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<marquage typemarq="souligne">Chapitre 2. The principle of benefit-

sharing in the utilization of natural plant and human genetic resources:
par Hlne BOUSSARD et Aphrodite SMAGADI

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2006/4 - Volume 17
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Boussard H. et Smagadi A., <marquage typemarq="souligne">Chapitre 2. The principle of benefit-sharing in the
utilization of natural plant and human genetic resources: beyond the property and no-property rights paradigms,
Journal International de Biothique 2006/4, Volume 17, p. 29-53.

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1242-7 - CH02 11/04/07 14:15 Page 29

Journal international de biothique, 2007, vol. 17, n 4

Chapitre 2
THE PRINCIPLE OF
BENEFIT-SHARING
IN THE UTILIZATION
OF NATURAL PLANT
AND HUMAN GENETIC
RESOURCES: BEYOND
THE PROPERTY
AND NO-PROPERTY RIGHTS
PARADIGMS
Hlne BOUSSARD* and Aphrodite SMAGADI**

* PhD Candidate, European University Institute, Department of Law, Florence. Helene.

boussard@eui.eu.
** PhD, Dorset Fellow of International Law Project Manager, British Institute of
International and Comparative Law, London. a.smagadi@BIICL.ORG.

29
1242-7 - CH02 11/04/07 14:15 Page 30

INTRODUCTION: THE PROBLEM

T he utilization of genetic resources is essential in the biotechnology industry:

plant, animal, and human genetic materials are extracted from their source,
their properties are studied and their prospective uses explored.1 A wide range of
products, such as medicines, cosmetics, chemicals, etc. are based on such resources.
Because of the growing regulation of the use of genetic resources in different
biotechnologies, the present paper proposes a parallel between the regimes
established at the international level for natural plant genetic resources (NPGRs) on
the one hand and human genetic resources (HGRs) on the other hand. Looking for
eventual cross-fertilization between the two, it focuses on the principle of benefit-
sharing and the issue of eligibility for compensation of the research participants,
whether tissue-sources for HGRs, or stewards of NPGRs.
The issue of benefit-sharing was initially raised in the practice commonly
known as biological prospecting or bioprospecting, namely the systematic search
for potentially valuable commercial applications for genetic resources. In the
context of bioprospecting practices, the biopiracy debate2 culminated during the
last three decades; the term describes the ways corporations from the developed
world claim ownership of, free ride on, or otherwise take advantage of the genetic
resources and indigenous knowledge and technologies of developing countries.
The biopiracy debate was initially related to NPGRs and intrinsically linked
to indigenous peoples knowledge over these resources, which provides guidance
to biotechnology research. In drug research, for instance, the medicinal
knowledge of the indigenous is particularly enlightening for further research and
drug development from very rare plant species.
With the development of human genetic research, bioprospecting extended
to the search of human genetic material and biopiracy comes to cover the
situation where HGRs, especially that of indigenous peoples, are explored by

1
K. Ten Kate and S. Laird, The Commercial Use of Biodiversity Access to Genetic
Resources and Benefit-Sharing (London: Earthscan Publications Ltd., 1999).
2
See e.g. B. Burrows (ed.), Out of Africa: Mysteries of Access and Benefit Sharing A report
by Jay Mc Gown (Edmonds/Richmond: Edmonds Institute, USA in cooperation with African
Centre for Biosafety, South Africa: 2006) published on the Internet at: http://www.edmonds-
institute.org/outofafrica.pdf (31 January 2006); also, on the ambivalent meaning of the term,
see G. Dutfield, Intellectual Property, Biogenetic Resources and Traditional Knowledge
(London: Earthscan, 2004) 52 and G. Dutfield, Access to genetic resources and intellectual
property rights: what is biopiracy? International Expert Workshop on Access to Genetic
Resources and Benefit Sharing, I. Identification of Outstanding ABS Issues: Access to GR and
IPR, Cuernavaca, Mexico, 24-27 October 2004.

30
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research institutions and industry for medicinal purposes, but without the
informed consent of tissue-sources and without any compensation. Because they
live in very often isolated environments, the genetic material of indigenous
peoples is of great scientific value. But other groups, e.g. family and diseased
groups, are targeted for genetic research and individual participants may well
carry the rare gene from which drugs will be derived.
Both in HGRs and NPGRs, the issue of eligibility for compensation is raised
therefore in individual and collective terms. The policy activism during the past
decade shows that the regulation of the use of genetic resources has caught the
attention of the international community. This development is in line with the
rapid biotechnology expansion, which creates new situations to be addressed by
the domestic and international policy-maker.
This regulatory effort started in environmental law with the Convention on
Biological Diversity (CBD)3 in 1992, which announces in its Article 1 that the fair
and equitable sharing of the benefits is one of its main objectives. But the Parties
to the Convention soon excluded its applicability to HGRs.4 In 1997, the UNESCO
Universal Declaration on the Human Genome and Human Rights (UDHGHR)
filled the gap and constituted the first international instrument setting up the two
premises of the principle of benefit sharing to regulate human genetic research:
the human genome in its natural state shall not give rise to financial gains
(Article 4) and benefits from advances in biology, genetics and medicine
concerning the human genome shall be made available to all (Article 12).
The regulation of genetic research excluding human genetics, and the
regulation of human genetics exclusively, herald benefit-sharing as the
enabling/empowering principle evoked to address the question of whether any
benefits are to be shared and who is entitled to receive them. In both cases, the
emphasis on the benefit-sharing principle started from the concern to reinstate
fairness and equity among all stakeholders in genetic research and use, and the
application of the principle has in effect the same result.

3
Convention on Biological Diversity, adopted on 5 June 1992 at the United Nations
Conference on Environment and Development (UNCED) in Rio de Janeiro, Brazil, 31 Intl
Legal Materials 822 (1992).
4
See Second ordinary meeting of the Conference of Parties to the Convention on Biological
Diversity, Decision II/I 1995, at 22: human genetic resources are not included within the
framework of the convention; Article 9 of the 2002 Bonn Guidelines repeats that human
genetic resources are excluded from their scope of application, see Sixth ordinary meeting
of the Conference of Parties to the Convention on Biological Divesity, Decision VI/24,
Access and benefit-sharing as related to genetic resources, Section A Bonn Guidelines on
Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of
their Utilization.

31
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However, the international instruments inaugurate two regulatory paradigms in

access and benefit-sharing. On the one hand, with the 1997 UNESCO Declaration
the legal character of HGRs proposed is that of the Common Heritage of
Mankind (CHM).5 On the other hand, genetic resources other than human have
traditionally been part of the CHM until the 1992 CBD which departed from the
CHM and instead proclaimed States sovereignty and the common concern of
mankind. The different legal status of genetic resources in the environmental
and human rights instruments regulating benefit-sharing provides the said
principle with different structures and rational underpinnings.
The present paper aims exactly at exploring the construction of the principle
of benefit-sharing evoked each time to define the compensation, if any, to
research participants, in bioprospecting activities, not only in the so-called
green biotechnology, namely biotechnology research and industrial
applications based on NPGRs, but also in red biotechnology, namely
biotechnology research and industrial applications based on HGRs. In doing so,
it intends to fill the gap in legal literature today, which focuses either on the field
of environmental law, or on the field of human rights law.
At this point, it is appealing that in spite of the discrepancies in the two
regimes, indications started to appear recently that speak for the convergence of
the two regimes. The Report issued in 2002 by the World Health Organization
(WHO) Advisory Committee on Health Research under the title Genomics and
World Health,6 includes a detailed discussion on the CBD approach to benefit-
sharing as potential guidance for benefit-sharing in genetic research.7
In the following sections, the existing international regulatory frameworks in
NPGRs and HGRs are separately examined in depth in order to explain the causa
of the principle in the two disciplines. After this analysis, the conclusion draws
the parallels and underscores that although the benefit-sharing principle is
common in both regulatory areas, its explanation differs, however the same
purpose is served and apparent links are under way.

5 Article 1 of the UDHGHR states that in a symbolic sense [the human genome] is the
heritage of humanity. Despite the controversy as to the legal status of HGRs, they will be
treated here in the light of the CHM.
6 Genomics and world health: report of the Advisory committee on health research, 2002, p.
254, Report by the Secretariat, EB111/12, 25 November 2002.
7
Ibid. 143 et seq.

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I. THE PRINCIPLE OF BENEFIT-SHARING

IN THE PROPERTY RIGHTS PARADIGM:
THE CASE OF NATURAL PLANT GENETIC RESOURCES
While biotechnology advancements inaugurated research to HGRs, the use of
NPGRs is a very old phenomenon.8 Today, bioprospecting detaches from public
research and is increasingly related to commercial activities: biotechnology
industry often builds upon the customary use of NPGRs and develops new
industrial applications for the manufacture of medicines, cosmetics, chemicals
and various products.
The growing competing interests in the use of NPGRs in biotech industry and
the fact that benefits were not returned to all stakeholders (private sector,
developing countries, indigenous peoples) called for the regulation of their use at
the international level. In this context, the principle of benefit-sharing emerged
to strike a balance between the numerous stakeholders: the fair and equitable
sharing of the benefits is one of the main objectives of the CBD and of the Food
and Agriculture Organization (FAO) International Treaty for Plant Genetic
Resources for Food and Agriculture (ITPGRFA), into force since June 29, 2004.
The primary goal of the present contribution is to inspect the theoretical
underpinning that led to the change of the legal treatment of NPGRs in
international law and the associated evolution of the benefit-sharing concept in
international legal texts. It is argued that the principle of benefit-sharing grows
upon economics and human rights considerations (A); the two lines of arguments
complement each other and strengthen the foundation of the principle of benefit-
sharing today. Some practical cases are then briefly described to exemplify the
theoretical analysis (B).

8
The flow in the use of NPGRs started out with their customary use and development to
cover food, shelter, and healthcare needs, with numerous food products, medicines and
other useful applications developed by man from basic wild plant species. Later, scientists
and researchers attention was attracted and upon realization of the value of the resources,
commercial research and development flourished, see M. Bystrm, P. Einarsson, G.A.
Nycander, Fair and Equitable: Sharing the benefits from use of genetic resources and
traditional knowledge, (Swedish Scientific Council on Biological Diversity, 1999), 17,
published on the Internet at: www.internat.environ.se/documents/nature/biodiver/final.pdf
(20 July 2004).

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A. The theoretical underpinnings of the shift to property rights

1. The economics approach to benefit-sharing: property

and conservation incentives

According to Articles 1 and 15 of the 1992 CBD, state sovereignty is one of

the main principles governing genetic resources. Before the CBD, NPGRs were
considered CHM and treated as global commons. The CHM character of NPGRs
was stated in the FAO 1983 International Undertaking.
Notably, placing genetic resources in the CHM has a symbolic meaning: it
signifies the importance of these resources for all humanity and should not be
incompatible with the exercise of state sovereignty. In effect, resources located in
and extracted from the territory of a specific country differ significantly from
classic global common resources, which are not clearly circumscribed by national
borders, such as those located in domestic seas or airspace.9 Although CHM does
not imply that resources are accessible to and usable by anyone without
restrictions, in practice genetic resources ranked in the CHM are treated as
commons, resulting in overuse and extinction.
This treatment of NPGRs as commons created a market failure known as
biopiracy. One reason was that the biodiversity goods and resources market was
not able to adequately involve and compensate all stakeholders, especially those
who were responsible for the resources conservation, directing them to
alternative and more destructive uses of these resources. Another reason was that
the sourcing of the biological resources in bioprospecting undertakings was
unsustainable and threatened species with extinction.10
In this context, environmental economics offer useful insights on why and how
the markets can be employed for conservation purposes. A resource, such as
biodiversity, makes available a multiplicity of goods and services. Following the
criteria of rivalry between the consumers and exclusion of other users, the theory

9
Dutfield (2004) 10; L. Glowka, A Guide to Designing Legal Frameworks to Determine
Access to Genetic Resources (Gland, Switzerland Cambridge and Bonn: IUCN, 1998) 4.
10 See J. Goodman and V. Walsh, The Story of Taxol: Nature and Politics in the Pursuit of an
Anti-Cancer Drug (Cambridge: Cambridge University Press, 2001); K. Ten Kate, and A.
Wells, The Access and Benefit Sharing Policies of the United States National Cancer
Institute - A Comparative Account of the Discovery and Development of the Drugs
Calanolide and Topotecan, Submission to the Executive Secretary of the Convention on
Biological Diversity by the Royal Botanic Gardens, Kew, 1998.

34
1242-7 - CH02 11/04/07 14:15 Page 35

of goods distinguishes among different types of goods:11 private goods, toll

goods (leisure clubs in national parks), mixed goods (or Common Pool
Resources-CPR, such as libraries) and pure public goods (global commons).
The character of a good can change over time, and property rights are set up
or changed de facto or de jure depending on the balance between the benefits of
defining property rights and the costs of their enforcement (Coase/Demsetz
paradigm).12
In a market intensive society, decisions on the production and consumption
patterns for goods and resources cause costs and benefits, in other words,
negative and positive externalities.13 When the decision-maker does not bear all
the costs or reap all the benefits from his/her actions, a market failure arises.
In economic terms, environmental problems are seen as externalities, and the
failure of the market to mitigate social costs and scarcity of resources calls for
governmental intervention to correct the market failure. When NPGRs are
treated a commons as rival and non-exclusive goods, their use creates
externalities, i.e. degradation and loss of biodiversity, and these externalities are
born by the local populations/developing countries. The latter, while responsible
for the conservation and sustainable use of the biological wealth, do not receive
any profits from its use.
Since the delimitation of property rights over genetic resources throughout the
world cannot be regulated by an international treaty, the least that the
international community could do in the case of biodiversity conservation was to
assign sovereignty rights to the States and call for benefit-sharing. The CBD

11
See U. Baruffol, Contractual Regulation of Access to Information on Biodiversity for
Scientific and Commercial Use The Novartis-UZACHI Biolead Project, Diploma Thesis,
Zrich: Forstwissenschaftliche Beitrge 30, Professur Forstpolitik und Forstkonomie,
2003), 8 drawing the table from I. Kissling and Th. Volken, Ressourcenkonomie III.
Institutionelle Aspekte der Ressourcennutzung, Unterlagen zum Fachgebiet Forstliche
Ressourcenkonomie, Professur fr Forstpolitik und Forstkonomie, Departement
Forstwissenschaften ETH, Zrich, 2000, 18.
12
Th. Merrill, Introduction: The Demsetz Thesis and the Evolution of Property Rights
(2002) 31 Journal of Legal Studies, S331; H. Demsetz, Toward a Theory of Property
Rights II: The Competition between Private and Collective Ownership Rights (2002) 31
Journal of Legal Studies, S653; H. Demsetz, Toward a Theory of Property Rights (1967)
57 American Economic Review, 347; R. H. Coase, The Problem of Social Cost (1960) 3
Journal of Law and Economics, 1.
13
See OECD, Handbook of Market Creation for Biodiversity Issues in Implementation
(Paris: OECD, 2004), 35-36; OECD, Harnessing Markets for Biodiversity Towards
Conservation and Sustainable Use (Paris: OECD, 2003), 122; E. U. Petersmann,
International and European Trade and Environmental Law after the Uruguay Round
(London/The Hague/Boston: Kluwer Law International, 1995), 11-17; Bromley (1991) 59.

35
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replaces the CHM in its text with the common concern of mankind and
reaffirms the State sovereignty over genetic resources.14 In turn of sovereign
authority, States have accepted the increased responsibility to regulate and
manage access and benefit sharing. Similarly, the FAO International Undertaking
was revised in 1991 to align itself to the CBD and thus stated that the common
heritage of mankind [...] is subject to the sovereignty of the states over their plant
genetic resources. The recent emphasis in exercising control over biological
resources contrasts markedly to past approaches largely due to the fact that States
now feel the pressure of scarcity, while not long ago natural assets were perceived
as abundant and conservation measures unnecessary.15
The adoption of the sovereignty principle in the CBD inclines to the above
explained Coase/Demsetz property-related paradigm. However, as an
international treaty, the CBD highlights States sovereign rights over genetic
resources within their borders, but cannot interfere with the property status of
these resources within the States borders.16
Although state sovereignty, is a property-allied concept, because of the
exclusive right assigned to the sovereign to exercise control over a geographical
region, it should be clarified that sovereignty differs from property: sovereign
rights are the rights wielded by the State by regulating its citizens behavior by
passing and enforcing laws and by being recognized from the international
community as an independent State; whereas property rights grant their holder
the right to use and enjoy and own the thing or idea over which s/he has rights
and are subject to national legislation.
Many States tend to assign property rights over genetic material. In fact the
current trend to allocate extensive rights leads to fragmentation of the physical
matter and increases transaction costs.17 In access and benefit-sharing agreements
proliferated property rights act as disincentive in foreign investment and disturb
investment efforts. In order to advance investment, it is submitted that States
avoid the assignment of State property rights over genetic material and opt for the

14
CBD Articles 1, 6, 8, 10 and 15. Article 15 of the CBD. Also, the Agenda 21 establishes
clearly the sovereign right of States over resources found within their borders and stresses
the duty to conserve biodiversity and promote sustainable development.
15
A. C. Kiss, La notion de patrimoine commun de lhumanit (1983) 175 Recueil des Cours
Collected Courses of the Hague Academy of International Law, Acadmie de droit
international, 103 and 194; Lesser (1997) 13.
16
Glowka (1998) 4 and 31; J. Chaves, The Andean Pact and Traditional Environmental
Knowledge in N. P. Stoianoff (ed.), Accessing Biological Resources - Complying with the
Convention on Biological Diversity (New York: Kluwer Law International, 2004), 244.
17
M. Heller and R. S. Eisenberg, Can Patents Deter Innovation? The Anticommons is
Biomedical Research (1998) 280 Science, 696.

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physical unity of the matter:18 The role of the State is that of qua supervisor of
the undertakings within its territorial control, and not that of the qua owner of the
genetic material.

2. The human rights approach to benefit-sharing: indigenous peoples

rights19
Complementary to environmental economics, human rights come to add in the
application of benefit-sharing principle in the use of NPGRs. Property rights
constitute the basis for individual and collective claims by indicating the
stakeholders in the bioprospecting undertakings and ensure their reward.
Grounded on cultural and social values, property rights institutions are not
systematized universally in the same way and customary systems have been
developed especially by local and indigenous communities, clearly indicating the
owner/manager/possessor of the resources. During the colonial era, however,
customary systems were considered backward and statutory systems were
implanted; in the end, the latter failed to replace the former, and today the two coexist.
Presently, rich in biological diversity developing countries host large indigenous and
local communities and face a dual system of property rights allocations. In these cases,
property rights allocation is innately linked to the recognition of indigenous peoples
rights, their right to self-determination and the respect of their customary institutions.
Indeed, the CBD by emphasizing the contracting parties obligation to respect
the customary use of resources and traditional knowledge, practices and
innovations, and to enact legislation,20 recognizes the need to protect indigenous
18 Actually, the Roman tradition suggested that who ever owns the land owns the property all
the way to heaven and all the way to the center of the earth (Latin maxim Cuius est solum
eius est usque ad coelum et usque ad inferos), but the 20th century codes abandoned this
roman rule of physical entity, see e.g. German Brgerliches Gezetbuch (BGB 1900 and
1919) paras 1012-1017 and Italian Codice Civile (1942); this movement was criticized by
mid-20th century civil law scholars for the violation of the modern ideal of unified property;
see F. Parisi, The Fall and Rise of Functional Property (2005) George Mason law &
Economics Research Paper n 05-38, November 17, 2005, 18.
19
See below at II.A.I The human rights-based approach : the right to self-determination.
20
CBD Article 8(j) (in situ conservation), contracting parties agree, subject to their national
legislation, to respect, preserve and maintain knowledge, innovations and practices of
indigenous and local communities embodying traditional lifestyles relevant for the
conservation and sustainable use of biological diversity and promote their wider
application with the approval and involvement of the holders of such knowledge,
innovations and practices and encourage the equitable sharing of the benefits arising from
the utilization of such knowledge, innovations and practices. Also, according to CBD
Article 10(c) (sustainable use of components of biodiversity), parties agree to protect and
encourage customary use of biological resources in accordance with traditional cultural
practices that are compatible with conservation or sustainable use requirements.

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peoples and the difficulties arising from conflicting customary and statutory
regulations, especially with regards to the control of lands and resources.
The spirit of the CBD is in line with the current trends in modern international
law for indigenous peoples rights, protected by a number of international
instruments,21 especially by the recent UN Declaration on the Rights of
Indigenous Peoples by the Human Rights Council on 29 June 2006. However, if
states are not mobilized towards protection of indigenous rights at the domestic
level, the materialization of these internationally proclaimed rights is not
possible. Failure of the state to protect its citizens rights and more specifically
those of its indigenous and local communities signifies failure to identify the real
stakeholders and failure to meet the requirements of the benefit-sharing principle.
Because full-protection of indigenous peoples rights is inherently related to
the affirmation of their sovereignty over their lands and resources and puts in
question the traditional understanding of the concepts of sovereignty and self-
determination, indigenous peoples rights protection is in the center of tensions in
modern international legal thinking.
Self-determination was primarily conceptualized as a political aspiration
against decolonization and gradually crystallized into a principle and a right. The
right to self-determination runs defunct, if ownership, management and control
rights over natural resources are not recognized. States with large indigenous
communities within their territories are reluctant to fully accept the right of
indigenous peoples to self-determination and the hereof derived sovereign rights
to their lands and resources, because they regard such recognition as a threat to
their own sovereignty.
Today, the meaning of self-determination is being reviewed and detaches from
its initially political nature. Self-determination stands for the summa/synthesis of
individual human rights and vice-versa, namely respect for human rights and self-
determination supplement and strengthen each other.22 Most governments with
indigenous communities within their territories oppose full recognition of
indigenous peoples self-determination, because they fear that such recognition
will lead to recognition of their independence. The current tensions on the

21
See the various UN system bodies and documents on indigenous peoples: Indigenous
Peoples, The UN System at Work at: http://www.un.org/issues/m-indig.html (24/01/2007);
especially mentioned the ILO Convention No 107 and 169, the two Covenants of 1966 and
the Declaration of Indigenous Rights adopted by the Human Rights Council in Summer
2006.
22
A. Cassese, Self-Determination of Peoples A Legal Reappraisal (Cambridge: Cambridge
University Press, 1995) 337.

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1242-7 - CH02 11/04/07 14:15 Page 39

reconceptualization of the meaning of self-determination argue that revisiting the

concept does not put in question the States authority within its boundaries, but
adapting it to current reasoning in the temporal context.23 The fact that the draft
UN Declaration on the Rights of Indigenous Peoples was debated for at least ten
years is indicative of these tensions, because the text includes much of the
material for the reconstruction of the concept of self-determination in relational
terms, even at an under-developed stage.24
It should be here noted that the state ownership system over exhaustive
resources seriously impairs human rights, and in particularly indigenous peoples
rights over the resources they manage. Especially with regards to indigenous and
local communities rights, there is no data proving the participation or at least
consent of these communities to transfer control of the subsurface resources to
the state. Recent regional and domestic case law lend support to a definition of
natural resources over which indigenous peoples may assume property rights that
includes subsurface resources.25
Despite the differences between subsurface and genetic resources, because the
latter are contained in natural resources and after all they are of an informational
rather than tangible character, parallels can be drawn following the
jurisprudential evolution so as to support physical unity of the matter and thus
include genetic resources in the scope of natural resources.

B. Property rights over plant genetic resources in practice

Before the CBD, intellectual property laws were the main distribution
mechanism for the monetary benefits arising from the use of the resources, but
their application was not applauded. The following sections present several

23
Indicative bibliography on the international law discussion: J. Castellino and N. Walsh
(eds) International Law and Indigenous Peoples Raoul Wallenberg Institute human rights
library series (Leiden/Boston: M. Nijhoff, 2005); B. Kingsbury, Reconciling Five
Competing Conceptual Structures of Indigenous Peoples Claims in International and
Comparative Law (2002) 34 International Law and Politics, 101 ; P. Aikio and M.
Scheinin (eds), Operationalizing the Right of Indigenous Peoples to Self-Determination
(Turku/Abo: Institute for Human Rights, Abo Akademi University, 2000); R.
McCorquodale (ed), Self-Determination in International Law, (Aldershot/Burlington
USA/Singapore/Sydney: Ashgate/Dartmouth, 2000); Cassese (1995).
24
See especially Articles 25-26 and 29-30 of the Declaration.
25
See Final Report of the Special Rapporteur Erica-Irene Daes, Doc. E/CN.4/Sub.2/2004/30
issued on 13 July 2004, for the 56th session of the UN Sub-Commission on Human Rights
(26 July-13 Aug. 2004); the report is indicative of the developments in the field of
indigenous peoples sovereignty over genetic resources.

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1242-7 - CH02 11/04/07 14:15 Page 40

examples that highlight the consequences of the changed character of genetic

resources.

1. Bioprospecting before the CBD

There are many cases that received attention in the international media and
show that the failure to share the benefits deriving from the use and marketing of
the specific plant resources raised public opinion against the bad and rich North
and in favor of the good and poor South. Under cover of the CHM principle,
resources and knowledge located in another country (country of origin) than the
country of the user industry were accessed and used freely without sharing of the
arising benefits with the country of origin. This practice created many tensions
and clearly failed to address the mission today of the developed world to support
capacity building efforts in developing countries to add value and profit from
their resources.
Awarded patents under this regime have been challenged and revoked, such as
the Turmeric,26 the Ayahuasca27 and the Neem.28 By way of indication, the Neem
tree patent, a fast growing evergreen tree whose bark, leaves and seeds have
various medicinal and pesticide properties, is broadly known among Hindus and
Muslims as the curer of all ailments and the blessed tree. The US based
chemical company W.R. Grace worked on a natural insect repellant essence
contained in the tree and obtained US patents on the extracting process, which
was actually developed on the basis of the process employed by Indian farmers,
but with no compensation of the farmers for their contribution. A number of
environmental activists and international environmental groups successfully filed
petitions with the US Patent and Trademark Office and the EPO seeking to
invalidate the patent on the ground that its novelty exists in the context of the
ignorance of the West.29

26
Reexamination Certificate, U.S. Patent No. 5,401,504 B1 (requested Oct. 28, 1996) (issued
Apr. 21, 1998) (canceling all claims in original patent on turmeric).
27
L. M. Fecteau, The Ayahuasca Patent Revocation: Raising Questions about U.S. Patent
Policy (2001) 21 Boston Third World Law Journal, 69.
28
Case No. T0146/01-3.3.2, Method for Controlling Fungi on Plants by the Aid of
Hydrophobic Extracted Neem Oil (B.A. Eur. Patent Office Mar. 8, 2005) (upholding on
final appeal the 2001 revocation of European Patent Office neem patent.
29
See Schuler in J. M. Finger and Ph. Schuler (eds.), Poor Peoples Knowledge Promoting
Intellectual Property in Developing Countries (Washington, D.C.: OUP/The World Bank,
2004) 161; C. R. McManis, The Interface between International Intellectual Property and
Environmental Protection: Biodiversity and Biotechnology (1998) 76 Washington
University Law Quarterly, 255.

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2. Private Sector and Corporate Social Responsibility

Corporate social responsibility is a very promising development in the areas

of human rights and environmental protection.30 Private companies are afraid of
environmental or human rights black-listing and adopt codes of conduct and
other contractual practices in order to comply with international standards on
human rights and environment.
For instance, in 1991, the pharmaceutical giant Merck and Company31
implicitly acknowledged an obligation to compensate for the seed of raw plant
germplasm in a much-publicized venture with the government of Costa Rica
(through Cost Ricas National Institute of Biodiversity - INBio).32 Under the
agreement, Costa Rica was to provide Merck with plant, animal or microbial
samples, and INBio agreed to contribute 10% of the budget and 50% of any
royalties to the governments National Park Fund for the conservation of national
parks in the country. Merck agreed to provide technical assistance and training to
establish drug research capacity in Costa Rica, however, the results of the
program of any potential drug candidate are unclear.33
The contractual approach to bioprospecting has an advantage over intellectual
property systems, in that costs, benefits and risks can be better distributed
between the collecting organization and the source country: contractual
provisions determine the benefits portion and allocation, they are flexible
accommodating the parties will and they can be concluded even in absence of

30
R. Mullerat (ed.), Corporate Social Responsibility: The Corporate Governance of the 21st
Century (The Hague: Kluwer Law International, 2005; F. Francioni, Four ways of
enforcing international responsibility for human rights violations of multinational
corporations, paper presented at the Workshop Biotechnology, International Law and
Human Rights, (unpublished manuscript, on file with the author); C. Avery, Business and
Human Rights in a Time of Change, in T. Kamminga and S. Zia-Zarifi (eds.) Liability of
multinational corporations under international law (The Hague/Boston: Kluwer Law
International, 2000) 17.
31
In 1996 the Merck and Company merged with Sandoy. The result of the merger is Novartis,
based in Basle, Switzerland.
32
For a full account of the 10-year experience in bioprospecting in Costa Rica see J. Cabrera
Medaglia, Bioprospecting Practices in Practice: A Decade of Experiences at INBio in
Costa Rica (2004) IP Strategy Today No. 11-2004, 27.
33 P. Gehl Sampath, Regulating Bioprospecting: Institutions for Drug Research, Access and
Benefit-Sharing (Tokyo/New York: UNU Press, 2005) 30; L. H. Caporale, The
Merck/INBio Agreement: A Pharmaceutical Company Perspective in M. J. Balick, E.
Elizabetsky, and S. A. Laird (eds.), Medicinal Resources of the Tropical Forest -
Biodiversity and its Importance to Human Health (New York: Columblia University Press,
1996), 137.

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domestic intellectual property laws in the source-country. However, the uneven

negotiating powers between the developing source country and the multinational
pharmaceutical company that has strong legal divisions and the further incapacity
of developing countries to analyze information provided by the industry, are
some of the shortcomings of this approach.

3. State regulatory regime: how much intervention

Since the CBD came into force, there is an international obligation for benefit-
sharing. However, the CBD is an international treaty, and as such much is
expected to be materialized through national action. The CBD itself is very
epigrammatic in its instructions on the implementation of the principle. Article 15
lays down the main principles for access and benefit-sharing: state sovereignty,
Prior Informed Consent and Mutually Agreed Terms. But the CBD provisions
remain void, if the States take no action.
The Bonn Guidelines, a soft law instrument decided by the Conference of the
Parties to the CBD at their 6th Meeting in 2002,34 offer valuable guidance on the
operationalization of the CBD principle on benefit-sharing. Still these guidelines
are very broad in character and cannot cover all local needs and particularities.
Several States have already enacted legislation on access and benefit-sharing,35 the
Philippines and the Andean Pact being of the first to legislatively address the issue.
Andean Pact Decision 39136 is the first regional approach for access to genetic
resources and benefit-sharing. On the one hand, it is crucial that neighboring
countries harmonize legislation, because if only one or few of them enact such
regulations, this is a comparative disadvantage for those regulating the issue. On
the other hand, the regional decisions are ineffective, if they are not accompanied
by national legislations.
Although the Andean Pact Decision inaugurates a positive development of
coordinated access and benefit-sharing regulations in countries sharing biological
diversity, this does not mean that shortcomings were absent.
The Andean Pact Decision 391 Common Regime on Access to Benefit
Sharing, in its article 6 provided that genetic resources and their by-products

34 See footnote 4 above.

35
See database on the CBD web site at: http://www.biodiv.org/programmes/socio-eco
benefit/measures.aspx.
36 Decision 391, 2 July 1996, Common Regime on Access to Genetic Resources, the
electronic version of all decisions of the Andean Communicty are available at
http://www.comunidadandina.org/.

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which originated in the Member Countries are goods belonging to or the heritage
of the Nation or of the State37 in each Member Country, as stipulated in their
respective national legislation. Further, it foresees that those resources are
inalienable, not subject to prescription and not subject to seizure or similar
measures, without detriment to the property regime applicable to the biological
resources that contain those genetic resources, the land on which they are located
or the associated intangible component.38
Hence, Decision 391 makes a clear distinction between genetic and biological
resources.39 Biological resources can be negotiated by anyone having a right over
them; but only the state has rights over genetic resources and the state alone can
negotiate benefit sharing provisions from the use of genetic resources.
Accordingly, any right given to a person or entity, like for instance a forest
concession, over natural resources does not imply rights over genetic material
found in the natural resources or the area over which the concession extends.
The risk of this proliferation of property rights over the matter creates
complex procedures and an unfriendly investment environment, driving
companies away from the utilization of genetic resources: multiple individuals
and/or entities have rights of exclusion over genetic resources resulting into use
below the social optimum. This conclusion renders bioprospecting an inadequate
tool for biodiversity conservation.
Besides, such robust sovereign rights over raw genetic materials may threaten
the autonomy and interests of individuals/communities: the State is the ultimate
decision maker on the use of the genetic resources, and it might thus put pressure
on local/indigenous communities to cooperate and grant their consent under the
terms discussed between the user entity and the State.
Regrettably, the Andean Pact Decision was not accompanied by provisions
securing the rights of indigenous peoples. The example of Philippines,40 the first
that adopted access and benefit sharing legislation, tackles the benefit-sharing

37
Emphasis added.
38
Emphasis added.
39
CBD Use of Terms: Biological resources includes genetic resources, organisms or parts
thereof, populations, or any other biotic component of ecosystems with actual or potential use
or value for humanity. Genetic resources means genetic material of actual or potential value.
40 Executive Order 247 Guidelines on Bioprospecting, 18/05/1995 and subsequently,
Republic Act No. 9147: Wildlife Resources Conservation and Protection Act, 30/07/2001,
Implementing Rules and Regulations (IRR) of Republic Act n 9147, Joint DENR-DA-
PCSD Administrative Order No. 01 Series of 2004, 18/05/2004 and Guidelines for
bioprospecting activities in the Philippines, 14/05/2004, all available at the CBD website at
http://www.biodiv.org/programmes/socio-eco/benefit/measures.aspx.

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issue more successfully, especially because of the act for the protection of
indigenous peoples,41 which is applicable in parallel with the benefit-sharing
regulation. Also, the Philippines regime used to be highly interventionist as well,
which resulted in the absence of any applications for access and benefit-sharing
and lead to the revision of the legal environment.

II. THE PRINCIPLE OF BENEFIT-SHARING

IN THE NO-PROPERTY RIGHTS PARADIGM:
THE CASE OF HUMAN GENETIC RESOURCES
The principle of benefit-sharing as eligibility for compensation of research
participants is quite new in the discussions surrounding the use of HGRs at
domestic and international levels: participation in research, which used to
constitute an act of altruism, is now perceived as subject to compensation,
whether monetary or not. In genetic research, the emergence of new individual
interests can be justified by the perception of the genetic information as a
continuum of the individual or of the group identity. But here the consideration
of property rights is inappropriate. It is precisely because HGRs are intrinsically
linked to the person that property rights cannot accrue to the person. So far courts
denied property rights to the individual over his/her tissues, on the basis of the
principle of human dignity and of the economic consequences for the scientific
project that remuneration of all participants would represent.42 But the non-
recognition of individual property rights over the human genetic material does
not mean that the benefit-sharing principle cannot be met through different paths,
as it will be shown in the following paragraphs.
The principle of benefit-sharing irrupts in genetic research at the international
level through the UNESCO bioethics declarations under two forms: a principle
of international human rights law and a constituent element of the CHM.
International human rights law and the CHM constitute two normative
superstructures, which come into play to ensure the protection of the individual
and the interests of present and future generations respectively. The concept of
superstructure supposes a legal construction that strengthens the domestic
regime at the international level. It reflects the idea that the protection granted at

41
The Indigenous Peoples Rights Act (IPRA), Republic Act n 8371, 29 October 1997.
42
Three American courts have so far settled the issue: Moore v. regents, 51 Cal. 3d. 120; 271 Cal.
Rptr 146; 733 P.2D 279 (Cal. 1990) (Moore case); Greenberg v. Miami Childrens hospital,
264 F. Supp. 2d 1064 (S.D. Fla 2003) (Greenberg case); The Washington University v.
William J. Catalona, Case n 4:03CC, 01065 SNL (E.D. Miss 2006) (Catolana case).

44
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the international level leaves intact the regime which is attached to the good at
the domestic level, where there is much confusion as to whether genes are
property and to whom they belong.43
Firstly, the principle of benefit-sharing appears as a general principle in public
international law and in international human rights law more specifically.44 It is
recognized in favor of participants in research by the Human Genome
Organization (HUGO),45 the World Health Organization (WHO)46 and Article 15
of the 2005 UDBHR.47 It consists of a legal principle with a strong ethical origin,
since it builds upon the ethical principles of beneficence, distributive and
retributive justice and solidarity.48 International human rights law comes to
ensure state obligations towards individuals, among which tissue-sources
whose DNA is in issue.
Secondly, the benefit-sharing principle comes as a corollary of the CHM,
which arguably encompasses since the 1997 UDHGHR the human genome.49
The CHM concept of comes to fulfill the insufficiency of state sovereignty for
the long-term regulation of common resources in the interests of present and
future generations. It prohibits public or private appropriation of the asset and
requires the cooperation between states to exploit and preserve the common
good. It aims at the realization of the theory of inter-and intra- generational
equity.

43
A. Schonmann, From make believe to doomsday eve : or should we patent genes ? (1998)
17 Medecine and law, 455.
44
B.M. Knoppers, Population genetics and benefit-sharing (2000) 3 Community genetics,
213.
45
HUGO Ethics Committee, Statement on benefit-sharing, 9 April 2000, 3. HUGO advocates
that there be prior discussion with groups or communities on the issue of benefit-sharing
and that profit-making entities dedicate a percentage (e.g. 1%-3%) of their annual net
profit to healthcare infrastructure and/or to humanitarian efforts.
46
WHO, Proposed international guidelines on ethical issues in medical genetics and genetic
services (1998), WHO/HGN/GL/ETH/98.1. The World Health Organization proposed that
in cases where genetic research produces diagnostic tests or new therapies, equity requires
that donors, or the community generally, should receive some benefit.
47
Universal Declaration on Bioethics and Human Rights, Article 15a: Benefits resulting from
any scientific research and its applications should be shared with society as a whole and
within the international community, in particular with developing countries. In giving
effects to this principle, benefits may take any of the following forms: (i) special and
sustainable assistance to, and acknowledgement of, the persons and groups that have taken
part in the research.
48
Q. Renzong, Human genome and philosophy: what ethical challenge will human genome
studies bring to the medical practices in the 21st century (2001) 324 C.R. Acad. Sci. Paris,
Sciences de la vie/life sciences, 1102.
49
Article 1 of the Universal Declaration on the Human Genome and Human Rights, see supra
note 5.

45
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Each superstructure, human rights law and the CHM regime, provides a
specific function to the principle of benefit-sharing in the use of HGRs (A). The
hypothesis is that the principle of benefit-sharing constitutes an autonomous
regulatory tool in the common heritage of mankind regime and not only an end
as it is in the human rights-based approach. Practical measures for the
implementation of the principle are next explored to illustrate the validity of the
hypothesis (B).

A. Dual functional approach

In the rights-based approach, the right to self-determination is often invoked to
justify the eligibility for compensation of the individual. The interaction between
bioethics and law gives rise to a hybrid concept, that in order to be workable,
requires further clarification of its rational underpinning (1). In the concept of
common heritage of mankind, the balance between competing interests is
objectified through the use of equity (2).

1. The human rights-based approach: the right to self-determination

Looking for the rational underpinning of the principle of benefit-sharing, the

right to self-determination refers to two distinct normative concepts, i.e. the legal
political human right and the bioethical principle of autonomy.
The bioethical principle of self-determination is mainly conceived as an
individual entitlement. It aims at the preservation of human sovereignty over
personal dignity and individual freedoms.
The legal concept appeared in the first article of the two international human
rights covenants of 1966.50 It is considered either as a collective right or, in the
words of the Human Rights Committee, as an essential condition for the
effective guarantee and observance of individual human rights.51 Right or
premise to right allocation, self-determination aims to protect and enable groups
to prosper and transmit their culture as well as to participate fully, as a group, in
the political, economical and social process. It involves major structural and
institutional changes in a state and affects groups and individuals in and even
beyond the state. With the issue of biopiracy affecting indigenous peoples, the

50
Article 1 (1) of the International Covenant on Civil and Political rights, 1966 and Article
1(1) of the International Covenant on Economic, Social and Cultural Rights, 1966.
51
CCPR, General Comment 12, the right to self determination (Article 1), paragraph 2,
Twenty-first session, 1984.

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protection offered by the principle over external resources for ensuring the
recognition of their political identity extended to internal resources for the
groups to protect their genetic identity.
From two autonomous understandings of self-regulation, a dual move is being
witnessed today towards their convergence: the individualization of the
collective right on the basis of bioethical premises and the collectivization of
individual autonomy on the basis of indigenous rights.
As a result, the line between the legal and ethical understandings of self-
determination has become blurred and the right is now a mixed (individual and
collective) human right which borrows the meaning of the ethical principle. It
applies to any situation external and internal in which people are suffering from
oppression by subjugation, domination, or exploitation. It puts on states an
obligation to free peoples or individuals from exploitation. Such normative
construction leads to the recognition of group consent or community rights.
Thus the right to self-determination is a gateway to the right to control over
genetic resources and genetic information: it empowers groups and individuals
to claim a share in the benefits derived from research on genetic resources and
information. Such construction is well under way and requires to be now
judicially assessed.
However, even when fully accepted, the right to self-determination may not be
satisfied at all, because there is always a risk that the weak parties in the
bioprospecting undertaking will be exploited by their powerful counterparts and
the rights to grant consent and receive remuneration will be infringed.
Consequently, the rights-based approach of benefit-sharing limits itself to a
subjective justification of the principle of benefit-sharing, without effectively
eliminating the risk of exploitation of individuals/communities i.e. the situation
in which a party takes unfair advantage of the tissue-source. The risk of
exploitation does not end with the consent of the individual.52 For this reason an
external and objective institution/actor is required to guarantee the application of
the principle. Should this view prevail, the approach of equity deriving from
CHM is preferred.

52
D.B. Resnik, Are DNA patents bad for medicine? (2003) 65 Health policy, 181-197.

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2. The Common Heritage Equity53

At the domestic level, the Greenberg case54 reaffirms the role of equity to
counterbalance the deprivation of research participants from legal entitlements
over the benefits generated through research. In this case, the claimants had
instigated research to isolate the gene for Canavan disease55 and supplied
biological materials and resources for the investigation. The fact that the doctors
and hospitals patented the genes without informing the participants was
recognized by the court as an unjust enrichment. This cause of action comes
into play in instances of equitable decision-making, where the defendant gains at
the plaintiffs expense, even in absence of actual corresponding loss. It
constitutes a powerful legal alternative, when tort, contract and property theories
are inadequate. As such, this cause of action, amounts to the principle of equity,
a legal principle based on morality and fairness, which is at the disposal of the
judge to particularize justice and avoid the application of rigid rules.56
Equity in common law and equity in international law do not have the same
origin, neither the same function.57 However, the Greenberg case invites to
consider it in its potentially far-reaching scope and broad application. There is
still a strong resistance in considering equity as a formal source of law in
international law: in theory, equity serves the law-interpreting rather than the law-
making process and in the words of the International Court of Justice (ICJ),
equity is not in itself a source of obligation where none would otherwise exist.58
But in the case-law of the Court, equity was used not only as an interpretive rule
(equity infra legem) or a corrective rule (equity prater legem) but also as an
autonomous rule that may depart from the legal rule (equity contra legem).59

53
T. Franck and D.M. Sughrue, The international role of equity-as-fairness (1993) 81
Georgetown law journal, 574.
54
Greenberg v. Miami Childrens hospital research institute, Inc. 264 F. Supp. 2d 1064 (S.D.
Fla. 2003). D.L. Greenfield, Greenberg v. Miami childrens hospital: unjust enrichment
and the patenting of human genetic material (2006) 15 Annals of health, 213-229. K.
Oberdorfer, The lessons of Greenberg: informed consent and the protection of tissue
sourcesresearch interests (2004) 93 Georgetown law journal, 365-389.
55
Canavan disease, one of the most common cerebral degenerative diseases of infancy, is a
gene-linked, neurological birth disorder in which the white matter of the brain degenerates
into spongy tissue riddled with microscopic fluid-filled spaces.
56 D. L. Greenfield, see note 55, 214.
57
R. Lapidoth, Equity in international law (1987) 81 American society of international law,
135-155.
58 ICJ Judgment, Border and transborder armed action, (Nicaragua v. Honduras), jurisdiction
and admissibility, 20 December 1988, ICJ Rep. 1988, 12, para. 94.
59
ICJ Judgment, North Sea Continental Shelf, ICJ Rep. 1969, p. 213.

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In this context of uncertainty, one could legitimately consider that equity as a

source of law is well under way in international environmental law. Building
upon the theory of inter-and intra-generational equity developed by E. Weiss,60
T. Franck considers equity under the guise of the common heritage of mankind
as a tool for the allocation of scarce resources among states.61 The so-defined
common heritage equity applies to resources that ab initio do not belong to
anybody. This is the case of HGRs, which only once isolated from the individual
are object of property rights and intellectual property rights:62 the property
rights paradigm becomes applicable from here.
As a result the tissue-source has no property right over his/her biological
samples, but a legal entitlement to share benefits accrues to him/her and to the
genetic community that can be asserted on the basis of being equitable and that
directly derived from the principle of benefit-sharing.

B. Benefit-sharing in practice: externalisation of the control of HGRs

Unlike human rights law, the implementation of which relies heavily on the
state apparatus, recognition of the CHM for HGRs results in the externalization
of the resources control at the global level; such externalization will be
considered in the following paragraphs after presenting the current fragmented
practice in the control of the use of HGRs and the benefit-sharing application.

1. Current practice
a. State model
There is no clear picture of how many countries are attempting to regulate cross-
border flows of DNA. In absence of response, it is at least possible to say that there
are few laws relating to rights of donors in tissues taken for medical research.63

60
E.B. Weiss, In fairness to future generations: international law, common patrimony and
intergenerational equity (Tokyo: United Nations University; N.-Y.: Transnational
publishers, 1989).
61
T. Franck and D.M. Sughrue, see note 54, 566.
62
This stems from a reading a contrario of Article 4 of the UNESCO Declaration on the
human genome and human rights and is corroborated by the European and the United
States patent offices.
63
R. Kneller, Ownership of inventions derives from natural products and human tissues, and
sharing of benefits from the commercialization of such inventions (2000) 6 CASRIP
publication series: rethinking international intellectual property, 218-224. According to
this article, the story begins back in 1997 when senior Chinese geneticists expressed
concern that if foreign laboratories analyze Chinese tissue samples, discoveries related to
these samples would likely be patented and commercialized by foreigners, and China
would not share in the commercial benefits.

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In this legal scarcity, the Chinese system of prevention from uncompensated

removal of Chinese human genetic resources is quite unique. Since 1998, the
Human Genetics Resources Administration of China (HGRAC) has been
entrusted with the control of all activities related to the collection and export of
human genetic data.64 It reviews the benefit-sharing and related obligations
formalized in a contract as part of the project approval process. Organizations or
individuals must apply to the HGRAC and the Science and technology and the
Public Health Ministries for a permit to take, dispatch or transport human genetic
materials out of China.65 The Chinese and foreign collaborators must jointly
apply for and co-own patents. As such the Chinese model of contract of
collaboration satisfies the interests of scientists and research institutions in source
countries. By contrast, it is not sure that it serves the interest of scientists in
research institutions in developed countries, neither provide tissue-sources with
guarantees that the use of the information will not harm them.66

b. Mixed Models: contractual and regulatory regimes

Ad hoc regulations govern national biobanks. The Icelandic case illustrates a
mix of statutory and contractual norms. The government allowed Decode
Genetics, a Reykjavik based company, to commandeer the genetic, medical and
family histories of the entire population of Iceland. In a subsequent contract
between Decode Genetics and Hoffman-La-Roche, the two companies agreed on
a free access to medicines resulting from genetic research led from Icelandic
databases.67
By contrast, in Estonia, the government mandated obtaining a specific
informed consent for both the use of health data and DNA samples in its Gene

64
Q. Renzong, see note 49, 1102. In June 1998, the Chinese state council issued the Interim
measures for protecting human genetic resources. It was drafted with the help of Chinese
scientists and geneticists and states that: (1) Every country has the responsibility for
protecting its own genetic resources; (2) the relation between both sides of cooperation
should be equal; (3) the benefits brought by the research should be shared by both sides;
and (4) the informed consent is mandatory.
65
Anyone planning to export human specimens from which human genetic resources can be
derived whole blood must apply to the Human Genetic Resources Administration of
China (HGRAC), a small specialized agency jointly established by the Ministry of Science
and Technology (MOST) and Ministry of Health (MOH). These reports are subject to the
Interim measures for the Administration of Human Genetic Resources, promulgated by
the State Council on June 10, 1998. In the case of an international collaborative project, the
Chinese partner to the project is to apply to the HGRAC.
66 R. Kneller, see note 64, 223.
67
B.M. Knoppers, Le gnome humain: le patrimoine commun de lhumanit? (Montral :
Muse de la civilisation, 1992), 27-28.

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Bank. Samples were coded rather than anonymized so that eventually, results for
better health management can be given back to the persons and families that
participated.68

c. Private Model (corporate)

The American Medical Association invited research institutions to share
profits from commercial use of human tissues and its products with patients, in
accordance with lawful contractual agreements. In Canada, such model is
illustrated by Newfound Genomics which promised to return a percentage of net
profits to an independent foundation set up by the company for the population.
Compensation in research agreement is eased by the bargaining power that
families and civil society acquire by organizing themselves. In that case, share of
profits can be given to organizations representing the patients, such as the
Canavan Foundation or the American Cancer Society.
In the corporate social model, material transfer agreements (MTAs) constitute
legal tools tailored to follow the management of intellectual property rights so as
to ensure the principle of benefit-sharing with donor institutions. First applied in
NPGRs, they extended to human genetic resources. The MTA can grant donor
institutions capacity to influence licensing decisions and can impose the sharing
of the royalties accruing initially to the user with the source institution. It can
also provide for data-sharing and for appropriate opportunities for source country
researchers to conduct research and receive training in the foreign collaborating
institution (non-monetary benefits).69

2. Need for a global authority?

The CHM postulates that the regulation of access and share of benefits is in
the hands of a third entity, independent from the stakeholders. Originally the
CHM model is centralized, i.e. implemented by a global authority. It is the
example of the Law of the Sea which sets up the International Seabed Authority
in charge with the licensing and regulation of mineral exploration and
exploitation of the deep sea bed. Another model is the Scientific Committee of
Antarctic Research for Antarctic, which to some extend is associated to the
CHM.

68
There is as technological uncertainty as to the protection afforded by the process of
anonymisation. See M. Tallacchini, Rhetoric of anonymity and property rights in human
biological materials (HBM) (2005) 22 Law and the human genome review, 152-175.
69
R. Kneller, see note 64.

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By analogy, a global authority could be put in place to supervise genetic

research. In order to adjust the CHM model to the protection of individual
rights and interests, it was proposed a system complementary to the model of
local research ethics committees: an international agency would supervise
activities of national, regional or international biobanks.70 This would constitute
a step forward compared to the current model in which an ethics committee is
created to tackle social, legal and ethical issues that could raise the project (e.g.,
the Human Genome Organisation (HUGO) ethics committee for the Human
Genome Project and the UK ethics committees for the UK biobank). HUGO,
which has recently been urged to step up the role of a UN for the human
genome71 is an organization well-positioned to take on this responsibility.
Another alternative is to standardize the existing multicentre research ethics
committees so as to ensure a decentralized, but rationalized, implementation of
the CHM.
Finally, besides institutionalization, whether centralized (global authority) or
decentralized (multicentre research ethics committees), proposals are made to
create a global fund to dispatch benefits and that profit-making entities dedicate
a percentage (i.e. 1-3%) of their annual net profit to healthcare infrastructure
and/or to humanitarian efforts.72
To conclude, bioethical assets shape the legal treatment of HGR. The solution
proposed at the international level with the CHM model is a trump card to
override the human rights-based approach and to operationalize the principle of
benefit-sharing, end in itself, through the control of independent authorities.

CONCLUSION
Beyond the divide between property and no-property rights paradigms, the
rational underpinning and implementation of the principle of benefit-sharing in
HGRs and NPGRs invite delving into a twofold cross-fertilization.
Firstly, human rights law expands as to support the principle in the treatment
of the two kinds of genetic resources. Complementary to property rights in
NPGRs and alternative to equity in HGRs, the right to self-determination

70 M. Deschnes, Le suivi de lthique des projets de recherche en gntique (2004) 35 Revue

de droit de lUniversit de Sherbrooke, 199. The author also proposed that a statutory data
protection commission should be in charged with the data management. Ibid., 202.
71 HUGO-A UN For the human genome (2003) 34 Nature genetics, 115-116.
72
HUGO Ethics Committee statement on benefit-sharing, 9 April 2000. B.M. Knoppers,
Genetic benefit-sharing (2000) 290 Science, 49.

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supports the principle of benefit-sharing in NPGRs and HGRs. In both cases, it

goes beyond its original political understanding to meet the needs of the
individuals and of the community. The evolution of the concept goes hand in
hand with the growing adoption of the rights-based approach in the different
branches of international law and the two mutually strengthen each other.
Secondly, as to the implementation of the principle, the WHO in its 2002 report
entrusts national governments with the task to consider the sharing of benefits in
relation to the interests of its peoples in HGR as well as NPGR: the state, direct
beneficiary or not of the principle of benefit-sharing, would be the mandatory
intermediary to ensure the realization of the principle. At first glance, this moves
away the summa divisio between CBD model and the CHM model. Unlike the
CBD, which acknowledges state sovereignty and lets the state decide about
ownership, the CHM for HGRs, without denying state sovereignty, rejects state
ownership. But the borderline between the CHM and the CBD is rather tenuous when
it comes to decide how much exactly state intervention is needed. In the CBD model
for NPGRs, the state acts both in its own interest and in humanitys interest. By
contrast, the CHM in HGRs dictates that a third party, independent from the
stakeholders, controls the application of the benefit-sharing principle but does not
necessarily bypass the role of the state as a regulatory authority to organize the
control. The different understandings of CHM for NPGR, i.e. free access, and HGRs,
i.e. controlled access, evidenced the fluctuating content of the legal regime of the
CHM. And that is the reason why the WHO report is allowed to apply ones
regulatory framework to the other, notwithstanding the difference of legal treatments.
To be sure, the state is called to act as a supervisor of the bioprospecting
undertakings and protect the rights of the citizens within its boundaries without
discouraging research and/or potentially lucrative investments in its resources, be
it natural plant or of human nature. This is particularly topical today with the
accelerated movement on indigenous rights protection: indigenous peoples being
often stewards or tissue-sources of the material are vulnerable with regards to the
utilization of the resources they manage/conserve or provide, and the state is
therefore called to fulfill its role in the enforcement of the international human
rights norms. At the same time, the increasing role on the private sector in
development initiatives should be advanced by laying down a fertile investment
environment, where the state oversees and intervenes when human rights
violations block the realization of the benefit-sharing principle.
This paper was an attempt to scrutinize the theoretical construction and legal
reasoning today that call for the establishment of the benefit-sharing principle in
modern biotechnologies; in doing so it pointed at the machinery and the actors. The
next step is to assess the amount and determine the content of the compensation,
but this requires further research.
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