35
Department of AYUSH and NISCAIR Department of AYUSH and NISCAIR International Conclave International Conclave on Traditional Medicine on Traditional Medicine New Delhi, November 16-17, 2006 New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Dr. Shakeel Bhatti Head Head Genetic Resources, Traditional Knowledge and Genetic Resources, Traditional Knowledge and Biotechnology Section Biotechnology Section World Intellectual Property Organization World Intellectual Property Organization (WIPO) (WIPO) Geneva, Switzerland Geneva, Switzerland Legal policy framework for Legal policy framework for traditional knowledge protection traditional knowledge protection

Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

Embed Size (px)

Citation preview

Page 1: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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

Page 2: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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

Page 3: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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

Page 4: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

Objective (i) Recognize valueObjective (i) Recognize value

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

Page 5: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

Objective (ii) Promote Objective (ii) Promote RespectRespect

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

Page 6: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

Obj.(iii) Meet Needs of TK Obj.(iii) Meet Needs of TK HoldersHolders

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

Page 7: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

Obj.(iv) Promote TK Obj.(iv) Promote TK Conservation Conservation

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

Page 8: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

Obj.(viii) Repress unfair usesObj.(viii) Repress unfair uses

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

Page 9: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

Obj.(ix) Cooperation wh other Obj.(ix) Cooperation wh other agreements and processesagreements and processes

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

Page 10: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

Obj.(x) Promote Innovation Obj.(x) Promote Innovation

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

Page 11: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

Obj.(xi) Prior Informed Obj.(xi) Prior Informed ConsentConsent

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

Page 12: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

Obj.(xii) Equitable Benefit-Obj.(xii) Equitable Benefit-sharingsharing

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

Page 13: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

Obj.(xiii) Preclude improper Obj.(xiii) Preclude improper IPRsIPRs

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

Page 14: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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

Page 15: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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

Page 16: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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

Page 17: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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’

Page 18: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

B.1 Protection against B.1 Protection against Misappropriation Misappropriation (Art.1)(Art.1)

1. Traditional knowledge shall be protected 1. Traditional knowledge shall be protected against misappropriation.against misappropriation.

2. Any acquisition or appropriation of TK by 2. Any acquisition or appropriation of TK by unfair or illicit means constitutes an act of unfair or illicit means constitutes an act of misappropriation.misappropriation.

Page 19: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

B.1 Protection Against B.1 Protection Against Misappropriation Misappropriation (Art.1)(Art.1)

2.(cntd) 2.(cntd) Misappropriation may also include:Misappropriation may also include: deriving commercial benefit from the acquisition or deriving commercial benefit from the acquisition or

appropriation of TK when the person using that appropriation of TK when the person using that knowledge knows, or is grossly negligent in failing knowledge knows, or is grossly negligent in failing to know, that it was acquired or appropriated by to know, that it was acquired or appropriated by unfair means; and unfair means; and

other commercial activities contrary to honest other commercial activities contrary to honest practices that gain inequitable benefit from practices that gain inequitable benefit from traditional knowledge.traditional knowledge.

Page 20: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

B.1 Protection Against B.1 Protection Against Misappropriation Misappropriation (Art.1)(Art.1)

3. In particular, legal means should be available to suppress:3. In particular, legal means should be available to suppress:

(i) acquisition of TK (i) acquisition of TK byby theft, bribery, coercion, fraud, trespass, breach or theft, bribery, coercion, fraud, trespass, breach or inducement of breach of contract, breach or inducement of breach of inducement of breach of contract, breach or inducement of breach of confidence or confidentialityconfidence or confidentiality, breach of fiduciary obligations or other , breach of fiduciary obligations or other relations of trust, deception, misrepresentation, the provision of relations of trust, deception, misrepresentation, the provision of misleading information when obtaining prior informed consent for misleading information when obtaining prior informed consent for access to TK, or other unfair or dishonest means;access to TK, or other unfair or dishonest means;

(ii) acquisition of TK or exercising control over it (ii) acquisition of TK or exercising control over it in violation of legal in violation of legal measures that require prior informed consentmeasures that require prior informed consent as a condition of access to as a condition of access to the knowledge, and use of TK that violates terms that were mutually the knowledge, and use of TK that violates terms that were mutually agreed as a condition of prior informed consent concerning access to agreed as a condition of prior informed consent concerning access to that knowledge;that knowledge;

Page 21: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

B.1 Protection Against B.1 Protection Against Misappropriation Misappropriation (Art.1)(Art.1)

3. In particular, legal means should be available to suppress:3. In particular, legal means should be available to suppress:

(…)(…)

(iii) (iii) false claims or assertions of ownershipfalse claims or assertions of ownership or control over TK, including or control over TK, including acquiring, claiming or asserting IPRs over TK-related subject matter by 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 a person who knew that the IPRs were not validly held in the light of that TK and any conditions relating to its access; andthat TK and any conditions relating to its access; and

  (iv) commercial or industrial use of TK without just and appropriate (iv) commercial or industrial use of TK without just and appropriate compensation to the recognized holders of the knowledgecompensation to the recognized holders of the knowledge, when such , when such use has gainful intent and confers a technological or commercial use has gainful intent and confers a technological or commercial advantage on its user, and when compensation would be consistent with advantage on its user, and when compensation would be consistent with fairness and equity in relation to the holders of the knowledge.fairness and equity in relation to the holders of the knowledge.

Page 22: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

B.1 Protection Against B.1 Protection Against Misappropriation Misappropriation (Art.1)(Art.1)

4.4. TK holders should also be effectively protected against TK holders should also be effectively protected against other acts of unfair competition, including acts specified in other acts of unfair competition, including acts specified in Article 10Article 10bisbis of the Paris Convention of the Paris Convention. This includes false or . This includes false or misleading representations that a product or service is misleading representations that a product or service is produced or provided with the involvement or endorsement produced or provided with the involvement or endorsement of traditional knowledge holders, or that the commercial of traditional knowledge holders, or that the commercial exploitation of products or services benefits holders of exploitation of products or services benefits holders of traditional knowledge.traditional knowledge.

Page 23: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

B.2 Legal Form of Protection B.2 Legal Form of Protection (Art.2)(Art.2)

1.1. Protection may be implemented throughProtection may be implemented through a special law on TKa special law on TK; the ; the laws on intellectual property, including unfair competition law and laws on intellectual property, including unfair competition law and the law of unjust enrichment; the law of torts, liability or civil the law of unjust enrichment; the law of torts, liability or civil obligations; criminal law; laws concerning the interests of obligations; criminal law; laws concerning the interests of indigenous peoples; regimes governing access and benefit-indigenous peoples; regimes governing access and benefit-sharing; sharing; or any other law or a combination of any of those lawsor any other law or a combination of any of those laws..

2.2. The form of The form of protection need not be through exclusive property protection need not be through exclusive property rightsrights, although such rights may be made available, as appropriate, , although such rights may be made available, as appropriate, for TK holders , including through existing or adapted IP rights for TK holders , including through existing or adapted IP rights systems, in accordance with the needs and the choices of TK systems, in accordance with the needs and the choices of TK holders, national laws and policies, and international obligations.holders, national laws and policies, and international obligations.

Page 24: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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.

Page 25: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head 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.

Page 26: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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

(cntd)(cntd)2.2. Use of traditional knowledge for non-commercial purposes Use of traditional knowledge for non-commercial purposes

need not incur an obligation for compensation, but suitable need not incur an obligation for compensation, but suitable benefit-sharing from such uses should be encouraged, benefit-sharing from such uses should be encouraged, including access to research outcomes and involvement of including access to research outcomes and involvement of the source community in research and educational activities.the source community in research and educational activities.

3.3. Those using traditional knowledge beyond its traditional Those using traditional knowledge beyond its traditional context should make every reasonable endeavor to identify context should make every reasonable endeavor to identify the source and origin of the knowledge, to acknowledge its the source and origin of the knowledge, to acknowledge its holders as the source of the traditional knowledge, and to holders as the source of the traditional knowledge, and to use and refer to the knowledge in a manner that respects and use and refer to the knowledge in a manner that respects and acknowledges the cultural values of its holders. acknowledges the cultural values of its holders.

Page 27: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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

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

Page 28: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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

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

Page 29: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

B8: Exceptions and limitations B8: Exceptions and limitations (Art.8)(Art.8)

1.1. The application and implementation of protection of The application and implementation of protection of traditional knowledge should not adversely affect:traditional knowledge should not adversely affect:

(i) the continued availability of traditional knowledge for the (i) the continued availability of traditional knowledge for the customary practice, exchange, use and transmission of customary practice, exchange, use and transmission of traditional knowledge by traditional knowledge holders;traditional knowledge by traditional knowledge holders;

          (ii) the use of traditional medicine for household purposes, (ii) the use of traditional medicine for household purposes, use in government hospitals, or for other public health use in government hospitals, or for other public health purposes; andpurposes; and

          (iii) other fair use or fair dealing with traditional (iii) other fair use or fair dealing with traditional knowledge, including use of traditional knowledge in good knowledge, including use of traditional knowledge in good faith that commenced prior to the introduction of protection.faith that commenced prior to the introduction of protection.

Page 30: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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

Page 31: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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.

Page 32: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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.

Page 33: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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.

Page 34: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

Current Commenting Current Commenting ProcessProcess

Member-driven processMember-driven process 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

Page 35: Department of AYUSH and NISCAIR “International Conclave on Traditional Medicine” New Delhi, November 16-17, 2006 Dr. Shakeel Bhatti Head Genetic Resources,

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