1. 1 Biodiversity legislation globally and in Brazil Carla Tiedemann C. Barreto 4th Annual International Symposium Ahmedabad, India / Feb. 2008 ©2008 Carla Tiedemann C.Barreto ©2008 Carla Tiedemann C.Barreto pictures: pictures:www.ibama.gov.brwww.ibama.gov.br

2. 2 INTERNATIONAL SCENARIO Initial discussions on strategies to protect environment in the 70ies. Ex: endangered species Initial discussions on strategies to protect environment in the 70ies. Ex: endangered species Prevailing concept: biological resources as common heritage of mankind Prevailing concept: biological resources as common heritage of mankind Increasing number of patents for products and processes involving biological and genetic resources Increasing number of patents for products and processes involving biological and genetic resources

3. 3 CONVENTION ON BIOLOGICAL DIVERSITY (CBD – 1992) Starting point to current system of protection Starting point to current system of protection United Nations Conference on Environment and Sustainable Development – Rio de Janeiro, Brazil – 1992 United Nations Conference on Environment and Sustainable Development – Rio de Janeiro, Brazil – 1992 CBD came into force in December 1993 CBD came into force in December 1993 190 parties 190 parties

4. 4 Convention on Biological Diversity (CBD – 1992)  PRINCIPLES:  Conservation of Biological Diversity  Sustainable Use of its Components  Fair and Equitable Distribution of Benefits  Valorization of Social Diversity / Preservation of Associated Traditional Knowledge  RIGHT X RESPONSIBILITY (sovereignty)  REGULATION OF ACCESS / DISTRIBUTION OF BENEFITS  CONCEPT OF BIOLOGICAL DIVERSITY including: Microorganisms, plants and animals; Microorganisms, plants and animals; Ecosystems Ecosystems Diversity among species and populations Diversity among species and populations

5. 5 NATIONAL LEGISLATION COLOMBIA  1995 – Biodiversity ad hoc group  2 different proceedings for granting access  Property rights divided into:  Genetic and Biochemical Resources  Biological Resources ECUADOR  1996 – State as title holder  Commercial use subject to special regulation  Ancestral Rights and control over:  Traditional Knowledge / Intangible Components  Genetic Resources

6. 6 NATIONAL LEGISLATION COSTA RICA  1998 – Protection of Industrial and Intellectual Property Rights  Hybrid System of Protection – Traditional IPR and “sui generis Communitarian Intellectual Rights”  Biodiversity encompassing, among others: Cultivated Resources Cultivated Resources Chemical and Biochemical Resources Chemical and Biochemical Resources Derivatives or Products Derived from Biological Resources Derivatives or Products Derived from Biological Resources

7. 7 NATIONAL LEGISLATION - COSTA RICA Access and Benefit-Sharing:  Access limited in number of samples and time  Many compensation and benefit-sharing options: Technology Transfer Technology Transfer Training Training Royalties Royalties Upfront Payment Upfront Payment Support for Conservation Support for Conservation “Milestones” “Milestones”

8. 8 NATIONAL LEGISLATION PERU  Law Project on Access/ Indigenous Communities, NGO’s, Ministries and Patent Office  Specific law / Special implementing rules for Traditional Knowledge registration  Prior Informed Consent – National representative organization

9. 9 NATIONAL LEGISLATION PHILIPPINES Two pieces of law:  Executive Order No. 247/1995: prospecting of biological and genetic resources, by-products and derivatives  Indigenous Peoples Rights Act (1997): recognizes, protects and promotes Indigenous Cultural Communities’ and Indigenous Peoples’ Rights (Ex: ownership to ancestral domains, cultural integrity, self- government, own customary laws)

10. 10 NATIONAL LEGISLATION - PHILIPPINES  Biological Resources owned by the State (full control and supervision)  In Indigenous Ancestral Lands:  Access only with Prior Informed Consent according to their own customary laws  Right to veto bioprospecting  Research Agreement between Prospector and Government with copy to Community  Royalties to Government and Community

11. 11 NATIONAL LEGISLATION - PHILIPPINES  Implementing and Enforcing Agency: Inter-Agency Committee on Biological and Genetic Resources  Various Government Agencies  Academic Community  One representative from an NGO  One representative of an Indigenous People’s Organization  Traditional and Alternative Medicine Act Promoting use and development of traditional medicine Promoting use and development of traditional medicine Improving its quality and status Improving its quality and status

12. 12 NATIONAL LEGISLATION BRAZIL  Mega diverse country  More than 200,000 species registered  Over 56,000 reported plants in different biomes Amazon and Atlantic Forest Amazon and Atlantic Forest Cerrado Cerrado Caatinga Caatinga Pantanal Pantanal Pampa Pampa Coastal region and waters Coastal region and waters

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18. 18 Source: wwf.org,br

19. 19 NATIONAL LEGISLATION – BRAZIL LEGAL BACKGROUND  1988 Constitution – Common Heritage of Mankind  CBD - signed 1992  Approved by Congress (1994)  Effective in 1998 (Decree 2.519/98)  Since 1995 – Attempts to implement and regulate  Main regulation: Provisional Bill 2.186-16/2000  Access to Biological Resources and Traditional Knowledge  Share of Benefits / Prior Informed Consent  Transfer of Technology

20. 20 NATIONAL LEGISLATION – BRAZIL REGULATING AGENCY Council for the Management of Genetic Resources – CGEN Composition:  Representatives of Government Bodies and Public Research Entities, including: Brazilian Environment and Renewable Resources Institute - IBAMA Brazilian Environment and Renewable Resources Institute - IBAMA Indigenous Affairs Body – FUNAI Indigenous Affairs Body – FUNAI Brazilian Patent and Trademark Office – BPTO Brazilian Patent and Trademark Office – BPTO  Private sector (2003) – “permanent guest entities” Indigenous and Other Local and Rural Communities Indigenous and Other Local and Rural Communities Environmental NGO’s Environmental NGO’s Academic and Private Sectors Academic and Private Sectors General Attorney’s Office General Attorney’s Office

21. 21 NATIONAL LEGISLATION – BRAZIL ATRIBUTIONS:  Deliberate and Issue Technical Rules for Access and Shipment of Samples  Issue Directives / Approve Contracts for Access and Benefit-Sharing  Regulate Access to Biological Resources and Traditional Knowledge relating to:  Technological development  Biological prospection  Other commercial and industrial purposes  Scientific research (IBAMA / CNPq)

22. 22 NATIONAL LEGISLATION – BRAZIL WHO CAN BE AUTHORIZED:  National institutions, public or private, engaged in R&D in biological or related areas  Foreign legal entities / joint project with a Brazilian Institution SHIPMENT OF SAMPLES:  Authorization by CGEN (exception)  Previous Signature of Material Transfer Undertaking or of a Use and Benefit-Sharing Agreement  Deposit of Sub-Sample in a Brazilian Depositary Institution recognized by CGEN (also for access)

23. 23 NATIONAL LEGISLATION – BRAZIL Purpose:  Keep evidence of accessed material in Brazil  Clarify possible doubts regarding origin  TRADITIONAL KNOWLEDGE  Right to Decide on Use / Prior Informed Consent  Derive Profits from its Economic Exploitation  Have the origin indicated in all publications, use and exploitation  Curb use, test, research/exploitation by unauthorized third parties  Prevent disclosure, broadcast or retransmission of data

24. 24 NATIONAL LEGISLATION – BRAZIL  PRIOR INFORMED CONSENT / DIFFICULTIES: Place of access / Persons or Entities to be heard: Indigenous lands – Indigenous Affairs Body Indigenous lands – Indigenous Affairs Body Protected Area – Competent Official Entity (ies) Protected Area – Competent Official Entity (ies) Private Property – Owner of the Land Private Property – Owner of the Land National Security Areas – Council of National Defense National Security Areas – Council of National Defense Continental Shelf, Exclusive Economic Region – Maritime Authority Continental Shelf, Exclusive Economic Region – Maritime Authority More than one visit to the area to obtain consent

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26. 26 NATIONAL LEGISLATION – BRAZIL  2004 – Previous Consent of Proprietor of Private Areas dismissed for scientific research with no potential for commercial use.  Written document remains obligatory:  prospection  technological development  Indigenous communities

27. 27 NATIONAL LEGISLATION – BRAZIL BENEFIT-SHARING AGREEMENTS  Potential for commercial use  Parties:  Applicant (national institution authorized to access)  Institution of destiny (shipment)  Proprietor of the area (public or private) OR  Representative of indigenous community + Indigenous Affairs Body OR  Representative of local community  Government  Efficacy : agreement and registration by CGEN

28. 28 NATIONAL LEGISLATION – BRAZIL MANDATORY CLAUSES  quantification of samples and intended use  method of benefit-sharing and access and transfer of technology;  intellectual property rights  jurisdiction in Brazil BENEFIT-SHARING POSSIBILITIES:  Share of profits / payment of royalties  Technology transfer  licensing of products and processes  training of human resources

29. 29 NATIONAL LEGISLATION – BRAZIL TRADITIONAL KNOWLEDGE / PROTECTION:  data basis  Publication PENALTIES (administrative sanctions)  Seizure of samples  Embargo of activity  Suspension of registration, patent, license or authorization  Loss or suspension of participation in official financing  Fine: US$ 5,000.00 to US$ 28 million (legal entities) CIVIL AND CRIMINAL LAW PROJECT

30. 30 INTELLECTUAL PROPERTY RIGHTS Impact on conservation and sustainable use Impact on conservation and sustainable use CBD 16.5 -The contracting parties shall cooperate in order to ensure that IPR are supportive of and do not run counter to the objectives of the Convention. CBD 16.5 -The contracting parties shall cooperate in order to ensure that IPR are supportive of and do not run counter to the objectives of the Convention. Conflict with TRIPS? Conflict with TRIPS? CBD 22.1 – The provisions of the CBD shall not affect the rights and obligations of any contracting party deriving from any international agreement, except where the exercise of those rights and obligations would cause a serious damage or threat to biological diversity CBD 22.1 – The provisions of the CBD shall not affect the rights and obligations of any contracting party deriving from any international agreement, except where the exercise of those rights and obligations would cause a serious damage or threat to biological diversity No definition of serious damage or threat / Other conventions No definition of serious damage or threat / Other conventions

31. 31 INTELLECTUAL PROPERTY RIGHTS BRAZIL – INPI RESOLUTION 134/2006 New regulation /application forms for patents (PCT and non-PCT) Immediate effects on future and pending applications as from Nov. 10, 2006 Mandatory identification whether the subject matter refers to samples of the Brazilian genetic heritage or not: Evidence of compliance with Provisional Bill 2186-16/01: number and date of CGEN’s access authorization Evidence of compliance with Provisional Bill 2186-16/01: number and date of CGEN’s access authorization Identification of the origin of the genetic resource and associated traditional knowledge. Identification of the origin of the genetic resource and associated traditional knowledge. Pending applications as from June 30, 2000: supplemental form / no charge

32. 32 INTELLECTUAL PROPERTY RIGHTS Criticism: o Art. 31 Provisional Bill 2186-16/01 - grant x filing o Mandatory disclosure of origin and access authorization data could not hinder application o No negative declaration in Provisional Bill o Option: application form x any time before grant o Access authorization by CGEN takes too long o Conflict with TRIPS: new substantive requirement for grant of patents not foreseen in 27 TRIPS x new formality allowed by 62 TRIPS

33. 33 CONCLUSION Simple and expedite proceedings for access authorization Access regulation at regional and international levels: unnecessary competition on access and benefit-sharing conditions unnecessary competition on access and benefit-sharing conditions better enforcement mechanisms better enforcement mechanisms Creativity in negotiating benefit-sharing In-depth knowledge of country’s legislation and proceedings Investment in research and transfer of technology Investment in research and transfer of technology Important marketing tool Important marketing tool

34. 34 THANK YOU VERY MUCH ! ctiedemann@superig.com.br carlatiedemann@gmail.com