Brazil was one of the first countries to implement an Access and Benefit Sharing legislation for genetic resources and associated traditional knowledge: the Provisional Act 2186-16/ 2001, according to the Convention on Biological Diversity. The intention was to prevent biopiracy and ensure the fair and equitable sharing of benefits arising from the use of this biodiversity. In practice, however, this law created barriers to Research & Development (R&D), brought obstacles to innovation and patents, interfered in international collaborations and failed to distribute benefits satisfactorily. It was therefore criticized by civil society and the scientific community, who demanded legislation with clearer and simpler rules with less bureaucratic approaches and capable of establishing an atmosphere of tranquility and legal certainty to stimulate research and technological development that makes use of Brazilian biodiversity. After almost 15 years of maturity of the legal framework, President Dilma Rousseff sanctioned, on May 20, 2015, Law 13.123 (Biodiversity Law), which came into force on November 17, 2015. Consequently, the Provisional Act 2186-16 was revoked, however the regulatory decree was not published within 180 days. Finally, after almost 6 months, on 11/05/2016, the Decree 8.772 that regulates the Law was published. Thus, we had a scenario in which there was a law in force without regulation, which prevented its implementation. That is, we had for 6 months a legal vacuum. Now we have the law and the regulation, however we do not have the means to comply with the legislation, that is, the electronic registration and notification system available.
Under the new law, prior authorization procedures were replaced by a registration during research and technological development phase and by a notification prior to the start of economic exploitation of a finished product or reproductive material arising from access to genetic resources of the country and the access to associated traditional knowledge. That is, the benefit sharing occurs only when marketing such products.
According to the new definitions of access to genetic resources and research, the law reaches all activities carried out with Brazilian biodiversity, including activities that were not contemplated by Provisional Act 2186-16, such as research related to molecular taxonomy, phylogeny, molecular ecology, molecular epidemiology, etc. To develop any of these activities it will be required only an electronic registration through a system developed by the Ministry of Environment.
Another novelty of this new legal framework is that, in the article referring to the definitions used in the law, there is a single paragraph ensuring that the microorganism that has been isolated from substrata of the national territory, the territorial sea, the exclusive economic zone or the continental shelf is part of the national genetic resources.
Rigarding to benefit sharing, the rules are clearer and are prefixed. The benefit sharing may be non-monetary and monetary. In this case, the percentage will be 1% fixed or up to 0.1% per sectoral agreement. The Federal Government will be named as beneficiary of the benefit sharing, in the case of access to the genetic resources. And in the case of associated traditional knowledge, the beneficiaries will be indigeneous peoples, traditional communities and traditional farmers. Microenterprises, small businesses, individual microentrepreneurs, traditional farmers and their cooperatives with annual gross revenue equal to or less than that established in relevant legislation shall be excluded from the obligation to share benefits. The intermediate product, which is used in the production chain, which will add it in its production process, as an input, excipient and raw material, for the development of another intermediate product or finished product - is also exempt from the obligation to share benefits.
The new law establishes the National Fund for Benefit Sharing (FNRB), of a financial nature, linked to the Ministry of Environment, in which the user must deposit the amount of 1% or up to 0.1% (by sectoral agreement) of the net income obtained from the sale of the finished product or reproductive material from the national genetic resources. In the case of economic exploitation of product or reproductive material originated from associated traditional knowledge of identifiable origin, the deposit in the FNRB will be 0.5% of the annual net revenue. The monetary resources deposited in FNRB arising from economic exploitation of finished product or reproductive material from access to traditional knowledge will be used exclusively for the benefit of traditional knowledge holders. When the monetary resources deposited in FNRB are arising from the economic exploitation of finished products that come from access to genetic resources obtained from ex situ collections, they will be partially (60 to 80%) intended for the benefit of these collections.
As for regularization of the Provisional Act 2186-16 noncompliance, the rules are more flexible, there will be 100% exemption from payment of fines for irregularities related to the previous rules for research. In the case of technological development, the exemption may be up to 90% of the fines and the remaining due amount can be reversed on projects for conservation, sustainable use of biodiversity; technology transfer; free distribution of products in programs of social interest; etc.
There were also changes regarding the composition of the ABS National Competent Authority (Conselho de Gestão do Patrimônio Genético – CGEN), aiming to include representatives of civil society with the right to voice and vote. Now the representation of the academy, indigenous populations, traditional communities and traditional farmers and the business sector is 45%, and the other 55% will be representatives of federal public administration bodies and entities.
Regarding research undertaken by foreigners, the law determines that foreign institutions can only access Brazilian biodiversity in partnership with a Brazilian institution that, for all legal purposes, will be responsible for the activities of access to genetic resources. Therefore, the registration is the Brazilian institution responsibility. After completing the registration form, a receipt will be automatically issued.
Text by the researcher Manuela da Silva.