Draft paper.
Not for citation.
Comments very welcome.
Professor Stefan Elbe, Dr. Anne Roemer-Mahler, and Christopher Long
Centre for Global Health Policy
Department of International Relations
School of Global Studies
University of Sussex
Brighton BN1 9SN
United Kingdom www.sussex.ac.uk/globalhealthpolicy/
Tel. +44 (0)1273 678724
Fax. +44 (0)1273 673563
Email: a.roemer-mahler@sussex.ac.uk
Abstract: How are governments partnering with pharmaceutical companies in order to protect populations against health threats? Mitigating such threats – whether in the form of pandemics (SARS, avian flu, swine flu), bioterrorist attacks (anthrax, smallpox, plague), or emerging infectious diseases (HIV/AIDS, malaria and tuberculosis) – is a political priority for governments around the world. Yet current efforts to strengthen health security will only succeed if governments can form effective and sustainable partnerships with the pharmaceutical industry. Such collaboration is necessary to ensure that new drugs and vaccines are developed, that they are available in sufficient quantities, that they are in the places where they are needed, and that they can be made safely available at the right time. So how are governments persuading market-oriented pharmaceutical companies to focus on health security threats in a context where their commercial research and development priorities increasingly lie in other areas? And how are some pharmaceutical companies already developing new business models to respond to the new health security agenda? How, moreover, can the tension between ‘industry-as-partner’ and
‘industry-as-lobbyist’ inherent in some of these public-private partnerships be managed responsibly? This paper delineates a new research agenda analyzing the formation, workings and effectiveness of pharmaceutical public-private collaborations for strengthening health security. It focuses specifically on a case study on publicprivate collaborations to address drug-resistant tuberculosis.

Introduction
This paper introduces a research project that recently started at the Centre for
Global Health Policy at the University of Sussex (UK), and which is funded by the
European Research Council. It examines the role of pharmaceutical companies in public-private collaborations to address health security threats. The project focuses specifically on health security threats from influenza pandemics, bioterrorism, and drug-resistant tuberculosis.
Protecting populations and economies against acute cross-border public health threats is a pressing political priority for countries in Europe and around the world.
The World Health Organization (WHO) has warned that a new pandemic infecting roughly 25% of the world population (a figure derived from previous pandemics), would affect more than 1.5 billion people and cause enormous social disruption due to a rapid surge in illnesses and deaths (WHO 2007: 47). Even in the ‘best-case’ scenario of producing only relatively mild symptoms, a pandemic would create substantial health-care costs and require governments to implement costly pandemic management plans – both of which could weaken the prospects of a recovery in the world economy (Smith et al. 2009). Infectious diseases like HIV/AIDS, tuberculosis and malaria are claiming close to five millions lives every year in low- and middleincome countries (LMICs). Finally, the ongoing threat of bioterrorism requires continued preparedness for the deliberate release of a biological agent by a hostile political group, as emphasized in the European Commission’s policy on chemical, biological, radiological and nuclear (CBRN) security.
These health challenges are no longer viewed ‘merely’ as important international health issues; increasingly they are perceived as threats to global security
(WHO 2007; EC 2009). The rapid proliferation of the notion of ‘health security’ in a
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wide array of international policy debates and official documents exemplifies the growing importance that governments and other actors now attach to managing acute, transnational disease threats (WHA 2001; GHSI 2002; WHO 2007; Aldis 2008;
European Council 2008; EC 2009; Fidler and Gostin 2008; Elbe 2009, 2010). The
World Health Organization has made strengthening health security one of its core strategic priorities for the coming years, defining it as ‘the activities required, both proactive and reactive, to minimize vulnerability to acute public health events that endanger the collective health of populations living across geographical regions and international boundaries’ (WHO 2007: ix). Similarly, the European Commission is now developing its own Health Security framework focusing on three core areas: 1) prevention of health threats; 2) preparedness; and 3) responses to threats (EC 2011).
The recently completed ‘Stakeholder Consultation on Health Security in the European
Union’ (EC 2011) also reaffirmed the key role that the European Union (EU) needs to play in health security. It recommended that the EU should show global leadership in health security by building upon the success of recent initiatives such as the EU
Health Security Committee (HSC), the Global Health Security Initiative (GHSI), and the European Centre for Disease Prevention and Control (ECDC).
These concerted efforts to strengthen health security require governments to form effective and sustainable partnerships with numerous stakeholders – including the scientific, medical, legal, and public health communities, as well as private industry. Pharmaceutical businesses will have a particularly crucial role to play in this area because it is they who develop the new therapies – like vaccines, antiviral medications, and antibiotics – needed for strengthening health security. That is why governments have been forming a number of new public-private collaborations with pharmaceutical companies, hoping to ensure that new therapies are developed, that
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they are available in sufficient quantities, and that they are available in the placed they are needed. But exactly how have governments been persuading market-oriented pharmaceutical companies to focus on health security threats, especially in a context where their commercial research and development priorities lie in other areas? And how have some pharmaceutical companies, in turn, developed business models that respond to the health security agenda? How, moreover, can the tension between
‘industry-as-partner’ and ‘industry-as-lobbyist’ be responsibly managed in these emerging public-private partnerships? This paper delineates a new research agenda analyzing the formation, workings and effectiveness of pharmaceutical public-private collaborations for strengthening health security. In so doing, it explores the multiple, complex and occasionally contradictory ways in which security policy has become transformed into a site of intensified pharmaceutical development, production and consumption – or what we might simply call the ‘pharmaceuticalization’ of security.
The Role of Pharmaceuticals in Global Health Security
Considerable scholarly attention has focused on the role of government, public health, medical, and scientific communities in strengthening health security systems and processes (e.g. pandemic preparedness, surveillance, laboratory safety, etc.).
Much less attention, by contrast, has been accorded to the crucial role of the pharmaceutical industry in strengthening health security. Even at the wider level of global governance, where there has been research directly on the pharmaceutical industry, this literature has tended to focus almost exclusively on intellectual property protection and access to medicines (Roemer-Mahler 2012; Valbona 2009; Shadlen
2007; Sell and Prakash 2004; Sell 2003; Drahos and Braithwaite 2001/2002). Very little is therefore known about the role of pharmaceutical companies in shaping, and
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responding to, public-private collaborations for strengthening health security. That oversight is surprising for at least three reasons.
First, pharmaceutical companies are one of – if not the
– most important private actors in the quest to strengthen health security. Protecting populations against health-based threats in the 21 st
century requires widespread access to drug-based therapies like vaccines, antiviral medications, antibiotics, antitoxins, and so forth.
Governments also need the pharmaceutical industry to provide scientific and technical expertise in order to manage supply chains and to ensure drug safety. The evolution of health security, and the prospects of strengthening it, cannot be understood without detailed knowledge of central role played by pharmaceutical companies as core actors in this field.
Second, our exploratory research for this project indicates that some pharmaceutical companies have already begun to adapt their business strategies in response to the emerging health security agenda. Faced with competing pressures like a declining number of new products in the discovery ‘pipeline’, growing international competition, prominent drugs coming off patent and/or having to be withdrawn over safety concerns, the International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA) is now positioning the pharmaceutical industry as an active
‘partner’ in global health security. A better understanding of the role of public-private collaborations in health security is therefore also necessary to trace some of the deeper transformations affecting the pharmaceutical sector as a whole.
Finally, public-private partnerships for health security also need to manage difficult policy-making tensions. On the one hand, the public sector has an overriding interest in strengthening health security, and doing so in as cost-effective a manner as possible – especially given increased pressure on public finances. On the other hand,
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pharmaceutical companies are commercial businesses at their core that need to remain profitable, and that are ultimately accountable to their shareholders. The enhanced role of pharmaceutical companies in health security policy thus generates a tension between the role of ‘industry-as-partner’ and ‘industry-as-lobbyist’ – as recently highlighted in the controversy around the World Health Organization’s handling of the 2009 influenza A (H1N1) pandemic. More research on the role of pharmaceutical companies in public-private partnerships is therefore necessary to determine how these tensions can be responsibly managed in future.
Against that background, this paper sets out a new research agenda on health security – one that focuses, for the first time, directly on pharmaceutical companies as core actors in health security policy. In so doing, this research project sits at the intersection of three broader sets of scholarly literatures and debates. First, there is a rapidly expanding, social science literature directly on health security – located mostly in the disciplines of International Relations and Security Studies, but also in
Geography and Anthropology. So far this research has focused on three broad areas.
First, a number of studies have evaluated which health issues pose deeper security threats (Price-Smith 2001; Kassalow 2001; Elbe 2003; Fidler 2003; Garret 2005;
McInnes and Lee 2006, Fidler and Gostin 2008; Price-Smith 2009). Second, scholars drawing on securitization theory have analysed how the framing of health issues as security threats can both benefit and also distort the international politics of health in substantial ways (Davies 2008; Elbe 2006; McInnes 2006; Fidler 2007; Ingram 2007;
Leboeuf and Broughton 2008). These two research agendas have probed the evidence base linking health issues and security concerns, have analyzed issues of political control over the framing of these health issues, and have identified some of the wider political repercussions of the rise of health security. More recently, a third research
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agenda on health security has also been opened up – focusing on the question of how the health-security interface is beginning to reshape traditional security practices
(Elbe 2009, 2010, 2011). Notwithstanding this increasingly rich research in health security, however, there has been no systematic study of the central role that pharmaceutical businesses play in this crucial area of international politics.
Beyond the health security literature, there is also a much broader literature on the political economy of the pharmaceutical industry. In International Relations, for example, a voluminous and wider literature on political economy has highlighted the impact of political factors on economic processes and vice versa, and has produced in-depth studies enhancing our understanding of how globalisation shapes the economic and political challenges faced by both governments and corporations
(Stopford and Strange 1991; Gilpin 2000; Grieco and Ikenberry 2003; Goddard et al.
2003). This literature has also produced important studies focusing on how the pharmaceutical industry has shaped the evolution of global governance, especially in the area of intellectual property rights (Drahos and Braithwaite 2001/02; Sell 2003;
Bach and Newman 2010; Roemer-Mahler 2010), and through a number of formal public-private partnerships (Croft 2005; Scheffler and Vikram 2005; Buse and
Harmer 2007).
That literature also shows how the international political economy of pharmaceutical production is rapidly evolving in light of changing regulatory environments, increased international competition (especially generic medicines), scientific and technological advances, and the growth of pharmaceutical markets in middle-income countries. Pharmaceutical companies are thus implementing new strategies both with regard to their market- and their non-market (i.e. social and political) environments. Whilst there have been a few, welcome economic studies of
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these recent developments undertaken in relation to Indian pharmaceutical companies
(Gehl Sampath 2008), and within the wider context of international development
(Shadlen 2007), this literature has not – to our knowledge – produced a study of the role that pharmaceutical companies play specifically in the area of health security.
Finally, there is also scholarly literature on the wider role that pharmaceutical products play in society and in social life. The latter has been studied intermittently for over twenty years, but more recently there has been a significant resurgence of scholarly interest – especially in the disciplines of sociology and anthropology – around the social prominence of pharmaceutical products (Petryna, Lakoff and
Kleinman 2007; Whyte, van der Geest, and Hardon 2002; Lakoff 2005; Gabe and
Davis 2009; Clarke, Mamo, Fosket, Fishman, and Shim 2010). This literature points to the significant increase in use of prescription medications in recent decades.
Whereas drug sales were fairly static between the 1960s and the 1980s in Western countries, they tripled to US$ 400 billion worldwide between 1980 and 2002, even reaching US$ 600 billion by 2007 (Abraham 2010: 607). Scholars have coined the new term – ‘pharmaceuticalization’ – to capture this striking trend and the growing penetration of pharmaceutical products in our lives.
This sociological and anthropological literature on pharmaceuticals and pharmaceuticalization is relevant to the proposed project because the dominant strategies used to strengthen health security potentially reinforce the wider social trend towards pharmaceuticalization; put differently, these security strategies too are based on the development, acquisition and use of new pharmaceutical products (in the form of vaccines, antiviral medications, antibiotics, and so forth). Yet this nascent sociological and anthropological literature has so far tended to focus on individual medicines, or therapeutic classes of medicines (like anti-depressants, ‘life-style’
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drugs, etc.); it too has not analyzed health security policies as an important site where pharmaceutical companies and products are playing an increasingly prominent role.
Focusing specifically on the role of pharmaceuticals in health security can thus generate new and deeper knowledge about the core actors in health security policy, the changing global political economy of pharmaceutical production, and current societal trends regarding pharmaceutical consumption.
Research Questions
In order to analyze the role that pharmaceuticals and pharmaceutical companies are plying in health security policy, the research agenda pursues three core research questions. First, how are governments trying to incentivise pharmaceutical companies to become more active partners in strengthening health security? This dimension of the project analyses the historical evolution of health security debates and policies, and maps the different kinds of public-private partnerships that have been formed with pharmaceutical companies in order to strengthen health security over the past decade. This question will also identify which tasks and responsibilities for strengthening health security have been included in these partnerships, and in which areas it has been more difficult to form effective partnerships. Particular attention will be paid to how governments have sought to incentivise market-oriented pharmaceutical companies to join such partnerships, especially in contexts the companies’ commercial research and development priorities increasingly lie in noncommunicable diseases rather than the infectious diseases that triggered the notion of global health security.
Second, the agenda will also approach this topic from the perspective of the pharmaceutical companies, asking how have pharmaceutical companies begun
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adapting their business strategies in order to respond to the health security agenda?
Under this question, the research agenda will identify and map the pharmaceutical companies that have chosen to participate in public-private partnerships for strengthening health security. Furthermore, it will analyse the key drivers behind the decisions of these companies to participate, including changes in global market structures and industry organisation, international regulation and evolving security agendas. Here the project will also seek to identify some of the major obstacles for forming such partnerships from the perspective of pharmaceutical companies.
Finally, and in especially in those areas were successful collaborations have emerged, the agenda will also explore how public officials are managing the tension between ‘industry-as-a-partner’ and ‘industry-as-lobbyist’ inherent in public-private partnerships for strengthening health security? This question traces how the emergence of the pharmaceutical industry as a partner in health security is being perceived and managed by public bodies in light of the underlying commercial interests of pharmaceutical businesses. This question will also identify the strategies through which this tension is being managed in these partnerships.
Theoretical Framework: Towards the Pharmaceuticalization of Security?
The conceptual framework for this research agenda will be drawn from pharmaceuticalization theory. Developed recently in the discipline of sociology, pharmaceuticalization theory is a recent body of thought that traces the growing social influence of pharmaceutical products across a range of different areas of social life.
The notion of ‘pharmaceuticalization’ is not inherently pejorative; it principally captures the soaring availability, use and social penetration of pharmaceutical products in various aspects of our lives. Williams et al. (2011: 2) thus define
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pharmaceutical as ‘the translation or transformation of human conditions, capabilities and capacities into opportunities for pharmaceutical intervention.’ Abraham, by contrast, defines more broadly as ‘the process by which social, behavioral or bodily conditions are treated or deemed to be in need of treatment, with medical drugs, by doctors or patients’ (Abraham, 2009: 100).
The latter definition is particular pertinent to this project because it includes not just bodily conditions, but also wider social conditions. This wider perspective thus enables us to ask whether – in the broader domain of world politics – security policy has not undergone a similar process of pharmaceuticalization over the past decade? With the rise of the health security agenda, many governments now believe that it is necessary to proactively develop, acquire, and stockpiles a large volume of medical countermeasures to protect their populations against the threats posed by bioterrorism, pandemics and emerging infectious diseases. Through that process, pharmaceutical products – in the form of vaccines, antivirals, antitoxins, etc. – have recently begun to play a much more central role in security policy. The study will thus explore the ways in which the rise of health security, as a way of framing and managing global health, further promotes the acquisition and use of pharmaceuticals around the world – for example, by prompting countries to create large national stockpiles of pharmaceutical supplies to protect their populations against the twin threats of naturally occurring and deliberately released infectious diseases. Through the adoption of this interdisciplinary theoretical approach, the project thus wishes to trace how security policy has emerged over the past decade as another important area of social and political life where pharmaceuticals and pharmaceutical products have begun to play a more prominent role and function – or what we might simply call the
‘ pharmaceuticalization’ of security
.
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Observing increased rates of global pharmaceutical consumption, pharmaceuticalization theory has done more than develop definitions of pharmaceuticalization; it has also begun to identify several possible explanations for the increased use of pharmaceutical products to address medical and social problems.
These multiple drivers include:
1.
new bio-medical advances enabling many novel therapies to be developed for a wide range of purposes;
2.
the broader medicalization of existence which encourages the tendency to prescribe a ‘pill for every ill’;
3.
more aggressive industry promotion including direct-to-consumer advertising which increases demand for pharmaceutical products;
4.
changes in consumer behaviours making consumers both more knowledgeable about available therapies and more assertive about demanding access to them; and
5.
changing government ideologies leading to lower levels of regulation in the global pharmaceutical market (Abraham 2009, William et al. 2010).
Our research agenda on the role of pharmaceutical companies in security policy will be able to contribute to the further development of pharmaceuticalization theory by illuminating which of these factors (or combination of factors) best explains the dynamics of pharmaceuticalization specifically in the security sector, and – indeed – to discern whether our case studies point to additional and previously unexplored drivers of pharmaceuticalization. These aims and objectives will be realized through the detailed study of a number of public-private partnerships for strengthening health security that have emerged across three different domains of the health security
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agenda: (i) pandemic preparedness; (ii) bioterrorism; and (iii) emerging infectious diseases.
The paper will now introduce the three case studies with a particular focus on the third case study. Anne Roemer-Mahler, who is presenting the paper at the international conference of the Association for Public Policy Analysis &
Management, is taking the lead on this research stream, and will discuss in more detail the research design for this case study.
Case Study 1: Pandemic Preparedness in Europe
A renewed influenza pandemic would have devastating economic and social consequences for Europe and the world. Prompted by recent experiences with SARS,
H5N1 (Bird Flu) and H1N1 (‘Swine’ Flu) , many European countries have been actively preparing themselves for such a scenario. As a crucial part of their pandemic preparedness planning, several governments have also invested billions of Euros (the exact price charged remains a commercial secret) in creating precautionary stockpiles of pharmaceutical supplies like vaccines and antiviral medications. The most prominent of these pharmaceutical products is the anti-viral medication oseltamivir
(brand name: Tamiflu
), which has rapidly established itself as the ‘first line of defence’ for pandemic preparedness planning. For this reason, Tamiflu has been selected as the central case study for this research strand.
In order to answer the first research question, the case study will trace the rise of pandemic preparedness debates in Europe, and how these enabled a crucial transformation of Tamiflu from being a new seasonal influenza drug, to becoming the
‘premier’ medical countermeasure for pandemic preparedness planning. Here the case study will trace the evolution of health security debates at the World Health
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Organization and other national pandemic preparedness organizations in response to
SARS and avian influenza. It will also analyse the nature of the advance purchase agreements that were completed with the pharmaceutical company Roche, which manufactures and distributes the drug internationally. This will be accomplished by interviewing the PI’s existing contacts at the World Health Organization and the
Global Health and Security Initiative. European governments with established stockpiles will also be selectively approached for interviews, as will contacts in the
European Centre for Disease Prevention and Control (ECDC).
In order to answer the second research question, this strand will analyse how the evolving discourse on health security created an opportunity for the pharmaceutical company Roche to position itself as a partner for pandemic preparedness that could help European governments create national stockpiles of the drug. This will be accomplished through searches of official documents on health security and pandemic threats at the World Health Organization and other prominent policy forums. It will also trace and compile the annual sales figures for Tamiflu achieved by Roche, which are publicly available through their annual company reports and are available online.
Building upon the findings of the investigations by the Council of Europe and the European Parliament, this case study will pay particular attention to how the
WHO handled potential conflicts of interests around its recommendations regarding the use of Tamiflu for pandemic preparedness planning. This is particularly important given recent controversies surrounding its use. In 2009, the internationally respected
Cochrane Collaboration published a review of 20 existing studies that explored the effects of Tamiflu on otherwise healthy adults, and found that there is no concrete evidence that it prevents serious medical conditions linked to the flu, such as
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respiratory infections and pneumonia (Jefferson et al 2010). Recent studies in Japan have also underlined the dangers of the drug for children and adolescents, as the drug has been linked to incidence of teen suicide and self-harm, prompting authorities to ban the drug’s use among children and adolescents. Here the project will identify the mechanisms that the WHO now has in place to manage the tension between ‘industryas-partner’ and ‘industry-as-lobbyist’.
Case Study 2: Bioterrorism in the United States
Governments are concerned to protect their populations against the possible consequences of a deliberate release of a biological agent (as well as the possibility of an accidental release of such agents from a laboratory). However, many of the biological agents that could potentially be used in such an attack are quite rare – meaning there is no ‘natural’ market for selling medical therapies that would protect people against these threats. Developing medical countermeasures against biological attacks has therefore not been a commercial priority for pharmaceutical companies.
However, with the increased concern over bioterrorism, especially after
September 11, 2001 and the subsequent anthrax letters, the US government in particular has established a number of well-funded partnerships with pharmaceutical companies in order to develop a substantial stockpile of new medical countermeasures. Over the past decade alone, the United States has invested more than US$ 50 billion for civilian research on biodefense (Franco 2008). That makes the
United States the country that is by far the most engaged in this particular area of health security. For this reason, and also because the United States government is comparatively open in terms of publicly disclosing many of its activities in this area, the United States has been chosen as the best case study for this project.
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In order to answer the first research question, the case study will trace the evolution of the policy debate on bioterrorism in the United States, both before and after the events of 2001. It will explore, in particular, the political background to the creation of Project BioShield under the Bush administration. This new programme was used by the United States government as a way of incentivising the pharmaceutical sector to develop new medical countermeasures against a range of biological agents. This research will be accomplished through reviewing the scholarly literature and government reports on Project BioShield, of which several are publicly available. This part of the research will also look at the challenges that the programme has encountered in terms of failed products, the costs involved, wider problems with administering the programme effectively, and concerns that pharmaceutical companies had about the legal repercussions of potentially using new products that had not yet been fully approved by the Food and Drug Administration (FDA). This will be accomplished through collecting publicly available reports on Project
BioShield. Further background information will be gathered by site visits and interviews at the Department of Health and Human Services, the Department of
Defense, and the Department of Homeland Security.
The second research question will be explored by analyzing a number of pharmaceutical companies that have developed products through the BioShield programme. Particular attention will be paid to finding out how many different new medical countermeasures have been developed through this programme, and how many of them have also been procured for the Strategic National Stockpile (SNS). To do so, this aspect of the research strand will focus on the workings of the Biomedical
Advanced Research and Development Agency (BARDA) in the United States.
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BARDA was created in 2006 through the Pandemic and All-Hazards Preparedness
Act . The explicit purpose of creating BARDA was to use BioShield funds in order to commission pharmaceutical companies to undertake research for developing new medical countermeasures, and for generating additional production capacity so that they could be included in the country’s Strategic National Stockpile. Using reviews of the existing scholarly literatures, grey literatures, and interviews with officials from
BARDA drawn from existing contacts, this part of the research will also look at the mechanisms for managing potential conflicts between public health and commercial objectives. The final research question will be explored through site visits and semistructured interviews at BARDA headquarters, and will look at how the tension between commercial and public health priorities are being managed in these new partnerships.
Case Study 3: Tuberculosis
The third project stream focuses on a health threat that is particularly prevalent in LMICs, tuberculosis. Given that tuberculosis is particularly prevalent in LMICs and that some of these countries have strong pharmaceutical industries themselves, this project stream will look specifically at the role that pharmaceutical companies from LMICs have played in such collaborations, and investigate whether and, if so, how their involvement and contributions differ from that made by pharmaceutical companies from high-income countries (HICs).
Infectious diseases emerging from LMICs are one of the health issues identified as security threats. The HIV/AIDS pandemic that spiraled in LMICs in the
1990s has been the most prominent disease discussed in this context, with debates focusing on the impact of HIV/AIDS eases on military readiness, state stability and
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international peacekeeping operations. HIV/AIDS was designated as a national security threat both by the Bill Clinton and George W. Bush administrations, as well as a threat to international peace and security by the United Nations Security Council
(Resolutions 1308 and 1983). In addition to these more traditional security concerns, the HIV/AIDS pandemic prompted concerns about its impact on human security in
LMICs. Introduced in the UNDP Human Development Report 1994, the human security concept applies the notion of security to the individual rather than the state, and encompasses seven areas including economic, food, health, environmental, personal, community and political security. The Joint United Nations Programme on
HIV/AIDS (UNAIDS) argued that ‘the AIDS epidemic is claiming not only human lives, but destroying structures of governance that ensure human security’ (UNAIDS
2003).
Tuberculosis as a Health Security Threat
More recently, attention has shifted to tuberculosis as a threat to state and human security. Of particular concern are those strains of the disease that are resistant to one or several drugs used for treatment. Tuberculosis is one of the most widespread infectious diseases in the world and the second leading cause of death from an infectious disease - after HIV/AIDS. It is caused by the bacillus Mycobacterium tuberculosis and typically affects the
lungs (pulmonary tuberculosis) but can affect other sites as well (extrapulmonary tuberculosis). The disease is spread in the air when people who are sick with pulmonary tuberculosis expel bacteria, for example by coughing.
WHO estimates that about one-third of all people in the world are carriers of the bacillus although only approximately 12 million people were estimated to have
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active tuberculosis. The development of active tuberculosis is associated with a weakened immune system due to other illnesses, such as HIV/AIDS for instance, or due to poverty. It is estimated that approximately 8.7 million people were newly infected in 2011, with approximately 1.4 million people dying of the disease (WHO
2012).
Tuberculosis has received increased attention in international health security debates with the rise of drug-resistant forms of the disease. WHO distinguishes between two forms of drug-resistant tuberculosis. Multi -drug-resistant tuberculosis
(MDR-TB) is resistant to the two most powerful first-line drugs. Extensively drugresistant tuberculosis (XDR-TB) is resistant to any of the antibiotics that are commonly used in treating tuberculosis in addition to being resistant to at least one of the three injectable second-line drugs. In 2011, there were an estimated 630,000 cases of MDR-TB
(WHO 2012).
In addition to the significant health burden that tuberculosis imposes on affected individuals and societies, the disease also entails a considerable economic burden. First, the disease significantly reduces the productivity of people living with it. This is the case even when they are treated because medicines have to be taken for a long time. The treatment of drug-susceptible tuberculosis takes on average 6-9 months and that of MDR-TB approximately 20 months. In addition, patients often suffer from considerable side effects. The economic effects of the disease are aggravated because tuberculosis a ffects mostly adults in the economically productive age groups.
Second, the treatment of tuberculosis is expensive. While the price of the medicines an individual has to take to treat drug-susceptible tuberculosis is not very high with approximately USD 22 per patient for a six-months treatment course, the
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large number of affected people and the long duration of treatment means that the overall burden on society is considerable. In addition, many governments provide tuberculosis treatment for free, which poses a significant the burden on public budgets. In the case of MDR-/XDR-TB the cost of the required medicines is much higher than that for drug-susceptible tuberculosis. While the exact price varies considerably because treatment must be individualized according to the drugresistance profile of a patient, estimates are that a standard regimen for MDR-TB lasting 24 months ranges between USD 4000 and USD 6000
1
(Médecins Sans
Frontières and the International Union Against Tuberculosis and Lung Disease 2012).
Tuberculosis and particularly MDR-/XDR-TB are linked to other health security threats. First of all, the spread of tuberculosis is linked to the HIV/AIDS pandemic because the weakened immune system of people living with HIV/AIDS significantly increases the chances of developing active tuberculosis.
In 2011, 1.1 million (13%) of the 8.7 million people who developed tuberculosis worldwide were
HIV-positive (WHO 2012).
Moreover, both the diagnosis and the treatment of tuberculosis is much more difficult and expensive with HIV patients. Secondly, the rise of MDR-/XDR-TB is linked to the broader phenomenon of antimicrobial resistance. In recent years, the problem of a growing range of microbes developing resistance to existing drugs while only a few new antimicrobial medicine are being developed has come to the attention of many governments. Earlier this year, the UK’s chief medical officer argued that growing resistance to antibiotics should be ranked along with terrorism on a list of threats to the nation (Walsh 2013).
Finally, the rise of MDR-/XDR-TB has been linked to the trade in counterfeit drugs (Khazan 2013; Barber et al 2009; Laserson et al 2001). The concern is that sub-
1 This regime includes eight months of injectable capreomycin. Four medicines in particular weigh heavily in the overall cost of a DR-TB regimen: capreomycin, moxifloxacin, PAS and cycloserine.
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standard and therefore less effective ingredients in medicines contribute to the development of resistant strains of the disease. This is of particular concern in LMICs where some estimate that up to 30 percent of tuberculosis drugs are of sub-standard quality (Bate 2012).
As a result, several governments and international organizations consider tuberculosis a potential threat to national and international security (Enemark 2013;
Kendall 2012). For instance, the US government has declared MDR-TB “an emerging public health threat” (HSS et al 2003: 52), and already in 1993, WHO announced that
TB was a “global emergency” (WHO 2003).
The Dilemma: Implementing Policies to Increase Drug Supply in the Face of
Low Market Demand
The key policy response to the growing threat perception of tuberculosis has been to increase the availability of medicines to treat the disease. The goal to increase the availability of medicines includes both the availability of existing drugs and the availability of new drugs
2
.
This policy response relies on pharmaceutical companies to manufacture drugs and invest in research and development for new medicines. Both has been problematic in the case of tuberculosis medicines because the effective market demand for tuberculosis medicines is low. The global market for first-line tuberculosis medicines, i.e. medicines to treat drug-susceptible tuberculosis, was
2 The limited number of new drugs being developed is problematic because existing treatments suffer from a range of severe problems. Firstly, existing medicines have to be taken for a long period, which makes it difficult for patients to complete their treatment. This, in turn, contributes to the development of drug-resistant strains, which are even more complicated to treat. Furthermore, tuberculosis treatment often causes severe side effects, which is debilitating for patients and increases the burden on their lives and on society at large. Finally, the current drug regimen is not compatible with some commonly used antiretroviral therapies for HIV/AIDS. In order to avoid drug-drug interactions in patients infected with both HIV/AIDS and tuberculosis, the treatment regimen for one of the diseases must be modified in a way that is medically sub-optimal.
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estimated to be between UDS 261 million and USD 418 million (Schwalbe et al
2008). The global market for second-line drugs, i.e. drugs to treat MDR-/XDR-TB, was estimated to be approximately USD 300 million (Médecins Sans Frontières and the International Union Against Tuberculosis and Lung Disease 2012).
There are several reasons why the effective market demand is low despite the high prevalence of the disease. Firstly, tuberculosis is largely a disease of the poor.
This means that most patients cannot afford to pay even for the relatively cheap medicines required to treat drug-susceptible tuberculosis, let alone for the expensive treatment of MDR-/XDR-TB. Even in countries where governments provide tuberculosis treatment for free effective market demand is limited by the financial capacity of governments to subsidize treatment costs. A second reason that limits effective market demand is the low level of diagnosis. It is estimated that only about two thirds of people living with active tuberculosis are diagnosed. In the case of
MDR-TB, the rate of diagnosis is estimated to be only approximately 19 percent
(WHO 2012). Finally, the market for second-line medicines, i.e. those drug required to treat MDR-/XDR-TB is highly fragmented because patients require different combination regimes due to different drug-resistant profiles. In addition, packaging requirements differ across countries, which drives up production costs (Médecins
Sans Frontières and the International Union Against Tuberculosis and Lung Disease
2012).
An additional consideration for companies in deciding about R&D investments for new tuberculosis drugs is the opportunity costs of foregoing investment in R&D for other medicines. For instance, non-communicable diseases such as cardiovascular and neurological conditions, diabetes and cancer, are on the rise not only among the wealthy populations of HICs but also among the fast rising
22

middle-classes of LMICs. The returns on investing in medicines for diseases of the well-off may well be higher than those on investments in medicines for diseases of the poor, such as tuberculosis.
Many of the reasons for the low effective market demand for tuberculosis drugs resemble those for the low market demand for drugs to treat other diseases prevalent mainly in LMICs, often termed ‘neglected diseases’. The complicated treatment of drug-resistant strains of tuberculosis further increases the problem of a market too small to incentivize strong commercial interest in drug supply. As a result, only a few manufacturers supply tuberculosis drugs. For example, just one company dominates the supply of active pharmaceutical ingredients for rifampicin, the Indian company Lupin, and one company dominates the supply of a key intermediate for ethambutol, the US producer Dow Chemical (Matiru and Ryan 2007). Even for drugs for which at least two suppliers are available are often reliant on the same manufacturer for the active pharmaceutical ingredient (Médecins Sans Frontières and the International Union Against Tuberculosis and Lung Disease 2012).
With regard to new medicines to treat tuberculosis, only one new drug has been brought to the market for approximately 40 years. Bedaquiline 3 was approved in
December 2012 by the USFDA as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis. Bedaquiline was developed by Janssen
Therapeutics, a subsidiary of Johnson&Johnson, and the Global Alliance for TB Drug
Development co-sponsored the phase II efficacy trial.
The Solution: Public-Private Collaborations
The global policy response on tuberculosis with its focus on increasing drug
3 The trade name for bedaquiline is Sirturo, and the code names areTMC207 and R207910
23

supply has encountered the problem of low effective market demand for these drugs and, as a consequence, limited commercial interest on the part of pharmaceutical companies to deliver. To address this problem, governments, international organization and NGOs have called for collaborations between governments, pharmaceutical companies and civil society.
In the past two decades, a range of collaborations has been set up at national and international levels to increase the availability of tuberculosis medicines. The
STOP TB Partnership, founded in 2000 and administered by WHO, includes partner organizations from international, nongovernmental and governmental sectors. While its main focus is on awareness raising, it also hosts the Global Drug Facility (GDF) to ensure uninterrupted access by national programs to tuberculosis medicines for implementation of the directly observed treatment, short- course (DOTS), the WHO’s recommended strategy for controlling the disease. Tuberculosis also became one of the three focus areas of the Global Fund to Fight AIDS, Tuberculosis and Malaria, which distributed US$19.3 billion to 572 programs in 144 countries (Global Fund
2010) between 2002 and 2010 (insert reference).
The Stop TB Partnership/GDF and the Global Fund essentially function as global procurement mechanisms for existing tuberculosis medicines. In addition, a range of initiatives has been set up that promote the development of new tuberculosis drugs and vaccines. Among the largest global initiatives are the Global Alliance for
TB Drugs Development, or short TB Alliance, and Areas. While the TB Alliance engages in the development of new combination therapies Aeras focuses on the development of new vaccines and biologics.
24

Research Questions
Pharmaceutical companies are a key factor in the global tuberculosis response.
They are key to the supply of existing medicines and the development of new treatments. Consequently, their collaboration in cross-sectoral partnerships is indispensable. Yet, effective market demand for tuberculosis medicines is low. This raises the question why some pharmaceutical companies have become involved in those partnerships and why other have not. This project stream will investigate:
how governments, international organizations and NGOs have sought to incentivize pharmaceutical companies to supply tuberculosis medicines despite limited market demand;
why some pharmaceutical companies have responded to such incentives and why others have not;
how pharmaceutical companies contribute to such collaborations, and how we can explain potential differences in their contributions;
whether such collaborations have generated conflicts of interests between partners from different sectors and, if so, how such conflicts have been addressed.
The research project will investigate these questions by studying two of the largest collaborations focusing on tuberculosis drug development: the TB Alliance and Areas.
Established in 2000 as a not-for-profit product development partnership, the
TB Alliance sees itself as catalyzing global efforts in the search for new TB regimes.
Moreover, the Alliance seeks to lead “a revolution in the way that TB drugs are developed”, which “evaluates novel combinations of TB drugs — instead of single drugs — as part of a single development program, enabling the development of novel
25

TB drug regimens that have potential to transform treatment for drug-sensitive and drug-resistant tuberculosis. This approach offers the potential to reduce the time previously needed to develop a novel treatment regimen by up to 75%, shortening the clinical development from decades to years” (TB Alliance 2013).
The TB Alliance involves partner organizations from public, the private nonfor profit and the business sectors. Drug regulatory, disease prevention and international development agencies from Western Europe and US are involved as well as the Chinese Center of Disease Control and Prevention, Brazil’s Oswaldo Cruz
Foundation, the Indian Council of Medical Research, and the South African Medical
Research Council. Among pharmaceutical companies, most partner organizations are large companies from Europe and the US, including Abbott, AstraZeneca, Bayer,
Gilead, GSK, J&J, Novartis, Sanofi. Yet, the TB Alliance has also worked with pharmaceutical companies from middle-income countries, such as Lupin from India and moksha8 from Mexico.
Aeras was founded in 2003 and, like the TB Alliance, is a product development partnership. Unlike the TB Alliance, Aeras focuses on the development of new vaccines to replace the only existing vaccine against TB, Bacillus Calmette–
Guérin (BCG) vaccine. The BCG vaccine is over 90 years old and only partially effective. It provides some protection against severe forms of pediatric TB, but is unreliable against adult pulmonary TB, which accounts for most of the disease burden worldwide.
Funded largely by the Bill and Melinda Gates Foundation, Netherlands
Ministry of Foreign Affairs, the UK Department for International Development, the
US Centers for Disease Control, the Danish International Development Agency, and the Research Council of Norway, it brings together a wide variety of partners from the
26

public sector, academia, NGOs and pharmaceutical companies. Most pharmaceutical companies are vaccine and biologics companies from Europe, Japan and the US, including Crucell, Emergent BioSolutions, Immune Solutions, ImmunoBiology,
Intercell, Okairos, Otsuka, Sanofi Pasteur and Statens. Yet, Aeras works also with several companies from China, including the China National Biotec Group, CanSino and the Wuha Institute of Biological Product, and the Indian vaccine producer Serum
Institute.
As explained above, both organizations work with pharmaceutical companies from a range of countries, including from both HICs and LMICs. This enables us to investigate whether the roles that pharmaceutical companies from HICs and LMICs play in such collaborations differ in, if so, how and why.
Comparing the Roles of Pharmaceutical Companies from HICs and LMICs in
Public-Private Collaborations
Why is a special focus on pharmaceutical companies from LMICs and a comparison of the roles played by companies from LMICs and HICs an interesting analytical angle for this research project?
Most research on the role of pharmaceutical companies in global governance in general and in global health partnerships in particular has focused on big pharmaceutical companies from the US and Western Europe [insert references]. Few studies have been conducted on the role of pharmaceutical companies from LMICs
(exceptions are, for example, Shadlen 2007; Roemer-Mahler 2010; 2012). A better understanding of their potential contribution to the global tuberculosis response is warranted for several reasons.
27

First, China and India have the largest numbers of new tuberculosis cases and have the highest burden of MDR-/XDR-TB. At the same time, these countries are home to some of the fastest growing domestic pharmaceutical industries. Moreover, there is evidence that the Chinese and Indian governments prefer to buy medicines from domestic pharmaceutical producers (Wilson and Rao 2012). This raises the question whether and, if so, how the Chinese and Indian governments and global donor organizations try to involve domestic pharmaceutical producers from these countries into the global tuberculosis response.
Second, pharmaceutical companies from China and India are already important producers of tuberculosis drugs. 80-85 percent of active pharmaceutical ingredients are produced in China, and India is a major producer of tuberculosis drug formulations (Médecins Sans Frontières and the International Union Against
Tuberculosis and Lung Disease 2012). While pharmaceutical companies from both countries have as yet limited capacity for research and development, the idea that
LMICs can contribute to the development of medicines to meet the needs of their populations is not new. In fact, the Global Strategy and Plan of Action on Global
Health, Innovation, and Intellectual Property, adopted by the World Health Assembly in 2008, states that “strengthening of the innovative capacity of developing countries is essential to respond to the needs of public health” (WHO 2008).
In addition, there are reasons to expect that the role of pharmaceutical companies from LMICs in public-private collaborations may differ from that of companies from HICs. Drawing on existing theoretical and empirical research, we hypothesize that differences may exist in three ways: o First, pharmaceutical companies from LMICs may be able to provide tuberculosis medicines at lower prices than producers from HICs because
28

of lower development and manufacturing costs. o Second, they may be able to produce drug-delivery systems and combination therapies that are more suitable to patient needs in LMICs because they may have greater expertise in supplying LMICs pharmaceutical markets. o Third, they may take a greater interest in developing/manufacturing medicines for small markets and markets with low profit margins because
 their production costs are lower and consequently their profit margins higher than those of HIC producers;
 their opportunity costs are lower because they do not have access to the large and high-profit margins of HICs;
 they are not publicly traded and therefore less tied to expectations of short-term investment returns.
The specific position of LMIC pharmaceutical companies may also mean that different incentives on the part of governments and other organizations are required to facilitate their collaboration in partnerships. For instance, the lack of research expertise and technical infrastructure found with many LMIC producers may make it less likely that incentive mechanisms that have been successfully used in HIC work for LMIC producers. For instance, so-called pull-mechanisms, which incentivize the development of new technologies with rewards to be reaped when the product is delivered, such as prizes or marketing exclusivity for instance, are less likely to work in a context where the very infrastructure required for innovation is lacking. Yet, the lack of research infrastructure may be turned into an incentive to engage LMIC producers in partnerships if the partner organizations can provide access to it.
29

Conclusion
This paper has delineated a new research agenda on the role of pharmaceuticals and pharmaceutical companies in strengthening health security through the exploration of a range of public-private partnerships emerging to manage the threats of bioterrorism, pandemic preparedness, and tuberculosis. It is hoped that the collective findings of the research project can advance our knowledge in at least three ways.

First, the project seeks to advance the study of global health security by undertaking the first detailed study of the role of pharmaceutical companies as central actors in health security. That should provide us with a more detailed and in-depth understanding of the multiple actors involved in health security policy.

Second, the project hopes to advance the study of the political economy of the pharmaceutical industry by examining how pharmaceutical companies respond to and also shape the health security agenda. We also hope that the study will contribute more generally towards bridging the gap between the fields of international political economy and security studies that have so far characterised the International Relations scholarship on global health.
 Third, the project will introduce the concept of ‘pharmaceuticalization’ to the disciplines of International Relations and Security Studies. Here we believe on the basis of our preliminary research that the project is likely to find that security policy is emerging as a crucial international site where the process of pharmaceuticalization is being advanced within and across borders – albeit not necessarily in a linear or uncomplicated way. We hope to capture a phenomenon that we suspect is simultaneously unfolding across three domains
30

of security policy – pandemic preparedness, bioterrorism, and emerging infectious diseases – and which we call the pharmaceuticalization of security.
31

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