Issues in Bioprospecting: Lessons from the Field

1. 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

2. 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

3. 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

4. COLLECTION, SOURCING, ACQUISITION (Through PIC, MAT, and MTA) EXTRACTION SCREENING LEAD BASED or MECHANISM BASED PRIMARY SCREENS RANDOM BIOMOLECULES – BIOLOGICAL ACTIVITY/GENES – TRAITS ISOLATION & CHARACTERIZATION SECONDARY SCREENS STRUCTURAL ELUCIDATION TRIALS & TESTS (CLINICAL, GENETIC STABILITY, BIOSAFETY) PRODUCT DEVELOPMENT IPR GENERATION / PROTECTION BENEFIT SHARING Bioprospecting : Essential elements RAW OR VALUE – ADDED MATERIALS/DERIVATIVES (GENETIC RESOURCES / TK) MARKETING

5. Biodiversity & IPR/TK Biotechnology Bioprospecting Information technology • Drug Development • Pharmaceuticals • Agro-chemistry • Cosmetics • Proteins • Enzymes • New crop varieties • GMOs • GM Foods, Designs. etc Herbal technology Benefit sharing Sustainableuse Conservation Bioinformatics IPR Bioprospecting: Major Areas

6. 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 Synthesis & SARA studies Compound bank screening Selection development candidate

7. Elements of Natural Product Discovery-Random Screening ACQUISITION Raw material: field collections, culture collections, screening libraries, etc EXTRACTION PRIMARY SCREENS ISOLATION & CHARACTERIZATION STRUCTURAL ELUCIDATION PRE-CLINICAL & CLINICAL DEVELOPMENT SECONDARY SCREENS

8. 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 Bioactive Extracts Selection of Effective combinations of extracts Bioactive Molecules 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

9. Bioprospecting Programmes - Examples • InBio – Merck Agreement: Beginning of a Bioprospecting Era • Shaman Pharmaceuticals • International Cooperative Biodiversity Groups (ICBG)

10. 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- )

11. 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)

12. 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.

13. 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

14. 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

15. Issues of Bioprospecting(Contd..) • Intellectual Property Rights(IPR) Protection • Traditional Resource Rights of Indigenous Communities • Bioethics and Biosafety • Transgenics • Transgenic foods • Transgenic medicines

16. 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.

17. 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.

18. Benefit sharing with an indigenous tribe (Contd..) 10000 plant species are used by tribes of India 8000 Medicinal Total 10000 species 325 3500 Edible 425 Pesticides 550 Fibre 1000 Others Gums, Resins & Dyes

19. 900 sp. Ayurveda 700 sp. INDIAN SYSTEMS OF MEDICINE Unani 600 sp. Siddha 250 sp. Amchi 30 sp. Modern 8000 species Benefit sharing with an indigenous tribe (Contd..) THE INDIAN FLORA (ca 17500 species)

20. 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.

21. 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.

22. 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.

23. 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 fruitssaying thatwhen consumed they would reduce fatigue and provide energy.

24. 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.

25. 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.

26. 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 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.

27. 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.

28. 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.

29. 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.

30. Impact on Removing Poverty from this Initiative DWELLING Present Past

31. Impact on Removing Poverty from this Initiative LIVING CONDITIONS Present Past

32. 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

33. 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

34. 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

35. Thank You