Overview about process and projects approved by the Brazilian National Authority – CGEN

GSS Sustainability | GSS Bioinovação

Francine H. Leal Franco leal@gssconsult.com

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 leal@gssconsult.com www.gssconsult.com

Av. Iguaçu, 2820 Conjunto 403 – Água Verde – Curitiba – Paraná 41 9963-0655

Obrigada!

leal@gssconsult.com