Registration and Access Authorization

What activities should be registered?

Article 12 of Law No. 13.123/2015 provides that the following activities must be registered:

  1. access to genetic heritage or associated traditional knowledge within the country carried out by a national natural or legal person, public or private;
  2. access to genetic heritage or associated traditional knowledge by a legal entity headquartered abroad associated with a national scientific and technological research institution, public or private;
  3. access to genetic heritage or associated traditional knowledge carried out abroad by a national natural or legal person, public or private;
  4. sending a sample of genetic heritage abroad for the purpose of access, in the cases of items I and II above;
  5. sending a sample containing genetic heritage by a national, public or private legal entity, to provide services abroad as part of research or technological development.

When should activities be registered?

The registration must be carried out prior to the shipment, or the application for any intellectual property right, or the commercialization of the intermediate product, or the dissemination of the results, final or partial, in scientific or communication means, or the notification of the finished product or reproductive material developed as a result of access (Article 12, § 2, Law No. 13.123/2015).

Which activities should be authorized by CGEN?

According to the new legislation, the following activities may, at the discretion of the Federal Government, be carried out with prior authorization, pursuant to the regulation (Article 13, Law No. 13.123/2015):

  1. access to genetic heritage or associated traditional knowledge in an area indispensable to national security, which will take place after approval by the National Defense Council;
  2. access to genetic heritage or associated traditional knowledge in Brazilian jurisdictional waters, on the continental shelf and in the exclusive economic zone, which will take place after approval by the maritime authority.