Books, Drugs and Seeds: the Politics of Access
Susan K. Sell
Professor of Political Science and International Affairs
George Washington University
Comments welcome: susan.sell@gmail.com
Prepared for the Transatlantic Consumer Dialogue, “The Politics and Ideology of
Intellectual Property”, March 20-21, 2006, Brussels; and the International Studies
Association annual meeting, San Diego, March 22-26, 2006.
Books, Drugs and Seeds: the Politics of Access1
Abstract
In recent years developing countries, NGO activists, multinational corporations and their
home countries increasingly have clashed over intellectual property policies. All
intellectual property is not alike; for example, one could argue that movies and compact
discs are not core components of economic development. One could not make that case for
books, drugs and seeds. Access to educational materials (including scientific and other
scholarly journals and educational software), life-saving medicines, and seeds for
sustainable agriculture is the sine qua non of economic development. Education, health and
food security are central components of economic development, yet the strong trend
toward transforming these into private commodities for sale at premium prices through
higher levels of intellectual property protection has made them less available to those who
need them most. This paper examines the “North-South” politics of access to these
essential inputs by analyzing the politics of multilateral and bilateral negotiations
surrounding patent and copyright policies pertaining to books, drugs, and seeds. In
particular, it identifies the structural features, the key actors and coalitions in each sector,
and the multilateral institutions and bilateral treaties shaping the politics of access. It
compares progress in each of these “access campaigns” and speculates about possible
strategies that developing countries might use to increase access to books, drugs and seeds.
Earlier versions of pieces of this argument have appeared as: Susan K. Sell, 2004. “The Quest for Global
Governance in Intellectual Property and Public Health: Structural, Discursive, and Institutional Dimensions”
Temple Law Review 77:2: 363-399; and Susan K. Sell, 2004. “What Role for Humanitarian Intellectual
Property? The Globalization of Intellectual Property Rights” Minnesota Journal of Law, Science &
Technology 6:1: 191-211.
1
Acronyms
ABIA
AIDS
BIO
CBD
CGIAR
COP
CPTech
DMCA
DNA
DRM
EC
EU
FAO
FTAA
GATT
GURTs
HAI
HIV
IATP
IGC
IIPA
IIPI
IMF
IP
IPR
IPC
IUPGR
MSF
NAMA
NGO
NIH
NIEO
OAPI
OECD
PBRs
PCT
PGR
PhRMA
PTO
SPLT
TK
TRIPS
UNCTAD
American BioIndustry Alliance
acquired immunodeficiency syndrome
Biotechnology Industry Organization
Convention on Bio-Diversity
Consultative Group on International Agricultural Research
Conference of the Parties (CBD)
Consumer Project on Technology
Digital Millennium Copyright Act
deoxyribonucleic acid
digital rights management
European Community
European Union
Food and Agriculture Organization
Free Trade of the Americas Agreement
General Agreement on Tariffs and Trade
genetic use restriction technologies
Health Action International
human immunodeficiency virus
Institute for Agriculture and Trade Policy
Intergovernmental Committee on Intellectual Property, Genetic Resources,
Traditional Knowledge and Folklore (WIPO)
International Intellectual Property Alliance
International Intellectual Property Institute
International Monetary Fund
intellectual property
intellectual property right
Intellectual Property Committee
International Undertaking on Plant Genetic Resources (FAO)
Medecins sans Frontieres
Non-agricultural market access
non-governmental organization
National Institutes of Health (US)
New International Economic Order
Organisation Africaine de la Propriete Intellectuelle
Organization for Economic Cooperation and Development
Plant breeders’ rights
Patent Cooperation Treaty
plant genetic resources
Pharmaceutical Research and Manufacturers Association
Patent and Trademark Office (US)
Substantive Patent Law Treaty
Traditional Knowledge
Agreement on Trade-Related Aspects of Intellectual Property Rights
United Nations Conference on Trade and Development
4
UNDP
UNESCO
UNHCHR
UNICEF
UPOV
USDA
USTR
WHA
WHO
WIPO
WTO
WWF
United Nations Development Program
United Nations Educational, Scientific and Cultural Organization
United Nations High Commissioner on Human Rights
United Nations Children’s Fund
Union for the Protection of New Varieties of Plants
United States Department of Agriculture
United States Trade Representative
World Health Assembly
World Health Organization
World Intellectual Property Organization
World Trade Organization
World Wildlife Fund
5
INTRODUCTION
In recent years developing countries, NGO activists, multinational corporations and
their home governments increasingly have clashed over intellectual property policies. All
intellectual property is not alike; for example, one could argue that movies and compact
discs are not core components of economic development. One could not make that case for
books, drugs and seeds. Access to educational materials (including scientific and other
scholarly journals and educational software), life-saving medicines, and seeds for
sustainable agriculture is the sine qua non of economic development. While education,
health and food security are central components of economic development, the strong trend
toward transforming these into private commodities for sale at premium prices through
higher levels of intellectual property protection has made them less available to those who
need them most. This paper examines the “North-South” politics of access to these
essential inputs by analyzing the politics of multilateral and bilateral negotiations
surrounding patent and copyright policies pertaining to books, drugs, and seeds. In
particular, it identifies the structural features, the key actors and coalitions in each sector,
and the multilateral institutions and bilateral treaties shaping the politics of access. It
compares progress in each of these “access campaigns” and speculates about possible
strategies that developing countries might use to increase access to books, drugs and seeds.
The dramatic expansion of intellectual property rights threatens to reduce access to
life-saving medicines, essential crops and educational materials. For example, intellectual
property policies have contributed to the high cost of essential medicines, keeping them
out of reach of the world’s poor. Similarly, while advances in biotechnology may
potentially enhance the nutritional content of basic crops (i.e., vitamin A-enriched "golden
rice")2, regulatory trends and new technologies threaten to reduce access to such
innovations for those who need it most. While the age of the Internet has increased
potential access to educational materials, the digital divide notwithstanding, digital rights
management technologies have hampered access to such materials. “The institution of
property is extremely complex, and more importantly, political” (Aoki, 2003: 317). Yet we
are no closer to resolving these controversies. “More often than not, rather than being an
answer, the issue of property rights is only the beginning of a long series of vexing
questions” (Coombe, 1998: 59).
This paper begins by outlining what is at stake in these debates. It goes on to
2
Leaving aside the highly contentious issue of genetically modified organisms
6
discuss parallels between books, drugs and seeds and highlights how intellectual property
protection can be an obstacle to access. The next section surveys the structural, discursive
and institutional dimensions of the politics of access. The section on institutions addresses
the debate over the role of the World Trade Organization (WTO) in relation to other
international organizations. It then surveys intellectual property policymaking in the World
Intellectual Property Organization (WIPO), the United Nations Food and Agriculture
Organization (FAO), the Convention on Biological Diversity (CBD), the United Nations
High Commissioner on Human Rights (UNHCHR) and the World Health Organization
(WHO). The paper then concludes by addressing both obstacles to and opportunities for
increasing access to books, drugs and seeds.
WHAT IS AT STAKE?
At the global level, the most important international public law governing
intellectual property rights is the 1995 Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS) administered by the World Trade Organization (WTO). Unlike
most international law, TRIPS is binding and enforceable. The WTO may authorize states
to sanction those found to be in violation of the agreement. TRIPS reflects the interests of
intellectual property owners. Indeed, its very existence and much of its substance owe
much to just a handful of global firms based in the United States (Braithwaite and Drahos,
2000: 12; Matthews, 2002: 7; Sell, 2003: 75). TRIPS extends patent rights for twenty
years, requires developing countries to offer patent protection for pharmaceuticals, sharply
circumscribes the conditions under which states may issue compulsory licenses, and
reduces states’ autonomy in crafting domestic intellectual property policies that suit their
diverse levels of innovation and economic development. From the standpoint of economic
development and technology transfer, TRIPS represents the most challenging public
international law. In a sharply worded and bold critique, a United Nations Development
Program (UNDP) report stated that “‘[c]ountries at low levels of human technological
capability cannot benefit significantly from TRIPS . . . . Developing countries are not
likely to be even at least as well off under TRIPS as they would be outside it’” (McDowell,
2003). While some critics, such as the UNDP, call for TRIPS’s abolition, others argue that
it is workable for developing countries if interpreted appropriately (Reichman and Lange,
1998: 49-68). Everyone agrees that the short-term consequences will be massive resource
transfers from developing countries to owners of intellectual property. The World Bank
has estimated that TRIPS should yield an annual nineteen billion dollars for the United
States, whereas South Korea would sustain the largest loss – fifteen billion dollars
(Newfarmer et al. 2001:137.)
Countries that consume and import intellectual property will pay a higher premium
to those who produce and export it. Under TRIPS, countries have agreed that importation
of a product constitutes “working” the patent. However, importation represents only a
passive mode of technology transfer and once again raises concerns that firms will use
patents to maintain import monopolies. Those concerns had animated the earlier New
International Economic Order (NIEO) approach to patents (Sell, 1998: 28-29). Another
7
consequence of TRIPS is that it offers “hardly any incentive for the patentee to license his
technology. The technology holder can serve the large and small markets with his
enhanced rights without licensing the technology” (Verma, S.K., 2001: 344).
Overall, TRIPS reflects and promotes the interests of global corporations that seek
to extend their control over their intellectual property. These firms, acting through the
United States government (and with the support of Europe and Japan), largely captured the
WTO process and succeeded in making public international law to suit their particular
needs.
The rationale for intellectual property rights is that they provide incentives for
creation and the dissemination of innovation. Without the compensation made possible by
intellectual property rights, public goods will be underprovided. However, the merits of
granting exclusive rights to intellectual property owners have to be balanced against the
economic effects of higher product and transaction costs and the potential "exclusion from
the market of competitors who may be able to imitate or adapt the invention in such a way
that its social value is increased" (Trebilcock and Howse, 1995: 250). In short, intellectual
property rights reflect an inherent tension between creation and diffusion. Should
intellectual property rights be treated as "a public goods problem for which the remedy is
commodification, or a monopoly of information problem for which the remedy is
unfettered competition" (Boyle, 1992: 1450)?
The market-based, or commodification, justification for strong intellectual property
rights is that patents and licenses provide incentives to "increase the number of
commercially available products and thereby serve the public interest" (Lieberwitz, 2004:
782). However, it is important to ask which publics are served? In agriculture,
stakeholders include private sector seed companies, public corporations, research institutes,
and resource-poor farmers (UNCTAD-ICTSD, 2003: 108). In health, stakeholders include
non-generic pharmaceutical companies, generic pharmaceutical companies, public sector
health providers, and people who need health care. Rights-holders benefit, as do those who
have the resources to participate in the commercial market. But market-based solutions
alone fail to serve the poor and the marginalized, such as the millions afflicted with
HIV/AIDS in Africa and Asia and smallholder subsistence farmers in much of the global
South. Of the estimated 42 million infected with HIV/AIDS in the developing world, and
the 6 million with full-blown AIDS who need anti-retroviral treatment to stay alive, only
300,000 are receiving these drugs and 100,000 of them are in Brazil (Lamptey, 2003: 650).
Lettington observes that "approximately 75% of the world's undernourished are
smallholder farmers" (Lettington, 2003: 7). Furthermore, about 75% of sub-Saharan
Africa’s people are rural and depend upon agriculture for their livelihoods (Taylor and
Cayford, 2004: 280).
Market mechanisms to deliver innovation into the public domain fail spectacularly
in the oligopolistic markets of the contemporary life sciences industries. Indeed,
"international markets for technologies are inherently subject to failure due to distortions
attributable to concerns about appropriability, problems of valuing information by buyers
and sellers, and market power, all strong justifications for public intervention at both the
domestic and global levels" (Maskus and Reichman, 2004: 288). Therefore, the policy
8
challenge is where to strike the balance, and to explore options that may maximize the
benefits provided by intellectual property rights while minimizing the harms produced by
over-extension of such rights. In this regard, policymakers must make room for
humanitarian intellectual property policies that promote social goals such as protecting
public health, alleviating malnutrition, and promoting the development of human capital
though access to knowledge and educational materials.
WHAT DO BOOKS, DRUGS AND SEEDS HAVE IN COMMON?
What do books, drugs and seeds have in common? First of all, they are crucial to
life chances. Furthermore, access to these items has the potential to spur lasting
development and build capacity for innovation. For example, the World Health
Organization (WHO) has recognized this through its list of essential medicines that should
be available for public procurement (WHO), and the Food and Agriculture Organization
(FAO) has maintained a list of 35 staple crops that no one may own in order to facilitate
access. As Dutfield suggests, “to argue that imitation is an essential stage in learning to
innovate and – that it can even be creative in itself – is stating the obvious. Admittedly,
anybody with the right equipment can copy a music CD and will learn very little by doing
it. But copying a new medicine, especially a complex protein-based drug, is another story
entirely” (2005a).
Secondly, each of these sectors is characterized by marked economic concentration
that has only increased over the past several decades. The combination of expanded
intellectual property rights and relaxed anti-trust enforcement has led to economic
concentration in the life sciences industries. This situation has translated “economic power
into greater influence over policymaking that has hitherto been seen as the realm of the
public sphere” (Buse et. al., 2002: 261). In pharmaceuticals just since 1999, Zeneca
acquired Astra, Hoescht acquired Marion Merrel Dow, Sandoz and Ciba-Geigy merged,
Glaxo Wellcome and SmithKline Beecham merged, Pharmacia and Upjohn merged with
Monsanto, Sanofi-Syntelabo SA was the object of a hostile takeover by Aventis, and
Pfizer’s acquisitions made it the largest world company with revenues of $53 billion in
2004 (roughly 40% more than #2 GlaxoSmithKline) (Rosenberg, 2006: 65). The global
market shares of the largest non-generic pharmaceutical companies in 2003 were as
follows: Pfizer, 11%; GlaxoSmithKline, 6.9%; Merck & Co. 5%; AstraZeneca, 4.8%. and
Johnson & Johnson, 4.7% (Rosenberg, 2006: 69). The vertical integration of plant
breeding, agrichemical and food processing corporations led to a situation by the late
1990s in which "the top ten seed companies . . . control[led] 30 percent of the world's
US$23 billion commercial seed market" (GAIA/GRAIN, 1998a: 13). Corporate plant
breeders are obtaining broad patents that will have far reaching consequences. Breeders are
patenting entire species (cotton), economic characteristics (oil quality), plant reproductive
behavior (apomixis) and basic techniques of biotechnology (gene transfer tools)
(GAIA/GRAIN, 1998a: 13). Six major industrial groups now control most of the
technology "'which gives freedom to undertake commercial R&D in the area of GM
crops". These are (i) Agrevo and Plant Genetic Systems (PGS); (ii) Du Pont and Pioneer;
(iii) ELM, DNAP, Asgrow and Seminis; (iv) Monsanto, Calgene, DeKalb, Agracetus, PBI,
9
Hybritech and Delta and Pine Land Co.; (v) Novartis; and (vi) Zeneca, Mogen and Avanta"
(Dutfield, 2003a: 170; see also Pistorius and van Wijk, 1998: 119-124). Furthermore, in
agro biotechnology six companies alone hold 75% of all US patents granted to the top 30
patent-holding firms: Monsanto, Du Pont, Syngenta, Dow, Aventis, and Grupo Pulsar
(Dutfield, 2003a: 154; see also Fowler, 1994: 146). Two multinational companies, Archer
Daniels Midland and Cargill control about 75% of the global cereals trade; while 50% of
the world’s coffee supply comes from smallholder farmers, 40% of global coffee trade is
controlled by just four companies (IATP, 2005: 3). “High levels of corporate concentration
mean most of the benefits of trade liberalization will be captured by multinational food
giants such as Cargill, Nestle and Wal-Mart rather than by farmers and exporters in
developing countries” (ActionAID, 2006: 12). This combination of economic
concentration with extensive and broad patenting means that a handful of global
corporations are making huge inroads toward control of the world's food supply and are
entangling farmers an increasingly complex web of licensing and royalty obligations.
Large mergers also have been the rule in the academic publishing industry, again
leading to further economic concentration. Since 1990 merger activity in this sector has
increased (Munroe, 2005). By 2001 the top ten scientific, technical and medical publishers
accounted for 63.4% of the industry; Elsevier Science’s share is 22.9%, Kluwer’s is 11.1%
and Thomson’s is 10.7% (Foer, 2005). Adding legal periodicals to the mix places Reed
Elsevier first with $8 billion in 2002 total earnings; Thomson second with $7.7 billion;
Wolters Kluwer third with $4.02 billion; Springer fourth with its 2004 earnings 880
million euros); Wiley fifth with $854 million; Blackwell sixth with $273 million, and
Taylor and Francis seventh with $236.4 million (Case, 2005). As Maskus and Reichman
suggest, "the natural competitive disadvantages of follower countries may become
reinforced by a proliferation of legal monopolies and related entry barriers that result from
global minimum intellectual property standards. Such external restraints on competition
could consign the poorest countries to a quasi-permanent status at the bottom of the
technology and growth ladder" (2004:2xx).
Third, the increasing commercialization of agriculture and medicine means that
developing country farmers and the diseases of the poor will be ignored by firms for sound
economic reasons (Dutfield, 2003c: 495). As a number of commentators point out, the
current system skews research towards rich and middle-income countries' markets and
sectors (Barton, 2003; Lettington, 2003; Rai and Eisenberg, 2003). In the public health
sector this means the neglect of tropical diseases in favor of cancer and so-called lifestyle
drugs (i.e., for obesity, balding, and erectile dysfunction). For example, only 13 of 1233
new drugs marketed between 1975 and 1997 were approved for tropical diseases. “As a
result, the rhetoric of strong intellectual property rights leading to innovation that meets
social needs rings particularly hollow in this setting” (Hammer, 2002: 888). In the
agriculture sector this means concentrating on developing crops unsuitable for subsistence
and smallholder farming and not pursuing research beneficial for less lucrative microclimates (Lettington, 2003). There are few private sector incentives to support basic
research “that offers only a long-run and uncertain benefit for industry, but is crucial for
society” (Barton, 2003: 17). Historically, seed companies preferred to develop hybrids
because farmers must purchase new hybrid seed every planting season (UNCTAD-ICTSD,
10
2003: 107). For plant varieties lacking this built-in biological protection, plant breeders
can appeal to Plant Breeders’ Rights (PBRs). PBRs have led to increased private
investment in agricultural research and have played an important role, particularly in the
development of ornamental plant varieties. PBRs "generally do not encourage breeding
related to minor crops in small markets" (UNCTAD-ICTSD, 2003: 106). As a result, the
private sector under-invests in crops and technologies suitable for smallholder farmers and
these public goods are underprovided.
Fourth, access to educational materials, drugs and seeds concerns the balance
between private rights and public obligations, private ownership and the public domain,
and commercial versus humanitarian objectives. Books, drugs and seeds are at the center
of a complex political dynamic between stakeholders. Like a three-dimensional
chessboard, the institutional and regulatory landscape of these politics is multilayered and
multifaceted. For example, just considering the intersection between public health, trade
and intellectual property, governance is complicated by the diverse institutions involved,
including the World Health Organization (WHO), the International Monetary Fund (IMF),
the World Bank, the World Trade Organization (WTO), and the World Intellectual
Property Organization (WIPO).
Global governance means devising, implementing, and enforcing policies in a way
that accommodates a broad range of stakeholders and publics. Challenges to providing
effective global governance that balances public interests with private rights include trade
pressures, economic coercion, multi-layered governance (i.e., local, national, bilateral,
regional, international), the complexity of intellectual property policy jurisdiction across
multilateral organizations, the simultaneous development of hard and soft law in diverse
venues with conflicting mandates and values, and unequal access to resources and
institutions. Among the central features of the quest for global governance in intellectual
property are the blurring lines between public and private, the increasing role of the private
sector in public policymaking, growing global inequality, constricted autonomy for the
weak, and the inappropriateness of “one-size-fits-all” policies for diverse contexts.
HOW INTELLECTUAL PROPERTY PROTECTION CAN BE AN OBSTACLE TO ACCESS
Intellectual property protection can be an obstacle to access in a number of ways. In
recent years intellectual property protection has been dramatically expanded, notably
through the WTO TRIPS but also in domestic, bilateral and regional agreements. The
baseline for property rights has moved quite far in the direction of private reward over
public access. Rights which used to be considered to be privileges or exceptions have
superseded obligations of rights holders to the public. A legitimate international
intellectual property rights regime must recognize the variegated constellation of interests
and abilities within and between countries. A one-size-fits-all approach makes no sense in
light of the historical record of economic development. If nations are to craft policies
appropriate to their levels of economic development and comparative advantages in
innovation and imitation, they must reclaim their autonomy. Every country that has
achieved significant levels of economic development began by treating intellectual
11
property policy as tool of public policy. At different historical moments particular state
and market actors have defined social efficiency as the public-regarding policy of
dissemination and competition. At others, different constellations of state and market
actors have defined it as protection and exclusion to encourage innovation (Sell and May,
2001: 472). To insist that all countries adopt high protectionist standards of protection
denies them the opportunity to pursue the public policy strategies that every “developed”
country enjoyed. Lax intellectual property protection, compulsory licensing, working
requirements, keeping certain sectors off-limits in terms of property rights and
discriminating against foreign rights holders were all key features of the developed
countries’ public policy strategies. Intellectual property rights should be the servant, not
the master, of broader public policy goals.
The combination of economic concentration and expanded property rights has
resulted in higher costs, especially in academic journals and pharmaceuticals. For instance
between 1984 and 2001, when the consumer price index of price increases across the
economy was 70%, the cost of library subscriptions to periodicals in law rose 205%, in
medicine, 479%, and in physics and chemistry 615% (Foer, 2005). Publishers have been
earning super profits as a result of their monopolies in academic publishing. Companies
have gained increased market share through vertical integration. Cargill is a good example
of this dynamic in the agricultural sector:
Cargill . . . runs a huge financial services unit, a seed and fertilizer business, is one
of the top three beef producers in the U.S. and runs a worldwide transportation
business. . . . The market power of companies such as Cargill leave producers as
price-takers, forced to accept whatever price Cargill and companies like it are
willing to pay. Farmers, the weakest link in the chain, are left accepting prices
below their cost of production year after year and cheap produce is dumped on
world markets, while corporate profits rise. (IATP, 2005: 8).
Patent thickets have been another important problem. Patent thickets have
proliferated, in which overlapping patent rights require those seeking to commercialize
new technology to obtain licenses from multiple patent holders (Carrier, 2003: 1090-1; see
also Rai and Eisenberg, 2003). For instance, when genomics researchers Peter Beyer and
Ingo Potrykus sought to make their vitamin A-enriched golden rice available to the
International Rice Research Institute (IRRI) they faced significant delays because the
technology underlying golden rice was divided among seventy patents held by thirty-two
organizations (Phillips, 2004: 181). The transaction costs delayed access for over a year
and a half. Additionally, patent thickets can create entry barriers for breeders of new
varieties in crop development. Breeders must build upon existing techniques and varieties
to develop new transgenic plant varieties. The breeder of a new variety may face a bundle
of property rights such as “plant variety rights, patents on plants, as well as several patents
relating to transformation technology, the selectable marker employed, the gene coding for
the protein, the promoter, and various regulatory elements and modifications needed to
express genes adequately in plant cells” (Pistorius and van Wijk, 1999: 148). If a rights
holder denies just one element of this package of technologies commercialization of the
new variety could be blocked (Pistorius and van Wijk, 1999: 148). Lettington worries that
private intellectual property rights could block public sector access to “innovations and
12
germplasm that may be adaptable to smallholder needs and conditions while also limiting
public research options due to concerns over unhindered distribution of the products of its
research” (Lettington, 2003: 8).
Firms seeking to lock in their market positions have also used contract law to
extend exclusivity beyond the life of the patent. Perhaps the most notorious such contracts
have been Monsanto’s technology use agreements. Monsanto held the patent on
glyphosate, a potent weed killer marketed as “Roundup”. Monsanto also had isolated a
glyphosate-tolerant gene and developed a variety of “Roundup Ready” (or glyphosatetolerant) crops. In 2000, Monsanto’s patent on glyphosate expired. Now that other firms
were free to manufacture and sell glyphosate, Monsanto sought to retain its marketing
advantages and protect its investment in glyphosate-tolerant plants. Monsanto developed a
technology agreement, a contract between the grower and Monsanto, that stipulated that as
a condition of purchasing Monsanto Roundup Ready seed the farmer was obligated to use
Monsanto’s Roundup herbicide, to implement an “Insect Resistance Management”
program using only Monsanto insecticides, and permit Monsanto to inspect the farmer’s
fields for potential seed pirating (Nachtigal, 2001: 58-61). Under these agreements farmers
are forbidden to save seeds. The grower may use the seed to plant only one crop “to be
sold for consumption by a Monsanto authorized commercial purchaser” (Nachtigal, 2001:
76). In effect, this prevents the farmer from choosing cheaper new forms of glyphosate
that appeared on the market after Monsanto’s patent expired.
New ways of blocking access to material have emerged in the copyright context.
The US Congress passed the Digital Millennium Copyright Act (DMCA) in 1998 that
gives legal recognition and protection of digital rights management (DRM). The software
and entertainment industry, music and film associations lobbied very hard for protection of
works disseminated over the Internet (Yu, 2004: 910). They prevailed over the vociferous
opposition of public interest advocates such as librarians, law professors, and electronic
civil liberties activists (Vaidhyanathan, 2001: 175). The DMCA offers broad protection for
digital works. As Reichman and Uhlir pointed out:
In effect, the DMCA allows copyright owners to surround their collections of data
with technological fences and electronic identity marks buttressed by encryption
and other digital controls that force would-be users to enter the system through an
electronic gateway. To pass through the gateway, users must accede to nonnegotiable electronic contracts, which impose the copyright owner’s terms and
conditions without regard to the traditional defenses and statutory immunities of
copyright law (2003: 378).
Further, the DMCA prohibits circumvention of any technological protection against
copying and prevents the production of any device or provision of any service designed to
defeat protection mechanisms. As Vaidhyanathan argued, for the first time the law “puts
the power to regulate copying in the hands of engineers and the companies that employ
them. It takes the decision-making power away from Congress, courts, librarians, writers,
artists, and researchers” (2001: 174). The use of DRM presents a major challenge to
previous practices regarding fair use or, in European terms, fair dealing. Fair use refers to
the uncompensated use of copyrighted material for private, educational or research use. It
13
seems likely that the deployment of DRM technologies will consolidate or even worsen the
uneven distribution of information and knowledge across the digital divide.
The report by the Commission on Intellectual Property Rights (that the British
Department for International Development commissioned) concluded that for developing
countries, “where Internet connectivity is limited and subscriptions to on-line resources
unaffordable, [DRM technologies] may exclude access to these materials altogether and
impose a heavy burden that will delay the participation of those countries in the global
knowledge-based society” (Commission on Intellectual Property Rights, 2002: 106). The
extra controls that subscription online services and copy-protected products allow content
owners serve to diminish the hard won compromises for users embedded in doctrines of
fair use and fair dealing (May and Sell, 2006: 184).3
It is not just law that can create access barriers. Access blocking technologies are
proliferating rapidly in the current environment. In addition to DRM technologies that are
protected by law, in the agricultural sector access barriers can exist within the seed itself.
The classic blocking technology from the agricultural sector is of course hybrid seed.
Hybrid seeds do not breed true to type. A farmer using hybrid seed one year will have to
purchase new hybrid seed for the next. The advent of hybrid technologies in the 1920s led
to the first major push for property rights in seeds (Fowler, 1994: 52). 1998 ushered in a
revolutionary change when Delta and Pine Land, a subsidiary of Monsanto, along with the
US Department of Agriculture (USDA) obtained a patent on a copy-protection technique
for plants – not unlike DRM in the digital environment. Genetic Use Restriction
Technologies (GURTs), a.k.a. “Terminator” technologies, block the plant from replicating
itself by rendering harvested seeds sterile. It is a strategic business technology designed
“to prevent farmers from replanting saved seed and thereby undercut seed company
monopolies” (Dutfield, 2003c: 491). Like DRMs it expands the rights holders’ control of
the technology beyond the scope of the law (fair use limits in the former case, patent terms
in the latter). Syngenta, DuPont and BASF have been granted or have applied for patents
for GURTs in 2003, indicating industry support for pursuing this route to protect seeds
from unauthorized replication (van Wijk, 2004: 122). Both the USDA and Delta and Pine
Land seek to expand the use of GURTs to increase the proprietary value of US-owned seed
companies and to open developing country markets. According to Harry Collins of Delta
and Pine Land, co-owner of the patent with the USDA, the patent “’has the prospect of
opening significant worldwide seed markets to the sale of transgenic technology for crops
in which seed currently is saved and used in subsequent plantings’” (quoted in Dutfield,
2003c: 493). However, if yields from GURT-protected seeds are disappointing, and require
greater dependence on expensive agrichemical inputs “then farming communities could
suffer both financially and nutritionally” (Dutfield, 2003c: 494).
STRUCTURAL, DISCURSIVE AND INSTITUTIONAL DIMENSIONS OF THE POLITICS OF
For instance, End User License Agreements (EULAs) set ‘’copyright-plus’ use conditions on publications.
EULAs on private software often forbid reverse engineering and other actions that copyright law permits”
(Busaniche, 2005),
3
14
ACCESS
The development of intellectual property policy is shaped by developments in three
dimensions: structural, discursive, and institutional. The structural dimension is
characterized by glaring economic and political power asymmetries between developed
and developing countries and between the haves and the have-nots in all countries. The
discursive dimension involves agenda setting, framing and linking issues and promulgating
ideas to mobilize others for change. The institutional dimension highlights the wide and
diverse array of organizations charged with addressing intellectual property issues.
The structural dimension has fostered the ascendance and consolidation of the
global life sciences industries in health and agriculture, and the publishing industry. Battles
between commercial and social agendas in intellectual property are hardly waged on a
level playing field. Given acute power asymmetries, what are the possibilities available to
the weak through discursive and institutional strategies? One of the more striking aspects
of the current global order is the fact that governance exists at multiple levels and in
multiple forums. This is a double-edged sword insofar as it makes governance more
complicated, but it also offers flexibility and new opportunities to shape governance. The
“weak” must become adept at playing the multi-level, multi-forum governance game. As
Laurence Helfer has pointed out, governments, non-governmental organizations (NGOs),
and commercial actors are engaging in “regime shifting” that reveals “an acute awareness
by government officials, international secretariats, and non-state actors of the fluidity of
lawmaking processes, and reveals such actors’ keen ability to assess the comparative
institutional advantages offered by different negotiating fora for achieving particular goals”
(2004: 71).
Furthermore, stakeholders are fomenting and exploiting “strategic
inconsistencies” between institutions, norms and rules to press for different approaches to
problems (Raustiala and Victor, 2003: 25).
Deftly advancing different types of arguments and mobilizing different players in a
variety of international institutions, these actors have begun to alter rules and procedures
that affect health, agriculture and access to educational materials. What are the
relationships among various international organizations? What perspectives do they
promote? Who is defining and shaping these perspectives? When these perspectives
conflict, what perspective prevails and why? Are international organizations roughly equal
or do they exist in strictly hierarchical relation to each other? How malleable are these
relationships? Can discursive and institutional strategies alter these relationships?
Global intellectual property rules in the WTO emerged from a vigorous corporate
campaign to link intellectual property and trade. This campaign employed economic
expertise, effective discursive strategies, and forum shifting to persuade the United States
government to redefine its interests in intellectual property protection (Sell, 2003). The
result was a dramatic global expansion of protections for rights holders and penalties for
violators of intellectual property rights. In the wake of TRIPS, a vigorous civil society
campaign, working in concert with a number of developing countries, has mobilized to
protest this expansion of rights, particularly in the face of the HIV/AIDS pandemic. It
15
appears that the momentum that the public health activists have generated is contagious. In
the past several years the movement has broadened to include campaigns for access to
seeds4, educational materials, rights to food security, and rights for indigenous peoples,
and the recognition of the contributions of traditional knowledge. Arguing that intellectual
property should be construed as a human rights or development issue, rather than a trade
issue, these civil society campaigns have scored some victories in challenging the
corporate perspective. These campaigns seek to limit the expansion of intellectual
property rights and reduce such rights for essential medicines, seeds and educational
materials in an effort to contain costs and increase access. TRIPS opponents, consisting of
consumer groups, NGOs, and a number of developing country governments, have used
“counter-experts” to challenge the trade-based conception of intellectual property rights in
favor of a humanitarian perspective. The corporate TRIPS architects have been forced to
respond to this challenge and engage the debates of the civil society and developing
country groups.
The contest among these competing knowledge networks is raging in the WTO
over diverse interpretations of TRIPS. Moreover, it is animating deliberations in the
WHO, WIPO, the FAO, CBD, and the UNHCHR. Governance in this area is complicated
by the fact that different groups are scoring “victories” in some venues, while opposing
groups are scoring “victories” in other venues. For instance, while the access to medicines
agenda has moved forward in both the WHO and the WTO, industry and those favoring
TRIPs-Plus standards have tried to move forward with the Substantive Patent Law Treaty
(SPLT) deliberations in WIPO which threaten to reverse any gains achieved in other
forums. The United States, at the behest of non-generic pharmaceutical firms,
agrichemical companies and copyright-based industries is pursuing an aggressive course
of bilateral and regional intellectual property and investment agreements that threaten to
undermine any broader gains for developing countries seeking access to drugs, seeds and
educational materials.
Examining structural, discursive and institutional dimensions of the quest for
humanitarian global intellectual property governance helps to highlight both the obstacles
to, and the opportunities for, advancing humanitarian or social concerns over competing
commercial values when necessary. The international organizations dealing with
intellectual property issues are embedded in a broad structural context of unevenly
distributed political and economic power. “[P]olicy content has been closely aligned with
global shifts in power and influence among key policy actors” (Buse, 2002: 256). The
structure of the organizations varies in reflecting these inequalities. For example, an
organization like the IMF mirrors unequal power relationships with weighted voting
according to monetary contribution, whereas the United Nations General Assembly’s onenation one-vote system formally obscures these inequalities. Furthermore, one of the
major developments in the health sector has been “the rapid growth of public-private
partnerships in recent years [that] has given the private sector unprecedented entrée into
policy-making circles in national governments and key organizations such as WHO,
UNICEF, and the World Bank” (Buse, 2002: 262). Access to and participation in various
As I demonstrate later in the paper the “seed wars” predated TRIPS, but in the wake of TRIPs the earlier
Farmers’ Rights movement has broadened to include Traditional Knowledge.
4
16
organizations is uneven, and the costs of participating in venues such as the WTO can be
prohibitive for those without substantial resources (Shaffer, 2004a).
Discursive dimensions are also important. Information plays an important role in
the policy process. However, information is not knowledge (Comor, 2001: 393). Given
bounded rationality, actors employ filters to identify useful and interesting information
(Jones, 2001: 26, Tversky and Kahneman, 1981: 435). People transform information into
knowledge by employing different normative frames. Frames are “specific metaphors,
symbolic representations, and cognitive cues used to render or cast behavior and events in
an evaluative mode and to suggest alternative modes of action” (Zald, 1996: 262). Since
agenda-setting and advocacy involve both the provision of information and normative
frames, they crucially influence policy debates and outcomes (Sell and Prakash, 2004:
145). For instance, casting intellectual property as a trade issue has very different
implications than framing it as a food security, public health or human rights issue.
According to John Braithwaite and Peter Drahos, “webs of dialogue” can be an important
source of change in international politics. “Webs of dialogue” or “webs of persuasion”
describe efforts in which actors seek to alter others’ interests. As they suggest, “[i]ssue
definition is the first form of persuasion delivered by dialogic webs that is a prerequisite
for a global regime” (Braithwaite and Drahos, 2000: 553). Indeed, in their survey of
global business regulation, they conclude that webs of dialogue catalyze change much
more frequently than do webs of coercion.
Global governance in intellectual property protection, as exemplified by TRIPS in
the WTO, has come about by the mechanism of coercion (Abbott, 2002a: 469). However,
in the aftermath of TRIPS, and the contest between those who frame intellectual property
as a trade issue and those who frame it as a human rights and access issue, webs of
dialogue are becoming increasingly important. As Braithwaite and Drahos point out,
“[d]ialogic webs offer individuals the possibility of micro action to secure macro change”
(Braithwaite and Drahos, 2000: 7). Competing knowledge networks participate in dialogic
webs in their efforts to define issues, persuade others to redefine their interests, and inject
normative commitments that shape prescriptions and seek to persuade others that
“compliance is morally right” (Braithwaite and Drahos, 2000: 553). Authors working in
the rational choice tradition focus on processes given preferences. As Patrick Jackson has
pointed out, rationalist accounts are silent on the issue of legitimacy; “[w]hat vanishes
from sight . . . are any notions of persuasion, learning, reflective reconsideration, or any of
the other activities that go on when a leader tries to render a policy acceptable to an
audience” (Jackson, 2002: 735, 744). Authors concerned with questions of legitimacy and
negotiation processes focus on the content of actors’ beliefs and principled argument
(Albin, 2001: 1-3; Coleman and Gabler, 2002: 481; Crawford, 2002: 11-14; Keck and
Sikkink, 1998: 1-8;; Muller, 2001: 160). Principled argument used in dialogic webs has the
potential to alter actors’ interests and outcomes. While coercion is a viable weapon of the
strong, principled argument can be a potent asset for the weak to bring about desired
change—especially when coupled with the strategic use of institutions. As two critics of
the access campaigns stated, “if ideas matter, then the proponents of the New International
IP Agenda should be considered formidable. The NGOs pushing this agenda are wellfunded, well-organized and smart. They are also persistent, as they have proposed to curtail
17
intellectual property rights in one international forum after another, even where IP was not
the main issue” (Schultz and Walker, 2005: 82).
The institutional dimension concerns the broad range of different multilateral
institutions that are promulgating laws, declarations, resolutions, hard and soft law related
to global public health, agriculture and educational resources. These institutions reflect
competing conceptions of which values should be promoted. Since WTO law is binding
and enforceable, it is imperative to examine its role and its relationship to other institutions
to assess the prospects for and obstacles to global governance in intellectual property.
International law scholars also address the institutional dimension in a lively debate about
the boundaries of the WTO and the extent to which declarations, laws, and regulations
promulgated in other venues are relevant to WTO deliberations. It also addresses the
question of what role the WTO should play in resolving politically-charged value conflicts.
This issue is central to conflicts over intellectual property because a variety of different
international organizations have weighed in on the matter, and these organizations reflect
competing and conflicting conceptions of intellectual property. Competing values are at
stake both outside of and within the WTO. For example, WTO judicial panels hearing
cases involving pharmaceutical patent protection face
a major dilemma.
[They] cannot simply recognize a public good in interpreting the TRIPS
Agreement. [They] must rather take account of concerns over competing public
goods as reflected in the agreement’s provisions The ultimate issue in
choosing among the production of public goods becomes institutional because
different institutions offer different opportunities for actors to participate, affecting
which perspectives on the appropriate balancing are advanced (Shaffer, 2004a:
464).
This raises an urgent problem of which perspectives should have pride of place in
interpretations of states’ rights and obligations.
STRUCTURAL DIMENSIONS
The contemporary global intellectual property regime is embedded in a broad
structural context characterized by asymmetrical power relationships (Sell, 2003). Over the
past thirty years, the globalization of finance and the ideological shift represented in the
early 1908s by the Reagan and Thatcher revolutions' embrace of unfettered faith in the
marketplace has increased transnational corporations’ power vis-à-vis the state. States,
seeking to be globally competitive, have liberalized their markets, engaged in deregulation
and privatization, and have implemented new regulatory structures designed to promote
efficiency and enforce market-friendly behavior. According to Cerny, “the institutions of
the state itself are increasingly marketized or ‘commodified’, and the state becomes the
spearhead of structural transformation to international market norms both at home and
abroad” (Cerny, 2000: 304). States have increasingly commodified activities by putting
once-public activities into the market. Prominent examples include the privatization of
prisons, hospitals, military support services, and even “mission-critical” functions such as
providing protection for head of the Coalition Provisional Authority, L. Paul Bremer III, in
18
the U.S. occupation of Iraq. The expansion of intellectual property rights, and the
privatization of federally funded research under the Bayh-Dole Act5, must be seen as an
instance of this larger trend.
These broad economic changes have had profound effects on developing countries.
Earlier models of economic development such as import-substituting industrialization
once-popular in Latin America and India became discredited through economic stagnation
and the debt crises of the 1970s and 1980s. The success of the East Asian "Tigers"
vindicated export-led development and integration into global markets. Many developing
countries subsequently reversed decades-old policies of economic nationalism in favor of
market liberalization and privatization, and consequently slashed public budgets.
Developing country governments began to compete to attract foreign investment and eased
former restrictions of foreign investors' activities. The new push toward export-led growth
meant that developing countries needed access to industrialized country markets. Their
trade dependence upon such countries, particularly the United States, gave the United
States considerable economic leverage over developing countries seeking access to its
large market. Using Super 301 of the U.S. Trade Act, the USTR, at the behest of hightechnology firms, threatened trade sanctions against developing countries unless they
adopted and enforced highly protectionist intellectual property policies. Such economic
coercion was an important factor behind developing countries' ultimate acceptance of
TRIPS.
This liberalizing agenda favors finance capital and other mobile factors of
production (Baker, 2000: 364). Transnational firms in knowledge-intensive sectors such as
pharmaceuticals, chemicals, software, and entertainment "have the resources, motivations
5
The 1980 Bayh-Dole Act allowed “grantees to seek patent rights in government-sponsored research results”
(Rai and Eisenberg, 2003: 290). The idea behind this was that many inventions with commercial potential lay
fallow in university laboratories, and that patenting opportunities would give universities incentives to
“scour” research labs for significant and marketable inventions (Lieberwitz, 2004). This was part of a larger
governmental quest in the late 1970s and 1980s to pursue economic competitiveness vis-à-vis Japan in
particular. The Bayh-Dole Act has prompted a flurry of university patenting activity, at least a ten-fold
increase since 1979 (Rai and Eisenberg, 2003: 292). The Bayh-Dole Act has had beneficial effects in
generating revenue for cash-strapped public universities. For instance, the $300 million patent infringement
award that the University of Minnesota won for the development of the drug Ziagen has provided muchneeded funding for research and graduate student support. University patent portfolios also help to attract
private sector funding, especially in biotechnology.
However, the Bayh-Dole Act has also created new divisions within universities. As Rai and
Eisenberg point out, the legislation makes no distinction between upstream and downstream research, and as
a result more and more research tools have become patent-protected (2003: 290-1). An unintended
consequence of the Bayh-Dole Act has been the dramatic reduction of open access to research tools.
Technology transfer offices are charged with patenting and licensing technology to generate revenue for the
institution. Research scientists are more interested in having access to “open science” (Rai and Eisenberg,
2003: 305). In copyright, the parallel is between university presses seeking to generate revenue, and
educators seeking to maximize access to copyrighted works. Bayh-Dole has also increased university
collaboration with private sector biotechnology firms, and has raised many questions about academic
freedom, research priorities, and incentives. Some critics have gone so far as to assert that universities have
lost their sense of public mission (Lieberwitz, 2004).
19
and capabilities to roam the world searching for the kind of opportunities that promise
lucrative rewards" (Germain, 2000: 81). These privileged sectors participate in
“globalized” markets in so far as “there are a small number of participants who know one
another and operate across countries with a common conception of control” (Fligstein,
1996: 663). TRIPS reflected the wishes of these privileged sectors and globalized their
preferred conception of control by establishing a high standard of intellectual property
protection.
Beyond extending property rights, competitiveness concerns moved the United
States to relax its antitrust policies. The Reagan Administration codified this approach in
the Antitrust Division's Merger Control Guidelines of 1982. Reflecting the influence of the
Chicago School of Economics the new guidelines abandoned a populist focus on market
structure in favor of the Chicago school's focus on price theory. In this view anticompetitive business practices are those that reduce output and increase prices; business
practices that expand output are pro-competitive (Sell, 1998: 158). In contrast to earlier
approaches, according to the Chicago school, "high levels of market concentration and the
exercise of market power may be indicative of efficiencies" (Eisner, 1991: 105). The 1982
guidelines presented an expanded definition of relevant markets; this had permissive
effects. The guidelines allowed for the introduction of non-structural factors, such as
foreign competition or the possession of new technology that was important to long-term
competitiveness (Eisner, 1991: 198). The Justice Department argued that "anti-trust law
should not be applied in a way that hinders the renewed emphasis on competitiveness"
(Hoff, 1986: 19).
The consequence of this new thinking was to remove most intellectual property
licensing from antitrust scrutiny. Under the Reagan administration, "the executive agencies
viewed the economic incentives provided by intellectual property rights as legitimate
means of extracting the full economic benefit from innovation. Intellectual property rights
acted as a 'magic trump card' allowing many previously suspect arrangements to proceed
without challenge from the FTC or DOJ" (Hayslett, 1996: 382).
Furthermore, intellectual property rights have been dramatically expanded in recent
years to cover things such as computer programs, compilations of data, genes, entire plant
species, software algorithms, pharmaceutical products and processes, and “practices in
local agriculture, medicine and education which were outside of market relations” (Arup,
1998: 367-81; see also Correa, 2002: 550). This combination of relaxed antitrust policies
and expanded intellectual property rights has promoted economic concentration in high
technology sectors, and particularly in the life sciences industries As Maskus and
Reichman point out, “weak enforcement of antitrust laws then further reinforces the
barriers to entry erected upon this thicket of rights, while the need to stimulate and
coordinate investment in complex innovation projects justifies patent pools, concentrations
of research efforts, and predatory practices formerly thought to constitute misuses of the
patent monopoly" (Maskus and Reichman, 2004).The consequences include enhanced
political power of these industries, a reduction in the number of suppliers of certain kinds
of technology, a reduction in competition, and higher costs of technology. As Assad Omer
suggests:
20
Developing countries are confronted with the following dilemma: on the one side,
in order to attract more investment and technology they have to press to open up
their markets, and on the other side, the reduction of regulatory barriers gives rise
to the emergence of anti-competitive behaviour of firms (Omer, 2001: 312).
Even more ominously, Drahos and Braithwaite argue that:
The globalization of intellectual property rights will rob much knowledge of its
public good qualities. When knowledge becomes a private good to be traded in
markets the demands of many, paradoxically, go unmet. Patent-based R&D is not
responsive to demand, but to ability to pay. . . . Much of what happens in the
agriculture and health sectors of developed and developing countries will end up
depending on the bidding or charity of biogopolists as they make strategic
commercial decisions on how to use their intellectual property rights” (2002: 167168).
The structural power of global firms is reflected in the membership of key policy
making committees in US trade institutions. These committees assist US trade negotiators
in designing policies for multilateral, regional and bilateral trade. The United States Trade
Representative’s (USTR) agricultural Trade Advisory Committee represents these
corporations: Altria, Archer Daniels Midland, Blue Diamond Growers, Burger King,
Campbell Soup, Cargill, ConAgra, General Mills, Hershey Foods, HJ Heinz, Land O’
Lakes, Louis Dreyfus, McDonalds, Monsanto, Sunkist Growers, Sun Maid Growers, WalMart, and Yum! Restaurants.6 The USTR’s Industry Trade Advisory Committee on
Intellectual Property Rights includes representatives for Pfizer, Eli Lilly and Company,
PhRMA, Merck & Company, Inc., Biotechnology Industry Organization, Time Warner,
Inc., International Anti-Counterfeiting Coalition, Recording Industry Association of
America, Intellectual Property Owners Association, John Wiley and Sons, Inc., and
Association of American Publishers. None of these firms or organizations is pressing for
more balance between private rights and the public domain. The reach of these advisory
committees can be quite broad. For instance, ActionAid reported that the most influential
non-governmental organization in Brazilian agricultural trade policy is the Institute for the
Study of Trade and International Negotiations (ICONE). ICONE is supported by the
Brazilian Agribusiness Association that is funded by Cargill, Archer Daniels Midland,
Bayer, Monsanto and Pioneer Hi-Bred. “Issues such as protecting food security and poor
farmers’ livelihoods are not on its agenda” (ActionAid, 2006: 30). US-based firms work
with their subsidiaries abroad to develop support for their positions.
Structural features at the macro level shape the micro level, as manifest in the
under-provision of drugs for tropical diseases, public health budgets reduced under IMF
conditions, and the constrained ability of governments to meet public health needs.
“Increasingly [IP] rights have invaded the research commons itself and made it both costly
and difficult to obtain cutting-edge technologies needed for public health, agricultural
production, environmental protection and the provision of other public goods” (Maskus
6
Yum! Brands is a group of US fast food chains including Kentucky Fried Chicken, Pizza Hut and Taco
Bell. In January 2005 Yum! formed the Food Trade Alliance to lobby the American government to liberalize
agriculture in the WTO. The Alliance seeks the cheapest prices for farmers’ goods and the broadest market
access possible (ActionAid, 2006: 30).
21
and Reichman, 2004). Market incentives are insufficient for stimulating agricultural
products suited for smallholder farmers in developing countries. DRMS and monopolies in
academic publishing reduce access to educational materials. Weak regulatory frameworks
in low and middle income countries confronting global life sciences markets and
consolidated publishing markets leave their populations particularly vulnerable (Buse,
2002: 260).
Focusing on the formal features of intellectual property law, texts and institutions,
one sees plenty of room for state discretion and flexibility in adapting the global minimum
standards to local concerns. However, this formal universe is embedded in a system of
asymmetrical power relationships and global capitalism that constrain weaker states'
abilities to take advantage of the flexibilities crafted into the law. In both the medicines
issue and agriculture, developing countries have not taken full advantage of TRIPS
flexibilities. This is largely because they are eager to attract foreign investment and are
concerned about alienating potential foreign investors. They also are eager to have access
to technologies that may help them to further develop, provide reliable nutrition, and
address a myriad of pressing problems. Most of these countries lack significant bargaining
leverage and the capacity to resist the high-pressure tactics of the USTR and the industries
that it represents.
DISCURSIVE DIMENSIONS OF AGRICULTURE
The battle over agriculture revolves around a number of related issues. In
examining the regulatory environment the central question is how much discretion do
states have in limiting intellectual property rights to support smallholder agriculture and
environmentally sustainable agricultural practices? Critics of the increasing
commodification of what was once treated as the public domain have raised at least seven
issues of concern: 1) threats to traditional agriculture and food security ; 2) abuses of
monopoly power; 3) increased dependence on costly commercial agriculture; 4) threats to
biodiversity; 5) "biopiracy"; 6) questions of benefit sharing; and 7) the status of traditional
knowledge.
Agricultural issues attracted substantial attention in the early 1980s during the socalled “seed wars” in which activists protested patents on living organisms (such as plant
varieties) first in the US and Canada, and then in the Food and Agriculture Organization.
At that time activists expressed concern about genetic erosion and the dangers that
property rights in plant varieties posed to traditional farmers’ rights and smallholder
agriculture. Farmers’ rights to save and exchange seeds came under increasing attack with
expanded property rights over seeds and germplasm. In what Pistorius and van Wijk have
called the “third agro-food order” crop development conglomerates overtook the state in
dominating agricultural research, crop development and dissemination of seeds (1998:
105). Rather than emphasizing national food needs, these conglomerates emphasize saving
the world from food shortages (Pistorius and van Wijk, 1998: 125). Their conservation
strategies include securing long-term access to biological material and promoting
strengthened property rights to safeguard their R&D investments (Pistorius and van Wijk,
22
126). Large scale agribusiness promotes mono-cropping and uniform seeds that deplete the
soil over time and heighten dependence on the conglomerates to provide the seed and
inputs. Those opposed to IP protection and private rights over plant varieties fear their loss
of control over the use of their plant genetic resources. They fear that the use of their
traditional varieties may be prohibited if they carry genes covered by a patent (Pistorius
and van Wijk, 1998: 183). According to C. Montecinos, of the Centro de Educacion y
Technologia in Santiago Chile,
‘The only way to fight those [northern industrial] monopolies is by fighting megamarkets. This will happen when we reclaim diversified production systems based
on local resources and knowledge, when agriculture ceases to be an inputconsuming machine, when farmers reclaim the right to use and develop their own
technology, when we stop eating the same thing in Manila, Pittsburg and
Concepcion, and our health no longer depends on Monsanto and Ciba Geigy. This
will also be the only way in which indigenous peoples and farmers will become the
primary beneficiaries of what their societies have created and continue to create’
(quoted in Pistorius and van Wijk, 1998: 184).
While not all farm-oriented NGOs and indigenous peoples’ groups support this total
rejection of the monopolies, they do promote alternative agricultural production strategies
“directed at the autonomous improvement of subsistence conditions in the poorest rural
areas” (Pistorius and van Wijk, 1998: 184). They argue for support for organic farming,
low-input oriented farming, the use of landraces and on-farm saved seed, and biological
insecticides as viable alternatives (Pistorius and van Wijk, 1998: 194).
Biopiracy is a second major area of contention. In the lead-up to TRIPS American
and European negotiators invoked the language of “piracy” and “theft” to label what were
in fact perfectly legal practices by foreigners. Developing countries routinely were accused
of stealing American and European intellectual property. The rhetoric of biopiracy has
turned the “piracy” rhetoric back on industrialized countries (Shiva, 1997). It accuses them
of stealing the genetic diversity and genetic resources of the geopolitical South, patenting
these resources and/or traditional knowledge, and then selling the products back to them at
exorbitant prices. Activists also underscore the danger that the people who have used these
genetic resources and/or techniques for ages may be denied using them with the
introduction of property rights over these held by foreigners.
Another area of concern is the terms of access to such resources and whether
foreigners using these resources should be required to disclose the origin of the resources
in their patent filings. Many developing countries are pressing for disclosure requirements
and the establishment of a benefit sharing regime in which indigenous peoples would be
compensated for use of the resources and would be entitled to a share of any royalties
earned by commercializing the derived products. Finally, a number of developing countries
argue that traditional knowledge, including plant genetic resources, must be protected from
bio-pirates. While the means for doing so are highly controversial (Kuanpoth, 2006: 13952), some argue that they should assert intellectual property rights over traditional
knowledge and folklore. Others promote the establishment of databases to document and
catalog traditional knowledge to make it more transparent when it is included in a patent
application. This would assist patent examiners in establishing prior art. Still others reject
23
applying property rights and commodifying traditional knowledge at all.
Not surprisingly, the agrichemical and biotechnology industry has a different
perspective on the issues. The life sciences conglomerates resist any attempt at being
forced to include disclosure of origin in patent applications. They argue that it would
inject unacceptable levels of uncertainty into the process of commercializing
biotechnology. They argue that this uncertainty would have a chilling effect on investment
in bio-prospecting (Gorlin, 2006: 4). Industry views these agriculture issues as investment
issues. Since the 1980s when it linked intellectual property to trade, it underscored a strong
relationship between high levels of intellectual property protection and foreign investment.
Given that many developing countries are eager for foreign investment, industry leverages
this vulnerability to press its agenda (Correa, 2004: 345-46). It prefers contractual
approaches such as the Merck-InBio deal and the Novzymes/Biotec access and benefit
sharing agreement in Thailand (ABIA, 2005) in which firms underwrote bio-prospecting
programs and agreed to share a percentage of any royalties derived from
commercialization of the genes found.
Technological, judicial and legislative changes together have produced a radical
shift from public to private provision of seeds. As Aoki points out, “the private seed
market for grains was almost non-existent at the beginning of the twentieth century, due to
free government seed distribution and the widespread practice of farmer seed saving”
(Aoki, 2003: 268-9). Farmers traditionally have saved seeds and reused them. They traded
seeds with each other, sold seeds to each other, and created and experimented with new
hybrids. In these ways they have contributed to the planet's biodiversity. In the past, US
laws covering plant varieties incorporated the concept of farmers' rights in which farmers
retained their freedom to engage in these important and traditional activities. Legislative
changes extending property rights in plant varieties, such as the 1970 adoption of the
United States Plant Variety Protection Act, “increased the expectations of seed industry
profits and thereby helped to stimulate an upsurge in mergers and acquisitions” (Dutfield,
2003a: 149). Furthermore, in August 1994 the US Congress amended the Plant Variety
Protection Act and removed the farmer's exemption so that now “it is expressly illegal for
farmers to sell or save seeds from proprietary crop varieties without receiving permission
from breeders and paying royalties” (Shulman, 1999: 90). Ironically, according to Aoki,
the commodification of germplasm has transformed the US patent office (PTO), “which in
the early 19th century began to collect and catalog and make freely available seeds”, into
“by the beginning of the twenty-first century, a primary means by which the ages-old
practice of farmer seed-saving is under serious and vociferous legal attack” (Aoki, 2003:
331). In Aoki's words, “the intersection of biotechnical knowledge and methods and
expanded legal protections for plant breeders transforms seed germplasm into a paradigm
commodity” (Aoki, 2003: 261).
Life sciences corporations “emerged out of a wave of mergers, acquisitions, joint
ventures and strategic partnerships involving companies in a wide range of fields such as
chemicals, seeds, processed foods, dietary supplements and pharmaceuticals” (Dutfield,
2003a: 147-8). Advances in biotechnology spurred the consolidation process throughout
the 1970s and especially the 1980s. The 1973 development of the recombinant DNA
24
technique, which enabled foreign genes to be inserted into microorganisms, launched the
era of commercial biotechnology (Dutfield, 2003a: 138). It is noteworthy that while the
path breaking Cohen-Boyer method for combining DNA from different organisms was
patented, “the patents were licensed non-exclusively and cheaply to encourage firms to
take licenses rather than to challenge the patents” (Rai and Eisenberg, 2003: 300). This
technology had been federally funded, and “many observers attribute the rapid progress of
the biotechnology industry to the fact that this technology was made widely available
rather than licensed exclusively to a single firm” (Rai and Eisenberg, 2003: 300). In 1980
the US Supreme Court ruled in Diamond v. Chakrabaty (447 U.S. 1980) that a man-made
oil eating bacterium could be patented. This case led to the expansion of rights to own
living organisms and injected greater certainty into the development of commercial
biotechnology. The ability to acquire patents on altered life forms helped biotechnology
start-up companies to raise venture capital.
With the advent of genetic engineering, plant breeders sought even stronger
protection of their investments by pursuing patent protection. TRIPS ultimately placed
restrictions on patenting of life forms (to the dismay of the American biotechnology
industry). Article 27 permits the exclusion of plants and animals from patentability, but
27.3(b) requires that members provide protection for plant varieties or an “effective sui
generis” (uniquely tailored) system. However, there really is no consensus on what a sui
generis system needs to include, and as Sutherland points out, the negotiating history of
Article 27 provides little guidance because it provides no record of the meaning of sui
generis (Sutherland, 1998: 295). American intellectual property industry activists have
been pushing the Union for the Protection of New Varieties of Plants (UPOV) as the model
sui generis system. UPOV, to which fifty (UPOV 2002) mainly industrialized countries
subscribe, was last amended in 1991. The 1978 version of UPOV provided two limitations
on the monopoly rights of plant breeders. First, other breeders could freely use UPOVprotected varieties for research purposes. Second, farmers could reuse the seed for the
following year's harvest under certain conditions. The 1991 revision “narrowed down the
exemption for competing breeders and it deleted the so-called farmer's privilege... [It]
extends the breeders' monopoly right to the product of the farmer's harvest” (GRAIN,
1999: 2). “Although the UPOV system allows on-farm replanting, its rules restrict farmers'
freedom to buy seed from sources other than the original breeders” (UNCTAD-ICTSD,
2003: 107). UPOV91 “does not authorize farmers to sell or exchange seeds with other
farmers for propagating purposes” (Helfer, 2002: 17). Additionally, before the adoption of
UPOV91, plant breeders were forced to choose to protect their plant varieties with either a
plant breeder’s right (PBR) or a patent. UPOV91 “removed the 1978 Act's ban on dual
protection and now permits member states to protect the same plant variety with both a
breeders' right and a patent” (Helfer, 2002: 15). Grassroots activists are convinced that
American industries are seeking this same approach through TRIPS by pushing a particular
interpretation of sui generis protection under Article 27.3(b). Any country wishing to join
UPOV today must sign the 1991 treaty. It is very generous to the corporate plant breeder.
Countries eschewing the UPOV system, can adopt sui generis systems of protection that
allow “farmers to acquire PBR-protected seed from any source and/or requiring protected
varieties to display qualities that are genuinely superior to existing varieties” (UNCTADICTSD, 2003: 107).
25
A number of developing countries have favored a sui generis approach that protects
them from biopiracy and explicitly honors farmers’ rights. Laurence Helfer has analyzed
developing countries’ options under 27.3 (b) to assess how much policymaking discretion
follows from each option. States that adopt TRIPS and ratify or accede to UPOV91 have
the least policy flexibility (Helfer, 2002: 37). While corporate plant breeders would prefer
that developing countries adopt UPOV91 as their domestic legislative standard, these
countries are by no means required to do so. States wishing to retain maximum flexibility
and discretion to serve the needs of smallholder agriculture would be well advised to adopt
TRIPS only (Helfer, 2002: 37). As John Barton suggests, "the chances are that for a poor
nation, neither a UPOV nor a regular patent approach will actually encourage privatesector research. Hence, such a nation is probably best-off adopting minimum compliance
with TRIPS" (2003: 12).
TRIPS’ Article 27.3(b) preserves “significant leeway for national governments to
work out the precise manner in which they will balance protection of IPRs against other
international obligations and national objectives" (Helfer, 2002: 31). TRIPS, unlike
UPOV91, preserves the right for subsistence farmers to exchange seed. States are free to
incorporate both subsistence farmer exemptions and research exemptions in national plant
breeders’ rights legislation (Barton, 2003: 23-24). Countries wishing to adopt the stronger
UPOV91 system should consider incorporating waivers for subsistence farmers or
smallholder exemptions (Barton, 2003). In countries lacking in significant private sector
competition, as is often the case in poor countries, public sector seed provision will be
important to promote competition to stimulate both variety and lower prices (Barton, 2003:
14).
In developing countries a large number of farmers are smallholders, who do not
participate in the market sector in any substantial way. Indeed, in developing countries
“80% of the total seed supply is produced on farm” (van Wijk, 2004: 121). Smallholder
farmers engage in seed-saving, replanting, and "across-the-fence" exchange. This is
especially in countries (many in Africa) where neither the public nor the private sector
plays a significant role in producing or distributing seed" (UNCTAD-ICTSD, 2003: 107).
The smallholder farming sector plays an important role in contributing to national food
needs. "Small holder farmers produce fifty-one percent of Latin America's maize, seventy
seven percent of its beans and sixty one percent of its potatoes while in Africa they
produce the majority of grains and legumes and almost all root, tuber, and plantain crops"
(Lettington, 2003: 13). For example, in Peru between 50-60%, and in Kenya between 7080% of the population depends on smallholder agriculture for their livelihood (Lettington,
2003: 13).
In a comparative study of smallholder farming in Peru and Kenya, Lettington did
not find evidence that Plant Variety Protection (PVP) legislation harmed smallholder
agriculture. However, he argued that “the current system of PVP legislation is failing to
create solutions to existing problems” (Lettington, 2003: 32). In particular, it creates
incentives that direct energy away from catering to subsistence farmers' needs in favor of
26
large commercial agricultural enterprises. It also facilitates the promotion of the use of
commercial seed (as opposed to landraces or “wild” cultivars). “The end result has been a
hastening of the deterioration of food security in these areas” (Lettington, 2003: 34).
Lettington suggests that governments that seek to limit the cost of seed in economically
and climatically marginal areas may “need to place limits on the nature of intellectual
property rights” (2003: 34). Lettington recommends that:
The activities of smallholder farmers, in particular the saving, use, exchange, and
sale of farm-saved seed, should be explicitly stated as not subject to the rights of
intellectual property rights holders. In accordance with the purposes and
objectives of TRIPS, effort should be made to develop effective incentives for
research targeted at smallholder farmers.... Limited exceptions to intellectual
property rights should be permitted to promote the adaptation of protected
products to the needs of smallholder farmers. These should apply to both
research and development and to manufacturing and distribution (2003: 8).
DISCURSIVE DIMENSIONS OF HEALTH
The battle over access to essential medicines revolves around the rights to issue
compulsory licenses and to manufacture and export generic versions of brand name drugs.
Global brand name pharmaceutical corporations seek to restrict the ability of generic
manufacturers to produce and distribute essential medicines. African countries in the grip
of the HIV/AIDS pandemic, Brazil, India, and their NGO advocates seek to clarify
interpretations of TRIPS that permit compulsory licensing, parallel importing, generic
manufacture and export. The debate over TRIPS and access to medicines has galvanized a
broad range of stakeholders. Brand name pharmaceutical companies (a.k.a. global
pharma), developed and developing country governments, the USTR, NGOs representing
public health and consumer interests, and generic drug manufacturers are all participating
in this vigorous debate. Among the competing values embedded in TRIPS are the
generation of knowledge, the facilitation of “undistorted” trade, and the protection of
public health (Shaffer, 2004: 460).
On one side of the TRIPS and access to medicines debate are those who support
strong intellectual property protection for pharmaceuticals and argue that, if anything,
TRIPS is too weak. These advocates highlight the high costs of developing new drugs, the
importance of strong property rights as incentives for innovation, and the need for
substantial compensation for providing life saving drugs (Grabowski, 2002: 850-53). This
view is most prominently associated with the brand name global pharmaceutical industry,
the United States, and the USTR. It has also been influential in the WTO. The industry
fears that any expansion of cut-rate drugs will undermine its markets, particularly if they
find their way into high income industrialized country markets. Global pharma highlights
the potential health dangers of widespread generic production, “piracy,” and the use of
drugs without the supervision, dosing instructions, and regulatory controls covering global
pharma’s products (Symposium, 2002: 729).
27
Perhaps the most frequently offered argument from supporters of global pharma is
that the big problem is not patents but poverty (Calfee, 2003; Bate and Tren, 2003). This
view has been promulgated in industry-supported American think tanks such as the
American Enterprise Institute and the International Intellectual Property Institute (IIPI).
Roger Bate and Richard Tren presented their remarks at an American Enterprise Institute
forum on “unelected” NGOs. The United States-based Pharmaceutical Research and
Manufacturing Association (“PhRMA”), an industry-lobbying group, is hardly subtle about
its efforts to enlist academics to promote its cause. The Washington Post has referred to
these as “hall-of-mirrors techniques by which special interests amplify their arguments
through seemingly unconnected third parties” (Washington Post, 2003, June 9). For
example, for 2005, PhRMA budgeted $1 million for an:
[I]ntellectual echo chamber of economists – a standing network of economists and
thought leaders to speak against federal price control regulations through articles
and testimony.” It has set aside $550,000 “for placement of op-eds and articles
by third parties” and at least $2 million for outside research and policy groups “to
build intellectual capital and generate a higher volume of messages from credible
sources” backing industry positions. Overall, the group will devote $12.3 million
to “alliance development,” . . . with . . .economists, doctors, patients, and minority
groups (Washington Post, 2003).
PhRMA frequently cites a “Harvard study” that “proves” that patents are no
obstacle to access to antiretroviral medicines in Africa (Attaran and Gillespie-White, 2001:
1888-91). Amir Attaran was an adjunct lecturer in public policy at Harvard, and his
coauthor, Lee Gillespie-White, worked for a PhRMA-supported think tank International
Intellectual Property Institute (IIPI). The oft-cited paper originated as a study that PhRMA
commissioned with its think tank (IIPI) headed by Bruce Lehman, former United States
Commissioner of Patents (Abbott, 2002a: 485, n. 62). The United States trade delegation
relied on this then unpublished study in its Talking Points in late September 2001 in the
run up to the WTO Doha Ministerial meeting (Abbott, 2002a: 485).
Substantively, advocates of PhRMA’s position object to any weakening of
intellectual property protection through public health exceptions. They reject compulsory
licensing as a policy tool to bring the costs of essential medicines down. They reject
parallel importing (Symposium, 2002: 727), whereby states can take advantage of
differential pricing policies and import the cheapest version of the brand name patented
pharmaceutical product. Overall, they ardently oppose any efforts to weaken the
international system of intellectual property protection. Instead, they advocate increased
foreign aid, drug donations from firms, and “protection for international price
discrimination against the threat of ‘grey market’ arbitrage” (Bloche, 2002: 838).
On the other side of the debate is an alliance of developing country governments
and NGOs campaigning for access to essential medicines. They argue that patent
protection is a barrier to access and that public health exceptions to patent rules are
necessary to prevent needless deaths. They advocate compulsory licensing, generic
competition, and fixed rates of compensation for pharmaceutical companies.
28
Among the most outspoken advocates of this position are James Love of American
consumer activist Ralph Nader’s Consumer Project on Technology (CPTech), and Ellen ‘t
Hoen of Médecins Sans Frontières (MSF). They consistently have attacked PhRMA’s
positions on these issues. Ellen ‘t Hoen points to strong intellectual property protection as
one important barrier to access; she argues that patent protection leads to high prices and
limited access (‘t Hoen, 2002: 29). MSF and other NGOs have expressed a number of
concerns about TRIPS, including high drug prices, reduced availability of quality generic
alternatives, inadequate research and development into tropical diseases, and bilateral
pressures on developing countries to adopt patent protection that exceeds the requirements
of TRIPS (‘t Hoen, 2002: 29-30). Furthermore, Love has challenged PhRMA’s claims that
its companies spend $500-800 million developing each new drug. Love has argued that
the majority of important HIV/AIDS drugs were actually developed by the public National
Institutes of Health (NIH), and funded by taxpayers’ dollars (CPTech, 2000). Love and
others have also criticized the Attaran and Gillespie-White 2001 argument (Symposium,
2002: 732-5; CPTech et al., 2001).
Brazil, India, and the African group of countries have been leaders in the
intergovernmental efforts to address their public health emergencies. As José Viana, a
Brazilian trade delegate, remarked, “[t]he Brazilian government has consistently supported
the idea that public health should not be subordinate to abuses of economic power” (Viana,
2002: 311). Activists have praised Brazil’s policies of providing universal access to
HIV/AIDS drugs (Rosenberg, 2001: 26). Brazil has used the threat of compulsory
licensing7 to negotiate steep drug discounts with global pharma. It also has committed
resources to producing generic drugs. Its policies have helped to create a market for high
quality generic drugs (Symposium, 2002: 702). Creating a market has encouraged
competition that has brought HIV/AIDS drugs prices down from $10,000 to $150 a year
per patient.8 As a WHO report concludes, “[c]ompetition is perhaps the most powerful
policy instrument to bring down drug prices for off-patent drugs” (Abbott, 2002a: 472 n.
702). Above all, the access to medicines campaign endorses the right of developing
countries to compulsory license drugs, to produce and export generic drugs, and to take
advantage of parallel importing to seek out the lowest cost medicines.
INSTITUTIONAL DIMENSIONS:THE WTO
Ever since the Uruguay Round of trade talks ended in 1993, a number of World
Trade Organisation (WTO) members have pressed for clarifications of TRIPS. Developing
country members have engaged in sharply pitched battles with developed country
governments over broken promises and unfinished business.
TRIPS requires all WTO members to increase protection and enforcement of
intellectual property rights. When negotiating parties agreed to TRIPS it was part of a quid
pro quo in which developing countries agreed to high standard intellectual property
7
8
Seizing the patent
But see MSF on the continued high costs of second-line therapies, www.msf.org
29
protections in exchange for access to developed countries’ agricultural markets and the
liberalization of developed countries’ agricultural sectors. In the wake of the Uruguay
Round developed countries have failed to make good on their promises to cut domestic
supports for agriculture, while they aggressively have pursued WTO action against
developing countries for failure to implement intellectual property policies. They also have
pursued a vigorous campaign of bilateral and regional investment and trade agreements
that incorporate “TRIPS-Plus”9 standards of intellectual property protection. However,
Brazil successfully challenged the United States over its cotton subsidies; the WTO ruled
in Brazil’s favor in May 2004 (ICTSD: 7). Brazil is considering placing sanctions on U.S.held intellectual property (cross-retaliation) if the U.S. does not meet its deadline to cut
cotton subsidies.
At the Doha WTO Ministerial meeting in Qatar in November 2001, member states
launched a so-called “development round”. The most pressing intellectual property issues
in the Doha Development agenda address public health, biopiracy, indigenous people and
traditional knowledge. For example, member states adopted the Doha Declaration on
TRIPS and Public Health that stated that nothing in TRIPS should interfere with member
states’ ability to provide public health. Today, many developing countries are focusing on
the unfinished business of the Doha Round. In addition to agricultural market access, the
unfinished business in intellectual property includes: the ability of developing countries to
export generic drugs made under compulsory license; the relationship of TRIPS to the
Convention on Biological Diversity (CBD); provisions to protect plants and genetic
material located in developing countries from biopiracy; benefit sharing arrangements;
implementation; and the expansion of geographical indications. All but the last item are
central to the Doha development agenda, although the EU is pushing hard to expand
geographical indications. The acrimonious ending to the Cancun WTO Ministerial meeting
in August 2003 put the negotiating spotlight on agriculture, but intellectual property issues
received extra attention in October 2005 in the face of a global threat of an avian flu
pandemic.
INSTITUTIONAL DIMENSIONS, THE WTO: SOCIAL ISSUES AND LEGAL
DEBATES
Since the WTO administers TRIPS, the “hard law” that public health and human
rights advocates have sought to clarify and interpret in flexible ways, it is important to
examine the role of the WTO in greater detail. Clearly, agriculture, public health,
education and trade have both social and economic dimensions. NGOs and developing
countries have criticized the WTO as being insufficiently responsive to social needs. The
question arises, to what extent should social policy be incorporated into the WTO? If so,
how should it be incorporated? “While many accept the WTO essentially as currently
constituted, others find it increasingly difficult to conceive of a multilateral trade regime
confined exclusively to promoting economic efficiency through trade liberalization, in
isolation from other values” (Stein, 2001: 508 n. 106). José Alvarez argues that one’s
9
TRIPS-plus refers to standards that are either more extensive than TRIPS standards or that eliminate
options under TRIPS standards (Drahos, 2001: 793).
30
analysis of the WTO is dependent upon one’s perspectives on the relevant stakeholders and
the WTO’s mandate. While some maintain that the WTO strictly exists to serve the
“producers of goods,” others see the WTO as charged with serving “marginalized
developing countries, NGOs and individuals” (2002: 154). Indeed, the question is how to
balance the interests of these stakeholders within a trade framework. Ultimately, the
questions of linking public health, agriculture, education, intellectual property, and trade
are both normative and political.
We can approach these issues more systematically by considering two analytic
dimensions: the reasons behind linking trade and social policy and the mechanisms for
doing so. Reasons for linking trade and/or public health, sustainable agriculture or
education could be:
(1) normative (because linkage is demanded by justice and fairness); (2) coherence
(because a free trade regime would simply not make sense if [public health,
education or sustainable agriculture are] ignored); (3) consequentialist (because
free trade will adversely affect [public health, education or sustainable
agriculture]; (4) strategic (because linking these issues in a creative package deals
leads to more effective negotiations as to all); or (5) effectiveness (because the
more effective WTO approach to dispute settlement can be usefully “borrowed”
to the benefit of [public health, education or sustainable agriculture] (Alvarez,
2001: 12).
A second dimension is the mechanisms for linking these issues. At least three
institutional alternatives exist within the WTO for balancing competing policy goals. The
first would be to interpret TRIPS flexibly in order to facilitate national solutions to balance
conflicting goals; the second would be to apply TRIPS stringently to establish a common
floor that all nations would have to meet so as to limit national interpretive discretion; and
the third would be for the judicial panel to engage in judicial activism on a case-by-case
basis, taking into account the broader policy landscape (e.g., WHO, UNAIDS, The United
Nations Conference on Trade and Development (UNCTAD) (Shaffer, 2004a: 468). The
first route would give developing countries more scope to tailor the TRIPS provisions to
their specific needs. The second would rest ultimate authority in the intergovernmental
political bargain struck in achieving TRIPS. This approach would leave it up to states to
negotiate trade-offs between public health and trade. The third route, frequently advocated
by legal scholars pushing non-market agendas, would empower WTO judicial panels to
resolve value conflicts. Public health or agriculture or education and trade could be linked
interpretatively in a top down manner whereby the WTO’s Appellate Body would interpret
the meaning of the relevant laws (interpretive linkage).
Advocates of a broader stakeholder approach for the WTO, such as Robert Howse,
argue that “[r]ather than attempt once again to decide what is ‘in’ or ‘out of’ the WTO, we
should try to mold the rules and their interpretation to structure the interaction of the
trading regime with other powers and authorities, both domestic and international, in a
legitimate manner” (Howse, 2002: 112). With this perspective, legitimacy would be the
yardstick by which to measure the process and outcomes. As Gregory Shaffer suggests,
“scholars of different ideological orientations tend to identify their ideological goals with
particular institutions and thus tend to idealize those institutions. Power tends to disappear
31
within their preferred institutions” (2004b: page #). However, one must examine these
institutions in their political context, and that invariably implicates power.
For example while the WTO judicial “interpretive” approach may seem appealing
on its face, both Shaffer and Jeffrey Dunoff have made compelling arguments against it.
First, as Shaffer points out, structural asymmetries militate against extensive developing
country participation in WTO litigation (2004a: 472-4). For example, in many cases the
costs of litigating a WTO claim ($300 to 400 thousand in attorneys’ fees) are prohibitive.
“The ‘haves’ come out ahead in litigation at the international level where legal expertise is
highly specialized and expensive” (Shaffer, 2004b: page #). Dunoff has argued that based
on the General Agreement on Trade and Tariffs (“GATT”)/WTO record, panels are more
likely to decide cases in ways that militate against a non-market outcome (2001: 1007-11).
This argument powerfully questions the assumption that judicial activism would tend in a
“progressive” direction. Furthermore, “WTO judicial bodies decide . . . cases in a highlycharged political context. They are not free from political pressure, even if they do not
expressly take it into account. They have their own institutional interests at stake”
(Shaffer, 2004b). “The WTO Appellate Body operates not as an ideal neutral judge, but
one that takes into account its own institutional interests and shapes decisions to encourage
compliance and consensus” ”(Shaffer, 2004b; see also Smith, 2003: 74-80).
Analysis of the Shrimp/Turtle case pertains to the prospects of the WTO’s
representation of a broader range of stakeholders. While parallels between access to
medicines, agriculture, educational materials and the Shrimp/Turtle case are inexact 10, the
Shrimp/Turtle case seems to serve as a Rorschach ink blot test in legal scholarship.
Scholarly interpretations of the significance of the case are hardly unambiguous. Some
scholars advocating a broader stakeholder approach to trade find hope in the case, whereas
others are far more wary. The first group of analysts argues that Shrimp/Turtle provides an
important precedent for enlarging the WTO’s scope beyond trade. The second group
bemoans the Shrimp/Turtle case for stretching the WTO too far. The third group draws
more pessimistic conclusions about the significance of the case for WTO judicial activism.
I will discuss each group in turn.
Advocates for change and for expanding the WTO’s mandate conclude that the
Appellate Body report in the Shrimp/Turtle Case “abandoned the WTO’s isolationism, that
the WTO is a self-contained system . . . . by examining whether an endangered species was
an exhaustible resource, by referring to international environmental law” (Gathii, 2001:
155). The Appellate Body referred to “a baseline in actual international environmental law
that was contained in the Rio Declaration on Environment and Development” (Howse,
2002: 110). Howse cites the Beef Hormones and Asbestos cases as additional examples of
the Appellate Body’s use of “a variety of jurisprudential techniques” to address the balance
of economic and social values (2002: 109). James Thuo Gathii also notes that the
Appellate Body endorsed Article 31 of the Vienna Convention on the Law of Treaties as
an interpretive reference for the WTO in the Standards for Gasoline case. In his judgment,
“such instructions come down to a ‘recognition that the General Agreement is not to be
10
E-mail from Gregory Shaffer, Nov. 23, 2003 (on file with author)
32
read in clinical isolation from public international law’” (Gathii, 2001: 156)11 Joost
Pauwelyn argues that “WTO rules are not the alpha and omega of all possible trade
relations between states. Other more detailed or special rules of international law . . .
continue to be highly relevant” (2001: 540).
These analysts advocate the fuller explicit incorporation of social issues into the
WTO and tend to highlight normative and consequentialist arguments to support their
position. Further, they advocate interpretive linkage by invoking WTO Appellate Body
decisions in defense of their arguments and the possibilities for expanded linkage (Abbott,
2000: 64; Bloche, 2002: 833-4; Charnovitz, 2002: 211; Gathii, 2001: 155-7; Gathii, 2002:
316; Pauwelyn, 2001: 556-61; Howse and Mutua, 2000). Some authors argue that social
policy is already deeply embedded in the WTO (Gathii, 2001: 138-9). For example, M.
Gregg Bloche argues that in the WTO system the protection of health has become “a de
facto interpretive principle when disputes arise over members’ treaty obligations” (2002:
825). According to Bloche, the Doha Declaration on TRIPS and Public Health “has
interpretative weight under the Vienna Convention on the Law of Treaties, as either a
‘subsequent agreement between the parties regarding the interpretation’ of TRIPS or
‘subsequent practice in the application of the treaty which establishes the agreement of the
parties regarding its interpretation’” (2002: 842, and nn. 96-97). Gathii agrees, arguing
that “[w]hat the Doha Declaration . . . does as a matter of law is not insignificant. It
mandates reading the TRIPS Agreement in light of its objectives and principles, thereby
giving countries a legal basis in the Agreement itself to argue in favor of public policies”
(2002: 305).
Others argue that the WTO should be restricted to trade, period, (Bhagwati, 2002:
133-4; Steger, 2002: 145) and advocate an incrementalist, bottom-up approach. These
analysts tend to highlight strategic reasons and advocate “negotiation linkage.” This group
also presents a narrower conception of the WTO’s mandate (Steger, 2002: 137-40). At the
end of the day, these analysts warn about the dangers of expanding the WTO’s mandate in
the absence of a prior political consensus among the member states (Alvarez, 2002b: 4).
They raise concerns about the WTO’s resource constraints (Bhagwati, 2002: 132) and the
dangers of a damaging backlash if the WTO gets too far ahead of its membership (Alvarez,
2001: 15-17). Both Jagdish Bhagwati and Debra Steger are careful to define their sense of
the WTO’s ultimate purpose. For Bhagwati, it is to promote “non-coercive trade” as a
“mutually beneficial phenomenon” (2002: 127). By this yardstick he believes that TRIPS
has no place in the WTO. Steger defines the WTO as an institution dedicated to promoting
freer trade via the norm of nondiscrimination (and not fairness) (2002: 139). Bhagwati,
unlike the first group of commentators, sharply criticizes the Shrimp/Turtle decision for
precisely the reasons that the other commentators praised it. As he states:
[I]t would be more prudent for it not to let earlier findings be replaced so drastically
as in the shift from the Tuna/Dolphin to the Shrimp/Turtle decisions, which was
doubtless influenced to some degree by the environmental lobbies of the North.
Instead, such dramatic reversals or changes are better made in negotiations than in
courts (2002: 133-34).
Quoting WTO Appellate Body Reports on United States – Standards for Reformulated and Conventional
Gasoline, May 20, 1996, 35 I.L.M. 603 (1996).
11
33
Bhagwati fears the explicit introduction of non-market criteria as opening a
“Pandora’s box” (2002: 133) and favors a stricter compartmentalization of functions
between various international organizations. He believes, for example, that labor standards
should be addressed in the International Labor Organization (ILO) and not the WTO.
Some see this as a potentially cynical position – to shunt sensitive issues off to venues in
which “words don’t matter,” using less authoritative institutions as a safety valve to defuse
controversy (Helfer, 2004: 56-57; Shaffer, 2001: 38).
Steger also favors
compartmentalization out of acute resource constraints as much as principles. For
example, Douglas Irwin has pointed out that the WTO has a staff of only 500 (300 of
whom are translators), and an annual budget of just $77 million. By contrast the World
Bank employs 6,000 people and has an annual budget of about $8 billion, and even many
NGOs have much bigger budgets than the WTO. The World Wildlife Fund’s annual
budget is $360 million, and Greenpeace has a budget of about $120 million (Irwin, 2002:
186). According to Eric Stein, one must question:
[W]hether the global commitment to free trade is strong enough to sustain a
significant expansion of WTO competence to the full scope of trade-related
environmental, social, and sustainable development issues. . . . For both the
‘nationalists’ concerned about state sovereignty, and the liberals concerned about
democracy, the answer may be to ‘stop the integration’ and allow other (less
integrated) international agencies (e.g., the ILO and mechanisms established by
environmental treaties) to deal with the other values (2001: 507).
These analysts trace the development of the GATT/WTO system as a “bottom-up”
process (Alvarez, 2001: 19; Jackson, J., 2002: 125). As such, they recommend that its
continued evolution rest on a political process of negotiation among member states.
Ultimately, these authors see the problems as essentially political and therefore advocate
political solutions. Insofar as the WTO is “a system of rules,” the “normative problems of
interpreting and applying those rules . . . cannot be avoided” (Steger, 2002: 138). Steger
takes direct aim at the analysts who champion the Appellate Body’s potential to expand
WTO’s purview. As Steger states, “this challenge - of redefining and clarifying the values
and policy objectives that the international community believes should trump the value of
freer trade - is too big and too important to be left to the judicial branch of the WTO, even
at its highest level, the Appellate Body” (2002: 144).
A third group of scholars endorses a broader mandate for the WTO, that it should
conform to a stakeholder model (Trebilcock and Howse, 1999: 54-56), but disagrees on
mechanisms. As Dunoff states:
Debates within and about the WTO tend to be consequentialist. That is, they tend
to argue over what results will follow from adopting this or that rule, and whether
such outcomes are desirable. In this context, the ‘desirable’ outcome is typically
understood to be the outcome that maximizes economic welfare. But it is surely a
mistake to understand the new trade issues exclusively in consequentialist terms
(2001: 1008).
Indeed, the new trade issues (such as intellectual property) are distributional and are not
about “expanding the pie” (Dunoff, 2001: 1008). While Dunoff and Shaffer subscribe to
34
the broad stakeholder view, they part company with Howse and Gathii insofar as they are
leery about a “top-down” Appellate Body incorporation mechanism.
Scholars emphasizing the deeply political universe of the WTO draw different
conclusions from the Shrimp/Turtle case (Dunoff, 2001: 984; Smith, 2003: 88-89). For
instance, Dunoff argues that the Shrimp/Turtle case presents an ambiguous picture for
champions of incorporation of “trade and” in the WTO (2001: 984-85). While heralded as
a major step forward insofar as the Appellate Body held that “dispute resolution Panels and
the [Appellate Body] itself have legal authority to receive amicus briefs and other materials
from NGOs,” (Dunoff, 2001: 984-85) in fact the Appellate Body “proceeded to largely
ignore the NGO arguments and instead ‘focus’ solely on the arguments the United States
presented in its ‘main submission’” (Dunoff, 2001: 985). Surveying additional cases,
Dunoff concludes that WTO trends are a step backwards for advocates of greater NGO
involvement in WTO deliberations. Rather than representing the infusion of independent
ideas into the deliberative process, NGO submissions are routinely ignored unless adopted
by one of the parties to the dispute. In essence, this has had the effect of diluting the
possibilities of NGO input. “While doctrinal developments deprive NGOs of a powerful
rhetorical argument about the closed nature of WTO dispute resolution, the actual
procedure used effectively excludes NGOs from WTO dispute resolution” (Dunoff, 2001:
987).
INSTUTIONAL DIMENSIONS: PUBLIC INTERNATIONAL LEGAL REGIMES, INSTITUTIONS,
HARD AND SOFT LAW: WIPO, FAO, CBD, UNHCHR, AND WHO
The WTO is arguably the most important institution governing global intellectual
property policy. However, TRIPS is not the only important public international legal
regime covering global intellectual property, and the WTO is not the only significant
venue. WIPO, the Food and Agriculture Organization (FAO), the Convention on
Biological Diversity (CBD), the United Nations High Commissioner for Human Rights
(UNHCHR), and the WHO are all actively engaged in making public international law in
intellectual property. The following section seeks to map out the broader institutional
terrain, focusing on WIPO, FAO, the CBD, the UNHCHR, and the WHO. As Stein points
out, “any effort to rank [International Intergovernmental Organizations (IGOs)] in a
hierarchical way is fraught with difficulties” (Stein, 2001: 495). However, it is important
to highlight each organization’s perspective on the issues before discussing the
relationships among them.
This discussion of the institutional dimensions of global public policymaking
requires exploring the reasons for shifting from one forum to another, the available
options, the choice of institutions, and the role of the WTO. According to Helfer, there are
four main reasons why actors strategically choose to shift forums: “to help achieve desired
policy outcomes[;] to relieve political pressure for lawmaking in other international
venues[;] to generate counter[-]regime norms[;] and to integrate those norms into the WTO
and WIPO” (Helfer, 2004: 53). These reasons are not mutually exclusive. Of these four
reasons, only the second, the “safety valve” strategy, is pursued in order to preserve the
35
status quo.12 “[S]tates and interest groups can use regime shifting as a safety valve,
consigning an issue area to a venue where consequential outcomes and meaningful rule
development are unlikely to occur” (Helfer, 2004: 56). The other three are pursued in
order to effect change.
Governments, private actors, and NGOs all engage in forum shifting. Forum
shifting can be done horizontally, across institutions, as in the case in which the United
States pushed to move intellectual property policymaking from WIPO to GATT for the
Uruguay Round (Sell, 1998: 105). Forum shifting can also involve vertical moves across
levels of governance, such as the United States’ use of Super 301 of U.S. trade laws to
coerce developing countries into adopting higher standards of intellectual property
protection, or its more recent efforts to use bilateral and regional intellectual property and
investment treaties to secure “TRIPS-Plus” protection in developing countries (Drahos,
2001: 792-3). Actors may also choose among different institutions favoring those that
afford them better access or those whose philosophies resonate more closely with their
own goals. For example, actors can select a forum in which previously marginalized
issues get a better reception. This can provide them with opportunities to propose and
experiment with policy approaches to the issues (Helfer, 2004: 55). Forum shifting can
provide governments that are critical of TRIPS a “safe space” in which to exchange
information, develop soft law, and craft viable policy alternatives that address their
concerns (Helfer, 2004: 58). Such soft law forums as the WHO and the CBD have proven
to be significant incubators of alternative approaches, or “counter-regime norms,” to
TRIPS. As Helfer suggests:
[E]mbedded in the very idea of counterregime norms is a more strategic
understanding of legal inconsistencies, one in which states consciously create
conflicts as a way to subvert the prevailing legal landscape and provide fuel for
renegotiating principles, norms, and rules to reflect their interests more accurately.
. . . [D]eveloping countries and NGOs used precisely this strategic approach in
seeking to integrate the new rules developed in biodiversity . . . public health, and
human rights regimes into the WTO and WIPO. [Such forum shifting] can also
function as an intermediate strategy that allows developing countries to generate
the political groundwork necessary for new rounds of intellectual property
lawmaking in the WTO and WIPO. When adopting this ‘integrationist’ strategy,
developing countries use regime shifting to shore up support from hesitant allies,
vet competing reform proposals, and generate common negotiating
positions which they then introduce into the two organizations (2004: 59-60).
This strategy can also support the development of competing discourses that can
change the way parties read TRIPS and are willing to apply it.13 Furthermore, these
competing discourses can challenge various domestic political bargains and integrate a
broader range of viewpoints and parties into the issues. They can raise the political costs
12
This is the approach that the US is pursuing in WIPO in discussions of a development agenda. The US
maintains that development issues do not belong in WIPO, and thus far is recommending that the discussions
be sidelined onto a committee with a mandate only to discuss the issue.
13. E-mail from Gregory C. Shaffer, Professor of Law, University of Wisconsin Law School, to Susan K. Sell, November 23, 2003 (on file
with author).
36
of defending the status quo (Sell and Prakash, 2004: 143-175). With this in mind, the
following discussion surveys TRIPS-related activity in diverse forums.
WORLD INTELLECTUAL PROPERTY ORGANIZATION
The NIEO negotiations on the revision of the Paris Convention for the Protection of
Industrial Property took place in WIPO, which administered the Paris Convention. In the
mid-1980s, in the waning days of those stalled negotiations, dissatisfied American
negotiators shifted intellectual property deliberations out of WIPO and into GATT.
Americans, seeking high protectionist norms for intellectual property, favored GATT
because it would permit them to link intellectual property protection to trade. The U.S.
negotiators anticipated better results owing to the large and attractive U.S. market that
could be used as negotiating leverage. The forum shifting of the mid-1980s was a major
blow to WIPO’s morale and prestige. However, it has bounced back with renewed energy.
Since then, WIPO has substantially transformed itself from a relatively sleepy, albeit
highly competent, organization into a more entrepreneurial agency with a mission to prove
its continued relevance to intellectual property owners.
Unlike many international organizations, WIPO is almost self-sufficient. Rather
than relying upon government handouts and grants, WIPO earns nearly ninety percent of
its operating budget from its administration of the Patent Cooperation Treaty (PCT)
(Doern, 1999: 111; WIPO, 2001). The biggest users of the PCT are the global
corporations engaged in producing knowledge-intensive products and processes, such as
the global life sciences industries and the financial services industries. These corporations
also are the most ardent champions of high protectionist norms for intellectual property.
These budgetary facts behind WIPO undoubtedly compromise its image as a technocratic,
objective civil servant.
The resurgence of WIPO troubles many supporters of a development agenda.
Sisule Musungu notes that WIPO reflects “a build up of significant bias against latecomers
to the intellectual property field” (2005: 4). WIPO is now regarded as being much more
sympathetic to industry interests than it had been in the past. Furthermore, developing
country WIPO delegates come from intellectual property offices that are socialized to favor
protection (Drahos, 2002: 785); the professional camaraderie among intellectual property
lawyers from both North and South means that discussions are far less adversarial than is
the case in WTO.14
WIPO actively provides technical assistance to developing countries as they seek to
comply with TRIPS. Those who pay WIPO’s freight undoubtedly shape its advocacy, and
it has urged a number of developing countries to adopt “TRIPS-Plus” provisions in their
One glaring example of this can be found in the WIPO publication entitled, “Striking a Balance: Patents
and Access to Drugs and Health Care” at http://www.wipo.int/aboutip/en/studies/publications/health_care.htm in which WIPO, “despite the adoption of the Doha Declaration on
the TRIPS Agreement and Public Health in November 2001. . . essentially labels all the concerns that
developing countries have raised with regard to TRIPS and public health as ‘myths’ four years later”
(Musungu, 2005: 7 and at note 43).
14
37
national legislation. For example, WIPO assisted in formulating the revised Bangui
Agreement for the Organisation Africaine de la Propriete Intellectuelle (OAPI) countries.
This agreement goes further than TRIPS by placing greater restrictions on the issuance of
compulsory licenses and prohibiting parallel imports (Commission on Intellectual Property
Rights, 2002). Indeed, in the wake of TRIPS,
[t]he United States regularly sent lawyers for the U.S. pharmaceutical and
copyright industries to Geneva as ‘faculty’ of the World Intellectual Property
Organization. . . to teach developing country representatives about intellectual
property matters and to draft ‘model’ laws for their consideration. Industry
successfully lobbied Congress to allocate funds for these ‘educational’ efforts”
(Shaffer, 2004a: 476).
WIPO is also conducting negotiations on a Substantive Patent Law Treaty (SPLT)
that aims for harmonization of patent law globally. After a failed effort that ended in 1991,
new talks began in 2001. The U.S. and the EU also have been engaging in forum-shifting
by taking some of their unmet concerns to WIPO (Musungu, 2005). This latter move is
particularly intriguing given their audacious shifting of many intellectual property issues
out of WIPO and into the GATT in 1986 at the outset of the Uruguay Round (Sell, 1998;
Braithwaite and Drahos, 2000). At the time the U.S. expressed frustration that WIPO was
too focused on North-South issues and sought an alternative forum in which the U.S. had
more leverage. Industry leaders welcomed the intellectual property-trade linkage as being
more effective in realizing their interest in higher standards of intellectual property
protection. Now that intellectual property issues have received so much unwelcome
attention in the WTO, the U.S. and EU have turned their attention to WIPO. Many suspect
that the momentum behind the renewed effort is animated by a quest to increase property
rights protection beyond that embodied in TRIPS and to universalize TRIPS-Plus
standards.
Developing countries have also seized opportunities to press their agendas, which
are more fully developed in other venues, within WIPO. Developing countries have
pressed for disclosure of origin and benefit sharing systems within WIPO. They sought to
link biodiversity issues to the 1999 WIPO Patent Law Treaty negotiations by proposing the
incorporation of the CBD recommendation that intellectual property applicants, when
using genetic resources, prove that they had obtained informed prior consent to access
those resources (Helfer, 2004: 62). In response, WIPO agreed to establish a separate body
within WIPO to address intellectual property aspects of resources and traditional
knowledge (South Centre and CIEL, 2005a: 16). Subsequently, the Intergovernmental
Committee on Intellectual Property, Genetic Resources, Traditional Knowledge and
Folklore (IGC) has conducted a number of studies that reflect the developing countries’
concerns as expressed in the CBD’s Conference of the Parties (COP). Developing
countries have also requested that the WIPO Secretariat examine the implications of the
SPLT for the IGC’s work, that “illustrates their increasing recognition of the need to
coordinate lawmaking not only across different regimes or across venues . . . but also in
different fora within the same intergovernmental organization” (Helfer, 2004: 71).
38
In 2004 a group of developing countries (Group of Friends for Development)
proposed a development agenda for WIPO.15 The U.S. objected, arguing that WIPO is not
a development agency but an organization specializing in intellectual property (Musungu,
2005: 4; WIPO document IIM/1/2). The General Assembly created an intergovernmental
process to discuss the proposal, which met three times (in April, June and July 2005). At
the end of the July meeting the group was unable to reach a consensus on continuing the
process due to the opposition of the US and Japan (Musungu, 2005: 4). In closed informal
meetings, delegations argued over whether discussions should continue in the high-level
intergovernmental meetings that report directly to the General Assembly, or be consigned
to a minor technical body, the Permanent Committee on Co-operation for Development
Related to Intellectual Property (PCIPD) (ICTSD, 2005: 22). Those favoring high
standards of intellectual property protection, such as the US, sought to confine discussions
of “development” issues such as disclosure of origin and genetic resources to the IGC
(presumably where “words don’t matter”). By contrast the US, Japan and the European
Patent Office proposed high level discussions on issues of interest to them, such as
definition of prior art, grace period, novelty, non-obviousness/inventive step (Correa,
2005b: 4, n. 14).
In June 2005 the Friends of Development, led by Brazil, “expressly linked the
development agenda to the Substantive Patent Law Treaty under elaboration at WIPO,
refusing to discuss the latter in the absence of progress on the former” (ICTSD, 2005: 22).
The group succeeded in halting progress on a SPLT, holding it hostage to meaningful,
substantive progress on a development agenda.
WIPO is institutionally constrained from pressing very far on issues that its main
constituency (users of the PCT) opposes. WIPO has worked hard to get back into the good
graces of the OECD since 1986, and it seems unlikely that WIPO would jeopardize its
position by directly challenging the high protectionist agenda (May and Sell, 2006: 214).
Indeed, playing on this very sensitivity, the U.S. delegate warned WIPO not to pursue a
substantive development agenda; he said “we support WIPO. We would not want to
change WIPO in a direction that would diminish that support” (IP-Watch, 2005. 11 April).
A number of industry representatives, including former US Patent and Trademark Office
official Bruce Lehman and civil society groups sympathetic to the US position issued a
letter urging WIPO not to be diverted from its mission by a “so-called development
agenda” (IP-Watch, 2005, 14 April). In June 2005 the U.S. PTO issued a press release
bemoaning the impasse over the patent law harmonization talks at WIPO stating that, “the
impasse also raises serious questions as to whether WIPO is even a viable forum for
further meaningful patent discussions” (PTO, 2005). The Director of the Office of
International Relations at the U.S. PTO, Lois Boland remarked that “’WIPO appears to be
facing a serious identity crisis, underscoring the need to consider alternative approaches for
achieving harmonization . . . Our users have spoken in no uncertain terms about their need
for progress in this area’” (PTO, 2005). At the November 2005 WIPO General Assembly
industry lobbyists showed up to express their opposition to a development agenda. As
Argentina and Brazil presented the proposal to WIPO’s General Assembly. The proposal was co-sponsored
by Bolivia, Cuba, the Dominican Republic, Ecuador, Egypt, Iran, Kenya, Peru, Sierra Leone, South Africa,
Tanzania and Venezuela. WIPO document WO/GA/31/11 (September/October 2004).
15
39
reported in IP-Watch “one industry source said they were there for an ‘anti-development
agenda’” (IP-Watch, 2005, 4 November). Eric Smith, head of the International Intellectual
Property Alliance (a very powerful US-based copyright lobbying organization) stated that
the development agenda was “revisionist” and that if its proponents “can convince the rest
of the world to change it, good for them. But they won’t” (IP-Watch, 2005. 11 November
11).
Nonetheless, WIPO held the first of two week-long meetings of the Provisional
Committee on Proposals Related to a WIPO Development Agenda (PCDA) in late
February 2006. The US is determined that WIPO’s mandate to promote intellectual
property protection is not compromised by the development agenda. The US proposals
included the following suggested topic: “counterfeiting and intellectual property:
development’s antonym” (IP-Watch, 2006a, 24 February). Both China and Brazil argued
that it did not belong on the agenda. Industry was out in force for these meetings. Director
General of Brussels-based CropLife (a biotechnology and crop industry association),
Christian Verschueren, expressed concern that “’the entire IP concept is under attack’” and
that “the industry is being put into a defensive corner ... and the need for IP is no longer
taken for granted” (IP-Watch, 2006b, 24 February). Jacques Gorlin, speaking on behalf of
the ABIA, stated that “we think industry’s comparative advantage is telling a story. . . .
The message will be: ‘We are the people who you are depending on to generate
commercial benefits. If you do it through the disclosure system, it ain’t gonna happen’”
(IP-Watch, 2006. 2 March).
Gorlin was a key player in the origins of TRIPS as consultant to the Intellectual
Property Committee (IPC). The IPC, made up of 12 CEOs of US-based global firms with
large intellectual property portfolios, mobilized transnational private sector and
governmental support for TRIPS and drafted major portions of TRIPS (Sell, 2003). Gorlin
has now formed the ABIA to continue industry advocacy in multilateral, bilateral, and US
government forums. Member companies include: Bristol Myers-Squibb, Eli Lilly, Hana
Biosciences, General Electric, Merck, Pfizer, Procter & Gamble and Tethys Research
(ABIA). At least half of these firms participated in the original IPC. ABIA is leading the
lobbying fight to preserve and promote patents on life forms and is targeting activities at
WIPO, WTO and CBD. The ABIA plans to lobby its allies, the US, Australia, Canada,
Korea, Japan and New Zealand, as well as work with India’s biotechnology industry to try
to soften India’s negotiating stance (IP-Watch, 2006, 2 March).
At a side event that CropLife hosted during the WIPO meetings, deputy director
general of WIPO Rita Hayes defended WIPO”s technical assistance programs and
underscored the positive role that intellectual property protection plays in agriculture. She
highlighted golden rice as “an example of a product that was IP-protected but licensed and
available in a number of developing countries (containing vitamin A which helps prevent
blindness in children)” (IP-Watch, 2006c, 24 February). Recall that patent thickets actually
delayed the availability of golden rice for over a year and a half (Phillips, 2004: 181).
Another side event during these talks addressed access to digital books. Panelists
included industry and NGO representatives. Teresa Hackett of Electronic Information for
40
Libraries highlighted copyright-related obstacles to access to educational materials for
libraries and suggested that license fees and rights clearance create major burdens for
developing countries’ libraries (IP-Watch, 2006d, 24 February). Hackett expressed her
support for the WIPO development agenda and a Chilean proposal for studies on the
impact of IPRs on education in developing countries; “’Why not give developing countries
the same flexibilities that developed countries had when they developed?’ Hackett said”
(IP-Watch, 2006d, 24 February).
FOOD AND AGRICULTURE ORGANIZATION
The United Nations Food and Agriculture Organization (FAO) is charged with
leading international efforts to defeat hunger. It focuses on developing rural areas, sharing
policy expertise, and providing a neutral forum for states to negotiate agreements and
debate policy (www.fao.org). In the early 1980s, “Cary Fowler, a former political activist
who during the 1980s opposed the extension of IPRs to life-forms, decided that forumshifting was a game that the weak could also play. . . .Fowler and [Pat] Mooney identified
the FAO as the most promising arena” (Dutfield, 2002: 14). Having honed their advocacy
skills in battles over legislative activity in North America, they brought their campaign to
the FAO. According to Fowler, the progressive extension of property rights with no
commitment to conserving genetic diversity led activists such as himself and Pat Mooney
to “develop a strategy and set it to work in a new but potentially friendlier arena” (1994:
180). The 1981 biennial conference of the FAO marked a shift in the discourse and
strategy over plant genetic resources. Mooney and Fowler had consulted with the Mexican
ambassador to the FAO prior to the meeting and had provided the Mexican president with
reports on genetic resources. The ambassador arrived armed with proposals for the
establishment of an international gene bank and an international legal convention for the
exchange of genetic resources (Fowler, 1994: 181).
Shifting to the FAO was a strategic move for two reasons: first, it shifted the center
of gravity from American to developing country interests, and second, it broadened the
discourse beyond patenting plant varieties to the broader connections between patenting,
genetic conservation and development issues (Fowler, 1994: 181-2). As Fowler states, this
campaign “show[ed] how new arenas can help radically alter power relationships,
encouraging various responses from the disadvantaged – including a search for yet new
arenas. The development of new technologies add[ed] fuel to the political fire by adding
potential value to the botanical materials found in the Third World” (Fowler, 1994: 180).
At issue was the one-way flow of germplasm from the genetically rich geopolitical
South to the North (Kloppenbeurg, 2005). During the UN debates over a New
International Economic Order (NIEO) in the 1970s developing countries and industrialized
countries clashed over what constituted the “common heritage of mankind” (Sell, 1998).
Industrialized countries considered landraces, or wild cultivars (a.k.a. folk varieties), to be
the common heritage of mankind, ensuring free and easy access to germplasm from the
South. However, they asserted property rights in industrialized countries’ breeders’ plant
varieties. Raustiala and Victor have referred to this distinction as “raw” versus “worked”
41
germplasm (2003: 5). Indeed in the current discussions over Traditional Knowledge (TK),
advocates for TK protection argue that what Northern plant breeders consider to be “raw”
is in fact the product of on-farm innovations over generations.
In 1983 negotiators agreed to the International Undertaking on Plant Genetic
Resources (IUPGR) against the adamant opposition of the U.S., U.K., Australia and major
seed companies. The non-binding undertaking was designed to ensure conservation and
unrestricted availability and sustainable utilization of plant genetic resources for future
generations by providing a flexible benefit and burden sharing framework (Dutfield, 2005:
15). Negotiators also established a new FAO commission on Plant Genetic Resources
where states could discuss and monitor the non-binding undertaking. The US tried to
boycott the Commission but 93 countries were represented at its first meeting in 1985. It is
now the largest FAO Commission with 161 members and the EU (Dutfield, 2005: 15).
Beginning in 1989 the IUPGR incorporated Pat Mooney’s notion of “farmers’
rights” “to acknowledge the contribution that farmers have made to conserving and
developing plant genetic resources” (Dutfield, 2005: 15). The notion was to safeguard the
rights of farmers to “work with, and live from, farming systems based on diversity, in the
face of expanding monocultures and uniform seeds” (GRAIN, 2005). Developing countries
sought to address the inequities arising from a system in which they lacked open access to
improved varieties bred by seed companies, especially when some of those “worked”
resources were based on developing countries’ “raw” germplasm (Raustiala and Victor,
2003: 12). Many developing countries perceive that the industrialized countries have
profited from the existence of biological resources to the detriment of the countries in
which they reside. The 1989 IUGR asserted the principle of unrestricted access and
common heritage of both raw and worked germplasm. “The industrialized countries relied
on the principle to continue their open access to raw PGR, yet refused to accept the
undertaking’s principle of open access to worked PGR” (Raustiala and Victor, 2003: 13).
Developing countries took a new tack in the late 1980s and began to see property
rights in raw germplasm, “green gold” (Kuanpoth, 2006: 139), as a way to acquire wealth.
Gene-rich countries could deny access to their biological riches and cut deals with
companies that wanted to engage in bio-prospecting. Over the years developing countries
have been abandoning the “common heritage” conceptions of biological resources and
have asserted their sovereign rights to their exploitation. Access can be privatized
effectively under the rubric of sovereignty and attendant rights of states over their own
natural and cultural resources. Costa Rica’s nonprofit, private National Biodiversity
Institute (INbio) struck a deal with Merck & Company to help underwrite INbio’s
biodiversity prospecting plans (Reid et al., 1993). Once the Merck agreement was signed
(September 1991) Costa Rica began to restrict access to its biological resources.
Asserting property rights in biological resources has been controversial (for both
worked and raw varieties). As Jack Kloppenburg has noted, it can be questioned:
whether the whole farmers’ rights orientation was the proper way to go and
whether there simply weren’t too many contradictions embedded in trying to use
the master’s tools to dismantle the master’s house. . . . I think that the types of socalled alternative or community or traditional resource rights that have so far
42
been developed are really derivatives of Western intellectual property. . . . On the
other hand, I don’t know what else can be done” (Kloppenburg, 2005).
In any case, the 1991 Annex to the 1983 FAO Undertaking reflected this new
approach and stated that “the concept of mankind’s heritage is subject to the sovereignty of
states over their plant genetic resources” (quoted in Raustiala and Victor, 2003: 16). The
2001 FAO Treaty that came into force in 2004 has been sharply criticized as being a
bonanza for plant breeders and a disaster for farmers’ rights. On the plus side, the FAO
Treaty’s approach to access and benefit sharing does not follow the Merck-INbio model of
bilateral contracting, but rather enables parties to:
jointly create a multilateral system that gives everyone access on equal terms to the
whole set of resources covered. . . . It recognizes that access itself is the main
benefit to be shared, and aims to facilitate it rather than limit it by exclusive
contracts and patents. Second, any monetary benefits generated through the
system are to be pooled and used to support conservation and sustainable use
efforts, rather than enrich any single provider” (GRAIN, 2005).
While it falls well short of a generalized system of mutual access to all plant genetic
resources for food and agriculture, it provides an alternative “that doesn’t lock all
international seed exchanges into a tangle of bilateral contracts” (GRAIN, 2005).
However, it clearly enshrines the notion of property rights over genetic resources.
In the negotiations developed countries resisted any measures that would prevent their
patenting of genetic resources, whereas developing countries wanted to limit the scope of
the treaty to protect any business opportunities that might result from providing individual
genes on the global market (GRAIN, 2005).
In 2004 the FAO adopted a human rights and a food security frame for its
Voluntary Guidelines on the Right to Food. 188 member states adopted the guidelines
entitled “Voluntary Guidelines to Support the Progressive Realization of the Right to Food
in the Context of National Food Security” (FAO, 2004). This means that states have
pledged to work toward the goal of supporting the right to food. Advocacy groups
supporting vulnerable populations endorse this approach because it focuses on the likely
impact of trade policies and provides international mechanisms to hold economic actors
accountable when domestic processes fail to promote or protect human rights (IATP, 2005:
5). Under international law, a human rights rubric provides mechanisms for states, groups
and individuals to make their case (IATP, 2005: 5).
CONVENTION ON BIOLOGICAL DIVERSITY
The Convention on Biological Diversity (CBD) emerged out of the 1992 United
Nations Environment Program’s “Earth Summit” in 1992. It was a response to growing
alarm about species loss, the erosion of genetic diversity and the accelerating destruction of
rainforests. The CBD is yet another international law that includes intellectual property
elements. Unlike TRIPS and WIPO efforts, it more explicitly and squarely incorporates
provisions that developing countries favor. The CBD recognizes the rights of indigenous
43
cultures to preserve their knowledge resources; Article 8(j) recognizes communal
knowledge. The CBD conception challenges the TRIPS view that endorses the western,
individualistic conception of knowledge ownership; this western perspective draws a sharp
line between “folklore” and “science.” CBD stresses that biological resources are
sovereign resources of states, whereas TRIPS enforces private property rights over them.
Article 8j concerns the need to respect and preserve communal knowledge resources to
ensure the sanctity of traditional practices and also “to promote their wider application
with the approval and involvement of the holders of such knowledge.” Many developing
countries and NGOs endorse CBD as a way of combating biopiracy in which global life
sciences’ corporations expropriate genetic resources and traditional knowledge without
authorization or compensation. W.R. Grace’s patenting of neem tree seed extracts became
a lightning rod for this controversy. Furthermore, the CBD also offers more opportunities
for upholding farmers’ rights against “biogopolists.” Article 8(j) calls for respect and
preservation for “innovations and practices of indigenous and local communities
embodying traditional lifestyles relevant for the conservation and sustainable use of
biological diversity.”16
The CBD’s Conference of the Parties (COP), the CBD member states that decide
how to apply and implement the CBD, has addressed the degree of the CBD’s
compatibility with TRIPS. “After the entry into force of TRIPs, developing states led by
China and the Group of 77 and sympathetic NGOs such as the World Wildlife Fund
began to express concern over the relationship between intellectual property rights and the
CBD’s access and benefit sharing rules” (Helfer, 2004: 33). The COP convened a panel of
experts that led to the adoption of the Bonn Guidelines in 2002, which stipulated that
applicants for intellectual property rights should disclose the origin of any genetic
resources or related knowledge relevant to the subject matter. Such disclosures are meant
to facilitate monitoring whether applicants have received prior informed consent of the
country of origin and complied with the country’s conditions of access (Helfer, 2004: 29).
While the CBD’s COP states have urged cooperation with the WTO and WIPO, they have:
[P]ointedly refrained from ceding jurisdiction over biodiversity-related intellectual
property issues to these organizations and instead are attempting to influence the
terms of the debate by setting agendas, convening meetings, suggesting topics for
further study, proposing a memorandum of understanding with WIPO ,and
directing the CBD’s Executive Secretary to seek observer status with the TRIPS
Council (Helfer, 2004: 34).
India was the first to call for the primacy of the CBD over TRIPS Article 27.3(b)
(the provision requiring members to provide protection for plant varieties either by patents
or an effective sui generis system) and argued that TRIPS should be amended to comply
with the CBD (Tejera, 1999: 981). Participants negotiating TRIPS agreed to revisit Article
27.3(b) four years after the date of entry into force (1999). Since 1998 the TRIPS Council
has engaged in discussions to address the relationship between the CBD and TRIPS Article
27.3(b). Jonathan Hepburn has argued that the Article 27.3(b) review process in the TRIPS
Council has been important in building developing country negotiators’ confidence and
issue-specific knowledge (2002). At first discussions focused on the mandate of the review
16. Convention on Biological Diversity (“CBD”), June 5, 1992, art. 8(j), 31 I.L.M. 818, 825.
44
process, but broadened to include acknowledgment of diverse sui generis approaches to
plant variety protection, concerns about indigenous peoples, and the relationship between
TRIPS and the CBD (Hepburn, 2002). India, Brazil and the African group submitted
papers to the TRIPS Council and delegations also began to acknowledge the relevance of
the CBD and the international treaty of the FAO (Hepburn, 2002). Developing countries
succeeded in incorporating these issues into the formal negotiating mandate of the WTO’s
Doha Ministerial Declaration at Qatar in 2001.
The WTO Ministerial Declaration of November 2001 instructed the TRIPS Council
to examine the relationship between the TRIPS Agreement and the CBD (Abbott, 2002a:
489). This is an important development insofar as it constitutes a frank recognition of
conflicts that need to be addressed. It also demonstrates the migration of an issue
developed in the CBD into the WTO; the developing countries’ proposals were derived
from the Bonn Guidelines (Helfer, 2004: 59-62). This is yet another instance of fomenting
strategic inconsistency in order to bring conflicting values into sharp relief.
The 2001 Doha Ministerial Declaration instructed the TRIPS Council to examine
the relationship between TRIPS and the CBD. This relationship has yet to be resolved.
Developing countries have been keen to amend TRIPS so that it will support the objectives
of the CBD (South Centre and CIEL, 2005a:1). Seventeen countries have formed the
Group of Like-Minded Megadiverse Countries, representing between 60 and 70 per cent of
the biodiversity of the planet (South Centre and CIEL, 2005a: 2).17 So-called megadiverse
countries want to halt unauthorized and uncompensated commercialization of their
biological and traditional knowledge resources. They have pressed for TRIPS amendments
that would require member states to disclose the source and country of origin of biological
resources and traditional knowledge and to provide evidence of prior informed consent and
benefit sharing. While states could adopt these policies in national patent systems,
developing countries have argued that without an international agreement national level
laws would do little to stop biopiracy (South Centre and CIEL, 2005a: 8). By contrast, the
US prefers contract law to more global regulation. Alan Oxley, chairman of the Australian
Asia-Pacific Economic Cooperation Study Centre, commented on his Centre’s PhRMAfunded study championing a free market approach and he argued that India and Brazil
sought a “new regime of control” and “unnecessary regulation” (IP-Watch, 2005. 13
December). Susan Finston, Associate Vice President for Intellectual Property for PhRMA,
and Executive Director of the ABIA, expressed objections to Peru’s efforts to regulate
biopiracy and said that it had set up a “bio-piracy Gestapo” (IP-Watch, 2005. 15
December). Jacques Gorlin maintains that bio-piracy regulation mandating patent
disclosure obligations in the Philippines, Colombia, Brazil and Peru have “dilute[d]
property rights and . . . devalue[d] the genetic resources in the ground” (Gorlin, 2006: 4).
Industry staunchly opposes any linkage between patents and benefit sharing and advocates
a contractual approach to benefit sharing (ABIA; checkbiotech.org, 2006).
While implementing a disclosure requirement would not stop all misappropriations
of biological and traditional knowledge resources, it could help to improve the patent
17
Bolivia, Brazil, China. Colombia, Costa Rica, Democratic Republic of Congo, Ecuador, India, Indonesia,
Kenya, Madagascar, Malaysia, Mexico, Peru, Philippines, South Africa, and Venezuela.
45
examination process regarding prior art. A September 2004 submission from Brazil, India,
Pakistan, Peru, Thailand and Venezuela highlighted that beyond prior art, disclosure
requirements would also “be useful in cases relating to challenges to patent grants or
disputes on inventorship or entitlement to a claimed invention as well as infringement
cases” (WTO, 2004, Brazil et al.: para. 5).This would help reduce the prevalence of patents
that lack novelty or an inventive step. While not a panacea, a number of costly and timeconsuming cases of litigation could have been avoided with the disclosure requirements.18
Developing countries would prefer a binding requirement that contains noncompliance penalties through the WTO Dispute Settlement Mechanism, whereas the
European Union has been sympathetic as long as “non-compliance with the requirement
does not affect the validity or enforceability of the granted patent” (Correa, 2005: 6). This
would seem to undercut the purpose of curtailing biopiracy. As Graham Dutfield argues:
to be truly effective, the legal means should be made available to allow
governments to challenge the patent’s legality in the jurisdiction in which it was
granted if they consider a foreign patent they were not notified about may have
been for an invention resulting from resources or traditional knowledge acquired
under their ABS (access and benefit sharing) regulations (2005: 4).
Therefore Dutfield recommends a higher standard than either voluntary or mandatory
disclosure. A third way would be to require “proof of legal acquisition” to connect the
patent system more strongly to the CBD’s access and benefit sharing provisions, especially
for those countries directly providing the resources (Dutfield, 2005: 2).
Dutfield argues that both mandatory disclosure and legal proof of acquisition might
work very well in the context of pharmaceuticals. The non-generic pharmaceutical industry
opposes mandatory disclosure (Smolders, 2005: 2) and has favored contractual
arrangements for bio-prospecting such as the 1991 deal between Costa Rica’s INBIO and
Merck (Reid, et. al. 1993).
At the WTO Hong Kong Ministerial meeting in December 2005, Brazil, India and
Peru aggressively negotiated to include provisions in the final Ministerial text exhorting
the Director General to intensify consultations on outstanding implementation issues –
specifically on the TRIPS-CBD relationship. India argued that without addressing the
disclosure of origin of material in patent applications there would be no development
package (IP-Watch, 2005. 15 December). The US, and global pharmaceutical and
biotechnology companies strongly resisted agreeing to negotiate the disclosure issue (IPWatch, 2005. 17 December).
Peru’s efforts to take a strong position on disclosure seemed to be ironic in light of
the fact that it had just signed a bilateral deal with the US that incorporated the US’s
preferred contractual approach to the issue. The US-Peru bilateral free trade agreement is
TRIPS-Plus and endorses the utilization of contracts for protecting biodiversity. The US
had been negotiating a broader Andean FTA but Colombia and Ecuador broke off
18
E.g., turmeric and camu camu, but not ayahuasca. See Correa, 2005: 3, IP-Watch 28/10/05. Also see
Dutfield, 2005: 5-8 for a skeptical view.
46
negotiations in November 2005 over TRIPS-Plus provisions. The US-Peru FTA disclosure
requirements appear in a “side letter” to the agreement stating that access to genetic
resources and benefit sharing “can be adequately addressed through contracts” (IP-Watch,
2005. 17 December). Some sources at the WTO meeting argued that Peru had sold out and
feared that the contract provisions meant that “companies could negotiate contracts with
indigenous communities without any transparency and in this case without any
requirements to disclose . . . from whom and where they obtained their resources” (IP
Watch. 2005, 17 December). Furthermore the unequal bargaining power of the parties
does not bode well for equitable deals. While Peru had been prominent in pushing for
TRIPS-CBD linkage, critics blamed the US for its strategy of dividing coalitions through
bilateral deals.
The Hong Kong text calls for the WTO General Counsel to review progress and
“take any appropriate action” by July 31, 2006 on implementation issues. The final text
altered the earlier language urging the Director General to “continue with” his consultative
process on implementation issues, such as CBD and geographical indications; the new text
urges him to “intensify” his consultative process. The Indian Minister of Commerce and
Industry, Kamal Nath, was pleased with the new language and with the deadline for review
(IP-Watch, 2005, 18 December).
The Europeans and the Swiss may attempt to link support for disclosure of origin to
progress on geographical indications (South Centre and CIEL, 2004a: 10). The Europeans
have been increasingly adamant about progress on geographical indications in the WTO
(IP-Watch, October 28, 2005). The EU is seeking the establishment of a legally binding
multilateral registration and notification system of geographical indications for wines and
spirits (e.g. Champagne, Bordeaux) and the extension of protection of geographical
indications for products other than wines and spirits (South Centre and CIEL, 2004a: 13).
It appears that the supporters of the TRIPS-CBD linkage and geographical indications may
join forces to achieve their desired outcomes. Swiss and EU proposals in WIPO have been
sympathetic to developing countries’ concerns and may be designed to shore up
developing countries’ support for geographical indications in WTO. The US opposes both
positions and US industry has been particularly energized and vocal in its opposition.
“Industry is concerned that the Swiss and EC proposals in WIPO may provide long-term
legitimacy to those who seek to launch the WTO negotiations” (Gorlin, 2006: 4).
HUMAN RIGHTS
Human rights organizations increasingly have devoted their attention to intellectual
property issues. Under a human rights rubric, intellectual property is recast as “a social
product with a social function and not primarily as an economic relationship” (Chapman,
2002: 867). According to critics of the access campaigns:
By advocating these human rights of access, IP skeptics seek to create a conflict
with intellectual property rights, which give their owners the right to control and
47
exclude others. . . . Since advocates view “human rights obligations” as having
“primacy” over economic policies and agreements, then it follows that intellectual
property rights are secondary, to be treated as limited exceptions (Schultz and
Walker, 2005: 84).
Human rights organizations adopt resolutions, declarations, and reports that are not legally
binding. “In July 2000, an NGO consortium composed of the Lutheran World Federation,
Habitat International Coalition, and the International NGO Committee on Human Rights in
Trade and Investment submitted a statement to the Chair of the Sub-Commission” on the
Promotion and Protection of Human Rights (Helfer, 2004: 49). The statement underscored
fundamental conflicts between TRIPS and human rights. In November 2000, the UN
Committee on Economic, Social, and Cultural Rights held a day- long session on
intellectual property rights, which led to the adoption of a statement in November 2001
endorsing a normative framework for intellectual property rights. The UN High
Commissioner’s report on the impact of TRIPS on human rights addressed the medicines
issue (UNHCHR, 2001). This report endorsed the public health and developing country
activists’ position on TRIPS and highlighted the high cost of patented drugs as a barrier to
health. It also discussed Brazil’s program as a positive model for expanding access to
medicines. In this venue, NGOs, independent experts, and developing countries have
framed the TRIPS rules as “a threat to economic, social, and cultural rights” and have
displayed an antagonistic approach to TRIPS (Helfer, 2004: 46). The Sub-Commission on
the Promotion and Protection of Human Rights has criticized the WTO quite sharply,
stating in one draft report that “the WTO is a ‘veritable nightmare’ for certain sectors of
humanity and criticize[d] WTO rules as ‘grossly unfair’” (Dunoff, 2001: 998). The WTO
Secretariat responded by criticizing the report’s methodology, language, and conclusions,
claiming that they were unsubstantiated by the evidence. The Secretariat suggested “a
meeting with WTO officials to correct the ‘significant misunderstandings’ included in the
report” (Dunoff, 2001: 999). The Sub-Commission has requested that the High
Commissioner for Human Rights seek observer status with the WTO for the ongoing
review of TRIPS (Chapman, 2002: 880).
Patrick Wojahn points out that the right to health is guaranteed under numerous
conventions including Article 12 of the International Covenant on Economic, Social and
Cultural Rights (“ICESCR”), Article 25 of the Universal Declaration of Human Rights,
and Article 11 of the Convention on the Elimination of All Forms of Discrimination
Against Women (2001/2002: 466). Even though the United States has not ratified the
ICESCR, Wojahn argues that the right to health should be considered to be “customary
international law” because 143 states are parties to the Covenant and the right to health is
included in numerous other treaties (2001/2002: 496). The UN human rights bodies have
focused considerable attention on intellectual property issues, spanning public health,
technology transfer, agriculture, indigenous peoples, and cultural dimensions of human
rights. These bodies would like to see human rights concerns prevail over intellectual
property rights. Many of the human rights approaches to health have been developed from
the World Health Organization (Wojahn, 2001/2002: 469), again underscoring the
migration of issues across institutions. This broad human rights rubric is strategic insofar
as it “brings activists on narrower issues into the network of IP skeptics, for example,
48
medical groups with respect to patents and librarians with respect to copyright” (Schultz
and Walker, 2005: 84). It thereby facilitates broader mobilization.
WORLD HEALTH ORGANIZATION
The WHO is a specialized agency of the UN system. Its mandate is to direct and
coordinate authority for health work (Stein, 2001: 497). The WHO has the largest budget
of all the specialized agencies, with an annual budget of “$1.8 billion dollars contributed
by its 193 member states” (Volansky, 2002: 229). Since TRIPS, the WHO increasingly
has been drawn into trade issues, and NGOs have had considerable access to the
institution. In 1999, “the WHO … granted official status to nearly two hundred NGOs”
(Stein, 2001: 498). Even though global pharma has an important voice in the WTO
through its powerful OECD member states that contribute significant funding, the WHO
has been criticized for its “failure to cooperate with the private sector” (Stein, 2001: 498).
The director-general, secretariat, and health expert staff significantly shape agendas and
outcomes.
The WHO has been active in the access to essential medicines campaign (Sell,
2002: 504-06). Governments and NGOs first deliberated in the WHO over the very issues
that led to the Doha Declaration on TRIPS and Public Health. In 1996, public health
activists and developing country member states, including Brazil, South Africa, and
Zimbabwe, expressed concerns about access to medicines in connection with globalization
and TRIPS. The World Health Assembly adopted a resolution on a Revised Drug Strategy
that asked the WHO to examine the impact of the WTO on national drug policies and
essential drugs and to make recommendations for collaboration between the WTO and the
WHO. “This resolution gave the WHO the mandate to publish, in 1998, the first guide
with recommendations to Member States for implementing TRIPS while limiting the
negative effects of higher levels of patent protection on drug availability” (‘t Hoen, 2002:
36). The WHO Essential Drugs Policy concentrates on the supply and use of about 250
drugs that are considered to be the most essential and important for public sector provision.
In 1998, Zimbabwe’s Minister of Health asked Bas van der Heide of the NGO
Health Action International (HAI) to produce a draft resolution for a “Revised Drug
Strategy.” The Revised Drug Strategy is a document designed to assist developing
countries in their health planning and policy implementation. The proposed document
drew from work that HAI had been doing with consumer activist Ralph Nader’s group
CPTech headed by James Love. Van der Heide and Love had crafted language for the
Free Trade of the Americas negotiations advocating compulsory licensing and parallel
importing, as well as stressing the priority of health concerns over commercial interests.
“A small technical group within the WHO began to prepare and distribute concrete
recommendations for coping with TRIPS by using the built-in flexibility to ameliorate the
effects of introducing its requirements. These recommendations included . . . authorizing
parallel importation and granting compulsory licenses where appropriate” (Abbott, 2002a:
474-75). This incensed the non-generic global pharmaceutical industry because the
document endorsed the very practices that this sector was fighting through the USTR.
49
“The U.S. and a number of European countries unsuccessfully pressured the WHO in an
attempt to prevent publication of the guide” (‘t Hoen, 2002: 36). Commercial
pharmaceutical interests felt that the WHO’s involvement in this issue presented a threat to
a trade-based approach. The United States has resisted the WHO’s efforts to help
developing countries gain access to medicines, but the European Communities has shifted
its views in recent years and has become more supportive of the WHO’s role in this area
(Helfer, 2004: 42).
In May 1999, the WHO’s World Health Assembly unanimously enacted resolution
WHA 52.19 calling upon member states to ensure equitable access to essential drugs and
review options under international agreements to safeguard access to these medicines
(WHO, 2000). The WHO continues to pursue strategies designed to increase developing
countries’ access to essential drugs. As Abbott points out:
A number of training seminars regarding TRIPS implementation have been
conducted with public health, patent office, and trade officials. These activities of
WHO remain relatively unpublicized because increased attention would risk
drawing a stronger reaction from Pharma. However, it is becoming substantially
more difficult to find developing country officials who are unaware of
compulsory licensing, parallel importation, and the importance of patent
application reviews (2002a: 475).
In 2001, the WHO adopted two resolutions that addressed the need to strengthen
policies to increase access to medicines and the need to evaluate the impact of TRIPS (‘t
Hoen, 2002: 36). It also published a bulletin highlighting the WHO’s policy guidelines
and urging developing countries to refrain from implementing TRIPS-Plus intellectual
property provisions (Helfer, 2004: 44; WHO, 2001).
In the spring of 2001, the Zimbabwean Ambassador Boniface Chidyausiku
requested a special TRIPS Council session on access to medicines. The session was held
in June. The Quaker United Nations Office in Geneva provided support for developing
country delegates, and a number of legal scholars, economists, and activists provided
technical support (Sell, 2002: 512). As expressed by the Brazilian delegate, the meetings
were intended to “eliminate the imprecision in international agreements concerning public
health. In matters involving public health, developing countries wish WTO judges to
interpret the TRIPS Agreement in a manner that benefits public health” (Viana, 2002:
314). The TRIPS Council resolved to continue analyzing the degree of flexibility afforded
by TRIPS and planned future meetings on the issue. Momentum to address the issue
accelerated throughout the summer and fall. The United States withdrew a WTO
intellectual property case against Brazil, the UN General Assembly held a special session
devoted to the HIV/AIDS pandemic, and UN Secretary-General Kofi Annan announced
the establishment of a Global Fund to Fight AIDS, Tuberculosis, and Malaria (Sell, 2002:
513). In September 2001, the TRIPS Council met again to discuss the access to medicines
issue. The African group presented a draft text for a ministerial declaration on TRIPS and
public health, which emphasized that “[n]othing in the TRIPS Agreement shall prevent
Members from taking measures to protect public health” (‘t Hoen, 2002: 39).
50
In the September preparations for the upcoming WTO Doha Ministerial meeting,
some participants discussed the possibility of WHO/WTO collaboration in preparing a
guide to assist developing countries in implementing TRIPS while protecting public health.
An accidentally-leaked memo provided a WTO critique of WHO’s role (Abbott, 2002a:
475, n. 26). Australia mistakenly included an e-mail message from the then-Director of
Intellectual Property for the WTO, Adrian Otten, in a submission to the TRIPS Council
and then recalled it. The message states:
[T]o be frank, I have my doubts about the wisdom and feasibility of attempting a
joint guide with WHO and this still remains to be seen . . . . I do feel very strongly,
for reasons indicated below, that we should not send it to WHO prior to Doha.
....
I have two major concerns on the TRIPS side. The first and most important is that I
think it unnecessarily risky for the WTO Secretariat to share texts on the TRIPS
Agreement’s provisions on pharmaceuticals with the WHO at this stage . . . . It is
important to recognize that there is a network which includes the leading nongovernmental people, certain people in the WHO Secretariat, . . . and many
developing country delegates and nothing that is given to WHO can be relied
upon to remain confidential. My second concern about TRIPS is that it does not, as
yet, contain a section which discusses the positive impact of the TRIPS Agreement
on public health, namely through promoting research and development into new
drugs.
....
The main messages that we would want to give are: (a) that open trade and a
movement towards more open trade brings with it higher standards of health; and
(b) concerns that the WTO rules will stand in the way of legitimate health measures
19
are unfounded.
Not only does the message reveal a somewhat tense relationship between the two
organizations, but it also clearly incorporates the PhRMA perspective as revealed in
Otten’s “second concern.” Indeed, PhRMA executives have boasted about their close
relationship with and extensive access to the WTO Secretariat (Basu, 2003; Reuters, 2003).
In the run up to the November 2001 WTO Doha Ministerial meeting, human rights
activists supported the WHO’s approach to the medicines issue (Chapman, 2002: 879) and
participated in the access to medicines lobbying process. On September 11, 2001 terrorists
attacked the United States using gas-filled passenger planes as bombs hitting the World
Trade Center’s Twin Towers, the Pentagon and a field in Pennsylvania. The next month,
some media and postal workers in the U.S. died from exposure to anthrax spores sent
through the mail. In the shaken and uncertain climate of late 2001, American policymakers
feared that the anthrax incidents heralded the launch of a major bio-terror attack. Both the
Canadians and Americans threatened to issue compulsory licenses to seize Bayer’s patents
on Cipro to ensure adequate stockpiles of the most effective drug for treating anthrax.
Ultimately neither Canada nor the U.S. followed through on the threat, but just as Brazil
had done in the past, they both negotiated deep price discounts with Bayer.
19. Posting of Mike Palmedo, mpalmedo@cptech.org, to IP-Health Listserv, Adrian Otten Missive on WTO/WHO Cooperation, at
http://lists.essential.org/pipermail/ip-health/2001-September/001900.html (Sept. 21, 2001).
51
On the eve of the November 2001 Doha meeting, everyone was well aware of the
irony that the U.S. had done precisely that for which it had criticized the Brazilians and
harassed the South Africans. Led by the African group and Brazil, a coalition of
developing countries stuck together and insisted that without clarification of the public
health flexibilities in TRIPS and reassurances of immunity from prosecution there would
be nothing to discuss at Doha. Their threat to walk away from the negotiations was
credible, and since the developed countries were so eager to launch a new more
liberalizing round the parties quickly reached agreement on the Doha Declaration on
TRIPS and Public Health (Odell and Sell, 2006). While various stakeholders had different
assessments of the significance of this declaration, developing countries saw it as a
significant victory for their position that TRIPS must not stand in the way of providing
medicines in public health emergencies (Sell 2003: 161-162). While not, by its terms,
legally binding, it largely embraced the WHO and NGO view that TRIPS should not be a
barrier to developing countries seeking access to medicines. This opens the possibility that
the norms expressed in the Doha Declaration could become legally binding either through
a dispute resolution report that so holds or otherwise.20 The African group and its
supporters also sought clarification that nothing in TRIPS should prevent countries from
exporting generic drugs to poor countries, but the Declaration postponed the politically
contentious issue of the ability of generic manufacturers to export drugs to countries
without manufacturing capacity. This was deferred to the so-called Paragraph 6
negotiations at the TRIPS Council. The WTO deadline for resolving that issue came and
went in December 2002. The United States, reflecting the wishes of its brand name
pharmaceutical corporations, stood alone and used its veto to block the interpretation that
21
140 other countries had supported.
Meanwhile, the WHO busily tried to craft
constructive approaches to this issue.
A May 2003 WHO report endorsed the NGO/developing country approaches to the
medicines issue (WHO, 2003). The report emphasized the neglect of tropical diseases, the
Doha Declaration’s recognition that pharmaceutical products require special treatment, and
the negative effects of patent protection on drug pricing. Further, the report recommended
expanded competition as the most effective way to reduce drug prices. The report also
took a critical view of “TRIPS-plus” provisions as being detrimental to health care. The
director-elect of the WHO, Lee Jong-wook, announced measures that will make Brazil’s
AIDS policy the foundation for the WHO efforts in this area. He asked the Brazilian
Health Minister to release Paulo Teixeira, head of the administration’s AIDS program, “to
formulate the new policy for combating AIDS throughout the world, based on Brazil’s
22
experience.”
This represented important recognition of Brazil’s leadership role and
support for the developing countries’ and NGO positions.
20.E-mail from Professor Jeffrey Dunoff, Professor of Law, Temple University, Beasley School of Law, to Susan K. Sell, November 13,
2003 (on file with author).
21. Larry Elliott & Charlotte Denny, U.S. Wrecks Cheap Drugs Deal, THE GUARDIAN, Dec. 21, 2002 (characterizing pharmaceutical
companies’ intense lobbying efforts and Vice President Cheney’s intervention in talks as instrumental in U.S. refusal to relax global patent laws),
available at http://www.guardian.co.uk/international/story/0,3604,864071,00.html.
22. Posting of Mike Palmedo, mpalmedo@cptech.org, to IP-Health Listserv, WHO to Adopt Brazilian Model to Fight AIDS/HIV, FIN.
TIMES LTD., May 21, 2003, available at http://lists.essential.org/pipermail/ip-health/2003-May/004779.html.
52
The May 2003 World Health Assembly meeting on improving access to essential
medicines was particularly volatile. The United States presented a resolution that
neglected even to mention the Doha Declaration and did little more than assert the value of
strong intellectual property protection as a stimulus for innovation.23 The U.S. proposal
further requested the WHO to refer member states to the WTO and WIPO for assistance in
implementing TRIPS obligations.24 Brazil proposed a resolution, supported by Bolivia,
Ecuador, Indonesia, Peru, Venezuela, and South Africa on behalf of the members of the
WHO African Region. The Brazilian proposal reflected developing countries’ concerns
about access to medicines and called for an independent commission to examine the
relationship between intellectual property rights, innovation, public goods, and public
health. The developing countries sought an international committee much like the UK
Commission on Intellectual Property Rights,25 which was critical of overly strong patent
rights as a barrier to access (CIPR, 2002: 22). When it was clear that no one supported the
U.S. resolution, the Brazilian, American, and several African delegations worked out a
compromise that a WHO committee adopted by consensus. The resolution called for the
establishment of a time-limited independent commission, and it omitted any reference to
“TRIPS-Plus” obligations in bilateral and regional trade agreements. NGOs bemoaned the
fact that the developing countries’ proposals had been watered down in the compromise.
However, the Doha Declaration was prominently featured in the resolution, and Member
States were urged to arrive at a solution to the Paragraph 6 Doha Declaration impasse prior
to the Cancun WTO Ministerial in September 2003 (WHO, 2003, May 28).
A TRIPS Council meeting held June 4th through 6th, 2003 ended in a deadlock
over the Paragraph 6 issue. Harvey Bale, President of the Geneva-based International
Federation of Pharmaceutical Manufacturers Associations, stated that there had been no
progress since the talks collapsed in December 2002. He referred to the December
sixteenth draft text as “a license to steal” and claimed that “all research-based companies
26
have problems with December 16.”
However, just before the Cancun Ministerial in September 2003, developing
countries threatened to hold the Round hostage in the absence of a Paragraph 6 agreement.
The United States finally relented in its adamant opposition to developing countries’
proposals for a Paragraph 6 solution. The deal authorized any member state lacking
sufficient pharmaceutical manufacturing capacity to import necessary medicines from any
other member state. This waiver of TRIPS Article 31(f) (restricting compulsory licensing
only to supply one’s domestic market) included procedural safeguards to prevent diversion
of cheap medicines to rich countries’ markets (WTO Council on TRIPS 2003; Matthews,
2004a). Therefore according to the August 30th deal, generic copies of drugs made under
compulsory license can be exported to countries lacking production capacity (WTO, 2003).
23. Posting of Nathan Ford, Nathan.FORD@london.msf.org, to IP-Health Listserv, Sparks Fly Over Patents and Vital Drugs at World
Health Assembly, LANCET, May 31, 2003, available at http://lists.essential.org/pipermail/ip-health/2003-May/004816.html.
24. Posting of Cecilia Oh, ceciliaoh@yahoo.com, to IP-Health Listserv, Third World Network Info. Service, WHO Adopts Resolution on
IPRs and Public Health After Wrangling Over Text, THIRD WORLD NETWORK, May 29, 2003, available at http://lists.essential.org/pipermail/iphealth/2003-May/004815.html.
25. Id.
26. Posting of Mike Palmedo, mpalmedo@cptech.org, to IP-Health Listserv, Richard Waddington, No Shift on Drugs at Trade Talks –
Industry Chief, REUTERS, May 22, 2002, available at http://lists.essential.org/pipermail/ip-health/2003-May/004773.html.
53
The August 30th 2003 decision also included a Chairman’s Statement, emphasizing the
“Members’ ‘shared understanding’ that the Decision will be interpreted and implemented
on a ‘good faith’ basis in order to deal with public health problems and not for industrial or
commercial policy objectives” and their agreement to take steps to prevent drug diversion
to third markets (Matthews, 2004b: 11). According to James Love, Director of CPTech, the
Chairman’s Statement was approved by Pfizer CEO Hank McKinnell and the office of
Karl Rove, President Bush’s Deputy Chief of Staff in charge of policy (Love, 2005). The
Decision also includes a list of 23 countries that agreed to opt out of the system as
importers, 11 awaiting accession to the European Union pledging to use the waiver only in
cases of “extreme emergency” until such time as they gain membership and will then opt
out completely, and finally a group of 13 additional countries that pledged only to use the
waiver in cases of extreme emergency (WTO, WT/GC/M/82, 13 November 2003: p. 7,
para. 29). Many of these countries are concerned about whether they can “opt back in” in
the event of an avian flu pandemic (IP-Watch, 25 October 2005). In the US, Senator
Charles Schumer called for the compulsory licensing of Roche’s Tamiflu to ensure
adequate supplies (Ip-health, 2005, 18 October, Message 15).
By the end of the Doha negotiations, member states needed to decide upon the
permanent status of the Paragraph 6 agreement on compulsory licensing and access to
medicines. The August 30th 2003 Decision was a temporary measure pending final
agreement. The questions that dominated the negotiations over Paragraph 6 on the eve of
December 2005 the WTO Hong Kong Ministerial meeting were: 1) Should the August 30 th
decision be included in Article 31 of TRIPS?; 2) What is the relationship between the
Statement of the Chairman of the General Counsel and the August 30th decision? What is
its legal status?
The African group of countries proposed that the August 30th Decision be
incorporated into Article 31 as an amendment to TRIPS, but recommended that both the
Chairman’s Statement and the annex of the Decision that details “best practices” regarding
packaging and manufacturing drugs to prevent diversion of low-cost medicines to highincome markets be excluded. The African Group argued that the Chairman’s Statement
should not be part of the amendment as it was not part of the August 30th Decision, and
opposed any elevation of the statement’s legal status (WTO, 2005, IP/C/W/440). The
African group suggested that certain measures recommended in the annex on drug
diversion would be costly (Matthews, 2004b: 7). The African group’s proposal received “a
fairly hostile response from developed countries” (South Centre and CIEL: 2004a: 5). In
2004 Mozambique, Zimbabwe, and Zambia issued compulsory licenses for selected
antiretroviral drugs, which helped to underscore the African group’s desire for an enduring
solution (South Centre and CIEL, 2004a: 11). Kenya had tried to issue compulsory licenses
for HIV/AIDS drugs under the waiver, but two European pharmaceutical companies
holding the patents stopped them and offered voluntary licenses instead (IP-Watch, 2005. 6
December). The EU and the United States have insisted that the Chairman’s Statement and
the annex be retained in any amendment. This reflects their concerns about drug diversion.
Informal discussions between the African Group, the US, and the European
Community (with the TRIPS Council Chair, Ambassador Choi Hyuck of Korea present)
angered a number of developing countries. Argentina, Brazil and India protested their
54
exclusion from and the lack of transparency in these deliberations (IP-Health, 2005,
Oct.28). Ultimately the African Group and the United States worked out a compromise. In
the end, delegates voted to adopt the waiver as an amendment to TRIPS that includes
Article 31bis, the waiver, one annex on terms and conditions, and an appendix on the
assessment of pharmaceutical manufacturing capabilities (IP-Watch, 2005, 6 December,
10:53pm). In a rather elaborate compromise arrangement (“choreography”) the Chairman’s
Statement was read aloud and adopted, and developing countries that in 2003 had agreed to
opt out of the waiver except in cases of national emergencies had to restate their
commitment. During the process no one was allowed to embellish his or her remarks in
any way.
Even though the final agreement did not mirror the original African Group
proposal, a number of African delegations were pleased with the outcome. One delegate
expressed relief that the uncertainty generated by the waiver was resolved as it is now a
permanent part of TRIPS (IP-Watch, 2005 6 December 12:36am). Another developing
country delegate said that “political pressure” had led the Africans to soften their stance
and that “the deal was a matter of ‘not losing what you already have’” (IP-Watch, 2005, 6
December, 12:36am). While the US did not succeed in having the Chairman’s Statement
incorporated as a footnote to the text (which would have elevated its legal status), USTR
Rob Portman hailed the agreement as a “landmark achievement” and took credit for
making it happen (IP-Watch, 2005, 6 December, 10:53pm). Non-generic pharmaceutical
companies “welcomed the agreement to maintain ‘anti-diversion measures and other
aspects of the ‘chairman’s statement’” (IP-Watch, 2005, 7 December).
As a number of public health activists and NGOs immediately stressed, the
amendment is disappointing for those advocating easy access to generic medicines. It
comes with numerous conditions that make it difficult to use; this is one reason why not
one country has availed itself of the August 2003 waiver (Doctors Without Borders, 2005,
December 10). CPTech Director James Love stated that “big pharmaceutical companies
and the EU” bullied developing country negotiators into accepting the deal; he referred to
this “awful decision” as being “anti-consumer, anti-competition and anti-free trade”
(CPTech, 2005. 6 December). Many NGOs suspected that developing countries were
pressured into the deal so that WTO members would have something to show after four
years of talks; they further presumed that the US and EU were desperate for a deal to
“deflect attention from their lack of movement in agriculture and their anti-development
proposals in NAMA and Services” (CPTech, 2005, 3 December).
Additionally, Members agreed to grant Least Developed countries an extension
until July 2013 before they are required to comply with TRIPS. Zambia had proposed an
extension through 2020 against the US, Japanese and Swiss preference for reviewing
extensions on a case-by-case basis. The 2013 deadline represents a compromise between
these two approaches. In the meantime, least developed countries may not roll back any
existing intellectual property laws unless they are already more stringent than TRIPS.
Significantly, this decision came about one week before the December 6th TRIPS
amendment agreement. According to one proponent of high standards of IP protection this
was a strategic move designed to provide some results to make the WTO process seem
55
valuable, especially given the fact that no one expected movement on agriculture.
Furthermore, he maintains that this decision took “a lot of hot air out of the activists (sic)
balloon” and lessened “the risk of a disastrous weakening of TRIPS in Hong Kong” (IP
Blog, 2005, 29 November).
The WHO also acknowledged the relevance of human rights and public health in
late January 2006. The WHO’s Executive Board submitted to the World Health Assembly
(its highest decision making body) a resolution to consider a “Global Framework on
Essential Health Research and Development”. Brazil and Kenya supported the resolution,
which recognized the potential for public sector and open source methods of conducting
medical research and development (ip-health; 2006, Feb. 24).
CONCLUSIONS
Even without obvious economic power, the African block, Brazil, India, and their
NGO advocates have begun to make inroads on global intellectual property policy by
strategically shifting forums and advancing new arguments. For instance, the CBD recasts
intellectual property as both an environmental issue and a potential obstacle to sustainable
agriculture. Environmental preservation and the ability of states to feed their own people
are powerful values that can lead people to question the primacy of economic efficiency as
the sole yardstick by which to measure policy effectiveness. Redefining intellectual
property from being a trade issue to a public health issue resulted in the Doha Declaration.
This has opened up an important space for debate on the costs and benefits of intellectual
property protection as enshrined in TRIPS. Recasting intellectual property as a human
rights issue could be an effective strategy to the extent that intellectual property rights are
implicated in battles over the rights to food, medicines and educational materials. No
single “reframing” alone will open up the dialogue and change global policies, but
cumulative concerted efforts from a variety of angles could to a more balanced approach to
intellectual property rights
Soft and hard law developed in non-WTO venues via developing countries’
strategic forum shifting has enhanced their bargaining power within the WTO and WIPO.
Developing countries and their NGO supporters deliberately promoted issue migration, on
health from the WHO to the WTO, and on human rights and indigenous people to WIPO:
[Strategic forum shifting] facilitates a proactive negotiating strategy, enabling
governments and NGOs to coordinate their efforts around hard and soft law
proposals first vetted and refined in other international venues. This integrationist
approach also allows states to justify their demands for reform by invoking rules
and principles endorsed by officials of intergovernmental organizations and by
legal and technical experts. Support from these seemingly neutral actors gives the
demands the imprimatur of legitimacy. And it allows proponents to frame their
arguments as rational efforts to harmonize potentially inconsistent treaty
obligations and soft law standards that many states have agreed to, rather than as
self-interested attempts to distort trade rules or to free ride on foreign creators or
inventors. Seen from this perspective, even the soft law intellectual property
56
standards generated in the biodiversity . . . public health, and human rights regimes
have hard-edged consequences. They act as progenitors of proposals to revise
legally binding rules within the WTO and WIPO (Helfer, 2004: 61).
Returning to issues raised at the outset, it is important to bear in mind the
relationships among international institutions. Given the fact that the WTO embodies hard
law, it exists in somewhat of a hierarchical relationship compared to its soft law
counterparts. Beyond the hard/soft law distinction, the WTO has cooperated more
extensively with those international institutions (IMF and World Bank) that share its basic
pro-market philosophy (Dunoff, 2001: 999). Indeed, the WTO also has expressed some
overt antagonism toward both the WHO and the UNHCHR. International organizations
involved in intellectual property issues are divided over the merits of diverse multilateral
approaches to intellectual property protection. The WTO and WIPO seem to champion the
interests of property holders over property users (or producers over consumers), whereas
the CBD, the FAO, the human rights organizations, and the WHO promote approaches that
at the very least seek to balance the rights of producers and consumers. These divisions
provide opportunities for developing countries and NGOs to change the agenda by
reframing issues in ways that enlarge their scope of action. While the WTO and WIPO
seem to represent both the economically and politically most powerful, the work of the
WHO, the FAO and the CBD can have an impact on the work of these other agencies.
Nonetheless, since much of the debate over TRIPS interpretations will be discursive
(Shaffer, 2004a: 476), “soft law will be an important tool for WTO panels to use in
resolving . . . arguments [over competing objectives]” (Helfer, 2004: 77). While the
deliberate generation of counter-regime norms in alternative forums has many benefits, it
also risks the injection of further uncertainty and incoherence into efforts at global
governance of intellectual property (Helfer, 2004: 75). Without authoritative guidelines
for resolving such issues, it may facilitate outcomes that favor the structurally powerful at
the expense of others.
OBSTACLES
Focusing on TRIPS and the letter of the law, one may conclude, as does Helfer,
that states implementing their TRIPS requirements in good faith are unlikely to have their
laws challenged successfully (2002: 34). However, public international law such as TRIPS
is embedded in a broader context of asymmetrical power relationships between developed
and developing countries, and between producers and consumers of the fruits of
intellectual property. This context reduces the amount of leeway that poor states have in
devising regulatory approaches that are most suitable for their individual needs and stages
of development.
One of the most important assets for developing country negotiators in the WTO is
peripheral vision to stay abreast of the proliferation of intellectual property policymaking
in diverse institutional settings. The US and the EU have been able to exploit resource
disparities and shift forums whenever it suits their interests. This holds true of the shift
from WIPO to WTO and back again, as well as the shifting between multilateral, bilateral
57
and regional negotiations. The biggest threat to any gains that developing countries may
bargain for, or even achieve, in the Doha round of trade negotiations lies outside of the
WTO. At the end of the Uruguay Round negotiators did not share consensual assessments
of TRIPS. Negotiators from the United States and the European Union tended to see
TRIPS as a floor – a minimum baseline for intellectual property protection. By contrast,
developing country negotiators saw it more as a ceiling – a maximum standard of
protection beyond which they were unwilling and/or unable to go.
Given this perspective, it should come as no surprise that the U.S. and the EU
aggressively have been pursuing efforts to ratchet up TRIPS standards, to eliminate TRIPS
flexibilities and close TRIPS loopholes. Playing a multi-level, multi-forum governance
game, countries like the United States have been able to extract a high price from
economically more vulnerable parties eager to gain access to large, affluent markets
(Abbott, 2005: 350-354; Correa, 2004; Vivas-Eugui, 2003). Bilateral Investment Treaties,
Bilateral Intellectual Property Agreements, and regional Free Trade Agreements concluded
between the U.S. and developing countries, and between the Europe Union and developing
countries invariably have been TRIPS-Plus (Drahos, 2001; Dutfield, 2003b). For example
in the intellectual property provisions covering agriculture in these agreements, developing
countries are most often required to ratify or accede to UPOV91 as their sui generis system
of protection, and “to undertake ‘all reasonable efforts’ to make patent protection available
for plants” (South Centre/CIEL, 2004: 12).
In recent years developing countries have begun to challenge this discrepancy
between the multilateral rules and the TRIPS-Plus standards proposed in regional and
bilateral agreements. In late 2005, Ecuador and Colombia broke off talks with the US over
TRIPS-Plus issues and had refused to agree to TRIPS-Plus standards. However, in late
February 2006 the US and Colombia concluded an agreement that includes TRIPS-Plus
standards despite the best efforts of some Colombian negotiators to counteract them
(USTR, 2006; Ip-Watch, 2006e). In Russia’s simultaneous negotiations for its accession to
the WTO as well as for a bilateral deal with the United States, Russia’s lead negotiator on
WTO accession, Maxim Medvedkov, has endorsed TRIPS but has balked at the TRIPSPlus demands. He stated that “I think we have to draw a line between WTO and bilateral
issues” (IP-Watch, 2005. 24 October). This reflects Russia’s view of TRIPS as a ceiling
and not a floor.
According to Peter Drahos the US and its IP activist industries have been engaged
in a “one-way ratchet” for intellectual property systematically obtaining higher levels of
protection (Drahos, 2004: 55-61). As the International Chamber of Commerce points out,
“the chain of national intellectual property laws will only be as strong as its weakest link,
and the ability to meaningfully enforce rights will be crucial” (ICC, 2005: 13). Nothing in
TRIPS prevents states from adopting stronger forms of protection, and the US and its
industries increasingly are coordinating enforcement through a number of venues. Industry
representation in the USTR advisory committees (IFAC-3 and IFAC-15), overlapping
memberships in industry associations such as the Business Software Alliance (BSA) and
the International Intellectual Property Alliance (IIPA), and ad hoc mobilization vehicles
such as ABIA increase the information exchange among private actors and the USTR to
58
monitor compliance, negotiate and enforce TRIPS-Plus deals and lobby at national and
multilateral levels. For example, Microsoft is a member of the IIPA, BSA and IFAC-3
(Drahos, 2004, 69). This thick network has resulted in a centralized system of private
governance that enlists the USTR for legitimation and enforcement and heightens
opportunities for rent-seeking (Drahos, 2004: 77).
A particularly pernicious example of this is the Gleevec case in South Korea.
Gleevec is a leukemia drug that was developed with assistance from the US Orphan Drug
Act, under which the US government paid for 50% of the private sector costs of clinical
trials (Ip-health, 2001). Swiss drug maker Novartis owns the patent. The drug costs
roughly $27,000 per year per patient in the U.S., keeping it out of reach of most. In late
2001 Novartis suspended supply of Gleevec to South Korea because Novartis failed to get
the price it sought from the South Korean government. The US, Swiss and Japanese had
accepted the price of US$19.50 per pill27 during the Novartis-South Korean negotiations.
Novartis directly approached Korean leukemia patients offering them a co-payment
exemption if they would convince the South Korean government to accept that price. The
patients refused. Rather than negotiating a lower price, the South Korean government
sought to contain costs by excluding chronic phase chronic myelogenic leukemia (CML)
patients from insurance coverage. Hae-joo Chung, Director of Equipharm project, issued a
plea on behalf of the People’s Health Coalition for Equitable Society for global consumer
and health groups to endorse its quest to get the South Korean government to restart
negotiations with Novartis and resume supply – even if meant resorting to compulsory
licensing in line with the Doha Declaration on TRIPS and Public Health (Ip-health, 2001).
These health groups appealed to the Korean Intellectual Property Office and requested
adjudication for the grant of a non-exclusive license to import generic Gleevec from India
for the public interest because Korean CML patients were imperiled by unstable supplies
and high prices (Ip-health, 2003).
While Novartis is a Swiss company, the USTR supported Novartis in this case.
Facing declining profitability in the European market, makers of potentially high profit
drugs like Gleevec are turning to emerging middle income markets in Asia and Latin
America to make up the difference (Benvenisti and Downs, 2004). In order to ensure the
success of this strategy they must fend off generic challengers in these markets. As
Benevisti and Downs suggest, the USTR intervened on behalf of Novartis in order to
“prevent a precedent that might eventually damage the profitability of products
manufactured by its own firms” (2004). Indeed, the Korean decision to reject the generic
importation option under compulsory license incorporated the very language that USTR
Robert Zoellick had been promoting in his efforts to limit the scope of the Doha
Declaration on TRIPS and Public Health. The Korean government denied the petition on
the grounds that CML was neither “infectious” nor likely to cause “an extremely
dangerous situation in our nation” (Ip-health, 2003; Abbott, 2005: 328-336). As James
Love of CpTech remarked, “’the U.S. government does not control the price of drugs in its
own country but it is telling Korea what they should charge’” (quoted in Benevisti and
Downs, 2004). This example highlights the intrusive reach of what Drahos calls the
“nodal enforcement pyramid” that global IP-based firms and their governments deploy
27
Daily dosages range from 4 to 8 pills a day.
59
(2004). Asymmetrical power relations and the political influence of global high-technology
industries continue to shape intellectual property policy. Given the expansion of
intellectual property rights and unequal distribution of economic and political power across
the globe, developing countries face new challenges in navigating the system to their
benefit.
OPPORTUNITIES
The foregoing has important implications for the various access campaigns and
intellectual property governance more generally. The access to medicines campaign, in
particular, has provided several important lessons. Reframing issues can be an effective
way of creating space for debate and reconsideration of the conventional wisdom. By
recasting intellectual property as a public health issue, policy makers increasingly are
forced to confront the unconscionable trade off between economic gain and unnecessary
death. This has raised the political costs for those seeking to defend the status quo. “In a
world of asymmetric power, developing countries enhance the prospects of their success if
other U.S. and European constituencies offset the pharmaceutical industry’s pressure on
U.S. and European trade authorities to aggressively advance industry interests” (Shaffer,
2004a: 450). When brought to light through public action and media attention, the use of
economic coercion to reduce access to medicines can become “politically unpalatable for
U.S. and EC government and corporate elites” (Shaffer, 2004a: 476; Sell and Prakash,
2004: 163-65). By mobilizing to reduce domestic political support for the status quo in the
most economically powerful and influential countries, “developing countries retain greater
leeway to formulate intellectual property policies to fit their own needs” (Shaffer, 2004a:
481).
Developing countries will need considerable support to enable them to resist
pressures to adopt TRIPS-Plus provisions in bilateral and regional agreements.
Highlighting the unintended and devastating consequences of particular policies can be a
powerful rhetorical strategy. The HIV/AIDS pandemic underscored just how costly
overly-strong patent protection can be. The anthrax/bio-terror threat in the United States
led American policy makers to threaten compulsory licensing of Bayer’s Cipro to ensure
adequate supplies. The access to medicines campaign capitalized on this hypocrisy and it
softened the American stance at Doha. Additionally, the SARS epidemic of spring 2003
led to an expansion of the WHO’s mandate and a further empowerment of NGOs within
the public health context. In May 2003, the WHO assembly approved changes to
international health regulations to strengthen the WHO’s ability “to respond to global
public health threats based on information from non-government sources.”28 The looming
avian flu situation has also prompted intensive discussion about access to Roche’s Tamiflu
and alternative ways of making it widely available in the event of a catastrophic worldwide
pandemic.
28. Posting of Mike Palmedo, mpalmedo@cptech.org, to IP-Health Listserv, Frances Williams, WHO to Gain Advisory Role on
Pharmaceutical Patents, FIN. TIMES, May 28, 2003, available at http://lists.essential.org/pipermail/ip-health/2003-May/004803.html.
60
Developing countries should do what they can to preserve their autonomy in
adopting intellectual property policies that suit their levels of development. They should
resist TRIPS-Plus initiatives in bilateral and regional trade and investment agreements,
insisting upon TRIPS as their maximum standard. They should seek out technical
assistance that encourages them to use existing TRIPS flexibilities. They also need to
participate in global standard-setting exercises concerning competition policy and address
the way that they would like to regulate foreign firms' acquisition of local firms (Barton
2003: 14). Promoting genuine competition is an important policy objective. At the national
level, developing countries should pursue vigorous competition legislation. Competition
law can provide an important check on abuses of intellectual property rights. Even though
the Reagan administration gutted American antitrust practice with respect to intellectual
property rights in the name of competitiveness, consumer groups and developing countries
can lobby for competition policies that check the abuses of the new “global knowledge
cartels” (Drahos and Braithwaite, 2002: 206). Indeed, for most of the twentieth century
American antitrust laws kept patent power in check (Sell, 2003: 5-6). Competition policies
can facilitate healthy markets and keep costs down. Technical assistance directed to this
end would be invaluable.
In order to reduce some of the power asymmetries, it would be helpful to
institutionalize expertise and technical support for developing country delegations in
Geneva. Drahos has suggested the establishment of a “counter Quad” for developing
countries that would function somewhat like the Cairns Group of agricultural exporters
(2003: 96). The idea would be to provide continuity and technical support on diverse
issues to help balance information and expertise asymmetries between the resourceabundant delegations and most of those from developing countries. This expertise would
need to be provided by developing countries’ representatives and experts eager to protect
developing countries’ interests. Support provided by the Quaker United Nations Offices in
Geneva during the negotiations over the Doha Declaration on TRIPS and Public Health is
a good example of this latter type of assistance. UNCTAD, in conjunction with ICSTD,
also has assembled a panel of intellectual property experts that have helped craft reports
and documents to assist developing countries’ negotiators in negotiating intellectual
property issues. Developing countries could use their own version of the industry-led IPC
and ABIA to counteract foreign pressure.
Developing countries also could exploit the domestic critiques of the American
patent system, as documented by Jaffe and Lerner (2004). In large measure the U.S. is
seeking to universalize its own patent system. To the extent that the existing system is
pathologically flawed, as critics contend, negotiators can challenge the adoption of the
system elsewhere. At WIPO’s Open Forum on the Draft Substantive Patent Law Treaty
(SPLT) in March 2006, a number of commentators pointed out pervasive problems with
the U.S. system. For example, Duke Law Professor Jerome Reichman pointed out that ”no
one in the developed world at the moment really knows what a proper functioning patent
system for the twenty-first century should look like. . . . [T]he United States’ patent system
is in a dreadful mess and badly needs reform” (2006: 6). Given this state of affairs it makes
no sense to try to impose this “dysfunctional” system on the rest of the world (Reichman,
2006: 14). Argentine economist Carlos Correa warned that developing countries would be
61
harmed if induced to import a patent regime increasingly seen as “malfunctioning in
developed countries, and often stifling rather than promoting innovation” (Correa, 2005b:
7). This critical perspective is not limited to a handful of professors; indeed, the U.S.
Federal Trade Commission and the National Academies have both issued highly critical
reports of the current system (Federal Trade Commission, 2003; National Research
Council, 2004).
Developing countries should also exploit differences between the U.S. and the EU
over such issues as software patents, business method patents (neither of which the EU
allows; Reichman, 2006), as well as their different positions on geographical indications
and disclosure. Developing countries may be able to solicit EU support for a mandatory
disclosure requirement in exchange for supporting the EU’s geographical indications
proposals. Developing countries may be able to exploit US and EU differences over price
controls for pharmaceuticals (Abbott, 2005). Furthermore, in the FTA context, developing
country negotiators may be able to identify American industry allies that also object to
high pharmaceutical prices. Large employers like General Motors have to pay increasingly
high rates for medical plans for their employees and escalating prescription drug prices are
a substantial component of the burden. Developing countries need to maintain coalition
solidarity and resist US efforts to “divide and rule” (Odell, 2006).
As far as access to educational materials is concerned, Ruth Okediji advocates an
international principle of fair use, or fair dealing, to maintain limitations on copyright.
Restrictions on copyright for educational purposes and for the dissemination of scientific
information are important components of economic development and innovation.
Reproduction and translation rights “operate in tandem as barriers to access in developing
countries” (Okediji, 2005: 24). Limits and exceptions to copyrights are “important strategic
and doctrinal tools to facilitate economic development by providing citizens with the basic
means to engage in intellectual endeavors and to participate in the global knowledge
economy” (Okediji, 2005: 40). For copyright, CPTech has recommended the formation of
collective management organizations in order to facilitate access to copyrighted works
(CPTech, 2002). Open source options such as Linux and Creative Commons licenses are
important tools to expand access.
Many commentators have advocated private-public partnerships to develop and
disseminate medicines, copyrighted works and crop technologies. An example of a global
private-public partnership is the Global Alliance for Vaccines and Immunizations (GAVI)
launched by Bill Gates, together with the executive heads of WHO, UNICEF, the World
Bank and Merck & Co (Buse, 2002: 51). Critics of these arrangements argue that they give
private sector actors special access to U.N. decision making without corresponding access
for recipient countries and marginalized groups (Buse, 2002: 60). In health the privatepublic partnerships often are designed to discourage the use of compulsory licensing,
stressing instead long-term drug donation programs or programs such as the Bristol-Myers
Squibb and UNAIDS’ “Bridging the Gap” in southern Africa (Buse, 2002: 35). The
Accelerating Access Initiative, a joint effort between U.N. agencies and five major
pharmaceutical companies, to provide discounted AIDS drugs was launched after intense
public outcry and in an effort to head off debates over differential pricing and compulsory
licensing (Kapczynski et al, 2005). Critics worry that these arrangements may create long-
62
term dependence and/or vulnerability.
public goods.
In any case, they are no panacea for providing
Ever since the passage of the Bayh-Dole Act of 1980, when American universities
could patent the fruits of federally funded research, they have had incentives to assert
proprietary rights over their innovations. Universities play an important role in innovation.
They may feel caught between the conflicting imperatives of attracting private sector
funding and generating revenue through patenting activity on the one hand, and promoting
public goods through “humanitarian IP” policies on the other. The choices may not be so
stark, and there may be ways to navigate the contours of the current system to better
balance competing imperatives. Universities could play a significant role in preserving the
balance between exclusion and access. Land grant universities must continue to make
available the fruits of their research to those who need it most on terms that the recipients
can live with (Schuh, 2004: 359-371). For example, in the medicines sector, there could be
clauses in agreements to allow a university to sub-license to generic manufacturers if its
patent conflicts with efforts to distribute affordable drugs for HIV/AIDS victims in subSaharan Africa. Rai and Eisenberg offer a modest and sensible suggestion that for
publicly-funded research “decisions about the dividing line between the public domain and
private property should be made by institutions that are in a position to appreciate the
tensions between widespread access and preservation of commercial incentives without
being unduly swayed by institutional interests that diverge from the overall public interest”
(2003: 303). In other words, they argue that public funding agencies should decide what
fruits of their investments to patent. They also advocate addressing the upstream
/downstream research tool issue by devising “a system that distinguishes cases in which
proprietary claims make sense from cases in which they do not” (Rai and Eisenberg, 2003:
303). Research tool exemptions would be useful to help to preserve the domain of open
science.
In biotechnology a number of projects and experiments are currently underway and
are modeled after the open source software movement. Stephen Maurer, Arti Rai and
Andrej Sali have advocated an open source drug discovery approach to reduce costs of
drugs designed for tropical diseases (Maurer, et. al: 2004). A number of universities have
granted the nonprofit drug company OneWorld Health exclusive licenses to compounds
and medicines (Kapczynski et al: 2005). Amy Kapczynski, Samantha Chaifetz, Zachary
Katz, and Yochai Benkler have worked on a model Equitable Access License at Yale
University under the auspices of Universities Allied for Essential Medicines (Kapczynski
et. al: 2005). An Australian initiative, Biological Innovation for Open Society (BIOS) 29 has
adapted the free software movement to agricultural biotechnology to catalyze a new selfsustaining commons for researchers. BIOS aims to create portfolios of essential research
tools and to license them under a license modeled after the GNU General Public License
(GPL) (Kapczynski et al: 2005). Richard Jefferson, scientist and initiator of BIOS, stated
that, “’so much of what we want to do is all tied up in somebody’s intellectual property. . .
. It’s a complete sclerotic mess, where nobody has any freedom of movement. Everything
that open source has been fighting in software is exactly where we find ourselves now with
29
http://www.bios.net
63
biotechnology’” (quoted in Kapczynski et al: 2005). Jefferson has created two technologies
that circumvent proprietary tools for biotechnological crop improvement. One of these
technologies, a method for introducing new genes into plants, bypasses numerous patents
and has been successfully used in a Chinese project to create transgenic rice lines
(Feldman, 2004: 127). The Public Intellectual Property Resource for Agriculture (PIPRA)
seeks to facilitate the development and dissemination of crops for developing countries and
promote commons-based crop development.30 In addition to these efforts to try to reclaim
the commons and facilitate access, some have promoted the concept of awarding prizes for
innovation and developing R&D treaties to require contributions toward the development
of neglected public goods (Hubbard and Love, 2004).
One very broad-based movement is the support for an “access to knowledge” treaty
that would begin to construct an alternative framework for intellectual property.31 This
treaty initiative came out of WIPO’s decision to examine proposals for a development
agenda in 2004 (Drahos, 2005: 15). As Drahos suggest, “the crucial conceptual move . . .
would be for the treaty to link the instrumental status of intellectual property to the
promotion of . . . basic rights” such as the rights to food, health, and education (Drahos,
2005: 17). In other words it would be targeted at restoring intellectual property’s status as a
servant of broader goals rather than the master (as it seems to be today). Casting the treaty
effort as a human rights approach might work insofar as it is a familiar norm that states
already have publicly committed to. As Rosemary Coombe points out, “social networks
are becoming more vocal . . . and link together hitherto unimagined coalitions of
environmentalists, feminists, farmers, food and health activists, indigenous peoples, and
religious groups in the articulation of alternative moral economies of value” (Coombe,
2004). Cross-sectoral mobilization and the broadening of participation under a common
frame are necessary if champions of an alternative are to prevail. While the different access
campaigns have different particular concerns, they could unite under an access to
knowledge banner.
30
http://www.pipra.org
31
http://www.cptech.org/a2k/
64
References
Abbott, Frederick, 2000. “Distributed Governance at the WTO-WIPO: An Evolving Model
for Open-Architecture Integrated Governance” Journal of International Economic Law 3:
63
Abbott, Frederick, 2002a. “The Doha Declaration on the TRIPS Agreement and Public
Health: Lighting a Dark Corner at the WTO” Journal of International Economic Law 5:
Abbott, Frederick, 2002b. “Compulsory Licensing for Public Health Needs: the TRIPS
Agenda at the WTO after the Doha Declaration on Public Health,” Occasional Paper 9.
February. Geneva: Quaker United Nations Office. http://www.afsc.org/quno.htm
Abbott, Frederick, 2004. “The Doha Declaration on the TRIPS Agreement and Public
Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreements”
Quaker United Nations Office, Occasional Paper 14 (April).
http://www.quno.org
Abbott, Frederick, 2005. “The WTO Medicines Decision: World Pharmaceutical Trade
and the Protection of Public Health” American Journal of International Law 99: 317-358.
ActionAid International, 2006. “Under the Influence: Exposing Undue Corporate Influence
over Policy-Making at the World Trade Organization” at: http://www.actionaid.org
Albin, Cecilia, 2001. Justice and Fairness in International Negotiation Cambridge:
Cambridge University Press.
Alvarez, Jose, 2001. “Trade and the Environment: Implications for Global Governance:
How Not to Link: Institutional Conundrums of an Expanded Trade Regime” Widener Law
Symposium Journal 7: 1
Alvarez, Jose, 2002a. “The WTO as Linkage Machine” American Journal of International
Law 96: 146
Alvarez, Jose, 2002b. “Foreword: the Boundaries of the WTO” American Journal of
International Law 96: 1
American BioIndustry Alliance, 2005: “Views on the Establishment of an ABS/IR”
(October 12). http://www.abialliance.com
Aoki, Keith 2003. "Weeds, Seeds & Deeds: Recent Skirmishes in the Seed Wars", 11
Cardozo Journal of International and Comparative Law (Summer): 247.
Arup, Christopher, 1998. “Competition Over Competition Policy for international Trade
and Intellectual Property” Prometheus, 16: 367-81.
65
Attaran, Amir and Lee Gillespie-White, 2001. “Do Patents for Antiretroviral Drugs
Constrain Access to AIDS Treatment in Africa? Journal of the American Medical
Association 286: 1886-1892.
Baker, Andrew, 2000. "Globalization and the British 'Residual' State" in Richard Stubbs
and Geoffrey Underhill eds. Political Economy and the Changing Global Order 2nd ed.
(Oxford: Oxford University Press): 362-372.
Barton, John 2003. “Nutrition and Technology Transfer Policies”, UNTAD/ICTSD
Capacity Building project on Intellectual Property and Sustainable Development”
(August). http://www.iprsonline
Basu, Sanjay, 2003. “Patents and Pharmaceutical Access” May 29.
http://www.zmag.org/content/showarticle.cfm?ItemID=3694
Bate, Roger and Richard Tren, 2003. “Do NGOs Improve Wealth and Health in Africa?
http://www.aei.org/docLib/20030612_batepub.pdf
Benvenisti, Eyal and George Downs, 2004. “Distributive Politics and International
Institutions: the Case of Drugs” Case Western Reserve Journal of International Law 36:
21-52.
Bhagwati, Jagdish, 2002. “Afterword: The Boundaries of the WTO: the Question of
Linkage” American Journal of International Law 96: 126
Bloche, Greg, 2002. “WTO Deference to National Health Policy: Toward an Interpretive
Principle” Journal of International Economic Law 5: 825
Bond, Patrick, 1999. “Globalization, Pharmaceutical Pricing, and South African Health
Policy: Managing Confrontation with U.S. Firms and Politicians” International Journal of
Health Services 29, 4: 765-792.
Boyle, James, 1992."A Theory of Law and Information: Copyright, Spleens, Blackmail,
and Insider Trading", California Law Review 80: 1415-1540.
Braithwaite, John and Peter Drahos, 2000. Global Business Regulation Cambridge:
Cambridge University Press.
Busaniche, Beatriz, 2005. Interview with Beatriz Busaniche, Seedling October.
http://www.grain.org/convergence/?id=103
Buse, Kent et. al. 2002. “Globalisation and Health Policy: Trends and Opportunities” in
Kelly Lee et al eds., Health Policy in a Globalising World Cambridge: Cambridge
University Press
Calfee, John, 2003. “Patently Wrong: Free Drugs are No Panacea for Poor Nations”
66
Washington Times January 28: A21.
Carrier, Michael 2003. "Resolving the Patent-Antitrust Paradox through Tripartite
Innovation", 56 Vanderbilt Law Review 1047.
Case, Mary M. 2005. “Increasing Concentration in the Publishing Industry: A Recent
History of Publisher Mergers and pricing in the Literature of Science, Technology,
Medicine and Law” (power point presentation on file with author).
Cerny, Philip, 2000. "Political Globalization and the Competition State", in Richard Stubbs
and Geoffrey Underhill eds, Political Economy and the Changing Global Order 2nd ed.
(Oxford: Oxford University Press): 300-309.
Chapman, Audrey, 2002. “The Human Rights Implications of Intellectual Property
Protection” Journal of International Economic Law 5: 861
Charnovitz, Steve, 2002. “The Legal Status of the Doha Declaration” Journal of
International Economic Law 5: 207
Checkbiotech.org, 2006. “Biotech Firms form alliance TRIPS” January 10.
http://www.checkbiotech.org
Coleman, William and Melissa Gabler, 2002. “Agricultural Biotechnology and Regime
Formation: a Constructivist Assessment of the Prospects” International Studies Quarterly
46: 481-506.
Commission on Intellectual Property Rights, 2002. Integrating Intellectual Property
Rights and Development Policy
http://www.iprcommission.org/papers/text/final_report/reportwebfinal.htm.
Comor, Edward. 2001. “The Role of Communications in Global Civil Society: Forces,
Processes, Prospects” International Studies Quarterly 45
Consumer Project on Technology, 2005. “Statement of CPTech on TRIPS Amendment” 6
December 2005, http://www.cptech.org/ip/wto/p6/cptech12062005.html
Consumer Project on Technology, 2005. “WTO Members Should Reject Bad Deal on
Medicines: Joint Statement by NGOs on TRIPS and Public Health” 3 December.
http://www.cptech.org/ip/wto/p6/ngos12032005.html
Consumer Project on Technology, 2002 “CPTech’s Page on Collective Management of
Copyrights” http://www.cptech.org/cm/copyrights.html
Consumer Project on Technology, 2000. “Background Information on fourteen FDA
Approved HIV/AIDS Drugs” June 8. http://www.cptech.org/ip/health/aids/druginfo.html
67
Consumer Project on Technology et al., 2001. “Comment on the Attaran/Gillespie-White
and PhRMA Surveys of Patents on Antiretroviral Drugs in Africa, October 16.
http://www.cptech.org/ip/health/africa/dopatentsmatterinafrica.html
Coombe, Rosemary, 1998. “Intellectual Property, Human Rights and Sovereignty: New
Dilemmas in International Law Posed by the Recognition of Indigenous Knowledge and
the Conservation of Biodiversity” Indiana Journal of Global Legal Studies 6.
Coombe, Rosemary, 2004. “Commodity Culture, Private Censorship, Branded
Environments, and Global Trade Politics: Intellectual Property as a Topic of Law and
Society Research” Austin Sarat, ed. The Blackwell Companion to Law and Society Malden,
MA.: Basil Blackwell: 369-391.
Correa, Carlos, 2002. “TRIPS and Access to Medicines: Internationalization of the Patent
System and New Technologies” Wisconsin International Law Journal 20: 523
Correa, Carlos, 2004. “Investment Protection in Bilateral and Free Trade Agreements:
Implications for the Granting of Compulsory Licenses” Michigan Journal of International
Law 26: 331-53.
Correa, Carlos, 2005a. “The Politics and Practicalities of a Disclosure of Origin
Obligation”, Quaker United Nations Office, Occasional Paper 16 (January).
http://www.geneva.quno.org
Correa, Carlos, 2005b. “An Agenda for Patent Reform and Harmonization for Developing
Countries”, prepared for the Bellagio Dialogue on “Intellectual Property and Sustainable
Development: Revising the agenda in a new context”, International Center for Trade and
Sustainable Development ) ICTSD) 24-28 September. Bellagio, Italy. On file with author.
Crawford, Neta, 2002. Argument and Change in World Politics: Ethics, Decolonization
and Humanitarian Intervention, Cambridge: Cambridge University Press.
Doern, Bruce, 1999. Global Change and Intellectual Property Agencies N.Y.: Routledge
Doctors Without Borders, 2005. “The Second Wave of the Access Crisis: Unaffordable
AIDS Drug Prices Again” December 10. available at:
http://www.doctorswithoutborders.org/news/hiv-aids/briefing_doc_12-10-2005.
Drahos, Peter, 2001. “BITS and BIPS: Bilateralism in Intellectual Property” Journal of
World Intellectual Property Law 4, 6 (November).
Drahos, Peter, 2002. “Developing Countries and Intellectual Property Standard-Setting”
Journal of World Intellectual Property 5, no. 5: 765-789.
Drahos, Peter and John Braithwaite, 2002. Information Feudalism, London: Earthscan
Publications, Ltd.
68
Peter Drahos, 2003. “When the Weak Bargain with the Strong: Negotiations in the World
Trade Organization” International Negotiation 8: 79Drahos, Peter. 2004. “Securing the Future of Intellectual Property: Intellectual Property
Owners and their Nodally Coordinated Enforcement Pyramid” Case Western Reserve
Journal of International Law 36:1: 53-78.
Drahos, Peter, 2005. “An Alternative Framework for the Global Regulation of Intellectual
Property Rights” Centre for Governance of Knowledge and Development, Working Paper.
Regulatory Institutions Network, the Australian National University.
http://cgkd.anu.edu.au/menus/workingpapers.php
Dunoff, Jeffrey, 2001. “”The WTO in Transition: Of Constituents, Competence and
Coherence” George Washington International Law Review 33: 979
Dutfield, Graham. 2005a. “The US and Europe are ‘Intellectual Property
Fundamentalists”, SciDev.Net, March 11. http://www.scidev.net/dossiers
Dutfield, Graham. 2005b. “Thinking Aloud on Disclosure of Origin” Quaker United
Nations Office, Occasional Paper 18 (October).
Dutfield, Graham, 2003a. Intellectual Property Rights and the Life Science Industries
(Aldershot, UK: Ashgate Publishing Limited).
Dutfield, Graham. 2003b. "Sharing the Benefits of Biodiversity: Is There a Role for the
Patent System?" Journal of World Intellectual Property
Dutfield, Graham, 2003c. “Should We Terminate Terminator Technology?” European
Intellectual Property Review, 491-495,
Dutfield, Graham, 2002. “Trade, Intellectual Property and Biogenetic Resources: A Guide
to the International Regulatory Landscape” http://www.quno.org
Eisner, Marc, 1991. Antitrust and the Triumph of Economics: Institutions, Expertise, and
Policy Change, Chapel Hill, University of North Carolina Press.
Federal Trade Commission, 2003. “To Promote Innovation: The Proper Balance of
Competition and Patent Law and Policy” http://www.ftc.gov/os/2003/10/innovationrpt.pdf
Feldman, Robin, 2004. “The Open Source Biotechnology Movement: Is It Patent Misuse?”
Minnesota Journal of Law, Science & Technology 6:1: 117-167.
Fligstein, Neil, 1996. "Markets as Politics: A Political-Cultural Approach to Market
Institutions", American Sociological Review 61 (August): 656-673.
69
Food and Agriculture Organization (FAO), 2004. “Voluntary Guidelines to Support the
Progressive Realization of the Right to Adequate Food in the Context of National Food
Security. http://www.fao.org/righttofood
Foer, Albert, 2005. “Antitrust Perspectives on Mergers in the Academic Publishing
Industry” presented at The Information Access Alliance and the American Antitrust
Institute Invitational Symposium on Antitrust Issues in Scholarly and Legal Publishing”
Washington, D.C. February 11. (on file with author).
Fowler, Cary, 1994. Unnatural Selection: Technology, Politics and Plant Evolution
Yverdon, Switzerland: Gordon and Breach.
GAIA/GRAIN, 1998a. "Intellectual Property Rights and Biodiversity: the Economic
Myths" Global Trade and Biodiversity in Conflict 3: 1-20,
http://www.grain.org/publications/gtbc/issue3.htm
GAIA/GRAIN, 1998b. "TRIPS versus CBD", Global Trade and Biodiversity in Conflict,
Issue No. 1 (April). http:www.grain.org/publications/issue1-en-p.htm
GAIA/GRAIN, 1999. "UPOV on the War Path", Seedling (June).
http://www.grain.org/publications/jun99/jun991.htm
Gathii, James, 2001. “Institutional Concerns of an Expanded Trade Regime: Where Should
Global Social and Regulatory Policy Be Made?: Re-characterizing the Social in the
Constitutionalization of the WTO: A Preliminary Analysis” Widener Law Symposium
Journal 7: 137
Gathii, James, 2002. “The Legal Status of the Doha Declaration on TRIPS and Public
Health Under the Vienna Convention on the Law of Treaties” Harvard Journal of Law &
Technology 15: 291
Gellman, Barton, 2000. “Gore in Conflict for Health and Profit” The Washington Post May
21. http://www.washingtonpost.c...rticle&nodecontentID=A41297-2000May20.
Germain, Randall, 2000. "Globalization in Historical Perspective" in R. Germain, ed.
Globalization and Its Critics London: Macmillan: 67-90.
Hammer, Peter 2002. “Differential Pricing of Essential AIDS Drugs: Markets, Politics and
Public Health”, Journal of International Economic Law 5:4 (December): 883-912.
Gorlin, Jacques, 2006. “Additional Patent Disclosure Requirements for Biotech Inventions
in Play in WTO, WIPO and CBD” Stockholm Network: Know IP – Stockholm Network
Monthly Bulletin on IPRs (February) 2:1: 3-4.
Grabowski, Henry. 2002. “Patents, Innovation and Access to New Pharmaceuticals”
Journal of International Economic Law 5: 849
70
GRAIN, 2005. “The FAO Seed Treaty: From Farmers’ Rights to Breeders’ Privileges”,
Seedling (October) http://www.grain.org/seedling/?id=411
Hayslett III, T. 1996. "1995 Antitrust Guidelines for the Licensing of Intellectual Property:
Harmonizing the Commercial Use of Legal Monopolies with the Prohibitions of Antitrust
Law" Journal of Intellectual Property Law 3 (Spring): 375-405.
Heald, Paul, 2003. "The Rhetoric of Biopiracy", 11 Cardozo Journal of International and
Comparative Law (Summer): 519.
Helfer, Laurence, 2002. “Intellectual Property Rights in Plant Varieties: an Overview with
options for National Governments” FAO Legal Papers Online.
http://www.fao.org/Legal/pub-e.htm
Helfer, Laurence, 2004. “Regime Shifting: The TRIPs Agreement and New Dynamics of
International Intellectual Property Lawmaking” Yale Journal of International Law 1, 71
Hepburn, Jonathan 2002. “Negotiating Intellectual Property: Mandates and Options in the
Doha Work Program,” Occasional Paper 10. November. Geneva: Quaker United Nations
Office. http://www.quno.org
‘t Hoen, Ellen, 2002. “TRIPS, Pharmaceutical Patents and Access to Essential Medicines:
A Long Way from Seattle to Doha” Chicago Journal of International Law 3: 27
Hoff, Paul, 1986. Inventions in the Marketplace: Patent Licensing and the U.S. Antitrust
Laws Washington, D.C. American Enterprise Institute.
Howse, Robert, 2001. “The Boundaries of the WTO: From Politics to Technocracy – and
Back Again: The Fate of the Multilateral Trading Regime” American Journal of
International Law 96: 94
Howse, Robert and Makau Mutua, 2000. “Protecting Human Rights in a Global Economy:
Challenges for the World Trade Organization” International Centre for Human Rights and
Democratic Development,
http://www.ichrdd.ca/english/commdoc/publications/globalization/wtoRightsGlob.html
Hubbard, Tim and James Love, 2004. “A New Trade Framework for Global Healthcare
R&D” http://biology.plos.journals.org/archive/15457885/2/2/pdf/10.1371_journal.pbio.0020052-S.pdf
Institute for Agriculture and Trade Policy, 2005. “Planting the Rights Seed: A Human
Rights Perspective on Agriculture and Trade in the WTO”, Backgrounder No. 1 in the
Thread series. http://www.iatp.org and http://www.3dthree.org
71
International Centre for Trade and Sustainable Development, 2004. “Brazil Wins
Landmark Cotton Dispute” Bridges (May): 7.
International Centre for Trade and Sustainable Development, 2005. “WIPO Development
Agenda Status Unclear” Bridges (September/October): No. 9: 22.
IP Blog, 2005. “WTO Extends Deadline for Poor Countries to Implement TRIPS by Seven
Years” 29 November. http://www.ipblog.org/blog/IPBlog.nsf/dx/wto-extendsdeadline-for-poor-countries-to-imp...
Ip-health, 2001. “Re: Call for Endorsements on Glivec from South Korea” November 30.
http://lists.essential.org/pipermail/ip-health/2001-November
Ip-health, 2003. “Text of Korean Decision in Glivec Case” March 10.
http://www.lists.essential.org/pipermail/ip-health/2003/March
Ip-health, 2005. “Deadlock on TRIPS and Public Health Deliberations on a “Permanent
Solution” October 28, 2005.
http://lists.essential.org/pipermail/ip-health/2005-October/008531.html
Ip-health digest, 2006; Vol.1 #1875, Feb. 24. http://lists.essential.org/pipermail/iphealth/2006-February
IP-Watch, 2005. “Nations Clash on Future of WIPO Development Agenda” 11 April.
http://www.ip-watch.org
IP-Watch, 2005. “Non-Profits, Industry Offer Views on WIPO Development Agenda” 14
April. http://www.ip-watch.org
IP-Watch, 2005. “Avian Flu Issues Could Arise at TRIPS Council Meeting,” 25 October.
http://www.ip-watch.org
IP-Watch, 2005. “IP Issues Reappear on Agenda of WTO Talks” 14 October.
http://www.ip-watch.org
IP-Watch, 2005. “Official: In WTO Talks, US Pushes Russia to Restrictive TRIPS
Standard” 24 October. http://www.ip-watch.org
IP-Watch, 2005. “Pandemic Fears Raise Questions about WTO Health Waiver Opt-Out”
27 October. http://www.ip-watch.org
IP-Watch, 2005. “TRIPS Council Issues Still Alive for WTO Ministerial” 28 October.
http://www.ip-watch.org
IP-Watch, 2005. “EU Elevates Geographical Indications as Priority for Hong Kong” 28
October. http://www.ip-watch.org
72
IP-Watch, 2005. “Interview with Eric Smith, President, International Intellectual Property
Alliance” 4 November. http://www.ip-watch.org
IP-Watch, 2005. “Industry Concerned about Development Agenda at WTO” 4 November.
http://www.ip-watch.org
IP-Watch, 2005. “African Countries Ready to Accept TRIPS and Public Health Deal” 6
December, 12:36am. http://www.ip-watch.org
IP-Watch, 2005. “WTO Strikes Agreement on TRIPS and Public Health on Eve of
Ministerial” 6 December, 10:53pm. http://www.ip-watch.org
IP-Watch, 2005. “TRIPS Health Amendment Evokes Harsh NGO Reaction, Industry
Caution” 7 December. http://www.ip-watch.org
International Treaty on Plant Genetic Resources for Food and Agriculture
http://www.fao.org/ag/cgrfa/itpgr.htm
IP-Watch, 2005. “Experts Debate IP Issues as Hong Kong WTO Ministerial Opens” 13
December. http://www.ip-watch.org
IP-Watch, 2005. “TRIPS Public Health Announcement Questioned ; China Implements
Decision” 14 December. http://www.ip-watch.org
IP_Watch, 2005. “India, Brazil Tie Biodiversity Negotiations to Doha Development
Package” 15 December. http://www.ip-watch.org
IP-Watch, 2005. “Peru Attempts Strong WTO Position on Disclosure Despite Weaker US
Deal” 17 December). http://www.ip-watch.org
IP-Watch, 2005. “Latest WTO Ministerial Draft Urges Discussion on IP Issues to
Intensify, Adds Review Date” 18 December, 11:51am. http://www.ip-watch.org
IP-Watch, 2006. “Biotech Firms Form Alliance to Fight Off Possible TRIPS
Amendments” 6 January. http://www.ip-watch.org
IP-Watch, 2006a. “The Hunt is on to Advance or End Development Agenda at WIPO”, 24,
February. http://www.ip-watch.org
IP-Watch, 2006b. “Industry’s Take on WIPO Development Talks: An Interview with
Director General of CropLife”, 24 February. http://www.ip-watch.org
IP-Watch, 2006c. “Agricultural IP Issues Debated at Industry Side Event to WIPO
Meeting” 24 February. http://www.ip-watch.org
73
IP-Watch, 2006d. “Biotech Industry Fights Disclosure in Patents on Three IP Policy
Fronts” 2 March. http://www.ip-watch.org
Ip-Watch, 2006e. “Groups Decry Impact of IP and Health Terms in US Trade
Agreements” 3 March. http://www.ip-watch.org
International Chamber of Commerce, 2005. “Current and Emerging Intellectual Property
Issues for Business: A Roadmap for Business and Policymakers” http://www.iccwbo.org
Irwin, Douglas, 2002. Free Trade under Fire Princeton: Princeton University Press.
Jackson, John, 2002. “Afterword: The Linkage Problem – Comment on Five Texts”
American Journal of International Law 96: 118Jackson, Patrick, 2002. “Jeremy Bentham, Foreign Secretary: or, the Opportunity Costs of
Neo-Utilitarian Analyses of Foreign Policy” Review of International Political Economy, 9:
Jaffe, Adam and Josh Lerner, 2004. Innovation and Its Discontents: How our Broken
Patent System is Endangering Innovation and Progress, and What to Do about it
Princeton: Princeton University Press.
Jones, Bryan. 2001. Politics and the Architecture of Choice: Bounded Rationality and
Governance Chicago: University of Chicago Press.
Kapczynski, Amy, Samantha Chaifetz, Zachary Katz, and Yochai Benkler, 2005.
“Addressing Global Health Inequities: An Open Licensing Approach for University
Innovations” The Berkeley Technology Law Journal
Kuanpoth, Jakkrit, 2006. “Closing in on Biopiracy: Legal Dilemmas and Opportunities for
the South” in Ricardo Melendez-Ortiz and Vicente Sanchez, Trading in Genes:
Development Perspectives on Biotechnology, Trade and Sustainability London: Earthscan:
139-52.
Keck, Margaret and Kathryn Sikkink, 1998. Activists without Borders: Advocacy Networks
in International Politics Ithaca: Cornell University Press.
Kloppenburg, Jack, 2005. “Interview with GRAIN” Seedling (October)
http://www.grain.org/seedling/?id=414
Lamptey, Peter, 2003. “Future Challenges in the Global Fight against HIV/AIDS in
Developing Countries” Emory International Law Review 17:2: 645-661.
Lettington, Robert 2003. "Small-scale Agriculture and the Nutritional Safeguard under
Article 8(1) of the Uruguay Round Agreement on Trade-Related Aspects of Intellectual
Property Rights: Case Studies From Kenya and Peru" (November) get URL from Bridges
74
Lieberwitz, Risa, 2004. "Book Review: The Marketing of Higher Education: The Price of
the University's Soul: Universities in the Marketplace: The Commercialization of Higher
Education. By Derek Bok." 89 Cornell Law Review (March): 763.
Love, James, 2005. “No Gift to the Poor: Strategies used by US and EC to protect big
pharma in WTO TRIPS negotiations”, December 1st, Working Agenda available at:
http://workingagenda.blogspot.com/2005/12/no-gift-to-poor-strategies-used-by-us.html
Marden, Emily, 1999. “The Neem Tree Patent: International Conflict over the
Commodification of Life” Boston College Environmental Affairs Law Review 22: 279-295.
Maskus, Keith and Jerome Reichman, 2004. “The Globalization of Private Knowledge
Goods and the Privatization of Global Public Goods” Journal of International Economic
Law 279.
Matthews, Duncan, 2004a. “WTO Decision on Implementation of Paragraph 6 of the Doha
Declaration on the TRIPS Agreement and Public Health: A Solution to the Access to
Essential Medicines Problem?” Journal of International Economic Law 7 (1): 73-93.
Matthews, Duncan, 2004b. “Is History Repeating Itself? Outcome of the Negotiations on
Access to Medicines, the HIV/AIDS Pandemic and Intellectual Property Rights in the
World Trade Organisation” Electronic Law Journal, LGD 2004(1)
http://www2.warwick.ac.uk/fac/soc/law/elj/lgd/2004_1/matthews/
Maurer, Stephen, Arti Rai and Andrej Sali, 2004. “Finding Cures for Tropical Diseases: Is
Open Source and Answer?” http://salilab.org/pdf/136_MaurerBIOESSYS2004.pdf
May, Christopher and Susan K. Sell, 2006. Intellectual Property Rights: A Critical History
Boulder: Lynne Rienner Publishers.
McDowell, Natasha, 2003. “WTO Patent Rules Should be Scrapped” Science and
Development Network,
http://www.scidev.net/NEWS/index.cfm?fuseaction=readnews&itemid=429&language=1
(February 26th).
Medecins sans Frontieres, Health Action International, and Consumer Project on
Technology, 1996. “Amsterdam Statement” November 25-26.
http://www.cptech.org/ip/health/amsterdamstatement/html
Merges, Robert. 2000. “One Hundred Years of Solicitude: Intellectual Property Law,
1900-2000. California Law Review 88: 2187-2240.
Muller, Harald, 2001. “International Relations as Communicative Action” in Karin Fierke
and Knud Jorgensen eds. Constructing International Relations: The Next Generation N.Y.:
M.E. Sharpe
75
Munroe, Mary H. 2005. “The Academic Publishing Industry: A Story of Mergers and
Acquisitions” http://www.niulib.niu.edu/publishers/ (Sept. 30 update). (visited 2/23/06).
Musungu, Sisule, 2005. “Rethinking Innovation, Development and Intellectual Property in
the UN: WIPO and Beyond” TRIPS Issues Papers 5, Quaker International Affairs
Programme, Ottawa Canada.
Nachtigal, Nicole, 2001. “Casenote: A Modern David and Goliath Farmer v. Monsanto:
Advising a Grower on the Monsanto Technology Agreement 2001” Great Plains Natural
Resources Journal 6: 50-76.
National Research Council, 2004. A Patent System for the 21st Century Washington, D.C.:
National Academy Press
Newell, Peter and Dominic Glover, 2003. "Globalisation and the International Governance
of Modern Biotechnology. Business and Biotechnology: Regulation and the Politics of
Influence" Institute of Development Studies. http://www.gapresearch.org
Newfarmer, Richard et al., 2001. “Global Economic Prospects and the Developing
Countries” http://www.worldbank.org/prospects/gep2002/gep2002complete.pdf
Odell, John, 2006. Negotiating Trade: Developing Countries in the WTO and NAFTA
Cambridge: Cambridge University Press.
Odell, John and Susan K. Sell, 2006. “Reframing the Issue: the WTO Coalition on
Intellectual Property and Public Health, 2001” in Odell, ed. Negotiating Trade: Developing
Countries in the WTO and NAFTA Cambridge: Cambridge University Press: 85-114.
Okediji, Ruth, 2005. “The International Copyright System: Limitations, Exceptions and
Public Interest Considerations for Developing Countries in the Digital Environment”
International Centre for Trade and Sustainable Development, http://www.iprsonline.org
Omer, Assad. 2000. “An Overview of Legislative Changes” in Surendra Patel et al. eds,
International Technology Transfer: the Origins and Aftermath of the United Nations
Negotiations on a Draft Code of Conduct Springer. 295
Patent and Trademark Office, 2005. “Patent Law Harmonization Talks Stall; Brazil,
Argentina, India Oppose Compromise” June 14.
http://www.uspto.gov/main/homepagenews/bak2005jun14.htm
Pauwelyn, Joost, 2001. “The Role of Public International Law in the WTO: How Far Can
We Go?” American Journal of International Law 95: 535
Phillips, Ronald, 2004. “Intellectual Property Rights for the Public Good: Obligations of
U.S. Universities to Developing Countries” Minnesota Journal of Law, Science &
Technology 6:1 177-185.
76
Pistorius, Robin and Jeroen van Wijk, 1999. The Exploitation of Plant Genetic
Information: Political Strategies in Crop Development N.Y.: CABI Publishing.
Rai, Arti and Rebecca Eisenberg, 2003. "The Public Domain: Bayh-Dole Reform and the
Progress of Biomedicine" 66 Law & Contemporary Problems (Winter/Spring): 289.
Raustiala, Kal and David Victor, 2003. “The Regime Complex for Plant Genetic
Resources”, Working Paper 14, Program on Energy and Sustainable Development,
Stanford University (on file with author).
Reichman, Jerome, 2006. “Patent Law Harmonization and the Draft SPLT”
http://www.wipo.org
Reichman, Jerome and David Lange, 1998. “Bargaining around the TRIPS Agreement:
The Case for Ongoing Public-Private Initiatives to Facilitate Worldwide Intellectual
Property Transactions” Duke Journal of Comparative and International Law 9: 11
Reichman, Jerome and Paul Uhlir 2003. “A Contractually Reconstructed Research
Commons for Scientific Data in a Highly Protectionist Intellectual Property Environment”
Law and Contemporary Problems 66: 315-462.
Reid, W. and S. Laird, C. Meyer, R. Gamez, A. Sittenfeld, D. Janzen, M. Gollin and C.
Juma, 1993. Biodiversity Prospecting: Using Genetic Resources for Sustainable
Development Washington, D.C.: World Resources Institute.
Reuters, 2003. “Pfizer’s McKinnell Says Drug Patent Talks Progress” January 28.
http://lists.essential.org/pipermail/ip-health/2003-January/004184.html
Rosenberg, Barbara, 2006. “Market Concentration of the Transnational Pharmaceutical
Industry and the Generic Industries: Trends on Mergers, Acquisitions and Other
Transactions” in Pedro Roffe, Geoff Tansey and David Vivas-Eugui, Negotiating Health:
Intellectual Property and Access to Medicines London: Earthscan
Rosenberg, Tina, 2001. “Look at Brazil” The New York Times Jan. 28 (magazine).
Schuh, G. Edward, 2004. “Intellectual Property Rights and the Land Grant Mission”,
Minnesota Journal of Law, Science and Technology 6:1: 359-371.
Schultz, Mark and David Walker, 2005. “How Intellectual Property Became Controversial:
NGOs and the New International IP Agenda” Engage, Vol. 6:1: 82-98.
http://www.ngowatch.org (visited 02/24/06)
Sell, Susan K. 1998, North-South Politics of Intellectual Property and Antitrust Albany:
State University of New York Press.
77
Sell, Susan K. 2002. “TRIPS and the Access to Medicines Campaign” Wisconsin
International Law Journal 20: 481Sell, Susan K. 2003. Private Power, Public Law: the Globalization of Intellectual Property
Rights Cambridge: Cambridge University Press.
Sell, Susan K. and Aseem Prakash, 2004. “Using Ideas Strategically: The Contest between
Business and NGO Networks in Intellectual Property Rights” International Studies
Quarterly 48: 143-175.
Shaffer, Gregory, 2001. “The World Trade Organization Under Challenge: Democracy and
the Law and Politics of the WTO’s Treatment of Trade and Environment Matters”
Harvard Environmental Law Review 25: 1Shaffer, Gregory. 2003. Defending Interests: Public-Private Partnerships in WTO
Litigation Washington, D.C.: Brookings Institution Press.
Shaffer, Gregory, 2004a. “Recognizing Public Goods in WTO Dispute Settlement: Who
Participates? Who Decides?” Journal of International Economic Law 7:
Shaffer, Gregory, 2004b. “Power, Global Governance and the WTO: the Need for a
Comparative Institutional Approach” in Michael Barnett and Raymond Duvall eds., Power
in Global Governance Cambridge: Cambridge University Press.
Shiva, Vandana, 1997. Biopiracy: The Plunder of Nature and Knowledge. South End
Press.
Shulman, Seth. 1999. Owning the Future, New York: Houghton Mifflin Company.
Smith, James McColl, “WTO and Dispute Settlement: The Politics of Procedure in
Appellate Body Rulings” World Trade Review 2: 65
South Centre and Center for International Environmental Law, 2004a. “South Centre and
CIEL IP Quarterly Update: Fourth Quarter, 2004” http://www.southcentre.org
South Centre/CIEL (Center for International Economic Law), 2004b. “Intellectual
Property and Development: Overview of Developments in Multilateral, Regional, and
Bilateral Fora”, http://www.southcentre.org
South Centre and Centre for International Environmental Law, 2005a. “South Centre and
CIEL IP Quarterly Update: Third Quarter 2005”. http://www.southcentre/org
South Centre and Center for International Environmental Law, 2005b. “South Centre and
CIEL IP Quarterly Update: Second Quarter, 2005”. http://www.southcentre/org
78
Steger, Deborah, 2002. “Afterword: The Boundaries of the WTO: The ‘Trade and. . .’
Conundrum – A Commentary” American Journal of International Law 96:135Stein, Eric, 2001. “International Integration and Democracy: No Love at First Sight”
American Journal of International Law 95: 489
Sutherland, Johanna 1998. “TRIPS, Cultural Politics and Law Reform” Prometheus 16:3:
291-303.
Symposium, 2002. “Global Intellectual Property Rights: Boundaries of Access and
Enforcement” Fordham Intellectual Property, Media and Entertainment Law Journal 12:
675
Taylor, Michael and Jerry Cayford, 2004. “Biotechnology Patents and African Food
Security: Aligning America’s Patent Policies and International Development Interests”,
Minnesota Journal of Law, Science and Technology (December): Vol. 6, No. 1: 277-304.
Tejera, Valentina, 1999. “Tripping over Property Rights: Is it possible to reconcile the
Convention on Biological Diversity with Article 27 of the TRIPS Agreement?” New
England Law Review 33 (Summer): 967-987.
Trebilcock, Michael and Robert Howse, 1995. The Regulation of International Trade
(N.Y.: Routledge).
Tversky, Amos and Daniel Kahneman, 1981. “The Framing of Decisions and the
Psychology of Choice” Science, 211.
UNCTAD-ICTSD, 2003, UNCTAD-ICTSD Project on IPRs and Sustainable Development
http://www.iprsonline
United Nations High Commissioner for Human Rights, 2001. “The Impact of the
Agreement on Trade-Related Aspects of Intellectual Property Rights on Human Rights:
Report of the High Commissioner” http://www.eldis.org/static/DOC5597.htm
UPOV, 2002. "States Party to the International Convention for the Protection of New
Varieties of Plants" http://www.upov.int/eng/ratif/pdf/ratifmem.pdf
United States Trade Representative, 2006, “United States and Colombia Conclude Free
Trade Agreement” February 27. http://www.ustr.gov
Vaidhyanathan, Siva, 2001. Copyrights and Copywrongs: the Rise of Intellectual Property
and How It Threatens Creativity NY: New York University Press.
Van Wijk, Jeroen, 2004. “Terminating Piracy or Legitimate Seed Saving? The Use of
Copy-Protection Technology in Seeds” Technology Analysis & Strategic Management 16:
121-141.
79
Verma, S.K. 2001. “The TRIPS Agreement and Development” in Surendra Patel et al. eds,
International Technology Transfer Springer.
Viana, Jose 2002. “Intellectual Property Rights, the World Trade Organization and Public
Health: the Brazilian Perspective” Connecticut Journal of International Law 17: 311
Vick, Karl, 1999. “African AIDS Victims Losers of a Drug War” The Washington Post
December 4: A1.
Vivas-Eugui, David, 2003. “Regional and Bilateral Agreements and a TRIPS-plus World:
the Free Trade Area of the Americas Agreement (FTAA)”, Quaker United Nations Office,
http://www.quno.org
Volansky, Mark, 2002. “Comment: Achieving Global Health: A Review of the World
Health Organization’s Response” Tulsa Journal of Comparative and International Law 10:
223Washington Post, 2003. “Behind the Lobbying Curtain” June 9: A20.
Wojahn, Patrick, 2001/2002. “Comment: Conflict of Rights: Intellectual Property Under
TRIPS, the Right to Health, and AIDS Drugs” UCLA Journal of International Law &
Foreign Affairs 6: 463World Health Organization (WHO), Essential Drugs and Medicines Home Page,
http://www.who.int/medicines
World Health Organization, 2000. “Revised Drug Strategy” (March 13)
http://www.who.int/gb/ebwha/pdf_files/WHA53/ea10.pdf
World Health Organization, 2001. “Policy Perspectives on Medicines: Globalization,
TRIPS and Access to Pharmaceuticals” (March).
http://www.who.int/medicines/library/edm_general/6pagers/PPM03ENG.pdf
World Health Organization, 2003. “Intellectual Property Rights, Innovation and Public
Health May 12. http://www.who.int/gb/ebwha/pdf_files/WHA56/ea5617.pdf
World Health Organization, 2003. “Fourth Report of Committee A (Draft), May 28.
http://www.who.int/gb/ebwha/pdf_files/WHA56/ea5666.pdf
World Intellectual Property Organization, 2001. “Revised Draft Program and Budget
2002-2003”,
http://www.wipo.int/documents/en/documents/govbody/budget/2002_03/rev/pdf/pbc4_2.p
df.
80
World Trade Organization, “Declaration on the TRIPS Agreement and Public Health,”
WT/MIN(01)/DEC/2,20 November 2001.
http://www.wto.org/english/thewto_e/minist_e/min01/mindecl)trips_e.htm
WTO, Brazil, India, Pakistan, Peru, Thailand and Venezuela, 2004. “Elements of the
Obligation to Disclose the Source and Country of Origin of Biological Resources and/or
Traditional Knowledge used in an Invention”, WTO document. IP/C/W/429, September 21
WTO Council on TRIPS, 2003. “WTO Decision on Implementation of Paragraph 6 of the
Doha Declaration on the TRIPS Agreement and Public Health” IP/C/405.
WTO, 2003. “Implementation of Paragraph 6 of the Doha declaration on the TRIPS
Agreement and Public Health” September 2. WT/L/540 http://docsonline.wto.org
WTO, 2005. “Compulsory Licensing of Pharmaceuticals and TRIPS” October. TRIPS and
Health: FAQs. http://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm
WTO, 2005. “Legal Arguments to Support the African Group Proposal on the
Implementation of Paragraph 11 of the 30 August 2003 Decision” March 1. IP/C/W/440.
Yu, Peter, 2004. “The Escalating Copyright Wars,” Hoftsra Law Review 32: 907-951.
Zald, Mayer. 1996. “Culture, Ideology and Strategic Framing” in Doug McAdam et al. eds.
Comparative Perspectives on Social Movements: Political Opportunities, Mobilizing
Structures and Cultural Framings. Cambridge: Cambridge University Press.