Biodiversity, Genetic Resources and related knowledge in India

1. Biodiversity, Genetic Resources and related knowledge in India

2. 21st Century • Biodiversity was considered to be a common property till 20th century. • It was in the Earth Summit in 1992 at Rio that the first the world forum agreed on the sovereign rights of states over their Biodiversity. • This was enshrined in the Convention on Biological Diversity was signed in June 1992.

3. 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.

4. 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.

5. 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.

6. 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.

7. WTO & TRIPs • WIPO was established in Geneva in 1970 • Patent Corporation Treaty (PCT), 1970 • WIPO became a UN agency in 1974 • General Agreement of Trade and Tariffs(GATT) Ministerial meetings (1986-1994), Uruguay Round Conference (URC), 1994 • Final Round of URC and Declaration of the final Act to form WTO on 15th April 1994 • World Trade Organization (WTO) came into being in 1995 • WTO administered Trade Related aspects of Intellectual Property Rights (TRIPS)

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

9. 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.

10. 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)).

11. CBD Provisions for Access & Benefit Sharing (Article 15) Article 15.1: Authority to determine access Party has the authority to determine access to genetic resources, subject to national legislation. Article 15.2: Access for environment-friendly uses Each Party shall endeavor to facilitate access to genetic resources for environmentally sound uses by other contracting Parties and not imposes restrictions that run counter to the objectives of the Convention. Article 15.4: Mutually Agreed Terms Access to genetic resources shall be on mutually agreed terms.

12. CBD Provisions for Access & Benefit Sharing Article 15 Contd. Article 15.5: Prior Informed Consent Access shall be subject to Prior Informed Consent of the Contracting Party providing such resources, unless otherwise determined by that Party. Article 15.6: Scientific research and development Party receiving genetic resources from another Party shall endeavor to develop and carry out scientific research based in genetic resources provided by other Contracting Parties with full participation of, and where possible in, such Contracting Parties.

13. CBD Provisions for Access & Benefit Sharing Article 15.7: Equitable Benefit Sharing Parties to take legislative, administrative or policy measures, as appropriate, with the aim of sharing in a fair and equitable way the results of research and developments and the benefits arising from the commercial or other utilization of genetic resources with the Contracting Party providing such resources, and such sharing shall be upon mutually agreed terms.

14. 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.

15. 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.

16. 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.

17. 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.

18. FAO- International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR- (2001) and ABS process The Treaty, which has come into force since 2001, aims at conservation and sustainable use of plant genetic resources for food and agriculture (PGRFA) and the fair and equitable sharing of the benefits arising out of their use for sustainable agriculture and food security. The Treaty provides for an efficient, effective and transparent multilateral system to facilitate both access to and fair and equitable sharing of benefits arising from the utilization of PGRFA on a complementary and mutually reinforcing basis (Article 10.2).

19. FAO- International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR- (2001) and ABS process (Contd.) In accordance with Article 10.1 of the Treaty, 64 plant genetic resource groups (35 food crops + 29 forage crops) for the food and agriculture have been currently brought under the Multilateral Systems of Access and Benefit Sharing (Annex I of the ITPGR). The treaty also obliges its Parties to take necessary legal or other appropriate measures to provide access to other Contracting Parties through the Multilateral Systems, and insists that the facilitated access shall be provided pursuant to a standard Multilateral Transfer Agreement (MTA), containing all access & benefit sharing provisions under 12.3 a, d and g and 13.2 d (ii) of the Treaty. The Treaty also restricts the recipient Party to claim any intellectual property or other rights on the genetic resources or their genetic parts or components in the form received from the Multilateral System (Article 12.3 d).

20. World Summit on Sustainable Development 2002 • WSSD Plan of Implementation Article 44(o) calls upon States to: “Negotiate an international regime on benefit sharing relating to genetic resources within the framework of the CBD taking into consideration the Bonn Guidelines”

21. Access and Benefit Sharing: Common Approaches CBD and ITPGR, and the Bonn Guidelines provide a broad framework for ABS procedures. The main features of ABS mechanisms include: (i) Prior Informed Consent (ii) Mutually Agreed Terms (iii) Material Transfer Agreements, and (iv) Benefit–sharing agreements through monetary and non-monetary means.

22. ABS Policies and Programmes: The Indian Initiatives The Biological Diversity Act 2002 (No.18 of 2003) The core of the ABS provisions and their effective implementation in the territorial jurisdiction of India is dealt with in the Biological Diversity Act 2002(enacted on December 11, 2002 and received the assent from President of India on February 5, 2003) and in the Biological Diversity Rules 2003 (in force since April 15,2003). The Act provides for regulated access to biological and genetic resources by bona-fide end-users for different purposes, including scientific research, commercial uses, bio-survey, bio-utilization, conservation and other sustainable uses, etc. The over all implementation of the Act will be coordinated by three functional bodies viz. The National Biodiversity Authority (NBA), the State Biodiversity Boards (SBB), and the Biodiversity Management Committee (BMC). NBA is the national competent authority to discharge all decisions pertaining to ABS.

23. ABS Policies and Programmes: The Indian Initiatives (Contd..) The Protection of Plant Varieties and Farmers’ Rights (PPVFR) Act, 2001 (Act 53 or 2001) The PPVFR Act 2001 and the Rules framed under this Act, called the PPVFR Rules 2003, deal primarily with the protection of plant breeder’s rights over the new varieties developed by them and the entitlement of farmers to register new varieties and also to save, breed, use, exchange, share or sell the plant varieties, which the latter have developed, improved, and maintained over many generations. The Act is a deviation from the 1991 UPOV Model and can be regarded as an alternate ‘sui generis’ system that accord protection of the rights of the formal innovations of a plant breeder and the informal knowledge system and traditional plant varieties of the farmers as well (Sahai, 2003). The important provisions contained in this Act relevant to ABS are those on the protection of farmers rights and the mechanisms suggested for compensation or benefit-sharing (Brahmi et al. 2004)

24. ABS Policies and Programmes: The Indian Initiatives (Contd..) Indian Experiment in Benefit Sharing: “TBGRI Model” or “Kani Model” or “Pushpangadan Model” India has the distinction of being the first country in the world in experimenting a benefit-sharing model that implemented the Article 8(j) of CBD, in letter and spirit. It was the Tropical Botanic Garden and Research Institute (TBGRI) in Kerala (where Dr. P. Pushpangadan was director) that demonstrated indigenous knowledge system merits support, recognition and fair and adequate compensation. The model, which later on came to be known as “TBGRI Model” or “Kani Model” or “Pushpangadan Model”, relates to the sharing of benefits with a tribal community in Kerala, the Kanis, from whom a vital lead for developing a scientifically validated herbal drug (Jeevani) was obtained by scientists of TBGRI.

25. ABS & Like-Minded Megadiverse Countries(LMMC) • Cancun Declaration (February 2002) • Cusco Declaration on Access to Genetic Resources, TK and IPR(November 2002) • Kuala Lumpur Communiqué on Institutional Building (July 2003)

26. ABS REGIME: LMMC STRATEGIES • Development of Uniform Model of MTA to ensure: • Sovereign Rights • Statutory Rights • Legal Rights • Customary Rights, if any, of participants/stakeholders • Enactment of National ABS Laws: • 40 CBD Parties enacted/in the process of enactment

27. ABS REGIME: LMMC STRATEGIES • Claims of Country of Origin vis a vis Country Providing Genetic Resources : • Parties to Claim All Legal Rights on All Benefits from the use of Genetic Resources & TK by Third Parties • MTAs and MATs should include such legitimate claims and rights

28. ABS REGIME: LMMC STRATEGIES • Claims of Country of Origin vis a vis Country Providing Genetic Resources : Constraints • Proof of Country of Origin/Centre of Origin of exotic species in ex-situ depositories • Determination of Ownership and authority of PIC on Pre-CBD ex-situ collections • Lack of accurate Accession data on records of ex-situ introduction of exotic and native species • Absence of evidence on Genetic Origin/Wild Ancestries of domesticated or cultivated species

29. ABS STRATEGY: CONCERTED ACTIONS REQUIRED BY LMMC • Enactment and Harmonization of National Legislations on ABS by all LMMC members. • Capacity building at country level in terms of: - • Easily understood definitions • Completion of Steps of PIC, MTA and MAT • Building resources inventories under different property regimes

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