1. Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources, Traditional Knowledge and Biotechnology Section World Intellectual Property Organization (WIPO) Geneva, Switzerland Legal policy framework for traditional knowledge protection

2. Overview 1. Introduction 2. draft Objectives & Principles for TK 3. Current commenting process 4. Application: international, regional 5. Next steps

3. Based on experiences with ten existing TK laws already in force (WIPO/GRTKF/IC/5/INF/4) ; Based on experiences with ten existing TK laws already in force (WIPO/GRTKF/IC/5/INF/4) ; Based on proposals from Committee Members; Based on proposals from Committee Members; Based on extensive global commmenting Based on extensive global commmenting I. Process: How did the Committee arrive at the objectives & principles? Based on 7 years of WIPO work with TK holders (starting with FFMs in 1998); Based on 7 years of WIPO work with TK holders (starting with FFMs in 1998); Based on 5 years of IGC discussions (reflects policy positions of countries and TK holders) Based on 5 years of IGC discussions (reflects policy positions of countries and TK holders)

4. Key features of draft WIPO Provisions Not new; simply distils existing frameworks and experiences; Not new; simply distils existing frameworks and experiences; Does not address legal form, but only substance of protection; Does not address legal form, but only substance of protection; Provides protection for holders/provider countries of TK; Provides protection for holders/provider countries of TK; prevents misappropriation, rather than creates private property rights over TK; prevents misappropriation, rather than creates private property rights over TK;

5. Existing TK Laws analyzed African UnionAfrican Model Legislation for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources of 2000; African UnionAfrican Model Legislation for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources of 2000; BrazilProvisional Measure Regulating Access to the Genetic Heritage, Protection of and Access to Associated TK BrazilProvisional Measure Regulating Access to the Genetic Heritage, Protection of and Access to Associated TK ChinaRegulations on the Protection of Varieties of Chinese Traditional Medicine and the Patent Law of 2000; ChinaRegulations on the Protection of Varieties of Chinese Traditional Medicine and the Patent Law of 2000; Costa RicaLaw on Biodiversity (Law No. 7788 of 1998); Costa RicaLaw on Biodiversity (Law No. 7788 of 1998); IndiaBiological Diversity Act of 2002; IndiaBiological Diversity Act of 2002; PeruLaw Introducing a Protection Regime for the Collective Knowledg of Indigenous Peoples Derived from Biological Resources PeruLaw Introducing a Protection Regime for the Collective Knowledg of Indigenous Peoples Derived from Biological Resources PhilippinesIndigenous Peoples Rights Act of 1997; PhilippinesIndigenous Peoples Rights Act of 1997; PortugalLaw Establishing a Legal Regime of Registration, Conservation, Legal Custody and Transfer of Plant Endogenous Material PortugalLaw Establishing a Legal Regime of Registration, Conservation, Legal Custody and Transfer of Plant Endogenous Material ThailandAct on Protection and Promotion of Traditional Thai Medicinal Intelligence; ThailandAct on Protection and Promotion of Traditional Thai Medicinal Intelligence; United StatesIndian Arts and Crafts Act of 1990 and other relevant measures. United StatesIndian Arts and Crafts Act of 1990 and other relevant measures.

6. I. Policy Objectives Recognize value Recognize value Promote respect Promote respect Meet the actual needs of TK holders Meet the actual needs of TK holders Promote conservation and preservation of traditional knowledge Promote conservation and preservation of traditional knowledge Empower holders of traditional knowledge and acknowledge the distinctive nature of traditional knowledge systems Empower holders of traditional knowledge and acknowledge the distinctive nature of traditional knowledge systems Support traditional knowledge systems Support traditional knowledge systems Contribute to safeguarding traditional knowledge Contribute to safeguarding traditional knowledge Repress unfair and inequitable uses Repress unfair and inequitable uses Concord with relevant international agreements and processes Concord with relevant international agreements and processes Promote innovation and creativity Promote innovation and creativity Ensure prior informed consent and mutually agreed terms Ensure prior informed consent and mutually agreed terms Promote equitable benefit-sharing Promote equitable benefit-sharing Promote community development and legitimate trading activities Promote community development and legitimate trading activities Preclude the grant of improper IP rights to unauthorized parties Preclude the grant of improper IP rights to unauthorized parties Enhance transparency and mutual confidence Enhance transparency and mutual confidence Complement protection of traditional cultural expressions Complement protection of traditional cultural expressions

7. II. General Guiding Principles Responsiveness to the needs and expectations of traditional knowledge holders Responsiveness to the needs and expectations of traditional knowledge holders Recognition of rights Recognition of rights Effectiveness and accessibility of protection Effectiveness and accessibility of protection Flexibility and comprehensiveness Flexibility and comprehensiveness Equity and benefit-sharing Equity and benefit-sharing Consistency with existing legal systems governing access to associated genetic resources Consistency with existing legal systems governing access to associated genetic resources Respect for and cooperation with other international and regional instruments and processes Respect for and cooperation with other international and regional instruments and processes Respect for customary use and transmission of traditional knowledge Respect for customary use and transmission of traditional knowledge Recognition of the specific characteristics of TK Recognition of the specific characteristics of TK Providing assistance to address the needs of TK holders Providing assistance to address the needs of TK holders

8. III. Specific Substantive Principles (TK) 1. 1. Protection Against Misappropriation 2. 2. Legal Form of Protection 3. 3. General Scope of Subject Matter 4. 4. Eligibility for Protection 5. 5. Beneficiaries of Protection 6. 6. Fair and Equitable Benefit-sharing and Recognition of Knowledge Holders 7. 7. Principle of Prior Informed Consent 8. 8. Exceptions and Limitations 9. 9. Duration of Protection 10. 10. Transitional Measures 11. 11. Formalities 12. 12. Consistency with the General Legal Framework 13. 13. Administration and Enforcement of Protection 14. 14. International and Regional Protection

9. II.B Substantive Principles misappropriation norm misappropriation norm general definition of misappropriation general definition of misappropriation specific acts of misappropriation: specific acts of misappropriation: acquisition of TK by theft, bribery, coercion, breach of contract, misrepresentation, etc acquisition of TK by theft, bribery, coercion, breach of contract, misrepresentation, etc defensive protection of TK defensive protection of TK acquisition of TK in violation of prior informed consent acquisition of TK in violation of prior informed consent commercial use of TK without equitable compensation or benefit- sharing commercial use of TK without equitable compensation or benefit- sharing other acts of unfair competition other acts of unfair competition

10. TK Protection Against Misappropriation, Article 1 Art.1.1: ‘Traditional knowledge shall be protected against misappropriation.’ §1 establishes an international norm against misappropriation 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 non-exhaustive definition of what is an «act of misappropriation» Art.1.3 ‘The following acts, in particular, shall be prohibited:’ §3 lists specific acts of misappropriation, which at a minimum 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’

11. B3: General scope of subject matter (Art.3) 1.These principles concern protection of TK against misappropriation and misuse beyond its traditional context, and should not be interpreted as limiting or seeking to define the diverse and holistic conceptions of knowledge within the traditional context. 2.For the purpose of these principles only, the term “traditional knowledge” refers to the content or substance of knowledge that is the result of intellectual activity in a traditional context, and includes the know-how, skills, innovations, practices and learning that form part of TK systems, and knowledge that is embodied in the traditional lifestyle of a community or people, or is contained in codified knowledge systems passed between generations. It is not limited to any specific technical field, and may include agricultural, environmental and medicinal knowledge, and knowledge associated with genetic resources.

12. B6: Benefit-sharing and recognition of knowledge holders (Art.6) 1.Commercial or industrial use of TK should be subject to just and appropriate compensation for the benefit of the TK holder, when such use has gainful intent and confers a technological or commercial advantage, and when compensation would be consistent with fairness and equity in relation to TK holders. Liability for compensation should, in particular, arise where the knowledge was accessed or acquired in a manner that creates a reasonable expectation that benefits from such use should be shared equitably, and where the user is aware of the distinctive association of the knowledge with a certain community or people. Compensation should be in a form that responds to the express needs of the TK holders and is culturally appropriate.

13. B7: Principle of Prior Informed Consent (Art.7) 1. The principle of prior informed consent should govern any direct access or acquisition of TK from its traditional holders, subject to these principles and relevant national laws. 3.The holder of TK shall be entitled to grant prior informed consent for access to TK, or to approve the grant of such consent by an appropriate national authority, as provided by applicable national legislation.

14. B9: Duration of protection (Art.9) Protection of TK against misappropriation should last as long as the TK fulfills the criteria of protection, in particular as long as it is maintained by TK holders, remains distinctively associated with them and remains integral to their collective identity. Possible additional protection against other acts, which may be made available by relevant national or regional laws or measures, shall specify the duration of protection under those laws or measures

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

16. B12: Consistency with legal frameworks (Art.12) 1.In case of TK which relates to components of biological diversity, access to, and use of, that TK shall be consistent with laws regulating access to those components of biological diversity. 2.Traditional knowledge protection should be consistent with existing IP systems and supportive of the applicability of relevant international IP standards to the benefit of holders of traditional knowledge.

17. B14: International and Regional Protection (Art.14) Legal and administrative mechanisms should be established to provide effective protection in national systems for the traditional knowledge of foreign rightsholders. Measures should be established to facilitate as far as possible the acquisition, management and enforcement of such protection for the benefit of traditional knowledge holders in foreign countries.

18. Current Commenting Process Member-driven process Member-driven process More than 300 pages of comments More than 300 pages of comments Diverse views on draft provisions Diverse views on draft provisions Comments invited on all 3 parts of document; Comments invited on all 3 parts of document; Asia-Pacific Meeting in India developed Asian technical comments; Asia-Pacific Meeting in India developed Asian technical comments; Next steps in hands of Member States Next steps in hands of Member States

19. Application of WIPO Provisions International International CBD draft International Regime on ABS CBD draft International Regime on ABS WGIP Draft Guidelines on Heritage of Indig Peoples WGIP Draft Guidelines on Heritage of Indig Peoples Regional Regional draft SAARC Framework on Protection of TK draft SAARC Framework on Protection of TK draft ARIPO, OAPI instrument(s) on TK draft ARIPO, OAPI instrument(s) on TK National National Mongolia, Sri Lanka, etc Mongolia, Sri Lanka, etc

20. draft SAARC Framework for Protection of TK TK holder TK TK holder TKIdentifiableUnidentifiable Disclosed Compensatory liability  TKH Compensatory liability  NCA Undisclosed Prior Informed Consent & MAT

21. Conclusion draft Objectives & Principles are outcome of 5 years of work by Committee members draft Objectives & Principles are outcome of 5 years of work by Committee members numerous Member States are already applying them at regional or national level numerous Member States are already applying them at regional or national level commenting process on the drafts is ongoing commenting process on the drafts is ongoing next steps are in hands of Member States next steps are in hands of Member States