Presentation on theme: "Issues in Bioprospecting: Lessons from the Field"— Presentation transcript:
1 Issues in Bioprospecting: Lessons from the Field P. PushpangadanNational Botanical Research InstituteRana Pratap Marg, LucknowIUCN 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. 1993The 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 Bioprospecting: Major Areas Chemical prospectingDrug and pharmaceuticalsPesticidesCosmeticsFood additivesOther industrially valuablechemical productsGene prospectingGenetic EngineeringCrop developmentFermentationCell cultureBionic prospectingDesignsSensor technologiesArchitectureBioengineeringBio-modeling
4 Bioprospecting : Essential elements RAW OR VALUE – ADDED MATERIALS/DERIVATIVES(GENETIC RESOURCES / TK)LEAD BASED or MECHANISM BASEDCOLLECTION, SOURCING, ACQUISITION(Through PIC, MAT, and MTA)EXTRACTION SCREENINGRANDOMPRIMARY SCREENSBIOMOLECULES – BIOLOGICAL ACTIVITY/GENES – TRAITSISOLATION & CHARACTERIZATIONSTRUCTURAL ELUCIDATIONTRIALS & TESTS(CLINICAL, GENETIC STABILITY, BIOSAFETY)IPR GENERATION / PROTECTIONBENEFIT SHARINGSECONDARY SCREENSPRODUCT DEVELOPMENTMARKETING
5 Bioprospecting: Major Areas Biodiversity &IPR/TKSustainableuseBenefitsharingBioinformaticsIPRBiotechnologyInformationtechnologyHerbalBioprospectingConservationDrug DevelopmentPharmaceuticalsAgro-chemistryCosmeticsProteinsEnzymesNew crop varietiesGMOsGM Foods, Designs. etc
6 Elements of Natural Product Mechanism-based Screening Selection of molecular targetPurification of reagentsDevelopment of assayDrug designIDENTIFICATION OF LEADNatural product screeningSynthesis & SARA studiesSelection development candidateCompound bank screeningCombinatorial chemical libraries
7 Elements of Natural Product Discovery-Random Screening ACQUISITIONRaw material: field collections, culture collections, screening libraries, etcEXTRACTIONPRIMARY SCREENSISOLATION & CHARACTERIZATIONSTRUCTURAL ELUCIDATIONPRE-CLINICAL & CLINICAL DEVELOPMENTSECONDARY SCREENS
8 TOXICOLOGICAL AND EFFICACY EVALUATION Prospecting for drugs and pharmaceuticals from traditional knowledge (Ethnopharmacological Approach)Bioactive MoleculesProduct Development & Pharmaceutics: Dosage FormsTOXICOLOGICAL AND EFFICACY EVALUATIONActivity Guided IsolationSelection of Effective combinations of extractsPharmacodynamicsBioactive ExtractsPharmacokineticsMulti-centric, Randomized,Clinical TrialsFinal ProductMarketing & Benefit Sharing with the Traditional CommunitiesInteraction with Traditional communities and obtaining Ethno medical information with Prior Informed ConsentSelection of Potential Herbal(s)/Formulation(s)Literature SurveyDevelopment of ScientificallyValidated herbal drugs/formulationsClinical Dosage formsSafety Efficacy EvaluationThe Product DevelopmentShelf Life Studies
9 Bioprospecting Programmes - Examples InBio – Merck Agreement: Beginning of a Bioprospecting EraShaman PharmaceuticalsInternational Cooperative Biodiversity Groups (ICBG)
10 Bioprospecting Programmes : Examples from India CSIR Coordinated Programme on Drug Discovery ( )New Millennium Indian Technology Leadership Initiative (NMITLI) – Planning Commission/CSIR( )Dept. of Biotechnology – Bioprospecting and Molecular Taxonomy Programme( )
11 Issues of Bioprospecting Access and Benefit Sharing (ABS)Access Norms and PoliciesOwnership and Sovereign Rights on Biodiversity – Who owns the resources?Prior Informed Consent (PIC) – Principles and PracticesMutually Agreed Terms (MAT)Material Transfer Agreements (MTA)
12 Issues of Bioprospecting(Contd..) Access and Benefit Sharing (ABS)Benefit SharingMonetary BenefitsAccess 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 SharingNon-monetary BenefitsSharing R&D resultsCollaboration in S&T and development programmes (Biotechnology)Participation in Product DevelopmentCollaboration in Education and TrainingAdmittance to ex situ facilities and databanksInstitutional Capacity BuildingHuman Resource DevelopmentInformation ExchangeContribution to Local EconomyContribution to other domestic benefitsFood and Livelihood security benefitsSocial RecognitionJoint IPRs
14 Issues of Bioprospecting(Contd..) Conservation of biodiversity.Sustainability of Genetic Resource StocksUncertainties and opportunistic behaviorsSuccess rate of bioprospecting programmesMarket TrendsNational and International Legal and Policy EnvironmentCapacity Building in Biodiversity inventorying, and bioprospecting technologiesBiotechnologyHerbal TechnologyInformation Technology
15 Issues of Bioprospecting(Contd..) Intellectual Property Rights(IPR) ProtectionTraditional Resource Rights of Indigenous CommunitiesBioethics and BiosafetyTransgenicsTransgenic foodsTransgenic medicines
16 Tribal Settings in India Benefit sharing with an indigenous community (tribe) – A Case StudyTribal Settings in IndiaIndia 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 Tribal Settings in India Benefit sharing with an indigenous tribe (Contd..)Tribal Settings in IndiaPopulation 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 10000 plant species are used by tribes of India Benefit sharing with an indigenous tribe (Contd..)10000 plant species are used by tribes of India8000MedicinalTotal species3253500 Edible425Pesticides1000 Others550 FibreGums, Resins & Dyes
19 INDIAN SYSTEMS OF MEDICINE Benefit sharing with an indigenous tribe (Contd..)INDIAN SYSTEMS OF MEDICINE8000 speciesAyurveda900 sp.Unani700 sp.THE INDIAN FLORA (ca species)Siddha600 sp.Modern30 sp.Amchi250 sp.
20 Benefit sharing with an indigenous tribe (Contd..) The Kani experimentDuring 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 Interaction with Kani Tribe Benefit sharing with an indigenous tribe (Contd..)Interaction with Kani TribeIn 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 Interaction with Kani Tribe Benefit sharing with an indigenous tribe (Contd..)Interaction with Kani TribeAfter 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 whenconsumed they would reduce fatigue and provide energy.
24 Scientific Investigations Benefit sharing with an indigenous tribe (Contd..)Scientific InvestigationsCollected adequate samples of this plant for detailed investigations at Regional Research Laboratory, (RRL), Jammu. Soon after reaching back at RRL, Jammu, Dr. Pushpangadanconducted 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 patentsThree patents on the different pharmacological activities of the compounds isolated from this plant were made by RRL, Jammu.
26 Drug “Jeevani” was ready Benefit sharing with an indigenous tribe (Contd..)Drug “Jeevani” was readyWithin 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.
27 Drug “Jeevani” was released Benefit sharing with an indigenous tribe (Contd..)Drug “Jeevani” was releasedAfter the necessary pharmacological evaluation and clinical study, the drug was released for commercial production.
28 Bottlenecks in implementation of the same Benefit sharing with an indigenous tribe (Contd..)Bottlenecks in implementation of the sameHowever, 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 Actual transfer of money Benefit sharing with an indigenous tribe (Contd..)Actual transfer of moneyto Kani tribeTBGRI transferred the money due to Kani tribe (Indian Rupees 650 thousand) in Feb They are now regularly getting 50% of royalty.
30 Impact on Removing Poverty from this Initiative DWELLINGPastPresent
31 Impact on Removing Poverty from this Initiative LIVING CONDITIONSPastPresent
32 Bioprospecting Contracts Any Bioprospecting contract should include:Entry of access feeCollection fee for samples collectedProcessing fee for processing done, if anyRoyalty 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 legislationAn 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 registersPreparation of Electronic Database(Access to Patent Office)Access to Database with prior informed consentNegotiation and signing of agreement(s)Development of marketable product/s (with S&T intervention)Commercialization of the productsBenefit sharing with the indigenous/ local communities