Department of AYUSH and NISCAIR Department of AYUSH and NISCAIR ““International Conclave International Conclave on Traditional Medicineon Traditional Medicine””

New Delhi, November 16-17, 2006 New Delhi, November 16-17, 2006

Dr. Shakeel BhattiDr. Shakeel BhattiHeadHead

Genetic Resources, Traditional Knowledge and Genetic Resources, Traditional Knowledge and Biotechnology SectionBiotechnology Section

World Intellectual Property Organization (WIPO)World Intellectual Property Organization (WIPO)Geneva, SwitzerlandGeneva, Switzerland

Legal policy framework for Legal policy framework for traditional knowledge protection traditional knowledge protection

OverviewOverview

1.1. Introduction Introduction

2.2. draft Objectives & Principles for TKdraft Objectives & Principles for TK

3.3. Current commenting processCurrent commenting process

4.4. Application: international, regionalApplication: international, regional

5.5. Next stepsNext steps

Based on experiences with Based on experiences with ten existing TK ten existing TK lawslaws already in force already in force (WIPO/GRTKF/IC/5/INF/4)(WIPO/GRTKF/IC/5/INF/4);;

Based on Based on proposals from Committee Membersproposals from Committee Members;;

Based on Based on extensive global commmenting extensive global commmenting

I. Process: How did the Committee I. Process: How did the Committee arrive at the objectives & arrive at the objectives &

principles?principles? Based on Based on 7 years of WIPO work7 years of WIPO work with TK with TK

holders holders (starting with (starting with FFMs in 1998);FFMs in 1998);

Based on Based on 5 years of IGC discussions 5 years of IGC discussions (reflects policy positions of countries and TK (reflects policy positions of countries and TK

holders)holders)

Key features of draft WIPO Key features of draft WIPO ProvisionsProvisions

Not newNot new; simply ; simply distils existing distils existing frameworksframeworks and experiences; and experiences;

Does not address legal form, but Does not address legal form, but only only substance of protection;substance of protection;

Provides Provides protection for holders/provider protection for holders/provider countries of TK;countries of TK;

prevents misappropriation,prevents misappropriation, rather than rather than creates private property rights over TK;creates private property rights over TK;

Existing TK Laws analyzedExisting TK Laws analyzed African UnionAfrican Union AAfrican Model Legislation for the Protection of the Rights of frican Model Legislation for the Protection of the Rights of

Local Local Communities, Farmers and Breeders, and for the Communities, Farmers and Breeders, and for the Regulation of Regulation of Access to Biological Resources Access to Biological Resources of 2000;of 2000;

BrazilBrazil Provisional Measure Regulating Access to the Genetic Provisional Measure Regulating Access to the Genetic Heritage, Heritage, Protection of and Access to Associated TKProtection of and Access to Associated TK

ChinaChina Regulations on the Protection of Varieties of Chinese Regulations on the Protection of Varieties of Chinese Traditional Medicine Traditional Medicine and the Patent Law of 2000;and the Patent Law of 2000;

Costa RicaCosta Rica Law on Biodiversity (Law No. 7788 of 1998);Law on Biodiversity (Law No. 7788 of 1998);

IndiaIndia Biological Diversity Act of 2002;Biological Diversity Act of 2002;

PeruPeru Law Introducing a Protection Regime for the Collective Law Introducing a Protection Regime for the Collective Knowledg of Knowledg of Indigenous Peoples Derived from Indigenous Peoples Derived from Biological Resources Biological Resources

PhilippinesPhilippines Indigenous Peoples Rights Act of 1997;Indigenous Peoples Rights Act of 1997;

PortugalPortugal Law Establishing a Legal Regime of Registration, Conservation, Legal Law Establishing a Legal Regime of Registration, Conservation, Legal Custody and Transfer of Plant Endogenous Material Custody and Transfer of Plant Endogenous Material

ThailandThailand Act on Protection and Promotion of Traditional Thai Medicinal Act on Protection and Promotion of Traditional Thai Medicinal Intelligence;Intelligence;

United StatesUnited States Indian Arts and Crafts Act of 1990 and other relevant Indian Arts and Crafts Act of 1990 and other relevant measures.measures.

I. Policy ObjectivesI. Policy Objectives Recognize valueRecognize value Promote respectPromote respect Meet the actual needs of TK holdersMeet the actual needs of TK holders Promote conservation and preservation of traditional knowledgePromote conservation and preservation of traditional knowledge Empower holders of traditional knowledge and acknowledge the distinctive nature of Empower holders of traditional knowledge and acknowledge the distinctive nature of

traditional knowledge systemstraditional knowledge systems Support traditional knowledge systemsSupport traditional knowledge systems Contribute to safeguarding traditional knowledgeContribute to safeguarding traditional knowledge Repress unfair and inequitable usesRepress unfair and inequitable uses Concord with relevant international agreements and processesConcord with relevant international agreements and processes Promote innovation and creativityPromote innovation and creativity Ensure prior informed consent and mutually agreed termsEnsure prior informed consent and mutually agreed terms Promote equitable benefit-sharingPromote equitable benefit-sharing Promote community development and legitimate trading activitiesPromote community development and legitimate trading activities Preclude the grant of improper IP rights to unauthorized partiesPreclude the grant of improper IP rights to unauthorized parties Enhance transparency and mutual confidenceEnhance transparency and mutual confidence Complement protection of traditional cultural expressionsComplement protection of traditional cultural expressions

II. General Guiding PrinciplesII. General Guiding Principles Responsiveness to the needs and expectations of traditional knowledge Responsiveness to the needs and expectations of traditional knowledge

holdersholders Recognition of rightsRecognition of rights Effectiveness and accessibility of protectionEffectiveness and accessibility of protection Flexibility and comprehensivenessFlexibility and comprehensiveness Equity and benefit-sharingEquity and benefit-sharing Consistency with existing legal systems governing access to associated Consistency with existing legal systems governing access to associated

genetic resourcesgenetic resources Respect for and cooperation with other international and regional Respect for and cooperation with other international and regional

instruments and processesinstruments and processes Respect for customary use and transmission of traditional knowledgeRespect for customary use and transmission of traditional knowledge Recognition of the specific characteristics of TKRecognition of the specific characteristics of TK Providing assistance to address the needs of TK holdersProviding assistance to address the needs of TK holders

III. Specific Substantive Principles (TK)III. Specific Substantive Principles (TK)

1. Protection Against Misappropriation

2. Legal Form of Protection

3. General Scope of Subject Matter

4. Eligibility for Protection

5. Beneficiaries of Protection

6. Fair and Equitable Benefit-sharing and Recognition of Knowledge Holders

7. Principle of Prior Informed Consent

8. Exceptions and Limitations

9. Duration of Protection

10. Transitional Measures

11. Formalities

12. Consistency with the General Legal Framework

13. Administration and Enforcement of Protection

14. International and Regional Protection

II.B Substantive PrinciplesII.B Substantive Principles

misappropriation normmisappropriation norm general definition of misappropriationgeneral definition of misappropriation specific acts of misappropriation:specific acts of misappropriation:

acquisition of TK by theft, bribery, coercion, breach of contract, acquisition of TK by theft, bribery, coercion, breach of contract, misrepresentation, etcmisrepresentation, etc

defensive protection of TKdefensive protection of TK acquisition of TK in violation of prior informed consentacquisition of TK in violation of prior informed consent commercial use of TK without equitable compensation or benefit-sharingcommercial use of TK without equitable compensation or benefit-sharing other acts of unfair competitionother acts of unfair competition

TK Protection Against Misappropriation, Article 1

Art.1.1: ‘Traditional knowledge shall be protected against misappropriation.’

§§1 establishes an 1 establishes an international norm against international norm against misappropriation of TKmisappropriation of TK

Art.1.2: ‘Any acquisition, appropriation or utilization of TK by unfair or illicit means constitutes an act of misappropriation.’

§§2 gives a 2 gives a non-exhaustive non-exhaustive definitiondefinition of what is an «act of what is an «act of misappropriation»of misappropriation»

Art.1.3 ‘The following acts, in particular, shall be prohibited:’

§§3 lists specific acts of 3 lists specific acts of misappropriation, which at a misappropriation, which at a minimum shall be preventedminimum shall be prevented

Art.1.3(i): general acquisition of TK by improper means (theft, bribery, coercion, fraud, trespass, breach of contract, deception, misrepresentation, breach of confidence or confidentiality, breach of fiduciary obligations or relations of trust) ;

Art.1.3(ii): acquisition of TK in violation of PIC ;

Art.1.3(iii): claiming ownership or IPRs over TK in violation of defensive protection ;

Art.1.3(iv): commercial or industrial use of TK without just and appropriate compensation when required;

Art.1.3(v): willful offensive use of TK of particular moral or spiritual value to its holders ;

Art.6: ‘Fair and Equitable Benefit-sharing and Recognition of Knowledge Holders’

Art.7: ‘Principle of Prior Informed Consent’

B3: General scope of subject matter B3: General scope of subject matter (Art.3)(Art.3)

1.1. These principles concern protection of TK against misappropriation These principles concern protection of TK against misappropriation and misuse beyond its traditional context, and should not be and misuse beyond its traditional context, and should not be interpreted as limiting or seeking to define the diverse and holistic interpreted as limiting or seeking to define the diverse and holistic conceptions of knowledge within the traditional context. conceptions of knowledge within the traditional context.

2.2. For the purpose of these principles only, the term For the purpose of these principles only, the term “traditional “traditional knowledge” refers to the content or substance of knowledge that is knowledge” refers to the content or substance of knowledge that is the result of intellectual activity in a traditional context, and includes the result of intellectual activity in a traditional context, and includes the know-how, skills, innovations, practices and learning that form the know-how, skills, innovations, practices and learning that form part of TK systems, and knowledge that is embodied in the part of TK systems, and knowledge that is embodied in the traditional lifestyle of a community or people, or is contained in traditional lifestyle of a community or people, or is contained in codified knowledge systems passed between generationscodified knowledge systems passed between generations. It is not . It is not limited to any specific technical field, and may include agricultural, limited to any specific technical field, and may include agricultural, environmental and medicinal knowledge, and knowledge associated environmental and medicinal knowledge, and knowledge associated with genetic resources. with genetic resources.

B6: Benefit-sharing and recognition of B6: Benefit-sharing and recognition of knowledge holders knowledge holders (Art.6)(Art.6)

1.1. Commercial or industrial use of TK should be subject to just Commercial or industrial use of TK should be subject to just and appropriate compensation for the benefit of the TK and appropriate compensation for the benefit of the TK holder, when such use has gainful intent and confers a holder, when such use has gainful intent and confers a technological or commercial advantage, and when technological or commercial advantage, and when compensation would be consistent with fairness and equity in compensation would be consistent with fairness and equity in relation to TK holdersrelation to TK holders. Liability for compensation should, in . Liability for compensation should, in particular, arise where the knowledge was accessed or particular, arise where the knowledge was accessed or acquired in a manner that creates a reasonable expectation acquired in a manner that creates a reasonable expectation that benefits from such use should be shared equitably, and that benefits from such use should be shared equitably, and where the user is aware of the distinctive association of the where the user is aware of the distinctive association of the knowledge with a certain community or people. knowledge with a certain community or people. Compensation should be in a form that responds to the Compensation should be in a form that responds to the express needs of the TK holders and is culturally appropriate.express needs of the TK holders and is culturally appropriate.

B7: Principle of Prior Informed Consent B7: Principle of Prior Informed Consent (Art.7)(Art.7)

1.1. The principle of prior informed consent should The principle of prior informed consent should govern any direct access or acquisition of TK from govern any direct access or acquisition of TK from its traditional holders, subject to these principles its traditional holders, subject to these principles and relevant national laws. and relevant national laws.

3.3. The holder of TK shall be entitled to grant prior The holder of TK shall be entitled to grant prior informed consent for access to TK, or to approve informed consent for access to TK, or to approve the grant of such consent by an appropriate national the grant of such consent by an appropriate national authority, as provided by applicable national authority, as provided by applicable national legislation.legislation.

B9: Duration of protection B9: Duration of protection (Art.9)(Art.9)

Protection of TK against misappropriation should last as Protection of TK against misappropriation should last as long as the TK fulfills the criteria of protection, in long as the TK fulfills the criteria of protection, in particular as long as it is maintained by TK holders, particular as long as it is maintained by TK holders, remains distinctively associated with them and remains distinctively associated with them and remains integral to their collective identity. Possible remains integral to their collective identity. Possible additional protection against other acts, which may be additional protection against other acts, which may be made available by relevant national or regional laws made available by relevant national or regional laws or measures, shall specify the duration of protection or measures, shall specify the duration of protection under those laws or measuresunder those laws or measures

B11: Formalities (Art.11)(Art.11)

1. Eligibility for protection of TK against acts of misappropriation and other acts of unfair competition should not require any formalities.

2. In the interests of transparency, certainty and the conservation of TK, relevant national authorities may maintain registers or other records of traditional knowledge, where appropriate and subject to relevant policies, laws and procedures, and the needs and aspirations of TK holders. Such registers may be associated with specific forms of protection, and should not compromise the status of hitherto undisclosed TK or the interests of TK holders in relation to undisclosed elements of their knowledge.

B12: Consistency with legal frameworks B12: Consistency with legal frameworks (Art.12)(Art.12)

1.1. In case of TK which relates to components of In case of TK which relates to components of biological diversity, access to, and use of, that TK biological diversity, access to, and use of, that TK shall be shall be consistent with laws regulating access to consistent with laws regulating access to those components of biological diversitythose components of biological diversity. .

2.2. Traditional knowledge protection should be Traditional knowledge protection should be consistent with existing IP systems consistent with existing IP systems and supportive of and supportive of the applicability of relevant international IP standards the applicability of relevant international IP standards to the benefit of holders of traditional knowledge.to the benefit of holders of traditional knowledge.

B14: International and Regional B14: International and Regional Protection Protection (Art.14)(Art.14)

Legal and administrative mechanisms should be Legal and administrative mechanisms should be established to provide effective protection in national established to provide effective protection in national systems for the traditional knowledge of foreign systems for the traditional knowledge of foreign rightsholders. Measures should be established to rightsholders. Measures should be established to facilitate as far as possible the acquisition, facilitate as far as possible the acquisition, management and enforcement of such protection for management and enforcement of such protection for the benefit of traditional knowledge holders in the benefit of traditional knowledge holders in foreign countries.foreign countries.

Current Commenting Current Commenting ProcessProcess

Member-driven processMember-driven process More than 300 pages of commentsMore than 300 pages of comments Diverse views on draft provisionsDiverse views on draft provisions Comments invited on all 3 parts of Comments invited on all 3 parts of

document;document; Asia-Pacific Meeting in India Asia-Pacific Meeting in India

developed Asian technical comments;developed Asian technical comments; Next steps in hands of Member StatesNext steps in hands of Member States

Application of WIPO Application of WIPO ProvisionsProvisions

InternationalInternational CBD draft International Regime on ABSCBD draft International Regime on ABS WGIP Draft Guidelines on Heritage of WGIP Draft Guidelines on Heritage of

Indig PeoplesIndig Peoples RegionalRegional

draft SAARC Framework on Protection of draft SAARC Framework on Protection of TKTK

draft ARIPO, OAPI instrument(s) on TKdraft ARIPO, OAPI instrument(s) on TK NationalNational

Mongolia, Sri Lanka, etcMongolia, Sri Lanka, etc

draft SAARC Framework for draft SAARC Framework for Protection of TK Protection of TK

TK TK holderholderTKTK

IdentifiableIdentifiable UnidentifiableUnidentifiable

DisclosedDisclosed CompensatorCompensatory liability y liability TKHTKH

CompensatorCompensatory liability y liability NCANCA

UndisclosedUndisclosed Prior Informed Prior Informed Consent & Consent & MATMAT

ConclusionConclusion draft Objectives & Principles are outcome draft Objectives & Principles are outcome

of 5 years of work by Committee of 5 years of work by Committee membersmembers

numerous Member States are already numerous Member States are already applying them at regional or national applying them at regional or national levellevel

commenting process on the drafts is commenting process on the drafts is ongoing ongoing

next steps are in hands of Member Statesnext steps are in hands of Member States