On 05.12.2016, it was published the Decree n. 8772/2016 (“Decree”), that regulates Law No 13.123/2015 (“Act”), which provides for access to genetic resources, the protection and access to associated traditional knowledge and the sharing of benefits for conservation and sustainable use of biodiversity.
The Regulation, in similarity to the Act, stipulates that the following activities are subject to its regulations: (i) access to genetic resources or associated traditional knowledge; (Ii) remittance abroad of genetic heritage samples; and (iii) economic exploitation of finished product or reproductive material originating from access to genetic resources or traditional knowledge performed after the enactment of the Act.
The following activities are excluded from the Decree: (i) economic exploitation of finished product or reproductive material, and (ii) access to genetic resources or traditional knowledge completed before 06.30.2000, publication date of the Provisional Measure No. 2,052/2000, which regulates the Convention on Biological Diversity in Brazil.
The Regulation also defines the composition of the Board of the Genetic Heritage Management (CGen), responsible, among others, for coordinating and implementing policies regarding genetic resources management and traditional knowledge. In this sense, 12 (twelve) seats are held by the Federal Administration and 9 (nine) for civil society representatives. The Regulation states that the decisions shall be passed by a simple majority, which means the Federal Government does not depend on the agreement of the civil society for approval of any matter within the CGen.
It is worth noting that the Regulation sets out a number of guidelines for obtaining prior informed consent to access traditional knowledge of identifiable origin, such as the participation of indigenous peoples, traditional communities or traditional farmers in the definition of shared benefit modalities resulting from economic exploitation.
Finally, various administrative offenses are defined and may be punished with a warning, fine, temporary suspension of rights, embargo of activities, partial interdiction or total suspension of the activity, or the suspension or cancellation of certification or authorization. Fines can range from $ R10,000.00 (ten thousand Reais) to R$ 10,000,000.00 (ten million Reais) when the offense is committed by a legal entity
The lawyers of Bastilho Coelho Advogados are available for more information.