Biological Diversity Act & ABS through National biodiversity authority

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1 in collaboration with MINISTRY OF INDIAN COUNCIL OF ENVIRONMENT & FORESTS MEDICAL RESEARCH International Conference on Access and Benefit Sharing for Genetic Resources March 6-7, 2008, Magnolia Hall, India Habitat Centre, Lodhi Road New Delhi, India Implementation of Biological Diversity Act & ABS through National biodiversity authority K. Venkataraman National Biodiversity Authority Chennai India

2 Earth has enough for everyone s s need but not enough for even one man s s greed Shri Mahatma Gandhi. How much is available for the Future?

3 Like Minded Megadiversity Countries of the World 65% LMMC NET WORKING OF PARTENERS!!! WHAT IS TO BE DONE FOR DUPLICATION OF RESEARCH??? Map showing the LMMCs: : Bolivia, Brazil, China, Colombia, Costa Rica, Democratic Republic of Congo, Ecuador, India, Indonesia, Kenya, Madagascar, Malaysia, Mexico, Peru, Philippines, South Africa and Venezuela.

4 I ` N D I A The Great

5 BIODIVERSITY Plants & Animals : million sp. 30m?; 100m?. 1 m Animal (75% Insect); 2,48, 000 Higher Plants, 69,000 Fungi, 31,000 Protozoa, 27,000 Algae, Bacteria & 1000 Viruses Biodiversity in India as on today 90,000+ Species of Animals 46,000+ Species of Plants Bacteria , Fungi Identified so far: 1.77 million sp. (17,70,000) 8% + of world s s biodiversity

6 Wild Relatives Of Crops CROP NO.OF RELATIVES Millets 51 Fruits 104 Spices and condiments 27 Vegetables and pulses 55 Fiber crops 24 Oil seeds, tea, tobacco & Sugarcane 12 Medicinal Plants 3000

7 IMPORTANT CENTRAL ACTS HAVING RELEVANCE TO BIODIVERSITY Fisheries Act, Destructive Insects and Pests Act, Indian Coffee Act, Agricultural Produce ( Grading and Marketing) Act, Import and Export (control) Act, & Rubber (Production and Marketing) Act, Tea Act, Prevention of Cruelty to Animals Act, Customs Act, Seeds Act, Wildlife (Protection) Act, 1972 and Wildlife (Protection) Amendment Act,1991. Marine Products Export Development Authority Act, Water (prevention and Control of Pollution) Act, Tobacco Board Act, Territorial water, Continental Shelf, Exclusive Economic Zone and other Maritime Zones Act,1976. Water (Prevention and Control of Pollution) Cess Act, Coconut Development Board Act, Maritime Zones of India (Regulation and Fishing by Foreign Vessels) Act,1980. Forest (Conservation) Act, Air (Prevention and Control of Pollution) Act, National Oilseeds and Vegetable Oils Development Board, Agricultural and Processed Food Products Export Development Authority Act, 1985/1986. Environment (Protection) Act, Spices Board Act,1986. National Diary Development Board, New Seed Development Policy, Foreign Trade (Development and Regulation) Act Biological Diversity Act, 2002 Protection of Plant Verities and Farmers Right Act, Geographical Indication 30 different Acts Biodiversity Act

8 IMPORTANCE OF BIODIVERSITY ACT other than 30 different Acts in India 1. Regulated use of Biodiversity (NBA as Regulatory Authority) 2. Sovereign Rights of India over Biological Diversity and stop Biopiracy 2. To protect the biodiversity outside the Protected Areas of India 4. Sustainable utilisation and Equitable Benefit Sharing 5. Does not overrule already existing Acts

9 abs Three tire system of governance of ABS National Biodiversity Authority (NBA) State Biodiversity Board (SBB) Biodiversity Management Committees (BMC)

10 Biological Diversity Act, 2002 NATIONAL BIODIVERSITY AUTHORITY Access to biodiversity by Foreigners STATE BIODIVERSITY BOARD BIODIVERSITY MANAGEMENT COMMITTEE Access to biodiversity by INDIANS For commercial use NBA and SBB are required to consult BMC for access for commercial purposes

11 S T A T E B I O D I V E R S I T Y NBA BO A R DS

12 U N I O N T E R I T O R I E S

13 Biological Diversity Act, 2002 Seed Act ABS Tribal Act Biological Diversity ACT 2002 Wildlife Act, 1972 Protection of plant Variety and Formers Right Act SYNERGY Geographical Indication Seed Act PATENT ACT

14 ABS Policies and Programmes The Indian Initiatives Biodiversity and associated traditional knowledge are two capital resources of India, and they form the prime focus of all the sectoral and cross-sectoral programs centered on sustainable development. The significant initiatives of India are: The World Heritage Convention (1972); Convention on International Trade in Endangered Species of Flora and Fauna (CITES( 1975); Ramsar Convention on Wetlands (1975( 1975); FAO s International Undertaking on Plant Genetic Resources (FAO 1983); Convention on Biological Diversity (CBD( 1992); Agenda 21 (1992); UN Framework Convention on Climate Changes (1992); UN Convention to Combat Desertification (1994); The Trade Related Intellectual Property Rights (WTO-TRIPs TRIPs 1994); Cartagena Protocol for Biosafety to CBD (2000); FAO International Treaty on Plant Genetic Resources for Food and Agriculture ( FAO, 2001), Global Strategy for Plant Conservation ( GSPC 2002); The Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the benefits Arising out of their Utilization (2002), etc.

15 NBA-Access Access and Benefit sharing India addressing the issues of ABS based on:- Bonn Guidelines and other model frameworks, Meetings of the COP & ABS WG Through An Expert Committee Constituted By Nba Consists Of Members From Various Region Essential steps of PIC, MTA, MAT,, and agreements for sharing the benefits arising from the production and commercialization of any product or technologies derived from the genetic resources, its components and/or derivatives and the associated knowledge

16 BD Act & Access (Section 3) (1) No person from outside India, or an institution which is not registered in India or has foreign participation can obtain any biological resources occurring in India or knowledge associated thereto for research or for commercial utilisation or for bio-survey and bio-utilisation utilisation,, without approval from NBA. (2) No person from India can collect biological resources for commercial utilization without intimation to the SBBs except vaids and hakims.

17 abs The NBA lays down guidelines for the access to biological resources, and for fair and equitable benefit sharing besides advising the Central Government on conservation of biodiversity. The BDA consider a variety of monetary and non-monetary compensation of the benefit claimers. For e.g. the NBA has the power to not only order monetary compensation but to direct terms relating to (Sec 21(2)) transfer of technology, joint ownership, location of research facilities within a certain area, the association of local scientists and if necessary, the setting up of venture funds.

18 Transfer of Research Results Results of research can not be transferred to any person outside India without approval of NBA. (Section 4) It does not include Publication of research papers or presentation in seminar/symposia

19 IPRs (Section 6) IPRs No person can apply for any IPR in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the approval of the NBA Provided that if a person applies for a patent, permission of the NBA may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority

20 IPR Under Section 6(2) NBA may ( not shall )) impose benefit sharing fee or royalty, the collection of which would be utilized for the benefits to the right holders, or conservation of the resources or for the social economic development of the areas from where the resource has been accessed (Section 27(b)). While the second tier in the BDA, that is the SBB, advises the State Government on any guidelines issued by the Central Government on matters relating to conservation of biodiversity, its sustainable use and equitable sharing of benefits, the bottom tier the BMC, at the regional level for the purpose of promoting conservation, sustainable use and documentation of biological diversity (Section 41).

21 IPR The NBA and the SBB are required to consult BMC while taking any decision pertaining to the use of local biological resources and associated knowledge occurring within the jurisdiction of BMC. Violation of the provision of the BDA attracts penalties of up to five years imprisonment or Rs.10 lakhs ($25 k) fine unless the damages caused is more, in which case the fine is higher.

22 As per Patent (Amendments) Act, 2002 Declare source of biological material used in the patent Deposit material in designated repository

23 BIOLOGICAL DIVERSITY ACT obtaining biological materials is concerned, there are no restrictions on local communities, limited restrictions on Indians and stronger restrictions on foreign nationals and entities. transfer of information relating to research on bio resources, the restriction is applicable to all. application of IPR, all parties are obliged to seek the approval of NBA who may impose monetary or non-monetary benefit sharing.

24 FORM I (see rule 14) (Application form for access to Biological resources and associated traditional knowledge Part A 1. Full particulars of the applicant Name: Permanent address: Address of the contact person / agent, if any, in India: Profile of the organization (personal profile in case the applicant ant is an individual). Please attach relevant documents of authentication): Nature of business: Turnover of the organization in US$: 2. Details and specific information about nature of access sought t and biological material and associated knowledge to be accessed Identification (scientific name) of biological resources and its traditional use: Geographical location of proposed collection: Description / nature of traditional knowledge ( oral / documented): d): Any identified individual / community holding the traditional knowledge: Quantity of biological resources to be collected (give the schedule): Time span in which the biological resources is proposed to be collected: Name and number of person authorized by the company for making the t selection: The purpose for which the access is requested including the type and extent of research, commercial use being derived and expected to be derived from it: Whether any collection of the resource endangers any component of o biological diversity and the risks which may arise from the access:

25 contd 3. Details of any national institution which will participate in the Research and Development activities. 4. Primary destination of accessed resource and identity of the location where the R&D will be carried out. 5. The economic and other benefits including those arriving out of any IPR, patent obtained out of accessed biological resources and knowledge that are intended, or may accrue to the applicant or to the country that he/she belongs 6. The biotechnological, scientific, social or any other benefits obtained out of accessed biological resources and knowledge that are intended, or may accrue to the applicant or to the country that he/she belongs 7. Estimation of benefits, that would flow to India/ communities arising out of the use of accessed bioresources and traditional knowledge 8. Proposed mechanism and arrangements for benefit sharing. 9. Any other information considered relevant.

26 Part B Declaration contd I/ we declare that: Collection of proposed biological resources shall not adversely affect the sustainability of the resources; Collection of proposed biological resources shall not entail any environmental impact; Collection of proposed biological resources shall not pose any risk r to ecosystems; Collection of proposed biological resources shall not adversely affect the local communities; I/we further declare the Information provided in the application form is true and correct and I /We shall be responsible for any incorrect rect / wrong information. Place Date Signed Name Title

27 Prior Informed Consent for access of bioresources Form I Application fee (Rs 10,000/=) Expert Committee to evaluate Want of more information if any Authority meeting for approval Approval (Public view) or Rejection Appeal Agreement

28 FLOW CHART FOR APPROVAL OF APPLICATIONS BY NBA VERIFICATION APPLICATIO N ACCESS OF BIODIVERSIT Y IPR AND TK FAUNA CHAIRMA N SECRETAR Y FLORA FINDIN GS SECRETAR Y AUTHORIT Y DECISION TAKEN APPLICAN T MICROBIA L WE B SIT E SBB BMC 45 DAYS 45 DAYS

29 STATUS OF APPLICATION APPROVAL BY NBA AS ON NOVEMBER 2007 DETAILS OF FORM FORM I ACCESS OF BIORESOURCES FOR RESEARCH / COMMERCIAL PURPOSE Sec=3 FORM II TRANSFER OF RESEARCH RESULTS Sec=4 FORM III INTELLECTUAL PROPERTY RIGHTS Sec=6 FORM IV THIRD PARTY TRANSFER Sec=21 COLLABORAT IVE RESEARCH Sec=5 5 TH AUTHORITY MEETING APPROVED APPLICANTS TH AUTHORITY MEETING APPROVED APPLICANTS TH AUTHORITY MEETING APPROVED APPLICANTS TH AUTHORITY MEETING APPROVED APPLICANTS TH 10 AUTHORITY MEETING APPROVED APPLICANTS TOTAL APPLIC ATIONS APPROV ED AGREEM ENT SIGNED BY NBA WITH APPROVED APPLICANTS Not Applica ble

30 ACCESS FOR RESEARCH AND COMMERCIAL PURPOSE th 7th 8th 9th 10th TOTAL Agrement Withheld/in process APPROVALS NUMBER OF APPLICATIONS

31 ACCESS FOR RESEARCH/COMMERCIAL PURPOSES SRILANKA JAPAN USA UNITED KINDON AUSTRALIA GERMANY SWITZERLAND CZECHSLOVAKIA FRANCE APPLICANTS APPLICATIONS

32 TRANSFER OF RESEARCH RESULTS th 8th 9th 10th TOTAL Agrement Withheld/in... APPROVALS 5th APPLICATIONS

33 TRANSFER RESEARCH RESULTS APPLICAITONS FORM II IICT, HYDRABAD MAHYCO APPLICANTS

34 INTELLECTUAL PROPERTY RIGHTS th 7th 8th 9th 10th TOTAL Agrement Withheld/in process APPROVALS APPLCIATIONS

35 INTELLECTUAL PROPERTY RIGHTS CSIR INDUSTRIES TRUST INDIVIDUAL 13 ICMR UNIVERSITIES ORGANISATION APPLICATIONS

36 THIRDPARTY TRANSFER th 9th 10th TOTAL Agrement Withheld/in process APPROVALS 7th 5th APPLICATIONS

37 THIRDPARTY TRANSFER U SA AFRICA GERMANY S.AFR IC A U K M A LA YSIA PHILIPPINES IN DONESIA COUNTRIES FRANCE APPLICATIONS

38 COLLABORATIVE RESEARCH PROJECTS th 8th 9th 10th TOTAL 5th Agrement Withheld/in process APPROVALS APPLICATIONS

39 ACCESS APPLICATIONS TO NBA 1000 NUMBER OF APPLICATIONS FORM I FORM II FORM III FORM IV Collaborative Research Linear (FORM III ) 1 5th 1 7th 8th 9th 10th APPROVALS TOTAL Agrement Withheld/in process

40 A.B.S. Stepwise process Application for Access Expert Committee Views and opinions of the Members for collection of additional information Evaluation Benefitsharing 5% Royalty for sublicensing Placing the application Authority for approval IPR 5% net profit Acc- Res Acc-Com T.o.Res.R Third Party transfer Provisional approval for signing the agreements Final approval for access & agreement signed for benefit sharing if any PROCESS IS ON

41 Access Agreement (Mutually Agreed Term) 1. Agreement on Access to Biological Resources for Research/Bio-survey survey and Bioutilisation 2. Agreement on Access to Biological Resources for Commercial Purposes

42 Access Agreement (Mutually Agreed Term) Signed Between Whereas The Parties hereto agree as follows: 1. Definitions 2. Grant of Approval 3. Assignment 4. Conditions for Access to Biological Resources 5. Royalty and other Benefit Sharing 6. Reports and Audit 7. Term and Termination 8. Notice 9. Arbitration 10. Governing Law and Jurisdiction 11. Waiver 12. Severability 13. Modification 14. Entire Agreement 15. Representations Schedules forms Benefit sharing through Biodiversity Fund

43 Revocation of access Revocation of access or approval granted to an applicant will be done only on the basis of any complaint or suo moto under the following conditions: (i) violation of the provisions of the Act or conditions on which the approval was granted (ii) non-compliance of the terms of the agreement (iii) failure to comply with any of the condition of access granted (iv) on account of overriding public interest or for protection of environment and conservation of biodiversity (Rule 15, Sub rule 1). After having withdrawn the access permit, the Authority is required to send an order of revocation to the concerned Biodiversity Management Committee and the State Biodiversity Board for prohibiting the access and to assess the damage, if any, caused, and steps to recover the damages (Rule 15, Sub rule 2).

44 Restriction for access The Act imposes certain restrictions on request related to access to biological resources and traditional knowledge if the request is on: (i) Endangered taxa (ii) Endemic and rare taxa (iii) Likely adverse effects on the livelihood of the local people (iv) Adverse and irrecoverable environmental impact (v) Cause genetic erosion or affect ecosystem function (vi) Purpose contrary to national interests and other related international agreements to which India is Party (Rule 16, Sub rule 1).

45 National Biodiversity Fund (Section 27) Would be funded from Grants and loans by the Government Other charges and royalties

46 National Biodiversity Fund Would be used for (Section 27) Channeling benefits to the benefit claimers Conservation and promotion of biological resources and development of areas from where these resources and related knowledge is accessed Socio-economic development of these areas in consultation with local bodies

47 State Biodiversity Fund Shall be used for (Section 32) where such biological resources or knowledge The management and conservation of heritage sites Compensating or rehabilitating any section of the people economically affected (heritage sites) Conservation and promotion of biological resources Socio-economic development of areas from associated thereto has been accessed

48 Local Biodiversity Fund (Section 42-44) Shall be used for conservation and promotion of biodiversity and for the benefit of the community

49 National Biodiversity Fund NATIONAL, STATE AND LOCAL Contributions from National & International Organisations Application fee Form 1-4 Compensations deposited Benefit shares awarded Biodiversity Fund Grant in aid from Central Government Reimbursement of Benefit shares Reimbursement of compensation Supporting conservation

50 Determination of Benefit Sharing

51 Determination Of Equitable Benefit Sharing (Section 21) The NBA shall while granting approvals under section 19 or ensure that the terms and conditions subject to which approval is granted secures equitable sharing of benefits arising out of the use of accessed biological resources, their by products, innovations and practices associated with their use and applications and knowledge relating thereto in accordance with mutually agreed terms and conditions between the person applying for such approval, local bodies concerned and the benefit claimers. (1)

52 Determination Of Equitable Benefit Sharing (Section 21) The National Biodiversity Authority shall, subject to any regulations made in this behalf, determine the benefit sharing which shall be given effect in all or any of the following manner, namely (2) grant of joint ownership of intellectual property rights to the National Biodiversity Authority or where benefit claimers are identified to such benefit claimers; (a) Transfer of Technology; (b) Location of production, research and development units in such areas which will facilitate better living standards to the benefit claimers; (c)

53 Determination Of Equitable Benefit Sharing (Sec. 21 Act) Association of Indian scientists, benefit claimers and the local people with research and development in biological resources and bio survey and bio utilization; (d) Setting up of venture capital fund for aiding the cause of benefit claimers; (e) Payment of monetary compensation and non monetary benefits to the benefit claimers as the National Biodiversity Authority may deem fit. (f)

54 Criteria for Equitable Benefit Sharing (Rule -20) The Authority shall by notification in the Official Gazette formulate the guidelines and describe the benefit sharing formula. (1) The guidelines shall provide for monetary and other benefits such as royalty; joint ventures; technology transfer; product development; education and awareness raising activities; institutional capacity building and venture capital fund.. (2)

55 Criteria For Equitable Benefit Sharing (R-20) The formula for benefit sharing shall be determined on case by case basis.(3) The Authority while granting approval to any person for access or for transfer of results of research or applying for patent and IPR or for third party transfer of the accessed biological resource and associated knowledge may impose terms and conditions for ensuring equitable sharing of the benefits arising out of the use of accessed biological material and associated knowledge. (4)

56 Criteria For Equitable Benefit Sharing (R-20) for such approval and the Authority in consultation with the local bodies and benefit claimers and may be decided in due regard to the defined parameters of access, the extent of use, the sustainability aspect, including measures ensuring conservation and sustainable use of biological diversity. The quantum of benefits shall be mutually agreed upon between the persons applying impact and expected outcome levels, (5)

57 Criteria For Equitable Benefit Sharing (R-20) Depending upon each case, the Authority shall stipulate the time frame for assessing benefit sharing on short, medium and long term benefits. (6) The Authority shall stipulate that benefits shall ensure conservation and sustainable use of biological diversity. (7)

58 Criteria For Equitable Benefit Sharing (Rule -20) Where biological resources or knowledge is accessed from a specific individual or a group of individuals or organizations, the Authority may take steps to ensure that the agreed amount is paid directly to them through the district administration.. Where such individuals or group of individuals or organizations cannot be identified,, the monetary benefits shall be deposited in the National Biodiversity Fund. (5)

59 Criteria For Equitable Benefit Sharing (R-20) Five percent of the assessed benefits shall be earmarked for the Authority or Board as the case may be, towards administrative and service charges.(9) The Authority shall monitor the flow of benefits as determined (d) under the sub-rule (4) in a manner determined by it. (10)

60 Timing of benefits Short-term, term, medium-term and long-term benefits including up-front payments, milestone payments and royalties on a case-by by-case basis. Milestone payments are often the best in cases where there is uncertainty in the kinds/volumes of benefits that might arise on a case-by by-case basis. The benefit sharing guidelines with enough flexibility for both provider and applicant in terms of commercial use of genetic resources.

61 Distribution of benefits As per the BD Act, benefits may be shared fairly and equitably with to resource management, scientific and/or commercial process to promote conservation and sustainable use of biological diversity. There is no mention about community ownership of genetic resources, and in the absence of clear guidance on ownership of resources, there is always scope for confusion in sharing the benefits.

62 REGULATIONS/GUIDELINES NATIONAL BIODIVERSITY AUTHORITY I. GUIDELINES Collaborative Research Projects (Section 5 of BD Act) Access, Benefit Sharing and Material Transfer (Section 3, 21 of BD Act) Normally Traded Commodities (Section 40 of BD Act) Designation of Repositories (Section 39 of BD Act) Transfer of Research Results (Section 4 of BD Act)

63 For more information Please Contact:

Access and Benefit Sharing and the Biological Diversity Act of India: A Progress Report

Access and Benefit Sharing and the Biological Diversity Act of India: A Progress Report RIS Research and Information System for Developing Countries www.ris.org.in/abdr.html Asian Biotechnology and Development Review Vol. 10 No. 3, pp 69-80 2008, RIS. All rights reserved 69 Printed in India