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

• 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

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

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

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

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

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

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

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 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)

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

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

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..)

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..)

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..)

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..)

‘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..)

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..)

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..)

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..)

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..)

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..)

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..)

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..)

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..)

Past Present

DWELLING

Impact on Removing Poverty from this Initiative

LIVING CONDITIONS

Impact on Removing Poverty from this Initiative

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

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