12 Access and Benefit Sharing And Traditional Knowledge

Ms Alphonsa Jojan Joseph

epgp books

 

 

 

Introduction

 

The concept of ‘access and benefit sharing’ (ABS) was adopted in international law in one of the Rio conventions, that is, the Convention on Biological Diversity 1992 (CBD). The Convention came into force on 29th December 1993. As of today, 194 countries are parties to the Convention. The international legal framework on ‘access and benefit sharing’ is elaborated in the legally binding instrument adopted under the CBD, that is, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization 2010 (Nagoya Protocol).

 

India, being a party to the CBD, has enacted the Biological Diversity Act, 2002 which gives effect to the Convention and provides for conservation, sustainable utilization and equitable sharing of the benefits arising out to the utilization of biological resources.

 

Learning Outcomes

 

This unit intends to provide a basic understanding of the legal framework on access to biological resources and the obligation to share the benefits arising out of the utilization of the biological resources. It primarily deals with the concepts and principles relating to access and benefit sharing (ABS); the relevant provisions of the international instruments like the CBD and the Nagoya Protocol; the relevant provisions of the national law, that is, the Biological Diversity Act, 2002 enacted by India in compliance with the C BD and Rules and Regulations thereunder.

 

Important Concepts and Principles relating to Access and Benefit Sharing

 

3.1 State’s sovereignty over natural resources

 

The CBD, and the concept of ABS, recognize the internationally accepted principle of sovereignty of States over their natural resources. Article 15(1) of the CBD lays down that the authority to determine access to genetic resources is with the national government and is subject to the national legislation (Article 15(1)), and that Parties shall make appropriate legal, administrative or policy measures for benefit sharing (Article 15(6)).

 

3.2 Biological resources and genetic resources

 

The CBD provides for facilitated access and imposes benefit-sharing obligations with respect to genetic resources (when access is granted) but recognizes the right of the Contracting Parties to decide on their national regulatory and policy framework on access and benefit sharing. While CBD focuses on genetic resources, the ABS regulation in India is focused on biological resources. ‘Biological resource’1 is a broad category, which includes ‘genetic resource’2.

 

3.3 ‘In-situ and ex-situ conditions’

 

Biological resources and genetic resources can be sourced from both in-situ conditions and ex-situ conditions. In-situ conditions are defined in the CBD as conditions where genetic resources exist within ecosystems and natural habitats, and in case of domesticated or cultivated species, in the surrounding where they have developed their distinct properties (Article 2). Ex-situ conditions are human made, for example gene banks, botanical gardens, seed banks, and microbial culture collections.3The Indian ABS regulation makes no distinction between resources sourced from in-situ conditions or ex-situconditions as long as the country providing the resource is the country of origin of that resource or has acquired acquired the genetic resources in accordance with the Convention. Further, it does not make any distinction between wild and cultivated resources as their definitions of biological resources and genetic resource.

 

3.4 Access and Benefit Sharing (ABS)

 

Biological resourcesare utilized for a wide range of activities including basic research like taxonomy to the development of commercially important products like drugs, cosmetics, botanicals, improved varieties of crops, animals, etc. in different sectors like pharmaceuticals, cosmetics, agriculture, horticulture, biotechnology etc.4Users include researchers, universities, botanical gardens, gene banks, companies, etc.5 While the users benefit from the use of biological resources, there was no legal framework which aimed at channeling a share of the benefits to the providers before the CBD. In addition, in some cases, the traditional knowledge systems of the Indigenous Peoples and Local Communities (IPLCs) about the biological resources form the basis for further research and development of the resources.

 

The concept of ABS is premised on the notion that the manner in which biological resources are accessed, and ways in which the benefits of their use are shared, can create incentives for their conservation and sustainable use, and can contribute to the creation of a fairer and more equitable economy to support sustainable development.6 Therefore, the ABS regime seeks to provide a procedure for accessing the biological resources or genetic resources (as provided in the national legislation) and the knowledge associated with it, and an obligation for sharing of the benefits arising out of utilization of the resources.

 

The main principles of access and benefit sharing are:

 

(a) Prior Informed Consent (PIC) of the country providing the resources and the IPLCs, whenever they have an established right over the resources and associated knowledge) unless otherwise mentioned (Article 15(5), CBD and Article 6, 7, 12, 13, Nagoya Protocol);and

 

(b) Mutually Agreed Terms (MAT) between the user and the provider and in accordance with the relevant provisions (Article 15(4), CBD and Article 5, Nagoya Protocol).

 

3.5 Prior Informed Consent (PIC)

 

Prior Informed Consent is the approval/permission given by the Indigenous Peoples and Local Communities (IPLC), whenever they have established rights over the resources, in accordance with the national laws/regulations. The consent is given prior to access and after the authority is informed about the relevant factors that will enable the authority to decide whether approval needs to be given, and if yes, the conditions of access and benefit sharing.

 

The Bonn Guidelines on Access to Genetic Resource and Fair and Equitable Sharing of the Benefits Arising out of their Utilization elaborated the basic principles of Prior Informed Consent.These include legal certainty and clarity; facilitated access at minimum cost; consent of relevant competent authorities and relevant indigenous and local communities in accordance with domestic law (Article 26). It also elaborates on elements of PIC which includes access through competent authorities; specification of use; procedure which includes provision of all relevant information that enable the competent authorities to make decisions; a transparent process and written permits (Articles 27-40).

 

3.6 Mutually Agreed Terms (MAT)

 

Mutually Agreed Terms are terms and conditions that the user and the provider of the biological resources arrive at after negotiations. The Bonn Guidelines lay down the basic requirements of MAT which involves legal certainty and clarity about ABS process and procedure; minimization of transaction costs by (a) promoting awareness of Governments’ and other relevant stakeholders about mechanisms and contractual arrangements of ABS, (b) providing for users’ and providers’ obligation, (c) developing framework/model agreements for related use, etc. (Article 42-43). Another important component of MAT is the coverage of ‘the conditions, obligations, procedures, types, timing, distribution and mechanisms of benefits to be share’(Article 45-50, Bonn Guidelines)

 

4. International Framework on Access and Benefit Sharing and the Principles and Rules

 

The international legal framework on ABS is primarily governed by legally binding instruments like the Convention on Biodiversityand the Nagoya Protocol. The Bonn Guidelines, adopted by 180 countries under the CBD, are voluntary in nature, but they also played an important role by assisting Parties,Governments and other stakeholders in developing strategies for access and benefit-sharing,and in identifying the steps involved in the process of obtaining access to genetic resources and benefit-sharing.7 However, after the entry into force of the Nagoya Protocol, the references to the Bonn Guidelines are for information purposes only.

 

4.1 Convention on Biological Diversity

 

Article 1 of the Convention on Biological Diversity, 1992 (CBD) lays down ‘fair and equitable sharing of the benefits arising out of the utilization of genetic resources’ as one of its objectives and stipulates that this objective has to be pursued in accordance with the relevant provisions of the Convention.

 

The principal provision governing ABS is Article15 of the CBD. Article 15(1) recognises the sovereign right of the States over their natural resources and provides that authority to determine access to genetic resources is with the national government and subject to the national legislation. Article 15(2) requires the Contracting Parties to endeavor to facilitate access for environmental friendly uses and not to impose restrictions that counter the objectives of the Convention. With respect to access to genetic resources, Article 15(5) subjects access to the Prior Informed Consent (PIC) of Contracting Party providing such resources, unless otherwise determined by the Party and Article 15(4) calls for Mutually Agreed Terms (MAT) for accessing the resources. Article 15(6) envisages that the benefits arising out of utilisation of the accessed genetic resources be shared, fairly and equitably, with the Contracting Party providing such genetic resources. In order to enable benefit sharing, the Contracting Parties shall provide for the appropriate legal, administrative or policy measure for such benefit sharing. It also requires that such sharing should be based on mutual agreed terms (Article 15(7)). The CBD defines thecountry providing the genetic resources will be the (a) country which is the country of origin of the genetic resources or (b) the country which has acquired the genetic resources in accordance with the CBD (Article 2).

 

4.2 Nagoya Protocol On Access To Genetic Resources And Fair And Equitable Sharing Of Benefits Arising From Their Utilization

 

The Nagoya Protocol on Access and Benefit Sharing, which was adopted at Nagoya, Japan on 29 October 2010, complements and elaborates the obligations under Article 15 of the CBD. Provisions relating to access to genetic resources and traditional knowledge (TK) are provided respectively in Articles 6, 7, 12, 13 and 14 of the Nagoya Protocol.

 

While Article 6 of the Protocol reiterates most of the obligations of the Contracting Parties in Article 15 of the Convention on Biodiversity, it describes in detail the various requirements for ABS, such as:

 

(a)Clear, certain and transparent domestic access and benefit-sharing legislation or regulatory requirements;

 

(b)Fair and non-arbitrary rules and procedures on accessing genetic resources;

 

(c)Information on procedure for applying for prior informed consent;

 

(d)Clear and transparent written decision by a competent national authority, in a cost-effective manner and within a reasonable period of time;

 

(e)Clear rules and procedure for Mutually Agreed Terms including dispute settlement clauses, terms of benefit sharing including IPR, terms on third party use, terms of change of intent.

 

Parties are under a legal obligation to consider the indigenous and local communities’ customary laws, community protocols and procedure in accordance with the domestic law with respect to traditional knowledge associated with the genetic resources (Article 12(a)). The role of indigenous and local communities in the ABS process at various stages is emphasised through various provisions including Articles 6(2), 7, and 12, etc.

 

4.3 Other relevant international instruments

 

4.3.1 International Treaty on Plant Genetic Resources for Food and Agriculture

 

The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA)deals with conservation and sustainable use of plant genetic resources of food and agriculture (Article 1). It has its own provisions for benefit sharing as it establishes a global multilateral system for benefit sharing.8 The food crops and forages listed in Annex 1 of the Treaty (known as Annex 1 crops) are covered under the Multilateral System under ITPGRFA. The Contracting Parties have to take appropriate measure for facilitated access if the access is for the purpose of utilisation and conservation for research, breeding and training for food and agriculture but such purpose does not include chemical, pharmaceutical and/or other non-food/feed industrial uses (Article 12). Benefit sharing provisions (monetary and non-monetary) are provided in Article 13 of ITPGFRA.

 

4.3.2 Trade Related Intellectual Property Rights

 

There exist proposals to create a positive link between the WTO’s Agreement on Trade Related Intellectual Property Rights (the TRIPS) and the Convention on Biodiversity (the CBD)inorder to ensure benefit sharing and to raise the standard of intellectual property protection and to prevent granting of intellectual property rights to those who have not substantially improvedupon existing prior art to claim that they have invented somethi ng new.Several developing countries (including India) have advocated the introduction of an obligation to disclose the origin of biological materials (and th e associated knowledge) claimed in patent applications.9

 

5. National Framework on Access and Benefit Sharing

 

The Biological Diversity Act, 20 02 (BDA)governs access and benefit sharing regulation in India. The Act deals with conservation, sustainable use and access and benefits sharing of the biological resources and associated knowledge.

 

As discussed in the unit on Bio diversity, the Central Government and State Govvernments have a pivotal role to play in the conservation and sustainable use of biodiversity. The National Biodiversity Authority, State Biodiversity Boards and Biodiversity Management Committeesare the co mpetent authorities that have different roles to play with regard to access to biological resources occurrin g in India/obtained from India, sustainable use or sustain able collection of the resources intended to be accessed, and sharing of benefits wherever applicable. TheBDA is in addition to the forest or wildlife laws that are in force in India (section 59).

 

The National Biodiversity Authority has notified the Guidelines on Access to B iological Resources and Associated Knowledge and Benefits Sharing Regulations in 2014 (ABS Guideli nes), which lay down the procedure for accessing biologic al resources and associated knowledge; the mod e of benefit sharing, the utilization of the benefit-sharing amount etc.

 

The Act has also constituted the National Biodiversity Fund, a State Biodiversity Fund and Local Biodiversity Funds under section 27, 32 and 43 respectively.

 

5.1  Important terms/ activities/actors in the national framework on access an d benefit sharing

 

5.1.1 Biological resources (section 2(c))

 

The Act governs, inter alia, acce ss to ‘biological resources’,which is defined in section 2(c) of the BDA. The definition of biological reso urces is wide in nature. The scope of the definition has been challenged before the National Green Tribunal (NGT) in several cases. In one such case, a B iodiversity Management 9 Correa, Carlos M. “Establishin g a Disclosure of Origin Obligation in the TR IPS Agreement.” Quaker UnitedNations Office, Occasional Paper 12, August 2003.

 

Committee argued that coal is a biological resource and extraction of coal, therefore, is governed by the BDA.10 The Ministry of Coal and the National Biodiversity Authority has conveyed to the NGT that coal is a mineral and not a biological resource.11

 

5.1.2 Value added products (section 2(p))

 

The Act excludes value-added products from the purview of biological resources.‘Value-added products’ are defined as products, which may contain portions or extracts of plants and animals in unrecognisable and physically inseparable form.

 

5.1.3 Research, Bio-survey and Bio-utilisation and Commercial utilisation (sections 2(m), (d) and (f) respectively)

 

The Act regulates access for specific purposes for specific persons. The activities covered are:

 

(a) “Research” which is defined as the study or systematic investigation of any biological resources or technological application, that uses biological systems, living organisms or derivatives thereof to make or modify product or processes for any use (section 2(m));

 

(b) “Bio-survey and Bio-utilization” means survey or collection of species, subspecies, genes, components and extracts of biological resources for any purpose and includes characterization, inventorisation and bioassay (section 2(d));

 

(c) “Commercial Utilization” means end uses of biological resources for commercial utilization such as drugs, industrial enzymes, food flavors, fragrance, cosmetics, emulsifiers, oleoresins, colors, extracts and genes used for improving crops and livestock through genetic intervention, but does not include conventional breeding or traditional practices in use in any agriculture, horticulture, poultry, dairy farming, animal husbandry or bee keeping (section 2(f)).

 

5.1.4 Benefit Claimers (section 2(a))

 

The BDA mandates the National Biodiversity Authority, the national authority regulating access to biological resources and knowledge associated thereto, to ensure that the person applying for such approval, the local bodies concerned and the benefit claimers mutually agree upon the terms and conditions of the access and benefit sharing agreement. In addition, the Act stipulates sharing of benefits with the benefit claimers.

 

Benefit claimers are defined in the Act as (a) conservers of the biological resources and their by-products;

 

(b) creators and holders of knowledge and information relating to the use of such biological resources, innovations and practices associated with such use and application. The benefit claimers have a pivotal role to play in formulating the terms and conditions of the access and the benefit sharing agreement as discussed above. While BDA does not explicitly mention rights of indigenous and local communities, they can fall under the definition of ‘benefit claimers’.

 

The benefits include grant of joint ownership of intellectual property rights, location of production-research-development units to facilitate better living conditions to the benefit claimers, association of benefit claimers with research and development, setting up of venture capital for aiding the cause of benefit claimers, and payment of monetary compensation and other non-monetary benefits to the benefits claimers.

 

5.1.5 Biodiversity Management Committees (BMC) (section 41)

 

The Biodiversity Management Committees are the statutory bodies constituted by local bodies within their areas with an aim to promote conservation, sustainable use and documentation of biological diversity. They are important bodies in the decentralized decision making process with respect to access and benefit sharing since they are required to be consulted by the NBA and the SBB while taking any decision relating to the use of biological resources and knowledge associated with such resources occurring within their territorial jurisdiction.

 

The Biological Diversity Rules, 2004 provide that the functions of the BMCs include preparation of the People’s Biodiversity Register (PBR) in consultation with the local people; and to advise the NBA and the SBBs in any matters referred to them for granting approval (Rule 22(6)-(10)). The PBRsinclude comprehensive information on the availability and knowledge of local biological resources, their medicinal or any other use or any other traditional knowledge associated with them. While the role of PBRs in the ABS process is not defined in the BDA, they are a potential database that can identify benefit claimers for facilitating consultation and negotiation of mutually agreed terms of access and benefit sharing with the benefit claimers.

 

5.2  Regulation of Access

 

Chapter II of the BDA lays down the regulatory provisions relating to access to biological resources or knowledge associated with it. The basic principles and elements of Prior Informed Consent and Mutually Agreed Terms are incorporated in BDA through sections 3, 4, 6, 7 and 21 and through the ABS Regulations. The Act and the Rules describe the competent authorities and THE stakeholders that are involved in the process (sections 19, 20, 21 and 41(c), BDA); timing and deadlines for approval (Rules14(3), 15(3), 18(3) and 19(3)); specification of use (para (h) of Form I under Rules etc.); procedure for applying (sections 19(1) and (2) read with Rules 14, 17, 18 and 19). The Act and the Rules also lay down the requirement of approval for third party transfer (section 20), change of use from the original access, and permission for applying for intellectual property (section 6); modes of benefit sharing (Section 21 read with Rule 20) which form an integral part of the basic requirements of the MAT.

 

The regulatory scope of the BDA is discussed below in terms of activities and persons requiring prior approval, exceptions under the Act etc.

 

5.2.1 Activities regulated by the National Biodiversity Authority

 

Activities specified in sections 3, 4 and 6 of the BDA require prior approval of the NBA before the persons concerned undertake the same. Access without prior approval is a cognizable and non-bailable offence punishable under section 55(1) (section 55 read with section 58). In order to transfer biological resources and/or knowledge, which is the subject matter of an approval to another third party, permission from the NBA under section 20 is required.

 

5.2.2 Activities regulated by State Biodiversity Boards

 

According to section 7 of the BDA, a person who is a citizen of India or a body corporate, association or organization which is registered in India, has to give prior intimation to the SBB concerned for obtaining biological resources for commercial utilization, or bio-survey and bio-utilization for commercial utilization. The procedure for application and intimation is dealt with under section 24(1) of the Act.

 

States are also empowered to make their own rules under section 63 of the Act. Access without prior intimation is a cognisable and non-bailable offence punishable under section 55(2).12

 

Some of the State Biodiversity Boards like the Madhya Pradesh Biodiversity Board have issued legal notice to several companiesincluding breweries, distilleries directing them to intimate the Board for commercial utilisation of the biological resources and to deposit 2% of the gross sales or gross revenue on the financial year with the State Biodiversity Fund. About 13 cases including original applications and appeals were filed before the Central Zone of the NGT against the legal notice.13The cases called for immediate notification of the ABS Guidelines and they are still pending before the Tribunal.

 

5.2.3 Activities requiring prior approval of the NBA

 

The following activities require prior approval of the NBA:

 

(i) Obtaining biological resources occurring in India or knowledge associated thereto for biodiversity related activities (section 3)

 

Section 3 stipulates that certain categories of persons (section 3(2) persons) are required to take approval from the NBA for undertaking biodiversity related activities namely, research, commercial utilization and bio-survey and bio-utilization.

 

(a) Persons regulated (section 3(2) persons)

 

A person who is not a citizen of India;

 

A citizen of India, who is a non-resident as defined in section 2(30) of the Income Tax Act, 1961;

 

A body corporate, association or organization incorporated or registered outside India;

 

A body corporate, association or organization registered in India with non-Indian participation in its share capital or management.

 

(b) Activities covered

 

Section 3 of the BDA regulates the following activities:

 

Research which is defined in section 2(m);

 

Commercial Utilization which is defined in section 2(f);

 

Bio-survey and bio-utilization defined in section 2(d).

 

(ii) Transferring research result to section 3(2) persons

 

The BDA, in section 4, states that any person who is transferring research results relating to any biological resources occurring in, or obtained from, India for monetary consideration or otherwise to any section 3(2) non-Indian citizen or persons requires the prior approval of the NBA. Transfer does not include publication of research papers or disseminationof knowledge in any seminar or workshop, if such publication is as per the guidelines issues by the Central Government.

 

Exception to sections 3 and 4

 

Collaborative research projects are exempted from the purview of sections 3 and 4 of the BDA if the projects satisfy certain conditions.

 

They conform to the policy guidelines issued by the Central Government,

 

They are approved by the Central Government.

 

The Central Government has issued Guidelines relating to Collaborative Research Projects.

 

(iii) Restriction in applying for Intellectual Property Rights (IPR)

 

Section 6 provides that previous approval of the NBA is mandated before a person applies for intellectual property rights, in or outside India, for any invention based on any research or information on a biological resource obtained from India. But if a person applies for a patent, permission of the NBA can be obtained after acceptance of the patent but before sealing of the patent by the patent authority concerned. In other words, in case of patents, a person can obtain permission of the NBA after filing but before the grant of patent.14

 

Applications made for a right under India’s Protection of Plant Varieties and Farmers’ Rights Act, 2001 are exempted (section 6(3), BDA).It is pertinent to note that there are separate benefit sharing obligations under that law.

 

(iv) Restriction and prohibition of access to biological resources.

 

The Biological Diversity Rules, 2004 provide the grounds on which the access to biological resources can be restricted or prohibited. The grounds are:

 

(a) If the request for access is for any endangered taxa,

 

(b) If the request for access is for any endemic and rare species,

 

(c) If the request is likely to result in adverse effect on the livelihoods of the local people,

 

(d) If the request for access may result in adverse environmental impact which may be difficult to control and mitigate,

 

(e) If the request for access may cause genetic erosion or affect the ecosystem function,

 

(f) Use of resources for purposes contrary to national interest and other related international agreements entered into by India.

 

5.3 Section 40 of the Biological Diversity Act

 

Section 40 of the BDA empowers the Central Government to declare that any provisions of the Act shall not apply to any items, including biological resources normally traded as commodities. Accordingly, the Central Government has issued a notification declaring that provisions of the BDA will not be applicable to 190 biological resources specified in the notification provided that they are traded as commodities.15It has also issued another notification exempting crops specified by the Department of Agriculture and Cooperation which the Department considers necessary from amongst the crops listed in Annex I of the ITPGRFA, being food crops and forages covered under the Multilateral System from the application section 3 and 4 of the BDA, for the purpose of utilization and conservation for research, breeding and training for food and agriculture.16

 

5.4 Fair and equitable benefit sharing

 

Fair and equitable benefit sharing is defined in section 2 of the BDA as sharing of benefits as determined by the NBA under section 21 of the BDA. Section 21 provides for the fair and equitable sharing of benefits, which needs to be mutually agreed by the provider, and the user of the biological resources and/or knowledge associated with it.

 

The NBA determines fair and equitable benefit sharing while giving approval under sections 19 and 20 for activities mentioned in sections 3, 4, 6 and 20 of the BDA. While giving approval, the NBA is mandated to ensure that the terms and conditions subject to which the approval is granted secure equitable sharing of benefits arising out of the use of the accessed biological resources, their by-products, innovations and practices associated with their use and applications and knowledge associated thereto. This has to be in accordance with the mutually agreed terms and conditions between the person applying for such approval, the local bodies concerned and the benefit claimers.

 

5.4.1 Forms of benefit sharing

 

Benefit sharing can be both in monetary and non-monetary modes. Section 21(2) of the BDA lays down the following forms of benefit sharing:

 

a) Grant of joint ownership of intellectual property rights to the NBA or where benefit claimers are identified, to such benefit claimers;

 

b) Transfer of technology;

 

c) Location of production, research and development units in such areas which will facilitate better living standards to the benefit claimers;

 

d) Association of Indian scientists, benefit claimers and the local people with research and development in biological resources and bio-survey and bio-utilization;

 

e) Setting up of venture capital fund for aiding the cause of benefit claimers;

 

f) Payment of monetary compensation and other non-monetary benefits to the benefit claimers.

 

It is pertinent to note that if the biological resource or knowledge associated with it was a result of access from a specific individual or group of individuals or organizations, the NBA may direct the amount to be paid directly to such individual or group of individuals or organisations in accordance with the terms of any agreement and in such manner as it deems fit (Proviso to section 21(3), BDA).

 

The ABS Regulationspecifies formula for benefit sharing as given in the Table below, modes of benefit sharing (Regulation 15), and processing of applications (Regulation 16). The new ABS Regulation also refers to the benefit sharing imposed by SBBs.

 

5.4.2 Procedure for giving approval

 

The NBA after receiving the application has to make enquiries, if necessary, consult an expert committee, (section 19(3), BDA), and based on the merit of the application, approve or reject the application by an order. The factors that will be considered while processing the applications are specified in Regulation 16(5) of the ABS Regulations. In addition, while giving approval, the NBA has to also determine benefit sharing with respect to the application received under section 19 as discussed earlier.

 

The SBBs after receiving intimation under section 24(1), may, in consultation with the local bodies concerned and after making such enquiry, by order prohibit or restrict any such activity if it is of the opinion that such activity is detrimental or contrary to the objectives of conservation and sustainable use of biodiversity or equitable sharing of benefits arising out of such activity.

 

5.4.3 Procedure for appealing against the orders of NBA and SBB

 

Any determination of benefit sharing or order of the NBA and SBB can be challenged by any person who is aggrieved by such determination or order by filing an appeal to the NGT as provided in section 52 of the BDA.

 

6. Case Studies: ABS in India

 

6.1 Kani Tribe17

 

The model of access and benefit sharing between the Tropical Botanical Garden and Research Institute (TBGRI) and the Kanitribe for sharing the benefits arising out of utilization of a plant called ‘aarogyapacha’ pre-dates the CBD. TBGRI developed a drug called ‘jeevani’ using the Kani tribe’s traditional knowledge about the anti-fatigue properties of ‘aarogyapacha’. Later,TBGRI transferred the technology for production of the drug through a licenceto AryaVydhya Pharmacy under an agreement. According to the agreement, the Kani tribe is entitled to a share of the licence fee and royalty on sales of the drug.

 

6.2 The BtBrinjal case

 

The authorized officersunder the BDA filed a criminal complaint (under section 61 read with section 55 of the Act)against the Maharashtra Hybrid Seed Company, the University of Agricultural Sciences Dharwad and othersfor violation of sections 3, 4 and 7 of the Act.18 The main contention was that the University and the Company have entered into an agreement for research and development of genetically modified brinjal without the prior approval of the NBA. The Company being a section 3(2) company had not obtained the prior approval of the NBA for accessing local brinjal varieties for developing the genetically modified brinjal. The University was accused of violating section 4, that is, transferring the research result without the prior approval of the NBA. The High Court of Karnataka, in criminal appeal by the University and others, has concluded that there is a prima facie violation of section 4 of the Act.19

 

7. Summary

 

The international framework on access and benefit sharing is primarily dealt with under the CBD (especially Article 15) and the Nagoya Protocol. The national framework on ABS is under the Biological Diversity Act, 2002 and the Biological Diversity Rules, 2004. The Biological Diversity Act regulates the access to biological resources and knowledge associated with it by certain persons for certain purposes including research andcommercial utilization. The regulatory bodies under the Act are the National Biodiversity Authority and the State Biodiversity Boards. The Biodiversity Management Committees constituted at the local level also has an advisory role in the regulation of access to biological resources and the equitable sharing of the benefits associated with it. The Biological Diversity Act and the Rules also providethe procedure to apply for prior approval, the competent authorities for granting approval, etc. But there are many issues with respect to the application of the Act especially the definition of biological resources, commercial utilization, etc.

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Weblinks

 

On international legal framework

 

•Secretariat of the Convention on Biological Diversity.“Revised Infokit”on URL http://www.cbd.int/abs/infokit/revised/web/all-files-en.pdf

•Thomas Greiber, et al. “An Explanatory Guide to the Nagoya Protocol on Access and Benefit-sharing.” IUCN, Gland, Switzerland (2012) on URL https://portals.iucn.org/library/efiles/documents/EPLP-083.pdf

•Secretariat of the Convention on Biological Diversity.“Access and Benefit-Sharing in Practice:Trends in Partnerships Across Sectors.” Montreal, (2008) on URL https://www.cbd.int/doc/publications/cbd-ts-38-en.pdf

•Natural Justice. “Access and Benefit Sharing: E-series of on International Framework that Support Indigenous People, Local Community, and their Territories and Areas.” On URL http://naturaljustice.org/wp-content/uploads/pdf/Access-and-Benefit-Sharing.pdf