The Ministry of Health defines conditions for regularizing activities resulting from access to Genetic Heritage and Associated Traditional Knowledge carried out by foreign institutions

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On April 30, 2020, came into forceOrdinance No. 199, of April 22, 2020, which establishes the conditions for executing the term of commitment by foreign institutions and the Union, in order to regularize the access to genetic heritage and associated traditional knowledgeunder the terms of Law No. 13,123 of 2015.

Regularization of access is necessary for users who have carried out activities resulting from access to genetic heritage or associated traditional knowledge between June 30, 2000 and November 16, 2015,lacking authorization or having authorization in progress.

According to article 11, § 1 of Law No. 13,123/2015, access to genetic heritage or associated traditional knowledge by a foreign natural person is prohibited. However, according to article 12, item II of the same Law, access by a legal entity based abroad associated with a, public or private, national institution for scientific and technological research, is permitted.

In this sense, Ordinance No. 199/2020 establishes that the following activities must be regularized by executing a specific Term of Commitment, signed by the legal representative of the foreign institution:

I – access to genetic heritage or associated traditional knowledge;

II – access and economic exploitation of a product or process resulting from access to genetic heritage or associated traditional knowledge, according with Provisional Measure No. 2,186-16/2001;

III – remittance of a sample of genetic heritage abroad; or

IV – disclosure, transmission or retransmission of data or information that integrate or constitute associated traditional knowledge;

The form of the aforementioned Term of Commitment will be made available within 30 (thirty) working days from the publication of this ordinance, i.e., from April 23, 2020, at the website of the Ministry of Environment.

The deadline for presenting the Commitment Document will be 1 (one) year countered from the publication of the official act of the Executive Secretary of the Genetic Heritage Management Council – CGen making available a version of the National System for the Management of Genetic Heritage and Traditional Knowledge Associate – SisGen containing the functionalities for registering the access and notification carried out by foreign institutions.

In addition to executing the Commitment Document, the foreign institution must sign a declaration stating that it is in regular operation and properly constituted in accordance with the legislation of its State of residence.

According to the Ordinance, Terms of Commitments from foreign institutions already presented can be replaced by the new model.

The Ordinance also establishes that it is the responsibility of the foreign institution to enter into a partnership or association with a national institution for registering the access at SisGen and failure to comply with such requirements will result in the application of civil, criminal and administrative sanctions.


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