New Rules For Genetic Resources

Author:Ms Marta García
Profession:Moeller IP Advisors
 
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On May 11, 2016 the Brazilian government published Decree No. 8,772, which regulates Law No. 13,123/2015, related to the access of components of the Brazilian genetic heritage, protection of and access to associated traditional knowledge and the sharing of benefits for the conservation and sustainable use of Brazilian biodiversity.

This law defines genetic resources as "information of genetic origin resulting from plant, animal, microbial species or species of other nature, including substances derived from the metabolism of these living beings," while traditional knowledge relates to the "information or practice of indigenous peoples, traditional communities and traditional agriculture on the properties or direct or indirect uses of genetic resources."

Decree No. 8,772 lists the following activities as being subjected to the requirements of Law No. 13,123/2015: I) access to genetic resources or associated traditional knowledge; II) shipment abroad of genetic resources samples; and III) commercial exploitation of finished products or reproductive material (plant propagation or animal reproduction material of any genus, species or cultivation resulting from sexual or asexual reproduction) obtained from access to genetic resources or associated traditional knowledge performed after the entry into force of Law No. 13,123/2015.

As we reported previously in this blog, biodiversity Law No. 13,123/2015 revoked Provisional Measure No. 2186/2001, aimed at fighting against biopiracy by ensuring that Brazilian indigenous communities received enough compensation for scientific research involving genetic resources of Brazilian biodiversity and traditional knowledge.

Provisional Measure No. 2186/2001 was criticized as being excessively bureaucratic, since it required prior authorization for the access to national genetic resources or associated traditional knowledge, which required the submission of documentation and reports to the Board of Management of Genetic Heritage (CGEN), causing delays and high costs for applicants.

Law No. 13,123/2015 established that access to genetic resources must be requested through an electronic registry in a database, which has been established by Decree No. 8,772 as the National Genetic Heritage Management and Associated Traditional Knowledge System (SISGen).

According to the Regulations set forth in Decree No...

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