The Ministry of the Environment implemented on Monday (6) the National Genetic Heritage and Associated Traditional Knowledge Management System (SisGen). This platform is the result of the approval of the new Biodiversity Law (Law 13.123 / 15), which regulates the development activities of patents and resulting products, of research activities related to the use of genetic information from plant, animal, microbial species (including those isolated from humans and animals) and other natural origins, originating in the national territory, as well as the traditional knowledge of indigenous peoples and Brazilian culture.
The new legislation replaces the provisional measure that had been in force since 2001, which was constantly the target of complaints from the scientific community, due to its limitations. A direct result of the 1992 Convention on Biological Diversity and the Nagoya Protocol signed in 2010 by 193 countries, the Biodiversity Law seeks to guarantee legal security for researchers linked to research institutions, universities or industries, safeguarding the Brazilian genetic heritage from biopiracy and use improper.
From now on, responsible researchers who in some way, directly or indirectly, work with materials originating and derived (including by-products) from the Brazilian genetic heritage, even those involving studies in silico, must register at the beginning of each project on the SisGen platform. Registration is mandatory and will be necessary to ensure that publications, presentations at conferences, filing of patents, sending samples to foreign partner institutions, provision of related services and product development can be carried out without risk of penalties and sanctions for those involved.
Activities that involve access to genetic heritage or traditional knowledge in an area considered essential to national security, or in jurisdictional waters or under national jurisdiction, must be previously authorized by the Genetic Heritage Management Council (CGen).
Scientific research in progress that already has prior authorization, and requests that are being processed, must be adapted to the new legislation, and researchers must register on the platform. Research projects carried out between June 30, 2000 and November 20, 2015, in disagreement with the legislation currently in force, must be regularized by the researchers, with registration on the SisGen platform within a period of one year (therefore, until November 6, 2018).
Those researchers who requested intellectual property rights, made commercial use of a developed product or published partial or final project results between November 17, 2015 and November 6, 2017, must carry out the regularization of the research on the platform, also within the period of one year.
Unicamp
The Dean of Research (PRP) prepared a set of guidelines for researchers to ensure that Unicamp's scientific activities are in accordance with the new Biodiversity Law. An internal ordinance formalized the new composition of the Genetic Heritage Working and Monitoring Group (PATGEN).
Chaired by researcher Glyn Mara Figueira, from the Pluridisciplinary Center for Chemical, Biological and Agricultural Research (CPQBA), the Working Group has representatives from teaching and research units that in one way or another develop work related to the national genetic heritage, in addition to Agência Inova Unicamp and the Attorney General’s Office.
The information prepared by the Genetic Heritage Working and Monitoring Group for use by the Unicamp community can be consulted at PATGEN website. In case of doubts about the procedures to be adopted, the responsible researchers should contact the Ministry of the Environment by email cgen@mma.gov.br. SisGen can be accessed at the address https://sisgen.gov.br.
