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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 Gene prospecting


• Drug and pharmaceuticals
• Pesticides • Genetic
• Cosmetics Engineering
• Food additives • Crop development
• Other industrially valuable • Fermentation
chemical products • Cell culture

Bionic prospecting
• Designs
• Sensor
technologies
• Architecture
• Bioengineering
• Bio-modeling
Bioprospecting : Essential elements
RAW OR VALUE – ADDED MATERIALS/DERIVATIVES
(GENETIC RESOURCES / TK)

COLLECTION, SOURCING, ACQUISITION


(Through PIC, MAT, and MTA)

EXTRACTION SCREENING
LEAD BASED or
RANDOM PRIMARY SCREENS 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
• Drug Development
Herbal
technology • Pharmaceuticals
• Agro-chemistry
• Cosmetics
• Proteins
• Enzymes
Sustainable Benefit • New crop varieties
Conservation sharing Bioinformatics
use • 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 Synthesis & SARA
chemical libraries studies

Compound bank Selection development


screening
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
Selection of Effective Bioactive Molecules
combinations of extracts
Clinical Dosage forms
Pharmacodynamics
Safety Efficacy Evaluation
Product Development & Pharmaceutics: Dosage Forms
The Product Development
Pharmacokinetics
Shelf Life Studies
Multi-centric, Randomized,
Clinical Trials Clinical Trials
Final Product 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

• 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?
• 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
• 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.
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
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
Issues of Bioprospecting(Contd..)

• Intellectual Property Rights(IPR)


Protection
• Traditional Resource Rights of
Indigenous Communities
• Bioethics and Biosafety
• Transgenics
• Transgenic foods
• 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
Benefit sharing with an indigenous
THE INDIAN FLORA (ca 17500 species) tribe (Contd..)

INDIAN SYSTEMS OF MEDICINE


mmunities (oral
Co )
al

ib
Tr
are used by
900 sp. Ayurveda

700 sp. Unani

600 sp.
s

Siddha
t
an

250 sp. Amchi


Pl
l a

in 30 sp.
i c Modern
d
Me
8000 species
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 (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..)

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 anti-
fatigue 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, 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.
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:
• 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