New regulation on Brazilian Genetic Heritage postpones deadline for regularization of the Brazilian biodiversity access register

The use and exploitation of Brazilian genetic heritage and the so-called associated traditional knowledge are regulated by international treaties and by the Biodiversity Law, which establishes rules for registration in the Brazilian National System for Management of Genetic Heritage and Associated Traditional Knowledge (SisGen) of any “access” to such resources of Brazilian biodiversity.

The “access” concept stablished by the aforementioned Law is quite broad and comprises research and development activities (up to the finished product phase for consumption) that use samples of species considered native from Brazil and/or use the traditional knowledge regarding its properties and applications.

Under the Brazilian Biodiversity Law (Law 13.123 / 2015), any and all “access” must be informed by means of a declaratory register in SisGen, for monitoring by the responsible Council – the CGen.

The system has given rise to doubts and uncertainties since its implementation though, either as to the adequate way to insert information in the available forms or due to system bugs and gaps. One example of inconsistency generated by SisGen itself refers to the impossibility of completing the registration procedure when the user does not know the registration number of an input or a raw material – necessary for the manufacture of a final product – and supplied by third parties (“intermediate product”), if such input contains elements of the BGA or associated traditional knowledge.

After a long-term period of uncertainty, Resolution No. 14 of October 19, 2018 addressed this problem suggesting that users should fill SisGen’s forms with the information that such intermediate products are “ex situ samples” from “commerce”. Moreover, users in this situation would have a period of one (1) year to regularize their respective registrations with SisGen, that is, until October 19, 2019.

The solution proposed by Resolution No. 14, however, has been thoroughly criticized within the CGen council itself. The Brazilian National Confederation of Industry – CNI, represented at CGen by Counsel Mário Augusto de Campos Cardoso, highlighted that the provision “creates discomfort for users because information is being distorted to fit system parameters.”

Moreover, Resolution No. 14 alternative solution for regularization does not provide any helpful guideline whenever the intermediate product containing an element of BGA or associated traditional knowledge is acquired from a third party established abroad.

Due to these difficulties and criticisms, and the imminent expiration of the legal deadline, several civil society bodies represented at CGen requested the replacement of Resolution No. 14 by a new regulation. The new proposed resolution, approved at the CGen meeting of October 02, 2019, was just published on October 11, 2019 in the Brazilian Federal Official Gazette No. 198.

Under the new rule – Resolution No. 23/2019, which completely revokes the previous one – the period for registration regularization is indefinitely postponed in cases where the user has no knowledge of the access registration number of the intermediate product acquired from a third party or from a foreign supplier.

In practical terms, all institutions and companies that have “accessed” the the Brazilian genetic heritage, under the terms of the law, through the use of intermediate products containing BGA elements which do not have a
registration number or purchased from foreign suppliers will have a new regularization deadline of 1 (one) year counted from the date of release of the new version of SisGen – which has no foreseen deadline yet.

Thus, users in this situation are exempt from any action at this time and must wait until a new version of SisGen is fully available.

If you have any questions, please do not hesitate to contact our expert team.