On May 11, 2016 the Federal Government published the Decree No. 8,772, which aims to regulate and clarify the provisions contained in Law No. 13,123/2015 – the Genetic Heritage Access Law – which address access to genetic heritage, protection and access to the associated traditional knowledge, and the sharing of benefits for conservation and sustainable use of biodiversity in Brazil.
The main regulated points are:
• The establishment of the National Genetic Heritage Management and Associated Traditional Knowledge System (SISGen) to carry out and control the access to the national genetic heritage and associated traditional knowledge;
• The definition of standards for the sharing of benefits arising from economic exploitation of a finished product or reproductive material that result from access to genetic heritage of Brazilian species;
• The regulation of the Benefit-Sharing National Fund (FNRB);
• The establishment of administrative sanctions; and
• The provision of rules for the adequacy / regularization of activities carried out under the previous legislation or activities in which there were access to national genetic resources without authorization.
The previous legislation required prior authorization for the access of national genetic resources or associated traditional knowledge. Going forward, a simple registration will be enough. The registration must be done, for example, in order to send material abroad, prior to requesting any intellectual property right and prior to publishing a scientific paper, among other requirements.
The new Decree also sets out the basis for the sharing of benefits resulting from economic exploitation of a finished product or reproductive material that results from access to national genetic heritage or associated traditional knowledge. The sharing of such benefits may or may not be monetary, and micro and small companies and individual entrepreneurs will be free from benefit sharing.
Finally, there will be a term of one (1) year from the availability of the system that allows the electronic registration (SISGen), so that activities carried out under the previous legislation can be adjusted to the new legislation (carrying out registration and sharing of benefits in case of economic exploitation). Moreover, activities in which there was access to genetic resources without authorization may be regularized within the same term. In order to regularize patent applications filed at the BPTO, applicants must submit proof of registration with SISGen.
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