Theboodiversityact 2002 121031122050 Phpapp01

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“The Biodiversity Act, 2002”

Manish SharmaM. Pharm. Sem-II

Pharmaceutical Management & regulatory affairs

1The Biodiversity Act, 2002



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 StateGovernments

Biodiversity Management Committees




Forms

Significance/ Role in PharmaceuticalIndustry

Nagoya Protocol

Conclusion

References

The Biodiversity Act, 2002 3



Introduction

Developed countries use the biogeneticresources accessed from the developingcountries. It results in beginning of theunprotected flow of genetic information from thedeveloping countries to the capital-rich west,

and a protected flow in the reverse directionmainly through patents and Plant Breeders’Rights (PBR)

The Biological Diversity Act 2002 was born out ofIndia's attempt to realise the objectives

enshrined in the United Nations Convention onBiological Diversity (CBD) 1992 whichrecognizes the sovereign rights of states to usetheir own Biological Resources




An Act to provide for conservation ofbiological diversity, sustainable use of its

components and fair and equitable sharingof the benefits arising out of the use ofbiological resources, knowledge and formatters connected therewith or incidental

thereto. This Act may be called the Biological

Diversity Act, 2002




Definitions

“biological diversity” means the variabilityamong living organisms from all sources andthe ecological complexes of which they arepart and includes diversity within species or

between species and of eco-systems;

“biological resources” means plants,animals and micro-organisms or partsthereof, their genetic material and by-

products (excluding value added products)with actual or potential use or value, butdoes not include human genetic material;




“commercial utilization” means end uses of

biological resources for commercialutilization such as drugs, industrialenzymes, food flavors, fragrance, cosmetics,emulsifiers, oleoresins, colors, extracts andgenes used for improving crops andlivestock through genetic intervention, butdoes not include conventional breeding ortraditional practices in use in anyagriculture, horticulture, poultry, dairy

farming, animal husbandry or bee keeping;




“sustainable use” means the use ofcomponents of biological diversity in such

manner and at such rate that does not leadto the decline of the biological diversitythereby maintaining its potential to meetthe needs and aspirations of present and

future generations;




Regulation of Access to BiologicalDiversity

Sec. 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.




(2) The persons who shall be required to takethe approval of the National BiodiversityAuthority under sub-section (1) are thefollowing, namely :-

(a) a person who is not a citizen of India;

(b) a citizen of India; who is a non-resident asdefined in clause (30) of section 243 of1961 of the Income-tax Act, 1961;

(c) a body corporate, association ororganization

(i) not incorporated or registered in India; or

(ii) incorporated or registered in India under anylaw for the time being in force which has anynon-Indian participation in its share capital ormanagement.




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 making

such application: Provided that if a person applies for a

patent, permission of the NationalBiodiversity Authority may be obtained

after the acceptance of the patent butbefore the sealing of the patent by thepatent authority concerned:




Provided further that the NationalBiodiversity shall dispose of the

application for permission made to itwithin a period of ninety days from thedate of receipt thereof.

Process for approval:

1. Application shall be made in form III forgetting approval with fee of 500.

2. Authority investigate the application and ifsatisfy approval shall be granted as a

written agreement.




National biodiversity authority

sec. 8. The head office of the nationalbiodiversity authority shall be at chennai.


Members

Chairperson

ex-officio(10)

non-official(5)




ex-officio(10)

Ministry ofTribal Affairs

(1)

Ministry of Environment andForests (2)

whom1 shall be ADG/DG

Ministry ofAgricultureResearch

andEducation

(1)

Ministryof

Biotechnology (1)

Ministryof OceanDevelop

ment (1)

Ministry ofAgriculture and

Cooperation(1)

Indian Systemsof Medicine and

Homeopathy(1)

Science andTechnology

(1)

Scientific andIndustrial

Research (1)




non-official(5)

specialists andscientists having

special knowledgeof, or experience in

conservationof biological

diversity

sustainableuse of

biologicalresources

equitable

sharing ofbenefits

representativesof industry

Conservers,creators &

knowledge-holdersof biologicalresources



Sec. 11.The Central Government may remove any memberfrom NBA who has –


Removal

ofmember

from NBA

adjudgedas an

insolvent

Offence ofmoral

turpitude

physicallyor

mentallyincapable

financial orother interest

abusing

position



Functions and powers of thenational biodiversity authority

Sec. 18.(1) It shall be the duty of the National

Biodiversity Authority to regulateactivities, and

(2) grant approval for undertaking anyactivity referred to in section 3, 4 and 6.

(3) The National Biodiversity Authority may –

(a) advise the Central Government on mattersrelating to the conservation of

biodiversity, sustainable use of itscomponents and equitable sharing ofbenefits arising out of the utilization ofbiological resources;




(b) advise the State Governments in theselection of areas of biodiversity

importance as heritage sites and measuresfor the management of such heritagesites;

(4) The National Biodiversity Authority may,

on behalf of the Central Government, takeany measures necessary to oppose thegrant of intellectual property rights in anycountry outside India on any biologicalresource obtained from India or

knowledge associated with such biologicalresource which is derived from India.




State biodiversity board

Sec. 22.

(1) With effect from such dates as the StateGovernment may appoint, for the purposesof this Act, a Board for the State to beknown as the ________________(name

of the State) Biodiversity Board.(4) The Board shall consist of the following

members, namely:-a) a Chairperson

b) five ex-officio members

c) five members from among the experts in mattersrelating to conservation of biological diversity,sustainable use of biological resources and equitablesharing of benefits arising out of the use of biologicalresources.




Sec. 23.

The functions of the State BiodiversityBoard shall be to –

(a) advise the State Government, on mattersrelating to the conservation of

biodiversity, sustainable use of itscomponents and equitable sharing of thebenefits arising out of the utilization ofbiological resources;

(b) regulate by granting of approvals orotherwise requests for commercialutilization or bio-survey and bio-utilizationof any biological resource by Indians;




Procedure for third party transfer

of accessed biological resource

• Person shall make an application to theAuthority in Form IV, accompanied by a feeof ten thousand rupees in the form of Bankdraft or cheque drawn in favour of the

Authority.• The Authority shall after collecting any

additional information, decide upon theapplication as far as possible within a periodof six months of receipt of the same.

• The approval as may be granted in the formof a written agreement decided by theAuthority.




Duties of the central and the stategovernments

Sec. 36.

To develop national strategies, plans, etc., forconservation, 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 useof biological diversity and provide measuresfor protection, including sui-generis system.




Sec.39

Powers of Central Govt. to designateRepositories:

(1) Designate institutions as repositories fordifferent categories of biologicalresources.

(2) To keep safe custody of the biologicalmaterial including voucher specimens.

(3) To keep safe custody of any new taxondiscovered by any person.




Biodiversity management committees

Sec.41.

For the purpose of

promoting conservation,

sustainable use and documentation ofbiological diversity including preservationof habitats,

conservation of land races, folk varieties

and cultivars, domesticated stocks andbreeds of animals and micro organisms,

chronicling of knowledge relating tobiological diversity.




(a) “cultivar” means a variety of plant that

has originated and persisted undercultivation or was specifically bread forthe purpose of cultivation;

(b) “folk variety” means a cultivated variety of

plant that was developed, grown andexchanged informally among farmers;

(c) “landrace” means primitive cultivar thatwas grown by ancient farmers and theirsuccessors.




FormsI Application form for access to Biological resources and

associated traditional knowledge

10,000

II Application for seeking prior approval of National Biodiversity

Authority for transferring the results of research to foreign

nationals, companies, NRI’s, for commercial purposes.

5000

III

Application for seeking prior approval of National BiodiversityAuthority for applying for Intellectual Property Right

500

IV

Application form for seeking approval of National Biodiversity

Authority for third party transfer of the accessed Biological

resources and associated traditional knowledge.

10,000

V

Form of Memorandum of Appeal Within 30-45

days

VI Notice for hearing of the appeal

VII Form of notice




Significance/ Role in Pharmaceutical

Industry

The 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 any

foreign 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 Property

Rights (IPRs) in or outside India for aninvention based on research or informationpertaining to a biological resource and




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 taxa

c. likely adverse effects on the livelihood ofthe local people

d. adverse and irrecoverable environmentalimpact

e. cause genetic erosion or affect ecosystemfunction




Nagoya Protocol

The 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 the

Convention 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 providingthe genetic resources




Access obligations:-

Domestic-level access measures are to:

a) Create legal certainty, clarity andtransparency

b) Provide fair and non-arbitrary rules andprocedures

c) Establish clear rules and procedures for

prior informed consent and mutually agreedterms

d) Provide for issuance of a permit orequivalent when access is granted

e) Create conditions to promote andencourage research contributing tobiodiversity conservation and sustainableuse




a) Pay due regard to cases of present orimminent emergencies that threaten

human, animal or plant healthb) Consider the importance of genetic

resources for food and agriculture for foodsecurity

Benefit-sharing obligations:-Domestic-level benefit-sharing measuresare to provide for the fair and equitablesharing of benefits arising from theutilization of genetic resources with thecontracting party providing geneticresources.





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Theboodiversityact 2002 121031122050 Phpapp01