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date: 28 February 2021

The Politics of Pandemic Influenza Preparedness

Abstract and Keywords

This chapter explores the ideas, concepts, norms, and agendas that have shaped the structures and actors governing the field of pandemic influenza preparedness. It begins by tracing the historical origins of the disease, then discusses the World Health Organization’s attempts to better respond to influenza pandemics through the development of biomedical knowledge and tools. The chapter then examines how, since the end of the Cold War, pandemic influenza has gained new prominence, in part as a result of its portrayal as a social, economic and political ‘threat’, which has prompted a transformation in the governance arrangements regarding the disease. The governance of pandemic influenza thus serves as a microcosm of the trends, actors, challenges and obstacles confronting global health governance more broadly.

Keywords: pandemic influenza, EBM, vaccines, antivirals, global health governance

In 2007 the World Health Organization (WHO) declared pandemic influenza ‘the most feared security threat’ because of its ability to spread easily between humans; the difficulty in controlling it; and the number of fatalities inflicted by previous outbreaks, epidemics, and pandemics (WHO 2007, 45). Influenza, in short, is a ubiquitous disease genetically predisposed to mutation and adaptation, making it difficult to develop one definitive, effective countermeasure. Periodically a new strain emerges against which humans have little to no immunity, and influenza vaccines remain our best defense. For these reasons, especially since the start of the new millennium, pandemic influenza preparedness has involved the stockpiling of pharmaceuticals—for those countries that can afford to do so—as the hallmark of ‘responsible government’. This has been actively encouraged by key global institutions such as the WHO, the World Bank, the United Nations (UN), and the International Monetary Fund (IMF).

The governance arrangements for pandemic influenza, however, have undergone an important evolution since the start of the twenty-first century. Originally developed exclusively around intergovernmental collaboration in the 1950s, they have since become far more complex, reflecting a more interconnected, globalised reality. The focus of this chapter is to examine how pandemic influenza governance arrangements have changed over the past hundred years (and how they have not); the norms and ideas influencing preparedness; and the various actors, institutions, and resources that have been brought to bear in this critical area of public policy. The chapter concludes with an analysis of what these changes signify for the future of pandemic influenza governance.

(p. 532) From Disaster to Discovery and Global Surveillance

Influenza epidemics and pandemics have been regular features of human existence for the better part of one thousand years. Indeed, the first record of an influenza epidemic was documented to have adversely affected England, Germany, and Italy in 1173 ce (Cunha 2004). The first influenza ‘pandemic’ (defined as affecting two or more regions) appears to have occurred around 1510, having spread from northern Africa into the Middle East and then to Europe (Quinn 2008). Over the next four hundred years influenza epidemics and pandemics were recorded with such frequency that they were statistically evaluated to occur on average once every 19.8 years (Eichel 1922). Crucially, however, throughout this extensive history of human interaction with influenza the etiological agent responsible—a virus—remained undiscovered until the start of the twentieth century, with various explanatory theories ranging from the wrath of the gods to cosmological events and foul-smelling mists (or ‘miasma’) (Patterson 1986).

The 1918 Spanish influenza pandemic remains to this day one of the four most significant epidemiological events in recorded human history. This one event, which spanned approximately an eighteen-month period around the end of World War I, resulted in the death of an estimated forty million people worldwide. The case fatality ratio (number of deaths divided by the number of infections), at 2.5 percent, was comparatively high compared to seasonal influenza (Taubenberger 2006), but critically, it is important to appreciate that the vast majority of people infected—some 97.5 percent globally—actually survived. During the 1918 pandemic a number of farmers had noted that a similar illness had appeared in pigs, and this observation then prompted a group of scientists to investigate whether a correlation existed (Smith, Andrewes, and Laidlaw 1933). In 1933 it was discovered that a virus was responsible for causing influenza, and that influenza did indeed have the ability to move between different species (i.e., it was zoonotic).

As a direct consequence of the severe morbidity and mortality inflicted by the 1918 Spanish flu, public perceptions regarding the danger posed by the disease shifted markedly. For a time influenza became known as a ‘war disease’ (Francis 1947, 10), prompting the US military in 1941 to establish the Armed Forces Epidemiological Board to undertake research and development into influenza vaccines even as World War II raged in Europe (Hoyt 2006). These efforts were replicated across a variety of countries, including the Soviet Union, the United Kingdom, Australia, Argentina, and Canada, amongst others (Watterson and Kamradt-Scott 2016). In the wake of World War II, work on influenza vaccines shifted to the civilian sector, concentrated in a small number of high-income countries. Concern about a repeat of what had happened in 1918 nevertheless remained high, and in 1946, when the decision was taken to establish a new universal health agency in the form of the World Health Organization, one of the first tasks assigned to the Interim Commission of the WHO was to institute a new programme to monitor and study the virus.

(p. 533) The commission initiated its work the following year by establishing the World Influenza Centre in 1947 in London, with the threefold objective of planning against the emergence of future pandemics; developing control methods to limit their impact when they did occur; and reducing adverse economic impacts (Payne 1953). In 1950 the third World Health Assembly (WHA)—the supreme decision-making body of the WHO—approved the creation of the Expert Committee on Influenza to provide specialist advice. The committee met for the first (and only) time in 1952, when it was decided to establish the Global Influenza Surveillance Network (GISN). The GISN’s primary function was to identify and trace the circulating strains of influenza, which it accomplished through progressively building a worldwide network of national influenza laboratories that would openly share the information they gathered with WHO reference laboratories (now labeled ‘WHO Collaborating Centres’). In 1952 an initial forty laboratories joined the GISN (Jensen and Hogan 1958), but indicating the level of concern that continued to exist about a potential repeat of 1918, by 1977 the network had expanded to some ninety-eight laboratories in seventy countries (Pereira 1979).

A related function of the GISN was to provide assistance to the WHO’s member states in responding to influenza outbreaks, epidemics, and pandemics when they arose. The GISN was put to the test soon after its creation with the 1957 Asian flu pandemic. This event proved significant for two specific reasons, the first of which was that the virus caused approximately two million fatalities worldwide. Although substantially less than the 1918 Spanish flu pandemic, the 1957 Asian flu pandemic nevertheless caused considerable anxiety. The outbreak started in February 1957 in central China—one of the few countries that was not part of the GISN at the time—before spreading to Hong Kong, Manila, Singapore, and Japan, where samples of the virus were isolated. The data collected by Singapore and Japan were then shared with the WHO Collaborating Centres in London, Washington, DC, and Melbourne, which confirmed that the strain of the virus was novel. The WHO was then officially notified on May 23, 1957, about the presence of a novel influenza virus, but by this stage the virus had already begun to circulate widely via sea routes, with cases being reported from Indonesia to Manila and from Moscow to the Persian Gulf (Payne 1958; Langmuir 1961; Tognotti 2013). Over the following months the virus continued to spread internationally, reaching its peak in the Northern Hemisphere in the closing months of 1957 before gradually lessening throughout 1958. Whilst officially the number of deaths attributed to the pandemic was two million, in several countries, such as India and China, no record was made of the level of human morbidity and mortality, leaving many to speculate that the actual number of deaths was much higher (Quinn 2008).

The second reason the 1957 influenza pandemic proved so significant was also arguably the only positive feature of the crisis; namely, it generated overwhelming evidence of the effectiveness of influenza vaccines in saving lives. Prior to the 1957 influenza pandemic, the scientific community was divided on the utility of vaccines, with various clinical trials offering mixed results. As a direct consequence of the spread of the 1957 virus, however, several governments, including those of the United States and the United Kingdom, instituted widespread influenza vaccination campaigns. The evidence (p. 534) gathered from these campaigns definitively revealed the utility of vaccination, and since then vaccination has become recognised as the cornerstone of pandemic preparedness. To that end, the GISN increasingly began to share the data it gathered on circulating viral strains with pharmaceutical manufacturers to facilitate the production of influenza vaccines. This strategy proved particularly beneficial when the Hong Kong flu pandemic commenced in 1968.

The 1968 influenza pandemic reportedly again began in China, but given that external relations with the Communist state had deteriorated even further since the late 1950s, the virus was not detected until it reached Hong Kong and Singapore (Kilbourne 2006; Quinn 2008). From Hong Kong the virus then continued to spread around Asia before being carried to the United States by US Marines returning from Vietnam. By the winter of 1968–1969 it had spread to Europe (Tagnotti 2013). The WHO officially notified governments that a pandemic was under way on August 16, 1968, and by mid-September—based on the experience of the 1957 pandemic—laboratories in the United States started work on developing a new pandemic-specific vaccine. Vaccination campaigns were then able to officially commence just two months later, on November 19, though the virus ‘had largely spent itself [in the United States] by the end of 1968’ (Hillman 1969, 623). This reportedly resulted in less domestic uptake of the vaccine, but the upshot of less interest in vaccination by US citizens was that the vaccines were then available to be utilised in parts of Europe and the Southern Hemisphere, where the pandemic was still unfolding (Hillman 1969).

The collective experience of both the 1957 and 1968 pandemics conclusively revealed that influenza vaccines were effective in reducing human morbidity and mortality. As a result, a number of governments in high-income countries (HICs)—where the majority of vaccine manufacturers were located—focused their efforts over the next few decades on ensuring greater vaccine yield in faster time frames (Kamradt-Scott 2013). Increased recognition of the utility of antiviral medications as a second line of defense added to the influenza pharmaceutical ‘arsenal’ (Glezen 1996; Mendel and Sidwell 1998), but the ability to produce pandemic-specific influenza vaccines—which, crucially, relied on seasonal influenza vaccine manufacturing capacity—remained the core capability that many Western governments were keen to maintain.

Importantly, however, the apparent success of influenza vaccines in reducing human sickness and death had an unanticipated and converse impact on international pandemic preparedness policy and practise. For decades the primary concern driving international collaboration had been the possibility that the 1918 Spanish flu pandemic would be repeated. Whilst a number of influenza experts periodically attempted to highlight the ongoing hazard of an influenza pandemic (WHO 1988; Webster 1994), for most HICs that maintained influenza vaccine manufacturing capacity, the risk of 1918 being revisited perceptibly lessened. Instead, throughout the latter half of the twentieth century influenza became increasingly viewed as a controllable disease that was most appropriately addressed by individual governments, ideally through vaccination campaigns that had been verified by biomedical knowledge and techniques such as clinical trials (Hota and McGeer 2007). The consequence of the lack of interest in collective action (p. 535) approaches by wealthier governments was a concomitant reduction in influenza-related funding. Disturbingly, this culminated in a situation in which when the 1997 outbreak of H5N1 influenza occurred in Hong Kong, reigniting fears that another influenza pandemic was imminent, the influenza division of the WHO had been reduced to just one full-time staff member (Kamradt-Scott 2012).

A New Era of Awareness and Vigilance

The 1997 H5N1 outbreak proved a timely wake-up call about the threat of pandemic influenza. From the mid-1990s a number of government-based entities such as the US Institute of Medicine produced reports and other documents that underscored the menace posed by ‘emerging and re-emerging infectious diseases’ in an increasingly interconnected, globalised world (Lederberg 1996; Morens and Fauci 2012). Within this context, prominent public health officials had been warning that the world was ‘overdue’ for another influenza pandemic; thus when the 1997 H5N1 outbreak occurred, killing six of the eighteen people who became infected, anxiety rapidly grew that another pandemic was imminent. Whilst the controversial action of Hong Kong’s then health minister, Margaret Chan, in ordering the culling of the territory’s entire domestic poultry population was credited with having prevented a pandemic (MacPhail 2009), in hindsight it is now clear that the virus had already spread to wild bird populations, which carried the virus farther afield, eventually seeding H5N1 outbreaks amongst birds and humans in early 2003. Nonetheless, the 1997 outbreak prompted HICs to again devote attention and resources to the disease, and with renewed funding (and more staff), the WHO subsequently released its first official guidelines on pandemic preparedness in 1999 (WHO 1999).

With the release of the inaugural pandemic influenza guidelines in 1999, several key global governance institutions, such as the World Bank, the IMF, and the UN, progressively joined the WHO in advocating that governments strengthen their preparedness. In 2003 the emergence of the Severe Acute Respiratory Syndrome (SARS) virus again elevated concerns that a pandemic was imminent. Yet whereas the coronavirus that caused SARS was rapidly contained (within four months of spreading internationally), the H5N1 virus, which had reappeared in China at the same time as SARS, was not so easily suppressed (Heymann and Rodier 2004; Uyeki 2008). Over the next few years multiple outbreaks of H5N1 occurred in Southeast Asia before spreading to the Middle East, Africa, and parts of Europe (Fauci 2006). The spread of H5N1 did not culminate in a pandemic, however, because the virus has—at least to date—failed to achieve effective human-to-human transmission, instead only infecting people who came into close contact with diseased birds (Uyeki 2008). Nevertheless, between 2003 and 2009 anxiety remained high that H5N1 would instigate a new pandemic, and based on (p. 536) the advice of key global governance institutions, many governments sought to protect their populations through stockpiling antiviral medications and gaining access to influenza vaccines.

Perversely, the demand for H5N1 influenza vaccines grew to such an extent that it inadvertently fractured the WHO’s GISN. Confronted with a growing number of H5N1-related cases, in 2006 Indonesia’s president authorised the then health minister, Siti Fadilah Supari, to purchase a stockpile of H5N1-specific vaccines. Whilst several pharmaceutical manufacturers indicated they would be prepared to sign an advance purchase agreement (APA) with the Indonesian government to supply the requested vaccines, they also indicated that Indonesia would only receive its vaccines after other APA agreements had been filled (Kamradt-Scott and Lee 2011). Since Indonesia was the country with the highest number of H5N1-related fatalities, this response understandably infuriated the Indonesian authorities. When several related infringements related to the GISN’s virus-sharing arrangements also came to light, Supari announced in January 2007 that Indonesia would cease sharing samples of the H5N1 virus with the WHO’s GISN, claiming ‘viral sovereignty’ (Sedyaningsih et al. 2008).

Indonesia’s controversial decision was condemned by some as effectively holding the world to ransom (Fidler 2008), but it garnered support from several other low-income countries (LICs) that also were struggling to access vaccine stocks (Fedson 2009). Indeed, whilst Indonesia was the only country to publicly announce it had ceased sharing influenza virus samples, and commentators concluded Supari’s decision was possibly motivated more by domestic political ambitions (Hameiri 2014), a number of countries reportedly considered following Indonesia’s lead. In response, the WHO convened a series of intergovernmental sessions throughout 2007 and 2008 in an attempt to find a diplomatic solution. When the initial meetings failed to arrive at a consensus, a more formal intergovernmental open-ended working group (OEWG) was established. Between 2010 and 2011 the OEWG met formally three times in addition to holding a series of consultation meetings with civil society organisations. Concurrent with these meetings, Indonesia pursued its claims of ‘viral sovereignty’ through the Convention on Biological Diversity conference in an attempt to strengthen its negotiating position within the OEWG meetings. In May 2011 the 64th WHA endorsed a new agreement—the 2011 Pandemic Influenza Preparedness Framework (PIPF) (Krishnamurthy and Herder 2013).

The 2011 PIPF has substantially altered the nature of the WHO’s GISN, transforming it from a network exclusively funded by governments into a new public-private partnership. The GISN has also been renamed the Global Influenza Surveillance and Response System, or GISRS. Under the new agreement pharmaceutical manufacturers are no longer permitted to access data and biological samples on circulating virus strains to develop influenza vaccines without committing to ‘benefit-sharing’ arrangements that include, for instance, providing a percentage of influenza vaccines at heavily discounted prices. Other ‘benefits’ include such measures as technology transfers and improved access to diagnostic reagents and influenza test kits—resources that many LICs previously struggled to obtain. Pharmaceutical companies that seek to access the data and (p. 537) biological samples must also contribute to the operating costs of the reformed network, collectively contributing 50 percent of the network’s expenses. The division of payments amongst companies is purportedly ‘based on transparency and equity, based on their nature and capacities’ (WHO 2011, 18). Importantly, however, for an agreement that is explicitly limited to ‘the sharing of H5N1 and other influenza viruses with human pandemic potential’ (WHO 2011, 8), it has nevertheless encountered a number of implementation challenges. For instance, despite the fact that since 2012 private industry has been expected to contribute half the network’s operating costs, as the WHO secretariat noted in 2017, ‘not all companies pay their contributions by the expected deadline’, reportedly impeding capacity building (WHO 2017a, 18). Similarly, due to ongoing human resource limitations, for more than half a decade the WHO secretariat has been compelled to focus on negotiating the Standard Material Transfer Agreement 2, which facilitates delivery of ‘benefit’ products (e.g., vaccines, reagents) in a pandemic with only the larger pharmaceutical manufacturers (WHO 2017a, 59–60). This has meant, however, that small to medium companies have avoided entering into formal agreements with the WHO even though they may still be accessing—and financially benefitting from—GISRS biological materials. Moreover, it has been discovered that even laboratories that have signed agreements have not consistently utilised the Influenza Virus Traceability Mechanism, which tracks the sharing of GISRS biological materials and triggers the PIPF ‘benefit sharing’ process (WHO 2017a, 14). In short, due to a variety of issues, the reformed GISRS is still not operating as envisaged.

By contrast, one of the programmes that has potentially exceeded expectations is the Global Action Plan (GAP) for Influenza Vaccines. The GAP was launched in 2006 with the aim of improving global influenza vaccine manufacturing capacity, which at the time was limited to approximately 1.5 billion doses per annum. Further, the entire influenza vaccine manufacturing capacity was located in HICs. The GAP explicitly sought to redress this by encouraging technology transfers and investment in low- and middle-income country (LMIC) vaccine manufacturing capacity, and by November 2016—in testament to efforts undertaken by the WHO and other partners—global vaccine manufacturing capacity had increased to an estimated 6.4 billion doses per year. Some fourteen new vaccine manufacturers had also been established in middle-income countries, reducing the world’s reliance on highly industrialised countries’ manufacturing capacity (WHO 2016). Although these achievements fall short of the GAP’s 10-billion-dose target, it nevertheless has substantially increased the international community’s preparedness for the next influenza pandemic.

Whilst work was under way to reform the GISN and anxiety remained high about the threat of another pandemic, prompting investment in the GAP, the first pandemic of the twenty-first century began in March 2009 in Mexico. Intriguingly, however, it was not the much-feared H5N1 virus that proved to be the responsible etiological agent, but instead a novel strain of H1N1 usually found in pigs. In mid-March 2009 an unusually high number of influenza-like illnesses were identified by the Mexican health authorities at a time when seasonal outbreaks were expected to be declining. In response, the Mexican Directorate General of Epidemiology ordered that surveillance for acute (p. 538) respiratory diseases be heightened, and over the first ten days in April nongovernmental and government-based agencies reported an outbreak of influenza-like illness in La Gloria, Veracruz, that had reportedly affected a large proportion of the local inhabitants (WHO 2009a; Brown 2009; Shkabatur 2011). Under a trilateral agreement amongst the United States, Mexico, and Canada, clinical specimens collected from patients were sent to the US Centers for Disease Control and Prevention (CDC) in Atlanta and the National Microbiology Laboratory of the Public Health Agency of Canada for testing. Confirmation that these samples were of a novel strain of influenza A (H1N1) came in late April, but by this time the virus had not only spread to Mexico City but also internationally to the United States and Canada (WHO 2009a). By June 1, 2009, the WHO had received confirmed reports of H1N1 cases in sixty-four countries, prompting the organisation to officially declare on June 11, 2009, the first pandemic of the twenty-first century (WHO 2009b).

Compared to previous pandemics, the severity of the 2009 H1N1 influenza pandemic initially appeared far less significant, provoking questions about whether the WHO had been unduly influenced to declare a pandemic. Three investigations—two external and one internal—were subsequently launched into the WHO’s decision-making processes and response, but in handing down their findings all three concluded that the WHO had not been pressured into making its determination. When the WHO director general officially declared the pandemic over on August 10, 2010, a total of 18,449 fatalities had been formally attributed to the H1N1 virus (WHO 2010). It was later estimated, however, that the number of deaths directly attributable to the virus globally was more likely between 123,000 and 203,000, and that the number of deaths arising from H1N1-related complications increased the overall human morbidity to 400,000 (Simonsen et al. 2013). Whilst the 2009 H1N1 virus was thus far less virulent than pandemics of the twentieth century, it nonetheless proved to be a significant global event and worthy of the WHO’s description of a ‘pandemic’.

In the aftermath of the 2009 H1N1 pandemic, the wider international community was beset by what has been described as ‘pandemic fatigue’. This ‘fatigue’, which refers to a generalised reluctance to even discuss pandemic-related issues or topics (Dumiak 2012), persisted for several years and was compounded by the 2008 financial crisis, which discouraged further investment in pandemic preparedness (Brahmbhatt and Jonas 2015). As a phenomenon, however, it proved particularly problematic, given that in the wake of the H1N1 pandemic, several recommendations for reforming the WHO and creating new rapid response mechanisms for responding to health crises had been ignored—mechanisms that in the wake of the 2014 West African Ebola outbreak were re-examined, endorsed, and finally, actioned (McInnes 2015; Gostin et al. 2016). In implementing these reforms, however, pandemic preparedness has been increasingly devolved from the WHO to include other global actors not traditionally associated with health, let alone pandemic influenza preparedness.

Indeed, since 2005 several prominent institutions and actors, such as the IMF, the World Bank, UNICEF, and more recently the Gates Foundation, have been actively engaged in strengthening global pandemic preparedness. The form of these institutions’ (p. 539) interventions has varied, but a common theme—consistent with the WHO—has been encouraging countries to gain ready access to and/or stockpile influenza vaccines and antiviral medications to help protect their respective populations (IMF 2006; UNSIC and World Bank 2010). In October 2014, due to the failure of the international community to respond appropriately to the 2014 West African Ebola outbreak, the World Bank escalated its commitment by announcing plans to establish a ‘pandemic emergency facility’ to act as an insurance mechanism, whereby investors pay a premium that is then drawn upon to assist vulnerable countries in the event of an unanticipated crisis (Ross, Crowe, and Tyndall 2015). This facility was formally launched in May 2016 (World Bank 2016). A similar high-level intervention by the Gates Foundation that linked with other partners (including the Wellcome Trust, Germany, Japan, and Norway) witnessed the launch of the Coalition for Epidemic Preparedness Innovations (CEPI) in January 2017, which is designed to facilitate research and development into new vaccines for diseases with pandemic potential, including influenza (Moon et al. 2017; Gellin and Qadri 2016).

Whilst some commentators have interpreted the rise of these ‘nontraditional’ actors as evidence of the ever-diminishing authority of the WHO (Lidén 2014), it must also be accepted that strengthening global pandemic preparedness was never intended to be the sole responsibility of one organisation. Pandemic influenza is, and is likely for some time to remain, an existential threat that requires collective action to mitigate. Admittedly, whilst the international network created in 1952 to address the threat of influenza pandemics was in dire need of reform by the start of the new millennium, the fact that the GISRS has only recently been augmented by other institutions arguably reflects decades of neglect rather than a failure of the WHO’s systems per se. In fact, as the preceding narrative outlines, public awareness and government commitment to addressing the threat of influenza pandemics has varied widely over the past century, from periods of intense anxiety that culminated in considerable resource allocations to overt lack of interest. Within this situation, the WHO as an institution has remained central, as have various norms, ideas, and values that have shaped the public policy response to this disease.

The Norms and Ideas Shaping Pandemic Policy

Central to pandemic influenza policy and practise over the previous century has been avoiding a repeat of 1918. The Spanish flu pandemic continues to remain one of the most devastating epidemiological events in recorded human history (Walters 1978), and the risk that it may be repeated—and conceivably made worse as a consequence of globalisation—has exercised pandemic planners and policymakers for decades. In this respect, the spectre of 1918 has loomed large, and fear has proven to be a powerful motivating force, (p. 540) driving forward not only influenza-related science but also policy decisions aimed at preventing a repeat.

Within this historical context the primary focus has been on averting excessive human morbidity and mortality. Given that seasonal influenza epidemics generally result in a small proportion of lives lost, most medical professionals (and therefore policymakers) accept that the disease will kill some people despite their best efforts (Graham-Rowe 2011). In most HICs, however, since the 1950s and the discovery of the efficacy of influenza vaccines, considerable emphasis has been placed on vaccinating the most vulnerable population groups, traditionally those immunocompromised individuals at either end of the life spectrum. Biomedical knowledge, techniques, and technologies have thus remained central to influenza-related policy since the early twentieth century, and the influence of biomedicine in shaping pandemic preparedness policy has continued to grow and solidify over time. Even so, as highlighted later in this article, the field has also been extensively shaped by a variety of other competing ideas and normative agendas, resulting in political contestation over the most appropriate way to deal with the issue.

Prior to discussing the norms and ideas that have shaped pandemic policy over the past century, it is important to note a particular feature that has customarily informed pandemic planning and preparedness policy, one that has now been potentially invalidated. As noted previously, the 1918 pandemic resulted in an overall global case fatality ratio of approximately 2.5 percent. This meant that the vast majority of people infected with the Spanish flu virus went on to make a full recovery. Yet in subsequent pandemic planning and preparedness decision-making, it has often been assumed that in order for an influenza virus to achieve effective human-to-human transmission—thereby creating the potential for a pandemic—the virulence of the virus would diminish to the extent that the case fatality ratio would not exceed that of the 1918 Spanish flu virus (Morens et al. 2010). Put another way, public health professionals and pandemic policymakers have traditionally viewed the 1918 Spanish flu pandemic as the ‘worst case scenario’ that they need to prepare for (Moxnes and Albert Christophensen 2008).

In 2011 experiments conducted by two distinct groups of scientists who manipulated the H5N1 avian influenza virus raised the possibility that an airborne strain of influenza could emerge naturally that may infect humans and retain its current case fatality ratio in excess of 50 percent (Herfst et al. 2012; Imai et al. 2012). Whilst controversy raged over whether the scientists should have been permitted to conduct and then publish their research (Herfst, Osterhaus, and Fouchier 2012), the arguably more important discovery that an influenza pandemic capable of killing more than 2.5 percent of those infected worldwide could emerge naturally—and the existential threat that virus represents—has yet to sufficiently permeate international preparedness and planning. The catastrophic nature of such a development defies all contemporary planning scenarios, including those of the WHO and of countries with the most advanced healthcare systems (e.g., WHO 2017b). Although this research arguably warrants further attention and consideration by policymakers, historically other issues have dominated the influenza policy sphere.

(p. 541) As previously noted, the centrality of biomedical knowledge, techniques, processes, and interventions to the control of influenza was evident from the inception of the WHO’s influenza programme in 1947. Biomedical evidence derived from clinical trials, for instance, was used in 1952 to explain why vaccination was not—at that time—recommended as an effective clinical intervention. By 1958, however, the clinical evidence derived from multiple vaccination trials conducted throughout the 1957 Asian flu pandemic permitted the WHO to definitively declare influenza vaccination as effective in reducing human morbidity and mortality. Since that time subsequent data generated through biomedical techniques have ensured vaccination has remained the ‘cornerstone’ of pandemic influenza preparedness. In this regard, the utilisation of scientifically generated clinical data driving medical knowledge and informing health-related policy is not especially new (Pope 2003), but following the introduction and codification of evidence-based medicine (EBM) practises in the mid-1990s, demand for ‘evidence’ to inform pandemic influenza policy has grown even stronger. Associated with this emphasis on technical scientific data has been the idea that such information is apolitical because it is objectively (‘scientifically’) acquired.

Originally developed in Canada in the early 1990s, EBM has been progressively, extensively integrated into contemporary medical practise worldwide, instructing and informing the discipline of biomedicine along a series of core principles. These principles—that decisions are based on the best available evidence, that the problem determines the nature and source of evidence to be obtained, that epidemiological and biostatistical ways of thinking provide the best evidence, that conclusions are only useful if they assist in managing patients or healthcare decisions, and that performance should be constantly evaluated—assist adherents of EBM to categorise and stratify all modes of scientific inquiry and knowledge into distinct ‘levels of evidence’ (Davidoff et al. 1995). Within this system, systematic literature reviews drawing on randomised controlled trials (RCTs) that assess the efficacy of therapeutic (e.g., drug-based and surgical) interventions are classified as the ‘gold standard’ of evidence, followed closely by meta-analyses (systematic literature reviews that use quantitative methods to summarise the results of trials). The lowest category of evidence is expert opinion (Sackett and Rosenberg 1995).

Within pandemic influenza preparedness and planning, EBM and evidence-based policy have now assumed preeminent status, with policymakers consistently framing their justifications for specific policy decisions on the ‘evidence’. One of the most prominent examples of EBM techniques informing and validating specific policy responses relates to the importance now attached to accessing influenza vaccines and antivirals. In 2009, for example, within a matter of days following the announcement of the H1N1 epidemic in Mexico, attention had shifted to the capacity of pharmaceutical companies to manufacture vaccines and the shortfall that would ensue due to global demand (Cohen and Enserink 2009). Soon thereafter pressure began to mount on those same companies to convert from producing seasonal influenza vaccines to a pandemic-specific version, even though it was accepted that this might result in unintended deaths due to shortages in seasonal vaccine availability (Collin et al. 2009). The importance of (p. 542) these pharmaceutical interventions, which had been validated through EBM-related techniques, was further manifested when it was revealed that of the estimated US$1.48 billion needed to support the ninety-five least-resourced countries to respond adequately to the H1N1 pandemic, some US$1.14 billion (77 percent) was allocated to purchasing ‘H1N1 vaccines and other medicines’ (UNSIC and World Bank 2010, 30).

As a method that advances apolitical ‘objective’ data, EBM has become so compelling that other fields have sought to either co-opt its techniques or emphasise their own capabilities in generating equivalent statistical data, to gain comparable political influence in shaping policy decisions. For example, even at the launch of the World Influenza Centre in 1947, it was recognised that influenza pandemics could have a devastating impact on not only national economies but also international trade. In this regard, the economic consequences of a widespread influenza pandemic have long been recognised. Especially since the late 1990s, however, a series of econometric studies examining the potential impacts on national productivity, social cohesiveness, and economic functioning have increasingly been used to evaluate mitigation strategies (such as vaccination programmes), justify policy decisions, and further emphasise the need for pandemic planning (Meltzer et al. 1999; Gust et al. 2001). As time passed, various government bodies increasingly combined EBM and economic analyses—such as ‘cost-benefit analysis’ techniques—in determining their planning and policy priorities for influenza (Nichol 2001; Belsey 2009). Similar arguments have been used to justify the creation of the World Bank’s new Pandemic Emergency Financing Facility, which aims to help countries become ‘better prepared for and able to respond to pandemics as well as [the international community’s] ability to handle the next pandemic on a global level,’ largely through offsetting the economic losses that would otherwise ensue (World Bank 2017). This trend has continued to such an extent that especially when it comes to pandemic influenza preparedness policy, EBM and econometrics are often now inseparably entwined.

Indeed, it has now become commonplace to fuse cost-benefit analyses with evidence-based medical interventions to rationalise pandemic-related policies. Studies are now habitually produced that use mathematical modeling and statistical inference to scrutinise pandemic influenza prevention and containment strategies and also draw on evidence-based data of specific medical interventions (e.g., vaccination, stockpiling antiviral medications) to justify or invalidate particular policy decisions (Ferguson et al. 2006). Whilst attention has often focused on pharmaceutical-based interventions that can be more readily quantified through EBM techniques such as RCTs (Balicer et al. 2005), these same strategies have been expanded recently in an attempt to quantify nonpharmaceutical or social-distancing measures such as school closures, measures that historically have been characterised by a ‘lack of evidence’ (Cauchemez et al. 2009, 473). The extension of these methods thus represents a new phase in evidence-based decision-making whereby a combination of ideas is used strategically to determine policy directions.

A third and closely aligned concept that has become increasingly observable in pandemic influenza preparedness policy has been ‘security’. As previously noted, for a time (p. 543) after the 1918 Spanish flu pandemic influenza was openly described and considered a ‘war disease,’ to the extent that during World War II the US military created a dedicated influenza unit. With the commencement of the Cold War, more traditional security issues overshadowed the security implications of a widespread pandemic; however, by the mid-1990s and the emergence of the ‘human security’ agenda, threats to human health arising from emerging and re-emerging infectious diseases once again gained prominence. The ‘securitisation’ of pandemic influenza commenced in earnest following the 1997 H5N1 outbreak in Hong Kong, eventually culminating in the WHO officially declaring pandemic influenza to be ‘the most feared security threat’ just ten years later (Kamradt-Scott and McInnes 2012). Security-themed arguments have since been deployed extensively to highlight the menace posed by pandemic influenza, ranging from those that emphasise the threat to individual health and well-being, to the adverse impacts on national economies and social functioning, to the wider international state system as a whole (Garrett 2005; Enemark 2009; Elbe 2011). Amongst the security-based claims can be found statistically derived data pertaining to the potential numbers of lives lost in the form of pandemic fatality predictions, as well as various disaster scenarios of damage inflicted on the global economy. These trends have encouraged the development of a policy narrative that emphasises the all-encompassing catastrophic nature of an influenza pandemic which, ‘when’ it eventuates will not only result in large numbers of physical deaths but also cause severe economic, social, and conceivably political calamity. In sum, especially since the start of the twenty-first century there has been a functional conflation of EBM, economic, and security-constructed agendas influencing and directly informing global pandemic influenza preparedness policy.

In fact, whereas pandemic influenza policy remained largely within the purview of the WHO throughout the second half of the twentieth century, since the start of the new millennium a diverse range of actors have entered the policy sphere. The entrance of these actors (many unconventional as health actors) has necessitated a political shift, or evolution, in the governance of pandemic influenza, moving it further away from being perceived as simply a biomedical issue. In so doing, these actors have added further legitimacy to the three dominant themes shaping pandemic influenza policy, either through emphasising one particular idea or by blending the ideas within their own policy guidance. For instance, whereas institutions such as the IMF have produced a number of policy documents that focus explicitly on the economic impacts arising from an influenza pandemic (IMF 2006), other entities such as the World Bank and the International Working Group on Financing Preparedness (IWGFP) have sought to seamlessly meld EBM-derived data regarding the threat to human health and well-being with economic and security concerns to argue for increased investment in pandemic preparedness (UNSIC and World Bank 2010; IWGFP 2017). As a result, economic, EBM, and security ideas are now firmly entrenched within pandemic influenza policy development.

Intriguingly, whereas a number of other health policy fields have been actively shaped by the concept of human rights (Shiffman 2009; McInnes and Lee 2012), pandemic influenza policy has remained substantively devoid of such arguments. The most closely affiliated conceptualisation of ‘rights’ entering pandemic influenza policy discourse (p. 544) arose in 2007, following Indonesia’s announcement that it would cease sharing influenza virus samples with the WHO’s GISN. Indonesia’s health minister argued for a reform of the existing virus-sharing system, in part, on the principle of ‘equity’—that all countries deserved access to life-saving influenza vaccines (Supari 2008, 83). Importantly, however, neither Indonesia nor the countries that diplomatically supported Indonesia’s position throughout the OEWG meetings sought to extend the rights-based argument beyond this particular context. As a consequence, the PIPF has remained assiduously narrowly focused, pertaining only to the sharing of influenza viruses with pandemic potential, and whilst improved access to medicines remains a contentious issue within the broader global health movement, notions of ‘human rights’ have failed to resonate within contemporary pandemic influenza governance arrangements.

More broadly, the politics surrounding pandemic influenza has contributed to some significant transformations in global health. The ‘threat’ this particular disease poses has become so accentuated that it has obliged governments to place a very strong emphasis on developing and maintaining robust disease surveillance capacities and regularly report the technical data derived from those activities to the WHO. In so doing, however, it has furthered a disjuncture between global health objectives and national sovereignty.

More specifically, since the late 1990s HICs have been at the forefront of encouraging the international community (and particularly LICs) to become better prepared for the next influenza pandemic. Yet whilst HICs have ostensibly sought to emphasise the ‘utilitarian benefits of cooperation’ in strengthening disease surveillance capacities (Katz and Fischer 2010, 8), their actions have been widely interpreted as self-motivated, even ‘knowingly blind to the issue of inequalities within or between countries’—that is, more about protecting ‘the West from the rest’ (Quinn and Kumar 2014, 270; Rushton 2011). Concurrent with this development, the emphasis placed on the global, collective nature of the ‘threat’ has in turn encouraged countries to place considerable importance on securing access to pharmaceutical stockpiles to protect their populations, thereby not only generating a further dichotomy between the ‘haves’ and ‘have-nots’ but also starkly juxtaposing global, shared vulnerability with national interests, security, and sovereignty.

Conclusion

It is a common refrain amongst public health professionals and policymakers that another influenza pandemic ‘is not a matter of if, but when’. Even with tremendous medical advances, the creation of a dedicated international surveillance network, and quadrupling global vaccine manufacturing capacity since the start of the new millennium, the menace of another influenza pandemic wreaking widespread human suffering and severe economic disruption remains. This is principally because the influenza virus is prone to mutation, and the ease with which the virus moves amongst a number of species makes it a poor candidate for global eradication. Since the late 1950s the best defence (p. 545) continues to be vaccines, but ensuring they are effective against the specific pandemic strain takes time, often months, meaning that lives may be lost in the interim. Added to this, although global vaccine manufacturing capacity has been substantially improved since 2006 due to increased investment and technology transfers to LMICs, it nevertheless remains constrained. Measures have been taken to improve equitable access to vaccines via initiatives such as the 2011 PIPF and GAP, but these too are limited in scope.

As this chapter has sought to highlight, the governance arrangements surrounding influenza have a long pedigree within international relations. Established at the end of World War II, the global influenza surveillance network progressively expanded its international reach, gathering biomedical knowledge and evidence on measures that might assist in preventing a repeat of the devastating 1918 Spanish flu pandemic. Over time the network continued to grow, influenced and shaped by the emergence of the EBM movement and recognition that pandemics could cause widespread social and economic disruption, eventually prompting their identification as a threat to the state system as much as to individual health and well-being. In 2007 the network suffered a crisis of confidence following Indonesia’s decision to cease sharing H5N1 avian influenza virus samples, citing several breaches of trust. Four years and a series of high-level diplomatic negotiations later, a new public-private partnership and framework for cooperation emerged. Although only time and another influenza pandemic will tell, the international community can only hope that the revised pandemic influenza system is up to the challenge.

In the interim, however, the field of pandemic influenza public policy will remain one of competing ideas, priorities, and political agendas. As this chapter has highlighted, biomedical knowledge, later encapsulated and promoted as apolitical, technical ‘evidence’; economic considerations; and security arguments have powerfully shaped the structures and actors involved in addressing the risk of another influenza pandemic. These agendas and competing worldviews have evolved and been forced to adapt over decades, punctuated by periods of both hypervigilance and profound apathy. Moreover, the proposed solutions for dealing with the hazard—namely pharmaceutical interventions—acutely highlight global disparities between wealthy HICs and their less economically robust counterparts. In short, the politics of pandemic influenza serves as a microcosm of global health politics more broadly, with, unsurprisingly, all the commensurate challenges that represents.

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