What Brazil Fiocruz Biodiversity Biobank and Genomic Resources Governance under Law 13,123/2015 (CGen) requires
Brazil's principal biobank and genomic resources governance framework is established by Law 13,123/2015 (Lei da Biodiversidade), which regulates access to Brazilian genetic heritage and traditional knowledge associated with genetic heritage and the sharing of benefits arising from such access. The Council for the Management of Genetic Heritage (Conselho de Gestao do Patrimonio Genetico, CGen), under the Ministry of the Environment and Climate Change, administers the Brazilian National System of Genetic Heritage Management and Associated Traditional Knowledge (SisGen) for registration of access, shipment, and benefit-sharing. Fiocruz (Fundacao Oswaldo Cruz) operates the Biodiversity and Health Biobank and is a key institutional actor for human and pathogen genomic resources in Brazil, while the Botanical Garden of Rio de Janeiro (JBRJ) participates in the Global Genome Biodiversity Network (GGBN) for plant genomic resources. Biosafety governance is set out in Law 11,105/2005 (Lei de Biosseguranca) and implementing regulations administered by the National Biosafety Council (CNBS) and the National Biosafety Technical Commission (CTNBio). The Law regulates the construction, cultivation, production, manipulation, transport, transfer, import, export, storage, research, commercialisation, environmental release, and disposal of genetically modified organisms and their derivatives. Personal data protection under the Lei Geral de Proteção de Dados (LGPD) Law 13,709/2018 applies to processing of human genomic data including in biobanks. The Ministry of Science, Technology and Innovation (MCTI) and the Ministry of Health regulate human genomic research with ethics oversight by the National Research Ethics Commission (CONEP) and local research ethics committees.
Pillar: Biotech & Genomics · Authority: Ministry of the Environment and Climate Change (Brazil) and Fiocruz · Version: 1.0.0 · Last updated:
Primary source: https://www.gov.br/jbrj/en/subjects/news/jbrj-participates-in-ggbn-conference
SHA-256 integrity: 743115681f146fa75bcd390896a45b6ff261c756c1973092988d7831aec74207
Primary Citations — 8 traced to source
- Lei No. 13,123 of 20 May 2015 (Lei da Biodiversidade) - regulates access to Brazilian genetic heritage and traditional knowledge associated with genetic heritage.
- Decree 8,772 of 11 May 2016 - implements Law 13,123/2015 and establishes the National System of Genetic Heritage Management (SisGen).
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