On April 23, 2020, the Ministry of the Environment (MMA) has published Ordinance No.199/2020 (“Ordinance”), by means of which it established the conditions for the presentation of Commitment Terms by foreign institutions, for purposes of regularization of activities carried out with Brazilian biodiversity in disagreement with law in force within the period of June 30 th , 2000 and November 16 th , 2015. Now, on May 23 rd , 2020, the Ministry of the Environment has made available 6 (six) templates of Commitment Terms, which encompasses the following situations:
(i) Annex I – access to genetic heritage and economic exploitation of finished products – sharing of benefits in the monetary modality;
(ii) Annex II – access to genetic heritage and economic exploitation of finished products – sharing of benefits in the non-monetary modality;
(iii) Annex III – access to non-identifiable associated traditional knowledge with economic exploitation;
(iv) Annex IV –access to identifiable associated traditional knowledge with economic exploitation;
(v) Annex V – access and economic exploitation by users exempt from sharing benefits; and
(vi) Annex VI – shipment, bioprospecting, or technological development without economic exploitation of finished products.
Aside from the presentation of specific Commitment Terms, the regularization procedure shall involve (i) the registration of the access activities with Brazilian genetic heritage or associated traditional knowledge within SisGen platform1 (National System for the Management of Genetic Resources and Associated Traditional Knowledge); (ii) the registration of economic exploitation of finished product or reproductive material by means of notification of finished product or reproductive material; and (iii) sharing of benefits, as the case may be. Measures hereinabove shall be executed after the presentation of said Commitment Terms.
It is important to notice that the registration of access activities hereinabove within SisGen shall be carried out in association or partnership with a Brazilian institution. However, notification of product or reproductive material and benefit sharing shall be carried out by foreign company in solo.
Finally, concomitantly with the presentation of the Commitment Terms, foreign institution shall execute and present a statement to declare that that it is in regular operation and properly constituted according to the legislation of its country of residence.
The Commitment Terms aforesaid shall be presented within the period of 1 (one) year, counted as of the publication of official act by the Executive Secretariat of the Cgen (Council for the Management of Genetic Resources), providing a new version of the SisGen platform, containing the functionalities necessary for its operation by foreign users.
Please note that Cgen has established no date for the release of SisGen new version. However, it is expected to occur already in the first half of 2020, since tests with said new version are already in progress.
In view of the novelties brought by the Ordinance, it is recommended that foreign institutions from several sectors (pharmaceutical, chemical, cosmetic, food, sanitizing, agricultural, etc.) that have developed research and/or development activities with biodiversity to adopt the following measures:
(i) carry out an analysis of their portfolio in order to identify whether they have used genetic resources from Brazilian biodiversity or traditional knowledge associated with them in this process;
(ii) verify if the activities developed by them in Brazil and / or abroad shall be regularized in accordance with Brazilian law; and
(iii) define an adequate strategy to regularize their activities, including the presentation of a Commitment Terms and establishment of a partnership or association with a national institution.
It is worth mentioning that the lack of regularization can subject foreign institutions to fines of up to 10 million reais, without prejudice to the imposition of other severe administrative sanctions, such as the seizure of products.
1SisGen is an online platform wherein users shall comply with all obligations set forth by Law No. 13.123/2013.
João Emmanuel Cordeiro Lima | joaoemmanuel@
Anita Pissolito Campos | anita@
Sócios Seniors da área de Direito Ambiental. Reconhecidos na área pelo renomado guia internacional Who’s Who Legal.
Juliana S. Busto | juliana@
Sócia Especialista em Direito Ambiental e
