Brazilian Biodiversity law: Despite enhancements, new rules are criticized by the scientific community

New law will require all researchers working with samples of biological material in Brazil to take precautions in order to follow the law. The regularization of all projects and accesses must be held until November 5

The biological diversity found in Brazil is incalculable and the fear of biopiracy lead Brazil to approve, in 2001, a law to curb such practices, the so-called provisional measure 2.186. Now, the law nº 13.123, from May 20th, 2015, called the Biodiversity Law, created by Decree No. 8.772/2016, will enter into force. It contains the new rules for access to genetic heritage and associated traditional knowledge of Brazilian biodiversity resources. In practice, the legislation will require that all research and development institutions in the Biology and related fields, product manufacturers and producers or researchers operating, respectively, finished product or reproductive material, developed from genetic heritage take precautions to follow the law regarding the registration of this material and the international shipment consignment.

The procedures for registration, finished product notification, sample shipment form and others provided by law, shall be carried out in the Brazilian National System of Management of Genetic Heritage and Associated Traditional Knowledge (SisGen) on the website: https://sisgen.gov.br/paginas/login.aspx All projects and access should be updated until November 5, 2018. The electronic system of the genetic heritage Management Council (CGen) is expected to go into operation by the end of August.

According to Dr. Manuela da Silva, who coordinates the sectoral Chamber of the Academy of CGen, the current law has brought advances compared to the previous, but still needs work, especially in the case of research without commercial purposes. She stresses the importance of researchers gathering to criticize and make suggest using the Academys Sectoral Chamber, the adequate and legitimate place for these discussions and proposals, since it is composed by representatives of the Academy, including the Brazilian Botanical Society (SBB), Brazilian Society of Microbiology (SBM), Brazilian Society of Zoology (SBZ), Brazilian Anthropology Association (ABA), experts in biotechnology and metagenomics, besides directors of CGen, including the Brazilian Society of the Progress of Science (SBPC), Ministry of Science, Technology, Innovation and Communication (MCTIC) and Ministry of Environment (MMA). I believe we are advancing in the achievements of the Academy in the context of the Biodiversity Law, she celebrates.

Among the resolutions adopted by the sectoral Chamber (in March), is, for example, resolution No. 05, which will establish a single term between the Brazilian and the foreign institution, with a shelf life of up to 10 years (and no more only 5 years), which include all shipments for the same recipient. This new resolution revoked Resolution No. 01 on the previous Material Transfer Agreement (TTM).

Despite the advances, Brazilian researchers studying Brazilian biodiversity published a letter in the journal Science entitled Brazils government attacks biodiversity with harsh criticism of the new Law and its negative consequences. The document refers to the system created as Draconian and Byzantine. In it, researchers warn of the risk of compromising scientific research as well as its noncompliance, including unregistered dissemination of scientific results, even based only on public databases such as GenBank, or data, or previously published results, will bring heavy fines. The researchers point out that commercial activities such as the export of ornamental fish, plants, grains and other marketable products, are not affected by the law. According to them, if not repealed or reformed, this Byzantine maze of requirements and unnecessary threats will decimate scientific research on Brazilian biodiversity. The document also stresses that the Brazilian government should implement laws that facilitate international collaboration and encourage research on biodiversity rather than stifle it. Otherwise, a substantial part of the worlds biodiversity and its benefits may quietly disappear behind a wall of bureaucracy. The letter is signed by researchers from the Philosophy, Sciences and Arts School of Ribeirão Preto, the Institute of Biosciences (IB), the Zoology Museum (MZ) at São Paulo University (USP) and the National Museum at Rio de Janeiro Federal University (UFRJ).

On the other hand, Dr. Maria de Lourdes Oliveira, virologist of the Instituto Oswaldo Cruz (IOC/Fiocruz), points out that most critics pointed out by the scientific community refers to the application of the new Legal framework biodiversity in non-profit scientific research. To her, such critical analysis is essential, salutary and brings important contributions. Any process introducing new bureaucracies to those existing already is against innovation in any area, it constitutes a setback. And, exactly under such perspective, the new Legal Framework for Science, Technology & Innovation, was approved, facilitator landmark in several respects, a remarkable advance. If we aim to innovate, we need to streamline processes. Otherwise, it will be complex to survive in a globalized world, where excellence and swiftness are words of order. The role of the researcher, the scientist, is to think, to generate and apply knowledge to improve the quality of life. Turning researchers into bureaucrats to feed, filling dozens of government databases that do not talk to each other is a waste of energy, time, and resources – the latest for Brazilian taxpayers – has invaluable scientific and economic impact she adds. The researcher assures that SisGen, a proposed system for registering accesses in the scope of the new Biodiversity Law, constitutes one of these bases. For her, the new Legal framework has undeniable, indisputable value in the context of the economic exploitation of our biodiversity. What we can imagine and criticize is the obligation to register, the level of detail required for the development of non-profit research. Finally, the expert stresses that the critics are not only towards museologist colleagues, but involve researchers working in different areas such as epidemiology, phylogeny, ecology, zoology, among others. In this context, for example, the IOC sent the CGen a document on the negative impact of the law and the difficulties it imposes for conducting research with importance in Public Health, as well as on the referential activities of our laboratories for the Ministry of Health and World Health Organization, focused on epidemiological and laboratory surveillance of diseases she concludes.

In another manifestation published in the Annals of the Brazilian Academy of Sciences (ABC), researchers from almost 40 different institutions say that, if the law takes effect, will cause a bureaucratic collapse of biodiversity research in Brazil. According to the article Brazilian legislation on genetic heritage harms Biodiversity Convention goals and threatens basic biology research and education , biological collections and laboratories based in Brazil will no longer work due to high operating costs and legal impediments that affect the access to national biodiversity by foreigners. On the global stage, the Brazilian science surely will lose competitiveness, points out the document.

Sandro Bonatto, a geneticist and professor at the Pontifical Catholic University of Rio Grande do Sul (PUC-RS), who works with evolution and conservation of biodiversity, agrees with colleagues. According to him, the new rules, especially the registration in SisGen, are harmful. In practical terms simply because it will require, in some cases, huge waste of time for researchers to a pointless activity (for biodiversity conservation purposes), he argues. The geneticist believes that the new rules should bring very strong new benefits to counterbalance this cost in working hours of scientists. Dr. Bonatto regrets the bureaucracy and reminds that scientists already have to obtain several authorizations (Sisbio, CITES, etc.).

Asked about the criticisms levelled at electronic register provided for in Law 13.123/2015, the President of the Genetic Heritage Management Council (CGen) of the Ministry of Environment, Raphael Samuel Marques, ensures that most of the concerns have been resolved in the CGen by the Academy itself, which is a member and sits with voice and vote in this Council. Ainda de acordo com ele, essas críticas já foram respondidas por outros cientistas, inclusive representantes da SBPC, da Fiocruz, e pelo Professor Dr. Bráulio Dias, who besides being a scientist, has been Executive Secretary of the Convention on Biological Biversity at the United Nations. The article signed by representatives of SBPC and by Dr. Bráulio can be accessed here.

The MMA Technical Area claims that the Brazilian Academy is very large and diverse and, since the new law on access to and distribution of benefits is still recent, not all researchers are aware of the advances that it brings  to encourage research, technological development and innovation. According to them, the group featuring criticism of the declaratory operational system, SisGen, is very specific, composed by researchers working with taxonomy and work in museums. In response, the technial area emphasizes the importance of the comparative analysis between the Brazilian legislation and laws from other countries to learn how it sits in this panorama. Among those who are intimate to other legislations, there is a consensus that law 13.123/2015 is the one those encouraging research and innovation, and that might be a model for the world. The National Industry Confederation (CNI) has made a comparative study in over 100 countries, which corroborates this perception. . Also according to the technical area of MMA, it is clear that the criticism of the System arises from the ignorance about the new legislation and the instruments for its implementation. The MMA has prepared a public notice about each of the issues pointed by taxonomy researchers in Science . At the end of the Note, a table summarizes the major complaints and how they are actually being addressed in legislation and what can be done to address the scientists concerns.

Resolutions and technical orientations approved in the recent months should facilitate the process

Dr. Manuela da Silva clarifies that the issues pointed by researchers in the mentioned articles were dealt with in resolutions and technical orientations approved in the recent months. She explains that with the resolution No. 10, June 19, researchers from the Phylogeny, taxonomy, systematics, ecology, biogeography and epidemiology fields, may register their researches using a simple form, which will be available in the next version of SisGen. The researcher will be able whether to indicate the registration numbers, single indicators of default Resource Locator (URL) or equivalent in which are found this information in databases, information systems or open access repositories to the Brazilian State.

According to Dr. Manuela, other resolutions also simplify the completion of the SisGen. It is the case of CGen Resolution nº 6, from March 20, which establishes the minimum taxonomic level required to identify each group of organisms in the case of biodiversity research in taxonomy and phylogeny, as follows: I – domain (Archaea, Bacteria and Eukarya) case of microscopic bacteria, fungi, and other microorganisms, with the exception of viruses; II-class, in the case of macroscopic algae; III-order, in the case of macroscopic fungi and animals; and IV-Family, in the case of viruses and plants. That is, the researcher who studies macroscopic fungi or insects may only indicate the order of these organisms, without the need to indicate the species of each sample. So, you will have the opportunity to make only one record for a given order instead of 1000 records of different copies of the same order, he adds.

Still regarding the minimum taxonomic level requirements, Resolution No. 8 from March 20th establishes that the researcher from any area, including those involved in technological development, studying non-isolated microorganisms from samples of substrates, for example, by means of metagenomics, may indicate the Domain as taxonomic level. Thus, the researcher will make a maximum of three records, one for each domain, i.e. to Archaea, Bacteria and Eukarya. Resolution No. 7, of March 20th simplifies the requirement to indicate the geographical location.

Since the implementation of resolutions Nos. 6, 7 and 8 of March 20, 2018 and resolution No. 10 of June 19, 2018 depends on new features to be implemented in the SisGen, the technical guidance CGEN nº 3, of June 19 was approved, which clarifies that the date of release of the registration by the CGen will be the release date of the SisGen version that contains these features. Therefore, those researches included in the scope of Resolutions No. 6, 7, 8, and 10, will have one year counting after the release of the new version of SisGen to be registered she explains.

Adequacy and regularization of access to the samples of genetic heritage and associated traditional knowledge

Under the previous law, research in epidemiology, evolution, phylogeny, ecology and other areas were exempted from prior registration, for understanding they had no profitable means. The new legal framework, introduced the compulsory registration of these.

It is considered as genetic heritage all genetic information originated from plants, animals, microbial species or species of other kinds, including substances derived from the metabolism of these living beings.

Access without proper registration and authorisation by the MMA is liable to fines to the researcher and the institution. The penalties range from warnings to fines for breaching the terms and may vary from R$10 thousand to  R$100 thousand (independent researcher) and from R$100 R$1 million per project (institution).

More information can be obtained by clicking here .

On the webpage of the Sectoral Chamber of the Academy of CGen  you can also find links/information and support documents for the understanding of the legislation and the correct completion of SisGen.

Other informational materials can be accessed on the Fiocruz website .…