ACCESS AND BENEFIT SHARING: ISSUES AND OPTIONSshodhganga.inflibnet.ac.in/bitstream/10603/12824/13/13_chapter 7.pdf · 240 CHAPTER VII ACCESS AND BENEFIT SHARING: ISSUES AND OPTIONS

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CHAPTER VII

ACCESS AND BENEFIT SHARING:

ISSUES AND OPTIONS

Access and Benefit Sharing (ABS) issues within the context of Plant Genetic Resources

(PGR) comprise a substantial portion of the current debates regarding the formation and adoption of

Intellectual Property regulatory frameworks1. Access refers to the ability of individuals to acquire or

use genetic resources found in PGR for a multitude of purposes, not limited to commercial

application2. However, benefit-sharing issues are explicitly within the context of

commercialization3. Financial incentives to access PGR for commercialization is substantial,

particularly if there is sufficient demand for the resultant product. Yet, if the resource was originally

held by someone other than the party who successfully commercialized it concerns arise as to

whether or not those who originally held the resource are to receive a portion of the monetary or

non-monetary benefits accrued from its sale.

1. Relevance of Access and Benefit Sharing

The relevance of ABS is significant4 due to the large amount of genetic resources that have

commercial viability in a number of formal sectors, including pharmaceuticals, biotechnology, seed,

horticulture, botanical medicine5, cosmetic and personal care and food and beverage sectors. It is

found that, of the 25 best selling drugs worldwide, 42 per cent of the sales of these drugs were of

those derived from PGR. Similarly, of the top 150 drugs prescribed in the United States, 57 per cent

of the prescriptions filed were for pharmaceuticals6 that contained at least one major compound

‘derived or patterned after compounds from biological diversity’7. This commercial aspect of PGR

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has been the driving force behind the search for undiscovered genetic resources that may have

significant commercial potential.

2. Prior Informed Consent and Material Transfer Agreement

Prior Informed Consent8 and MTAs are instrumental in any agreement relating to ABS

issues9, as they together formulate a potential strategy in determining the terms by which genetic

resources are to be transferred from one party to another. There are many arguments stating that the

granting of any patent should be legally conditional on two factors10.

PIC and full disclosure of where the resources were sourced

from, or

The geographic origin of the resource.

The rationale is straightforward; if it is clearly stated where the resources came from and

whether or not the original holders had agreed to provide them to the interested party, disputes

regarding bio piracy can be avoided11. The rationale for PIC is to allow for any transfer of resources

to be undertaken under a set of explicit circumstances; more specifically, it ideally provides for the

‘green light’ on whether or not resources are to be transferred or not. The rationale then is to ensure

that if resources are to be exchanged across boundaries, they will mobilize only if there exist an

agreement or statement that ensures that those originally holding the resource are indeed aware and

in agreement that the resource can be provided to an outside party. It is to recognize those original

holders as the keepers of the resource by ensuring that their permission has been granted before any

resources are taken or provided by them.

While PIC exists for resource holders to allow the transfer of resources, MTAs are more

explicit in creating a mechanism to determine how much the resources are worth in their raw form,

either in monetary or non-monetary terms12. In short to may define MTAs as those agreements that

establish standards for the transfer of biological resources for research and possible

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commercialization in exchange for benefits to the party recognized as the supplier. In exchange,

MTAs usually grant the recipient of the material the right to apply for patents if any of the material

has commercial potential.

Generally, these agreements are implemented by assuring the supplier a fixed percentage of

the revenues acquired from the commercialization of a product that had resulted from the raw

genetic material provided, combined with a fixed amount for the bulk of all genetic resources

accessed13. The actual remuneration varies from agreement to agreement, as do the precise terms of

the remuneration. While the precise details of agreements within intermediary institutions (i.e.

botanical gardens, gene banks) are often publicly available, those between the private sector and

their suppliers are generally confidential. Thus, it is difficult to ascertain what best practices for

MTAs entail. To date, very few firms in the private sector have developed their own codes of

conduct for MTAs that would be CBD compliant.

3. Mutually Agreed Terms

Mutually Agreed Terms (MAT) is conditions and provisions of access and benefit-sharing,

among others, negotiated between the user and the provider and involving other relevant

stakeholders. MAT are negotiated in a manner that builds confidence and a relationship of trust

between owners, managers or custodians of genetic resources who are the providers, and the users

of genetic resources, and that establishes the basis for a long-term, transparent and respectful

relationship and communication between them. MAT are negotiated in good faith by both users and

providers, respecting the terms and understanding of Prior Informed Consent, allowing benefits to

flow to the owners, managers or custodians of the genetic resource, and facilitating access. MAT

take into account the differences in capacities and needs of the providers, including governments,

and indigenous and local communities, holders of ex situ collections, and the intended user

organisations, to allow fair processes of negotiation and equitable outcomes in the benefits to be

shared.

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4. Technology Transfer

Article 16 of the CBD addresses technology transfer. It recognizes “that both access to and

transfer of technology among Contracting Parties is essential elements for the attainment of the

objectives of this Convention”. The Contracting Parties are obliged to undertake “to provide and/or

facilitate access for and transfer to other Contracting Parties of technologies that are relevant to the

conservation and sustainable use of biological diversity or make use of genetic resources and do not

cause significant damage to the environment.” Transfer of technology to developing countries is

also to be on fair and most favourable terms.

Technology transfer arises in a number of places in the Bonn Guidelines. It is listed as one

of the objectives of the Guidelines, as part of fair and equitable benefit-sharing in the

responsibilities of users of genetic resources, and as a type of non-monetary benefit that may be

shared.

While the provisions on technology transfer in the CBD are quite lengthy, they leave the

implementation of technology transfer up to the Contracting Parties. The international regime needs

to go beyond these statements and explore more explicit guidelines to promote technology transfer,

particularly of technologies relating to genetic resources. At the same time, community members

received the training they need to better manage their local resources, which can be understood as a

form of technology transfer. The regime should also investigate more specific ways to resolve the

technology transfer gap in the existing ABS framework to the benefit of developing countries.

Finally, technology transfer in an international regime should relate to the first gap in the current

ABS framework. It should help make the connection between access to genetic resources and the

conservation and sustainable use thereof14.

At the same time, it must be recognized that the existing technology transfer provisions in

the CBD were some of the most contentious articles during the negotiations. At the Earth Summit in

Rio de Janeiro in 1992, the U.S. refused to sign the Convention largely due to the technology

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transfer provisions in Article 16 and the fear that they would run roughshod over Intellectual

Property Rights. One of the benefits of an international regime on ABS that consists of a variety of

binding and non-binding elements is that non-agreement on contentious issues like technology

transfer need not result in the failure of the entire regime.

5. International Fora on Access and Benefit Sharing

International level measures for Access and Benefit Sharing are;

5.01. The Convention on Biological Diversity, 1992

One of the three objectives of the CBD15, as set out in its Article 1, is the ‘fair and equitable

sharing of the benefits arising out of the utilization of genetic resources, including by appropriate

access to genetic resources and by appropriate transfer of relevant technologies, taking into account

all rights over those resources to technologies, and by appropriate funding.’16

A framework for the implementation of this third objective of the Convention with respect

to access to genetic resources is provided in Article 15 of the Convention. In addition, Article 8(j)

contains provision to encourage the equitable sharing of the benefits arising from utilization of

knowledge17, innovations and practices of indigenous and local community embodying traditional

lifestyles relevant for conservation and sustainable use of biological diversity.

While CBD envisages that access to genetic resources and realization of benefits is subject

to national legislation through formalisation of PIC and MATs, India has been emphasizing that

such national action alone is not sufficient to ensure realization of benefits to the country of origin

or provider country. This is particularly so in cases where genetic material sourced from one

country is utilized in another country for developing products and processes on which patent

protection is obtained. The onus of benefit sharing must also be shared by the user country to create

an enabling environment and confidence through legislative measures so as to ensure compliance of

PIC stipulations and equitable sharing of benefits as visualized in the Convention.

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5.02. Bonn Guidelines and Conference of the Parties (COP)

A major achievement of COP VI was the adoption of the Bonn guidelines18 on access to

genetic resources and the fair and equitable sharing of the benefits arising from their

utilization19.The Guidelines were recognized as a useful first step of an evolutionary process20 in the

implementation of relevant provisions of the Convention related to access to genetic resources and

benefit-sharing. They will be kept under review by the COP and the need for their further

refinement will be considered on the basis of relevant developments under the Convention,

including those on issues such as Traditional Knowledge and technology transfer.

The guidelines assist Parties, Governments and other stakeholders in developing an overall

access and benefit-sharing strategy, and in identifying the steps involved in the process of obtaining

access to genetic resources and benefit-sharing21. More specifically, these voluntary guidelines are

meant to assist Parties, Governments and other stakeholders when establishing legislative,

administrative or policy measures on access and benefit-sharing and/or when negotiating

contractual arrangements for access and benefit-sharing.

The Bonn Guidelines were also considered including, the use of terms in the Bonn

Guidelines; measures to support compliance with the PIC of the contracting party providing genetic

resources and MAT on which access was granted in COP with users of such resources under their

jurisdiction; other approaches, complementary to the Bonn Guidelines, to assist Parties with the

implementation of the access and benefit-sharing provisions of the Convention; and, needs for

capacity-building identified by countries to implement the Bonn Guidelines.

The Conference of the Parties at its seventh meeting22, addressed the Bonn Guidelines. The

COP recognized that the Guidelines are making a useful contribution to the development of national

regimes and contractual arrangements for access and benefit-sharing and to the implementation of

the objectives of the Convention. It also recognized that some developing countries had

encountered constraints due to inadequate capacity to fully utilize the guidelines in the formulation

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of their national access and benefit-sharing legislation. Parties, Governments, indigenous and local

communities and all relevant stakeholders were invited to continue to promote the wide

implementation of the voluntary Bonn Guidelines. They were also encouraged to submit further

information on relevant experience and lessons learned, including success and constraints, in the

implementation of the Guidelines. Other issues of relevance to the Bonn Guidelines were also

addressed by the Conference of the Parties in Decision VII/19, such as the use of terms, and other

approaches, complementary to the Bonn Guidelines to assist with the implementation of the ABS

provisions of the Convention.

At its eighth meeting23, the Conference of the Parties noted the progress already

accomplished and urged Parties to continue implementing the Bonn Guidelines and to share

experiences and lessons learned in their implementation as well as in the development and

implementation of national and sub-national measures.

5.03. The Food and Agriculture Organization (FAO)

The ITPGRFA culminated in November 2001 after almost seven years of negotiations. The

Treaty is unique; its main objective is the ‘conservation and sustainable use of plant genetic

resources for food and agriculture and the fair and equitable sharing of the benefits arising out of

their use, in harmony with the CBD, for sustainable agriculture and food security24.’ The treaty also

establishes a MLS of ABS for plant genetic resources for 64 food crops; these crops were chosen as

they account for approximately 85 per cent of global human nutrition25. It proposes to achieve this

through ‘information exchange, technology transfer, capacity-building, and the mandatory sharing

of the monetary and other benefits of commercialization of products incorporating material

accessed from the MLS. However, access within the multilateral system is limited. Only those

wishing to access PGR for ‘research, breeding, and training for food and agriculture are permitted’.

Those wishing to use PGR within the MLS for ‘chemical, pharmaceutical and/or other non-

food/feed industrial uses’ are not allowed access.

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5.04. The World Intellectual Property Organization

The WIPO began its work on ABS and TK in 2000 through the Intergovernmental

Committee on Genetic Resources, Traditional Knowledge and Folklore (GRTKF)26. During its five

sessions, Member States including Indigenous Peoples Representative Organizations have

discussed legal, policy; economic and scientific aspects related to TK, including TK related case

studies on TK protection, analysis of IPRS principles, Sui Generis alternatives for TK protection,

revision of national legislation and draft policies27.

The Fifth Session28 of the Intergovernmental Committee was supposed to end of the

Committee’s mandate, therefore forcing Member States to decide on the future existence and work

of the Committee. Positions among Members have been extremely varied ranging from the need to

launch within WIPO and the Committee negotiations for the development of an international Sui

Generis regime for the protection of TK to stressing the need for the continued work in analyzing

options and alternatives for TK protection. Due to the lack of consensus on how to continue work

within the Committee, the Committee left the next General Assembly of WIPO (meeting in

September, 2003) to decide on the way forward. The General Assembly decided to extend the

mandate of the Committee for further work, research and discussions with no clear indication on

whether and when an international negotiation process for an international treaty or convention for

the protection of TK might be agreed upon and started. The Intergovernmental Committee has

contributed significantly to the policy and conceptual discussion29 of TK related issues. Key

elements analyzed through information documents, parallel workshops during sessions, country

submissions, etc., inter alia: the role of registers and data bases in the protection of TK; the role of

contracts in protecting TK; incorporating new requirements into IPRS legislation to ensure

appropriate disclosure; current examples of TK protected through IPRS instruments; national drafts

and legislation on TK; relationships between TRIPs and CBD; TK in the public domain.

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5.05. World Trade Organisation (WIPO) and Trade Related Aspects of Intellectual

Property Rights (TRIPS)

Various countries have made submissions about the review of article 27.3 (b) of TRIPS,

which in some cases include suggestions on TK .The relationship between the TRIPS Agreement

and the CBD has been addressed by the Secretariat of the WTO30. This relationship, including the

protection of TK, was examined by the Committee on Trade and Environment (CTE) at the WTO.

The CTE was formally established in 1995 by the WTO General Council to examine the

relationship between the provisions of the multilateral trading system and trade measures for

environmental purposes, including those pursuant to Multilateral Environmental Agreements

(MEAs). The CTE considered the provisions of the TRIPS Agreement relevant to its work on the

environment under item 8 of its agenda. Some developing countries have argued that the TRIPS

Agreement must be reviewed in light of the obligations on States under Article 8(j) of the CBD31.

The African Group has been particularly active in relation to the review of article 27.3(b). It wants

that provision to be harmonized with the CBD, the objective of which is ‘to protect the rights of

indigenous people and local farming communities and to protect and promote biological diversity’.

The proposal of the African Group demanded that such harmonization also be made with the FAO

International Undertaking on PGR, which ‘seeks to protect and promote Farmers’ Rights and to

conserve plant genetic resources’. The group argues that: “…by mandating or enabling the

patenting of seeds, plants and genetic and biological materials, Article 27.3(b) is likely to lead to

appropriation of the knowledge and resources of indigenous and local communities”32.

5.06. The Nagoya Protocol on Access and Benefit Sharing, 2010

This protocol was adopted by the COP to the CBD at its tenth meeting on 29 October 2010

in Nagoya, Japan33. The Nagoya Protocol on Access to Genetic Resources and the Fair and

Equitable Sharing of Benefits Arising from their Utilization to the CBD is an international

agreement which aims at sharing the benefits arising from the utilization of genetic resources in a

fair and equitable way, including by appropriate access to genetic resources and by appropriate

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transfer of relevant technologies, taking into account all rights over those resources and to

technologies, and by appropriate funding, thereby contributing to the conservation of biological

diversity and the sustainable use of its components.

5.06.01. Main Provisions of the Nagoya Protocol

The important and main provisions of the Nagoya Protocol are34;

A definition of the objective, use of terms, scope and

relationship with other international instruments of the

Nagoya Protocol

Elaboration on the principles and main requirements on the

fair and equitable sharing of benefits and access to genetic

resources and TK

Several possible mechanisms for implementation, including a

multilateral benefit sharing mechanism and an access and

benefit-sharing clearinghouse

Measures to promote compliance with legal and regulatory

requirements, as well as with MAT and,

Measures to promote tools and awareness raising, capacity

building and transfer of technology activities on ABS.

The Nagoya Protocol will be open for signature by Parties to the Convention from 2nd

February 2011 until 1st February 2012 at the United Nations Headquarters in New York. The fair

and equitable sharing of the benefits arising out of the utilization of genetic resources is one of the

three objectives of the CBD. It ensures that balanced access to genetic resources on the basis of PIC

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and MAT. The Nagoya Protocol also ensures the fair and equitable sharing of benefits while taking

into account the important role of TK.

6. Regional Developments in Access and Benefit Sharing

Calls for an international legal instrument for regulating ABS have multiplied over the past

few years. The Group of LMMC (Like Minded Mega diverse Countries) in particular has played a

pivotal role in promoting this view and calling for its consideration within CBD, WIPO and other

forums. Very simply, national ABS policy and legal measures and jurisdictional limitations make

control of the flows of genetic resources extremely complicated therefore, international measures

are necessary if, ultimately, the objectives of the CBD are to be fully achieved.

The Johannesburg Plan of Implementation (World Summit on Sustainable Development,

2002), explicitly recognized the need for countries to negotiate an international regime on ABS.

Bearing in mind the elements suggested and proposed in the Bonn Guidelines, a specific ABS

Protocol to the CBD may be an option through which operationalize this regime35. Focusing on

obligations and compromises from countries which utilize genetic resources and harmonizing

national procedures in providing countries could pave the way for an effective international

instrument on ABS. Another possibility for an international regime may be for COP to agree on

specific adjustments to national laws and regulations (in user and provider countries) as a means to

facilitate the realization of the benefit sharing objectives of the CBD. This option might not require

the negotiation of an international instrument per se but, rather, an agreement (may be a COP

Decision-with prior guidance from the Panel of Experts on ABS) through which these legislative

changes could be materialised at the national level but having an overall impact in ensuring an

equitable sharing of benefits from the flows of genetic resources worldwide.

Numerous countries have adopted ABS policies and legislation36. Examples include the

Andean Community of Nations -Venezuela, Colombia, Ecuador, Peru, and Bolivia (Common

Regime on Access to Genetic Resources, 1996); the Organization of African Unity -53 countries-

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(African Model Law on the Protection of the Rights of Local Communities, Farmers and Breeders

and for the Regulation of Access to Biological Resources, 1998); the Philippines (Executive Order

247, Prescribing Guidelines and Determining a Regulatory Framework for the Prospecting of

Biological and Genetic Resources, by-products and derivatives, for Scientific and Commercial

Purposes and Other Purposes, 1996); Brazil (Medida Provisoria 2.186-16 on access to genetic

resources and Traditional Knowledge, 2001) ; Nepal (Draft Policy on Access to Genetic Resources

and Benefit Sharing, 2001) ; Costa Rica (Biodiversity Law, Law 7788, 1998); Bhutan (Biodiversity

Act of Bhutan, 2003). Common elements and features in these different instruments include: some

general provisions (including scope, exceptions, etc.); the type of contracts, permits or

authorizations through which access is permitted; the conditions under which access could be

allowed; the stages and structure of an administrative procedure; the recognition of a national

competent authority; and references to IPRS and TK. PIC procedures are especially critical and

their features vary according to different countries.37 In some cases, PIC is provided by a national

representative organization (e.g. Peru); in others PIC will be attained through traditional decision

making processes among indigenous peoples e.g. Panama38.

7. Access and Benefit Sharing: Legislations in India

India has signed and ratified both the CBD and the Seed Treaty, it is bound to make a

concerted effort to ensure that the broad objectives of the Convention, the Bonn Guidelines and the

Seed Treaty are addressed at a domestic level39, and that proper guidelines for ABS mechanisms are

in place. While concerns relating to biodiversity in the Indian context certainly predate the CBD,

the formal process of interaction and debate around the issues within ABS at the national level

began in India after the conclusion of the UNCED towards the end of 1992. After a very long

process of national and state level consultations, the Indian government in May 2000 finally

adopted the Biological Diversity Act. The Act is clearly rooted as a response to the obligations

imposed on India by the CBD, but perhaps more importantly, its existence is due to the need for

national legislation on issues related to the ABS of genetic resources.

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During the same time as the development of the BDA, efforts were also underway to draft

legislation to satisfy the Sui Generis provision that Article 27.3 of TRIPS presented. The Indian

government in August 2001 passed the resulting law, the Protection of Plant Varieties and Farmers’

Rights Act (PPVFRA). The PPVFRA is unique in the sense that it establishes the existence of

farmers’ rights at a national level. More specifically, it establishes the right of farmers to sell their

seed to others (except branded seed), thereby ensuring that this source of income is retained40.

With respect to Access and Benefit Sharing, the PPVFRA is relevant here as it contains a

provision for a funding source that would allocate financial resources for the holders of varieties.

This fund, termed the National Gene Fund, would act as a conduit for funds that would be

disseminated among communities who could be shown to hold claim to the resources accessed.

There is a strong potential for overlap between these two Acts, especially with regards to

those elements of the Acts that relate to ABS issues. It is clear, particularly within the context of

experiences such as the Kani and Tropical Botanical Garden and Research Institute (TBGRI), that

proper legislation is required to guide future benefit sharing agreements. Yet, the creation of such a

framework is a long and difficult process, particularly when there is a plurality of agreements that

could have direct relevance to the issues at hand41.

7.01. The Biological Diversity Act (BD Act), 2002

The BD Act outlines a framework for allowing which parties can access PGR. The Act

outlines a process by which resources can be accessed, and details the procedural hierarchy that

exists for those parties interested in doing so. One of the main objectives of the Act is the equitable

sharing of benefits arising out of the use of biological resources.

The Act defines biological resources as ‘plants, animals and microorganisms and parts

thereof, and their genetic material and by-products, with actual or potential use or value, but does

not include human genetic material.’

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7.01.01. Access Issues

There are three levels by which any application to access resources must pass; the national,

the state, and the village level. The Bill states that one level cannot act without others permission;

that is, no decision at the national or state level can be taken without consultation at the village

level42. At the national level, NBA will be the first contact for any party wishing to access PGR.

The NBA considers applications on a proposal-by-proposal basis, and ensures that any terms and

conditions of these proposals include an acceptable benefit sharing component. Moreover, before

obtaining any PGR from India, the party must go through the NBA. Similarly, at the state level,

SBB will be established, and will perform tasks very similar to that of the NBA. However, the role

of the SBB is distinct as it operates within the policy environment of the state, which is far from

uniform across all states. Finally, the Act establishes BMC, which will be governed by the existing

village level political mechanisms.

The Act is explicit regarding how parties from India (i.e. Indian nationals) and foreigners are

to be treated under the regulations. Specifically, approval is granted to Indian citizens only after

‘prior intimation’; approval to foreigners is only granted after prior approval43. The distinction is

because, while it could be possible to prosecute nationals within the Indian legal system, it would

more than likely not be possible for foreigners. Research activities are also subject to prior approval

by NBA; the BDA is not limited to monitoring access to resources alone, but also the results of

research. The transfer of research results ‘to any person who is not a citizen of India or a body

corporate or organization which is not registered or incorporated in India or which has any non-

Indian participation in its share capital or management’ cannot be disseminated without approval of

the NBA.

Similarly, “no person shall apply for any Intellectual Property Right by whatever name

called in or outside India for any invention based on any research or information on a biological

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resource obtained from India without obtaining the previous approval of the NBA before making

such application’”44.

7.01.02. Benefit Sharing Issues

Of particular relevance here is the establishment of a National Biodiversity Fund,

(NBF)which will be administered by the NBA, and State Biodiversity Funds, which will be

administered by the SBBs. Article 6(2) states that ‘the NBA may, while granting the approval under

this section, impose benefit sharing fee or royalty or both or impose conditions including the

sharing of financial benefits arising out of the commercial utilization of such rights’. As per the law,

the purpose of these funding mechanisms are to channel benefits to the conservers of biological

resources and creators and holders of knowledge, the conservation of areas where biological

resources are found, and the socio-economic development of such areas in consultation with the

local self-government concerned45.

A similar mechanism is stated to exist at the village level, composed of transfers from the

State Funds and other grants. This Local Biodiversity Fund shall be used ‘for conservation of

biodiversity in the areas falling within the jurisdiction of the concerned local body and for the

benefit of the community in so far such use is consistent with conservation of biodiversity’.

Nowhere in the text of the Act stated how the fund would be set up, and more importantly,

how actual amounts designated for the sharing of benefits will be calculated. It is ultimately up to

the SBBs to determine this. In the case of the Kani, the amount decided (50 per cent of revenues

earned by TBGRI) were arrived at via consulting standards proposed by the CSIR.46 Presumably,

SBBs would look to similar standards by which to gauge the actual amounts that would apply.

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7.02. Protection of Plant Varieties and Farmers’ Rights Act (PPVFRA), 2001

This Act directly relates to ABS issues, as IPRSs are the starting point for any discussion of

the policy implications of access issues, and benefit sharing concerns are explicitly dealt with

within the PPVFRA. The emergence of TRIPS, however, did consolidate the need for India to

develop a mechanism to protect plant varieties, as outlined in Article 27.3(b). The objective of the

PPVFRA as stated in its preamble is to establish “an effective system for the protection of plant

varieties, the rights of farmers and plant breeders, to encourage the development of new varieties of

plants”.

The balance between farmers’ rights and breeders’ rights; the PPVFRA makes an attempt at

balancing both, thus satisfying both the concerns of farmers regarding their ability to save, acquire,

and sell seed, but also the concerns of breeders who desire adequate protection for their research

and resultant technologies.

7.02.01. Access Issues

Under the PPVFRA then, farmers’ varieties of seeds are offered protection under a PBR;

moreover, an Essentially Derived Varieties (EDV) can only be granted if explicit permission is

granted by the farmers who hold the original genetic material that the EDV is sourced from. The

question then is how precisely farmers’ varieties are to be catalogued and thus conferred a PBR.

The Act states that a National Register of Plant Varieties ‘shall be kept at the head office of the

Registry, wherein shall be entered the names of all the registered plant varieties with the names and

addresses of their respective breeders, the right of such breeders in respect of the registered variety,

the particulars of the denomination of each registered variety, its seeds or other propagating

material along with specification of salient features thereof and such other matters as may be

prescribed47.’

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India certainly has the right of a sovereign state to formulate their own laws relating to PGR,

but the ability to defeat a claim outside India based on the varieties being documented in a CBR

may or may not constitute the requirement of novelty with regards to a patent. This is regardless of

the fact that it may be novel within the context of a PBR. More concretely however, the PPVFRA

states that a PBR cannot be awarded if the application for protection does not provide information

on where the genetic material was found, and what the parental lineage is of the variety. This

amounts to full geographic disclosure being conditional on accessing a PBR, which is perfectly

within the right of India to pursue.

7.02.02. Benefit Sharing Issues

With regards to Benefit Sharing provisions, the PPVFRA, like the BDA, introduces a NGF.

The purpose of the fund is to collect funds that are owed to the original holders of the genetic

resource that is being accessed, with the value of the amount to be determined by48:

The extent and nature of the use of genetic material of the

claimant in the development of the variety relating to which

the benefit sharing has been claimed;

The commercial utility and demand in the market of the

variety relating to which the benefit sharing has been

claimed.

The rationale for the fund is to act as a source of financial resources that is based on

payments made, either via a license or via benefits accrued, by those parties wishing to access

genetic resources owned by farmers or other groups in India. The Act states that Fund will contain

transfers relating to49:

The benefit sharing received in the prescribed manner from

the breeder of a variety or an EDV registered under this Act

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or propagating material of such variety or EDV, as the case

may be;

The annual fee payable to the authority by way of royalty for

resources acquired from a breeder of a variety registered

under the Act;

The compensation that may arise in a successful claim is

presented arguing that the genetic material was sourced from

local communities;

The contribution from any national and international

organisation and other sources.

The Gene Fund is a distinct and separate entity from the NBF of the BDA, though the aim of

each is rather similar. However, the NBA has nothing to do with the administration of the Gene

Fund; this fund is administered by ‘the Central Government’50.

This Fund is likely to be very modest. It should be used mainly for recognizing and

rewarding the contributions of tribal and farmwomen and men to the conservation and enhancement

of agro-biodiversity. The administration costs relating to this Fund should be borne by the

Government of India. Transparent and credible methods of recognizing individual and community

contributions will have to be developed. This can be done by a Standing Committee on Farmers’

Rights set up by the Authority. Since a majority of primary conservers are women, there must be

adequate representation of tribal and farm women on such a Committee. The manner in which the

community award should be utilized should be left to the community. In this respect, there could be

linkages between the provisions of this Act and the Biodiversity Management Committees proposed

to be set at the Panchayat/Local Body Level under the Biodiversity Act now before Parliament. And

it is clear that there are similarities between the PPV and the BDA. However, unlike the BDA, the

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PPVFRA does not detail how PIC could be accomplished. That is, it does not provide the

hierarchical framework that the BDA provides

8. Contractual Agreements for Benefit Sharing

In the Convention on Biological Diversity there are three particular means for

benefit sharing.

appropriate access to genetic resources

appropriate transfer of relevant technologies, and

appropriate funding.

The term benefit sharing involves a balance between access to genetic resources and fair and

equitable sharing of the benefits of their use through wide variety of monetary and non-monetary

mechanisms, ranging from profit sharing or equitable stakes in the bio-prospecting business, and

also technology transfer, training and collaborative research. Bio-prospection is the systematic

search of new sources of chemical compounds, genes, proteins, microorganisms and other products

that have economic potential and can be found in biodiversity. The process of obtaining resources

through the use of biodiversity in commercial products includes the negotiations and contracting

with industrialized enterprises. Some of the contractual agreements for benefit sharing are;

8. 01. JNTBGRI Model of Access and Benefit Sharing

The JNTBGRI51 is one of the foremost botanical research institutes in Asia. In its approach

to the study of indigenous tropical plants, it draws on experts from such scientific disciplines as

Ethno-medicine, Photochemistry, Pharmacology, and Ayurveda. Through the research of the

institute, numerous medicinal herbs have been identified with the result that many herbal products

have been developed and produced.

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In December 1987, under the All India Coordinated Research Project on Ethno-biology

(AICRPE)52, a team of scientists undertook a botanical expedition into the Agastyamalai forests.

They were accompanied by members of the Kani53 tribe as guides. During the expedition, the

scientist team observed that the Kani guides frequently ate black fruits of some plants which kept

them energetic and agile. They offered a fruit to the exhausted scientists during the trip. Upon

eating the fruits, the team felt immediately charged and full of energy and vitality. The tribals were

initially reluctant to reveal the identity of the fruit and pleaded that it was a time-honored tribal

secret and a sacred one. It was only after much persuasion, they showed the scientists the plant from

which the fruit was obtained. Kanis call the plant in their language as ‘Arogyapacha’. The plant

specimens were collected for study, and the plant was identified as Trichopus zeylanicus. Detailed

scientific investigation of the plant was subsequently carried out, including chemical screening to

isolate the active principles, and pharmacological screening. The fruit of the plant contained anti-

fatigue properties that the Kanis had identified. Studies on the leaves showed the presence of certain

glycolipids and non-steroidal compounds which possessed anti-stress, anti-hepatotoxic and

immune-modulatory or immune-restorative properties.

This study arrived at development of a drug called ‘Jeevani’ based on the knowledge of the

Kani tribe. ‘Jeevani’ is a restorative, immune-enhancing, anti-stress and anti-fatigue agent, based on

the herbal medicinal plant Arogyapacha, used by the Kani Tribes in their TRM. Within the Kani

tribe the customary rights to transfer and practice certain traditional medicinal knowledge are held

by Tribals healers, known as ‘Plathis’. The knowledge was divulged by three Kani tribal members

to the scientists of JNTBGRI who isolated 12 active compounds from Arogyapacha, and developed

the drug ‘Jeevani’.

The technology was then licensed to the Arya Vaidya Pharmacy (AVP) Ltd54, an Indian

pharmaceutical manufacturer pursuing the commercialization of Ayurvedic herbal formulations. A

Trust Fund was established to share the benefits arising from the commercialization of the TK-

based drug ‘Jeevani’. The operations of the fund with the involvement of all relevant stakeholders,

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as well as the sustainable harvesting of the Arogyapacha plant, have posed certain problems which

offer lessons on benefit sharing over genetic resources and associated Traditional Knowledge.

8.01.01. Benefit Sharing Arrangements between Kani Tribe and JNTBGRI

The Governing Body of the JNTBGRI authorized the JNTBGRI Director to transfer

technology for the manufacture of ‘Jeevani’ to interested parties on payment of an appropriate

license fee. Negotiations for the same were conducted by a committee constituted for this purpose

headed by the Chairman of the TBGRI Executive Committee who was also Chairman of the State

Committee on Science, Technology and Environment, Government of Kerala. This committee

recommended a transfer of the right55 to manufacture Jeevani to Arya Vaidya Pharmacy

(Coimbatore) Ltd. for a period of seven years at a license fee of Rs. 10 lakh (one million rupees,

approximately $25,000). JNTBGRI was also to receive two per cent royalty on any future drug

sales. This was done as per the guidelines of Council of Scientific and Industrial Research.

According to JNTBGRI, it was the best bargain that could be arrived at by their selection

committee. They emphasized that the license period is only for the purpose of a promotional

venture and that once the drug is able to establish a market for itself within the license period of

seven years, the license fee could be suitably enhanced and that it could be licensed to another

company if that is more beneficial. In a separate resolution approved by both the Governing Body

and the Executive Committee of the JNTBGRI, it was decided that the Kani Tribes would receive

50 per cent of the license fee, as well as 50 per cent of the royalties obtained by the TBGRI on sale

of the drug, as part of the benefit sharing arrangement for divulging the information. In November

1997 with the assistance of TBGRI, a trust was registered, named the Kerala Kani Samudaya

Kshema56 Trust. All the nine registered members of the Trust are Kani Tribals. The president and

vice president of the Trust are the two Kanis who imparted the Traditional Knowledge to JNTBGRI

regarding Arogyapacha.

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The objectives of the Trust are57:

Welfare and development activities for Kanis in Kerala

Preparation of a biodiversity register to document the

knowledge base of the Kanis

Evolving and supporting methods to promote sustainable use

and conservation of biological resources.

The first tranche of Rupees 5 lakh and royalties of Rupees 19,000 of the benefit sharing

formula were deposited in the account of Kani Samudaya Kshema Trust at Kuttichal Union Bank.

The first meeting of the Trust after the transfer was held at the Kallar Mattammodhu Kani tribal

settlement on March 19, 1999. In the meeting it was decided to grant as special incentives, Rs.

20,000 to Mallan Kani, Rs. 20,000 to Kuthy Mathan Kani and Rs. 10,000 to Eachen Kani, who

passed on the information to the scientists58. The Trust is currently working out a scheme to utilise

the funds. A tentative project is being worked out to set up a telephone booth, an insurance scheme

for pregnant women and to cover accidental deaths. Impact on conservation and sustainable

extraction of the plant during the harvest of leaves, some people uprooted the whole plant from their

gardens and some others took the wild herb from the forest59. This alerted the Forest Department

against possible large scale ‘smuggling’ of the herb. Scientists at JNTBGRI also felt that this should

not be done since sustainable collection of the leaves of the plant is possible. They emphasized that

only the leaves of the plant are required for the production of Jeevani. A pilot phase for cultivation

of the plant was undertaken in certain Kani settlements, in areas adjoining the Reserved Forest,

during the period 1994-96. It was supported by the Integrated Tribal Development Programme

(ITDP) initiated by the Directorate for Tribal Welfare, Government of Kerala. Fifty families were

given Rs. 1,000 (approximately $40) each by the ITDP to cultivate the plant. Under the scheme, the

JNTBGRI agreed to buy the harvested leaves from the families which were then supplied to AVP

for pilot phase production of Jeevani. However, there has been no further cultivation of the plant60.

This is because Trichopus zeylanicus is not included in the Forest Department’s notified list of

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minor forest produce. The Forest Department has hesitated in granting permission to the Tribals to

grow and harvest the leaves of Trichopus zeylanicus, largely due to earlier attempts by private

concerns to smuggle the plant out of the Reserved Forest area. In one incident, the Forest

Department seized 10,500 plants (loaded in two trucks) collected by Tribals for sale to a private

nursery near Thiruvananthapuram61. The Chief Conservator of Forests (Vigilance) is of the opinion

that though there may be no harm in the Kanis collecting the leaves of this plant for personal use,

pressures from outside commercial interests may cause the rapid depletion of the plant from the

area. In October 1996, AVP wrote to the Kerala Forest Department and the Tribal Welfare

Department proposing a plan for the cultivation of Arogyapacha whereby it would pay the Kanis

initial seed money for cultivation of the plant, and enter into an arrangement with the Tribals to buy

leaves harvested from those plants. The letter stated that AVP was prepared to buy five tonnes of

leaves a month and that at least 500 to 1,000 Kani families would be employed under such a

scheme. The company assured the State Departments that no private parties would be involved in

cultivation of the plant. The Forest Department, in its letter on October 1996, rejected AVP’s

proposal saying that the plant was endemic and its collection could not be permitted. A recent

report, however states that the Forest Department has agreed to consider including Trichopus

zeylanicus in its list of minor forest produce, and evolving a mechanism whereby AVP could buy

the leaves directly from the Kanis.

8.01.02. The Post benefit Sharing Effects

The benefit sharing experiment with the Kani Tribe showed dramatic effect on the Kani

Society in a short period of time. Some important outcomes of this experiment are the following62;

Constructed a community hall with necessary infrastructure

facilities

Purchased a jeep for transportation of people, marketing goods

and non-wood forest produce

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Kerala Kani Samudhaya Kshema Trust has been given

employment to two Kani tribesmen as driver of jeep and

helper and both of them are drawing salary every month

Telephone facilities have been provided to the office of the

trust

Construction of a small building for providing computer

facilities to the school children is in progress

Established rain water harvesting system

Negotiation is in progress to renew the manufacturing of

license of Jeevani to suitable pharmaceutical agencies for

another 7 years of period. It is suggested that license fees to

be doubled to minimum of Rs. 20 lakhs and royalty payment

also be doubled to 4 percent. This will provide more financial

benefit to the Kani Tribe.

8.02. The INBio-MERCK Agreement for Benefit Sharing

The National Institute of Biodiversity of Costa Rica (INBio) is a leader in the negotiation

and signature of benefit sharing agreements. Since its opening in 1989, INBio has signed around 11

agreements of this nature. The best-known benefit sharing agreement signed by INBio is the INBio-

Merck Agreement, which was signed in 1991, even before the Convention on Biological Diversity

was established. This agreement was the first attempt to use biodiversity in order to achieve the

commercialization of genetic and biochemical resources. The parties involved in this agreement

were INBio and Merck Sharp & Dome. The parties conceived the agreement as a contract to

collaborate in the investigation of the existent biodiversity in Costa Rica’s tropical forests in order

to establish its potential applications to human health and animals63.

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All INBio agreements contain 7 basic aspects. They are;

Direct payments in cash or knowledge exchanges (equipment,

training, technological know-how).

Payment of a significant percentage of the initial budget of the

project (10 per cent) and the returns of the

commercialization of the products (50per cent)

Cooperation clauses that stipulate the gradual translation of

the investigation processes to the supplier country, in order to

create new jobs and the achievement of industrial

development.

Minimum exclusivity.

Agreement on the samples property and patents property.

The use of chemistry synthesis, semi-synthesis and

domestication of the living sources, in order to avoid the

continuos extraction of the biotic material.

Legal Mechanisms that will provide protection to both parties.

8.03. International Cooperative Biodiversity Groups (ICBG) Program

The U.S. government, for its part, has developed similar partnerships with developing

countries to promote pharmaceutical prospecting and biodiversity conservation alike. The National

Institute of Health (NIH), the National Science Foundation, and the USAID established the five-

year International Cooperative Biodiversity Groups (ICBG) programme in 1993. The programme

funded partnerships between academics, companies, government agencies and local peoples and

local institutions in source countries to engage in bio-prospecting efforts throughout Latin America

and Africa. Its funding accounts for FY95 $2.35 million with capacity in 20 different institutions

and training over 130 individuals. The ICBG program stresses three primary goals:

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drug discovery

conservation of the environment and genetic resources of the

source country, and

development of sustainable economic activities for the people

of the source country

By adding economic value to biodiversity, therefore, this program aims to enhance the

motivations surrounding environmental conservation to the economic, political and health care

realms. In late February 1997, representatives from each group convened at NIH for the first

evaluation of the program by an outside review panel. Each of the five projects has developed its

own intellectual right structure. For instance, in one of the project, the U.S. side entered into a

contract with forest people in Peru, offering a ‘know-how’ license to compensate them for assisting

in American bio-prospecting efforts. A know-how license covers the intangible resources such as

in-depth knowledge that leads to the collection of certain plants. In exchange for annual payments,

milestone payments and royalties, the forest people are giving the U.S. interests involved the right

to use plant samples with their knowledge for a certain period of time64.

This evolving framework which takes into account intangible, Traditional Knowledge about

yet undiscovered species through fair compensation will further strengthen and validate the

increasingly close relationship between pharmaceutical and biotech companies on one side and

source countries and their indigenous peoples on the other.

8.04. Benefit Sharing by Shaman Pharmaceuticals, Inc.

Benefit Sharing by Shaman Pharmaceuticals, Inc., is a company located in South San

Francisco, Calif., that uses ethno-botany, as well as isolation and natural products chemistry, to

discover and develop novel pharmaceuticals. Agreements with culture groups and countries that

Shaman works with secure benefits for the use of plant resources and TK, both during the drug

discovery process and after a product is commercialised. At the beginning and during research

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expeditions, Shaman provides specific up-front compensation that responds to immediate needs of

country and indigenous collaborators. Long-term compensation will be available through the

Healing Forest Conservancy when a product is commercialized. Although the young company,

incorporated in 1990, is close to securing regulatory approval, at the present time Shaman has no

product and, consequently, no revenues. When a product is marketed, Shaman will channel a

percentage of profits for benefit sharing through the Conservancy, equally, to all collaborating

countries and culture groups65.

8.05. Benefit Sharing with the Local Communities of Suriname

The indigenous community of the Saramaka Maroons is composed of the ancestors of

escaped slaves. Though they are not native to Suriname, the Maroons have lived in the jungle for

nearly 300 hundred years, have their own language and are geographically and socially isolated

from the main population of Suriname. The homeland of the Maroons is the most virgin area of rain

forest left in the world and is potentially home to many species of plants and animals with

medicinal properties. For this reason, bio-prospecting, (looking for biological resources with

pharmaceutical properties) is a draw in this particular area. To protect the property rights of the

Maroon community a statement of understanding was established ensuring, “...a benefit-sharing

plan with a US$60,000 total advance payment from Bristol-Myers Squibb Pharmaceutical Research

Institute (B-MSPRI) into the Forest Peoples Fund (FPF), with additional contributions of $20,000 a

year as the ICBG is renewed” This agreement was established before prospecting began as to

ensure that some profits were earmarked for the Maroon community. The money allocated to the

fund is specified to be used for, “...projects involving community development, biodiversity

conservation and health care. If any products are commercialised from ethno-botancial collections,

50 per cent of Suriname’s share of any future royalties will go to the FPF and the other 50 per cent

will go to various ICBG partners in Suriname66”.

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8.06. The CSIR San Model of Benefit Sharing

‘Hoodia gordonii’, used by the San Bushmen, was patented by the South African Council

for Scientific and Industrial Research (CSIR) in 1998, for its appetite suppressing quality. A license

was granted to Phytopharm, for development of the active ingredient in the Hoodia plant, p57

(glycoside), to be used as a pharmaceutical drug for dieting. Once this patent was brought to the

attention of the San, a benefit-sharing agreement was reached between them and the CSIR in 2003.

This would award royalties to the San for the benefits of their indigenous knowledge. The San were

represented by a regional organisation formed under San leadership, the Working group of

Indigenous Minorities in Southern Africa (WIMSA)67.

This benefit-sharing agreement is one of the first to give royalties to the holders of TK used

for drug sales. The terms of the agreement are contentious, because of their apparent lack of

adherence to the Bonn Guidelines on Access to Genetic Resources and Benefit Sharing, as outlined

in the Convention on Biological Diversity (CBD). The San have yet to profit from this agreement,

as P57 has still not yet been legally developed and marketed.

9. Conclusion

The right to permanent sovereignty of indigenous peoples over natural resources is implicit

in international law particularly in the right of ownership of the lands they historically or

traditionally use and occupy, the rights to self-determination and autonomy, the right to

development, and the right to be free from discrimination amongst others. This right is a collective

right that requires the States to respect, protect, and promote the governmental and property

interests of indigenous peoples (as collectivities) in their natural resources. The legal expropriation

of the resources that once belonged to indigenous peoples, by the State, is discriminatory and

contrary to international law and constitutes vestiges of colonialism. This ought to be discarded to

ensure that Adivasis/indigenous people enjoy ownership of and benefits from the natural resources

on or under or otherwise pertaining to the lands they historically occupy and use. The authority of

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indigenous peoples to manage, conserve and develop their resources according to their own

institutions and laws must be adhered to. Where Adivasis/indigenous people, for valid legal

reasons, do not own or control the natural resources pertaining to all or a part of their lands or

territories, the Adivasis/indigenous people concerned must nevertheless share in the benefits from

the development or use of these resources without any discrimination and must be fairly

compensated for any damage that may result from development or use of the resources. Self-

determination, under certain conditions, collective ownership of lands and territories, exercise of

Customary Law according to social and cultural practices, legal and political representation through

their own institutions and control over their own indigenous knowledge are rights claimed by

Adivasis/ indigenous peoples that are not claimed normally by other sections. These explicitly calls

for securing legal recognition and lived experiences of the rights of governance of communities

over their biological resources; to collectively decide over development project/programmes by

recognizing the free, PIC of the Adivasi/IPs through the use of indigenous Customary Laws; to

collectively benefit from the use of their biological resources; to their innovations, practices,

knowledge and technologies acquired through generations; to collectively benefit from the

utilization of their innovations, practices, knowledge and technologies; to use their innovations,

practices, knowledge and technologies in the conservation and sustainable use of biological

diversity; and to the exercise of collective rights as legitimate custodians and users of their

biological resources.

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1 Corinna Heineke and Franziska Wolff, “Access to Genetic Resources and the Sharing of Benefits: Private Rights or

Shared Use for Biodiversity Conservation?” 6 Environmental Law Network International 26 (2004)2 Anderson Michael, “International Environmental Law in Indian Courts” 21 Review of European Community and

International Environmental Law 57 (1998)3 Cf. Jorge Cabrera Medaglia, A Comparative Analysis on the Legislation and Practices on Access to Genetic Resources

and Benefit-Sharing (ABS): Critical Aspects for Implementation and Interpretation Bonn: The ABS Project, IUCN

(2007)4 Sreenivasarao Vepachedu and Martha M. Rumore, “The Pharmaceutical Industry and the New Patent Regime in

India” Andhra Journal of Industrial News 10 (2005)5 Dr. R.K. Meena, “Intellectual Property Rights: Struggle Over Bio-resources” in Krishna Gopal, Sarbjit Sharma (Ed)

Proprietary knowledge: The Politics of Intellectual Property Rights 96 (2006)6 Rosa Castro Bernieri, “Intellectual Property Rights in Bilateral Investment Treaties and Access to Medicines: The

Case of Latin America” 9 The Journal of World Intellectual Property 548 (2006)7 See Ibid8 PIC is not defined in the CBD, but is broadly understood to mean consent given by parties to an activity after

disclosure of the reasons, risk and implications of the activity. PIC is best viewed as an ongoing ‘dynamic interactive

cycle’ of consultation, and not an event. It is a process through which users, owners and providers explore options,

identify common goals and build consent. PIC is also the process through which Mutually Agreed Terms can be

reached. However, users cannot realistically foresee all of the potential risks and implications within their research; and

PIC ‘hinges on the ability to successfully communicate complex abstract and culturally alien concepts’. See generally

Margaret Raven, “Protocols and ABS: Recognizing Indigenous Rights to Knowledge in Australian Bureaucratic

Organizations” Indigenous Law Bulletin Available at http://www.austlii.edu.au/au/journals/ILB/2006/39.html Accessed

on 28 February (2011)9 Stanley Kowalski, “Benefit Analysis of Genetically Modified Crops” Journal of Intellectual Property Rights 92

(2007)10 G. Dutfield, “Sharing the Benefits of Biodiversity: Is There A Role for the Patent System?” 5(6) Journal of World

Intellectual Property 899 (2002)11 Robert H Rines, “Should India and Other Countries Adopt the American ‘Business Methods’ Class of Patents?”

Journal of Intellectual Property Rights 183 (2007)12 K. Venkataraman, “Access and Benefit Sharing and the Biological Diversity Act of India: A Progress Report” 10(3)

Asian Biotechnology and Development Review 69 (2008)13 B. Tobin, “Monitoring Compliance under an International ABS Regime: The Role of an International Certificate

Scheme” 10(3) Asian Biotechnology and Development Review 95 (2008)14 See http://cisdl.org/biodiversity-biosafety/public/docs/abs.pdf Accessed on 17 December (2011)15 Signed by 150 government leaders at the 1992 Rio Earth Summit, the Convention on Biological Diversity is

dedicated to promoting sustainable development. Conceived as a practical tool for translating the principles of Agenda

21 into reality, the Convention recognizes that biological diversity is about more than plants, animals and

microorganisms and their ecosystems - it is about people and our need for food security, medicines, fresh air and water,

shelter, and a clean and healthy environment in which to live. See https://69.90.183.227/convention/ Accessed on 26

March (2011)

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16 For a detailed review of the substantial content of CBD, COP Decisions and SBSTTA Recommendations, as well as

to further understand the ABS and IPR process. See Secretariat of the Convention on Biological Diversity London:

Earthscan Publications Ltd. (2001)17 Dr. Matthew Rimmer, “Blame it on Biodiversity, Native Title, and Traditional Knowledge” 7 Southern Cross

University Law Review 12 (2003)18 For the complete text of the Bonn Guidelines See http.//www.biodiv.org/decisions Accessed on 24 September (2011)19 Decision VI/24 on Access and benefit-sharing as related to genetic resources See http://www.cbd.int/decisions/cop-

06.shtml?m=cop-06 Accessed on 23 September (2011)20 Kaushik Laik and Rohit Raj, “Changing Dynamics of the Patent Regime: An Economic Understanding” Journal of

Intellectual Property Rights 244 (2007)21 Joint Discussion Paper of WWF International and CIEL on Bio Diversity and Intellectual Property Rights: Reviewing

Intellectual Property Rights in Light of the Objectives of the Convention on Biological Diversity 3 March (2001)22 See Decision VII/19, Access and benefit-sharing as related to genetic resources (Article 15)

http://www.cbd.int/decisions/cop-07.shtml?m=cop-07 Accessed on 3 October (2011)23 Decision VIII/4, Access and Benefit Sharing. See http://www.cbd.int/decisions/ Accessed on 8 October (2011)24 Refer to Article 1.1 of the Seed Treaty. See http://www.ukabc.org/ITPGRe.pdf. Accessed on 8 October (2011)25 For the full list of crops, refer to ETC (2001b)26 The WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge

and Folklore (IGC) was established by the WIPO General Assembly in October (2000) (document WO/GA/26/6) as an

international forum for debate and dialogue concerning the interplay between Intellectual Property (IP), and Traditional

Knowledge, genetic resources, and traditional cultural expressions (TCEs)/(folklore). See http://www.wipo.int/tk/en/igc/

Accessed on 8 October (2011)27 See Ibid28 The fifth session of this Intergovernmental Committee discuss Intellectual Property issues that arise in the context of

(i) access to genetic resources and benefit-sharing; (ii) protection of Traditional Knowledge, whether or not associated

with those resources; and (iii) the protection of expressions of folklore. See

http://www.wipo.int/documents/en/meetings/2003/igc/index_5.htm Accessed on 8 October (2011)29 Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore;

Ninth Session. See www.wipo.int/ docs/mdocs/tk/en/wipo_grtkf_ic_9_9.doc Accessed on 8 October (2011)30 See Environment and TRIPS (WT/CTE/W/8 and W/8/Corr.1), The CBD and TRIPS (WT/CTE/W/50), The

Relationship Between the CBD and TRIPS with a Focus on Article 27.3(b) (WT/CTE/W/125)31 See “Protection of Biodiversity And Traditional Knowledge - The Indian Experience”, Submission by India to the

WTO, WT/CTE/W/15632 See WT/GC/W/20233 The Nagoya Protocol was adopted under the auspices of the Convention on Biological Diversity (CBD). As a

protocol to the CBD, the Nagoya Protocol is the instrument for the implementation of the Access and Benefit Sharing

provisions of the CBD. In this regard, the CBD provides the substantive, institutional and procedural basis for the

Nagoya Protocol. For example, the scope of the Nagoya Protocol is defined by the scope of Access and Benefit Sharing

provisions of the CBD. Moreover, institutional arrangements such as dispute settlement mechanisms and secretariat

services for the Nagoya Protocol will also be those already established under the CBD. Nevertheless, the Nagoya

Protocol is a new and separate international instrument. Countries need to sign and ratify the Nagoya Protocol for it to

enter into force. The Nagoya Protocol will only be legally binding for the countries that do sign and ratify it. In

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addition, only countries that have signed and ratified the CBD are able to sign the Nagoya Protocol. In other words,

countries such as the United States, which has not ratified the CBD, cannot sign or ratify the Nagoya Protocol.

Countries that have signed and ratified the CBD, say Armenia or Finland, can choose to sign and ratify or not - in this

latter case, countries would remain bound only by the overarching CBD provisions on Access and Benefit Sharing.

Finally, countries that sign and ratify the Nagoya Protocol will need to implement it through national legislation. The

Nagoya Protocol will open for signatures on 1 February 2011, for one year, and enter into force 90 days after the 50th

ratification. See http://www.ethicalbiotrade.org/news/wp-content/uploads/UEBT_ABS_Nagoya_Protocol_TB.pdf

Accessed on 8 October (2011)34 See Ibid35 See http://www.un.org/esa/sustdev/documents/WSSD_POI_PD/English/POIToc.htm Accessed on 3 November (2011)36 In 1998, Glowka estimated that over 50 countries were the process of developing their ABS policies and legislation.

See L. Glowka, A Guide to Designing Legal Frameworks on Access to Genetic Resources and Benefit Sharing. For a

review of the actual texts of many ABS laws and policies See http.//.www.grain.org Accessed on 8 October (2011)37 Manuel Ruiz , “Access to Genetic Resources, Intellectual Property Rights and Biodiversity: Processes and Synergies”

Paper Presented for the Seventh Meeting of the Conference of the Parties to the Convention on Biological Diversity (

2004)38 See Ibid39Asha Krishnakumar, “A Deal Blocked in Chhattisgarh” Economic and Political Weekly 20 (2003)40 This provision allowing farmers to sell seed is crucial; farmers provide around 85 per cent of the seed planted by

farmers in India. If farmers could not sell seed due to IPR that would restrict a farmers’ ability to do so, the most likely

party to fill this void would be private seed firms who, if industrialized economies can be considered a proxy for an

alternative scenario, would offer seeds according to their ability to act as monopolists. This scenario is even more

relevant in light of the limited (and diminishing) budget allocations given to public sector breeding efforts in India, who

would arguably be the other relevant source of seed for farmers.41 In what follows, we will contain our analysis to the BDA and the PPV. However, this is by no means and indication

that these are the only two pieces of Indian legislation that are relevant in our context. Sahai (2002) points out that the

Indian Forest Act, 1927 (rights over and administration of forest produce), the Wildlife (Protection) Act, 1972

(notification of the protection of certain plants by the state with exceptions for indigenous peoples), the Forest

Conservation Act, 1980, and the Environment Protection Act, 1986, all have relevance to the issues at hand. Kaushik

(2002) also mentions the Transfer of Property Act, 1882 as it relates to common property. However, to facilitate a more

meaningful exploration, we will only consider the BDA and PPV. It should be kept in mind however, that there is

overlap among extant policy, and in what follows the problems that can arise from this will be considered.42 Village level political processes are established in the Constitution of India. While Panchayats have existed in India

before Independence, they were only recently formally recognized as a system of governance. In 1993, the Constitution

of India was amended via the 73rd Amendment Act; this amendment formally institutionalizes the Panchayatas the third

level of governance, with the national and state being the first and second respectively. In essence, the Panchayati Raj

comprises the following: each village has an assembly of all the adult members called the Gram Sabha; a group of

villages have a Panchayat. The gist of the Constitutional amendment is that states are mandated to recognize Panchayats

as institutions of self-government, and have the responsibility to prepare plans for economic development and social

justice…A greater role for the Panchayati ecosystem management as envisaged by the Constitution 73rd Amendment

Act, 1993, by placing new matters under its jurisdiction, including land improvement, land consolidation and soil

conservation, social forestry and minor forest produce. These provisions there provide scope for local communities to

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play a role in governance relating to natural resources. It is within this context that the BMCs at the village, or

Panchayat level of operates. While this amendment applies nationally, certain states have been more successful than

others in this process of decentralized governance; on the one hand, Kerala has been relatively quite successful in

decentralizing authority, due to its politically left leaning government. The state of Bihar on the other hand, has hardly

made any efforts to further this process, due to the general lack of the rule of law that is prevalent there. In the end, it is

a very much state driven process, and depends substantially on the willingness of the state government to introduce the

reforms needed to decentralize.43 ‘Intimation’ is defined as ‘to make known publicly or formally’, refer to Article 7 of the BDA at See

http://www.grain.org/docs/india-biodiversityact-2002.pdf. Accessed on 9 October (2011)44 Refer to Article 6.1 of the BDA, 200245 Refer to Article 27.2 (b) of the BDA, 200246 CSIR is an autonomous body formed in 1942 before India gained independence; its broadly stated mission is to

“provide scientific industrial research and development that maximizes the economic, environmental and societal

benefits to the people of India”, though more recently it has been “to promote development of indigenous technologies

and utilization of indigenous resources.” See http://www.csir.res.in. Accessed on 9 October (2011)47 Refer to Article 13.1 of the PPVFRA, 2001

, Available at http://www.grain.org/docs/india-pvp-act-2000-en.PDF. Accessed on 9 October (2011)48 Refer to Article 26.5 of the PPVFRA, 200149 Refer to Articles 35.1, 41.4 and 45.1 of the PPVFRA, 200150 Refer to Article 45.1 of the PPVFRA, 200151 JNTBGRI (Jawaharlal Nehru Tropical Botanical Garden and Research Institute) is an autonomous body established

by the Government of Kerala in 1979. It has been accorded the status of a Center of Excellence in conservation and

sustainable utilisation of tropical plant diversity by the Ministry of Environment and Forests, Government of India.

Spread over 300 acres, the Garden System of JNTBGRI has over 50,000 accessions belonging to 7000 tropical plant

species. The garden system includes an Arboretum, Bamboosetum, Palmetum, Orchidarium and field collections of

medicinal plants, wild ornamentals and lesser known wild edibles. In addition to these, there are special conservatories

for rare, threatened and endemic plants, special assorted collections of Ficus, Cycads, Ferns, Cacti and Succulents,

Aquatic plants etc. The medicinal plant collection includes wild lesser known plants used by the indigenous

communities. As one of the National Gene Bank for Medicinal and Aromatic Plants established under the aegis of the

G-15 countries, JNTBGRI has established a field gene bank, seed bank, tissue repository and cryo bank of rare and

endangered medicinal and aromatic plants of tropical India. The R&D activities of TBGRI are integrated and

multidisciplinary in nature and are geared to achieve the most tangible results of conservation as well as of value added

and product oriented sustainable utilization of plant genetic resources of the region. See http://www.tbgri.in/ Accessed

on 12 October (2011)52 The Ministry of Environment and Forests, Government of India had launched an All India Coordinated Research

Project on Ethnobiology (AICRPE) in 1982, with the broad objective of preserving the knowledge system of our tribal

communities. The JNTBGRI was the Coordinating Centre of this multi-institutional, multi-disciplinary action oriented

research programme. See Ibid53 The Kanikar (Kani) inhabit the southern part of the Western Ghats. The British in their time had colonized the natural

wealth of the Kanikar’s ancestral domain which the states of Kerala and Tamil Nadu managed as internal colonies. (The

Attingal princely rulers recognised large parts of their ancestral domain in olden times. In the eighteenth century,

Marthandavarma Maharaja allotted 36,000 acres through a royal neetu (royal order) to 21 prominent Kanikars. Of this

273

25,954 acres and 82 cents are in Thiruvananthapuram and 10,045 acres and eighteen cents are in Kanyakumari districts.

The Indian state refuses to recognise this.) With the creation the two states Kerala and Tamil Nadu their ancestral

domain was divided. The states pushed them further to the periphery of smaller administrative units, that is, the

districts, taluks and panchayats. They live in parts of Thiruvananthapuram and Kollam districts in Kerala and

Tirunelveli and Kanyakumari districts of Tamil Nadu. Their population is about 25,000 of whom over threefourths live

on the Kerala side while the rest inhabit Tamil Nadu. (Raymond Gordon Jr. ed., Ethnologue: Languages of the World,

SIL Code: KEV, ISO 639-2: dra (Dallas: SIL International, 2005). All the existing studies on the TBGRI Kani ‘Model’

mention their population at about 16,000 confined only to Thiruvananthapuram district) The revenue and forest

departments of these two southern states now hold most of these lands while the remaining parts of the lands have been

appropriated and converted as estates and plantations by powerful non-Tribals. The Kanikars are pushed into marginal

enclaves scattered across the southern part of Western Ghats. A part of the ancestral domain of Kanikar covering 128 sq

km in the Thiruvananthapuram district has been declared the Neyyar Wildlife Sanctuary. Contiguous to Neyyar is the

Kalakkadu Wild Life Sanctuary (a tiger reserve) covering an area of 223 sq kms and the Mundanthurai Wildlife

Sanctuary of another 567 sq kms, both in the Tirunelveli District of Tamil Nadu. A larger area (that includes the Neyyar

Wildlife Sanctuary) of 1,701 sq kms was declared the Agasthyamala Biosphere Reserve in 2001. Access to these areas

is severely restricted, many thousands have been evicted and the remaining faces the threat of eviction. In addition,

large tracts of the Kanikar’s habitat are classified as forests in both the states. See Supra n. 13354 Arya Vaidya Pharmacy, (AVP) a Coimbatore based company has been manufacturing Ayurvedic drugs since 1948.

AVP is pursuing the commercialization of Ayurvedic and herbal formulations in a highly value based manner,

upholding high quality standards. See http://www.avpayurveda.com/ Accessed on 23 October (2011)55 The Agreement for Licensing of Know-how signed between Tropical Botanic Garden and Research Institute and The

Arya Vaidya Pharmacy (Coimbatore) Ltd., 10 November 1995. Full text of the agreement is available at

http://www.wipo.int/ tk/en/databases/contracts/texts/html/tbgri.html. Accessed on 23 October (2011)56 ‘Samudaya’ means ‘community’, ‘Kshema’ means ‘welfare’.57 Supra n. 558 See Ibid59 See Ibid60 See Ibid61 See Ibid62 See Ibid63 See http://www.unctad.org/trade_env/docs/Benefit%20Sharing.pdf Accessed on 12 December (2011)64 See http://www1.american.edu/TED/hpages/ipr/misa.htm Accessed on 4 December (2011)65 See http://www.cbd.int/doc/case-studies/abs/cs-abs-ng-a.pdf Accessed on 26 December (2011)66 See http://p2pfoundation.net/Benefit_Sharing_Under_the_Convention_on_Biological_Diversity Accessed on 8

December (2011)67 S. Tully, (2003). “The Bonn Guidelines on Access to Genetic Resources and Benefit Sharing” 12(1) Review of

European Community and International Environmental Law 84 (2008)