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
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 : 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 Information technology Herbal technology

Bioprospecting

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 Synthesis & SARA studies Selection development candidate

Combinatorial chemical libraries

Compound bank screening

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 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

Selection of Effective combinations of extracts

Bioactive Molecules

Pharmacodynamics

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.

10000 plant species are used by tribes of India

Benefit sharing with an indigenous tribe (Contd..)

8000 Medicinal
Total 10000 species

Pesticides Gums, Resins & Dyes

THE INDIAN FLORA (ca 17500 species)

Benefit sharing with an indigenous tribe (Contd..)

INDIAN SYSTEMS OF MEDICINE

e used b ts ar yT lan r ib lP

al

unities (ora mm l) Co

900 sp.

Ayurveda Unani Siddha Amchi Modern

700 sp.
600 sp. 250 sp. 30 sp.

8000 species

Me d ici n

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

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 Kanis 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 ingredients. standardized was herbal with formulation Trichopus to toxicity, formulated

zeylanicus and three other medicinal plants as its

Evaluations related 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