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LEGISLATION

Changing expectations

Biodiversity Law creates new rules for researchers and companies, but also leads to regulatory delays

036-039_Lei-da-Biodiversidade_242A bureaucratic impasse has created an unusual obstacle for scientists and companies doing research involving genetic material from terrestrial and marine organisms—plants, animals, algae and micro-organisms that make up Brazil’s biodiversity. For five months, they have been unable to send samples for studies abroad or publish scientific results from these materials. It turns out that the new Biodiversity Law (No. 13,123) came into force in November 2015, but its regulations have been delayed. This has created a legal vacuum, preventing entities such as the Brazilian Institute of the Environment and Renewable Natural Resources (IBAMA) and the National Council for Scientific and Technological Development (CNPq) from filling requests for current research samples, as they had done in the past. New authorizations to start research have also been suspended.

“Overnight our work stopped. Not having considered the rules for transitioning from one law to another is unacceptable,” says Luís Fábio Silveira, curator of ornithological collections of the USP Zoology Museum (MZ-USP). In December 2015, he received a letter from IBAMA turning down a request to send bird tissue samples to a laboratory in the United States, which was to do genetic sequencing of the material. The agency explained that it had no legal authority to issue licenses.

The problem occurred after the government chose to have informal consultations on the regulatory decree after approval of the law in May 2015. The suggestions were consolidated into a text presented in November 2015, the day before the law was to go into effect. The decree, however, contained items that were disputed by the Office of the Prosecutor for the Public Interest and organizations representing the scientific community and environmentalists, and the wording was removed. A new proposal was presented only in April 2015 for public comment until May 2, 2015. “This problem could have been avoided if the government had opened up the formal public comment period the day after approval of the law and discussed all suggestions beforehand, since there were 180 days before the law was to take effect. That way on the day after the new law went into effect, the regulations would already have been published,” says Bruno Sabbag, a professor of environmental law at Pontifical Catholic University of São Paulo (PUC-SP). “Keeping the previous legislation was not considered, because there were many problems in its application. It took years for authorization requests from companies to be processed because of excessive bureaucracy.”

Once there are regulations in place, research institutions and companies will have new rules for conducting studies of Brazilian biodiversity. It is already possible to highlight a number of changes that will affect the work of researchers and companies that depend on access to genetic resources, such as the pharmaceutical and cosmetics industries. Indigenous peoples, small farmers and traditional communities, such as former settlements of runaway slaves known as quilombos, will also be affected by the law. This is because they can be holders of what is known as traditional knowledge, that is, information and practices related to the use of native species, such as plants with medicinal properties, and they will be compensated for the use of this knowledge.

The main new feature of the law is that, in order to gain access to the biological material of species, only an electronic registration of the researcher or the company will be required, and that has to be done at the most advanced stages of the research, that is, before sending material abroad, claiming intellectual property rights, product marketing or dissemination of results in scientific circles or through publication. The previous legislation, a 2001 interim measure, required the researcher or company to make a prior request to entities such as IBAMA and CNPq, and, without such authorization, it was impossible to begin the research. “Absent the bureaucracy surrounding biodiversity access, the measure should expedite the process of developing new products,” says Elisa Romano, a policy and industry expert at the National Confederation of Industry of Brazil (CNI), one of the institutions representing the business sector during the preparation of the law.

The measure answers an old plea from the scientific community and companies, which in recent times have operated without strictly adherence to the law. “This happened because of the problems imposed by the 2001 interim measure and the legal uncertainty it caused,” says Romano. In some cases, companies had to pay huge fines. In 2010, for example, the cosmetics company Natura was fined R$21 million for use of biodiversity without authorization. “The registry is a step forward. Research can begin without the need to wait for permission from a public entity,” says Helena Nader, president of the Brazilian Society for the Advancement of Science (SBPC).

The wording of the regulations provide for establishment of the National Genetic Heritage Management System (SISGen), under the Ministry of the Environment (MMA), which will be responsible, among other things, for managing the registry. “The goal is to simplify the research and facilitate the oversight of registrants,” says Rafael Marques, director of the Department of Genetic Heritage at the MMA. Another requirement is that, in certain cases, scientists and companies will be required to seek permission directly from the indigenous peoples and traditional communities before beginning research involving their genetic heritage. This will be done only when it is possible to determine that a species to be studied is associated with traditional knowledge whose origin can be traced to a community. The authorization may be conveyed ​​in writing, signed by a representative of the community, or it can be through audiovisual means, with a recorded video testimony of the representative providing consent. The Genetic Heritage Management Council (CGEN), a part of MMA, will be responsible for overseeing the authorization and distribution of financial compensation.

Copal tree at the Botanical Institute in São Paulo: the plant has been used for centuries to treat skin wounds

Eduardo CesarCopal tree at the Botanical Institute in São Paulo: the plant has been used for centuries to treat skin woundsEduardo Cesar

Financial compensation
The law also includes new guidelines regarding the sharing of benefits. As a general rule, the company has to deposit 1% of net profits from the product into the National Benefit Sharing Fund (FNRB).  The money then gets distributed by the federal government to indigenous peoples and traditional communities. But if this type of research is demonstrably associated with traditional knowledge, the company will have to negotiate compensation directly with the group that owns the knowledge. In addition, it will have to transfer 0.5% of net profits from the product into the fund. Intermediate suppliers of products such as inputs and raw materials, micro-enterprises, individual micro-entrepreneurs and researchers are exempt from the rules of financial compensation. Romano, of CNI, notes that the law allows non-monetary compensation. “The company can make an agreement with the traditional community and instead transfer some technology to it. Other forms of cooperation between the parties involved are also possible, such as training and biodiversity conservation projects,” she says.

Vanderlan Bolzani, professor at the Chemistry Institute of São Paulo State University (IQ-Unesp), Araraquara campus, and member of the Steering Committee of the Biota-FAPESP Program, points out that the law requires only companies, not researchers, to share benefits.  “Basic research will benefit, for example, in studies of the molecular structure of plants. Science does not access biodiversity just to make money,” she says.

Other issues still depend on regulations of the law as yet undefined. The proposal initially presented by the Executive Branch, prepared ​​by MMA after the public comment period, worries several entities. The SBPC, for example, objects to the requirement that a researcher must register in advance with the Brazilian government in order to use public databases of DNA sequences and protein from abroad, such as GenBank. “No other country requires a researcher to register to use information from public international databases,” says Beatriz Bulhões, a science policy expert and SBPC’s representative to the Brazilian Congress.

The SBPC is also opposed to the creation of SISGen, which is provided for in the regulation, but was not mentioned in the law. And it argues that the new registry should be centralized at CNPq. “There is already a CNPq platform where research on biodiversity is recorded. It would be more efficient just to enlarge it, rather than creating a new system from scratch. This will result in unnecessary costs for the government,” says Helena Nader.

Tracking
Non-governmental organizations such as the Socioenvironmental Institute (ISA), also have reservations about the proposal. The argument is that the new legislation and decree that would prevail exclude issues of concern to indigenous peoples and traditional communities. By law, if a company finds an innovative application of a medicinal plant that bears no relationship to how it was used ​​by the traditional community, the community would receive no compensation. ISA advocates a more comprehensive compensation. “In these cases, communities have a role in the management of the species, without which it would not be available for exploitation,” says Nurit Bensusan, assistant coordinator of ISA policy and law.

ISA is also proposing investments in initiatives to more efficiently track the origin of traditional knowledge to produce fairer compensation. The problem is that this knowledge is often not confined to a single community, but spread out among various. “In the case of the oldest peoples, it is often difficult to trace the exact origin of knowledge,” says Maria das Graças Brandão Lins, coordinator of the Specialized Center for Aromatic, Medicinal and Toxic Plants of the Federal University of Minas Gerais (UFMG). She cites the example of a typical Cerrado tree, the barbatimão, whose bark is rich in a substance used to treat wounds and skin diseases. “The ancient literature shows that this knowledge was shared by several groups of people who lived in the Cerrado. There are not enough records to determine the exact origin of who first began exploiting the barbatimão,” she says.

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