India and the Nagoya Protocol on Access and Benefit Sharing N.L.S I.U. Pushpa Kumar Lakshmanan.

Transcription

1 India and the Nagoya Protocol on Access and Benefit Sharing Pushpa Kumar Lakshmanan UNDP-GEF Inception and 5-day Training the Trainers Workshop CEERA, National Law School of India University, Bengaluru 14 February 2018

2 The Convention on Biological Diversity (CBD) CONSERVATION In-situ and ex-situ conservation measures ecosystem approach Development of National Strategies, action plans, etc. Access and Benefit Sharing Article 15 Access to Genetic Resources Article 8(j) Traditional Knowledge Nagoya Protocol on ABS Article 1 objectives Conservation of Biological Diversity Sustainable Use of its components Fair and Equitable Sharing of Benefits arising out of utilisation Biotechnology and Biosafety Cartagena Protocol on Biosafety N-KL Supplementary Protocol on Liability and Redress relating to LMOs

3 For Conservation...

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5 Screenshot of CBD website

6 CBD website

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8 NAGOYA PROTOCOL ON ACCESS AND BENEFIT SHARING Protocol advances CBD s 3 rd Objective To facilitate access to Genetic Resources for Sustainable Use To recognize traditional knowledge and conservation efforts of Indigenous and local communities To ensure equity and justice in sharing Biological Resources and Traditional Knowledge Thereby boosting biodiversity conservation (Improving living conditions of local communities)

9 NAGOYA PROTOCOL ON ACCESS AND BENEFIT SHARING After 6 years of negotiation Nagoya Protocol on Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the CBD India ratified the Nagoya Protocol on 09 October 2012

10 Nagoya Protocol on ABS The objective covers a range of issues namely, fair and equitable sharing of the benefits arising from the utilization of genetic resources, appropriate access to genetic resources, appropriate transfer of relevant technologies, due consideration for all rights over those resources and to technologies, appropriate funding, and thereby contributing to the conservation of biological diversity and the sustainable use of its components.

11 The Protocol is built on... Recognition of sovereign rights over natural resources. Access to GR &TK - subject to Domestic ABS legislation. PIC of the provider Mutually Agreed Terms (MAT) Compliance Mechanism

12 ABC of the Protocol Access Benefit Sharing Compliance 3 Cs Consent Contract Compliance

13 PIC and involvement of indigenous and local communities in accordance with established rights. Parties to provide legal certainty, clarity and transparency on domestic ABS, PIC and MAT. Dispute settlement terms Check points IRCC (Internationally Recognized Certificate of Compliance )

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15 The Biological Diversity Act, 2002 The Biological Diversity Rules, 2004 Guidelines on Access to Biological Resources and Associated Knowledge and Benefits Sharing Regulations, 2014

16 Fair and Equitable Benefit Sharing Nagoya Protocol Legislative, Administrative and Policy measures Benefits from Utilization of GR, Subsequent applications and Commercialization Utilization of TK BD Act The BD Act takes care of most of it. Prior Approval from NBA, SBB

17 Authorities under the Biological Diversity Act Central Government State Government National Biodiversity Authority (NBA) State Biodiversity Boards (SBB) Biodiversity Management Committees (BMC)

18 Biodiversity Management Committees (BMC) 62,502 BMCs in 29 States (Except Bihar, Haryana, J&K) Collection fees to BMCs Sec. 41(3) Preparation of PBRs

19 BD Act Type of Access Where to Section 3 NON INDIANS - Research Bio-survey Bio-utilization for Research Section 4 Any person Transfer of Results of Research relating to BR to NON INDIANS For Monetary consideration or otherwise Section 19 Section 20 Any person Section 7 23(b) 24 * Publication of research papers in Seminars/ Workshop permitted Any person Application for IPR Transfer of Biological resources or knowledge INDIANS ABS??,, TK??? S. 7, 23 (b) Commercial Utilisation, Guideline 2 Bio-survey, Bio-utilisation for Commercial Utilization RESEARCH is exempted * Local people, growers, vaids, Hakims exempted Which Form? Prior Approval/ Benefit Sharing Apply? Agreement with NBA Form I NBA Determined by NBA (as per Section 21 and as ABS Guidelines 2014) - Upfront payment for resources of high economic value NBA Form II NBA Determined by NBA NBA Form III NBA Determined by NBA NBA Form IV NBA Determined by NBA SBB SBB in consultation with local bodies SBB may restrict, prohibit any activity SBB

20 Guidelines on Access to Biological Resources and Associated Knowledge and Benefits Sharing Regulations, 2014 Source: NBA

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22 Benefit Sharing PIC OF WHOM? CBD -ART. 15 (4) Party NP GR: Art6(1) PARTY/Local Community TK: Art7(1) Local community BS determination by whom? CBD -ART. 15 (1) STATE, BS to be given to whom? NP Art 5(1) Party BD Act: Party i.e., the STATE in consultation with

23 Article 6 Nagoya Protocol ACCESS TO GENETIC RESOURCES 1. In the exercise of sovereign rights over natural resources, and subject to domestic access and benefit-sharing legislation or regulatory requirements, access to genetic resources for their utilization shall be subject to the prior informed consent of the Party providing such resources that is the country of origin of such resources or a Party that has acquired the genetic resources in accordance with the Convention, unless otherwise determined by that Party. 2. In accordance with domestic law, each Party shall take measures, as appropriate, with the aim of ensuring that the prior informed consent or approval and involvement of indigenous and local communities is obtained for access to genetic resources where they have the established right to grant access to such resources.

24 THE SCHEDULED TRIBES AND OTHER TRADITIONAL FOREST DWELLERS (RECOGNITION OF FOREST RIGHTS) ACT, Duties of holders of forest rights. The holders of any forest right, Gram Sabha and village level institutions in areas where there are holders of any forest right under this Act are empowered to... (d) ensure that the decisions taken in the Gram Sabha to regulate access to community forest resources and stop any activity which adversely affects the wild animals, forest and the biodiversity are complied with.

25 Article 7 Nagoya Protocol ACCESS TO TRADITIONAL KNOWLEDGE ASSOCIATED WITH GENETIC RESOURCES In accordance with domestic law, each Party shall take measures, as appropriate, with the aim of ensuring that traditional knowledge associated with genetic resources that is held by indigenous and local communities is accessed with the prior and informed consent or approval and involvement of these indigenous and local communities, and that mutually agreed terms have been established.

26 Biological Diversity Rules, 2004 Rule 14. Procedure for access to biological resources and associated traditional knowledge... (3) The Authority shall after consultation with the concerned local bodies and collecting such additional information from the applicant and other sources, as it may deem necessary, dispose of the application, as far as possible, within a period of six months from the date of its receipts.

27 The Parties may develop... Community Protocols Model contractual clauses for benefit sharing

28 Article 8 Nagoya Protocol SPECIAL CONSIDERATIONS Domestic legislation or regulatory requirements, shall take into account: (a) simplified measures for non-commercial research (b) Pay due regard to cases of present or imminent emergencies that threaten or damage human, animal or plant health, as determined nationally or internationally provide for expeditious access to genetic resources and expeditious fair and equitable sharing of benefits (c) Consider the importance of genetic resources for food and agriculture and their special role for food security.

29 In India Simplified measures for non-commercial research Imminent emergencies Regulation 13, FORM B, Approval within 45 days Food and agriculture for food security Notification S.O. 3232(E) 2014: Exemption 3 an 4 Research, Breeding and Training for Food and Agriculture food crops and forages (ITPGRFA Notification Standard Material Transfer Agreement under the Multilateral System. Dept. Agriculture

30 Article 9 Nagoya Protocol CONTRIBUTION TO CONSERVATION AND SUSTAINABLE USE The Parties shall encourage users and providers to direct benefits arising from the utilization of genetic resources towards the conservation of biological diversity and the sustainable use of its components.

31 BD Act Conservation Role of Central Government Chapter 9: S.36- CG to develop National Strategies, Plans, etc. EIA, LMOs, TK, ex-situ, in-situ conservation sp. Directives to States to protect endangered S.38- CG to notify threatened sp. S.39- CG to designate repositories for bio materials S. 40 CG to exempt NTC

32 Conservation State Level S. 24(2) SBB, Rule 16: SBB to prohibit or restrict any activity S.37- State Govt. may notify in Off Gazette Biodiversity Heritage Sites (only 9 sites)

33 Art 15, 16 Nagoya Protocol Compliance with domestic law or regulatory mechanism of the other countries Compliance Measures To comply with the domestic law or regulatory systems of other countries where the GR or TK was obtained. And if BS obligations are met with

34 S 60 of the Norwegian Nature Diversity Act, 2009 Genetic material from other countries The import for utilisation in Norway of genetic material from a state that requires consent for collection or export of such material may only take place in accordance with such consent. The person that has control of the material is bound by the conditions that have been set for consent. The state may enforce the conditions by bringing legal action on behalf of the person that set them. When genetic material from another country is utilised in Norway for research or commercial purposes, it shall be accompanied by information regarding the country from which the genetic material has been received (provider country). If national law in the provider country requires consent for the collection of biological material, it shall be accompanied by information to the effect that such consent has been obtained. If the provider country is a country other than the country of origin of the genetic material, the country of origin shall also be stated. The country of origin means the country in which the material was collected from in situ sources. If national law in the country of origin requires consent for the collection of genetic material, information as to whether such consent has been obtained shall be provided. If the information under this paragraph is not known, this shall be stated. The King may make regulations prescribing that if utilisation involves use of the traditional knowledge of local communities or indigenous peoples, the genetic material shall be accompanied by information to that effect. When genetic material covered by the International Treaty on Plant Genetic Resources for Food and Agriculture of 3 November 2001 is utilised in Norway for research or commercial purposes, it shall be accompanied by information to the effect that the material has been acquired in accordance with the Standard Material Transfer Agreement established under the treaty.

35 Article 17 Nagoya Protocol MONITORING THE UTILIZATION OF GENETIC RESOURCES Designated checkpoints would collect or receive relevant information related to: prior informed consent, to the source of the genetic resource, to the establishment of mutually agreed terms, and/or to the utilization of genetic resources,

36 Check points

37 ABS CLEARING HOUSE

38 MONETARY AND NON-MONETARY BENEFITS 1. Monetary benefits may include, but not be limited to: (a) Access fees/fee per sample collected or otherwise acquired; (b) Up-front payments; (c) Milestone payments; (d) Payment of royalties; (e) Licence fees in case of commercialization; (f) Special fees to be paid to trust funds supporting conservation and sustainable use of biodiversity; (g) Salaries and preferential terms where mutually agreed; (h) Research funding; (i) Joint ventures; (j) Joint ownership of relevant intellectual property rights. 2. Non-monetary benefits may include, but not be limited to: (a) Sharing of research and development results; (b) Collaboration, cooperation and contribution in scientific research and development programmes, particularly biotechnological research activities, where possible in the Party providing genetic resources;

39 (c) Participation in product development; (d) Collaboration, cooperation and contribution in education and training; (e) Admittance to ex situ facilities of genetic resources and to databases; (f) Transfer to the provider of the genetic resources of knowledge and technology under fair and most favourable terms, including on concessional and preferential terms where agreed, in particular, knowledge and technology that make use of genetic resources, including biotechnology, or that are relevant to the conservation and sustainable utilization of biological diversity; (g) Strengthening capacities for technology transfer; (h) Institutional capacity-building; (i) Human and material resources to strengthen the capacities for the administration and enforcement of access regulations; (j) Training related to genetic resources with the full participation of countries providing genetic resources, and where possible, in such countries; (k) Access to scientific information relevant to conservation and sustainable use of biological diversity, including biological inventories and taxonomic studies; (l) Contributions to the local economy; (m) Research directed towards priority needs, such as health and food security, taking into account domestic uses of genetic resources in the Party providing genetic resources; (n) Institutional and professional relationships that can arise from an access and benefit-sharing agreement and subsequent collaborative activities; (o) Food and livelihood security benefits; (p) Social recognition; (q) Joint ownership of relevant intellectual property rights.

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41 Effect of the BD Act 59. Act to have effect in addition to other Acts. The provisions of this Act shall be in addition to, and not in derogation of, the provisions in any other law, for the time being in force, relating to forests or wildlife.

42 S.55 Penalties.- (1)Whoever contravenes the provisions of section 3, 4 or section 6 shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to ten lakh rupees. (2)contravention of the provisions of section 7: imprisonment up to three years, or with fine up to five lakh rupees, or with both. Offences are cognizable and non-bailable

43 Instances of Access and Benefit Sharing Access to Seaweed: About 2000 metric tones of seaweeds collected through self help groups of coastal districts of Tamil Nadu (Ramanathapuram, Tuticorin, Pudukottai and Tanjore) by M/s. Pepsico India Holdings Pvt. Ltd. and M/s. Ganesan & Sons and exported to Malaysia, Philippines and Indonesia for commercial purpose. The NBA fixe a 5% of FoB (Free on Board) amounting approximately Rs Lakhs from the exporter.

44 Access to Neem Leaves NBA approved an export of about 2000 Kilograms of Neem to Japan by Bio India Biologicals and determined a of FOB amounting to Rs. 55, from the exporter as benefit sharing. A part of the royalty amount was transferred to Amarchinta BMC for their contributions in planting more neem saplings in that area and for creating of awareness about biodiversity conservation. In this case, the Amarchinta BMC in Mahboobnager District, Andra Pradesh collected the neem leaves from Amarchinta village and dried them through special method by the villagers of Amrchinta before supplying to the exporter.

45 ABS involving Intellectual Property Rights An ayurvedic doctor from Pune, India, Dr. Geeta Pandurang Pawar has applied for prior approval seeking No objection Certificate for obtaining a patent for preparation of an ayurvedic anti snake venom comprising four medicinal plants. It was claimed that in the treatment of victims of snake bite, this anti venom tablet pinak will as a temporary relief instantly before victim is taken to the hospital. In this case, NBA has fixed the benefit sharing as 2% of the Gross sales or Gross revenue of the product derived from the use of biological resources accessed. On commercialization of the patent product and as per the conditions of the agreement with the NBA, the applicant has paid two installments towards royalty as benefit sharing to the NBA.

46 ABS guidelines percentage of BS How much so far? NTC and Value added Product Coconut Oil Chavanprash

47 Collaborative Research The Guidelines on Access to Biological Resources and Associated Knowledge and Benefit Sharing Regulations, 2014

48 Normally traded commodities s.40 Rationale? Conventional use and consumption RESEARCH So far 421 items included

49 ABS could be a great game changer

50 ABS An instrument of Global Justice?