Brazil: A legal entity based abroad may affiliate with a domestic institution for the purpose of registering with SisGen

In summary

On June 11, 2026, Federal Decree No. 13,014/2026 was published, allowing activities involving access to genetic resources or traditional knowledge conducted by a foreign legal entity based abroad to be registered in the National System for the Management of Genetic Resources and Associated Traditional Knowledge – SisGen by a national scientific and technological research institution, through a partnership agreement, even in the absence of scientific collaboration between the institutions.

In more detail

Federal Decree No. 13,014/2026 amended Federal Decree No. 8,772/2016, which provides for access to genetic resources, the protection of and access to associated traditional knowledge, and the sharing of benefits for the conservation and sustainable use of biodiversity.

The new Decree provides that activities involving access to Brazilian genetic resources or traditional knowledge associated with Brazilian biodiversity carried out by a legal entity headquartered abroad may be registered in SisGen by a national scientific and technological research institution, whether public or private, through a partnership agreement for registration purposes, when there is no scientific collaboration between the institutions.

Regarding responsibilities, under the terms of the new Decree, the national scientific and technological research institution will act based on the information provided by the legal entity based abroad and will not bear technical, scientific, or operational responsibility for activities carried out outside its scope of action or control. Thus, responsibilities will be divided among the parties as follows:

1. The national scientific and technological research institution shall: (i.a) register the access activity in SisGen, in accordance with the data and information provided by the legal entity based abroad; (i.b) maintain a record of the partnership agreement for registration purposes and of the information used for registration; (i.c) report to the competent authorities any indications of irregularities of which it becomes aware in the course of executing the partnership agreement for registration purposes; and (i.d) cooperate, when requested by the competent authorities, with monitoring activities related to the registered information; and
2. The legal entity based abroad, in turn, shall: (ii.a) provide the national scientific and technological research institution with complete, up-to-date, and accurate data and information necessary for registration in SisGen; (ii.b) ensure the accuracy and integrity of the data and information provided; (ii.c) comply with the legal obligations set forth in Law No. 13,123/2015, its regulations, and other applicable rules; and (ii.d) provide the SisGen registration number in the intellectual property application or in the registration of a product or process resulting from the access activity.

The regulation, which took effect on the date of its publication, addresses an operational need for access and regularization of foreign users’ activities within SisGen, which previously lacked an adequate legal framework outside of formal scientific collaboration structures.