66issues in bioprospecting

7/31/2019 66issues in Bioprospecting

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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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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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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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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


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.


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.


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


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


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.


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.


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


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 indigenous


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After the necessary

pharmacological

evaluation andclinical study, the

drug was released for

commercialproduction.

Drug Jeevani was released




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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




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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



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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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66issues in bioprospecting

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