issues in bioprospecting: lessons from the field p. pushpangadan national botanical research...
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Issues in Bioprospecting: Lessons from the Field
P. PushpangadanNational Botanical Research Institute
Rana Pratap Marg, Lucknow-226001IUCN 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, natural compounds, designs and whole organisms in wild life with a potential for product development by biological observation, and biophysical, biochemical and genetic methods without disruption to nature.
- Nicolas Mateo et al., 2001
WHAT IS BIOPROSPECTING?
• Exploration of biodiversity for commercially valuable 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 valuable chemical products
Gene prospecting
• Genetic Engineering
• 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
Herbal technology
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 target
Purification of reagents Development of assay
Drug design IDENTIFICATION OF LEAD
Natural product screening
Synthesis & SARA studies
Selection development candidate
Compound bank screening
Combinatorial chemical libraries
Elements of Natural Product Mechanism-based Screening
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SECONDARY SCREENS
Elements of Natural Product Discovery-Random Screening
ACQUISITIONRaw 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 Effective combinations of extracts
Pharmacodynamics
Bioactive Extracts
Pharmacokinetics
Multi-centric, Randomized,Clinical Trials
Final Product
Marketing & Benefit Sharing with the Traditional Communities
Interaction with Traditional communities and obtaining Ethno medical information with Prior Informed Consent
Selection of Potential Herbal(s)/Formulation(s)
Literature Survey
Development of ScientificallyValidated herbal
drugs/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 Cooperative Biodiversity Groups (ICBG)
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Bioprospecting Programmes : Examples from India
• CSIR Coordinated Programme on Drug Discovery (1996- )
• New Millennium Indian Technology Leadership Initiative (NMITLI) – Planning Commission/CSIR(2002- )
• Dept. of Biotechnology – Bioprospecting and Molecular Taxonomy Programme(1998- )
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Issues of Bioprospecting
• Access Norms and Policies
• Ownership and Sovereign Rights on Biodiversity – Who 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 situ facilities 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 communities inhabiting 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 indigenous community (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 occupy about 18.74% of the total area of the country, mainly in the hilly and forest areas of 19 states and union territories.
Benefit sharing with an indigenous tribe (Contd..)
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10000 plant species are used by tribes of India
Total 10000
species
8000 Medicinal
3500
Edib
le
1000
Oth
er
s550
Fib
r e Pesticides
Gums, Resins & Dyes
425
325
Benefit sharing with an indigenous tribe (Contd..)
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TH
E IN
DIA
N F
LO
RA
(ca
175
00 s
pec
ies)
Medicin
al Pla
nts
are
use
d b
y Tr
ib
al Communities (oral)
8000 species
Ayurveda900 sp.
Unani700 sp.
Siddha600 sp.
Amchi250 sp.
IND
IAN
SY
ST
EM
S O
F M
ED
ICIN
E
Modern30 sp.
Benefit sharing with an indigenous tribe (Contd..)
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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 indigenous tribe (Contd..)
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‘Kani’, a semi-nomadic tribal community inhabits in the forested mountains in and around ‘Agasthyamalai’ of the southern Western Ghat region of India. Their population as per the 1991 census of India is 1618.
The Kani Tribe
Benefit sharing with an indigenous tribe (Contd..)
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In December 1987, a team of scientists led by Dr. Pushpangadan was conducting an ethno-botanical survey and exploration in the Agasthya hills, of the Western Ghats in South India with the help of two young Kani men as guides.
During this visit, the author and his colleagues noticed that the Kani men were not taking any food and were eating only some small dry fruits. But they were quite energetic and agile.
Interaction with Kani Tribe
Benefit sharing with an indigenous tribe (Contd..)
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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
and provide energy.
Benefit sharing with an indigenous tribe (Contd..)
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Collected adequate samples of this plant for detailed investigations at Regional Research Laboratory, (RRL), Jammu. Soon after reaching back at RRL, Jammu, Dr. Pushpangadan
Scientific Investigations
conducted the first scientific test to validate the Kani’s claim on the anti-fatigue property of Arogyapacha.
Benefit sharing with an indigenous tribe (Contd..)
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Three patents on the different pharmacological activities of the compounds isolated from this plant were made by RRL, Jammu.
Filing of patents
Benefit sharing with an indigenous tribe (Contd..)
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Within a period of seven years a scientifically
validated, standardized herbal formulation
‘Jeevani’ was formulated with ‘Trichopus
zeylanicus’ and three other 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 indigenous tribe (Contd..)
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After the necessary
pharmacological
evaluation and
clinical study, the
drug was released for
commercial
production.
Drug “Jeevani” was released
Benefit sharing with an indigenous tribe (Contd..)
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However, it took almost two years to transfer
this benefit to be transferred to the Kani tribe
due 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 of the same
Benefit sharing with an indigenous tribe (Contd..)
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TBGRI transferred the money due to Kani
tribe (Indian Rupees 650 thousand) in Feb
1999. They are now regularly getting 50%
of royalty.
Actual transfer of money to Kani tribe
Benefit sharing with an indigenous tribe (Contd..)
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Past Present
DWELLING
Impact on Removing Poverty from this Initiative
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LIVING CONDITIONS
Impact on Removing Poverty from this Initiative
Past Present
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Bioprospecting Contracts
Any Bioprospecting contract should include:
• Entry of access fee
• Collection fee for samples collected
• Processing fee for processing done, if any
• Royalty on the final product
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Contract on Access to Traditional Knowledge could
include:• Access or consent fee for obtaining
the consent of the appropriate community for accessing closely held knowledge that is protected through a sui generis legislation
• An access fee for accessing information containing in biodiversity registers or other documents in the case of public domain or quazi public domain knowledge.
• A royalty on the final product that is developed from TK, by the bioprospector
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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/ local communities and Benefit-
sharing
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