the transformation of global health governance

DOI: 10.1057/9781137365729.0001

The Transformation of Global Health Governance

DOI: 10.1057/9781137365729.0001

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DOI: 10.1057/9781137365729.0001


Colin McInnesAdam Kamradt-ScottKelley LeeAnne Roemer-MahlerSimon RushtonOwain David Williams

© Colin McInnes, Adam Kamradt-Scott, Kelley Lee, Anne Roemer-Mahler, Simon Rushton and Owain David Williams 2014

All rights reserved. No reproduction, copy or transmission of this publication may be made without written permission.No portion of this publication may be reproduced, copied or transmitted save with written permission or in accordance with the provisions of the Copyright, Designs and Patents Act 1988, or under the terms of any licence permitting limited copying issued by the Copyright Licensing Agency, Saffron House, 6–10 Kirby Street, London EC1N 8TS.Any person who does any unauthorized act in relation to this publication may be liable to criminal prosecution and civil claims for damages.The authors have asserted their rights to be identified as the authors of this work in accordance with the Copyright, Designs and Patents Act 1988.First published 2014 byPALGRAVE MACMILLANPalgrave Macmillan in the UK is an imprint of Macmillan Publishers Limited, registered in England, company number 785998, of Houndmills, Basingstoke, Hampshire RG21 6XS.Palgrave Macmillan in the US is a division of St Martin’s Press LLC, 175 Fifth Avenue, New York, NY 10010.Palgrave Macmillan is the global academic imprint of the above companies and has companies and representatives throughout the world.Palgrave® and Macmillan® are registered trademarks in the United States, the United Kingdom, Europe and other countries.

This book is printed on paper suitable for recycling and made from fullymanaged and sustained forest sources. Logging, pulping and manufacturingprocesses are expected to conform to the environmental regulations of thecountry of origin.

A catalogue record for this book is available from the British Library.A catalog record for this book is available from the Library of Congress.www.palgrave.com/pivotdoi: 10.1057/9781137365729

Softcover reprint of the hardcover 1st edition 2014 978-1-137-36571-2

ISBN: 978–1–137–36572–9 PDFISBN: 978-1-349-47385-4

vDOI: 10.1057/9781137365729.0001

Contents

Acknowledgements vi

Notes on Contributors vii

List of Abbreviations ix

1 Global Governance and Health 1

2 HIV/AIDS 23

3 Pandemic Influenza 41

4 Tobacco Control 59

5 Access to Medicines and the International Patent Rights Regime 78

6 Conclusion: The Transformation of Global Health Governance 95

Bibliography 114

Index 142

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Acknowledgements

We have been working as a team on aspects of global health governance for half a decade now, supported in no small part by funding from the European Research Coun-cil under the European Community’s Seventh Framework Programme – Ideas Grant 230489 GHG. Additional support was provided by the National Cancer Institute, US National Institutes of Health, Grant No. CA-091021. During this time we have presented a variety of papers on the subject, and been privileged to conduct some 300 key participant interviews. We would like to thank all of those who commented on our work or spent time talking to us. In particular, we would like to thank David Reubi who contributed important insights in the early years of the project and who conducted some of the interviews on tobacco control. For this volume, Marie Woodling stepped in at (almost) the last moment to produce the index. Above all, we would like to thank Rachel Vaughan, who has worked with us throughout the project and whose peerless editorial skills were essential in completing this book. We would like to dedicate this book to her.

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Notes on Contributors

Colin McInnes is Director of the Centre for Health and International Relations (CHAIR) at Aberystwyth Univer-sity, and UNESCO Professor of HIV/AIDS, Education and Health Security in Africa. He has published widely on the international politics of global health, and has advised governments, international organisations and civil society.

Adam Kamradt-Scott is Senior Lecturer in the Centre for International Security Studies, Department of Govern-ment and International Relations, University of Sydney, Australia. Adam has previously worked as a health profes-sional, political adviser and public servant in Australia, and has published a number of articles and book chapters on pandemic preparedness and health security.

Kelley Lee is Professor of Global Health Policy in the Faculty of Health Sciences, Simon Fraser University, Canada, and London School of Hygiene and Tropical Medi-cine, UK. Her research and teaching focuses on the impacts of globalisation on communicable and non-communicable diseases and the implications for global governance.

Anne Roemer-Mahler is a Lecturer in International Rela-tions and a Fellow at the Centre for Global Health Policy at the University of Sussex, UK. Her work focuses on the role of pharmaceutical companies from India in access to medicines and vaccines. She received her PhD from the Department of International Development at Oxford University and later worked as a post-doctoral research fellow at the London School of Hygiene and Tropical Medicine.

viii

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Notes on Contributors

Simon Rushton is Faculty Research Fellow in the Department of Politics at the University of Sheffield, UK. He has written widely on the global politics of health, especially international responses to AIDS and issues around health, security and conflict. He edits the journal Medicine, Conflict & Survival and is an Associate Fellow of the Centre on Global Health Security at Chatham House.

Owain David Williams is presently a consultant on global health and access to medicines. He has worked in and around trade, health and Intellectual Property Rights issues for numerous years and was formerly a Research Fellow in the Centre for Health and International Relations at Aberystwyth University. His interests include political economy, access to medicines and pharmaceutical production in developing countries.

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List of Abbreviations

AFD Agence Française de Développement (French Agency for Development)

AIDS acquired immunodeficiency syndromeARVs anti retroviralsASEAN Association of Southeast Asian NationsBAT British American TobaccoCDC Centers for Disease Control and Prevention

(US)CFIA Central Fund for Influenza ActionCESCR UN Covenant on Economic, Social and Cultural

RightsCEWG Consultative Expert Working Group on Research

and Development: Financing and Coordination, WHO

CMH Commission on Macroeconomics and HealthCSO civil society organisationDFID Department for International Development

(UK)DoH Department of Health (UK)EBM Evidence-Based MedicineEMRO Eastern Mediterranean Regional Office, WHOFAO Food and Agriculture OrganizationFCA Framework Convention AllianceFCCC United Nations Framework Convention on

Climate ChangeFCTC Framework Convention on Tobacco ControlFTA Free Trade Agreement’sG8 Group of Eight (G7 group of advanced industrial

democracies plus Russia)

x

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List of Abbreviations

GAP global pandemic influenza action plan to increase vaccine supply

GATT General Agreement on Tariffs and TradeGAVI Global Alliance for Vaccines and ImmunisationGHG global health governanceGISN Global Influenza Surveillance NetworkGISRN Global Influenza Surveillance and Response NetworkGPA Global Programme on AIDSH1N1 ‘swine flu’H5N1 ‘avian influenza’HAART Highly Active Antiretroviral TherapyHICs high-income countriesHIV human immunodeficiency virusHIV/AIDS human immunodeficiency virus/acquired immunodefi-

ciency syndromeHSS health system strengtheningIHR(s) International Health RegulationsILO International Labour OrganizationINB Intergovernmental Negotiating BodyIPRs intellectual property rightsJICA Japan International Cooperation AgencyJTI Japan Tobacco InternationalLMICs low to medium-income countriesMDGs Millennium Development GoalsNCDs non-communicable diseasesNGO nongovernmental organisationOECD-DAC Organisation for Economic Co-operation and Develop-

ment-Development Assistance CommitteeOIE World Organization for Animal HealthPEPFAR [US] President’s Emergency Plan for AIDS ReliefPHI Public Health Innovation and Intellectual Property Divi-

sion, WHOPIP Pandemic Influenza PreparednessPIPF Pandemic Influenza Preparedness FrameworkPLWHIV people living with HIVR&D research and developmentSARS severe acute respiratory syndromeSDC Swiss Agency for Development and CooperationSTI sexually transmitted infection

xiList of Abbreviations

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TFI Tobacco Free InitiativeTPCs Transnational Pharmaceutical CompaniesTRIPS Trade Related Aspects of Intellectual Property RightsTTC transnational tobacco companiesUNAIDS United Nations Joint Programme on HIV/AIDSUNCED UN Conference on Environment and DevelopmentUNCTAD United Nations Conference on Trade and DevelopmentUNDP United Nations Development ProgrammeUNESCO United Nations Educational, Scientific and Cultural

OrganizationUNFCCC United Nations Framework Convention on Climate

ChangeUNGASS United Nations General Assembly Special SessionUNICEF United Nations Children’s FundUNODC United Nations Office on Drugs and CrimeUNSIC United Nations System Influenza CoordinatorUSAID US Agency for International DevelopmentWFP United Nations World Food ProgrammeWHA World Health AssemblyWHO World Health OrganizationWIPO World Intellectual Property OrganizationWTO World Trade Organization

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1Global Governance and Health

Abstract: This chapter discusses the relationship, in an age of globalisation, between global health governance and the governance of individual health issues such as HIV/AIDS, pandemic influenza, tobacco control and access to medicines. It does this within the context of changes to global governance more generally. It proposes a new way of envisaging this relationship, which captures the evolving political dynamics. In particular the chapter identifies a narrative of transformative change in global health governance based on three elements: the globalisation of health; the emergence of competing visions of global health governance; and the changing institutional landscape.

McInnes, Colin, Kamradt-Scott, Adam, Lee, Kelley, Roemer-Mahler, Anne, Rushton, Simon and Williams, Owain David. The Transformation of Global Health Governance. Basingstoke: Palgrave Macmillan. doi: 10.1057/9781137365729.0005.


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Introduction

In early 2007, Indonesia’s Minister of Health, Siti Fadilah Supari, announced her country’s decision to stop sharing its samples of the H5N1 influenza (‘bird flu’) virus with the World Health Organization (WHO). What appeared at first sight to be a fairly innocuous, technical decision, sparked a major diplomatic crisis. Since 1952, the WHO has been identifying circulating strains of the influenza virus to allow the development of vaccines and warn of novel strains with the potential to become pandemic. Central to this is the manner in which samples of the influenza virus are shared on a systematic and regular basis, from 135 recognised National Influenza Centres located in 105 areas, to one of six regionally distributed WHO Collaborating Centres. Here they are analysed to determine which strains are in active circulation and whether a new strain may be emerging (WHO, no date). Virus sharing was there-fore widely accepted as a global public good, where mutual interests had produced global norms and institutions to mitigate the potential human and economic costs of influenza.

In this context, the Indonesian decision not only appeared to under-mine an example of an effective global regime, but also came at a time when fears of a highly pathogenic influenza pandemic were high, and Indonesia was among the countries seen as a highly likely source of such an outbreak. The general reaction, especially from the United States, was extremely hostile, portraying Indonesia’s actions as reckless and threat-ening to global health security. Siti Supari, however, argued that virus samples were being passed on, without Indonesia’s knowledge or permis-sion, to private pharmaceutical companies to develop highly lucrative vaccines. Moreover, despite widespread recognition that Indonesia could potentially be the front line of an influenza pandemic, and there-fore in greatest need of vaccine supplies, the price set by pharmaceutical companies lay beyond the means of most Indonesians. Further, patent protections had been taken out by companies on the avian influenza virus itself, and Material Transfer Agreements concluded between WHO and pharmaceutical companies, without the consent of those countries providing virus samples. Supari claimed that this practice was ‘obviously unfair and opaque’ (Supari, 2007). Indonesian fears appeared vindicated in 2009–10 when, during the ‘swine flu’ (H1N1) pandemic, high-income countries received privileged access to the relevant vaccine, regardless of who was most at risk from the virus or which governments had provided

Global Governance and Health

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virus samples to manufacture the vaccine (WHO, 2007a; Fidler, 2010a; Knox, 2011; Sinha, 2011).

Although the Indonesian virus sharing crisis was eventually resolved in 2011, what the crisis appeared to confirm was that the traditional view of international health cooperation had been transformed. Historically seen as a largely technical arena focused on such tasks as developing guidelines for ‘best practice’, agreeing common nomenclature and supporting capacity building in healthcare delivery, it was now char-acterised by a greater diversity and, on many issues more divergent, range of interests and perspectives. International health cooperation is now known as global health governance (GHG), a term suggesting a qualitative shift from intergovernmental relations to a more complex global assemblage. Crucially, this sense of transformative change in governance, widely constructed as a consequence of globalisation (for example: Cockerham and Cockerham, 2010; Harman, 2012), was not limited to health, but was sensed more widely within the international system.

This first chapter sets out the concerns of this book and its underpin-ning approach. It begins by discussing global governance, allowing us to begin to interrogate the relationship with GHG. It then discusses the emergence of GHG as a distinct subject of study and practice. This allows us to locate our work within this developing subject area, before outlining the framework of analysis adopted (what we term the ‘three transformations’ in GHG). The book then proceeds to apply this macro-level framework to four case studies, each focusing on a particular issue widely constructed as central in and to the narrative of global health. These four issues balance the traditional focus in GHG on infectious and communicable disease, with more recent concerns over non-commu-nicable disease and distributive justice issues, and the appropriate and necessary governance responses to each.

The theoretical basis of this book is social constructivism. As Onuf (1989) argues, the social world does not exist independent of observation but is one of our own making, and that the ideas we use in observing and understanding the social world also shape that world. This does not mean that the material world is of no concern, but rather that the mate-rial and ideational interact with each other:

Constructivists hold the view that the building blocks of ... reality are idea-tional as well as material; that ideational factors have normative as well as instrumental dimensions; that they express not only individual but collective


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intentionality; and that the meaning and significance of ideational factors are not independent of time and place. (Ruggie, 1998, p. 33)

Therefore, we do not deny the importance of material factors in shap-ing GHG. Rather, we add to this the manner in which health and health issues are socially constructed (by language and other means), within a specific context of time and place, and through this construction possess meaning.

The transformation of global governance

The origins of the transformation in global governance are often identified as lying in the emergence of neoliberalism and free market capitalism as the dominant economic ideology in the 1980s and 1990s. Although not all forms of global governance are manifestations of neoliberalism, these ideas formed a powerful engine for subsequent changes. In particular, boosted by the end of the Cold War, these ideas established a global rationality legitimising a series of policies and empowering certain institutions such as the World Bank. Recognition in time of the failings of neoliberal policies such as structural adjustment, however, led ‘not [to] a rejection of neoliberalism, but a recognition of the need for a greater institutional embedding of neoliberal rationalities, in particular by paying greater attention to the mechanisms of govern-ance and securing the social conditions by which free markets could better operate’ (Joseph, 2012, pp. 95–6). Thus, neoliberalism provides an economic structure and rationalisation for a set of global norms, policies and institutions, which establish particular forms of global governance. For Cammack (2004) and others, this variant of neoliberalism is deeper than its earliest manifestation, as it involves the reconfiguration of states, institutions and social policies, as well as private actors’ forms of author-ity, by means of the transmission of ever wider sets of policy prescrip-tions and templates from the global level downwards.

This book argues that the transformation in global governance should therefore not be seen solely in economic terms, important though these are. Rather a series of simultaneous, and sometimes linked, develop-ments contributed to a wider sense of change in the 1990s. The ending of the Cold War affirmed not only the dominance of neoliberal econom-ics, but also opened up new possibilities for a diverse range of actors to play a more effective role in international relations based upon a shift


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in authority from states to global institutions with common and often ostensibly progressive norms (for example: Annan, 2000; Wheeler, 2001; Bellamy, 2009). For commentators such as Rosenau, however, this shift in the basis of authority was more complex and multi-faceted, involving multiple levels: from the subnational, through the state, to the transnational and global. Moreover, both Rosenau and Clark identified the concurrent phenomena of globalisation and fragmentation. Global change therefore appeared to them, not as a unidirectional progressive transformation in international relations, characterised by top-down developments, but as a series of changes pulling in sometimes very different directions. Using the term ‘global life’, Rosenau suggests that global governance is better understood as a change in an individual’s political horizons to incorporate the global (Clark, 1997; Rosenau, 1992, 1995, 1997).

Related to the above was a growing sense of the development of global civil society – social movements with transnational perspectives and interests, often seen as progressive forces promoting humanitarian-ism, rights and democratisation, or as key social mechanisms for giving voice to individual’s political interests in a globalised polity (see for example: Lipschutz, 1992; Falk, 1995; Held, 1996). Improved communi-cations from the 1990s on, also allowed ideas to be more widely shared – constructing what Webster (1995) termed the ‘information society’ – leading not only to the sharing of norms but also to the greater develop-ment of global epistemic communities. If, however, global civil society is conceived as, by and large, ‘grassroots’ movements impacting on global society and governance, then others identified the importance of global elites, not only in establishing their own epistemic communities, but also as capable of shaping policies and practices outside of tradi-tional governmental structures. Perhaps the most important example is the World Economic Forum held at Davos, Switzerland, but others included philanthropic enterprises such as the Bill and Melinda Gates, Clinton and Rockefeller Foundations. Avant, Finnemore and Sell (2010) also identify the emergence of ‘global governors [who] are authorities who exercise power across borders for purposes of affecting policy. Governors thus create issues, set agendas, establish and implement rules and programs, and evaluate and/or adjust outcomes’ (p. 2). For Avant et al., they are not only important as agents of global governance, but the character of their interactions is also an important feature of the international system.


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The sense of transformative change has therefore emerged from multi-ple directions, and with different stresses being given to the lines of force and agency at play in global governance. But what is also apparent is that the result, in terms of what global governance is, lacks focus and meaning. Although the loosening of the grip of states on international relations is common to all of the transformations identified earlier (see also Scholte, 2000), what replaces it is less clear. Most fundamentally, ‘it is not clear whether [global governance] really does refer to the govern-ance of the world on a global scale, or of whatever governance there is taking place in the world’ (Joseph, 2012, p. 90). Although clearly more than a ‘worldwide tilt from states to markets’ (Hewson and Sinclair, 1999, p. 5), there is no consensus about what this diverse set of changes to actors, norms and procedures actually means. Held and McGrew (2003) argue that it represents a shift from states to regimes; Avant et al. suggest a change in agenda setting, rule-making, implementation and monitoring (2010, p. 14); Rosenau (2006) suggests the emergence of a multi-centric globalised space, where political agendas are set and different rule systems collide; whereas others points to the emergence of new transnational networks (for example: Risse-Kappen, 1996; Keck and Sikkink, 1998).

The importance of the above for this book is four-fold. First, it demon-strates the contested nature of global governance – there is no set agree-ment on what it is and who it is for. Second, the sense of transformative change is clear and rooted in the narrative of globalisation. Third, this transformation in global governance is far more than increases in the speed and intensity of inter-state exchanges. These form a part of the transformational narrative, what may be described as a horizontal axis linking states. For example, bilateral aid programmes, such as the US President’s Emergency Plan for AIDS Relief (PEPFAR), form an impor-tant element of the patchwork of GHG. However, this is only part of the story. A vertical axis embracing actors ‘above’ the state (for example, international organisations) and ‘below’ (for example, civil society organisations) is also part of this new narrative. Finally, the transfor-mation of global governance opens up implications for its relationship with global health, and specifically with global health governance, and the governance of specific health issues such as HIV/AIDS or pandemic influenza. In particular it suggests a multi-level governance framework involving governance of specific issues, of health and of other policy sectors, within an overall context of transformed global governance.


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Health and global governance

Few analyses to date have either identified or discussed this multi-level nature, most implicitly assuming a nested relationship similar to Figure 1.1. In this relationship, the governance of specific health issues forms part of GHG, which in turn is part of broader global governance. The picture is one of a coherent relationship between multiple levels (for example: Fidler, 2010b; Frenk and Moon, 2013). However, this simplifies the often multi-sectoral nature of the policy world and narratives surrounding it. Thus health issues can affect macro-economic performance and vice versa; environmental issues can affect health; trade policies can affect both health and the environment. This suggests that the governance of these issues is similarly multi-sectoral. Rather than a nested approach, a Venn diagram may be a more appropriate representation of the interaction across vari-ous sectoral governances within an overall narrative of global governance (see Figure 1.2). This may also be repeated at the level of individual health issues. Thus, for example, the governance of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) may find areas

Global health governance

Global governance

Governance ofa health issue

Figure 1.1 Nested global governance


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of overlap with access to medicines. The overlapping nature of this model adds complexity, but continues to suggest a mutuality of interests through the overlapping nature of these relationships reflected in the govern-ance of sectors and issues. Following on from previous work (McInnes and Lee, 2012a), however, we see these relationships as characterised as much by conflict as by cooperation, with different sectors pursuing their own agendas which may or may not align with others, and which may change over time. Moreover this conflict is not only between, but within sectors. Thus, within GHG, there may be conflict over the allocation of resources or priority given to specific health issues, as seen for example in the debate over ‘AIDS exceptionalism’ (Smith and Whiteside, 2010). It is tempting therefore to replace Figure 1.2 with a ‘bumper car’ model where, at both the sectoral and issue levels, different governances ‘bump’ into each other (see Figure 1.3). But this suggests that governance is marked by

Figure 1.2 Global governance as overlapping interests


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an ongoing series of conflicts over issues and agendas, which ignores the potential of cooperation. Moreover the model poorly reflects the manner in which interests may change over time. Our approach, therefore, is one which resembles a kaleidoscope of continually changing patterns where some issues and sectors occasionally overlap, for mutual benefit, and on other occasions may bump into each other. The key analytical question therefore becomes one of understanding when, within this kaleidoscope of cooperation and contestation, do interests, ideas and institutions offer the potential for effective GHG? What circumscribes the prospects for GHG, and what drives its potentialities?

The emergence of global health governance

GHG shares the sense of transformative change and uncertainty over meaning described earlier for global governance more generally. Like

Sector

Issues

Globalgovernance

Figure 1.3 The bumper car model


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the broader field of global governance, GHG began to garner scholarly interest with the end of the Cold War (for example: Lee, 1992). Part of this was due to the removal of the constraints imposed by the Cold War’s narrow agenda, allowing new issues to emerge (McInnes and Lee, 2012b); and part was due to increased fears of emerging and re-emerging infectious diseases which, for the first time in generations, appeared to place high-income countries, as well as low to middle-income coun-tries, at increasing risk (Garrett, 1996; Price-Smith, 2001, 2002). A key development in the literature has been to broaden the idea of GHG away from a focus on the technical competencies of international institutions, and their ability (or lack of) to deal with emerging global issues, and towards a more politicised view of the relationship between the growing number of actors involved. GHG therefore became more than simply what the WHO and other global health institutions could and should do, to a more complex question of how these institutions related to other actors in responding to the globalisation of health (Dodgson et al., 2002; Harman, 2011a; Kay and Williams, 2009).

The literature on GHG therefore does not solely portray it in terms of a rational response to the development of a new global risk. Rather it reflects on many of the transformations identified earlier in global governance, albeit in a sector specific manner. Thus there is a strong sense that the locus of authority had shifted with the emergence of new and changed institutions. No longer were states the only relevant actors, and no longer was the inter-state or multilateral forum of the World Health Assembly – the governing body of the WHO – the unchallenged lead institution in global health (Lee, 1998). The influence of neoliberal economics and the free market could be seen in health sector reforms and especially the development of global public–private partnerships such as the Global Alliance for Vaccines and Immunisation (GAVI) Alliance, as it had been in the health sector liberalisation programmes precipitated in the neoliberal policies of the 1980s (Buse and Walt, 2000a, 2000b; Rushton and Williams, 2011). Civil society organisations began to emerge with a global focus, most obviously in the area of HIV/AIDS activism (McCoy and Hilson, 2009; Youde, 2012, pp. 99–114). New global elites could be identified, the most prominent of which were the five board members of the Bill and Melinda Gates Foundation. Global epistemic communities could be identified, not only in the biomedical sciences, but also in terms of development and health security. And like the wider field of global governance, there is uncertainty over its


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meaning or composition: whether for example it is a shift in the role of international organisations (Youde, 2012); the emergence of a new and dominant organising form determined by neoliberal economic principles (Williams and Rushton, 2011); the increased significance of international regimes (Fidler, 1999); or, as Youde comments, that there is, perhaps, ‘no single global health governance hierarchy and no single solution for global health concerns’ (Youde, 2012, p. 3).

Within this literature on GHG, therefore, a number of themes can be detected: (a) GHG is a response to, and a reflection of, an increas-ingly globalised world, including health determinants and outcomes; (b) it is characterised by existing institutions acquiring new meanings and mandates, and the proliferation of new institutional arrangements; and (c) an increased awareness that the global governance of health is not simply a technical or administrative matter, but a political realm of cooperation and contestation. Although these three themes provide a structure for our analysis of key transformations below, it is via the lens of cooperation versus contestation that this book departs from most analyses of GHG. Building on previous work (McInnes and Lee, 2012a), we argue that the politically contested nature of GHG has as much to do with competing frames of who and what health is for, as it has with competition among global actors. Using social constructivism, we start from the basis that GHG is socially shaped, creating a ‘reality’ which defines problems and solutions. This does not mean it is divorced from material events, rather it exists in a mutually constitutive relation-ship with them: constructed explanations embody material events, and these explanations in turn give meaning and significance to the material world.

Globalisation and fragmentation in global health governance

This book starts from the basis that GHG has been successfully constructed as a fact, even if doubts persist over its extent, meaning and nature. What it focuses on, however, is the neglect to date of how the macro-level narrative of GHG has been translated into (and reflects) mezzo-level narratives on specific issue areas such as HIV/AIDS and tobacco control. Previous analyses have tended to focus on either the ‘big picture’ of GHG (for example: Youde, 2012), or on specific issue areas


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(for example: Harman and Lisk, 2013). This book probes the relationship between the general and specific, how these have been constructed, and with what implications. It is not concerned with the micro-level of analysis – how health care is actually financed and delivered. Rather, it focuses on how the transformation in GHG manifests differently across different issue areas comprising global health, and how this in turn is shaped by and contributes to the higher-level perspective of GHG. To do this, we pick four health issues as balancing both the original focus of GHG on infectious disease (in this book, the chapters on HIV/AIDS and pandemic influenza), as well as non-communicable disease (tobacco, especially attempts to create global regulation on the sale of tobacco) and distributive issues (access to medicines and the international patent rights regime). Our suspicion, based on our previous work (McInnes and Lee, 2012a), was that each case study would reveal a different form of GHG: that the global governance of HIV/AIDS would be characterised by diverse interactions among international organisations, global civil society and states within the health sector and beyond; that pandemic influenza would demonstrate the continuing power of the state in the face of a potential global pandemic; tobacco would illustrate the clash of material interests and ideas between transnational tobacco companies (TTCs) and global health organisations; and that access to medicines would reveal how governance in other sectors, in this case intellectual property rights, can spill over into public health. The importance of such findings, across the governance of different issue areas, would be that macro-level narratives of GHG need to be far more nuanced, recognising that different forms of global governance co-exist; and that aspirations for a single, coherent form of GHG may be overly optimistic. Indeed, in a parallel to the work of Clark and Rosenau on the twin forces of globalisa-tion and fragmentation, we wish to explore whether GHG is both part of a wider global governance movement, influenced by trends and change outside of health, and that simultaneously it consists of multiple different governance structures, fracturing a supposed coherence.

For heuristic purposes, and based on the themes in the literature identified earlier, we identify three broad transformations as constitut-ing the macro-level narrative of GHG. These then provide the analytical structure for the next four chapters, which focus on the individual health issues identified earlier. This common structure allows us to explore the relationship between health governance at the macro-level, and the global governance of individual issues (the mezzo-level). The


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first of these transformations is that health is constructed as a global problem requiring global responses. The second transformation is the emergence of multiple, sometimes competing, ideas surrounding who and what health is for. It concerns the ideas which identify the nature of the problem and shape the nature of the response. The final trans-formation concerns the changed institutional architecture and actors in global health. If the first transformation concerns the construction of the field, and the second the nature of the problem and the possible responses, then this third transformation concerns who is constructed as a legitimate actor in making these responses. It is important, however, to re-emphasise that this divide is for heuristic purposes. Overlaps and links may exist among the three transformations. Thus, certain actors are likely to be linked structurally to certain ideas. For example, the World Bank’s framing of global health has derived from the belief in its macro-economic effects, with health and economic development form-ing a mutually constitutive relationship. Therefore, actors may not only be given legitimacy by the construction of the field but may also, in turn, shape how the field, problems and responses are constructed.

The methodology in this book generally follows Alexander George’s ‘structured focused’ approach for case studies (George, 1979). Our empirical work used available primary and secondary literature, and key informant interviews. Literature was identified using systematic keyword searches on online databases (including Google Scholar, ISI Web of Knowledge, JSTOR, LexisNexis, OCLC ArticleFirst and PubMed), with further sources cascading from these. Over 300 interviews were conducted in locations including Atlanta, Bangkok, Brussels, Canberra, Geneva, London, Manila, Nairobi, New York, Singapore and Washington DC, with policy-makers, government officials, civil servants (including staff at international organisations), civil society and academia. Inter-views were semi-structured using a common data bank of questions. All interviews were conducted on a confidential basis and, where recorded, transcribed to inform analyses. We have omitted direct reference to them where prior permission has not been given.

Transformation 1: ‘health is global’1

The first transformation is the globalisation of health, narratively constructed as the shift from ‘international’ to ‘global’ health, implying


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a qualitative shift in the nature of health interactions across borders (for an early and influential example of this, see Institutes of Medicine, 1997). This narrative is underpinned by reference to events in the material world. In particular, the 2003 outbreak of the novel severe acute respira-tory syndrome (SARS) coronavirus, fears in the middle of the last decade over the spread of a human transmittable variant of H5N1 (‘bird flu’), and the 2010 influenza pandemic appeared to vindicate the 1999 claim of the then WHO Director-General, Gro Harlem Brundtland, that today ‘there are no health sanctuaries’ (Brundtland, 1999). Instead health, like other sectors, could be constructed as being profoundly affected by the process of globalisation. Although globalisation is a contested subject, with disagreements over its nature and meaning, a number of ‘starting assumptions’ can nevertheless be made, which suggest a change in the range and intensity of social actions. Most understandings of globalisa-tion include notions of space–time compression, leading to a qualitative shift in the degree and nature of interconnectedness. This is facilitated by new technologies, allowing increased movement and exchange of people, goods, finance and ideas. Crucially, this results in social action no longer being bounded by territory, including the state. As Joseph points out however, globalisation is less a theory than a rationality which arises from a new set of social practices. The result is that globalisation is often presented as an unarguable fact to which there is no alternative (Joseph, 2012, p. 86). This is important because the manner in which globalisation has been presented as an uncontestable fact has allowed the mantra that ‘health is global’ (UK Department of Health, 2008) to become one of the dominant narratives in contemporary health policy. Health cooperation is no longer described as ‘international’ but ‘global’ in the face of globalisation.

Although the most commonly cited impact of globalisation concerned the speed and scale with which acute and severe infectious diseases might spread (for example, Garrett, 1994), a wide range of other effects were also identified. These include increased drug resistance, changing epide-miological patterns of health and disease, innovations in global informa-tion and communication technologies that influence health, changing patterns of health-related human behaviour, the global restructuring of health-related industries, the mobility of health professionals, and inno-vations in institutional mechanisms for collective action on health (Lee et al., 2002). At the same time, however, the creation and use of the term ‘global health’ has given a multiplicity of trends a shared meaning, which


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encourages us to see the world differently. Statements such as ‘health is global’, therefore, are not simply a reflection of an external reality, but a rallying call to reinterpret how we understand health and its determi-nants, and to draw attention to health issues. Health as global, in this sense, is normative in its framing or social construction of the subject: it is for someone and for some purpose, a progressive force to change the world for the better, not simply a reflection of an exogenous reality.

What has been far from universal, however, is how global health is defined and understood. A key reason for this is that multiple meanings and usages of the term arise from different, and often contested, norma-tive frames. From this perspective, which informs our understanding in this book, global health is not an unproblematic, rational reflection of developments in the material world. Instead, it is a contested field where different social constructions, expressed through normative frames, lead to different interpretations of what the field is, the goals to be achieved and the policy pathways that should be pursued to achieve them (see McInnes and Lee, 2012b).

Transformation 2: competing visions of global health governance

If GHG is cast as a response to globalising forces then, in our previous work, we identified that there is no single idea behind GHG, but rather a series of ideas that are sometimes in conflict or cooperation with each other (McInnes and Lee, 2012a). The second transformation we identify, therefore, is the emergence of competing visions of GHG. Specifically we use the idea of ‘framing’ to allow us to understand how these competing visions are operationalised (see also Gitlin, 1980). Framing occurs when an issue is presented in such a way as to tie it into a socially constructed reality, and through this, an issue can gain influence and policy purchase. Frames are deployed and promoted by a range of stakeholders, including governments, corporate actors, transnational advocacy groups, inter-national organisations and epistemic communities. As Haas describes, these are the ‘cognitive baggage handlers of constructivist analyses’ (Haas, cited in Youde 2005, p. 423). In global public health, competing ‘baggage handlers’ frame health issues in particular ways (for example as a biomedical, human rights, security or economic issue), in an attempt to generate or legitimise specific pathways of response on health issues.


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When they are successful, the chosen frame ‘resonates with public understandings, and is adopted as a new way of talking about and under-standing issues’. Actors are likely to modify their behaviour accordingly (Finnemore and Sikkink, 1998, p. 897). For example, pandemic influenza has been framed by some global health actors as a security issue (or ‘threat’) to increase support for emergency preparedness and response planning (Kamradt-Scott and McInnes, 2012), while a network of public health advocates framed tobacco control as a human rights issue in an attempt to tie it into wider legislation on human rights (Reubi, 2012). But framing can also be constitutive of meaning; that is, frames may move beyond being merely a presentational artifice to promote certain actions, and become a means of shaping the way in which a health issue is understood. Frames achieve this by presenting an issue area in terms that have meaning for a worldview and, therefore, are associative with that worldview. Thus, framing pandemic influenza as a security threat has contributed, not only to certain actions being undertaken, but also to shaping understandings of the disease as a global health issue (namely as a transboundary threat). What may therefore begin as a political tactic to gain attention and resources for a health issue may become central to the construction of its very meaning.

The key advantage in using the concept of framing to expand our under-standing and explanation of GHG is its recognition of the importance of ideational factors. In short, the manner in which an issue is framed opens up specific acceptable pathways of governance response, based upon shared understandings (or what we term ‘visions’) of desired global health outcomes. How issues are framed can tap into powerful ideational forces that may prove as significant as institutional competencies, inter-ests and agendas (the subject of much of the existing GHG literature) in shaping GHG, including facilitating or hindering effective GHG. In this book we use five key frames: evidence-based medicine, security, devel-opment, economics and human rights (see Box 1.1). A close reading of policy debates on global health over the past two decades suggests these to be dominant frames used in the emerging realm of global health (for a fuller discussion, see McInnes and Lee, 2012a). Most of these frames are, of course, internally contested, with competing theories, method-ologies and approaches leading to different policy prescriptions (McInnes and Roemer-Mahler, forthcoming). However it is possible to identify a higher-level commonality in worldview that defines the frame as coher-ent despite internal contestations (see McInnes et al., 2012, S83–94).


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Transformation 3: the changing institutional landscape of global health governance

The third major transformation concerns the powerful narrative of an unprecedented increase in the range and number of institutions involved in governing global health since the mid-1990s. As WHO Director-General Margaret Chan (2011) observed, there have been ‘truly stunning increases in the number of actors, agencies, and initiatives funding or implementing programmes for health development. The landscape of public health is crowded’. The institutional players include established intergovernmental organisations concerned with health cooperation and those with wider mandates beyond health (such as the G8, World Bank and UN Security Council), as well as non-state actors (for profit and not for profit). Although some states continued to play an important agenda setting role, not least through bilateral and multilateral aid programmes such as PEPFAR, civil society organisations (such as the International AIDS Society, International Women’s Health Coalition and Framework Convention Alliance) have also gained prominence, not least in agenda setting and norm entrepreneurship (Keck and Sikkink, 1998; Mamudu and Glantz, 2009). Most striking however, has been the emergence of a range of ‘hybrid’ public–private and purely private (if not for profit) insti-tutions, which are now at the very heart of practical responses to global health. These include global health partnerships, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, the GAVI Alliance and charita-ble foundations, most notably the Bill and Melinda Gates Foundation. By the beginning of the 21st century, these new and sometimes institution-ally innovative actors had become recognised as central to, and legitimate actors in, GHG. This rise of non-state, private organisations and funding sources (which even if state-based in origin are disbursed by private or civil society organisations), has been accompanied by a shift towards private forms of authority in health governance (Rushton and Williams, 2011). This includes a deliberate diffusion of authority from the state and traditional inter-state multilateral forums. This shift has also involved a conscious strategy of engagement with the private sector, most notably but not exclusively the pharmaceutical industry, in the generation of governance responses to a very narrowly circumscribed, though impor-tant, range of diseases (communicable diseases with epidemic potential such as influenza, SARS, tuberculosis, HIV/AIDS). Many of these new global health institutions have assiduously sought to work with market


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actors to further their goals, perhaps most notably in the area of access to medicines. Far fewer have sought to challenge the potential role of markets in perpetuating health inequalities that have arguably created and perpetuated inequities of access. Moreover, these forms of GHG, by adopting resources, techniques, practices and language drawn from the corporate sector (Bishop and Green, 2008), represent a particular model of aid and health governance (Rushton and Williams, 2011).

The growth in the number of institutions involved in GHG has been two dimensional: increased funding attracts new institutional players, while others brought new sources of funding to global health. Although more often than not donated by G8 states, the modality of health decision-making and service delivery has unquestionably changed. Much of the new money earmarked for ‘global health’, until more recently, has been focused on selected diseases channelled through vertical programmes rather than supporting health systems. Moreover, other health issues (such as non-communicable diseases) posing significant, and even far greater, burdens of morbidity and mortality, as well as the social deter-minants of health (WHO, 2008a), have failed to attract commensurate policy priority and resources. Crucially, for the purposes of this book, this inequitable distribution of global health resources is directly reflected in the institutions and associated governance mechanisms that comprise GHG. Signs of a wider recognition of the imbalances that characterise GHG has been evidenced in the work of the WHO Commission on the Social Determinants of Health (WHO, 2008a), the increased attention to health systems strengthening (HSS) and the belated but growing prior-ity given to non-communicable diseases (NCDs); GHG, in this sense, continues to evolve. Some institutional arrangements remain narrowly focused, in terms of the issues and interests served, whereas others seek to directly challenge this agenda. The tensions between cooperation and contestation continue to be played out, shaping the ideas, interests and institutions that define global health thinking and practice.

Conclusion

This book explores how the narrative of transformational change in GHG has been reflected in individual health issues. Importantly however, this is done within a context, outlined in this chapter, where policy issues from other sectors of global governance (such as trade, human rights and secu-


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rity) may impact upon health, and where the governance of one health issue may impact upon another within GHG. Our theoretical basis is one of social constructivism. For us, GHG involves the interaction of events in the material world and ideational framings and interpretations. Our exploration proceeds with four chapters, each focusing on a particular health issue, and each structured by the three transformations identified in this chapter. We use a fairly orthodox assumption that globalisation is a key driver in the narrative of transformational change, and that globalisa-tion is more than ‘bilateralism on steroids’ but rather a qualitative change in the nature of global relations. Nevertheless, we accept that bilateralism is an important feature of this new global landscape – but it is not the only and arguably not the most important feature.

Given our theoretical underpinnings, it is perhaps unsurprising that we do not attempt to measure the degree of transformation in GHG. Rather, we accept it as a socially constructed ‘fact’, and are interested in how the macro-level narrative of change in GHG is mirrored in that of individual health issues. Nor are we especially interested in determining the effec-tiveness of GHG, though our research does lead us to suspect that one of the problems in seeing GHG as a ‘failure’ is that it is seen in terms of an end point – an effective mechanism, or system, for meeting global health needs and mitigating global health risks. Our empirical work – reflected in the subsequent chapters – leads us to consider it instead, simultane-ously, as a process of change and adaptation and as an arena where actors, institutions and ideas interact. One of the defining features of this proc-ess is contestation – between actors and institutions, and between ideas. It would be tempting to suggest that this contestation is a ‘problem’ in preventing the coherence of GHG and the harmonisation of policies, leading to sub-optimal results. But instead we see this as also possessing healthy attributes, not least in encouraging pluralism and democracy in GHG. It also enables progress through the interaction of different ideas and perspectives on health issues. As a result, we suspect that a settled, shared vision of GHG is unlikely and possibly undesirable.

Box 1.1 Five visions for framing global health

This box identifies, in broad terms, five ‘visions’ which underpin framings of global health – that is, they provide an idea which fram-ings can resonate with in order to legitimise or generate support for a particular response. These visions are presented here in terms of


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high-level commonalities and inter-subjective understandings, but they also consist of internal debates and contestations.

Evidence-Based Medicine (EBM)

By the late 1990s EBM had become fully embedded within the majority of medical (clinical) training programmes internationally. At its core, it encourages and reinforces positivist, rationalist ways of reasoning – namely, that a world exists independent of observation that can be analysed using epidemiological and biostatistical tools to provide data that will inform health-related policy decisions (see Davidoff et al., 1995; Rosenberg and Donald, 1995; Sackett et al., 1995; Sackett et al., 1996). Use of this frame is often identifiable by reference to ‘evidence’ to support decision-making and the deployment of particular techniques such as ‘systematic reviews’ to inform policy development. In this regard, language is strategic in that the adop-tion and use of terms such as ‘evidence based’ and ‘systematic’ reifies and reinforces rationalist thinking while simultaneously categorising and condemning other forms of reasoning as inferior (that is, who wouldn’t want to use evidence to support their decision-making? Who wouldn’t wish to be systematic?).

Human rights

Over the past 20 years, there has been a marked resurgence in public health and human rights (Reubi, 2012). Perhaps the two most signifi-cant issues in this resurgence were HIV/AIDS and, later, access to medicines (Olesen, 2006; Biehl et al., 2009; Rushton, 2012). However, other global health issues have also been framed as human rights problems, from maternal and child health to tobacco control (Shiff-man and Smith, 2007; Reubi, 2012), whereas from the late 1980s/early 1990s, the gradual shift from population to reproductive health also contributed significantly to the prioritisation of human rights in global health. Although the relationship between the moral–legal rhetoric of human rights and global health is highly contested, it is still possible to identify two particularly influential understandings. The first is that human rights are moral values that should guide public health experts and ensure that their policies and practices are not discriminatory, coercive or undemocratic (see Mann et al., 1994; Mann et al., 1999). The second is that the relationship between human


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rights and health is primarily about the right to health: the right to receive appropriate and affordable health care (see UNCESCR, 2000; Hunt, 2004; Hunt and Backman, 2008). Unlike the first definition, this conception of human rights and health emphasised the impor-tance of international legal norms, judicial enforcement mechanisms and human rights lawyers (Reubi, 2012).

Economics

This is a particularly diverse and internally contested vision. Market-based theories (that supply is best determined by demand, and price is best set by a ‘free’ market) compete with public-goods theories (that public provision of health is rational because of the innate qualities of health and its contribution to economic growth). Each theory, however, infers a rational basis of how to use and distribute scarce resources and it is this which underpins economic framings of health. The basic underlying logic that unites all vari-ants of economics in the context of health is that demand for health is inelastic (if you are ill then your demand for treatment does not vary with your income or the price of the treatment), and that the resources that can be devoted to health are scarce. The economic frame is therefore manifested when arguments about efficiency, choice and competitiveness are used to justify the distribution of these scarce resources in particular ways. Thus, health economics is about the rational basis for making choices regarding how to deploy and distribute scarce resources to optimally meet health needs (see Mills, 1997) and generally employs the methodology of classical liberal economics (for example, cost-benefit analysis).

Security

Like economics, security is highly contested. Traditionally, security has been narrowly understood in terms of a clear and present danger to the state, but over the past two decades this has broadened to include other referent objects and a wider range of risks, some of which may be more tangible than others (Buzan, 2001; Booth, 2007). This led Buzan to suggest that security is ‘essentially contested’ (see Booth, 2007, p. 99) – that is, a concept which generates unsolvable debates about its meaning and application. These contestations have allowed a variety of different terms to become used in the framing


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of health security, each implying different referent objects (in other words, whose security should be protected). These include human security, national security, international security and global health security. The underlying logic that is common to all forms of secu-rity, however, is that of threat and defence (see Gray, 2009), though sometimes alternative terms such as ‘risk’ and ‘protection’ might be used (see Williams, 2009). Thus, health becomes a security issue when it is perceived and presented in the following ways: (1) as a threat to someone or something, and (2) as something which defen-sive measures (either in the form of prevention or response) must be taken against. This is the hallmark of the security frame in global health: x is a threat/risk to a referent object in respect to which we must put defensive/protective measures y in place.

Development

Although there is no single, universally applicable narrative of development, most proponents share an enthusiasm to improve conditions and establish progress in the Third World, where the First World becomes something of a benchmark for measurement (for a critical perspective on this, see Escobar 1995, 2004). The ultimate goal of improving health in the Third World is presented as unarguable and a universal given; rather, the means to achieve it form the point of disagreement for advocates, with a plethora of theories such as modernisation, dependency and trickle-down economics going in and out of fashion (recent examples of this include Farmer, 2003; Sachs, 2005; Collier, 2007). Development narratives are characterised by a series of hierarchical binaries (developed/underdeveloped, donor/recipient, rich/poor, healthy/unhealthy, active/passive, hegemonic/subordinate, strong/weak, for example) which places the idea of ‘lack’ vis-à-vis the developed world at the heart of this frame (Escobar 1995, 2004).

Note

This is the title of the UK’s cross-departmental White Paper on global health, published in 2008 (Department of Health, 2008).

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2HIV/AIDS

Abstract: This chapter examines the global governance of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) by, first, tracing how HIV/AIDS came to be seen as a global issue requiring a concerted international response. Second, it identifies how different framings of ‘the AIDS problem’ – such as a security issue, a rights issue or a development issue – have affected international responses. Finally, it discusses how and why there have been so many changes in the global AIDS governance architecture. It demonstrates how these three transformations are interlinked, and how they have come together to produce an unprecedented global effort to tackle the disease. The chapter argues that HIV/AIDS has not just reflected the changes we have seen in global health governance – to a great extent it has been responsible for bringing them about.



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Introduction

HIV/AIDS1 has been the defining health crisis of the era of global health governance (GHG). It has caused death, ill health and suffering in every country of the world, but perhaps most notably in sub-Saharan Africa: 34 of the 36 countries with generalised HIV epidemics are in sub-Saharan Africa (UNAIDS, 2013). The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that there were approximately 21.5 million AIDS-related deaths worldwide in the first decade of the 21st century (UNAIDS, 2012). Whilst the number of new HIV infections seems to be declining, in 2012 they still amounted to some 2.3 million (UNAIDS, 2013). As a result of these shocking statistics, HIV/AIDS’ impact has been felt far beyond the traditional ‘health sphere’. It has had huge social, political and economic effects – not least in those countries with the highest prevalence rates. The ways in which the HIV/AIDS crisis has been interpreted and responded to internationally have also been central to the development of GHG. Kirton and Mannell (2007, p. 115) cite the spread of HIV as ‘the first sign of the failure of the old multilateral and regional health actors.’ Ilona Kickbusch, meanwhile, has argued that the disease ‘transformed public health into a global endeavour’ (2007, p. xi). As we show in this chapter, HIV/AIDS has been a vanguard for the ideas of global health and GHG, both reflecting and contributing to the ‘three transformations’ identified in the Introduction to this book. The disease has illustrated all too clearly the extent to which ‘health is global’; it has been a highly politicised issue and subject to a wide range of different ideas about who and what health is for; and the global response to it has led the way in pioneering new governance innovations.

This chapter examines in turn the ways in which HIV/AIDS was constructed as a global issue, how different framings of ‘the AIDS prob-lem’ have affected international responses, and how and why there have been so many changes in the global AIDS governance architecture over time. We also show how these three transformations are interlinked, and how powerful ideas about HIV/AIDS (for example the ways in which it is linked to international development, or the ways in which it threatens international security) and the material ‘facts’ of the pandemic have come together to produce an unprecedented global effort to tackle the disease. The apparatus of ‘global AIDS governance’ has grown exponentially over time, from a small office in the World Health Organization (WHO) in the mid-1980s to the current situation in which there are myriad governance

HIV/AIDS

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actors at the global, regional, national and local levels engaging with a multitude of political processes, internationally agreed targets, and multi-lateral, bi-lateral and domestically funded programmes. It used to make sense to talk about HIV/AIDS as a ‘neglected disease’; now it is more commonly criticised for disproportionately dominating the global health landscape (England, 2007). How can the constructivist approach adopted in this book help us grasp how and why this has happened? Our key points in this chapter are firstly that we need to understand the rise of HIV/AIDS to the top of the global agenda as the product of both material and ideational factors; and secondly that AIDS has not just reflected the changes we have seen in global health governance – to a great extent it has been responsible for bringing them about, radically altering the ways in which we perceive health beyond the borders of the nation state, and why we see it as necessary to respond to such problems on a ‘global’ basis.

HIV/AIDS as a global issue

Until the WHO established its ‘Control Programme on AIDS’ in 1986, Director General Halfdan Mahler considered HIV/AIDS to be a disease only affecting high-income countries (HICs). He was soon persuaded otherwise (Lee, 2009, pp. 58–9). By that stage it was already appar-ent that the human immunodeficiency (HI) virus – first identified as being linked to AIDS in 1984 (Gallo et al., 1984; Gallo and Montagnier, 2003) – was global in its geographical spread. Indeed it only took until 1985 for cases of AIDS to be identified in every region of the world (Sepkowitz, 2006). It is now well-established that the HI virus had been circulating in human populations, especially in Africa, long before it was identified. The ability to test for HIV and to diagnose AIDS, however, was a prerequisite to it being understood as a worldwide phenomenon. The growing realisation that the emerging pandemic was of such scale and severity that it was going to require an excep-tional global-level response was reflected in the rapid development of the WHO’s bureaucratic structures. The Control Programme on AIDS was superseded by the ‘Special Programme on AIDS’ in February 1987, and then by the ‘Global Programme on AIDS’ in January 1988 (Lee, 2009, pp. 58–9; Lisk, 2010, p. 14), the changes in nomenclature and status of these offices charting both the ever-expanding geographical


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focus of the WHO’s HIV/AIDS work and also the perceived need for the Organisation to have a permanent and sustainable department focussed on HIV/AIDS (Lisk, 2010, p. 14). By the mid-1990s a feeling had emerged that HIV/AIDS was too big for the WHO and that the multi-sectoral nature of the pandemic – the fact that it was more than just a health problem – necessitated a UN System-wide response. The creation of United Nations Joint Programme on HIV/AIDS (UNAIDS) in 1996 was intended to deliver this, bringing together and coordinat-ing the HIV/AIDS-related work of the spectrum of UN agencies with a genuinely global mandate.

The epidemiological ‘global-ness’ of the pandemic, however, cannot sufficiently explain why it was that HIV/AIDS came to be seen as one of the quintessential examples of a ‘global health’ issue. Many other diseases (both communicable and non-communicable) are similarly global in their occurrence, but few have become so widely understood as global health challenges. Even fewer have achieved anything like the promi-nence of HIV/AIDS in GHG. That HIV/AIDS came to be understood as ‘global’ is perhaps even more surprising because the HI virus is in many respects unlike rapidly transmissible pathogens such as severe acute respiratory syndrome (SARS) and influenza, which have also been at the forefront of claims about the ‘global’ nature of health in the world today (see Chapter 3). HIV is much more difficult to transmit than influenza, for example. And, unlike influenza, it cannot be transmitted through casual social contact (flying on the same aeroplane; sitting in the same classroom) but only through the transmission of contaminated body fluids. As a result, it spreads through populations much more slowly than flu or SARS. Thus, whilst HIV has provoked more than its fair share of fear (and continues to do so), it is in many ways dissimilar to the dread scenario of an infectious, rapidly spreading and highly deadly virus that crosses the globe and infects millions in a matter of days.

If the material ‘facts’ of HIV/AIDS cannot adequately explain why this and not other diseases came to be seen as ‘global’, then we need to look at the ways in which ideas were used to construct it as such. In the HIV/AIDS case there was no single narrative of ‘global-ness’, but rather a range of narratives which each pointed to different reasons for understanding HIV/AIDS as global and which (as we shall see in the next section of this chapter) served to shape global responses in a variety of ways. Here we focus on three distinct (although overlapping) ways in which HIV/AIDS was constructed as a global concern, at the same time identifying

HIV/AIDS

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some of the agents responsible for forwarding those constructions and successfully make the case that ‘AIDS is global’.

The first is a genuine, arguably cosmopolitan, humanitarian concern for the well-being of individuals around the world. HIV/AIDS is a disease which is striking not only in its effects on the body, but also in its impact on families and communities. AIDS often kills the relatively young, the poor and the socially disadvantaged; but even the recognition of those facts speaks to a notable shift in perceptions of the disease that occurred only gradually and as a result of determined activism. In the early days of the epidemic (and, regrettably, still today in many places) HIV/AIDS was associated primarily with ‘irresponsible’ or ‘immoral’ individual behavioural choices. Terms such as ‘gay plague’ were a common feature of early public debates over HIV/AIDS (see for example: Daily Telegraph, 1983). The US commentator Patrick Buchanan famously wrote in his newspaper column that ‘The sexual revolution has begun to devour its children. And among the revolutionary vanguard, the Gay Rights activists, the mortality rate is highest and climbing’ (Buchanan, 1983, p. 311). Similar, if less stridently expressed, views were also common in government circles. Indeed it was not until 1987 that Ronald Reagan first used the word ‘AIDS’ in public, and when asked what people should do about AIDS he replied ‘Just say no’ (Gill, 2006, p. 10). Even the early scientific nomenclature – ‘Gay-Related Immune Deficiency’ – reflected this view of HIV/AIDS as being linked to particular sexual identities and particular forms of ‘risky’ behaviour.

A range of factors contributed to the remarkable transition that HIV/AIDS has undergone, from a ‘politics of blame’ to a ‘politics of humani-tarianism’. These include material changes in the nature of the epidemic, especially the emergence of huge and generalised epidemics in sub-Saha-ran Africa; improved epidemiological understanding of the relationships between HIV infection and other social and economic factors, not least poverty; sustained efforts by activists and others to destigmatise people living with HIV; and the recognition that the worst-affected countries of the Global South could not tackle HIV/AIDS without significant external assistance. Nowhere was this shift seen more starkly than in the US Christian right’s increasing concern with HIV/AIDS in the develop-ing world, an engagement motivated by humanitarian considerations which, due to their domestic political power, was extremely influential in Washington policy circles. Although there were also other factors at work, the demands of the Evangelical lobby that President George W.


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Bush do more to address HIV/AIDS as a ‘global emergency’ were highly significant in bringing about the President’s Emergency Plan for AIDS Relief (PEPFAR), even more so since it was backed by key conserva-tive voices such as that of Senator Jesse Helms, traditionally a critic of large-scale foreign aid programmes (Dietrich, 2007). The emphasis placed by this and other lobbies on both the human costs of HIV/AIDS (which recognised (global) social and economic determinants) and on the existence of responsibilities to people living with HIV/AIDS beyond our borders – including ensuring they had access to treatment (see Chapter 5) – was one of the ways in which HIV/AIDS was constructed as a ‘global’ issue. As we argue throughout this book, this construction rests not only upon certain material ‘facts’ (the number of people dying from AIDS in sub-Saharan Africa, for example) but also upon those facts being interpreted as having a particular significance according to an established set of ideas and values.

A second way in which HIV/AIDS has been constructed as ‘global’ is through its linkages to international development. Promoting develop-ment has – in the 21st century in particular – assumed the status of a top-tier global political challenge. Development has become a global concern, and as a result the obstacles to development also become global issues. AIDS’ prominence in the development discourse has, therefore, contributed to the understanding of it as a global, not just an individual or national, issue. For example, in We the Peoples, the report of UN Secretary-General Kofi Annan to the UN General Assembly’s Millennium Summit at which the Millennium Development Goals (MDGs) were adopted, HIV/AIDS was presented as a key obstacle to international development. Indeed such is the emphasis on HIV/AIDS in the report that Hulme (2007, p. 10) notes that, ‘a Martian reading the final chapter of We the Peoples could reasonably conclude that HIV/AIDS was the only health problem facing the Earth’s poor people’. Other health issues (including low spending on health care; a lack of research into neglected diseases; and a lack of access to drugs, vaccines and other basic interventions) were highlighted in the report. However, after briefly noting them, the report said: ‘It is beyond the scope of this report to explore all of these challenges. I wish here to focus on a specific health crisis that threatens to reverse a generation of accomplishments in human development, and which is rapidly becoming a social crisis on a global scale: the spread of HIV/AIDS’ (Annan, 2000). The following year, the UN General Assembly’s Declaration of Commitment on AIDS

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(which ultimately led to the creation of the Global Fund, discussed later) echoed this reasoning in paragraph 11 which notes ‘with grave concern that HIV/AIDS is compounding poverty and is now reversing or imped-ing development in many countries’ (UN General Assembly, 2001). The MDGs have motivated significant investment in AIDS – not least through the Global Fund – but what the rhetoric around the MDGs also exemplifies is a broader claim: that AIDS is a global issue not just because it occurs globally, but also because it undermines global development, in particular the economic progress of those countries with the highest burden of the disease.

The idea that HIV/AIDS could pose a national, regional and interna-tional security threat is a third way in which it has been seen as (poten-tially) global in its effects. The theory that high levels of HIV prevalence could destabilise states and undermine the effectiveness of militaries and security services became particularly prominent in the late 1990s and early 2000s, especially amongst US security policy communities, and later in the UN Security Council (McInnes and Rushton, 2010). That the Security Council passed Resolution 1308 declaring HIV/AIDS a ‘threat to international peace and security’ was a major statement of the global implications of the disease. Indeed, the Council’s first meeting of the millennium was on HIV/AIDS (the first time it had ever discussed a health issue), which suggests the extent to which governments by then recognised the ‘global-ness’ of the issue. Further, this meeting in turn contributed to the further construction of HIV/AIDS in global terms and legitimised the calls for an augmented global response: the Security Council’s seal of approval added weight to the claim that HIV/AIDS is a global issue, notwithstanding that some of the empirical claims that underpinned Resolution 1308 have come under critical scrutiny (Barnett and Prins, 2006; McInnes, 2011).

It is clear, then, that HIV/AIDS is ‘global’ in a variety of ways – or at least that it has proven susceptible to being constructed as ‘global’ in a variety of ways. But why was HIV/AIDS a disease around which it was possible to successfully argue that it is ‘global’ when similar cases have not been built around other health challenges? Here we point to a combination of agency and facilitating conditions (both material and ideational). First, as is evident in the earlier examples, HIV/AIDS has been deliberately framed as global in various ways by a range of actors, not only to draw attention to the issue, dramatise it and encourage the devotion of resources to tackling it, but also to seek to influence the


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ways in which those resources are deployed. The success of those efforts, however, was dependent on the material and ideational context in which they occurred. The empirical existence of a huge number of people living with HIV and AIDS around the world was one clear prerequisite: successfully making the arguments that the disease has development and security implications in particular rested upon a critical mass of infections in particular geographical regions. Yet other contextual issues, including those we discussed in Chapter 1 of this book, mattered too, including: the idea that health is affected by globalisation; the broadening global political agenda post-Cold War; and the existence of a ‘zeitgeist’ prioritising international development as a global concern around the turn of the millennium.

Constructing responses to HIV/AIDS

The various efforts to construct HIV/AIDS as a global issue were made in order to motivate and/or legitimise global responses to the pandemic. One of the clearest aims was to persuade donor governments to commit resources to the fight against HIV/AIDS. The previous section examined three versions of the ‘AIDS is global’ narrative that could each be readily translated into arguments for more money to be committed: as ‘the right thing to do’ in the case of the humanitarian narrative; as necessary for achieving other global goals in the case of international development; and as enlightened self-interest in the case of the security narrative. In the case of HIV/AIDS, perhaps more than any of the other health issues we examine in this book, a wide range of different frames – including all of those that we discussed in Chapter 1 – have been in evidence. These different ideas have shaped what kind of problem HIV/AIDS is consid-ered to be, and also what we should do about it at all levels, including the global.

Yet, as we also show in this section, it is again the case that not everything comes down to ideas. The nature of global governance responses has also been profoundly affected by material factors. Perhaps the clearest example of this was the development of Highly Active Antiretroviral Therapy (HAART), which came on stream in 1996. That scientific breakthrough completely transformed the global governance of HIV/AIDS, shifting the emphasis from prevention to a primary focus on rolling out treatment across the world. Formal political commitments

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to ensuring universal access to treatment followed, as did a huge level of investment channelled through the Global Fund, PEPFAR and other funding mechanisms. Even here, however, it was the combination of the material and the ideational that mattered: medicines of course had to exist in order to be rolled out, but the political commitment to do so had to be generated too – and that was brought about by a set of ideas and discourses.

The enormous scale of the global response to HIV/AIDS sets it apart from other global health issues and has attracted criticism from those who argue that HIV/AIDS has been disproportionately prioritised vis-à-vis other areas of health (England, 2007, 2008). The inclusion of HIV/AIDS in the MDGs was a crucial moment in bringing about this prioritisation. Whilst HIV/AIDS had already received international attention prior to the turn of the millennium (UNAIDS, for example, was launched in 1996), the MDGs both drove a massive increase in international investment in HIV/AIDS and cemented its place on high-level political agendas over the early years of the 21st century. Many major donors and multi-lateral agen-cies explicitly focussed their efforts on meeting the goals, and a number of new institutions were created specifically to address them. HIV/AIDS’ inclusion amongst the MDGs therefore made it one of the major benefici-aries of the MDG-driven development agenda and significantly raised its profile in global health governance. Shiffman and colleagues found that, between 1998 and 2007, funding for HIV/AIDS rose from 5.5 per cent of overall health aid to nearly half (Shiffman et al., 2009). This rise was due in no small part to the MDGs. There was, however, nothing pre-ordained about AIDS making it into the MDGs. As David Hulme (2007) points out, HIV/AIDS had not been included in previously negotiated sets of targets. The Organisation for Economic Co-operation and Development-Development Assistance Committee’s (OECD-DAC) International Development Goals (effectively, the forerunner of the MDGs), for exam-ple, made no explicit mention of HIV/AIDS. Yet the General Assembly’s Millennium Declaration pledged to have ‘halted, and begun to reverse, the spread of HIV/AIDS, the scourge of malaria and other major diseases that afflict humanity’ by 2015 – the target encapsulated in MDG6.2 The framing of HIV/AIDS not just as an international development issue but also as one of the pre-eminent international development challenges was a crucial factor in its inclusion in the MDGs and thus a vital part of the explanation for the scale of the global governance response to HIV/AIDS. The disease was successfully framed as a stumbling block to development,


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which could not be overcome without assistance. The necessary solu-tions, it was argued, are beyond the capacity of individual states (Pirages, 2007, pp. 625–7). The acceptance by the relatively wealthy countries of the developed world of the need for them to play their part in financing that response was clearly reflected in the MDG commitments they agreed to, and later in the Global Fund and PEPFAR which they financed.

Development concerns do not, of course, explain everything, and there seems to be little doubt that the framing of HIV/AIDS in security terms also had an impact in motivating a concerted global response. Certainly security considerations played a part in motivating President George W. Bush to launch PEPFAR, by some distance the largest bi-lateral funder of HIV/AIDS programmes over the past decade. The notion that HIV/AIDS constituted a security threat had largely been forwarded by the United States (McInnes and Rushton, 2013), and subsequently formally endorsed by the UN Security Council. The view that AIDS had the potential to destabilise states – especially in sub-Saharan Africa, but also, some feared, in the more strategically important ‘next wave’ of states which included Russia, India and China (Gow, 2002; National Intelligence Council, 2002) – was thus well-established by the time PEPFAR was announced, and was reflected in the ‘Emergency’ in the programme’s name. Without interven-ing directly to head off this looming security threat, the logic went, the international community (not least the United States) could find itself facing a much larger and more expensive task: of stabilising states and dealing with the consequences of collapse. Thus the identification of HIV/AIDS as a particular kind of problem (in this case a security problem) played a part in persuading Western governments – especially the US government – to invest resources in tackling it. It also helped shape some of the ways in which those resources were spent. An example of this was the US Department of Defense’s assistance to African militaries in coping with the effects of HIV and AIDS on their military effectiveness.

As this shows, the different ways in which HIV/AIDS has been constructed as a global problem have impacted not only on the scale of the global response, but also affected the ways in which governance inter-ventions have been targeted and implemented. Here we show through three illustrative examples some of the ways in which particular fram-ings of HIV/AIDS have affected governance responses. The first example shows how the fundamental norms and principles underpinning the global governance of HIV/AIDS have come to reflect ideas around health and human rights. The second shows how the ideas that have informed

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the HIV/AIDS’ response have articulated with wider global governance processes and ideologies, allowing a degree of exceptionality from the dominant neoliberal economic paradigm. Finally the third example shows how economic ideas have shaped specific HIV/AIDS initiatives ‘on the ground’ in developing countries. Through these examples, therefore, we show the impact of the ideational on global AIDS governance at all levels: its underpinning principles, its relationship to global governance more broadly and how it can play out at the level of specific interventions. In the next section of the chapter we take this a stage further, examining the ways in which the institutional ‘architecture’ of global AIDS govern-ance has developed over time, and the role of ideas in this process.

The extent to which human rights concerns have been at the heart of global AIDS governance is one of the things that has been most distinc-tive about it, and one of the clearest ways in which the global HIV/AIDS response has represented a challenge to traditional ways of ‘doing business’ in global governance. Jonathan Mann is widely credited with playing a pivotal role in ensuring that human rights considerations were at the heart of the AIDS response at the global level. As the first head of the WHO’s Global Programme on AIDS (GPA) in the early 1990s, Mann ensured that human rights were prominent in the WHO’s approach, not least through establishing a human rights office within the GPA (Fee and Parry, 2008, p. 61). The legacy of Mann’s work is the extent to which human rights considerations have shaped the form and nature of AIDS policy. All major global governance discourses in the HIV/AIDS field now feature human rights prominently, and their legitimacy would quickly be called into question if they failed to do so. As is reflected throughout this book, the idea of a human right to health is well-established and has been used in relation to a wide variety of different health issues – from access to medicines to the right of people not to be exposed to second-hand smoke. In the HIV/AIDS case perhaps more than any other, however, the rights of people living with HIV (PLWHIV) have been front and centre and, crucially, have been specified in terms that go far beyond the general invocation of a ‘right to health’, instead being expressed as a range of civil and political rights, and in some cases economic and social rights as well.

The second example concerns the ways in which the framing of HIV/AIDS as a global development and security crisis enabled a challenge to be posed to neoliberal orthodoxies. As Ingram (2013), drawing on Sparke (2009 ), argues, HIV/AIDS was placed outside the neoliberal paradigm for dealing with infectious diseases (that wealth breeds health) by its framing


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as ‘an exceptional humanitarian emergency with security implications’ (Ingram, 2013, p. 441). Instead it became a leading example of what Sparke describes as ‘market foster care’, where limited, targeted interven-tions are justified because health problems are sufficiently exceptional as to prevent the normal mechanisms for economic growth operating. We address the access to medicines issue in far greater detail in Chapter 5 of this book, but at this point it is sufficient that this illustrates the ways in which particular framings of AIDS as a global problem enabled global AIDS governance to go against the grain of global economic orthodoxy. However, as Ingram (2013) also notes, the exceptionality of HIV/AIDS in this respect has more recently come under threat: there has been a declin-ing sense of emergency, and HIV/AIDS is gradually being brought back into line with the neoliberal development paradigm premised on the idea of scarcity and more forgiving of the existence of inequalities.

Our third example illustrates how economic ideas have impacted in very specific ways on programme implementation, and have led to new ways of attempting to prevent HIV infection. Sophie Harman (2011b ) has examined the use of ‘conditional cash transfers’ in an attempt to change individual behaviour, either by encouraging behaviours associated with a decreased likelihood of infection, or by discouraging individuals from engaging in ‘risky’ behaviour. Harman looked at two World Bank-backed pilot studies, in Tanzania and Malawi. In the first, payments of $10–$15 per month were made to girls who regularly attended school, something that is associated with delaying sexual activity amongst young girls. In the second, individu-als from 18 to 30 were discouraged from engaging in unsafe sex through a system of regular screening for STIs, with payments being conditional upon them not acquiring STIs during the time of the project. Underpinning both of these initiatives were a set of economics-derived assumptions about the rationality of individual behavioural choices, and about the potential of money to alter the cost–benefit analyses individuals make. As Harman argues, there are clear ethical questions raised by such approaches, but at the very least they demonstrate the extent to which economic ideas and framings have come to influence some governance responses.

Institutions and actors concerned with HIV/AIDS

In this final section of this chapter we look at the development of the global AIDS governance architecture and the relationships between that

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process, the framing of the HIV/AIDS pandemic, and broader changes in global governance. It is clearly the case that the timing of HIV/AIDS’ emergence and spread affected the nature of the global governance framework that developed in response to it. As we noted in the previ-ous chapter, in the post-Cold War period there was a transformation of global governance that went far beyond health, bringing with it a raft of new norms, policies and institutions – as well as a perceptible shift in authority away from states and towards a variety of other public, private and civil society actors. These trends had a number of implications for global health governance specifically, including (i) a multiplication of actors and the entrance into the health policy arena of a range of institu-tions who had not previously seen health as part of their remit; (ii) the legitimisation of private forms of authority; and (iii) an increased role for (global) civil society – including within formal governance arrange-ments. Each of these trends is abundantly evident in the global response to HIV/AIDS, but, crucially, in each case it would also be true to say that HIV/AIDS served as a vanguard. Developments in the global govern-ance of health were in part a response to the global political zeitgeist, but they were also affected by the complex and multi-sectoral nature of the HIV/AIDS pandemic. HIV/AIDS changed ideas about how ‘governance’ should be done, and about what ‘good global governance’ looks like.

First, there is no doubt that we have seen a multiplication of HIV/AIDS governance actors. Some of these have been existing organisations who have begun to address HIV/AIDS for the first time. One of the most high profile was the G8, which had an established record in addressing health prior to HIV/AIDS (its first health commitment was made in 1980 (Kirton and Guebert, 2009, p. 2)). The G8’s engagement with HIV/AIDS from 1996 onwards has far outstripped its interest in any other health issue. Kirton and Guebert (2009, p. 4) also find that AIDS has been the health issue over which the G8 has performed best in terms of fulfilling the commitments it has made. HIV/AIDS’ place on the agenda of such an influential group of states has played an important part in maintain-ing its profile – as well as in more concrete outcomes such as the creation of the Global Fund, which can be traced back to a G8 initiative.

Even the ‘core’ global HIV/AIDS institutions, however, exemplify the diversity and multiplication of HIV/AIDS governance actors. UNAIDS, for example, is a ‘co-ordinating body’, bringing together 11 UN bodies, each of which had been addressing HIV/AIDS from their own perspec-tive. Its establishment in 1996 was a recognition of the multi-sectoral


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and multi-faceted nature of ‘the AIDS problem’, and a reaction against the narrower medical/public health-based approach of the WHO, which until then had been taking the lead on HIV/AIDS (Parker, 2000, p. 43; Lisk, 2010, chapter 3). UNAIDS began with six ‘co-sponsors’ (WHO, UNDP, UNESCO, UNFPA, UNICEF and the World Bank) and over time this has increased to the current 11 (with the addition of UNHCR, WFP, UNODC, UN Women and the ILO). The wide variety of policy spheres covered by these agencies shows just how broadly HIV/AIDS has become understood as a political, social and economic issue, how many agendas it now appears on and how closely it is linked with other areas of global governance; from migration to gender, from drugs to labour standards.

Like other areas of global health, HIV/AIDS has also been subject to a trend for creating new institutions rather than utilising the exist-ing ones. The Global Fund, for example, was created as an independ-ent body3 in a deliberate effort to bypass the existing UN institutions, including UNAIDS. Institutional proliferation, however, comes at a cost. Indeed, such is the complexity of the current global AIDS governance architecture that even Michel Sidibé, Executive Director of UNAIDS, and someone who would be presumed to have a vested interest in that organisation’s continuation, has called for a ‘radical simplification’, argu-ing that

The global health architecture needs no more than three agencies: one to handle financing; one to set norms and standards; and one for advocacy and accountability. An effective apex mechanism could bring different actors together, including the private sector. That is all the complexity needed. (Sidibé and Buse 2013, p. 2149)

The current institutional architecture creates complexity and inefficiency at the global level, but the burdens that it places on national governments who are required to liaise with – and meet the requirements of – multiple external partners are even more problematic (McInnes and Lee, 2012b, p. 123, figure 5.4).

Second, as part of this multiplication of actors, the rise of private forms of authority around HIV/AIDS has been notable. The emphasis on ‘partnership’ shows this clearly. The attempt to improve the global response to the fight against HIV/AIDS, both technically and financially, through partnership with the private sector and other stakeholders was, for example, one of the innovative features of the Global Fund’s design. Whilst it was not the first ‘global health partnership’, the Global Fund

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(along with Global Alliance for Vaccines and Immunisation (GAVI), which focuses on delivering vaccinations) is certainly the most high profile, and by far the best funded. Yet despite the claims that the Global Fund was to operate as an apolitical and technical financial institution, there was no shortage of politics in the process leading up to its crea-tion (Barnes and Brown, 2011). The Global Fund Board structure that emerged from this political process includes representatives of donor and recipient governments, non-governmental organisations, the private sector (including businesses and philanthropic foundations) and affected communities. Although the private sector and foundation repre-sentatives are significantly outnumbered by country representatives, it is nevertheless notable that they have been given a seat at the table in a full voting capacity. For some this opens up a desirable incorporation of private resources and expertise into global governance arrangements. For others, it raises concerns over the potential use of such positions for the pursuit of private interests, as well as ethical problems around the private sector being given a say over the allocation of huge sums of (mostly) public money (Williams and Rushton, 2011).

Third, and particularly notable in the case of global AIDS governance, is the extent to which civil society has been incorporated into formal governance arrangements as well as performing important roles in serv-ice delivery. This is another area in which HIV/AIDS has been a leader, and again this can be seen clearly through the inclusion of developing and developed country nongovernmental organisation’s (NGOs) on the Global Fund Board as well as representatives of affected communities. This specific institutional arrangement is in fact a manifestation of some-thing more profound that has been seen in the HIV/AIDS case specifi-cally. This is the idea – simple in theory, but in reality a radical challenge to traditional multi-lateral politics – that those affected by HIV/AIDS have the right to have a place within governance arrangements. This idea, captured in the ‘GIPA principle’ (Greater Involvement of People Living with HIV and AIDS) has, thanks to the demands of advocates and PLWHIV over many years, now become so well-established that it has come to be seen as crucial to the legitimacy of HIV/AIDS initiatives at all levels. UNAIDS has five NGO representatives on its Programme Coordinating Board – the first time ever a United Nations Programme had formal civil society representation on its governing board (UNAIDS, n.d.). Civil society has also been given an influential role in reporting on country progress under the United Nations General Assembly Special


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Session (UNGASS) reporting system (Peersman et al., 2009). And this is without even mentioning the vital part that NGOs and faith-based organisations play as implementers of prevention, treatment and care programmes in countries across the world.

The institutional framework of global AIDS governance has evolved in a way that exemplifies and has contributed to the changes in global governance more broadly in the post-Cold War era. The number and variety of actors dwarfs that of 15 years ago. We need to be clear, however, that states remain central to the global response. National governments still have the leading role to play in tackling HIV and AIDS within their countries and – despite the high levels of international aid – domestic funding for HIV/AIDS still far outstrips international donations. Furthermore, that international aid is itself overwhelmingly from state sources, whether delivered bilaterally (as with PEPFAR) or multilaterally (as with the Global Fund). National governments, then, are still the most important governance actors. But they do not govern alone.

Conclusion

This chapter has examined the ways in which the three transformations that we trace in this book have played out in the case of HIV/AIDS. We have argued here that all three have been apparent, and that HIV/AIDS has not just reflected the changes that we have seen in global health governance but that it has played an important part in bringing those changes about. To some extent this is a self-fulfilling prophecy: HIV/AIDS has been one of the most prominent global health issues of the past 20 years, and as such it is no surprise that global health governance has developed in ways that in part at least reflect developments around the disease. In terms of our academic understanding of GHG it is also the case that much of what ‘we know’ is derived from the case of AIDS. Just as HIV/AIDS has captured policy attention, so has it preoccupied academics working in the global health field. In particular HIV/AIDS has dominated International Relations’ engagement with global health. It is for this reason that we address HIV/AIDS in this book. But it is also for this reason that we look elsewhere, at other health issues and challenges – pandemic influenza, access to medicines and tobacco control – in order to judge whether HIV/AIDS governance is typical or not, and whether its size and prominence might distort our view of the field as a whole.

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There is certainly ample reason to believe that HIV/AIDS may in some respects be exceptional vis-à-vis other global health issues. Its human cost has been huge, in some countries becoming the leading cause of death. It has, as we have seen, been widely understood as having a range of nega-tive effects beyond individual health status: in particular on international development and on the stability of the most severely affected societies. HIV/AIDS has become widely understood as a global emergency and this in itself has allowed the global HIV/AIDS response to ‘break free’ from some of the ties that might otherwise bind. It has been at the forefront of debates over access to medicines. The West has made commitments in relation to ARV access which (whilst not yet achieved even in the case of ARVs) go far beyond what has been promised in relation to other health issues. The pharmaceutical industry too has given ground on HIV/AIDS medication far more willingly than it has on other types of medication.

We must ask why. For us, as we have attempted to show in this chap-ter, any explanation must take into account both material and ideational factors. The material facts of the HIV/AIDS pandemic mattered, but it was the way in which these facts were framed and interpreted that created the sense of emergency which in turn allowed for the excep-tionalisation of HIV/AIDS. A wide range of actors have played a part in the construction of HIV/AIDS as a global priority. Influential states have seen it as a threat to their interests (as with US concerns over its security implications) or have seen themselves as having a moral duty to address it (as with Blair, Brown and Bush at the G8’s Gleneagles Summit). More striking still, however, has been the profound influence of civil society on the global governance of HIV/AIDS. This is in large part a result of HIV/AIDS’ origins in communities with a history of facing discrimination and stigma which meant that grassroots activism was vital in making the voices of those touched by HIV and AIDS heard. No one could have predicted, however, the extent to which civil society movements would become integrated into the institutional structures of global AIDS governance, becoming essential markers of their legitimacy and representativeness.

Notes

Our use of the term ‘HIV/AIDS’ reflects its common usage during much of the period under investigation in this chapter, and is indeed still


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commonplace in much of the International Relations literature. However contemporary terminology would differentiate more clearly between HIV (a virus spread by human to human contact) and AIDS (a syndrome of infections and diseases which develops in human immune systems weakened by the virus HIV). We have also referred to ‘global AIDS governance’ to maintain consistency with many of the early governance programmes.HIV/AIDS is the focus of targets 6A (‘Have halted by 2015 and begun to reverse the spread of HIV/AIDS’) and 6B (‘Achieve, by 2010, universal access to treatment for HIV/AIDS for all those who need it’), http://www.un.org/millenniumgoals/aids.shtml, date accessed 17 December 2013.It is technically a foundation, established under Swiss law.

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3Pandemic Influenza

Abstract: This chapter discusses global efforts to prepare for a flu pandemic. It begins by exploring the history of influenza and why it came to be seen as a global issue. From here, it examines the global governance of pandemic influenza. This includes the role that specific biomedical advances have played in shaping and constructing influenza surveillance and response and the influence of security concerns in planning for a pandemic. In the third section, it surveys the institutions and actors engaged in pandemic influenza preparedness and response to reveal that, in direct contrast to other, more contemporary health issues such as human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), access to medicines and tobacco control, the governance system surrounding pandemic influenza has remained largely unchanged.



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Introduction

In stark contrast to HIV/AIDS, pandemic influenza has been a persist-ent menace to humanity for millennia. Unsurprisingly, therefore, many of the foundations, key ideas and norms that inform the governance arrangements surrounding pandemic influenza prevention and control are well established. Indeed, many of the current structures were created either in the immediate aftermath of World War II or before. Since that time, the governance structures – and the norms and ideas underpin-ning them – have remained integral to the international community’s efforts to prevent and control influenza epidemics and pandemics, and have remained not only resilient but also staunchly resistant to change. In this chapter, and by way of additional contrast to the previous, we explore how path dependency has emerged around the governance of pandemic influenza that has largely resisted the three transformations described in the opening pages of this book.

The chapter proceeds in three parts. In the first section we explore the history of the disease and the particular characteristics of the virus that prompted its recognition as a global issue. From here, we examine how the governance arrangements emerged in the post-war era, and the role that specific biomedical advances have played in shaping and constructing the global architecture for influenza surveillance and response – technological developments that have, to a large extent, continued to determine how this disease is perceived and treated even as broader transformations in global health have occurred. In the third section, we survey the institutions and actors engaged in pandemic influenza preparedness and response to reveal that, in direct contrast to other, more contemporary health issues such as HIV/AIDS, access to medicines and tobacco control, the governance system surrounding pandemic influenza has remained largely unchanged.

Indeed, path dependency can actively impede transformation. By the middle of the last century, government-led technical cooperation had been established and pharmacological solutions developed, which in turn made the governance of pandemic influenza highly resistant to the changes identified elsewhere in this book. Even Indonesia’s contro-versial 2007 decision to cease sharing H5N1 (‘bird flu’) avian influenza virus samples with the Global Influenza Surveillance Network (GISN), in an attempt to bring about lasting change to governance arrange-ments, had only very limited success. Moreover, unlike HIV/AIDS,

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which has witnessed the emergence of strong civil society advocacy, diverse governance arrangements and multiple challenges to established authority, pandemic influenza has remained firmly embedded within an intergovernmental framework where states remain the primary actors to the virtual exclusion of all others. In this environment, civil society and non-government organisations have remained largely on the periphery, and changes to the systems and processes have only occurred with the full knowledge and consent of state-based actors.

Pandemic influenza differs from HIV/AIDS in one other distinct way too, in that for much of the second half of the 20th century the disease was largely overlooked. Of course, pandemic influenza was not alone in this regard – overall concern regarding the majority of infectious diseases waned amongst high-income countries due to broader ‘changes in health care priorities, diminished resources, and the need to focus the limited available manpower and funds on the HIV/AIDS epidemic’ (WHO, 1994, p. 845). Influenza – as a disease that had been proven could be effectively managed by pharmaceutical countermeasures such as vaccination – commanded much less attention, and as such, resources for dealing with the disease at the international level were progressively and systematically scaled back. The emergence of a highly virulent strain of H5N1 avian influenza in Hong Kong in 1997 renewed global interest in the disease, and sparked an explosion of concern that another influenza pandemic was imminent. Since that time, pandemic influenza has once again risen to new heights with the World Health Organization (WHO) declaring the disease ‘the most feared security threat’ (WHO, 2007b, p. 45) that, for some countries, even eclipsed terrorism. In this chapter we examine the disease’s meteoric return and how the transformations occurring in the broader context have in fact served to further reify and entrench the existing governance arrangements.

Pandemic influenza as a global issue

In many respects, influenza personifies the health risks arising from globalisation – it is a highly transmissible respiratory disease that causes mild to severe illness in humans, spreads easily via droplet form (i.e. airborne), and can survive outside the human body on surfaces for up to 72 hours in the right conditions (Boone and Gerba, 2005), is highly prone to mutation meaning previous exposure does not confer immunity and


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possesses an extensive host range (including humans, pigs, birds, horses, ferrets, whales and seals) making it virtually impossible to eradicate. Correspondingly, the ubiquity with which influenza has spread around the world, readily carried by both humans and animals, has a long history. Early European accounts provide evidence of localised influenza epidemics dating as far back as 1173; however it is also clear from the description provided that even by the 20th century the disease was already well known and recognisable. The earliest influenza pandemic (defined as affecting two or more regions of the world) appears to have originated in Africa in 1510:

The disease ... came from the island of Melite in Africa, into Sicily; so into Spain and Italy, from that over the Alps into Portugal, Hungary, and a great part of Germany, even to the Baltic Sea; every month shifting its situation with the wind from East to West, so into France, Britain. It attacked at once, and raged all over Europe, not missing a family, and scarce a person. (as quoted in Quinn, 2002, p. 45)

Infact, as international trade, travel and urbanisation increased, so too did the frequency and severity of influenza epidemics to the extent that – at least throughout Europe, where the epidemiological impact of these events was regularly documented – they were observed to occur every few years. Periodically, a particularly severe form of the disease would emerge, with pandemics striking in 1580, 1729–30, 1732–53, 1781–2, 1830–1, 1833–4, 1850–1, 1857–8, 1874–5, and 1889–90. Following these events, medical practitioners, unaware that the disease was caused by a virus, proffered various theories on how influenza spread ranging from foul-smelling mists (miasma) to meteorological and telluric conditions to divine retribution and immorality (Hirsch, 1883; Patterson, 1986). What medical consensus there was related to the disease’s devastating impact on communities and the lack of a definitive, effective prevention or treatment (DeLacy, 1993). Yet, although it was expected that wherever the disease struck deaths would follow, equally it was recognised that many of those affected would recover. For over 800 years of documented experience, therefore, influenza was not ranked amongst the world’s deadliest killers – at least, not when compared against other diseases like smallpox and plague – and for those who survived, influenza became a regular feature of the human condition.

The 1918 Spanish Influenza pandemic however changed these percep-tions of influenza. Even by contemporary standards, this one event – which is estimated to have killed approximately 40 million people

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worldwide – is ranked as one of the three most devastating epidemio-logical events in recorded human history (Walters, 1978). Arriving as it did at the end of World War I, for a time influenza even became known as a ‘war disease’, so closely were peoples’ perceptions of the disease linked with the global conflict (Francis, 1947). What was particularly remarkable about this event was that the virus was able to circulate the world between 3 and 5 times over an 18-month period before the advent of modern air travel, and that, unlike conventional influenza outbreaks that afflicted the very young, old or infirm, those who suffered the highest morbidity and mortality in 1918 were between 25 and 45 years of age. As a result, the global case fatality rate was estimated to be approximately 2.5 per cent (Taubenberger, 2009). As we go on to explore in greater depth below, the impact of this event spurred considerable progress in influenza-related research and prompted the emergence of effective preventative therapies. Nonetheless, even to the present day the 1918 Spanish Flu remains the benchmark against which the international community prepares for.

Having said this, for much of the 20th century influenza was viewed as a regular but minor irritant. This perception persisted despite the impact of two further pandemics, the 1957 ‘Asian Flu’ and the 1968 ‘Hong Kong Flu’, which killed 2 million and 1 million people respectively. In fact, widespread recognition of the menace that influenza poses to the entire international community did not ultimately resurface until 1997 when an outbreak of H5N1 avian influenza in Hong Kong infected 18 people and caused the death of 6 (Snacken et al., 1999). This outbreak caused particular alarm, principally because for the better part of the former decade health professionals and security experts had been warn-ing of the ‘threat’ of emerging and re-emerging infectious diseases. This trend, combined with the fact that several prominent virologists such as Robert Webster, Paul Glezen and Stephen Morse had been warning that the world was ‘overdue’ for another influenza pandemic contributed to a growing awareness of human interconnectedness – and subsequent universal vulnerability – that now existed amongst the international community as a result of technological progress (Webster and Kawaoka, 1994; Morse, 1995; Glezen, 1996; Lederberg, 1996).

The recognition of pandemic influenza as a global menace was there-fore not particularly sudden or shocking, but rather emerged gradually, as the disease vied for attention amongst a multitude of other health issues. It is also in this respect that the disease only gained attention as a


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global problem largely due to the broader social, economic, technologi-cal and cognitive changes that were occurring as a result of globalisation. Indeed, influenza’s potential to cause widespread human suffering and death was well known prior to 1997 and had been evidenced on multiple occasions. As we explore later though, for the latter half of the 20th century the disease had come to be seen as less of a hazard due to infre-quency of pandemics, the international surveillance systems that had been established to monitor and track the disease and the proven effi-cacy of influenza vaccines and antiviral medications. Combined, these developments engendered in the international community a measure of security (or at the very minimum indifference) from the menace of pandemic influenza – security that was then splintered in 1997.

Poignantly, the 1997 H5N1 outbreak also highlighted the disease interface that exists between humans and animals. Many public health specialists have long been cognisant of the fact that the majority of new, emerging infectious diseases are zoonoses – diseases that originate in the animal world but cross the species barrier to infect humans. The H5N1 avian influenza outbreak in Hong Kong provided a very timely reminder of this dynamic, of the susceptibility arising from human–animal inter-action and of the complete vulnerability to new strains of highly virulent influenza. For unlike other issues explored in this book such as HIV/AIDS and tobacco control, a new strain of influenza with pandemic potential can arise at any time to infect any individual irrespective of their socio-economic predisposition, personal risk behaviour(s) or access to healthcare services.

Constructing responses to pandemic influenza

The 1918 Spanish Flu pandemic inspired considerable scientific research into identifying the cause of the disease and how to prevent its trans-mission. In so doing it also contributed to the dominant framing of the disease, which persists to the current day (see also Kamradt-Scott, 2012a). Based on empirical observations throughout the 1918 pandemic, it was widely suspected that influenza could transfer between pigs and humans (Shope, 1958). In 1931, advances in electron microscopy allowed for the influenza virus to be identified and isolated from pigs, and from human tissue samples two years later (Smith, Andrewes and Laidlaw, 1933). This discovery in turn prompted experimentation with

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developing an influenza vaccine. Much of the initial work was conducted by the US military after the outbreak of World War II, because of the disease’s recognised potential impact on troop readiness, and concern that another pandemic of similar lethality to the 1918 Spanish Flu would emerge at the end of the second global conflict. The conclusion of the war, however, brought with it other health-related challenges and, as the international community became consumed with combatting the effects of diseases like malaria and smallpox (Fenner et al., 1988), work on developing an effective influenza vaccine passed into the hands of civilian health authorities.

By the mid- to late 1940s a number of new civilian-led initiatives designed to mitigate the impacts of influenza pandemics had been launched. Following from the work conducted by the US military, vari-ous Western countries commenced clinical trials to evaluate the benefits of influenza vaccination. Notably, the efficacy of influenza vaccines was not immediately apparent, largely because work in identifying the vari-ous strains of influenza, the most appropriate medium to grow the virus, the dosage required to confer immunity and the like, was still incom-plete. To supplement the efforts of individual countries, in 1946 the Interim Commission tasked with helping usher the WHO into existence established the Global Influenza Programme. Under this programme the World Influenza Centre was founded in London the next year with the three-fold objective to plan against the reoccurrence of future pandem-ics, develop control methods to limit the impact of pandemics when they did appear and limit the economic impacts of influenza epidemics and pandemics wherever possible (Payne, 1953). In 1950, the third World Health Assembly (the supreme decision-making body of the WHO comprised exclusively of member states), requested that a committee be formed to guide the organisation’s activities. The Expert Committee on Influenza, which met for the first and only time in 1952, consequently recommended the creation of a Global Influenza Surveillance Network (GISN) that would support the international community combat epidemics and pandemics.

Although the network has expanded in both size and global reach, its function of identifying circulating influenza strains to inform the development of medical countermeasures has effectively remained unchanged in over 60 years of operation. In 1952 when it was first created, it comprised 40 laboratories, but has progressively grown to include over 135 institutions in 105 countries. The network operates on


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the basis of national health authorities forwarding surveillance data and virus samples to WHO reference laboratories (otherwise described as WHO Collaborating Centres) that then isolate and identify the domi-nant strains. From here, epidemiological information is passed to phar-maceutical manufacturers to develop seasonal influenza vaccines, and in the event of a new strain emerging, a pandemic-specific vaccine. This arrangement persisted – unchanged – until the finalisation of the 2011 Pandemic Influenza Preparedness (PIP) Framework (discussed later) that was negotiated in the wake of Indonesia’s decision in 2007 to cease sharing H5N1 virus samples.

It is in this regard that the late 1950s marked a particular turning point in influenza prevention and control practices – one that was, and has continued to be, denoted by an overwhelming reliance on biomedi-cal, scientifically justified evidence. Initially in 1952, for example, the WHO’s Expert Committee on Influenza had no choice but to observe that vaccination was at best ‘an experimental procedure’ (WHO, 1953, p. 10) due to the fact that influenza vaccine trials in the United Kingdom and the United States had provided mixed results (Francis et al., 1947; Davenport, 1979). By 1959 though, medical opinion regarding influ-enza vaccines had perceptibly shifted. The WHO Expert Committee on Respiratory Virus Diseases, which succeeded the influenza committee, observed in its first report that ‘Experience in many countries has now established vaccination as the most efficient method for the preven-tion of influenza’ (WHO, 1959, p. 15). The modification of views was due, in large part, to the considerable evidence that had been collated from annual seasonal influenza epidemics and various clinical trials (Davenport, 1979). Added to this, widespread use of laboratory- and community-based public health surveillance in the context of the 1957 Asian Flu pandemic further strengthened the case for vaccines and validated the importance of widespread surveillance. In fact, when combined, these techniques allowed national health authorities, and by default the WHO, to not only monitor the progressive spread of the 1957 pandemic, but also to identify and isolate the strains of virus responsible, distinguish between ‘influenza-like illnesses’ and the number of real cases, develop strain-specific vaccines, and then assess their efficacy (Brady, 1958; Stewart, 1958). As a result, not only was the WHO Expert Committee on Respiratory Virus Diseases able to note that vaccines were an ‘efficient’ means of protecting human popula-tions, they were also able to conclude that ‘A reduction in the incidence

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of the disease of two-thirds or more has repeatedly been observed’ (WHO, 1959, p. 15).

Over the next decade, emphasis was increasingly placed on refining the vaccines to ensure better efficacy, less toxicity and greater yield within a shorter timeframe (WHO, 1969). Those countries that could afford to do so, namely high-income countries, built or strengthened their pharmaceutical manufacturing capacity to produce influenza vaccines. The WHO’s influenza programme, which was seen as ‘an authoritative source of information on the occurrence of influenza and its spread from one country to another’, was instrumental in framing vaccines as the ultimate means of combating the disease, observing ‘Vaccination is the only established procedure for conferring protection against influenza’ (WHO, 1969, pp. 8, 39). As a result, vaccines have been actively promoted (and increasingly viewed) as the definitive measure for preventing and controlling influenza epidemics and pandemics.

The demonstrated efficacy of influenza vaccines encouraged the notion that governments could effectively manage the disease by themselves, a perception actively encouraged and promoted by the WHO. Vaccination campaigns, which had been validated by respected medical techniques and knowledge to be the most effective means of reducing human morbidity and mortality, were actively endorsed as a responsible inter-vention (Hota and McGeer, 2007). The arrival of antiviral medications in the 1960s added to the pharmacological arsenal and further embed-ded the belief that government-led initiatives could manage the public health problem of influenza without the need for strong international intervention. Noting this downturn of interest at the international level, in 1988 the then directors of the WHO Collaborating Centres issued a statement calling for the WHO influenza programme to be ‘maintained and strengthened because, by facilitating the earliest possible detection of new epidemic strains of influenza virus and recommending the use of new antigenic variants for vaccines, it provides the foundation for activities to prevent and control the disease’ (WHO, 1988a, p. 457). The call, however, went largely unheeded until the 1997 outbreak of H5N1 in Hong Kong.

The lack of attention paid to influenza can be easily appreciated when considering the broader political and epidemiological events of the mid- to late 20th century. As noted earlier, for example, the majority of Western countries had eliminated many of the infectious diseases that continued to present significant public health challenges in other parts


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of the world through advanced healthcare systems and ready access to pharmaceuticals – that is, until the arrival of HIV/AIDS in the 1980s. At the same time, the wider public health community had become focussed on eradicating certain specific diseases such as malaria (unsuccessfully) and smallpox, and launching new campaigns such as ‘Health for All by the Year 2000’; all of which consumed both considerable attention and resources. The continuing Cold War between the Soviet Union and United States distracted and preoccupied security sector personnel, while finan-cial crises in the mid-1970s placed additional pressure on political leaders to reduce public expenditure wherever possible, resulting in a scaling back of international commitments. For those countries that could – literally – afford to care about influenza, therefore, the focus was on ensuring ready access to pharmaceuticals such as vaccines and antivirals, which many possessed. For other countries’ political and health leaders, confronted by a raft of far more pressing health needs, preparing against the risk of another influenza pandemic was an indulgence they could not afford.

Nonetheless, throughout the 1970s, 1980s and early 1990s research continued to be conducted by a few, albeit notable influenza specialists. Whereas work on improving vaccine efficacy and yield continued apace, attention also turned to other control measures and how cost-effective these measures were compared to the economic impacts and human costs of pandemics (Kavet, 1977; Douglas, 1987; Fedson, 1987; Ruben, 1987). These studies, which began to feed into broader discussions around the ‘threat’ posed by infectious diseases and the security land-scape of the post-Cold War world, ensured that concern about influenza and its wider societal impacts progressively gathered momentum. It is also in this regard that the disease began to be increasingly framed in terms of security. In particular the language of ‘threat’ was used to raise awareness of the issue on decision-makers’ agendas. Supported by stud-ies that utilised statistics and epidemiological modelling (often based on the experience of the 1918 Spanish Flu pandemic), various writers, policymakers, public health experts and academics started advocating that pandemic planning was a critical measure that governments needed to undertake to offset the risk to national economic growth (Gross, 1996; Webster, 1997). Although much of the international community was preoccupied with the impacts of the latest infectious disease – namely HIV/AIDS that we examined previously – some government agencies took the warnings seriously and began actively evaluating existing contingency plans and devising new measures (see Marwick, 1996).

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It was not surprising, therefore, that the 1997 H5N1 outbreak renewed pressure on the WHO and on governments to strengthen international pandemic preparedness. For the WHO the pressure came in the form of reinvigorating its influenza programme, which had been progressively downsized in both personnel and resources due to a lack of interest and financial support from member states. By way of response the organisa-tion immediately began developing new guidelines on how member states should prepare for mitigating the ‘threat’ of another influenza pandemic. The WHO’s first official pandemic influenza preparedness guideline document was then released in 1999, and outlined in broad terms the steps that countries should take to protect their respective populations in developing vaccination and other control strategies, strengthening surveillance systems, and ensuring access to critical supplies such as vaccines and personal protective equipment (WHO, 1999). Likewise, high-income countries began conducting exercises to evaluate the wide-spread impacts of natural and human-induced adverse health events. Plans were developed that used scenarios supported by epidemic model-ling and clinical attack rates to predict human morbidity and mortality, and then design interventions to mitigate the disease’s effects (Goodman and Anderson, 1997; Tam, 1999; CDC, 2000). Economic studies were similarly commissioned that examined potential impacts to national productivity, and social and economic functioning to evaluate mitiga-tion strategies (such as vaccination programmes), to inform policy, and justify the need for further pandemic planning (Meltzer et al., 1999; Gust et al., 2001). But ultimately, between 1997 and 2003 interest in influenza prevention and control continued to fluctuate until the reappearance of the H5N1 avian influenza ‘Bird Flu’ virus in parts of Asia that coincided with the 2003 severe acute respiratory syndrome (SARS) outbreak.

By mid-2004 as the H5N1 virus progressively spread around the world, the international community entered a state of constant alert (WHO, 2011a). Importantly, this occurred within the context of heightened security anxieties and of increased global sensitivities over infectious disease. The 11 September 2001 terrorist attacks on New York and Wash-ington, the war with Afghanistan and then in March 2003 the invasion of Iraq following concerns over its development of weapons of mass destruction, all provided a context of heightened anxiety over security. Contemporaneous with the invasion of Iraq, the global dissemination of the SARS-associated coronavirus was seen as a ‘wake up call’ ( Campbell, 2004, p. 5) generating significant political commitment in tackling


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disease threats (Kamradt-Scott, 2010). Within months of SARS having been successfully contained, however, several small outbreaks of the H5N1 ‘Bird Flu’ virus were recorded in Southeast Asia. As the number of outbreaks increased throughout 2004, and despite several containment exercises targeting domestic bird populations, several countries that had never previously recorded outbreaks began reporting new human cases of H5N1 (Webster and Govorkova, 2006). As a result, new pressure was brought to bear on leaders to better respond to what was clearly being portrayed as an emerging threat.

By 2005, persuaded of the growing threat of H5N1 influenza (Obama and Lugar, 2005), governments the world over implemented a range of new pandemic planning and preparation activities. Moreover, govern-ment officials were so persuaded by the threat of pandemic influenza that the need for comprehensive pandemic planning was presented to citizens as self-evident (Stephenson and Jamieson, 2009). In this, the two dominant frames – security and evidence-based medicine – became mutually reinforcing and served to highlight the importance of ready access to pharmacological measures. Those wealthier countries that had not already done so began to stockpile large quantities of influenza vaccines and antiviral medications, in many cases keeping the location of such supplies a closely guarded secret. Some countries also took their contingency planning activities further by entering into advance purchase agreements with pharmaceutical manufacturers to procure large quantities of a pandemic-specific vaccine in the event it was required.

In 2009 these various contingency plans were put to the test when a novel strain of the ‘swine flu’ (H1N1) influenza virus emerged from Vera Cruz, Mexico. Throughout the weeks and months that followed, the WHO played a key role in coordinating international response efforts, consolidating statistics and information on the virus’ spread, and issuing recommendations on treatment, quarantine and international travel and trade issues. The organisation was also observed to use its status as an advocate for global health to encourage its wealthier member states and pharmaceutical manufacturers to donate supplies of influenza vaccines and antivirals from their respective national stockpiles to help countries that lacked access to these pharmaceuticals (Fidler, 2010c). For the most part, governments fully complied with the WHO’s guidance and recom-mendations, but a few countries were noted to institute measures that contravened the global norms that had been previously codified in the

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revised International Health Regulations (2005) on disease reporting and trade sanctions (Hodge, 2010; Katz and Fischer, 2010).

Institutions and actors concerned with pandemic influenza

Unsurprisingly given this narrative, when compared against the govern-ance arrangements of relatively new diseases like HIV/AIDS, the global governance of pandemic influenza has remained comparatively stable over time. Moreover, despite the fact that several new actors have emerged in the field of pandemic preparedness – a number of which we examine later – the existing governance arrangements and processes remain closely aligned to state-based structures. Indeed, the governance arrangements surrounding pandemic influenza are largely intergovern-mental in nature, concentrated around the WHO and involve surpris-ingly few non-state actors. Admittedly, political interest in pandemic influenza prevention and control has ebbed and waned throughout the years, which may help partially explain why these arrangements have remained so constant and free from external interference. Certainly, the creation of the WHO’s global influenza programme, its related surveil-lance network, and the proven efficacy of vaccines created a measure of path dependency – one whereby the disease has been predominantly viewed as a manageable hazard so long as technical cooperation and access to pharmacological solutions – remains unfettered.

The only challenge to the existing system of influenza surveillance and control occurred in 2007, when the Indonesian government announced that it would cease sharing H5N1 virus samples with the WHO network, citing a breakdown of ‘mutual trust’ (Sedyaningsih et al., 2008). Indonesia’s decision was prompted by a perceived governance failure: the country’s inability to obtain ready access to necessary influenza vaccines, despite the fact that they provided the original virus samples that pharmaceutical manufacturers were using to develop the inoculations. However, in reject-ing the established governance arrangements by refusing to share virus samples, Indonesia’s actions provoked a storm of controversy and accusa-tions that the international community was effectively being held to ransom (Garrett and Fidler, 2007; Holbrooke and Garrett, 2008). In response, the WHO initiated a series of high-level intergovernmental consultation meet-ings to resolve the diplomatic impasse. Some four years later the Pandemic


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Influenza Preparedness (PIP) Framework was passed by the 58th World Health Assembly (WHA) in May 2011; yet despite the diplomatic success, ultimately the new framework agreement has done little to amend the existing structures or ensure the more equitable distribution of vaccines and other benefits that it was ostensibly designed to address.

For example, under the PIP Framework, pharmaceutical manufactur-ers that utilise the virus samples forwarded to the WHO by member states are now required to make ‘partnership contributions’ to defer some of the operating costs of the network. These companies are also required to make a proportion of their products (including, for example, vaccines, antivirals and reagents) available to low-income countries at low cost. Beyond this, however, other than renaming the GISN the Global Influ-enza Surveillance and Response Network (GISRN), the WHO-led tech-nical cooperation network has remained substantively unchanged and intact. National influenza centres still forward their samples and data to one of six WHO Collaborating Centres, which then forward the infor-mation on the latest strains to pharmaceutical manufacturers to produce influenza vaccines. Accordingly, notwithstanding the recent adjustments to the network’s structure and financing, GISN/GISRN has remained the central feature of international influenza governance arrangements.

Having said this, through the wider WHO influenza programme there have been significant achievements made in increasing global vaccine manufacturing capacity and securing commitments from high-income countries to donate antivirals and other supplies. Via the Global Pandemic Influenza Action Plan to Increase Vaccine Supply, for instance, the international community witnessed a virtual doubling of global manufacturing capacity to an estimated 1 million doses per annum by 2010 (WHO, 2013a). This strengthening of capacity has been achieved largely through technology transfers and through supporting a number of low to medium-income countries develop domestic influenza vaccine manufacturing capacity – capacity that will likely aid low-income coun-tries gain ready access to lifesaving medicines in the next pandemic. In addition, the WHO’s lobbying of member states in the context of the 2009 H1N1 influenza pandemic witnessed a number of high-income countries agreeing to donate proportions of their own national stockpiles of antiviral medications and personal protective equipment to the WHO to distribute based on demonstrated need.

Yet, importantly, not all of the recent efforts to strengthen global pandemic preparedness can be attributed solely to the WHO. As indicated

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earlier, particularly since the beginning of the 21st century there have been several new actors emerge that, although not traditionally health-orientated, have made notable contributions. For example, following the re-emergence of the H5N1 avian influenza virus in late 2003 the Food and Agriculture Organization, the World Bank, the World Organization for Animal Health, European Union and USAID amongst others, have taken a prominent role in helping to strengthen and enhance animal-related influenza surveillance and integrate this more fully with human health initiatives (led by the WHO) under the banner of ‘One Health’ (CDC, 2013). Multiple government development agencies such as USAID (United States), JICA (Japan), DFID (United Kingdom), SDC (Switzer-land) and AFD (France) have subsequently joined with UN agencies and the governments of Australia, China, Thailand, Vietnam, Cambodia and Indonesia, philanthropic institutions such as the Bill and Melinda Gates Foundation and regional organisations like the EU in aligning their development assistance to advance the ‘One Health’ agenda to reduce the threat of influenza pandemics and other new zoonoses (European Union, 2011). At the same time, other UN agencies (with donor support) such as United Nations Children’s Fund (UNICEF) and the United Nations Development Programme (UNDP) had likewise launched initiatives aimed, respectively, at awareness raising of hygiene practices in local communities (UNICEF, 2006), and administering a Central Fund for Influenza Action (CFIA) to assist with urgent financing of international, regional and country-level preparedness (Bile and Dunn, 2012).

As a consequence of all the activity generated by these various agen-cies, and in recognition of the fact that South East Asia remained the region most severely affected by the H5N1 virus, in 2005 the Associa-tion of Southeast Asian Nations (ASEAN) leadership requested the UN Secretary-General to establish a mechanism to help coordinate interna-tional assistance and thereby avoid duplication of effort. This request in turn prompted the creation of the office of the United Nations System Influenza Coordinator (UNSIC), which was given the mandate not only to assist in coordinating the various UN agencies involved in pandemic preparedness, but also ensure that the UN itself was fully prepared and had instituted measures to protect its personnel. Between 2005 and 2010 UNSIC and the World Bank subsequently oversaw the receipt and disbursement of new financial pledges to strengthen global pandemic preparedness, and released a series of annual reports detailing the work accomplished to date (UNSIC and World Bank, 2010).


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Of course, the foremost group of non-state actors engaged in influenza prevention and control are the drug companies that manufacture influ-enza vaccines and antivirals. Pharmaceutical manufacturers have been an integral part of the global governance arrangements for decades, and their role is unlikely to diminish as long as influenza continues to cause human morbidity and mortality. The role that pharmaceutical compa-nies play in managing the disease and the arrangements overseeing their participation and inclusion have been robustly defended by govern-ments, even when that role has been openly challenged (for example, Indonesia). In fact, in the context of the PIP Framework negotiations great care was taken (and continues to be taken) to ensure that no phar-maceutical manufacturers would exit vaccine or antiviral production due to new costs imposed on their continued participation in the WHO-led network. Moreover, under the WHO’s global pandemic influenza action plan to increase vaccine supply (GAP) the international community has actively sought to increase the number of pharmaceutical companies engaged in vaccine-related research and development and production, with new initiatives launched in at least 11 new countries. These trends and the subsequent restructuring of the former GISN into a new public–private partnership speak to the importance with which these companies will remain to contemporary governance arrangements.

Beyond these more obvious examples though, a number of other non-state actors have also entered the pandemic influenza prevention and control space. For example, various Internet-based search engines such as Google Flu Trends, Health Map and Influenzanet, amongst others, have demonstrated considerable utility in supplementing existing state-based or WHO-led influenza surveillance initiatives through data-mining and analysis techniques (Butler, 2013). Faith-based organisations such as Muhammadiyah and civil society organisations such as the Red Cross have played a significant role in assisting local communities prepare for a pandemic, either through training and education in hygiene practices, building poultry enclosures to reduce human exposure or lobbying governments for additional resources to strengthen preparedness (Caballero-Anthony et al., 2013). Similarly, industry groups and corpo-rations have been heavily involved in business continuity planning at the local, regional and international levels. Initially much of this activity occurred at the prompting of governments, but particularly in the wake of the 2003 SARS outbreak that was estimated to have cost the Asian region between US$30 and 100 billion in economic losses (Smith, 2006),

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businesses have been increasingly observed to undertake such planning and preparation independently. Moreover, in the wake of the 2009 H1N1 influenza pandemic, some industry groups have even been observed to encourage the development of business preparedness ‘platforms’ to assist companies (and even competitors) ensure that in the event of another pandemic that personnel are protected and supply chains remain free as possible from disruption (Kamradt-Scott, 2012b).

Overwhelmingly however, the bulk of contemporary influenza governance arrangements remain firmly embedded within state-based structures. Since the 1997 outbreak of H5N1 influenza in Hong Kong there has been an evident influx of new actors and institutions involved in pandemic influenza governance. Yet the majority of these new entities are intergovernmental organisations that comprise exclusively member states. In certain areas such as disease surveillance and education, non-state actors like civil society organisation’s (CSO’s), philanthropic founda-tions and faith-based organisations have emerged to fulfil specific needs and/or implement particular programmes aimed at strengthening local preparedness. Yet, when compared systematically against the array of state-based actors, these remain few and far between. Indeed, even when there have emerged calls for new solutions to improve coordination and cooperation, with the exception of a limited number of private sector activities, the preference of the international community seems to have defaulted to creating or expanding intergovernmental arrangements (for example UNSIC). Moreover, throughout all of this activity the WHO’s global influenza programme has remained the central feature of the inter-national community’s attempts to detect, prevent and control pandemic influenza when new influenza strains emerge. It is in this regard that even when attempts have been made to genuinely reconstitute the global governance arrangements surrounding influenza, ultimately very little change to the structures, norms and processes has transpired.

Likewise, on reflection, it should come as little surprise that the bulk of efforts aimed at mitigating pandemic influenza continue to remain largely centralised around the production and supply of pharmacologi-cal solutions: namely, influenza vaccines and antivirals. Admittedly the proven efficacy of these drugs to confer immunity and/or reduce the severity of influenza-related illness provides a powerful incentive for the international community to continue to promote their widespread uptake. In this regard, the advocacy surrounding increasing global production capacity arguably should be expected, even welcomed and


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embraced. Yet intriguingly, despite attempts by a limited number of government-based and civil society protagonists to highlight the inequi-ties surrounding access to these medications as a human rights issue (see for example White and Banda, 2009), the existing state-based mecha-nisms and actors have been slow to respond to the demonstrated need.

Conclusion

In this chapter we have explored how the governance arrangements around pandemic influenza differ significantly from some of the other themes examined in the book. What the pandemic influenza case highlights is that where government-led technical cooperation can be established early, and proven pharmacological solutions emerge, there is a strong potential for path dependency to develop that is resilient against transformative pressures. Indeed, we have shown how despite recent attempts to disrupt, even revolutionise, the existing structures, processes and norms surrounding pandemic influenza prevention and control, they have instead remained staunchly resistant to change. We attribute this in part to the fact that humanity is universally vulnerable to the disease and that, due to the widespread socio-economic consequences of a pandemic, governments have maintained a strong interest and control over the mechanisms designed to alert and respond to the emergence of a new pandemic.

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4Tobacco Control

Abstract: This chapter begins by reviewing how tobacco control came to be seen as a global issue. The chapter then describes responses to tobacco-related diseases. In particular it identifies the contested framing and reframing of tobacco control, by public health and tobacco industry advocates, as both a rights-based issue and an economics issue. This has led to a proliferation of institutional arrangements. The chapter argues that, although World Health Organization (WHO) has played a central role, state and non-state actors have been key actors in shaping the global governance of tobacco control. It finds that industry and public health advocates have been locked in a battle of both material and ideational power, with the latter having the potential to overcome shortfalls in the former.



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Introduction

Tobacco use kills an estimated 6 million people annually, a figure expected to rise to 8 million by 2030 unless more effective public health policies are adopted worldwide. Cigarettes comprised 92 per cent of revenues in the global tobacco market in 2010 (Euromonitor Interna-tional, 2011). Around 100 million people died of tobacco use during the 20th century, a figure predicted to reach 1 billion lives during the 21st century. These trends persist despite longstanding and substantial evidence of the deadly health effects of tobacco use (WHO, 2013b). In general, smoking prevalence in North America, Europe, Australia and New Zealand is in decline, but persistent or rising in certain population groups (for example, young females). Tobacco use is also growing within low to medium-income countries (LMICs), most notably in the so-called emerging markets targeted by transnational tobacco companies (TTCs).

The global governance of tobacco control offers an illuminating case study of the three transformations analysed in this book, and provides broader lessons concerning global health governance (GHG). This chap-ter begins by reviewing how, after many decades of efforts focussed at the individual level, national governments agreed to make tobacco control a global issue. The chapter then describes the construction of responses to tobacco-related diseases through its contested framing and refram-ing by public health and tobacco industry advocates. This, in turn, has led to a proliferation of institutional arrangements that constitute the global governance of tobacco control. The chapter argues that, although WHO has played a central role, state and non-state actors have been key actors in shaping the global governance of tobacco control. The chapter concludes by discussing how this case study relates to the broader themes of the book. It finds that industry and public health advocates have been locked in a battle of both material and ideational power, with the latter having the potential to overcome shortfalls in the former.

From changing individual behaviour to global action

A widely held perception about tobacco control, which remains to the present day, is the need for effective interventions focussed on chang-ing individual behaviour. Implicit within this focus is the attribution of

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ultimate responsibility on the individual engaging in tobacco use, and an embedded assumption of personal choice. Indeed, tobacco-related diseases continue to be described as ‘lifestyle’ diseases, emphasising the focus on individuals choosing to engage in ‘risky’ behaviour. Cast in this way, efforts to introduce stronger tobacco control measures have often met with resistance based on arguments that governments should not intervene in individual lifestyle choices or that such individuals should be accountable for their own actions. Since the 1960s, tobacco control polices have aimed to protect certain individuals from tobacco use (particularly minors), better inform individuals of the risks of tobacco use (through labelling, health education campaigns) and limit marketing that encourages individuals from taking up the habit (by implementing restrictions on advertising). In these approaches, tobacco control has been focussed at the individual behaviour level, and thus the responsibil-ity of local and national governments. Within this context, this section describes how an important shift occurred, from the above described focus on the individual, to addressing tobacco control as a global (trans-boundary) issue. Along with important evidence of the globalisation of the tobacco industry, strategic efforts led by WHO to frame the issue as a collection action problem led to international efforts to successfully negotiate the Framework Convention on Tobacco Control (FCTC).

Until the late 1980s, most tobacco control activities were focused at the local and national levels, and primarily adopted in certain high-income countries such as the United States, Canada and Australia. Stronger tobacco control policies in these countries were adopted from the 1960s, prompted by accumulating evidence of the harmful health effects of smoking, beginning with a seminal study of the link between smoking and lung cancer (Doll and Hill, 1954), followed by the US Surgeon General’s Report in 1964.1 However, measures adopted were gradual and partial, in the form of restrictions on marketing and adver-tising, minimum age of sale requirements, and health warning labels. Funding for tobacco control also remained relatively low compared to other public health priorities. As a result, smoking prevalence and the adverse health effects continued to rise over the next decades (Rabin and Sugarman, 2001).

International cooperation on tobacco control can be dated to the first World Conference on Tobacco and Health (renamed Tobacco or Health) held in New York in 1967. Participants reviewed the scientific evidence on the harmful health effects of smoking, and exchanged information


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on tobacco control policies in different countries. In 1970, the WHO Director-General presented a report to the 23rd World Health Assembly (WHA) on ‘The limitation of smoking’ calling, inter alia, for an end to cigarette advertising and promotion. This was accompanied by the adop-tion of the first WHA resolution on tobacco control (WHA 23.32) which set out the ‘Health consequences of smoking’ in strong terms (WHO, 1970). With no binding authority, however, the resolution was limited to calling upon WHO member states to refrain from smoking at WHA meetings and discourage smoking through educating young people. It also urged the Food and Agriculture Organization (FAO) to study crop substitution alternatives in tobacco-producing countries.

The initially limited scope of tobacco control at the international level was reflected in the size and status of the WHO Tobacco and Health Unit, located under the Substance Abuse Programme, and resourced by only a handful of staff and a small budget. The Unit focused on collecting and aggregating available data on tobacco use and its health consequences in member states. However, with only a few countries collecting such data, and substantial definitional and methodological variation of such data, comparable and comprehensive findings on tobacco and health could not be achieved. Consequently, Unit efforts to facilitate the strengthening of tobacco control efforts by member states remained limited.

As tobacco control policies slowly gained ground in high-income countries during the 1960s and 1970s, leading to a gradual decline in smoking prevalence, the tobacco industry began to set its sights on new markets in LMICs. As Shepherd (1985) describes, these markets were essential to compensate for declining sales in ‘traditional markets’, and tobacco companies thus adapted by restructuring and shifting operations into a more global-oriented strategy. The pressures exerted by the US Trade Representative on Asian countries to open their tobacco markets from the mid-1980s can be understood as part of the industry’s reorien-tation (Frankel, 1996; Chantornvong and McCargo, 2001).

It was this expansion into emerging tobacco markets that prompted a shift in the tobacco control community efforts. For example, the first World No Tobacco Day was held in 1988 with the theme ‘Tobacco or Health: Choose Health’. The 7th World Conference on Tobacco and Health, held in Perth, Australia, focused on the issue of tobacco in the developing world. It is during this period that prominent public health advocates in high-income countries began to draw attention to the

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health risks being spread worldwide by the transnational activities of tobacco companies. In a 1988 WHO report entitled Smokeless Tobacco Control, based on the findings of a WHO Study Group (chaired by Greg Connolly then at the Massachusetts Department of Public Health and including Mike Daube and Judith Mackay), as well as describing the chemical constituents, biochemistry and bioassays for carcinogenicity, health effects, prevalence patterns and trends in use,

The Study Group expressed alarm at the well financed, highly sophisticated marketing programmes that transnational tobacco manufacturers have recently initiated in order to promote smokeless tobacco worldwide. It was the Group’s opinion that, if countries did not act now, tens of millions of children would become dependent on nicotine and the progress made in controlling the smoking epidemic would be nullified by the diseases caused by smokeless tobacco. (WHO, 1988b, p. 5)

However, recommended measures to address this risk continued to be seen as the responsibility of individual governments:

Countries with a history of smokeless tobacco use were urged immediately to institute aggressive regulatory and educational programmes to combat it, while those with no recent history of such use were urged to ban the intro-duction of the various products or any other new form of tobacco in order to prevent the spread of the smokeless tobacco epidemic. (WHO, 1988b, p. 6)

More concerted efforts by WHO to strengthen tobacco control were evident at the 45th WHA in 1992, with the adoption of Resolution 45.20, which encouraged increased collaboration among international organisations. As described by Toma et al. (2008), however, efforts to protect public health remained tempered by a perceived need to balance action against the potential economic impacts on tobacco-producing countries. The idea for an international legal instrument to strengthen tobacco control emerged during this period, put forth by Americans Ruth Roemer and Allyn Taylor (Roemer et al., 2005). This was an inno-vative idea, drawing on the experience of the United Nations Framework Convention on Climate Change (UNFCCC or FCCC) negotiated at the UN Conference on Environment and Development (UNCED) held in Rio de Janeiro in 1992. By 1995, WHO member states agreed to inten-sify collective action, adopting WHA48.11 calling for ‘An international strategy for tobacco control’ including the adoption of an international instrument. This was followed in 1996 by WHA49.17 by which member states agreed to fast track negotiation of a FCTC.


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Despite the adoption of this resolution, little happened until newly elected Director-General Gro Harlem Brundtland made tobacco control one of two cabinet priorities (along with the Roll Back Malaria initiative) in 1998. Internally, this new priority was reflected in the restructuring of WHO into interrelated clusters, and the elevation of the Tobacco Free Initiative (TFI) led by Derek Yach. Externally, TFI faced considerable challenges in moving forward the FCTC negotiations. The invoking of the existing treaty-making powers, under Article 19 of the WHO Consti-tution, had not been done before. TFI had to overcome the long neglect of tobacco control by member states and the donor community. And, perhaps most importantly, WHO needed to counter strong and ongoing opposition by the tobacco industry, and some governments with strong economic interests in tobacco (for example the United States, Japan, Malawi). The tobacco industry remained ever watchful of these develop-ments (BAT, 2000a), and countered with arguments for ‘sensible regula-tion’ at the national level. British American Tobacco (BAT), for example, claimed that it was beyond the jurisdiction of WHO to adopt a binding treaty that would restrict national policy-making powers, and that a WHO treaty would interfere with the existing trade and other treaties:

WHO claims that a binding international treaty on tobacco is appropriate because tobacco use presents ‘a problem that cuts across national bounda-ries, cultures, societies and socio-economic strata.’ The same could be said, however, of any other social issue common to many countries – from unem-ployment to education, from poverty to health care, from crime to consumer protection. Each of these issues ‘cuts across national boundaries, cultures, societies, and socio-economic strata,’ in the sense that they are shared issues. No one would suggest, however, that these issues are appropriate subjects of ‘international legislation,’ simply because they are shared. Neither is tobacco.Properly regarded, international agreements are tools for responding to problems shared by many countries that cannot effectively be dealt with by sovereign governments acting alone. Problems like transboundary air and sea pollution, protection of migratory species, international navigation, and elimi-nation of trade barriers simply cannot be addressed through unilateral action. Tobacco-related issues are different. They can be addressed at the national level (and even by political subdivisions of a nation) in a manner consistent with national sovereignty and country-specific policy choices. That is the level at which, and the manner in which, tobacco issues ought to be addressed.

Traditionally, WHO has focused on issues of communicable diseases and public hygiene. It has not focused on the regulation of products that

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are deemed to have health effects. Recognising these limitations, WHO documents on the tobacco issue attempt to characterise the voluntary consumption of legal products by adult consumers as a ‘disease.’ We should be wary of permitting expansion of WHO jurisdiction based simply on WHO’s willingness to stretch the concept of ‘disease.’ Doing so amounts to a license for WHO to intervene in other areas traditionally reserved to national authorities, including regulation of pharmaceuticals, foods and beverages, to name just three examples. (BAT, 2000b, pp. 3, 5)It is in this context that the negotiation and implementation of the FCTC can be understood as a battle of ideas between industry and public health advocates. By the late 1990s, amid the continued flow of clear clinical and epidemiological evidence of the harmful health effects of tobacco use, WHO recognised that available evidence needed to be framed in ways that would generate public support. This began by publishing the stark figures on annual tobacco deaths to show that tobacco control, relative to its public health impact, was significantly neglected. This anomaly was drawn to the attention of Brundtland, when she assumed office, who promptly made it one of two cabinet-level priorities.

Once tobacco control received internal priority, TFI staff reframed the issue as global in two ways. First, Yach and Bettcher (1998a, 1998b) wrote about the links between globalisation and health, and then drew attention to the transnational dimensions of tobacco control (Yach and Bettcher, 2000). The key shift was to reframe tobacco control as a global issue that needed collective action. This led to the use of language reminiscent of infectious disease outbreaks, until then the focus of global health concerns, to increase recognition of the cross/transborder nature of tobacco production and consumption. Thus, the issue began to be called the ‘tobacco pandemic’ and the industry as a ‘vector’ causing tobacco-related disease and death worldwide. Brundtland (1999, p. 1) described tobacco as a ‘problem [that] extended beyond the bounds of public health, and beyond national frontiers’.

Constructing global responses to tobacco-related diseases

Four frames – biomedicine, economism, security and human rights – characterise the core ideas put forth by tobacco control advocates and opponents that have shaped global responses to tobacco-related diseases.


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First, biomedicine has been a key ideational battleground. As scientific evidence on tobacco and health began to accumulate from the 1950s, denial by the industry of its veracity, through the creation of doubt or posing of alternative explanations, was used to prevent or delay the adoption of tobacco control measures. This remains a core tactic of the industry to the present day. Beginning in 1954 with the publication of ‘A Frank Statement to Cigarette Smokers’ (Tobacco Industry Research Committee, 1954) in 400 major American newspapers, intended to quell public concerns about the carcinogenic nature of cigarette smok-ing, tobacco companies have consistently denied the validity of tobacco and health evidence (Brandt, 2012). The manufacturing of controversy over evidence of the harmful health effects of second-hand smoke, for example, is well documented (Oreskes and Conway, 2010; Rochel de Camargo, 2012). Moreover, policies to address the health risks of tobacco are similarly undermined as lacking in scientific rigour despite the contrary (Moodie et al., 2012). For instance, tobacco companies claim ‘there is no proof to suggest that the plain packaging of tobacco products will be effective in discouraging young people to smoke, encouraging existing smokers to quit, or increasing the effectiveness of health warn-ings’ (BAT, n.d.a).

A second important ideational frame has been economics, with the industry arguing effectively that the sector creates valuable tax revenues and employment. In addition, it has been claimed that TTC expansion into emerging markets brings new trade opportunities and foreign direct investment (Gilmore and McKee, 2004). As stronger tobacco control measures have been proposed at the global level, industry has warned of the administrative costs of creating new institutional mechanisms:

WHO interference in highly technical tax and appropriations issues would set an undesirable precedent for international control of policy questions that belong in the domain of national and subnational tax policy. ... the persistent dangers of creating a new international bureaucracy, as contemplated in the current FCTC proposal. Such institutions take on a life of their own, demanding (and some-times wasting) large contributions from taxpayers. (BAT, 2000b, p. 6)

Third, human rights have been an important frame for the industry’s libertarian arguments defending smoking behaviour. Industry advocates have argued that smoking is ultimately an individual choice, later refin-ing the argument that it is the right of adults to choose to use tobacco without the interference of governments. This has remained a power-ful narrative, resonating with those who favour a minimal role for

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government in regulating behaviours. During FCTC negotiations, WHO was regularly accused of being heavy-handed, interfering with the rights of the smoker and national governments: ‘[W]e encourage debate and dialogue on sensible public policies surrounding our products and their use. We are committed to protecting the freedom of adults who choose to smoke to do so’ (BAT, 2000b, p. 2). At the national level, smokers’ rights groups, many supported by industry such as Forest in the United Kingdom, have adopted similar language, emphasising encroachment on civil liberties and even discrimination:

Encroachment into the home and family life of smokers has in some cases become blatant and intrusive, with local authorities, health bodies and hous-ing associations adopting policies that restrict the right of people to act freely in their own home or vehicle. The surveillance of smokers has increased sharply with the use of tracking and surveillance equipment to monitor their activities and movements. Employers are routinely and unfairly discriminat-ing against staff who smoke and are adopting tactics that are based not on education but on harassment and intimidation. (Forest, 2011)

These ideas have been reinforced by think tanks on the political right, many of which again receive tobacco industry funding:

The question of whether you enjoy smoking or not is irrelevant – what matters is that adults are allowed to make their own decisions without meddling from the government. Unfortunately the EU seems to have no regard for civil liberties. (Bowman, 2010)

A fourth ideational frame, security, has strongly influenced efforts to address the illicit tobacco trade. Detailed evidence of large-scale and worldwide tobacco smuggling began to emerge in the late 1990s, esti-mated to account for one-third of the world cigarette market and cost US$40 billion annually in lost customs revenues. Importantly, there has been accumulating evidence that some of the proceeds from the illicit trade supported terrorist and organised criminal groups (Willson, 2009):

Smugglers take the same routes today – driving SUVs along paved roads or with guidance from the Tuareg and satellite phones – to move weapons, drugs, and, increasingly, humans – through the Sahara for transport across the Mediterranean Sea. The paths are no longer known as the Salt Roads of the Tuareg, but as the ‘Marlboro Connection’, named after the most lucrative contraband along this 2,000-mile corridor. ... After crackdowns on fundraising following the 9/11 attacks, terrorist groups worldwide have increasingly


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turned to criminal rackets, officials say. And smuggling cigarettes – either untaxed or counterfeit – has proved a particularly lucrative, low-risk way to fund operations. (Doward, 2013)

The tobacco industry has linked these developments to heavy-handed regulation, arguing that higher taxation fuelled the illicit trade. Japan Tobacco International (JTI) (n.d.), for example, maintains that ‘One primary cause of illicit trade is high taxation in relation to neighbouring countries. Raising taxes increases the incentive for criminals to partici-pate in the illicit trade of tobacco, and can entice consumers to switch from legitimate to illegal tobacco products.’

For public health advocates, mobilising a global response to the long neglect of tobacco control required changing the dominant ideas fram-ing the issue. Beginning with the evidentiary base, as stated earlier, there was no lack of evidence and simply generating more evidence would have limited impact. Instead, TFI reframed the evidence in population health terms, depicting tobacco-related diseases as having significant and worldwide impact. New epidemiological data showing morbidity and mortality at higher levels than previously known, and increasing trends, were publicised. Importantly, attention was given to defining clear evidence-based interventions – proven measures to reduce tobacco use. As described by Frank Chaloupka (Professor of Economics, Univer-sity of Illinois),

[T]obacco companies are going to oppose many of the interventions we are talking about and are going to come with their own arguments. We need solid evidence to be able to demonstrate the effectiveness of different interventions. ... If we don’t have the evidence to support our arguments, then the industry is going to be able to pick them apart very quickly. (Chaloupka, 2010)

This view is supported by Douglas Bettcher (former TFI staff and now WHO Director of Non-communicable Disease Prevention) who described the strategy:

Packages or evidence-based approaches towards implementation have been so powerful, the same way as the DOTS strategy, DOTS Plus strategy on TB ... the MDGs are a package or an approach ... this language starts to emerge actually as a kind of science of quantifying problems, health problems, devel-opment problems, then identifying measures to intervene and then being able to measure them. (Bettcher, 2010)

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WHO placed strong emphasis on quantitative data to demonstrate the effectiveness of interventions. As described by Katherine Deland (TFI, WHO),

Traditionally, measurability has been central to treaty topics. That is, countries have most commonly made agreements regarding things one can count – borders that delineate acres of land, numbers of fish from proprietary fisher-ies, quantities of arms. Building from that foundation, it is complicated to imagine how to fashion implementable, enforceable international agreements about things we can’t as easily measure – health, human rights, environmen-tal quality. The way agreements evolve out from these big, aspirational ideas is to focus on the parts that are measurable, for instance metric tonnes of a particular substance or product – things you can count. (Deland, 2010)

A surveillance system to measure not only mortality and morbidity, but also ‘deaths averted’, was thus developed. TFI also worked with the US Centers for Disease Control and Prevention (CDC) to create the Global Youth Tobacco Survey and other global surveys. According to Bettcher, it was this capacity to demonstrate ‘evidence-based interventions’ that secured funding from the Bloomberg Initiative to Reduce Tobacco Use, and Bill and Melinda Gates Foundation, to which ‘the whole notion of evidence and impact are very important’ (Bettcher, 2010). With new funding, TFI created a surveillance team in 2007 to establish ‘compre-hensive information systems for tobacco control that didn’t exist before’. Finally, MPOWER was launched to provide ‘identifiable, measurable and comparable criteria across countries’ on tobacco control measures, and to assist countries in scaling up implementation of demand reduction provisions of the WHO FCTC (Bettcher, 2010).

A second way WHO changed the ideas framing global tobacco control was by challenging longstanding economic arguments by industry. Prior to the 1990s, few economists worked on tobacco control (Chaloupka, 2010). The ascendance of health economics (Mills, 1997), punctuated by the publication of the World Development Report 1993: Investing in Health, and creation of the WHO Commission on Macroeconomics and Health, led tobacco control advocates to recognise the powerful influence of economic arguments. As Townsend points out, economics is ‘a very powerful tool ... to influence government ... [which is] aware of the bottom line’ (Townsend, 2010). WHO formed a partnership with the World Bank to publish Curbing the Epidemic: Governments and the Economics of Tobacco Control (World Bank, 1999), a now seminal report countering industry arguments that tobacco produces net economic


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benefits to societies. Within the World Bank, according to co-author Chaloupka, the work went against the prevailing ideas about market mechanisms, trade liberalisation and deregulation:

It was not something that was supported at the Bank as we were develop-ing it but I think there were key people in leadership positions who really understood it and took it on and helped us move it forward ... we had to explain why governments should be intervening in this market which went beyond the traditional public health arguments and showed that there was an economic rationale as well. (Chaloupka, 2010)

For WHO (2003, p. 4), these data enabled a direct response to industry claims:

The most common concerns about tobacco price increases are that govern-ment revenues may fall and jobs may be lost due to reduced tobacco consump-tion, that smuggling may increase dramatically, and that an increase in price disproportionately burdens lower-income smokers. These consequences are either false or overestimated. The economic and health benefits from tobacco price increases appear to outweigh any disadvantages.

Importantly, economic evidence from the World Bank was seen as a ‘cata-lyst’ for policy action by providing ‘a clear lens of what didn’t necessarily exist in non-communicable diseases, what worked to reduce tobacco use, what was cost-effective and what could be seen from countries in all levels of development’ (Bettcher, 2010). The importance of economic arguments to global tobacco control led TFI to create a Tobacco Control Economics Team in 2007:

You have to go to Ministries of Finance, you have to go to other sectors and you have to speak their language. So we’ve tried to. This team then really is a group of specialized economists that can help ministries of finance to articu-late from a public health perspective why it’s good but also then to raise taxes but also help them to do the modeling and to sell the tax increases and the scaling up of their financial systems to support tobacco control taxes through an economist lens. (Bettcher, 2010)

In 2010 former World Bank economist Ayda Yurekli became its coor-dinator, working closely with ministries of finance on economic and tax issues, and providing technical support on tobacco tax systems and addressing government concerns about the economic impacts of tobacco control measures (Chaloupka, 2012). To date, the team has produced 17 country profiles on the economics of tobacco (WHO, n.d.). WHO has

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also created a Tobacco Tax Simulation Model and published a Technical Manual on Tobacco Tax Administration:

Evidence shows that a well-administered tobacco tax leads to the desired result of reducing consumption and its crippling health consequences, and not producing the terrible economic outcomes often portrayed by the tobacco industry. In fact, increased tax and prices for tobacco actually benefit governments by increasing revenues, which can then be used for state services, such as healthcare. This win–win result of reducing consumption and increasing revenues should be embraced during this period of economic hardship, when governments face increasing needs to find new ways to fund spending, particularly for health care. Tobacco taxation is a simple and effective means of increasing revenues without adverse effects on the economy (WHO, 2010, p. 9).

A third way ideas were reframed to support global tobacco control was to counter arguments favouring smokers’ rights. This was achieved in two ways. First, a strong emphasis was placed on the role of addiction. Around 70 per cent of current smokers wish to quit but, due to the strong addictive nature of nicotine, find they cannot (Reinberg, 2011). Until 1994, the year tobacco executives testified to a US Congressional hearing on the subject, the industry maintained that nicotine is not addictive. Internal documents made publicly available since revealed, however, that the industry has long been aware of nicotine’s addictive-ness, designing products specifically to optimise the ‘hit’ of nicotine in tobacco products. These revelations led to youth prevention becoming central to the FCTC (Article 16 Sale to and by minors).

Second, smoking was reframed in terms of the rights of non-smokers not to be exposed to second-hand smoke. Strong evidence emerged in the 1980s that spouses of smokers had a higher risk of developing lung cancer than spouses of non-smokers. Attention was also given to chil-dren exposed to smoking in the home or elsewhere (National Research Council, 1986; US Surgeon General, 1986; Eriksen et al., 1988). Risks to workers in enclosed workplaces, such as bars, restaurants and airplanes, were also emphasised, supported by legal cases resulting in large compensatory settlements (Sweda, 2004). This evidence supported the adoption of FCTC Article 8 Protection from exposure to tobacco smoke and the adoption of restrictions to smoking in public places worldwide from the 1990s.

Following the signing of the FCTC in 2003, ideas related to security became influential during the negotiation of its first protocol on the


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illicit tobacco trade. Security concerns, amid the heightened vigilance following the terrorist attacks on 11 September 2001, bolstered the argu-ment that illicit trade be the subject of the first FCTC protocol (WHO, 2011b). Although public health and industry advocates disagreed on the root causes of cigarette smuggling, both agreed that the trade was benefiting organised crime and terrorist organisations. As described by BAT (n.d.b):

Illicit trade is not just the work of small operators. Organised crime is increas-ingly dominant. The rewards can be high. Just one shipping container full of trafficked cigarettes could earn a criminal gang more than US$1 million.Interpol, the international police organisation, says gangs that traffic drugs, arms and people are also behind the illicit cigarette and alcohol trade. The US Department of Justice says some also have ties to terrorist organisations.

Similarly, Altria (which owns Philip Morris) states:

Illicit trade ... funds criminal organizations. Drawn by high profits and low risk, a wide range of criminals currently distribute and sell illicit cigarettes in the United States. These criminals range from small-time smugglers to organized crime and organizations tied to terrorism. (Altria, n.d.)

Views remain divided, however, on the policy interventions needed to address the problem. The industry has argued against higher tobacco taxes, plain packaging and other measures that allegedly contribute to increased smuggling:

The black market is driven by ever higher tobacco taxes, particularly when taxes and therefore prices in neighbouring countries are much lower. Weak criminal penalties, poor border controls, low arrest rates and corruption in some parts of the world add to the problem. We see it as vitally important that governments establish workable tax regimes and economic policies that do not create conditions that encourage illicit trade, with strong border controls and effective laws to combat it. (BAT, n.d.b)

On plain packaging, industry advocates have argued that the policy would lead to an increase in counterfeiting and support terrorism:

Any standardisation of pack appearance may make it more difficult to spot and track smuggled tobacco because the lack of distinguishing features make it more difficult to identify ... groups such as the PKK, Islamic Jihad, Al-Qaeda, Hezbol-lah and Hamas are widely known to finance their terrorist operations through selling counterfeit or non-duty- paid tobacco. (Sheridan and Ramm, 2013)

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Moreover, the industry has questioned the mandate of WHO to deal with law enforcement issues:

[S]muggling is also the issue most adequately dealt with through existing structures for the coordination of police and customs enforcement, including the World Customs Organizations (WCO). WHO intervention in this area would be counterproductive inasmuch as it will involve the same police and customs officials in a different international regime. (BAT, 2000b, p. 7)

However, the negotiations coincided with successful legal cases brought by the European Union, Canadian government and US Department of Justice which found TTCs complicit in the illicit trade (Tran, 2004; Austen, 2008).

Overall, public health advocates and the tobacco industry have engaged in what Beland calls the ‘politics of insecurity’ (Beland, 2007, p. 317). In the case of the former, framing tobacco as a security concern has been another effective way of raising the priority given to addressing the illicit trade by key non-health sectors. The tobacco industry, in contrast, has slowed policy measures, such as increased taxation and plain packag-ing, by arguing their likely impact on smuggling. To some extent, these arguments have been undermined by evidence from internal documents suggesting the industry’s own complicity in the illicit trade to gain market presence, circumvent market barriers (for example, import bans and quotas) and ultimately earn substantial profits (Collin et al., 2004; Lee and Collin, 2006). Nevertheless, security remains a key concern among governments with the coming together of material circumstances (namely increased cigarette smuggling by criminal groups) and the idea-tional power of the security frame.

Institutions and actors concerned with global tobacco control

The global governance of tobacco control since the 1990s has been characterised by a greater diversity of both state and non-state actors. As an international treaty, the FCTC was formally an intergovernmen-tal process of negotiation among sovereign states convened by WHO. In practice, the WHO Director-General and Tobacco Free Initiative staff exercised strong leadership in initiating and shaping the process. Engagement with non-state actors, from the pre-negotiation phase to


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implementation, was a distinctive feature of the FCTC process and, as a result, can be considered as breaking new ground in GHG.

The long neglect of tobacco control by WHO member states, beyond periodic acknowledgement of the scale of the problem, changed in May 1995 with the adoption of a WHA resolution to initiate negotiation of an international instrument. In 1996, resolution WHA49.17 was adopted requesting the Director-General to initiate the development of a WHO Framework Convention on Tobacco Control (WHO FCTC). With this mandate, and after Director-General Brundtland identified tobacco control as a key priority, member states adopted resolution WHA52.18 to establish a FCTC Working Group and Intergovernmental Negotiating Body (INB). The resolution mapped out an integrated process for develop-ing the FCTC, and possible related protocols, with the full participation of member states. The mission of the Working Group, open to participation by all member states and regional economic integration organisations, was to prepare the draft elements of the treaty for submission to the 53rd WHA. The Working Group produced a draft of possible elements of the FCTC, and a final report was delivered to the 53rd WHA in May 2000.

Following this state-led process, WHO conducted public hearings in October 2000 which can be described as a transformation in GHG in two ways. First, the hearings invited a large number of diverse non-state actors to submit their views about the forthcoming process. WHO received over 500 submissions, with representatives of over 160 organisa-tions and institutions giving verbal testimony including representatives of the tobacco industry, tobacco farming groups, public health agencies, women’s groups, community-based organisations and academic institu-tions. In this way, a significant number of non-state actors contributed to the negotiation process from its earliest stages, a degree of involvement that would continue throughout the negotiation process and beyond to treaty implementation.

Second, the nature of non-state participation in treaty negotiations was notable. As well as public hearings and consultations, non-state actors were encouraged to become accredited as observers. Accredita-tion of several groups, as officially recognised observers, were even ‘fast tracked’. WHO staff recognised the importance of ensuring regional and local non-state actors were well represented in negotiations, particu-larly to balance strong tobacco industry interests. In many cases, civil society organisations brought an important pro-health voice to counter active industry lobbying. This was seen as especially critical given the

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accreditation of individuals with industry links on state delegations (for example: China, Japan, Italy and Zambia).

The tobacco industry, as a non-state actor, was permitted by WHO to submit evidence to the public hearings but excluded from the formal negotiations, including observer status. As Brundtland (2000, p. 2) stated,

[Tobacco companies] re-state well known predictions that international action to reduce tobacco use will lead to sudden and massive job losses, people driven further into poverty and threats to the sovereignty of nations. As we heard from other groups, these predictions do lead to genuine concern among decision makers: however, careful research has also shown that in most cases the predictions have no evidence base. It thus seems likely that the companies are trying to confuse the negotiating process that will be taken forward by delegates from WHO’s 191 Member States (emphasis added).

The decision to exclude the tobacco industry from negotiations was supported by a WHO enquiry into ‘Tobacco company strategies to undermine Tobacco Control Activities at the World Health Organization’ by a Committee of Experts on Tobacco Industry Documents (WHO, 2000). Similar concerns were raised by WHO regional offices (WHO/EMRO, 2004). The evidence cited in the 260-page report countered arguments that the tobacco industry was a legitimate stakeholder in the negotiations and, more generally, tobacco control.

A key development that further enhanced the role of pro-public health non-state actors in FCTC negotiations was the formation of the Framework Convention Alliance (FCA) in 1999. Composed of over 350 organisations in more than 100 countries, the FCA became a staunch supporter of the FCTC negotiations, as the basis of effective global tobacco control by rallying support worldwide, monitoring industry involvement, and even briefing state delegates (Collin et al., 2002). As Mamudu and Glantz (2009, p. 150) write,

[T]he FCA successfully used strategies, including publication of a newsletter, shaming symbolism and media advocacy to influence policy positions of countries during the FCTC negotiation. The FCA became influential in the negotiation process, by mobilising tobacco control civil society organisations and resources with the help of the Internet, and framing the tobacco control discussion around global public health.

New funding supported these efforts:

Ted Turner had just created the UN Foundation and we were one of the first recipients of funding. We directed that immediately to create a cadre of


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NGOs and sparkplugs in the media around the world using a fairly hard-hitting campaign, one that WHO had never used before, going explicitly after a corporate sector, which WHO also had never done before. (Yach, 2005)

At the same time, civil society organisations (CSOs) were not reticent to criticise when negotiations fell short of expectations. CSOs argued, for example, that the final text was considerably weakened by countries with tobacco interests:

In fact and the 75 other civil society groups comprising the Network for Accountability of Tobacco Transnationals (NATT) have charged that the new draft treaty text slides backwards from the positions advocated by the great majority of countries in key areas such as tobacco promotion and prioritizing public health over trade in tobacco. (Anon, 2003)

For WHO, however, compromises were seen to be needed to secure the signatures of key member states. The large number of countries that signed the treaty in 2003, and the rapid pace of ratification by the requisite 40 countries by February 2005, enabled the instrument to come into legal force relatively quickly. For many tobacco control advocates, however, the compromises went too far, especially as those countries declined to sign or ratify the agreement (Mamudu and Glantz, 2009). Although comprehensive in scope, few FCTC measures were made obligatory, and hopes that stronger measures through additional protocols would add strength has so far come to nought with the exception of the protocol on illicit trade. For GHG, while the FCTC negotiations involved an unprec-edented range of actors, perhaps even setting a precedent for future GHG processes, powerful vested interests coalesced across state and non-state actors to limit the authority of WHO and the treaty to regulate strongly.

Conclusion

The three themes addressed in this book are well-illustrated by the global governance of tobacco control since the 1990s, although the relationship among the three themes differs from the other case studies. The harmful health effects of tobacco use became a policy issue from the 1950s, supported by substantial scientific evidence. At the national level in selected countries, public concern began to rise, and tobacco control policies began to be adopted. However, the policies adopted were not commensurate with the health risks posed despite the weight

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of evidence supporting stronger and quicker action. In most countries, tobacco control remained a low priority. The elevation of tobacco control to a global governance issue marked an importance change in approach. Public health advocates, notably WHO Director-General Brundtland and the leadership of TFI, recognised the importance of collective action. The restructuring and successful expansion of the tobacco industry into emerging markets worldwide, reflecting its adaptation to and shaping of globalisation processes, was recognised as needing a response beyond individual states. In short, the transformation of the tobacco industry was met by a similar transformation in GHG.

Although this chapter recognises the key importance of material power for explaining how the tobacco industry has continued to thrive, despite the deadly nature of its products, a fuller understanding of the industry’s resilience must take account of ideational power. The findings of this chapter suggest the battle over tobacco control policy, from the 1950s onwards, was fought with both material and ideational power. Alongside direct countering of longstanding economic and rights-based arguments by the industry, WHO led efforts to refine the presentation of the evidence base to produce measurable data of global health impacts and interventions. It is when public health advocates reframed the issue in this way that new political impetus was achieved.

Finally, the institutions and actors involved in global tobacco control demonstrate a key transformation in GHG. The FCTC was initiated by member states and WHO as an intergovernmental organisation. Nevertheless, selected non-state actors were strategically brought into the treaty-making process, both as essential advocates for stronger regulation, but also as legitimate and legitimising players in achieving collective action on tobacco control. It was recognised that powerful state and non-state actors opposed to the FCTC were actively engaged in undermining WHO and negotiations. An alliance of public health advocates, underpinning the essentially intergovernmental negotiation process, was recognised as essential.

Note

The US Surgeon General produced his first report on ‘Smoking and Health’. Its conclusions corroborated those of the RCP, and the US Surgeon General has produced annual reports since 1967 on the health consequences on smoking.

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5Access to Medicines and the International Patent Rights Regime

Abstract: The focus of this chapter is the World Trade Organization’s (WTO’s) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) as a central component in trade-related governance affecting the pharmaceutical industry. TRIPS is therefore illustrative of how health issues and outcomes are not necessarily determined by actors and institutions primarily associated with health. The chapter begins by discussing how intellectual patent rights and access to medicines came to be understood as a global health issue with the coming into force of TRIPS in 1995. Second, the chapter traces the manner in which TRIPS and its adverse health impacts were subsequently challenged by counter-framings based on human rights. Finally, we link TRIPS to the emergence of institutions and actors involved in addressing the access to medicines issue.


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Introduction

The last two decades have seen considerable policy and scholarly focus on the issue of international patent rights and access to life-saving and life-prolonging medicines, not least because an estimated 2 billion people in the world continue to lack the ability to use or purchase these essential medicines (UN Millennium Project, 2005). Debates have concentrated on the impact of trade governance on health, the effective-ness of global health governance (GHG) and the relationship between global and national health policy-making. A specific concern has been the extent to which the global patent regime, which protects innovation in new medicines and health technologies, may simultaneously limit access to, or development of, these same products, most especially in low to medium-income countries (LMICs).

The particular focus for this chapter is the World Trade Organization’s (WTO’s) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (World Trade Organization, 1994). However, TRIPS is only one, albeit central, component of a wider system of trade-related governance affecting the pharmaceutical industry. Other bilateral, regional and plurilateral platforms of trade governance are important elements of a wider trade and intellectual property rights (IPR) regime. Moreover, patent protection is only one of a number of drivers of the problem of a lack of access to medicines in LMICs, others including market failure for developing drugs for neglected diseases, poor infra-structure and weak national health systems. Thus it would be overly simplistic to suggest a different approach to IPRs might alone resolve the problem of access to medicines. Nevertheless, what we examine here is how TRIPS represents the development of a global governance regime with significant health implications. TRIPS is a regime which did not originate in the health sector, and perhaps unsurprisingly therefore failed to prioritise health outcomes. Some have even gone so far as to suggest that, as a consequence of framing IPRs principally in terms of their economic utility, TRIPS did little to improve health outcomes, and had a detrimental effect on access to medicines.

TRIPS can therefore be viewed as the starting point in the trans-formation in a wider system of global governance affecting access to medicines. Moreover, the basic governance agenda established by TRIPS continues, albeit somewhat altered, today. Importantly, the transforma-tion in the governance of trade and IPRs preceded what the introduction


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to this volume described as a shift from international to global health governance. This case study is therefore illustrative of how health issues and outcomes are not necessarily determined (if they are ever at all) by actors and institutions primarily associated with health. This chapter addresses the problem of IPR and access to medicines in respect to the three thematic organising principles of this volume. We will, therefore, first broadly rehearse how IPR and access to medicines came to be understood and constructed as a global health issue with the coming into force of TRIPS in 1995. Second, the chapter traces the manner in which TRIPS and its adverse health impacts were subsequently chal-lenged by counter-framings. Finally, we link TRIPS to the emergence of increasingly specialised institutions and actors involved in addressing the access to medicines issue.

The emergence of access to medicines as a global issue

Demands for greater access to affordable essential medicines found concrete expression in the 1970s and 1980s. At this time many LMICs supported local production of generic medicines, using an import-substitution model of industrialisation with regulations targeted at meeting national needs. Weak, or entirely absent, patent protection was a characteristic of the pharmaceutical and medicines production strategies of many LMICs. At its meeting in Colombo in 1976, the Non-Aligned Movement criticised multinational pharmaceutical companies ‘as an instrument of northern domination’, and exerted pressure for medicines to be defined as public goods (Editorial Note, 1995). In 1975 the WHO Director-General Halfden Mahler told the World Health Assembly (WHA) that there was an ‘urgent need to ensure that most essential drugs are available at a reasonable price’ (Greene, 2010). This was followed in 1977 by the publication of WHO’s landmark Model List of Essential Drugs (WHO, 1977, since updated every two years) categorising some 208 medicines selected ‘with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness’ (WHO, 2013c). According to Greene, the Organisation envisaged a shift of basic medi-cines ‘from the private sphere into a public health commons’ (Greene, 2010). In 1981 the WHO established an Action Programme on Essential Drugs, with the Organisation playing a lead role in the development of

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national drug policies premised on increased public sector financing and ‘even closer regulation by the state’ (Murray et al., 1995). Despite these new initiatives, however, only a handful of LMICs were able to increase their drug manufacturing capacities (Chudnovsky, 1983; Ballance et al., 1992). Instead, during the 1980s to mid-1990s, policies of economic liber-alisation saw the denationalisation of many generic producers in LMICs, and access to medicines fading as a priority from the international health and development policy agenda.

It was not until TRIPS had come into force in the latter half of the 1990s that access to medicines was given concerted policy attention once again and, notably, now it was constructed as a global issue requiring a collective global governance response. This shift in perspective, from IPR and access to medicines being a matter of national drug policy to one of GHG, stems from the impact of the TRIPS agreement. As of 2013, some 159 WTO member states have implemented the TRIPS agreement (WTO, 2013), which seeks to ‘harmonise’ IPR laws internationally, includ-ing patents, making rights available in all WTO member countries, and subject to the WTO’s powerful dispute settlement body (Jackson, 2008). For all patents, a 20-year term of protection was awarded, surpassing the duration then required under many national legal systems (WTO, 1994). Crucially for our purposes, the agreement specifically included medicines as a new area to receive international patent protection. Previously, many countries had either not permitted drug patenting, or allowed the production of like products (chemically similar or identical drugs) by different processes (Ballance et al., 1992). In particular, many LMICs had historically chosen to exclude medicines from their patent laws, precisely because of different competing social values being placed on them (Chien, 2003, p. 864). This changed with TRIPS, leading critics of the agreement to argue that it shrank the policy space in which to pursue health goals (Shadlen, 2005).

High-income countries (HICs) and Transnational Pharmaceutical Companies (TPCs) have consistently argued that, without the presence of rewards guaranteed by virtue of temporary monopoly rights, pharmaceu-tical innovation and the incentive to invest in research and development (R&D) would soon disappear, leading to a net loss for the wider society. This problem is especially pressing in the area of drug development, where estimates have placed the R&D costs associated with getting a drug to market in the hundreds of millions of dollars, with the patent system acting as the only systemic pull mechanism for the substantial investment required


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for new products (DiMasi et al., 2003). Whilst this justification of the patent system may well be applicable for developed country markets, in applying the same logic across a global market promoters of TRIPS chose to ignore different national levels of income and economic development, thus posing problems in particular for LMICS (Drahos, 2003; Stiglitz, 2008).

In the five years following 1995, a transnational coalition emerged to challenge the trade-based governance of drugs, further embedding the relationship between IPRs and access to medicines as a global issue. Crucially, critics constructed it not as a threat to national health systems, but as a global issue requiring collective action in response. In particular, resistance to TRIPS quickly became a major platform of activity for a range of transnational civil society actors. One of the key drivers of this challenge was the role of the escalating HIV/AIDS pandemic in sub-Saharan Africa. In particular, resistance focussed on the availability of patent protected anti retroviral treatments (ARVs). These commanded prices too high (approximately US$10,000 per year per patient) to be affordable by many people living with human immunodeficiency virus (HIV) in sub-Saharan Africa (Waning et al., 2009), and therefore gave the emerging challenge to TRIPS its initial spur and international legitimacy. Resistance to the WTO IPR regime also generated considerable global media attention (Odelland Sell, 2003; Owen, 2013). In particular a transnational advocacy network crystallised around the high-profile South African legal dispute brought by 39 pharmaceutical firms (under the national association of South African pharmaceutical manufacturers) against South Africa’s Medicines Act of 1997 (Barnard, 2002; Heywood, 2009). The Medicines Act had been designed to facilitate the compulsory licensing of patented medicines alongside broader generic substitution of off-patent drugs, the importa-tion of generic versions of on-patent drugs produced in other countries and drug price transparency (Gray and Vawda, 2013). The South African case, brought between 1998 and 2001, inspired worldwide opposition to drug patenting (especially with regards to ARVs), particularly as the respondent to the case was President Nelson Mandela. The legal actions of the pharmaceutical firms, and political and economic pressures exerted by the US Trade Representative, prompted a global nongovernmental organi-sation (NGO) campaign on TRIPS and the access to medicines issue (Sell, 2001–02; Sell and Prakash, 2004; Ford, 2004; Heywood, 2009).

More generally, the implications of TRIPS for access to medicines were systematically linked with other critical global issues, such as biodiversity and agriculture, not least because the agreement also opened

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up the possibility of plant and biotechnological patents. Further, as the consequences of TRIPS became more apparent to LMICs, they began to develop formal and informal coalitions at global institutions such as the WTO and the World Intellectual Property Organization (WIPO). Thus access to medicines, and in particular IPR for pharmaceutical products, became a global issue both because of the nature of the agreement itself, establishing global protocols to protect patent rights, and because of the manner in which it was constructed by its critics as a global threat to health outcomes.

Framing responses to the problem of IPR and access to medicines

Although positive economic framings of IPRs initially drove interna-tional drug patent protection, counter-framing eventually influenced the construction of different types of institutional engagement with access to medicines problem, and to the development of increas-ingly specialised policies and initiatives directed at tackling cost and innovation. LMICs and civil society organisations initially cast access to medicines in terms of the right to health: that as a human right, affordable access to essential medicines should be given priority over patent rights (Sell and Prakash, 2004). This rights-based focus has also been instrumental in framing various UN and WHO initiatives on access (WHO, 2012, p. 30), and calls for prioritising health over trade policies have used the rights focus as a means of resonating with different audiences in order to gain political traction (Hogerzeil et al., 2006). For example, at the landmark WTO Doha Ministerial in 2001, WHO Director-General Gro Harlem Brundtland’s official statement began with an explicit use of the human rights frame. In particular she positioned the WHO alongside LMICs in seeking confirmation of the flexibilities in TRIPS, which would enable compulsory licensing and access to critical medicines on-patent:

Clarity on this flexibility would allow Members to formulate public health policies in ways that do not infringe the rights of patent holders. Access to health care is a human right and we all have an obligation to see this right progressively realized. This involves access to health facilities, prevention, care, treatment and support, and – of course – access to life-saving medicines. (Brundtland, 2001)


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Key LMICs, together with civil society groups, were powerful voices in a process of challenging the authority of the WTO by means of a strategy that has been described as ‘forum shifting’ (in which agents strategically switch to alternate platforms of governance and policy to advance objec-tives which are otherwise blocked or unobtainable in certain forums). Initially, these parties challenged the authority of the WTO by forum shifting the debate to institutions and bodies associated with human rights and not trade (Helfer, 2004). For example, in 2000 the UN Cove-nant on Economic, Social and Cultural Rights (CESCR) and the UN Sub-Commission on the Protection and Promotion Human Rights were both used to formally state that TRIPS and patent protections conflicted with the right to health, and should not do so (CESCR, 2000; United Nations Sub-Commission on the Promotion and Protection of Human Rights, 2000). Similarly, in 2003 a joint platform of United Nations Joint Programme on HIV/AIDS (UNAIDS) and the Office of the High Commissioner for Human Rights noted the negative impact of patents on peoples’ rights to access ARV treatment. In the report of this meeting the human right to access ARVs was given unequivocal primacy over patent rights entailed by trade agreements:

States should, in light of their human rights obligations, ensure that bilateral, regional and international agreements, such as those dealing with intellectual property, do not impede access to HIV/AIDS prevention, treatment, care and support, including access to antiretroviral and other medicines, diagnostics and related technologies. (Office of the United Nations High Commissioner for Human Rights and UNAIDS, 2003, p. 21)

At a more basic level the initial challenges to drug patents in the late 1990s also involved the strategic uses of a simple but powerful moral argument that, ‘medicines that could save or prolong lives were available, but their makers were refusing to sell them at marginal cost, choosing to let people to die to hold up profit margins’ (Odell and Sell, 2003, p. 100).

Although rights-based campaigns were important in igniting the international trade and health debate, and for securing the moral high ground, other frames have also been deployed. Following the anthrax attacks in the United States in 2001, and that country’s threat of compul-sory licensing to gain access to the necessary treatment, the issue of access to medicines became framed by security concerns. The willingness of the United States to threaten compulsory licensing during a state of national emergency was seized upon by critics, given the country’s opposition to the same policy for other countries seeking affordable treatments for HIV

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and other significant health needs. Likewise, medicines were also framed in terms of public goods, and even as global public goods, particularly with regard to the utility of providing access to medicines that prevented or curtailed the threat of pandemics (Kaul and Faust, 2001). In this instance we see linkages between the health security and the public goods frames, in which the absence of access to medicines resulting from their status as private goods is held to generate wider health security threats (Pang and Guindon, 2004). The economic counter-framing intensified after 1995, fighting fire with fire. In particular civil society groups, such as Consumer Project on Technology, challenged some of the key economic justifications for patent protection, such as estimates for the cost of innovation (Sell and Prakash, 2004). Analysis of the broader political economy of pharmaceuticals has, since this point, become more nuanced and aware of different dynamics accounting for market failures in the supply of drugs (Hollis, 2004; Ravvin, 2008; Selgelid, 2008; Pogge, 2009; Hollis and Pogge, 2010). Critiques have differentiated between a focus on the failure of the patent system (especially with respect to price and the adverse influence of secondary patenting – or ‘evergreening’ – on the dynamics of innovation), and on the often separate problem of market failure. Indeed, highlighting continued pharmaceutical market failure has become a powerful economic counter-frame with regard to the inef-ficiency of the patent system when markets are not present. It has also been used to criticise the operation of TPCs with respect to the health needs of the poor, and the focus of corporate R&D expenditures in a manner that fails to reflect the global burden of disease. Hence economic analysis yielded wider consciousness of the 90/10 gap1 and the problem of neglected diseases (Troullier et al., 2002; Rosiello and Smith, 2004). Market failure has also been highlighted in instances where diseases are comparatively rare, and therefore do not provide sufficient incentive for the investment in necessary R&D, with the resulting problem of ‘orphan diseases’ (which afflict people in both HICs and LMICs).

These important, critical economic challenges found resonance with the rapid growth of new initiatives in global health and development policy at the turn of the millennium. The need for improved access to healthcare and medicines was increasingly constructed as requiring greater financing and political intervention in the influential economic case for health investments made by the 2001 Commission on Macr-oeconomics and Health (CMH) (WHO, 2001), as well as in the basic thrust of the health-related Millennium Development Goals (MDGs)


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of the same year (UN, 2000a). The Commission and the MDGs were important turning points in the thinking and practical global policy directed at both global health and development issues at this juncture. Specifically for this chapter, there is an important transition apparent in the manner in which health is framed with respect to economic develop-ment and prosperity. Rather than a basic assumption that the market was the best means of allocating scarce resources, or that the poor would access better health only after economic prosperity was engendered, we see signals of commitment to a new virtuous circle; a discourse that has stressed the need for select interventions in health (particularly for HIV, malaria, TB and maternal mortality) as a necessary means of securing global economic development, by offering a healthy basis by which to escape poverty. This new virtuous circle frames the need for prior invest-ment in health to enable economic development, especially where disease negatively affected economically productive adults, hollowed-out state capacities or constituted an intolerable economic burden on poor people and states. A WHO summary of the CMH Report explicitly promotes the new framing of the relationship among health, poverty and economic development:

Until recently, economic growth was seen as a precondition for real improve-ments in health. But the Commission turned this notion around and provided evidence that improvements in health are important for economic growth. It confirmed that in countries where people have poor health and the level of education is low it is more difficult to achieve sustainable economic growth. (WHO, 2002, p. 10)

This new discourse and approach to health and economic development was central to the MDG project in particular, which would constitute from 2001 an unprecedented international health and development assistance platform until 2015 (Katz, 2004, 2005), within which wider access to medicines and other health technologies became necessary goals as well as measurable targets by which the disease-specific MDG could be monitored and measured (Vandemoortele, 2009; Fukuda-Parr and Yamin, 2013).

Institutions and actors

The coming into force of TRIPS can be understood as a key shift in the global governance of access to medicines from which other subsequent

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initiatives, institutional developments and policies have flowed. Indeed, the rules and architecture of an international system of IPRs have also served to shape, constrain and determine the effectiveness of subsequent initiatives of new and old health actors which have engaged with the problem of drug access. After all, TRIPS encompasses a relatively coher-ent international framework of norms, rules and obligations that have led to sets of policies and practices with regard to patent rights on drugs. The regime entails rights and obligations for all members of the WTO, and has now been implemented in the national systems in all but the Least Developed Country WTO members, who are presently exempt from acceding to full compliance. The focus of the WTO with respect to TRIPS has also changed subtly, moving from issues of implementation to a wider insistence that LMICs properly enforce the patent standards required by TRIPS within their domestic legislatures and courts (Correa, 2008; Sell, 2009). The regime has therefore matured and bedded down, with a commensurate focus on national availability and enforcement of rights. As a result, pharmaceutical corporations are increasingly able to use litigation strategies offered to them in WTO members’ national courts in order to preserve their monopolies and deter generic entrance, and rates of foreign held drug patents are rising in nearly all key generic producing developing counties (Correa, 2011). TRIPS has therefore become an established (if contested) multilateral framework.

Some of the most crucial agencies involved in the challenge to TRIPS were influential international NGOs, such as Oxfam, the Consumer Project on Technology, and Médecins Sans Frontières. Many of these were increasingly incorporated into the governance of the issue area, as representatives on the governing boards of many of the new access to medicines agencies. Moreover, international NGOs began to directly fund developing country trade missions in Geneva, and other forums, such as the Convention on Biological Diversity. In the late 1990s these NGOs provided an effective technical assistance programme in various governance fora and in areas of international law which had previously been a relatively arcane and moribund. Whereas awareness of the implications of TRIPS for access to medicines had been limited during the Uruguay Round, and capacity to meaningfully participate was corre-spondingly constrained, this changed rapidly after 1995 (Ford, 2004).

NGOs also worked alongside a range of advocacy and patient activist groups, which throughout the 1990s had campaigned for wider access to ARV treatments, and against medicines patenting. These groups


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included Act-UP, Health Gap, the South African Treatment Action Campaign and the Thai AIDS Access Coalition. These diverse groups would come to constitute the effective basis for a highly coordinated Transnational Advocacy Network crystallising around the access to medicines issue area (Keck and Siddink, 1998; Ford 2004). New and genuinely transnational alliances began to be forged on a range of intellectual property rights concerning critical areas of human life and ecology. The very reach of TRIPS thus succeeded in linking diverse, issue-based rights campaigns, most notably with regard to farmers’ rights and agriculture, indigenous rights and biodiversity and, of course, patient and health rights groups (Sell, 2001–02). This process of issue-linkage allowed access to medicines to rise in prominence as a global issue in health and trade (Muzaka, 2011).

As the TRIPS agreement became subject to challenge and counter-framing, policy innovation occurred within the WTO as an institu-tion. At the turn of the millennium, the problem of IPR and access to medicines was still largely articulated as requiring an amendment to the WTO patent rules. Thus the WTO’s Doha Ministerial Meeting of 2001 constitutes a significant high point of the period where the TRIPS faced unprecedented international attention and challenge, and where reform of TRIPS itself was widely viewed as the necessary global governance response to the access to medicines problem. The attempt to roll back or reform TRIPS very nearly succeeded, with paragraph 4 of the Declara-tion stating that:

The TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all. (WTO, 2001, paragraph 4)

Furthermore the Declaration affirmed the flexibilities present in TRIPS for compulsory licensing and the right of WTO members to determine what constituted an emergency requiring the obviation of patent rights. The WTO Council for TRIPS was also directed (in paragraph 6) to seek a solution for those countries that lacked the manufacturing capacities necessary to license and make generics. Nevertheless, the impact of the Declaration has proven to be only limited, and TRIPS still an important platform for governance as it acts as a baseline and basic standard of

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norms, rules and disciplines from which other TRIPS-plus objectives are being pursued (Drahos, 2001). Moreover, the challenge to TRIPS in the WTO has arguably led to a further widening and strengthening of the broader trade and IPR regime outside the WTO.

Although the WHO had not initially been a central agent in challeng-ing the governance authority of TRIPS, this changed rapidly in the years following 1995. The Organisation was used instrumentally by key LMICs, as a forum with considerable moral and technical authority over global health, thus providing a means of channelling resistance. In the 2000s at least, WHO was an organisation that also drew new focus upon the other drivers of the access to medicines problem, such as the financing of innovation for neglected diseases. The Organisation eventually became proactive in the governance of access to medicines, and did so often in the face of the contrasting political interests of its high-income member states. A number of key individuals working at WHO were also able to use their positions of authority in the Organisation to commission studies and reports, that formed part of the momentum to subsequent policy initiatives. These initiatives focussed on both specific IPR-related problems and on the wider drivers of the problem of access to medicines. Notable amongst these individuals are Hans Hogerzeil, former Director for Essential Medicines and Pharmaceutical Policies; Germán Velásquez, former Director of the WHO Secretariat on Public Health, Innovation and Intellectual Property; Richard Laing, editor of the Essential Drugs Monitor; and Precious Matsoso, Director of Division for Public Health Innovation and Intellectual Property (PHI) – in the late 2000s.2

In particular, the work and critical orientation of staff at the division for PHI, in the office of the Director-General, meant that WHO increas-ingly exercised its authority over health and access to medicines in a manner which challenged the trade and IPR regime by means of expert advice and empirically informed research on alternate systems for financing innovation. Thus the Revised Drug Strategy of 1998 specifically highlighted the presence of flexibilities within TRIPS (WHO, 1998). This was followed in the early 2000s by a number of critical reports which documented the negative impact of bilateral Free Trade Agreement’s (FTA’s) and TRIPS upon access to medicines (for example the study authored by the influential academic and advocate, Carlos Correa; see Correa, 2002). From 2003 to 2006 the WHO launched its Commission on Intellectual Property Rights, Innovation and Public Health (WHO, 2006), a far-reaching consultative process that analysed the empirics of


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patents and access to medicines, the failure of technology transfer, and the possibilities of different mechanisms for incentivising and funding pharmaceutical R&D. Its final report was adopted at the 61st World Health Assembly (WHA) in 2008. The Report’s final annex outlines the basis for WHO’s future strategy, noting that although IPRs had been an issue which had tended to dominate discussions in the Commission, policy at WHO would thereafter seek to move the agenda on to other pressing problems associated with the access issue. The report sets out the intention to ‘provide a medium-term framework for securing an enhanced and sustainable basis for needs driven essential health research and development relevant to diseases which disproportionately affect developing countries, proposing clear objectives and priorities for R&D, and estimating funding needs’ (WHO, 2008b, Annex 1, paragraph 13). The same WHA therefore mandated the Global Strategy and Plan of Action (WHO, 2008b) to this end. This is a wider platform of governance inno-vation with respect to access that focuses on the creation of sustainable systems of incentives for neglected diseases, whilst maintaining the right of use of TRIPS flexibilities. Finally, the WHO launched the Consulta-tive Expert Working Group on Research and Development: Financing and Coordination (CEWG) in 2010, which was specifically charged with examining alternative financing of drug development. This group would make a series of recommendations as to the financing and stimulating R&D for neglected diseases (WHO, 2012).

States, especially LMICs, have also been important actors. Most controversially their agency here has involved the use of compulsory licences (or simple threat of their use) to secure lower priced drugs. As early as 1996, Brazil enacted a patent law that stipulated that medicines should be locally manufactured to enjoy patent protection there. Brazil used this provision to threaten compulsory licences on ARV drugs held by Roche and Merck in order to force price discounts, whereas Thailand took similar steps in 1997 and 1998, but retreated in the face of political pressure from the United States (Vick, 1999). However, recent work by Beall and Kuhn traced only 24 instances (what they term episodes) where compulsory licences have been used or threatened in the post-TRIPS era. The strategy has been undertaken only by 17 countries to date, and it is particularly striking that two-thirds of compulsory licensing activity was concerned with human immunodeficiency virus/acquired immu-nodeficiency syndrome (HIV/AIDS) treatments (Beall and Kuhn, 2012, p. 1). Indeed, the influential UN MDG Gap Taskforce, reflecting on the

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causes of poor progress towards widening access to available medicines, noted in its 2012 report that the failure to invoke compulsory licences was driven by many countries simply not amending their national laws to facilitate the process:

Unfortunately, however, the use of these ‘TRIPS flexibilities’ is far from commonplace. One reason for this is that many countries have yet to amend their national laws to incorporate them fully. In a study of 95 countries, only about half of the countries were found to adjust their patent legislation to allow for the use of a patented invention without the authorization of the patent owner to obtain marketing approval of a generic product before the patent expired, as allowed by the so-called Bolar exception. (UN MDG Gap Taskforce, 2012, p. 67)

New institutions and governance platforms are also incrementally extending the international patent regime. Moreover, TPCs are still active in lobbying and pressuring for yet higher levels of patent protection and other market exclusivities. In the aftermath of the Uruguay Round, the architects of the TRIPS agreement did not simply sit back; rather they spurred on a process of widening, strengthening and deepening the regime. This has involved HICs extending levels of protection for phar-maceutical patents across bilateral, regional and plurilateral platforms of trade governance (such as the Trans Pacific Partnership Agreement). These agreements usually include TRIPS-plus clauses, which increase periods of data exclusivity (making more expensive the entrance of generic versions of medicines), patent terms and prohibitions on compulsory licensing and enforcement measures (El Said, 2010). Thus although TRIPS is still an important governance instrument, it also acts as a baseline and basic standard of norms, rules and disciplines from which other TRIPS-plus objectives are being pursued (Sell, 2010).

The reaction to TRIPS, and particularly the increased understanding of the economics of both patents and market failure, led to the emer-gence of a degree of consensus on the need to intervene in markets and innovation to widen the availability and supply of critical medicines. A range of new actors and initiatives have pioneered new ways of organ-ising health aid; they are business like, results oriented and are often focussed on biomedical interventions. Many of these actors have a direct role in supplying or discounting drugs, or in funding or brokering innovation. In this new governance system, we see the development of public–private partnerships and the emergence of mega philanthropic foundations, suggesting a private turn in GHG. The Global Fund, Global


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Alliance for Vaccines and Immunisation (GAVI) and a raft of specialised health instructions such as UNITAID, the Accelerating Access Initia-tive, Stop-TB and Roll Back Malaria, are just a few of an estimated 190 new international partnerships and other health agencies which have entered the stage since the late 1990s (Buse and Walt, 2000; Rushton and Williams, 2011). The system is complex, with complexity further engen-dered by civil society organisation ramping up efforts in health aid, and increasingly being used as proxy deliverers of health services, medicines and other resources by many of the traditional state donor programmes.

These organisations largely followed in the immediate wake of the 2001 MDG commitment to invest in selected disease interventions, most notably in HIV/AIDS, malaria and TB, and the investment of unprece-dented resources in global health and a range of vertical disease-focussed programmes. The new (and indeed old) actors have worked alongside principally US-based philanthropic foundations, most importantly the Clinton, Gates and Rockefeller foundations, in substantially scaling up the resources and agency targeted at health and select diseases (Ravis-hankar et al., 2009). The new GHG architecture has had an implicit focus on biomedical interventions and supply of medicines, vaccines and other treatments, at the expense, some argue, of basic interventions on public health, health systems and sanitation (Katz, 2004, 2005). These actors have been at the forefront of what can be described as intervention in the global pharmaceutical markets (see Williams, 2012). Indeed, states and new partnerships and foundations have assiduously targeted resources at the wider supply of critical drugs and healthcare technologies (such as bed nets), and done so in areas where the global pharmaceutical market was most conspicuously failing. As this interven-tion has gathered pace, most especially in the case of HIV/AIDS, it has also become more specialised with regard to responding to some of the more adverse aspects of the interaction of patents with the price of drugs already invented (including those both on-patent and generic), and with the need to create new incentive mechanisms for innovation in thera-peutic areas where patents simply fail to stimulate commercial interest.

A range of these actors actively finance the purchase of generic drugs, such as ARVs, to improve access to medicines. In reality much of the funding necessary for this has emerged from state donation, but the money is nonetheless channelled through many of the new actors (the major exception being HIV/AIDS and the US government’s President’s Emergency Plan for AIDS Relief (PEPFAR) programme). The scale of

Access to Medicines

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resources devoted to rolling out low-cost generics in the vertical disease programmes has proven a boon for the generics and API manufacturers of countries such as India and China. Price intervention is also associated with the Clinton CHAI programme, where block/bulk purchasing, price negotiations and demand forecasting have all been used to secure lower prices for ARVs (Youde, 2011). These actors have also begun to intervene in the case of neglected diseases, supplying a range of up front grants (so-called push mechanisms) for R&D consortia, or in one instance stimu-lating research on a pneumococcal vaccine with an advanced commitment for volume and price. Moreover, the Rockefeller Foundation has brokered the formation of a number of Product Development Partnerships, such as IAVI. Similarly, UNITAID, founded in 2006, represents both a serious attempt to generate sustainable revenues for R&D and drug purchases (via an airline ticket solidarity tax) and sought to untangle the complex thickets of patents that prevent research or development of combination therapies.

Conclusion

Although efforts over the past two decades to improve affordable access to essential medicines through GHG have achieved progress on price and innovation, a truly systemic governance solution prioritising health needs has not emerged. The new actors exploiting new modalities, particularly public–private partnerships, do not yet offer or supply such a solution. At the same time, and since the Doha Declaration in 2001, the global IPR regime has been able to widen and deepen and strengthen, and do so without the challenge present in the aftermath of the Uruguay Round (Sell, 2009; Williams, 2012). Moreover, as treatment for HIV/AIDS and other select diseases increased in the early 21st century, there has been a gradual diminishing in global public interest in the problem of access to medicines. This has created space for the IPR agenda to be revitalised in areas such as the ongoing Trans Pacific Partnership Agreement (still under negotiation at the time of writing). In the context of this book, this chapter reveals important facets to the transformation of global health governance. First, it is clear from this chapter that GHG does not exist independent of other sectors and governances, nor does it exist in an unproblematic ‘nested’ relationship with global governance more generally. Rather health ‘bumps into’ other sectors, and GHG competes with the governance and policies emergent from other sectors. Second,


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the world of ideas matters. TRIPS was successfully framed in economic terms but then challenged by the deployment of a counter-frame using rights-based arguments. In both instances, frames were instrumental – they were deployed to generate action. Moreover, the deployment of the counter-frame also opened up pathways for a new range of rights-based institutions to become involved in the governance of this issue. A mix of established and new actors has been involved in the global govern-ance of IPR and access to medicines. Established actors included states, the General Agreement on Tariffs and Trade (GATT) and the WHO, whereas both the WTO and TRIPS came into being only in 1995. Civil society organisations played a significant role in the counter-framing of the issue, whereas post-TRIPS a range of new actors became involved in the delivery of medicines, many of them using the new modality of public–private partnerships. Finally, and despite these latter institutional and policy developments, the governance of the access to medicines issue area remains profoundly associated with agreements, actors and institutions associated with global trade and intellectual property, this close governance relationship therefore continues to be problematic for more effective GHG.

Notes

The 90/10 gap refers to statistics that indicate that 90 per cent of global expenditures on medical R&D is devoted to disease burdens affecting 10 per cent of the world’s population (MSF, 2001).These members of staff were all interviewed at WHO, Geneva, in March 2010 as part of the ERC project.

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6Conclusion: The Transformation of Global Health Governance

Abstract: This chapter identifies how transformations in global health governance are reflected in the governances of specific health issues such as human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), pandemic influenza, tobacco control and access to medicines. It illustrates the importance of ideas such as security, rights, economics, development and bio-medicine in the formation and legitimisation of interests in global health. The chapter explains the link between global health governance and other areas of global governance. It also underscores the multi-sectoral nature of global health governance and how this is reflected in institutions and actors. Finally it suggests that the way forward in improving global health governance is to link health and other concerns both in the framing of issues and in institutional architecture.



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What is global health governance, where does it take place and to what extent has it been transformed? This book argues that global health governance (GHG) is not a coherent set of rules and norms that are made in an easily identifiable setting. Rather, it is made of a variety of policies – some complementary, some disjointed or even conflicting – which are made in multiple sites and at multiple levels of global governance. GHG is part of a wider system of global governance and shaped by policies and institutions in areas like development, security and trade. At the same time, GHG consists of the governance of a variety of specific global health issues, such as HIV/AIDS, pandemic preparedness, tobacco control and access to medicines.

The book set out to interrogate the relationship between these different sites and levels of global health governance. How are macro-level narra-tives about global governance and global health governance reflected at the mezzo-level, in the ideas and institutions governing specific health issues, such as HIV/AIDS, pandemic preparedness, tobacco control and access to medicines? How is GHG influenced by trends and changes in other areas of global governance, such as international development, security and trade? And to what extent do the governance structures of specific health issues show distinct characteristics and dynamics? In Chapter 1 we highlighted that the narrative of global governance is characterised by a sense of deep transformation that international rela-tions have experienced in the past three decades or so. In particular, we focussed on globalisation as the driver of GHG, the emergence of differ-ent framings and the political contestations that this helped to produce, and the proliferation of actors – including private actors – in GHG. This final chapter uses the same template to structure our conclusions.

Globalisation and GHG

There is a clear sense that the transformation in governance is driven by globalisation, the notion of a compression of time and space through new information and communication technologies, and a growing interdependence of peoples and states through the opening of markets and the ever faster movement of goods and people. In the narratives of global governance, in general, and GHG, in particular, globalisation has increased the number of problems that span national borders and can, therefore, not be solved by national governments alone. Some of

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the most pressing global problems affect the health of people across the globe, such as emerging and re-emerging infectious diseases and the rise of tobacco-related and other non-communicable diseases in countries across the globe.

The case studies examined in the previous chapters explored the link between globalisation and the global governance of specific health issues. All of them find that the emergence of governance responses at the global level was to some extent triggered by the sense that a specific health problem had acquired global dimensions, either with regard to the underlying causes and determinants of the problem and/or with regard to its effects and implications. Importantly, the constructivist approach adopted in this book, highlights that the recognition of a specific health issue as ‘global’ resulted from the interplay of material conditions with a process of social construction, during which those conditions were interpreted as constituting a global health problem.

One material condition that contributed to the recognition of a health issue in several case studies is an epidemiological situation that reaches crisis level in several countries. Only four years after HIV had first been clinically observed in 1981, it was detected in every region of the world. In the early to mid-1990s, it became widely known that HIV/AIDS had become a spiraling pandemic in many countries of sub-Saharan Africa. This development contributed not only to the recognition of HIV/AIDS as a global health threat, but also raised global awareness about insufficient access to medicines in many low to medium-income countries (LMICs). The spiraling HIV/AIDS epidemic in Africa, therefore, contributed not only to the recognition of HIV/AIDS as a global health problem, but also to that of access to medicines. Pandemic influenza has been a menace to humanity for many centuries. After the Spanish flu of 1918, however, it dropped off people’s consciousness due to the emergence of effective vaccines and the lower frequency of pandemics in the second half of the 20th century. The outbreaks of H5N1 (‘bird flu’) and severe acute respira-tory syndrome (SARS) around the turn of the millennium were key in bringing pandemic influenza back onto the global political agenda. The occurrence of a severe health problem in several countries is not restricted to infectious diseases, however. The case study on tobacco control shows that the spread of tobacco-related diseases in LMICs contributed greatly to the recognition of tobacco consumption as a global health problem.

This leads to a second material condition which several case studies identified as an important factor in the construction of health issues as


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global: the global expansion of markets. The increase of tobacco-related diseases in LMICs since the 1980s was closely related to the expansion of tobacco companies into these countries. Partly, this was driven by the desire to compensate for declining smoking prevalence in the traditional markets of high-income countries (HICs), which were implementing stricter tobacco control regulations; partly it was driven by the desire to benefit from the rapidly rising economies in emerging markets. Similarly, the issue of access to medicines became widely recognised as a global health problem in the context of the expansion of Western phar-maceutical companies into emerging markets in the 1980s. This move was, however, impeded by the fact that many LMIC governments did not, at the time, provide for the protection of patents on pharmaceutical products. This severely limited the prospects of Western pharmaceuti-cal companies to gain market shares in these countries, because local producers copied new medicines and sold them at lower prices. As a consequence, the strategy of Western pharmaceutical companies to expand into LMICs contained from the beginning a plan to establish a global regime for intellectual property rights (IPR) protection. The first major success was the World Trade Organization (WTO) TRIPS agree-ment, which established internationally binding minimum standards for IPR protection. Access to medicines had been a health problem in many LMICs for a long time. Yet, it was not considered a global problem because the impediments to access were considered to be largely local, including poverty, poor health systems and poor infrastructure. For the recognition of access to medicines as a global health issue, the TRIPS agreement was a crucial factor because its internationally binding char-acter represented a truly global obstacle to access to medicines.

The case studies show that material conditions were important for the conception of a specific health issue as global. Yet, the case studies also indicate that material conditions were not sufficient for the notion of a global problem to arise. One indication for this is that, in most cases, there was a temporal disconnect between the existence of certain material conditions and the recognition of a global health issue. For instance, evidence about the spread of tobacco-related diseases existed for more than a decade before the emergence of the global tobacco control movement. And Trade Related Aspects of Intellectual Property Rights (TRIPS) had been negotiated before it was seen as relevant for global health. Moreover, the case studies on HIV/AIDS and pandemic influenza highlight that the diseases/outbreaks which became known

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as the quintessential global health threats were perhaps not the most threatening. For instance, the HIV virus is much more difficult to trans-mit than other viruses: it cannot be contracted through casual social contact and does therefore not fit into the horror scenarios of a rapidly spreading pathogen that infects millions in a matter of days. Similarly, while individually tragic the impact of the H5N1 (‘bird flu’) avian influ-enza outbreak in 1997 was miniscule compared to the Spanish flu but it reintroduced pandemic influenza onto the global political agenda after several decades of neglect.

The role of social construction in the emergence of ‘global’ health issues is underscored also by our observations that, in most case stud-ies, a group of actors can be identified that interpreted a health issue as global and promoted such an understanding. With regard to HIV/AIDS, the US Christian right called on global humanitarian responsibilities to help people in low-income countries fight HIV/AIDS; the international development community defined HIV/AIDS a key obstacle to global development; and security policy circles interpreted HIV/AIDS as a potential threat to international security. The case study on tobacco control highlights the role of World Health Organization (WHO), its Director-General Gro Harlem Brundtland, and the staff of the WHO Tobacco Free Initiative (TFI) in defining tobacco use as a global health problem. In fact, their construction of tobacco as global health threat made use of language reminiscent of infectious disease outbreaks such as ‘tobacco pandemic’ to underscore their interpretation of the problem. The case study on global IPR regulation and access to medicines high-lights the role of NGOs and some LMIC governments in constructing the global IPR regime as a global health problem.

A third point illustrating the importance of social construction in the emergence of ‘global’ health problems is that they have often been linked to other issues on the global political agenda. The case studies indicate that the recognition of a health issue as global was facilitated when a connection could be established to other problems that had already been recognised as requiring global attention. For instance, as mentioned earlier, the construction of HIV/AIDS as a global problem was promoted by the international development community. International develop-ment had acquired a high priority on the international political agenda since the 1970s, and seen renewed attention after the end of the Cold War. The argument that ill-health in general, and HIV/AIDS, in particu-lar, constituted an obstacle to development was institutionalised in the


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World Development Report 1993: Investing in Health, the establishment of the Commission on Macroeconomics and Health, and the incorporation of HIV/AIDS in the Millennium Development Goals (MDGs). This in turn greatly contributed to establishing HIV/AIDS as a global problem. The acceptance of ill-health as an obstacle to development was a crucial factor also in the successful construction of (the lack of) access to medi-cines as a global health issue, as it was seen as impeding public health and, hence, development.

Another already existing issue of global concern that has been linked to health problems is international security, as the case studies on HIV/AIDS and pandemic influenza highlight. In the context of the post-Cold War, the international security agenda was being redefined, and the potentially destabilising effects of pandemics on entire states were discussed as a potential new threat to international security. Such argu-ments became particularly prominent in the late 1990s and early 2000s, and led to the UN Security Council Resolution 1308 declaring HIV/AIDS a ‘threat to international peace and security’ (UN, 2000b). Similarly, the case study on pandemic influenza illustrates that the 1997 outbreak of H5N1 avian influenza caused particular alarm because not only health professionals but also security experts had been warning of the ‘threat’ of emerging and re-emerging infectious diseases in the previous years.

The constructivist approach of this book emphasises that the social world does not exist independent of interpretations and that those interpreta-tions also shape that world. On the basis of this approach, the case studies highlight that the recognition of health issues as global was not a quasi-automatic response to globalisation; rather, the emergence of new material conditions was interpreted by specific social groups as constituting a global health problem, and this interpretation had particular resonance when it could be linked to already existing perceptions of other global problems.

Political contestation and cooperation in GHG

The second transformation in GHG identified earlier is the shift from a largely technical field to an area characterised by political contesta-tion and cooperation. The constructivist approach taken in this book highlights that the dynamics of political contestation and collaboration are shaped in important ways at the ideational level. In particular, the case studies show how frames have influenced and legitimised interests,

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and affected power relations. Clashes between different actors about the purpose and design of GHG are driven not merely by opposing material interests; rather, the case studies show that material interests are often intertwined with specific ideational framings regarding the nature of the health problem and, hence, the appropriateness of specific governance responses. Those frames may represent genuinely different worldviews that result in different interpretations of the problem and, hence, the appropriate solution. Yet, frames may also be used in a strategic manner to couch material interests in a wider ideational and normative picture.

How important the ideational level is to legitimise particular interests is evident in the tobacco case study. The opposition of tobacco companies to the increase of tobacco control is based on their desire to protect reve-nues and profits. Yet, the arguments tobacco companies have presented in the debate do not stress this private interest but focus on alleged interests of the public. Aligning private interests with public interests in political debates is a well-known strategy to increase legitimisation and to mobilise support from other social groups. The companies’ arguments that the industry created employment and tax revenues for govern-ments, and fostered foreign direct investment in LMICs appealed to a critical constituency: finance ministries. This constituency is particularly important in governments’ decision-making about new policies, includ-ing health policies and international treaties, because finance ministries assess their implications for government budgets. In addition, the companies argue that tobacco control interferes with individual liberty, an argument appealing in particular to conservative, libertarian groups in favour of a minimal role for government in society. Finally, tobacco companies speak to popular fears about crime and terrorism by arguing that price increases for cigarettes, a key component of tobacco control, contributed to illicit cigarette trade, which, in turn, benefited organised criminal and terrorist groups. The use of framing has been important also for tobacco control advocates. It appears that improved health has not been a strong enough argument to promote their cause. In particular, the WHO engaged with the industry’s framing that tobacco companies are important for economic development in order to win over finance ministries. In this context, the collaboration between the WHO and the World Bank was crucial as it mobilised the World Bank’s reputation for expertise in economics for the goal of tobacco control.

Similar dynamics can be observed in the case study on access to medicines. First, pharmaceutical companies (and other industries)


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framed their interest in stronger international IPR protection as impor-tant for their home countries’ exports and, hence, trade balance. This frame successfully appealed to the interests of ministries of finance and commerce in the United States and several European countries, and secured their governments’ support in pushing for an international treaty on IPR, which led to the TRIPS agreement (Sell, 2003). Our case study shows that this framing has been contested by those who see the global IPR regime as an obstacle to global health and international development. Moreover, it shows that the contestation at the ideational level has become institutionalised at the organisational level, juxtapos-ing international trade organisations, notably WTO, with international development organisations, such as United Nations Development Programme (UNDP) and United Nations Conference on Trade and Development (UNCTAD). Moreover, the frame contestation is also reflected in the positions taken by different government departments at the national level, notably between ministries of commerce and trade, on the one hand, and ministries of health and international development, on the other.

Another frame contestation that has shaped the global politics of access to medicines emerged between the frame that considers global IPR protection as necessary for the development of new medicines and the frame that sees global IPR protection as an obstacle for the accessibility of existing medicines. The former has been promoted particularly by phar-maceutical companies developing new drugs, which are based primarily in the United States and Western Europe, and their governments; the latter is used by governments from LMICs and nongovernmental organi-sation’s (NGO’s) working on humanitarian assistance and international development. This frame contestation, too, has become institutionalised at the organisational level. Some NGOs and LMIC governments focus on changing the global IPR regime. Global health initiatives working on the development of new medicines tend to work within the existing global IPR regime and focus on voluntary licensing of IP rights.

Conflict and contestation between frames is less of a dominant feature in the case studies on HIV/AIDS and pandemic influenza. Although our previous work showed how different frames (especially rights and security) might provide points of contestation in the case of HIV/AIDS (Rushton, 2012), both HIV/AIDS and pandemic influenza also demon-strate that the existence of different frames does not necessarily lead to conflict between them. Rather, key frames in operation in the global

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politics of HIV/AIDS and pandemic influenza have at times even been complementary. They have given different and complementary reasons for the issues be considered global problems, and why it is important to invest in the fight against them. The dominant framing of pandemic influenza in terms of Evidence-Based Medicine (EBM) has been comple-mented since the late 1990s by a security frame. Rather than challenging the EBM framing, the security frame has supported and reinforced it, and served to highlight the importance of access to vaccines and antiret-roviral medicines. Similarly, in the case study on HIV/AIDS we observe that two of the most influential frames, international development and security, have complemented and reinforced one another in the defini-tion of the disease as a global priority. The case study shows how the two frames appealed to and mobilised different audiences, and helped to create an ideational basis on which to legitimise cooperation.

The constructivist approach taken in this book also highlights how frames shape the dynamics of political contestation and cooperation by shaping the power relations between actors, and in particular that a successful framing confers ideational power. The importance of frames for power is particularly evident in the cases on IPR/access to medicines and tobacco control. In both cases, multinational companies with signifi-cant material power resources ended up having to make concessions to health advocates with considerably less material power. The case studies suggest that the health advocates were able to offset their material disad-vantage by using frames to mobilise support from and foster alliances with other groups.

The proliferation of actors in GHG

A second transformative change that we highlight is the proliferation of actors and, partly as a consequence, the shift from public to private authority. Some of these new organisations have been designed to facili-tate cooperation between states to address global problems. In the area of health, examples include United Nations Joint Programme on HIV/AIDS (UNAIDS) and UNITAID, which were created to foster cooperation on the fight against HIV/AIDS, malaria and tuberculosis. Other new actors are entirely new, or new to global health, especially from the private (for-profit and not-for-profit) sectors, which became involved in GHG. They include a wide variety of groups, such as commercial companies,


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advocacy groups, philanthropic foundations, not-for-profit initiatives providing health-related services, and public-private partnerships. The term ‘global health initiatives’ is used for a wide range of groups engaged in a variety of health issues and fulfilling different functions. They are run as not-for-profit entities and understood as private organisations, even though they usually depend to a significant degree on government funding. Often, global health initiatives combine advocacy for a specific health issue with the delivery of services, such as the development of new medicines and vaccines, their procurement or the creation of new funding mechanisms. Some of these initiatives, especially in the field of pharmaceutical development, operate like virtual (not-for-profit) companies. The shift from public to private authority is associated particularly with the rise of philanthropic foundations and private and public–private global health initiatives. Some philanthropic foundations, notably the Bill and Melinda Gates Foundation, have acquired political authority through the sheer volume of funding they control, which helps them shape the global health policy agenda and the development of global health expertise.

All case studies examined in this book observe a proliferation of actors. Yet, they underscore the need to qualify this narrative because the trend has unfolded much more strongly in some areas of GHG than in others. The case studies also highlight the need to qualify the narrative of the shift from public to private authority: first, the case studies find that states are still important – sometimes the most important – actors in global governance, and, second, the roles and functions of private actors vary greatly. At the horizontal level, new organisations for inter-state cooperation have emerged in all case studies analysed in this book. Among the most prominent in the global governance of HIV/AIDS are the G8, which had a record in addressing health prior to HIV/AIDS but have engaged with HIV/AIDS more than with any other health issue. Other international organisations that came to work on HIV/AIDS include UNDP, United Nations Children’s Fund (UNICEF) and the World Bank. A crucial development was the establishment of UNAIDS in 1996 as a ‘coordinating body’ of the UN on HIV/AIDS.

Many international organisations that moved into the global govern-ance of HIV/AIDS also started to work on the problem of access to medicines, as it had become closely associated with the HIV/AIDS pandemic. In addition, international organisations involved in global trade governance became involved in the global governance of access to

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medicines, notably WTO and various bilateral and regional free trade and investment treaties. They became involved in the global governance of access to medicines because global IPR governance falls largely under the remit of global trade governance. When the global IPR regime was identified as constituting a global health problem, global trade govern-ance organisations found themselves at the centre of the debate.

The case studies on pandemic influenza and tobacco control have found less involvement of new actors, and emphasise the key role played by the WHO. WHO’s Global Influenza Surveillance and Response Network (GISRN) and the TFI respectively have played the key role in establishing and running the global governance of these two issue areas. Some intergovernmental organisations not traditionally working on influenza preparedness have, however, become involved recently, such as the Food and Agriculture Organization (FAO), the World Bank and the World Organization for Animal Health (OIE). In addition, the office of the United Nations System Influenza Coordinator (UNSIC) was established to help coordinate the work of various UN agencies. The case study on tobacco control notes the least involvement of new public actors in global tobacco control. In fact, the WHO was itself a new actor and has taken the lead on governance of this issue since the late 1990s. It did enter into an important collaboration with another international organisation, however, namely with the World Bank to publish the report Curbing the Epidemic: Governments and the Economics of Tobacco Control (1999).

With regard to the involvement of private actors, our case studies show an even greater degree of variation than with regard to the involve-ment of new public actors. Starting with a commonality, however, we find that NGOs played an important role in the process of establishing health issues as global and bringing about global governance responses in all case studies except pandemic influenza. This is most evident in the case studies on HIV/AIDS and access to medicines. Activist groups, often consisting of, or working closely with, patient groups, played a crucial role in raising awareness about HIV/AIDS and its global dimen-sions. Similarly, NGOs were the first to take up the issue of the global IPR regime constituting a potential threat to access to medicines. In both cases, NGOs were also key in bringing about specific governance responses, such as including HIV/AIDS in the MDGs and bringing about the WTO Doha Declaration on the TRIPS Agreement and Public Health.


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The case study on tobacco control, too, highlights the role of NGOs in bringing about a specific governance response, the Framework Conven-tion on Tobacco Control (FCTC). Of particular importance was the NGO ‘Framework Convention Alliance’, which lobbied governments to support and implement the FCTC. An interesting aspect highlighted by this case study is the important role that the WHO played in mobilising NGO engagement. Global tobacco control efforts, including the FCTC, had been initiated largely from within the WHO. Yet, the WHO engaged with NGOs from an early point on, for instance through consultations, public hearings and by offering accreditation as observers. Engagement with NGOs was considered important, in particular, to balance lobbying from the tobacco industry, and legitimise collective action on tobacco control. The development of a global governance response for tobacco control did remain largely in the hands of WHO, but the engagement of NGOs was actively promoted and, to some extent, even formalised through the possibility of obtaining observer status.

With regard to the degree of formal involvement of NGOs in GHG, however, we observe a difference between the case study on tobacco control, on the one hand, and those on HIV/AIDS and access to medi-cines, on the other. In the latter two, some NGOs have become involved in GHG to the extent that they have taken on governance functions themselves. They have become partners in numerous global health initiatives, such as the Global Fund, GAVI and the Patent Pool, and have been given formal representation on governing boards. In these cases, NGOs have moved from the role of outside lobbyists to insiders that are directly and formally taking on the role of global governors.

Similar to NGOs, commercial companies shape GHG as both outside lobbyists and inside partners in global health initiatives. Whether they lobby for or against these initiatives depends on the type of governance response in question and on their business model. The role of commer-cial companies is least ambiguous in the case of tobacco control. The very product of the tobacco industry is the cause of the health problem identified. Any governance arrangements that are aimed at tightening tobacco control, therefore, meet with opposition from the tobacco indus-try. The clear position of the tobacco industry in this issue area of GHG explains why WHO took the unusual stance of limiting the engagement of tobacco companies in FCTC negotiations. Like other private groups, tobacco companies were permitted to submit evidence to the public hear-ings, but they were not given the opportunity to attend formal negotia-

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tions as observers. The role of pharmaceutical companies in HIV/AIDS, access to medicines and pandemic influenza is less straightforward. The key difference is that pharmaceutical companies produce a product that is central to addressing health problems – rather than being their cause. For this reason, governments and NGOs alike have usually been keen to establish cooperative relations with pharmaceutical companies. Prob-lems have emerged where there is a conflict between the social need for certain medicines and the existing business model to develop them.

This issue is highlighted in particular in the case study on IPR and access to medicines, but it runs across the cases on HIV/AIDS and pandemic influenza as well. The existing model for the development of new medicines and vaccines is based on the assumption that this can be done most effectively and efficiently as a commercial (in other words, for-profit) enterprise. The currently dominant model to guarantee prof-itability is the granting of temporary market monopolies. Companies that produce a new medicine or vaccine are granted the exclusive right to market the product for a specific period of time (through patents and other forms of IPR). Temporary market exclusivity guarantees the profitability of pharmaceutical development because, in the absence of competition, the innovator company is free to set the price for the new product – and to do that at a level that recoups investment costs and also reaps profits high enough to satisfy shareholders. From a govern-ance perspective, this model of pharmaceutical development creates problems at two levels: firstly, where there is social demand for medi-cines that is not matched by market demand (that is, when patients are too poor to afford the medicines they require from a medical perspective); secondly, where opportunity costs prevent pharmaceuti-cal companies from investing in the development of certain medicines that are needed to address public health problems (that is, when the returns on investment are higher for the development of medicines for other diseases).

The cleavage between pharmaceutical companies’ importance as a source of technologies required for improving health outcomes and their current business model impeding access to these very technologies has shaped their involvement in GHG. It has mobilised concerted lobbying attempts on the part of pharmaceutical companies to increase global IPR protection and enforcement, which has antagonised many public health advocates. At the same time, pharmaceutical companies have become involved in global health initiatives that work to make medicines and


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vaccines more accessible, and develop new products for hitherto neglected diseases, either through product development partnerships or new funding mechanisms.

Public–private, or entirely private, global health initiatives have acquired considerable political authority in some areas of GHG, such as HIV/AIDS and access to medicines. Their authority is based on their demonstrating new ways of addressing global health problems, such as not-for-profit pharmaceutical development and innovative funding mechanisms. It is based also on the sometimes considerable expertise that global health initiatives command, and not least on the financial backing they receive from foundations, notably the Bill and Melinda Gates Foundation. The case studies demonstrate, however, that the role and authority of global health initiatives is considerably greater in some areas of GHG, such as HIV/AIDS and access to medicines, than in others, such as pandemic influenza and tobacco control. This indicates that the narrative about the proliferation of actors and the shift from public to private authority in global governance has to be qualified. Moreover, even the case studies that observe an increasing role and authority of private actors maintain that state actors continue to play an important, if not the most important, role. In this context, the case stud-ies also highlight considerable variation in the role and importance of the WHO. The Organisation has played a leadership role in developing and implementing global governance responses to pandemic influenza and the rise of tobacco-related diseases. Its GISRN forwards national surveillance data and virus samples to WHO reference laboratories, which identify the dominant strains and pass relevant information on to pharmaceutical manufacturers to develop influenza vaccines. The GISRN was also instrumental in strengthening the role of global-level governance responses in the 1990s again, after pandemic preparedness had dropped off the international political agenda for several decades. In the case of tobacco control, WHO, under the leadership of Gro Harlem Brundtland, was key in establishing tobacco-related diseases as a global health issue. The WHO Director-General and the newly established TFI exercised strong leadership in initiating and shaping the negotiations that led to the first multi-lateral treaty created in WHO, the FCTC.

In the global governance of HIV/AIDS, the WHO started off in a central role. As the UN organisation mandated to promote international cooperation on public health, the WHO was one of the first interna-tional organisations to respond to the new disease, and established the

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Control Programme on HIV/AIDS. Reflecting the growing awareness of the scale of the disease and its increasingly global reach, the programme was expanded and renamed as the Global Programme on HIV/AIDS in January 1988. This was intended to reflect the need for the WHO to have a permanent and sustainable work programme focused on HIV/AIDS. By the mid-1990s, however, the leadership role of the WHO on HIV/AIDS was already put into question with the argument that the disease was a multi-sectoral problem and, hence, required a multi-sectoral governance response. This interpretation became institutionalised with the creation of UNAIDS in 1996.

With regard to the debate on IPR-related aspects of access to medi-cines, it took the WHO a few years to establish itself as an important forum of global political debate on the issue. When the debate emerged, IPR protection was still considered exclusively an issue of international trade governance, and the global IPR regime was institutionalised in an international trade treaty, TRIPS, which was administered by WTO. As a consequence, the debate on IPR and access to medicines initially focussed on WTO and on potential changes to the TRIPS agreement (which led to the WTO Doha Declaration on TRIPS and Public Hhealth in 2001). Although the WHO had addressed IPR-related aspects of access to medicines in 1998 in its Revised Drug Strategy, it took five more years for the Organisation to take a leadership role in the global debate. It was only in 2003 that WHO established the Commission on Intellectual Property Rights, Innovation and Public Health, followed by the Global Strategy and Plan of Action in 2008, and the Consultative Expert Working Group on Research and Development in 2010. These initiatives proposed alternative financing mechanisms for developing neglected disease drugs, and have contributed to consolidating exper-tise and moving the debate forward. Yet, they have largely left out the problem of how to improve access to existing medicines. The WHO has contributed little to addressing the continuing trend of expanding IPR protection through the growing network of bilateral and regional free trade and investment treaties, and largely left the debate on how to address problems of access to existing medicines to organisations oper-ating in the field of global trade governance.

How can we explain the divergent roles that the WHO has played in different areas of GHG? Our case studies suggest that a combination of three factors may help answer this question: leadership (or the lack thereof); institutional path dependence; and existing power relations.


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The case study on tobacco control emphasises the leadership of Gro Harlem Brundtland when she took over as Director-General and decided to focus on two global health problems in particular during her time in office: tobacco control and malaria. It also highlights the leadership of the staff of the TFI unit, including Derek Yach. Pandemic influenza is the other case study identifying a strong leadership role of the WHO, but this case indicates a different reason for the WHO’s pronounced role: institutional path dependence. The WHO took on the issue of pandemic preparedness shortly after its inception with the creation of GISN/GISRN in 1952, which became an authoritative source of information on the spread and emergence of new strains of the disease. The WHO lost its dominant role when pandemic preparedness became an issue of national policy in the 1970s and 1980s, but it was the global institution of choice to take up leadership again in the late 1990s with the outbreak of H5N1. The WHO’s established position in the global governance of pandemic preparedness combined with the availability and proven efficacy of an intervention technology, vaccines, may explain why the WHO leader-ship role in this area has so far not been questioned. Another reason may be that pandemic influenza has so far not been linked strongly to other global problems and, therefore, other actors and institutions have not yet laid claim on the leadership role.

The latter considerations emerge from the analysis of the other two case studies, IPR/access to medicines and HIV/AIDS. Similar to pandemic influenza, the case study on access to medicines illustrates the importance of institutional path dependency: with regard to the insti-tutional embeddedness of IPR in the WTO, in particular, and in global trade governance, in general. The link between IPR and trade had been institutionalised during the Uruguay Round negotiations of the General Agreement on Tariffs and Trade (GATT) in the 1980s before IPR was linked to health. Some kind of institutional ‘stickiness’ may, therefore, partly explain why the WHO has found it difficult to take over leader-ship from WTO with regard to IPR-related aspects of access to medi-cines. Yet, a closer look at the case reveals that the institutionalised link between IPR and trade has been supported by an alliance of powerful interests: the governments of the United States and the European Union, and IPR-sensitive industries such as the pharmaceutical, audio and recording and the software industries. The link between IPR and trade aligns the interests of these industries in temporary monopolies for their new products with the interests of their governments in protecting key

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export industries, which help counterbalance the growth of imports from emerging markets and, hence, help protect the countries’ trade balance. Several studies have demonstrated that the creation of a link between IPR and trade and its institutionalisation in national trade bodies and in WTO has been the result of a concerted political strategy (Sell, 2003; Ostry, 1990). The creators and beneficiaries of the link between IPR and trade are unlikely to accept that it is weakened by sharing governance competence for IPR with the WHO.

In the case of HIV/AIDS, the WHO lost its initial position as the lead agency in the global response in part because of the increasing belief that the pandemic, which cuts across all sectors of society, required a multi-sectoral response, and in part because other UN agencies and donor governments were dissatisfied with the effectiveness of the WHO’s efforts to coordinate the global response and perceived the WHO’s HIV/AIDS programme under Director-General Nakajima to be too narrowly focussed on HIV/AIDS as a health issue (Lisk, 2010, pp. 23–4). UNAIDS was created to address this problem, and although the WHO has maintained an important role as a UNAIDS co-sponsor (especially in technical areas such as the development of treatment guidelines) it no longer has lead status – even less so after the creation of the Global Fund, the most significant multi-lateral funding mechanism for AIDS, which bypassed the UN system entirely.

Conclusion: social construction and multi-sectoral dynamics in the transformation of GHG

That the governance of health globally has been transformed is, at its crudest level, suggested by the emergence and common usage of the term ‘global health governance’. This book, however, identified this transformation as consisting of three elements, which structured both the case studies and this final chapter, and explored how these macro-level transformations were reflected in the governances of specific health issues. Each of the case studies demonstrates the presence of each of the transformations, though to differing degrees and in differ-ent ways. That there is a high level of commonality should not obscure these differences.

This book also illustrates the importance of ideas and framing for the formation and legitimisation of interests and for the balance of


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power between groups. Furthermore, it shows that the process of social construction is an important link between GHG and other areas of global governance. The case study on access to medicines highlights how events in global trade governance have been interpreted at specific points in time as affecting global health. Hence, ideas and institutions governing global trade governance, such as WTO and its agreement on TRIPS, and the various bilateral and regional free trade and investment treaties, have shaped the development of GHG. Similarly, the case stud-ies on HIV/AIDS and pandemic influenza highlight how developments in international security, including the redefinition of the international security agenda after the end of the Cold War and new security concerns following the 2001 terrorist attacks and anthrax letters, have given rise to the notion of health security. This in turn, has shaped policy agendas and governance responses at the national and global levels in these two issue areas. Yet, the book also demonstrates that the link between GHG and other areas of global governance is not a one-way street. Events in global health have been noted in other areas of global governance, and interpreted with regard to their meaning for issues of international development, trade and security. The spiralling HIV/AIDS pandemic in many sub-Saharan African countries has contributed significantly to the redefinition of the role of health in international development. It has also reinvigorated global debates on how trade policies affect social development, and fed into emerging ideas of human security (for exam-ple Kaldor, 2007), which widen the notion of security to include not only states but also individual livelihoods.

The case studies therefore underscore the multi-sectoral nature of GHG, which is influenced by and, in turn, shapes developments in other areas of global governance. Moreover the case studies show that the multi-sectoral dynamics of global governance are at play not only with regard to the relations between global health and other areas of global governance, but also with regard to relations between different issue areas within GHG. This is evident most clearly in the cases of HIV/AIDS and access to medicines. The HIV/AIDS pandemic had triggered the engagement of numerous organisations from high-income countries and from the international community. Many of these organisations worked directly with patients in LMICs and, thereby, experienced first-hand the problems of access to medicines. This contributed greatly to raising global political attention for the issue, and, combined with the

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catastrophic dimension of the pandemic, helped bring the issue of access to medicines on the agenda of trade and security communities.

The multi-sectoral character of GHG has become manifest also in the institutional structures of global governance. As mentioned earlier, UNAIDS was founded in 1996 as a UN agency intended to reflect the multi-sectoral nature of HIV/AIDS; and UNSIC was created to coordi-nate influenza-related activities of various UN agencies. The institution-alisation of the multi-sectoral nature of global health is evident also in the case of access to medicines, where both the WTO Doha Declaration on the TRIPS Agreement and Public Health and the WHO Department of Public Health, Innovation and Intellectual Property reflect the inter-twined nature of trade and access to medicines.

The emergence of global governance institutions that reflect the multi-sectoral character of global health points to a promising avenue in the quest for more effective GHG. As mentioned earlier, framings of global health problems that emphasised the link to other global issues have not only contributed to greater contestation in GHG but also created room for cooperation by appealing to and mobilising different audiences around a common cause. The emergence of global governance organisations that reflect the multi-sectoral character of global health institutionalise both the ideational link and the coalition of interests that have formed around it. GHG, from this vantage point, resembles a kaleidoscope of continually changing patterns where ideas play a crucial role in fuelling conflicts between health and other global issues on some occasions, but can also create room for cooperation on other occasions.

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DOI: 10.1057/9781137365729.0012

access issues, 12, 53–4, 78–94, 96, 98–9, 101–2, 107, 109–11

see also international patent rights (IPRs)

economics of, 85–6framing of, 83–6institutions and actors

concerned with, 86–93Action Programme on

Essential Drugs, 80–1actors, see stakeholdersadvocacy groups, 87–8agriculture, 82–3aid programmes, 6, 17AIDS, see HIV/AIDSAIDS activism, 10, 27, 87–8, 105AIDS exceptionalism, 8, 33,

38–9Altria, 72Annan, Kofi, 28anthrax, 112antiretrovirals (ARVs), 30, 84,

90, 93Asian Flu, 45, 48Association of South East

Asian Nations (ASEAN), 55

BAT, see British American Tobacco (BAT)

Beland, D., 73Bettcher, Douglas, 65, 68, 70bilateral aid programmes, 6, 17

Bill and Melinda Gates Foundation, 5, 10, 17, 55, 69, 92

biodiversity, 82–3biomedicine, 66bird flu, see H5N1 influenzaBrazil, 90British American Tobacco

(BAT), 64Brundtland, Gro Harlem, 14,

64, 74, 77, 83, 99, 108, 109–10

Buchanan, Patrick, 27Bush, George W., 27, 32business community, 56–7,

106–7Buzan, B., 21

Cammack, P., 4capacity building, 3case studies, 13CDC, see Centers for Disease

Control and Prevention (CDC)

Centers for Disease Control and Prevention (CDC), 69

Chaloupka, Frank, 68, 69–70Chan, Margaret, 17China, 92cigarette smuggling, 67–8,

71–3, 101civil liberties, 67civil society, 5, 6, 17, 35, 37–8,

43, 56, 76, 82, 85

Index

Index

DOI: 10.1057/9781137365729.0012

Clark, I., 5Clinton Foundation, 5, 92, 93CMH, see Commission on

Macroeconomics and Health (CMH)

Cold War, 4, 10, 50, 112Commission on Macroeconomics and

Health (CMH), 85–6, 100communications, 5Consumer Project on Technology, 85,

87Convention on Biological

Diversity, 87Correa, Carlos, 89Covenant on Economic, Social and

Cultural Rights (CESCR), 84

Daube, Mike, 63Deland, Katherine, 69development, 16, 22

health interventions and, 86HIV/AIDS and, 28–9

distributive issues, 12Doha Declaration, 93, 105, 109, 113drug development, 81–2, 85, 90, 93,

102, 107drug resistance, 14

EBM, see evidence-based medicine (EBM)

economics, 16, 21, 66, 69–71, 85–6emerging markets, 98entrepreneurship, 17evergreening, 85evidence-based medicine (EBM), 16,

20, 68, 103

faith-based organisations, 56, 57Food and Agriculture Organization

(FAO), 105fragmentation, 5, 11–13Framework Convention on Tobacco

Control (FCTC), 61, 63, 73–4, 76, 77, 105–6

framing, 15–16, 19–22, 101–3of HIV/AIDS, 30–4

responses to patent rights and access to medicine, 83–6

free market capitalism, 4, 10

G8, 35GAVI alliance, 10, 17, 37, 91, 106gay rights, 27general agreement on tariffs and trade

(GATT), 110generic drugs, 88, 92–3George, Alexander, 13GISN, see Global Influenza

Surveillance Network (GISN)Glezen, Paul, 45global civil society, 5, 35, 37–8, 82Global Fund to Fight AIDS,

Tuberculosis and Malaria, 17, 29, 30, 32, 36–7, 38, 91, 106

global governance, 3, 95–7agents of, 5bumper car model of, 8–9definition of, 6health and, 7–9multi-sectoral dynamics in, 111–13nested, 7–8as overlapping interests, 7–8of tobacco, 59–77trade-related, 79–94transformation of, 4–6

global health governance (GHG), 1, 3access issues and, 78–94actors in, 103–11emergence of, 9–11fragmentation in, 11–13framing of, 15–16, 19–22globalisation and, 11–13, 95–100of HIV/AIDS, 23–40institutional landscape of, 17–18international cooperation and, 100–3international patent rights and, 78–94multi-sectoral dynamics in, 111–13of pandemic influenza, 41–58political contestation and, 100–3themes in, 11of tobacco control, 59–77transformations in, 13–19, 95–113

Index

DOI: 10.1057/9781137365729.0012

global health initiatives, 103–4, 108global health security, 22Global Influenza Programme, 47Global Influenza Surveillance and

Response Network (GISRN), 54Global Influenza Surveillance Network

(GISN), 42, 47–8, 54, 105global institutions, 5, 10, 17–18globalisation, 3, 5, 11–13

global health governance and, 11–13, 95–100

of health, 13–15health risks of, 43impacts of, 14–15, 46

global markets, 98Global Programme on AIDS (GPA),

33, 108–9Global Strategy and Plan of Action

(WHO), 90Google Flu Trends, 56government regulation, 66–7, 101GPA, see Global Programme on AIDS

(GPA)grassroots movements, 5Greene, J.A., 80

H1N1 influenza, 52–3, 57H5N1 influenza, 2–3, 14, 42, 43, 45, 46,

48, 49, 51, 52, 53, 55, 97, 99, 110HAART, see highly active antiretroviral

therapy (HAART)Harman, Sophie, 34health

development and, 22, 86economics and, 21global governance and, 7–9globalisation of, 13–15human rights and, 20–1security and, 21–2tobacco use and, 61, 65

health care, affordable, 21health economics, 69–71Health Map, 56health professionals, mobility of, 14health-related industries, 14health security, 85

health systems strengthening (HSS), 18Held, D., 6Helms, Jesse, 28high-income countries (HICs), 25,

81–2, 91, 98highly active antiretroviral therapy

(HAART), 30, 84HIV/AIDS, 6–8, 11, 23–40, 92, 96, 99, 112

access to medicines and, 82activism, 10, 27, 87–8, 105crisis of, 97development and, 28–9framing of, 30–4, 102–3global governance of, 12, 103–5,

108–9, 111, 112as global issue, 25–30, 100human rights and, 20, 33impact of, 24, 38–9institutions and actors concerned

with, 34–8, 103–5politics of, 27–8, 32prevention of, 30–1, 34responses to, 30–4as security threat, 29, 33–4, 100spread of, 25transmission of, 99treatment of, 30victims of, 27

homosexuals, 27Hong Kong Flu, 45Horgerzeil, Hans, 89Hulme, David, 31human rights, 16, 20–1, 33, 66–7, 84human security, 21, 112

import-substitution model, 80India, 92Indonesia, 2–3, 42, 53infectious diseases, 10, 43, 46, 49–50

outbreaks of, 14spread of, 14

Influenzanet, 56influenza pandemic, see pandemic

influenzainfluenza vaccines, 47–9, 52, 54, 56–8,

108

Index

DOI: 10.1057/9781137365729.0012

information and communication technologies, 14

information society, 5Institutes of Medicine, 14institutional landscape, 17–18, 112–13

of HIV/AIDS governance, 34–8of pandemic influenza, 53–8of patent regime, 86–93of tobacco control, 73–6

intellectual property rights, 12see also international patent rights

(IPRs)international cooperation, 2–3, 61–5,

100–3see also global health governance

(GHG)International Development Goals, 31International Health Regulations, 53international organisations, 10–11international patent rights (IPRs),

78–94, 98, 102, 107, 109–11economics of, 85–6framing of, 83–6institutions and actors concerned

with, 86–93international relations, 4, 5international security, 21–2, 100, 112

Joseph, J., 14

Kickbusch, Ilona, 24Kirton, J. J., 35

Laing, Richard, 89low- and middle-income countries

(LMICs), 60, 62, 79, 80–2, 89, 90, 97, 98, 112

Mackay, Judith, 63Mahler, Halfdan, 25, 80malaria, 50, 92, 110Mamudu, H., 75Mandela, Nelson, 82Mann, Jonathan, 33market-based theories, 21market expansion, 98

Material Transfer Agreements, 2Matsoso, Precious, 89Medecins Sans Frontieres, 87medicines

access to, 12, 78–94, 96, 98–9, 101–2, 107, 109, 110–11

development of new, 81–2, 85, 90, 93, 102, 107

prices of, 92–3as public goods, 80, 85

Medicines Act, 82Millennium Development Goals

(MDGs), 28–9, 31, 85–6, 100, 105Model List of Essential Drugs (WHO),

80moral issues, 20Morse, Stephen, 45MPower, 69Muhammadiyah, 56multilateral aid programmes, 17

National Influenza Centres, 2national security, 21neglected diseases, 85neoliberalism, 4–5, 11, 33–4Non-Aligned Movement, 80non-communicable diseases (NCDs),

18nongovernmental organizations

(NGOs), 37–8, 43, 87–8, 102, 105–6see also civil society

One Health agenda, 55Organization for Animal Health (OIE),

105organized crime, 67–8, 72Oxfam, 87

pandemic influenza, 2–3, 6, 14, 16, 41–58, 96, 99, 110, 112

compared with HIV/AIDS, 42–3framing of, 102–3as global issue, 43–6governance of, 42–58history of, 44–5, 46–7impact of, 51

Index

DOI: 10.1057/9781137365729.0012

institutions and actors concerned with, 53–8, 105

introduction to, 42–3politics of, 53–4preparedness for, 48, 54–5prevention and control of, 48–9,

51–3, 56–7research on, 46–7, 50responses to, 46–53as security threat, 43, 45–6, 51–2spread of, 43–4, 51technological developments in, 42threat from, 97tracking of, 46vaccine for, 47–9, 52, 54, 56–8, 108

Pandemic Influenza Preparedness (PIP) Framework, 48, 54

Patent Pool, 106patent rights regime, 12, 78–94, 98, 102,

107, 109–11path dependency, 42–3PEPFAR, see President’s Emergency

Plan for AIDS Relief (PEPFAR)pharmaceutical companies, 2–3, 17,

53–4, 56, 57–8, 80–2, 90, 91, 98, 101–4, 106–7

philanthropic enterprises, 5, 10, 17, 37, 57, 91–2

PIP Framework, see Pandemic Influenza Preparedness (PIP) Framework

political agendas, 99–100political contestation, 100–3politics of insecurity, 73President’s Emergency Plan for AIDS

Relief (PEPFAR), 6, 17, 27–8, 30–1, 32, 38, 92

private organisations, 17Public Health Innovation and

Intellectual Property (PHI), 89public-private partnerships, 10, 17,

36–7, 108

rare diseases, 85Reagan, Ronald, 27Red Cross, 56reproductive health, 20

research and development (R&D), 81–2, 85, 90, 93, 102, 107

Rockefeller Foundation, 5, 92, 93Roemer, Ruth, 63Rosenau, J. N., 5

secondary patenting, 85second-hand smoke, 66, 71security, 16, 21–2, 100, 112

health, 85HIV/AIDS and, 29, 33–4influenza virus and, 43, 45–6, 51–2tobacco control and, 67–8, 71–3

severe acute respiratory syndrome (SARS), 14, 26, 52, 56, 97

Shepherd, P. L., 62Sidibé, Michel, 36smallpox, 50Smokeless Tobacco Control, 63smokers’ rights, 71smoking, see tobacco usesocial constructivism, 3–4, 19, 99–100,

111–13South Africa, 82South East Asia, 55Soviet Union, 50Spanish influenza of 1918, 44–5, 46, 99stakeholders, 15–16

in global health governance, 103–11in HIV/AIDS governance, 34–8in international patent rights, 86–93in pandemic influenza, 53–8in tobacco control, 73–6

structural adjustment policies, 4sub-Saharan Africa, 24, 28, 32, 82, 97,

112Substance Abuse Programme, 62Supari, Siti Fadilah, 2

Taylor, Allyn, 63technology transfer, 89terrorist groups, 67–8, 72–3, 112Thailand, 90Third World, 22tobacco control, 11, 12, 16, 59–77, 96, 97,

99, 101, 109–10economics of, 69–71

Index

DOI: 10.1057/9781137365729.0012

at individual level, 60–1institutions and actors concerned

with, 73–6, 105–6international cooperation on, 61–5introduction to, 60second-hand smoke and, 66, 71smokers’ rights and, 71youth prevention, 71

Tobacco Free Initiative (TFI), 64, 73–4, 77, 99

tobacco industry, 60, 64, 66, 68, 75, 77, 101, 106

tobacco-related diseases, 65–75, 98, 108tobacco smuggling, 67–8, 71–3, 101Tobacco Tax Simulation Model, 70–1tobacco use

deaths from, 60, 65, 69prevalence of, 60, 98as risky behaviour, 61

trade agreements, 79–80, 87, 91, 104–5, 110, 112

Trade-Related Aspects of Intellectual Property Rights (TRIPS), 79–84, 86–9, 91–4, 98–9, 102, 109, 112, 113

Transnational Advocacy Network, 88transnational pharmaceutical

companies (TPCs), 2–3, 17, 53–4, 56, 57–8, 80, 81–2, 90, 91, 98, 101–2, 106–7

transnational tobacco companies (TTCs), 12, 60, 66, 68, 75, 77, 101, 106

Trans Pacific Partnership Agreement, 91TRIPS, see Trade-Related Aspects

of Intellectual Property Rights (TRIPS)

tuberculosis (TB), 92

UN Conference on Environment and Development (UNCERD), 63

UNITAID, 93, 103United Nation Programme on HIV/

AIDS (UNAIDS), 24, 26, 31, 36, 84, 103, 104

United Nations System Influenza Coordinator (UNSIC), 105, 113

United States, 50, 90

UN MDG Gap Taskforce, 90–1UN Security Council, 29, 32US Surgeon General, 77n1

Velasquez, German, 89virus sharing, 2–3

Webster, Robert, 5, 45We the Peoples, 28WHA, see World Health Assembly

(WHA)WHO, see World Health Organization

(WHO)WHO Collaborating Centres, 2WHO Commission on the Social

Determinants of Health, 18WHO Framework Convention on

Tobacco Control (WGO FCTC), 74World Bank, 4, 13, 69–71World Conference on Tobacco and

Health, 61–2World Development Report, 100World Economic Forum, 5World Health Assembly (WHA), 10,

47, 62, 80, 90World Health Organization (WHO),

2–3, 10, 17, 94, 108access to medicines and, 80–1,

89–90, 109HIV/AIDS work of, 25–6, 33, 108–9,

111pandemic influenza and, 47–8, 51,

53–4, 105, 108, 110tobacco control and, 61–5, 70, 73–7,

106, 108–10World Influenza Centre, 47World Intellectual Property

Organization (WIPO), 83World No Tobacco Day, 62World Trade Organization (WTO), 79,

83–4, 87–9, 94, 98, 102, 104, 109–13

Yach, Derek, 64, 65, 110Youde, J., 11Yurekli, Ayda, 70

zoonoses, 46