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. 8,772, the registration in the SISGen must be done prior to: the sending of material abroad, the application for any intellectual property right, the marketing of intermediate products or the dissemination of results in, for example, a scientific paper.
The new Regulations also establish the sharing of benefits resulting from commercial exploitation of a finished product or reproductive material resulting results from access to national genetic heritage or associated traditional knowledge. The decree specifies that the benefits can be a monetary or non-monetary compensation, such as the launching of projects for conservation and sustainable use of biodiversity or for the protection and maintenance of knowledge, innovations and practices of indigenous peoples, traditional communities and traditional farmers.
Additionally, Decree No. 8,772 clarifies that micro and small companies, as well as traditional farmers and individual entrepreneurs are exempt from benefit sharing.
The access to genetic resources or to associated traditional knowledge (and the commercial exploitation of finished products or reproductive material obtained therefrom) performed before June 30, 2000, are not subject to the requirements of Law No. 13,123/2015 and Decree No. 8,772/2016.
However, Decree No. 8,772/2016 has set a term of one year from the establishment of the SISGen for the activities listed above that were carried out under the previous legislation (Provisional Measure No. 2186/2001) to be adjusted to the provisions of the Law No. 13,123/2015. Additionally, in order for patent applications filed while Provisional Measure No. 2186/2001 was in force to comply with the new legislation, applicants will have to file a SISGen registration or access authorization receipt.
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