failing the global south: power and resistance in...
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Failing the Global South: Power and Resistance in
Medicines Governance
Belinda Townsend
BAppSc (HealthSc), BA (Hon) Deakin University
Thesis submitted in fulfilment of the requirement for the
degree of Doctor of Philosophy
Deakin University
August 2014
Acknowledgements
My deepest appreciation is for my supervisor and mentor Hans Löfgren for the
guidance, knowledge, time, and diligence that he gave me in my journey as a PhD
student and as an emerging health activist. Hans opened my eyes to the political
economy of health and I am so very thankful for his mentorship and for the doors
he opened for me to meet other inspiring and knowledgeable health activists. The
end of this thesis journey is bittersweet with the sudden passing of Hans. I am
committed to taking up the torch as best I can to continue to fight for a more
equitable system in global health.
I also thank Steven Slaughter for your helpful advice on structure and argument,
and for your support following Hans passing. Thanks to Nick Henry for your
constructive comments and Colleen Keane for proofreading the thesis. Thank you
Evelyne de Leeuw for pushing me to publish and for urging me to examine the
history of contemporary developments. I would also like to acknowledge the
support and friendship of David Legge and Deborah Gleeson from PHM
Australia. Thanks for bringing me on board and for the opportunity to participate
in the WHO WATCH and see firsthand the political dynamics of health. Finally,
thank you to my partner Michael for your humour and support, to my family,
friends, the TRIBE and to my fellow PhD students Helen, Michael and Petra who
have provided immense support.
Publications
Townsend, B. 2010. The Political Domain of Global Health Governance: Norms,
Tensions and Challenges. Paper presented to the international conference
Pharmaceuticals in Developing and Emerging Economies: Production,
Innovation, and Access to Medicines in the Wake of TRIPS. University of
Hyderabad, India 17–19 September 2010.
Townsend, B. 2011. Re-conceptualising Global Health Governance through
Discourse: Potentials for Discursive Democracy. Paper presented to the
International Studies Association annual conference Global Governance:
Political Authority in Transition. Montreal, Canada 16–19 March 2011.
Townsend, B. Martin, E. de Leeuw, E. and Löfgren, H. 2012. Global Health
Governance: Framework Convention on Tobacco Control (FCTC), the Doha
Declaration, and Democratisation. Journal of Administrative Sciences 2(2): 186–
202.
Townsend, B. 2013. The Battle for Neglected Diseases. Paper presented to the
International Studies Association annual conference The Politics of International
Diffusion: Regional and Global Dimensions. San Francisco, California 3–6 April
2013.
de Leeuw, E. Townsend, B. Martin, E. Jones, C.M. and Clavier, C. 2013.
Emerging Theoretical Frameworks for Global Health Governance. In E. de
Leeuw and C. Clavier, eds. Health Promotion and the Policy Process. Oxford:
Oxford University Press.
Legge, D. Gleeson, D. Löfgren, H. and Townsend, B. 2014. Australia’s Position
on Medicines Policy in International Forums: Intellectual Property Protection and
Public Health. Journal of Australian Political Economy 73: 23-51.
Abstract
Global medicines governance is failing to meet the health needs of the South.
Despite decades of international policymaking, problems of lack of access to
essential medicines, insufficient research and development (R&D) to meet the
health needs of the poor, and irrational use of drugs continue with devastating
consequences. This thesis examines the history, conflicts and transformations in
the evolution of global medicines governance over the last 70 years. The research
draws on records, reports and policy statements of intergovernmental
organisations and central actors. Developments in medicines R&D, production,
access, and regulation are situated within broader shifts in the global political
economy. This enables an understanding of specific events over time, including
turning points, major actors and interests served. This critical historical approach
of the long term patterns of ideas and power is absent in the literature. The thesis
demonstrates that global medicines governance has evolved through battles that
principally reflect the North-South divide. The United States and its allies have
blocked several multilateral initiatives that threaten the profits of their
pharmaceutical firms. The pharmaceutical industry has exercised significant
power and influence over governments, the World Health Organization (WHO)
and other international institutions. Resistance on the part of many countries of
the South has shaped a pattern of forum-shifting by governments, firms, and
globally networked advocacy non-government organisations. This interplay of
power and resistance is reflected in discursive conflicts, detailed in this thesis,
through which the norms, and rules for global medicines governance have
evolved. The findings show that in general, the counter-hegemonic discourses of
the global South have not been effective against the material power of well-
resourced governments and private actors. It appears that, in the face of stark
inequities in material power, the dominant discourse has been controlled by
powerful actors. When the South has been effective, it is mainly because the
interests of NGOs and local pharmaceutical firms have aligned. This raises
important implications for health advocacy NGOs and those seeking to resist the
status quo. The thesis has found examples where resistance has been most
successful in national contexts, such as in courts in South Africa, India and
Kenya. This suggests that the national level is where NGO may have a more
substantive impact. This does not mean that protest and advocacy should not
occur at the global level, rather global advocacy is strengthened if it is interlinked
with the national or local context.
Table of Contents
Chapter One: The Evolution of Global Medicines Governance 1
Approach 5
Sources 11
Terminology 14
Thesis structure 17
Chapter Two: A New International Economic Order: Health for All
and Essential Medicines 22
Medicines policy and the WHO in the 1940s 23
Medicines and the Third World 25
A New International Economic Order and Health for All 34
The battle for essential medicines 44
Conclusion 53
Chapter Three: Neoliberalism: Selective Health Care and
Private Rights 54
Medicines under neoliberalism 55
Selective Primary Health Care and essential medicines 63
The Tropical Disease Research Program: failing the global South 69
Intellectual property ‘rights’ 72
Conclusion 82
Chapter Four: AIDS Exceptionalism, Safeguards and Patents 84
AIDS exceptionalism and private rights 85
The South African lawsuit 96
The battle for a revised drug strategy 100
Public health safeguards 104
Safeguards, IP and medicines R&D 110
Conclusion 117
Chapter Five: Counterfeits, Regulation and IP 119
Counterfeits, quality-assurance and the WHO 121
The WHO, Global Fund and PEPFAR 126
Counterfeits and Nigeria 133
Counterfeits and intellectual property: IMPACT 140
Conclusion 149
Chapter Six: Neglected Tropical Diseases, Partnerships and IP 151
MSF and the drugs for neglected diseases network 153
The turn to product-development partnerships: 2000–2002 157
A battle between commissions: 2002–2003 161
Neglected tropical diseases and the WHO: 2004–2006 165
Partnerships: 2007–2012 170
The demise of the R&D treaty: 2007–2012 174
Conclusion 179
Chapter Seven: Power and Resistance 181
The TRIPS PLUS agenda 182
Novartis versus India: ‘the pharmacy of the developing world’ 187
Bayer versus India: patent linkage and public health safeguards 195
Emerging resistance in the global South 200
Conclusion 202
Conclusion 204
Appendix One: Glossary 212
Appendix Two: Key Primary Source documents 215
Appendix Three: USTR 301 Watch List 1995–2000, Pharmaceuticals 226
Appendix Four: ‘TRIPS PLUS’ US Free Trade Agreements 227
Appendix Five: Global Medicine Donation Programs 228
Appendix Six: Example of NGO Naming and Shaming 229
Appendix Seven: Compulsory Licensing Practices Medicines 2001–2012 230
Reference List 232
Abbreviations
ACT artemisinin-based combination therapy
ACT UP AIDS Coalition to Unleash Power
APBI Association of the British Pharmaceutical Industry
APED Action Programme on Essential Drugs
API active pharmaceutical ingredient
ARV Anti-retroviral
CDC Centers for Disease Control and Prevention
CPAA Cancer Patients AIDS Association (India)
CpTech Consumer Project on Technology
CRO Contract Research Organisation
DANIDA Danish International Development Agency
DND Drugs for Neglected Diseases working group
DNDi Drugs for Neglected Diseases initiative
EC European Commission
EFPIA European Federation of Pharmaceutical Industries and
Associations
EML Essential Medicine List
EU European Union
EWG Expert Working Group: Financing and Coordination
FAPMA Federation of African Pharmaceutical Manufacturers
Associations
FDA Federal Drug Administration
FDC Fixed-dose combination
FTA Free trade agreement
GATT General Agreement on Tariffs and Trade
GAVI Global Alliance for Vaccines and Immunisation
GFATM The Global Fund to Fight HIV/AIDS, Tuberculosis, and
Malaria
GCP Good Clinical Practices
GMP Good Manufacturing Practices
GSP Generalized System of Preferences
GSPA-PHI Global Strategy and Plan of Action on Public Health,
Innovation and Intellectual Property
G-77 Group of seventy seven
HAI Health Action International
HIV/AIDS Human Immunodeficiency Virus/ Acquired
Immunodeficiency Syndrome
IARC International Agency for Research on Cancer
IBFAN International Baby Food Action Network
ICH International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for
Human Use
IFPMA International Federation of Pharmaceutical Manufacturers
and Associations
IGWG Intergovernmental Working Group
IP intellectual property
IMF International Monetary Fund
IMPACT International Medicines Product Anti-Counterfeiting
Taskforce
INTERPOL International Criminal Police Organization
IPAB Intellectual Property Appellate Board (India)
ISI Import-substitution industrialisation
KEI Knowledge Ecology International
MDR-TB Multidrug-resistant tuberculosis
MMV Medicines for Malaria Venture
MNC Multinational Corporation
MPP Medicines Patent Pool
MSF Médecins Sans Frontières
NACP National AIDS Control Program
NAFDAC National Agency for Food and Drug Administration and
Control
NGO Non-government organisation
NIEO New International Economic Order
NIH National Institutes of Health
ODA Official Development Assistance
OAPEC Organization of Arab Petroleum Exporting Countries
OECD Organization for Economic Co-operation and Development
OPEC Organization of the Petroleum Exporting Countries
OTC Over the counter
PDP product-development partnership
PEPFAR United States President’s Emergency Plan for AIDS Relief
PhRMA Pharmaceutical Research and Manufacturers of America
PLWA People living with AIDS
PMA Pharmaceutical Manufacturers Association of South Africa
PMG-MAN Pharmaceutical Manufacturers Group of the Manufacturers
Association of Nigeria
PTNCs Pharmaceutical transnational corporations
R&D Research and Development
SPHC Selective Primary Health Care
TAC Treatment Action Campaign
TAN Transnational Advocacy Networks
TRIPS Agreement on Trade-Related Aspects of Intellectual
Property Rights
UNAIDS Joint United Nations Programme on HIV/AIDS
UNICEF United Nations Children’s Fund
UNCTAD United Nations Conference on Trade and Development
UNCTC United Nations Centre on Transnational Corporations
UNDP United Nations Development Programme
UNECLAC United Nations Economic Commission on Latin America
UNESC United Nations Economic and Social Council
UNIDO United Nations International Development Organization
USTR United States Trade Representative
UNASUR Union of South American Nations
UNESD UN Department of Economic and Social Development
USSR Union of Soviet Socialist Republics
WHA World Health Assembly
WHO World Health Organization
WIPO World Intellectual Property Organization
WTO World Trade Organization
1
C H A P T E R O N E
The Evolution of Global Medicines Governance
Medicines advance the health of society to the extent that they protect, maintain
and restore people’s health (WHO 2004d)1. The provision of effective,
therapeutic, safe and affordable medicines has long been a core concern of
governments and policymakers. This thesis demonstrates that the interrelated
issue areas of research and development (R&D), production, quality control, and
regulation of medicines have been on the agenda of the ‘directing and
coordinating authority on international health’, the World Health Organization
(WHO), since its creation (WHO 1946). Medicines also serve an economic value
as commodities (Löfgren 2013). They generate billions of dollars in profits
annually for business firms, and when they are traded internationally, contribute
positively to the trade balance of exporting countries2. In 2013, the top ten
international pharmaceutical firms accumulated more than $430 billion (US) in
revenue from the sale of medicines and health products (FiercePharma 2014).
These functions create tensions for governments, which are often constrained by
imperatives to create conditions favourable to pharmaceutical industry
investments (Schrecker 2009; 2011). This tension is particularly acute when
medicines policy threatens to constrain the profits of pharmaceutical firms. Policy
to strengthen the rational use of medicines, for example, requires regulation that
1 It is also the case that some medicines can cause harm. Some studies, for example, have shown adverse drug reactions in over fourteen per cent of hospital in-patients (Davies et al 2009). 2 In 2009 the United Kingdom had a positive trade surplus of £7 billion in the pharmaceutical sector, the largest surplus of all industrial sectors (Association of the British Pharmaceutical Industry 2011).
2
constrains profits. Medicines are used irrationally when they are not
therapeutically effective or safe, not prescribed for the right condition or
acceptable to a patient, not administered correctly, and/or are unnecessarily
expensive (Basco 2004; Laing N.D.; WHO 2013b)3. In contrast, medicines are
used rationally when people have affordable access to essential medicines that are
used appropriately, in doses that meet their requirements, and for an adequate
period of time (WHO Expert Committee on the Selection of Essential Drugs
1997).
Conflict between the economic and health functions of medicines is also reflected
in the uneven distribution of medicines research and development (R&D).
Because of profit motives, R&D remains skewed towards health conditions and
ailments in wealthy countries (Evans, Shim and Ioannidis 2014). There is
insufficient R&D for conditions that predominantly affect populations in the
global South. Existing treatments are often not adapted to health needs in poor
countries, nor are they of optimal dosage or appropriate for children (Leach,
Paluzzi and Munderi 2005: 10; MDG Gap Task Force 2008: 44).
From the perspective of the global South, there is an urgent need to strengthen
global governance to support the health value of medicines4. Fifty per cent of all
deaths in the global South are preventable, in that adequate treatment exists but is
not readily accessible (MDG Gap Task Force 2012; Médecins Sans Frontières
3 The irrational use of medicines increases the risk of adverse drug reactions and drug resistance (WHO 2013b; Woroń et al. 2007). Drug resistance contributes to increases in the frequency and severity of epidemics, to re-emerging transmission rates and to increasing fatality rates (Bloand 1999). 4 As a student of both politics and health, this health need informs my perspective in examining the global governance of medicines.
3
2010d; United Nations 2010; WHO 2011d). Irregular supply, unaffordable prices,
incorrect prescribing and poor compliance have created a situation in which the
WHO (2013a) reports that more than 50 per cent of all medicines are used
irrationally (see also Kar, Pradhan and Mohanta 2010; Pablos-Méndez et al.
1998).
Drug resistance to key treatments has spread, creating drug resistant strains of
tuberculosis, malaria and tropical diseases (Pablos-Méndez et al. 1998)5. This is
not limited to the global South, with multi-drug resistant tuberculosis (MDR TB)
spreading amongst the poor in New York for over two decades (Pablos-Mendez et
al. 1990). Experts in malaria warn that increasing resistance could be a ‘disaster
for the control and treatment of malaria and bring eradication efforts to a
standstill’ (Dondorp et al. 2011). Similarly, the increasing spread of resistance
would reverse the downward trend in Human African trypanosomiasis
prevalence, leading to resurgence in a form that resists available medicines
(Barrett et al. 2011)6.
The thesis hypothesis is that the aforementioned problems are not principally the
result of a lack of scientific knowledge or world resources, rather they reflect
political conflict, power and a crisis of global governance (Kay and Williams
2009b; Kickbusch 2005; Lee 2009a; McInnes and Lee 2012a). Indeed, medicines
policy is increasingly governed at the global level in which the ‘rules and norms
5 These include anthelminthic drugs albendazole and mebendazole, the only effective onchocerciasis medicine ivermectin, medicines for sleeping sickness elfornithine and melarsoprol and antileishmanial drugs (Albonico, Engels and Savioli 2004; Bryceson 2002; Gloecknera et al. 2009; Hotez et al. 2007). 6 While it is beyond the scope of this thesis, a broader conflict in health is that of the dominance of biomedicine and the often neglected social and economic determinants of health (see Commission on Social Determinants of Health 2008; Schrecker 2011).
4
governing world order’ are shaped by the interactions of governments,
intergovernmental institutions, multinational corporations and non-government
organisations (Held et al. 1999: 50; Rosenau 1992). In this thesis I ask, why is the
global governance of medicines failing to meet the health needs of the global
South?
In order to address this research question I pose three subsidiary questions for
investigation:
Who are the actors that have shaped the global governance of medicines?
What discourses have shaped global medicines governance?
What have been the turning points in the evolution of this domain?
The thesis finds that global medicines governance has evolved through a battle
that principally reflects the North–South divide7. This divide is shaped by the
conflict of interest between capital and health which is taking place
transnationally at the global level. The United States and its allies have blocked
several multilateral initiatives that have aimed to strengthen the health value of
medicines when these have threatened the profits of their pharmaceutical firms.
The pharmaceutical industry has exercised significant influence over
governments, the World Health Organization (WHO) and other international
institutions. The capacity of global medicines governance to meet the needs of the
South is constrained by the power of the international pharmaceutical industry.
Health advocacy NGOs have become important allies to governments in the
global South in their resistance to the industry. Through their global operations
7 The nuances of the North-South divide are explored in the thesis.
5
and dense linkages of exchange and participation, these NGOs exhibit
characteristics of a global advocacy network (see Keck and Sikkink 1998: 8;
1999: 92). The thesis suggests that NGOs can play a key role in supporting
governments to resist pressures from the industry, particularly when the ambitions
of local firms and NGOs align. To remain independent, however, NGOs must
assess their participation in new global health partnerships, in which they work
closely alongside international pharmaceutical firms.
Approach
This research contributes to an emerging field of political inquiry into the global
governance of health policy8. Research in this field has proliferated since
Kickbusch and de Leeuw (1999), Lee, Buse and Fustukian (2002b) and Lee et al.
(2003) identified a lack of scholarship in this field (see Buse, Hein and Drager
2009; Cooper and Kirton 2009; Cooper, Kirton and Schrecker 2007; Fidler 2001;
2008; 2009; Foller and Thorn 2008; Hein, Bartsch and Kolhmorgen 2007; Kay
and Williams 2009a; Keefe and Zacher 2008; Kickbusch 2009; Kirton and
Guebert 2009; Labonté, Blouin and Forman 2009; Poku, Whiteside and Sandkjaer
2007; Rushton and Williams 2011; Schrecker 2009). Research in global health
can be separated into two phases based on the central research questions, themes
and arguments. The first phase correlates to emerging research in globalisation
and health in the late 1990s. The core research questions in this period were
explanatory, focused on globalisation and its impact on health. Lee and Dodson
8 The creation of academic journals Globalization and Health (2005), Global Public Health (2006), Global Health Governance (2007), Global Health Action (2008), Global Health Promotion (2009) and Health Diplomacy Monitor (2010), along with a growing contingent of the global health group within the International Studies Association are testimony to this expanding scholarship.
6
(2003:137) coined the phrase ‘paradox of globalisation’ to illustrate the concern
that globalisation was exacerbating inequality. In this period, scholars drew on a
few political science theories and concepts to investigate global heath. These
include Manuel Castell’s ‘network society’ (Kickbusch and de Leeuw 1999),
Kuhn’s ‘paradigms’ (Kickbusch 2003), Haas’ ‘epistemic communities’ (Lee and
Goodman 2002) and Cox’ ‘transnational managerial class’ (Lee and Zwi 2003).
The second phase from the mid to late 2000s focused on understanding health
problems as governance issues. The practice of governance was a key focus, as
health partnerships emerged such as UNAIDS, GAVI and the Global Fund. Since
the mid-2000s scholars have increasingly framed global health problems within
the politics of global governance (Kickbusch 2005). Key themes of scholarship
include the effect of neoliberalism on health policy (Ingram 2009; Lee, Buse and
Fustukian 2002b; Lee and Zwi 2003; McGregor 2001; Navarro 2007; Porter, Lee
and Ogden 2002; Rowden 2009; Rushton and Williams 2012; Sanders 2003;
Schrecker 2009; Sparke 2009), responses to HIV/AIDS (Foller and Thorn 2008;
Harman and Lisk 2009; Hein, Bartsch and Kolhmorgen 2007; Lisk 2010; Poku
2004; Poku, Whiteside and Sandkjaer 2007; Worgart 2009), the securitisation of
health policy (Altman 2003, 2008; Elbe 2006; Fidler 2007; McInnes and Lee
2006; Rushton 2010), the global governance of influenza (Kamradt-Scott and Lee
2011; Lee and Fidler 2007), the emergence of global health partnerships (Bartsch
2007; Bull and McNeill 2007; Buse 2004; Buse and Walt 2000b, 2002; Williams
2012) and the role of philanthropists and private foundations in global health
(McCoy et al. 2009; Moran 2011; Rushton and Williams 2011).
7
More recently, scholars have identified a gap in the literature. What has ‘largely
gone unexplored’ are the underlying preferences, ideas, worldviews and
motivations of actors in global health governance (see Bartsch, Huckel and
Kohlmorgon 2009; Buse et al. 2009; Lee 2009a; McInnes and Lee 2009; Sparke
2009). Fidler (2008: 60), for example, has lamented that ‘none of the leading
theories adequately captures what is happening with the rise of non-state actors…
particularly the growing ability of these actors to exercise material capabilities
vis-à-vis states and each other, and the resulting impact of this ability on how
ideas play a role’. This thesis is a response to this lacunae and call for a ‘new
research agenda’ (McInnes and Lee 2009).
This thesis traces the history, conflicts and transformations in the evolution of
global medicines governance over 70 years. This critical historical approach
‘stands apart from the prevailing order of the world to ask how that order came
about’ (Cox 1996: 24). This analysis of long term patterns of ideas and power is
often absent in the literature, yet it enables an understanding of specific events
within broader shifts and changes over time, including identifying turning points,
major actors and whose interests have been served. Developments in the issue-
areas of medicines R&D, production, access, and regulation are situated within
broader political economic shifts over time, including the rise and fall of the New
International Economic Order (NIEO) and the dominance of neoliberalism in the
global political economy. This historical perspective also enables a long-term
view of the role of the World Health Organization in medicines governance.
8
The thesis is informed by critical theory which gives attention to the role of
ideological forces in reconciling society to the imperatives of capitalism, with the
aim of emancipating from such forces (Held 1980). The thesis draws on an
interpretive framework which explains change in society through the combined
effect of structures and actors (see Adler 1997; Finnemore 1996; Raskin 2002;
Sell 2003; Wendt 1992: 7). In this perspective, social structures are the common
understandings, shared discourses, and worldviews which shape actors’
preferences (see Dryzek 2006b; Holzscheiter 2011; Risse 2007; Steffek 2003)9.
The thesis uses the term ‘discourse’ to encapsulate these narratives. A discourse is
a set of assumptions which provide a narrative for thinking about a particular
topic in a particular historical moment. Discourses are often unspoken and taken
for granted, yet they are widely shared and ‘hold a powerful grip on our
imaginations and psyches because they offer the promise of resolution for scary
problems’ (Stone 2002: 139).
The term ‘discourse’ is used in different ways (see Dryzek 2006a; Fairclough
1992; Foucault 1980; Howarth 2000). On the one hand, actors are embedded in
social structures which constrain their actions. On the other, actors can reproduce
these discourses in ways that suit their ambitions (Sell 2003). The thesis
conceptualises discourse within a ‘co-constitutive relationship between agents and
social structures’ by which actors can challenge, contest and transform discourses
(Risse 2007). This follows its usage by the political theorist John Dryzek (1997),
whose study of environmental politics identified competing discourses like human
rights and environmental sustainability. This use of discourse is compatible with
9 Nation-state sovereignty, for example, is a social construction that did not exist pre-Westphalia (Castells 2008).
9
the term ‘frame’ by those in social movement literature (see Keck and Sikkink
1998; Tarrow 1998) and more recently in global health (McInnes and Lee 2012b).
The purpose of studying discourse is to investigate how framing processes shape
understanding, and identify whose interests are served by discourse.
The thesis demonstrates that whether medicines are valued primarily for their
curative qualities or for their economic returns is the outcome of social dynamics
and power relations. Whether access to medicines is considered a human right, or
whether medicines are considered a private intellectual property ‘right’ of
pharmaceutical firms is the result of power. The discourses that dominate reflect
the interests of the actors who shape the ‘underlying rules of the game’ (Adler
1997: 336; Barnett and Duvall 2005:2; Held and McGrew 2004: 8).
This type of investigation is emerging in the field of global health (see Labonte´
and Gagnon 2010; Lee 2009a; McInnes et al. 2012; Rushton 2012; Shiffman
2009: 38). In their study of foreign policy and health, McInnes and Lee (2006)
assert that a ‘health security frame’ is prioritising foreign security concerns of the
West over public health policy and the health needs of the developing world. Sell
(2007) and Sell and Prakesh (2004) characterise global changes in intellectual
property rules as a ‘battle to change the terms of discourse’. Hein (2007) depicts
global health as a struggle between ‘market creation’ and ‘social creation’
interests, while Kickbusch’ (2003) reflects on the role of paradigms in health.
More recently, Rushton and Williams (2012: 153) argue that neoliberalism is a
‘deep core’ of contemporary global health governance that combines in ‘powerful
ways with the dominant paradigms’ to constrain problem solving options
10
(Rushton and Williams 2012: 163). Indeed, this ‘deep core’ of neoliberalism is
reflected in the evolution of global medicines governance.
In this respect, the thesis also contributes to literature on the rise of non-state
actors in global governance (see Avant, Finnemore and Sell 2010; Castells 2008;
Hale and Held 2011; Rushton and Williams 2011; Stone 2008). Globalisation has
enabled non-state actors to acquire authority (Hall and Biersteker 2002: 4).
Authority is not only the capacity for brute force, and it is distinguished from
coercion because it is a recognition of deference, whether explicit or implicit
(Avant, Finnemore and Sell 2010; Cutler 1999: 2). Non-state actors can acquire
material, institutional, ideational (principled or moral), expert or capacity-based
authority in global governance (Avant, Finnemore and Sell 2010: 5). Non-state
actors may be ‘delegated’ authority by states, such as the World Trade
Organization (WTO), they may acquire expert authority if they are perceived by
the global community to be experts in a field, or they may possess capacity-based
authority because they have shown to effectively produce results (Avant,
Finnemore and Sell 2010: 11). Claims to authority affect agency and the roles of
non-state actors in agenda-setting, mobilising public opinion, coalition building
and, ultimately, influencing politics.
The thesis demonstrates the power and influence of the international
pharmaceutical industry in global medicines governance. The industry has
material, institutional, expert and capacity-based authority and has considerable
influence on many governments and intergovernmental institutions. Health-
advocacy NGOs, such as Health Action International (HAI), Médecins Sans
11
Frontières (MSF), Knowledge Ecology International (formerly Consumer Project
on Technology), the Treatment Action Campaign (TAC) and Oxfam, have
opposed the industry’s attempts to shape global medicines governance. These
NGOs have led public advocacy campaigns based on naming and shaming and
mobilising public opinion, and have participated in institutional advocacy through
access to elites and decision-makers (Losey 2014). NGOs have acted in an
informal advocacy network that has exhibited characteristics of a ‘transnational
advocacy network’ as defined by Keck and Sikkink (1999: 98). NGOs have co-
hosted international conferences, engaged in formal collaborations, issued joint
policy statements, shared strategies, and created international information sharing
through the internet.
Sources
The thesis draws on a critical analysis of primary source documents (see
Appendix Two and below). The primary sources were selected throughout the
research as I proceeded to identify the intergovernmental institutions and actors
that were shaping global medicines governance. I initially focused on institutions
and actors identified in secondary literature, such as the World Health
Organization and World Trade Organization. Through the research I conducted a
rigorous collection of primary sources from a number of institutions. For
example, I read all of the resolutions and decisions of the governing bodies of the
World Health Organization from the 1940s to the present. I read all over the
World Bank annual development reports. I searched the GATT archive for all
documents that referred to ‘medicines’, ‘intellectual property’, ‘R&D’ and
‘pharmaceuticals’. I also searched archives of UNCTAD and UNIDO for
12
‘pharmaceuticals’ in the 1970s. I initially began my analysis in the 1970s because
that is when the WHO’s essential medicines policy was established. However,
from this research I became aware that these debates went back earlier and so
searched for reports on meetings in the early years of the WHO (1940s).
The analysis involved reading the sources to identify the actors that were seeking
to shape medicines governance, their positions and their strategies, including the
way that they framed the debate. This was the first layer of analysis. The second
layer was to identify the outcome of the conflicts – the outcome of the debates in
various intergovernmental institutions and events to identify who ‘won’. The third
layer was to situate these struggles within a broad historical narrative, including
what was occurring in different institutions at the same time, and what was
occurring over time within and across these institutions.
The primary source documents that I have analysed include summary records and
resolutions of the governing bodies of the WHO, the United Nations Conference
on Trade and Development (UNCTAD), United Nations General Assembly,
General Agreement on Tariffs and Trade (GATT), World Trade Organization
(WTO), Conference of Non-Aligned Countries, United Nations Sub-Commission
for the Protection and Promotion of Human Rights and United Nations Economic
and Social Council (UNESC)10. These primary sources also include reports of the
aforementioned organisations along with those from the World Bank, United
Nations International Development Organisation (UNIDO), the World Intellectual
Property Organisation (WIPO), the Joint United Nations Programme on
10 In the case of GATT, I searched the GATT Digital Archive Depository of Documents between 1947 and 1995 for the term ‘intellectual property’ and/or ‘R&D’.
13
HIV/AIDS (UNAIDS), United Nations Children’s Fund (UNICEF), the Global
Fund to Fight HIV/AIDS, Tuberculosis and Malaria, the International Medicines
Anti-Counterfeiting Taskforce (IMPACT), UNITAID, Medicines for Malaria
Venture (MMV), Drugs for Neglected Diseases initiative (DNDi), and the
Medicines Patent Pool (MPP).
The thesis also draws on ‘expert’ commissions, such as the Commission on
Essential Health Research for Development (1990), the WHO Commission on
Macroeconomics and Health (2002), the United Kingdom’s Commission on
Intellectual Property Rights (2002), the WHO’s Commission on Intellectual
Property Rights, Innovation and Public Health (CIPIH), WHO Expert Working
Group on Research and Development: Financing and Coordination (EWG) (2010)
and WHO Consultative Expert Working Group on Research and Development:
Financing and Coordination (CEWG) (2012). In addition, I draw on government
laws and reports and statements by government leaders.
I have also examined policy statements and reports from non-state actors,
including the International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA), the Pharmaceutical Research and Manufacturers
Association of America (PhRMA), and health advocacy non-government
organisations like Health Action International (HAI), the AIDS Coalition to
Unleash Power (ACT UP), Médecins Sans Frontières (MSF), Treatment Action
Campaign (TAC) and the Consumer Project on Technology (CpTech). Academic
literature also serves as primary source evidence, including Third World
economic papers in the 1960s and 1970s and academic publications by staff of
14
NGOs. This material is supported by secondary literature, drawing on the work of
scholars in a range of fields including law, politics and health. I also conducted
informal discussions with experts and activists at the Third People’s Health
Assembly (PHA3) in Cape Town, South Africa in July 2012 and in my
participation in the People’s Health Movement ‘WHO Watch’ at the January 2013
Executive Board meeting of the WHO in Geneva, Switzerland.
Terminology
A number of concepts and terms used in the thesis require clarification. The
global South traditionally refers to those countries defined by the United Nations
Development Program (UNDP) as ‘developing countries’. The relevance of the
terms ‘South’ and ‘North’ is called into question by some, in particular since the
UNDP has very recently classified several of these countries as ‘highly’
developed. However, this divide is still relevant as the global North refers to the
47 countries determined to be ‘very highly’ developed (United Nations
Development Programme 2013). Essential medicines are defined by the WHO
Expert Committee on the Selection and Use of Essential Drugs (2000) as ‘those
medicines that satisfy the priority health care needs of the population, which
should be available at all times and in adequate amounts, in the appropriate
dosage forms, with assured quality and adequate information, and at a price the
individual and community can afford’. Prior to the early 2000s, the term ‘essential
drugs’ was widely used (Laing 2003). For simplicity, the thesis uses the term
essential medicines (except in quotes). ‘International pharmaceutical firms’ refer
to those multinational pharmaceutical companies that operate as global entities
and in global space and are headquartered predominantly in Europe and the
15
United States (Fortune Global 500 2009; see Appendix One for a glossasy of
more terms). These firms are also referred to as pharmaceutical transnational
corporations (PTNCs). The thesis uses the terms HIV and AIDS interchangeably
and the acronym HIV/AIDS (Sabatier 1989: 1). Where the terms ‘low-income’ or
‘middle-income’ are used, the thesis draws on sources which have generated data
using the World Bank’s income categories (see World Bank 2013).
Terminology to describe poor-quality medicines is politically charged.
Substandard medicines, for example, are typically defined as medicines produced
by licensed manufacturers which fail to pass quality standards (WHO N.D.g). In
the WHO, the terms ‘spurious/falsely labelled/falsified/counterfeit’ refer to
medicines that are ‘deliberately and fraudulently mislabelled with respect to
identity and/or source’ (WHO 2014b). This definition is broader than the
definition of substandard and includes medicines which contain correct
ingredients (WHO 2014b). While scholars have recently proposed new definitions
(see Attaran et al. 2012), this conflation of terms around quality of medicines and
intellectual property remains a significant issue in global health, as this thesis
demonstrates in chapter five.
International health refers to the ‘traditional forms of interstate co-operation on
health through diplomacy, treaty-making and the creation of international
institutions’ (Rushton 2008). Rapid spread of diseases, environmental issues and
problems of access to medicines are examples in which one’s health can no longer
be ‘viewed in isolation from that of another’ (Kickbusch 2005). Health issues
increasingly ‘circumvent, undermine or are oblivious to the territorial boundaries
16
of the state… and are beyond the capacity of state institutions to address alone’
(Buse et al 2002: 270). We now speak of global governance to refer to ‘not only
the formal institutions and organisations through which the rules and norms
governing world order are (or are not) made and sustained... but also the
organisations and pressure groups – from MNCs, transnational social movements
to the plethora of non-governmental organisations – which pursue goals and
objectives and have a bearing on transnational rule and authority systems’ (Held
et al 1999:50).
In addition, new communication technologies such as the internet have facilitated
a global public sphere. This global public sphere is a ‘space of communication
and ideas that emerge from society’ outside the state system, operating beyond the
‘limits of national boundaries’ (Castells 2008: 78; Dryzek 2006; Nanz and Steffek
2004: 321; Scholte 2005: 283)11. Global civil society is the organised component
of the public sphere that is comprised of voluntary associations seeking to shape
social rules (Castells 2008: 78; Scholte 2005: 214). Civil society is said to be
global when these voluntary associations have a global focus, use global
infrastructure, and are financed globally (Castells 2008; Kaldor 2005; Scholte,
2007: 311).
Authority is the ability to ‘induce deference in others’ (Avant et al 2010: 10).
Authority is bound with power, and governance and power are ‘inextricably
linked’ (Barnett 2005: 2). Power is more than force and is produced ‘in and
through social relations’, shaping ‘the capacities of actors to determine their own
11 The public sphere does not exist in a vacuum, however, and exists alongside and interacts with the state system (Lipschutz 2005).
17
circumstances and fate’ (Barnett 2005). Barnett and Duvall (2005) have usefully
identified a framework for power. Compulsory power refers to direct control,
such as the use of force. Institutional power is the exercise of indirect control,
through for example international institutions. Structural power is the
‘constitution of social capacities and interests of actors in direct relation to each
other’, such as labor and capital under the capitalist system (Barnett and Duvall
2005:3). Finally, productive power is the ‘production of subjectivity in systems of
meaning and signification’ that includes discourse and systems of knowledge
(2005:3). These aspects of power inform the thesis research.
Thesis structure
The thesis is structured according to its historical approach, with each chapter
examining a particular time period. In addition to the review of relevant literature
presented in this chapter, the empirical chapters of the thesis each contain a
literature review integrated in the text. Chapter two commences the historical
study with the creation of the World Health Organization in the 1940s and
concludes with the formation of the WHO’s essential medicines policy and
Action Programme on Essential Drugs in the early 1980s. The chapter situates
developments in international medicines policy in this period within broader
shifts in international politics that were the result of demands by the global South
for a fairer international system. The chapter demonstrates that Third World
discourse enabled the global South to champion their economic and health
ambitions, and shape the vision of a New International Economic Order (NIEO)
and ‘Health for All’. The chapter shows, however, that over four decades the
United States government opposed and prevented a role for the WHO in
18
addressing the medicine needs of developing countries, in particular when such
policy threatened the profits of its pharmaceutical firms. The chapter argues that,
despite the NIEO ambitions, the international governance of medicines in this
period was inadequate to meet the health needs of the global South.
Chapter three commences in the early 1980s and concludes with the establishment
of the World Trade Organization’s Trade Related Agreement on Intellectual
Property Rights (TRIPS) in the mid-1990s. The chapter argues that the global
governance of medicines in this period privileged the economic interests of
international pharmaceutical firms and failed to address the health needs of the
global South. Medicines governance was transformed through shifts in economic,
health and trade policy in this period that were the result of a broader forum-
shifting strategy of the United States and its allies to block the New International
Economic Order. In the domain of economic policy, neoliberal economic
restructuring strengthened the dominance of international pharmaceutical firms in
global medicines research and development (R&D), production, and trade. In
health policy, the World Bank and UNICEF promoted ‘selective’ primary health
care, which complemented economic reforms by providing a rationale and
justification for a narrow role for government in health. Finally, shifts in
international trade policy in this period presented new global architecture for
medicines R&D that privileged the private ‘rights’ of patent holders over the
health needs of the global South.
Chapter four examines developments in global medicines governance through the
1990s to the World Trade Organization’s Doha Declaration on TRIPS and Public
19
Health in 2001. The chapter demonstrates that the global governance of medicines
in this period strengthened a global norm for intellectual property ‘rights’ as a
prerequisite for medicines research and development (R&D). This legitimised the
historical neglect of the health needs of developing countries, because it framed
this neglect as a logical outcome in the absence of IP protection. The chapter
shows that the Doha Declaration was a product of resistance on the part of several
developing countries and NGOs against pressures to enforce IP measures beyond
those of TRIPS. These actors championed a discourse for ‘public health
safeguards’ which enabled them to reassert health needs against patent ‘rights’.
The chapter argues, however, that this discourse was co-opted by the United
States and the international pharmaceutical industry, who framed the protection
and enforcement of their IP ‘rights’ as a safeguard for the development of new
medicines. I show that the World Health Organization shifted its position in
support of the enforcement of strong IP ‘rights’ as a strategy to reclaim its
authority in global health.
Chapter five examines the globalisation of regulatory requirements for medicines
and the diffusion of intellectual property ‘rights’ in global medicines regulatory
initiatives in the 1990s and 2000s. The chapter argues that the international
pharmaceutical industry and its proponents played a key role in raising minimum
international regulatory standards, beyond mere health and safety benefits, as part
of their strategy to block foreign competition from generic firms. It situates the
creation of the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, the
WHO’s pre-qualification program and the United States bilateral aid program for
HIV/AIDS within this strategy and the broader historical struggle over the
20
production and supply of medicines. The chapter subsequently highlights the role
of Nigeria as a global advocate for the industry-led IMPACT in the WHO. The
chapter shows that Nigeria’s support for IMPACT has created a division in the
global South over the WHO’s role in this initiative. This has enabled the
pharmaceutical industry to continue to pursue the enforcement of IP in IMPACT
and has delayed effective governance to address the problem of a lack of capacity
in the South to regulate medicines.
Chapter six examines the evolution of the global governance of medicines for
tropical diseases, culminating in the rejection of an R&D treaty in the WHO in
2012. The chapter shows that the plight of communities living with tropical
diseases re-emerged on the global agenda in the 1990s through the advocacy of
Médecins Sans Frontières (MSF) and a global network of activists and NGOs.
These actors championed a counter-discourse to TRIPS that was premised on
conceptualising essential medicines as ‘public goods’. The chapter argues that this
‘public goods’ discourse was the broader political context in which
pharmaceutical firms and their proponents created product-development
partnerships (PDPs) that became the dominant mode of governance for R&D for
tropical diseases. This model principally serves to reinforce global norms for the
protection of intellectual property ‘rights’. Indeed, the chapter argues that the
creation of PDPs enabled the United States and its allies to block an R&D treaty
in the WHO that threatened to replace IP as a global norm for medicines R&D.
Finally, chapter seven examines the contemporary situation of power and
resistance in global medicines governance. It demonstrates that the status quo is
21
one in which the United States government and the pharmaceutical industry are
attempting to raise global norms for the protection and enforcement of
pharmaceutical intellectual property ‘rights’ beyond the requirements of TRIPS.
This ‘TRIPS PLUS’ agenda threatens access to new medicines in developing
countries because it inhibits generic competition and affordable access to
medicines. The chapter focuses on recent landmark corporate litigation in India
that has been led by some international firms in an attempt to secure ‘TRIPS
PLUS’ IP standards. India is significant for the global South because many
developing countries rely on Indian manufacturers for their essential medicines.
The chapter shows that India has resisted the TRIPS PLUS agenda with the
support of a loose alliance of generic firms and health advocacy NGOs. This
suggests that when economic and health objectives align, governments in the
global South can resist industry pressure. These alliances are also evident in an
increasing counter-movement amongst middle-income countries.
22
C H A P T E R T W O
A New International Economic Order: Health for All and Essential Medicines
This chapter commences this historical and empirical study with the creation of
the World Health Organization in the 1940s and concludes with the formation of
the WHO’s essential medicines policy in the early 1980s. The chapter situates
developments in medicines policy in this period within broader shifts in
international politics that were the result of demands by the global South for a
fairer international system. The chapter demonstrates that through the rise of
Third World discourse, many developing countries articulated a set of demands
related to medicines research and development (R&D), production, access and
regulation through the United Nations (UN). This discourse enabled the global
South to champion their economic and health ambitions, and shape the vision of a
New International Economic Order (NIEO) and ‘Health for All’. The chapter
shows, however, that over four decades the United States government opposed a
role for the WHO in addressing the medicine needs of developing countries,
particularly when such policy threatened the profits of its pharmaceutical firms.
Indeed, in the late 1970s, the International Federation of Pharmaceutical
Manufacturers and Associations (IFPMA) played a key role in weakening the
WHO’s essential medicines policy. The chapter argues that, despite the NIEO
ambitions, the international governance of medicines in this period was
inadequate to meet the health needs of the global South.
23
The chapter draws on an analysis of records, resolutions and reports of the WHO,
United Nations Conference on Trade and Development (UNCTAD), United
Nations International Development Organisation (UNIDO), United Nations
Conference on Transnational Corporations (UNCTC), Non-Aligned Movement,
United Nations General Assembly and Third World academic literature (see
Appendix Two).
Medicines policy and the WHO in the 1940s
The World Health Organization was formally created in 1948 as a specialised
agency of the United Nations. Upon its formation, the organisation appeared to
have multiple claims to authority. Member-states seemingly delegated authority
to the WHO through its mandate as the ‘directing and coordinating authority for
international health’ (WHO 1946). The WHO was also imbued with a moral
authority through its objective for ‘all peoples of the highest possible level of
health’ as a ‘fundamental right’ (WHO 1946). Shortly after it was established, and
in response to the creation of new medicines like penicillin, the WHO Secretariat
asserted a role for the organisation in setting international standards and non-
proprietary names for medical substances (Chisholm 1950: 1022; WHA3.11
[1950] in WHO 1973a: 128)12. This technical function and expert authority was
welcomed by its member states, of which there were 59 in 1949. That year,
member states of the WHO agreed that the coordination of biomedical research
was an ‘essential function’ of the WHO (WHA3.19 [1949] in WHO 1973a: 23). 12 Prior to 1945 little drug development occurred in the pharmaceutical industry. The discovery of penicillin during World War Two, however, led to the expansion of public sector investment in R&D in industrialized countries and the proliferation of pharmaceutical R&D firms which to this day remain headquartered in Europe and the United States (see Cockburn 2004; Dutfield 2003; Grabowski 2011; Sunder Rajan 2006; Taggart 1993).
24
The WHO’s early work thus focused on developing control plans for malaria,
tuberculosis and venereal diseases, and the coordination of research for medicines
for malaria (Chisholm 1950: 1022; EB5.R10 [1949] in WHO 1973a: 67).
However, the WHO’s authority became politically contested amongst member-
states shortly after it was created. Indeed, conflict over the role of the WHO in the
governance of medicines threatened the WHO’s broader claims to authority.
In 1947, the first Expert Committee on the Unification of Pharmacopoeias13
called for ‘a comprehensive list of the drugs considered to have outstanding value
in medical practice…to be divided into a primary list of the most essential drugs’
(cited in WHO Expert Committee on the Selection of Essential Drugs 1977). It
would be another 30 years, however, before the WHO would formally adopt an
essential medicines policy (see below). This significant delay was the result of
politics. In 1949, the problem of inadequate access to medicines was first raised
internationally at the World Health Assembly (WHA)14. Several countries with
limited resources asserted that ‘it was the function of WHO…to provide essential
medical supplies...to countries which do not produce these commodities and
which, because of the lack of necessary currencies, are unable to import them’
(cited in Chisholm 1950: 1025). This view of the role of the WHO was shared by
the first Director General of the WHO, Brock Chisholm, who argued that the
objective of the organisation was to ‘make it possible for all people to share in the
13 This committee was set up by the WHO interim Commission to carry on the work of the League of Nations to implement an international agreement for the unification of pharmacopeias (WHO 2006g: ix). 14 The World Health Assembly is the decision-making and governing body of the WHO which comprises all member-states of the United Nations. It meets annually in Geneva Switzerland.
25
benefits of medical and sanitary sciences’ (Chisholm 1950: 1022)15. The United
States, however, opposed this role for the WHO and claimed that ‘medical
supplies, like other commodities, should now be obtained through the normal
peacetime economic machinery’ (Chisholm 1950: 1025). These contrasting
positions were indicative of early tensions over the role and function of medicines
in society.
The broader political economic context in which the 1949 World Health
Assembly took place was the emergence of the Cold War, in which conflict
between the Soviet Union and the United States took place on numerous political
fronts16. The 49 member states of the WHO were politically divided. The United
States linked its support for health programs like malaria to its anti-Communist
efforts (Farley 2008: 159). Indeed, the Soviet Union briefly left the WHO in 1949
(Lee 2009b). Despite the one-state one-vote mechanism upon which the
organisation was established, the WHO was oriented to creating consensus
amongst the divided member states. Because of US resistance, however, member-
states could only agree that the WHO would make medicines available on an
‘extremely limited scale and under special circumstances’ (Chisholm 1950: 1025;
EB6.R3 [1950] in WHO 1973a:21). Thus, in the 1940s the United States was
effective in determining a limited role for the WHO in the provision of medicines.
Medicines and the Third World
15 Brock Chisholm promoted ‘social medicine’ beyond a narrow focus on biomedicine and disease, much like the contemporary public health focus on the social determinants of health (Farley 2008: 113; Lee 2009b: 17). 16 The two year delay between the signing of the WHO constitution in 1946 and its formal establishment in 1948 was due to the onset of the Cold War (Lee 2009b).
26
This chapter has so far shown that medicines emerged on the agenda of the
newly-formed WHO in the 1940s amidst political conflict. In this section I
demonstrate that the 1950s and 1960s saw the rise of Third World discourse in
which the global South formed a critique of the international system, including
the dominance of international pharmaceutical firms in the supply of medicines.
This movement emerged outside the United Nations, yet it was influential on
many UN organisations. The section shows, however, that it was not until the
1970s that the global South secured UN support for its vision of a fairer
international system, including a restructuring of the governance of medicines.
As the previous section has explained, the WHO was formed in the broader
political context of the Cold War. This period, in particular the 1950s and early
1960s, was also characterised by rapid decolonisation (Rowden 2009: 56). Across
Asia and Africa, newly independent developing countries shared a common desire
for freedom and independence. Despite their different cultural and economic
backgrounds, their leaders began to foster a common ambition. In 1955, the first
Asian-African conference in Bandung Indonesia was significant for the formation
of a project for the Third World. Opening the conference, Indonesia’s President
Sukarno celebrated that:
Irresistible forces have swept the two continents. The mental, spiritual,
and political face of the whole world has changed and the process is not
complete…hurricanes of national awakening and reawakening have swept
over the land, shaking it, changing it, changing it for the better (Sukarno
cited in McTurnan 1956: 43–44).
27
The 29 governments in attendance at Bandung were united by ‘a common
detestation of colonialism in whatever form it appears…and a common
determination to preserve and stabilise peace in the world’ (President Sukarno
cited in McTurnan 1956: 43–44). To achieve this aim, they agreed that they
would not enter into strategic alliances with either the Soviet Union or United
States, and subsequently came to be known as the Non-Aligned Movement
(Sneyd 2005; Thompson 2003)17. Their aspirations were forged in solidarity as a
project for the Third World, one premised on political and economic
independence, non-violent international relations, and a focus on the United
Nations as the prime institution for global justice (Asian-African Conference of
Bandung 1955; Prashad 2007: 27). This emphasis on peace and security in Third
World discourse aligned well the ambitions of the United Nations. The Non-
Aligned Bandung communiqué, for example, came to inform the Charter of the
United Nations International Atomic Energy Agency (Prashad 2007: 58).
At the core of Third World discourse was a common set of economic and political
objectives that were premised on this critique of colonialism. ‘Dependency
theory’ arose in academic and political circles to reflect developing countries’
opposition to the dominance of former colonial countries in the international
economic system (see Baran 1957; Cardoso and Falsetto 1979; Frank 1967). In
Third World discourse, ‘neo-colonialism’ and ‘imperialism’ were terms used to
describe the continuing cultural and economic domination of colonial countries
over the Third World (see Singham 1976: 8). Based on this critique, a group of
countries in the global South promoted a number of economic objectives to end
17 Despite this policy rhetoric for non-alignment, six of the 29 states at Bandung did have military-economic arrangements with the US and Britain (Prashad 2007: 53).
28
this dependence. The United Nations Economic Commission on Latin America
(UNECLAC) championed import-substitution industrialisation (ISI) to promote
local industrialisation. The policy instruments of ISI involved direct government
participation in industries and the protection of domestic industry through
protective tariffs, special preferences and preferential exchange rates (Baer 1972:
98). Throughout the 1950s and early 1960s, several developing countries, in Latin
America in particular, implemented policies aimed to enhance their economic
autonomy through the local production of essential goods, including medicines18.
In the 1960s, the global supply of medicines was dominated by pharmaceutical
firms headquartered in Europe and the United States (Ballance, Pogany and
Forstner 1992; Lall 1974: 144)19. Even India, the most advanced of the
developing countries with respect to pharmaceutical production, was dominated
by a small number of international corporations (UNCTAD 1976: 4)20.
International companies maintained an oligopoly through their ownership of
subsidiary firms, through licensing arrangements, and their concentration of
patents. In the 1960s, Third World discourse enabled a critique of the
international patent system which subsequently led to shifts in patent law in
several countries in the global South.
The patent system in existence in the 1960s was the Union of the Paris
Convention on Industrial Policy which established rules of non-discrimination for 18 Aside from India and Korea, most developing countries did welcome foreign investment for local manufacturing under ISI (Sell 1998: 56). The process of ISI did achieve economic growth in some countries. Brazil, for example, expanded its industrial product growth rate by over 260 per cent by the mid-1960s (Baer 1964: 415). 19 These firms were ‘highly integrated’ in that they conducted R&D, production, manufacturing, and marketing (Malerba and Orsenigo 2001; Taggart 1993). 20 In Mozambique, international pharmaceutical firms supplied 90 per cent of the medicines by brand name (Turshen 2001: 201).
29
the protection of trade in ‘industrial property’ (Paris Convention for the Protection
of Industrial Property 1883). While only one-fifth of the developing world had
officially joined the Union, several countries had modelled their patent laws on
former colonial powers (Deere 2008; Okediji 2003; Ricketson 1987; UNCTAD
1975: 4; WTO 1947)21. In 1961, Brazil, the only member developing country
since the inception of the Paris Convention, raised the issue of patents and their
effect on developing countries’ industrialisation at the General Assembly of the
United Nations (UNESA, UNCTAD and WIPO 1975: 35). Brazil proposed that
the UN Secretary General prepare a study on the effects of patents on developing
countries. After political manoeuvring between member states, however, this
resolution was largely stifled by the United States and its allies, which were
supportive of the patent system (May 2010; United Nations General Assembly
1961: 23). Nonetheless, what emerged throughout the 1960s and 1970s was a
widespread critique of the patent system amongst academic and political circles in
the Third World (see Greer 1973; Grundmann 1970; Penrose 1973; Vaitsos
1972).
The two main targets of criticism of the patent system by Third World academics
were the overwhelming ownership of patents by foreign entities, and the fact that
many patents were not used to develop products in developing countries. Vaitsos
(1972: 74) documented, for example, that in Chile, foreign ownership of
pharmaceutical patents increased from 35 per cent in 1937 to over 98 per cent in
1967. This increase in foreign patents was not translated into usage with the
21 The majority of those developing countries that had joined the Union had done so after the main principles were established and had little influence on amendments to the Convention (UNCTAD 1977: 6).These rules were not uniform because different governments had ratified different versions of the Union (UNCTAD 1975: 5).
30
majority of pharmaceutical patents going unexploited, meaning they were not
used for production and not licensed to third parties. In Columbia in the 1960s,
for example, only 10 out of over 3000 patents were produced (Vaitsos 1972: 78).
The government of India was scathing in its critique and asserted that the real
rationale for patents was not that they were an incentive for domestic activity as
claimed, but that they were used to protect export markets from competition (cited
in Vaitsos 1972: 78).
Thus, several developing countries revised their patent laws in this period to
promote local production (Sell 1998). In 1970, member states of the Andean
community22 strengthened their national regulations over the operations of foreign
businesses including limits on foreign investors’ use of patents (Decision 24 1970
in UNCTAD 2001: 47). That same year India reduced the period of patent
protection for pharmaceutical processes from 16 to 7 years and ruled out patents
for pharmaceutical products (Lall 1974: 165). The following year, Brazil
amended its Patent Law so that chemical, pharmaceutical or nutritional products
were not eligible for patents (Deere 2008; Gontijo 2005). Several other countries
in the global South (and North) chose not to implement product and/or process
patents for industrial technology (Deere 2008).
A noteworthy exception to these revisions of the patent system was the
paradoxical creation of the World Intellectual Property Organization (WIPO) in
the late 1960s. In 1967, 39 member states – 9 of which were developing countries
– agreed to establish WIPO with the aim of promoting ‘the protection of
22 The Andean Community is a trade bloc that was founded in 1969 by Bolivia, Chile, Colombia, Ecuador, and Peru.
31
intellectual property throughout the world through cooperation among States and,
where appropriate, in collaboration with any other international organization’
(Convention Establishing the World Intellectual Property Organization 1967).
The creation of WIPO reflected tensions between Third World demands for
reduced patent protection on the one hand, and the position of the United States,
which favoured more stringent protection on the other. Indeed, WIPO was likely a
political response to the creation of two United Nations bodies a few years earlier,
UNCTAD and the United Nations Industrial Development Organization
(UNIDO). Both UNCTAD and UNIDO were established in the mid-1960s to
promote and accelerate the industrialisation of developing countries. In
UNCTAD, developing countries had begun to negotiate preferential tariff rates
between themselves with the aim of ‘increasing export earnings, promoting
industrialisation and accelerating economic growth’ (Generalised System of
Preferences [1968], Resolution 21 (ii) in UNCTAD N.D.)23. The creation of
WIPO did little to stem the widespread critique of the patent system in the 1960s,
however. This conflict would come to a head over 20 years later (see next
chapter).
In addition to this critique and revision of industrial and patent systems, Third
World discourse also enabled a language in which scholars, academics and policy
makers could criticise the high price charged for medicines by international firms
23 The US and its allies initially responded to the demands of the global South through the multilateral General Agreement on Tariffs and Trade (GATT) by adopting the Declaration on Promotion of Trade of Less-Developed Countries (1962) which called for ‘immediate steps’ to be taken for the ‘progressive reduction and elimination of barriers to the exports of less developed countries’ (GATT 1962: 24; United Nations Department of Economic and Social Affairs 1963). This was mainly rhetorical, however, and UNCTAD and UNIDO became the favoured forum for the Group of 77 to negotiate trade preferences.
32
in the global South (Antezana 1981). Throughout the 1960s, expenditure on
medicines in several developing countries doubled to nearly four times that of the
growth of their Gross National Product (GNP) (Piachaud 1980). In former French
colonies Algeria, the Congo, and Tunisia, the price of medicines by French
companies were higher than they were in France (Turshen 2001: 202). The rising
price of medicines, which did little to stimulate economic industrialisation in the
global South, contributed to significant cost pressures on governments.
Throughout the 1960s, over one-third of the health budget in Thailand and over
two-thirds of the health budget in Bangladesh was spent on medicines (UNESC
1981: 4). The need to reduce the price of medicines became a national issue
across the global South, and indeed in industrialised countries (Mamdani 1992:
12). Through both pricing and patenting, Third World discourse enabled a critique
of the oligopoly of foreign pharmaceutical firms in the supply of medicines in the
global South (UNIDO 1978: 9)
As the supply and pricing of medicines received increasing attention, medicines
regulation emerged on the agenda of the WHO. The catalyst was the thalidomide
disaster in 1962, in which the over-the-counter (OTC) medicine thalidomide was
the cause of birth defects in several countries. In 1963, member states of the
WHO granted the organisation a new role in medicines governance by agreeing to
communicate to the WHO any detection of ‘serious adverse side effects’ of
medicines (WHA16.35 [1963] in WHO 1973a: 159). Shortly after, several
developing countries called for the WHO to exert international authority over
international pharmaceutical firms, which they claimed were pressuring them to
allow unregulated medicines sales. This culminated in a request to the second
33
Director General of the WHO, Marcolino Gomes Candau, to examine ways to
ensure the quality control of medicines (WHA16.38 [1963] in WHO 1973a: 130).
As a Brazilian public health specialist, Candau was sympathetic to these calls
(Kaplan 1983). Nonetheless, it was not long before member states were publicly
critical of the ‘unsatisfactory situation’ by which they claimed that the WHO had
not adequately assisted them in implementing quality control measures
(WHA18.36 [1965] in WHO 1973a: 131).
In the late 1960s, the WHO developed a set of principles and guidelines for
pharmaceutical and manufacturing quality control, known as Good Manufacturing
Practices (GMP) (WHA22.50 [1969] in WHO 1973a: 133). These guidelines
were based on the practices of the American Food and Drug Administration
(FDA) which was emerging as a ‘gold standard’ in medicine regulation
(Carpenter 2010: 694). Indeed, American-based international pharmaceutical
firms played a key role in promoting the WHO GMP because they could meet the
standards at a lower cost than generic firms based in the global South (Carpenter
2010: 715). Many developing countries appeared more concerned about the
‘widespread misleading information’ on the effectiveness of medicines by
pharmaceutical advertising (EB41.R24,WHA21.41 [1968] in WHO 1973a: 144).
Despite their calls for WHO support, however, they did not secure consensus
from other member states to provide a role for the WHO in regulating
pharmaceutical marketing.
In parallel to these conflicts over medicines regulation, the rise of Third World
discourse saw new attempts by the WHO to strengthen its role in health research.
34
In the mid-1960s the Chief of the WHO Tuberculosis Unit, Halfdan Mahler, was
receptive to the Third World movement and made a passionate call for a ‘radical
reappraisal and perhaps equally radical extension of our efforts in health research’
(cited in WHO 1964). Around this time, the WHO Secretariat proposed that
member states establish a World Health Research Centre to meet this purpose.
Tensions were evident in the WHA, however, as several states refused to
acknowledge such a role for the WHO. Eventually the idea of a World Health
Research Centre was abandoned in place of a division of research on
epidemiology and communications science within the WHO (WHA17.37 [1964],
WHA18.43 [1965] in WHO 1973a: 28; WHO 2008d: 91)24.
This chapter has so far demonstrated that the rise of Third World discourse in the
1950s and 1960s enabled several developing countries to revise their industrial,
trade and patent laws, which affected the governance of medicines. Notably, this
movement formed outside the United Nations through the Non-Aligned
Movement. While the UN was receptive to this project, its organisations were
constrained by the opposition of the United States government. Third World
discourse led to renewed debates in the WHO over medicines pricing, advertising,
production, regulation and the coordination of research in this period. These
conflicts laid the groundwork for subsequent battles, as the thesis will show.
A New International Economic Order and Health for All
24 This conflict over the role of the WHO in medicines research re-emerges 40 years later (chapter six).
35
This section shows that it was a combination of the oil crisis and the broadening
of the Non-Aligned Movement in the early 1970s which forced a softening of the
United States opposition to the Third World project. This enabled the Declaration
for a New International Economic Order (NIEO) in the United Nations that
reflected the demands of the global South. This section demonstrates that the
NIEO discourse emboldened UNCTAD to critique the international patent
system, informed the creation of the WHO’s Tropical Disease Program, and was
translated into a vision for ‘Health for All’ in the WHO. These developments
were conducive to the health ambitions of the global South with respect to the
governance of medicines.
A turning point for the global South in the ambitions for the Third World project
was the oil crisis and the outbreak of the fourth Arab-Israeli war in the early
1970s. In 1973 the United States effectively ended the fixed-rate exchange system
by removing its currency from the Gold Standard, triggering a dramatic fall in the
price of oil25. That same year, the Middle-East was occupied by the outbreak of
the fourth Arab-Israeli war. In response to both the collapse of the oil price and
the war, the Organization of Arab Petroleum Exporting Countries (OAPEC)
raised the price of their oil and embargoed their oil exports to the United States
(and the Netherlands) in an attempt to pressure the United States to withdraw its
support for Israel (Licklider 1988: 206). Within a year the international price of
oil had increased by more than 500 per cent (Ikenberry 1986: 105; White 1975).
This commodity power exercised by the Arab oil-exporting countries took the
industrialised economies by surprise (White and Bidwell 1978). Despite the rising 25 This Accord had been established in the 1940s to promote a fixed exchange rate system whereby countries’ currencies were either fixed to the US dollar or the standard set by the dollar (Rowden 2009: 55).
36
oil prices, non-oil-exporting developing countries remained united alongside their
Arab counterparts in calls for a fairer international economic system26. Soon after,
the Non-Aligned Movement shifted its position away from ‘non-alignment’ to an
anti-imperial stance and welcomed as members socialist countries like Cuba. This
was a cause for concern for the US and led to a softening of the US opposition to
the Third World demands, in particular when ‘it became clear that the
conservative members of OPEC were going to join the radical ones in bidding for
the political leadership of the Third World’ (Thomas Enders, Assistant Secretary
of United States and American envoy to the United Nations General Assembly
cited in Frank 1975: 1481; Gosovic and Ruggie 1976).
In softening their stance against the Third World, the United States and its allies
(Germany, France, Japan and the UK) agreed to the adoption of a Declaration on
the Establishment of a New International Economic Order in the United Nations
(1974)27. This Declaration reflected the discourse of the Third World and was
centred on a ‘commonality of ideas’ for equity, sovereign equality,
interdependence, justice and peace (Cox 1979: 260; United Nations General
Assembly 1974: 1). The NIEO Declaration asserted that the ‘greatest obstacles’ to
the full emancipation and progress of developing countries were the remaining
‘vestiges of alien and colonial domination, foreign occupation, racial
discrimination, apartheid and neo-colonialism in all its forms’ (United Nations
General Assembly 1974). It aimed to facilitate a fairer international system for 26 Brazil, for example, reported that 40 per cent of its export earnings went to oil payments in the early 1970s (Gosovic and Ruggie 1976: 320; Toye and Toye 2005; 169). 27 The US, Germany, France, Japan and the UK annexed several reservations to the text. For example, in response to the oil mobilisation, the United States asserted that ‘such artificial attempts to manage markets which ignore economic realities and the legitimate interests of consumers as well as producers run the risk of political confrontation on the one hand and economic failure on the other’ (American Ambassador Scali cited in White 1975: 548).
37
developing countries (United Nations General Assembly 1974). At the core of the
NIEO was the sovereign equality of states and the sovereign rights of states over
their economic and social systems as an ‘inalienable right’28. In the 1970s the
Declaration for a NIEO was widely considered as evidence of the increasing
political power of the global South (see White 1975: 543; White and Bidwell
1978: 626).
The rise of the NIEO in the United Nations emboldened the agencies of the UN to
introduce and implement rules that were aligned with these ambitions. Notably,
UNCTAD finally commenced negotiations to create new international rules for
technology transfer and the patent system with the ambition of promoting local
production, including for medicines. While this was opposed by the United States
and its allies, developing countries retained a majority of votes within UNCTAD
to pursue their objective (Vaitsos 1976: 85). In the mid-1970s UNCTAD released
its review of the patent system (UNCTAD 1975). This report clearly reflected the
NIEO, it emphasised the importance of ‘public rights’ in patent laws (UNCTAD
1975: 8) and was critical of the Paris Convention for an imbalance that favoured
the private sector (see also UNCTAD 1977: 4). UNCTAD (1975:19) asserted that
the Paris Convention was in ‘direct opposition to the objective of promoting
domestic industrialization in the developing countries’.
Notably, UNCTAD (1975: 2) cautioned developing countries against relying on
measures like compulsory licensing, which were provisions in the Paris
Convention that enabled governments to override patents without patentee
28 This conception of natural rights would later be challenged under neoliberalism (see chapter three).
38
consent, based on certain conditions. UNCTAD (1975: 2) largely saw these
measures as ineffective because of ‘examination procedures, the behaviour of
transnational corporations (TNCs), and lack of know-how’. It stressed the need to
employ a full range of policy instruments and ‘move away from the limited and
limiting emphasis on one single policy, namely compulsory licensing, which has
proved such a poor remedy’ (UNCTAD 1975: 17). This is significant in light of
the re-emergence of this debate two decades later, in which the global South came
to rely on compulsory licensing ‘safeguards’ and appeared to ignore these earlier
cautions (see Chapter four).
In its review, UNCTAD (1975: 2) concluded that the ‘international patents system
is not, in its present form, proving to be of benefit to the developing countries and
that it is instead having a negative effect on their development’. Interestingly, the
newly established WIPO requested to be included as a co-author on the UNCTAD
report, despite having a very different ideological approach to the patent system.
According to May (2010: 24), this was a strategy of the WIPO Director General,
Arpad Borsch, to ‘link up’ with the UN and increase the exposure of WIPO to the
global South. In 1975, UNCTAD (1975: 17) recommended that a revision of the
Paris Convention take place to give member states the right to adopt legislative
measures, ‘providing for use or expropriation by the government of patented
inventions for whatever purposes are deemed necessary for national
development’. This revision process commenced shortly after in WIPO, and
signalled the success of Borsch in convincing developing countries that WIPO
was the appropriate venue for such deliberations (see more in following chapter).
Soon after, UNCTAD commenced its own negotiations on a Draft Code of
39
Conduct on Technology Transfer, which aimed to facilitate technology transfer
and research and development in developing countries (more detail in following
chapter; Roffe [Chief of Legal Policies UNCTAD] 1985: 693; Thomas 1998:
2107-8). These developments would ultimately fail in the 1980s with the demise
of the NIEO (see next chapter). The point for this chapter is that the global South
was successful in shifting the policy approach of the United Nations in the 1970s
when the NIEO was at its peak.
The NIEO Declaration was also a turning point for a shift in the WHO. In parallel
to the NIEO Declaration, Halfdan Mahler, former Chief of the Tuberculosis Unit
was appointed as the third Director General of the WHO in 1973 (WHO 1973b).
Mahler brought the issue of the need for effective medicines in developing
countries back on the WHO agenda (WHO 1973b, 1974b). Indeed, Mahler linked
the health needs of developing countries to the moral authority of the WHO by
claiming that the NIEO gave the WHO a ‘moral imperative’ (Mahler 1975b):
There is an urgent need to ensure that the most essential drugs are
available at a reasonable price and to stimulate research and development
to produce new drugs adapted to the real health requirements of
developing countries (Mahler 1975a).
As Mahler promoted the medicine needs of the global South, medicines became a
significant point of focus in the Non-Aligned Movement. In 1975, developing
countries through the World Health Assembly called on the WHO to assist in the
formulation of national medicines policies that would link research, production
and distribution of medicines with ‘real health needs’, and to advise governments
40
on ‘the selection and procurement, at reasonable costs, of essential medicines’
(paragraph 3(b) WHA28.66 [1975] in WHO 1985a: 73; WHO 1975c). The
following year, the conference of the Non-Aligned Movement began to co-
ordinate amongst the member states plans for cooperation in the production,
procurement and distribution of medicines (Fifth Conference of Heads of State or
Government of Non-Aligned Countries 1976). Sri Lanka, Papua New Guinea,
Cuba, Costa Rica, India, Egypt, Mexico, Pakistan, and Peru shared their
experiences in creating national medicines formularies with the broader
movement (Antezana 1981; Capo 1983; Mamdani and Walker 1985; Turshen
2001: 204). It was within the Non-Aligned Movement that developing countries
formed a concerted policy for medicines which linked industrial and social
objectives. The fifth Conference of the Non-Aligned Countries called for the
exclusion of pharmaceutical patents, the removal of brand names, the adoption of
generic names, and the creation of regional co-operative pharmaceutical
production and technology centres (Fifth Conference of Heads of State or
Government of Non-Aligned Countries 1976: 2).
The Non-Aligned Movement was influential in the United Nations. The UN
Secretary General attended the 1976 conference and committed the UN as a
global body that would respond to its concerns (Singham 1976: 4). Soon after,
UNCTAD, WHO and UNIDO formed a joint task force to implement the Non-
Aligned Movement’s recommendations (Greene 2010; United Nations General
Assembly 1976; WHA22.54 [1969] in WHO 1973a: 134). The WHO adopted
policies to promote the use of generic names in national medicines formularies, as
well as price regulation (WHA31.32 [1978] in WHO 1985a: 75). WHO Director
41
General Mahler responded to calls for WHO assistance in the regulation of
medicines by calling for member states to grant the organisation ‘not just
technical but political and moral authority to protect developing countries’ (WHO
1975b).
The NIEO also emboldened the WHO to intensify its work in co-ordinating
biomedical research (WHO 1974a; WHA28.70 [1975] in WHO 1985a: 33). In
1976 the WHO’s Advisory Committee for Medical Research approved the
establishment of a Special Programme for Research and Training in Tropical
Diseases (TDR) under the purview of the WHO (WHO 1976). The objective of
TDR was to develop tools for the control of eight diseases; malaria, leprosy,
schistosomiasis, visceraland cutaneous leishmaniasis, onchocerciasis, lymphatic
filariasis, Chagas disease and human Africantrypanosomiasis (HAT), and to
strengthen the research capacity of the affected countries themselves (WHO
1978).
TDR received widespread support within the United Nations and was co-
sponsored by the United Nations Children’s Fund (UNICEF), the United Nations
Development Programme (UNDP) and the World Bank. Member states of the
WHO initially allocated 11 million dollars to TDR, which at the time represented
about two-thirds of global spending on research into tropical infectious diseases
(WHO 2008d: 106). WHO Director General Mahler also adopted WHO research
policy guidelines, which gave attention to the role of WHO in strengthening
national research capabilities and promoting cooperation and transfer of existing
and new scientific knowledge ‘to those that need it’ (WHA30.40 [1977] in WHO
42
1985a: 35). Through TDR, the WHO strengthened its role in co-ordinating
biomedical research with the aim of developing new and effective medicines for
the global South.
The aforementioned developments in the WHO led to the creation of a new
international health policy framework. In 1978, at the first international
conference on Primary Health Care in the Union of Soviet Socialist Republics
(USSR), the WHO and UNICEF translated the NIEO into the vision of ‘Health
for All’. This was encompassed within the Declaration of Alma Ata (WHO and
UNICEF 1978) which asserted that:
…the existing gross inequality in the health status of peoples is of
common concern to all countries and must be drastically reduced. An
equitable distribution of health resources, both among countries and
within countries, leading to universal accessibility to Primary Health Care
and its supporting services is therefore fundamental (WHO 1981a).
Through Alma Ata, member states of the WHO agreed that their ‘main social
target’ would be the attainment ‘by all people of the world of a level of health that
will permit them to lead a socially and economically productive life by the year
2000’ (WHO 1981a)29. Access to medicines was a clear objective: ‘essential
health care will be accessible to all individuals and families, in an acceptable and
affordable way, and with their full involvement’ (WHO 1981a).
29 The World Health Assembly subsequently launched the Global strategy for health for all by the year 2000 at the thirty-fourth World Health Assembly in 1981 (WHA34.36 [1981] in WHO 1985a).
43
The most urgent need regarding drugs at this stage is to make it possible
for the vast majority of the world's people who live in the developing
countries to have access at a cost they can afford…. the aim of such a drug
policy should be to ensure the constant availability of and access to
efficacious drugs of acceptable quality and safety to all in need wherever
they live and whatever their socioeconomic status, including dwellers in
urban slums and rural areas (Director General Haldfan Mahler cited in
WHO 1985b).
This discourse of ‘Health for All’ enabled the WHO to present a strong case for
medicines policies that centred on improving the health of society. For the WHO
(WHO 1981a) this meant ‘selecting technology that is appropriate for the
country… adaptable to various local circumstances, acceptable for whom it is
used and to those who use it, and maintainable with resources the country can
afford’. At the core of ‘Health for All’ was the responsibility of governments in
providing health care. This included, but was not limited to, establishing national
medicines policies and legislation, the selection of medicines, pricing, regulation,
procurement, quality assurance, and providing ethical criteria for medicine
promotion and enforcement (WHO 1981a). In this way, the ambitions for ‘Health
for All’ with respect to medicines were aligned with the industrial economic
objectives of the global South. Indeed, as explained in more detail below, the
bodies of the UN linked the two ambitions together. UNIDO (1978), for example,
promoted the local production of medicines within this vision of improving R&D
for health needs in the global South. Similarly, in their industrial economic
policies, both UNCTAD and UNIDO linked the practices of international
pharmaceutical firms with the WHO’s health concern over the irrational use of
medicines (UNCTAD 1980: ix; UNIDO 1978: 23).
44
The NIEO and the new policy for ‘Health for All’ finally led the WHO to publish
its first Model List of Essential Drugs in 1977, which comprised 208 generic
medicines and vaccines known to be therapeutically effective (WHO Expert
Committee on the Selection of Essential Drugs 1977). The WHO defined
essential medicines as of ‘utmost importance, and hence basic, indispensable and
necessary for the health needs of the population. They should be available at all
times, in the proper dosage forms to all segments of society’ (WHO Expert
Committee on the Selection of Essential Drugs 1977). The creation of this list
was symbolic in conceptualising essential medicines as public goods rather than
mere commodities (Greene 2010: 483). The WHA subsequently endorsed the
establishment of an Action Programme on Essential Drugs and Vaccines (APED)
within the WHO to address the problem that ‘large segments of the world’s
population do not have access to the most essential drugs and vaccines that are
indispensable to their health care’ (WHA31.32 [1978] in WHO 1985a: 74, see
more below). WHO Director General Mahler located the Action Programme in
the office of the Director General, signifying its importance to the Secretariat30.
The battle for essential medicines
30 Despite the eventual weakening of essential medicines policy at the international level, many European governments did introduce laws consistent with the WHO’s medicines policy. Germany introduced rules for the rational prescription of medicines in the public health system (UNCTAD 1982: iv). Norway, Denmark and Holland legislated restrictions on ‘nonessential’ medical products (Walt and Harnmeijer 1992: 30). The Netherlands was instrumental in establishing the international conference on the Rational Use of Drugs in Nairobi in 1985 which expanded the work of the WHO beyond advising on selection and procurement encompassing advice on distribution, rational use of medicines, and quality assurance (WHO 1985b). Even some states in the United States introduced laws permitting pharmacists to substitute generics in place of branded medicines (Chowdury 1995: 10).
45
The WHO’s Model List of Essential Medicines (1977) triggered a significant
political contest in and outside the WHO. In this section I demonstrate that the
WHO’s ambitious vision for essential medicines policy was weakened by the
strong opposition of several international pharmaceutical firms and the
government of the United States. Essential medicines policy was not abandoned,
however, and I highlight the key role of the bodies of the United Nations, which
engaged in a public discursive contest with the pharmaceutical industry. The
international health advocacy network, Health Action International (HAI), was
also formed by national consumer non-government organisations in this period to
counter the voice of the IFPMA. Indeed, conflict over medicines policy was a
catalyst for and, in part, an outcome of the emerging influence of non-state actors
in international medicines policy.
In 1968, several international firms headquartered in Europe and the United States
formed their global lobbying association, the International Federation of
Pharmaceutical Manufacturers and Associations (IFPMA), in response to the
Third World project (see IFPMA. N.D.). As discussed above, developing
countries had successfully brought the patent system onto the agenda of
UNCTAD and had begun to revise their patent laws to enhance local production
of medicines. These moves threatened the profits of the international firms, who
had maintained an oligopoly on drug supply in most developing countries. The
international firms also created national and regional lobbying associations under
the umbrella of the IFPMA, including the Pharmaceutical Manufacturers of
America (PMA; 1958), the Japan Pharmaceutical Manufacturers Association
(1968), the European Federation of Pharmaceutical Industries and Associations
46
(EFPIA; 1978), and the Association of the British Pharmaceutical Industry
(APBI).
In 1971, the WHO granted the IFPMA status in the organisation as an officially
recognised non-government organisation (NGO) (EB39.R44 [1971] in WHO
1973a: 550). This enabled the IFPMA to attend the WHO governing bodies as an
observer and to lobby the member-state delegations in attendance.Initially, the
WHO sought to appease the IFPMA by consulting the organisation over its plans
for its Model List of Essential Medicines (Walt and Harnmeijer 1992: 30). After
the release of the list in 1977, however, the IFPMA publicly declared the concept
of essential medicines ‘completely unacceptable’ (cited in Tiefenbacher 1977:
23).
The IFPMA began a concerted attack on the WHO’s Medicine list by framing the
list as a threat to public health (IFPMA cited in Laing et al. 2003). The IFPMA
argued to governments and to national medical associations that the use of
restricted lists ‘could severely retard medical care and would discourage
investment by the pharmaceutical industry in research’ (cited in Reich 1987: 49).
The lobbying group sought to undermine the WHO by convincing medical
associations that the essential lists would restrict the ‘rights’ of prescribers and
would threaten the quality of medicines. This strategy was effective in several
countries (see Chowdury 1995: 9; Lasagna 1979: 232). In Sri Lanka and in
Bangladesh, for example, private medical doctors joined local representatives of
the international pharmaceutical industry in opposing reforms (Chowdury 1995:
67; Reich 1995: 61). In Brazil, an early scheme for essential medicines was
47
opposed by the medical profession (UNCTAD 1976: 8). On the international
scene, the largest ally for the industry was the United States government, which
echoed the industry claims. Several of the international firms, such as Pfizer, were
headquartered in the United States. Despite the ambitions of the global South, in
the WHO the US delegation framed the WHO medicines list as one that would
‘prevent therapeutic progress, be a major disincentive to research, and prevent the
important discovery of new indications for drugs’ (WHO 1985b).
This discursive challenge by the IFPMA and US was accompanied by their
flexing of material power. The international pharmaceutical firms of the IFPMA
represented a significant proportion of the source of the world’s medicines.
Acting as a bloc, the IFPMA members refused to cooperate with the WHO and
UNICEF’s plans for a bulk purchasing scheme for essential medicines in African
nations, as requested by the Non-Aligned Movement (see above; Walt and
Harnmeijer 1992: 33, 41). In the WHO, the United States opposed the Director
General Mahler’s call for member-states to grant the organisation ‘not just
technical but political and moral authority to protect developing countries’ (WHO
1975a, 1975b). The US even withheld its financial contribution to the WHO in
1986 and 1987, which many attribute to its anger over the WHO’s position on
medicines (Hardon 1992: 60; Turshen 2001: 203)31. This resistance was felt in the
budget of the WHO. Only France provided the extra-budgetary resources for the
WHO Action Programme in its early years (Walt and Harnmeijer 1992: 32)32.
31 In the 1980s the United States contributed 25 per cent of the WHO’s budget (Chowdury 1995: 138). 32 The WHO’s budget relies on assessed contributions from member-states based on a percentage of their GDP and on extra donations.
48
Despite the material constraints on the WHO in this period, the United Nations
organisations played a key role in keeping the concept of essential medicines
alive by maintaining a strong discursive challenge to the IFPMA and US. WHO
Director General Mahler was outspoken in rejecting the US claim that the WHO
was overstepping its role in medicines policy. Instead, Mahler asserted that such a
role was within the constitutional mandate of the organisation (WHO 1985b).
UNIDO was vocally critical of the ‘continuous state of dependence’ in the global
South ‘on expensive, inappropriate technology developed and controlled by
foreign transnational corporations’ (UNIDO 1978: 33). UNCTAD (1980: 21)
shared this critique. When the IFPMA asserted that a program of centralised bulk
procurement for medicines would reduce the availability of medicines, UNIDO
publicly refuted this claim, pointing to the quickness of non-patent-observing
producers in making medicines available (UNIDO 1978: 13). UNIDO and the
United Nations Conference on Transnational Corporations (UNCTC) praised the
efforts of developing countries like Sri Lanka and Brazil who had turned to
centralised procurement and tendering for generic suppliers from non-patent-
observing sources (Reich 1995; UNCTC 1984; UNIDO 1978). Despite the refusal
of the IFPMA firms to cooperate with UNICEF and WHO, UNICEF strengthened
its Packing and Assembling Centre (UNIPAC) and enhanced its competitive
tendering and bulk purchasing through generic sources (UNICEF-WHO Joint
Committee on Health Policy Session 1987). With few extra-budgetary funds for
its Action Programme on essential medicines, the WHO turned to supporting
essential medicines projects that were sponsored by development agencies, such
as the Danish International Development Agency (DANIDA) (Walt and
Harnmeijer 1992: 33).
49
The role of the patent system in medicines R&D was a significant source of
political conflict between the UN organisations and the IFPMA. The IFPMA
claimed that strong pharmaceutical patent protection was needed in the global
South to recoup R&D costs, ‘to reduce the price of drugs would be to reduce the
amount of research carried out and put a brake on medical progress’ (IFPMA in
WHO 1985b). UNIDO and the UNCTAD directly challenged this claim and
pointed out that for those medicines developed primarily for developed
economies, ‘there was no lack of incentive created by poor countries buying
elsewhere’ (UNCTAD 1980: 7; UNIDO 1978: 13). UNCTAD (1976:4) revealed
that the R&D expenditures of IFPMA firms were not as high as their marketing
and sales figures, which damaged the industry’s claims (see also Chew 1985;
SCRIP 1988). UNCTAD (1980: 4) asserted that much of the ‘so-called research
in industrialised countries goes into the development of more pleasing tastes,
colours and packaging…towards the unnecessary and inappropriate consumption
of medical drugs’. The WHO DG Mahler was critical of the lack of transparency
within the pharmaceutical industry:
It is still difficult to know how much money is required to generate new
drugs. In my humble opinion the only way to even start to sort out this
question is to collect relevant and coherent facts; they are very difficult to
get hold of (Mahler cited in WHO 1985b).
The UN organisations not only opposed the IFPMA’s claims, they advocated for a
socially oriented system for medicines R&D that did not prioritise patents. For the
WHO DG Mahler, ‘the consequential pattern of drug development, with its
50
emphasis on treatment and prevention of the common diseases of affluent
communities, draws criticism as being ill-adapted to global therapeutic needs’
(WHO 1985b). Thus, Mahler called for ‘socially oriented approaches to new drug
development’ (Mahler 1975a). UNCTAD (1980: 25) emphasised the strong role
of government in supporting local R&D, ‘no developing country – in fact no
country at all – can afford laissez-faire in research; this activity should be directed
towards certain specific goals and objectives reflecting national needs’. UNIDO
(1978) also foresaw a different system, one in which developing countries would
contribute towards R&D according to their incomes and health needs. These
proposals for a socially-oriented approach to medicines R&D would re-emerge
thirty years later, albeit in different forms through different actors (see Chapter
six).
Illustrative of the strong position taken by the UN organisations in this period was
the WHO policy on patents. In this context of ‘the need for affirmative action’,
member-states of the WHO agreed that:
It shall be the policy of the WHO to obtain patents...or interests in patents
on patentable health technology developed through projects supported by
WHO, where such rights and interest are necessary to ensure development
of the new technology: the organization shall use its patent rights, and any
financial or other benefits associated therewith, to promote the
development, production, and wide availability of health technology in the
public interest (WHA35.14 [1982] in WHO 1985a: 82).
This conflict between the IFPMA and the UN was a catalyst for the formation of
the international health advocacy network Health Action International (HAI) in
51
1981. In response to the IFPMA’s pressure on the WHO, over 50 consumer
organisations from 26 countries established Health Action International (HAI)
with the stated aim to resist ‘the ill-treatment of consumers by multinational drug
companies’ (Fazal 2006: 4)33. HAI was supportive of the WHO’s proposals for
restrictive medicines lists and for improved medicines registration and went even
further in seeking the ‘decommercialisation’ of medicines (Fazal 1983; 2006: 5;
Hardon 1992: 57). As a consumer health group, HAI supported medicines policy
that strengthened its health value. In the early 1980s, HAI and the IFPMA
engaged in a discursive battle at the World Health Assembly and the Executive
Board of the WHO. Indeed, HAI and the IFPMA became embroiled in a struggle
over the issue of medicines marketing and regulation in the early 1980s. This
conflict (explained below) exemplifies the rising influence of non-state actors in
the WHO in this period, and demonstrates the powerful resistance of the IFPMA
and the United States to attempts to establish medicines policy that threatened the
profits of these firms.
The catalyst for the battle over an international code of marketing for medicines
was the WHO’s International Code of Marketing of Breast Milk Substitutes
(WHO 1981b) that was secured through the advocacy of the International Baby
Food Action Network (IBFAN) (Laing 2003; Lee 2010: 7)34. For HAI, IBFAN’s
success in securing this code demonstrated what could be achieved in medicines
regulation. HAI subsequently advocated for an international code on the
33 The intention of HAI was and remains to ‘resist such obstruction through community action at the grassroots level’ (Roland Fett spokesperson for BUKO cited in Fazal 2006: 4). 34 This code was approved by all member states of the WHO except the US. While it was a landmark case for health regulation of transnational corporations, the code ‘fell short’ because it does not penalise actors who do not comply (Lee 2010).
52
marketing of medicines (Health Action International 1982). The IFPMA pre-
empted HAI’s proposal, however, and in 1982 released its voluntary code of
marketing, which was rejected by HAI and by several developing countries. The
IFPMA resistance was stronger than that of Nestle and HAI was unable to garner
support from several member states, in particular those headquartered by the
IFPMA firms. Eventually, after years of struggle in the WHO, Charles Medawar
of HAI lamented that it was ‘unrealistic to expect WHO to become involved in
formal, full-scale international regulation’ (see Medawar 1985). Years later, the
WHO eventually developed the weaker ethical criteria for marketing to serve as
‘general principles…that did not constitute legal obligations’ (WHA 41.17 [1988]
in WHO 1993: 89).
In addition to weakening international rules on marketing and regulation, the
WHO’s essential medicines policy was also weakened to serve as a guideline for
the public sector in developing countries. This coincided with the IFPMA shifting
its position from outright opposition to the concept of essential medicines to
acceptance (at least in public rhetoric) that essential medicines policy could be
used in the public sector in developing countries (see Greene 2010; Peretz 1983).
By the early 1980s, most of the member states of the WHO agreed to weaker text
which recognised essential medicines policy as primarily for the public sector in
developing countries (Chowdury 1995; Laing 2003: 42). This was still opposed
by the United States, and Japan and West Germany abstained from voting. This
weaker focus on guidelines was pushed by the IFPMA who argued that the WHO
‘could not perform as a supranational regulatory body’, which was subsequently
confirmed by the WHO Secretariat (IFPMA 1985; WHO 1985b).
53
Conclusion
This chapter has examined the evolution of international medicines governance
between the creation of the WHO and the formation of the WHO’s essential
medicines policy. The chapter has shown that over four decades, the United States
government opposed and prevented a role for the WHO in international medicines
policy, in particular when such policy threatened the profits of its pharmaceutical
firms. The chapter has situated developments in international medicines
governance within broader shifts in the global political economy in this period. In
the 1960s, Third World discourse enabled the global South to demand
international governance in the issue-areas of medicines research and
development (R&D), production, access and regulation. This strengthening of
solidarity between Soviet, Middle-Eastern, Asian and African countries in the
early 1970s forced the softening of the opposition of the United States, which
enabled the vision of a New International Economic Order in the United Nations.
The adoption of the NIEO informed the WHO’s project of Health for All and the
WHO’s Model List of Essential Drugs in the late 1970s. These developments
were the catalyst for the formation of the international pharmaceutical lobby
group, the International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA), which exerted economic power and shaped a weakening
of the WHO’s essential medicine policy.
54
C H A P T E R T H R E E
Neoliberalism: Selective Health Care and Private Rights
Following on from the previous chapter, this chapter commences the study in the
early 1980s and concludes with the establishment of the World Trade
Organizations’ Trade Related Agreement on Intellectual Property Rights (TRIPS)
in the mid-1990s. The chapter shows that shifts in the global governance of
medicines in this period privileged international pharmaceutical firms and failed
to address many of the health needs of the global South. Medicines governance
was transformed through shifts in economic, health and trade policy that were the
result of a broader forum-shifting strategy of the United States and its allies to
block the New International Economic Order and promote neoliberalism.
The chapter demonstrates that neoliberal economic restructuring strengthened the
dominance of international pharmaceutical firms in global medicines research and
development (R&D), production and trade. In health policy, I show that the
World Bank and UNICEF promoted a turn to ‘selective’ primary health care
(SPHC) that complemented economic reforms by providing a rationale and
justification for a narrow role of government in health. Under this approach,
several core aspects of the WHO’s essential medicines policy were neglected and
shifted to the periphery, with a devastating effect on health. In addition, shifts in
international trade policy in this period, in which the TRIPS agreement was
finalised, presented new global architecture for medicines R&D that privileged
the private ‘rights’ of patent holders over the health needs of the global South.
The chapter highlights the role of international pharmaceutical firms in shaping
55
TRIPS, and the role of the World Bank and General Agreement on Tariffs and
Trade (GATT) in diffusing neoliberal reforms in international economic, health,
and trade policy.
The chapter draws on an a critical analysis of summary records, resolutions, and
reports of the governing bodies of the World Health Organization (WHO), the
United Nations Conference on Trade and Development (UNCTAD), the General
Agreement on Tariffs and Trade (GATT), as well as World Bank reports, annual
reports of the United States Trade Representative (USTR), and statements by
government leaders (see Appendix Two).
Medicines under neoliberalism In this section I demonstrate that neoliberal economic restructuring in the 1980s
extended the dominance of international pharmaceutical firms in the global
supply of medicines. The United States played a key role in creating the structural
conditions which enabled the World Bank and International Monetary Fund to
emerge as dominant sources of financial aid for developing countries in the 1980s
and 1990s. Through this position of dominance, these global economic
institutions imposed conditional loans premised on neoliberal policy reforms that
contributed to an overall decline in the share of world medicines production and
consumption in the global South.
In the early 1980s, the United States government strengthened its opposition to
the ambitions of many developing countries in the New International Economic
56
Order. This coincided with the spread of neoclassical economic theory within
academic and political circles in the US and the UK. In contrast to Third World
discourse, neoclassical economic theory is premised on a critique of Keynesian
government intervention in the market (see Hayek 1944). In political circles,
neoclassical economics was intertwined with liberal assumptions of the primacy
of the individual, and individual rationality and responsibility (McGregor 2001;
Rowden 2009; Sambala, Sapsed and Mkandawire 2010). The President of the US,
Ronald Reagan, and the United Kingdom’s Prime Minister, Margaret Thatcher,
were influenced by neoliberalism (Thatcher 1993: 169; Sell 1998: 97). Reagan
and Thatcher viewed the private sector, or the ‘free market’ as the most effective
form of governance (Harvey 2005; Ranelagh 1991; Reagan 1984, 1988; Thatcher
1993: 169)35. Both leaders implemented neoliberal policies domestically by de-
regulating their economies, reducing government expenditure and privatising
publicly owned entities (Harvey 2005; Navarro 2007).
Neoliberalism provided the United States and its allies with a new language to
oppose the NIEO. American neoclassical economists framed the Third World
demands for international social justice and re-distribution as ‘monopolistic’ and
‘discriminatory’ (see Johnson 1976: 13). In contrast to the Third World critique of
the structural inequalities within the international system, these inequalities were
depicted under neoclassical economics as the result of ‘laziness, recklessness and
lack of individual responsibility’ within developing countries (see Johnson 1976:
13). The United States government reformed its foreign aid program in the early
35 Despite this rhetoric to the ‘free market’, neoliberalism does not do away with the role of the state. As the chapter and thesis demonstrates, the state and government remain crucial to protecting and promoting the market (Löfgren and Benner 2007; Rowden 2009; see more below).
57
1980s in support of private enterprise (Livingston 1992). This signified a shift in
the position of the US and its allies against the NIEO. Whereas the US had
softened its stance in the early 1970s amidst the oil crisis (see previous chapter),
in the 1980s Reagan and Thatcher aggressively opposed the NIEO in the United
Nations. Instead they asserted that developing countries adopt and promote trade
liberalisation, foreign investment and privatisation to meet their economic
objectives (Goldstein 1982; Livingston 1992; Toye and Toye 2005).
Because the United Nations organisations were strong supporters of the NIEO,
the United States turned to the World Bank as an ally. Unlike the United Nations,
the United States exerted significant influence over the World Bank36. While the
US is the largest funder to the UN and to the World Bank, UN organisations work
on ‘one state one vote’. At the World Bank, however, the US retains over fifteen
per cent of the voting power through its financing role, and has effective veto
power because the Bank requires at least eighty-five per cent agreement from
votes (Stein 2008: 7). In 1981, former Bank of America President A.W Clausen
became President of the Bank and initiated sweeping reforms, replacing many
staff with American economists (Rowden 2009). By 1991, over 80 per cent of all
Senior Staff of the policy, research and external affairs departments of the Bank
had been trained in US or UK universities (Woods 2000). This coincided with a
refinement of the policy ambitions of the Bank towards poverty reduction through
‘facilitating capital investment, private foreign investment and international trade’
(World Bank 1989). These internal shifts occurred at the same time that the Non-
36 By the early 1980s the World Bank had been in existence for over thirty years, and was mainly a source of financial loans for European countries in post-war restructuring.
58
Aligned Movement was demanding that the global economic institutions be made
more democratic (New Solidarity International Press Service 1976; WIPO N.D)37.
The World Bank was soon at odds with the United Nations over favoured
industrial economic and development policy for the global South. While the
United Nations was supportive of the NIEO, the World Bank’s annual
‘development’ reports formed a critical view of the role of the state in economic
development (World Bank 1981, 1983, 1985). The Bank opposed several UN-
supported policies, such as subsidised interest rates, minimum wage laws and
price restrictions (World Bank 1983: 53). At the same time, the World Bank was
not highly critical of tariff barriers imposed by the United States and other
industrial countries, which UNCTAD rejected (UNCTAD 1975, 1976, 1977,
1980).
A turning point for the demise of the NIEO was in the early 1980s when the
World Bank emerged as the only source of ‘quick dispersing foreign exchange’
for developing countries (Weaver 1995: 4). This was a result of a combination of
policy shifts by the United States and by private commercial banks. Commercial
banks had increased their loans to developing countries eight-fold in the 1970s as
a result of the declining price of raw commodities, which a majority of
developing countries relied upon for their essential imports, like crude oil (Baer
1964; Singham 1976; United Nations Department of Economic and Social Affairs
1963: 1; World Bank 1985: 4)38. In the late 1970s the United States government
and several commercial banks increased their interest rates, with the US
37 The Non-Aligned movement sought to reform these economic institutions, viewing them as agents of structural asymmetries in the international system (WIPO N.D). 38 If the terms of trade had remained stable over the 1960s, the aggregate purchasing power of developing countries would have been greater by over two billion dollars (United Nations Department of Economic and Social Affairs 1963: 2).
59
increasing its interest rates from less than one per cent to 11 per cent (Helleiner
1994; Soederberg 2004). Within two years between 1978 and 1980, the debts of
oil-importing developing countries increased from 26 billion to over 708 billion
dollars (World Bank 1981: 1). This rising debt was met with US restrictions on
money supply and the suspension of new loans by private commercial banks. In
1982, the debt crisis was made manifest when Mexico announced that it could not
finance its debts. The World Bank and the International Monetary Fund, another
entity in which the US held veto power (Stein 2008), emerged as the only source
of foreign exchange for several developing countries.
Through their newfound position of dominance in global lending, the World Bank
and the IMF required that recipients of their loans implement neoliberal policy
reforms. These ‘national structural adjustment loans’ were oriented to ‘shock’
recipient countries towards expanding exports through trade liberalisation, de-
regulation, and privatisation (Homedes and Ugalde 2005; Joyce 2000; Labonté
and Schrecker 2009: 12; Rowden 2009; Weaver 1995: 4; World Bank 1980: iii;
World Bank 1981: 55, 103). Core policy prescriptions included the de-valuation
of national currencies and the reduction of government expenditure in favour of
privatisation (Ballance, Pogany and Forstner 1992; Joyce 2000; Labonté and
Schrecker 2007; Weaver 1995: 9, 152; World Bank 1993: 45). In the 1980s and
1990s, the World Bank and IMF negotiated over 950 of these structural
adjustment loans with countries in the global South (Easterly 2001). These kinds
of reforms were also implemented by governments of their own accord, without
prompting from the World Bank. Several Asian and Latin American
governments, for example, strongly promoted foreign investment and
60
privatisation throughout the 1980s (Hansen 1989: 51). This reflected the diffusion
of neoliberalism and the demise of the NIEO, which was also a result of the
breakdown in solidarity between developing countries in this period. Arab oil-
exporting countries, Latin American countries and Asian countries had negotiated
separate trade deals with the US and industrial countries, which led to the
breakdown of solidarity between the Group of 77 countries (Toye and Toye
2005).
These reforms contributed to an overall decline in the share of world medicines
production in the global South by 1990 (excluding South and East Asia)
(Ballance, Pogany and Forstner 1992: 3, 23). Production in developing countries
represented nearly 23 per cent of total world production in 1975, yet it decreased
to just over 18 per cent in 1990 (Ballance, Pogany and Forstner 1992: 23). The
de-valuation of national currencies, which was a core policy prescription of the
economic institutions, led to significant increases in the price of raw material
imports, making the production of medicines prohibitively expensive for several
countries (Ballance, Pogany and Forstner 1992: 152; Nur, Postma and de Wilde
1989: 236; Owino 1996: 158). De-valuation also increased the price of imported
medicines39. In Tanzania, the de-valuation of the shilling caused the price of
medicines to rise by over 300 per cent (Turshen 2001: 99). Instead of increasing
their share in export trade, the share of global trade in the global South declined to
less than 10 per cent (of total global trade) (WHO 1988b: 25)40.
39 As a whole, developing countries still relied on imports for over 40 per cent of their essential medicines. This figure was higher in African nations, who sourced 96 per cent of their essential medicines from Europe (WHO 1988b: 26). 40 India was an exception and doubled its medicines exports in one year between 1988 and 1989 (Ballance, Pogany and Forstner 1992: 196; Bhutta 2001). This was because India did not implement these kinds of neoliberal reforms. India’s Drugs Policy (1978)
61
The debt crisis and the aforementioned policy reforms also contributed to an
overall decline in developing countries’ share of the world consumption of
medicines (Bhutta 2001; Holm 1995: 102; Tevera 1995; World Bank 1996: 714).
By the late 1980s, less than 15 per cent of all medicines were consumed in
developing countries, three-quarters of which in only eight countries (Ballance,
Pogany and Forstner 1992: 204; Bol, Polderman and Schonhals 1989: 186;
Hansen 1989: 53; WHO 1988b: 9)41. Decreasing government expenditure on
health and a lack of foreign currency for medicines procurement were particularly
destructive. In Nigeria, the health budget in 1985 was one third of the 1981 health
budget (Bol, Polderman and Schonhals 1989: 189). Lack of access to essential
medicines remained a crucial problem for many developing countries (Ballance,
Pogany and Forstner 1992: 216). By the early 1990s, over 80 per cent of countries
in the African region were deemed to have ‘very low’ access to essential
medicines (WHO 2004d: 62).
In contrast to the austerity measures imposed in the global South, the United
States, Japan and Germany expanded their public expenditure on medicines
research and development (R&D) in this period (Cockburn and Henderson 1997;
Commission on Health Research for Development 1990: 57; Malerba and
Orsenigo 2001: 9; WHO 2004d: 13). Throughout the 1980s over three-quarters of
global pharmaceutical R&D was located in seven countries: the US, France,
Germany, Italy, Japan, Switzerland, and the UK (Cockburn 2004; Dutfield 2003;
reserved major areas of the market for the Indian sector (Gupta 1999: 154; see more Chapter seven). 41 This figure decreased from the 23.9 per cent of the total share of world medicine consumption in 1975 (Ballance, Pogany and Forstner 1992: 31).
62
Grabowski 2011; Sunder Rajan 2006; Taggart 1993; WHO 1988b: 35). In
addition to expanding their public expenditure on R&D, Germany (1968), Japan
(1976), Switzerland (1977), Italy (1978) and France (1978) strengthened their
pharmaceutical patent protection at the request of the international pharmaceutical
firms (Boldrin and Levine 2008: 3).
The United States implemented the strongest levels of patent protection as it
brought all molecular biology under its patent system (Angell 2004; Boldrin and
Levine 2008; Chu 2008; Cockburn 2004). The 1980 Bayh-Dohl act enabled
public institutions in the US to patent and commercialise research (Di Maio
2010). In 1984 the Drug Price Competition and Patent Term Restoration Act
introduced patent linkage in the US, by which intellectual property was linked to
medicines regulation through the US Federal Drug Administration (FDA). These
reforms led to a proliferation of private biotechnology companies42. By the late
1980s, 95 per cent of all new medicines were developed in the US, UK, France,
Germany, Italy, Japan, and Switzerland (WHO 1988b: 37)43. In parallel, this
period was characterised by numerous mergers and acquisitions in the
pharmaceutical industry, which transformed the industry landscape by creating an
increased concentration of large international pharmaceutical firms. This was, in
part, a response to the threat of generic competition, as several ‘blockbusters’
were coming off patent in the aforementioned countries (Ballance, Pogany and
Forstner 1992: 179).
42 These firms initially held strong positions of linkage with the larger R&D companies. By 1990, however, their importance decreased as large international firms once again dominated industry partnerships (Roijakkers 2006: 431). 43 Several of these were ‘blockbuster’ medicines which generated billions of dollars in sales annually (Ballance, Pogany and Forstner 1992; Grabowski 2011: 110).
63
As a result of these policy reforms in the global South and North, by the late
1980s, 25 international pharmaceutical firms, 14 of which were located in the US,
accounted for over half of all medicines sales (Ballance, Pogany and Forstner
1992: 110). Over 70 per cent of their sales were exports (Taggart 1993; WHO
1988b: 33). Their dominance in supply varied in the global South, from 50 per
cent of supply in Argentina, to 70 per cent in India and 78 per cent in Brazil, 90
per cent in Ecuador and nearly 100 per cent in most African countries (Olukoshi
1996; Tevera 1995; WHO 1988b; 28).
Selective Primary Health Care and essential medicines
In this section I demonstrate that the World Bank and UNICEF adopted and
promoted an approach for ‘selective’ primary health care (SPHC) that shifted
international health policy under neoliberalism. This approach complemented
neoliberal economic reforms by providing a rationale and justification for a
narrow role for government in health. Under this approach, several core aspects of
essential medicines policy were neglected and shifted to the periphery, with
devastating effect on health in the global South. This shift in international health
policy was part of a broader forum-shifting strategy of the United States to block
the NIEO and move international health policy to the purview of the World Bank.
In the 1970s international health policy was shaped by the WHO’s vision of
‘Health for All’, which emphasised the responsibility of government and the
public sector in providing health care (see previous chapter). In the late 1970s, the
United States turned to the World Bank to contest ‘Health for All’ as part of a
64
broader forum–shifting strategy to block the NIEO. In 1979, at the request of the
US Agency for International Development, the World Bank first entered the
health domain by establishing its own Population, Health and Nutrition
Department (Ruger 2005; World Bank 2011). The World Bank and the US
Agency for International Development, in collaboration with the Canadian
Development Agency, the Rockefeller Foundation and the Ford Foundation,
began to promote a different approach to health policy which they called
‘selective’ primary health care (Cueto 2004; World Bank 1981). The foundation
for this approach was a policy paper co-authored by Kenneth Warren of the
World Bank titled Selective Primary Health Care: An Interim Approach to
Disease Control in Developing Countries (see Walsh and Warren 1979).
In contrast to ‘Health for All’, SPHC was premised on the primacy of economics
and the principle of ‘cost effectiveness’ in assessing health interventions (Walsh
and Warren 1979). Whereas ‘Health for All’ conceptualised health as the state of
complete mental, spiritual and physical wellbeing, under SPHC health was
viewed within a narrow lens as merely the absence of disease (Magnussen, Ehiri
and Jolly 2004; Walsh and Warren 1979). SPHC focused on the individual and
technological level, which reflected the neoliberal emphasis on the primacy of the
individual (Gupta 1999; Walsh and Warren 1979: 971). Social and environmental
determinants of disease were overlooked as outside the remit of health policy.
Importantly, the discourse of SPHC provided a rationale for a narrow role of
government in health care, which complemented reductions in government
expenditure on health as required by economic reforms in many developing
countries in this period (see above; Berman 1982; Gish 1982; Wisner 1988).
65
As SPHC became the motto of the World Bank, the Bank came into conflict with
the WHO, which resisted this shift away from ‘Health for All’ (Mahler 1980).
The Bank found allies, however, in numerous national medical associations who
viewed the social and economic objectives of ‘Health for All’ as largely
unattainable (Cueto 2004). A turning point for this battle was the adoption of
SPHC within the United Nations Children’s Fund (UNICEF). UNICEF was more
receptive to this approach because it had historically targeted aid through this
kind of ‘vertical program’ in its work donating emergency supplies in response to
disease outbreaks. In the 1980s the World Bank and UNICEF began to work
together to promote a select number of health interventions in the global South,
mainly immunisation programs, oral rehydration programs, and breastfeeding
education campaigns (known as GOBI) (Cueto 2004; Homedes and Ugalde 2005:
83; Wisner 1988: 967; World Bank 1980: 57). These programs reflected the
SPHC emphasis on the individual. In parallel, the United States led a shift in
donor health funding to the World Bank. By 1990 the Bank had superseded the
WHO as the largest source of funding for health (World Bank 1993: 166)44.
The World Bank maintained the concept of essential medicines under SPHC. This
was because the idea of a narrow list of the most essential medicines aligned well
with the SPHC emphasis on cost-effectiveness (World Bank 1981: 100, 1993:
145). The World Bank played a key role in re-orienting medicines governance
that was ultimately detrimental to the health needs of the global South. In
accordance with the prioritisation of the private sector as the most efficient form 44 Through this influence the World Bank would later develop a new method for assessing disease mortality, Disability Adjusted-Life Years (DALYs), that would become commonplace in health policy (World Bank 1993: 152, see Chapter six).
66
of governance, the World Bank encouraged the procurement of medicines through
the private sector. Indeed, as much as two-thirds of all medicines purchased in
developing countries in the 1980s were procured through ‘private rather than
public channels’ (Ballance, Pogany and Forstner 1992: 203). Through this turn
away from the public-sector ambitions of ‘Health for All’, medicines became
detached from the broader primary health care vision of strengthening public
health systems (World Bank 1980: 56)45. This contributed to medicines shortages
in public health systems and inadequate public systems of distribution in a
majority of developing countries (Bhutta 2001: 714; Bol, Polderman and
Schonhals 1989: 203; Mwega and Kabubo 1993; Owino 1996: 163; Tevera 1995:
84; Third World Network 1994; WHO 1988b: 54). Indeed, several scholars have
attributed these reductions in expenditure in public health systems as a significant
contributing factor to the resurgence of diseases in developing countries that were
once thought to be under control, such as malaria, guinea worm and cholera
(Farmer 2001; Lee 2003; Lee and Dodgson 2003; Popoola 1993; Porter, Lee and
Ogden 2002).
The World Bank also required several countries to remove pharmaceutical price
controls as a condition of receiving loans, such as in Jamaica in 1991 (see
Appendix in Marston 1991). Throughout the 1980s and early 1990s price
regulation was abandoned in over half of low and middle-income countries
(WHO 2004d: 72). The World Bank and UNICEF also required recipients to
introduce user fees for health services and essential medicines as a cost recovery
45 The World Bank responded to criticisms of its policy approach in the early 1990s by co-opting the language of ‘Health for All’, however, it essentially retained the same policy prescriptions (see Cueto 2004; Newell 1988; for criticisms see Werner and Sanders 1997; World Bank 1993).
67
mechanism, known as the Bamako Initiative (World Bank 1987). These were
often out of reach for the poor and contributed to a lack of access to essential
medicines (Holm 1995; Lunde, Mamdani and Maitai 1989: 148; Mwega and
Kabubo 1993; Tevera 1995; Walt and Harnmeijer 1992: 41; World Bank 1993:
118).
Through this position of dominance in financial lending for medicines, the World
Bank required recipients to procure essential medicines through UNICEF (World
Bank 1993: 146). This effectively removed the sovereignty of recipient
developing countries to retain national control over medicines procurement. It
also led to a re-emergence of medicines regulation issues on the international
agenda. This was because UNICEF required that medicine manufacturers meet
the WHO Good Manufacturing Practices (GMP) (see previous chapter). In the
1980s a majority of developing countries did not adhere to the GMP because they
could not satisfy inspection standards required by UNICEF and donors as a result
of a lack of resources (Ballance, Pogany and Forstner 1992; Bol, Polderman and
Schonhals 1989: 200; Islam and Rifkin 1989; Lunde, Mamdani and Maitai 1989:
149; Nur, Postma and de Wilde 1989: 12, 17; Owino 1996: 157; World Bank
1993: 152)46. This was due to the debt crisis and to reductions in government
expenditure as a consequence of economic reforms. The UNICEF/GMP
standards, in the absence of economic support to developing countries,
contributed to the overall decline in developing countries’ share of world
medicines production in this period (Elliot 1993). In this way the World Bank’s
46 In 1992 the WHO Executive Board noted that many drug regulatory authorities did not have the resources to regulate drug advertising (EB89.R2 [1992] in WHO 1993). India was an exception.
68
economic reforms and medicine policies worked together against the interests of
the people of the global South.
As the World Bank shaped medicines governance in this period, the WHO was
hamstrung by donors and had limited resources. A review of the WHO’s Action
Programme on Essential Drugs (APED) in the late 1980s found that the
organisation lacked the staff and resources to adequately assist governments to
develop essential medicines policies (see Islam and Rifkin 1989: 22). As detailed
in the previous chapter, the ADEP relied on limited extra budgetary funds to
operate. A consequence of this inadequate funding was that several core aspects
of essential medicines policy could not be implemented. By the mid-1990s,
almost two-thirds of all countries had failed to implement a national medicines
policy (WHO 2004d: 53). A majority of developing countries also lacked public
resources to fund work on the rational use of medicines, such as adequate training
for health workers (Ascobat, Dabelstein and Hausman 1989: 73,153). As a result,
the irrational use of medicines continued as a widespread problem throughout the
1980s and 1990s, in both the North and the South (WHO 2004d: 75).
These policy failures reflected US and international pharmaceutical industry
pressure on the WHO and developing countries to not implement policies that
threatened industry profits. In the 1980s and 1990s, the US and UK threatened
trade restrictions on several developing countries when they attempted to
implement essential medicines policies in the private sector (Mamdani 1992; Tan
69
1988: 11; Turshen 2001: 206)47. In some countries, like Colombia, the Europe
Economic Commission explicitly prevented the use of their financial aid to fund
programs for the rational use of medicines (Hansen 1989: 50). Several donor
governments also explicitly tied their foreign aid to the procurement of medicines
from their international pharmaceutical firms (Turshen 2001: 202). In 1988 the
incumbent Director General of the WHO, Hiroshi Nakajima, relocated the ADEP
out of the office of the Director General, a move seen by many as a response to
US pressure (Greene 2010).
The Tropical Disease Research program: failing the global South
In this section I situate the failure of the WHO’s Tropical Disease Research
program in the 1980s and 1990s within these developments in economic and
health policy in this period. Through neoliberal economic re-structuring,
governments in the global South allocated meagre resources to medical research.
While the US and several European governments increased their R&D spending,
R&D became increasingly concentrated on conditions affecting wealthy
countries. In the main, international pharmaceutical firms refused to co-operate
with the WHO’s TDR. The discourse of ‘selective’ primary health care reinforced
and provided a justification for this continued neglect.
In the 1980s, pharmaceutical R&D was significantly concentrated in a few
countries in Europe and the United States. The debt crisis, combined with
neoliberal economic re-structuring, meant that governments in the global South 47 Some international pharmaceutical companies sent private ‘consultants’ to lobby and pressure developing country governments not to implement national medicines programs (Turshen 2001: 203).
70
had few resources for R&D. Only 0.0025 per cent of global expenditure on health
research was directed towards capacity building for R&D in the global South
(Commission on Health Research for Development 1990: 75). This R&D
concentration in a select group of high-income countries led to an increasing
share of new medicines developed specifically for conditions affecting wealthy
countries (Ballance, Pogany and Forstner 1992: 19; WHO 1988b: 17). Tropical
diseases received low R&D priority, and less than five per cent of the total global
expenditure on health research was devoted to the health needs of developing
countries (Commission on Health Research for Development 1990: 33; WHO
1988b: 45).
The discourse of ‘selective’ primary health care (SPHC) that had become
dominant through the World Bank and UNICEF lending reinforced the neglect of
R&D for tropical diseases. SPHC was premised on a model by which
governments would ‘select’ health care interventions according to a narrow range
of criteria. These included the prevalence of disease morbidity and mortality,
whether disease controls existed, and above all, the price of interventions (see
Walsh & Warren 1979: 972). Those diseases and health conditions that primarily
affected developing countries, but did not have adequate existing medicines,
including Lassa fever, Chagas disease, African trypanosomiasis, leprosy,
leishmaniasis and filariasis, were categorised by proponents of SPHC as ‘low
priority’ (see Walsh & Warren 1979: 968).
This neglect was evident in the lack of financial resources for the WHO’s
Tropical Disease Research program. The TDR’s budget remained stagnant at 20
71
million dollars per annum throughout the 1980s (WHO 1988a: 71)48. In 1986, the
WHO Executive Board noted that member state contributions to TDR had fallen
short of requirements to meet health needs (EB77.RD [1986] in WHO 1993: 110).
That same year, the US withheld its contribution to the WHO, and the subsequent
World Health Assembly made no mention of the problems besieging the TDR
(WHO 1993). Shortfalls in the budget revenue of the WHO meant that technical
support for TDR also declined (WHO 1988a: 66)49.
Overall, the international pharmaceutical industry refused to co-operate with the
WHO’s tropical disease research program (WHO 2007c: 34). In an attempt to
entice industry, the TDR appointed scientists from the private sector on its
advisory committees, a move unparalleled in other health institutes. In the mid-
1980s TDR did succeed in convincing the pharmaceutical firm Merck to donate to
WHO its TDR-sponsored ivermectin for treatment of onchocerciasis. This
appeared to be a one-off case, however, as it soon emerged that the TDR had no
control over the medicines it sponsored. Throughout the 1980s the TDR could not
find industry partners to develop artemisinin-based medicines for malaria (WHO
2007c: 37, see more Chapter six). The derivatives could not be patented and
therefore could not be used to generate blockbuster profits for the industry. In the
early 1990s, international pharmaceutical firm Aventis (now Sanofi-Aventis)
stopped production of its TDR-sponsored elfornithine for sleeping sickness, citing
reduced profits. TDR did not publicly push the company to re-commence
production. A later review of TDR confirmed that TDR did not investigate 48 Reflecting the turn to ‘selective’ primary health care, an independent review committee of the TDR program emphasised ‘efficient resource utilisation’ in the face of severe budget constraints placed on the program (WHO 1988a: 16). 49 The US withheld its contributions to the WHO in 1986 and 1987 (see previous chapter).
72
implementation after it sponsored medicines and suffered from problems of
control (UNDP/World Bank/WHO Special Programme for Research and Training
in Tropical Diseases [TDR] 2000). The TDR faced similar pressures as the WHO
to remain a technical ‘neutral’ organisation without a political or advocacy role
(WHO 1985b).
In the early 1990s, member states of the World Health Assembly formally
‘appealed’ to the international pharmaceutical industry to increase R&D
collaboration with TDR (WHA43.18 [1990] in WHO 1993: 111). Not long after,
the World Bank entered the debate over medical R&D. In its report Investing in
Health (World Bank 1993: 153), the Bank argued that the low levels of R&D for
tropical diseases required more public support for the private sector in the global
South (World Bank 1993: 153). In 1986-1987, for example, member states gave
49.5 million to TDR for tropical disease research, a fraction of the 30 billion
global investment in health research (Commission on Health Research for
Development 1990:40). The World Bank began to champion strong intellectual
property patent laws for medicines as the appropriate governance for improving
R&D for the health needs of developing countries (see World Bank 1993: 152).
This position reflected the ambitions of the international pharmaceutical firms,
who had long opposed the NIEO moves to weaken patent laws in the global South
(see previous chapter).
Intellectual property ‘rights’
73
In this section I demonstrate a third policy shift in global medicines governance
under neoliberalism, by which an international intellectual property ‘rights’
agreement was established by member states of the newly formed World Trade
Organization. The Trade Related Aspects of Intellectual Property Rights
agreement (TRIPS) extended intellectual property and patent protection for a
range of products and processes, including medicines. TRIPS presented new
global architecture for medicines R&D that privileged the private ‘rights’ of
patent holders over the health needs of the global South. This agreement was part
of the broader forum-shifting strategy of the United States to block moves to
weaken patent law in UNCTAD and WIPO through the NIEO. The formation of
the TRIPS agreement has been studied by several scholars (see Drahos 1995;
Muzaka 2011; Sell 2003). I contribute to this scholarship by highlighting the role
and agency of the GATT Secretariat in the negotiations which led to TRIPS.
In the late 1970s, the US strengthened its opposition to the NIEO proposals for a
weakening of international patent rules in UNCTAD and in WIPO (Braithwaite
and Drahos 2000; Deere 2008; Muzaka 2011; Roffe [Chief of Legal Policies
UNCTAD] 1985; Sampath and Roffe 2012; Sell 2003; United Nations General
Assembly 1985). The US was significantly influenced by international
pharmaceutical firms which saw the NIEO revisions in UNCTAD as a threat to
their profits. US-based firms like Pfizer gained political access to the US
government through the appointment of its representatives on government
business councils and through its financing of public institutions like the
American Enterprise Institute (Drahos and Braithwaite 2002). Drahos (1995) and
Drahos and Braithwaite (2002) and Sell (2003) have detailed how pharmaceutical
74
firms collaborated with the US government to persuade their industry
counterparts in Japan, Europe and Canada to lobby respective governments to
oppose the NIEO patent revisions. Through the late 1970s and early 1980s, the
US and allied governments formed the view that a strong international IP
agreement was necessary to protect their exports, in particular their medicines
exports (see Angell 2004; Cockburn 1992; National Economic Development
Office 1986; Sell 2003; Taggart 1993).
In the late 1970s the United States began a concerted campaign to shift the
deliberations on intellectual property in WIPO to the General Agreement on
Tariffs and Trade (GATT). This was part of a broader strategy by the US to block
the NIEO proposals, including those that weakened international patent norms.
Like the World Bank and IMF, the GATT was a multilateral economic institution
that has presided over world trade rules since the mid-1940s. While the GATT
was favoured by the US, throughout the 1970s the organisation had been
neglected by the global South, which had negotiated trade rules primarily through
UNCTAD (see previous chapter)50. As part of this forum-shifting strategy, the US
framed intellectual property as a matter of trade and of specific importance to
trade liberalisation. In their first submission to the GATT on intellectual property
matters in 1979, the US and European Economic Commission (EEC) jointly
framed intellectual property as a trade issue by arguing that infringement of IP or
‘counterfeiting’ blocked legitimate trade and reduced exports of IP-intensive
countries (GATT 1979). This view of intellectual property was in stark contrast to
the NIEO critique in UNCTAD, in which developing countries saw IP rules as a 50 The GATT sought to allay developing countries demands in the mid-1970s when it implemented reforms for preferential and non-reciprocal treatment for developing countries in trade as requested by UNCTAD (1975: 24).
75
barrier to their trade and economic growth. The Non-Aligned Movement initially
opposed this attempt to shift negotiations on IP rules to the GATT (GATT 1989).
A turning point for the US and EEC was the ongoing stalemate over the revisions
to the Paris Convention in WIPO. The United States and its allies refused to
negotiate on the UNCTAD proposal to weaken IP rules in the Paris Convention.
In an attempt to break the stalemate, the developing country members of the
GATT eventually agreed to a request by the US to task WIPO and GATT with a
joint study to examine the ‘appropriateness’ of action on ‘counterfeiting’ and
trade within GATT (Director General of the General Agreement on Tariffs and
Trade 1983; Drahos and Braithwaite 2002: 109; Ministerial Declaration 1982 in
GATT 1983: 1). This tactic provisionally brought IP onto the agenda of GATT in
1983.
Throughout the mid-1980s the United States, European Economic Community
and Japan increasingly framed intellectual property as a trade matter and an
inalienable ‘right’ of the private sector (GATT 1986b: 3; GATT Information and
Media Relations Division 1990: 12; GATT Negotiating Group on Trade-Related
Aspects of Intellectual Property Rights 1987: 3, 25; GATT Secretariat 1987;
Government of Sweden 1994: 37; Sell 2003: 45). The Non-Aligned Movement
continued to oppose this move. At the 1986 Non-Aligned Conference of Heads of
State, the Non-Aligned Movement agreed that that the GATT ‘did not have the
jurisdiction in the area of services, intellectual property and investment’ (GATT
1986a: 6). India led the Non-Aligned Movement within the GATT (GATT 1989).
76
The GATT Secretariat played a key discursive role in convincing several
developing countries that intellectual property was a trade matter and that the
GATT was the most appropriate site for IP rules. Just as UNCTAD was a
proponent of the NIEO, the GATT Secretariat emerged as a key supporter of IP
within its trade remit (GATT 1984b; GATT Secretariat 1985: 10). In the mid-
1980s, the GATT Secretariat conducted its own review of the Paris Convention
on Industrial Property, albeit with no formal mandate from its member states. The
GATT Secretariat concluded that governments had only two options, that of
either maintaining the current IP standards in the Paris Convention or of
strengthening these IP rules (GATT Secretariat 1985). The Secretariat ignored the
decade-long work by UNCTAD, and the work underway in WIPO to weaken the
Paris Convention rules on IP (see previous chapter). Furthermore, the GATT
Secretariat began to use the term ‘piracy’ to refer to the unauthorised use of
intellectual property (GATT Secretariat 1985). This reflected the view of the US
and its allies (home to international pharmaceutical firms in particular), which
claimed that intellectual property was a ‘right’, and that to ignore this ‘right’ was
‘piracy’ (GATT Council 1991b: 88; 1994c: 22; Sell 2003).
Indeed, through its joint task force with WIPO, the GATT Secretariat was
influential in convincing the WIPO Secretariat that IP was a trade matter
appropriate for GATT. Shortly after the joint task force commenced, WIPO began
to criticise measures like parallel importation on the grounds that they were
‘obstructing trade’ (Director General of the General Agreement on Tariffs and
Trade 1983; GATT Secretariat 1985: 29). In the report of the joint task force of
GATT and WIPO, both organisations claimed that an international agreement on
77
‘counterfeits’ was necessary for ‘consumer safety’ (GATT Secretariat 1985: 14;
GATT 1983). This was the first time that these economic institutions would
appear to conflate intellectual property matters with issues of consumer safety and
regulation although, as this thesis demonstrates, they would not be the last (see
Chapter five).
As the GATT Secretariat and WIPO Secretariat began to support a strong
international intellectual property agreement through GATT, developing countries
found fewer allies in the international system. The World Bank and the IMF
publicly supported the GATT as the ‘appropriate’ venue for negotiations on
intellectual property rules (Braithwaite and Drahos 2000; World Bank 1993: 3).
The United Nations Centre on Transnational Corporations (UNCTC) and the
United Nations Department of Economic and Social Development (UNESD),
which were strong supporters of the NIEO in the 1970s, were significantly
downsized in the early 1990s at the request of the US, Japan and EEC (Lipschutz
and Rowe 2005). In 1993, the United Nations Industrial Development
Organization (UNIDO), once an outspoken critic of the international
pharmaceutical firms, was re-structured to service private sector development (see
UNIDO N.D).
In addition to these pressures on the global South, in the GATT negotiations the
US and its allies tied their proposal for an international agreement on IP to a
broader set of trade negotiations known as the Uruguay Round (Sell 2003). This
meant that the negotiations on reducing tariffs, a long-held objective of the global
South, would only commence when member-states agreed to negotiate on IP in
78
the GATT. This eventually led to an agreement among the member states that
they would commence negotiations on an agreement on ‘counterfeit trade’ on the
proviso that the intellectual property measures agreed upon ‘do not become
barriers to legitimate trade’ (GATT 1986a; GATT Group of Experts on Trade in
Counterfeit Goods 1985b, 1985c, 1985d; GATT Preparatory Commitee 1986: 10,
13).
This political power exerted by the US and EEC inside the GATT was also
reflected in trade pressure outside the multilateral system. In 1984, the United
States revised its Trade and Tariff Act to require the US President, then Ronald
Reagan, to consider the ‘extent of adequate protection’ of US intellectual property
‘rights’ when determining trade benefits with other countries (GATT 1984a: 3).
Known as Special 301, this law also required the United States Trade
Representative to release annual reports that identified those governments that,
according to the USTR, ‘deny adequate and effective protection of intellectual
property rights or fair and equitable market access for US exporters’ (Office of
the United States Trade Representative 1994). The Pharmaceuticals Research and
Manufacturers of America (PhRMA), the lobby group for the pharmaceutical
industry, was a driving force behind these revisions to the Trade Act (Pugatch
2004)51.
In 1985, the US promoted its revised Trade Act to all member states of the GATT
as a show of force (GATT Group of Experts on Trade in Counterfeit Goods
51 The PhRMA was formerly named the Pharmaceutical Manufacturers of America (PMA) (1958). It was renamed in the late 1990s as firms sought to project their image as global innovators. The PhRMA filed 301 objections to the USTR with respect to alleged patent infringement in Brazil in 1987, before the Trade Act was officially amended (Pugatch 2004: 67).
79
1985a). Soon after, the US suspended trade benefits with India, who was the
most vocal developing country in opposing pharmaceutical intellectual property
protections (GATT Council 1994c: 165). In the early 1990s, the United States
Trade Representative (USTR) named Brazil, India, Chinese Taipei, and Thailand
as Priority Watch countries in its Special 301 reports (GATT Council 1994c).
Brazil, South Korea, Taiwan, Hong Kong and Singapore subsequently faced
increased tariffs on their exports to the US (Grimwade 2003: 51). The European
Union was a ‘quiet free rider’ on the US efforts, often bringing in negotiators
after the US had started to take action on a country (Drahos cited in Deere 2008:
50; see also Panagariya 2002). The US and EEC aimed to pressure developing
countries to extend intellectual property measures and to agree to an international
agreement on intellectual property that included pharmaceutical patent protection
(Braithwaite and Drahos 2000; Drahos and Braithwaite 2002; Pugatch 2004: 106).
As mentioned above, the GATT Secretariat was instrumental in bringing IP onto
the agenda of GATT. Through the late 1980s and early 1990s, the GATT Council
and the GATT Secretariat played a key role in pushing developing countries to
agree to an international agreement on intellectual property. The GATT Council
increasingly framed intellectual property as an inalienable ‘right’ of the private
sector (GATT Council 1991b, 1992b, 1994a, 1994c). The GATT Council
commenced Country Trade Reviews in which it reviewed domestic intellectual
property laws and accepted complaints from international pharmaceutical firms
(GATT Council 1991a; 1991b: 88).
80
The GATT Secretariat and GATT Council echoed the demands of international
pharmaceutical firms by framing intellectual property as a prerequisite for
research and development for new medicines (GATT Council 1994c: 22; GATT
Secretariat 1994: 1). In 1992, the GATT Council praised the Pharmaceuticals
Manufacturers Association of Canada (PMAC), a national association of the
IFPMA, when it announced that it would increase expenditure on R&D in Canada
if Canada strengthened its patent protection (GATT Council 1992a: 135). The
following year, Canada removed provisions for the compulsory licensing of
medicine patents in its Intellectual Property Law Improvement Act of 1993,
claiming that it had done so to generate a ‘more positive investment climate…by
improving IPR thereby encouraging basic R&D in many sectors’ (GATT Council
1995: 20; see also GATT Council 1994a). In its trade review of Canada a year
later, the GATT Council again reiterated the industry view that Canada’s IP rules
in the 1980s which allowed for compulsory licenses were the cause of the past
poor R&D investment in the country (GATT Council 1994a).
The US and GATT pressure proved to be too much and several developing
countries undertook reforms to strengthen intellectual property protection for
medicines in this period (namely Argentina, Bangladesh, Benin, Brazil, Burkina
Faso, Chile, China, Columbia, Ecuador, Indonesia, the Republic of Korea,
Malaysia, Mali, Mexico, Paraguay, Peru, Thailand and Venezuela) (Deere 2008:
51). This signified a collapse of solidarity between the global South, with
countries like India maintaining the Non-Aligned position. It was not just
developing countries but also Austria, Denmark, Greece, the Netherlands, Spain,
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and Sweden who extended pharmaceutical patent protection for medicines
(Taggart 1993).
Ultimately, the negotiations in GATT reflected a power imbalance between the
North and South. Over 70 per cent of the material submitted to the IP negotiating
group of the GATT came from the US and EU (Drahos 2004). Many developing
countries did not have enough resources to maintain their delegates in the
negotiations, and only 20 governments were involved in the end stage of
finalising the agreement on IP (Deere 2008; Drahos and Braithwaite 2002: 10).
Ascension to the newly forming World Trade Organization (WTO), which was to
replace the GATT, was tied to agreement on IP, meaning developing countries
would need to agree on IP rules to access trade benefits in the WTO (Braithwaite
and Drahos 2000; Deere 2008: 197; Sell 2003)52. The foundations of the
numerous agreements on trade negotiated in this period, including the agreement
on IP rules, were premised on non-discrimination, most-favoured-nation and
national treatment. These differed markedly from the principle of preferential
treatment for developing countries that was a core focus of trade deliberations in
the 1970s (see previous chapter; GATT Secretariat 1994: 15; UNCTAD 1975:
24). Indeed, they reflected the collapse of the NIEO as neoliberalism became
dominant in global economic institutions.
The culmination of the negotiations on an IP agreement in GATT was the Trade
Related Aspects of Intellectual Property Rights agreement (TRIPS) in 1994.
52 The US, EU and Switzerland also made use of the GATT Country Trade Review mechanisms to push countries who sought to join the WTO, like Panama, to align their national IP legislation to their demands). (GATT 1994: 48; GATT Council 1994b: 7, 9, 17; WTO 1996a: 39).
82
Overall, TRIPS represented a win for the US and its allies as it required
signatories to extend intellectual property protection for medicines and other
products for a minimum of 20 years and grant exclusive marketing rights for the
duration of patent terms (Article 28, Article 33, WTO 1994)53. The agreement
represented a significant shift away from the ambitions of the Non-Aligned
Movement to weaken patent laws under the Paris Convention. Instead, TRIPS
strengthened these patent rules, notably through requirements on both product and
process patents for medicines. TRIPS was designed as a set of principles to be
implemented in national law and did contain flexibilities on the definitions of
novelty, as well as provisions to protect public health and promote socioeconomic
and technological development (Article 8, WTO 1994)54. Nonetheless, the IP
agreement represented new global architecture for the governance of medicines
that privileged the private sector (May 2010). This was because, under TRIPS,
measures like compulsory licensing could not be easily granted on economic
grounds, such as the insufficient workings of a patent in-country, which were a
central case made by developing countries under the NIEO (Pugatch 2004: 143,
see previous chapter). Indeed, TRIPS legitimised a discourse by which IP was
seen as a private ‘right’ of firms (Sell 2003).
Conclusion
53 Developing countries were granted five years extension on implementing the agreement, and least developed countries were granted 11 years extension (GATT Secretariat 1994: 14). 54 Member states can exclude from patentability inventions to protect human, animal or plant life or health (Article 27.2 WTO 1994). They can also exclude diagnostic, therapeutic and surgical methods for the treatment of humans or animals’ (Article 27.3a WTO 1994).
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This chapter has demonstrated that shifts in the global governance of medicines in
the 1980s and early 1990s privileged international pharmaceutical firms and
failed to adequately meet many of the health needs of the global South. The
governance of medicines was transformed through shifts in economic, health and
trade policy that were the result of a broader forum-shifting strategy of the United
States and its allies to block the New International Economic Order. The chapter
has highlighted the role of the World Bank and the General Agreement on Tariffs
and Trade (GATT) in diffusing these reforms. In health, the turn to ‘selective’
primary health care complemented economic reforms by providing a rationale and
justification for a narrow role for government. The rise of the World Bank in
health lending coincided with resource constraints on the WHO, which prevented
the organisation from delivering on its mandate. In particular, the WHO’s
Tropical Disease Research program failed to deliver new medicines for the global
South. Under ‘selective’ primary health care, several core aspects of essential
medicines policy were neglected and shifted to the periphery, with devastating
effect on health. Finally, the TRIPS agreement presented new global architecture
for medicines R&D that privileged the private ‘rights’ of patent holders over the
health needs of the global South.
84
C H A P T E R F O U R
AIDS Exceptionalism, Safeguards and Patents
The previous chapters have examined the evolution of the global governance of
medicines from the end of the Second World War to the establishment of the
World Trade Organization (1994). Through the rise and fall of the NIEO, they
have situated shifts in international medicines policy within broader
transformations in the global political economy. In this chapter I examine
developments in global medicines governance through the 1990s to the World
Trade Organization’s Doha Declaration on TRIPS and Public Health in 2001. I
demonstrate that the global governance of medicines in this period strengthened a
global norm for intellectual property ‘rights’ as a prerequisite for medicines
research and development (R&D). This legitimised the historical neglect of the
specific health needs of developing countries, because it framed this neglect as a
logical outcome in the absence of IP protection and profit motive.
The Doha Declaration is widely praised by public health advocates because it
confirms that governments have flexibility in implementing their intellectual
property laws under TRIPS to address the health needs of their population
(Abbott and Reichman 2007; 't Hoen 2002; Sun 2004). Indeed, this chapter shows
that the Doha Declaration was a product of resistance on the part of several
developing countries and NGOs against pressures to enforce IP measures beyond
those of TRIPS. These actors championed a discourse for ‘public health
safeguards’ which enabled them to re-assert health needs against patent ‘rights’. I
argue, however, that this discourse was co-opted by the United States and the
85
international pharmaceutical industry, who framed the protection and enforcement
of their IP ‘rights’ as a safeguard for the development of new medicines. I
demonstrate that corporate litigation against South Africa, which was the catalyst
for this struggle, was a strategy of the international firms to narrow the debate
over medicines and patents to a legal interpretation of the TRIPS agreement. I
show that the World Health Organization enabled this narrowing of the debate as
it shifted its position in support of the enforcement of strong IP ‘rights’ as a
strategy to reclaim its authority in global health.
The chapter draws on an analysis of records, resolutions and reports of the
governing bodies of the World Health Organization (WHO), General Agreement
on Tariffs and Trade (GATT), World Trade Organization (WTO), United Nations
Conference on Trade and Development (UNCTAD) and United Nations Sub-
Commission for the Protection and Promotion of Human Rights, reports of the
Joint United Nations Programme on HIV/AIDS (UNAIDS), World Bank, United
States Center for Disease Control (CDC), United States Trade Representative
(USTR), statements by government leaders and staff of global institutions, the
Pharmaceutical Research and Manufacturers of America (PhRMA), CIPLA,
Health Action International (HAI), Médecins Sans Frontières (MSF), ACT UP,
and the Treatment Action Campaign (TAC) (see Appendix Two).
AIDS exceptionalism and private rights The HIV/AIDS epidemic was a catalyst for shifts in international medicines
governance in the late 1980s and early 1990s that ultimately privileged the private
86
‘rights’ of international pharmaceutical firms over the health needs of the global
South. This section demonstrates that a discourse of AIDS exceptionalism
emerged on the international agenda in the late 1980s, and that this discourse
enabled a shift in the international response to AIDS because it aligned with
‘selective’ primary health care (SPHC). I situate the development of effective
HIV/AIDS medicines within broader shifts in this period, including the
finalisation of the TRIPS agreement, a reduced role for the WHO in health
research, and the loss of the WHO’s international authority over HIV/AIDS.
When effective antiretroviral therapy for HIV/AIDS was finally developed, it was
patented and priced out of reach of the majority of people living with AIDS
(PLWA).
In the early 1980s scientists at the US Center for Disease Control (CDC)
discovered a ‘rare pneumonia’ amongst a group of gay men (Centers for Disease
Control 1981). Unknown to the scientific community at the time, the illness was a
virus that was spreading across the globe with high rates of morbidity and
mortality55. Because the first detection of the virus was amongst gay men it was
initially called ‘gay-related immunodeficiency syndrome’ (Centers for Disease
Control 1981). The disease was re-named ‘acquired immunodeficiency syndrome’
(AIDS) in 1982 when it became clear that heterosexual couples and children were
also infected (UNAIDS 2008). Nonetheless, HIV/AIDS came to be associated
with marginal groups in society and gay men, drug users, sex workers and the
poor were framed as ‘risk groups’ by the scientific community due to higher rates
of infection than the general population (Sabatier 1989: 69).
55 In the early 1980s death rates were high for people who contracted the virus (Sabatier 1989: 5).
87
How governments responded to HIV/AIDS was shaped by ideology and politics.
The conservative US President Ronald Reagan was slow to respond to the spread
of the disease and remained publicly silent on HIV/AIDS for most of his
presidency (1981-1989)56. When he did finally acknowledge the disease, Reagan
framed HIV/AIDS within a discourse of moral conservatism and individual
responsibility (Reagan 1987d). Reagan initially opposed expansion of the US
government’s budget for basic research in order to develop effective medical
treatment for HIV/AIDS (Bush 1990; Reagan 1987c). Morality, he argued, would
‘teach the same lesson for prevention as medicine’ (Reagan 1987c).
Due to a lack of scientific knowledge on the epidemiology of the virus, and
because the disease was associated with marginal groups in society, people living
with AIDS (PLWA) endured significant stigma and discrimination. In the United
States, for example, people of Haitian nationality were prevented from donating
blood due to fears that the virus had spread from Haiti. West Germany, Cuba,
Iceland, South Africa and the Soviet Union imposed quarantine restrictions on
PLWA (Sabatier 1989: 70). Over 34 countries implemented travel restrictions on
PLWA in an attempt to prevent the spread of the virus (Chang et al. 2013). Wild
theories that the virus had emerged from human copulation with monkeys in
Africa inflamed anti-colonial and anti-racist sentiment in African nations. In
response, many African countries denied the existence of AIDS or blamed it on
former colonial powers (Sabatier 1989). Government disinterest, denial, and
stigma meant many PLWA received little support. This was compounded by
neoliberal economic re-structuring in several developing countries, which reduced
56 Reagan only publicly spoke about the disease on six occasions, all in the last half of his presidency (Reagan 1987a, 1987b, 1987c, 1987d).
88
public services and imposed user fees on health care (see previous chapter,
Farmer 2001; Lee and Zwi 2003; Poku and Sandkjaer 2007; Rowden 2009;
Sanders and Sambo 1991).
Government inaction was reflected at the international level in the slow response
of the WHO to the spread of the disease. The WHO had no member-state mandate
to address HIV/AIDS and it was also suffering from significant budget constraints
(see previous chapter). In the early 1980s member states provided WHO with
resources to employ one staff member to work on sexually transmitted diseases
(UNAIDS 2008: 13). The United States CDC therefore led the initial response,
developing the first mother-to-child transmission guidelines and organising the
first AIDS conference in 1985 (US Department of Health and Human Services
2011). In the late 1980s, member states finally agreed to establish international
surveillance of HIV/AIDS in the WHO. Few developing countries participated in
surveillance, however, which was a consequence of anti-colonial tensions and
limited public resources in developing countries to fund health surveillance
(Sabatier 1989; UNAIDS 2008: 13).
It was in this context of strained government health services, denial and
discrimination that PLWA and their supporters formed non-government
organisations and advocacy groups. These groups, which formed in several
countries including Brazil, Uganda, South Africa, Thailand and the United States,
advocated for their governments to respond to HIV/AIDS as a human rights issue
(UNAIDS 2008). In the United States, NGOs demanded that PLWA ‘be included
in all AIDS forums with equal credibility as other participants, to share their own
89
experiences and knowledge’ (Advisory Committee of the People with AIDS
1983). Advocacy on the part of NGOs and activists in Brazil eventually led to the
Brazilian government forming its Brazilian National AIDS Control Program
(NACP) in 1986 (Mandisa 2013). Gay rights groups and AIDS groups came
together in the US to form the AIDS Coalition to Unleash Power (ACT UP). ACT
UP organised mass protests and ‘die ins’ and demanded a co-ordinated
government response to AIDS that included investment in medical research57.
This discourse for the human rights of PLWA was accommodated under
neoliberalism and was soon adopted, at least rhetorically, at the international
level. The idea of individual human rights for PLWA aligned with the emphasis
on the rights of the individual under neoliberalism (see previous chapter).
Language to this effect emerged in resolutions on the human rights of PLWA in
the WHO; [there is] ‘no rationale for measures that limit the rights of the
individual’ (WHA45.25 [1992] in WHO 1993: 127)58. Neoliberalism was also the
broader context by which member states of the World Health Assembly agreed to
support AIDS NGOs and include NGO representatives on their national AIDS
committees (WHA42.34 [1989] in WHO 1993: 124; see also Harvey 2005). In the
WHO, health as a human right ‘without distinction of race, religion, political
belief, economic or social condition’ had been a guiding principle since its
constitution (WHO 1946). In 1988, the World Health Assembly agreed that
discrimination against people with HIV/AIDS was against human rights and
57 ‘Die ins’ were a strategy by which activists would chain themselves in government buildings or the headquarters of international pharmaceutical companies to bring media attention to their cause. 58 Despite these commitments, the US only recently repealed Section 212(a) of its Immigration and Nationality Act which prevented non-citizens with a ‘communicable disease of public health significance’ from admission in the country without a waiver (see Rushton 2012).
90
established a Special Programme for AIDS within the WHO (WHA41.24 [1988]
in WHO 1993)59. Jonathan Mann who headed the WHO Special Program was a
strong supporter of this human rights discourse: ‘the protection of the uninfected
majority depends precisely and is inextricably bound with the protection of the
rights and dignity of infected persons’ (Jonathan Mann cited in Sabatier 1989: iv;
Mandisa 2013; UNAIDS 2008).
As HIV/AIDS was increasingly framed as a human rights issue, a discourse of
AIDS exceptionalism emerged on the international agenda. This was in part a
result of a strategy of some staff of the WHO to garner financial support for their
HIV/AIDS program amidst a broader decline in funds for the organisation (WHO
1987, see previous chapter). Staff of the WHO program on HIV/AIDS framed
AIDS as an exceptional disease that required exceptional funding. This aligned
with the World Bank and UNICEF’s approach to ‘selective’ primary health care
(SPHC) under neoliberalism (see previous chapter). HIV/AIDS was infectious
with high rates of mortality and morbidity and it therefore met two criteria of
SPHC (See Walsh and Warren 1979). No effective treatment existed in the 1980s,
which was the third criteria for assessing health interventions under SPHC. The
individual nature of HIV/AIDS transmission, however, meant that advocates
could point to individual responsibility as a preventative measure (See Walsh and
Warren 1979). Thus, this discourse of HIV/AIDS exceptionalism was
accommodated under SPHC which enabled governments to justify public
expenditures in health care. By 1990, the WHO programme for HIV/AIDS was
59 The United Nations Sub-Commission for the Protection and Promotion of Human Rights also enacted numerous resolutions on the human rights of PLWA (United Nations Sub-Commission for the Protection and Promotion of Human Rights 1992, 1993, 1995, 1996; see also UNESC 1987; United Nations General Assembly 1987; WHO 1987).
91
the largest funded program in WHO history (UNAIDS 2008: 16). In its first
report dedicated to ‘Investing in Health’, the World Bank (1993: 16) called for
‘billions more dollars’ in government aid to combat the disease.
The rise of AIDS exceptionalism was a turning point in which the US government
expanded its public support for R&D into HIV/AIDS treatment. In the late 1980s,
the Reagan administration finally increased the US government budget for
research from a meagre 10 million to 400 million dollars (Reagan 1987c; Mandisa
2013). So exceptional was HIV/AIDS that in 1987 the US Department of Health
and Human Services and the French Institute Pasteur agreed to ‘share the patent’
of an AIDS antibody test kit (Reagan 1987a). Reagan’s successor, George Bush,
increased the HIV/AIDS budget to over three billion dollars in his first year of
office (Bush 1990). In 1995, Bush’s successor Bill Clinton establishment a
Presidential Advisory Council on HIV/AIDS, which included representatives of
US-based international pharmaceutical firms (Clinton 1995a, 1996). Clinton
asserted that a cure for AIDS was his administration’s ‘top priority’, and that he
would ‘oppose any effort to undermine the research effort in the face of budget
cuts’ (Clinton 1995b)60. These increases in US government support for medical
research were directed to US-based international pharmaceutical firms. President
Clinton convened high level meetings between US government politicians,
scientists and leaders of the US-based international pharmaceutical industry, and
praised the private sector as the champion for a cure (Clinton 1996). It is
noteworthy that this shift in the US occurred in parallel to neoliberal economic re-
structuring in the global South, by which several developing countries allocated
60 Bush’s successor President Clinton spoke about AIDS publicly on 39 occasions in his tenure, the most of any US President (Clinton 1993a, 1993b).
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no resources for government expenditure on medical research (see previous
chapter).
As the US intensified its R&D efforts to develop effective treatment for
HIV/AIDS in collaboration with US-firms, the role of the WHO in co-ordinating
health research appeared to weaken. In January 1986, members of the WHO
Executive Board called for the Director General to co-ordinate clinical trials of
antiretroviral drugs that showed promise (EB77.R12 [1986] in WHO 1993: 120).
This text was deleted from the resolution, however, by the time it reached the
World Health Assembly later that year. Again in 1992, member states of the
WHO Executive Board asked the Director General to ‘intensify biomedical
research’ in the organisation (EB89.R19 [1992] in WHO 1993: 126). This text
was subsequently altered in the World Health Assembly to request the Director
General to ‘continue negotiations with the pharmaceutical industry to facilitate
access to affordable vaccines and drugs’ (WHA45.35 [1992] in WHO 1993: 128).
This had broader implications beyond HIV/AIDS, and appeared to signal the
demise of the WHO in co-ordinating health research.
These shifts occurred in parallel to the finalisation of the TRIPS agreement (see
previous chapter). Indeed, shortly after TRIPS was finalised, in 1996 the US
initiated and won the first disputes over alleged pharmaceutical IP infringement
with India and Pakistan in the newly-formed World Trade Organization. At issue
was Article 70(8) of TRIPS which required that developing countries implement
‘mailbox’ provisions for pharmaceutical patent protection to backdate patent
applications from 1995 onwards (Office of the United States Trade
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Representative 1996; WTO 1996b, 1996c, 1996f). The USTR reported that it
initiated the disputes on the behalf of several US pharmaceutical companies,
which claimed they stood ‘to lose significant revenues if the longer TRIPS patent
term is not applied to their existing patents’ (USTR Ambassador Michael Kantor,
cited in Office of the United States Trade Representative 1996; WTO 1996d,
1996e). The United States targeted India because it had the most developed
domestic production capacity for medicines in the global South. Pakistan was
likely targeted because it had the largest recorded shift away from originator
medicines to generics, in terms of domestic market share, of any developing
country (WHO 2004d: 41). In addition, both countries had increased their
domestic medicine exports in the 1980s unlike the majority of developing
countries (WHO 2004d: 26).
In this same period, a new smaller UN organisation was created which gained
international authority over HIV/AIDS. This was enabled by tensions between
WHO staff over the exceptional status of HIV/AIDS in the organisation. The
incumbent third Director General of the WHO, Hiroshi Nakajima, felt that the
disease received too much attention at the expense of other conditions, like child
diarrhoea (New York Times News Service 1990). Indeed, the vertical focus of the
WHO’s Special Programme on a single disease was in contrast to the broader
vision of ‘Health for All’ that still guided much of the WHO’S work (Bayer 1994;
England 2008; Lazzarini 2001). Nakajima wanted to rein in the AIDS programme
so that resources were devoted to the regional and country level offices of the
WHO (Lisk 2010: 22). Jonathan Mann, Director of the WHO Special Programme
on HIV/AIDS, was opposed to this move. Mann subsequently resigned in protest
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to Nakajima and to what he saw as government inaction to meet the health needs
of those with HIV/AIDS (New York Times News Service 1990; Pincock 2013;
UNAIDS 2008: 17). According to the former Executive Director of the WHO
Special Program for HIV/AIDS, Michael Merson (2006), Mann’s resignation only
exacerbated tensions between WHO and the World Bank, which had formed its
own HIV/AIDS program and was competing with WHO for donor resources.
These tensions enabled donors to forum shift HIV/AIDS away from the WHO to
a new organisation, the Joint United Nations Programme on HIV and AIDS
(UNAIDS) in 1994 (UNESC 1994).
UNAIDS was hailed as an ‘innovative partnership’ because it was designed to tap
into the work of the ‘coordinating bodies’ including the WHO, United Nations
Population Fund, International Labour Organization, United Nations
Development Programme, UNICEF and the World Bank (PEPFAR N.D).
Critically, in contrast to the WHO, UNAIDS was created with a small
‘Programme Coordinating Board’ of only 22 member states allocated from five
regions. The ‘Western Europe and other’ region, which comprised European
nations, the US, Canada, and Australia were allocated the largest representation of
seven seats on the Board (nearly one third of all votes). Thus, the US and its allies
obtained a greater share of power over decision-making in UNAIDS than they
had previously had in other UN bodies61.
Finally, in 1996, US-based international pharmaceutical companies announced
that they had developed effective highly-active antiretroviral (ARV) therapy for 61 Japan, China, India, Russia (minus 3 years), and the United States (minus 4 years) have maintained long-term membership on the PCB of UNAIDS since it was created (UNAIDS N.D).
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AIDS. These medicines were seen as lifesaving and they demonstrated significant
reductions in mortality rates (Carpenter 1997; Gulick 1997; Hammer, Katzenstein
and Hughes 1996). The ARVs were patented and were prohibitively expensive for
a majority of PLWA because the international firms charged over 20,000 (US)
dollars per patient per year (Schwatlander, Grubb and Perriens 2006). Indeed, the
cost of the ARVs were a contributing factor to them not being included on the
WHO’s Essential Medicines List in 1997 (WHO Expert Committee on the
Selection of Essential Drugs 1997: 13)62. AIDS NGOs reacted angrily to the
prohibitive prices and the United States government responded to domestic
advocacy by purchasing the ARV treatments for US citizens through its AIDS
Drugs Assistance Program (ADAP) (Luiz and Silva 1996; Nunn 2009: 85)63. The
United States and its allies initially rejected a proposal for a global fund to assist
developing countries to purchase the ARVs, however, citing the expensive cost of
medicines and the ‘parlous nature of developing country health services’ ([1997]
in UNAIDS 2008, see more next chapter).
The consequence of forum-shifting HIV/AIDS from WHO to UNAIDS soon
became evident when UNAIDS formed a ‘partnership’ with five international
pharmaceutical companies. In 1997 UNAIDS offered a trial group of developing
countries [Chile, Cote d’ivoire, Uganda and Vietnam] a reduced price on the
HIV/AIDS ARVs to around 7000 dollars (US) per person per year (UNAIDS
2008: 69). The firms were seeking IP protection in exchange for the price offers,
62 The following year, only one ARV zidovudine was added to the WHO list with a warning that triple drug therapy was ‘beyond the budgets’ of most national medicines programs (WHO Expert Commitee on the Selection of Essential Drugs 1998: 35). 63 An estimated one in three PLWA in the United States currently rely on the program as of 2013. The ADAP continues to procure only patented medicines from US pharmaceutical companies (AVERTing HIV and AIDS N.D; NASTAD 2013).
96
which were still prohibitively expensive. This demonstrated that UNAIDS was
privileging the private ‘rights’ of the international pharmaceutical firms over the
health needs of PLWA in the global South.
The South African lawsuit
In this section I show that a group of international pharmaceutical firms sued the
government of South Africa in 1997 as a strategy to narrow the international
debate over medicines and patents to a legal interpretation of the TRIPS
agreement. This litigation, which took over five years before it was withdrawn by
the firms, effectively blocked South Africa from ensuring access to HIV/AIDS
medicines for its citizens. I first explain the context for the litigation and then
demonstrate that the industry lawsuit was a catalyst for the mobilisation of health
advocacy NGOs.
In 1996, South Africa had one of the highest rates of HIV prevalence in the world
(Mba 2007). HIV prevalence amongst pregnant women in Lesotho was at an all-
time high at 26 per cent (Zungu-Dirwayi et al. 2004: 17). The development of
effective HIV/AIDS ARVs that year provided a shimmer of hope for PLWA. The
price of ARVs, however, at up to 20,000 dollars per patient per year, made them
unaffordable for the majority of South Africans (Schwatlander, Grubb and
Perriens 2006). Pharmaceutical firms did not offer a reduced price for their ARVs
to South Africa through UNAIDS. Even if they had, the ARVs would still have
been out of reach for a majority of South Africans.
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These prohibitive prices created tension for the new anti-apartheid government,
which had recently affirmed the right to health in its new constitution.
Specifically, the constitution provided for a Bill of Rights which included the
right of ‘everyone’ to ‘have access to...health care services, including
reproductive health care’ (section 27.1(a) Constitution of Republic of South
Africa 1996: 1255)64. The right to health was in tension with the ‘rights’ of patent
holders to charge what they liked through monopolies granted by the patent
system, and at the time South Africa granted 20 years patent protection. In
December 1997, the South African government introduced legislation through the
‘Medicines and Related Substances Control Amendment Act 90’ which gave the
Minister power to improve the supply of affordable medicines through measures
like compulsory licensing and parallel importation (Section 10(15C) Medicines
and Related Substances Control Amendment Act 90 of 1997: 10)65. These
measures, which were outlined in the TRIPS agreement, meant the government
could enable domestic generic firms to produce the ARVs or they could import
generic ARVs from other countries when they became available.
This promise of more affordable ARVs was blocked that year when a group of 40
international pharmaceutical firms sued the government and obtained a High
Court interdict, which prevented the Act from becoming law (Mandisa 2013: 139;
PhRMA 2000f). This was an unprecedented move which demonstrated the power
of the international pharmaceutical industry. The firms claimed that the proposed
64 The Bill also required that the government of South Africa ‘must take reasonable legislative and other measures, within its available resources to achieve the progressive realisation of … these rights’ (section 27.1 Constitution of Republic of South Africa 1996: 1255). 65 This Act also covered other issues of medicines governance including traditional medicines.
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Medicines Act was a ‘violation’ of the South African constitution and the TRIPS
agreement (PhRMA 2000f). This litigation prevented South Africa from
implementing the legislation. Thus, the firms effectively prevented access to life-
saving medicines for millions of South Africans. This was evident when the South
African government added several HIV/AIDS ARVs on its national Essential
Medicines List in 1997, with a warning that the medicines were ‘very costly and
cannot be provided on a mass scale by the public health services…it may only be
provided on a limited and selective basis or for academic and research purposes
only’ (cited in Laing 2003)66.
The South African lawsuit was a strategic move by the international
pharmaceutical companies to pressure South Africa and other developing
countries to implement intellectual property measures beyond the requirements of
TRIPS. In public, the PhRMA claimed that the Act was a ‘violation’ of TRIPS
(PhRMA 2000f). In private, however, the PhRMA admitted that the provisions of
the Act ‘has some basis in fact’ (United States Department of State 1998). The
international firms were aware that South African Medicines Act was ‘not
actionable through WTO dispute settlement procedure’, a glaring admission that
they knew that the agreement was consistent with TRIPS (PhRMA 2000f; United
States Department of State 1998). Nonetheless, the PhRMA firms called on the
US government for support, warning that the Act posed a ‘serious threat to the
viability of American pharmaceutical investment in South Africa’ (PhRMA
2000f).
66 Notably, the official UNAIDS account of this period neglect any mention of the corporate lawsuit in South Africa (see UNAIDS 2008).
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The United States Trade Representative supported the industry lawsuit and added
South Africa on the US Special 301 Watch List with the rationale that South
Africa’s proposed Medicines Act granted the health minister ‘ill-defined
authority…to abrogate patent rights’ (Office of the United States Trade
Representative 1998, 1999). Unlike the international firms, the USTR did not
publicly assert that the Act was inconsistent with TRIPS. It did not have to
however, because it had recently amended its Trade Act which enabled the USTR
to accuse any country that it denied ‘adequate’ IP protection, even if it were in
compliance with TRIPS (Office of the United States Trade Representative 1994,
1995).
The South African litigation confirmed the fears of international NGOs, which
had begun to share information amongst themselves about the potential
implications of TRIPS for access to medicines. The US NGO Consumer Project
on Technology (CpTech) was an important organisation in this informal network.
James Love of CpTech had attended meetings on TRIPS at the WTO organised
by Argentinean generic pharmaceutical firms in the mid-1990s. According to
Love (2011b), the then Head of IP at the WTO, Adrien Otten, was sceptical of the
possibility of generic production of patented medicines in TRIPS signatory
countries. CpTech subsequently began coalition-building with other NGOs and
contacted the international advocacy NGO Health Action International (HAI),
which had been active in international medicines policy since the early 1980s (see
Chapter two). The two NGOs held the first of several meetings on TRIPS and
medicines in Bielefeld Germany in 1996, which was attended by several health
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and development NGOs, including Médecins Sans Frontières (MSF) and Oxfam
(Sell 2003).
The developments in South Africa in 1997 confirmed the NGO’s fears, and they
began to advocate for the United States to drop its support for the pharmaceutical
litigation. This public advocacy was initially centred on a legal interpretation of
TRIPS, in response to the firms’ accusation that South Africa’s Act was
inconsistent with TRIPS. The NGOs pointed out that measures like compulsory
licensing and parallel importation were consistent with TRIPS (see Nader, Love
and Weissman 1997). They also created issue-linkage by demonstrating that the
pharmaceutical litigation was preventing more affordable access to medicines.
The NGOs began to frame the industrial property measures like compulsory
licensing and parallel importation as necessary ‘public health safeguards’ (Nader,
Love and Weissman 1997). This was a counter-discourse to intellectual property
‘rights’ which had been diffused through the World Trade Organisation and was
at the centre of the firm lawsuit in South Africa.
The battle for a revised drug strategy In this section I demonstrate that the United States and its allies opposed and
prevented an attempt by many developing countries and NGOs to prioritise health
over IP in the WHO. I first show that a discourse for ‘public health safeguards’
emerged amongst NGOs in response to the litigation in South Africa and enabled
several developing countries to forum-shift deliberations on medicines and
patents back to the WHO. The United States and its allies strongly opposed this
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move and they subsequently diminished the WHO’s authority by requiring the
WHO to consult the WTO on all matters related to IP and medicines. Indeed,
conflict over a Revised Drugs Strategy in the WHO ultimately led to a policy shift
by the WHO Secretariat through which the incumbent Director General, Gro
Harlem Brundtland, promoted IP as a prerequisite for medicines R&D.
In early 1998, shortly after corporate litigation commenced in South Africa, the
Zimbabwean Health Minister, Dr Timothy Stamps, asked staff of the NGO Health
Action International (HAI) to assist in the drafting of a Revised Drug Strategy
(Sell 2003: 148). In the draft resolution presented to the World Health Assembly,
the Health Ministry of Zimbabwe invoked a discourse of ‘public health
safeguards’ as a strategy to get member states of the WHO to prioritise public
health over commercial interests (Paragraph 1(2) in United States Department of
State 1998). This draft resolution also called for governments to review their
options under the WTO TRIPS agreement to ‘safeguard access to essential drugs’
(Paragraph 1(2) in United States Department of State 1998). Not only did this
move demonstrate an attempt by Zimbabwe to forum-shift the debate over
medicines and IP back to the WHO, but it also illustrated that the NGOs were
engaged in both public and institutional advocacy.
At the 1998 World Health Assembly the NGOs played a key role in information-
sharing and diffusing their counter discourse for ‘public health safeguards’. The
NGOs held a series of workshops at the event in which they stressed to public
health officials of several developing countries that compulsory licensing and
parallel importation were ‘public health safeguards’ and were consistent with
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TRIPS (Love 1998). James Love and Ralph Nader of CpTech told developing
countries officials that the United States was spreading misinformation regarding
TRIPS (Love 1998; Nader, Love and Weissman 1999). The NGOs distributed
their own material to the member-state delegations in which they repeated their
call for governments to protect ‘public health safeguards’ (Consumer Project on
Technology 1998). Several delegations, such as South Africa, explicitly drew on
the NGO material as they supported the Revised Drug Strategy (Consumer
Project on Technology 1998; Goosen 1999; United States Department of State
1998). The diffusion of this ‘public health safeguards’ discourse was also evident
in the WHO Action Programme on Essential Drugs, which released a report at the
time of the Assembly promoting compulsory licensing and parallel importation
measures as ‘public health safeguards’ (Action Programme on Essential Drugs
1998)67.
The United States and its allies, in particular the UK, Germany, Australia, the EU
and Switzerland, strongly opposed the draft resolution. Privately, the EU mission
concluded that ‘no priority should be given to health over intellectual property
considerations’ (European Commission 1998). The EU mission also privately
reported that the language of the resolution was of ‘considerable concern among
the pharmaceutical industry in EU member states and likeminded members of the
U.S.A’ (European Commission 1998). This suggests that the US and its allies
were strongly influenced by their respective pharmaceutical firms. The United
States was particularly opposed to the report of the WHO’s ADEP, which
supported the use of ‘public health safeguards’ (Action Programme on Essential 67 The report came with the disclaimer that it presented the views of the authors only and not the WHO. One of the authors was Pascale Boulet, who went on to work for MSF’s Access campaign and the Medicine Patent Pool (see Chapter six).
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Drugs 1998). This was because, in the US view, the ADEP had confirmed these
‘safeguards’ without consensus from the World Health Assembly. The US argued
that the WHO had no grounds for comment on matters that related to intellectual
property and trade (Holmer 2000; United States Department of State 1998). It
attacked the WHO for ‘bias’ and put strong pressure on the Director General of
the WHO, Gro Harlem Brundtland, and the Secretariat to maintain ‘WHO
impartiality’ (United States Department of State 1998).
This political conflict over the Revised Drug Strategy ultimately led to a policy
shift by the WHO Secretariat, which was a key turning point for the global
governance of medicines. The Director General, Gro Harlem Brundtland, sought
to allay US concerns by requiring the Action Program on Essential Drugs to
revise its report with input from the World Trade Organization. In the revised
report of the ADEP, Brundtland publicly claimed that the ‘protection of
intellectual property rights goes hand-in-hand with successful research and
development’ (cited in Action Programme on Essential Drugs 1998). This
signified a shift in the WHO which had historically been sceptical of the industry
claims that IP enforcement was clearly linked to R&D (see WHO 1985b). When
the text of the Revised Drug Strategy was finally agreed upon by member states at
the subsequent World Health Assembly, the United States insisted on language in
the resolution that required the WHO to consult the WTO on all trade matters
(Holmer 2000; United States Department of State 1998; WHO 1998b, 1998c,
1999b). This move effectively diminished the authority of the WHO and elevated
the WTO as authoritative in matters relating to norms and rules guiding medicines
R&D and production.
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Public health safeguards In this section I demonstrate that a coalition of NGOs and developing countries
were more successful in diffusing the discourse for ‘public health safeguards’ at
the World Trade Organization than they were at the WHO. I show that NGOs
intensified their networking and created an informal global advocacy network
through which they shared information and strategies. Through coalition-building
between NGOs and developing country delegations at the World Trade
Organization, these actors were ultimately successful in pressuring the WTO to
confirm these ‘public health safeguards’ as consistent with TRIPS. Not long after,
the Indian generic firm CIPLA announced the development of a fixed-dose
combination (FDC) ARV, which it offered to developing countries at a
substantially lower price than the originator firms. This development and the
resultant discourse around it was a significant turning point in global medicines
governance.
In the late 1990s domestic and international NGOs expanded their networking and
campaigning for access to HIV/AIDS medicines, which demonstrated their ability
to set agendas and shape global politics. In South Africa, which was still facing
corporate litigation, AIDS rights activists joined together with anti-apartheid
activists to form the Treatment Action Campaign (TAC)68. Members of the TAC
engaged in coalition-building with Thai AIDS activists at international
conferences. Through this networking a specific campaign emerged regarding
fluconazole, an essential medicine for the management of cryptococcal 68 The TAC would later take the South African government to court and win over the government’s responsibility under the new constitution to provide ARV treatment for mother-to-child transmission, extended counselling and testing services for HIV/AIDS (UNAIDS 2008: 109).
105
meningitis, a common infection in PLWA (Love 2011b). In 1998, Thai AIDS
activists successfully lobbied the Thai government to enable generic production
of fluconazole, of which Pfizer had been granted exclusive marketing rights. As
part of a strategy of public shaming, awareness raising, and securing affordable
medicines, the TAC began to smuggle the Thai generics into South Africa.
Pfizer also had a monopoly over fluconazole in South Africa through the patent
system. Whereas the Pfizer originator was priced at R80.24 and R28.57 in the
private and public sectors, the Thai smuggled generic was secured by TAC for
R1.78 (Mandisa 2013: 154). The international NGOs MSF, HAI and Cptech took
to the Lancet to publicise the stark price differences as part of a strategy of public
shaming and awareness raising (see Perez-Casas et al. 2000; Wilson et al. 1999).
Indeed, the international NGOs linked the fluconazole campaign to the broader
issue of access to medicines and the pharmaceutical litigation against South
Africa (see Perez-Casas et al. 2000). This generated significant public pressure on
Pfizer, which ultimately led to Pfizer offering its branded fluconazole free to the
public sector in South Africa for the treatment of cryptococcal meningitis and
oesophageal candidiasis in AIDS patients (Hardwick [Senior Vice President of
Pfizer] 2001; Perez-Casas et al. 2000)69. The NGOs had shamed Pfizer, and in
doing so had demonstrated their discursive power. The success of the fluconazole
campaign emboldened the NGOs in their broader campaign against the corporate
litigation in South Africa. Indeed, following the fluconazole campaign, MSF won
the Nobel Peace Prize for its humanitarian work and used the winnings to form its
own Access to Medicines campaign. MSF then began to work with the TAC to
69 Pfizer refused to offer a voluntary licence to South Africa for generic production of fluconazole.
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create its own treatment program for PLWA in Khayalitsha, South Africa
(Mandisa 2013: 109, see more on MSF in Chapter six).
Networking between NGOs in South Africa and the US served as a ‘boomerang’
effect by which the NGOs brought the US-supported corporate litigation against
South Africa onto the agenda of the American public elections (Keck & Sikkink
1999). In 1999, AIDS rights groups and activists in the US formed the ‘Global
Health Access Project’ (Health GAP) in solidarity with the South Africa activists.
That year, US group ACT UP followed the Presidential Campaign of Al Gore
across the country, publicly shaming the US for supporting the pharmaceutical
litigation against South Africa. The activists in both countries used symbolism
and issue-linkage in which they framed the corporate lawsuit as a form of medical
apartheid, chanting ‘Gore’s greed kills’ at public events (Borger 1999; Mandisa
2013: 149). Information-sharing was also intensified in this period as the NGOs
developed the email list serve ‘E drug’ to ‘speed up’ communications between
health professionals and activists in support of the concept of essential medicines
(E-DRUG 1999).
A turning point for developing countries and NGOs was at the World Health
Assembly in 1999. A defiant South Africa revealed that the WTO had privately
advised that the ‘clauses in question’ at the core of the South litigation were
compliant with TRIPS (Goosen 1999). This information confirmed for developing
countries that measures like compulsory licensing and parallel importation were
consistent with the TRIPS agreement. Not long after, the Brazilian President
Cardoso issued a Presidential Decree that amended Brazil’s Industrial Property
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law so as to expand the conditions by which the government could issue a
compulsory licence (Brazil 1999). Like South Africa, Brazil had promised to
provide all ‘individuals living with HIV/AIDS…free of charge … all medication
necessary for treatment’ (Article 1 Law 9313 1996). The prohibitive price of
ARVs meant that Brazil could not deliver on its promise. The Brazilian Health
Minister Serra justified the policy in the context of the health needs of PLWA;
There is a Presidential decree that allows for patents to be broken in the
case of abusive prices, and two of our AIDS drugs are candidates for this
clause. … Not that our motivations are just economic…it’s human, it’s
about solidarity (Serra Pressiona Laboratórios 1999; see also Nunn 2009:
11).
The discourse for ‘public health safeguards’ enabled a language through which
developing countries could revise their industrial patent laws in ways that met
health needs, and as a consequence, also met the economic ambitions of their
domestic generic firms. One month later, at the World Trade Organizations’
Seattle Ministerial, developing countries presented a unified group and demanded
that the WTO recognise that ‘public health safeguards’ were compliant with
TRIPS. Indeed, several developing countries re-asserted demands with respect to
medicines policy that were reminiscent of the New International Economic Order
(see Chapter two). Zambia, Jamaica, Kenya, Pakistan, Sri Lanka, Tanzania,
Uganda and Zimbabwe all made submissions to the WTO Ministerial in which
they asserted that price controls on essential medicines were ‘public health
safeguards’ (WTO 1999a). Indonesia, Malaysia, Nigeria, Pakistan, Sri Lanka and
Uganda also made submissions in which they sought for the TRIPS agreement to
exclude from patentability those medicines on the WHO’s Model List of Essential
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Drugs (WTO 1999a). These moves demonstrated a counter forum-shifting
strategy after the US blocked their attempts to reassert a role for the WHO in the
Revised Drug Strategy (see above).
NGOs were active at the WTO conference and played a key role in pressuring the
WTO to respond to the demands of the global South. Indeed, the broader context
of the Seattle conference was the international protests, popularly known as the
anti-globalisation movement (Castells 2004: 97). Health advocacy NGOs held
their own meetings on ‘access to medicines and TRIPS’ at the Seattle Conference,
which were attended by more than 350 delegates from over 50 countries, as well
as the United Nations Development Program (UNDP), the WHO, and the WTO
(Health Action International, Médecins Sans Frontières and Consumer Project on
Technology 1999). Facing a broad range of criticisms that centred on the WTO as
an agent of the global North, the WTO also held a number of NGO-focused
forums in which it invited the health advocacy NGOs, as well as the PhRMA and
IFPMA to attend70. The WTO issued a booklet at the Seattle Ministerial in which
it responded to the main sources of criticism. This booklet finally confirmed that
measures like compulsory licensing and parallel importation were ‘safeguards’
consistent with TRIPS (WTO 1999b)71. This was significant, despite the WTO
Ministerial ultimately collapsing due to disagreements principally between the US
and EU over agricultural tariffs (Muzaka 2011).
70 At the event, the IFPMA argued that the TRIPS agreement was ‘globalizing research’ and represented the ‘first global attack on counterfeit drugs’ (International Instititute for Sustainable Development 1999). 71 The WTO was also critical of ‘misinformation’ on TRIPS that had spread through ‘bilateral discussions’ (WTO 1999b: 41).
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The WTO’s confirmation of ‘safeguards’ led to intensified advocacy by the
NGOs. In 2000 the South African TAC and the US Health Gap jointly organised
the first march for universal access to HIV treatment at the Durban International
AIDS conference in South Africa. Together, the NGOs demanded the ‘right to
access to treatment’ and framed the denial of this right as ‘tantamount to
genocide’ (ACT UP 2000). At the conference, Brazil announced that it had
achieved price reductions of up to 70 per cent for its HIV/AIDS antiretrovirals
since it had commenced generic production (Mandisa 2013: 113). This
demonstrated to the international community the benefits of generic production
for affordable access to medicines. In addition, CpTech and MSF made affidavits
to the South African Supreme Court in which they linked the health needs of
PLWA to the provisions of the Medicines Act under threat in the industry
litigation (Love 2001a).
A significant turning point in this struggle came in September 2000 when Yusuf
Hamied, long-time Executive Director of the Indian generic pharmaceutical firm
CIPLA, announced that CIPLA had developed the first fixed-dose combination
(FDC) ARV comprising stavudine, nevirapine and lamivudine (Hamied 2000).
Hamied offered the FDC to developing countries at a price of 800 dollars per
patient per year (Raaj 2013: 58). This was a significant price reduction from that
offered by the international firms for the individual ARVs. While CIPLA had
economic objectives in providing generic ARVs, Hamied framed his decision to
produce the generics as a symbol of support for the health needs of the ‘Third
World’ (Hamied 2000). HIV prevalence in India was low, ranging from half a per
cent of the population in northern states to two per cent in southern states [in
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2000] (Arora et al. 2008). Hamied invoked the ‘human tragedy’ of HIV/AIDS and
the lack of access to medicines amongst the world’s poor as the rationale for
generic production when he wrote to the originator firms requesting voluntary
licences (CIPLA 2000a, 2000b).
Safeguards, IP, and medicines R&D
In this section I demonstrate that the United States and the international
pharmaceutical industry co-opted the ‘public health safeguards’ discourse by
framing IP ‘rights’ as a necessary safeguard for medicines research and
development (R&D). I demonstrate that this strategy was enabled by the WHO
Secretariat, which shifted its position in support of IP ‘rights’ as it sought to
remain a relevant organisation under neoliberalism. The Doha Declaration on
TRIPS and Public Health confirmed the presence of safeguards, but at the same
time it diffused a global norm that IP ‘rights’ are a prerequisite for medicines
R&D. In doing so, it legitimised the historical neglect of the specific health needs
of the global South as a logical outcome in the absence of patent monopolies.
Following the announcements by CIPLA to supply generic ARVs, the United
States appeared to soften its stance in Africa and subsequently withdrew its
formal support for the pharmaceutical litigation against South Africa. In
December 2000, President Clinton issued a Presidential Executive Order on
HIV/AIDS which declared that the US would not pressure sub-Saharan African
countries to revise their IP laws with respect to the regulation of HIV/AIDS
medicines (Paragraph 1(a) Clinton 2000a). This order was largely rhetorical,
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however, because it did not prohibit US officials from ‘consulting’ sub-Saharan
African governments over their IP laws (Section 3(a) Clinton 2000a). Indeed, it
presented a strategy by the US to absorb the developing country and NGOs claims
for ‘public health safeguards’ within its broader push for the enforcement of
strong intellectual property protection for medicines.
In response to the threat of CIPLA’s generic ARV, Clinton proclaimed that sub-
Saharan African countries could implement ‘flexibilities’ while at the same time
ensuring that ‘fundamental intellectual property rights of US businesses and
inventors’ are protected (Clinton 2000b). In parallel, however, the USTR released
its annual Special 301 report, which maintained India on its annual Priority Watch
List. The rationale for including India was because ‘although not required to do so
under the TRIPS Agreement until 2005, India has yet to provide patent protection
for pharmaceutical and agricultural chemical products’ (Office of the United
States Trade Representative 2000). Inclusion on the Priority Watch List signalled
impending trade sanctions as a punitive measure. Thus, while the US appeared to
soften its stance against Africa, where no generic firms developed ARVs, it
sought to prevent Indian generic firms from supplying more affordable life-saving
generics to Africa. International pharmaceutical firms also adopted a new strategy
after the WTO confirmed that ‘safeguards’ were consistent with TRIPS. The
PhRMA asserted that any governments which implemented ‘safeguard’ measures
were required under TRIPS to ensure compensation ‘equal to the market value of
the patent’, meaning the monopoly price (PhRMA 1999c). The international firms
used this claim to reject CIPLA’s request for voluntary licences based on an offer
of five per cent royalties (CIPLA 2000a).
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While in public the United States withdrew its support for the pharmaceutical
litigation against South Africa, in private the US intensified its collaboration with
pharmaceutical firms to pressure countries to adopt IP measures beyond those
required by the TRIPS agreement. In 1999 and 2000, at the request of the
PhRMA, the US pressured Israel to withdraw a proposed Act that would have
allowed parallel importation of medicines (Office of the United States Trade
Representative 1999, 2000; PhRMA 2000b)72. As part of this strategy, both the
USTR and PhRMA framed the alleged infringement of their ‘rights’ as
‘pharmaceutical piracy’ and ‘pirate production’ of ‘pirate products’ by ‘pirate
companies’ (Office of the United States Trade Representative 1999; PhRMA
2000c, 2000e; Sell 2003). The USTR and PhRMA positions were so closely
aligned that the USTR Special 301 report in 2000 mostly reflected complaints
raised by the PhRMA (Office of the United States Trade Representative 2000;
PhRMA 2000a, 2000b, 2000e, 2000f, see Appendix Three).
While developing country governments were under significant pressure by the US
and the industry, NGOs and CIPLA continued their resistance. In February 2001,
CIPLA announced on the front page of the New York Times that it would sell its
FDC ARV to MSF for only 350 dollars per patient per year (McNeil 2002). This
offer dramatically shifted perceptions in the international community about the
affordability of ARVs for the global South. Indeed, it appeared to indicate that the 72 The PhRMA also pressured several developing countries to weaken their essential medicines policies in this period. The PhRMA opposed Vietnam’s attempt to de-register several foreign pharmaceutical products in 1996, in which it convinced the US to require Vietnam to back down as part of US-Vietnam trade negotiations (PhRMA 1999c). PhRMA drafted a bill in Venezuela on the issue of generic promotion and substitution and pricing that was ‘positive’ for industry (PhRMA 2000d). It also pressured the governments of Japan and Taiwan to withdraw reference pricing schemes for pharmaceuticals (PhRMA 1999a, 1999b).
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writing was on the wall for the pharmaceutical industry in its corporate litigation
against South Africa.
A significant turning point in global medicines governance in this period was a
policy shift of the WHO in support of the private ‘rights’ of international
pharmaceutical firms, over the ambitions of the global South. In April 2001, two
months after the dramatic CIPLA price offer, the WHO organised the first
international meeting on financing essential medicines. The WHO was required to
jointly host the meeting with the World Trade Organization as mandated through
the Revised Drug Strategy. At the meeting, the WHO Secretariat promoted a new
partnership it had established with five international pharmaceutical firms that
offered low-income countries a reduced price on their ARVs (Brundtland 2001a;
Piot 2001; WHO 2001b: 1,2). This deal appeared to mimic that of the UNAIDS
partnership in 1997 (see above). The international firms called for recipient
countries to increase their patent protection and to reduce price controls on
medicines in exchange for the price reductions (Bale 2001; Hardwick [Senior
Vice President of Pfizer] 2001). At approximately 7000 dollars per patient per
year (WHO 2001b: 1,2), the ARVs were still out reach for a majority of PLWA
and were significantly more expensive than the generics produced in Brazil and
by Indian generic firms73.
The WHO ARV deal represented a policy shift in the WHO to promote
‘differential pricing’, by which international pharmaceutical firms offer tiered
pricing according to government income levels, as the ‘appropriate’ measure for
73 A Ugandan treatment centre shifted away from the WHO initiative to source cheaper generic ARVs through CIPLA (Schwatlander, Grubb and Perriens 2006).
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achieving affordable access to medicines in developing countries (Commission on
Macroeconomics and Health 2001: 114). NGOs opposed this shift and in the
WHO they continued to promote the safeguard measures like compulsory
licensing and parallel importation (Nader 2001; 't Hoen and Moon 2001).
Nonetheless, the WHO Director General Brundtland was convinced that the IP
system was a necessary ‘safeguard’ for the development of new medicines.
Indeed, Brundtland asserted that ‘WHO’s position is clear: intellectual property
rights must be protected. We depend on them to stimulate innovation’
(Brundtland 2000, 2001b).
This policy shift in the WHO was part of a broader move by Brundtland to re-
assert a role for the organisation in promoting economic development
(Commission on Macroeconomics and Health 2001; Lee 2009b: 114)74.
Brundtland, who was appointed on her credentials as Norway’s former Finance
Minister, was under significant pressure by donors to reform the organisation so
as to meet their interests (Lidén, 2014). In 2001 the WHO was over 20 million
dollars in deficit and the US had reduced its contributions to the regular budget
fund (Lee 2009b: 43). Brundtland commissioned a group of economists from the
World Bank, IMF and American universities to create a new vision for the role of
the WHO. This Commission worked closely with international pharmaceutical
firms and adopted the language of intellectual property ‘rights’ as a necessary
prerequisite for the development of new medicines (Commission on
74 The Commission reflected the turn to ‘selective’ primary health care (SPHC) (see Chapter three). For example, while the Commission acknowledged that sanitation, water and agricultural investments were important, it saw these as existing outside the health sector (Commission on Macroeconomics and Health 2001: 10).
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Macroeconomics and Health 2002: 84, 14)75. Indeed, the Commission ignored the
Brazilian and Indian generic developments and instead promoted differential
pricing by international pharmaceutical firms as the most appropriate mode of
governance for meeting the health needs of the global South.
This shift in the WHO was a blow to the ambitions of NGOs and several
developing countries to elevate health needs over IP ‘rights’. As a consequence,
many developing countries forum-shifted back to the WTO, which had appeared
more receptive to their vision of ‘safeguards’ than the WHO. In June 2001, the
Africa group (member states of the African region) requested a special session of
the WTO on access to medicines. At the session Zimbabwe submitted a draft
resolution on behalf of a large group of developing countries, which asserted that
‘nothing in the TRIPS Agreement should prevent Members from taking measures
to protect public health’ (Consumer Project on Technology et al. 2001;
Submission by the Africa Group et al. 2001). In the subsequent deliberations,
India made the case for local medicines production within a broader context of
unworked patents. This claim was broader than public health, and it resembled
that of the earlier demands of developing countries in the 1970s under the New
International Economic Order (see Chapter two). The US and Switzerland
vehemently opposed India’s proposal, however, slamming such an ‘industrial
development policy’ as inconsistent with TRIPS (Consumer Project on
Technology et al. 2001). This demonstrated that the discourse of public health
safeguards was narrower than the NIEO, in which UNCTAD (1975) had
75 The Commission even suggested that high-income countries extend intellectual property protection and exclusivity ‘rights’ beyond the requirements of TRIPS (Commission on Macroeconomics and Health 2002).
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cautioned governments against solely relying on measures like compulsory
licensing because of longstanding issues over technology transfer76.
In the draft resolution at the WTO, the US and its allies demanded that text be
inserted alongside Zimbabwe’s that ‘patents are important for public health
policies because they provide incentives for research and development into new
drugs…TRIPS is part of the solution and not part of the problem of meeting
public health crises in poor countries’ (WTO TRIPS Council 2001; Zoellick
2001). In this way the discourse of safeguards was absorbed within the broader
push for IP ‘rights’. In December that year the member states of the WTO finally
agreed to the Doha Declaration on TRIPS and Public Health:
Recognising that intellectual property protection is important for the
development of new medicines (paragraph 3 WTO 2001)…We agree that
the TRIPS agreement does not and should not prevent members from
taking measures to protect public health…we affirm that the Agreement
can and should be interpreted and implemented in a manner supportive of
WTO Members’ rights to protect public health and, in particular, to
promote access to medicines for all (paragraph 4, WTO 2001)77.
Through this Declaration, governments confirmed and extended a global norm by
which IP ‘rights’ were required for the development of new medicines. In doing
so, they legitimised the historical neglect of the specific health needs of
developing countries as a logical outcome due to the absence of IP protection.
76 In 1997 UNCTAD offered a weak assessment of TRIPS, merely cautioning developing countries for ‘balance’ (UNCTAD Secretariat 1997). 77 The Declaration also extended the deadline for TRIPS implementation with respect to patents for medicines for least-developed countries to 1 January 2016 (WTO 2002).
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After the Doha Declaration, the group of international pharmaceutical companies
finally withdrew their corporate litigation against South Africa (Love 2011b).
Conclusion This chapter has examined developments in global medicines governance which
led to the World Trade Organization’s Doha Declaration on TRIPS and Public
Health. I have argued that the global norm for IP ‘rights’ in medicines R&D was
strengthened. AIDS emerged on the global agenda through a discourse of AIDS
exceptionalism. In the late 1990s, corporate litigation against South Africa
became a core conflict by which NGOs, generic pharmaceutical firms and
developing countries asserted a discourse for ‘public health safeguards’ which
enabled them to reassert health needs against patent ‘rights’. The production of
generic HIV/AIDS antiretrovirals in India was a significant turning point which
forced the United States and international pharmaceutical industry to respond to
the demands of this informal coalition and advocacy network. The chapter has
shown, however, that the United States and international pharmaceutical industry
co-opted this counter-discourse by framing IP ‘rights’ as a safeguard for new
medicines. The World Health Organization enabled this co-option by siding with
international firms as it sought to reclaim its authority under neoliberalism. The
chapter has also highlighted the increasing power and influence of non-state
actors in global medicines governance. International pharmaceutical firms exerted
significant material power through corporate litigation and their influence on
governments and the World Health Organization. They were met with resistance
by health advocacy NGOs, which demonstrated discursive power through their
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role in agenda setting, information-sharing, issue-linkage and coalition-building.
The Indian generic firm CIPLA also exerted its own form of material power
through its generic production of ARVs. This resistance was no match, however,
for the power of the industry, which influenced the international forums through
which governments negotiated global rules and norms that were favourable to the
industry.
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C H A P T E R F I V E
Counterfeits, Regulation and IP
This chapter examines the globalisation of regulatory requirements for medicines
and the diffusion of intellectual property ‘rights’ in global medicines regulatory
initiatives in the 1990s and 2000s. The chapter demonstrates that shifts in the
global governance of medicines in this period facilitated the enforcement of
intellectual property ‘rights’ under the aegis of the WHO through an International
Medicines Product Anti-Counterfeiting Taskforce (IMPACT). The chapter shows
the pharmaceutical industry and its proponents diffused a discourse of
‘counterfeits’ that enabled the conflation of the health-regulation for medicines
with the enforcement of intellectual property (IP).
Effective medicines regulation serves a public health function by ensuring that
medicines are of good quality, are safe and are distributed correctly (WHO
2014a). This chapter argues that in the 1990s and 2000s, the international
pharmaceutical industry and its proponents played a key role in raising minimum
international regulatory standards, beyond mere health and safety benefits, as part
of their strategy to block foreign competition from generic firms. I situate the
creation of the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, the
WHO’s pre-qualification program and the United States bilateral aid program for
HIV/AIDS within this strategy and the broader historical struggle over the
production and supply of medicines. In this broader context, the chapter shows
that Nigeria emerged as a global advocate for the industry-led IMPACT in the
WHO. Since the early 2000s, Nigeria and its generic firms have targeted India
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and China as the source of ‘counterfeits’ as part of their domestic strategy to
facilitate local production. In doing so, Nigeria and many African countries have
become unofficial allies with the United States and the pharmaceutical industry at
the international level through their support of IMPACT. The chapter shows that
Nigeria’s support for IMPACT has created a division in the global South over the
WHO’s role in this initiative and the terms in which to address the public health
problem of substandard medicines. This has enabled the pharmaceutical industry
to continue to pursue the enforcement of IP in IMPACT and has delayed effective
global governance to address the problem of lack of capacity to regulate
medicines in the global South.
The chapter draws on an analysis of summary records, resolutions and reports of
the governing bodies of the World Health Organization, United Nations
Children’s Fund (UNICEF), United Nations International Development
Organization (UNIDO), World Trade Organization, International Conference on
Harmonization of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH), International Medicines Product Anti-Counterfeiting
Taskforce (IMPACT), Group of 8, Global Fund to Fight HIV/AIDS, Tuberculosis
and Malaria, International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA), Federation of African Pharmaceutical Manufacturers
Associations (FAPMA), Nigerian National Agency for Food and Drug
Administration and Control (NAFDAC), MSF and CIPLA (see Appendix Two).
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Counterfeits, quality-assurance and the WHO This section demonstrates that the international pharmaceutical industry brought
the issue of ‘counterfeits’ onto the agenda of the WHO in the 1990s. This was a
strategy of the IFPMA to conflate the health-regulation of medicines with the
enforcement of IP through a discourse of ‘counterfeits’. The section shows that in
parallel to the emergence of this ‘counterfeit’ discourse in the WHO, the industry
also secured harmonised regulatory standards between the United States, Europe
and Japan in the International Conference on Harmonization. These actors then
sought to promote these industry-led standards as de facto global standards
through the WHO.
The IFPMA first called on the WHO to ‘combat criminal counterfeiting’ at the
WHO’s Nairobi Conference on the Rational Use of Drugs in 1985 (see WHO
1985b). It was not clear at the meeting precisely what the IFPMA meant by
‘criminal counterfeiting’, but the industry was strongly opposed to the WHO’s
essential medicines policy (see Chapter two). A few years later, language to this
effect appeared in a World Health Assembly resolution which called on member
states to ‘cooperate with pharmaceutical manufacturers’ to detect and prevent the
exportation of ‘falsely labelled, spurious, counterfeited or substandard
pharmaceutical preparations’ (WHA41.16 [1988] in WHO 1993: 189). This
terminology was again undefined, but the resolution implicitly indicated different
issues facing regulators. A falsely labelled medicine, for example, is a different
issue to that of a medicine containing inadequate pharmaceutical ingredients,
though the two can be related. Indeed, the IFPMA strategically used this lack of
definition to conflate public health matters related to poor-quality medicines with
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the protection and enforcement of intellectual property (see IFPMA in WHO
1992: 5).
The enforcement of IP was a clear objective of the IFPMA and its proponents at
the first international meeting on ‘counterfeit drugs’ held jointly by the IFPMA
and WHO in 1992. In attendance were representatives of the International
Criminal Police Organization (INTERPOL), World Customs Organization (then
Customs Cooperation Council), International Narcotics Control Board, General
Agreement on Tariffs and Trade (GATT), and member states principally from the
North (WHO 1992). At the meeting, the IFPMA framed counterfeiting as an IP
issue that deprived ‘the manufacturer of his just rewards’ (cited in WHO 1992: 5).
Indeed, representatives of the IFPMA suggested that the WHO call on national
regulatory agencies to block the registration of ‘legitimately marketed products’
that ‘may be confused with established products based on superficial appearance
of the trademark’ (WHO 1992: 8). The GATT delegation presented the TRIPS
agreement, then still under negotiation in the GATT, as a solution that would
enable private companies to enforce their trademarks through the seizure of
suspected counterfeits (WHO 1992).
The WHO’s final report of the meeting also conflated quality-assurance and IP by
attributing the causes of ‘counterfeiting’ to poor regulation, lack of access to
medicines and poor IP protection (WHO 1992: 11-12). This conflation was also
evident in the WHO’s subsequent definition of counterfeits that was shaped by
the IFPMA:
a counterfeit is deliberately and fraudulently mislabelled with respect to
identity and/or source. Counterfeiting can apply to both branded and
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generic products and counterfeit products may include products with the
correct ingredients or with the wrong ingredients, without active
ingredients, with insufficient active ingredient or with fake packaging
(WHO 1993: 1).
Less than two years later, the TRIPS agreement defined counterfeits as goods that
infringed upon trademark ‘rights’ (Article 51, WTO 1994). The conflation of IP
with health-regulation subsequently emerged in many studies on ‘counterfeit
medicines’ which did not differentiate between substandard registered medicines,
fake unregistered medicines, and medicines alleged to infringe upon IP ‘rights’
(Shakoor, Taylor and Behrens 1997: 840). This conflation also emerged in
legislation in several countries. In 1996 the Philippines introduced a law on
counterfeit medicines in response to these developments in the WHO and GATT.
This law defined counterfeits as medicines with ‘insufficient quantities of active
ingredients’ alongside ‘medicines without authorization, trade mark, trade
name…or any likeness to that which is owned in the Bureau of Patent, Trademark
and Technology’ (WHO 1999a: 10). This reflected the view of the IFPMA, that
counterfeit medicines include those ‘close copies of the original that do not
appear to pose a hazard to health’ (cited in WHO 1996: 45).
In addition to bringing ‘counterfeits’ onto the agenda of the WHO, in this same
period the international pharmaceutical industry sought to use the WHO to
promote industry-led regulatory standards as de facto global standards. In the
early 1990s, the international pharmaceutical industry secured the support of the
regulatory agencies of the United States, European Commission and Japan to
harmonise their technical standards for the approval and registration of new
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medicines (ICH 2010: 7)78. This harmonisation was premised on the rationale that
it would lead to improved efficiency, reductions in costs and drug approval times,
and facilitate access to medicines (Vogel 1998: 10). Indeed, the industry push for
harmonisation was enabled by the advocacy of AIDS groups in the United States
in this period, who mounted a campaign against the US FDA for perceived
lengthy delays in approving potential life-saving medicines (Carpenter 2010; see
Chapter four)79.
The International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) was created in 1991
between the regulatory agencies of the US, EC and Japan and the national and
regional associations of the IFPMA (ICH 2010). By the late 1990s, the
pharmaceutical industry had driven the negotiation of 45 technical ICH
guidelines, which included efficacy testing such as clinical trial design, clinical
safety and good clinical practice, quality testing such as stability testing,
impurities and pharmacopoeia, and safety testing (Trouiller et al. 2002b: 146).
These were of a ‘high scientific level…using state-of-the-art-technology’ (WHO
2000). Many of these standards were not evidence based, nor did they
demonstrate additional health and safety benefits (WHO 2000). Guidelines on
clinical trials, for example, promoted placebo-controlled trials rather than
assessing efficacy against a comparator medicine. As Trouiller et al. (2002b: 148)
point out, this method is an ‘inflationary way of promoting pseudo innovator
78 In 1992 the European Commission established a centralised application procedure for the registration of biotechnology and innovator products amongst its member states, the European Medicines Evaluation Agency (EMEA) (Braithwaite and Drahos 2000: 370). 79 In 1989 the FDA allowed people living with AIDS a ‘personal use exemption’ to import medicines for personal use if they had been approved by another regulatory agency, such as Europe (Vogel 1998: 10). In 1992, the FDA began to charge ‘user fees’ to pharmaceutical firms which coincided with a reduction in drug approval times.
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medicines or me-too drugs’. While the ICH process initially applied to the
registration of new medicines, the EU subsequently required that all products
registered in the EU meet many of the ICH standards (WHO 2002d: 1). Indeed,
the ICH countries and firms began to promote the industry-led standards as de
facto international standards (ICH 2010; WHO 2002d: 13)80.
The WHO, which was an observer of the ICH Steering Committee, subsequently
became a member of the ICH Global Cooperation Group, without the approval of
its governing bodies (WHO 2000). The WHO shared the contact details of its
national information officers with the ICH Secretariat, which was based at the
headquarters of the IFPMA (WHO 1996). The WHO also revised its Good
Clinical Practice guidelines (GCP) in light of the ICH requirements (WHO 2002d:
19). The United States, Europe and Japan subsequently used the WHO’s
International Conference of Drug Regulatory Authorities (ICDRAs), which had
been established jointly between the US FDA and WHO, to promote global
adoption of the ICH standards (WHO 1996, 1999a: 15).
India and Brazil led a group of developing countries that became critical of the
WHO’s involvement in the ICH, in particular in the absence of approval from the
governing bodies and in light of the industry-led standards. In 1999 the WHO
subsequently established an independent review of WHO’s role in the ICH (WHO
2000: 145). This independent review found that most of the ICH guidelines were
not founded on evidence and did not demonstrate additional health and safety
benefits, but did contribute to significant costs for manufacturers (WHO 2002d: 80 In recent years, Pfizer representatives have called on middle-income countries to ‘harmonise’ their regulatory requirements within a discourse of improving access to medicines by reducing ‘drug delays’ (Wileman and Mishra 2010).
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21). ICH Q3A ‘Impurities in new drug substances’, for example, was not
premised on evidence of additional safety benefits81. Indeed, the review raised
‘serious concerns’ that if the ICH guidelines became global standards, local
manufacturing in developing countries could be ‘squeezed out’ (WHO 2000:
145). Remarkably, despite these findings, the review panel ultimately
recommended that the WHO establish mechanisms to review, modify and/or
adopt ICH standards as WHO guidelines (WHO 2000).
The WHO, Global Fund and PEPFAR This section demonstrates that the Global Fund to Fight HIV/AIDS, Tuberculosis
and Malaria, the WHO pre-qualification program and the United States bilateral
aid program for HIV/AIDS were part of a broader global struggle over the
production and supply of medicines. I argue that the catalyst for these
developments was the production of generic HIV/AIDS ARV’s in India. I argue
that the United States forum-shifted to its unilateral aid program, PEPFAR, as
part of a strategy to raise minimum international regulatory standards and block
competition from foreign generic firms.
In February 2001 the Indian generic firm CIPLA announced significant price
reductions for its new fixed-dose combination antiretroviral containing
lamivudine, stavudine and nevirapine (CIPLA and Médecins Sans Frontières
2001). This was a turning point in the battle over access to HIV/AIDS
antiretrovirals in the global South (see Chapter four). In the following month, the
81 ICH Q3A determines that a substance requires safety to be established if any ‘organic impurity’ is present in the amount of 0.1 per cent or more (in some cases 0.05 per cent) (WHO 2002d: 21).
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WHO launched a pilot pre-qualification program to assess HIV/AIDS medicines
against ‘international’ quality standards. The public rationale for this program was
that many developing countries did not have sufficiently-resourced national
regulatory authorities and were at risk of ‘substandard, counterfeit and/or
contaminated medicines’ (WHO 2001c). WHO also framed the program as a
potential strategy by which developing countries could resist the application of
‘unrealistic’ ICH standards that could block the supply of essential generic
medicines (WHO 2000: 149). Indeed, the WHO pre-qualification program
initially appeared to be a point of resistance to the industry-led ICH from
becoming de facto global regulatory standards.
In April 2001 international pharmaceutical firms began to publicly call for a
global fund to assist developing countries to procure essential medicines for
HIV/AIDS, tuberculosis and malaria (cited in Durman 2001). They were joined
by senior leaders in the United Nations organisations (see Abuja Declaration on
HIV/AIDS, Tuberculosis and Other Related Infectious Diseases 2001; Bellamy
2001). In June 2001, the United States and its allies in the Group of 8 announced
that they would launch such a fund for this purpose82. While the US and its allies
had initially opposed the idea of a fund in the late 1990s, the catalyst for this
policy shift appeared to be the development of cheaper Indian generic ARVs.
Shortly after the Global Fund announcements, in late 2001 a group of experts
designed the WHO pre-qualification program with the strongest requirements of
any national regulatory body at the time ('t Hoen et al. 2014). Manufacturers 82 The Group of 8 is a forum of the leaders of the United States, UK, Japan, France, Italy, Canada, Germany, and Russia which includes the EU (the EU does not have voting rights in the organisation).
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seeking pre-qualification from the WHO were required to comply with the newly
established WHO guidelines that included proof of bioequivalence for generics
(WHO N.D-a, 1998a)83. Manufacturers were directed to submit a dossier of data
on formulation, manufacturing, specifications, stability testing results, labelling,
patient information, interchangeability, pharmacology, toxicology, efficacy, and
sites of manufacture. Upon a successful application, the WHO subsequently
inspected manufacturers for their compliance with Good Manufacturing Practices,
sampled and tested drugs, and examined storage and distribution (WHO 2001c).
In early 2002 it became clear that the transitional working group of the Global
Fund was advising developing countries that only patented HIV/AIDS ARVs
would be eligible for procurement through the fund (Médecins Sans Frontières
2002a)84. This appeared to be based on an assumption that medicines which had
not been assessed by the regulatory authorities of the ICH were at risk of being
poor quality ('t Hoen et al. 2014). Indeed, this was the line advanced by IFPMA,
which released several ‘studies’ framing Indian generics as substandard and of
poor quality in this period (McNeil 2002). This policy contradicted the
longstanding practice of UNICEF, which had procured essential medicines
through the WHO’s Good Manufacturing Practices (GMP) for decades without
issue (CIPLA and Médecins Sans Frontières 2001; UNICEF 2000, 2013). Indeed,
by 2000 Indian generic firms were the largest suppliers to UNICEF (UNICEF
83 Two pharmaceutical products are bioequivalent ‘if they are pharmaceutically equivalent and their bioavailability after administration are similar to such a degree that their effects can be expected to be essentially the same’ (WHO 1998a). 84 The Global Fund was created as a mechanism for distributing aid, which comes mainly from governments. The Board of the Fund allocates aid to organisations for the procurement of medicines once they are approved by local ‘Country Coordinating Mechanisms’ that are local boards of the Fund in-country. Eligible countries are assessed according to income level, disease burden, and G20 membership (The Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria N.D-b).
129
2000; 5). CIPLA had also received FDA approval for its manufacturing facilities
in 1985 (CIPLA N.D). This suggests that the proponents of the fund were
requiring higher ICH regulatory standards as a strategy to block the procurement
of Indian generics.
In addition to this strategy, the transitional working group of the Global Fund was
unclear on whether recipient countries could use funds to import medicines
produced under compulsory licences in other countries. While the Doha
Declaration had recently clarified the use of ‘public health safeguards’ under
TRIPS, the agreement required that such safeguards be used ‘predominantly for
the domestic market’ (Article 31f-WTO TRIPS Council 2001). In ongoing
negotiations in the WTO, developing countries, NGOs and generic firms were
fighting to expand the terms of use of safeguards for countries with little
manufacturing capacity, which the United States opposed (Medpro Pharmaceutica
2002; Muzaka 2011: 94; 't Hoen 2009; 't Hoen & Chirac 2002). This struggle was
prominent on the global agenda throughout 2001 and 2002, which detracted from
the issue of medicines regulation. Nonetheless, MSF responded to the industry
claims of poor-quality Indian generics by forming its own pre-qualification
program. In 2001 and 2002 MSF sent its own pharmacists and experts to
manufacturers in India and Brazil to assess HIV/AIDS ARV product dossiers and
manufacturers according to the WHO’s Good Manufacturing Practices, and
subsequently published a guide to ARVs (Médecins Sans Frontières 2002c;
Médecins Sans Frontières, World Health Organization and UNAIDS Secretariat
2003).
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In March 2002, the WHO released its first list of pre-qualified HIV/AIDS
medicines which included 36 products, five of which were generics produced by
CIPLA (WHO N.D-e)85. The NGOs called on the Global Fund to recognise the
WHO pre-qualification program and the pre-qualified ARVs (Health GAP
Coalition 2001; Médecins Sans Frontières 2002c). The Global Fund subsequently
established a formal policy that it would only procure medicines that were pre-
qualified by the WHO or by one of the ICH countries (Waning et al. 2010).
UNICEF also changed its policy to require approval by WHO or one of the ICH
countries for the procurement of ARVs and anti-malarials (UNICEF 2011; WHO
N.D-f). In addition, the newly-created Global TB Drug Facility also required
WHO or ICH-country approval for TB medicines for national tuberculosis
programs (Matirua and Ryana 2007)86.
In early 2003 the United States shifted its funding for HIV/AIDS to a unilateral
initiative, the President’s Emergency Plan for AIDS relief (PEPFAR). This policy
shift was in part shaped by a strategy to secure the WHO pre-qualification
program as a ‘floor’ for global regulatory standards, and to maintain the
monopoly of international firms in the supply of ARVs procured through
PEPFAR. The new entity was endowed with 15 billion dollars in its first five
years, making it the largest government aid program for health in history. This aid
was targeted at 15 African countries for the treatment and care of people living
with AIDS (The Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria
2003: 17).
85 In the case of antimalarials, Novartis received a monopoly on pre-qualification until the WHO finally pre-qualified Chinese and Indian generic antimalarials in late 2005 (WHO 2013c). 86 The Global TB Drug Facility was established in 2001 to distribute medicines for tuberculosis.
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The US Global AIDS program that hosted PEPFAR determined that it would only
procure ARVs that had been approved by ICH countries (United States General
Accounting Office 2004; Venkatesh, Mayer and Carpenter 2012; Waning et al.
2010: 7). The Director of the program, Randall Tobias, framed his decision as one
based on scepticism of the safety of the WHO pre-qualification program: ‘maybe
these drugs are, in fact, exact duplicates of the research-based drugs. Maybe they
aren’t. Nobody really knows’ (cited in Associated Press in Dyer 2004)87. This
position was also promoted by the international firms, and the IFPMA publicly
claimed that the WHO pre-qualification of generics could ‘spread the current
plague of substandard and counterfeit medicines’ (IFPMA cited in McNeil 2002).
This scare tactic preserved the monopoly of originator firms through PEPFAR
because the US FDA practiced patent linkage, meaning that the FDA would not
approve generic versions of medicines that were patented in the United States
(Ferriter 2007; see Chapter three).
It was around this time that the United States finally agreed to expand the terms of
‘safeguards’ for countries with little manufacturing capacity in the World Trade
Organization. This was only negotiated, however, after the US collaborated with
international pharmaceutical firms to strike an informal agreement with a number
of countries that they would only use the safeguards in the case of emergencies
(WTO 2003). This paralleled announcements by the Global Fund that it would
require recipients to comply with international trade agreements (The Global
Fund to Fight HIV/AIDS, Tuberculosis and Malaria 2003: 17).
87 Tobias was previously CEO of the international pharmaceutical firm Eli Lilly (Bristol 2006).
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The US PEPFAR policy was not popular in the international community because
it slowed progress on the WHO’s plan to increase ARV treatment coverage to an
additional three million people by the end of 2005 (WHO/UNAIDS 2006). It was
also increasingly untenable after academic experts and NGOs released studies in
early 2004 that demonstrated the effectiveness of CIPLA’s generic FDC through
clinical trials conducted in Cameroon and southern India (Kumarasamy et al.
2005; Laurent et al. 2004). In March 2004, staff of the WHO revealed that the
FDA had approved originator FDCs on the basis of bioequivalence without the
need for clinical trials (Rago 2004: 13). This called into question the assertion of
the industry and the FDA that the WHO pre-qualification program should require
clinical trials for the generic FDC ARVs ('t Hoen et al. 2014). Nonetheless, to
secure higher regulatory norms through the WHO, the United States continued to
call into question the WHO pre-qualification program and created its own
‘review’ process in the FDA to tentatively approve generic ARVs for use in
PEPFAR programs (Office of the US Global AIDS Coordinator 2005). This was
in parallel to a policy change in UNICEF by which the organisation began to
require recipient countries to provide the patent status of ARVs ‘according to
international and national law’ (UNICEF 2011: 6). This was a first in UNICEF’s
history and demonstrated the diffusion of IP ‘rights’ as a global norm in the UN.
In August 2004, the WHO temporarily withdrew three Indian generic ARVs from
its pre-qualification list. This followed reported ‘discrepancies’ in bioequivalence
data submitted by the independent contract research organisations (CROs), and
their lack of compliance to the WHO’s Good Clinical Practices and Good
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Laboratory Practices (WHO 2004a)88. These withdrawals sent a wave of panic
across the international community and led MSF and others to temporarily
suspend its supply of these ARVs ('t Hoen et al. 2014). At issue was not that the
ARVs were a threat to health. Indeed, both CIPLA and Ranbaxy (the firms
affected) contracted new CRO’s to conduct bioequivalence studies and the ARVs
were subsequently pre-qualified by the WHO (WHO 2004b, 2005b). The damage
was done, however, and the tentative withdrawals served to support the US scare
campaign. The US FDA subsequently took over two years to approve CIPLA’s
FDC (Raaj 2013: 61)89.
Counterfeits and Nigeria This chapter has so far demonstrated that in the 1990s and early 2000s, the
pharmaceutical industry and its proponents played a key role in raising minimum
international regulatory standards by forum-shifting between the WHO, Global
Fund, and PEPFAR. In addition, the industry brought the issue of ‘counterfeits’
onto the agenda of the WHO as part a strategy to conflate the health-regulation of
medicines with the enforcement of intellectual property. This section shows that
these developments contributed to additional barriers on medicine production in
the global South. It specifically focuses on Nigeria because in the early to mid-
2000s, the Nigerian government became a global advocate for international action
on ‘counterfeits’. The chapter argues that this move by Nigeria was part of a
88 By 2004, the WHO Secretariat was calling on member states to ‘meet international standards’ for quality assurance (WHO Secretariat 2003). 89 After the FDA finally approved generic ARVs, the price of originator ARVs began to drop (WHO/UNAIDS 2006: 21). There is no public information on whether PEPFAR has procured any Indian generics, what is known is that procurement from originator firms increased by 70 per cent after PEPFAR began to approve non-originator generics (WHO/UNAIDS 2006: 21). USAID finally accepted the WHO pre-qualification program in 2011 ('t Hoen et al. 2014).
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domestic strategy to facilitate local production. Nigeria and its generic firms
targeted India and China as the source of ‘counterfeits’ as part of their domestic
strategy, and in doing so they became unofficial allies to the United States and the
pharmaceutical industry at the international level. Nigeria is the focus of this
section because Nigeria is a key supporter of IMPACT, as shown in the final
section of the chapter.
As an oil-dependent nation, Nigeria was dramatically affected by the collapse in
oil prices in the early 1980s (Orubuloye & Oni 1996: 303, see Chapter three).
Like many developing countries, Nigeria was forced to adopt structural
adjustment reforms as a condition of IMF loans in the 1980s and 1990s that
dramatically altered the health system (see Chapter three). In 1984, the
government introduced user fees for health services, a first in Nigeria’s history
(Orubuloye and Oni 1996: 303). Government spending on health decreased
throughout the 1980s to less than two per cent of total government expenditure
(Popoola 1993). Infant mortality subsequently rose and the country became
dependent on donor funding for health (Orubuloye and Oni 1996; UNIDO 2011:
7). The devaluation of the Naira under structural adjustment led to a significant
increase in the price of medicines, and was met with the withdrawal of all major
international pharmaceutical firms from Nigeria by the late 1980s. This
transformed the drug distribution system that was previously organised through
wholesale distribution by the international firms (Peterson 2014: 132). Local and
Indian generic firms stepped in to fill the gap, but the system of distribution
shifted predominantly to unofficial markets.
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In 1989, over 100 children died in the Nigerian towns of Ibadan and Jos after
consuming a paracetamol syrup containing toxic ethylene glycol solvent instead
of propylene glycol (NAFDAC 2005). It is unknown whether the syrup was a
poor-quality legitimate medicine or an unregistered fake medicine. However, the
incident led to claims by Nigerian generic firms that half of all the medicines in
Nigeria were fake (cited in NAFDAC 2005)90. It was around this time that
Nigeria supported a WHA resolution on counterfeit medicines (see above). The
Nigerian government subsequently legislated its Counterfeit and Fake Drugs and
Unwholesome Processed Foods (Miscellaneous Provisions) Act (1990). This Act
established a Task Force on Counterfeit and Fake Drugs to enforce laws
prohibiting the manufacture, trade and sale of ‘counterfeit and fake’ medicines
(Mwalimu 2009: 477). In 1993, Nigeria established an independent National
Agency for Food and Drug Administration and Control (NAFDAC), shifting
regulatory authority out of the Ministry of Health due to perceived ineffectiveness
on combating fake medicines. While these moves were framed domestically in
terms of addressing public health, the World Trade Organization (WTO 1998)
asserted that the Nigerian government’s actions in this period were in response to
calls for better enforcement of intellectual property ‘rights’ in WTO Trade Policy
Reviews. Indeed, the Nigerian definition of counterfeits was broad enough to
encompass issues of IP, including ‘any drug or drug product which is not what it
purports to be….which label or container or anything accompanying the drug
bears any statement, design or device which makes a false claim for the drug or
which is false or misleading’ (Section 14 in Federation of Nigeria 1999).
90 Subsequent academic studies suggested that the core problem was not widespread fakes but poor quality-control in manufacturing (Taylor et al. 2001).
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By the late 1990s, Nigeria’s health care system was ranked the fifth poorest of all
member states of the WHO. HIV/AIDS, respiratory diseases and malaria were the
top three causes of mortality, and the country had the fourth highest prevalence of
tuberculosis in the world (UNIDO 2011). Nigeria had become reliant on donor
funding for health aid, and in 2002 through Global Fund resources the
government initiated one of the first free HIV/AIDS ARV programs in Africa
with supplies from CIPLA (Peterson 2014). Indeed, the Global Fund has provided
most of the funding for treatments for people living with malaria and tuberculosis
in Nigeria, with the country receiving over one billion dollars from the Fund (as
of 2009, UNIDO 2011: 12)91. Since 2003, the United States PEPFAR program
has also provided the largest contribution of funds for HIV/AIDS in Nigeria,
donating approximately 270 million dollars per year and supplying 83 per cent of
Nigeria’s ARVs (UNIDO 2011: 18). This increase in health aid has increased
access to some essential medicines in the country, but Nigerian firms have been
locked out of procurement through international organisations because they have
not yet secured WHO pre-qualification or approval from ICH countries92.
In the same period that the Global Fund and PEPFAR began to fund the
procurement of many essential medicines in Nigeria, the United Kingdom funded
the re-structuring of NAFDAC (PATHS2 2014). This aid enabled an expansion of
NAFDAC, including a refurbishment of laboratories and extended training for
regulators (Garuba, Kohler and Huisman 2009). The United States pharmacopeia
also provided financial support to NAFDAC, and the international firm Novartis
91 Despite this funding, TB prevalence tripled in Nigeria between 2002 and 2008 (UNIDO 2011). This was a reflection of the poor state of the public health system. 92 In the 1980s and 1990s UNICEF required manufacturers of essential medicines to meet WHO Good Manufacturing Guidelines, but they were not required to meet the stringent ICH standards that are now applied under the WHO pre-qualification program.
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began to fund training, stock management and drug distribution for malarial
programs in Nigeria and several other African countries (NAFDAC 2013;
Novartis 2012). This re-structuring was in parallel to the appointment of new
staff, including a new NAFDAC Director General, Dora Akunyili, who took a
strong stance on corruption in the agency and fired many other staff. Akunyili
also began a concerted public campaign against ‘counterfeit medicines’. The new
NAFDAC framed the problem of poor quality medicines in the country as a
problem of fake medicines and claimed that India and China were the source of
these ‘fake/counterfeit’ medicines (NAFDAC 2005). Indeed, India was ultimately
forced to respond to NAFDAC allegations by enabling NAFDAC officials to set
up a base in India to assess medicines for export to Nigeria before they left the
country (Raufu 2002, 2003)93.
NAFDAC’s campaign against Indian and Chinese ‘counterfeits’ intensified in the
mid-2000s as the government introduced laws to strengthen local production. In
2004 the government legislated Nigeria’s amended National Drug Policy (2004)
that aimed to secure local firms as the source of at least 70 per cent of the
country’s medicine needs by 2008 (UNIDO 2011: 1). At the time, capacity
utilisation of Nigeria’s 120 local pharmaceutical firms was less than 40 per cent
(UNIDO 2011: 41). Through the newly-formed Pharmaceutical Manufacturers
Group of the Manufacturers Association of Nigeria (PMG-MAN), local firms
called on the government to secure Nigeria as the ‘leading distributor and
manufacturer of essential medicines for Africa’ (cited in UNIDO 2011: 1)94.
93 In 2009 India introduced life imprisonment and China introduced the death penalty for individuals responsible for the export of substandard finished products to Nigeria and other countries (UNIDO 2011: 30). 94 Nigeria has the largest number of pharmaceutical companies in West Africa.
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NAFDAC subsequently required that importers produce drugs in Nigeria within
10 years of registration and introduced a ban on imports for several medicines that
were produced locally (NAFDAC 2005; UNIDO 2011: 49)95. NAFDAC
continued to accuse India as the source of ‘fake drugs’ and called on the WHO to
support Nigerian firms to secure WHO pre-qualification to ‘reduce the
importation of counterfeit medicines’ (NAFDAC 2005; Orhii 2013: 19). Under a
pharmaceutical production project sponsored by Germany, UNIDO (2011: iii)
also echoed these calls for Nigeria to support local firms ‘to reduce the
penetration of counterfeit products’. Indeed, Nigeria’s strategy appeared to be that
of targeting India and China as the source of ‘counterfeits’ to bolster local
production and secure pre-qualification for its generic firms.
At the 11th international conference of drug regulatory authorities in 2004,
Nigeria was a key advocate for an international convention on counterfeit
medicines (NAFDAC 2005). This meeting, hosted by the WHO, was principally
focused on the enforcement of intellectual property. INTERPOL, the World
Customs Organization and World Intellectual Property Organization reported on
extensive training provided to regulatory authorities on IP ‘crime’ and
enforcement (WHO 2004c: 11,13). WHO representatives confirmed that the
WHO definition of counterfeits ‘encompassed’ IP protection and enforcement
under TRIPS and called on member states to ‘implement and enforce anti-
counterfeiting legislation’ (WHO 2004c: 14).
95 This included tariffs of 50 per cent on medicine imports that local manufacturers had the capacity to produce (UNIDO 2011: 49).
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NAFDAC continued to promote action on counterfeits with a definition that
encompassed IP measures: ‘clones of fast moving drugs… [and] drugs with the
same quantity of active ingredients of the genuine brand’ (NAFDAC 2005).
NAFDAC (2005) claimed that the ‘counterfeit drug problem’ was due to
‘countries in Asia which have little regard for patent protection…companies may
be producing legitimate goods at one end of the factory and counterfeits at the
other’. This position brought NAFDAC into conflict with AIDS activists in
Nigeria, as Peterson (2014) observed at a conference on ARVs in 2005. At issue
was the parallel importation of medicines, a safeguard under TRIPS. NAFDAC
officials claimed that parallel importation would enable the importation of fake
drugs, while activists focused on the need to secure the provision of generics
(Peterson 2014: 136).
It is notable that while Nigeria championed an international convention on
counterfeit medicines premised on the enforcement of intellectual property, IP
laws in Nigeria remain ‘more or less non-existent’ (UNIDO 2011: 53). The WTO
has accused Nigeria of becoming ‘more protectionist’ in light of its legislations on
local medicines production (WTO 2005). Despite this criticism, Nigeria has not
faced any sanctions for non-compliance with TRIPS in the WTO. This may be
because Nigerian firms produce off-patent essential medicines and have not
secured WHO pre-qualification (UNIDO 2011: 1)96. A second explanation is that
WTO trade sanctions would hurt multinational oil companies that are the main
exporters of oil and gas from Nigeria (in joint ventures with the government),
which represent 90 per cent of Nigeria’s industrial activity (Peterson 2014).
96The local pharmaceutical manufacturing industry is currently able to meet 25 per cent of local demand for medicines (UNIDO 2011: 31).
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Counterfeits and intellectual property: IMPACT
In 2006, the WHO Secretariat began hosting an International Medicines Product
Anti-Counterfeiting Taskforce (IMPACT) that was principally driven by the
international pharmaceutical industry and its proponents to promote the
enforcement of IP ‘rights’. This section shows that Nigeria led a group of African
countries in blocking attempts by India, Brazil, and several developing countries
to disengage the WHO from IMPACT. This division in the global South enabled
the industry to continue to pursue IP through IMPACT, by conflating health–
regulation with IP through the ‘counterfeits’ discourse. Indeed, ongoing political
struggles in the WHO over both terminology and leadership delayed effective
global governance to address structural problems of a lack of capacity to regulate
medicines in developing countries.
The idea of an international convention on counterfeit medicines was first
proposed at the 11th international conference of drug regulatory authorities in
2004 (see above). In 2006, the WHO presented a draft proposal to the 12th
international conference of drug regulatory authorities that had been developed by
a private consultant and former advisor to the private sector, Michelle Forzeley
(WHO 2006b). The paper on which IMPACT was founded made the case for an
international taskforce on ‘counterfeit medicines’ to expand criminal punishment
for the ‘production, manufacture, sale, distribution, delivery, importation and
exportation of any counterfeit drug’ (WHO 2006b: 19). Counterfeiting was
vaguely defined as ‘a forgery: a copy or imitation…made without authority or
right’ (WHO 2006b: 6). Participants at the meeting, which included the IFPMA,
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INTERPOL and some regulatory authorities such as NAFDAC, called on WHO
to establish an entity along these lines (WHO 2006c).
IMPACT was formed later that year as a voluntary taskforce between
international firms, regulatory authorities, INTERPOL, the World Customs
Organization, WIPO and WHO. The WHO Secretariat agreed to co-ordinate
IMPACT and to provide one-third of the taskforce’s funds (WHO Secretariat
2008)97. The remaining two-thirds were donated by the European Commission,
Australia, Germany, Italy and the Netherlands. The WHO Secretariat also hosted
IMPACT in its ‘Health Technology and Pharmaceuticals Cluster’ at the WHO
headquarters in Geneva and agreed to disseminate IMPACT reports and
documents with official WHO insignia (IMPACT 2006: 5). The WHO did not
seek the approval of its governing bodies, the Executive Board or World Health
Assembly when it established IMPACT (Legge et al 2014). Indeed, IMPACT
would operate in the WHO Secretariat for two years before it was placed on the
agenda of the governing bodies in 2008.
International pharmaceutical firms were key drivers behind IMPACT. The
Director General of the IFPMA was appointed chair of its technology working
group and was tasked with conducting workshops for medicines regulators to
facilitate ‘knowledge sharing’ between regulators and industry (IMPACT
Secretariat 2011: 42). The DG of the IFPMA was also responsible for creating
and disseminating an ‘information checklist’ for regulators to assist in
97 That same year when WHO member states sat to appoint a new Director General, the Under Secretary of the United Nations emphasised the need for WHO to combat ‘counterfeit drugs’ (WHO 2006f: 12).
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determining the authenticity of medicines. The European Federation of
Pharmaceutical Industries and Associations (EFPIA) drafted a revision of the
WHO’s Good Distribution Practices for Pharmaceutical Products, that
emphasised close relationships between customs agencies and regulatory
authorities and the seizure of suspected counterfeits (IMPACT 2008; WHO
2009b: 10). These were later presented to the World Health Assembly by the
WHO Secretariat as the work of ‘IMPACT’, obfuscating the role of the IFPMA.
IMPACT operated for two years out of the public spotlight and without the
knowledge of several member states. In this period, reference to ‘counterfeits’ re-
emerged on the agenda of the governing bodies of the WHO. At the WHO
Executive Board meeting in 2007, Liberia and Kenya voiced separate concerns
that ‘counterfeit medicines’ were a threat to health (WHO 2007a: 203; WHO
2007h: 62). The EU and Switzerland subsequently secured language in a WHA
resolution on malaria that called on member states to ‘implement policies that
prohibit the production, marketing, distribution and the use of counterfeit
antimalarial medicines’ (EB120.R16 [2007] in WHO 2007a: 123; WHA60.18
[2007] in WHO 2007g: 76). This was met with calls by the United States for the
WHO Secretariat to promote action on ‘counterfeiting’, which was re-affirmed by
the Assistant General of the WHO (WHO 2007h: 68, 72). Text in a resolution on
‘Health Technology’ was also proposed by the WHO Secretariat, which called on
member states to ‘fight against counterfeit medical devices’. This was
subsequently removed, however, after Bahrain questioned the conflation of
counterfeits with intellectual property (EB120.R21 [2007] in WHO 2007a: 308).
The UN International Narcotics Control Board also called on member states to
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combat ‘counterfeiting of medicines and their distribution’ in an obscure WHA
agenda item on Cervical Cancer (WHO 2007h: 287).
At the 2008 World Health Assembly, Nigeria on behalf of the Africa group,
called on member states to establish and enforce legislation on counterfeit
medicines and support IMPACT (WHO 2008c: 116)98. Now in the public
spotlight, India and the South-East Asian region of member states and several
South American member states criticised the initiative as an agency for
intellectual property protection (WHO 2008c). Speaking at the meeting, the
IFPMA attempted to refute this critique by arguing that counterfeiting was not a
matter for ‘patents’ (cited in WHO 2008c). Outside the WHO, however, Pfizer
was urging the US Senate Finance Committee to negotiate an ‘anti-counterfeiting’
agreement ‘to defend IP protection around the world’ (Kindler 2008: 6).
Indeed, the Organisation for Economic Cooperation and Development (OECD)
issued a report on the ‘economic impact of counterfeiting and piracy’ in this
period, which clearly framed the IMPACT initiative as a governance mechanism
to enforce and protect intellectual property (OECD 2008)99. This report outlined a
rationale for the protection and enforcement of trademarks to extend monopolies,
because ‘trademark duration is typically longer then patents’ (OECD 2008: 356).
The OECD report also focused on alleged IP infringements of active
pharmaceutical ingredients (APIs) in India (OECD 2008: 346). Not long after the
report was issued, the WHO introduced the pre-qualification of APIs using
98 At the previous Executive Board meeting the U.A.E and Tunisia had requested an agenda item on IMPACT for the WHA (WHO 2008a: 171). 99 IMPACT defines ‘counterfeits’ as ‘when there is a false representation in relation to identity and/or source…including any misleading statements with respect to name…or marketing authorisation holder’ (IMPACT Secretariat 2011: 53).
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stringent industry-led ICH standards (such as Q3A) that were not based on
evidence of additional health and safety benefits (WHO 2001c, 2013b) (see
footnote 79 on page 124). This suggests that the WHO pre-qualification of API’s
was not principally driven by concerns over public health quality matters, but
rather IP considerations. This conflation has appeared more recently in the United
States Trade Representative’s 2014 Special 301 Watch Report (Office of the
United States Trade Representative 2014: 20) which alleges that IP-infringing
‘counterfeit’ medicines are made with API’s that are ‘not made according to
Good Manufacturing Practices’100.
A turning point which brought IMPACT onto the public agenda was in late 2008
when Kenya introduced an Anti-Counterfeiting Act that threatened access to
generic medicines. The Kenyan Ministry of Industry introduced an Anti-
Counterfeiting Act which outlined criminal measures against ‘counterfeiting’ and
contained a broad definition of counterfeits as:
the manufacture, production…or making, whether in Kenya or elsewhere,
of any good whereby those protected goods are initiated in such manner
and to such a degree that those other goods are identical or substantially
similar copies of the protected goods (Ngugi 2012: 19).
AIDS rights activists in Kenya initiated a lawsuit in response to the Act in the
High Court, claiming that it limited access to medicines and infringed upon
Kenya’s constitutional guarantee for the right to health (Ngugi 2012: 2). This
advocacy by AIDS rights groups informed a subsequent policy shift by the
100 WHO has increasingly aligned its regulatory standards with the ICH guidelines ‘wherever possible’ (Smid 2010; WHO N.D-h).
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Kenyan Ministry of Health, which dissented from the African group’s support for
IMPACT at the WHO. Speaking at the World Health Assembly, the Kenyan
delegation questioned the true intentions of IMPACT and WHO for allowing the
taskforce to use official WHO insignia (WHO 2010c)101.
In addition to this apparent conflation of IP and public health, in this same period
customs authorities in the Netherlands seized at least 17 shipments of legitimate
generic medicines in transit from India to Brazil, Peru, Columbia, Ecuador,
Mexico, Portugal, Spain and Nigeria, on the alleged grounds of suspected
counterfeiting (Mara and New 2009; Shashikant 2009). It was apparent that
customs agencies were acting on the complaints of international firms. India and
Brazil led a group of developing countries in protesting the seizures, and they
were supported by the health advocacy NGOs (Third World Network 2010).
Brazil criticised the seizures at the subsequent WHO Executive Board in 2009 but
was met with protest from the European Commission, which argued that the
WHO was not an appropriate forum for discussions of ‘trade disputes’ (WHO
2009a). Yet at the World Trade Organization two months later, the European
Commission framed the seizures on the grounds of protecting public health (cited
in Mara and New 2009)102.
These developments led to intensified efforts by the South-East Asian and South
American blocs at the WHO to remove IMPACT (WHO 2009a, 2009e, 2010c).
101 The Ministry of Industry had legislated the Act without consulting the Ministry of Health (WHO 2010c). Four years later in 2012 the High Court of Kenya ultimately agreed with the AIDS groups that the Act could threaten access to medicines and required revisions to remove discrepancy (Ngugi 2012). 102 India and Brazil initiated informal dispute settlement with the EU at the WTO in May 2010, which was withdrawn in 2011 (Press Information Bureau Government of India 2011).
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The new WHO Director General, Margaret Chan, attempted to distance the
organisation by claiming that WHO only participated in IMPACT ‘in the public
health dimension’ (WHO 2009d: 59). At the request of Thailand, Chan
commissioned an external review of the activities of IMPACT and potential
conflicts of interest in the organisation, yet the report of this review was never
publicly released (WHO Director General 2011). Despite the efforts of several
developing countries, the WHO did not disengage from IMPACT. This was
because Nigeria and the Africa group (excluding Kenya and South Africa) refused
to support the South- East Asian and South American countries (WHO 2010c).
Indeed, the new NAFDAC Director General, Paul Orhii, claimed that IMPACT
was not about IP:
I cannot see how fighting counterfeits can negatively affect generics…this
public health topic has become the victim of another debate…on trade and
intellectual property that is certainly legitimate but that should take place
in other fora…and not affect our efforts aimed at protecting public health
from the threat of counterfeits (IMPACT Secretariat 2011: 5).
Nigeria’s refusal to disengage WHO from IMPACT is the result of a structural
problem in global medicines governance in which African firms have been locked
out of supplying many essential medicines to their populations. Indeed, Kenya’s
main pharmaceutical firm Cosmos and Ghana’s Danadam are reportedly
compliant with the WHO’s Good Manufacturing Practices, yet they have been
unable to secure WHO pre-qualification because it requires more stringent
regulatory standards and associated prohibitive costs (Osewe, Nkrumah and
Sackey 2008: 35, 37). Thus, while the WHO pre-qualification program was
initially conceived to prevent the ‘squeezing out’ of local firms in the supply of
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essential medicines, it has inadvertently become a barrier for generic firms in the
global South, particularly in Africa.
The WHO pre-qualification program has so far failed to address lack of capacity
in national regulatory authorities. This is because the WHO has received few
funds from donors for this purpose (WHO 2005a)103. In the absence of effective
national regulatory authorities, the WHO pre-qualification program is a bandaid
solution that does not address the issue of poor-quality and substandard medicines
in use in developing countries. Donors have selectively targeted bilateral aid to
regulatory authorities in Africa that appears to be offered in exchange for their
government support for IMPACT. The United States Agency for International
Development is presently funding sub-Saharan African government agencies to
implement ‘actions against counterfeit medicines’ (Office of the United States
Trade Representative 2014: 20). This has created a divide between Africa and
Asia and Latin America in the WHO104.
In addition to these barriers, the Global Fund has also prevented African firms
from supplying medicines to their populations, even when they have received
WHO pre-qualification. Zimbabwe’s main pharmaceutical firm Varichem finally
received WHO pre-qualification for its ARVs in 2010. It has been unable to
secure supply in the Global Fund, however, because its ARVs are priced higher
than some foreign generics (The Herald 2012). These higher prices are in part a 103 The WHO has also been unable to source sustainable funding from member states for its basic pre-qualification program ('t Hoen et al. 2014). 104 The United States Trade Representative (Office of the United States Trade Representative 2014: 20) continues to conflate the issue of quality-assurance with intellectual property via a discourse of ‘counterfeits’. The USTR has recently framed Brazil, China Indonesia, Peru, Russia and ‘especially India’ as the source of alleged pharmaceutical ‘counterfeits’ that create ‘consequences for health and safety’ (Office of the United States Trade Representative 2014).
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result of the Global Fund and other agencies requiring WHO pre-qualification of
API’s. The Board of the Global Fund has blocked attempts by some African
countries to procure locally produced ARVs that are more expensive than Indian
generics (United States General Accounting Office 2003: 31)105. This reflects the
tensions between the Fund’s finite resources on the one hand, and the need for
sustainable medicines production on the other. This tension also demonstrates an
emerging conflict between the South, namely India, China and African nations
over generic medicines production.
In light of these constraints, African manufacturers have recently launched the
Federation of African Pharmaceutical Manufacturers Associations (FAPMA),
which is founded on a critique of ‘unfair competition from Asian importers’ and
premised on a vision for an ‘African-based industry that would leave very little
room for infiltration by counterfeit and fake medicines’ (Federation of African
Pharmaceutical Manufacturers Associations N.D)106. This demonstrates that
African firms are putting pressure on their governments to support local
production by framing foreign generics as threats to public health. In the WHO,
this has translated into a stalemate between member states over appropriate
terminology to address the problem of ‘spurious, substandard, falsely labelled,
falsified, counterfeit medicines’ (referred to as SSFFC) (WHO 2011c)107. This has
105 In the Global Fund, the United States and its allies have nine seats compared to six seats for countries in the South. Non-state actors also have voting rights, including two NGOs, one private sector representative (currently Merck), and one private foundation (currently the Gates Foundation) (The Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria N.D-a, see more chapter seven). It is unclear if India or China would support efforts by African countries to change the Global Fund rules to enable the procurement of generics from African firms. 106 The IFPMA has funded African regulatory conferences since the mid-2000s. 107 While IMPACT eventually moved out of the WHO headquarters in Geneva, the WHO did not officially dissociate itself from IMPACT.
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delayed effective global governance to assist the global South in addressing the
public health problem of lack of capacity to regulate medicines.
Conclusion
This chapter has examined the globalisation of international regulatory standards
for medicines and the diffusion of IP ‘rights’ in global medicines regulatory
initiatives in the 1990s and 2000s. The chapter has demonstrated that the
international pharmaceutical industry and its proponents played a key role in
raising minimum international regulatory standards for medicines, beyond mere
health and safety requirements, as part of a strategy to block competition from
generic firms. The chapter has shown that the Global Fund to Fight HIV/AIDS,
Tuberculosis and Malaria, the WHO’s pre-qualification program and the United
States’ aid program PEPFAR, were part of this broader struggle over the
production and supply of medicines. This struggle principally focused on
HIV/AIDS ARVs and to a lesser extent medicines for malaria and TB, with other
conditions and medicines left somewhat on the periphery. The chapter has
demonstrated that the pharmaceutical industry brought the issue of ‘counterfeits’
onto the agenda of the WHO as part a strategy to conflate the health–regulation of
medicines with the enforcement of intellectual property. This has broader
implications for many diseases and medicines. The chapter has specifically
examined how these developments led to the government of Nigeria becoming a
global advocate for international action on ‘counterfeits’ in the WHO. Nigeria and
its generic firms have targeted India and China as the source of ‘counterfeits’ as
part of a domestic strategy to facilitate local production. In doing so, Nigeria and
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many African countries have become unofficial allies with the United States and
the pharmaceutical industry at the international level through their support of the
industry-led IMPACT. Nigeria has led a group of African countries in blocking
attempts by India, Brazil, and several developing countries to remove the WHO
from IMPACT. This has enabled the industry to continue to pursue IP through
IMPACT by conflating health–regulation with IP through the ‘counterfeits’
discourse. Indeed, ongoing political struggles in the WHO over both terminology
and leadership have delayed effective global governance to address public health
issues facing the global South.
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C H A P T E R S I X
Neglected Tropical Diseases, Partnerships and IP
This chapter examines the evolution of the global governance of medicines for
tropical diseases, culminating in the rejection of an R&D treaty in the WHO in
2012. The chapter demonstrates that product-development partnerships (PDPs)
have become the dominant mode of governance for the research and development
(R&D) of medicines for tropical diseases. This model principally serves to
reinforce global norms for the protection of intellectual property ‘rights’. Indeed,
the chapter argues that the creation of PDPs enabled the United States and its
allies to block an R&D treaty in the WHO that threatened to replace IP as a global
norm for medicines R&D.
The chapter shows that the plight of communities living with tropical diseases re-
emerged on the global agenda in the 1990s through the advocacy of Médecins
Sans Frontières (MSF) and a global network of activists and NGOs. These actors
contested the TRIPS rationale for IP ‘rights’ as a prerequisite for R&D to meet
the health needs of the South. They championed a counter-discourse that was
premised on conceptualising essential medicines as ‘public goods’. A core
proposal of the NGOs was that of a globally binding R&D treaty. This was
envisioned to catalyse the development of medicines for tropical diseases as
public goods, and create new norms for R&D that challenged the IP ‘rights’
system. Brazil, Kenya and many developing countries took up the NGO call for
an R&D treaty at the WHO in the mid-2000s. The chapter argues that this ‘public
goods’ discourse was the broader political context in which pharmaceutical firms
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and their proponents created product-development partnerships and the WHO
administered industry-donated drugs. Throughout the 2000s, international
pharmaceutical firms and NGOs forum-shifted between different partnerships, in
an attempt to establish their preferred norms for medicines R&D. While the turn
to partnerships resulted in industry participation in much-needed R&D for
tropical diseases, this shift ultimately contributed to the collapse of the R&D
treaty in the WHO. The chapter shows that the international pharmaceutical
industry gained privileged access to WHO ‘expert’ commissions in this struggle,
which embroiled the WHO in controversy and raised questions over its
independence.
The chapter draws on a critical analysis of summary records, reports and policy
statements of the governing bodies of the World Health Organization (WHO), UK
Commission on Intellectual Property Rights, WHO Commission on
Macroeconomics and Health, WHO Commission on Intellectual Property,
Innovation and Public Health, WHO Expert Working Group on R&D: Financing
and Coordination, WHO Consultative Expert Working Group on R&D: Financing
and Coordination, the Medicines for Malaria Venture (MMV), Drugs for
Neglected Diseases initiative (DNDi), Global TB Alliance, Medicines Patent Pool
(MPP), The World Economic Forum, IFPMA, Microsoft, MSF, and the Drugs for
Neglected Diseases network (see Appendix Two).
MSF and the drugs for neglected diseases network
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This section demonstrates that MSF played a key role in raising the issue of
medicines for tropical diseases back on the global agenda in the 1990s and early
2000s. MSF established a coalition of academics and activists who shared a
critique of IP ‘rights’ as a global norm for medicines R&D. These actors focused
on ‘neglected’ tropical diseases to champion a counter-discourse that was
premised on abandoning the patent monopoly system and de-linking the costs of
R&D from the price of new medicines. At the core of this counter-discourse was a
proposal for a globally binding R&D treaty in the WHO.
MSF was formed as an emergency medical relief organisation in the late 1970s
(Dodier 2011: 8)108. It expanded its operations in African and Asian countries
throughout the 1980s, coinciding with structural economic reforms in many that
constrained government health spending (Redfield 2008: 132, see Chapter three).
In the absence of sufficient public health systems, MSF developed ‘emergency
health kits’ for its medical volunteers, which were eventually authorised and
distributed by the World Health Organization (Vidal and Pinel 2011: 30, see
Chapter three). Through this fieldwork, MSF staff became increasingly aware of
the lack of available treatment for several health conditions specific to developing
countries. Moreover, many treatments recommended by the WHO were ‘archaic,
ineffective and toxic’ (see MSF 2001a: 2). This led MSF to challenge the WHO
over several of its treatment guidelines. In the late 1980s, for example, MSF
called on the WHO to amend its guidelines for the treatment of meningitis, a
108 MSF was formed by former staff of the French Red Cross who left the organisation in protest after the Nigerian army attacked medicines volunteers amidst the Nigerian civil war (Dodier 2011).
154
leading cause of mortality in developing countries (d’Alessandro 2011)109. MSF
created its own epidemiology centre and conducted clinical and epidemiological
studies in Uganda, Sudan, Nigeria, Mali and Ethiopia. Eventually, after
intensified public advocacy, the WHO amended its treatment guidelines for
meningitis in line with MSF’s recommendations (d’Alessandro 2011; WHO
2001a: 117).
In the mid-1990s, the international pharmaceutical firm Aventis ceased
production of elfornithine, MSF’s preferred treatment for the condition of African
trypanosomiasis, citing reduced profits. The WHO’s Tropical Disease Research
program had funded the development of elfornithine, but was unwilling to
publicly criticise Aventis and unable to secure a new source of production (Corty
2011: 143). This was a catalyst for MSF to intensify public advocacy on the basis
of its newfound expertise in tropical diseases (see Varaine 1997). MSF’s first
campaign targeted the pharmaceutical company Bristol-Myers-Squibb (BMS)
after MSF discovered that BMS marketed an elfornithine-based depilatory cream
for hair removal. MSF also campaigned for the WHO to change its treatment
guidelines for malaria to artemisinin-combination therapies (ACTs), which was
eventually adopted by the WHO’s Tropical Disease Research program (Le Pape
and Defourny 2001: 68, see more below).
In the late 1990s, MSF joined CpTech, Oxfam and Health Action International in
a global campaign to support the government of South Africa against an
international pharmaceutical industry lawsuit (see Chapter four). Through
109 MSF argued that two doses of the medicine oily chloramphenicol were more effective than the WHO’s recommendation of eight days treatment of intravenous ampicillin.
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networking with the NGOs and activists, MSF subsequently established a formal
‘Drugs for Neglected Diseases’ (DND) advocacy group comprising academic
experts and activists from around the globe, including some staff of the WHO
TDR (see Depoortere, Legros and Torreele 2001; MSF 2001b; Trouiller et al.
2002a; Walgate 2002). The participants shared a critique of the assumption that
the enforcement of IP ‘rights’ and monopoly pricing was a prerequisite for
medicines R&D (see Chapter four). MSF and the DND sought to expose
problems with the market-based R&D system by publishing studies which
demonstrated that R&D was significantly skewed to conditions affecting wealthy
countries (see Ford & Torreele 2001; Health Action International, Médecins Sans
Frontières and Consumer Project on Technology 1999; International Instititute for
Sustainable Development 1999; Pécoul et al. 1999; Trouiller et al. 2002a). A key
finding by the DND, which became a frequently cited figure, was that between
1975 and 1999 only 16 of all new medicines developed in the world were for
tropical diseases (see Trouiller et al. 2002a).
In the countries in which MSF worked, tropical diseases such as African human
trypanosomiasis, Chagas disease, intestinal parasitic diseases, leishmaniasis,
leprosy, lymphatic filariasis, malaria, schistosomiasis, onchocerciasis and
tuberculosis were leading causes of death and disability (Trouiller et al. 1999).
The neglect of tropical diseases by the pharmaceutical industry was justified by
the discourse of ‘selective’ primary health care, which evaluated tropical diseases
as ‘low priority’ (see Chapter three, Walsh & Warren 1979). MSF and the DND
began to frame tropical diseases as ‘neglected tropical diseases’ to bolster their
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critique of the market-based IP driven system110. This advocacy led to a wider
global debate about the relevance of intellectual property for those conditions
predominantly affecting developing countries (Drahos and Braithwaite 2002: 8).
MSF and the DND championed a counter-discourse to TRIPS, which called for
essential medicines to be re-conceptualised as ‘public goods’ rather than the
private ‘rights’ of firms (see Ford and Torreele 2001; Hubbard and Love 2004;
Médecins Sans Frontières 2002c; Medicines Patent Pool 2013; Trouiller et al.
2002a). This was premised on the principle that medicines for tropical diseases be
funded by the public sector, be made affordable through de-linking price from the
costs of R&D, produced as generics without IP ‘rights’, transferred to developing
countries, and be provided to communities on a not-for-profit basis (see MSF
2001a; Pécoul 2000; Trouiller et al. 2002a: 28).
This counter-discourse was reminiscent of the WHO’s earlier attempts to re-orient
medicines R&D in the 1960s and 1970s (see Chapter two, Mahler 1975a). The
WHO’s Tropical Disease Research program that was established in the 1970s to
address this problem had largely failed due to the resistance of the pharmaceutical
industry (see Chapter three). Access to medicines in the post-TRIPS environment
was also affected by bilateral trade agreements through which the United States
exercised pressure for the adoption of patent laws beyond the requirements of
TRIPS (Consumer Project on Technology et al. 2001; Love 2001b, Love 2002,
see Chapter seven). In this broader political context, the NGOs coalesced around
a shared vision for a globally binding R&D treaty in the WHO. They envisioned
this treaty as a catalyst for the development of medicines for tropical diseases and
110 To the author’s best knowledge the phrase ‘neglected tropical diseases’ emerged on the international agenda through the MSF-led DND.
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as a mechanism to create new norms for governments to resist bilateral trade
pressures (see DNDi 2002; Ford and Torreele 2001; Love 2001b; MSF 2001a;
Pécoul 2000; Walgate 2002). Core aspects of the proposed treaty were that it
would be funded by the public sector based on a percentage of GDP, allocate
R&D to health needs, de-link prices from the cost of research, expand the market
for generics, and transfer technology to the global South (Pécoul 2000). MSF
raised the idea of a globally binding R&D treaty on the international agenda at the
inaugural WHO/World Bank Ministerial Conference on Tuberculosis and
Sustainable Development and the International Conference on Infectious Diseases
in 2000 (Orbinski 2000; Pécoul 2000).
The turn to product–development partnerships: 2000–2002 In the early 2000s, pharmaceutical firms and their proponents created product-
development partnerships (PDPs) for medicines for tropical diseases. In this
section I argue that these PDPs were a response to the NGO’s ‘public goods’
discourse that had emerged on the global agenda. I highlight the key role of
private philanthropists in the turn to partnerships and show that these PDPs
enforced IP ‘rights’. NGOs responded to the creation of partnerships by
establishing their own PDP, the Drugs for Neglected Diseases initiative (DNDi).
Amidst the NGO advocacy for a new ‘public goods’ system for the research and
development of medicines for tropical diseases, the Bill and Melinda Gates
Foundation emerged on the global health landscape. The Gates foundation was a
philanthropic initiative of Bill Gates, founder of the software firm Microsoft
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(McCoy and McGoey 2011: 146). In 2000, shortly after the NGOs began their
campaign for an R&D treaty, Gates donated 25 million dollars to support a new
PDP, which came to be known as the Medicines for Malaria Venture (MMV)
(Medicines for Malaria Venture 2009: 8)111. This was followed by a one million
dollar donation from the multinational oil and gas corporation Exxon Mobile, and
led to the forum-shifting of the MMV out of the WHO’s Tropical Disease
Research program to an independent entity (Medicines for Malaria Venture 2009:
8). This signalled the effective demise of the WHO’s TDR, which subsequently
became a partner among many in PDPs (WHO 2007c: 65).
Shortly after the formation of the Medicines for Malaria Venture, Gates and the
Rockefeller Foundation financed the creation of a Global TB Alliance to develop
medicines for tuberculosis (Global TB Alliance N.D-c)112. This coincided with
the launching of a ‘Global Health Initiative’ in the World Economic Forum by
Gates, Nestle and several international pharmaceutical firms with the purpose of
‘actively promoting public–private partnerships’ (The World Economic Forum
N.D-a)113. Gates and other private foundations have played a key role in the turn
to product-development partnerships for medicines, representing over 90 per cent
of all funding for PDPs (Commission on Intellectual Property Rights Innovation
and Public Health 2006: 75; Policy Cures 2011: 90)114.
111 The first global health partnerships were the International AIDS Vaccine Initiative (1996), Roll Back Malaria (1998) and STOP TB Partnership (1998) (see Bartsch 2011). 112 The Rockefeller Foundation has a long history in international health since the early 1900s (Williams & Rushton 2011: 4) and has been a key advocate of the turn to ‘selective’ primary health care since the 1980s (see Chapter three). 113 The World Economic Forum is an international organisation comprising over 1000 multinational corporations (The World Economic Forum N.D-b). 114 The Gates foundation also provides funds to the United Nations Population Fund (UNFP), UNAIDS, the World Bank and the WHO (Moran 2011; Rushton and Williams 2011).
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The Gates Foundation and the pharmaceutical industry were appointed as voting
members on the new PDP governing boards (Medicines for Malaria Venture N.D;
Global TB Alliance N.D-a). This was indicative of the entry of private sector
representation in global governing bodies (see Buse 2004; Buse and Walt 2002).
The Global Fund to Fight HIV/AIDS, Malaria and Tuberculosis, a partnership
created in this period to finance the distribution of medicines, maintains private
sector representation on all of its governing bodies (Transitional Working Group
of the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria 2001: 1, see
Chapter five)115. Similarly, the Global Alliance for Vaccines Initiative (GAVI),
another partnership created with funding from Gates to distribute vaccines to
developing countries, maintains private sector representation on its global and
national boards (GAVI Alliance 2013 N.D; WHO 2002c). The inclusion of
private actors as voting members was new in global health and, as Buse (2004:
24) has shown, many of these partnerships ‘overlooked’ the need for effective
policies to prevent undue commercial interests.
The MMV and Global TB Alliance were founded on strong support for the
enforcement of intellectual property ‘rights’ (Buse and Walt 2002; Pugatch, Chu
and Tortensson 2012: 39). This reflected not only the interests of the international
firms but that of Gates, who as head of Microsoft was a strong advocate of the
TRIPS agreement. Indeed, Microsoft has publicly opposed any measures that
115 On average, representatives from the private sector and civil society (44 per cent) and bilateral and multilateral institutions (18 per cent) outweigh government sector representation on the national boards of the Global Fund (The Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria 2003: 67). Gates maintains a permanent position on the Global Fund Board despite the fact that the Fund is predominately funded by governments (The Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria 2013). In addition, nearly half of the recipients of the Global Fund for HIV/AIDS treatment are non-state actors (The Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria 2006: 31).
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would ‘weaken’ intellectual property in the global South (see Microsoft 2002).
This suggests that the turn to PDPs was as much about countering the ‘public
goods’ discourse of the NGOs as it was about facilitating R&D.
In addition to sponsoring PDPs, many international pharmaceutical firms
responded to the NGO advocacy for a ‘public goods’ R&D system by offering
drug donations and price reductions on their existing medicines for tropical
diseases to the WHO (WHO 2001b: 4, see Appendix Five). Sanofi-Aventis finally
agreed to resume production and to donate its TDR-sponsored elfornithine for
sleeping sickness (see section above). In 2001, Novartis and the WHO signed a
10-year agreement in which Novartis offered its patented malaria artemisinin-
combination therapy (ACT) arthemether/lumefantrine (Coartem) at a reduced
price of USD 1.57 per treatment for distribution to endemic countries through the
WHO (Novartis 2011 ).
MSF and the DND initially responded to this turn to PDPs by creating their own
not-for-profit product-development partnership, the Drugs for Neglected Diseases
initiative (DNDi). In 2002, MSF secured the support of the Indian Council of
Medical Research, the Kenyan Medical Research Institute, the Malaysian
Ministry of Health, the Oswaldo Cruz foundation/Fiocruz Brazil, Institute Pasteur
(France), and the WHO’s TDR to create DNDi as a public-oriented partnership to
develop new medicines for tropical diseases (Boulet 2011; DNDi 2002, 2010,
N.D; Kant, Seth and Sharma 2005; Médecins Sans Frontières 2002b; Walgate
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2002)116. Former MSF-staff Bernard Pécoul and Pascale Boulet were appointed to
head the entity (DNDi 2003). In contrast to MMV and the Global TB Alliance,
DNDi was premised on the principle that any medicines that it developed would
be ‘public goods’ and not accorded any intellectual property protection. MSF and
the DND wanted to demonstrate that they could develop medicines for tropical
diseases without intellectual property protection and with the transfer of
technology to the global South. MSF maintained its call for an R&D treaty and
argued that partnerships like DNDi were not a panacea and did not relieve
governments of their responsibilities in health R&D (Pécoul cited in WHO 2003d:
4).
A battle between two commissions: 2002–2003
This conflict over the norms guiding product-development partnerships for
medicines for tropical diseases was part of a broader struggle over the global rules
for medicines R&D. In this section I show that these competing visions of the
R&D system were evident in the WHO’s Commission on Macroeconomics and
Health (2002) and the United Kingdom’s Commission on Intellectual Property
Rights (2002). While Brundtland’s Commission on Macroeconomics and Health
(2002) supported the industry perspective, the United Kingdom’s Commission on
Intellectual Property Rights (2002) recommended that developing countries
implement pro-competitive patent systems. These international commissions were
116 DND is headquartered in Geneva with network offices in Asia, Africa, Japan, India and Latin America (Kant, Seth and Sharma 2005). DNDi initially identified sleeping sickness, Chagas disease, leishmaniasis and malaria as its focus (Boulet 2011).
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a turning point that finally brought the issue of IP and medicines onto the agenda
of the WHO’s governing bodies.
The Commission on Macroeconomics and Health was established by the Director
General of the WHO, Gro Harlem Brundtland, to secure the organisation’s health
mandate under the prevailing neoliberal order (see Chapter four). Brundtland
sought to frame health as a necessary requirement for economic development, and
she appointed economists from American universities, the World Bank and IMF
as expert Commissioners to make this case. The Commission subsequently
worked closely with international pharmaceutical firms and devoted a
considerable section of its report to the issue of medicines for tropical diseases.
Indeed, the commissioners explicitly acknowledged the advocacy of CpTech,
Health Gap, MSF, Oxfam, and the Treatment Action Campaign in bringing this
issue onto the global agenda (Commission on Macroeconomics and Health 2001:
126).
In contrast to the NGOs, the Commissioners argued that the lack of R&D for
medicines for tropical diseases was a problem of ‘poverty not patents’, and
praised the industry for its drug donations (WHO 2012c: 88). They created a
‘typology’ that segmented diseases according to markets ability to pay, and in
doing so carved off ‘type three’ diseases that ‘overwhelmingly affect poor
countries’ (Commission on Macroeconomics and Health 2001: 78). The
Commissioners framed the problem of the ‘neglect’ of tropical diseases as one of
insufficient support for the private sector (Commission on Macroeconomics and
Health 2001; 2002: 84, 88, 114). This was indicative of a policy shift by the
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WHO Secretariat under Brundtland in which the WHO supported IP ‘rights’ and
public-private partnerships (WHO 2002a, 2002b, N.D-c). Brundtland praised
these partnerships for ‘bridging the gap between market opportunities and
people’s needs’ (cited in Global TB Alliance N.D-b).
A turning point in this unfolding conflict was the release of the report of the
United Kingdom’s Commission on Intellectual Property Rights that same year
(Commission on Intellectual Property Rights 2002). The UK Commission had
been established in response to the conflict over HIV/AIDS medicines and TRIPS
in the late 1990s (paragraph 149, Secretary of State for International Development
2002: 6, see Chapter four). The UK Commissioners were experts in IP and
medicines R&D and included Argentinian activist lawyer Carlos Correa and the
Director General of the Indian Council of Scientific and Industrial Research,
Ramesh Mashelkar (Commission on Intellectual Property Rights 2002: 2). Like
the WHO Commission on Macroeconomics and Health, the UK Commission
concluded that intellectual property did ‘little to stimulate research on diseases
that particularly affect poor people’ (Commission on Intellectual Property Rights
2002: 14). Unlike the WHO Commission, the UK Commission was more
supportive of the demands of developing countries. The Commissioners
recommended that:
… developing countries should, within the constraints of international and
bilateral obligations, provide a pro-competitive patent system that limits
the scope of subject matter that can be patented; applies strict standards of
patentability; facilitates competition; includes extensive safeguards against
abuses of patent rights; and encourages local innovation (Commission on
Intellectual Property Rights 2002: 23).
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The UK Commission report was widely praised by the NGOs, who welcomed the
report as a ‘powerful evidence-based critique of the health and development
problems caused by the one-size-fits-all approach of WTO patent rules’ (Oxfam,
cited in International Centre for Trade and Sustainable Development [ICTSD]
2002). In contrast, the IFPMA, PhRMA and Microsoft opposed the report, with
Microsoft issuing a public statement that the recommendations would ‘seriously
undermine developing world efforts to become significant producers…of
software and other IP’ (IFPMA 2002; Microsoft 2002; PhRMA 2002)117.
The UK Commission appeared to be a catalyst for the WHO Secretariat to finally
include the issue of intellectual property and medicines on the agenda of the
governing bodies of the WHO (WHO 2003c). Shortly after the UK report was
released, the WHO Secretariat issued its own report on medicines and IP to the
World Health Assembly. This report largely ignored the findings of the UK
Commission and instead promoted differential pricing and partnerships with
industry as the preferred mode of governance to deliver affordable medicines
(WHO 2003c). This signalled the Secretariat’s policy shift to support IP ‘rights’
and led NGOs to accuse the Secretariat of watering down the Doha Declaration
on TRIPS and Public Health (Love 2003; MSF Campaign for Access to Essential
Medicines et al. 2003).
Despite the WHO Secretariat’s support for IP, developing countries were
emboldened by the work of the UK Commission. At the 2003 World Health
Assembly, Brazil led a group of developing countries in calling on the WHO to 117 Shortly after the release of the UK Commission report, the Gates Foundation donated a further 40 million dollars to the Medicines for Malaria Venture (Medicines for Malaria Venture 2009: 14).
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establish an independent commission on medicines and intellectual property
(Médecins Sans Frontières et al. 2003; WHO 2003a). They were met with strong
opposition from the United States. Indeed, the United States and its allies refused
to support the creation of a WHO Commission on medicines, IP and R&D until
member states agreed to narrow the scope of the commission to examine those
diseases that disproportionately affect developing countries, ‘type three diseases’
(see Thompson 2003). The United States also insisted on text in the resolution
that emphasised ‘the importance of intellectual property rights’ in fostering R&D
for essential medicines (WHA56.27 [2003] in WHO 2003b).
Neglected tropical diseases and the WHO: 2004–2006 This section examines key developments in the period between 2004 and 2006, in
which the WHO Commission on Intellectual Property Rights, Innovation and
Public Health worked. I argue that increasing calls in the public sphere for an
R&D treaty were the broader political context in which the WHO re-prioritised
tropical diseases. The WHO established a new department for the Control of
Neglected Tropical Diseases (NTDs) and began a partnership with industry to
administer seven industry-donated drugs to communities ‘at risk’ of one or more
tropical diseases. This action on NTDs was unprecedented and it demonstrated a
significant policy shift in response to intensified calls for a new R&D framework.
The WHO Commission on Intellectual Property Rights, Innovation and Public
Health was formally established in 2004 and tasked with evaluating the role of
intellectual property in the creation of new medicines for those diseases that
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‘particularly affect poor people’ (Commission on Intellectual Property Rights
Innovation and Public Health 2006: iv). The WHO Director General appointed
commissioners that included government ministers, economists, public health
academics, the activist lawyer Carlos Correa and the Director General of the
Association of the British Pharmaceutical Industry (ABPI). In the two years that
the WHO Commission met with stakeholders, support for a public-oriented
system for R&D intensified. The former head of the World Bank, Joseph Stiglitz,
supported a medical innovation prize fund premised on de-linking the costs of
R&D from the price of medicines (Stiglitz 2006). Several members of the US
House of Representatives, UK House of Commons , and European Parliament
joined academics, CpTech, Third World Network, MSF, Oxfam and HAI in
collectively calling on the Commission to evaluate the NGO’s proposal for a
global biomedical R&D treaty (Allen et al. 2006; CpTech 2005; Love 2006a).
As public support for an R&D treaty increased, the WHO held several
international meetings on tropical diseases. The first of these, attended by member
states, experts, NGOs and the pharmaceutical industry, centred on competing
discursive perspectives, namely neoliberalism, human rights, and public goods
(WHO 2003d). By the time of the second WHO meeting in 2005, neoliberal
‘health economics’ dominated the discussion (WHO 2005c). The WHO applied
the World Bank’s disability-adjusted life years (DALYs) formula to highlight the
economic impact of tropical diseases on productivity (WHO 2006h: 16)118. WHO
argued that Chagas disease in Latin America, for example, caused over one
118 DALYs is a formula for quantifying the burden of disease from morbidity and mortality (World Bank 1993). It is calculated as a sum of Years of Life Lost (YLL, number of deaths x standard age of life expectancy at death in years) plus Years Lost due to Disability (YLD, number of incident cases x average duration of case x severity of disease) (WHO N.D-d).
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billion dollars a year in lost economic productivity (WHO 2006h: 16). Tropical
diseases were framed within the language of ‘selective’ primary health care
(SPHC) (WHO 2005c: 33). While they had previously been considered ‘low
priority’ under SPHC, the WHO now argued that the industry drug donations
were ‘cost effective’ measures that enabled the re-prioritisation of tropical
diseases (see Walsh & Warren 1979; WHO 2006h: 18; Chapter three).
The WHO subsequently established a Department of Control of Neglected
Tropical Diseases, signalling a policy shift in the organisation to address tropical
diseases as a group (WHO 2007f: 7). Shortly after, the WHO released its first
manual on treatment guidelines for four tropical diseases, namely lymphatic
filariasis, onchocerciasis, schistosomiasis, and soil-transmitted helminthiasis. The
guidelines recommended the regular mass administration of several industry-
donated medicines as ‘preventative chemotherapy’ for communities perceived to
be at risk (WHO 2006h: 4)119. This covered many member states of the WHO. All
four diseases were prevalent in most of the African region, soil-transmitted
helminthiasis was prevalent across the South American and South-East Asian
regions and most of the Western Pacific region, and lymphatic filariasis was
prevalent across most of the South-East Asian and Western Pacific regions (WHO
2006i: 37-38). Thus the firms stood to gain considerable brand awareness through
their donations120.
119 The frequency of mass administration ranges from once to twice a year (WHO 2006i: 22). 120 This new WHO policy was articulated in a Global Plan to combat NTDs 2008–2015 and was met with expanded drug donations by industry (WHO 2007b: 39, see Appendix Five).
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Indeed, these policy shifts in the WHO were met with intensified action on
tropical diseases by the International Federation of Pharmaceutical Manufacturers
and Associations (IFPMA). The IFPMA shifted its public position to support new
governance mechanisms for ‘health products which the market fails to deliver’
(IFPMA N.D). The IFPMA also began to produce a ‘status report’ on industry
engagement in ‘neglected tropical diseases’, with several IFPMA firms
establishing R&D ‘centres for neglected diseases’ in India, Spain, the United
States, Singapore and Italy (IFPMA 2012b; Jenner [Director Intellectual Property
and Trade IFPMA] 2010: 1).
These moves by the industry did not detract from developing countries taking up
the NGO’s proposal for an R&D treaty. At the WHO’s Executive Board meeting
in January 2006, Kenya, Brazil, Sudan and Pakistan called for the establishment
of a global framework on health R&D which resembled that of the R&D treaty
(Gerhardsen and New 2006; Love 2006b; ‘t Hoen 2006; WHO 2006a: 111). This
draft resolution reflected the key principles of the ‘public goods’ discourse and
was based on a public-oriented system for medicines R&D that de-linked the
price of medicines from the costs of research. This resolution was put forward by
the developing countries before the release of the report of the WHO Commission
on Intellectual Property Rights, Innovation and Public Health. This enabled Japan
to stall the negotiations and shift the proposal to the World Health Assembly after
the expected release of the report (WHO 2006a).
Prior to the 2006 World Health Assembly, the NGO Intellectual Property Watch
alleged that the IFPMA had accessed and commented on the draft report of the
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WHO Commission (Gerhardsen and New 2006). According to an anonymous
commission member, comments from the IFPMA had appeared in the tracking
records of the draft report. This news was met with anger amongst many
developing countries and NGOs. Yet one month later, the Commission report was
released. The WHO Commission echoed the main findings of the WHO
Macroeconomics and UK Commissions and concluded that IP was not a
‘significant boost’ to develop medicines for diseases that predominantly affected
developing countries (Commission on Intellectual Property Rights, Innovation
and Public Health 2006: 85). The report was criticised, however, by its own
Commission members Carlos Correa and Pakdee Pothisiri (Senior Deputy
Permanent Secretary of Health to the Thai Government) for not sufficiently
elaborating on ‘profound distortions’ in the patent system that obstruct generic
competition (Commission on Intellectual Property Rights, Innovation and Public
Health 2006: 201). This dissent and the revelations of industry influence suggest
that the WHO Commission was constrained along the North-South divide.
Despite these constraints, many developing countries tried to negotiate on a
global framework for health R&D at the World Health Assembly. On this
occasion the European Commission led the opposition to the developing
countries’ proposal (WHO 2006e: 63). Leaked documents by the NGOs revealed
that the European Commission was strongly influenced by the IFPMA in its
position to block the treaty (Balasubramaniam 2006). On a parallel agenda item,
the United States blocked an attempt by Cuba, South Africa and Bolivia to create
a role for the WHO in assessing the public health impact of trade agreements
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(WHO 2005a; WHO 2006d: 37)121. The United States and European Commission
ultimately weakened the resolution on the report of the WHO Commission to
merely note that IP was an ‘inadequate incentive’ for medicines R&D in
‘uncertain markets’ (WHA 59.24 in WHO 2006d). This demonstrated the power
of the United States and its allies in preventing the WHO from acting on the
mandate of the global South for a new health R&D framework.
Partnerships: 2007–2012 As the call for a global ‘public goods’ R&D framework intensified in the WHO,
international pharmaceutical firms and NGOs forum-shifted between different
partnerships in an attempt to establish their preferred global norms for medicines
R&D. This section demonstrates that firms and their proponents principally
supported and created initiatives that enforced their IP ‘rights’. In contrast, NGOs
used their partnerships to promote the ‘public goods’ model and ‘name and
shame’ companies to share their patents and knowledge. I argue that the
enforcement of IP in some PDPs created problems for access to medicines. This
in turn created tensions for NGOs, in particular when NGOs supported initiatives
that appeared to contradict their principled objectives.
The first medicines developed under the MSF-led Drugs for Neglected Diseases
initiative (DNDi) were two fixed-dose combination antimalarials artesunate/
amodiaquine (ASAQ) and artesunate/mefloquine (ASMQ) (DNDi 2007). ASAQ
was developed by DNDi in association with the international firm Sanofi-Aventis,
121 The United States alleged that the WHO was demonstrating bias (WHO 2005a; WHO 2006d: 37).
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and ASMQ with the public institute Fiocruz Brazil (Wells, Diap and Kiechel
2013). DNDi secured a technology-transfer between Brazil and CIPLA and the
medicines were offered at a ‘no profit no loss’ price to public organisations,
international organisations and NGOs in endemic countries. Unlike the Medicines
for Malaria Venture, none of the DNDi partners acquired intellectual property for
ASAQ or ASMQ. Indeed, the NGOs promoted the medicines as evidence of
successful R&D without the need for IP.
In addition to DNDi, NGOs played a key role in establishing a Medicines Patent
Pool (MPP) to develop new fixed dose combinations and generic HIV/AIDS
medicines (Médecins Sans Frontières 2010f; Stop AIDS campaign N.D;
UNITAID 2011). In 2009 MSF and Knowledge Ecology International (formerly
CpTech) convinced the United Nations General Assembly and the board of
UNITAID to host the Patent Pool (Medicines Patent Pool 2013; UNITAID and
WHO Secretariat 2009; United Nations General Assembly 2011)122. Ellen ‘t
Hoen, former Director of MSF’s Access campaign, was appointed to head the
initiative. The MPP relies upon the voluntary participation of IP-holding entities
to share their patents and knowledge in order to facilitate generic production and
new combination ARVs. MSF subsequently began a global campaign to name
and shame companies to share their patents with the MPP (Médecins Sans
Frontières 2010f; Stop AIDS campaign N.D; 't Hoen 2011; UNITAID 2011, see
Appendix Six)123. The United States National Institute of Health was the first
122 The IFPMA strongly opposed this initiative and the United States blocked the involvement of the WHO in the Medicines Patent Pool beyond pre-qualifying medicines (IFPMA 2009; WHO 2010c). 123 DNDi also developed a combination of two sleeping sickness medicines, elforthnithine and nifurtimox, which was approved by the WHO Essential Medicines List in 2009 (WHO Expert Committee on the Selection of Essential Medicines 2009).
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entity to donate its IP on the ARV drug darunavir to the MPP in 2011 (UNITAID
2011)124.
In response to these developments in the DNDi and MPP, international firms’
forum-shifted their negotiations over R&D for medicines for tropical diseases to
the World Intellectual Property Organization (WIPO). In 2011, Pfizer led the
establishment of an R&D-based partnership in WIPO called WIPO Re:Search
(IFPMA 2011; WIPO Magazine 2013). This was a strategy of the firms to
maintain their control over IP. Unlike the DNDi and MPP, WIPO Re:Search was
founded on a strong commitment to IP ‘rights’. The firms claimed that they would
collaborate through WIPO Re:Search to share compound and patent information
to promote the development of medicines for tropical diseases (IFPMA 2012a;
WIPO Magazine 2013; WIPO Secretariat 2005). These moves paralleled an
expansion of the Gates Foundation’s donations to the Medicines for Malaria
Venture of a further 100 million dollars to subsidise the procurement of
antimalarials in the private sector in developing countries (Medicines for Malaria
Venture 2009: 32). This program reflected the private sector orientation of Gates
and MMV as the appropriate mode of governance for the distribution of
medicines.
This section as so far demonstrated that NGOs and international firms were
engaged in a battle over the global norms guiding R&D in PDPs. These norms
have real life implications, in particular when the enforcement of IP creates
barriers for access to medicines. The first, and only, medicine developed so far
124 Johnson and Johnson has refused to share its patent on darunavir, however, and has thwarted the access ambitions of MPP for the drug.
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under the Global TB Alliance, for example, is bedaquiline for multi-drug resistant
TB. This medicine was launched by an affiliate of Johnson & Johnson in 2013,
nearly a decade after the firm secured patent protection in many countries,
including in India until 2023 (MSF 2014, N.D; Walker and Tadena 2013).
Johnson & Johnson has not yet disclosed what it will charge for the drug in India.
However, it has suggested that it will charge 3000 dollars for a six-month course
in middle and upper-middle income countries (MSF 2014). This makes the drug
prohibitively expensive for the estimated 66,000 people living with multi-drug
resistant TB in India (Travasso 2013)125.
The problem of ensuring access to medicines in product-development
partnerships has created tensions for NGOs when they have supported initiatives
that appear to contradict their principled objectives. In the case of the Medicines
Patent Pool, NGOs have supported licences between international and generic
firms that exclude middle-income countries, such as Brazil and Mexico (Burke
2013). Two hundred thousand people living with AIDS in Mexico, and half a
million in Brazil, have been locked out of these licensing arrangements (UNAIDS
2012). This appears to contradict the MPP’s principled ambitions of ensuring
access to medicines for all (Dodier 2011; Saez 2012)126.
125 The FDA has raised some concerns over the drug because it increases the risk of death by nine per cent (Mahajan 2013). 126 In a similar example, MSF was initially appointed by the WHO to negotiate with pharmaceutical firms to reduce the price of TB medicines in the Global TB Drug Facility. MSF had little negotiating power because many countries granted firms patent protection. Thus, the price of second line TB medicines remains‘exorbitantly priced’ and out of reach for many communities in the global South (Staff member of the WHO Global TB Drug Facility Matiru 2009: 1–3). MSF subsequently called on governments to use TRIPS ‘safeguards’ to secure cheaper prices (see Gupta et al. 2001).
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Similarly, while MSF has criticized WIPO Re:Search for locking out patients
living outside ‘least developed’ countries from its licensing arrangements, DNDi
has joined WIPO Re:Search (DNDi 2011; von Schoen-Angerer 2011)127. This has
enabled WIPO Re:Search to make claims to principled authority through its
association with these global advocates for the poor128. To the extent that NGOs
appear to compromise their principled authority in order to strengthen their
capacity-based authority in R&D partnerships, their legitimacy as advocates for
the poor may be threatened129.
The demise of the R&D treaty: 2007-2012 In the same period that NGOs and firms forum-shifted between partnerships, calls
for an R&D treaty intensified in the World Health Organization. Between 2007
and 2012, member states of the WHO agreed to a Global Strategy and Plan of
Action and created two expert committees to resolve the problem of R&D for the
health needs of the South. This section demonstrates that the international
pharmaceutical industry gained privileged access to these WHO ‘expert’
commissions, which embroiled the WHO in controversy and raised questions over
its independence. It also shows that solidarity in the South weakened in this
period, in part as a result of industry drug donations and the creation of PDPs.
127 According to the United Nations Development Index, there are 34 WTO members classified as ‘least developed’ (UN-OHRLLS 2013). 128 Many PDPs rely on NGO involvement to appear legitimate (Buse and Walt 2000a). The International AIDS Vaccine Initiative (IAVI), for example, relies upon NGO involvement to advocate governments and ‘build demand’ for an AIDS vaccine (Chataway and Smith 2006: 21, 23). 129 When NGOs channel ‘putative discontent into activities that do not upset the status quo’ they are vulnerable to this critique (Dryzek 2012: 110). Lipschultz (2005) has shown that NGO campaigns in labor, trade and environment are often focused on markets and distributive politics and do not challenge the underlying status quo and the constitutive ‘rules of the game’.
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Indeed, I argue that the United States and its allies successfully blocked the
proposal for an R&D treaty proposal by appealing to PDPs as the appropriate
global governance for medicines for tropical diseases.
In 2007 the WHO convened its first ‘strategic and technical advisory group’ for
the prevention and control of NTDs. This group of experts subsequently defined
17 diseases as ‘neglected tropical diseases’, namely Buruli ulcer, Chagas,
taeniasis/cysticercosis, dengue, dracunculiasis, echinococcosis, Endemic
treponematoses (Yaws), foodborne trematodiases, Human African
trypanosomiasis, Leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis,
rabies, schistosomiasis, trachoma and soil-transmitted helminthiases (WHO
2007e). The criteria for this categorisation were unclear and many diseases, like
malaria and tuberculosis, were left out. The WHO definition of NTDs appeared to
be based on whether or not product-development partnerships had been created.
That same year, member states of the WHO formed an inter-governmental
working group in response to the recommendations of the WHO Commission on
Intellectual Property Rights, Innovation and Public Health. The inter-
governmental negotiations, which lasted between 2007 and 2009, aimed to
develop a strategy for ‘sustainable R&D for diseases disproportionately affecting
developing countries’ (WHA59.24 [2006] in WHO 2006d). In the negotiations, a
group of South American countries fought for the inclusion of the biomedical
R&D treaty on the agenda (WHO 2008b)130. While they were successful in
130 They were supported by the WHO Commission on Social Determinants of Health (Commission on Social Determinants of Health 2008: 137), which called on member states to evaluate ‘mechanisms other than patents’ for the development of medicines for conditions predominantly affecting developing countries. This Commission had been
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raising the R&D treaty as a proposal on the agenda, in late 2008 the WHO was
mysteriously removed as a ‘stakeholder’ from their proposal (objective 2.3(c) in
WHO 2008b). This sparked anger from Bolivia and Suriname, but Switzerland
refused to re-instate the WHO as a stakeholder on the R&D treaty item (WHO
2008b, 2009c, 2009d). This was indicative of the tensions between the North and
South, in which member states could only agree to a set of ambitions that failed to
reconcile substantive issues over medicines and IP (WHA61.21 [2008] WHO
2011b: 1).
Following the end of the inter-governmental negotiations, the WHO member
states established a second independent group of experts. The WHO Expert
Working Group on R&D: Financing and Coordination (EWG) was formed to
independently assess a range of proposals to create sustainable funding and
international co-ordination of R&D to address the specific health needs of the
global South. The EWG was embroiled in allegations of corruption, however, in
late 2009 when WikiLeaks revealed that the IFPMA had accessed the draft report
(WikiLeaks 2009). Following this leak, committee member Cecilia Lopez
Montaño of Colombia publicly urged member states to reject the forthcoming
report, citing manipulation by corporate interests (Montaño 2010). Indeed, the
final report of the EWG demonstrated that the committee had assessed proposals
according to their ‘acceptability’ to the pharmaceutical industry (Expert Working
Group 2010: 18). The EWG rejected proposals for milestone prizes by
Bangladesh and the NGOs after the pharmaceutical industry opposed them
because they operated ‘outside the IP system’ (Expert Working Group 2010: 63).
established by member states to collect global evidence on the social determinants of health and their impact of health inequity.
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The EWG had also rejected the proposal for a global R&D treaty yet gave no
explanation as to why (Expert Working Group 2010: 86). WikiLeaks revealed
that the IFPMA strongly opposed the treaty (WikiLeaks 2009).
South Africa, Colombia, Bolivia, India, Suriname, Bangladesh, Kenya and
Thailand were scathing of the EWG for the apparent influence of the industry and
its lack of transparency (Governments of Bolivia and Suriname 2010; WHO
2010a; 2010c: 3, 4)131. The Union of South American Nations (UNASUR),
Kenya, India, Indonesia and Brazil called for a new working group to re-evaluate
and expand the number of proposals under consideration (WHO 2010c: 3, 4)132.
The United States, European Commission and French delegations initially
opposed creating a new group, yet they eventually agreed when they secured the
membership of Paul Herrling, head of corporate research at international firm
Novartis (CIDEPRO et al. 2011)133. Thus, in 2010 a new Consultative Expert
Working Group (CEWG) was established under the WHO to ‘take forward’ the
work of the EWG (WHA 63.28 [2010] in WHO 2010b).
This Commission, which worked between 2010 and 2012, ultimately supported
many of the proposals that reflected the ‘public goods’ discourse, including
pooled funds, milestone prizes, patent pools and a globally binding R&D treaty
(Consultative Expert Working Group on Research and Development: Financing
131 Margaret Chan, Director General of the WHO subsequently conducted an internal investigation that did not reveal who had leaked the report to the IFPMA (Mullard 2009; WHO 2010a). 132 The Union of South American Nations (UNASUR) include Argentina, Bolivia, Chile, Colombia, Ecuador, Guyana, Paraguay, Peru, Suriname, Uruguay and Venezuela (Bolivarian Republic of) (WHO 2012c: 54). 133 As Head of Novartis research department, Herrling would subsequently play a key role in litigation against India over its granting of a compulsory licence for cancer medicine Glevic (see Chapter seven, Novartis 2013a).
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and Coordination 2012: 63)134. In addition, the CEWG supported the removal of
‘TRIPS PLUS’ measures like data exclusivity, which the United States was
pressuring other countries to adopt through its bilateral trade agreements
(Consultative Expert Working Group on Research and Development: Financing
and Coordination 2012: 54, see Appendix Four). The CEWG was widely praised
by the NGOs and led Kenya and the South American region to once again call for
a binding R&D convention at the 2012 World Health Assembly (WHO 2012c).
The R&D treaty ultimately collapsed in the WHO due to a weakening of
solidarity amongst the global South and strong opposition from the United States
and its allies. Solidarity amongst developing countries was weakened because
countries such as Thailand began to publicly support strong IP protection for
medicines (WHO 2007h)135. In addition, by the late 2000s the WHO had
administered industry drug donations for tropical diseases to over 670 million
people (WHO 2010d: ii). Indeed, shortly before the release of the CEWG report
in 2012, the Gates Foundation, WHO and several international firms announced
the highly-publicised London Declaration, in which many firms committed to
expanding their drug-donation programs for tropical diseases (Bill and Melinda
Gates Foundation Press Release 2012, see Appendix Five)136. These drug
134 NGOs which made submissions to the CEWG on the R&D treaty included Health Action International, Initiative for Health & Equity in Society, Knowledge Ecology International, MSF, Third World Network, All India Drug Action Network, Berne Declaration, People’s Health Movement and the Centre for Trade and Development India (CENTAD) (Consultative Expert Working Group on Research and Development: Financing and Coordination 2012: 50). 135 Only a year earlier, senior Thai government official Pothisiri had criticised ‘profound distortions’ within the patent system (Commission on Intellectual Property Rights, Innovation and Public Health 2006: 201, see above). 136 This widely publicised campaign of drug donations failed to acknowledge increasing evidence of drug resistance to several of the key industry donated treatments, including the only effective onchocerciasis medicine ivermectin, medicines for sleeping sickness elfornithine and melarsoprol and antileishmanial drugs (Albonico, Engels and Savioli 2004; Bryceson 2002; Gloecknera et al. 2009; Hotez et al. 2007).
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donations, along with the development of some new medicines in the product-
development partnerships, enabled the United States, European Commission,
Switzerland, Australia, Canada, Japan and Monaco to block the R&D treaty at the
World Health Assembly (WHO 2012b, 2012c)137.
Conclusion This chapter has examined the evolution of the global governance of medicines
for tropical diseases, culminating in the demise of an R&D treaty in the WHO. It
has shown that MSF played a key role in raising the issue of medicines for
tropical diseases back on the global agenda in the 1990s and early 2000s. MSF
established a coalition of academics and activists that championed a ‘public
goods’ norm for medicines R&D that was premised on abandoning the patent
monopoly system and de-linking the cost of R&D from the price of new
medicines. This ‘public goods’ discourse was the broader political context in
which pharmaceutical firms and their proponents created product-development
partnerships (PDPs) and the WHO began the administration of industry-donated
drugs. The chapter has demonstrated that international pharmaceutical firms and
NGOs forum-shifted between different partnerships in an attempt to establish
their preferred global norms for medicines R&D (see also Williams 2012). The
enforcement of intellectual property ‘rights’ in some PDPs created barriers for
access to medicines, which in turn created tensions for those NGOs that
participated in these initiatives. Nonetheless, the turn to PDPs as the dominant
form of governance for medicines for tropical diseases ultimately enabled the 137 As of early 2014 the discussion over R&D at the WHO was focused on existing partnerships.
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United States and its allies to block the R&D treaty at the WHO. Furthermore, the
chapter has shown that the international pharmaceutical industry gained
privileged access to WHO ‘expert’ commissions in this period, which embroiled
the WHO in controversy and raised questions over its independence.
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C H A P T E R S E V E N
Power and Resistance
This chapter examines the contemporary situation of power and resistance in
global medicines governance, with a particular focus on India. I demonstrate that
the status quo is one in which the United States government and the
pharmaceutical industry are attempting to raise global norms for the protection
and enforcement of pharmaceutical intellectual property ‘rights’ beyond the
requirements of TRIPS. This ‘TRIPS PLUS’ agenda threatens access to new
medicines in developing countries because it inhibits generic competition and
affordable access to medicines.
This dynamic of power and resistance is evident in recent landmark decisions of
corporate litigation in India that have been led by some international firms in an
attempt to secure ‘TRIPS PLUS’ IP standards. India is significant for the global
South because many developing countries rely on Indian manufacturers for their
essential medicines. The chapter shows that India has resisted the ‘TRIPS PLUS’
agenda with the support of a loose alliance of generic firms and health advocacy
NGOs. This suggests that when economic and health objectives align,
governments in the global South can resist industry pressure. These alliances are
also evident in an increasing counter-movement amongst middle-income
countries. The chapter draws on an analysis of texts of trade agreements, court
documents, reports of the United States Trade Representative, the Global Fund to
Fight HIV/AIDS, Tuberculosis and Malaria, and NGOs (see Appendix Two).
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The TRIPS PLUS agenda This section demonstrates that the contemporary situation in global medicines
governance is one in which the United States government is seeking to elevate
global norms for IP ‘rights’ for pharmaceuticals beyond the requirements of
TRIPS. Since the Doha Declaration on TRIPS and Public Health (WTO 2001),
the United States has intensified its bilateral and regional trade negotiations in
which it pressures other countries to raise IP measures in an apparent exchange
for trade benefits. This ‘TRIPS PLUS’ agenda threatens access to new essential
medicines in developing countries to the extent that it creates longer patent
duration and monopoly rights.
Since the negotiation of TRIPS in the World Trade Organization in the mid-
1990s, the United States government has finalised ‘free trade’ agreements (FTAs)
with 20 other countries (Office of the United States Trade Representative N.D-a).
The title ‘free trade agreement’ reflects the neoliberal objective of open markets
and de-regulation. These agreements have been negotiated bilaterally with one
other country, such as Australia, or regionally, with a group of countries such as
the ‘Dominican Republic-Central America-United States’ FTA with Costa Rica,
El Salvador, Guatemala, Honduras, Nicaragua and the Dominican Republic. Like
the WTO agreements, these FTAs are negotiated in private between governments,
with the text kept confidential from citizens until they have been signed by the
negotiating parties.
In these trade agreements, the United States government has offered
improvements in market access through measures like reducing tariff barriers, in
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exchange for stronger intellectual property protection and enforcement protection
for pharmaceuticals beyond the requirements of TRIPS (Bhardwaj, Raju and
Padmavati 2013; Public Citizen 2011). These higher standards of IP protection
are often outlined in separate intellectual property ‘chapters’ in the trade
agreements, which participating governments must negotiate in order to secure
benefits for trade market access (see Australian Fair Trade and Investment
Network [AFTINET] 2013; Cohen-Kohler, Forman and Lipkus 2008; Collins-
Chase 2008; Correa 2009; de Albuquerque Possas 2008; Drahos 2007; Drahos et
al. 2004; Koivusalo 2003; Koivusalo, Schrecker and Labonté 2009; Malpani
2009; Médecins Sans Frontières 2013b; Office of the United States Trade
Representative N.D-a; Sell 2007; TAC 2013).
The first of these TRIPS PLUS trade agreements was the North American Free
Trade Agreement (NAFTA) between the United States, Canada and Mexico that
was finalised in the same year as TRIPS. In the NAFTA agreement, Canada and
Mexico agreed to the United States demands for stricter conditions on the
granting of compulsory licences, and to establish border enforcement procedures
for IP ‘rights’ beyond trademark and copyright (Office of the United States Trade
Representative N.D-c: 187,189). These measures were ‘TRIPS PLUS’ because
they were not required in the TRIPS agreement and they were more stringent than
TRIPS.
After the Doha Declaration on TRIPS and Public Health in 2001, the United
States intensified its bilateral trade negotiations and signed two more agreements
with Chile and Singapore in 2003. In the United States–Chile trade agreement,
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Chile agreed to ‘TRIPS PLUS’ measures, including the provision of extensions
for patent terms, limits on the grounds for revoking a patent, preventing public
interest objections to patents, and preventing the registration of generics through
test data protection (Office of the United States Trade Representative 2013-a: 16;
OXFAM 2004). Similarly, in the United States–Singapore trade agreement,
Singapore agreed to measures for the extension of patent terms, to limit the
grounds for revoking a patent, extend IP protection to ‘biotech plants and
animals’, protect pharmaceutical test data for five years, and prevent marketing
approval for ‘patent violating products’ (Office of the United States Trade
Representative N.D-b: 6,7, see Appendix Four).
Likewise, in the United States–Australia trade agreement (2004), Australia agreed
to limit the grounds for revoking a patent, provide measures to extend patent
terms, protect pharmaceutical test data for five years (for marketing approval),
and prevent the marketing of medicines that infringe patents (patent linkage)
(Office of the United States Trade Representative N.D-e)138. These IP chapters in
the post-Doha trade agreements were ‘broadly consistent’ with the objectives of
the US-based pharmaceutical industry. Indeed, the US Industry Functional
Advisory Committee on Intellectual Property Rights for Trade Policy Matters,
which included representatives from PhRMA, saw the IP measures as key
‘precedential provisions’ for US trade agreements in the future (Industry
Functional Advisory Committee on Intellectual Property Rights for Trade Policy
138 Australia limited the grounds for revoking a patent to only those claims that would justify the refusal to grant a patent in the first place (Office of the United States Trade Representative N.D-e).
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Matters 2004: 2)139. The industry viewed these ‘TRIPS PLUS’ provisions as a
‘baseline’ for IP standards in future FTAs (Office of the United States Trade
Representative 2013a: 4).
Similar ‘TRIPS PLUS’ IP measures for pharmaceuticals were negotiated in the
subsequent Dominican Republic–Central America–United States Free Trade
Agreement (2004), United States-Morocco Free Trade Agreement (2004), United
States–Bahrain Free Trade Agreement (2006), United States–Oman Free Trade
Agreement (2006), United States–Peru Trade Promotion Agreement (2006),
United States–Panama Trade Promotion Agreement (2007), United States–
Republic of Korea Free Trade Agreement (KORUS) (2007) and United States–
Colombia Trade Promotion Agreement (2011) (Office of the United States Trade
Representative N.D-a, N.D-f). Recent leaked texts of an intellectual property
chapter of the Trans Pacific Partnership Agreement under negotiation between the
United States, Australia, Malaysia, Singapore, Japan, New Zealand, Chile,
Brunei, Vietnam, Canada, Mexico and Peru, also demonstrate pressures to impose
‘TRIPS PLUS’ standards (see WikiLeaks 2013). The text, leaked by WikiLeaks
in 2013, shows that the United States is seeking more stringent IP ‘rights’ on data,
extensions for IP protection, increases in penalties for infringements and
limitations on exceptions to IP ‘rights’ (Lopert and Gleeson 2013; Love 2013;
Médecins Sans Frontières 2013b)140.
139 IFAC-3 aims to ‘promote the adequate and effective protection of intellectual property rights on a global basis’ and advises the US government. It includes representatives of the PhRMA and individual pharmaceutical firms (Industry Functional Advisory Committee on Intellectual Property Rights for Trade Policy Matters 2004: 3, 22). 140 The United States has proposed stronger penalties on IP infringing ‘counterfeits’ in the TPP agreement under negotiation (see WikiLeaks 2013).
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In addition to these trade agreements, the United States Trade Representative
continues to ‘name and shame’ countries in its Special 301 Priority Watch List for
alleged pharmaceutical intellectual property infringement (see Chapter three).
This often results in trade sanctions against those perceived IP infringing
countries. The majority of those countries included on the 2014 Special 301
Watch List and second-tier Watch List, for example, were for alleged
pharmaceutical IP infringement (Office of the United States Trade Representative
2014)141. The key points for this chapter with respect to the contemporary
situation of global medicines governance is that these trade agreements and trade
pressures have reinforced TRIPS as a ‘floor’ rather than a ‘ceiling’ for global IP
norms for medicines. These ‘TRIPS PLUS’ measures threaten to delay access to
new essential medicines because they limit the scope that governments have to
refuse or revoke IP ‘rights’ or use the hard-fought public health safeguards of
TRIPS (see Kerry and Lee 2007).
The broader consequences of these trade agreements for global medicines
governance is that they are shaping the structural conditions that reinforce the
United States dominance in the global political economy. Since the United
States–Australia free trade agreement (2004), for example, US exports to
Australia have increased by 33 per cent (to nearly 19 billion dollars annually),
while exports from Australia to the United States have only increased by three
and a half per cent (just shy of eight billion dollars) (Office of the United States
141 USTR Priority Watch List (2104): China, India, Russia, Algeria, Argentina, Indonesia, Pakistan, Thailand and Venezuela. Watch List: Brazil, Canada, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Finland, Guatemala, Paraguay, Peru, Turkey, and Vietnam (Office of the United States Trade Representative 2014).
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Trade Representative 2013b)142. Similarly, since the US–Singapore trade
agreement, US exports to Singapore have increased by 31 per cent (to 21.5
billion), while exports from Singapore to the US have only increased by two per
cent (to 15 billion) (Office of the United States Trade Representative 2013c, N.D-
c)143. The trade agreements appear to be reinforcing US dominance, which in turn
enables the United States to exert pressure on other countries to raise IP norms.
Novartis versus India: ‘the pharmacy of the developing world’ This chapter has so far shown that the contemporary situation in global medicines
governance is one in which the United States government, on behalf of the US-
based pharmaceutical industry, is raising global IP ‘rights’ norms for
pharmaceuticals. The following sections examine this interplay between power
and resistance in India in the recent decade. The outcome of these struggles in
India has global implications because many developing countries rely on Indian
generics for their essential medicines (Hafner and Popp 2011; UNICEF 2011).
After a brief summary of India’s historical position in medicines governance, this
section examines the landmark case of corporate litigation initiated by Novartis
after India rejected Novartis patent application for cancer medicine Glevic in
2006. This case, which lasted over seven years, demonstrates Novartis attempt to
enforce ‘TRIPS PLUS’ measures in India. The case also shows the dynamic
142 Similarly, since the United States–Chile FTA, the United States has maintained a positive trade surplus with Chile (of nearly three billion dollars), despite trade between the two countries decreasing considerably (US has reduced imports from Chile by a third and Chile has reduced imports from US by a quarter) (Office of the United States Trade Representative 2013a). 143 Since NAFTA, US exports to Canada and Mexico have increased by over 270 per cent, representing over a third of the total US exports in 2013. This figure was lower than US imports from Canada and Mexico (at 613 billion) because many companies subsequently moved to Mexico to take advantage of lower environmental and labor standards (Strachan 2011).
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alliances between domestic and global NGOs and generic firms that have
strengthened India’s resistance to this corporate pressure.
Unlike many developing countries, India strengthened its domestic
pharmaceutical manufacturing capacity in the 1970s, 1980s and 1990s. In 1970,
India led demands for a New International Economic Order (NIEO), and
introduced legislation that reduced the period of patent protection for
pharmaceutical processes and removed patents for pharmaceutical products (Lall
1974: 165)144. In the late 1970s, India introduced a Drugs Policy (1978) that
reserved major areas of medicine production for the Indian sector (Gupta 1999:
154). Throughout the 1980s, India was insulated from World Bank structural
adjustment reforms and doubled its medicine exports (Ballance, Pogany and
Forstner 1992: 196; Bhutta 2001; WHO 2004d: 26). India led resistance to the
TRIPS agreement, yet it was forced to concede after the United States suspended
trade benefits with the country, and the solidarity of the Non-Aligned Movement
declined (GATT 1989; GATT Council 1994c: 165).
In the mid-1990s, India was forced to introduce ‘mailbox’ provisions for
pharmaceutical patent protection after the United States won a formal dispute in
the World Trade Organization (WTO 1996c, 1996f, see Chapter four page 93).
India introduced trademark legislation through its Trade Marks Act in 1999
(Government of India 2013: 108). As a developing country, India was not
required to implement laws compliant with TRIPS until 2005. This enabled
Indian generic firms to produce cheaper HIV/AIDS antiretrovirals (ARVs) and 144 India’s legal framework was influenced by the former British colonial rulers. India had introduced patent legislation through the Protection of Inventions Act as early as 1856 (Government of India 2013: 107).
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become the largest supplier of generic ARVs in the world (Hamied 2000; Raaj
2013: 55, see Chapter four). By the early 2000s, Indian generic firms were the
largest suppliers of essential medicines to UNICEF and to many countries in the
global South (Hafner and Popp 2011; UNICEF 2000: 5).
In 2005 India became compliant with TRIPS through its Patent (Amendments)
Act (Indian Ministry of Law and Justice 2005). Reflecting India’s historical
opposition to the enforcement of pharmaceutical patents, the Act contained strict
conditions for the conferral of IP ‘rights’, including local working requirements
and measures for affordability (Basheer 2006; Indian Ministry of Law and Justice
2005). The Act sought to strike a balance between IP and the public interest, and
it was designed to prevent pharmaceutical ‘evergreening’, a practice in which IP
holders extend the term of monopoly ‘rights’ through measures such as
incremental changes to existing products (Faunce and Lexchin 2007; Madras
High Court 2007). Section 3(d) of India’s Patent Amendments Act excluded from
patentability:
…the mere discovery of a new form of a known substance which does not
result in the enhancement of the known efficacy of that substance…or any
new property or new use for a known substance…or the mere use of a
known process [in the absence of a new product or new reactant] (Section
3(d) Indian Ministry of Law and Justice 2005).
According to the Act, salts, esters, ethers, polymorphs, isomers, complexes,
combinations and other derivatives of known substances do not satisfy the criteria
of inventiveness and are not eligible for IP protection, ‘unless they differ
significantly with regard to efficacy’ (Indian Ministry of Law and Justice 2005).
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India’s Patent Amendments Act represented a national interpretation of TRIPS
that was premised on strict conditions for IP protection. It was also the beginning
of an intensified period of patent litigation in India with respect to product patents
and pharmaceuticals (see Nair, Fernandes and Nair 2014: 80).
Shortly after India’s Patent Amendments Act was finalised, the Indian generic
firms NATCO, Hetero and CIPLA filed pre-grant patent oppositions to Novartis’
application for a patent on its cancer medicine Glevic (imatinib mesylate). This
patent opposition centred on Section 3(d) of India’s amended Patent Act, in which
the firms argued that Glevic, the beta crystalline form of imatinib mesylate, was
not inventive and was previously published in an earlier patent outside India
(Assistant Controller of Patents and Designs 2006)145. Novartis had filed a patent
application for Glevic in India in 1998 under the ‘mailbox’ provisions (see page
93). In 2003, before the ‘mailbox’ was due to be opened, Novartis had secured
exclusive marketing rights in India that prevented the Indian generic firms from
producing and selling their generic versions of the drug. This exclusivity led to a
tenfold increase in the price of the drug, which was considered a life-prolonging
treatment for chronic myeloid leukaemia and gastrointestinal stromal tumours that
require ongoing lifelong treatment (Ecks 2008: 167; Nair, Fernandes and Nair
2014: 80).
Hetero, NATCO and CIPLA were joined by the Indian Cancer Patient Aid
Association (CPAA) that also filed a patent opposition to Novartis’ Glevic. The
Indian Cancer Patient Aid Association’s pre-grant patent opposition centred on 145 The base compound of imatinib mesylate was previously patented in other countries but was not eligible for a patent in India because it was created before the TRIPS Agreement was finalised in 1994 (Menghaney 2012: 22).
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the issue of lack of access to Glevic in India due to the high prices charged by
Novartis (Cancer Patients Aid Association 2005). At the time Novartis was
charging 30,000 dollars (US) per patient per year, a price out of reach for the
majority of cancer patients in India (Menghaney 2012: 15)146.
In January 2006, the Indian Assistant Controller of Patents and Designs denied
Novartis’ application for a patent for Glevic on the grounds of lack of
inventiveness, citing Section 3(d) of India’s Patent Amendments Act (Assistant
Controller of Patents and Designs 2006)147. This move was praised by health
advocacy NGOs, yet it was strongly opposed by Novartis (Novartis 2007). In a
similar vein to the pharmaceutical lawsuit against South Africa in the late 1990s,
Novartis initiated litigation in the Madras High Court to secure IP protection for
Glevic. This litigation was not simply about Glevic, however, as Novartis
explicitly sought to invalidate India’s Amended Patent Act, in particular Section
3(d), on the grounds that it was inconsistent with TRIPS and violated India’s
Constitution (see below Madras High Court 2007; Novartis 2013a)148. Thus, the
lawsuit had broader implications for medicines production in India and access to
medicines in the global South.
The Novartis litigation drew considerable criticism from Indian patient advocacy
groups and global NGOs that began to work together to ‘name and shame’
Novartis to withdraw its litigation. MSF began a global petition ‘Novartis: Drop
146 The price of Glevic increased tenfold after 2003 when Novartis secured the exclusive marketing rights (Nair, Fernandes and Nair 2014: 80). 147 At issue was that Novartis claim for Glevic was for a beta crystalline form of imatinib mesylate. The base compound of imatinib mesylate was not eligible for a patent in India because the TRIPS Agreement was finalised in 1994 (Menghaney 2012: 22). 148 Novartis asserted that Section 3(d) was unworkable, vague, arbitrary and conferred ‘un-canalised powers on the Patent Controller’ (Madras High Court 2007: 35).
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the Case!’ which collected over half a million signatures in less than a year and
was supported and promoted by the South African anti-apartheid Archbishop
Desmond Tutu and the former Swiss President (Médecins Sans Frontières 2013c).
The NGOs engaged in both public and institutional advocacy. In the Madras High
Court proceedings, the Cancer Patient AIDS Association was the voice for the
NGOs. The CPAA was represented by Anand Grover, who later became Special
Rapporteur for the United Nations Human Rights Council. In the court, Grover
argued that the high prices charged by Novartis for Glevic violated the ‘right to
health’ in the Indian constitution (cited in Ecks 2008: 174). Grover also charged
that the High Court did not have the jurisdiction to determine whether Section
3(d) was consistent with TRIPS, nor did Novartis have the legal standing to
invoke the TRIPS because it was a private legal company (Arup 2012; Madras
High Court 2007: 129).
In 2007, after no more than a year of court proceedings, the Madras High Court
ultimately agreed with Grover that the court did not have the jurisdiction to
determine whether Section 3(d) was consistent with TRIPS (Madras High Court
2007). The Indian government subsequently transferred Novartis patent appeal for
Glevic to the newly-established Intellectual Property Appellate Board (IPAB).
IPAB had been established in 2003 to hear appeals on trademarks and amended in
2007 to hear appeals from the decision of the Controller of patents (Lee 2014:
288). The remaining broader issue of whether Section (3d) of India’s Patent
Amendments Act was unconstitutional remained with the Madras High Court. In
late 2007, the Madras High Court determined that India’s Patent Amendments
Act was constitutional. The Judge cited the intentions of the Act to prevent
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evergreening, provide access to medicines, and meet constitutional obligations to
provide ‘good health care’ to its citizens (Madras High Court 2007). This
represented a win for the NGO movement and demonstrated the importance of the
NGO’s public health advocacy in enabling resistance to Novartis’ pressure.
In 2008 IPAB rejected Novartis’ appeal for a patent on Glevic, echoing the
decision of the Assistant Controller that Glevic did not satisfy the criteria of
‘inventiveness’ under Section 3(d) and did not show significant signs of
efficacy149. This decision was not only about the issue of inventiveness, with the
IPAB explicitly criticising the high price charged by Novartis and problem of lack
of access to medicines in its decision:
Rs 120,000/- per month for a required dose of the drug from a cancer
patient…in our view is too unaffordable to the poor cancer patients in
India. Thus, we also observe that a grant of product patent on this
application can create havoc to the lives of poor people and their families
affected with the cancer for which this drug is effective. This will have
disastrous effect on the society as well (cited in Supreme Court of India
2013: 11).
The IPAB judgement did little to stem Novartis, and in early 2009 Novartis
subsequently filed a Special Leave Petition in the Indian Supreme Court
challenging the High Court and Assistant Controller’s decisions on Glevic. Like
its first litigation, Novartis’ litigation in the Indian Supreme Court was not simply
149 IPAB partly reversed the decision of the Patent Controller and held that the beta crystalline form was novel and inventive, however, it maintained that Bayer did not satisfy 3(d) because it did not show enhancement of efficacy (Nair, Fernandes and Nair 2014: 81).
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about Glevic, but was a legal challenge and ‘test’ of India’s Patent Act, in
particular Section 3(d) (see Novartis 2013b).
This litigation was again met with intensified advocacy on the part of both
domestic patient organisations in India and international health advocacy NGOs.
ACT UP France, the Berne Declaration, Avaaz, and MSF began global campaigns
to name and shame Novartis, accusing the firm of blocking access to medicines
(see ACT UP Basel 2013; Avaaz 2013; Bayer 2012; Berne Declaration 2012;
Médecins Sans Frontières 2010b, 2010c, 2010e; von Schoen-Angerer et al.
2013)150. This advocacy resembled the ‘boomerang effect’ of transnational
advocacy networks as detailed by Keck and Sikkink (1999). The international
NGOs served as allies to domestic NGOs and brought international attention to
the litigation and its consequences. The NGOs linked the national struggle in
India with the broader implications for access to medicines by framing India as
the ‘pharmacy of the developing world’ (Médecins Sans Frontières 2010a, 2010b,
2010e; von Schoen-Angerer 2010).
In 2013, after seven years of litigation, the Indian Supreme Court ultimately
rejected Novartis appeal for a pharmaceutical product patent for Glevic (Arup
2012: 129; Government of India Ministry of Commerce & Industry 2013). Like
the Assistant Controller and IPAB, the Supreme Court ruled that the application
for Glevic, for the beta crystalline form of Imatinib Mesylate, ‘fails in both the
tests of invention and patentability as provided under section 2(1) and section
150 Avaaz.org is an online campaign platform that was created in 2007 and has over 37.5 million members from over 194 countries (Avaaz 2014). The Berne Declaration is a Swiss NGO that has campaigned for more equitable North-South relations since 1968 (Berne Declaration 2014).
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3(d)’ of India’s Patent Act (Supreme Court of India 2013: 96). The decision was
widely praised by the NGO community and demonstrated successful resistance by
India to the corporate industry pressure to implement ‘TRIPS PLUS’ rules and
norms151.
Bayer versus India: patent linkage and public health safeguards This section examines a second landmark case of corporate litigation in India, that
of Bayer and its cancer treatment Nexavar (sorafenib tosylate). Like Novartis,
Bayer attempted to create ‘TRIPS PLUS’ intellectual property measures in India
through litigation. In a similar dynamic to the Novartis litigation, I demonstrate
that India resisted this pressure with the support of an alliance of domestic and
global NGOs and local generic firms.
In 2008, amidst the Novartis lawsuit over Glevic, a second landmark case in
corporate pharmaceutical litigation commenced in India. The catalyst for this
litigation was CIPLA’s application for marketing approval to the Drug Controller
General (DCGI) for its generic version of Bayer’s then-patented Nexavar
(sorafenib tosylate), a treatment for kidney cancer and advanced renal cell
carcinoma. When Bayer became aware of this marketing application, it
subsequently initiated a lawsuit in the Delhi High Court to block the Drug
Controller from granting the licence to CIPLA. Bayer argued that CIPLA’s
generic was ‘spurious’ under Section 17B of India’s Drugs and Cosmetics’ Act
151 The Vice Chairman and Managing Director of Novartis India subsequently framed the Supreme Court ruling as a ‘setback for patients that will hinder medical progress for diseases without effective treatment options’ (cited in Novartis 2013b).
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(Delhi High Court 2010). According to this Act, a drug is considered spurious in
India:
…if it is an imitation of, or is a substitute for, another drug or resembles
another drug in a manner likely to deceive or bears upon it or upon its
label or container the name of another drug unless it is plainly and
conspicuously marked so as to reveal its true character and its lack of
identity with such other drug (Delhi High Court 2010).
This litigation represented an attempt by Bayer to create patent linkage in India by
conflating trademark protection with broader IP ‘rights’ protection. Bayer’s claim
that CIPLA’s generic was ‘spurious’ was not about trademarks, rather Bayer
attempted to conflate patent ‘rights’ with the trademark protections in the Drugs
and Cosmetics Act. Patent linkage is not a requirement of TRIPS and is a ‘TRIPS
PLUS’ measure for the protection and enforcement of IP ‘rights’. If Bayer’s
litigation were to succeed, it would have broader implications for access to
medicines because it would block marketing approval for generics that were
alleged to infringe on any number of IP ‘rights’. Indeed, after Bayer filed its suit,
the Delhi High court granted an interim injunction that prevented the DCGI from
granting marketing approval to CIPLA until the court resolved the matter. While
this injunction was only for the drug in question, the DCGI initially refused to
accept any applications for marketing approval from any generic companies
(Action Against AIDS Germany 2009).
In a similar vein to the ongoing Novartis litigation, the Indian Cancer Patient Aid
Association requested that it be included as an interested party in the Bayer case
in the Delhi High Court. This was subsequently confirmed, and the CPAA
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became a vocal ally in support of CIPLA. In the court proceedings, the CPAA
argued that any patent linkage would negatively affect public health, and it was
critical of Bayer for its attempt to link the two separate systems for patents and
regulatory approval. It was the CPAA’s legal team that called on the court to
clarify that its injunction only referred to Bayer’s drug and not all generics
applying for marketing approval, which the court subsequently confirmed (cited
in Delhi High Court 2010). CIPLA made similar arguments and in 2010 the Delhi
High Court ultimately agreed with CPAA and CIPLA and rejected Bayer’s suit.
The court determined that patent law and the regulatory approval of medicines
were ‘separate’ in India, and that the Director Controller General could only
ensure that generic applications for marketing did not contain a similar name to
the brand name (trademark) (Bouchard et al. 2011; Delhi High Court 2010). The
CPAA praised the court decision and publicly ‘named and shamed’ Bayer for
attempting to introduce patent linkage that ‘would have seriously impacted the
early entry of generic drugs…’ and thus affect access to medicines (Grover in
Ermet and Mara 2009). The High Court Judge was also critical of the firm for
what he called ‘vexations or luxury litigation’, and he ordered Bayer to pay Rs
675,000 to India and CIPLA (Ermet and Mara 2009).
Following the High Court’s rejection of Bayer’s litigation, the Indian firm
NATCO formally requested a voluntary licence from Bayer to produce a generic
version of the drug, which Bayer subsequently refused (Nair, Fernandes and Nair
2014: 85). NATCO then submitted an application for a compulsory licence for
Nexavar on the grounds of lack of affordability. At issue was that Bayer’s version
was sold at Rs. 285,000 per month (approx. USD 4743.00), a price out of reach
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for the majority of cancer patients in India (Menghaney 2012: 39). In its
compulsory licence application, NATCO cited Section 84(1) of India’s Patent Act
that enabled compulsory licensing if ‘the patented invention is not available to the
public at a reasonably affordable price’ (Indian Ministry of Law and Justice 2005;
Nair, Fernandes and Nair 2014: 85). Once again, NGOs weighed in to the court
case, with James Love of Knowledge Ecology International (KEI) supporting
NATCO and filing affidavits to the Controller of Patents (Love 2011a):
If the government determines that a price of Rs 280,430 per month for a
cancer drug is reasonably affordable, then the law does not provide
meaningful protection to people living in India, and it does not meet the
standard adopted by the World Trade Organization in 2001 to implement
intellectual property laws in a manner to promote access to medicine for
all (Love 2011a: 16).
On March 9 2012 the Indian Controller General of Patents, Designs and
Trademarks issued India’s first compulsory licence to NATCO to produce a
generic version of Nexavar. The Controller General determined that Bayer had
not met the health needs of people with cancer in India. Bayer was ‘neglectful’
because it only imported limited quantities, had not taken ‘adequate steps’ to
manufacture the product in India, and priced the drug ‘out of reach’ of most of the
people in need (Controller of Patents 2012: 13). The order included provisions
that NATCO make the medicine affordable at R8.800 for a month’s therapy and
pay six per cent royalties to Bayer. This landmark decision was widely praised by
NGOs, and James Love of Knowledge Ecology International framed the
compulsory licence as a ‘big win for cancer patients’ (James Love cited in
Chatterjee 2013).
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Not satisfied with the outcome, Bayer subsequently appealed the decision in the
Intellectual Property Appellate Board, arguing that the order ‘weakens the
international patent system and endangers pharmaceutical research’ (cited in
Bayer 2012; International Centre for Trade and Sustainable Development 2012).
In 2013, less than a year later, IPAB rejected Bayer’s appeal and maintained the
compulsory licence to NATCO, extending the royalty payment from NATCO to
Bayer to seven per cent (Dhar 2012; Intellectual Property Appellate Board 2012;
Löfgren 2012; Srivastava and Satyanarayana 2014)152. Again, NGOs hailed the
outcome as a win for access to medicines. MSF urged India to issue more
compulsory licences for new essential medicines and to challenge the ‘pursuit of
excessively high profits over health needs’ (Médecins Sans Frontières 2013a).
Like the landmark Novartis case, the Bayer litigation in India was symbolic of the
dynamics between power and resistance in contemporary global medicines
governance. Bayer’s attempt to create patent linkage and prevent the compulsory
licence on Nexavar through multiple lawsuits demonstrated the firms’ aggressive
promotion of the ‘TRIPS PLUS’ agenda. Bayer and Novartis were supported by
the United States government, which has maintained India on its Special 301
Priority Watch List for alleged pharmaceutical IP infringement and explicitly
cites India’s compulsory licence to NATCO in its rationale (Office of the United
States Trade Representative 2014: 40). The intervention of domestic and global
NGOs in the Bayer litigation and in public advocacy around the litigation
demonstrate the key role that NGOs have come to play in supporting local firms
and governments in their resistance to this TRIPS PLUS agenda. Indeed, the
152 Bayer appealed to the Bombay High Court in April 2014. On 15 July 2014 the Bombay High Court dismissed Bayer’s appeal and upheld the compulsory licence.
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Bayer lawsuit confirms that affordable access to medicines is a key factor for
consideration in IP law in India, which is a significant development for access to
medicines in the global South.
Emerging resistance in the global South
In this section I demonstrate that resistance to the TRIPS PLUS agenda appears to
be increasing in global medicines governance in a number of middle-income
countries. Like India, I show that the dynamic alliances between local firms and
NGOs are unfolding in other countries, and I highlight the role that NGOs have
come to play in championing the health needs of poor patients.
In similar moves to India, in 2008 the Thai government secured free treatments of
Novartis’ Glevic for cancer patients after it threatened to issue a compulsory
licence for the drug (Moon 2009: 13). That same year, Thailand granted
compulsory licences for cancer medicines docetaxel, letrozole, and erlotinib (see
Appendix Seven). Also in 2008, the Bangladesh Department of Patents, Designs
and Trademarks suspended the approval of pharmaceutical patents until 1 January
2016 (while preserving ‘mailbox’ requirements, see page 91) (Azam and
Richardon 2010: 9). This was for Bangladesh firms to take advantage of the
TRIPS extension for pharmaceutical patents for ‘least developed’ countries, of
which Bangladesh is the only country with adequate local pharmaceutical
manufacturing capacity (Yusuf and Alam 2008). These moves demonstrate some
resistance to the ‘TRIPS PLUS’ agenda in key middle-income and low income
countries.
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Recent developments in China also appear to show increasing resistance to the
‘TRIPS PLUS’ agenda. In 2011, the Chinese generic firm Aurisco applied to the
State Intellectual Property Office for a compulsory licence for Gilead’s
HIV/AIDS and hepatitis B medicine Viread (tenofovir disoproxil fumarate)
(China Ministry of Commerce 2012; Ellis 2013). At 240 dollars per month,
Viread was beyond the reach of most Chinese patients, of which there were an
estimated 90,000 people living with AIDS and up to 130 million people living
with hepatitis B (Ellis 2013). In May 2012, China’s State Intellectual Property
Office revised its Measures for Compulsory Licensing of Patent Implementation
to enable the issuance of compulsory licences to local firms in cases of public
interest, including ‘for reasons of public health’. In 2013, China became no longer
eligible for Global Fund grants to procure treatments for HIV/AIDS (The Global
Fund to Fight HIV/AIDS, Tuberculosis and Malaria 2014: 17). That year, China’s
State Intellectual Property Office revoked Gilead’s patent for Viread, citing a lack
of novelty and inventiveness (Ellis 2013)153. This decision reflected India’s earlier
revocation of Novartis’ Glevic on the same grounds, and it demonstrated that
China was also willing to override stringent IP enforcement for pharmaceuticals
to meet the health needs of patients. China’s revocation of Gilead’s patent for
Viread was not only about health needs, however, with Aurisco likely to compete
with Indian and South African generic firms in international procurement
agencies like the Global Fund (The Global Fund to Fight HIV/AIDS,
Tuberculosis and Malaria 2014: 17).
153 The USTR recently elevated China to its Special 301 Priority Watch List for allegedly enabling the marketing approval of generic medicines prior to the expiration of data exclusivity periods (Office of the United States Trade Representative 2014: 36).
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Health advocacy NGOs have often led the charge against ‘TRIPS PLUS’
measures in developing countries. The Indian Network for People living with
HIV/AIDS, Uttar Pradesh Network of People Living with HIV/AIDS, the
Network of Maharashtra People living with HIV and the Initiative for Medicines
Access & Knowledge (IMAK) have filed many patent oppositions in India since
2005 (MSF N.D). In Kenya, in 2012 the Kenyan High Court ruled in favour of
litigation brought by AIDS activists that the Kenyan Anti-Counterfeiting Act
(2008) was a threat to access to medicines and to Kenya’s constitutional right to
health (Ngugi 2012, see Chapter five). These developments suggest that the
contemporary situation in global medicines governance is one which NGOs and
local firms can help governments to resist pressure by the international
pharmaceutical industry.
Conclusion This chapter has examined the contemporary situation in global medicines
governance. It has demonstrated that the status quo is one in which the United
States government and international firms are pursuing a ‘TRIPS PLUS’ agenda.
Through trade agreements, the United States has secured the ‘ratcheting up’ of IP
in many countries. These measures raises serious concerns over access to new
medicines because they inhibit governments from using the hard-fought ‘public
health safeguards’. The chapter has examined two landmark cases in India that
has seen increasing patent litigation since it became compliant with TRIPS in
2005. Novartis and Bayer are two firms that have attempted to create TRIPS
PLUS measures through litigation in many court forums. India has so far resisted
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these pressures with the aid of a loose alliance of local generic firms and health
advocacy NGOs that, while having differing motivations, have coalesced around
shared objectives that benefit both citizens and local firms. NGOs have played a
key role in championing the health needs of patients and have engaged in both
institutional and public advocacy through their participation in legal proceedings
and public campaigns. Similar developments are unfolding in China and other
middle-income developing countries. This suggests that resistance to industry
pressure in the global South is possible, in particular when the economic interests
of local firms and health objectives of NGOs align.
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Conclusion
This thesis took as its starting point the failure of global medicines governance to
meet the health needs of the world’s poor. Despite over 70 years of international
policymaking, the problems of lack of access to essential medicines, insufficient
research and development to meet health needs, and irrational use of medicines
persist with dire consequences (MDG Gap Task Force 2012; Médecins Sans
Frontières 2010d; United Nations 2010; WHO 2011d). From this stand point, I
asked, why is the global governance of medicines failing to meet the health needs
of the global South? I posed three subsidiary questions for investigation: who are
the actors that have shaped the global governance of medicines? What discourses
have shaped global medicines governance? What have been the turning points in
the evolution of this domain?
The thesis has examined the history, conflicts and transformations in the
evolution of the global governance of medicines over several decades.
Commencing with the formation of the World Health Organization (WHO) in the
1940s, the thesis has situated shifts in international medicines policy within
broader transformations in the global political economy. In doing so, the research
has drawn on an emerging field of scholarship in global health that investigates
the actors and discourses that shape policy, and the interests that these actors and
discourses serve (see Labonté and Gagnon 2010; Lee 2009a; McInnes et al. 2012;
Rushton 2012; Shiffman 2009: 38).
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The historical focus of the thesis has enabled a long-term analysis in which
specific events and turning points are situated in a broader struggle that has
unfolded over many decades. This demonstrates that global medicines governance
has evolved principally through a battle that reflects the North–South divide.
Since the 1940s, the United States government and its allies have repeatedly
weakened multilateral initiatives that could have secured more equitable and
affordable access to medicines and promoted the rational use of medicines,
because these initiatives threatened the profits of their pharmaceutical firms. The
political and economic power of the United States is reflected in the ultimate
demise of the New International Economic Order (NIEO), through which the
global South had sought to transform international medicines governance in the
1970s. Since the early 1980s, neoliberalism has remained the dominant political
economic ideology that has shaped global governance, and facilitated the
dominance of the international pharmaceutical industry in the production and
supply of medicines. The pharmaceutical industry has exercised significant power
and influence over governments, the World Health Organization (WHO) and
other international institutions. The story told in this thesis demonstrates that the
capacity of global medicines governance to meet the needs of the South has been,
and continues to be, constrained by the power of the international pharmaceutical
industry.
This thesis has also demonstrated the building of a counter-movement of
resistance amongst developing countries, their generic pharmaceutical firms, and
domestic and globally networked health advocacy non-government organisations
(NGOs). It has argued that this resistance has been most successful when
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developing countries have acted in solidarity en bloc, and when the objectives of
local firms and health advocacy NGOs have aligned. India, in particular, has led
resistance to corporate litigation and trade pressures with the support of both local
firms and a global network of NGOs. This suggests that claims to ‘human rights’
for access to medicines are a useful point of resistance in global medicines
governance (see Schrecker 2011: 161), in particular when local industry and
NGOs coalesce around shared goals.
The thesis has shown that health advocacy NGOs have secured principled, expert
and capacity-based authority in global medicines governance. Domestic and
international NGOs have formed an informal global network through which they
have engaged in public and institutional advocacy, and acted as global advocates
for the world’s poor. They have also secured positions of influence in new global
health partnerships, through which they often work alongside those same firms
that they ‘name and shame’ in their public advocacy. Indeed, the presence of
NGOs on partnership boards provides these partnerships with claims to principled
authority and legitimacy. This dynamic can create tensions for NGOs to the extent
that they can appear to support initiatives that do not reflect their principled
objectives.
This finding is significant for the legitimacy of health advocacy NGOs in global
medicines governance, now and into the future. To the extent that NGOs appear
to privilege claims to capacity-based authority, by participating in initiatives that
do not reflect their principled objectives, their legitimacy may be weakened. This
has consequences for their alliances with local generic firms and developing
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country governments. Addressing this tension must be on the agenda of NGOs,
particularly as the NGO landscape becomes more complicated with the
emergence of patient organisations that receive funding from the pharmaceutical
industry (see Jurberg 2008; Lambert 2009; Schrecker 2011: 160)154. To remain
independent from corporate influence, NGOs must assess their participation in
new global health partnerships in which they work closely alongside
pharmaceutical firms.
This thesis has also contributed to knowledge about the key role of discourse and
ideas in shaping the underlying rules and norms for global medicines governance.
The thesis has shown that whether medicines are valued primarily for their
curative qualities or for their economic returns is the outcome of social dynamics
and power relations. Whether access to medicines is considered a human right, or
whether medicines are considered a private intellectual property ‘right’ of
pharmaceutical firms, for example, is the result of power. Understanding the
consequences of this discursive struggle can contribute to improved knowledge of
the reasons for the continued failings of global governance in addressing the
health needs of the South.
The thesis has shown, for example, that intellectual property ‘rights’ norms have
become the status quo in global medicines governance. Despite the hard-fought
‘public health safeguards’ in TRIPS, few countries have implemented these
154 The UK charity Cancerbackup and some arthritis charities have been linked to providing unbalanced support for some cancer and arthritis medicines that are produced by the international firms from which they have received funding (Lambert 2009: 5). Similarly, in Brazil, international firms have paid patient organisations to initiate litigation with the government for access to their medicines (Jurberg 2008; Schrecker 2011: 160).
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because of political pressures and lack of capacity (see Appendix Seven). Instead,
differential pricing schemes have also become the status quo. These have been
limited, however, to vaccines, contraceptives, and ARVs in least-developed
countries and are not as effective as generic competition (Waning et al. 2009:
5)155. Middle-income countries with poor populations have also been locked out
of these schemes (Hellerstein 2004; Maskus and Ganslandt 2002; Scherer and
Watal 2002; Yadav 2010). Yet, because these schemes reflect the intellectual
property ‘rights’ agenda, they remain dominant in global medicines governance.
More broadly, the thesis finds that in general, the counter-hegemonic discourses
of the global South have not been very effective against the material power of
well-resourced governments and private actors. When the South has been
effective, it is mainly because the interests of NGOs and local pharmaceutical
firms have aligned. This calls into question the discursive power of these counter-
hegemonic discourses. It appears that, in the face of stark inequities in material
power, the discursive power of the materially weak has not been very effective
and that the dominant discourse has been controlled by powerful actors.
This finding raises important questions for health advocacy NGOs and those
seeking to resist the status quo. The thesis has found examples of where resistance
has been most successful in national contexts, such as in national courts in South
Africa, India and Kenya. This suggests that the national level is where NGO may
have a more substantive impact. This does not mean that protest and advocacy
should not occur at the global level, rather global advocacy is strengthened if it is
155 More than 80 per cent of HIV/AIDS ARV’s commonly purchased through differential pricing are between 23 and 500 per cent more expensive than generics (Waning et al. 2009: 25).
209
interlinked with the national or local context. In addition, the partnering between
local generic producers and health advocacy NGOs can to some extent serve both
interests. In addition, NGOs have appeared more effective when they have
brought health into trade forums. Unfortunately, they have not been as
successfully in bringing trade issues into health forums. This is required, and
strategies to engage government health ministers with trade issues is necessary.
This historical study has also enabled a critique of the role of the World Health
Organization in global medicines governance over time. As a member-state
driven organisation that is oriented to consensus, the WHO has been constrained
by power asymmetries between North and South. In recent decades, the WHO has
become even more dependent on the will of donor states which have made the
organisations’ budget increasingly reliant on voluntary donations that are
earmarked for specific objectives156. As a result of this donor dependence, the
WHO has been unable to deliver on its mandate to strengthen national drug
regulatory authorities, has not secured sustainable financing for its pre-
qualification program, nor has it been able to effectively negotiate material
transfer agreements for influenza vaccines ('t Hoen et al. 2014; WHO 2005a,
2011e: 132; 2013a)157.
As a member state driven organisation, the WHO is constrained. Ultimately, more
cohesion is required in the global South to enable the organisation to meet its
156 Up to 80 per cent of the WHO’s revenue is now from earmarked donations (Brown, Cueto & Fee 2006; WHO 2011c).The WHO’s operating budget is merely equivalent to that of the Massachusetts General Hospital (van der Rijt and Pang 2013). 157 Despite many years of negotiations, the WHO’s Pandemic Influenza Preparedness Framework (2011) has failed to secure improved access to vaccines in poor countries (see Kamradt-Scott and Lee 2011: 839).
210
objectives. Developing countries need to call for a shift in the balance of funding
away from voluntary contributions that are earmarked, and towards assessed
contributions. This means that developing countries, in particular middle-income
countries must improve their financing of the organisation. Changes in financing
and a cohesive voice of the ‘South’ are required to strengthen the WHO.
The WHO has increasingly turned to partnerships in lieu of the constraints. The
thesis has shown that the WHO has engaged in many partnerships with industry
that have ultimately privileged the IP ‘rights’ of private firms over the health
needs of the South. The International Medicines Product Anti-Counterfeiting
Taskforce (IMPACT) is the most notable example of industry influence on the
WHO, in which firms continue to pursue their IP agenda under the rhetoric of
medicine safety and quality. In addition, the Gates Foundation, which has driven
product-development partnerships that cement IP ‘rights’ as a global norm in
medicines R&D, is now one of the main donors to the WHO (Sridhar, Frenk and
Moon 2014). In light of these findings, the thesis argues that the WHO should not,
as some scholars have recently suggested, ‘embrace the private sector’ (Sridhar
and Gostin 2011; Sridhar, Gostin and Yach 2012; van der Rijt and Pang 2013: 3)
if it is to deliver on its mandate of improving medicines governance to meet
health needs. The WHO must work to counter the influence of the pharmaceutical
industry if it is to secure effective medicines governance for the global South. The
WHO is currently (as of October 2014) revising its terms of engagement with
non-state actors. The WHO must strengthen its conflict of interest policies with
respect to its engagement with the pharmaceutical industry. Again, it is member
states and developing countries that must take a cohesive and strengthened
211
approach to support the WHO in this regard. The arguments presented in this
thesis also contribute to a discussion about the structural and political reasons for
core aspects of effective medicines governance remaining on the periphery of
global governance. The rational use of medicines, a key part of the WHO’s
essential medicines policy, remains neglected by most governments, creating a
situation in which at least 50 per cent of all medicines used worldwide are used
irrationally (WHO 2013a). The global R&D system is based on monopoly pricing
and IP ‘rights’, and relies on the widespread irrational use of medicines to recoup
R&D costs. This points to a structural constraint on the pursuit of effective global
medicines governance to meet the health needs of all peoples, in both the South
and the North.
According to Lee (2009a:40), ‘the purpose of political analysis and interrogation
of global health is to raise the quality of contemporary debate about strengthening
global health governance’. This thesis has contributed to the scholarly research of
global health through the critical historical study of the changing nature of power
and discourse in the evolution of global medicines governance. It has
demonstrated that the capacity of global medicines governance to meet the health
needs of the South has been, and continues to be, constrained by the power of the
international pharmaceutical industry. The contemporary debate about
strengthening global health and medicines governance requires critical attention
to the role of power and discourse in order to enable opportunities for resistance
and effective governance to meet the health needs of the world’s poor.
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Appendix One: Glossary
Compulsory licensing an authorization to a person other than the patentee
to do, without authorisation of the patentee, acts
which would otherwise by excluded by the patent
(UNESA, UNCTAD and WIPO 1975).
Differential pricing differential pricing (also called tiered pricing) is the
adaptation of product prices to the purchasing
power of consumers in different geographical or
socio-economic segments (Yadav 2010: 8).
Essential medicines ‘those medicines that satisfy the priority health care
needs of the population, which should be available
at all times and in adequate amounts, in the
appropriate dosage forms, with assured quality and
adequate information, and at a price the individual
and community can afford’ (WHO Expert
Committee on the Selection and Use of Essential
Drugs 2000).
Export purchasing power ‘export earnings deflated by the general price level
for internationally traded goods’ (World Bank
1981: 21)
Gross national product an estimate of the total value of all legal goods and
services produced in a country in a specified time
plus income earned by domestic residents from
overseas investments, minus income earned in the
213
domestic market accruing to overseas (foreign)
residents
Most-favoured-nation any advantage a Member gives to the nationals of
another country must be extended immediately and
unconditionally to the nationals of all other
Members, even if such treatment is more favourable
than that which it gives to its own nationals (GATT
Secretariat 1994: 15)
National treatment nationals of other Members must be given treatment
no less favourable than that accorded to a Member's
own nationals
Patent an ‘exclusive right granted for an invention, which
is a product or a process that provides, in general, a
new way of doing something, or offers a new
technical solution to a problem’ (WIPO 2013)
Rational use of medicines defined as when people have affordable access to
essential medicines which are used appropriately, in
doses that meet their requirements, and for an
adequate period of time (WHO Expert Committee
on the Selection of Essential Drugs 1997).
Tariff a tax levied on products when they cross the
boundary of a customs area
Technology transfer the transfer of systematic knowledge for the
manufacture of a product, for the application of a
214
process or for the rendering of a service (UNCTAD
1985: 694).
215
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226
Appendix Three: USTR 301, 1995–2000 Pharmaceuticals
Year USTR 301 Priority Watch
List (Pharmaceuticals)
USTR 301 Watch List (Pharmaceuticals)
1995 Costa Rica, Egypt, Pakistan, Guatemala
1996 Costa Rica, Egypt, Guatemala, Columbia,
Kuwait, Oman, Peru, Jordan, Romania,
Brazil, Australia
1997 Egypt, European Union,
India
Australia, Costa Rica, Guatemala,
Columbia, Kuwait, Oman, Jordan, Korea,
Pakistan, the United Arab Emirates,
Venezuela
1998 Egypt, Israel Australia, Costa Rica, Jordan, Qatar and
South Africa
1999 Argentina, the Dominican
Republic, Egypt,
Indonesia, Israel
Australia, Costa Rica, Ecuador, Hungary,
Oman, Pakistan, the Philippines, Qatar,
UAE, Vietnam, Jordan, Korea, Romania,
South Africa
2000 Argentina, Egypt, India,
Israel
Brazil, Lebanon, Vietnam, Qatar.
Sources: (Office of the United States Trade Representative 1995, 1996, 1997,
1998, 1999, 2000).
227
Appendix Four: ‘TRIPS PLUS’ US Free Trade Agreements
Agreement Year ‘TRIPS-Plus’ provisions
Chile 2003 No public interest objectives and principles
Provides for extension of the patent term
Limits grounds for revoking a patent
Prevents registration of generics during entire patent
term provides for test data protection
Singapore 2003 No public interest objectives and principles
Provides for extension of the patent term
Limits grounds for revoking a patent
Provides patent holders with means to block parallel
importation
Provides for test data protection
Prevents registration of generics relying on originator
test data during the entire patent term
Limits grounds for using compulsory licensing
Australia 2004 Restrictions on issuing a compulsory licence
Data exclusivity for five years
Drugs under a patent claim cannot be marketed
Sources: (Drahos et al. 2004; OXFAM 2004).
228
Appendix Five: Global Medicine Donation Programs
Year Company Medicine / health need
1998 Pfizer Zithromax / blinding trachoma
1998 Merck Mectizan / Onchocerciasis
1998 GlaxoSmithKline Albendazole / lymphatic filariasis
2000 Pfizer Diflucan (fluconazole) / HIV/AIDS
2000 Novartis Multidrug therapy/ leprosy
2001 Sanofi -Aventis Pentamidine, melarsoprol and
elfornithine / sleeping sickness
2002 Bayer Germanin / sleeping sickness
2007 J&J Mebendazole / intestinal worm
2007 Merck Cesol/ schistosomiasis
2007 Bayer Lampit (nifurtimox)/ Chagas
2007 Novartis Triclabendazole/ fascioliasis
2009 Bayer Nifurtimox and elfornithine / sleeping
sickness
2011 Gilead Sciences amBisome / visceral leishmaniasis
2012 Eisai 2.2 billion tables diethylcarbamazine
(DEC) / lymphatic filariasis
Sources: (Eisai 2012; Gilead 2011; Mectizan Donation Program 2013; Novartis Foundation for Sustainable Development 2013; Pfizer 1998, 2000; Sanofi-aventis 2006; WHO 2007d, 2007f, 2012a, N.D-b).
229
Appendix Six: Example of NGO Naming and Shaming
Source: (Stop AIDS campaign N.D)158.
158 Stop AIDS campaign is an initiative of the United Kingdom Consortium on AIDS and International development, a network of over 80 organisations, including Oxfam, which formed in the late 1980s and which advocates the British government (UK Consortium on AIDS and International Development N.D).
230
Appendix Seven: Compulsory Licensing Practices Medicines 2001–2012
Medicine Disease Year Country
Sildenafir (Viagra) Erectile
dysfunction
2002 Egypt
HIV/AIDS medicines HIV/AIDS 2003 Zimbabwe
lamivudine HIV/AIDS April 5 2004 Mozambique
September 21
2004
Zambia
October 5 2004 Indonesia
stavudine HIV/AIDS April 5 2004 Mozambique
September 21
2004
Zambia
nevirapine HIV/AIDS APRIL 5 2004 Mozambique
September 21
2004
Zambia
October 5 2004 Indonesia
didanosine (ddl) HIV/AIDS September 29
2004
Malaysia
zidovudine (AZT) HIV/AIDS September 29
2004
Malaysia
231
lamivudine+zidovidine HIV/AIDS September 29
2004
Malaysia
All HIV/AIDS medicines HIV/AIDS 2005 Ghana
Efavirenz HIV/AIDS November 29
2006
Thailand
March 2007 Indonesia
May 4 2007 Brazil
Kaletra (LPV+RTV) HIV/AIDS January 25 2007 Thailand
April 14 2010 Ecuador
Plavix (clopidogrel
bisulfate)
Heart disease January 25 2007 Thailand
lamivudine +
nevirapine + stavudine
HIV/AIDS July 2007 Rwanda
docetaxel cancer 2008 Thailand
letrozole cancer 2008 Thailand
erlotinib cancer drug 2008 Thailand
sorafenib tosylate
(Nexavar)
cancer drug March 2012 India
Sources: (Beall & Kuhn 2012; Love 2007; 't Hoen 2009).
232
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