Common Approaches to Access to and Benefit Sharing of Genetic Resources and Associated Knowledge Some Examples from India


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Common Approaches to Access to and Benefit Sharing of Genetic
Resources and Associated Knowledge

Some Examples from India

P. Pushpangadan & K. Narayanan Nair

National Botanical Research Institute

226001, India


Genetic resources are
biological materials of animal, plant, microbial or
other origin that contain functional units of heredity and of actual or potential
values for humanity
. They constitute an integral component of biological
diversity and provide the basis not only for the

continuous evolution and
maintenance of the life

supporting systems on earth, but also for the
sustainable economic, scientific, technological, cultural and spiritual development
of humankind. There is a growing body of information on the significant
ntributions that genetic resources make to global economy and global
intellectual property regimes (ten Kate & Laird 1999, Dutfield 2000, Laird & ten
Kate 2002). Ranging from subsistence uses by indigenous and local
communities for their livelihood securit
y to the high

tech research and
development programmes on bioprospecting, genetic resources and associated
traditional knowledge find an ever increasing demand and utility in a diverse
array of sectors such as biopharmaceuticals, biotechnology, including

biotechnology and health care, crop protection, agricultural seed production,
horticulture, phytomedicines, cosmetics and personal care, and a myriad of other
areas of products and processes development based on wild and domesticated
resources and their derivatives.

The rapid developments in biotechnology (particularly molecularly biology
and genetic engineering), herbal technology, information technology, and the
liberalized global trade policies and emerging intellectual property re
gime provide
umpteen opportunities to the multinational pharmaceutical, biotech and seed
companies, both in public and private sectors, to venture into promising
bioprospecting programmes, based on genetic resources and the associated
traditional knowledge
. According to a recent survey by Laird & ten Kate (2002),
the global estimate on the annual sale values of the following selected products
derived from genetic resources amounts to about US $ 500 billion.


Annual sale values


US $ 300 billion (1998 figures)

Crop protection

US $ 30 billion (1997 figures)

Agricultural Seed

US $ 30 billion (1997 figures)


US $ 16

19 billion (1998 figures)

Botanical Medicines

US $ 20 billion (1999 Jan

Nov. figures)

and Personal care

US $ 75 billion (1998 figures)


US $ 471

474 billion


See definitions of “Genetic Material” and “Genetic Resources” given in Artic
le 2 of Convention on
Biological Diversity (CBD).


Such estimates reflect only the consumptive use value of those
genetic resources and their derivatives that are being marketed globally
through major multinational companies
. Estimation of the total economic
values accrued from multifarious uses of genetic resources at local and
national level is, however, a complex process as many countries do not
maintain adequate data and information records on the source of
extraction, qu
antum of resources extracted, utilization patterns,
consumption level, marketing channels, market prices, demand and
supply of the resources, and conservation and regeneration potentials of
the extractive sources, etc. The economic evaluation of genetic re
becomes far more cumbersome when the environmental, existence,
cultural and aesthetic values of such resources are to be estimated along
with their direct consumptive economic values. Furthermore, human have
tapped economic potentials of only about


20 % of the biological
resources of the world. The focus of biotechnologists and bioprospectors
today is on the as yet untapped genetic resource wealth that holds many
untold promises and potentials for several key sectors of food, agriculture,
ines, pharmaceuticals and other biotech industries. Genetic
resources and associated knowledge thus represent two invaluable
resource bases for bioprospecting, sustainable economic development
and for conservation of biological diversity.

The recent trend
s in bioprospecting in the biotechnology

rich but

poor nations of the North necessitate an ever increasing
demand for access to genetic resources and traditional knowledge that
are available in the biodiversity

rich but biotechnology

oor nations of
the South. This has also triggered conflicting interests and common
concerns among all stakeholder states, organizations, institutions,
individuals, and communities involved in collection, characterization,
conservation, sustainable utilizat
ion, and documentation of genetic
resources and traditional knowledge at local, national, regional and global
levels. Several international conventions, treaties, legal and policy
instruments are in position today, which provide for transparent
and measures for regulated access to and equitable sharing
of benefits arising out of sustainable use of genetic resources and
traditional knowledge. The United Nations Convention on Biological
Diversity (CBD
signed by 150 countries at the Earth Summit in
Rio de
Janeiro, 3
14 June 1992) is the first international legal instrument that
brought out a radical change from the then prevailing common perception
on genetic resources as “common heritage of mankind” to a legally
binding regime that confers “soverei
gn rights” to the states over their own
biological resources (including genetic resources and traditional


Access and Benefit Sharing (ABS): International Scenario

Convention on Biological Diversity (CBD)

CBD is a dynamic international law (ca
me into force since
December 29, 1993 and ratified by 188 countries as on 12

October 2004)
founded upon the three main objectives: (i) conservation of biological
diversity, (ii) the sustainable use of its components, and (iii) fair and
equitable sharing
of the benefits arising from the use of genetic resources,
including by appropriate access to genetic resources and by appropriate
transfer of relevant technologies (Article 1). CBD has triggered a renewed
impetus on the Contracting Parties or States to de
velop appropriate
measures to regulate access and to promote benefit sharing in relation to
genetic resources and traditional knowledge. The most relevant provisions
on access to genetic resources, traditional knowledge and benefit sharing
are stipulated i
n Articles 8 (j), 15, 16, and 19 of the Convention:

CBD Provisions for Access, Benefit Sharing and

Protection of Traditional Knowledge

Article 8 (j):

Protection of

Promote the wider application of
the knowledge, innovations and
actices of indigenous and local
communities with their approval
and involvement and encourage
the equitable sharing of the benefit
arising out of sustainable use of
the knowledge, innovations, and
practices of indigenous and local

Article 15.

Authority to
determine access

Party has the authority to
determine access to genetic
resources, subject to national

Article 15.2:

Access for
friendly uses

Each Party shall endeavor to
facilitate access to genetic
resources for

sound uses by other contracting
Parties and not imposes
restrictions that run counter to the
objectives of the Convention.

Article 15.4:

Mutually Agreed

Access to genetic resources shall
be on mutually agreed terms.

Article 15.5:

rior Informed

Access shall be subject to Prior
Informed Consent of the


Contracting Party providing such
resources, unless otherwise
determined by that Party.

Article 15.6:

Scientific research
and development

Party receiving genetic resources
another Party shall endeavor
to develop and carry out scientific
research based in genetic
resources provided by other
Contracting Parties with full
participation of, and where
possible in, such Contracting

Article 15.7:

Equitable Benefit

Parties to take legislative,
administrative or policy measures,
as appropriate, with the aim of
sharing in a fair and equitable way
the results of research and
developments and the benefits
arising from the commercial or
other utilization of genetic
urces with the Contracting
Party providing such resources,
and such sharing shall be upon
mutually agreed terms.

Article 16.3:

Transfer of

Access to and transfer of
technology using genetic
resources to countries providing
the genetic resources

Article 19.1:

Participation of
genetic resource
providing countries
in biotechnological

The Contracting Party receiving a
genetic resource shall take
legislative, administrative or policy
measures as appropriate, to
promise effective participat
ion by
providers of genetic resources,
especially developing countries in
biotechnological research

CBD thus provides a fundamental framework for the Parties to
develop appropriate national legislations and policy guidelines to facilitate
air and transparent means and mechanisms for access to and equitable
sharing of benefits accrued from the use genetic resources and traditional
knowledge. Immediately after the CBD came into being, another


international body called the World Trade Organiza
tion (WTO) was
established in June 1994 for streamlining and regulating the trade
relations of the world. Most of the countries have signed both CBD and
WTO. But there arose certain contradictions in the Trade Related
Intellectual Property Rights (TRIPs) u
nder the WTO with those of CBD.
The ministerial conference of the member countries of WTO was
constituted to iron out the contradiction and to harmonize TRIPs and CBD,
and thereby to create a fair and enabling situation for all countries of the
world. Simi
larly CBD has also constituted Conference of Parties (COP) to
streamline and implement the CBD directives. Access and benefit sharing
issues have become the central themes for subsequent detailed
discussions and decisions

making under CBD, TRIPs, and the
Intellectual Property Organization (WIPO). CBD began to address the
ABS issues and their implementation since Fourth Meeting of the
Conference of Parties (COP

IV) held in Bratislava (Slovakia) in May

In its efforts to evolve an internationa
l regime for access and benefit
sharing based on genetic resources and traditional knowledge, CBD has
constituted two separate working groups and one Expert Panel viz. (i) Ad

hoc Open

ended Working Group on Traditional Knowledge {CBD/COP
IV/9/1998} (ii
) Ad

hoc Open

ended Working Group on Access and
Benefit Sharing {CBD/COP V/6/2000} and (iii) Panel of Experts on Access
and Benefit Sharing (CBD/COP IV/8, 1998). The terms of references of
these Working Groups and Expert Panel included mainly the devel
of a framework that would help assist Parties to develop national and
regional regulations or guidelines on ABS, with special focus on evolving
standards and principal elements of “Prior Informed Consent (PIC)”,
“Mutually Agreed Terms (MAT)”, “Mater
ial Transfer Agreements (MTA)”
and Monetary and Non

monetary Benefit Sharing Agreements.

The Bonn Guidelines

One of the significant outcomes of CBD’s work on
ABS is the development of the “
Bonn Guidelines on Access to Genetic
Resources and Fair and Eq
uitable Sharing of the Benefits Arising out of
their Utilization
” at the October 2001 meeting of the Ad

hoc Open

ended Working Group on Access and Benefit Sharing held in Bonn, which
were adopted at the Sixth Meeting of the Conference of Parties held i
April 2002 in the Hague (COP Decision VI/24). The Bonn Guidelines are
voluntary in nature and are a useful first step of an evolutionary process in
the implementation of relevant provisions of the CBD related to access to
genetic resources and associated

traditional knowledge and sharing of
benefits arising from the commercial or other utilization of such resources,
with the exclusion of human genetic materials. The Guidelines are
intended to provide the Parties and Stakeholders with a transparent
rk to facilitate access to genetic resources and ensure fair and
equitable sharing of benefits through standard practices and procedures of
PIC, MAT, MTA, and other relevant agreements. The Guidelines provide
details of an overall strategy and the essentia
l steps, elements and


principles to be adopted in developing access and benefit sharing regimes
by the Parties and Stakeholders. Several countries have already
incorporated the key elements as suggested in CBD and the Bonn
Guidelines in to their national/r
egional policies and legal framework.
(UNEP/CBD/COP3/20/1996; GRAIN/BRL/Access & Benefit Sharing
, accessed on 12/10/2004). Some examples of such
important national or regional laws on biodiversity, traditional knowledge
and ABS are:



(Effective in five countries: Bolivia, Colombia,
Ecuador, Peru and Venezuela)

Andean Community Decision
391: Common Regimes on Access to Genetic Resources

(2 July



The ASEAN Framework Agreement on Access to
Biological and Genetic
Resources (24 Feb. 1996).



Draft Biodiversity and Community Protection Act of
Bangladesh (29 September 1998).



Supreme Decree No. 24676 Regulation Of Decision 391
on the Common Regimes for Access to Genetic Resources (21
June 1997)



Provisional Measures on Access to Genetic Resources
and Traditional Knowledge No. 2: 186.16 (23 August 2001).


Costa Rica

The Biodiversity Law No. 7786 (30 April 1998);
Presidential Decree on ABS No. 31

514 (3 April 2003).



Biological Diver
sity Act (11 December 2002); Biodiversity
Rules (15 April 2004).


Organization of African Unity

African Model Legislation for the
Protection of the Rights of Local Communities, Farmers and
Breeders and for the Regulation of Access to Biological Resources



Draft Legislation on Access to Biological resources and
Community Rights (2004).



Law Introducing a Protection Regime for the Collective
Knowledge of Indigenous People Derived from Biological
Resources (10 August 2002).



Department of Environment and Natural Resources
Administrative Orders 96

20 (9 July 1996).


South Africa

National Environmental Management: Biodiversity
Act (7 June 2004).

The access norms in the regional or national legislations may vary
on the procedures of Prior Informed Consent, particularly on the
authority(ies) entitled to grant such consents. The Andean Pact Common


Systems on Access, the Philippines Access Regulations, Costa Rican
Laws, Bangladesh Biodiversity Law require that the a
pplicant seeking
access to genetic resources and traditional knowledge obtain the PIC from
the National Competent Authority as well as the Indigenous or Local
Communities; whereas the Biological Diversity Act of India, ASEAN
Framework Agreements on ABS req
uire PIC from the National Authority.
While there is broader consensus on appropriate methods for involvement
of the indigenous and local communities and other relevant stakeholders
in the negotiations of ABS arrangements, the legislations in many
s do not provide exclusive rights or ownerships on genetic
resources and traditional land resources to the community stakeholders.
In many such cases the States have complete authority over the
biogenetic resources and all other related matters, whereas th
e local or
indigenous communities are often alienated from their traditional lands
and community resources. Protection of the customary rights of the
traditional communities and also the intellectual property wealth ingrained
in their traditional knowledge
, practices and innovations is an important
adjunct to achieve the CBD objectives.


International Treaty on Plant Genetic Resources for Food and
Agriculture (ITPGR

(2001) and ABS process

The Treaty, which has come into force since 2001, aims at
nservation and sustainable use of plant genetic resources for food and
agriculture (PGRFA) and the fair and equitable sharing of the benefits
arising out of their use for sustainable agriculture and food security. The
Treaty provides for an efficient, effe
ctive and transparent multilateral
system to facilitate both access to and fair and equitable sharing of
benefits arising from the utilization of PGRFA on a complementary and
mutually reinforcing basis (Article 10.2).

In accordance with Article 10.1 of th
e Treaty, 64 plant genetic
resource groups (35 food crops + 29 forage crops) for the food and
agriculture have been currently brought under the Multilateral Systems of
Access and Benefit Sharing (
Annex I

of the ITPGR). The treaty also
obliges its Parties t
o take necessary legal or other appropriate measures
to provide access to other Contracting Parties through the Multilateral
Systems, and insists that the facilitated access shall be provided pursuant
to a standard Multilateral Transfer Agreement (MTA), co
ntaining all access
& benefit sharing provisions under 12.3 a, d and g and 13.2 d (ii) of the
Treaty. The Treaty also restricts the recipient Party to claim any
intellectual property or other rights on the genetic resources or their
genetic parts or compon
ents in the form received from the Multilateral
System (Article 12.3 d).

The Benefit Sharing Provisions under the Treaty enables the
Contracting parties to facilitate fair and equitable benefit sharing through
the following mechanisms: (a)
Exchange of

(e.g. catalogues


and inventories, information on technologies, results of technical, scientific
and socio

economic research, including characterization, evaluation and
utilization) (b)
Access to and transfer of technology

(e.g. technologies fo
the conservation, characterization, evaluation and use of plant genetic
resources for food and agriculture, including technologies transformed
through genetic materials, improved varieties and genetic materials
developed through the use of PGRFA accessed

under Multilateral
System) (c)
Capacity building

(Proposed measures include: (i)
establishing and/or strengthening programmes for scientific and technical
education and training in conservation and sustainable use of PGRFA, (ii)
developing and strengtheni
ng facilities for conservation and sustainable
use of PGRFA in developing countries and countries with economy in
transition, and (iii) carrying out scientific research preferably in developing
countries and countries with economy in transition, in coopera
tion with
institutions of such countries, and capacity building in relevant research
fields when they are needed (d)
Sharing of monetary

and other benefit of
: (commercial benefit sharing through involvement of
private and public sectors t
hrough partnerships and collaboration in
research and technology development; deposit of an equitable share of
the benefit accrued from the commercialization of a product from the
accessed PGRFA to the ‘Trust Fund’ to be established under the provision
19.3 (f) of the Treaty; the level, form and manner of the payment to be
decided by the Governing Body that has been established under the
Treaty comprising all Contracting Parties; mechanism for direct or indirect
flow of the shared benefits to and from in

all countries, especially the
developing countries and countries with economy in transition (Article
13.3); modalities for voluntary benefit sharing contributions to the
multilateral systems by the food processing industries that benefit from
the PGRFA a
ccessed from other Contracting Parties.

In essence the ITPGR and CBD contain complementary provisions
on access and benefit sharing based on the standard principles and
procedures of PIC and MTA.

TRIPS Agreement and ABS Issues


discussions on the relationship between the Agreement
on the Trade Related Intellectual Property Rights (TRIPs) and CBD’s ABS
Work Group and also about the ways to harmonize intellectual property
issues related to biological and genetic resources and asso
knowledge with the core CBD objectives have been taking place since
1999. Despite several meetings of the TRIP Council, COPs to CBD, and
other relevant organizations and agencies, no consensus has been
reached as yet on the prevailing issues of acco
rding legal intellectual
property protection to genetic resources and associated traditional
knowledge. Article 27.3 (b), particularly the clauses of patenting on life
forms and developing a
sui generis
system for protection of plant varieties,
is the main

bone of contention of the ongoing debate between WTO


members from the developing countries and those from the industrialized
developed countries. The Group of developing countries has made nine
submissions to the TRIPs Council for reviewing the Article 27
.3(b) and
other relevant provisions of TRIPs and makes them supportive to the CBD
objectives. In a recent submission to the Council, the developing country
group comprising Bolivia, Brazil, Cuba, Ecuador, India, Peru, Thailand,
Venezuela, raised the follow
ing three demands for incorporation in to the
provision mandating applicants for a patent relating to biological resources
or traditional knowledge to: (i) disclose the source of origin of biological/
genetic resources, (ii) provide evidence on prior infor
med consent, and (iii)
evidence on benefit sharing agreement (IP/C/W/403 of 4 June 2003;
IP/C/W/420 of 12 March 2004; IP/C/W/429 of 20 September 2004). These
issues adequately express the concern of the mega
biodiversity countries
that are rich in genetic
resources and traditional knowledge, but poor in
their biotechnologies. However, the debate on TRIPs

harmonization is still continuing without having reached any conscientious
decisions. The developed countries’ argument is that integrating
ual property issues with CBD provisions is unnecessary and
unwarranted. An alternate suggestion to the debate by some of the
European Countries is to include, in appropriate cases, declaration of the
origin of genetic material in patent applications as a
voluntary requirement
and include penalty system for failure to comply with the declaration, in
which case the patent would be rejected or withdrawn. The Like Minded
Megadiverse Countries (LMMC) in the developing countries and the
countries with their ec
onomy in transition are pushing ahead with their
demands to meet a legally binding solution to the three major issues
raised by them.

World Intellectual Property Organization (WIPO) and ABS & Article 8 (j)

The CBD Secretariat and ABS Work Group have been
studying the
possible mechanisms to address the ABS issues regarding prior informed
consent, benefit
sharing agreements, technology transfers on the basis of
mutually agreed terms and other relevant provisions with reference to
WIPO, UNCTAD, and other orga
nizations. The LMMC Group, who was
the first to raise these issues for discussion in the context of CBD,
however, objects any idea of a strong collaboration with WIPO due to the
apprehension that the interests of these countries would not be addressed
ropriately at WIPO, whose prime concern is to negotiate and
implement the IPR policies concerning the monopolistic rights of individual
or corporate innovators. The WIPO’s Intergovernmental Committee (ICG)
on Intellectual Property and Genetic Resources
and Traditional
Knowledge and Folklore is now examining the issues of ABS and
traditional knowledge (WIPO, 2001).


Access and Benefit Sharing: Common Approaches

CBD and ITPGR, and the Bonn Guidelines provide a broad
framework for ABS procedures. The main

features of ABS mechanisms
include: (i) Prior Informed Consent (ii) Mutually Agreed Terms (iii) Material
Transfer Agreements, and (iv) Benefit

sharing agreements through
monetary and non
monetary means. Apart form the frameworks as
suggested in the above

international policy documents and guidelines,
several other national, international, and regional institutions, agencies
and community organizations have developed different models of access
and benefit

sharing agreements, MTAs, MATs, etc. (Laird, 20
02). A few
examples of such model agreements on ABS contracts, bioprospecting
partnerships include:
The Andean Pact Decision 391 and Contracts

The Pew Conservation Fellows Biodiversity Research Protocols

Royal Botanic Garden Policy on Acces
s to Genetic Resources and
Benefit Sharing
(RBG, Kew 1998);

Common Policy Guidelines for
Participating Botanic Gardens on Access to Genetic Resources and
Benefit Sharing
(Cartagena 2000);

The Limbe Botanic Garden Policy on
Access to Genetic Resources and B
enefit Sharing

Biodiversity Registers and Honey Bee Network for chronicling and
protection of Local People’s Innovations (India); Draft Research Policy for
Protected Areas in Cameroon
); etc. Although
these frameworks and models are useful in developing appropriate ABS
agreements, they cannot serve as absolute or comprehensive
mechanisms as the objectives, standards and procedures of ABS will vary
considerably from Partie
s to Parties. As outlined in the Pew Conservation
Fellows Biodiversity Research Protocols (1996), any biodiversity research
contract in general and the ABS agreements in particular may cover the
following five categories: (1) Non

extractive, non

cial research
(2) Extractive but primarily non

commercial research (3) Non

research with possible commercial potentials (4) Extractive research
intended for commercial development, and (5) Conservation research
intended for protection of bio
diversity (Laird, 2002).

Before framing an ABS agreement, each Party, State, organization,
institution, individuals or local and indigenous communities should ponder
over some of the following pertinent questions like, (i) What resources and
knowledge ar
e to be accessed? (ii) What for these are accessed? (iii)
Where from these have to be accessed and in what forms and what
quantities? (iv) Are these resources owned by the State, local and
indigenous communities or other stakeholders? (v) Does the national

in the country from which the resources are to be accessed permit such
access for the purpose indented by the Party? (vi) Who the national
authority to grant the access and prior informed consent to the Party
seeking the resources and TK? (vii) What

access norms and benefit

sharing agreements are mandated in the country providing the resources
and TK? (viii) What are the technological and human resource capabilities
available in both the resource provider and user Parties? (ix) Is the access


is made

with a predetermined plan of any product development and /or its
subsequent commercialization? (x) Is the access made directly or through
intermediaries? (xi) What precautionary measures are planned to avoid
any legal or ethical entanglements between the
resource/ knowledge
provider and user during the entire course of the access

benefit sharing
deal? (xii) Does the access

benefit sharing deal reflect mutual concerns
and respect to the Parties’ constitutional, environmental, ethical and other
codes of co
nduct? (xiii) Does the access and subsequent uses and
commercialization of the products or technologies derived from them
cause any infringement to the environmental safety, ecological balance,
conservational ethos, traditional wisdom, equity and moral pri
nciples and
intellectual or other forms of individual or collective rights of any person or
community or organization? (xiv) What are the domestic and global
benefits to be accrued from transnational access of genetic resources and

These are only some
general thoughts on the whole process of
access and benefit sharing, but these would help one to adhere to the
principles of ethics and equity in striking a harmonious and transparent
ABS agreement. Regulated access to genetic resources and traditional
wledge for any environment

friendly and sustainable use needs to be
promoted as long as the access is made subject to the national
legislations and the relevant international laws and treaties to which the
country is a Party. However, illegal plunderin
g of any country’s biological
or intellectual wealth through stealthy ways and means amounts to bio
piracy and bio
imperialism. Many examples of such piracy are available
today, which have only helped to deepen the conflicts between the
nations of the South and the biotechnology

rich nations
of the North (Shiva, 1998; Shiva
et al.

2002). Despite having introduced
the “doctrine of sovereign rights”, CBD’s attempts to harmonize the
international trade and intellectual laws have not been s
uccessful. This
situation has led to a kind of insecurity among many of the biodiversity

rich countries in dealing with the issues of transnational access and
bioprospecting partnership with multinational companies and institutions.
Eventually these cou
ntries often have to assume a defensive position
rather than focusing on to build up their technological capabilities to
prospect their valuable resources and knowledge for their economic well
being and sustainable development. The current situation is su
ch that
both the developing countries and the developed industrialized countries
cannot simply do away with their own strengths. What the former lack is
the biotechnological capabilities for which they are largely dependent on
the developed countries, whi
le the developed countries look up to the
developing countries for new sources of genetic resources and associated
knowledge required for their bioprospecting and biotechnological
programms. Coming in terms with each other through a harmonious but

acceptable legal mechanism is the only possible way out to
overcome the current dilemma between the South and North. CBD is the


most relevant legal instrument that has set forth the most enabling
provisions for fair and transparent mechanisms for access

to and transfer
of biological and genetic resources and relevant technologies among the
Parties of the Convention. If all the Contracting Parties adhere to the
ethical and equity principles for facilitating fair, transparent and regulated
access to and
transfer of genetic resources and technologies it would help
greatly to resolve most of the unresolved issues related to ABS and
protection of intellectual property rights and customary rights of the
traditional communities.

So, most of the biodiversity
ich countries like India are addressing
the issues of ABS in relation to genetic resources and traditional
knowledge in the face of a contemporary complex situation as mentioned
above. Given the international guidelines such as the Bonn Guidelines
and oth
er model frameworks, one of the serious concerns for
implementing uniform standards and elements is the absence of
appropriate definitions of various terms related to genetic resources and
traditional knowledge and other components of biodiversity in the n
legislations and other documents on biodiversity. Through a decision
taken at its Seventh Meeting of the COP in Kuala Lumpur in 2004, the
CBD secretariat has initiated a process to compile the national definitions
that each Party has accorded to th
e following terms:
access to genetic
resources, benefit sharing, commercialization, derivatives, provider, user,
stakeholder, ex situ collection, voluntary nature, and other relevant terms
(CBD/COP 7/19/2004).

Another concern in relation to developing AB
procedures at national or institutional level is the lack of adequate capacity
and experience in evolving equitable bioprospecting partnerships that
would cover all essential steps of PIC, MTA, MAT, and agreements for
sharing the benefits arising from th
e production and commercialization of
any product or technologies derived from the genetic resources, its
components and/or derivatives and the associated knowledge. The
disproportionate distribution of biodiversity and biotechnology across the
world, and
the North
South divide in policy and legal issues related to
biodiversity, biotechnology, traditional knowledge, global trade and
intellectual property protection are other reasons that cause delay in
implementing a transparent and comprehensive internatio
nal regime on
access and benefit sharing.

Prior Informed Consent (PIC)

The provisions of Prior Informed Consent (PIC) as stipulated in
Article 15.5 of CBD is the first essential step in the best practice for any
Access and Benefit Sharing involving genetic

resources and indigenous or
traditional knowledge. PIC helps the Parties and other participating
stakeholders involved in an ABS contract/agreement to take informed
decisions pertaining to all administrative, legal and ethical matters on
access, benefit s
haring, technology transfer, capacity building and other
relevant matters with greater transparency and accountability. PIC also


helps facilitate prior negotiations and structured discussions on the shared
objectives, scope, duration, legal certainty and c
larity on ABS process,
benefit sharing and other agreements based on mutually agreed terms
among all relevant stakeholders.

While the basic principles and over all strategic approach to PIC
procedures of ABS at national or institutional level show uniform
ity, the
specific terms and conditions as well as the over all structure of each ABS
contract/agreement will vary significantly depending up on: (a) the specific
purpose of an applicant seeking access to genetic resources and TK from
another contracting Pa
rty, (b) the administrative, legal and policy
frameworks on ABS as well as the scientific and technological capabilities
of the Parties in facilitating a fair and transparent ABS deal, (iii) the
mutual concerns of the Parties for conservation of biodiver
sity and
equitable sharing of all kinds of benefits arising from the sustainable use
of the resources and associated knowledge, data and information
accessed. The Bonn Guidelines suggest that the basic principles of a PIC
system on ABS at national level sh
ould include:


Legal certainty and clarity


Minimum transition cost for access


Restrictions on access based only on legal grounds and subject to
national legislations and CBD


Consent for access to be obtained from the competent national
authority and where r
equired from other relevant stakeholders such
as indigenous and local communities, subject to the national
legislations of the provider country.

The Guidelines recommend that the PIC system may include the following
key elements:


Competent authority (ie
s) granting or providing for evidence of PIC
i.e. Prior informed consent of the competent national authority (ies)
and other relevant stakeholders, as appropriate, should be obtained
for accessing genetic resources from either ‘

’ or ‘


ources, subject to the national legislations in the provider country.
The PIC process, where appropriate, should ensure active
involvement of all relevant stakeholders from indigenous and local
communities to the government levels. PIC process should also
respect the provisions of CBD Article 8 (j), national legislations and
customary laws, in obtaining the PIC and approval of indigenous or
local communities for accessing their traditional knowledge,
innovations and practices.


Timing and Deadlines
systems should accord appropriate
time frame and deadlines for both applying and granting of access
by the provider and user countries respectively.



Specification of use

The application for PIC should clearly spell out
the specific uses for which the cons
ent has been granted. The
competent authority of provider country may stipulate in clear terms
the permitted specified use(s) while granting access permit to the
user country, so that further prior informed consent could be sought
for any change in the us
es of the resource being accessed or for
which the consent was already granted. The applicant for access to
genetic resources and/or associated traditional knowledge may
clearly spell out the special needs for using the resources or
knowledge being accesse
d for taxonomic, systemic or conservation
research, etc.


Procedures for obtaining PIC

PIC may be obtained through an
application in a format as prescribed by the provider country, and
may contain the following information, which are only indicative and
y vary depending upon the type of ABS processes and
stakeholders involved:


Legal entity and affiliation of the applicant and/or collector
and contact person, when the applicant is an institution.


Type and quantity of genetic resources to which access is


Starting date and duration of the activity.


Geographical prospecting area.


Evaluation of any possible impact of the activity on
conservation and sustainable use of biodiversity (in both the
user and provider countries).


Specification of intended use.


Identification of place/institution where R & D on the
accessed resource will take place.


Information on the R & D methods and schedules of


Identification of local bodies (including indigenous and local
community organization) for collaboratio
n in R & D.


Possible third party involvement.


Purpose of the collection, research and expected results.


Kinds/Type benefits arising from the access, including
benefits from derivatives or products arising from the
commercial and other utilization of the ge
netic resources.


Indications of benefit sharing arrangements.

(xi v)



Treatment of confidential information.



Mechanism for consultation of relevant stakeholders
Subject to the
merit of the PIC application and also in terms of the relevant
national and c
ustomary laws, the provider country may facilitate
negotiation and detailed discussions on the access programme and
all proposed activities, including possible benefit sharing
mechanisms, with all relevant stakeholders, involving local or
indigenous commun


PIC Processes
The application for access through PIC and
granting of access by the competent national authority (ies) should
be documented in written form through an easy and transparent
process. The grant of access could be in the form of a permit


or any other means as decided by the national authority.
The provider country may record all such issuance of all permits or
licenses through a national registration system.

Mutually Agreed Terms (MATs)

Article 15.7 of CBD stipulates that the
results of scientific research
and development and any other benefit arising from the sustainable use of
a genetic resource accessed by a Party shall be shared with the
Contracting Party providing the resource in a fair and equitable manner
based on “mutua
lly agreed terms”. The basic principles for developing
MATs are almost the same as discussed above under PIC, but may focus
more specifically on terms and conditions that both the Parties will agree
up on for an effective and transparent, legally binding A
BS process. The
Bonn Guidelines suggest the following basic requirements for arriving
“mutually agreed terms” between the provider and user countries for
access and granting of genetic resource:


Permitting only use of resources in order to take into ac
ethnical concerns of the particular indigenous and local
communities concerned.


Ensuring continued customary use of genetic resources and
associated knowledge.


Provisions for IPR use through joint research and claims on the
rights on inventions obtai
ned and to provide licenses by common


Provisions for joint IPR rights according to degree of contributions.

MATs in written formats may contain the following indicative parameters
and terms:


Type and quantity of genetic resources, and the
ical/ecological area of activity.


Any limitation on the possible use of the material accessed.


Recognition of the sovereign rights of the country of origin.




building in various areas to be identified in the


A clause on renegotiation
for any change of use for which the
consent was granted.


Whether or not to transfer genetic resources to third parties
without ensuring the third parties enter into similar agreements
except for taxonomic and systematic research that is not related


Protection to local knowledge, innovations and practices of
indigenous and local communities and promotion of customary
use of biological and genetic resources in accordance with
traditional practice of local and indigenous communities.


Treatment of confidential information.


Provision for benefit sharing resulting from the commercial or
other utilization of genetic resources and their derivatives and


Sharing Agreements related to Access to Genetic Resources

agreed terms” in accordance with Article 15.7 of CBD
should pay adequate attention to reaching an agreement on fair and
equitable sharing of benefit arising from the commercial or other utilization
of the resources accessed. The terms and conditions for be
nefit sharing
may vary from case to case depending up on the type of the access deal
that has been agreed up on by the Parties/stakeholders concerned. Bonn
Guidelines provide the following the conditions, obligations, and
mechanisms of benefit sharing:

es of Benefits:

The types of benefits may include monetary and non

benefits. The
monetary benefits

may broadly cover the following as per
mutually agreed terms:


Access fees.



front payments.


Milestone payments.


Sharing of Royalties.


se fees in case of commercialization.


Special fees to be paid to trust funds supporting conservation and
sustainable use of biodiversity.


Salaries and preferential terms on mutually agreed terms.


Research funding.



Joint ventures.


Joint ownership of relevan
t intellectual property rights.



benefits may include:


Sharing of research and development results.


Collaboration, cooperation and contribution in scientific research
and development programme, particularly biotechnological
research acti
vities, where possible in the provider country;


Participation in product development.


Collaboration, cooperation and contribution in education and


Admittance to


facilities of genetic resources and to


Transfer to the provider
of the genetic resources of knowledge
and technology under fair and most favorable terms, including
on concessional and preferential terms where agreed, in
particular, knowledge and technology that make use of genetic
resources, including biotechnology, or

that are relevant to the
conservation and sustainable utilization of biotechnological


Strengthening capacities for technology transfer to user
developing country Parties and to Parties that are countries with
economics in transition, and techno
logy development in the
country of origin that provides genetic resources. Also to
facilitate abilities of indigenous and local communities to
conserve and sustainably use their genetic resources.


Institutional capacity



Human and material resou
rces to strengthen the capacities for
the administration and enforcement of access regulations.


Training related to genetic resources with the full participation of
providing Parties, and where possible, in such Parties.


Access to scientific information re
levant to conservation and
sustainable use of biological diversity, including biological
inventories and taxonomic studies.


Contributions to the local economy.


Research directed towards priority needs, such as health and
food security, taking into account
domestic uses of genetic
resources in provider countries.


(xi v)

Institutional and professional relationships that can arise from
an access and benefit

sharing agreement and subsequent
collaborative activities.


Food and livelihood security benefits.


Social reco


Joint ownership of relevant intellectual property rights.

Timing of Benefits

The time frame of benefit

sharing may be specified.
Benefits could be near
term, medium
term or long
term depending upon
the circumstances. These may include up


payments, milestone
payments and royalties.

Distribution of benefits
The benefits arising from the ABS contract should
be shared in a fair and equitable manner among all those who have
contributed to the resource management, R & D and commercialization
rocess, including governmental, non

governmental or academic
institutions and indigenous and local communities.

Mechanisms for Benefit

This may vary from case to case
depending upon the types/kinds of benefits (monetary or non

efits), specific conditions in the country and stakeholders involved. The
best benefit

sharing could be one that has been struck between the
participating countries/stakeholders through prior informed consent and
mutually agreed terms. Active participat
ion of all partners in the ABS
process, including R & D, marketing, and commercialization must be
ensured through development of joint ventures & license and creation of
trust funds, etc.

Material Transfer Agreements: Key Elements (MTAs)

All access pe
rmits or license or any other means of granting access
to genetic resources and associated knowledge should be appended with
a standard “Material Transfer Agreement” by the provider country to the
user as per prior informed consent and mutually agreed term
s. MTAs may
vary in their formats and contents depending up on the type of resources
and knowledge being accessed and the terms mutually agreed up on by
the participant countries.

Bonn Guidelines provide a framework for developing MTAs with
following ele


Introductory Provisions


Preamble with reference to CBD.


Legal status of the provider and user of genetic


Mandate and/or general objectives of provider and user.



Access and benefits

sharing provisions


Description of genetic resour
ces covered by the MTAs
with accompanying information.


Permitted uses of genetic resources, their products or
derivatives under MTAs.


Statement on any change of use that would require new
PIC and MTA.


Statement as to whether IPR is sought and if so, under
what conditions.


Terms of benefits

sharing with details of the type/kind
of benefits to be shared.


Clause on non
warranties guaranteed by provider on
identity and/or quality of the material provided.


Statement on whether the genetic resources and/or
mpanying information may be transferred to the third
parties and, if so, on what conditions such transfers
would be permitted.


Definitions of various terms (in clear cut wordings so as
to avoid ambiguities and any possible misleads).


Duty to minimize envir
onmental impacts of collecting


Legal provisions


Obligation to comply with MTA.


Duration of the agreement.


Notice to terminate the agreement.


Statements on certain obligations in certain clause
survive the termination of the agreements.


ndent enforceability of individual clauses in the


Events limiting the liability of either party (such as of God,
fire, flood, etc.).


Dispute settlements arrangements.


Assignments or transfer of rights.


Assignments, transfer or exclusion of the r
ights to claim
any property rights, including intellectual property rights,
over the genetic resources received through the material
transfer agreements.



Choice of law.


Confidentiality clause



ABS Policies and Programmes: The Indian Ini

India has always been playing a proactive role in the development
and implementation of several global, international, regional and national
policies and programs related to environment, biodiversity, trade,
intellectual property rights and other

relevant areas. Biodiversity and
associated traditional knowledge are two capital resources of India, and
they form the prime focus of all the sectoral and cross
sectoral programs
centered on sustainable development. The significant initiatives that India

have taken in enacting several national legislations and in developing
strategic action plans are examples to demonstrate the country’s
commitment to the major international conventions, treaties, laws,
strategies such as The World Heritage Convention (
1972); Convention on
International Trade in Endangered Species of Flora and Fauna (CITES
1975); Ramsar Convention on Wetlands (1975); FAO’s International
Undertaking on Plant Genetic Resources (FAO 1983); Convention on
Biological Diversity (CBD 1992); Agen
da 21 (1992); UN Framework
Convention on Climate Changes (1992); UN Convention to Combat
Desertification (1994); The Trade Related Intellectual Property Rights
TRIPs 1994); Cartagena Protocol for Biosafety to CBD (2000);
FAO International Treaty on P
lant Genetic Resources for Food and
Agriculture ( FAO, 2001), Global Strategy for Plant Conservation ( GSPC
2002); the Bonn Guidelines on

Access to Genetic Resources and Fair and
Equitable Sharing of the benefits Arising out of their Utilization (2002), et
CBD is the most comprehensive legal instrument that addresses the
issues of access and benefit sharing involving genetic resources and
traditional knowledge. Consequent to the ratification of CBD by India on
18 February 1994 and in pursuance of the CO
P decisions of CBD that
followed, the Government of India, particularly the Ministry of Environment
& Forests (MoEF)

the national focal point of CBD, has taken several
steps in implementing the CBD provisions through interactive
stakeholder consultation
s and integrated cross
sectoral planning and

making processes. While the specific details of such initiatives
are available in the various reports, publications and web sites of nodal
agencies such as MoEF (
please see
the discussion below will be precisely on those initiatives focused on the
access and benefit sharing of genetic resources and traditional

The Biological Diversity Act 2002 (No.18 of 2003)


core of the ABS provisions and their effective implementation
in the territorial jurisdiction of India is dealt with in the Biological Diversity


Act 2002(enacted on December 11, 2002 and received the assent from
President of India on February 5, 2003) and

in the Biological Diversity
Rules 2003 (in force since April 15,2003). The Act provides for regulated
access to biological and genetic resources by bonafide end
users for
different purposes, including scientific research, commercial uses,
biosurvey, bio
tilization, conservation and other sustainable uses, etc.
The over all implementation of the Act will be coordinated by three
functional bodies viz. The National Biodiversity Authority (NBA), the State
Biodiversity Boards (SBB), and the Biodiversity Manage
ment Committee
(BMC). NBA is the national competent authority to discharge all decisions
pertaining to ABS, including prior informed consent process, approval for
access to and transfer of biological resources and scientific research
results & technologies

to foreign citizens, companies and non
Indians (NRIs), prior approval for applying for IPRs based on biological
resources or traditional knowledge obtained from India, fixing criteria for
benefit sharing, approval of third

party transfer of acc
essed biological
resources and traditional knowledge, and several other matters related to

Procedures for Access to biological resources and associated traditional

The Act stipulates norms for access to biological resources and
l knowledge based on three ways:


Access to biological resources and traditional knowledge to
foreign citizens, companies and NRIs based on ‘prior
approval of NBA’ (Section 3 of the Act).


Access permits to Indian citizens, companies, associations
and other

organizations registered in India on the basis of
‘prior intimation to the State Biodiversity Board’ concerned
(Section 7 of the Act).


Exemption of prior approval or intimation for local people and
communities, including growers and cultivators of
rsity, and

who have been
practicing indigenous medicines (Section 7 Of the Act).

The key procedures to be followed for access to biological
resources and traditional knowledge are dealt with under Rule no 14 (1

10 sub rules) of the Biod
iversity Rules 2003. These provisions are laid
down to ensure effective, efficient and transparent access procedures
through written agreements and applications in prescribed formats.
Applicants seeking access to biological resources and traditional
dge are required to submit an application in
(annexed to
the Biodiversity Rules 2003) along with an application fee of Rs. 10,000/

The NBA through appropriate consultation mechanisms shall dispose of
the application and communicate its decision to
grant access or otherwise


to the applicant within a period of six months from the date of receipt of
the application. The Authority is required to communicate the grant of
access to the applicant in the form of a written agreement duly signed by
an authori
zed official of the Authority and the applicant. The rule 14 also
stipulates the Authority to provide reasons in writing in cases of rejection
of an application and give reasonable opportunity to the applicant to
appeal. The Authority shall publicize the

approval granted through print or
electronic media and also shall monitor the compliance of the conditions
agreed up on by the Party and the applicant when the approval for grant
for access was accorded. The access procedures are only regulatory in
, but are not prohibitive in any manner to any applicant irrespective
of their nationalities, affiliations, origin, etc.

Revocation of access

Revocation of access or approval granted to an applicant will be
done only on the basis of any complaint or

under the following
conditions: (i) violation of the provisions of the Act or conditions on which
the approval was granted (ii) non
compliance of the terms of the
agreement (iii) failure to comply with any of the condition of access
granted (iv) on a
ccount of overriding public interest or for protection of
environment and conservation of biodiversity (Rule 15, Sub rule 1). After
having withdrawn the access permit, the Authority is required to send an
order of revocation to the concerned Biodiversity M
anagement Committee
and the State Biodiversity Board for prohibiting the access and to assess
the damage, if any, caused, and steps to recover the damages (Rule 15,
Sub rule 2).

Restriction for access

The Act imposes certain restrictions on request relate
d to access to
biological resources and traditional knowledge if the request is on: (i)
endangered taxa (ii) endemic and rare taxa (iii) likely adverse effects on
the livelihood of the local people (iv) adverse and irrecoverable
environmental impact (v) c
ause genetic erosion or affect ecosystem
function (vi) purpose contrary to national interests and other related
international agreements to which India is Party (Rule 16, Sub rule 1).

Transfer of research results

The Act does not pe
rmit any person to transfer the results of any
research relating to biological resources obtained form India for monetary
consideration to foreign nationals, companies or NRIs without the prior
approval of the Authority. Approval for such transfers shall b
e done on the
basis of an application to authority in FORM II along with the payment of
an application fee of Rs 5000/
. The Authority within a period of three
months from the receipt of an application shall take a decision on it. As in
the case of access
permits the Authority shall communicate the approval
for transfer of research results to the applicant in the form of a written


agreement duly signed by an authorized official and the applicant. The
authority shall communicate the reasons in case a request

for transfer of
research results was not granted and shall give reasonable opportunity
and time to the applicant for an appeal, if any (Rule 17, Sub rules 1

Procedure for prior approval before applying for IPR
: (Rule 18, Sub rules

All the con
ditions for granting approval for transfer of research
results shall be applicable to any person desirous of applying for a patent
or any other intellectual property rights, based on biological resources and
knowledge obtained form India. The Format for ma
king such applications
(FORM III) is annexed to the Biodiversity Rules 2003.

Procedures for third
party transfer of accessed biological resources or
: (
Rule 19, Sub rules 1

The Act permits transfer of accessed biological resources or
ional knowledge to a third party on the basis of the prior approval of
the Authority through a process of submitting an application in FORM IV
along with the payment of an application fee of Rs 10,000/
. The other
procedures remain the same as those stipul
ated for access to biological
resources and traditional knowledge under Rule 14.

Criteria for benefit sharing

The Act, subject to Section 21 and Rule 20 of the Biodiversity
Rules, insists up on including appropriate benefit sharing provisions in the
ess agreement and mutually agreed terms related to access and
transfer of biological resources or knowledge occurring in or obtained from
India for commercial use, bio
survey, bio
utilization or any other monetary
purposes. The Authority shall develop guid
elines and shall notify the
specific details of benefit sharing formula in an official gazette on a case
case basis. The suggested benefit sharing measures may include
“monetary benefits” such as royalty, joint ventures, technology transfer,
product dev
elopment, and “non

monetary benefits” such as education
and awareness raising activities, institutional capacity building, venture
capital fund, etc. The time frame and quantum of benefits to be shared
shall be decided on case
case based on mutually a
greed terms
between the applicant, Authority, local bodies, and other relevant
stakeholders, including local and indigenous communities. One of the
suggested mechanisms for benefit sharing includes direct payment to
persons or group of individuals through
district administration, if the
biological material or knowledge was accessed from specific individuals or
organizations. In cases where such individuals or organizations could not
be identified, the monetary benefits shall be paid to the National
sity Fund. Five percent of the benefits shall be earmarked for the
Authority or State Biodiversity Board towards the administrative service


Biodiversity Management Committee

The main function of the Biodiversity Management Committee
(BMC) cons
tituted under each local body as per Section 41 (1) of the Act
and Rule 22, Sub rules 1
11 of Biodiversity Rules, is to prepare People’s
Biodiversity Registers, which shall contain comprehensive information on
the availability and knowledge of local biolog
ical resources and medicinal
or any other traditional knowledge associated with them. Another
important functions of the BMC are to advise the State Biodiversity Board
and the National Biodiversity Authority on matters for granting approval, to
maintain da
ta about the local

and practitioners using the biological
resources, besides maintaining a register containing information on
access to biological resources and knowledge granted, details of
collection fee received and details of benefit sharing deri
ved and mode of
the sharing.

The ABS procedures stipulated under the Biodiversity Act 2002 are
in line with the provisions of international laws and policies, particularly
CBD and the Bonn Guidelines. The entire procedures as described in the
Act can contr
ibute substantially to facilitate an international regime of ABS
on genetic resources and traditional knowledge. However, the efficiency of
the Rules framed for the Act can only be judged on the transparency and
accountability with which these will be impl

The Protection of Plant Varieties and Farmers’ Rights (PPVFR) Act, 2001
(Act 53 or 2001)

The PPVFR Act 2001 and the Rules framed under this Act, called
the PPVFR Rules 2003, deal primarily with the protection of plant
breeder’s rights over the ne
w varieties developed by them and the
entitlement of farmers to register new varieties and also to save, breed,
use, exchange, share or sell the plant varieties, which the latter have
developed, improved, and maintained over many generations. The Act is a
deviation from the 1991 UPOV Model and can be regarded as an alternate

sui generis’

system that accord protection of the rights of the formal
innovations of a plant breeder and the informal knowledge system and
traditional plant varieties of the farmers a
s well (Sahai, 2003b). The
important provisions contained in this Act relevant to ABS are those on the
protection of farmers rights and the mechanisms suggested for
compensation or benefit
sharing (Brahmi
et al.
2004) for the contributions
of local communi
ties or farmers in the development of a new plant variety
(Sections 39, 40 & 41 of the Act and Rules 33 and 66). The section 40 of
the Act requires that the breeder or any applicant for registration of a new
plant variety shall disclose any information reg
arding the use of genetic
material conserved by any tribal or rural families in the breeding or
development of such variety. Willful non
disclosure of such information will
lead to rejection of the application for registration. Similarly, the Act also
res compensation of the contributions of any village or local


communities to the development of a variety registered under this Act.
Such compensation will be deposited to National Gene Fund. Another
important provision in support of the farmers’ conservat
ion efforts is the
recognition or rewards for a farmer who is engaged in conservation of
genetic resources of land races of wild relatives of economic plants and
their improvement through selection and preservation. The rewards will be
made from the Nation
al Gene Fund.

The Patent (Amendment) Act 2002 (Act 38 of 2002) (except provisions
relating to Appellate Board) and the Patent Rules 2003

This Act, which is an amendment to the Patent Act of 1970, is
significant in the sense that it stipulates disclosure o
f the “source and
geographical origin of the biological materials in the specification, when
used in an invention”. This issue of disclosure of source and geographical
origin is a contentious one that the LMMC and other developing and least
developing coun
tries are still pushing ahead with the WTO
new Patent Act of India includes two important clauses for revocation of a
patent on the grounds that: (i) the “complete specification does not
disclose or wrongly mentions the source of geographical or
igins of
biological materials used for the inventions”; (ii) the invention so far as
claimed in any claims of the complete specification is anticipated having
regard to the knowledge, oral or otherwise, available within any local or
indigenous community in

India or elsewhere”. These two provisions make
the Act TRIPs complainant and thus ensure protection of the rights of the
source country of a biological material or traditional knowledge of local or
indigenous community, and thereby enabling recognition an
d reward of
source countries and traditional knowledge holders through appropriate
benefit sharing mechanisms.

India has now the above three important national legislations
(pending the Patent (Amendment) Bill 2003) that address, among others,
the issues
of access and benefit sharing related to biological resources
and traditional knowledge. The Rules to implement these Acts are in place
or are in the process of finalization. Mutual synergies among the
implementing authorities of these would help achieve n
ot only an effective
implementation of the provisions of these Acts in the country but also in
defending India’s position in the international forums such as WTO
WIPO, etc.

Prior Informed Consent System and Benefit

Sharing Procedures: The NIF

The National Innovation Foundation (NIF), an autonomous society
established under the Department of Science and Technology,
Government of India in 2000, works for recognizing, respecting and
rewarding innovations and outstanding traditional knowledge at t
he grass
roots. NIF and the HONEY BEE Network under SRISTI (Society for
Research and Initiatives for Sustainable Technologies and Institutions), an


NGO based at Ahmedabad, have been scouting for documenting local
innovations and linking their innovations f
or further valorization with
Science and Technology experts, investors and entrepreneurs. NIF
maintains a separate National Register for green Grassroots
Technological Innovations and Traditional Knowledge. Until 2003, NIF has
scouted about 37000 innovatio
ns and traditional knowledge examples
from over 350 districts of India. Scouting and documentation; value
addition and R&D through a network of S&T experts, institutions, people’s
organizations, and rural and urban innovators for developing business and
ventures at local levels based on valorization of grass root level
innovations; intellectual property rights management; information and
technology dissemination; and benefit sharing are the various steps
involved in the NIF Programme on building of va
lue chain of grass root
innovations (Gupta 1999, 2001, 2003).

NIF has developed a model for facilitating the Prior Informed
Consent (PIC) system for local innovators and traditional knowledge
holders (see website

NIF Update and Explanatory note for PIC addressed to the Innovators and
the Traditional knowledge holders). The PIC models seek the innovators’
or tradit
ional knowledge holders’ consent for partial or full disclosure of
their innovation and disseminate them through print and web media, and
provide NIF mediation for value addition, patenting or other kinds of IPR
generation based on the local innovation or
traditional knowledge, and for
fixing criteria and the terms and conditions for sharing monetary or non
monetary benefits, if any, arising from the value addition, micro
development, patenting on a local innovation or traditional knowledge. The

process with regard to traditional knowledge holder and other grass
root innovations is a quite complex one. This cannot be compared with the
formal PIC process recommended for other ABS model involving
Government agencies, R&D institutions and other orga
nizations. The
awareness, capacities and exposure level of the local innovators to the
modern regimes of IPR scientific validation, management, trade policies,
etc. is either minimum or low. Empowering these communities with
knowledge and awareness on the
values and potentials of the rich
trove of knowledge they hold is an important exercise, which NIF
has been successfully accomplishing through their scouting programmes,
awareness campaigns, competitions and awards distribution conducted
for succe
ssful innovators. NIF suggests the innovator or the knowledge
holder to share their information on the following conditions:


With restrictions imposed


On commercial basis on terms for technology transfer, up front
payments, royalties, license fees, etc.



cost basis for personal application or household use only.


With further research and value addition in it



Any other conditions

The PIC model of NIF has both advantages and disadvantages.
The whole process of disclosure and dissemination of the l
innovations, either partially or fully, needs to be examined, whether they
affect adversely in eventual exclusion of potential innovations from
possible valorization and IPR claims and also any possible
misappropriation of such potentially useful inno
vations by others, and
thereby depriving the local innovator of his/her intellectual property and
customary rights.

The benefit sharing mechanism suggested by NIF’s PIC models
include four kinds of benefits viz. 1.
Individual (MI
tary awards, license fees or royalty from commercial exploitation of
technology or traditional knowledge, or any other monetary gain by
entrepreneurial process. This will be firstly paid to the individuals, who
may in turn share part of this with the commu
nity, innovation promotion
fund and institutions helping the value chain 2.
Monetary Collective

covers: trust funds, micro
venture funds, common property
infrastructure, etc to be shared with the communities 3.
Individual (NMI)

such as r
ecognition, a citation in a public function,
dissemination of one’s creativity through media or in workshops or other
public function, or using appellation on the product developed, business
venture, etc 4.
Monetary Collective (NMC)

includes: recognit
ion to
communities at appropriate levels for their collective wisdom, knowledge
and social or cultural organizations, etc.

The NIF benefit
sharing procedures also suggest separate formula
and modules for each kind of innovation on a case
case basis. Ben
sharing formula involving valorization with public or private R&D and the
community or individual innovators needs to be evolved based on
stakeholder consultations and on the degree of contributions by each
stakeholder through an effective cost
t analysis. The existing
complexities in the structure of the traditional knowledge domain itself, and
also the very nature of the existing IPR system that accord protection only
for the formal innovation based on the criteria of novelty, non
nd utility, are some of the major impediments in evolving any uniform
guidelines or model for access protection and benefit sharing involving
traditional knowledge systems held in traditional communities or the grass
root level innovators. However, NIF’s e
fforts to networking with the grass
root innovators so as to promote the local innovation and valorization of
such knowledge, protection of the intellectual property rights, and
equitable benefit sharing are gaining wider acceptance and credibility both
tionally and internationally.

Community Registers and Peoples’ Biodiversity Registers

The community gene bank and community agro biodiversity
register programmes and Peoples Biodiversity Register (PBR)


spearheaded by the MS Swaminathan Research Foundation
Chennai, the Foundation for Revitalization of Local Health Traditions
(FRLHT), Bangalore, and the Centre for Ecological Sciences at Indian
Institute of Science, Bangalore are examples of other useful mechanisms
and methods to chronicle the biogene
tic resources and associated
knowledge systems of the traditional communities and local or rural
people of the country. PBR is now accepted as a viable mechanism for
documenting people’s knowledge and biological resources under the
Biodiversity Management
Committees established under the Indian
Biological Diversity Act 2002. Development of comprehensive PBRs at
local level is a highly rewarding exercise which would not only help to
inventory and document the local biological and genetic resources along

the various actual uses and potential values of such resources, but
also to conserve and sustainably use the biocultural diversity for gainful
income generation and IPR generation through value addition and benefit
sharing processes (MSSRF, 1998; Ghate


2001; Kumar
et al.

Sahai 2003a). PBR also ensures active involvement of the local and
traditional communities in all decision
making processes related to
biological diversity and traditional knowledge, including issues of access
and benefit shar
ing. BMCs are entrusted with the preparation of PBRs and
to assist the SBBs and NBA in matters on ABS related to local biogenetic
resources and traditional knowledge.

The success story on compilation of community biodiversity
registers and community gene
bank programmes involving tribal
communities of the Jeypore tracts of Orissa with the guidance and support
from MSSRF is a good case study that demonstrates how the potential
benefits of such community biodiversity programmes help enhance the
livelihood op
tions and security of the local and traditional people. This
model of community agro
biodiversity programme has won the UN
Equator initiative Prize for poverty eradication and community
empowerment at World Summit for Sustainable Development (WSSD) at
nnesburg in August 2002 (see

/equator prize_2002 html).

Another community
based participatory conservation programme
that has won international acclaim through the Equator Awa
rd of 2002 is
the medicinal plant conservation and cultivation work achieved by
Medicinal Plants Conservation Centre, (MPCC), Pune with the support of
FRLHT ( see

initiative/ /equator priz
e_2002 html).

The MPCC with an effective involvement of local communities has
developed a decentralized system of nurseries, raising 50,000 plants of 50
different species and linking them with a network of herbal production
centers. The propagation and cu
ltivation of medicinal plants in nurseries
have helped to reduce the pressures of collection from the wild and hence
promoting the conservation of such valuable resources. The linkage with
herbal production centers has helped provide economic incentives to

communities involved in the MPCC programme. Such community network


programmes on bio
resources conservation and management contribute
to significantly to the implementation of national policies and programmes
on biodiversity, and intellectual property

rights and access and benefit
sharing involving genetic resources and traditional knowledge.

Indian Experiment in Benefit Sharing: “TBGRI Model” or “Kani
Model” or “Pushpangadan Model”

India has the distinction of being the first country in the world in
experimenting a benefit
sharing model that implemented the Article 8(j) of
CBD, in letter and spirit. It was the Tropical Botanic Garden and Research
Institute (TBGRI) in Kerala (where Dr. P. Pushpangadan was director)
that demonstrated indigenous knowle
dge system merits support,
recognition and fair and adequate compensation. The model, which later
on came to be known as “TBGRI Model” or “Kani Model” or
“Pushpangadan Model”, relates to the sharing of benefits with a tribal
community in Kerala, the Kanis
, from whom a vital lead for developing a
scientifically validated herbal drug (Jeevani) was obtained by scientists of
TBGRI. The TBGRI Model has got wider acclaims, acceptance and
popularity the world over, because it was the first of its kind that
ized the resource rights and IPR of a traditional community by way
of sharing equitably the benefits derived out of the use of a knowledge that
has been developed, preserved and maintained by that community for
many generations (Anand 1998, Anuradha, 1998,

Bagla 1999, Gupta,
2002, Mashelkar, 2003). Further, it demonstrates the vast and as yet

explored or untapped potentials of the Indian traditional knowledge
systems, particularly the traditional health care practices of the local and
indigenous peo
ple in India. It would, therefore, be interesting to give brief
background information regarding the traditional medicine system of India
and the genesis and operation of an ambitious programme

“All India
Coordinated Research Project on Ethnobiology (AIC
RPE), which led to
the TBGRI Benefit

sharing Model.

The Tribal Settings in India and their Knowledge Base

There are about 70 million tribes belonging to over 550
communities. They are in possession of a treasure of rich traditional
knowledge system assoc
iated with the conservation and use of wild flora,
fauna and other natural resources. The inroads of modernization are
presently posing imminent danger to this rich and varied knowledge
system of these communities, and it is likely that it may be complete
ly lost
to the humanity for all time to come. Recognizing this danger, Prof. M.S.
Swaminathan, the then Director General of Indian Council of Agricultural
Research (ICAR) mooted the idea of starting a research programme to
document the knowledge system of

the tribal communities of India in
1976. Consequently, an All India Coordinated Research Project on
Ethnobiolgy (AICRPE) was prepared under the guidance of Dr T.N.
Khoshoo, the then Director of the National Botanical Research Institute


(NBRI) at Lucknow.
Government of India finally launched the AICRPE
under the Man and Biosphere (MAB) Programme in 1982. The overall
objective of AICRPE was to make an in
depth study and analysis of the
multidimensional perspectives of the life, culture, tradition and knowl
system of the tribal communities of India. Initially the project was under
the Department of Science and Technology, but later transferred to the
Ministry of Environment and Forests, Govt. of India. The author, then a
senior scientist at Regional Res
earch Laboratory (RRL), Jammu (a
constituent laboratory of the Council of Scientific and Industrial Research

CSIR), was appointed as the chief coordinator of this massive
programme in 1983. It was operated at 27 centres in the country and
about 600 scie
ntists drawn from botany, zoology, sociology, anthropology,
ayurveda, chemistry and pharmacology worked in this project that lasted
for 16 years (1982
1998). AICRPE project documented various aspects of
the life, culture, tradition and knowledge systems i
ncluding those
associated with the use of over 10,000 wild plants used by tribes for
meeting a variety of their requirements (AICRPE Final Technical Report
1998; Pushpangadan 2002).

The Kani tribe and Arogyappacha (=Elixir of health)

The Kanis, a s
emi nomadic community, is the predominant tribe
inhabiting the forests of the southern most parts of the Western Ghats in
Kerala (in the districts of Thiruvananthapuram, Kollam and
Pathanamthitta), India. Traditional occupation of Kanis includes craftwork
like basket making, mat making using

stem, cane works, etc.
They are also engaged in collection of non
timber forest produces
(NTFPs) like honey, bee wax, medicinal plants, python fat, etc. The Kanis
are well known for their rich knowledge on med
icinal plants of the region.

In one of the field expeditions in the mountainous forests of the
Southern Western Ghats in Kerala, a few young Kani men accompanied
the AICRPE team led by its Chief Coordinator. During the arduous
trekking across the forests

the scientists noticed that the tribals frequently
ate some fruits, which kept them energetic and agile. The Chief
Coordinator and the accompanying scientist (Dr. S. Rajasekharan, an
Ayurvedic specialist) were almost exhausted at one time when they were
ffered these strange seeds. After consuming the same the scientists also
felt a `sudden flush of energy and strength’. When asked about the
source of the fruits, the Kani young men were first reluctant to reveal their
secret. The team convinced the Kani
men that if they passed on the
information to them they would not misuse it and that they would conduct
scientific investigation and, if found promising, a drug would be developed
for the welfare of the humanity. As the team leader Dr Pushpangadan also
ured the Kanis that if any marketable drugs/products were developed
from this plant, the financial benefits accrued from the same would be
equally shared with them and their community. The Kani men then
showed the plant to the scientists from which the fr
uit was obtained. The


scientists identified the plant as
Trichopus zeylanicus.
Burkill ex Narayanan. The Kanis call it

as `Arogyapacha’,
meaning evergreener of health or elixir of health.

Scientific investigation on Arogyappacha & dev
elopment of the herbal drug

Dr. Pushpangadan collected samples of this plant and took it to his
ethnopharmacology RRL, Jammu where he was working at
the time. He and his team at RRL carried out phytochemical and
pharmacological eva
luation of this plant. The study revealed that the plant
contained various biodynamic compounds notably certain glycolipids and
steroids compounds with profound adaptogenic and immuno
enhancing properties. RRL has filed two patents on the same. In the
meantime in 1990, Dr. Pushpangadan moved to Trivandrum to assume
the position of Director, Tropical Botanical Garden and Research Institute
(TBGRI). At TBGRI, he organized an ethnopharmacology division and
recruited a multidisciplinary team of scientists d
rawn from Ayurveda,
ethnobiology, biochemistry, phytochemistry, pharmacy and pharmacology.
Dr. Rajasekharan also joined this team as an Ayurvedic scientist. This
Division developed a scientifically validated and standardized herbal

with Arogyappacha as one of the constituents. This
drug after necessary clinical trials was transferred to Arya Vaidya
Pharmacy (AVP) Coimbatore Ltd. against a

fee of Rs. 10 lakh
(US$ 25,000) and a royalty of 2% at ex
factory sale rate. While
ferring the technology, TBGRI with the approval of its competent
authority agreed to share the

fee and royalty received from AVP
with the Kani tribe.

Kani tribe is an unorganized forest dwelling semi
nomadic tribe.
Our prime concern in the beginni
ng was therefore to evolve a viable
mechanism for receiving such funds and utilizing the same for the welfare
of the community. Several ways of sharing the benefits were discussed at
many levels and it was finally decided to set up a trust fund of the trib
The very idea of the trust fund had originated from very useful and
protracted discussion Dr Pushpangadan had with Prof. Anil K. Gupta, the
founder and coordinator of SRISTI and Honey Bee Network. It took
however, almost two years to transfer the benef
its to the tribe. With the
help of some local NGOs, TBGRI scientists and some motivated
government officials, the tribes were encouraged to form a registered trust
with Kani adults as its members. The trust was fully owned and managed
by the Kani tribe.

About of 60% of the Kani families of Kerala are now
members of this Trust. In February 1999, the amount due to them (Rs.
6.5 lakhs) and which was till then kept by TBGRI in a separate account
was transferred to the Trust. As per the rules of the Trust t
he license fee
and royalty received on account of the sale of `Jeevani’ drug will be in a
fixed deposit and only the interest accrued from this amount will be utilized
for the benefits/welfare of the members of the Kani tribe.


This model was thus develop
ed and perfected over a period of
about 12 years starting from 1987 to 1999 in full consultation with the Kani
tribe. In fact, the whole process of this benefit sharing started much
before the CBD was evolving. It took almost 3 years for the Kani tribe t
receive this benefit. The delay was mainly due to the inherent inability and
absence of any organized mechanism for Kani tribe to receive such
benefit. The secretary of Tribal and Scheduled Caste Department of
Government of Kerala played a crucial role

in the formation of the Kani
Trust and also in effecting a smooth transfer of the amount due to the
Kanis from TBGRI to the Kani Trust. The Kani Trust now continues to
receive the royalty.

All along these years, starting from 1987, it was the mutual trust
respect, transparency and frequent interaction and communication
between TBGRI and the Kani tribe that contributed to the success of this
sharing model.

In addition to the

fee and royalty that Kani Trust is receiving,
a large number of
Kani families are now getting benefit from the cultivation
of Arogyapacha and supply of the raw
material (i.e. the leaves of the
plant) to the pharmaceutical company for the production of the drug.
TBGRI has trained many tribal families for the cultivatio
n of `Arogyapacha’
in and around their dwellings in the forest.

Outcome and Lessons Learned

The sharing of benefits with the Kanis and formation of the Kani
trust fund have started showing positive impacts in the sense that the
tribal community is now beco
ming conscious about the values of and
rights over their knowledge system and associated biological resources.
These developments also have helped in bringing the Kani families to a
single organizational framework, so that the benefits accrued from the
st fund could be utilized for the economic well being and social
development in the Kani tribal hamlets. The benefit sharing experiments
like the TBGRI Model will help empower the traditional communities not
only to preserve their traditional knowledge sys
tem but also to encourage
them to bring in more innovations and value additions to their knowledge
and resources.

The TBGRI Model is perhaps a unique experiment ever done,
wherein the benefits accrued from the development of a product based on
an ethno
anical lead were shared with the holders of that traditional
knowledge. Considering the significant outcome of this model in
community empowerment, income generation and poverty eradication of a
tribal community, Dr. Pushpangadan was awarded with the UN
Initiative Prize (under individual category) at the World Summit on
Sustainable Development held in Johannesburg in August 2002. Now
with the CBD
Bonn guidelines and our national legislation on Biodiversity
in position, the TBGRI or Kani case study

could be taken as an ideal


model of equitable benefit sharing involving genetic resources and
associated traditional knowledge.


The issues of access, benefit sharing, technology transfers, and
intellectual property rights protection related
to genetic resources and
traditional knowledge are the most contentious ones that keep the
developed and developing countries divided in their attitude and
approaches. The intricate imbalance in the core objectives and directives
of CBD and TRIPs is a majo
r concern for the Parties or members of these
international laws. Among all the issues being debated between CBD
Secretariat and TRIPs Council, the question of providing legal protection
to genetic resources and associated traditional knowledge continues t
crop up at the inter
sessional meetings of CBD, TRIPs and WIPO. It is a
matter of grave concern that certain countries with powerful
biotechnologies are still reluctant to become a Party to CBD, but continue
to oppose the plea of the developing or the le
ast developed countries for
evolving an enabling and equitable legal mechanism for implementing the
international trade and intellectual property laws in relation to biodiversity,
genetic resources and traditional knowledge systems. The decision to
sh the “Group of Like
Minded Megadiverse Countries (LMMC)” at a
meeting of the ministers of environment and representatives from 13
countries at Cancun in Mexico on 18

February 2002 is a welcome step to
consolidate the position of these countries in the
international forums
related to biodiversity, trade and intellectual property rights. The ‘Cancun
Declaration’ of LMMC is the clear expression of the alarming concerns
and priorities of LMMC with regard to conservation and sustainable use of
biodiversity a
nd other relevant objectives, including capacity building and
human resource development, information technology exchange and
dissemination, policy decisions, scientific and technology cooperation,
biopartnerships, etc.

Appropriate national laws and polic
y guidelines on biodiversity and
ABS on biogenetic resources and traditional knowledge are in place in
many of the 18 LMMCs. One of the priority actions for the LMMC would be
to evolve effective mechanisms for developing as well as implementing
relevant le
gal instruments that could facilitate regulated access and
benefit sharing regime with stringent provisions to prevent any illegal and
inappropriate access and transfer of genetic resources and associated
knowledge by the any individual or corporate bodies

with vested interests.
The second important priority of LMMC would be to concentrate their
efforts in developing national and regional S&T capacity building and
human resource development programmes for harnessing the wealth of
biogenetic resources and tr
aditional knowledge shared by these countries.
Building up equitable bioprospecting partnership among the LMMC based
on mutually
agreed terms and transparent legal and policy support will be
a promising area that will help multilateral exchange or transfer



biological resources and associated information and knowledge, relevant
technologies, besides helping to build up human resources in the most
advanced areas of biotechnologies, herbal technologies and information
technologies. Mutual trust and cooperat
ion built up through multilateral
stakeholder consultations between the LMMC and other group of
developing countries or countries with economies in transition can go a
long way in bringing a new era of bio
partnership. Since the LMMC have
shared concerns a
nd interests to protect their biodiversity and traditional
knowledge systems, any collective efforts of the Group will help them
challenge the threats of increasing incidences of bio
piracy and
misappropriation of intellectual property rights of their biod
iversity and
traditional knowledge systems by the powerful lobbies of biotechnologies.
What is more important at the national level for all LMMC is to reaffirm
their commitment to evolving a transparent and viable mechanism for
regulated access and benefi
t sharing of genetic resources and associated
traditional knowledge. And, the prerequisite for developing an effective
ABS regime is building up a comprehensive information system on all
pertinent aspects of availability, diversity, distribution, economic
uses and
potentials, conservation status of biogenetic resources and associated
traditional knowledge along with information on the existing S&T
infrastructure and capabilities, including human resource wealth, national
and international legal and policy f
rameworks, current achievements and
future plans and priorities for capacity
building for conservation,
sustainable use, bioprospecting and economic valuation of their great
wealth of bio
resources and traditional knowledge .


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