66issues in bioprospecting
TRANSCRIPT
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Issues in Bioprospecting: Lessons fromthe Field
P. PushpangadanNational Botanical Research Institute
Rana Pratap Marg, Lucknow-226001
IUCN South Asia Regional Training Programme on Bioprospecting,
Access and Benefit Sharing, NBRI, 10-12, January 2005
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The systematic search for genes, naturalcompounds, designs and whole organisms inwild life with a potential for productdevelopment by biological observation, and
biophysical, biochemical and geneticmethods without disruption to nature.
- Nicolas Mateo et al., 2001
WHAT IS BIOPROSPECTING?
Exploration of biodiversity for commerciallyvaluable genetic and biochemical resources
- Eisner 1989, Reid et al. 1993
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Chemical prospecting
Drug and pharmaceuticals Pesticides Cosmetics Food additives
Other industrially valuablechemical products
Gene prospecting
GeneticEngineering
Crop development
Fermentation Cell culture
Bionic prospecting
Designs Sensor
technologies Architecture Bioengineering Bio-modeling
Bioprospecting: Major Areas
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RAW OR VALUE ADDED MATERIALS/DERIVATIVES
(GENETIC RESOURCES / TK)
MARKETING
LEAD BASED or
MECHANISM BASED
COLLECTION, SOURCING, ACQUISITION
(Through PIC, MAT, and MTA)
EXTRACTION SCREENING
RANDOM PRIMARY SCREENS
BIOMOLECULES BIOLOGICAL ACTIVITY/GENES TRAITS
ISOLATION & CHARACTERIZATION
STRUCTURAL ELUCIDATION
TRIALS & TESTS(CLINICAL, GENETIC STABILITY, BIOSAFETY)
IPR GENERATION / PROTECTION
BENEFIT SHARING
SECONDARY SCREENS
PRODUCT DEVELOPMENT
Bioprospecting : Essential elements
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Bioprospecting: Major Areas
Biodiversity &IPR/TK
Sustainableuse
Benefitsharing Bioinformatics
IPR
Biotechnology
Informationtechnology
Herbaltechnology
Bioprospecting
Conservation
Drug Development
Pharmaceuticals
Agro-chemistry
Cosmetics
Proteins
Enzymes
New crop varieties
GMOs
GM Foods,Designs. etc
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Selection of molecular targetPurification of reagents
Development of assay
Drug design IDENTIFICATION
OF LEAD
Natural product
screeningSynthesis & SARA
studiesSelection development
candidateCompound bankscreening
Combinatorial
chemical libraries
Elements of Natural ProductMechanism-based Screening
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SECONDARY SCREENS
Elements of Natural ProductDiscovery-Random Screening
ACQUISITION
Raw material: field collections, culture collections, screening libraries, etc
EXTRACTION
PRIMARY SCREENS
ISOLATION & CHARACTERIZATION
STRUCTURAL ELUCIDATION
PRE-CLINICAL & CLINICAL DEVELOPMENT
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Prospecting for drugs and pharmaceuticals from traditional knowledge(Ethnopharmacological Approach)
Bioactive Molecules
Product Development & Pharmaceutics: Dosage Forms
TOXICOLOGICAL AND EFFICACY EVALUATION
Activity Guided Isolation
Selection of Effectivecombinations of extracts
Pharmacodynamics
Pharmacokinetics
Multi-centric, Randomized,Clinical Trials
Final Product
Marketing & Benefit Sharing with the Traditional Communities
Interaction with Traditional communities and obtaining Ethno medicalinformation with Prior Informed Consent
Selection of Potential Herbal(s)/Formulation(s)
Literature Survey
Development of Scientifically
Validated herbaldrugs/formulations
Clinical Dosage forms
Safety Efficacy Evaluation
The Product Development
Shelf Life Studies
Clinical Trials
Final Product
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Bioprospecting Programmes -Examples
InBio Merck Agreement:
Beginning of a Bioprospecting Era
Shaman Pharmaceuticals
International CooperativeBiodiversity Groups (ICBG)
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Bioprospecting Programmes :Examples from India
CSIR Coordinated Programme on DrugDiscovery (1996- )
New Millennium Indian TechnologyLeadership Initiative (NMITLI)Planning Commission/CSIR(2002- )
Dept. of BiotechnologyBioprospecting and MolecularTaxonomy Programme(1998- )
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Issues of Bioprospecting
Access Norms and Policies
Ownership and Sovereign Rights onBiodiversityWho owns the resources?
Prior Informed Consent (PIC)
Principles and Practices Mutually Agreed Terms (MAT)
Material Transfer Agreements (MTA)
Access and Benefit Sharing (ABS)
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Issues of Bioprospecting(Contd..)
Access and Benefit Sharing (ABS)Benefit Sharing
Monetary Benefits
Access fees.
Up
front payments. Milestone payments. Sharing of Royalties. License fees in case of commercialization. Special fees to be paid to trust funds supporting
conservation and sustainable use of biodiversity. Salaries and preferential terms on mutually
agreed terms. Research funding. Joint ventures. Joint ownership of relevant intellectual property
rights.
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Issues of Bioprospecting(Contd..)
Access and Benefit Sharing (ABS)
Benefit Sharing Non-monetary Benefits
Sharing R&D results Collaboration in S&T and development
programmes (Biotechnology) Participation in Product Development Collaboration in Education and Training Admittance to ex situfacilities and databanks Institutional Capacity Building Human Resource Development Information Exchange Contribution to Local Economy Contribution to other domestic benefits Food and Livelihood security benefits Social Recognition Joint IPRs
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Issues of Bioprospecting(Contd..)
Conservation of biodiversity.
Sustainability of Genetic Resource Stocks
Uncertainties and opportunistic behaviors Success rate of bioprospecting programmes
Market Trends National and International Legal and Policy
Environment
Capacity Building in Biodiversity inventorying,
and bioprospecting technologies Biotechnology
Herbal Technology
Information Technology
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Issues of Bioprospecting(Contd..)
Intellectual Property Rights(IPR)Protection
Traditional Resource Rights of
Indigenous Communities Bioethics and Biosafety
Transgenics
Transgenic foods
Transgenic medicines
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Tribal Settings in India
India has over 70 million tribals
belonging to over 550 communitiesinhabiting in 5000 villages located
in and around forests region of the
country.
About 217 different dialects are
spoken by tribal communities in
India.
Benefit sharing with an indigenouscommunity (tribe) A Case Study
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Population of the individual tribe is as large as
about 5 million in Madhya Pradesh and as small
as 21 like Onges of Andaman Islands.
Tribal Settings in India
The tribals in the country occupyabout 18.74% of the total area of the
country, mainly in the hilly and forestareas of 19 states and unionterritories.
Benefit sharing with an indigenoustribe (Contd..)
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10000 plant species are used by tribes of India
Total10000species
8000Medicinal
Pesticides
Gums, Resins &
Dyes
Benefit sharing with an indigenoustribe (Contd..)
fi h i i h i di
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TH
E
INDIAN
FLORA(
ca17500
species)
Medici
na
lPlan
tsare
used
byTr
ibal
Communities(oral)
8000 species
Ayurveda900 sp.
Unani700 sp.
Siddha600 sp.
Amchi250 sp.
INDIAN
SYST
EMSOFME
DICINE
Modern
30 sp.
Benefit sharing with an indigenoustribe (Contd..)
fi h i i h i di
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The Kani experiment
During the course of an ethnobotanical
exploration, Pushpangadan and co-workers
(1987) came across an interesting use (anti-
fatigue) of a lesser known wild plant while
conducting the study on the forest dwelling
Kani Tribe of South Western Ghat
mountains.
Benefit sharing with an indigenoustribe (Contd..)
B fi h i i h i di
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Kani, a semi-nomadic tribal communityinhabits in the forested mountains in andaround Agasthyamalai of the southern WesternGhat region of India. Their population as per the
1991 census of India is 1618.
The Kani Tribe
Benefit sharing with an indigenoustribe (Contd..)
B fi h i i h i di
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In December 1987, a team of scientistsled by Dr. Pushpangadan was conducting anethno-botanical survey and exploration in the
Agasthya hills, of the Western Ghats in SouthIndia with the help of two young Kani men asguides.
During this visit, the author and his
colleagues noticed that the Kani men were nottaking any food and were eating only somesmall dry fruits. But they were quite energetic
and agile.
Interaction with Kani Tribe
Benefit sharing with an indigenoustribe (Contd..)
B fit h i ith i di
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After a strenuous mountain trek, the
author (Pushpangadan) and colleagues got
exhausted and were taking rest. Then the
Kani men accompanying them offered
those dry fruits saying that when
Interaction with Kani Tribe
consumed they would
reduce fatigue andprovide energy.
Benefit sharing with an indigenoustribe (Contd..)
B fit h i ith i di
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Collected adequate samples of this plant fordetailed investigations at Regional ResearchLaboratory, (RRL), Jammu. Soon after reaching
back at RRL, Jammu, Dr. Pushpangadan
Scientific Investigations
conducted the firstscientific test to
validate the Kanisclaim on the anti-fatigue property ofArogyapacha.
Benefit sharing with an indigenoustribe (Contd..)
B fit h i ith i di
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Three patents on the differentpharmacological activities of the
compounds isolated from this plant were
made by RRL, Jammu.
Filing of patents
Benefit sharing with an indigenoustribe (Contd..)
B fit h i ith i di
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Within a period of seven years a scientifically
validated, standardized herbal formulation
Jeevani was formulated with Trichopus
zeylanicusand threeother medicinal plants as its
ingredients. Evaluations related to toxicity,
efficacy, shelf life and clinical properties were
carried out by TBGRI, and the drug was ready by
the end of 1994.
Drug Jeevani was ready
Benefit sharing with an indigenoustribe (Contd..)
Benefit sharing with an indigenous
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After the necessary
pharmacological
evaluation andclinical study, the
drug was released for
commercialproduction.
Drug Jeevani was released
Benefit sharing with an indigenoustribe (Contd..)
Benefit sharing with an indigenous
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However, it took almost two years to transfer
this benefit to be transferred to the Kani tribedue to inherent problems of the tribe.
Kani tribe is an unorganized semi-nomadic
forest dwelling tribe. They later organized
themselves and formed a trust with over 50% of
adults from Kani Tribe as its members.
Bottlenecks in implementation ofthe same
Benefit sharing with an indigenoustribe (Contd..)
Benefit sharing with an indigenous
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TBGRI transferred the money due to Kanitribe (Indian Rupees 650 thousand) in Feb
1999. They are now regularly getting 50%
of royalty.
Actual transfer of moneyto Kani tribe
Benefit sharing with an indigenoustribe (Contd..)
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Past Present
DWELLING
Impact on Removing Poverty fromthis Initiative
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LIVING CONDITIONS
Impact on Removing Poverty fromthis Initiative
Past Present
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Bioprospecting Contracts
Any Bioprospecting contractshould include:
Entry of access fee
Collection fee for samplescollected
Processing fee for processingdone, if any
Royalty on the final product
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Contract on Access to TraditionalKnowledge could include:
Access or consent fee for obtaining theconsent of the appropriate community foraccessing closely held knowledge that is
protected through a sui generislegislation An access fee for accessing information
containing in biodiversity registers or otherdocuments in the case of public domain or
quazi public domain knowledge.
A royalty on the final product that isdeveloped from TK, by the bioprospector
S f di f i di / l l
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Survey, inventory & documentation of the indigenous
knowledge system and preparation of community registers
Preparation of Electronic Database
(Access to Patent Office)
Access to Database with prior informed consent
Negotiation and signing of agreement(s)
Commercialization of the products
Benefit sharing with the indigenous/ local communities
Development of marketable product/s (with S&T intervention)
Safeguarding IPRs of indigenous/ localcommunities and Benefit-sharing
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