Federal Decree Establishes New Rules for Registration of Access to Brazilian Biodiversity by Foreign Legal Entities
Federal Decree No. 13,014/2026 (the “Decree”) was recently published to amend Federal Decree No. 8,772/2016—which regulates Brazil’s Biodiversity Framework established by Federal Law No. 13,123/2015 (the “Brazilian Biodiversity Law” or the “Biodiversity Framework”)—and to establish provisions on the registration of activities involving access to Brazilian genetic heritage or traditional knowledge associated with Brazilian biodiversity, through an association agreement to be entered into between a legal entity headquartered abroad and a national scientific and technological research institution (when there is no scientific collaboration between the institutions), and to establish the Alliance of National Public Scientific and Technological Research Institutions for Biodiversity (“APBio”).
According to the Decree, the association agreement for registration purposes to be entered into between legal entities headquartered abroad and national scientific and technological research institutions shall apply when there is no scientific collaboration between the Brazilian institution and the foreign entity. The association agreement shall be exclusively administrative and regulatory in nature, and shall be aimed at complying with the requirements of the Biodiversity Framework, ensuring traceability of access activities, maintaining communication with the competent authorities, and enabling regulatory monitoring of the reported information.
The Decree also delineates responsibilities: the national institution shall: (i) register the activity in the National System for the Management of Genetic Heritage and Associated Traditional Knowledge (“SisGen”) based on the information provided by the foreign entity; (ii) maintain the records; (iii) report indications of irregularities; and (iv) cooperate with monitoring, without assuming technical, scientific, or operational responsibility for activities outside its control.
The foreign legal entity, in turn, must provide complete and up-to-date information, ensure its accuracy, comply with applicable legislation, and report the SisGen registration number in intellectual property applications or registrations of products or processes resulting from the access. The registration mechanism through an association agreement shall not apply when there is scientific collaboration between the national scientific and technological research institution and the legal entity headquartered abroad for the performance of the access activity; or when the national institution acts as an importer, subsidiary, controlled entity, affiliate, related party, or commercial representative of the foreign legal entity.
Furthermore, the decree also creates APBio, with voluntary alliance aimed at promoting institutional coordination, guidance, transparency, and dissemination of best practices related to such association agreements.
The Environmental, Climate Change and Sustainability practice of Tauil & Chequer Advogados in association with Mayer Brown LLP remains available to provide further clarification.
