The boodiversity act 2002


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The boodiversity act 2002

  1. 1. “The Biodiversity Act, 2002” Manish Sharma M. Pharm. Sem-II Pharmaceutical Management & regulatory affairs The Biodiversity Act, 2002 1
  2. 2. Contents Introduction Definitions Regulation of Access to Biological Diversity National Biodiversity Authority Functions and Powers of The National Biodiversity Authority State Biodiversity Board Duties of The Central and The State Governments Biodiversity Management Committees The Biodiversity Act, 2002 2
  3. 3.  Forms Significance/ Role in Pharmaceutical Industry Nagoya Protocol Conclusion References The Biodiversity Act, 2002 3
  4. 4. Introduction Developed countries use the biogenetic resources accessed from the developing countries. It results in beginning of the unprotected flow of genetic information from the developing countries to the capital-rich west, and a protected flow in the reverse direction mainly through patents and Plant Breeders’ Rights (PBR) The Biological Diversity Act 2002 was born out of Indias attempt to realise the objectives enshrined in the United Nations Convention on Biological Diversity (CBD) 1992 which recognizes the sovereign rights of states to use their own Biological Resources The Biodiversity Act, 2002 3
  5. 5.  An Act to provide for conservation of biological diversity, sustainable use of its components and fair and equitable sharing of the benefits arising out of the use of biological resources, knowledge and for matters connected therewith or incidental thereto. This Act may be called the Biological Diversity Act, 2002 The Biodiversity Act, 2002 5
  6. 6. Definitions “biological diversity” means the variability among living organisms from all sources and the ecological complexes of which they are part and includes diversity within species or between species and of eco-systems; “biological resources” means plants, animals and micro-organisms or parts thereof, their genetic material and by- products (excluding value added products) with actual or potential use or value, but does not include human genetic material; The Biodiversity Act, 2002 6
  7. 7.  “commercial utilization” means end uses of biological resources for commercial utilization such as drugs, industrial enzymes, food flavors, fragrance, cosmetics, emulsifiers, oleoresins, colors, extracts and genes used for improving crops and livestock through genetic intervention, but does not include conventional breeding or traditional practices in use in any agriculture, horticulture, poultry, dairy farming, animal husbandry or bee keeping; The Biodiversity Act, 2002 7
  8. 8.  “sustainable use” means the use of components of biological diversity in such manner and at such rate that does not lead to the decline of the biological diversity thereby maintaining its potential to meet the needs and aspirations of present and future generations; The Biodiversity Act, 2002 8
  9. 9. Regulation of Access to Biological DiversitySec. 3. (1) No person referred to in sub-section (2) shall, without previous approval ofthe National Biodiversity Authority, obtain anybiological resource occurring in India orknowledge associated thereto for research orfor commercial utilization or for bio-surveyand bio-utilization. The Biodiversity Act, 2002 9
  10. 10. (2) The persons who shall be required to take the approval of the National Biodiversity Authority under sub-section (1) are the following, namely :-(a) a person who is not a citizen of India;(b) a citizen of India; who is a non-resident as defined in clause (30) of section 243 of 1961 of the Income-tax Act, 1961;(c) a body corporate, association or organization (i) not incorporated or registered in India; or (ii) incorporated or registered in India under any law for the time being in force which has any non-Indian participation in its share capital or management. The Biodiversity Act, 2002 10
  11. 11. Sec. 6. (1) No person shall apply for anyintellectual property right, by whatever namecalled, in or outside India for any inventionbased on any research or information on abiological resource obtained from Indiawithout obtaining the previous approval of theNational Biodiversity Authority before makingsuch application:  Provided that if a person applies for a patent, permission of the National Biodiversity Authority may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned: The Biodiversity Act, 2002 11
  12. 12.  Provided further that the National Biodiversity shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof.Process for approval:1. Application shall be made in form III for getting approval with fee of 500.2. Authority investigate the application and if satisfy approval shall be granted as a written agreement. The Biodiversity Act, 2002 12
  13. 13. National biodiversity authoritysec. 8. The head office of the nationalbiodiversity authority shall be at chennai. Chairperson Members ex-officio (10) non-official (5) The Biodiversity Act, 2002 13
  14. 14. ex-officio (10) Ministry of Ministry of Environment and Tribal Affairs Forests (2) (1) whom1 shall be ADG/DGMinistry ofAgriculture Ministry Ministry Ministry of Research of of Ocean Agriculture and and Biotechno Develop CooperationEducation logy (1) ment (1) (1) (1) Indian Systems Science and Scientific and of Medicine and Technology Industrial Homeopathy (1) Research (1) (1) The Biodiversity Act, 2002 14
  15. 15. non-official (5) sustainableconservation use ofof biological biological diversity resources specialists and scientists having special knowledge of, or experience in equitablerepresentatives sharing of of industry benefits Conservers, creators & knowledge-holders of biological resources The Biodiversity Act, 2002 15
  16. 16. Sec. 11.The Central Government may remove any memberfrom NBA who has – adjudged Offence of as an moral insolvent turpitude Removal of member from NBA physically or abusing mentally position incapable financial or other interest The Biodiversity Act, 2002 16
  17. 17. Functions and powers of the national biodiversity authoritySec. 18.(1) It shall be the duty of the National Biodiversity Authority to regulate activities, and(2) grant approval for undertaking any activity referred to in section 3, 4 and 6.(3) The National Biodiversity Authority may –(a) advise the Central Government on matters relating to the conservation of biodiversity, sustainable use of its components and equitable sharing of benefits arising out of the utilization of biological resources; The Biodiversity Act, 2002 17
  18. 18. (b) advise the State Governments in the selection of areas of biodiversity importance as heritage sites and measures for the management of such heritage sites;(4) The National Biodiversity Authority may, on behalf of the Central Government, take any measures necessary to oppose the grant of intellectual property rights in any country outside India on any biological resource obtained from India or knowledge associated with such biological resource which is derived from India. The Biodiversity Act, 2002 18
  19. 19. State biodiversity boardSec. 22.(1) With effect from such dates as the State Government may appoint, for the purposes of this Act, a Board for the State to be known as the ________________(name of the State) Biodiversity Board.(4) The Board shall consist of the following members, namely:-a) a Chairpersonb) five ex-officio membersc) five members from among the experts in matters relating to conservation of biological diversity, sustainable use of biological resources and equitable sharing of benefits arising out of the use of biological resources. The Biodiversity Act, 2002 19
  20. 20. Sec. 23. The functions of the State Biodiversity Board shall be to –(a) advise the State Government, on matters relating to the conservation of biodiversity, sustainable use of its components and equitable sharing of the benefits arising out of the utilization of biological resources;(b) regulate by granting of approvals or otherwise requests for commercial utilization or bio-survey and bio-utilization of any biological resource by Indians; The Biodiversity Act, 2002 20
  21. 21. Procedure for third party transfer of accessed biological resource• Person shall make an application to the Authority in Form IV, accompanied by a fee of ten thousand rupees in the form of Bank draft or cheque drawn in favour of the Authority.• The Authority shall after collecting any additional information, decide upon the application as far as possible within a period of six months of receipt of the same.• The approval as may be granted in the form of a written agreement decided by the Authority. The Biodiversity Act, 2002 21
  22. 22. Duties of the central and the state governmentsSec. 36. To develop national strategies, plans, etc., for conservation, etc., of biological diversity:-(1) The Central Govt. provides in-situ and ex-situ conservation of biological resources.(2) To provide immediate measures for safety of biological areas rich in biological diversity.(3) The Central Govt. shall integrate the conservation, promotion and sustainable use of biological diversity and provide measures for protection, including sui-generis system. The Biodiversity Act, 2002 22
  23. 23. Sec.39 Powers of Central Govt. to designate Repositories:(1) Designate institutions as repositories for different categories of biological resources.(2) To keep safe custody of the biological material including voucher specimens.(3) To keep safe custody of any new taxon discovered by any person. The Biodiversity Act, 2002 23
  24. 24. Biodiversity management committeesSec.41. For the purpose of  promoting conservation,  sustainable use and documentation of biological diversity including preservation of habitats,  conservation of land races, folk varieties and cultivars, domesticated stocks and breeds of animals and micro organisms,  chronicling of knowledge relating to biological diversity. The Biodiversity Act, 2002 24
  25. 25. (a) “cultivar” means a variety of plant that has originated and persisted under cultivation or was specifically bread for the purpose of cultivation;(b) “folk variety” means a cultivated variety of plant that was developed, grown and exchanged informally among farmers;(c) “landrace” means primitive cultivar that was grown by ancient farmers and their successors. The Biodiversity Act, 2002 25
  26. 26. FormsI Application form for access to Biological resources and 10,000 associated traditional knowledgeII Application for seeking prior approval of National Biodiversity 5000 Authority for transferring the results of research to foreign nationals, companies, NRI’s, for commercial purposes.III Application for seeking prior approval of National Biodiversity 500 Authority for applying for Intellectual Property RightIV Application form for seeking approval of National Biodiversity 10,000 Authority for third party transfer of the accessed Biological resources and associated traditional knowledge.V Form of Memorandum of Appeal Within 30-45 daysVI Notice for hearing of the appealVII Form of notice The Biodiversity Act, 2002 26
  27. 27. Significance/ Role in Pharmaceutical IndustryThe NBA deals with the requests for accessto bio-resources and associated traditionalknowledge by foreign nationals, institutionsor companies, and all matters pertaining tothe transfer of research findings to anyforeign national, imposition of terms andconditions to secure equitable sharing ofbenefits, establish sovereign rights over thebio-resources of India and approval forseeking any form of Intellectual PropertyRights (IPRs) in or outside India for aninvention based on research or informationpertaining to a biological resource and The Biodiversity Act, 2002 27
  28. 28. associated traditional knowledge obtainedfrom India.The Act imposes certain restrictions onrequest made by industries related to accessto biological resources and traditionalknowledge if the request is on:a. endangered taxab. endemic and rare taxac. likely adverse effects on the livelihood of the local peopled. adverse and irrecoverable environmental impacte. cause genetic erosion or affect ecosystem function The Biodiversity Act, 2002 28
  29. 29. Nagoya ProtocolThe Nagoya Protocol is a supplementaryagreement to the Convention on BiologicalDiversity . To access genetic resources andthe fair and equitable sharing of benefitsarising from their utilization to theConvention on Biological Diversity.The Nagoya Protocol will create greaterlegal certainty and transparency for bothproviders and users of genetic resources by: Establishing more predictable conditions for access to genetic resources. Helping to ensure benefit-sharing when genetic resources leave the contracting party providing the genetic resources The Biodiversity Act, 2002 29
  30. 30. Access obligations:-Domestic-level access measures are to:a) Create legal certainty, clarity and transparencyb) Provide fair and non-arbitrary rules and proceduresc) Establish clear rules and procedures for prior informed consent and mutually agreed termsd) Provide for issuance of a permit or equivalent when access is grantede) Create conditions to promote and encourage research contributing to biodiversity conservation and sustainable use The Biodiversity Act, 2002 30
  31. 31. a) Pay due regard to cases of present or imminent emergencies that threaten human, animal or plant healthb) Consider the importance of genetic resources for food and agriculture for food securityBenefit-sharing obligations:- Domestic-level benefit-sharing measures are to provide for the fair and equitable sharing of benefits arising from the utilization of genetic resources with the contracting party providing genetic resources. The Biodiversity Act, 2002 31
  32. 32. The Biodiversity Act, 2002 32