abs mechanism for protection of traditional knowledge

ABS mechanism for protection of traditional knowledge and genetic resources

1) Introduction

Advancements in the field of genetic engineering found out that knowledge of

indigenous communities and genetic resources if channelized in appropriate manner

are capable of bringing out successful commercial products. The growing importance

of bio-technology and increasing number of patents granted to biotechnology based

inventions highlight the potential value of genetic resources and associated

traditional knowledge. The values of traditional knowledge in development of final

product have always been a subject of controversy. The relationship between access

to genetic resources and benefit sharing and intellectual property is based on the

principle that the grant of patents or any other intellectual property rights over

biodiversity related innovation should be conditioned of biodiversity components

being acquired, obtained or accessed legally1.

Most of the developed countries including Europe and US are having very liberal

approach towards granting of patents and usually patents are given to final products

based on traditional knowledge ignoring the common knowledge associated with the

invention. There are various examples regarding granting of patents in these

jurisdictions over products based on biological resources commonly used in

developing countries like use of turmeric in wound healing, composition of jamun,

bitter-gourd and eggplant for treatment in diabetes, various products obtained from

neem tree etc. Biopiracy is a rampant phenomenon in the globalised world which

made the developing countries to be more conscious about their valuable biological

resources. In order to prevent biopiracy and to create a sense of mutual trust there

was a need for an efficient mechanism to regulate the handling of genetic resources

and associated traditional knowledge.

This has led to the development of complex and controversial legal frameworks

regarding access to genetic resources and equitable benefit sharing. Biological

resources are common heritage of mankind but benefits of use of these resources

are exploited by Multinational companies and developed nations with their

technological advantage and financial resources2.

1 See Manuel Ruiz Muller, Disclosure of origin and legal provenance, available at http://ictsd.org/downloads/2011/12/disclosure-of-origin-and-legal-provenance-the-experience-and-implementation-process-in-south-america.pdf

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Intellectual property rights are basically negative rights providing for exclusivity. It

does not recognize the rights of traditional knowledge holders and discussions are

going on at various international forums for development of a compensation

mechanism that provides for at least an indirect recognition of their contribution to

modern technological developments. Granting exclusive rights to individuals for

products based on genetic resources will only worsen the situation of already

exploited biological resources.

The issue of access to genetic resources and equitable sharing of benefits have a

major focus on biodiversity conservation and its sustainable use3. Access regimes

are result of increased importance given to genetic resources and associated

traditional knowledge on the other hand benefit sharing mechanisms has been

developed as a response to absence of intellectual property protection under the

existing intellectual property regime. Relevance of access and benefit sharing

mechanism is due to large amount of genetic resources and associated traditional

knowledge is having commercial viability in a number of formal sectors, including but

not limited to pharmaceuticals, biotechnology, seeds, horticulture, botanical

medicine, cosmetics and personal care and food.

2) Access to genetic resources and Traditional Knowledge

Genetic resources are biological materials of plants, animals, microbial or any other

origin that contain hereditary information necessary for life and are responsible for

their useful properties and abilities to replicate4. For centauries indigenous

communities have managed to preserve these resources through trial and error

process by selecting crops and harvesting medicinal plants. Importance of genetic

resources and associated traditional knowledge lies with the fact that it constitutes

the basis for livelihood of bulk of the population of developing nations and that about

75% of world population depends on medicines based on traditional and plant based

2 See International regime of access and benefit sharing mechanism available at

http://www.sawtee.org/publications/Policy-Brief-16.pdf3 See Access to Genetic resources in Africa available at http://www.ias.unu.edu/resource_centre/ABS%20in

%20Africa.pdf4 See Kerry Ten Kate & Sarah A Laird, The Commercial Use of Biodiversity : Access to Genetic resources and

Benefit sharing available at http://books.google.co.in/books?id=-

yRfL4Q_t0cC&printsec=frontcover#v=onepage&q&f=false

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knowledge for their primary health care5. Advancements in the field of biotechnology

and genetic engineering have posed threats to the existing biological resources and

developing countries were forced to regulate access to their genetic resources.

Access in this context refers to the ability of individuals or corporations to acquire or

use genetic resources for a multitude of purposes and not limited to commercial

application6. Access to traditional knowledge and genetic resources in it is not a new

issue. Bio prospecting has been going on for decades and individuals and

corporations have yielded significant commercial returns out of it. Bio-prospecting

refers to the process by which individuals or parties actively seeks out genetic

resources found primarily in plants, but also in animals and micro organisms with aim

of isolating a compound or active ingredient and marketing the resultant product as

commercial commodity7.

Basically access regimes relate to identify the conditions under which the potential

users can obtain the resources or knowledge they need. Access regimes are often

seen as linked with benefit sharing but this is only in cases of establishing origin of

knowledge or resources used in a product or process which is patent protected.

Access regime is important not only as a platform for benefit sharing mechanism but

on a broader aspect as an assertion of rights of ownership on biological resources

and traditional knowledge and thereby as an essential ingredient of sovereignty of

the country8.

Between the assertion of sovereignty and willingness to provide facilitated access

there are ample scopes for devising legal regimes which can be strict or lenient 9. A

strictly regulated access regime can give more effective control over transfer of

resources outside the country and thereby provide the country with more control over

biodiversity conservation. But there is always a possibility that it might discourage bio

prospectors and affects long term research and trade prospects. On the contrary a

5 Ibid note 36 See Janak Rana Ghose, Access and benefit sharing systems: An overview of the issues and regulations

available at http://ranaghose.com/research/abs.pdf7 Ibid note 68 Convention on Biological Diversity9 See Cary Fowler, Protecting Farmer Innovation: The CBD and the question of Origin, The ABA’s Journal of law science and Technology 486(2001)

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liberalized access policy is likely to increase the interests of the bio prospector and

yield economic benefits for the country.

There are different considerations that can guide the governments in framing access

regimes. As best practice standards every access regime shall provide for Prior

Informed Consent, Disclosure of origins and Mutually Agreed Terms.

a) Prior Informed Consent ( PIC), Mutually Agreed Terms(MAT) and Disclosure of Origin(DOO)

The notion of prior informed consent is one of the basic principles of access regimes

at international level. Prior Informed Consent is the interface between assertion of

sovereignty and commitment to facilitate access ie providing states with

opportunities to determine conditions under which access to biological resources are

to be provided. It is the authorisation given by the national government to a bio

prospector to enter into nation and conduct research upon biological resources

under certain limitations which are mutually agreed upon10.

PIC is obtained in writing from the competent government authority, and from the

relevant stakeholders including local communities and indigenous people who are

owners or custodians of biological resources. PIC is greatly linked to benefit sharing

as it provides an initial opportunity to conduct negotiation for framing an effective

benefit sharing mechanism. Basic principle on which PIC is based includes need to

minimise cost of access and need to ensure that restrictions on access are

transparent. In context of genetic resources and associated traditional knowledge

PIC is significant to address the concerns about companies, research institutions

and other entities acquiring and using genetic resources from biodiversity rich

countries without knowledge and permission of rightful owners and holders11.

PIC is not intended to prevent adverse impacts of transfer of genetic resources and

associated traditional knowledge rather it lays emphasis on preventing exploitation of

biological resources as well as ensures that equitable benefits are accrued to the

owners or holder of those knowledge through such transfer. Involvement of

10 See ABS Management Tool, best Practice standard and handbook for implementing Genetic Resource Access and Benefit Sharing , available at http://www.iisd.org/pdf/2007/abs_mt.pdf11 See the issue of Bio piracy in several instances, as an example European Patent office granted patent over certain fungicidal properties of neem tree which as a matter of fact was a common knowledge for people of India.

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stakeholder ie original traditional knowledge holder is important while granting PIC or

entering MAT and it shall be the duty of the competent national authority to facilitate

the involvement of stakeholders throughout this process12.

Besides PIC, Mutually Agreed Terms are considered as a concept that can be

included in standard access regimes. Mutually Agreed Term are conditions and

provisions of access and benefit sharing, among others, negotiated between user

and provider and involving other relevant stakeholders13. MAT are negotiated in a

manner that builds confidence and relationship of trust between owners, managers

or custodians of genetic resources and users of genetic resources and establishes

basis for long term, transparent and respectful relationship and communication

between them14.

MAT should contain provisions regulating use of resources and specific ways in

which genetic resources are to be used, provision for joint ownership of IP rights

based on degree of contribution of the provider community to development of the

product and also provisions for joint research, any limitation imposed on access and

transfer of results by the provider country and conditions, obligations, procedures,

types, timing, distribution and mechanism of benefits to be shared15.

Disclosure of origin is one of the proposals put forward by developing nations in

WTO for protection of biological resources. According to these proposals the

applicant for patent should be asked to provide along with the application, detail of

the country from which he borrowed information regarding his invention, and provide

evidence to show that all legal requirements of the particular country for access and

fair and equitable benefit sharing arising from commercial use of such resources has

been fulfilled16.

The rationale behind all these measures is to ensure that in cases where biological

resources have to be exchanged abroad the holders of those resources should be

12 See section 34 of bonn guidelines13 Ibid note 1214 ibid15 See article 45 of bonn guidelines16 WTO Doha work programme –the outstanding implementation issue on the relationship between the TRIPS

and CBD , communication from India.pakistan, Brazil, Peru, Thailand and Tanzania, WT/GC.W.564,TN/C/W?

41,

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made aware of such transfer and to ensure that they receives an equitable share of

benefits which the user incur by using said resources.

3) Equitable Benefit sharing mechanism

Benefit sharing is a relatively new area that has been developed as a consequence

of rapidly changing paradigm concerning claims over genetic resources and

associated traditional knowledge. It is a compensation mechanism which is

developed as an alternative to grant of intellectual property rights to inventions based

on biological resources. Benefit sharing arrangements are intended to create or

strengthen capacity of the stakeholders through several mechanisms including

technology transfer and training which is relevant for conservation and sustainable

use of genetic resources. It is an additional indirect control mechanism that

accompanies the access regime.

Benefit sharing mechanism indicates sharing fairly and equitably with the country of

origin and other stake holders, benefits arising from use of genetic resources and

their derivatives including non monetary benefits and in cases of commercialization

monetary benefits .It aims to bring a harmony between the monopolistic intellectual

property regime and collective interest of the community in issues relating to genetic

resources and associated traditional knowledge. The rationale behind this

mechanism is that the holders of genetic resources and traditional knowledge are

entitled to receive an equitable share of benefits that arise from use of those

resources which may be expressed in terms of compensatory payments or other non

monetary benefits. Benefit sharing is an action of giving a portion of advantaged

derived from the use of genetic resources and traditional knowledge to the resource

providers in order to achieve justice in exchange17.

Before entry of force of CBD there was no international regime regulating transfers of

biological resources and any bio prospecting prior to CBD have taken place in a

legal vacuum and at best parties would have entered a bilateral contract with each

other18. The institutionalisation of concept of benefit sharing has evolved as a

response to conflicting interests of developing and developed nations and thereby as

17 seed Schroeder, Global medical ethics, benefit sharing: Its time for a definition available at www.justor.org/stable/2771983818 For example Merk in bio agreement which happened prior to CBD see www.ciesin.org/docs/008-129/008-129.htm

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an improvement to the existing compensation regime. For countries having more

biotech industries, benefit sharing is more restricting than the pre Biodiversity

convention system which would have allowed freedom to choose mode of access

and compensation and on the other hand as far as the countries of origin are

concerned benefit sharing have proved to be a venue through which governments

can acquire more authority towards other countries and towards holders of biological

resources19. Benefit sharing for developing countries has the advantage of granting

and recognizing certain rights to original holders and thereby providing a role for the

state in managing the resources and the compensation that comes in return20.

There are number of controversial factors associated with benefit sharing. One of the

disputes is regarding the threshold required by the claimants to be eligible for

claiming benefits. CBD provides that compensation is due for use of any kind of

genetic resources21 which indicates that a claim for compensation mechanism can

exists in all cases of research irrespective of its purpose being commercial or non

commercial. In effect it implies that even basic research using biological resources

and associated traditional knowledge is not free and requires compensation. Such a

wide approach would hinder access to knowledge and innovations through research.

Another controversy is related to monetary compensation. Benefit sharing has been

often conceived as a form of financial compensation. Monetary benefits can take the

form of access fees, royalty payment, license fees or contributions to be paid to

certain funds set up for this purpose. Monetary compensation remains controversial

as it tends to reduce benefit sharing to a one off financial transaction which may not

reach actual claimants. Further in situations where monetary compensation is

directed to a financial mechanism set up to receive monetary compensation for

further redistribution it may be allocated for a number of goals which may or may not

be of direct significance to the actual claimants22. In other words where monetary

compensation is channelled through an institution authorized by the states it has the

19 See M D Nair, TRIPS WTO and IPR, protection of Bio resources and traditional knowledge, available at www.ssrn.com 20 See the scope of access and benefit sharing under the international treaty available at http://www.bioversityinternational.org/fileadmin/bioversityDocs/Policy/Access_and_Benefit_Sharing/SGRP%202008%20Policy%20Brief_Scope%20of%20ABS%20under%20the%20Treaty.pdf21 See article 1 of CBD22 See Access and benefit sharing mechanism of genetic resources, ways and means for facilitating biodiversity research available at http://www.bfn.de/fileadmin/MDB/documents/service/skript163.pdf

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http://www.bfn.de/fileadmin/MDB/documents/service/skript163.pdf

http://www.bioversityinternational.org/fileadmin/bioversityDocs/Policy/Access_and_Benefit_Sharing/SGRP%202008%20Policy%20Brief_Scope%20of%20ABS%20under%20the%20Treaty.pdf

http://www.bioversityinternational.org/fileadmin/bioversityDocs/Policy/Access_and_Benefit_Sharing/SGRP%202008%20Policy%20Brief_Scope%20of%20ABS%20under%20the%20Treaty.pdf


potential to be of diverted use that may not be favoured by the traditional knowledge

holders

In order to resolve this number of other non monetary benefits have been proposed

as an alternative or as an addition to monetary benefits. These includes sharing of

research results with the original share holders and scientists of the country of origin

or to engage in collaboration and cooperation in scientific research and development

programmes with the research organisations of the resource owing countries. On the

commercial side it can include setting up of factories in the area of origin of genetic

resources or transfer of technologies developed on the basis of knowledge or

resources accessed or providing for joint ownership in intellectual property.

The implementation of benefit sharing schemes requires coordinated action on the

part of provider countries and user countries so that a common platform can be

created23. However this is proving difficult due to lack of an international mechanism

governing benefit sharing mechanism.

a) Benefit sharing mechanism in practise – the case of Arogyapacha and Hoodiya

First case concerns use of a plant named “Arogyapacha” which is found in southern

part of Western Ghats. The said plant was widely used by local tribal people; the

kani’s for its anti- fatigue properties and were unknown to outsiders since 1987.

Biologists of Tropical Botanic Garden and Research Institute (TBGRI) were looking

for a drug to reduce fatigue and persuaded some of the local kani people to share

their knowledge with them and the transfer of knowledge led TBGRI to development

of an innovative drug “Jeevani” with anti- fatigue properties.

The right to manufacture Jeevani were transferred to a private company and benefit

sharing scheme were setup in the initial stages. But in 1995 TBGRI came up with a

benefit sharing scheme as a part of a license agreement which ask the transferee to

give 50 percent of fee and royalty to the kani people24. The fund due to the kani

tribes were transferred to Kani Samudaya Kshema Trust, a trust with 500 kani

families as members which is meant to foster activities which would promote the

common benefit of the community. The benefit sharing scheme for Jeevani are 23 ibid24 See Ministry of environment and Forests, benefit sharing model experimented by TBGRI

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welcomed because it makes a genuine attempt to recognize contribution of Kani

people for the development of the final product “Jeevani” drug.

Another successful benefit sharing example is that of hoodia plant found in Africa

which is also having anti- fatigue properties like that of arogyapacha. Hoodia is a

kind of cactus found in Africa which is used by the “SAN”, African tribal people to

starve off hunger and thirst in long hunting trips. In 1995 South African Council for

scientific and industrial research patented hoodia’s appetite suppressing element25

and its potential use for curing obesity. In 1998 Ptfizer acquired a license of said

patent and started manufacturing a sliming drug as a cure for obesity. San tribal

people came to know about exploitation of their traditional knowledge in 2001 and

launched a legal action against South African Council for scientific and industrial

research for biopiracy and violation of principles of CBD. Later two sides entered into

negotiation for a benefit sharing mechanism and in 200226 a land mark agreement

were entered by both parties according to which SAN people would receive a share

of any future royalties received by South African Council for scientific and industrial

research.

On an overall scale benefit sharing mechanism is not necessarily a success story

though it provided for monetary benefits for the welfare of the members of the kani

tribe27 or to the SAN tribe. The Jeevani \ model has been criticised on the ground

that entire terms and conditions envisaged under the said agreement were

determined by outsiders ie Kerala Institute of Research Training and Development of

Scheduled Castes and Scheduled Tribes and not by stake holders. Kani tribals are

not fully integrated with the main stream society and any measures allowing access

to their lifestyle without giving them an opportunity to present their interests would

eventually lead to destruction of their life style.

Such benefit sharing practices shall not be accepted as a model for future benfit

sharing arrangements. An appropriate approach would be to start from principle of

prior informed consent and thereby giving the stake holders a chance to determine

25 See Shahid Alikhan and Raghunath mashelkar, Intellectual property and competitive strategies in the 21st centuary, Kluwer Law international , london26 ibid27 See C R Bijoy, Access and Benefit sharing from indigenous peoples perspective, The TBGRI – Kani model available at http://www.lead-journal.org/content/07001.pdf

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their own terms and conditions for transfer of biological resources and associated

knowledge.

4) International Access and Benefit Sharing regimes

The convention on Biological diversity is the basic treaty concerning the regulation of

access to biological resources and benefit sharing. However other international

institutions and instruments like WIPO, TRIPS and FAO have also developed

guidelines for creating an effective benefit sharing mechanism. This chapter would

be dealing with how ABS mechanism has evolved in the international scenario.

a) Convention on Biological Diversity and Access and Benefit Sharing Mechanism

The Rio Earth Summit which convened in June 1992, promulgated the Convention

on Biological Diversity which represented an attempt to establish an international

regime for conservation and utilization of world’s biological resources28 and for fair

and equitable sharing of benefits arising from the utilisation of genetic

resources29.The most important issue regarding intellectual property rights under

CBD is access to genetic resources and associated traditional knowledge and

equitable benefit sharing mechanism.CBD contains provisions related to access to

genetic resources, transfer of technology ,informed consent and sharing of

benefits30.

Article 1 of CBD provides that the parties should strive for a fair and equitable benefit

sharing mechanism for sharing of benefits arising out of utilisation of genetic

resources, including appropriate access to genetic resources and transfer of relevant

technologies and by appropriate funding31. However this objective must be read in

conjunction with those provisions of CBD that enable the contracting nations to take

control over genetic resources. CBD recognizes the sovereign rights of the nations

over their natural resources32 and the authority of the nations to determine access to

28 See F McConnell, The Biodiversity convention, A negotiating History available at www.ssrn .com 29 See CBD article 130 See article 15, 16 and 19 of CBD31 See http://www.cbd.int/convention/articles/?a=cbd-0132 See Article 3 of CBD

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genetic resources using national legislation33 and thereby providing for an

appropriate access and benefit sharing scheme.

Article 15 of CBD envisages the basic framework for an ABS mechanism. It reaffirms

the sovereign authority of the states over their biological resources and power of

competent national authority to control the access to these resources34. It specifically

provides that the access regimes could be subject to prior informed consent and

mutually agreed terms. Besides CBD also recognise the need for inclusion of

transfer of technology within MAT to achieve the objectives of CBD35.

CBD requires the state parties to initiate legislative and administrative measures for

sharing the results of research on biological resources as well as for sharing of

benefits arising from commercial and other application of these resources36.the most

controversial article in CBD related to ABS and IP is article 8(j) which requires

parties to frame national legislations which recognizes innovations and practices of

indigenous communities and to provide for an equitable benefit sharing mechanism

for sharing of benefits arising from the utilization of traditional knowledge and

practices.

One of basic problem with the provisions of CBD is that they are mostly

recommendatory in nature and not mandatory37. However concretisation of basic

principles relating to access and benefit sharing has been a subject of debates for a

number of years in different international foras in context of CBD. In 2002 the

Conference of parties adopted certain guidelines on access to genetic resources and

sharing of benefits which is known as the Bonn guidelines.

B. The Bonn guidelines on access to genetic resources and fair and equitable sharing of Benefits Arising out of their utilization

Bonn guides have been framed by the COP in 2001 as a framework for action for

contracting parties while framing their national legislations and are expected to assist

parties in developing an access and benefit sharing strategy in domestic legislations.

33 See article 15 of CBD34 See article 15(1) of CBD35 See article 16 of CBD

36See article 15(7) of CBD37 See Venekataraman and latha, IPR, TK and biodiversity of India JIPR july 2008

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The guidelines identify steps involved in access and benefit sharing process with an

emphasis on obligation for users to seek prior informed consent and to enter into

mutually agreed terms with stakeholders. Although these guidelines are not legally

binding it have been adopted by more than 180 countries giving them clear and

indisputable authority38.

Bonn guidelines require the state parties to establish a national authority to

determine the question of access to biological resources and to grant PIC and

facilitate negotiations for MAT and benefit sharing arrangements39.Bonn guidelines

emphasise on the need for involvement of stakeholders during negotiations under

MAT. It gives a brief outline as to how benefits derived from use of genetic resources

or associated traditional knowledge need to be shared between user and provider. It

also provides a long list of monetary and non monetary compensation which shall be

shared between the user and provider under MAT or a separate benefit sharing

agreement entered by the parties40. Monetary benefits include access fees, upfront

payments, milestone payments, royalties, license fees, research funding, joint

ventures and joint ownership in IP rights and Non monetary benefits include sharing

for R&D results, participation in product development, contribution for education and

training, transfer of technologies, Institutional capacity building etc41.

But on an overall scale Bonn Guidelines have not been widely implemented by the

nations42. As a result of this further discussions were initiated within CBD and COP

to create an international regime on Access and Benefit sharing mechanism. The

result of these discussions was the Nagoya protocol on access and benefit sharing,

2010.

C) Nagoya Protocol on Access to genetic Resources and the Fair and Equitable Sharing of Benefits arising From their Utilization

The Nagoya protocol is an international instrument adopted by the parties to CBD in

October 2010 to provide legal recognition to the third objective of CBD for a fair and

38 See Hamdallah Zedan on Bonn Guidelines available at http://www.planttreaty.org/sites/default/files/bonn_guidelines.pdf39 See article 14 of Bonn Guide lines40 See article 4541 See Appendix II to Bonn Guidelines42 Natalie P Stionanoff, Biological resources and benefit sharing, the intersection between traditional knowledge and intellectual property.

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equitable sharing of benefits arising from utilisation of biological resources and to

provide for an appropriate access mechanism and transfer of technologies. Basically

Nagoya protocol is reiterating what have been already declared under CBD and

Bonn guidelines.

It provides that the state parties have sovereign right over its biological resources

and can regulate access to these resources through PIC and MAT. The national

authority established for granting access should ensure participation of relevant

stake holders in all negotiation proceeding and PIC from stakeholders were made a

mandatory requirement43. It provides procedural guidelines that should be followed

by the states and the National authority established under domestic legislation while

dealing with ABS mechanism.

Concerning benefit sharing a long list of benefits is listed under the Protocol which

are to be considered by the competent national authority while framing a benefit

sharing agreement. Benefits envisaged under the protocol are more or less similar to

those enlisted under appendix 2 of Bonn guidelines. Protocol also prescribes

collaboration and cooperation in technical and scientific R&D programmes which

takes place in participation with provider parties44 and users. Protocol also give

special reference to the approach to be taken in cases of transboundary situations ie

in cases where the genetic resources or traditional knowledge used by the bio

prospectors are shared between the boundaries of two different nations45.

Nagoya protocol constitutes the latest ambitious approach to develop an

international instrument complementing the critical aspects of ABS regime provided

under the CBD. . Considering the positive and negative features the Protocol can be

regarded as a balanced instrument considering the clash of interests behind it46. But

actual utility of the protocol will only become visible during implementation stage.

D) International Organisations and ABS Mechanism

43 See article 6 of Nagoya protocol 44 See article 2345 See article 1146 See Evanson Chege Kamau, bevis Fedder and Gred Winter, The Nagoya Protocol, what is new and what are the implications for provider and user scientific community, available at http://www.lead-journal.org/content/10246.pdf

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Protection of traditional knowledge and biological resources from

unauthorized access is a topic of constant deliberation under various

international organizations like FAO, WIPO and WTO. Extensive

discussion on protection on plant varieties were taking place under FAO

since 1996 and in 2001 FAO adopted the International Treaty on Plant

Genetic Resources for Food and Agriculture or the Seed treaty. The

PGRFA treaty includes extensive provisions related to ABS mechanism

but in a constringe manner as it deals with only specific crops provided

under Annex 1. Treaty provides for establishing a multilateral system with

the intention to facilitate access to plant genetic resources for food and

agriculture and to share the benefits arising out the use of those resources

equitably47.

Access regime under PGRFA treaty is quite unique and it requires states to provide

access at a minimum cost for research, breeding and training for food and

agriculture as long as this is not for industrial use. Under PGRFA treaty the users are

barred from claiming IP protection on materials accessed from the multilateral

system48. Benefit sharing under the treaty is a direct consequence of facilitated

access and is meant to provide an incentive to parties to provide access to their

genetic resources. Treaty includes a standard list of benefits that can be shared

which includes exchange of information, access to and transfer of technology,

capacity building and the sharing of benefits from commercialisation.

Developing countries from Asia, Latin America and Africa have been active at the

meetings of WTO- TRIPS Council to point out the conflicts between the TRIPS and

CBD and for development of a frame work where WTO members can meet the

obligation under both these international instruments49. An important result of these

efforts of the developing nations was the Doha Ministerial Declaration which instructs

the TRIPS council to examine the relationship between the TRIPS agreement and

47 See article 10.2 of PGRFA 48 See article 12 and carry flower, The question of derivatives- promoting use and ensuring availability of non proprietary plant genetic resources.49 see Dutfield, Can the TRIPS Agreement Protect Biological and Cultural Diversity? Available @www.wipo.int/cgi-bin/koha/opac-detail.pl?bib=24572

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the CBD and to include in its working programme review of Article 27.3(b) of

TRIPS50.

Pursuant to the Doha Declaration the developing countries including India had

contented in the TRIPS Council that the TRIPS Agreement should be amended in

order to provide that a member shall require that an applicant for a patent relating to

biological materials shall provide along with the application the disclosure of source

of the biological source and/or any traditional knowledge used therein, evidence of

obtaining prior informed consent from the said nation and community and evidence

for entering in a fair and equitable benefit sharing mechanism under the national

regime of the country of origin51. Deliberations are currently happening within the

WTO General Council and the TRIPS Council to settle the north- south dispute

regarding incorporation of such a provision.

WIPO’s involvement with the issue of access to genetic resources commenced in

1999 with a study commissioned jointly with UNEP, on the role of intellectual

property in sharing of benefits arising from the use of biological resources and

associated traditional knowledge. Inter Governmental Committee were formed after

a series of discussion within various standing committees of WIPO in 2001 which

acts as an international forum for international policy debate, development of legal

mechanisms and for creating practical tools for protection of traditional knowledge

and traditional cultural expressions against misappropriation and misuse . IGC works

closely with the CBD in identifying feasible option for the protection of biological

resources in the context of access and benefit sharing52 and examines the feasibility

of using various forms of intellectual property rights as an effective tool for benefit

sharing.

Besides all international initiatives for a proper access and benefit sharing

mechanism there are number of regional instruments entered by nations to protect

their biological resources on a regional basis. These agreements have been

developed by regional economic organizations in an endeavour to set minimum

50 See Doha Ministerial Declaration available at http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_e.htm51 See RV Anuradha, Access, benefit sharing , intellectual property rights: establishing links between TRIPS and available at http://wtocentre.iift.ac.in/Papers/2.pdf52 See benefit sharing within WIPO, available at http://www.ias.unu.edu/resource_centre/UNU_ABS_Report_Final_lowres.pdf

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http://wtocentre.iift.ac.in/Papers/2.pdf


standards for determining access to genetic resources within a region and to ensure

that the domestic regulation relating to access and benefit sharing maintains a

uniform standard. Regional agreements mirror the negotiating strategy of developing

nations to protect their resources.

5) National Guidelines governing access and benefit sharing mechanism

Access to and transfer of genetic resources and recognition and equitable sharing of

benefits arising from the sustainable use of the accessed resources are also part of

discussions within the Indian legal sphere. India have introduced the concept of

access and benefit sharing in two different national legislations, The Protection of

Plant varieties and Farmers right Act and the Biodiversity Act. The schemes referred

in these legislations are related to the patent right even though the patent act is silent

on the issue.

A) ABS mechanism under the Protection of Plant varieties and Farmers rights Act

The PPVFR Act 2001 and the rules made under this Act is a sui generis system that

protects the right of formal innovations of a plant breeder and informal system of

knowledge of traditional plant varieties of farmers as well53. The Act does not

specifically address the issue of access to plant genetic resources. However since

the plant genetic resources are also under the scope of Biodiversity Act, it should be

construed that access related issue under this Act would be covered by Biodiversity

Act54. With regard to benefit sharing the Plant varieties Act provides a well defined

scheme under Section 26.

After publication of registration of variety in Plant variety journal any interested

parties including an NGO or a governmental body is permitted to raise a claim for

benefit sharing on that variety to National Authority. The substantive bases for a

benefit sharing claim under section 26 are the extent and nature of use of use of

genetic material of the claimant in the development of the variety and the commercial

utility and viability as well as demand for the variety in the market55. Authority plays a

53 See sahai Suman, India’s Plant variety protection and Farmers right Act, 2001 Current Scinence , 84(3)2003, 407-41254 See Intellectual property rights and sustainable development55 See section 26(5) of the Act

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central role in determination of benefit sharing as it is left to determine benefit

sharing on case to case basis on very general guidelines given under the Act

Section 41 introduces a compensation scheme which in effect is a kind of

penalisation for not sharing the commercial benefits of a variety developed on the

basis of plant genetic resources or knowledge of farmers. Any person or any

governmental or NGO can ask any designated organization to enquire into any claim

regarding contribution of people of a village or community in evolution of any variety

and on the basis of a proper enquiry the Authority shall grant shall grant a sum of

compensation to be paid to such person or group.

Amount awarded by the authority as benefit sharing and compensation are to be

paid to the National Gene Fund which is constituted under the Act to channelize

these as well as other funds that have to be paid by the breeders. The gene fund is

to be applied to support and reward farmers for their contributions to conserving and

improving plant variety and to pay amounts due as benefit sharing and

compensation. But neither the Act nor the Rules made there under give a precise

indication on how these benefits are to be distributed between the communities.

B) ABS Mechanism and Biological diversity Act

Government of India in 2002 enacted the Biodiversity Act implement the mandates of

CBD and to provide for conservation and sustainable use of vast biodiversity of India

and to establish a benefit sharing mechanism for fair and equitable sharing of benefit

arises out of use of biological resources. Unlike PPVFR Act, the Biodiversity Act

gives significant importance on conditions as to access to biological resources.

Unlike the PPVFR Act the Biodiversity Act give significant importance on conditions

as to access to biological resources which provides restriction on access for

conducting research to any foreign researcher or corporation without prior

permission of the National biodiversity authority. Act prohibits transfer of research

results to foreign corporations as well as obtaining IP rights over any product based

on biological resources or traditional knowledge.

Prior informed consent under Biodiversity Act is actually a weak form of PIC. PIC

under CBD mandate has to be obtained from the indigenous communities or affected

communities and the competent national authority. Biodiversity actually ignores the

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role of indigenous communities while granting access and thus Act doesn’t provide

an opportunity to these communities to present their interests.

National Biodiversity Authority is authorized to ensure while granting access that

conditions under which access is provided ensures an equitable sharing of

benefits56. Most significant contribution of biodiversity act is to provide that benefit

sharing could imply sharing of IP rights. Where benefit claimers can be specifically

identified the Biodiversity Authority is empowered to provide for joint ownership of IP

rights and on the other hand to allocate itself joint ownership rights where the benefit

claimers cannot be identified. Thus Biodiversity would have the power to directly

influence grant of patents even though it is not meant to participate in

implementation of patent Act57.

Act introduces number of non monetary compensation like transfer of technology,

R&D development at benefit claimers area to facilitate a better standard of living etc.

In cases where monetary compensation is chosen then authority is having

discretionary power to have the sum deposited in National biodiversity Fund setup

under the act or to paid to specific groups of individuals in cases where they can be

traced. On a whole the access and benefit sharing scheme under the Biodiversity

Act is much wider than that under the Protection of Plant varieties and Farmers

rights Act. However lack of specificity of the benefit sharing scheme and

discretionary powers given to the Authority in determining the scope of benefits to be

shared makes the whole scheme insignificant in the view of benefit claimers.

6) ABS mechanism and indigenous communities: does it offer an appropriate remedy?

ABS mechanism is considered to be a remedy for granting of Intellectual property

rights to inventions based on biological resources and traditional knowledge. Benefit

sharing is devised to provide indigenous communities a fair share of benefits that IP 56 See section 21(1) of biodiversity act57 see http://www.ias.unu.edu/binaries/UNUIAS_ProtectedAreasReport.pdf

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holders obtain from use of their resources and knowledge. Concept of traditional

knowledge and IP rights are basically contrary to each other. IP rights are individual

rights while traditional knowledge is community rights which do not fall within the

purview of IP rights.

CBD mandates parties to provide for prior informed consent and enter Mutually

Agreed Terms before granting access to traditional knowledge with participation of

stake holders. Underlying issue regarding PIC and MAT is to identify the relevant

stake holders. Traditional knowledge are common property of the particular

community which are developed through centuries old trial and error process and it

is difficult to identify a single holder or even a group of holders who could actually be

the representative of community and grant PIC or to whom the benefits are to be

shared.

Besides traditional communities like the Kani tribe or the San community are

basically sections which are not fully integrated with the mainstream society and it

would be impractical to expect members of these communities to stand in an equal

position and make claims for their rights while entering a PIC or MAT. Though

authorizing the competent national authority to represent the interest of the

community or certain other governmental (as happened in case of Jeevani) or

Nongovernmental organisation could be the only option and in such cases

community’s interest should be represented by outsiders and not the stake holders.

Another important aspect of traditional knowledge is the religious value or

sacredness attached with them. Indigenous communities consider these cultural

transmissions as sacred matters associated with their lifestyle and not as

commercial products. Communities consider them as secrets and sharing with

outsiders invites divine displeasure58IP laws which are essentially western in nature

are not able to analyse this aspect of traditional knowledge. For holders of sacred

knowledge getting a share of benefits as compensation for sharing their valuable

58

Intellectual Property needs and expectations of TK holders, WIPO report on Fact finding

missions on IP and TK(1998 -1999) available at www. wipo .int/tk/en/tk/ffm/ report /final/

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http://www.wipo.int/tk/en/tk/ffm/report/final/


knowledge or getting joint ownership in IP rights are not viable options but an

instrument which would destroy their age old traditions and beliefs.

As Andreass Bachmann quoted there is invariably a moral basis involved in fairness

aspect of benefit sharing59. But ethical consideration under CBD is just a political

arrangement to bring balance of interests between gene poor industrialized nations

and biodiversity rich nations who are craving for development. ABS mechanism

envisaged in CBD does not preclude intellectual property rather idea is that private

users may create and patent products based on legally acquired genetic resources

and share benefit generated by commercialization of these products with the

providers of genetic resources. Basically this idea fails to justify ABS from the angle

of traditional knowledge holders or genetic resources providers as it converts

common knowledge which is part of the lifestyle of indigenous communities into

exclusive rights

But on an overall scale ABS can be regarded as a platform for making consensus

between Intellectual property and rights of indigenous community. Developing

nations have to press in international foras for a stricter access regime which would

address the concerns of indigenous communities to a larger extent.

7) Conclusions and suggestions

Genetic resources and associated traditional knowledge are important leads for bio

prospecting and bio industry. Judicious and harmonious use of these resources in

bio prospecting can lead to sustainable human development in biodiversity rich

developing countries. The disproportionate distribution of biodiversity and associated

traditional knowledge and advancements in genetic engineering and biotechnology

in South and North countries continues to be a barrier in building mutually beneficial

bio-partnerships among these countries60. Shutting down the doors of nations to

prevent researchers and Multinational companies from accessing vast biological

resources of developing nations in the name of protecting interests of indigenous

communities is not feasible in the era of globalisation. ABS can prove to be a

59 See Andreass Bachmann, Ethical aspects of benefit sharing available at http://www.sib.admin.ch/uploads/media/ABS_Ethical_Aspects.pdf60 See pushpangathan, value addition and commercialization of biodiversity and associated traditional knowledge, available at www.nopciar.com

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http://www.sib.admin.ch/uploads/media/ABS_Ethical_Aspects.pdf


platform in which indigenous communities could make claims for their interests along

with the support of concerned national authority.

The analysis of access and benefit sharing mechanism indicates that there are

number of links between access to biological resources, traditional knowledge and

management of patentable inventions. Benefit sharing can be regarded as a

compensation for the absence of intellectual property protection for traditional

knowledge and genetic resources. It constitutes an instrument to address the

imbalance of the current intellectual property regime which leaves all public domain

knowledge outside the framework of protection but offers protection to innovations

made out of it. ABS mechanism can be regarded as an instrument to bridge the gap

between the CBD and the Intellectual property regime under the TRIPS.

Current IP regime under the TRIPS Agreement have already proved to be incapable

for protecting genetic resources or associated traditional knowledge. Increasing

instances of biopiracy in last decade is evidence for this. The implementation of

Doha Ministerial declaration is yet to take place as far as it relates to genetic

resources and traditional knowledge. The negotiations on harmonising CBD and

WTO TRIPS with reference to disclosure requirements of source of origin, Prior

Informed consent and benefit sharing in Patent application are still under way within

the TRIPS Council. Incorporation of disclosure requirements and prior informed

consent for patentable inventions having biological resources would help to prevent

misappropriation of patent system and for promotion of a fair and equitable benefit

sharing among the stake holders. Coupled with this requirement comes the need for

creating awareness among the stake holders. The Competent national authority

should initiate appropriate measures to ensure that the stakeholders before granting

PIC or entering into MAT are fully aware of the situation and is able to stand in an

equal footing with the MNC’s while putting forth their claims.

Development of an international treaty which conveys the objective of Nagoya

protocol would be a desirable option to harmonize the provisions of CBD and TRIPS

Agreement. At international level developing countries would be unable to force for

sharing of specific benefits for providing access unless a broad access and benefit

sharing regime is adopted in the context of Biodiversity convention. Said treaty could

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provide for a new arrangement for inventions based on biological resources or

associated traditional knowledge.

At national level benefit sharing mechanism does not constitute an effective

mechanism to foster innovation like intellectual property. Benefits sharing

mechanism especially when it relates to providing monetary compensation it act just

as a compensation mechanism for past contribution of communities and present

efforts for conservation. On the contrary nations should lay more emphasis on

sharing of non monetary compensation which would foster development of traditional

knowledge by improving the infrastructure of the provider country and also by

transfer of technologies and thereby improving research and development within its

boundaries.

As far as Indian position is concerned we are currently having two parallel benefit

sharing mechanism under two national legislations. An effort is needed to coordinate

the provisions relating ABS under both these legislations. Basically there is no need

to have separate benefit sharing mechanism under two Acts as the subject matter

are more or less similar. Procedural differences and confusion in this manner could

be avoided by bringing ABS mechanism of both Acts under a single institutional

structure. Besides legislative efforts need to be directed in order to include evidence

for PIC and contact for an appropriate benefit sharing mechanism within the

specification file along with the patent application. Benefit sharing regime would be

much strengthened and streamlined if it is applied as an integral part of patent

legislations.

On a whole benefits sharing should be viewed as a strategy for rebalancing the

current imbalances in intellectual property regime. Still there are number of factors

which acts as limitation for a proper benefit sharing mechanism like identification of

claimants, sharing of benefits in case of transboundary situations etc. Developing

countries should engage in constant deliberation for devising a sui generis system

that attempts to mitigate all these issues.

Bibliography

Books Referred

Acharya NK, Text book on Intellectual property Rights, Asia law house

Page | 22


Alikhan Shahida and Mashelkar Raghunath, Intellectual Property and

comparative strategies in the 21st century, Kluwer Law International

Bhandari M K, Law relating to Intellectual Property Rights, First edition, 2006,

Central Law publications

Debroy B, Intellectual Property Rights, BR Publishing corporation

Elizabeth Varkey, Law of Patents, First edition 2005, Eastern Book Co

Elizabeth Varkey, Law of Plant Variety Protection, First edition 2007, Eastern

Book company

Marett,Paul Intellectual Property Law, London sweet& Maxwell,1996

Maredia K M & Erbisch , Intellectual property rights in Agricultural

Biotechnology,1998

Articles Referred

ABS Management Tool, best Practice standard and handbook for

implementing Genetic Resource Access and Benefit Sharing , available at

http://www.iisd.org/pdf/2007/abs_mt.pdf

Access and benefit sharing mechanism of genetic resources, ways and

means for facilitating biodiversity research available at

http://www.bfn.de/fileadmin/MDB/documents/service/skript163.pdf

Access to Genetic resources in Africa available at

http://www.ias.unu.edu/resource_centre/ABS%20in%20Africa.pdf

RV Anuradha, Access, benefit sharing , intellectual property rights:

establishing links between TRIPS and available at


See Andreass Bachmann, Ethical aspects of benefit sharing available at


benefit sharing within WIPO, available at

http://www.ias.unu.edu/resource_centre/UNU_ABS_Report_Final_lowres.pdf

Cary Fowler, Protecting Farmer Innovation: The CBD and the question of

Origin, The ABA’s Journal of law science and Technology 486(2001)

carry flower, The question of derivatives- promoting use and ensuring

availability of non proprietary plant genetic resources.

Page | 23




C R Bijoy, Access and Benefit sharing from indigenous peoples perspective,

The TBGRI – Kani model available at

http://www.lead-journal.org/content/07001.pdf

Dutfield, Can the TRIPS Agreement Protect Biological and Cultural Diversity?

Available @www.wipo.int/cgi-bin/koha/opac-detail.pl?bib=24572

Doha Ministerial Declaration available at

http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_e.htm

Evanson Chege Kamau, bevis Fedder and Gred Winter, The Nagoya

Protocol, what is new and what are the implications for provider and user

scientific community, available at


F McConnell, The Biodiversity convention, A negotiating History available at

www.ssrn .com

sHamdallah Zedan on Bonn Guidelines available at

http://www.planttreaty.org/sites/default/files/bonn_guidelines.pdf

Intellectual Property needs and expectations of TK holders, WIPO report on

Fact finding missions on IP and TK(1998 -1999) available at

www. wipo .int/tk/en/tk/ffm/ report /final/

International regime of access and benefit sharing mechanism available at

http://www.sawtee.org/publications/Policy-Brief-16.pdf

Janak Rana Ghose, Access and benefit sharing systems: An overview of the

issues and regulations available at http://ranaghose.com/research/abs.pdf

Kerry Ten Kate & Sarah A Laird, The Commercial Use of Biodiversity :

Access to Genetic resources and Benefit sharing available at

http://books.google.co.in/books?id=-

yRfL4Q_t0cC&printsec=frontcover#v=onepage&q&f=false

Manuel Ruiz Muller, Disclosure of origin and legal provenance, available at

http://ictsd.org/downloads/2011/12/disclosure-of-origin-and-legal-provenance-

the-experience-and-implementation-process-in-south-america.pdf

M D Nair, TRIPS WTO and IPR, protection of Bio resources and traditional

knowledge, available at www.ssrn.com

Merk in bio agreement which happened prior to CBD see

www.ciesin.org/docs/008-129/008-129.htm

Page | 24

http://www.wipo.int/tk/en/tk/ffm/report/final/



Natalie P Stionanoff, Biological resources and benefit sharing, the intersection

between traditional knowledge and intellectual property.

pushpangathan, value addition and commercialization of biodiversity and

associated traditional knowledge, available at www.nopciar.com

scope of access and benefit sharing under the international treaty available at

http://www.bioversityinternational.org/fileadmin/bioversityDocs/Policy/

Access_and_Benefit_Sharing/SGRP%202008%20Policy%20Brief_Scope

%20of%20ABS%20under%20the%20Treaty.pdf

Schroeder, Global medical ethics, benefit sharing: Its time for a definition

available at www.justor.org/stable/27719838

Shahid Alikhan and Raghunath mashelkar, Intellectual property and

competitive strategies in the 21st centuary, Kluwer Law international , london

See sahai Suman, India’s Plant variety protection and Farmers right Act, 2001

Current Scinence , 84(3)2003, 407-412

Venekataraman and latha, IPR, TK and biodiversity of India JIPR july 2008

WTO Doha work programme –the outstanding implementation issue on the

relationship between the TRIPS and CBD , communication from India.

Pakistan, Brazil, Peru, Thailand and Tanzania, WT/GC.W.564,TN/C/W?41

Websites referred

www.heinonline.com

www.justor.com

www.ssrn.com

www.legalserviceindia.com

www.livemint.com

www.wipo.int

www.who.int

www.infojustice.org www.nopsciar.com

Page | 25

http://www.nopsciar.com/

http://www.infojustice.org/

http://www.who.int/

http://www.wipo.int/

http://www.livemint.com/

http://www.legalserviceindia.com/

http://www.ssrn.com/

http://www.justor.com/

http://www.heinonline.com/

abs mechanism for protection of traditional knowledge

Documents