Abstract
Federal Law No. 13.123/2015, known as the Brazilian Biodiversity Act, establishes rules for access to Brazilian genetic heritage, associated traditional knowledge and benefit-sharing. It is the second legislation adopted in Brazil since 2000 to regulate this subject. The Law brought about a new regime of access to and utilization of genetic heritage, highlighting simplified procedures for users who conduct research and technological development. This chapter presents the scope and instruments, including the declarations by users, administrative acts and agreements concerning access and benefit-sharing arising from the commercialization of products. It will also look at the actual registrations and notifications carried out by companies and research institutions in the National Genetic Heritage and Associated Traditional Knowledge Management System (SisGen) since it was released in 2017.
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Notes
- 1.
Ministry of Environment (2020); CBD (2020).
- 2.
Flora do Brasil (2020).
- 3.
Ibid.
- 4.
The list is available at: http://floradobrasil.jbrj.gov.br/reflora/listaBrasil/ConsultaPublicaUC/ConsultaPublicaUC.do#CondicaoTaxonCP.
- 5.
CBD (2020).
- 6.
Regulates item II from paragraph 1 and paragraph 4 of article 225 of the Constitution, Articles 1, 8, item “j”, 10, item “c”, 15 and 16, items 3 and 4 of the Convention on Biological Diversity, provides for the access to genetic heritage, protection and access to associated traditional knowledge, benefit-sharing and access to and transfer of technology for its conservation and use, and makes other provisions.
- 7.
Provisional measures must be transformed into a law through a National Congress vote, but until 2001 they could be reissued unrestrictedly. With the constitutional amendment n. 32/2001, the extension was limited to a single time, and provisional measures should be voted on for conversion into law within 60 days, under penalty of loss of effectiveness. The PM issued prior to amendment 32/2001 were kept in force until the definitive deliberation of the National Congress and this is why Provisional Measure No. 2.186-16/2001 became a “permanent” measure.
- 8.
According to article 16, para 9°, the prior consent shall be given by the indigenous community involved, after consulting the official Indian Affairs body, when the access occurs in indigenous lands or the competent body, when access occurs in protected area; or the owner of the private area, when the access occurs there or the National Defense Council, when the access takes place in an area essential for national security or the maritime authority, when the access takes place in Brazilian jurisdictional waters, on the continental shelf and in the exclusive economic zone.
- 9.
The Data presented in this study was updated until November 2015 in the CGEN’s website.
- 10.
Ministry of Environment (2015).
- 11.
Ministry of Environment (2014).
- 12.
“a natural or legal person, that accesses genetic heritage or associated traditional knowledge, or economically explores a finished product or reproductive material originated from access to genetic heritage or associated traditional knowledge”—Article 2, XV of Law 13.123/2015.
- 13.
CGEN Technical Guideline No. 9/2018.
- 14.
Resolution No. 12/2018 of CGEN. The Ministry of Environment released an English MTA version: https://www.mma.gov.br/images/arquivo/80043/resolucoes/Resolution_12_TTM_english_version_nova.pdf (accessed 21 September 2020).
- 15.
The jurisdiction and composition of CGEN are described in article 6, paragraph 1 of Law No. 13.123/15 and Chapter II of Decree No. 8.772/2016.
- 16.
All acts can be found in the Ministry of Environment website: https://antigo.mma.gov.br/patrimonio-genetico/conselho-de-gest%C3%A3o-do-patrim%C3%B4nio-gen%C3%A9tico/nrmas-do-cgen.html#delibera%C3%A7%C3%B5es (accessed 21 October 2021).
- 17.
The memories of meeting may be consulted in this website: https://www.mma.gov.br/patrimonio-genetico/conselho-de-gest%C3%A3o-do-patrim%C3%B4nio-gen%C3%A9tico/reunioes.html (accessed 21 October 2021).
- 18.
The Ministry of Environment provides the register data on its website: https://sisgen.gov.br/paginas/publicidade.aspx (accessed 21 September 2020).
- 19.
Agricultural activities include: activities of producing, processing and commercializing food, beverages, fibers, energy and planted forests (article 2° XXIV, Law 13.123/2015).
- 20.
CGEN Technical Guideline 2/2017.
- 21.
Law 13.123/2015, article 21 establishes: “In order to foster competitiveness of the beneficiary sector, the Federal Government may, at the request of the interested party and according to regulations, celebrate sectoral agreements to reduce the amount of benefit-sharing for up to 0.1% of the annual net revenue obtained from economic exploitation of finished products or reproductive material arising from access to genetic heritage or associated traditional knowledge from an unidentifiable origin”. The sectoral agreements rules are detailed in the Decree, Chapter V, Section VI.
- 22.
CGEN Resolution 13/2018.
References
Legal Texts
Constitution of the Federative Republic of Brazil 1988
Decree 2.519/ 1998, promulgates de Convention on Biological Diversity
Federal Decree 8.772 2015
Federal Law 13.123 2015
Legislative Decree n° 02/1994., https://www2.camara.leg.br/legin/fed/decleg/1994/decretolegislativo-2-3-fevereiro-1994-358280-publicacaooriginal-1-pl.html (accessed 3 November 2020)
Ordinance n° 01/2017., http://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/19351478/do1-2017-10-13-portaria-n-1-de-3-de-outubro-de-2017-19351409 (accessed 21 September 2020)
Ordinance n° 144/2021., https://www.in.gov.br/en/web/dou/-/portaria-mma-n-144-de-22-de-abril-de-2021-315696906 (accessed 21 October 2021)
Provisional Measure 2.186-16/2001
Resolution CGEN 12/2018, approves the Material Transfer Agreement Model, https://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/45993008/do1-2018-10-19-resolucao-cgen-n-12-de-18-de-setembro-de-2018-45992843#:~:text=1%C2%BA%20Aprovar%20o%20modelo%20de,do%20Anexo%20I%20desta%20Resolu%C3%A7%C3%A3o.&text=Cl%C3%A1usulas%20adicionais%2C%20de%20interesse%20espec%C3%ADfico,Resolu%C3%A7%C3%A3o%20ou%20na%20legisla%C3%A7%C3%A3o%20pertinente (accessed 21 October 2021)
Resolution CGEN 13/2018, establishes an alternative way of registering in the SisGen the samples that have been obtained in silico, https://www.mma.gov.br/images/arquivo/80043/resolucoes/res13-cgen.pdfhttps://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/45993017/do1-2018-10-19-resolucao-cgen-n-13-de-18-de-setembro-de-2018-45992861 (accessed 21 October 2021)
Technical Guideline n° 02/2017., https://www.gov.br/mma/pt-br/assuntos/biodiversidade/patrimonio-genetico/conselho-de-gestao-do-patrimonio-genetico-cgen-1/agenda/reunioes-anteriores (accessed 21 Ocotber 2021)
Technical Guideline No. 09/2018., https://mma.gov.br/images/arquivo/80043/orientacao-tecnica/ot9-cgen.pdfhttps://www.gov.br/mma/pt-br/assuntos/biodiversidade/patrimonio-genetico/conselho-de-gestao-do-patrimonio-genetico-cgen-1/normas-do-cgen/pdf/OrientaoTcnican9.pdf (accessed 21 Ocotber 2021)
Links
Convention on Biological Diversity (2020) Brazil Main Details, https://www.cbd.int/countries/profile/?country=br#facts (accessed 3 November 2020)
Flora do Brasil 2020 under construction (2020) Jardim Botânico do Rio de Janeiro, https://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/45993008/do1-2018-10-19-resolucao-cgen-n-12-de-18-de-setembro-de-2018-45992843#:~:text=1%C2%BA%20Aprovar%20o%20modelo%20de,do%20Anexo%20I%20desta%20Resolu%C3%A7%C3%A3o.&text=Cl%C3%A1usulas%20adicionais%2C%20de%20interesse%20espec%C3%ADfico,Resolu%C3%A7%C3%A3o%20ou%20na%20legisla%C3%A7%C3%A3o%20pertinente (accessed 3 November 2020)
Ministry of Environment (2014) CGEN Activities Report 2014, https://www.mma.gov.br/images/arquivo/80043/relatorio-cgen-2014.pdf (accessed 21 September 2020)
Ministry of Environment (2015) CGEN Activities Report 2015, https://www.mma.gov.br/images/arquivo/80043/documentos/relatorio%202015%20cgen.pdf (accessed 21 September 2020)
Ministry of Environment – Biodiversity (2020) https://www.gov.br/mma/pt-br/assuntos/biodiversidade/patrimonio-genetico/conselho-de-gestao-do-patrimonio-genetico-cgen-1/agenda/reunioes-anteriores (accessed 03 November 2020)
Ministry of Environment (2021) CGEN legislation, https://www.gov.br/mma/pt-br/assuntos/biodiversidade/patrimonio-genetico/conselho-de-gestao-do-patrimonio-genetico-cgen-1/normas-do-cgen (accessed 21 October 2021)
SisGen (2020), https://sisgen.gov.br/paginas/pubpesqatividade.aspx (accessed 21 September 2020)
http://floradobrasil.jbrj.gov.br/reflora/listaBrasil/ConsultaPublicaUC/ConsultaPublicaUC.do#CondicaoTaxonCP (accessed 3 November 2020)
Acknowledgments
Henry Philippe Ibañez de Novion—Environmental Analyst at the Ministry of Environment (DPG/SBio). He was Director of the Department of Genetic Resource, Secretariat of Biodiversity of the Ministry of Environment. Vice-Chairman of the Genetic Resource Management Council—CGEN and General Coordinator of Department of Genetic Resource’s Regulatory Affairs and Benefit Sharing.
Maira Smith—General Coordinator of Normative Acts and Decision-Making Processes of the Department of Support to the Genetic Resource Management Council (DCGen) of the Ministry of Environment.
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Mozini, L.M. (2022). Brazilian Biodiversity Law: Challenges and Opportunities for Industries and Research Institutions. In: Chege Kamau, E. (eds) Global Transformations in the Use of Biodiversity for Research and Development. Ius Gentium: Comparative Perspectives on Law and Justice, vol 95. Springer, Cham. https://doi.org/10.1007/978-3-030-88711-7_3
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