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Access to Genetic Heritage Component MEBB COP12.Pptx Overview about process and projects approved by the Brazilian National Authority – CGEN GSS Sustainability | GSS Bioinovação Francine H. Leal Franco [email protected] Biodiversity, why talk about it? Legal View Convention on Provisional Act nº Biological Diversity 2.186-16/2001 Decrees n.° 3.945/01 Decrees n.° 4.946/03 41 Resolutions Decrees n.° 6.915/04 Decrees n.° 5.459/05 9 Technical Decrees n.° 5.439/05 Orientations Decrees n.° 6.159/07 Provisional Act nº 2.186-16/2001 ¤ Access to components of genetic heritage existing within the Brazilian territory ¤ Access and protection of traditional knowledge associated to genetic heritage ¤ Fair and equitable sharing of benefits ¤ Access to technology and transfer of technology for the conservation and use of biological diversity Provisional Act nº 2.186-16/01 - CGEN ¤ Establish the Genetic Heritage Governing Council: ¤ Under the Ministry of Environment, is a regulatory and deliberative body; ¤ Composed of representatives of Federal Government entities responsible for the various actions covered by that Provisional Act; CGEN - Responsible for: ¤ Coordinating implementation of genetic heritage management policies ¤ Establishing: technical standards, criteria for access and shipment authorizations; guidelines for drafting the Contract for Use of Genetic Heritage and Benefit-Sharing; ¤ Deliberating on: authorizations for access and shipment of samples of genetic heritage components, with prior consent of its holder; authorizations for access to associated traditional knowledge, with the prior consent of its holder; ¤ Approving Contracts for Use of Genetic Heritage and Benefit-Sharing, and others. CGEN composition / Ministry ¤ Ministry of the Environment (MMA); ¤ Ministry of Science and Technology (MCT); ¤ Ministry of the Justice (MJ); ¤ Ministry of Health (MS); ¤ Ministry of Agriculture, Livestock and Food Supply (MAPA); ¤ Ministry of Development (MD); ¤ Ministry of Culture (MinC); ¤ Ministry of External Relations (MRE); ¤ Ministry of Development, Industry and Foreign Trade (MDIC); CGEN composition / Public Administration ¤ Brazilian Institute of Environment ¤ National Institute for Research in and Renewable Natural the Amazon (INPA); Resources (IBAMA); ¤ The Oswaldo Cruz Foundation; ¤ Rio de Janeiro Botanical Garden ¤ The Evandro Chagas Institute (IPJB); (IEC); ¤ National Counsel of ¤ National Indian Foundation Technological and Scientific (FUNAI); Development (CNPQ); ¤ National Industrial Property ¤ Brazilian Agricultural Research Institute (INPI); Cooperation (EMBRAPA); ¤ Palmares Cultural Foundation (FCP); CGEN composition / Civil society as permanent guests ¤ Traditional populations: ¤ Business Sector ¤ Academia ¤ NGOs ¤ Federal Public Ministry (MPF) Legislation’s Applicability ¤ CGEN is responsible for deliberating on authorizations for access and shipment of samples of genetic heritage components, with prior consent of its holder; ¤ Authorization for Access shall be given after prior consent of: ¤ The owner of the private area, when the access occurs there; ¤ The Government, when access occurs in a public or protected area; ¤ The indigenous community involved, after consulting the official Indian Affairs body (FUNAI), if the access occurs in indigenous lands; Who can apply for access? ¤ Access to genetic heritage components will only be authorized to: ¤ national institution, public or private, ¤ pursuing research and development activities in biology and related areas, ¤ I - evidence that the institution: ¤ was constituted under Brazilian law; ¤ performs research and development in the areas of biology and related activities; ¤ II - expertise for the performance of activities of access and shipment of samples of genetic heritage component of or access to associated traditional knowledge, where applicable; ¤ III - structure available for the handling of samples of genetic heritage component; Art. 16 – MP 2.186/01 Who should sharing benefits? ¤ The benefits arising from the economic use of the product or process developed from samples of genetic heritage components and associated traditional knowledge shall be shared in a fair and equitable manner among the contracting parties. ¤ The contracting parties must sign a Contract for Use of Genetic Heritage and Benefit-Sharing when probability of commercial use is apparent. Art. 24 – MP 2.186/01 How should sharing benefits? ¤ The benefits arising from the economic use of the product or process developed from a sample of a genetic heritage component or from associated traditional knowledge, may be, among others: ¤ I - Sharing of profits; ¤ II - Payment of royalties; ¤ III - Access and transfer of technologies; ¤ IV – licensing, without cost, of products and processes; and ¤ V – Capacity building of human resources; Art. 25– MP 2.186/01 How to get the Access and Shipment Authorization? ¤ Evidence that the institution carries out research and development in biological and related areas (eg. social contract); ¤ Research projects; ¤ Prior Consent Agreement; ¤ Contract for Use of Genetic Heritage and Benefit-Sharing; ¤ In cases of access to traditional knowledge related to genetic heritage provided, is necessary to present an anthropological report on the process of prior informed consent. ¤ During and after the process, these information are confidential. Access Authorization Answers and Elaboration of Answers and Development of the documents and Request of explanations by the Authorization explanations by the activities in the research negotiation of applicants CGEN applicants project contracts Documents Routing Process to CGEN’s Meeting analyses and Depósito de sub-amostra the evaluation Authorization requests of board of CGEN Granted Notificação dos produtos explanation by Relatório Anual CGEN Renovação da autorização 30 days 30 days 30 days 30 days Before Procedural Phase After Procedural Phase Procedural 4/6 months – time variable 2-5 years Phase Time variable Access Authorization Bioprospecting Commercialization Cientific Research + Technological Development Require Authorization from There is a perspective of IBAMA/CNPq Commercial use Annual Report (Article 16 § 4o MP) If identified the potential economic use from the Presentation on the products Intellectual property, capable or Formalize CURB developed (Res. 17) or not capable of protection With provider (Art 16 § 5o da MP) Renewal of Approval - CGEN Inform to CGEN and formalize Requests Authorization CURB with the land owner CGEN Management and Procedures of the process until authorization Management after authorization Who is in CGEN? 73 Business processes in progress and authorized 32 8 7 7 5 5 4 4 3 3 3 2 2 2 Who is in CGEN? Processes in CGEN applicants institutions Universities Private companies 26% 31% Public research institutions 43% What Brazil wants? Projects approved for separate use 4% 1% Cosméticos 3% 6% Pesquisa para fármacos 10% (universidades) Cosméticos/Fármacos 76% Outros Fármacos Não identificado Evaluation on Benefit Sharing in Brazil: contracts approved and pending in CGEN http://www.mma.gov.br/images/arquivo/80043/Apresentacao%20RB%20LARISSA%20SCHMIDT.pdf CGEN works? 292 QunatidadeQuantidade dede processos processos protocoladosprotocolados no ano 84 69 57 40 2002-2010 2011 2012 2013 2014 CGEN works? Average approval time of CGEN process 16,138011716 months 1110,99401709 months 5,9442028996 months 3,7190476193,7 months 2011 2012 2013 2014 GSS in CGEN ProcessosQuantidade no de CGENprocessos por da empresa GSS no CGEN Natura Inovação e Tecnologia de Produtos LTDA Solabia do Brasil Indústria e Comércio de produtos Biológicos PROCESSOS COM ASSESSORIA DA GSS Croda do Brasil Ltda. Firmenich11% GSS & Cia Processes Ltda Beraca Sabará Químicos e Ingredientes Ltda. IFF - Essências e Fragrâncias Ltda Atina Ind. Com. Ativos Naturais Ltda GSS in CGEN Number of offices / Project 15% 1 ofício / processo 31% 0 ofícios / processo Mais de 01 ofício / 54% processo GSS in CGEN Prazo médio para aprovação Média de 2 15% meses 31% 8% Média de 3 meses Média de 4 meses 46% Mais de 4 meses GSS in CGEN Votação dos Conselheiros 31% Unanimidade 1 voto contra 69% GSS Bioinovação GSS - Global Sustainable Strategy is a Brazilian company with offices in Curitiba (PR), São Paulo (SP) and Brasilia (DF) Multidisciplinary team Experience in national and international projects related to environmental markets, climate change, biodiversity and corporate sustainability. ¤ Biodiversity team experience: ¤ Management of more than 20 process at CGEN, including: development of strategies and risk analysis for new projects; ¤ Development and negotiation of research projects, prior consent agreement and contract for benefits sharing; ¤ Community mobilization in order to explain the overall process, rights and obligations of the parties related to the utilization of biodiversity; ¤ Negotiation of the prior consents and contracts; ¤ Creation a corporate benefits sharing policy. [email protected] Obrigada! Francine H. L. Franco [email protected] Av. Iguaçu, 2820 Conjunto 403 – Água www.gssconsult.com Verde – Curitiba – Paraná 41 9963-0655 .
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