Transcript Document

Issues in Bioprospecting: Lessons from
the Field
P. Pushpangadan
National 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
WHAT IS BIOPROSPECTING?
• Exploration of biodiversity for commercially
valuable genetic and biochemical resources
- Eisner 1989, Reid et al. 1993
• 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
Bioprospecting: Major Areas
Chemical prospecting
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Drug and pharmaceuticals
Pesticides
Cosmetics
Food additives
Other industrially valuable
chemical products
Bionic prospecting
• Designs
• Sensor
technologies
• Architecture
• Bioengineering
• Bio-modeling
Gene prospecting
• Genetic
Engineering
• Crop development
• Fermentation
• Cell culture
Bioprospecting : Essential elements
RAW OR VALUE – ADDED MATERIALS/DERIVATIVES
(GENETIC RESOURCES / TK)
COLLECTION, SOURCING, ACQUISITION
(Through PIC, MAT, and MTA)
EXTRACTION SCREENING
RANDOM
PRIMARY SCREENS
LEAD BASED or
MECHANISM
BASED
BIOMOLECULES – BIOLOGICAL ACTIVITY/GENES – TRAITS
ISOLATION & CHARACTERIZATION
SECONDARY SCREENS
STRUCTURAL ELUCIDATION
TRIALS & TESTS
(CLINICAL, GENETIC STABILITY, BIOSAFETY)
PRODUCT DEVELOPMENT
IPR GENERATION / PROTECTION
BENEFIT SHARING
MARKETING
Bioprospecting: Major Areas
Biodiversity &
IPR/TK
Biotechnology
Bioprospecting
Information
technology
Herbal
technology
Conservation
Sustainable
use
Benefit
sharing
Bioinformatics
• Drug Development
• Pharmaceuticals
• Agro-chemistry
• Cosmetics
• Proteins
• Enzymes
• New crop varieties
• GMOs
• GM Foods,
Designs. etc
IPR
Elements of Natural Product
Mechanism-based Screening
Selection of molecular target
Purification of reagents
Development of assay
Natural product
screening
Drug design
IDENTIFICATION
OF LEAD
Combinatorial
chemical libraries
Compound bank
screening
Synthesis & SARA
studies
Selection development
candidate
Elements of Natural Product
Discovery-Random Screening
ACQUISITION
Raw material: field collections, culture collections, screening libraries, etc
EXTRACTION
PRIMARY SCREENS
ISOLATION & CHARACTERIZATION
SECONDARY SCREENS
STRUCTURAL ELUCIDATION
PRE-CLINICAL & CLINICAL DEVELOPMENT
Prospecting for drugs and pharmaceuticals from traditional knowledge
(Ethnopharmacological Approach)
Interaction with Traditional communities and obtaining Ethno medical
information with Prior Informed Consent
Selection of Potential Herbal(s)/Formulation(s)
Literature Survey
TOXICOLOGICAL AND EFFICACY EVALUATION
Activity Guided Isolation
Development of Scientifically
Validated herbal
drugs/formulations
Clinical Dosage forms
Selection of Effective
combinations of extracts
Bioactive Molecules
Pharmacodynamics
Safety Efficacy Evaluation
The Product Development
Shelf Life Studies
Clinical Trials
Final Product
Product Development & Pharmaceutics: Dosage Forms
Pharmacokinetics
Multi-centric, Randomized,
Clinical Trials
Final Product
Marketing & Benefit Sharing with the Traditional Communities
Bioprospecting Programmes Examples
• InBio – Merck Agreement:
Beginning of a Bioprospecting Era
• Shaman Pharmaceuticals
• International Cooperative
Biodiversity Groups (ICBG)
Bioprospecting Programmes :
Examples from India
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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- )
Issues of Bioprospecting
Access and Benefit Sharing (ABS)
• Access Norms and Policies
• Ownership and Sovereign Rights on
Biodiversity – Who owns the resources?
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Prior Informed Consent (PIC) –
Principles and Practices
• Mutually Agreed Terms (MAT)
• Material Transfer Agreements (MTA)
Issues of Bioprospecting(Contd..)
Access and Benefit Sharing (ABS)
•Benefit Sharing
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Monetary Benefits
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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.
Issues of Bioprospecting(Contd..)
Access and Benefit Sharing (ABS)
• Benefit Sharing
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Non-monetary Benefits
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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
Issues of Bioprospecting(Contd..)
• Conservation of biodiversity.
• Sustainability of Genetic Resource Stocks
• Uncertainties and opportunistic behaviors
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Success rate of bioprospecting programmes
Market Trends
National and International Legal and Policy
Environment
• Capacity Building in Biodiversity inventorying,
and bioprospecting technologies
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Biotechnology
Herbal Technology
Information Technology
Issues of Bioprospecting(Contd..)
• Intellectual Property Rights(IPR)
Protection
• Traditional Resource Rights of
Indigenous Communities
• Bioethics and Biosafety
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Transgenics
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Transgenic foods
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Transgenic medicines
Benefit sharing with an indigenous
community (tribe) – A Case Study
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
tribe (Contd..)
Tribal Settings in India
 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.
 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..)
10000 plant species are used by tribes of India
8000
Medicinal
Total
10000
species
Pesticides
Gums, Resins &
Dyes
are used by
s
t
Tr
an
l
ib
P
l
munities (oral
m
)
Co
l
a
900 sp.
700 sp.
600 sp.
a
250 sp.
Me
d
i
c
in
8000 species
30 sp.
Ayurveda
Unani
Siddha
Amchi
Modern
INDIAN SYSTEMS OF MEDICINE
THE INDIAN FLORA (ca 17500 species)
Benefit sharing with an indigenous
tribe (Contd..)
Benefit sharing with an indigenous
tribe (Contd..)
The Kani experiment
During the course of an
ethnobotanical
exploration, Pushpangadan and co-workers
(1987) came across an interesting use (antifatigue) of a lesser known wild plant while
conducting the study on the forest dwelling
Kani
Tribe
mountains.
of
South
Western
Ghat
Benefit sharing with an indigenous
tribe (Contd..)
The Kani Tribe
‘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.
Benefit sharing with an indigenous
tribe (Contd..)
Interaction with Kani Tribe
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.
Benefit sharing with an indigenous
tribe (Contd..)
Interaction with Kani Tribe
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
consumed they would
reduce fatigue and
provide energy.
Benefit sharing with an indigenous
tribe (Contd..)
Scientific Investigations
Collected adequate samples of this plant for
detailed investigations at Regional Research
Laboratory, (RRL), Jammu. Soon after reaching
back at RRL, Jammu, Dr. Pushpangadan
conducted the first
scientific
test
to
validate
the
Kani’s
claim on the antifatigue
property
of
Arogyapacha.
Benefit sharing with an indigenous
tribe (Contd..)
Filing of patents
Three
patents
on
the
different
pharmacological
activities
of
the
compounds isolated from this plant were
made by RRL, Jammu.
Benefit sharing with an indigenous
tribe (Contd..)
Drug “Jeevani” was ready
Within a period of seven years a scientifically
validated,
‘Jeevani’
standardized
was
herbal
formulated
with
formulation
‘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.
Benefit sharing with an indigenous
tribe (Contd..)
Drug “Jeevani” was released
After the necessary
pharmacological
evaluation
and
clinical study, the
drug was released for
commercial
production.
Benefit sharing with an indigenous
tribe (Contd..)
Bottlenecks in implementation of
the same
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.
Benefit sharing with an indigenous
tribe (Contd..)
Actual transfer of money
to Kani tribe
TBGRI transferred the money due to Kani
tribe (Indian Rupees 650 thousand) in Feb
1999. They are now regularly getting 50%
of royalty.
Impact on Removing Poverty from
this Initiative
DWELLING
Past
Present
Impact on Removing Poverty from
this Initiative
LIVING CONDITIONS
Past
Present
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
Contract on Access to Traditional
Knowledge could include:
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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
Safeguarding IPRs of indigenous/ local
communities and Benefit-sharing
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)
Development of marketable product/s (with S&T intervention)
Commercialization of the products
Benefit sharing with the indigenous/ local communities