Access to Biological Resources and Benefit sharing in India

1. Access to Biological Resources and Benefit sharing in India P. Pushpangadan National Botanical Research Institute (Council of Scientific &Industrial Research), Rana Pratap Marg, Lucknow-226001 http://www.nbri-lko.org September 2004

2. Biodiversity • Biological diversity is the central tenet of nature, one of its key defining features. Evolution has produced an amazing variety of plants, animals and micro-organisms, intricately interconnected, and worthy of respect and conservation in their own right. Biodiversity is also the basis for the continuous evolution of species. This diversity is also the backbone of human societies and cultures.

3. Biodiversity • According to convention on Biological Diversity (CBD), biodiversity is “the variability among all living organism from all sources, including, interalia, terrestrial, marine and other aquatic ecosystems and ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems”.

4. Biodiversity The term ‘biodiversity’ is being taken in its holistic sense, to encompass all levels of biodiversity, ecological and evolutionary processes, including - Natural ecosystems: e.g. forests, grasslands, wetlands, deserts, mountains, coastal and marine areas, including the historical changes taking place in such ecosystems. Wild species and varieties: species of plants, animals and micro-organisms existing in their natural state and the genetic variation within each of these species.

5. Biodiversity Agricultural ecosystems: e.g. farmlands, pastures, capture fisheries, aquaculture, including historical changes in land-use patterns. Domesticated species and varieties: species of crops livestock (including poultry), captive-bred fish, pets and micro organisms in ex-situ collection and the genetic variation within each of these species. • In general we may say that Biodiversity exist at a various levels such as Species, genetic and habitat

6. Strength of India Biodiversity • Rich in all levels of biodiversity species, genes, habitat. • Rich in cultural diversity that generated rich fund of indigenous knowledge systems. • Humanity has tapped only a fraction of this nature’s vast genetic library. • Over 30-80% genetic resources of India and Asian countries are hitherto untapped. • Excellent opportunity for hunting novel genes, drugs, pharmaceuticals, new chemicals/raw materials for new industrial ventures.

7. Traditional Knowledge System (TKS) OR Indigenous Knowledge System (IKS) Community-based functional knowledge developed, preserved and maintained over many generations by the local and indigenous communities through their continuous interaction, observations and experimentation with their surrounding environment.

8. TKS/ IKS is • Unique to a given culture or society. • Result of co-evolution and co-existence of indigenous cultures and their traditional resource use.

9. UN Convention on the Biological Diversity (CBD) • Recognizes sovereign rights of nations over biological diversity. • Binds the parties to respect, preserve and maintain Traditional Knowledge (TK) • Stipulates just and equitable sharing of benefits arising from sustainable use of TK and traditional resources.

10. Access to Bioresources & associated knowledge • Access in this context refers to the ability of individual(s) or organizations(s) to acquire, exchange or use bio resources found in nature for multitude of purposes including commercial application.

11. The fundamental conflicts between CBD and WTO • CBD recognizes the sovereign rights of nations over their biological resources and associated knowledge systems. • Do not recognize any informal knowledge/ innovations of traditional communities for intellectual property rights. • Do not insulate Traditional Knowledge (TK) from intellectual piracy.

12. IPR & TK • IPR: The prime driving force behind industrial growth and development in the west in 19th & 20th centuries. • Do not recognize the informal system of innovation of indigenous people. • Do not provide mechanism for compensation or benefit sharing with indigenous people.

13. IPR & TK(Contd..) • IPR laws in general ignore the interest of traditional/local communities- • because their concept of intellectual property and resource rights are different from those of the advanced societies of developing countries and the developed North countries. • But there are ways in which these laws can serve the interests of these communities. • However, acquiring and defending IPR protection require access to information, good legal advice and financial resources-which are mostly beyond the reach of most of the indigenous people.

14. International Movements for Protection of TKS • First International Congress on Ethnobiology at Belem, 1987, came out with the ‘Declaration of Belem’. • The declaration recognized a basic obligation that procedures to be developed to compensate native people on their knowledge and on their biological resources. • Second International Congress on Ethnobiology at Kunming, China in 1990 resolved to establish a Global Action Plan, The “Kunming Action Plan” for • Specific and urgent action to stop the destruction of biological and cultural diversity as mandated in the ‘Declaration of Belem’. • Global Coalition for Biocultural Diversity to unite the indigenous people, scientists and environmentalists concerned with the protection of indigenous/ local people rights.

15. Relevant Provisions of CBD • Article 3 recognizes the sovereign rights of States over their biological resources. • Article 8(j) & 10(c) underlines the need to protect TK and points to the potential benefits to be realized from such knowledge through involvement of its holders and equitable benefit-sharing. • Article 15 states that when access to genetic resources is granted, it shall be on mutually agreed upon terms and subject to Prior Informed Consent. Incentives to biodiversity-rich countries to conserve and sustainably use their genetic resources, including joint research, access to & transfer of technology (Articles 15,16).

16. Relevant Provisions of CBD(Contd...) • Article 16.2 addresses issues surrounding the access to and transfer of technology, governed by patents. • Article 16.5 anticipates the difference in objectives between IPR regimes and the CBD and seeks to ensure that IPRs don't run counter to the CBD.

17. Relevant Provisions of TRIPs on Biological Resources • Under Article 27, virtually all inventions are to be patented if they are new, involve an innovative/inventive step and are capable of industrial application. • Exceptions to patentability include plants, animals ( other than microbes) and biological processes for the production of the above. However plant varieties must be protected either by sui generis or by patenting (27.3(b)).

18. TRIPS-CBD Relationship • Absence of explicit compatibility, Difference of approach and priority given to issues which are ultimately related. This has led to violation of the CBD (Articles 8,15 &16). • TRIPs ignores a vast range of valuable, traditional knowledge (TK) because it doesn't meet the standards of patentability.

19. TRIPS-CBD Relationship(Contd..) • TRIPs undermines CBD in cases of biopiracy, by putting the burden of proof on the source country rather than patentee. Identification of unique source material as required in Art.29 of TRIPs is insufficient. Lack of transparency in the patent application procedure. • TRIPs doesn't require the recognition of domestic laws protecting access to genetic resources and TK and subsequent benefit sharing.

20. IPR Issues / Benefit Sharing Strategies • Appropriate Procedures for IPR Protection/Benefit sharing • Documentation & Registration of TK – Medicinal plant use & Conservation at local , state and national level. • Contribution to TKDL & TKRC • Value addition to TK & Indigenous Medicinal Plants – Scaling up IPRs • Herbal drugs, Pharmaceuticals, Natural products & byproducts, Nutraceuticals, Functional foods, etc.

21. Bonn Guidelines of the CBD on Access and Benefit-sharing The sixth meeting of the conference of Parties to the CBD in April 2002 (COP 6) deliberated on the interpretation of Article 15, and arrived at Decision V!/24. This decision brought forth the “Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits arising out of their utilization”. One of the stated objectives of the Guidelines is to contribute to the development of mechanisms and access and benefit sharing regimes that recognize the protection of indigenous knowledge, innovations and practices of indigenous and local communities.

22. Main Provisions of Bonn Guidelines • The facilitation of prior informed consent of both the national government of the country of origin of the resource for transmittal as well as indigenous and local communities. • The development of mutually agreed terms to facilitate legal certainty and the minimization of cost. • The specification of non-monetary benefits the collector will provide, and whether, and under what conditions, the collector may transfer the collected genetic resources to another party.

23. Benefit Sharing Experiment with an Indigenous community (Tribe) in India Kani Model/Pushpangadan Model of Benefit Sharing (1995)

24. 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.

25. 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.

26. INDIAN TRIBALS • Primitive Hunter gather type • Primitive Agriculturists • Plain Agriculturists • Simple Artisans • Pastoral and Cattle Breeders • Industrial –Urban type

27. PLANTS USED BY TRIBALS

28. 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

29. PLANTS USED IN INDIAN SYSTEM OF MEDICINES

30. 900 sp. Ayurveda 700 sp. INDIAN SYSTEMS OF MEDICINE Unani 600 sp. Siddha 250 sp. Amchi 30 sp. Modern 8000 species THE INDIAN FLORA (ca 17500 species)

31. 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.

32. 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.

33. 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.

34. 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.

35. Scientific Investigations Collected adequate samples of this plant for detailed investigations at Regional Research Laboratory, (RRL), Jammu. Soon after reaching back at RRL, Jammu, Pushpangadan conducted the first scientific test to validate the Kani’s claim on the anti-fatigue property of Arogyapacha.

36. Scientific Investigations Conducted the standard ‘swimming performance’ on Swiss mice under three different conditions. The mice were given swimming test in tubs of water under: (1) Control mice fed with normal diet. (2) mice fed with synthetic steroidal drug – (Amphetamine) and (3) mice fed/ingested with macerated Kernels of the fruits of Arogyapacha.

37. Scientific Investigations After 3 hrs., the controlled ones exhausted and sank in water, and the mice fed with Amphitamine were found exhausted and sank after 6 hrs. Whereas the mice ingested with Arogypacha Kernels swam for about a period of 18 hrs. The swimming test were repeated and the results were found exciting. It prompted Pushpangadan and his colleagues at RRL, Jammu to pursue intensive phytochemical & pharmacological investigations in Arogyapacha.

38. Filing of patents Three patents on the different pharmacological activities of the compounds isolated from this plant were made by RRL, Jammu.

39. Reassurance of credit to the informants The ‘Kani’ people were kept informed of the progress of this interesting results and re-assured that if any marketable products were developed out of this plant, benefits derived from the products would be shared equally with them.

40. Dr. P. Pushpangadan assumed the charge of Director of TBGRI The investigators very soon realized that the classical pharmacological approach to study the traditional remedies of medicinal plants by isolating single compounds may not be satisfactory and an ethno-pharmacological approach was adopted to evaluate this plant. By this time Dr.Pushpangadan got the offer of the Directorship of Tropical Botanic Garden & Research Institute (TBGRI), Trivandrum and he accepted the same and joined there in November 1999.

41. Strengthened the scientific investigations At TBGRI, Dr. Pushpangadan soon established a full-fledged Ethno-pharmacology Division and recruited scientists from disciplines of Botany, Pharmacology, Phytochemistry, Biochemistry, Pharmacy and Ayurveda.

42. Drug “Jeevani” was ready Within a period of two 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.

43. Drug “Jeevani” was released After the necessary pharmacological evaluation and clinical study, the drug was released for commercial production.

44. Technology was transferred to Arya Vaidya Pharmacy While transferring the technology to The Arya Vaidya Pharmacy (AVP), Coimbatore a Private Company, TBGRI resolved to share the benefits (license fee & royalty, etc.) derived from the transfer of technology on a 1:1 basis with the Kani tribe.

45. 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.

46. 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.

47. 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

48. Thank You