Federal Decree No. 13.014/2026, published on June 10, 2026, created APBio – the Brazilian Association for Support of the Management of the National System for Access to Genetic Heritage and Associated Traditional Knowledge and Benefit Sharing. Its purpose is to promote institutional coordination, guidance, transparency, and the dissemination of best practices related to association agreements for registration purposes. This measure is part of a set of actions adopted by the Federal Government to enable the registration of activities related to access to Brazilian genetic heritage and associated traditional knowledge by foreign companies.
Participation in APBio is optional and not a requirement for entering into association agreements. Therefore, foreign companies may enter into agreements with both member and non-member institutions of the Alliance.
During discussions held within the SisGen Thematic Chamber – coordinated by the Genetic Heritage Management Council (CGen) – it was reported that the association agreements signed with institutions participating in APBio should be operationalized, within the scope of the future SisGen 3.0, through a standardized electronic adhesion model. The expectation is that this functionality will simplify the formalization of the associations necessary for the registration of activities carried out by foreign companies, reducing transactional costs and providing greater legal certainty and uniformity to procedures.
Another innovation brought about by the Federal Decree is the creation of the so-called “association agreement for registration purposes,” an instrument that will allow foreign companies to register their access activities in the National System for the Management of Genetic Heritage and Associated Traditional Knowledge (“SisGen”) through a national scientific and technological research institution, even if there is no scientific collaboration between the parties.
The measure seeks to resolve one of the main difficulties faced by foreign companies subject to Federal Law No. 13.123/2015 (Brazilian Biodiversity Law), especially in cases where access to Brazilian genetic resources occurs without the direct participation of a Brazilian research institution.
Thus, the new Article 22-B of Federal Decree No. 8.772/2016 – amended due to the recently published Decree mentioned above – establishes that the national scientific and technological research institution will act exclusively to enable the registration of the activity in SisGen, exercising regulatory and administrative functions.
The published rule also expressly removes any technical, scientific, or operational responsibility of the Brazilian institution in relation to activities conducted by the foreign company outside its scope of action or control. In turn, the company based abroad will be responsible for providing the necessary information for registration, ensuring the veracity of this information, and fulfilling the other obligations foreseen in the legislation applicable to genetic resources and associated traditional knowledge.
Federal Decree No. 13.014/2026 entered into force on the date of its publication, June 10, 2026.
This material is exclusively institutional and informative in nature, limited to presenting general normative and administrative aspects of the subject.
Evelini Oliveira de Figueiredo Fonseca | evelini.fonseca@nascimentomourao.adv.br
Partner in the Environmental, Regulatory and Biodiversity Law area.
Bruna Aveiro Santos | bruna.aveiro@nascimentomourao.adv.br
Lawyer in the Environmental, Regulatory and Biodiversity Law area.
