On this Friday, September 5, Ordinance #1,392 of May 22, 2025, was published in the Federal Register establishing an Interministerial Working Group to regulate Articles 13 and 17 of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity. The Nagoya Protocol was ratified in Brazil by Decree #11,865 of December 27, 2023.

Coordinated by the Ministry of Environment and Climate Change, the Group will include representatives from the following government agencies and entities: the Ministry of Foreign Affairs; the Ministry of Development, Industry, Commerce, and Services; the Ministry of Science, Technology, and Innovation; the Ministry of Agriculture and Livestock; the Ministry of Health; the Ministry of Agrarian Development and Family Farming; the Brazilian Patent and Trademark Office (BRPTO); Brazil’s FDA (ANVISA); and the Federal Attorney’s Office (AGU).

The Group is advisory and will be responsible for formulating proposals to regulate Articles 13 and 17 of the Nagoya Protocol. Article 13 requires the country to establish a focal point with information on domestic authorities of competent jurisdiction, indigenous communities, and relevant locations. Article 17 concerns the monitoring of the use of genetic resources by:

• outlining checkpoints for users of genetic resources to submit information regarding prior consent, such as the source of genetic resources and mutually agreed terms;
• encouraging users and providers of genetic resources to include information on their implementation in signed agreements, as well as requiring the publication of reports;
• promoting the use of cost-effective communication tools and systems.

The Ordinance sets a 90-day deadline for submitting these proposals, which will begin from the date of the Group’s first ordinary meeting. The full text of Ordinance #1,392/2025 can be accessed in Portuguese here.

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