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Developing an Effective Access to Genetic Resources and Benefit
Sharing legal Regime in Nepal: Challenges and Opportunities
Submitted to
WWF Nepal
Baluwatar, Kathmandu
Submitted by
Dina Mani Pokharel
Development Law Associates
Babarmahal, Kathmandu
31st August 2015
i
Acknowledgement
Development Law Associates express its sincere gratitude to Mr. Santosh Nepal, Director, Policy
and Support and Diwakar Chapagain, Program Coordinator, Wildlife Trade Control Program,
WWF Nepal for their invaluable support, comments and feedbacks throughout the study.
We are very much indebted to everyone who helped us directly or indirectly in preparing this
report.
Dina Mani Pokharel
Development Law Associates
Maitighar, Kathmandu, Nepal
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Table of content: CHAPTER–ONE: INTRODUCTION …………………………………………...…………….1-2
CHAPTER–TWO: INTERNATIONAL OBLIGATION OF NEPAL……………………...…3-16
2.1 Convention on Biological Diversity 1992 ……………..…….…………….…..……….. 3
2.2 The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable
Sharing of Benefits Arising from their Utilization ………….………….…………...…...3
2.2.1 Objectives ………………………………………………………………………...4 2.2.2 Sustainable Use …………………………………………………………………...6
2.2.3 Access to Genetic Resources…………………………………………………….. 6
2.2.4 Benefit Sharing…………………………………………………………………... 7
2.2.5 Transfer of Technology…………………………………………………………....7
2.3 Financial Resources……………………….……………………………….…………….9
2.4 Financial Mechanism………………………………………………………………..…. 9
2.5 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, 2010………………………………………………..……………..9
2.5.1 Objectives ……………………………………………………………………….11
2.5.2 Scope …………………………………………………………………………….12
2.5.3 Access Obligations ………………………………………………………………12
2.5.4 Fair and Equitable Sharing of Benefits…………………………………………. 13
2.5.5 Compliance ……………………………………………………………………...15
CHAPTER–THREE: GOOD PRACTICES FROM OTHER COUNTRIES.…………….….17-35
3.1 Introduction……………………………………...……………………………………….17
3.2 India…………………………………………...…………………………………………17
3.3 Costa Rica………………………………..……………………………………….……...22
3.4 The Philippines……………………………………………………..……………………28
CHAPTER-FOUR: ACCESS AND BENEFIT SHARING IN NEPAL ………..…………...36-47
4.1 Introduction…………………………………………………………………………..…..36
4.2 Biodiversity Related Legislations and Policies in Nepal……………………………...…36
4.2.1 Forest Act and Regulation…………………..…………………………………..…37
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4.2.2 Nepal Biodiversity Strategy…………..…………………………………………....38
4.2.3 Nepal Agro Biodiversity Policy………………………………………………..…39
4.3 Proposed Bill on Access to Genetic Resources and Benefit Sharing, 2014…...........…...40
CHAPTER–FIVE ANALYSIS AND CONCLUSION……………………………………...47-52
5.1 Analysis…………………………………………………………………………………..47
5.2 Challenge in Implementation………………………………………………………….…49
5.3 Conclusion…………………………………………………………………………….…51
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CHAPTER ONE
INTRODUCTION
The Value of biogenetic resources and associated traditional knowledge has grown because of
shrinking supply and increased demand. The supply has shrunk primarily because of tropical
deforestation, agricultural intensification and other environmental problems like climate change,
air pollution, and deforestation etc. in regions of great biological diversity. Demand has grown
with the rise of biotechnology and its ability to assess access and use genetic materials.1 As the
value of genetic resources has arisen for the multinational companies and international agencies
for commercial purposes, the developing countries and the local and indigenous communities,
who are the custodian of those genetic resources and hold the traditional knowledge about their
uses, are deprived from the benefit arises from their use. Following the debate on biogenetic
resources and associated traditional knowledge, different international legal measures have been
developed to ensure the conservation of biological resources, access to genetic resources and
benefit sharing arising from the use of those genetic resources. In this regard Convention on
Biological Diversity (CBD) is import.
Nepal being a member of CBD has a national obligation to formulate an effective legislation on
access to genetic resources and benefit sharing (ABS). Further more being a rich in biodiversity,
it is in her interest to develop an effective ABS legislation to protect and better utilize biogenetic
resources and associated traditional knowledge in the interest of nation in general and in
particular in the interest of local and indigenous communities who are the custodian of those
resources. Realizing the importance of ABS law in Nepal, the process has been started and
government proposed a draft Bill on access to Genetic Resources and Benefit Sharing, 2002.
Later with some revision a revised Access to Genetic Resources and Benefit Sharing Bill, 2005
was proposed. Because of many reasons proposed bill could not be passed by the parliament.
Once again with some revision new draft is proposed as Access to Genetic Resources and
Benefit Sharing Bill, 2014. This bill has not yet been converted into legislation. This study aims
1 Gorg & Brand, ‘Contested Regimes in the International Political Economy: Global Regulation of Genetic Resources and the Internationalization of State’, 6(4) Global Environmental Politics, 108 (2006).
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to have a critical study on the proposed bill and the challenges and opportunity to pass the
proposed bill from the parliament.
Today, a pressing and complex problem in developing countries like Nepal is the inability to
convert its valuable biogenetic resources into an enhanced living standard of people. Thus, we
are in a paradoxical situation of having huge biodiversity and high level of poverty. Law in
action is one of the important tools to utilize biogenetic resources. Therefore, the country
urgently needs to make favorable laws policies and strategies to utilize existing biological and
genetic resources in a sustainable manner in order to address poverty and misery of its
population. Considering this need and being a party to CBD, Nepal is in a process of developing
an access and benefits sharing legislation in Nepal and proposed a revised bill in 2014. But the
proposed bill has not yet been converted into legislation. It is necessary to create a conducive
environment to pass the proposed bill from the parliament. In this regard it will be important to
analyze the content of the proposed bill. This will help us to revise the proposed bill prior to
tabling it before the parliament. Further it is also important to understand the underneath reasons
behind the delay.
In the following chapter we shall be reviewing the international law on access to genetic
resources and benefit sharing regime and obligation of Nepal to implement it. We will also in
general, review the existing national legislations of Nepal which has provision related to access
to natural resources and sharing of benefits accruing out its use. A comprehensive review and in-
depth analysis of the proposed ABS bill, 2014 will be done in order to identify the underlying
gaps between the current provisions, our international obligations and necessity of current time.
Case studies of good practices from the Philippines, India and Costa Rica will be done and
analysis will be made to determine if the good practices are applicable in context of Nepal or not.
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CHAPTER TWO
INTERNATIONAL LEGAL FRAMEWORK ON ACCESS TO
GENETIC RESOURCES AND BENEFIT SHARING
2.1 Introduction
Access to genetic resources is not only a local and national issue. It has an international
importance and significance. Therefore, certain international instruments are developed in the
international level for the effective regulation of access to genetic resources and benefit sharing.
In this regard, the Convention on Biological Resources) CBD) and the Nagoya Protocol on
Access to Genetic Resources and Benefit sharing are important. In the following section we will
briefly describe about the instruments.
2.2 Convention on Biological Diversity, 1992 The CBD is the first international umbrella convention that addresses the conservation,
sustainable use, fair and equitable sharing of benefits derived from the utilization of genetic
resources. 2 It was opened for signature at the United Nations Conference on environment in Rio
in 1992, and entered in to force on 29 December 1993. 196 countries are parties to the
convention up to 1 may, 2015. 3
The CBD provides a clear example of a global management regime for domestic resources as
there are no such global biological and genetic resources.4 CBD is considered as a landmark in
the environment and development field,5 because: (1) it is the first time that biodiversity is
comprehensively addressed in a convention6;(2) it is the first international convention that
2 REGINE ANDERSON, GOVERNING AGRO-BIODIVERSITY: INTERNATIONAL REGIMES, PLANT
GENETICS AND DEVELOPING COUNTRIES 141 (Oslo, 2007). 3 https://www.cbd.int/information/parties.shtml (last Visited May 1, 2015). 4 Timothy Swanson, Why is There Biodiversity Convention? The International Interest in the Centralized
Development Planning, 75(2) INTERNATIONAL AFFAIRS 307, 308 (1999). 5 Glowka Lyle et al, Guide to the Conventions on Biological Diversity 1(IUCN Environmental law Centre,
Environmental Policy and law paper no 30, 1994). 6 Id.
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addresses the problem of the loss of biodiversity in a global way;7(3) in addition to conservation
of biodiversity, it incorporates the issues of sustainable use of biological resources, access to
genetic resources, sharing of benefits, access to technology including biotechnology8; (4) it is
the first time that genetic diversity is specifically covered in a global convention9; (5) it is for the
first time conservation of biodiversity is recognized as a common concern of humankind
rejecting old notion of common heritage of mankind10; (6) It also recognizes the sovereign rights
of state over their biogenetic resources.11
It is also considered as a one of the most important developments in international law,
international relations, and in the field of environment and development.12 It is further argued
that it balances between the interest and need of both biogenetic resources owners and the
technology owners.13 The CBD is, sometimes, also termed as a 'biotrade convention' as it
encourages member states to facilitate access to genetic resources and take measures to ensure
fair and equitable sharing of benefits derived from the use of biogenetic resources.14 Salient
features of the CBD are discussed in the following sections.
2.2.1 Objectives
There are three objectives of CBD. They are: (1) the conservation of biological diversity, (2) the
sustainable use of its components, and (3) the fair and equitable sharing of the benefits arising
out of the utilization of genetic resources, by including (a) access to genetic resources taking into
7 Aphrodite Samgadi, Analysis of the Objectives of the Convention on Biological Diversity: Their Interrelation and
Implementation Guidance for Access and Benefit Sharing, 31(2) COLUM. J. ENVTL. L. 243,249 (2006). 8 See CBD art. 4, 15, 16. 9 Yann-huei Song, the Convention on Biological Diversity: United States Participation, Signature and Pending
Ratification, 28(1) EURAMERICA, 1, 3 (1998). 10 Aphrodite Samgadi, Analysis of the Objectives of the Convention on Biological Diversity: Their Interrelation and
Implementation Guidance for Access and Benefit Sharing, 31(2) COLUM. J. ENVTL. L. 243, 250 (2006). 11 CBD art. 3. 12 Yann-huei Song, the Convention on Biological Diversity: United States Participation, Signature and Pending
Ratification, 28(1) EURAMERICA, 1, 3 (1998). 13 G. Kristin Rosendal, Balancing Access and Benefit sharing and Legal protection of Innovations from
Bioprospecting: Impact on conservation of biodiversity, 15(4) JOURNAL OF ENVIRONMENT AND DEVELOPMENT 428, 432 (2006).
14 Santiago Carrizosa, Introduction, in ACCESSING BIODIVERSITY AND SHARING THE BENEFITS: LESSONS FROM IMPLEMENTING THE CONVENTION ON BIOLOGICAL DIVERSITY 1, 1 (Santiago Carrizosa et al. eds., 2004).
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account all rights over those resources, (b) transfer of relevant technologies, taking in to account
all rights to technology, and (c) funding.15
CBD objectives provided in Article 1 are not limited to the traditional call for conversation and
sustainable use of biological resources they also involve fair and equitable sharing of benefits
arising from their utilization. The last objective reflects economic consideration of the value of
biogenetic resources and their use in a sustainable manner. Therefore, we can say, with these
three objectives, the CBD sets out the balances between conservation, sustainable use and
sharing of benefits. Hence, the Article 1 is considered as the heart of the political agreement
upon which the Convention is founded.16
Undoubtedly, conservation of biological diversity is the first objective of the CBD. In general
conservation means the act or process of preservation of a material in its present state, protection
it from loss, damage or neglect. However, conservation in the context of CBD is more than
preservation. The CBD takes an anthropocentric approach and looks at conservation from human
perspective. Thus, conservation is linked with sustainable use and benefit sharing.17
The term sustainable use means a use that does not adversely affect the productivity both in short
and long term in the sense of being destroyed, used up or finished.18 The CBD defined the term
sustainable use to mean the use components of biological diversity in a way and at a rate that
does not lead to the long term decline of biological diversity, thereby maintaining its potential to
meet the needs and aspirations of present and future generations. 19 The CBD adopts three means
of sharing benefits: appropriate access to genetic resources, appropriate transfer of relevant
technologies, and appropriate funding.20
15 CBD, art.1. 16 Cyle Glowka et al., A guide to the Convention on Biological Diversity, 15 (IUCN Environmental Law Centre,
Environmental Policy and Law Paper No. 30, 1994). 17 Aphrodite Samgadi, Analysis of the Objectives of the Convention on Biological Diversity: Their Interrelation and
Implementation Guidance for Access and Benefit Sharing, 31(2) COLUM. J. ENVTL. L. 243, 252 (2006). 18ANANDA MOHAN BHATTRAI, PROTECTION OF HIMALAYAN BIODIVERSITY: INTERNATIONAL
ENVIRONMENTAL LAW AND A REGIONAL LEGAL FRAMEWORK 42(2010). 19 CBD art. 2. 20 Cyle Glowka et al., A guide to the Convention on Biological Diversity 15 (IUCN Environmental Law Centre &
IUCN Biodiversity Programme, Environmental Policy and Law Paper No. 30, 1994).
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2.2.2 Sustainable Use
Sustainable use of biological diversity and minimizing adverse impacts is of utmost importance
to ensure the rights of present and future generations. It encourages to adopt measures for,
protection and customary use of biological resources in accordance with traditional cultural
practices that are compatible with conservation and sustainable use requirements, supporting
local populations to develop and implement remedial action in areas where biodiversity has been
reduced and most importantly, encourages cooperation between government and private sector
for developing methods for sustainable use of biological resources.21
The convention urges the contracting parties to, “…. Adopt economically and socially sound
measures that act as an incentives for the conservation and sustainable use of biological
diversity.”22 This article compliments article 10 of the convention, which talks about the
sustainable use of biodiversity. Incentives play a pivotal role as motivation to work towards
sustainable use and protection of biological diversity.
2.2.3 Access to Genetic Resources
Access to genetic resources is not among the three objectives of the CBD, thus it is a secondary
norm under CBD.23Article 16 explicitly recognizes the sovereign rights of states over their
natural resources and further states that the authority to determine access to genetic resources
rests with the national governments subject to national legislation.24 However, the ‘country of
origin of genetic resources’25 shall endeavor to create conditions to facilitate access to genetic
resources for environmentally sound uses by other contracting parties and should not impose
restrictions that run counter to the objectives of the convention.26
21 Id. art. 10 (b), (c), (d), (e). 22 Ibid. 23 Regine Anderson, ‘Governing Agrobiodiversity’, Department of Political Science, Faculty of social Sciences,
University of Oslo, (2007), p. 168. 24 CBD, art. 15 (1). 25 Id. art. 2, “Country of origin of genetic resources means the country which possesses those genetic resources in in-
situ conditions.” 26 Id. art. 15 (2).
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The access to genetic resources is further balanced by making it subject to ‘prior informed
consent, ‘access to genetic resources shall be subject to prior informed consent of the contracting
party providing resources’ and access, where granted shall be on mutually agreed terms
(MAT).27 ‘Prior informed consent’ is more relevant where the power relation between the parties
is asymmetrical, as it protects the weaker party by requiring other party to reveal all the relevant
information useful for the determination of access such as the information relating to the party
seeking access, scope of application, purpose of access, prospective use and possible
environmental impacts. The access provisions are not retrospective and do not apply to genetic
resources already removed from a state, for example, germ-plasm already in international gene
banks.
2.2.6 Benefit Sharing
The CBD imposes specific obligation on each state to share, in a fair and equitable way, the
results of research and development with the party providing the genetic resources.28 Moreover,
the developed countries within the countries providing the resources shall also fairly and
equitably share the benefit arising from the commercial utilization of the genetic resources.29
Such sharing shall be on mutually agreed terms. Thus, the benefits arising from the use of
genetic resources commercially, in the research and development and in biotechnological
application, are to be shared on mutually agreed terms with the parties providing the resources.
The parties providing the resources are to be given the opportunity to participate in
biotechnological research.
2.2.5 Transfer of Technology
Under Article 16, the Convention adopts provisions regarding access to and transfers of
technology, which is basic to the conservation, and sustainable use of biological diversity. The
access to and transfer of technology among the parties are essential elements for the attainment
of the objectives of the Convention. Accordingly, each party undertakes to provide and / or 27 Id. art. 15 (6), (5). 28 Id. art. 15(7). 29 Id. art. 15(7).
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facilitate access for and transfers to other parties of environmentally friendly technologies that
are relevant or the conservation and sustainable use of biological diversity of that make use of
genetic resources.30 The Convention specifically states that technology includes biotechnology.31
The access to and transfer of technology to the developing countries shall be provided and or
facilitated under fair and most favorable terms, including on confessional and preferential terms
where mutually agreed.32 Each party is to take legislative, administrative or policy measures to
ensure that developing countries which provide genetic resources are provided access to and
transfer to technology which makes use of those resources on mutually agreed term.33 The state
parties are to take legislative, administrative or policy measures with the aim that the private
sector facilitates access to joint development and transfer of technology for the benefit of both
governmental institutions and the private sector of developing countries.34 The provisions of the
Convention governing transfer of technology are ambiguous in their treatment of intellectual
property rights. Clearly contemplating the use of licensing agreements, the Convention requires
the access and transfer to be provided on fair and most favorable terms, including on mutually
agreed concessional and preferential terms, consistently with the adequate and effective protection
of intellectual property rights. Parties are, however to cooperate to ensure that the intellectual
property rights are supportive of and do not run counter to its objectives.35
Under the CBD each party has an obligation to take legislative, administrative, or policy measure
to provide for the effective participation in biotechnological research activities by those
developing states, which provide for the genetic resources for such research.36 Each party shall
also advance priority access to developing states providing the genetic resources, on a fair and
equitable basis, to the result and benefits arising from biotechnologies based upon such genetic
resources. The CBD also calls upon the parties to consider the need for and the modalities of a
protocol setting at appropriate procedures, including in particular, advance informed agreement,
30 Id. art. 16 (1). 31 Id. art. 16 (1). 32 Id. art. 16 (2). 33 Id. art. 16 (3). 34 Id. art. 16 (4). 35 Id. art. 16 (2). 36 Id. art. 19 (1).
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in the field of safe transfer, handling and use of any living modified organism resulting groom
biotechnology that may have adverse effect on the conservation and sustainable use of biological
diversity. 37
2.5. Financial Resources Article 20 of the Convention addresses the issue of financial resources. Article 20(1) requires
parties to provide financial support and incentives in accordance with their capabilities for those
national activities that one intended to achieve the objectives of the Convention, in accordance
with its national plans, priorities and programs.
The developed countries are obliged to provide new and additional financial resources to the
developing countries to enable them to fulfill the obligations of the Convention and benefit from
its provision.38 The extent to which the developing countries will fulfill their obligation depends
on the effective implementation by developed countries of their commitments under the
Convention related to financial resources and transfer of technology.39
2.5. Financial Mechanism
Under Article 21 of the Convention there shall be a mechanism for the provision to provide the
financial resources to the developing countries on a grant or concessional basis. The institutional
structure for the operation of the mechanism shall be decided by the conference of the parties
established under the Convention.
2.5 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, 2010
37 Id. art. 19 (3). 38 Id. art. 20 (1). 39 Id. art. 20 (4).
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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
legally binding subsidiary agreement to the Convention on Biological Diversity which aims to
further develop the legal ABS framework provided by the CBD.40 The protocol provides a strong
basis for greater certainty and 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.41
The broad CBD objectives are a consequence of the contradicting interests of developing and
developed countries.42 Throughout the negotiation process, many States, particularly the
technology rich north that are the users of the resources43 were not willing to accept an
instrument that focused only on biodiversity conservation. On the other hand, the majority of
developing countries who are the custodians and owners of the biodiversity44 pushed for the
more directly use-oriented provisions, as well as made their participation in the negotiation
conditional on the inclusion on the convention the obligations and measures on three types of
access45
• Access to genetic resources subject to national authority;
• Access to relevant technology, including biotechnology; and
• Access for the providing States to benefits ultimately gained from the use of genetic
material in the development of biotechnology.
In the end, access to genetic resources and the fair and equitable sharing of the benefits arising
out of their utilization – in short, ABS – was introduced as the third objective of the CBD.46 With
an aim to further advance the implementation of the third (ABS) objective of the convention, in 40 Thomas Greiber et al, An Explanatory Guide to the Nagoya Protocol on Access and Benefit-sharing, 25 (IUCN,
2012). 41 The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising
from their Utilization to the Convention on Biological Diversity 2010, Introduction. 42 Thomas Greiber et al, An Explanatory Guide to the Nagoya Protocol on Access and Benefit-sharing, 4 (IUCN,
2012). 43 Michael I Jeffery Q.C., Bio prospecting: Access to Genetic Resources and Benefit-sharing under the Convention
on Biodiversity and the Bonn Guidelines, Singapore Journal of International & Comparative Law, 749(2002). 44 Id. at 751. 45 Glowka et al., A guide to Convention on Biological Diversity, 5 (IUCN, 1994). 46 Thomas Greiber et al, An Explanatory Guide to the Nagoya Protocol on Access and Benefit-sharing, 4 (IUCN,
2012).
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2002, the World Summit on Sustainable Development called for the negotiation of an
international regime, within the framework of the CBD, to promote and safeguard the fair and
equitable sharing of benefits arising from the utilization of genetic resources.47
In its seventh meeting, in 2004, the Convention’s Conference of the Parties reacted by assigning
its Ad Hoc Open-ended Working Group on Access and Benefit-sharing to elaborate and
negotiate an international regime on access to genetic resources and benefit-sharing in order to
effectively implement article 15 and 8(j)48 of the convention and its objectives.49 Finally, after
six years of negotiation, The Nagoya Protocol on ABS was adopted on 29 October 2010 in
Nagoya, Japan and entered into force on 12 October 2014, 90 days after the deposit of the fiftieth
instrument of ratification.50 The salient features of the protocol are discussed in the following
sections.
2.5.1 Objectives
The objective of the protocol is “the fair and equitable sharing of the benefits arising from the
utilization of genetic resources, including by appropriate access to genetic resources and by
appropriate transfer of relevant technologies, taking into account all rights over those resources
and to technologies, and by appropriate funding, thereby contributing to the conservation of
biological diversity and the sustainable use of its components.”51
The Protocol aims to set an international, legally binding framework to promote a transparent
and effective implementation of the ABS concept at the regional, national and local level in the
future. It lays down a model/framework for regulating the process of obtaining access to
47 The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising
from their Utilization to the Convention on Biological Diversity 2010, Intriduction. 48 CBD, art. 8(j) & 15. Article 8(j) deals about the traditional knowledge associated with the use of genetic resources
and article 15 is deals about access to genetic resources. 49 The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising
from their Utilization to the Convention on Biological Diversity 2010, Introduction. 50 See, http://www.cbd.int/abs/about/ (Accessed on 13th August, 2015). 51 The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising
from their Utilization to the Convention on Biological Diversity 2010, art. 1.
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biogenetic resources and traditional knowledge associated with such resources.52 It provides
general obligations upon contracting parties on sharing the benefits arising from the utilization of
such resources and knowledge as well as confers obligation to the parties to respect the domestic
legislation and regulatory requirements related to ABS, where the resources or knowledge have
been acquired.53 Furthermore, the protocol creates incentives to conserve and sustainably use
genetic resources by helping to ensure benefit sharing, and therefore enhances the contribution of
biodiversity to human well-being and sustainable development. 54
2.5.2 Scope
The Protocol applies to genetic resources within the scope of article 15 of the convention55 and
traditional knowledge associated with such resources56 that are covered by the CBD, and to the
benefits arising from their utilization.
2.5.3 Access Obligations
The issue of access to genetic resources and traditional knowledge associated with genetic
resources forms a core part of the ABS concept. It is addressed in different parts of the Nagoya
Protocol. Article 6(1) reiterates that states have sovereign rights over their natural resources. It
confers that access to genetic resources is subject to Prior Informed Consent (PIC) granted by the
provider country, unless otherwise determined.57With the aim of ensuring that the PIC or
approval and involvement of indigenous and local communities (ILCs) is obtained for access to
genetic resources where they have the established right to grant access to such resources, each
party shall take appropriate measures in accordance with domestic law.58Article 6(3) aims at
52 Thomas Greiber et al, An Explanatory Guide to the Nagoya Protocol on Access and Benefit-sharing, 25(IUCN,
2012). 53 Id. 54 See, http://www.cbd.int/abs/about/ (Accessed on 15th August, 2015). 55 See CBD, art. 15. 56 See CBD, art. 8(j). 57 See Nagoya Protocol, 2010, art. 6(1). 58 See Id. art. 6(2).
13
creating more legal certainty by introducing a number of measures that must be taken by all
Parties requiring PIC at the domestic level59:
• Create legal certainty, clarity and transparency
• Provide fair and non-arbitrary rules and procedures
• Establish clear rules and procedures for prior informed consent and mutually agreed
terms
• Provide for issuance of a permit or equivalent when access is granted
• Create conditions to promote and encourage research contributing to biodiversity
conservation and sustainable use
• Pay due regard to cases of present or imminent emergencies that threaten human, animal
or plant health
• Consider the importance of genetic resources for food and agriculture for food security
Article 7 regulates the access to traditional knowledge associated with genetic resources and
states that, in terms of access to traditional knowledge associated with genetic resources that is
held by ILCs, each party shall take appropriate measures, with the aim of ensuring that they are
accessed only with obtaining PIC or approval and involvement of the ILCs.60 Furthermore,
Article 7 clarifies that in such cases MAT have to be established with the ILCs.61
2.5.4 Fair and Equitable Sharing of Benefits
The protocol sets out core obligations for its contracting Parties to take measures in relation to
fair and equitable sharing of benefits arising from biogenetic resources. The issue of fair and
equitable sharing has been addressed in different articles of the protocol.
As per article 5(1), benefits originating from the utilization, commercialization and subsequent
application of genetic resources shall be shared in a fair and equitable way. Such benefits shall
be shared only with/between the party providing such resources (or the country of origin of such
59 See Id. art. 6 (3). 60 See Id. art. 7. 61 Thomas Greiber et al, An Explanatory Guide to the Nagoya Protocol on Access and Benefit-sharing, 27(IUCN
(2012).
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resources) or a party that has acquired the genetic resources in conformity with the CBD.
Furthermore, specific benefit-sharing arrangements must be established through mutually agreed
terms (MAT) between the provider and the user of genetic resources, thus on contract basis.62
In regard to resources that are held by ILCs in accordance with domestic legislation, each party
must take appropriate legislative, administrative or policy measures, with aim of ensuring that
benefits arising from the utilization of such resources are shared in a fair and equitable way with
the ILCs concerned based on MATs.63 As per article 5(4) the benefits may be monetary as well
as non-monetary including but not limited to those listed in the annex.64 The annex includes an
indicative and non-exhaustive list of potential monetary and non-monetary benefits to be
shared.65
Each party concerned must take appropriate measures in order to share the benefits arising from
the utilization of traditional knowledge associated with genetic resources in a fair and equitable
way with ILCs holding such knowledge. Such sharing shall be upon MATs.66
Article 967 of the protocol reaffirms the linkages between benefit-sharing and the other two
objectives of the CBD (conservation and sustainable use) by conferring obligation upon parties
to encourage their providers and users to direct benefits arising from the utilization of genetic
resources towards the conservation and sustainable use of biological diversity.
The protocol provides the legal basis of a potential consideration of a global multilateral benefit-
sharing mechanism in order to address the fair and equitable sharing of benefits arising from the
utilization of genetic resources and associated traditional knowledge in cases where bilateral
ABS on the basis of PIC is not possible.68 It further states that benefits derived through this
62 See Nagoya Protocol 2010, art. 5(1). 63 Id. art. 5(2). 64 Id. art. 5(4). 65 Thomas Greiber et al, An Explanatory Guide to the Nagoya Protocol on Access and Benefit-sharing, 28(IUCN,
2012). 66 Nagoya Protocol 2010, art. 5(5). 67 Id. art. 9. 68 Id. art.10.
15
potential mechanism shall be used to support the conservation of biodiversity and the sustainable
use of its components.69
2.5.5 Compliance
Compliance with ABS measures is a core issue of the Nagoya Protocol. According to Articles 15
and 16, each Party is obliged to take measures to provide that genetic resources and/or traditional
knowledge associated with these resources that are used within its jurisdiction have been
accessed in compliance with PIC and that MATs have been established, as required by the
provider countries’ ABS legislation or regulatory requirements of the other Party. 70 This
provision aims to “defend” the integrity of the PIC and MAT requirements of the provider
country (if such requirements exist at the domestic level). In other words, it aims to “promote”
compliance by individual users of genetic resources and associated traditional knowledge with
domestic ABS legal frameworks of provider countries.
In order to address situations of non-compliance with the measures taken under articles 15(1) and
16(1), parties shall take appropriate, effective and proportionate measures.71 Furthermore,
articles 15(3) and 16(3) oblige all parties to the protocol to extend appropriate co-operation in
cases of alleged violation of domestic ABS legislation or regulatory requirements of the provider
country.72 By giving discretion to choose between legislative, administrative, or policy measures
Articles 15 and 16 provide user countries flexibility in their implementation. Furthermore, they
require Parties only to take those measures that are appropriate and proportionate.
Article 18 aims to promote the enforcement of MATs between individual users and providers of
genetic resources and/or traditional knowledge associated with genetic resources. It intends to
support compliance with contractual obligations rather than domestic ABS legislation or
regulatory requirements. As a consequence it obliges party to73:
• Encourage contractual provisions on dispute resolution in mutually agreed terms; 69 Id. 70 See Id. art. 15, 16. 71 Id. art. 15(2) and 16(2). 72 See Id. art. 15(3) and 16(3). 73 See Id. art. 18.
16
• Ensure an opportunity is available to seek recourse under their legal systems when
disputes arise from mutually agreed terms;
• Take measures regarding access to justice;
• The utilization of mechanisms regarding mutual recognition and enforcement of foreign
judgments and arbitral awards.
The adoption of the Nagoya Protocol after six years of negotiations on 29 October 2010 in
Nagoya was a significant step forward for the implementation of the CBD. It entered into force
on 12 October 2014, 90 days after the deposit of the fiftieth instrument of ratification. However,
Nepal is yet to ratify the protocol. By providing a strong basis for greater legal certainty and
transparency for both providers and users of genetic resources, the Protocol significantly
advances the CBD’s ABS objective.
17
CHAPTER THREE
GOOD PRACTICES FROM OTHER COUNTRIES
3.1 Introduction
Access to Genetic Resources and Benefit Sharing (ABS) is also an international issue as CBD
and Nagoya Protocol has created a national obligation for contracting parties to the convention
and Protocol. For the purpose of fulfilling international obligations, different countries have
formulated national laws on ABS. In this regard the legal provisions and best practices are could
set good example for the countries like Nepal that is in the process of formulating national
legislation on ABS. In the following sections the legal framework on ABS in India, Costa Rica
and the Philippines are discussed.
3.2 India
India is one of the world’s most biodiversity rich regions, with approximately 8% (over 89,000
species of animals and 46,000 species of plants) of the world’s total variety of plants and
animals. Many policies, Acts, and Rules have been formulated by the Government of India with
an aim to safeguard the forest, wildlife and habitats that per se cover the default biodiversity by
direct and indirect means. Such government legislations prior to Biological Diversity Act 2002
are as follows:
• Indian Forest Act, 1927;
• Indian Wildlife Protection Act, 1972;
• Forest Conservation Act, 1980.
India signed the CBD on 5th June 1992 and ratified it on 18th February 1994 and as per the
mandate of the CBD, India is bound to make a concerted effort to ensure that the broad
objectives of the CBD and other associated relevant instruments are addressed at a domestic
level and proper guidelines for ABS mechanism are in place. Prior to the ratification of CBD by
India, there were no specific legislations or policies dealing with the issues related to biodiversity
18
and ABS. Even after the CBD entered into force in late 1993, it took India almost a decade to
introduce the biodiversity legislation. After a very extensive and long consultations and
discussions at different level, the government of India finally adopted the Biological Diversity
Act (BDA) in May 2002.
3.2.1 Biological diversity Act, 2002
The BDA aims to provide for conservation of biological diversity, sustainable use of its
components and equitable sharing of the benefits arising out of the use of biological resources.74
The BDA outlines a framework and process by which resources can be accessed, and details the
procedural hierarchy that exist for those parties interested in doing so.75 It also outlines measures
for sharing of benefits from the use of biodiversity, including transfer of technology, monetary
returns, joint research & development etc.76 Furthermore it provides measures to conserve and
sustainably use biological resources, including habitat and species protection, environmental
impact assessments (EIAs) of projects, integration of biodiversity into the plans, programmes,
and policies of various departments/sectors.77
3.2.1.1 Scope
The Act extends to the whole of India78 and regulates the issues relating to biological resources.
The Act defines biological resources as, plants, animals and microorganisms and parts thereof,
and their genetic material and by-products, with actual or potential use or value, but does not
include human genetic materials.79
74 The Biodiversity Act of India, 2002. 75 J.R. Ghose, “Access and Benefit Sharing Systems: An Overview of the Issues and the Regulation”19 (2003). 76 Sutar & Swain, Implementation of Biological Diversity Act in India: An Overview with Case Studies, Regional
Centre for Development Cooperation, 20-32 (2011). 77 Id. 78 The Biological Diversity Act of India, 2002, sec. 1 (2). 79 Id. sec. 2 (c).
19
3.2.1.2 Regulating Authorities
To oversee the conservation, sustainable use and sharing of the benefits from the use of
biological resources and traditional knowledge associated thereto, the Act has established
different regulating authorities at different level. At the national level, National Biodiversity
Authority (NBA) has been established.80 It is mandatory to get approval from the NBA prior to
conduct any activities related to biological resources.81 At the state level, State Biodiversity
Board (SBB) has been established82 and it performs functions similar to that of NBA (but in state
level). Finally, the Act establishes Biodiversity Management Committees (BMC)83, within every
local body and they shall be governed by existing village level political mechanism.
3.2.1.3 Access to Genetic Resources
Any parties interested in accessing the biological resources and/or traditional knowledge
associated thereto for research or for commercial utilization or bio-survey and bio-utilization
must obtain approval from the NBA prior to conducting such activities.84 This provision applies
only to the persons as specified by section 3 (2) of the Act85 and exempts Indian citizens and
institutions. However, Indians and Indian institutions need to inform the SBB prior to
undertaking any research with the intent of commercialization.86
The applicants interested in seeking access to biological resources and/or associated traditional
knowledge must fill application form for access to biological resources and/or associated 80 Id, sec. 8 (1). 81 Id.sec.3. 82 Id. sec. 22. 83 Id. sec. 41. 84 Id. Sec. 3 (1). 85 Section 3 (2) of the Act provides the list of persons who shall be required to take the approval of the National
Biodiversity Authority which are as follows: - a) a person who is not a citizen of India; b) a citizen of India, who is a non-resident as defined in clause (30) of section 2 of the Income-tax Act, 1961; c) a body corporate, association or organization-
i) not incorporated or registered in India; or ii) Incorporated or registered in India under any law for the time being in force which has any non-
Indian participation in its share capital or management. 86 Id. sec. 23 (b).
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traditional knowledge (form I) under the Act.87 Application processing fee of ten thousand Indian
currencies is levied on the applicants at the time of submitting the application.88 All applications
are reviewed in terms of nature and quantity of material to be accessed, the timing, geographical
location and other related issues.89 The applications are approved only after extensive
consultation is made with an expert committee90 and local bodies from whose jurisdiction the
biological resources and associated traditional knowledge will be accessed.91
Access to biological resources by local people and communities of the area, including growers
and cultivators of biodiversity, and vaids and hakims, who have been practicing indigenous
medicine are exempted from the purview of this Act.92 Furthermore, normally traded
commodities (NTCs) (Currently 190 species are designated as NTCs) are also exempted
provided they are used as commodities. The NBA shall give public notice of every approval
granted for access to biological resources.93
3.2.1.4 Benefit Sharing
The NBA is responsible for securing equitable sharing of benefits arising out of the use of
accessed biological resources, their by-products, innovations and practice associated with their
use and applications and knowledge relating thereto in accordance with MATs at the time of
granting approval to the applicants.94 The terms or manner of benefit sharing must be determined
by the NBA as provided in section 21 (2) 95of the Act.
87 Id. sec. 19 (1). 88 Access and Benefit Sharing Experiences from India, National Biodiversity Authority. This document can be found
at http://nbaindia.org/uploaded/pdf/ABS_Factsheets_1.pdf (Last Visited Sept. 19 2013). 89 Id. 90 The Biological Diversity Act (2002), sec. 41(2). 91 Id. 92 Id. sec. 7. 93 Id. sec.19 (4). 94 Id. sec. 21 (1). 95 As per section 21 (2) the benefit sharing must be determined in all or any of the following manner, namely: - a) grant of joint ownership of intellectual property rights to the National Biodiversity Authority, or where benefit
claimers are identified, to such benefit claimers, b) transfer of technology; c) location of production, research and development units in such areas which will facilitate better living standards to
the benefit claimers; d) association of Indian scientists, benefit claimers and the local people with research and development in biological
resources and bio-survey and bio-utilization;
21
It is mandatory to obtain prior approval of the NBA if anyone wishes to apply for intellectual
property rights (IPR) based on any research information on a biological resources obtained from
India96 and at the time of granting such approval the NBA may impose benefit sharing fee or
royalty or both or impose conditions including the sharing of financial benefits arising out of the
commercial utilization of such rights.97
The Act has established National Biodiversity Fund (NBF)98 with a purpose of channeling
benefits, to the conservers of biological resources and creators and holders of knowledge, for the
conservation of areas from where such biological resources of knowledge associated thereto has
been accessed and for the socio-economic development of such areas in consultation with the
local bodies concerned.99 All the grants and loans made by the central government as per section
26100 and monetary benefits arising from the benefit sharing shall be deposited to the NBF unless
otherwise directed by the NBA.101 However, in cases where biological resources were a result of
access from a specific individuals or group of individual organizations, the NBA may direct the
benefit procured to be paid directly to such parties in accordance with the terms of any
agreements.102
In the state level there is a State Biodiversity Fund (SBF), which is administered by the SBB.
The main aim behind establishing this fund is to provide for the management and conservation of
heritage sites and biological resources as well as helping in socio-economic development of
areas from where biological resources or knowledge associated thereto have been accessed.103 A
similar mechanism is designated to exist at the village level104; this Local Biodiversity Fund
e) setting up of venture capital fund for aiding the cause of benefit claimers; f) payment of monetary compensation and other non- monetary benefits to the benefit claimers as the National
Biodiversity Authority may deem fit. 96 Id. sec. 6 (1). 97 Id. sec. 6 (2). 98 Id. sec. 27. 99 Id, sec. 27 (2). 100 Id. Sec. 26. As per section 26, the central government may provide the NBA grants or loans to be utilized for
the purpose of achieving the objectives of the Act. 101 Id. sec. 21 (3). 102 Ibid. 103 Id. sec. 32. 104 Id. sec. 43.
22
(LBF) shall be used for “conservation of biodiversity in the areas falling within the jurisdiction
of the concerned local body and for the benefit of the community in so far such use is consistent
with the conservation of biodiversity.”105
The BDA in its preamble explicitly acknowledges the obligation under the CBD and states that
this very Act has been enacted to provide for conservation, sustainable utilization and equitable
sharing of benefits arising out of utilization of genetic resources and also to give effect to the
CBD. The objectives of the CBD have been addressed somehow in the BDA and it can be said
that India’s engagement with ABS issues has been progressive and noteworthy. However, there
are many things that is lacking in the BDA in comparison with the provisions of CBD. The BDA
vests absolute authority to the NBA for granting PIC, concluding MTAs, regulating the sharing
of benefits etc. Article 8 (j) of the CBD has been blatantly ignored by this Act as it does not give
any rights to the Indigenous people and communities relating to the granting of PIC, negotiating
the benefit sharing via MTAs etc. The provision of consulting the local bodies before granting
PIC is present but is not very exclusive.
The BDA imposes restriction not only to access but also to the transfer of results of such
research relating to any biological resources occurring or obtained from India to non-Indian
individuals and institutions without previous approval of the NBA. Furthermore, the Act makes
it mandatory for obtaining prior approval from the NBA if anyone wishes to apply for IPRs
based on any research or information on a biological resource obtained from India.106
3.3 Costa Rica
One of the reasons behind the success in bioprospecting and getting reasonable share of benefits
out of it in Costa Rica is its richness in biological and genetic resources. Costa Rica covers
51,100km2 of the world's terrestrial surface representing only 0.03 of the global territory.
However, it is considered as one of the most diverse region and identified as a biodiversity
105 Id. sec. 44. 106 Id. sec. 6.
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hotspot. It is estimated that 4%of all living species are available in Costa Rica.107 It has
contributed 25% of the national territory for national conservation area system.108
Biodiversity conservation efforts in Costa Rica are fruitful due to the development path followed
by it since 1940. This period is considered as a stable political system based on disarmament,
democratic government, high economic growth rates and substantial improvement in social
indicators.109 Different reports during 70s and 80s predicted that Costa Rica's productive forests
would disappear before the end of the century110. In this scenario introduction of protection
measures is the first response of Costa Rica. Second response was the introduction and
implementation of the payment of environmental services. Third response was introduction of
bioprospecting initiatives with the support of international and national actors.111 In other words,
the sustainable utilization of biodiversity in the form of nature oriented tourism, payment of
environmental services and bioprospecting played important role in the process of social and
economic development in Costa Rica.112
Costa Rica's biodiversity conservation policy that is largely based on trilogy principle of 'save,
know and use' played important role in biodiversity conservation, its sustainable use and fair and
equitable sharing of benefits arises out of its utilization. Save means protecting biodiversity
through a protected area system; know means knowing the biodiversity that exist in the country;
and use means sustainable use of biodiversity for gaining larger goal of social and economic
benefit for the country.113 Costa Rica's biodiversity conservation policy and strategy has not only
become able to control the rapid rate of declination of forest and biodiversity and improve in the
107Garmen & Karin Holm-Mueller, ‘The Effectiveness of Access and Benefit sharing in Costa Rica: Implications for
national and International Regimes’, 53 ECOLOGICAL ECONOMICS, 453(2005). 108See http://www.inbio.ac.cr/en/que-es-inbio/acerca.html, (last Visited 16 Aug. 16, 2015). 109 Rodrigo Gamez, ‘The Link Between biodiversity and Sustainable Development: Lessons From INBio's
Bioprospecting Programme in Costa Rica’, in Charles R. McManis (ed.) Biodiversity and law: Intellectual Property, Biotechnology and Traditional Knowledge, EARTHSCAN, 78(2007).
110 Id. at 79. 111Garmen & Karin Holm-Mueller, ‘The Effectiveness of Access and Benefit sharing in Costa Rica: Implications for
national and International Regimes’, 53 ECOLOGICAL ECONOMICS, 453(2005). 112 Rodrigo Gamez, ‘The Link Between biodiversity and Sustainable Development: Lessons From INBio's
Bioprospecting Programme in Costa Rica’, in Charles R. McManis (ed.) Biodiversity and law: Intellectual Property, Biotechnology and Traditional Knowledge, 79 (EARTHSCAN, 2007).
113 Id.at 79.
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scenario, it has been equally successful for its sustainable utilization too.114 In this regard, a
robust legal and policy environment has contributed a lot in this endeavor.
3.3.1 Political and Legal Security
One of the factors behind the success in bioprospecting projects and effective regulation of
access to genetic resources in Costa Rica is the favourable socio-political climate. Costa Rica has
been considered as one of the most stable and robust democracies in Latin America. Political
stability greatly helped Costa Rica to win its good reputation for bioprospecting.115. In a stable
political scenario, Costa Rica also has comprehensive biodiversity law and a bi-law on access
and benefit sharing. Legal security and the clearly defined and assigned property rights over
biological resources are other important reasons for companies to choose Costa Rica as a
research location.116
With an endeavor of implementing CBD, Costa Rica enacted and implemented biodiversity Law
No. 7788 in 1998117. The Biodiversity Law in full compliance to CBD defines the condition
under which bioprospective activities should be carried out in Costa Rica.118 The Major objective
of the Act is the conservation of biodiversity, the sustainable use of the resources and equitable
distribution of benefits.119. The Act grants exclusive sovereign right to the state over the
components of biodiversity.120 This law is applicable to the components of biodiversity that are
found under the sovereignty of the State as well as to the processes and activities carried out
under its jurisdiction or control inside or outside the state subject to national jurisdiction.121 This
law aims to regulate the use and management of biological resources and associated knowledge
and equitable distribution of the benefits and derived costs of the use of the components of
114 Garmen & Karin Holm-Mueller, ‘The Effectiveness of Access and Benefit sharing in Costa Rica: Implications for
national and International Regimes’, 53 ECOLOGICAL ECONOMICS 453(2005). 115 Id. 116 Id.at. 456. 117 Before the enactment of the biodiversity law access to genetic resources and benefit Sharing (ABS) was regulated
in the framework of the law of Wildlife Conservation and corresponding Regulations. 118 Rodrigo Gamez, ‘The Link Between biodiversity and Sustainable Development: Lessons From INBio's
Bioprospecting Programme in Costa Rica’, in Charles R. McManis (ed.) Biodiversity and law: Intellectual Property, Biotechnology and Traditional Knowledge, EARTHSCAN, 2007, p.83.
119 Biodiversity Act of Costa Rica, sec.1. 120 Id. sec.2. 121 Id. sec. 3.
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biodiversity.122 However this law, in line with Bonn Guidelines,123 excludes the access to human
genetic resources.124
Neither this law restricts the exchange of biochemical or genetic resources and associated
knowledge among the indigenous people and local communities for non-profit making purposes,
nor does it affect on the autonomy of universities in teaching or research in the field of
biodiversity for non-commercial purposes.125
For the purpose of effective regulation of biodiversity conservation, sustainable use of its
components and fair and equitable sharing of benefits, this law adopted the following general
principles:126
• Respect for all forms of life;
• The components of biodiversity are valuable;
• Respect for cultural diversity; and
• Intra- and inter-generational equity.
The National Commission for the Management of Biodiversity (CONAGBIO) is established
under the Ministry of Environment and Energy with a broader mandate formulating and
implementing access and benefit sharing policies in Costa Rica127. The commission is the
decentralized organ of the ministry and the minister of environment and energy shall be the
chairperson of the commission. The member of the commission consists the Minister for
Agriculture or his representative, Minister for Health or his representative, Executive Director of
The National System Of Protection Area, A representative of the Costa Rican Institute of Fishing
and Agriculture, representative of the Minister of Foreign Trade, representative of the National
Small Farmers Board, representative of National Indigenous Peoples Board, representative of the
National Council of Rectors, representative of the Costa Rican Federation for the Conservation
of the Environment and a representative of the Costa Rican Union of Chambers of Commerce.128
122 Id. sec. 3 123 The Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising out of
Their Utilization, 2002, Clause 9. 124 Biodiversity Act, Costa Rica, Sec.4. 125 Ibid. 126 Id. sec 9. 127 Id. sec 13. 128 Id. sec 15.
26
There is also a Technical Office to the Commission to assist the commission in fulfilling its
objectives.129
Besides, formulating effective access and benefit sharing policies, the commission is also
responsible for obligatory consultation in procedures of request for protection of intellectual
property rights relating to biodiversity. This also constitutes the general rules for access to
genetic resources for the protection of intellectual rights concerning biodiversity.130 This law
Clearly sets the following basic requirements for access:131
• Prior informed consent of the representatives of the place where the access will occur.
They may be the regional councils of Conservation Areas, the owners of farms or the
indigenous authorities when it is in their territories;
• Approval of the prior informed consent by the Technical Office of the Commission;
• The terms of technology transfer and equitable distribution of benefits, when there are
any, as agreed in the permits, agreements and concessions, as well as the type of
protection of associated knowledge demanded by the representatives of the place where
the access will occur;
• The definition of the ways in which the said activities will contribute to the conservation
of species and ecosystems;
• The designation of a legal representative resident in the country, when it concerns people
or legal persons living outside the country.
The prior informed consent of the biogenetic resources provider is the mandatory under this law.
In this regard the technical office should inform interested parties about the application that they
should attach the prior informed consent given by the proprietor of the landed estate where the
activity will take place or by the authority of the indigenous community when it is in their
territories and the director of the Conservation Area.132 Special right to indigenous and local
129 Id. sec 15. 130 Id. sec 62. 131 Id. sec 63. 132 Id. sec 65.
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communities have been given to oppose any access to their resources and associated knowledge
if the proponent has other motive to their cultural, spiritual, social, economic or other interest.133
The Technical Office of the Commission is obliged to organize and maintain permanently
updated a Register of rights of access to genetic components and biochemical. The registered
information will be publicly available, except for trade secrets.134 This Act made it mandatory to
get access permit for all research programs or bioprospecting related to genetic material or
biochemical of biodiversity to be carried out in Costa Rican territory.135 The Act fixed the
validity period for the access permit a maximum of three years, subject to renewable at the
discretion of the Technical Office of the Commission.136 Such access permits are non-
transferrable. It is materially limited to the authorized genetic components or biochemical, and
can only be used in the area or territory expressly indicated in the permit.137
Regarding benefit sharing technical office is mandated in conformity with the General Rules of
the Commission to set up the obligation to the interested party to deposit up to ten percent (10%)
of the research budget and up to fifty percent (50%) of the bonuses which it collects in favour of
the National System of Conservation Areas, the indigenous territory or the private owner
providing access to the genetic resources. Moreover, mandate is also given to the technical office
to determine the amount which in each case should be paid by the interested parties for
administrative costs, as well as any other benefit or technology transfer which forms part of the
prior informed consent.138
Costa Rica is generally considered as a successful example for a relatively successful strategy of
access to genetic resources and benefit sharing.139 Costa Rica is not only taken as a popular and
successful example of access and benefit sharing, but it is also regarded probably the most
studied access and benefit sharing case and considered as most advanced, transparent and
133Id. sec 66. 134 Id. sec 67. 135 Id. sec 69. 136 Id. sec 70. 137 Id. sec 70. 138 Id. sec 76. 139Garmen & Karin Holm-Mueller, ‘The Effectiveness of Access and Benefit sharing in Costa Rica: Implications for
national and International Regimes’, 53 ECOLOGICAL ECONOMICS, 458 (2005).
28
experienced one140. The experiences of Costa Rica clearly shows that just a formulation of
national access and benefit sharing legislation is not sufficient for getting benefit from
bioprospecting activities as the effectiveness of access and benefit sharing mechanism is
influenced by different factors like assigning property rights and intellectual property rights,
accounting for time lags, Political and legal security in biogenetic resources provider country,
information asymmetry concerning the behaviour of the inventor, administrative complexity,
market structure etc.141 In the following sections some of the important factors behind the
success of bioprospecting in Costa Rica are dealt briefly.
3.4 Philippines
The Philippines is one of the richest countries in Southeast Asia in terms of biodiversity. It
signed the CBD in June 1992 and ratified it in October 1993.142 Prior to the ratification of CBD,
there were no significant legislations regulating access and benefit sharing relating/derived from
biogenetic resources and associated traditional knowledge. “The Guidelines for the Collection of
Biological Specimens in the Philippines”, which was adopted in 1990 by government agencies
and academic institutions was the only legal document dealing with issues related to bio
prospecting in the Philippines.143 Rather than being a regulatory framework for bio prospecting,
these guidelines were mainly an administrative coordination and permit system.144
3.4.1 The Presidential Executive order 247, 1995
The Presidential Executive order 247 (EO 247) Prescribing Guidelines and Establishing a
Regulatory Framework for the Prospecting of Biological and Genetic Resources, their By-
products and Derivatives, for scientific and Commercial Purposes145 was the first national
140Id. at452. 141Garmen & Karin Holm-Mueller, ‘The Effectiveness of Access and Benefit sharing in Costa Rica: Implications for
national and International Regimes’, 53 ECOLOGICAL ECONOMICS 449-52(2005). 142List of parties, retrieved from https://www.cbd.int/convention/parties/list/ (Last Visited Sept.17, 2015). 143A. Smagadi, ‘National Measures on Access to Genetic Resources and Benefit Sharing – The case of the
Philippines’, Law, Environment and Development Journal, 60 (2005). 144Id. 145Executive order no 247, 18 May 1995.
29
legislation on ABS ever to be introduced.146 In accordance with the provision of section 15147 of
the EO 247, the document was further clarified by the Implementing Rules and Regulations on
the Prospecting of Biological and Genetic Resources (Implementing Regulations)148. Together,
the EO 247 and the Implementing Regulations established the first detailed legal framework for
bio prospecting and access to biogenetic resources.
The preamble of the EO 247 reasserts the mandate of article 16 of the CBD and reaffirms the
rights of indigenous cultural communities to preserve their knowledge and practices and use
them directly or indirectly for commercial use.149
3.4.1.1 Scope
The EO 247 governs all biological and genetic resources in public domain, including natural
growth in private lands owned by state that can be utilized by both foreign and local individuals,
and government as well as private entities and organization.150 Furthermore, it covers all the
activities related to bio prospecting aimed at discovering, exploring, or using biogenetic
resources for pharmaceutical development, agricultural, and commercial applications.151 It
however excludes traditional uses from its scope.152
3.4.1.2 The prior informed consent
The Implementing Rules and Regulations define PIC as, ‘the consent obtained before
undertaking any bioprospecting activity by the applicant from the Local Community, including
Indigenous Peoples, concerned individuals and government agency after disclosing full scope
146K. Swiderska et al., Developing the Philippines’ Executive Order no 247 on Access to Genetic Resources,
Participation in Access and Benefit- Sharing Policy, International Institute for Environment and Development, (2001).
147Section 15 of the Executive order 247 states, “The implementing rules and regulations shall be formulated by the Inter-Agency Committee and signed by the Secretary of Department of Environment and Natural Resources not later than three months after the effectively of the Executive Order.”
148Administrative Order no 96- 20, Inter- Agency Committee and Department of Environment and Natural Resources, 1996.
149 Executive Order 247, 1995, preamble. 150 Section 3.1(a), Implementing Rules and Regulations on the Prospecting of Biological and Genetic Resources,
Administrative Order No. 96-20, 2004. 151 Id. sec. 3.1(b). 152 Id.
30
and intention of the bioprospecting activity, in a language and process understandable to the
community.’153
The Regulations requires that biological and genetic resources bioprospecting must be done only
after obtaining PIC from the concerned Indigenous Peoples, Communities, Individuals and
concerned government agencies.154 In cases where PIC is to be obtained of indigenous cultural
communities, the consent of the concerned communities must be obtained in accordance with
their customary laws.155 Once the PIC has been obtained and the application for carrying out
bioprospecting activities156 has been accepted, the contracting parties depending upon on the
nature of the activities envisaged must sign either an academic research agreement (ARA)157 or a
commercial research agreement (CRA)158.159 Only after fulfilling the aforementioned procedures
bioprospecting activities may be conducted.
3.4.1.3 The Inter-Agency Committee
The Inter-Agency Committee is a body established by the EO as the regulatory body to ensure
that the provisions of the EO are enforced and properly implemented.160 The committee is
located within the Department of Environment and Natural Resources and supported by a
technical secretariat.161
In formation of the committee to ensure the participation of all the relevant agencies and
concerned communities a multi- stake holder approach was chosen. As a result the committee is
153 Id. sec. 2(1) (w). 154 Id. sec. 7. 155 Id. sec. 7(1)(2). 156 See, Id. sec.7. 157 Academic research agreement deals with the prospecting of biogenetic resources for purely academic purpose
and only duly recognized Universities and academic institutions of the Philippines and domestic governmental and intergovernmental entities can apply for this type of agreements.
158As per section 3 of the EO 247, “If the research and collection of biological and genetic resources is intended, directly or indirectly, for commercial purposes, the agreement must be a Commercial Research Agreement.”
159 EO 247, 1995, sec.3. 160 EO 247, 1995, sec. 6. 161 Implementing Rules and Regulations, 2004, Sec. 10 & 11.
31
comprised of representatives from all concerned stakeholders including, Indigenous
communities, nongovernment organization and government agencies.162
The committee processes application for research agreements and depending on the nature and
character of the prospecting activity, if deemed appropriate, recommends for approval to the
concerned government agencies.163 It also works on ensuring the rights of indigenous and local
communities in regard to right over biological resources, use of traditional knowledge associated
with genetic resources etc. as stated in section 3 and 4 of the executive order.164 The committee
holds power to issue necessary rules and regulations in order to effectively implement the
provisions of the EO165, ‘Implementing Rules and Regulations’ which was formulated in 1996
can be an example in this context. The Committee also functions as the national focal point for
all the access and benefit sharing procedures.
The EO further specifies that all bioprospecting activities should not in anyways, harm
biodiversity, ecological balances or affect the inhabitants where such activity is being carried
out. An Environment Impact Assessment must be done in order to determine the possibility or
feasibility of such activities. Bioprospecting without an agreement are considered criminal
offence and any act that comes in contrast with the agreement can result in cancellation or
revocation of the agreement, confiscation of collected material, forfeit of bond and perpetual ban
from prospecting activities in the Philippines.
3.4.2 The Wildlife Resources Conservation and Protection Act 2001
The Wildlife Resources Conservation and Protection Act166 entered into force in 2001 with an
objective of conserving and ensuring the sustainability of all wildlife resources habitats in the
Philippines.167 The Act together with its Implementing Rules and Regulations168and Draft
162 EO 247, 1995, sec. 6. 163 Id. sec. 7(a). 164 Id. sec. 7 (e). 165 Id. sec. 7(j). 166 Wildlife Resource Conservation and Protection Act, Republic Act No. 9147 of the year 2001. 167 Id. section 2. 168 Implementing Rules and Regulations on the Prospecting of Biological and Genetic Resources, Administrative
Order No. 96-20, 2004.
32
Guidelines for Bio prospecting Activities in Philippines169provides an elaborated framework
specifically for bioprospecting and benefit sharing.170
The Act defines bioprospecting as, research, collection and utilization of biological and genetic
resources for purposes of applying the knowledge derived there from solely for commercial
purposes171; and considers such activities as legal once the proponent formally declares,
compliance with and commitment(s) to reasonable terms and conditions that may be imposed by
the concerned agency, which are necessary to protect biological diversity.172
3.4.3 Draft Guidelines for Bioprospecting Activities in the Philippines
In terms of Access and Benefit Sharing legislations, Draft Guidelines for Bio prospecting
Activities in the Philippines has introduced detailed benefit sharing provisions, which were
lacking in previous laws. The Guidelines form an attempt to streamline the access and benefit
sharing procedure in the Philippines, facilitate compliance, and establish a cost-effective,
transparent, and standardized system. It also provides guidelines for obtaining PIC of resource
providers, and in negotiations for fair and equitable sharing of benefits arising from
bioprospecting with relevant parties.173
It applies to all biological and genetic resources such as wildlife, private lands, ex situ
collections, protected areas, and ancestral domains found within the Philippines.174 However,
collection of resources for application in traditional field along with other exceptions175 falls
beyond the scope of the law.
169 The Draft Guidelines were issued according to section 14 of the Wildlife Act and Rule 14(1) of the Implementing
Rules to Wildlife Act. Which states that, “The Department of Agriculture and the Palawan Council for Sustainable Development must issue joint guidelines specific for bioprospecting.”
170 A. Smagadi, ‘National Measures on Access to Genetic Resources and Benefit Sharing – The case of the Philippines’, Law, Environment and Development Journal (2005), P. 60
171 Wildlife Resource Conservation and Protection Act, Republic Act No. 9147 of the year 2001, sec.5 (a). 172 Wildlife Resource Conservation and Protection Act, Republic Act No. 9147 of the year 2001, sec. 14. 173 Draft Guidelines for Bioprospecting Activities in the Philippines, sec. 4. 174 Draft Guidelines for Bioprospecting Activities in the Philippines, sec. 2. 175 As per section 3 of the Guidelines, it does not apply to the following uses of biological resources:
• Traditional Use • Subsistence consumption • Conventional Commercial consumption for direct use such as logging or fishing
33
The procedure of obtaining PIC is almost identical to the EO 24 except for some changes in
procedure of publishing notifications and public consultations. As per the guidelines the
applicants should inform interested parties of their intention to carry out bioprospecting activities
through a letter of intent. A summary of the research proposal must be made available to the
concerned communities in a language that is comprehendible to them; this requirement was
missing from the EO 247. Instead of 60 days as mandated by EO 247, now the concerned
agencies or private owners have 30 days to issue the PIC making the procedure more practical. It
is also mandatory to obtain the free and prior informed consent (FPIC) from the indigenous
people and communities as determined by their customary laws.
In regard to benefit access and benefit sharing, the draft guidelines significantly limit the
freedom of parties of bioprospecting agreements with regards to the benefits to be shared.
Chapter VI of the Draft Guidelines deals about the benefit sharing derived from bioprospecting.
It specifies every single detail of the process, including the kinds of benefits that can be shared,
who can be the beneficiaries, the provisions for minimum upfront payment, royalties,
bioprospecting fees, non monetary payments etc.176 In addition, it put in a place a mechanism for
monitoring the principles of fairness and equity in benefit sharing, with a checklist of suggested
indicators.177
The new legal framework contained in the draft guidelines covers the inadequacies of previous
laws and responds to the loopholes and drawbacks by introducing new provisions. It is
noteworthy that the draft guidelines set a uniform procedure for accessing genetic resources used
for commercial purposes and clarifies previous overlaps between the different legislative
instruments. However, at the moment the draft only has status of a code of conduct and does not
bind or supersedes any existing laws. The EO 247 together with its Implementing Regulations
• Scientific research on wildlife under section 15 of the Wildlife Act • Scientific research on agro diversity • Existing Procedures of collection and transport of wildlife species exclusively for commercial or
conservation breeding or propagation under sections 17 and 24 of the Wildlife act; and • Ex-situ collections currently accessed under international agreements where the Philippines is a party.
176 See Chapter VI of the Draft Guidelines for Bioprospecting Activities in the Philippines for more details. 177 See Section 23 and Annex V of Draft Guidelines for Bioprospecting Activities in the Philippines.
34
has established a detailed access and benefit sharing legal framework based on the principles of
CBD, which regulates the bioprospecting to a much higher level.
However, it does not regulate the subsequent use of these benefits or ensure that the benefit
would reach the source communities or that the benefits would be used to foster conservation, as
required by the CBD. When it was first implemented, it received negative responses from
academics and other research bodies about its long and tedious approval process for concluding
research agreements. Many concluded that its regulatory measures were discouraging to
advancement of research on biological resources.178
In order to cover the deficiency of the EO 247 and other laws, the draft guidelines were
introduced in joint initiation of Protected Areas Wildlife Bureau (PAWB) and DENR as a part of
project called, “support to the implementation of EO 247 in the Philippines” funded by GTZ.
The draft guidelines introduced detail provision for benefit sharing which was lacking in the
previous laws. It also widened its application by including Ex Situ collections under its scope for
the first time. Even the provision of CBD does not apply to Ex Situ collections.
The draft guide is expected to give the bioprospecting measures of the Philippines a new height
after it comes to force. The draft guidelines have reaffirmed the rights of the Indigenous peoples
and communities over biogenetic resources and made it mandatory for the proponents to obtain
PIC as well as FPIC from them before conducting any activities of bioprospecting. Furthermore,
it also regulates the benefits derived from the biogenetic resources and ensures that the providing
and affected communities receive the benefits.
Apart from the above-mentioned legal instruments, the use of biological resources in the
Philippines is governed by a number of other legislations, including the Indigenous Peoples’
Rights Act179, the Traditional and Alternative Healthcare Act180, and the National Museum
178 K. Liebig et al., “Governing Biodiversity- Access to Genetic Resources and Approaches to Obtaining Benefits
from their Use: The Case of the Philippines “, Reports and Working Papers, German Development Institute, 1-107 (2002).
179 Republic Act 8371 of the year 1997. 180 Republic Act 7586 of the year 1992.
35
Act181. The provisions of these laws are in conformity to the EO 247, however, they could; in
some cases influence the legal force or interpretation of the primary ABS laws.182 In this way the
Philippines has undertaken the national implementation of ABS measures.
181 Republic Act 8492 of the year 1998. 182 Perry S. Ong, ‘Access and Benefit Sharing: Experiences from the Philippines, A Mega Diverse Developing
Country’, Wildlife Conservation Society of the Philippines (2005).
36
CHAPTER FOUR
ACCESS AND BENEFIT SHARING IN NEPAL
4.1 Introduction
Nepal is gradually shifting from preservation to conservation model of resource management,
which will definitely open multiple avenues of opportunities but at the same time bring in risks
of resource exploitation and bio-piracy. As value of biogenetic resources increases and supply
becomes limited, it is eminent that western multinational companies turn to developing countries
like Nepal for access to the valuable raw materials. In one way it will help us bridge the gap of
lack of investment, expertise and modern technologies and also help us tap into the extent of
advantages that can be reaped out of our resources. However, an effective access and benefit-
sharing framework will be quintessential for developing countries like Nepal to ensure that
resources are sustainably used and benefit sharing will be done in an equitable way. Furthermore,
Nepal has international obligations (as discussed in Chapter II) to “…develop national strategies,
plans or programs for the conservation and sustainable use of biological diversity or adapt for
this purpose existing strategies, plans or programs which shall reflect, Inter alia”.183 In this light
we will be reviewing Nepal’s existing legislations and policies, which are related to biodiversity,
access and benefit sharing and assess it’s strength and weakness and also Nepal’s compliance to
its international obligations.
4. 2 Biodiversity Related legislations and policies in Nepal
In this section we will review some of the legislations that are related the conservation of
biodiversity explicitly or implicitly. Some of them have some provisions of ABS and some of
them do not have any provision for ABS, but sets foundation for the further development of legal
and policy framework for ABS in Nepal.
183 CBD, art. 3 (a).
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4.2.1 Forest Act and Regulation
The Forest Act of 1993 was promulgated with an objectives, to achieve the basic needs of the
public in general, to attain social and economic development along with promoting a healthy
environment, to ensure the development and conservation of forest, to ensure the proper
utilization of forest products and to extend co-operation in the conservation and development of
private forest by managing the national forest in the form of government managed forest,
protected forest, community forest, leasehold forest and religious forest.184
The Forest Regulation of 1995 was introduced as per section 72 of the Forest Act of 1993; the
Regulation carries a deep significance in the sense that only after the promulgation of Forest
regulation of 1995 the Forest Act of 1993 was implemented.185
The access and benefit sharing provisions for forest products and services in different forest
regimes will be explored below: -
Government-managed forests - occupy the largest area under the national forest. The right to
ownership and sale or distribution of forest products of government managed forests vests
exclusively in government of Nepal.186The prescribed officer however can issue license for
utilization, removal or sale and distribution, export and transportation of forest products by
paying the prescribed fees.187
Community managed forests - are given right to independently, develop, conserve, use and
manage the Forest and sell and distribute the Forest Products independently by fixing their
prices according to Work Plan.188The tenure right has been provided to the Community Forest
User Groups (CFUG) however, there is no provision relating to granting access to other parties
except the CFUG for forest products.
184 See, The Forest Act, 1992, Preamble. 185 Community Forestry in Nepal – Current Issues and Way Forward, A Discussion Note September 2003. 186 Forest Act 1993, sec. 20. 187 Id. sec. 20 (1). 188 Work plan must be prepared pursuant to section 28 of the Forest Rules 1995 and should be mandatorily approved
by the District Forest Officer.
38
Leasehold forestry189 - The government of Nepal can hand over a part of national forest as a
leasehold forest to individuals, groups or organization for the purposes like producing raw
materials needed for industry, to sell, distribute or utilize the forest products by promoting
afforestation etc. Leasehold groups have the authority to extract forest products, distribute them
among themselves, and sell the surplus to the outside people in accordance with the provisions of
the operational plan.
Private forest190- Section 38 of Forest Act states, “The owner of the Private Forest may develop,
conserve and manage the Private Forest and utilize or sell and distribute the Forest Product by
fixing their prices according to his/her own will.”
The Act and Regulation both have provision regarding ownership, access to forest product and
benefit sharing but they do not explicitly regulate access to biogenetic resources and benefit
sharing accruing out of its use.
4.2.2 Nepal Biodiversity Strategy (2014- 2020)
Nepal Biodiversity Strategy is a strategic framework for the conservation of Nepal’s
Biodiversity. ‘The overall goal of the NBSAP is to significantly enhance the integrity of Nepal’s
ecological systems by 2020, thereby contributing to human well-being and sustainable
development of the country. The objective of developing the NBSAP is to provide a strategic
planning framework for conservation and sustainable use of biodiversity and biological
resources of Nepal for enhancing local livelihoods and eco-friendly national development, and
equitable sharing of the benefits accrued from utilization of biological resources among all
sections of the society.’191
It is revised from the earlier Nepal Biodiversity Strategy (2002) and Implementation Plan (2006-
2010) after rigorous and extensive consultations engaging a wide range of stakeholders from 189 Forest Act 1993, sec. 31. 190 Forest Act 1993, sec. 38. 191 Government of Nepal, Ministry of Forest and Soil Conservation, Nepal Biodiversity Strategy and Action Plan,
2014- 2020, 76 (2014).
39
national to community level. It provides a comprehensive account of the Nepal’s biodiversity;
identifies the threats192; describes the key efforts, achievements and gaps in the management of
biodiversity193; presents strategic approaches, theme-specific strategies and associated priorities
for actions; and outlines the implementation arrangement.194 The strategies and priority actions
take into consideration of the national needs in terms of conservation, sustainable use of its
components and equitable sharing of benefits.
4.2.3 Agro Biodiversity Policy 2007
The government introduced Agro biodiversity policy in 2007 emphasizing on conservation,
promotion, and sustainable use of agro-biodiversity. It makes policy arrangements for equitable
distribution of opportunities and benefits arising from access to and utilization of agro-genetic
resources and materials. It also provides some substantive rights such as ownership of traditional
and local agricultural genetic resources to the farmers.195 Under it’s working policy, it provides
focus on adopting a benefit sharing systems based on mutually agreed terms by developing
national legislation and regulations.196
There are many other biodiversity related cross-sectoral policies, strategies, regulatory
frameworks, however, they do not embody provisions for access and benefit sharing in terms of
biogenetic resources. We will briefly discuss different such policies and strategies below,
Sustainable Development Agenda for Nepal (2003) emphasized the need for more effective
management of forests, ecosystems and biodiversity in order to achieve the goal of sustainable
development. It further recommended promoting people’s participation in forestry resource
development, and enhancing economic benefits to local people from protected areas.197 Interim
Constitution of Nepal 2063 has directed the state to make arrangements for the special protection
of the environment and of rare wildlife and provide for protection of forest, vegetation and
192 Id. at 25- 32. 193 Id. at 36- 72. 194 Id. at 76- 82. 195 National Agro biodiversity Policy of Nepal, Page 5, (3(iv)) – Available at
http://www.farmersrights.org/pdf/asia/Nepal/Nepal-agrobiodivpolicy07.pdf (Last Visited Aug. 31, 2015). 196 Id. at 8 (5.2). 197 Government of Nepal, Minsistry of Forest and Soil Conservation, Nepal Biodiversity Strategy and Action Plan
(2014- 2020), Annex 23(2014).
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biodiversity, its sustainable use and for equitable distribution of benefits accrued.198 Nepal
Biodiversity Strategy (2002) which has been now replaced by Nepal Biodiversity Strategy (NBS)
and Action Plan (2014- 2020), aimed on providing a strategic planning framework for the
conservation of biological diversity, maintenance of ecological processes and systems and
equitable sharing of benefits. Nepal Biodiversity Strategy Implementation Plan 2006’s overall
goal was to contribute in achieving the objectives set by NBS 2002.
4. 3 Proposed Access to Genetic Resources and Benefit Sharing Bill, 2014
Being a party to CBD and realizing the importance of national regime on access and benefit
sharing, Government of Nepal formed a Task Force to develop an appropriate legal mechanism
on access and benefit sharing in Nepal.199 According to its mandate, the Task Force has
proposed Bill on Access to Genetic Resources and Benefit Sharing, 2002. Due to political
instability and in the later period lack of parliament, the Bill could not be translated into Act. The
Ministry again reviewed the Bill and proposed Access to Genetic Resources and Benefit Sharing
Bill, 2005. Bill was tabled before the parliament, but due to the resistant from the indigenous
and nationalities communities, the Bill was returned back to the Ministry of Law, Justice,
Constitutional Assembly and Parliamentary Affairs (MOLJPA) and the Ministry forwarded back
the Bill to the Ministry of Forest and Soil Conservation (MOFSC).200 Taking in to
considerations, the Bill has been revised by the MOFSC and again proposed an Access to
Genetic Resources and Benefit Sharing Bill, 1014 and forwarded the Bill to the MOLJPA.
Now, the Bill is under consideration in the MOLJPA. The MOLJPA has not yet been forwarded
the Bill to the parliament considering the process of constitution making. The Ministry of
MOLJPA informed to the MOFSC that the Bill should be revised in line with the upcoming
constitution. Therefore, there is no scope of having a new Access to Genetic Resources and
Benefit Sharing (ABS) legislation before the new constitution is promulgated. Still there is
198 Id. 199 Surendra Bhandari,‘Intellectual Property Rights and Rights over Biological Resources and Traditional
Knowledge: Significance of Documentation and Registration of Biological Resources and Traditional Knowledge in Nepal’, 134 (4), Nayadoot, 49 (2003).
200 Information is based on Personal interview with Kumar Yonjan
41
reservation from the side of indigenous and nationalities communities in the proposed Bill as
they argue that the Bill does not protect their rights over biogenetic resources and associated
traditional knowledge.
Now, it will be worthy to critically review and analyse the content of the proposed Bill in line
with the international standards and the practices of other countries. Objectives, ownership,
documentation and registration of genetic resources and associated traditional knowledge,
approval for preliminary scientific study and sample collection, access approval, constitution of
National Biodiversity Council are some of the most important provisions of the proposed Bill.
Now, it will be imperative to highlight the important provisions of the Bill.
4.3.1 Objective
One of the important objectives of the proposed Bill is to fulfil the international obligation by
implementing CBD in Nepal. Bedsides, conservation and sustainable use of genetic resources
and traditional knowledge; Access to genetic resources and associated traditional knowledge;
equitable sharing of benefits arising from access, use and export of genetic resources and
associated traditional knowledge; and protection of rights of local and indigenous communities
over traditional knowledge, skill, innovations, technology and practices are other important
objectives.201
4.3.2 Ownership
The draft Bill has granted sovereign right to the state over genetic resources and genetic
materials available in Nepal.202 Nevertheless, the ownership of genetic resources and genetic
materials to be found in Nepal shall be as follows:203
• Genetic resources and genetic materials lying in private land, forests and water resources
shall be that of a person or organisation owning such land in which such objects exist;
201 See, Access to Genetic Resources and Benefit Sharing Bill, 2014, preamble. 202 Access to Genetic Resources and Benefit sharing Bill, 2014, sec. 3. 203 Id. sec. 4.
42
• Genetic resources and genetic materials lying in a land, forests and water resources
owned by more than one individual or organization, ownership shall be granted to the
related community;
• Genetic resources and genetic materials found elsewhere except mentioned above shall
be that of the Government of Nepal.
• In the case of traditional knowledge of local communities, the draft law granted the
ownership rights to related local communities.204
4.3.3 Documentation
The proposed Bill has given the mandate to individuals, local communities, organizations,
elected local bodies or government, separately or collectively, prepare documents on biological
and genetic resources and associated traditional knowledge It is mandatory to inform to the
National Biodiversity Council before initiating documentation. The Council itself may prepare
register. The register shall describe the origin, availability, ownership, methods of use, condition
and significance of biological diversity and traditional knowledge, skill, innovation, technology
and practice of the local community and other things related there to as prescribed. The Council
shall be the depository of every document.205
4.3.4 Prior Informed Consent
It is mandatory to get prior informed consent of the individual, organization and local
communities who has ownership over the biological and genetic resources and genetic materials
and associated traditional knowledge related with the use of such biological and genetic
resources and materials before documentation of such resources. 206
204 Id. sec. 5. 205 See, Id. sec. 6. 206 Id. sec. 7.
43
4.3.5 Preliminary Scientific Study, Sample Collection and Access Approval
Any person or organization wishing for access to genetic resources and genetic materials shall be
required to make an application to the Council for preliminary study and collection of sample
with supplying following information in the format as prescribed and payment of required fee:207
• Identification of the applicant and particulars;
• Objective of the study;
• Proposal of the study;
• Description of the biological and genetic resources, genetic material and associated
traditional knowledge to be collected;
• Genetic resources, genetic materials and their components, derivatives, place, process,
procedures and quantity of sample;
• Particulars of required financial and other resources for the proposed activities and
human resources to be involved in the activities of collection of samples;
• Information related with prior applications, if any;
• Information related with the rights and ownership over genetic resources and genetic
materials and associated knowledge of local communities;
• Expected outcome from financial and scientific perspective;
• Particulars of secret matters to be maintained; and
• Any other information required by the council.
While examining the application, if it appears appropriate to grant approval for the study and
collection of sample of any genetic resources and genetic materials, the Council shall, by
prescribing time, location, and other necessary conditions for the study and collection of sample
of such genetic resources and genetic materials, grant approval. No approval shall be granted for
preliminary study and collection of sample for commercial utilization. It is also mandatory to
deposit the study report to the Council. No individual or institution can claim IPRs based on
study and sample collection under this section.
Regarding access approval, section 12 makes it mandatory to submit a proposal by any person or
organization wishing for access, use or export of genetic resources and genetic materials to the
207 Id. sec. 11.
44
Council in a prescribed format along with the technical and benefit sharing reports, preliminary
study report, payment of required fee and information about identification of the proponent and
other related information.
The proposal also should describe the objectives of the proposal; statement of the reports on
preliminary study and collection of sample; detailed statement of genetic resources sought for
access, use and export; collection method and procedure and quantity of genetic resources sought
for access; statement relating to the ownership of genetic resources and associated traditional
knowledge asked for access; economic and scientific results expected from the research;
statement of confidential matters, if any; and other information as prescribed by law and required
by the Council.
4.3.6 Benefit Sharing
Benefit sharing is the core objective of the proposed Bill. According to Section 24, the sharing
and distribution of benefit arising from the access and use of genetic resources, between
contracting parties of the agreement, will be made as mentioned in the agreement. The economic
benefit received by the state will be distributed as follows208:
• Fifty percent to the Government revenue, twenty percent to the local community and the
remaining thirty percent to the Council fund; if the ownership of the resource lies with
the Government;
• Fifty one percent to the local community, individual or organisation, nineteen percent to
the Council and the remaining twenty percent to the Government revenue; if the
ownership of the resource lies with the local community, individual or organisation.
Nevertheless, the owner of the resources should share ten percent of its share with local bodies.
The amount to be received by the local communities shall be distributed by the local bodies
where the community is affiliated.
208 Id. sec. 24.
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4.3.7 Institutional Mechanism
A council named as the ‘National Genetic Resources Conservation Council’ shall be established
for the conservation, promotion and sustainable use of genetic resources and associated
traditional knowledge with a view to sharing the benefits arising from the use of such resources
and knowledge and protect the rights and interests of the local community with regard to their
traditional knowledge. The Council shall be an autonomous body.209
Government of Nepal is authorized to constitute the Council. Government shall nominate six
experts from the disciplines of environmental science, botany, biology, agricultural science,
forestry, environmental law, ensuring that at least one of them should be a woman; one woman
and one man from indigenous communities; three persons, one woman, one dalit and one farmer,
working in the respective field; two ex-officio members, each from Ministry of Forests and Soil
Conservation and Ministry of Agriculture Development. The Secretary of the Ministry of Forest
and Soil Conservation shall serve as the chairperson of the Council. 210
Role and Responsibilities of the council shall be as follows:211
• Formulate and implement necessary policy, plan and programs regarding protection,
promotion and sustainable use of the genetic resources, genetic materials and traditional
knowledge related with the use of those genetic resources and genetic materials;
• Formulate and implement necessary policy, plan and programs related with access, use
and export of genetic resources, genetic materials, and traditional knowledge related with
the use of such genetic resources and genetic materials;
• Formulate and implement necessary policy, plan and programs for the effective
monitoring of the activities of contracting party who obtained licence for access, use and
transport of genetic resources and genetic materials;
• Formulate and implement necessary policy, plan and programs related with transfer of
technology and benefit sharing arises from access to, use and export of genetic resources
and genetic materials;
209 Id. sec. 27(1) & (2). 210 Id. sec. 28. 211 Id. sec. 29.
46
• Formulate and implement necessary policy, plan and programs for the protection of
traditional knowledge of local communities that is useful for the use of genetic resources
and genetic materials;
• Fixing fee for biodiversity documentation and registration, preliminary study, sample
collection and the access and use of genetic resources and genetic materials.
Furthermore, it is a responsibility of the council to formulate the effective policies, plans and
programs making it more professional and updated by way of research, scientific data collection
and analysis. It has to conduct various awareness, information dissemination and observational
programs in the area of access to genetic resources and associated traditional knowledge about
their use. The council shall work as a contact point for foreign governments and international
organizations. It shall be the duty f the council to submit its annual report incorporating its
activates to the National Biodiversity Coordination Committee.212
212 Id. sec. 29(2), (3), (4) & (5).
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CHAPTER FIVE
ANALYSIS AND CONCLUSIONS 5.1 Analysis
Being a party to the CBD213, it is a national obligation for Nepal to formulate an effective
national legislation on access to genetic resources and benefit sharing (ABS). Though the process
of formulation of national ABS legislation has been started in 2002, the process has not yet been
completed. The proposed Access to Genetic Resources and Benefit Sharing bill, 2014 is a
positive step, however, there are shortcomings. Now, it will be worthy to discuss some of the
provisions of the proposed bill for the improvement.
5.1.1 Definition and Recognition of Indigenous Communities
In the earlier draft, there was not a word ‘indigenous communities’. The draft was guided by the
mindset that the term ‘local communities’ represents indigenous communities as well. Further,
there is an opinion that if we incorporated indigenous communities, then, there would be demand
from other groups as well and it would be difficult to enlist the name of different groups in the
law. It is interesting to note that in the present form of Bill, in the preamble the word ‘local and
indigenous nationalities’ have been incorporated. Furthermore, the definition of local
communities included indigenous nationalities.214 This was incorporated in the proposed Bill
because of serious demand from indigenous communities. They have further demand that the
word reflected in the preamble has not yet well reflected in the related provision of the bill.
Therefore, it will be worthy to reflect the spirit of the preamble in the content of the Bill.
5.1.2 Composition of National Biodiversity Conservation Council
As described above, the experts and bureaucrats dominate the Council. In the proposed structure
of the Council there shall be only two representatives from indigenous nationalities, one Dalit
213 Nepal ratified CBD on 23 December 1993. 214 See, Access to Genetic Resources and Benefit Sharing Bill, 2014, sec. 2(i).
48
and one farmer.215 The leaders of indigenous communities argue that as the objective of the Bill
was to protect the rights of local and indigenous communities and ensure their right to benefit
sharing arising from the use of genetic resources and associated traditional knowledge, majority
in the council should be from those communities. Therefore there should be a discussion about
the increase the number of representative from local and indigenous communities.
5.1.5 Prior Informed Consent
There was also a strong critical view about the provision on prior informed consent as the
proposed law equates it with public hearing. They have an opinion that public hearing is a
consultation process and a process of informing people and getting their feedback. Since local
and indigenous communities are the owner of genetic resources and associated traditional
knowledge, they should have final say on any bioprospecting project. Thus, public hearing
cannot be equated with prior informed consent. In this regard, the provision of the Costa Rica
Biodiversity Act could be a good example where the prior informant consent of local and
indigenous communities is the mandatory.
5.1.6 Benefit Sharing
There was more or less satisfaction on benefit sharing proposed by the draft Bill. However
indigenous communities’ representatives have an opinion that local and indigenous communities
should get more share than proposed in the Bill. They were more critical of the provision that
local communities should contribute ten percent of their share to local bodies. As compare to the
Indian, Philippines, and Costa Rica, the provision of benefit sharing in the proposed bill is more
progressive.
5.1.7 Relationship with Other Proposed Laws
Regarding the relationship with other laws, namely the proposed Plant Variety Protection and
Farmers' Rights Bill and the Industrial Property Rights Bill, most of the respondents are
215 See, sec. 28.
49
comfortable with the first one, though they have suggested to incorporate a provision in the
proposed law that access and benefit sharing issue in the case of plant varieties should be guided
and regulated by the Access and Benefit Sharing Law. However, representative of private seed
producers has an opinion that the proposed Bill has given too much emphasis on farmers' rights
and does not reflect the interest of private seed producers. Representative from private
companies further argues that the proposed Access to Genetic Resources and Benefit Sharing
Bill and the Plant Variety Protection and Farmers Rights Bill hinder the access on genetic
resources and innovations in the field of plant varieties.
Most of the respondents have shown their concern on proposed Industrial Property Rights Bill as
it may create problem in the implementation of Access to Genetic Resources and Benefit Sharing
Law. They strongly argue for the incorporation of mandatory disclosure provision in the
proposed law. They also suggested to incorporate a provision in the proposed Bill that access and
benefit sharing issue should be guided and regulated by Access and Benefit Sharing Law.
Like in India, There should be a provision in the Bill that with out prior approval of the council,
no one can apply for the IPR. In India, no one can apply for IPR whether in or outside India
based on the biological resources from India with out prior approval from the national
biodiversity Authority.216
5.2 Challenges in Implementation
Modern bioprospecting and access and benefit sharing is a complex process which requires not
only legal security, but also a strong and independent institutional mechanism and cooperation
and involvement of government, intermediary institutions, private firms, academics, and the
local and indigenous communities. The fair and equitable sharing of benefits is strongly affected
by the distribution of bargaining power that is strongly linked to market structure. All these
216 Biodiversity Act, of India, 2002, sec. 6. Section 6(1) of the Act provides, ‘No person shall apply for any intellectual property right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the previous approval of the National Biodiversity Authority before making such application’.
50
aspects affect the implementation of law to realize the objective of benefit sharing. So let's
highlight some of the possible challenges in the implementation of proposed of Bill.
• The proposed law has not made any distinction regarding the access approval for research
and sample collection between national academic institutions and foreign institutions.
This may create problems in the process of the implementation of the proposed law. This
complex process of access approval for national institutions may affect the capacity
enhancement of Nepali scientists and institutions;
• The Costa Rican Case clearly shows that INBio has an expertise in the field of
biodiversity and is competent to keep biodiversity inventory, accumulation of
information and dissemination of knowledge. There is lack of such institution in Nepal at
present and the proposed National Biodiversity Conservation Council may not have such
capacity in the beginning. There is also lack of financial and other resources to enhance
such capacities within a short span of time;
• The proposed Bill has not made clear distinction between the process of prior informed
consent and the public hearing. Further, the law is silent on the process and procedure of
public hearing and prior informed consent in the border areas of different Village
Development Committees and District Development Committees. It may create
challenges in the implementation process;
• The ‘local communities’ mentioned in the proposed law has social recognition rather than
legal, which also may create problem to ensure the representation of local communities in
the process of prior informed consent, negotiation and distribution of benefits;
• For the success of bio prospecting activities, the participation of all sectors, particularly
the local and indigenous community is crucial. Local and indigenous communities are not
consulted fairly in the law making process and they have strong objection to the process
and the content of the Bill. In this context, they may not cooperate in the implementation
process unless their demands are incorporated into the law before giving it legal status.
Further, the empowerment of local and indigenous communities is also critical to get fair
benefit from bio prospecting projects. In Nepal, indigenous and local communities are not
adequately aware of the value of genetic resources and their rights over such resources
and knowledge, which also may affect the realization of the objectives of the Bill.
51
Therefore, it is important to consult the concerned stakeholders including indigenous
communities before the Bill is approved by the ministry and tabled in the parliament.
Furthermore, awareness and capacity building programs should be organized for the
effective implementation of the law;
• The provisions of the proposed Bill are progressive, but it requires competent human
resources, technology and equipment, scientific laboratory and other infrastructure to
realize its objectives. These aspects are seriously lacking in Nepal, which may affect the
implementation of the proposed law;
• Political stability is a prerequisite to attract foreign investors to the country. If Nepal’s
present political instability continuous, it may affect the law making process. Even if law
is passed by the parliament, it may not make significant contribution to realize the
objectives of the proposed Bill in attracting the foreign companies for bio prospecting.
Costa Rican experiences show political stability is the key to success;
• It is worth noting that there is a strong feeling among the experts that proposed Bill has
made a complicated procedure to get access approval for foreign companies. It is
assumed that it would take minimum three years to complete the whole process to get
access approval. In the competitive global market bio prospectors may choose other
destination where the process is less complicated and less time consuming. It may hinder
the realization of the objective of proposed Bill.
5.3 Conclusion
There is no doubt that Nepal’s effort to formulate a national legislation on access and benefit
sharing is a good beginning. Although the process of enacting law has been started in 2002, but
the process has not yet been completed. The present form of bill is revised several times. Despite
certain weakness, it has come in a good shape. Therefore, is will be worthy to incorporate
suggestions from different stakeholders including indigenous nationalities communities in the
Bill and promulgate a law from parliament as soon as possible.
Furthermore, it is worth remembering that enacting a good legislation is not sufficient. It is more
important to create an enabling environment to implement it and realize its objectives. The
institutional mechanism, socio political situation, infrastructure, market structure, information
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mechanism, competent human resources, empowered local and indigenous communities and
cooperation and coordination from all sectors of society play a vital role in its effectiveness.
Thus, it is urgent to pay adequate attention to those aspects along with enacting adequate,
effective and comprehensive national legislation on access and benefit sharing.