New Decree Creates SisGen Registration Mechanism for Foreign Companies Accessing Brazilian Genetic Heritage and Associated Traditional Knowledge

Published yesterday, June 10, 2026, in the Brazilian Federal Official Gazette, Decree No. 13,014/2026 amends Decree No. 8,772/2016, which regulates Law No. 13,123/2015, to create a new mechanism for registering activities involving access to Brazilian genetic heritage and associated traditional knowledge carried out by legal entities headquartered abroad.

The main innovation introduced by the new rule is the possibility for foreign companies to register these activities in SisGen through a Brazilian scientific and technological research institution, whether public or private, even when there is no scientific collaboration between the parties. For this purpose, the parties must enter into an Association Agreement for Registration Purposes, an instrument of an exclusively regulatory nature designed to enable compliance with the obligations established under Brazil’s biodiversity access legislation.

The Decree clarifies that the Brazilian institution will act based on the information provided by the foreign company and will not be responsible for the technical, scientific, or operational aspects of activities carried out outside its scope of action or control.

The Brazilian institution will mainly be responsible for:

• carrying out the registration in SisGen;

• maintaining the relevant records;

• cooperating with the competent authorities in monitoring and inspection activities; and

• informing the competent authorities of any indications of irregularities of which it becomes aware within the scope of the Association Agreement for Registration Purposes.

  
  

The legal entity headquartered abroad, in turn, will remain responsible for:

• the accuracy and integrity of the information provided;

• compliance with all legal obligations arising from the Brazilian Biodiversity Law and its regulations; and

• informing the SisGen registration number in any intellectual property applications or product and process registrations resulting from the access activity.

  
  

The new model may not be used when there is effective scientific collaboration between the Brazilian institution and the foreign company for the performance of the access activity. It also may not be used in situations where there is a relevant corporate or commercial relationship between the parties, such as control, affiliation, commercial representation, or import arrangements.

In addition, the Decree establishes the Alliance of Brazilian Public Scientific and Technological Research Institutions for Biodiversity, known as APBio. This initiative will be coordinated by the Ministry of Science, Technology and Innovation and the Ministry of the Environment and Climate Change. APBio is intended to promote institutional coordination, technical guidance, transparency, and the dissemination of good practices related to the execution of association agreements. It may also promote support initiatives. Participation in the Alliance will be optional and will not be a requirement for entering into the agreements provided for under the new regulation.

This amendment represents an important step forward in the implementation of Brazil’s Biodiversity Law. It creates an alternative pathway for foreign companies that use Brazilian genetic heritage or associated traditional knowledge to regularize their activities in SisGen, without requiring the formalization of a scientific partnership with a Brazilian institution. At the same time, it seeks to strengthen traceability and oversight mechanisms for these activities by the competent authorities.

GSS continues to monitor regulatory updates that may affect your day-to-day activities. Please contact our team if you have any questions.