1 biodiversity legislation globally and in brazil carla tiedemann c. barreto 4th annual...

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Biodiversity Biodiversity legislation legislation

globally and in globally and in BrazilBrazilCarla Tiedemann C. BarretoCarla Tiedemann C. Barreto

4th Annual International Symposium4th Annual International SymposiumAhmedabad, India / Feb. 2008Ahmedabad, India / Feb. 2008

©2008 Carla Tiedemann C.Barreto©2008 Carla Tiedemann C.Barreto

pictures:pictures:www.ibama.gov.br

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INTERNATIONAL INTERNATIONAL SCENARIOSCENARIO

Initial discussions on strategies to protect Initial discussions on strategies to protect environment in the 70ies. Ex: endangered environment in the 70ies. Ex: endangered species species

Prevailing concept: biological resources as Prevailing concept: biological resources as common heritage of mankindcommon heritage of mankind

Increasing number of patents for products and Increasing number of patents for products and processes involving biological and genetic processes involving biological and genetic resourcesresources

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CONVENTION ON CONVENTION ON BIOLOGICAL DIVERSITY BIOLOGICAL DIVERSITY (CBD (CBD

– 1992)– 1992)

Starting point to current system of protectionStarting point to current system of protection

United Nations Conference on Environment and United Nations Conference on Environment and Sustainable Development – Rio de Janeiro, Sustainable Development – Rio de Janeiro, Brazil – 1992Brazil – 1992

CBD came into force in December 1993CBD came into force in December 1993 190 parties190 parties

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Convention on Biological Convention on Biological Diversity Diversity (CBD – 1992)(CBD – 1992)

PRINCIPLES:PRINCIPLES: Conservation of Biological DiversityConservation of Biological Diversity Sustainable Use of its ComponentsSustainable Use of its Components Fair and Equitable Distribution of Benefits Fair and Equitable Distribution of Benefits Valorization of Social Diversity / Preservation of Valorization of Social Diversity / Preservation of

Associated Traditional Knowledge Associated Traditional Knowledge

RIGHT X RESPONSIBILITY (sovereignty)RIGHT X RESPONSIBILITY (sovereignty) REGULATION OF ACCESS / DISTRIBUTION OF REGULATION OF ACCESS / DISTRIBUTION OF

BENEFITS BENEFITS

CONCEPT OF BIOLOGICAL DIVERSITY including:CONCEPT OF BIOLOGICAL DIVERSITY including:• Microorganisms, plants and animals; Microorganisms, plants and animals; • Ecosystems Ecosystems • Diversity among species and populationsDiversity among species and populations

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NATIONAL NATIONAL LEGISLATIONLEGISLATION

COLOMBIA COLOMBIA 1995 – Biodiversity ad hoc group1995 – Biodiversity ad hoc group 2 different proceedings for granting access2 different proceedings for granting access Property rights divided into:Property rights divided into:

Genetic and Biochemical ResourcesGenetic and Biochemical Resources Biological ResourcesBiological Resources

ECUADORECUADOR 1996 – State as title holder 1996 – State as title holder Commercial use subject to special regulationCommercial use subject to special regulation Ancestral Rights and control over: Ancestral Rights and control over:

Traditional Knowledge / Intangible ComponentsTraditional Knowledge / Intangible Components Genetic ResourcesGenetic Resources

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COSTA RICACOSTA RICA

1998 – Protection of Industrial and Intellectual Property 1998 – Protection of Industrial and Intellectual Property Rights Rights

Hybrid System of Protection – Traditional IPR and “Hybrid System of Protection – Traditional IPR and “sui sui generisgeneris Communitarian Intellectual Rights” Communitarian Intellectual Rights”

Biodiversity encompassing, among others:Biodiversity encompassing, among others:• Cultivated Resources Cultivated Resources • Chemical and Biochemical ResourcesChemical and Biochemical Resources• Derivatives or Products Derived from Biological Derivatives or Products Derived from Biological

ResourcesResources

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NATIONAL LEGISLATION - NATIONAL LEGISLATION - COSTA RICACOSTA RICA

Access and Benefit-Sharing:Access and Benefit-Sharing:

Access limited in number of samples and timeAccess limited in number of samples and time Many compensation and benefit-sharing options:Many compensation and benefit-sharing options:

• Technology TransferTechnology Transfer• TrainingTraining• RoyaltiesRoyalties• Upfront PaymentUpfront Payment• Support for ConservationSupport for Conservation• ““Milestones”Milestones”

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PERUPERU

Law Project on Access/ Indigenous Law Project on Access/ Indigenous Communities, NGO’s, Ministries and Patent Communities, NGO’s, Ministries and Patent Office Office

Specific law / Special implementing rules for Specific law / Special implementing rules for Traditional Knowledge registrationTraditional Knowledge registration

Prior Informed Consent – National Prior Informed Consent – National representative organizationrepresentative organization

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PHILIPPINESPHILIPPINESTwo pieces of law: Two pieces of law:

Executive Order No. 247/1995: prospecting of Executive Order No. 247/1995: prospecting of biological and genetic resources, by-products and biological and genetic resources, by-products and derivativesderivatives

Indigenous Peoples Rights Act (1997): recognizes, Indigenous Peoples Rights Act (1997): recognizes, protects and promotes Indigenous Cultural protects and promotes Indigenous Cultural Communities’ and Indigenous Peoples’ Rights Communities’ and Indigenous Peoples’ Rights

(Ex: ownership to ancestral domains, cultural integrity, self-government, (Ex: ownership to ancestral domains, cultural integrity, self-government, own customary laws)own customary laws)

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NATIONAL LEGISLATION - NATIONAL LEGISLATION - PHILIPPINESPHILIPPINES

Biological Resources owned by the State (full Biological Resources owned by the State (full control and supervision)control and supervision)

In Indigenous Ancestral Lands: In Indigenous Ancestral Lands: Access only with Prior Informed Consent according to Access only with Prior Informed Consent according to

their own customary laws their own customary laws Right to veto bioprospecting Right to veto bioprospecting

Research Agreement between Prospector and Research Agreement between Prospector and Government with copy to CommunityGovernment with copy to Community

Royalties to Government and CommunityRoyalties to Government and Community

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NATIONAL LEGISLATION - NATIONAL LEGISLATION - PHILIPPINESPHILIPPINES

Implementing and Enforcing Agency: Inter-Agency Implementing and Enforcing Agency: Inter-Agency Committee on Biological and Genetic ResourcesCommittee on Biological and Genetic Resources

Various Government Agencies Various Government Agencies Academic CommunityAcademic Community One representative from an NGO One representative from an NGO One representative of an Indigenous People’s One representative of an Indigenous People’s

OrganizationOrganization

Traditional and Alternative Medicine Act Traditional and Alternative Medicine Act • Promoting use and development of traditional Promoting use and development of traditional

medicinemedicine• Improving its quality and statusImproving its quality and status

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BRAZILBRAZIL

Mega diverse countryMega diverse country More than 200,000 species registeredMore than 200,000 species registered Over 56,000 reported plants in different biomesOver 56,000 reported plants in different biomes

• Amazon and Atlantic ForestAmazon and Atlantic Forest• CerradoCerrado• CaatingaCaatinga• PantanalPantanal• Pampa Pampa • Coastal region and watersCoastal region and waters

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Source: wwf.org,br

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NATIONAL LEGISLATION – NATIONAL LEGISLATION – BRAZILBRAZIL

LEGAL BACKGROUNDLEGAL BACKGROUND

1988 Constitution – Common Heritage of Mankind1988 Constitution – Common Heritage of Mankind CBD - signed 1992CBD - signed 1992 Approved by Congress (1994) Approved by Congress (1994) Effective in 1998 (Decree 2.519/98)Effective in 1998 (Decree 2.519/98) Since 1995 – Attempts to implement and regulateSince 1995 – Attempts to implement and regulate Main regulation: Provisional Bill 2.186-16/2000Main regulation: Provisional Bill 2.186-16/2000

Access to Biological Resources and Traditional Access to Biological Resources and Traditional KnowledgeKnowledge

Share of Benefits / Prior Informed ConsentShare of Benefits / Prior Informed Consent Transfer of TechnologyTransfer of Technology

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REGULATING AGENCYREGULATING AGENCY Council for the Management of Genetic Resources – Council for the Management of Genetic Resources – CGENCGENComposition:Composition:

Representatives of Government Bodies and Public Representatives of Government Bodies and Public Research Entities, including:Research Entities, including:

Brazilian Environment and Renewable Resources Brazilian Environment and Renewable Resources Institute - IBAMA Institute - IBAMA

Indigenous Affairs Body – FUNAIIndigenous Affairs Body – FUNAI Brazilian Patent and Trademark Office – BPTOBrazilian Patent and Trademark Office – BPTO

Private sector (2003) – “permanent guest entities”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 SectorsAcademic and Private Sectors General Attorney’s OfficeGeneral Attorney’s Office

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ATRIBUTIONS:ATRIBUTIONS:

Deliberate and Issue Technical Rules for Access and Deliberate and Issue Technical Rules for Access and Shipment of Samples Shipment of Samples

Issue Directives / Approve Contracts for Access and Issue Directives / Approve Contracts for Access and Benefit-Sharing Benefit-Sharing

Regulate Access to Biological Resources and Traditional Regulate Access to Biological Resources and Traditional Knowledge relating to:Knowledge relating to:

Technological developmentTechnological development Biological prospectionBiological prospection Other commercial and industrial purposesOther commercial and industrial purposes Scientific research (IBAMA / CNPq)Scientific research (IBAMA / CNPq)

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WHO CAN BE AUTHORIZED:WHO CAN BE AUTHORIZED: National institutions, public or private, engaged in R&D in National institutions, public or private, engaged in R&D in

biological or related areas biological or related areas Foreign legal entities / joint project with a Brazilian Foreign legal entities / joint project with a Brazilian

InstitutionInstitution

SHIPMENT OF SAMPLES:SHIPMENT OF SAMPLES: Authorization by CGEN (exception)Authorization by CGEN (exception) Previous Signature of Material Transfer Undertaking or Previous Signature of Material Transfer Undertaking or

of a Use and Benefit-Sharing Agreement of a Use and Benefit-Sharing Agreement Deposit of Sub-Sample in a Brazilian Depositary Deposit of Sub-Sample in a Brazilian Depositary

Institution recognized by CGEN (also for access)Institution recognized by CGEN (also for access)

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Purpose:Purpose: Keep evidence of accessed material in BrazilKeep evidence of accessed material in Brazil Clarify possible doubts regarding originClarify possible doubts regarding origin

TRADITIONAL KNOWLEDGETRADITIONAL KNOWLEDGE

Right to Decide on Use / Prior Informed ConsentRight to Decide on Use / Prior Informed Consent Derive Profits from its Economic ExploitationDerive Profits from its Economic Exploitation Have the origin indicated in all publications, use and Have the origin indicated in all publications, use and

exploitationexploitation Curb use, test, research/exploitation by unauthorized third Curb use, test, research/exploitation by unauthorized third

partiesparties Prevent disclosure, broadcast or retransmission of dataPrevent disclosure, broadcast or retransmission of data

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PRIOR INFORMED CONSENT / DIFFICULTIES: PRIOR INFORMED CONSENT / DIFFICULTIES:

Place of access / Persons or Entities to be heard:Place of access / Persons or Entities to be heard: Indigenous lands – Indigenous Affairs BodyIndigenous 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 DefenseNational Security Areas – Council of National Defense Continental Shelf, Exclusive Economic Region – Continental Shelf, Exclusive Economic Region –

Maritime AuthorityMaritime Authority

More than one visit to the area to obtain consent More than one visit to the area to obtain consent

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2004 – 2004 – Previous Consent of Proprietor of Previous Consent of Proprietor of Private Areas dismissed for scientific research Private Areas dismissed for scientific research with no potential for commercial use.with no potential for commercial use.

Written document remains obligatory:Written document remains obligatory: prospectionprospection technological developmenttechnological development Indigenous communities Indigenous communities

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BENEFIT-SHARING AGREEMENTSBENEFIT-SHARING AGREEMENTS Potential for commercial usePotential for commercial use Parties:Parties:

Applicant (national institution authorized to access)Applicant (national institution authorized to access) Institution of destiny (shipment)Institution of destiny (shipment) Proprietor of the area (public or private) ORProprietor of the area (public or private) OR Representative of indigenous community + Representative of indigenous community +

Indigenous Affairs Body ORIndigenous Affairs Body OR Representative of local communityRepresentative of local community

GovernmentGovernment Efficacy : agreement and registration by CGENEfficacy : agreement and registration by CGEN

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MANDATORY CLAUSESMANDATORY CLAUSES quantification of samples and intended usequantification of samples and intended use method of benefit-sharing and access and transfer of method of benefit-sharing and access and transfer of

technology; technology; intellectual property rightsintellectual property rights jurisdiction in Braziljurisdiction in Brazil

BENEFIT-SHARING POSSIBILITIES: BENEFIT-SHARING POSSIBILITIES: Share of profits / payment of royalties Share of profits / payment of royalties Technology transfer Technology transfer licensing of products and processeslicensing of products and processes training of human resourcestraining of human resources

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TRADITIONAL KNOWLEDGE / PROTECTIONTRADITIONAL KNOWLEDGE / PROTECTION: : data basisdata basis PublicationPublication

PENALTIES (administrative sanctions)PENALTIES (administrative sanctions)

Seizure of samplesSeizure of samples Embargo of activity Embargo of activity Suspension of registration, patent, license or authorizationSuspension of registration, patent, license or authorization Loss or suspension of participation in official financing Loss or suspension of participation in official financing Fine: US$ 5,000.00 to US$ 28 million (legal entities)Fine: US$ 5,000.00 to US$ 28 million (legal entities)

CIVIL AND CRIMINAL CIVIL AND CRIMINAL LAW PROJECTLAW PROJECT

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INTELLECTUAL PROPERTY INTELLECTUAL PROPERTY RIGHTSRIGHTS

Impact on conservation and sustainable use Impact on conservation and sustainable use CBD 16.5 -The contracting parties shall cooperate in CBD 16.5 -The contracting parties shall cooperate in

order to ensure that IPR are supportive of and do not run order to ensure that IPR are supportive of and do not run counter to the objectives of the Convention.counter to the objectives of the Convention.

Conflict with TRIPS? Conflict with TRIPS? CBD 22.1 – The provisions of the CBD shall not affect CBD 22.1 – The provisions of the CBD shall not affect

the rights and obligations of any contracting party the rights and obligations of any contracting party deriving from any international agreement, except where deriving from any international agreement, except where the exercise of those rights and obligations would cause the exercise of those rights and obligations would cause a serious damage or threat to biological diversitya serious damage or threat to biological diversity

No definition of serious damage or threat / Other No definition of serious damage or threat / Other conventions conventions

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BRAZIL – INPI RESOLUTION 134/2006 BRAZIL – INPI RESOLUTION 134/2006

New regulation /application forms for patents (PCT and non-PCT)New regulation /application forms for patents (PCT and non-PCT)Immediate effects on future and pending applications as from Nov. 10, Immediate effects on future and pending applications as from Nov. 10,

20062006

Mandatory identification whether the subject matter refers to samples of Mandatory identification whether the subject matter refers to samples of the Brazilian genetic heritage or not: the Brazilian genetic heritage or not:

Evidence of compliance with Provisional Bill 2186-16/01: number Evidence of compliance with Provisional Bill 2186-16/01: number and date of CGEN’s access authorizationand date of CGEN’s access authorization

Identification of the origin of the genetic resource and associated Identification of the origin of the genetic resource and associated traditional knowledge.traditional knowledge.

Pending applications as from June 30, 2000: supplemental form / no Pending applications as from June 30, 2000: supplemental form / no chargecharge

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Criticism: Criticism: o Art. 31 Provisional Bill 2186-16/01 - grant x filing Art. 31 Provisional Bill 2186-16/01 - grant x filing o Mandatory disclosure of origin and access Mandatory disclosure of origin and access

authorization data could not hinder applicationauthorization data could not hinder applicationo No negative declaration in Provisional Bill No negative declaration in Provisional Bill o Option: application form x any time before grant Option: application form x any time before grant o Access authorization by CGEN takes too longAccess authorization by CGEN takes too longo Conflict with TRIPS: new substantive requirement Conflict with TRIPS: new substantive requirement

for grant of patents not foreseen in 27 TRIPS x for grant of patents not foreseen in 27 TRIPS x new formality allowed by 62 TRIPSnew formality allowed by 62 TRIPS

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CONCLUSION CONCLUSION Simple and expedite proceedings for access Simple and expedite proceedings for access authorizationauthorizationAccess regulation at regional and international Access regulation at regional and international levels:levels: unnecessary competition on access and unnecessary competition on access and

benefit-sharing conditionsbenefit-sharing conditions better enforcement mechanisms better enforcement mechanisms Creativity in negotiating benefit-sharing Creativity in negotiating benefit-sharing In-depth knowledge of country’s legislation and In-depth knowledge of country’s legislation and proceedingsproceedings Investment in research and transfer of Investment in research and transfer of

technologytechnology Important marketing toolImportant marketing tool

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THANK YOU VERY THANK YOU VERY MUCH !MUCH !

[email protected]@superig.com.br

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1 biodiversity legislation globally and in brazil carla tiedemann c. barreto 4th annual...

Documents

cultivated resources

biological diversity

biochemical resources

populations diversity

biodiversity legislation

access property rights

national legislation

brazil carla tiedemann