Ordinance No. 01/2017 of the Genetic Heritage Management Council (CGEN) and Federal Law No. 13,123/15 (the new legal framework for biodiversity, which repealed Presidential Decree No. 2,186-16/2001) established the date of November 6, 2018, as the final deadline for regularization or adaptation in the National System of Management of Genetic Heritage and Associated Traditional Knowledge (SisGen).
Those who performed activities of access to Genetic Heritage (PG) and Associated Traditional Knowledge (CTA); shipment abroad of PG samples and economic exploration of a finished product or reproductive material resulting from access to PG or CTA are subject to the requirements of the new legal framework for biodiversity.
Access to PG or to CTA completed before June 30, 2000 (date of the first enactment of Presidential Decree No. 2,186/2001) and economic exploration of a finished product or reproductive material resulting therefrom are not subject to regularization or adaptation in SisGen required in the new legal framework for biodiversity.
In this case, an interpretation of the legislation leads to the understanding that it is the duty of the user to demonstrate that all stages of access, including technological development, were completed before June 30, 2000, through the presentation of some of the following documents: patent application; cultivar record; registration of the product with public agencies, or proof of commercialization of the product.
Activities carried out after that date are subject to regularization or adaptation, depending on whether or not the activities were carried out in accordance with Presidential Decree No. 2,186-16/2001. Thus, those that obtained authorization for access or economic exploration during the term of Presidential Decree No. 2,186-16/2001 and, according to it, were obliged to carry out the process of adaptation by registering access and reporting the finished product or reproductive material in SisGen.
For the adaptation, the user must distribute the benefits related to the economic exploration carried out as of the date of entry into force of Law No. 13,123/15, except when it was so done in the manner set forth in Presidential Decree No. 2,186-16/2001.
Regularization, on the other hand, is conditioned on the signature of a consent order, since it is applied to those who carried out the following activities in disagreement with Presidential Decree No. 2,186-16/2001:
- Access to PG or associated CTA;
- Access and economic exploration of a product or process arising from access to PG or CTA, which is dealt with in Presidential Decree No. 2,186-16, of August 23, 2001;
- Shipment of PG samples abroad; or
- Dissemination, transmission, or retransmission of data or information that are or constitute CTA.
The execution of a consent order between the user and the Federal Government is an essential condition for the regularization of activities and must provide for the following obligations: registration or authorization of access or remittance of PG or CTA; reporting of the product or process originating from access to PG or CTA; or distribution of the benefits obtained with respect to the time in which the product developed after June 30, 2000 based on access to PG or CTA was made available on the market, up to five years prior to the execution of the consent order. Once the consent order has been signed, the application and enforceability of administrative penalties shall be suspended.
In the event of access to PG or CTA solely for the purpose of scientific research, the user shall be exempt from signing a consent order and may be regularized by means of registration or authorization of the activity.
If the procedures for adaptation or regularization have not been carried out by November 6, 2018, according to the new legal framework for biodiversity, the ser shall be subject to penalties, including penalties of up to R$ 10 million, warnings, and product seizures.