How can foreign companies regularize activities from access to national genetic heritage?

Brazilian authorities seek to reduce bureaucratic processes and regularize activities resulting from access to biodiversity. With these efforts, on April 30, 2020 came into force Ordinance # 199/2020, published by the Ministry of the Environment, which establishes the necessary conditions for the signing of a term of commitment by foreign institutions with the Union, for the purpose of regularizing access to genetic heritage and associated traditional knowledge in accordance with the Brazilian Law on Biodiversity # 13,123/2015.

When we talk about biodiversity, it is unanimous that Brazil appears at the top of the megadiverse countries list hosting nearly 20 percent of Earth’s biological diversity. Brazil’s biodiversity is ever-expanding, with an average of 700 new species discovered each year, which increasingly attracts the interest of foreign industries. There is no doubt that this great economic potential must go hand in hand with responsibility for exploration.

As well established, genetic heritage refers to the genetic information of plant, animal, microbial species that occur naturally in Brazil or those that have acquired specific characteristics in the national territory. In this sense, the definition of genetic information is not superficial and applies to all parts of species, including the substances derived from the metabolism of these living beings. It goes without saying that genetic heritage is commonly related to some associated traditional knowledge.

According to said Ordinance, foreign companies that performed any of the following activities between June 30, 2000 and November 16, 2015 without association or partnership with a Brazilian institution must apply for the regularization:

(i) access to the genetic heritage or associated traditional knowledge;
(ii) access and economic exploitation of product or process derived from access to genetic heritage or associated traditional knowledge;
(iii) remittance of samples of genetic heritage abroad; or
(iv) disclosure, transmission or retransmission of data or information that compose or constitute associated traditional knowledge.

The regularization process is conditioned to the submission of a specific term made available within the National System for the Management of Genetic Heritage and Associated Traditional Knowledge (SisGen), regulated by the Ministry of the Environment, and which should be signed by a legal representative of the foreign company. Furthermore, it is also stated in the Ordinance that it is the duty of the foreign company to make an association or contract with a Brazilian institution to be able to register within SisGen, failure to comply with these requirements resulting in legal penalties.

Regularization is undoubtedly an important step as the activities related to genetic heritage have contributed to the development of new products, many of them protected by patents, for application in the most diverse sectors, such as cosmetics, pharmaceuticals, and agriculture.

Since Article 47 of Brazilian Law on Biodiversity # 13,123/2015 determines that the granting of intellectual property rights by the competent office on the finished product or reproductive material obtained from access to genetic heritage or associated traditional knowledge is conditioned to the registration or authorization, the goal is to remove any obstacles to promoting innovation and granting patents.

We are at your disposal should you need any assistance with this matter.

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