Pharmaceuticals and Security:The Role Of Public-Private Collaborations In

Strengthening Global Health Security

Draft paper.Not for citation.

Comments very welcome.

Professor Stefan Elbe, Dr. Anne Roemer-Mahler, and Christopher LongCentre for Global Health Policy

Department of International RelationsSchool of Global Studies

University of SussexBrighton BN1 9SNUnited Kingdom

www.sussex.ac.uk/globalhealthpolicy/Tel. +44 (0)1273 678724Fax. +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 public-private 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 middle-

income 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 21st 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

these recent developments undertaken in relation to Indian pharmaceutical companies

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(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’

drugs, etc.); it too has not analyzed health security policies as an important site where

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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 non-

communicable 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

adapting their business strategies in order to respond to the health security agenda?

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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

pharmaceutical as ‘the translation or transformation of human conditions, capabilities

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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 ‘industry-

as-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 semi-

structured 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 thelungs (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 drug-

resistant 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 affects 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 drug-

resistance profile of a patient, estimates are that a standard regimen for MDR-TB

lasting 24 months ranges between USD 4000 and USD 60001 (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.

20

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 drugs2.

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

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.

21

tuberculosis medicines, i.e. medicines to treat drug-susceptible tuberculosis, was

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

22

rise not only among the wealthy populations of HICs but also among the fast rising

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. Bedaquiline3 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 non-

for 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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