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. 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

4. Objective (i) Recognize value (i)recognize the holistic nature of traditional knowledge and its intrinsic value … and acknowledge that traditional knowledge systems are frameworks of ongoing innovation and distinctive intellectual and creative life … and have equal scientific value as other knowledge systems;

5. Objective (ii) Promote Respect (ii)promote respect for TK systems; for the dignity, cultural integrity and intellectual and spiritual values of the TK holders who conserve and maintain those systems; for the contribution which TK has made in sustaining the livelihoods and identities of TK holders; and for the contribution which TK holders have made to the conservation of the environment, to food security and sustainable agriculture, and to the progress of science and technology;

6. Obj.(iii) Meet Needs of TK Holders (iii)be guided by the aspirations and expectations expressed directly by TK holders, respect their rights as holders and custodians of TK, contribute to their welfare and economic, cultural and social benefit and reward the contribution made by them to their communities and to the progress of science and socially beneficial technology;

7. Obj.(iv) Promote TK Conservation (iv)promote and support the conservation and preservation of TK by respecting, preserving, protecting and maintaining TK systems and providing incentives to the custodians of those knowledge systems to maintain and safeguard their knowledge systems; (iv)promote and support the conservation and preservation of TK by respecting, preserving, protecting and maintaining TK systems and providing incentives to the custodians of those knowledge systems to maintain and safeguard their knowledge systems;

8. Obj.(viii) Repress unfair uses (viii)repress the misappropriation of TK and other unfair commercial and non ‑ commercial activities, recognizing the need to adapt approaches for the repression of misappropriation of TK to national and local needs;

9. Obj.(ix) Cooperation wh other agreements and processes (ix)take account of, and operate consistently with, other international and regional instruments and processes, in particular regimes that regulate access to and benefit ‑ sharing from genetic resources which are associated with that traditional knowledge;

10. Obj.(x) Promote Innovation (x)encourage, reward and protect tradition ‑ based creativity and innovation and enhance the internal transmission of TK within indigenous and traditional communities, including, subject to the consent of the TK holders, by integrating such knowledge into educational initiatives among the communities, for the benefit of the holders and custodians of traditional knowledge;

11. Obj.(xi) Prior Informed Consent (xi)ensure prior informed consent and exchanges based on mutually agreed terms, in coordination with existing international and national regimes governing access to genetic resources;

12. Obj.(xii) Equitable Benefit-sharing (xii)promote the fair and equitable sharing and distribution of monetary and non ‑ monetary benefits arising from the use of TK, in consistency with other applicable international regimes, the principle of prior informed consent and including through fair and equitable compensation in special cases where the individual holder is not identifiable or the knowledge has been disclosed;

13. Obj.(xiii) Preclude improper IPRs (xiv)curtail the grant or exercise of improper intellectual property rights over TK and associated genetic resources, by requiring, in particular, as a condition for the granting of patent rights, that patent applicants for inventions involving traditional knowledge and associated genetic resources disclose the source and country of origin of those resources, as well as evidence of prior informed consent and benefit ‑ sharing conditions have been complied with in the country of origin;

14. 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

15. 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

16. 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

17. 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’

18. B.1 Protection against Misappropriation (Art.1) 1. Traditional knowledge shall be protected against misappropriation. 2. Any acquisition or appropriation of TK by unfair or illicit means constitutes an act of misappropriation.

19. B.1 Protection Against Misappropriation (Art.1) 2.(cntd) Misappropriation may also include: deriving commercial benefit from the acquisition or appropriation of TK when the person using that knowledge knows, or is grossly negligent in failing to know, that it was acquired or appropriated by unfair means; and deriving commercial benefit from the acquisition or appropriation of TK when the person using that knowledge knows, or is grossly negligent in failing to know, that it was acquired or appropriated by unfair means; and other commercial activities contrary to honest practices that gain inequitable benefit from traditional knowledge. other commercial activities contrary to honest practices that gain inequitable benefit from traditional knowledge.

20. B.1 Protection Against Misappropriation (Art.1) 3. In particular, legal means should be available to suppress: (i) acquisition of TK by theft, bribery, coercion, fraud, trespass, breach or inducement of breach of contract, breach or inducement of breach of confidence or confidentiality, breach of fiduciary obligations or other relations of trust, deception, misrepresentation, the provision of misleading information when obtaining prior informed consent for access to TK, or other unfair or dishonest means; (ii) acquisition of TK or exercising control over it in violation of legal measures that require prior informed consent as a condition of access to the knowledge, and use of TK that violates terms that were mutually agreed as a condition of prior informed consent concerning access to that knowledge;

21. B.1 Protection Against Misappropriation (Art.1) 3. In particular, legal means should be available to suppress: (…) (iii) false claims or assertions of ownership or control over TK, including acquiring, claiming or asserting IPRs over TK-related subject matter by a person who knew that the IPRs were not validly held in the light of that TK and any conditions relating to its access; and (iv) commercial or industrial use of TK without just and appropriate compensation to the recognized holders of the knowledge, when such use has gainful intent and confers a technological or commercial advantage on its user, and when compensation would be consistent with fairness and equity in relation to the holders of the knowledge. (iv) commercial or industrial use of TK without just and appropriate compensation to the recognized holders of the knowledge, when such use has gainful intent and confers a technological or commercial advantage on its user, and when compensation would be consistent with fairness and equity in relation to the holders of the knowledge.

22. B.1 Protection Against Misappropriation (Art.1) 4.TK holders should also be effectively protected against other acts of unfair competition, including acts specified in Article 10bis of the Paris Convention. This includes false or misleading representations that a product or service is produced or provided with the involvement or endorsement of traditional knowledge holders, or that the commercial exploitation of products or services benefits holders of traditional knowledge.

23. B.2 Legal Form of Protection (Art.2) 1. Protection may be implemented through a special law on TK; the laws on intellectual property, including unfair competition law and the law of unjust enrichment; the law of torts, liability or civil obligations; criminal law; laws concerning the interests of indigenous peoples; regimes governing access and benefit-sharing; or any other law or a combination of any of those laws. 2.The form of protection need not be through exclusive property rights, although such rights may be made available, as appropriate, for TK holders, including through existing or adapted IP rights systems, in accordance with the needs and the choices of TK holders, national laws and policies, and international obligations.

24. 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.

25. 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.

26. B6: Benefit-sharing and recognition of knowledge holders (Art.6) (cntd) 2.Use of traditional knowledge for non-commercial purposes need not incur an obligation for compensation, but suitable benefit-sharing from such uses should be encouraged, including access to research outcomes and involvement of the source community in research and educational activities. 3.Those using traditional knowledge beyond its traditional context should make every reasonable endeavor to identify the source and origin of the knowledge, to acknowledge its holders as the source of the traditional knowledge, and to use and refer to the knowledge in a manner that respects and acknowledges the cultural values of its holders.

27. 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. 2.Legal systems or mechanisms for obtaining prior informed consent should ensure legal certainty and clarity; should not create burdens for traditional holders and legitimate users of TK; should ensure that restrictions on access to TK are transparent and based on legal grounds; and should provide for mutually agreed terms for the equitable sharing of benefits arising from the use of that knowledge.

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

29. B8: Exceptions and limitations (Art.8) 1.The application and implementation of protection of traditional knowledge should not adversely affect: (i) the continued availability of traditional knowledge for the customary practice, exchange, use and transmission of traditional knowledge by traditional knowledge holders; (i) the continued availability of traditional knowledge for the customary practice, exchange, use and transmission of traditional knowledge by traditional knowledge holders; (ii) the use of traditional medicine for household purposes, use in government hospitals, or for other public health purposes; and (ii) the use of traditional medicine for household purposes, use in government hospitals, or for other public health purposes; and (iii) other fair use or fair dealing with traditional knowledge, including use of traditional knowledge in good faith that commenced prior to the introduction of protection. (iii) other fair use or fair dealing with traditional knowledge, including use of traditional knowledge in good faith that commenced prior to the introduction of protection.

30. 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

31. (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.

32. 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.

33. 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.

34. Current Commenting Process Member-driven process Member-driven process 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

35. 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