

Vanderlan coordinated a theme project funded by FAPESP, with the participation of 40 scientists. The project entailed the search for and study of molecules among species found in the Cerrado and Mata Atlantica, Rain Forest, regions. The project was begun in 2005 and was concluded in 2009, yet the researcher never got the license to study the plants she needed. The license process was interrupted because the CGEN decided that it did not have the internal procedures necessary to evaluate and grant the license. Even so, enormous fines in millions of reals were imposed, due to a misunderstanding. “There was a huge misunderstanding. Ibama concluded that the group had sent genetic material abroad; actually, what happened was that a patent was filed by means of the Patent Cooperation Treaty (PCT), under which national phases of the project were continued in specific countries”,says Leopoldo Zuaneti, legal advisor to the Agência Unesp de Inovação, innovation agency. “We are planning to file an administrative appeal and trying to have closer ties with the authorities responsible for this matter to regularize the process”, he states.

art4319img3EDUARDO CESARVanderlan Bolzani says she is in favor of laws or  a way to protect the country’s natural resources. “It is no coincidence that I made a huge effort to comply with all the procedures to get a license from the CGEN”, she states. “We have not been able to collect any samples since 2005, due to an order handed down by the CGEN, which did not grant us the license we had anxiously hoped to get, and informed us that the request was ‘suspended’. It’s difficult to understand this! Isn’t the law applicable? Legally, we should not have been fined if we hadn’t received any document from the CGEN informing us of any irregularity in our request. We are training human resources in this field and producing research studies that will raise the scientific level of our country in international rankings. In fact, we were a pioneer group in this program run by FAPESP, which nowadays is a successful example of organized research studies on biodiversity”, she says. In 2007, Vanderlan was invited by the American Chemical Society to give a lecture at an international conference held in Las Vegas. During the lecture, she reported the sample collection problems faced by Brazilian researchers working with natural products and pharmacology. “One of the researchers who was coordinating the event emphasized: Professor, come collect samples in America. We don’t forbid scientists to do their work here”, she said.

According to the professor, the CGEN has difficulty dealing with projects classified as “bioprospecting”. “Recently, I have given a lot of thought to the stress caused by research studies on the chemistry of natural products and I ask myself if it’s all worthwhile! I’ve been thinking a lot about my next project – I’m going to use this word – which is misunderstood and has caused so many problems. The fact that a research study glimpses some kind of financial potential does not mean that this will materialize. This is something unpredictable and it doesn’t make any sense to block any kind of research that focuses on searching for models or prototypes of pharmaceuticals, cosmetics, agrochemical products, dietary supplements”, says the professor. One solution, says Vanderlan, would be to expand the license model of the CNPq, which she had helped test at the invitation of the organization. “At the time, I praised the license model and considered it  a huge advance that could be expanded to speed up the process of obtaining licenses for research projects with commercial potential and ensure that, if a patent were filed later on, the interested parties would make a point of discussing how the benefits would be shared”. Vanderlan stresses that Brazil has a natural vocation for research on natural products and that there are many researchers working in this field of research who do not realize that they are doing something illegal. “Many people continue doing research without realizing how vulnerable they are”,she says. “In the course of the International Biodiversity Year, during the Conference of the Parties, held in Nagoya, the world – including the Brazilian committee – commemorated significant advances. The Brazilian committee was viewed as a strong negotiator of the agreement. Nagoya was an example of political advances. Meantime, the avalanche of fines imposed by Ibama on Brazilian companies that generate employment and wealth and on public institutions that develop high-level research projects do not provide us with any reason to celebrate”, she adds.

Extracta Moléculas Naturais, a Rio de Janeiro-based company specializing in the exploitation of biodiversity, also feels stifled by the bureaucracy. In 2004, the company obtained a license from the CGEN to organize a collection of extracts for commercial purposes. This license is renewed every two years. Actually, this collection was ready, because the company started organizing it in 1999, prior to the government’s provisional measures. The license, however, does not allow the collection of extracts – nowadays comprised of 30 thousand potentially active substances – to be used by Extracta itself to conduct research and develop products. “The regulations in effect require that each project be registered with the CGEN; this is a process that takes at least 11 months, which means that we can’t begin the bioprospecting of the resources”, says Antonio Paes de Carvalho, the president of the company and a professor of the Federal University of Rio de Janeiro. “In the meantime, Extracta has obtained the support of Finep and Faperj funding agencies for two innovation projects with the potential of becoming financially feasible and resulting in industrial partnerships. Both projects were registered with the CGEN. However, we were recently informed that we would have to follow the 11-month ritual. There must have been some information-related problem, because following the instructions literally would have jeopardized the possibility of using our biodiversity in the innovation of pharmaceutical components in Brazil”, says Carvalho.

art4319img4EDUARDO CESARFood for the piranha fish
In 1999, Extracta entered into an agreement with multinational pharmaceutical company GlaxoSmithKline. The agreement provided for sample collecting activities in order to enable the organization of the sample collection. In addition, it provided for the transfer of technology, investments in infra structure related to high-speed robot triage, as well for the bioprospecting of the collection to isolate at least 10 molecules that would achieve targets of interest to research studies on human health. “At the time, it was the biggest technological outsourcing contract entered into by a pharmaceutical company in the Southern Hemisphere. News on the contract was even reported in Nature journal. And everything was done in compliance with the 1992 Convention on Biological Diversity”, recalls Carvalho. Due to the government’s provisional measures of 2000 and 2001, the work being done by Extracta slowed down and the pharmaceutical company decided not to renew the contract. “The regulatory framework drove away the international business community from the field of bioprospecting and from studies on the benefits of our biodiversity”, he says.

Braulio Dias, secretary of Biodiversity and Forests, states that the laws are here to stay. “Anyone betting on the possibility of going back to the former status quo stands to lose”, he says. “The world changes, society is dynamic and society’s expectations are reflected in the legal framework. One hundred years ago, for example, no patent requests were filed in Brazil. Anybody could take possession of knowledge generated by others. Additionally, many people thought this was a good thing. Patents arose as an incentive for companies to have a guarantee and the need arose to adapt to the new reality”. According to Dias, the access to genetic resources and the sharing of benefits are similar issues. “The Brazilian Constitution upholds the rights of the indigenous people, of the quilombolas (descendants of fugitive slaves). The Convention on Biological Diversity indicates the need to ensure the sharing of benefits. Respect for these rights is important from the ethical and environmental standpoint. If we do not respect the forest, it will not survive”, he states.

The secretary acknowledges, however, that the criticisms voiced by the researchers are valid and says that the internal procedures of the CGEN for the granting of licenses will be revised. “In the beginning, the granting of licenses for commercial use was a slow process. We went through a learning curve and the fact is that we are still in the curve. The first requests were the ones that were the most affected – they were the meat for the piranha fish”, he states. One of the aspects that the ministry intends to deal with is the granting of special licenses, extended to all the researchers working at a given institution. “It is already possible to obtain this kind of license nowadays and the objective is to improve research project evaluation and eliminate the bureaucracy related to this process”, says Dias. The secretary also agrees with the sharp criticisms voiced in relation to the laws, which indicate the exerting of control and the establishment of penalties but do not create any instruments to encourage research. “We have to expand the research efforts. The government has begun doing so already, through the launching of such programs as PPBio and Sisbiota, but this is not enough”, he says. The secretary was referring to the Program for Research on Biodiversity (PPBio), created by the Ministry of Science and Technology with the objective of providing support for biological collections and inventories and  funding projects focused on the sustainable stewardship of biodiversity and bioprospection, and to the National System for Research on Biodiversity (Sisbiota), a research network whose objective is to increase knowledge on biodiversity. The Sisbiota program is funded by the federal government and by 18 state agencies that provide funds for research projects, among which is FAPESP. “Ibama’s actions are a paradox: the government fines the government. Unless the registration system becomes efficient, the goals of PPBio and of Sisbiota could be adversely affected”, says Vanderlan Bolzani.

Definitive framework
Even though the legislation is here to stay, Braulio Dias states that it has to be improved. “A provisional measure is an emergency law. It is necessary to enact a definitive law”, he adds. This will not be an easy task, even within the realm of the federal government. In 1995, the then senator Marina Silva submitted the first bill of law on genetic resources and Congress began debating the issue. The discussion was overtaken by the enactment of the provisional measures of 2000 and 2001. In 2004, the CGEN forwarded a draft in this respect to the Office of the President of the Republic for the purpose of regulating the matter. Differences between the Ministry of the Environment and the Ministries of Science and Technology, Agriculture, Defense, and Foreign Relations led the draft to be set aside. In the opinion of Braulio Dias, the approval of the Nagoya Protocol (see Pesquisa FAPESP nº 178) has given rise to the possibility of making changes in the Brazilian legislation. “Strict control to verify whether the material is leaving Brazil illegally will no longer be necessary, because the countries where this material is being taken will also have to establish restrictions”, he states. The researchers prefer not to wait, because at least two years will be necessary before the Nagoya Protocol actually goes into effect. “We will have to mobilize researchers, learning institutions and research institutions and funding agencies to discuss radical changes in legislation with the CGEN”, says Carlos Joly, a professor at the Biology Institute of the State University of Campinas and coordinator of the Biota-FAPESP program.