Access and Benefit sharing from Genetic Resources

Dr Karan Veer Singh, Scientist
12/21/2017 ICAR-NBAGR KARAN VEER SINGH

Millions of people depend on biological (genetic) resources
and traditional knowledge for their livelihoods. While the
concept of an access and benefit sharing (ABS) regime is new,
access to biological resources and transfer of associated
traditional knowledge is centuries old.
ABS regimes facilitate access, thereby increasing the use of
biological resources and associated traditional knowledge,
while ensuring that the benefits are shared with the
traditional owners.

What are genetic resources?
• All living organisms (plants, animals and microbes) carry genetic
material potentially useful to humans
• These resources can be taken from the wild, domesticated or cultivated
• They are sourced from:
– Natural environments (in situ)
– Human-made collections (ex situ)
(e.g. botanical gardens, genebanks, seed banks and microbial culture
collections)
Access means obtaining, possessing and using genetic resources, their
derived products, and where applicable, intangible components for
purposes of research, bio-prospecting, conservation, industrial application
or commercial use.

Commercial use’ means any collection and use of genetic material for
profit making;
Genetic material’ means any genetic material of plant, animal, microbial
or other origin containing functional units of heredity;
‘Germplasm’ means genetic material capable of propagation;‘
Genetic resources’ means genetic material of actual or potential value;
‘Holotype’ means the single specimen chosen for designation of a new
species;
‘Intangible components’ means any information held by persons that is
associated with or regarding genetic resources within the jurisdiction of
India;
RELEVANT DEFINITIONS

BENEFIT SHARING
Monetary benefits may include but are not limited to:
(i) Access fees/fee per sample collected or otherwise acquired;
(ii) Up-front payments;
(iii) Milestone payments;
(iv) Payments of royalties;
(v) License fees in case of commercialisation;
(vi) Special fees to be paid to trust funds supporting conservation and sustainable use
(vii) Salaries and preferential terms where mutually agreed;
(viii) Research funding;
(ix) Joint ventures; and
(x) Joint ownership of relevant intellectual property rights.

Non-Monetary benefits may include, but are not limited to:
(i) Sharing of research and development results;
(ii) Collaboration, cooperation and contribution in scientific research &
development programmes, particularly biotechnological research
activities;
(iii) Participation in product development;
(iv) Admittance to ex situ facilities of genetic resources and to databases by
participating institutions;
(v) Transfer of genetic resources of knowledge and technology under fair &
most favourable terms, knowledge and technology that make use of
genetic resources, including biotechnology, or that are relevant to the
conservation and sustainable utilization of biological diversity;
(vi) Strengthening capacities for technology transfer
(vii) Institutional capacity building;
(viii) Human and material resources to strengthen the capacities for the
administration and enforcement of access regulations;
(ix) Training related to genetic resources with the full participation of country

GAPS
• No clear provision of how benefits are to be
distributed to local community (what is fair and
equitable?)
•Do the regulations cover biological resources as well?
•No standard form/provisions of the contents of PIC
and MTA – this may cause confusion to
providers/owners and users as this is a new issue for
the country

STRENGTHS
• Participatory and consultative process that was used
to develop regulations
•Comprehensive framework to regulate genetic
resources and benefit sharing
•Harmonized both regional and international (Bonn
Guidelines) laws on ABS.
•Clear provision for mandatory PIC and MTA to ensure
that the providers/owners receive benefits.

The Nagoya Protocol on Access to Genetic Resources and the Fair and
Equitable Sharing of Benefits Arising from their Utilization (ABS) to the
Convention on Biological Diversity is a supplementary agreement to the
Convention on Biological Diversity.
• It provides a transparent legal framework for the effective
implementation of one of the three objectives of the CBD: the
fair and equitable sharing of benefits arising out of the
utilization of genetic resources.
• The Nagoya Protocol on ABS was adopted on 29 October 2010
in Nagoya, Japan and entered into force on 12 October 2014.
Its objective is the fair and equitable sharing of benefits
arising from the utilization of genetic resources, thereby
contributing to the conservation and sustainable use of
biodiversity.

• The Nagoya Protocol applies to genetic
resources that are covered by the CBD, and to
the benefits arising from their utilization.
• The Nagoya Protocol also covers traditional
knowledge (TK) associated with genetic
resources that are covered by the CBD and the
benefits arising from its utilization.

• The Nagoya Protocol addresses traditional knowledge
associated with genetic resources with provisions on
access, benefit-sharing and compliance.
• It also addresses genetic resources where indigenous and
local communities have the established right to grant
access to them.
• Contracting Parties are to take measures to ensure these
communities’ prior informed consent, and fair and
equitable benefit-sharing, keeping in mind community
laws and procedures as well as customary use and
exchange

Tools and mechanisms to assist
implementation
• The Nagoya Protocol’s success will require effective implementation at the domestic level. A range
of tools and mechanisms provided by the Nagoya Protocol will assist contracting Parties including:
• Establishing national focal points (NFPs) and competent national authorities (CNAs) to serve as
contact points for information, grant access or cooperate on issues of compliance
• An Access and Benefit-sharing Clearing-House to share information, such as domestic regulatory
ABS requirements or information on NFPs and CNAs
• Capacity-building to support key aspects of implementation. Based on a country’s self-assessment
of national needs and priorities, this can include capacity to
– Develop domestic ABS legislation to implement the Nagoya Protocol
– Negotiate MAT
– Develop in-country research capability and institutions
• Awareness-raising
• Technology Transfer
• Targeted financial support for capacity-building and development initiatives through the Nagoya
Protocol’s financial mechanism, the Global Environment Facility (GEF)

Awareness-raising
• Article 21 of the Nagoya Protocol provides that each Party shall take
measures to raise the awareness of the importance of genetic resources and
traditional knowledge associated with genetic resources, and related access
and benefit-sharing issues. It also provides a list of such measures.
• Communication, education and public awareness are central to an effective
implementation of the Nagoya Protocol. Therefore, effective implementation
of Article 21 of the Nagoya Protocol plays a critical role for its overall success.
• In this context, the first meeting of the COP-MOP in decision NP-1/9 adopted
an Awareness-raising Strategy for the Nagoya Protocol on Access and Benefit-
sharing which aims at providing a systematic and coherent approach to assist
Parties in the implementation of Article 21.

Capacity-building and development
• Article 22 of the Nagoya Protocol provides that
Parties shall cooperate in the capacity-building,
capacity development and strengthening of
human resources and institutional capacities to
effectively implement the Protocol in developing
country Parties and Parties with economies in
transition.
• Parties are required to fully take into account the
needs of involvement of indigenous and local
communities and relevant stakeholders.

Compliance with the Protocol
• Article 30 of the Nagoya Protocol provides that the first meeting of
the Conference of the Parties serving as the meeting of the Parties
to the Nagoya Protocol (COP-MOP) shall consider and approve
cooperative procedures and institutional mechanisms to promote
compliance with the provisions of the Protocol and to address cases
of non-compliance. These procedures and mechanisms shall include
provisions to offer advice or assistance, where appropriate. They
shall be separate from, and without prejudice to, the dispute
settlement procedures and mechanisms under Article 27 of the
Convention.
• Compliance procedures are a common feature of many multilateral
environmental agreements. In general terms, they are intended to
support compliance with a treaty and facilitate or assist the Parties
to the treaty to implement their obligations.

Global multilateral benefit-sharing mechanism
(Article 10)
• Article 10 of the Protocol states that “Parties shall consider the need for
and modalities of a global multilateral benefit-sharing mechanism to
address the fair and equitable sharing of benefits derived from the
utilization of genetic resources and traditional knowledge associated with
genetic resources that occur in transboundary situations or for which it is
not possible to grant or obtain prior informed consent. The benefits
shared by users of genetic resources and traditional knowledge associated
with genetic resources through this mechanism shall be used to support
the conservation of biological diversity and the sustainable use of its
components globally.”
• Article 10 addresses issues that could not be resolved during the
negotiation of the Protocol and for which further discussion was required.
Through online discussions and expert meetings, the Parties have been
exploring the different aspects of Article 10, identifying areas of common
understanding and areas where further examination is necessary.

Model contractual clauses, codes of conduct,
guidelines and best practices and/or standards
• Articles 19 and 20 of the Protocol require each Party to
encourage, as appropriate, the development, update
and use of sectoral and cross-sectoral model
contractual clauses for mutually agreed terms, and
voluntary codes of conduct, guidelines and best
practices and/or standards in relation to access and
benefit-sharing. Furthermore, the Conference of the
Parties serving as the meeting of the Parties to the
Protocol (COP-MOP) shall periodically take stock of the
use of these tools and consider the adoption of specific
codes of conduct, guidelines and best practices and/or
standards.

Bonn Guidelines
• A major achievement of COP VI was the adoption of
the Bonn guidelines on access to genetic resources and
the fair and equitable sharing of the benefits arising
from their utilization (see Decision VI/24).
• The Guidelines were recognized as a useful first step of
an evolutionary process in the implementation of
relevant provisions of the Convention related to access
to genetic resources and benefit-sharing. They will be
kept under review by the COP and the need for their
further refinement will be considered on the basis of
relevant developments under the Convention,
including those on issues such as traditional knowledge
and technology transfer.

• WIPO Contracts Database and Draft Guidelines
• This on-line, searchable database of biodiversity-
related Access and Benefit-Sharing Agreements is
available on the WIPO website, with a particular
emphasis on the intellectual property aspects of
such agreements.
• Draft Intellectual Property Guidelines for Access
to Genetic Resources and Equitable Sharing of
the Benefits arising from their Utilization

Existing instruments, guidelines, codes of conduct
and tools addressing ABS
• Different types of genetic resources (e.g.: animal, plant,
microorganisms) are used by different types of users (e.g.:
botanic gardens, academic researchers, private companies)
for different purposes (research, commercialization) in a
variety of sectors (e.g.: agriculture, pharmaceutical,
horticultural, cosmetics, biotechnology).
• The following provides an overview of instruments,
guidelines, codes of conducts, policies and other tools
developed for different types of users of genetic resources
to assist with the implementation of the access and
benefit-sharing provisions of the Convention by responding
to the particular needs of their constituents.

Agricultural sector
• The International Treaty on Plant Genetic Resources for Food
and Agriculture (ITPGRFA) 2004: is an international agreement
with the overall goal of supporting sustainable agriculture and
global food security, allows governments, farmers, research
institutes and agro-industries to work together by pooling their
genetic resources and sharing the benefits derived from their
use. Facilitated access is granted for the first time at the
international level through its Multilateral System and its
Standard Material Transfer Agreement to 35 food crops as well as
29 genera forages listed in the Treaty. The fair sharing of benefits
arising from the use of these resources is also granted in a
multilateral way thanks to the Funding Strategy and the financing
of small scale projects, particularly in developing countries.

• International Code of Conduct for Plant Germplasm Collecting
and Transfer aims to promote the rational collection and
sustainable use of genetic resources, to prevent genetic erosion,
and to protect the interests of both donors and collectors of
germplasm. Among other elements, it sets out minimum
responsibilities of collectors, sponsors, curators and users of
collected germplasm, in the collection and transfer of plant
germplasm. The Code is addressed primarily to governments and
is to be implemented in harmony with the Convention on
Biological Diversity and other legal instruments protecting
biological diversity or parts of it. The Code, a voluntary one, was
adopted by the FAO Conference in 1993, and negotiated through
what is now the Commission on Genetic Resources for Food and
Agriculture, which also has the responsibility to oversee its
implementation and review.
Agricultural sector

Micro-organisms culture collections
• Micro-organisms Sustainable Use and Access Regulation
International Code of Conduct (MOSAICC)
With respect to microbial genetic resources, the
MOSAICC was developed by the Belgian Coordinated
Collections of Micro-organisms (BCCM) in 1997, with the
support of the European Commission.
It is a voluntary code of conduct which covers the terms
of access to microbial genetic resources, including the
terms of agreement on benefit-sharing, access to and
transfer of technology, scientific and technical
cooperation as well as technology transfer.

Significance of TK Protection
 TK valuable in global economy,
 Important for biotechnology based industries industry and
agriculture,
 Traditional societies depend on it for their food and
healthcare needs,
 Important for conservation and sustainable development
of environment and management of biodiversity,
 Food security of the country is linked to protection of TK
 Need to enable tribal communities to harness TK for their
economic uplift and growth Fast mobility of tribal societies

Large array of reported cases on misappropriation/biopiracy of
TK
Patents on natural products – neem, turmeric,
Basmati rice, Hoodia cactus, African potato,
ayahuasca, may apple
Infringement of many artistic works of
indigenous people of Africa, Australia

International Initiatives for Protection of TK
CBD – Art. 8(j); Bonn Guidelines on Access and Benefit Sharing
related to GRs
 WIPO – IGC (working since 2000); Efforts of PCT, IPC Revised
Draft Provisions for the Protection of TK, two sets of Draft
provisions – TCEs & TK
 WTO/TRIPS –
Art. 27(3)(b)
Art. 70(3)
Art. 71(1)
Doha Declaration-para 19 and 32

 FAO – ITPGRFA
 UNCTAD
 ILO Convention - No. 169 of 1989
 UN Sub-Committee on the Protection and Promotion of
Human Rights – Working Group on Indigenous
Populations
 UN Convention to Combat Desertification
 IGC Draft provisions list the issues to be considered by
policy makers while considering the form and means of
protection at national, regional and international level
International Organisations

SUMMARY OF INTERNATIONAL INITIATIVES
• Predominant View for devising a Sui Generis regime for TK
Protection
• Emphasis mainly on the IP protection which promotes the
marketable technology/product only, holistic character of TK
difficult to protect
• Demands of Developing Countries now mainly centered on the
following Two Issues:
– Patent applicant must disclose the country and source of origin
of biological material and TK;
– Patent applicant must provide evidence on compliance with
the country of origin’s laws on PIC and benefit sharing
India has moved for an amendment of Art. 29 of TRIPS along with
other countries in this respect.

Developed Countries’ prefer-
 Bilateral contracts; and
 Databases and Registers on TK – non-accrual of
economic benefits are not addressed by databases;
 only TK in the public domain is listed;
 part of defensive protection, little role in positive
protection of TK;
 static and rigid - not conducive for dynamic character of
TK; may fuel further piracy.

National/Regional Initiatives
• So far 24 National and 7 Regional initiatives have
been taken for TK protection
• Most of them have the CBD approach
• EU approach on indication of source (Recital 27 of
Biotechnology Directive)
• There is a wide variation in the scope and extent of
protection- covering community and farmers’ rights
in some cases, e.g. Model law for Africa

PROTECTION OF TK TO SAARC REGION
• SAARC countries are: Bangladesh, Bhutan, India,
Maldives, Nepal, Pakistan and Sri Lanka.
• SAARC Region is rich in TK and had been subjected to
misappropriation and bio-piracy of its TK in the past
• Rich in biodiversity, much of it is used in traditional
manner
• Region has a predominantly common cultural traditions
and share tremendous commonality, requiring a joint
approach on TK protection
• Joint efforts necessary for defensive as well as positive
protection of TK

SAARC-WIPO SUB-REGIONAL FORUM AND AGENDA FOR
TK PROTECTION
• Four meetings of the Forum: Colombo (1998),
Kathmandu (1999), Dhaka (2001) and Thimpu (2002),
and an Expert workshop in New Delhi (2003)
• Preservation and promotion of TK was identified as
one of the areas of cooperation in 1998
• The Third SAARC-WIPO Forum (2001)outlined the
strategy on TK protection with particular emphasis
on:

Collective ownership of TK
 Documentation of TK, establishing systems for access
and benefit sharing in relation to GRs, creation of a
community knowledge fund for these purposes, and
human resource development
 Proposed model legislation on TK, mechanisms,
contractual terms and practices, regulating access to and
benefit sharing in GRs, protection and conservation - a
model relevant for international protection of TK

 Documentation of TK ,including folklore
 Common stand at the IGC meetings
 Use of information technology for effective and
coordinated enforcement of IPRs (including TK); and to
designate focal points for coordination and follow-up
Agreed to build synergies on
collective action for the enforcement
IPRs on a sub-regional basis
Coordinated program for Regional Action
Fourth Meeting of the Forum Reiterated the decisions of the
Third Forum with the addition of preparing an inventory on TK,
particularly on known medicinal plants/their knowledge

Objectives of the protection
- prevent the misappropriation of TK
- ensure PIC and benefit sharing
- ensuring the distribution of benefits
- conservation of biodiversity
- rewarding innovations based on TK
The draft highlights:
• Role of Governments in positive protection
• Access Mechanism for TK

Main premise of Protection:
Bonn Guidelines
Capacity building of indigenous/ local people
 Access for non-commercial and educational purposes
•Modes of protection of TK : sui generis regime,
customary law, contractual terms, common law principles,
land laws etc.
•Identifying the national measures to preserve TK and
traditional ways of life , values and legal structure –
recognition of customary laws and protocols

DATABASES ON TK
Databases require in-puts on the following:
• Policy directions on the purpose of databases
• Involvement of the indigenous communities
• Consultation with the stakeholders
• Choice of mechanism of documentation
• Necessary Measures during documentation and after
documentation for continuous updating
India and Pakistan provide provisions under their laws.

National Attempts to Protect TK - India
• India: 3 Acts relevant on the issue
• Patents (Amendment) Act, 2005
• Protection of Plant varieties and Farmers’ Rights Act, 2001
• Biological Diversity Act, 2002- contains elaborate provisions
on benefit sharing but weak in prior informed consent and
involvement of communities in decision-making
Recently to protect the rights of tribals, the Government has
introduced a bill – Scheduled Tribes (Recognition of Forest
Rights) Bill, 2005; cleared by the Cabinet

Patents (Amendment) Act
– Makes biological processes as patentable, including
biochemical, biotechnological and microbiological
processes (sec. 5).
– Microorganisms are patentable (sec. 3(j)).
– For patent on biological material, specifications must
disclose the source and geographical origin of the
biological material used in the invention (sec. 10(d)).
– Non-disclosure a ground for opposition of the patent (sec.
25)

Patents (Amendment) Act
– A patent is refused or revoked for giving wrong
information about the source of geographical origin of
biological material (sec. 64(p)(q)).
– Plant varieties or essentially biological processes are non-
patentable (sec.3).
– An invention which, in effect, is traditional knowledge or
which is an aggregation or duplication of known properties
of traditionally known component/s is also non-patentable
(sec.3 (p)).

Protection of Plant Varieties and Farmers’ Rights Act, 2001
• Makes provisions for benefit-sharing and
compensation for traditional, rural and tribal
communities.
• Creates a nodal body – Plant Varieties and Farmers’
Rights Protection Authority at the national level.
• Provides for a National Gene Fund.
• Authority is empowered to determine the benefit
sharing for individuals or groups when a protected
variety is developed, using their genetic material.

Protection of Plant Varieties and Farmers’ Rights Act, 2001
• Amount of compensation dependent upon the
extent and use of their genetic material and the
commercial utility of the variety.
• Amount from the benefit sharing will be credited in
the Gene Fund, village community be paid out of it
for conservation and sustainable use of GRs

Biological Diversity Act, 2002
– Gives effect to the mandate of CBD and to some
extent PGRFA Treaty.
– Addresses generally issues of biodiversity
management, and PGR management in particular.
– Main focus is to address the issue of bio-piracy
and to protect, respect and conserve TK related to
PGRs of local people.

Biological Diversity Act, 2002
– Nodal Agency – National Biodiversity Authority;
– State Biodiversity Boards, Biodiversity
Management committees are also created
– Biodiversity Funds at central, state and local
levels.
• To check bio-piracy, access to PGRs is regulated.

Main Provisions of the Act
Act provides for the prior approval of the NBA:
• by foreign individuals, companies or associations to obtain any
biological resources occurring in India or knowledge thereto for
research, commercial utilization, bio-survey or bio-utilization.
• Transfer of research result relating to these resources, publication of
research papers etc. is exempted; collaborative research projects also
exempted; if guidelines are followed.
• Prior permission is also required if inventor seeking any kind of IPR in
or outside India of an invention based on biological research or
information on a biological resource obtained from India.

Documentation of bio-diversity TKDL
 the Bio-diversity Management Committees (at local level) are
entrusted with the documentation of bio-diversity – in order
to monitor and protect bio-resources to curb bio-piracy and
effectively challenge the IPRs granted in foreign jurisdictions.
 Varied private experiments in documentations are already
underway – open registers and close registers modes exist
 Other successful peoples’ biodiversity registers are Shristi and
Honey bee.
 Case of Arogyapacha

TKDL
 The Government of India has prepared a Traditional
Knowledge Digital Library (TKDL) on TK about medicinal
plants, to ward off incidence of piracy, containing 36,000
formulations used in Ayurveda, Unani, Siddha - Indian
system of medicine, from 14 ancient books.
 1,60,000 have been further transcribed
 Access to TKDL regulated through “Access Agreement”,
confidentiality to be maintained, TKDL information use is
limited to patent search and examination

Grey Areas
• Guidelines and framework on benefit sharing are yet to be
framed.
• Clearly establishes that creators and holders of TK do not
have property rights over their knowledge – but IPRs for
community fraught with some difficulties, both in
enforcement and grant.
• Biological Diversity Rules, 2004 framed. Act in force.
• Not clear whether the reward will be monetary or non-
monetary or both; whether monetary reward will be one-
time payment etc.
• No machinery provided for disputes resolution on ABS.
• Mode of benefit sharing and the identification of probable
stake-holders and distribution of benefit are fraught with
many problems.

• No definition of TK is attempted.
• The Act outlines the framework of benefit-sharing when the foreign party
is involved
 The Government’s approach in India towards IPRs and biological resources
is CBD – centric
– Actual operation of these legislations is yet to be seen
– Fine-tuning on benefit sharing is yet to be done
– Main efforts presently confined to check bio-piracy
– Mandatory disclosure of source pertaining to biological resources and
knowledge thereto in patent application has put in place
 On ABS, an international framework is necessary to facilitate the flow
of PGRs.
Grey Areas

Conclusion
• The three legislations provided ample scope to check the
misappropriation of TK- part of defensive protection
• Action is required for positive protection
• The effect of the Acts is yet to be seen, number of bodies
may not be working in unison
• A holistic approach to protect TK is required, for the
capacity building of the societies
• At regional/international level mutual recognition and
reciprocity in enforcement of TK important, which is yet
to be devised
• TKDL/documentation important but not the solution for
TK protection

Access and Benefit sharing from Genetic Resources

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