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New Biodiversity Law

The new Law on Biodiversity came into force on 11/17/2015, Law 13,123 / 2015. From this date, research with Brazilian genetic heritage, as well as the development of products such as our biodiversity, do not require prior authorization for its development. It will be necessary only a registry of the access activities with the genetic patrimony in an electronic cadastre denominated National System of Management of the Genetic Patrimony - SISGen, and that is being developed by the Ministry of the Environment - MMA.

 

Therefore, CNPq will no longer issue authorizations, nor will it record the future activities of research or development of products or processes, which should be done exclusively by SISGen. CNPq forms for registration of institutions and application for authorization are no longer available.

For research, it is sufficient to make a registration, provided that prior to the disclosure of its results, partial or final. For product development, a notification must be made prior to marketing.

 

Registration must also be done prior to the application of any intellectual property right or the sending of samples of genetic heritage, for access or even service activities.

Here are some guidelines on the transition to the Biodiversity Law.

 

1. I have a pending authorization request. What should I do?

 

Requests that were not authorized by CNPq until November 16, 2015 should be registered with SISGen. If the requests are for the purpose of scientific research, they should be registered in SISGen as a research until before the disclosure of their results. If the requests are for the purpose of bioprospecting or technological development, they should be notified in SISGen as technological development.

 

2. I have authorization in force. How to proceed?

 

The authorizations issued by CNPq that do not expire until November 16, 2015 will remain valid. The CNPq will pass on to the MMA all the data of the authorizations in force to be inserted in the SISGen. Subsequently, that Ministry should issue guidelines in this respect.

 

3. My authorization has expired. Should I submit the final report? Should I check the sub-sample deposit?

 

Yes. For the authorizations that have expired up to 11/11/2015, the requirements of the current legislation, which are final report submission together with the proof of the sub-sample deposit of the genetic heritage in a collection accredited by CGEN as a depositary, remain valid.

 

Further guidance may be obtained from the MMA at http://www.mma.gov.br/global-pattern/genetic-state-consumption-consultation. Questions should be sent to cgen@mma.gov.br.