On May 20 2015 the government enacted the Biodiversity Law (Federal Law 13,123/2015), which establishes rules for:
- access to genetic heritage;
- protection and access to associated traditional knowledge; and
- benefit sharing for the conservation and sustainable use of biodiversity.
According to the law, foreign individuals cannot access genetic resources or associated traditional knowledge. Further, the shipment of genetic heritage component samples abroad depends on prior registration, as well as on the signing of a material transfer agreement, as provided for by the Genetic Heritage Management Council (CGen).
The CGen is a plenary body affiliated with the Ministry of Environment. It concentrates deliberative, legislative, advisory and appellate functions and coordinates the development and implementation of policies that manage access to genetic resources, associated traditional knowledge and benefit sharing.
Pursuant to Article 17, the benefits arising from economic exploitation of finished products, reproductive materials obtained from the use of genetic resources found in Brazil or associated traditional knowledge – even if produced outside the country – must be shared in a fair and equitable manner. This benefit-sharing obligation is applied only to the manufacturer of a finished product or the producer of a reproductive material, regardless of who previously accessed the genetic resources or associated traditional knowledge. Thus, intermediate product manufacturers and developers of processes deriving from genetic resources or associated traditional knowledge along the production chain are exempt from sharing benefits, as are micro-enterprises, small businesses, individual micro-entrepreneurs and traditional farmers and their associations with gross incomes equal to or less than the maximum limit established by Federal Complementary Law 123/2006.
The text also provides for the creation of the National Fund for Benefit Sharing in order to enhance the genetic resources and associated traditional knowledge and promote their sustainable use. In addition, the law establishes a national benefit-sharing programme which will be implemented using the fund's resources.
Article 27 establishes that any action or omission that violates the mechanisms set out in the law will result in penalties which will vary according to the nature of the infraction, ranging from a warning to the cancellation of a certificate or authorisation. Fines will range from R1,000 to R10,000 if the violation is committed by an individual, and from R10,000 to R10 million if the infringement is committed by a legal entity or with its participation.
Applications to authorise access to or shipment of components of genetic heritage or associated traditional knowledge that are pending when the law comes into force(1) must be reformulated by the user in the form of requests for registration or authorisation for access or shipment. Applicants will have one year to authorise users which, between June 30 2000 and the date when the law comes into force, have conducted activities related to the exploitation of biodiversity not in accordance with the repealed law (Provisional Measure 2186-16/2001). Authorisation – except in the case of access to genetic resources and associated traditional knowledge exclusively for scientific research – is subject to commitment agreements.
The enactment of a commitment agreement suspends the application and payment of administrative penalties, provided that the infringement was performed before May 19 2015. Compliance with all obligations assumed under the commitment agreement eliminates administrative liability and reduces the amount of the penalties imposed by the relevant environmental authority by 90%.
Federal Law 13.123/2015 does not apply to human genetic heritage. Further, it prohibits access to genetic resources and associated traditional knowledge for practices which harm the environment, cultural reproduction or human health, as well as for the development of biological and chemical weapons.
For further information on this topic please contact Maria Alice Doria at Doria, Jacobina e Gondinho Advogados by telephone (+55 21 3523 9090) or email (email@example.com). The Doria, Jacobina e Gondinho Advogados website can be accessed at www.djga.com.br.
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