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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 Biological Diversity
Provisional Act nº 2.186-16/2001
Decrees n.° 3.945/01 Decrees n.° 4.946/03 Decrees n.° 6.915/04 Decrees n.° 5.459/05 Decrees n.° 5.439/05 Decrees n.° 6.159/07
41 Resolutions 9 Technical Orientations
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 and Renewable Natural Resources (IBAMA);
¤ Rio de Janeiro Botanical Garden (IPJB);
¤ National Counsel of Technological and Scientific Development (CNPQ);
¤ Brazilian Agricultural Research Cooperation (EMBRAPA);
¤ National Institute for Research in the Amazon (INPA);
¤ The Oswaldo Cruz Foundation;
¤ The Evandro Chagas Institute (IEC);
¤ National Indian Foundation (FUNAI);
¤ National Industrial Property Institute (INPI);
¤ 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
Request of Authorization
CGEN
Procedural Phase 4/6 months – time variable
After Procedural Phase 2-5 years
Elaboration of documents and negotiation of
contracts
Before Procedural
Phase Time variable
Development of the activities in the research
project
Depósito de sub-amostra Notificação dos produtos
Relatório Anual Renovação da autorização
30 days
Answers and explanations by the
applicants
Documents analyses and
requests of explanation by
CGEN
30 days 30 days
Routing Process to the evaluation board of CGEN
Answers and explanations by the
applicants
30 days
CGEN’s Meeting Authorization
Granted
Access Authorization
Cientific Research Bioprospecting
+ Technological Development
Commercialization
There is a perspective of Commercial use (Article 16 § 4o MP)
Formalize CURB With provider
Requests Authorization CGEN
Require Authorization from IBAMA/CNPq
If identified the potential economic use from the
Intellectual property, capable or or not capable of protection
(Art 16 § 5o da MP)
Inform to CGEN and formalize CURB with the land owner
Annual Report
Presentation on the products developed (Res. 17)
Renewal of Approval - CGEN
Management and Procedures of the process until authorization Management after authorization
Who is in CGEN?
73
32
8 7 7 5 5 4 4 3 3 3 2 2 2
Business processes in progress and authorized
Who is in CGEN?
Universities 26%
Public research institutions
43%
Private companies 31%
Processes in CGEN applicants institutions
What Brazil wants?
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
76%
10%
3% 6%
4% 1%
Projects approved for separate use
Cosméticos
Pesquisa para fármacos (universidades)
Cosméticos/Fármacos
Outros
Fármacos
Não identificado
CGEN works?
2002-2010 2011 2012 2013 2014
292
57 40
84 69
Qunatidade de processos protocolados Quantidade de processos protocolados no ano
CGEN works?
2011 2012 2013 2014
16,1380117
10,99401709
5,944202899
3,719047619
Average approval time of CGEN process 16 months
11 months
6 months
3,7 months
GSS in CGEN Processos no CGEN por empresa
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.
Firmenich & Cia Ltda
Beraca Sabará Químicos e Ingredientes Ltda.
IFF - Essências e Fragrâncias Ltda
Atina Ind. Com. Ativos Naturais Ltda
11% GSS Processes
Quantidade de processos da GSS no CGEN
GSS in CGEN
15%
54%
31%
Number of offices / Project
1 ofício / processo
0 ofícios / processo
Mais de 01 ofício / processo
GSS in CGEN
15%
8%
46%
31%
Prazo médio para aprovação
Média de 2 meses
Média de 3 meses
Média de 4 meses
Mais de 4 meses
GSS in CGEN
69%
31%
Votação dos Conselheiros
Unanimidade
1 voto contra
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.
Francine H. L. Franco [email protected] www.gssconsult.com
Av. Iguaçu, 2820 Conjunto 403 – Água Verde – Curitiba – Paraná 41 9963-0655
Obrigada!