TY - JOUR AU1 - Gostin, Lawrence O. AB - Abstract The international community vastly underestimates the risk and scale of our shared vulnerability to fast moving pathogens. Ranging from SARS and novel influenzas to Ebola and Zika, the world seems to be caught off guard, despite the regularity of global health threats historically. More importantly, when governments and international institutions underestimate the threat, they also underinvest in preparedness. Failure to prepare has deep costs in human lives and economic productivity. Here, I offer a pathway to preparedness for, and rapid response to, infectious disease threats: robust and resilient national health systems; strong institutions capable of leading, particularly the World Health Organization; and investments in research and development. Overall, the world needs a strong system of laws and governance, ranging from the International Health Regulations through to norms of transparency and accountability. To secure our common future, the world needs sustained investment and leadership. I propose a ‘security dividend’, both financial and institutional, to remake the global health security system. Global Health Crisis, Global Health Governance, Global Health Security, International Health Regulations, Security Dividend, World Health Organization I. INTRODUCTION The global community vastly underestimates the risk and scale of our shared vulnerability to fast moving pathogens. We seem to be taken off-guard with each global health crisis, ranging from Severe Acute Respiratory Syndrome (SARS) and its phylogenetic cousin Middle East Respiratory Syndrome (MERS) to pandemic influenza A (H1N1) and Ebola virus disease. Currently circulating threats include Zika virus and its associated neurologic harms to newborns,1 yellow fever in the face of vaccine scarcity,2 and novel influenzas (H7N9 and H5N6).3 The human and economic toll of explosive pandemics is a predictable consequence of underinvestment in preparedness. While we cannot predict which pathogen will cause the next pandemic, we know with a high degree of confidence that pestilences will continually challenge humankind.4 With an ever-growing population and, consequently, greater food production and animal/human interchange, zoonotic leaps to human populations is rising. Urbanization congregates people densely together, while globalization propels travel and mass migration, as microbes span the globe at greater speed. Climate change is altering the geographic reaches of disease vectors, with mosquito-borne illnesses (eg dengue, malaria, yellow fever, and Zika) moving to more northern latitudes. Pathogens genetically evolve and adapt to new ecological niches. Microorganisms (bacteria, fungi, viruses, and parasites) are growing resistant to antimicrobial drugs, making previously treatable diseases more lethal, including hospital-acquired infections (eg Methicillin-resistant Staphylococcus aurous), malaria, tuberculosis, and HIV/AIDS.5 The West African Ebola epidemic revealed deficiencies at every level of global defence: local health systems were overwhelmed; diagnostics, therapeutics, vaccines, and protective equipment were lacking; and the World Health Organization (WHO) response was slow and ineffective.6 The WHO acted more forcefully with Zika, but it has been unable to marshal the global funding needed for mosquito abatement, while the infection devastates pregnant women, taking a disproportionate toll on the poor. Despite the ongoing threat posed by Zika infection in the Americas and the risk of its spread to other regions, the WHO discontinued the declared public health emergency of international concern on 18 November 2016. With these threats posing formidable social, economic, and political challenges to both individual and society in risk,7 our world urgently needs a strong system of laws and governance, a sustained investment, and leadership to address the global health security crises.8 II. THE BUSINESS CASE FOR INVESTING FOR PREPAREDNESS The Commission on a Global Health Risk Framework (CGHRF)—one of four global commissions in the aftermath of the Ebola epidemic (Table 1)—estimated annualized expected losses from pandemics at $60 billion per year, amounting to $6 trillion in the 21st century.9 The CGHRF model, however, is highly conservative, including only direct economic costs. The National Bureau of Economic Research conducted a more inclusive examination of annual expected losses, concluding it could reach USD$490 billion, a major blow to economic growth and stability.10 Earlier, the World Bank modelled the economic impact of a single catastrophic pandemic, predicting a 5% loss in global gross domestic product (GDP), or approximately $3 trillion.11 TABLE 1 Four global commissions to advance global governance—WHO emergency operations and response   CGHRF  Harvard/LSHTM  UN panel  WHO interim assessment  Independent centre for preparedness & response  WHO should create a Centre for Health Emergency Preparedness & Response (CHEPR), governed by an independent Technical Governing Board, to coordinate global outbreak preparedness and response. (Rec. C.1)  WHO should create a unified Centre for Emergency Preparedness & Response with clear responsibility, adequate capacity, and strong lines of accountability. (Rec. 3)  WHO’s Program for Outbreaks & Emergency Management should be converted into a Centre for Emergency Preparedness & Response (CEPR) with unified command and control authority. (Rec. 7)  WHO should establish a Centre for Emergency Preparedness & Response that integrates its outbreak control and humanitarian functions. (Rec. 11) An independent board should oversee the Centre and provide an annual global health security report to the WHA and UN GA. (Rec. 12)  Create contingency fund for rapid response  By the end of 2016, WHO should create a sustainable contingency fund of US$100 million to support rapid deployment of emergency response capabilities. (Rec. C.3)  No recommendation.  WHO should establish a contingency fund for emergency response, managed by the CEPR. Member States should provide at least US$300 million in financing. (Rec. 20)  Member States and partners should contribute to a contingency fund in support of outbreak response, with a minimum target capitalization of US$100 million. (Rec. 8)  Communications & outbreak monitoring  WHO should generate a high-priority ‘watch list’ of outbreaks, released daily to national focal points and weekly to the public. (Rec. C.7)  Responsibility for declaring a PHEIC should be delegated to a transparent and politically protected WHO standing committee. (Rec. 4)  WHO must re-establish itself as the authoritative body for health emergencies, capable of rapidly and accurately informing governments and the public about the severity and extent of an outbreak. (Rec. 14)  The IHR Review Committee should consider the creation of an intermediate level of emergency to alert the international community at an earlier stage of a health crisis before it becomes a global threat. (Rec. 5)    CGHRF  Harvard/LSHTM  UN panel  WHO interim assessment  Independent centre for preparedness & response  WHO should create a Centre for Health Emergency Preparedness & Response (CHEPR), governed by an independent Technical Governing Board, to coordinate global outbreak preparedness and response. (Rec. C.1)  WHO should create a unified Centre for Emergency Preparedness & Response with clear responsibility, adequate capacity, and strong lines of accountability. (Rec. 3)  WHO’s Program for Outbreaks & Emergency Management should be converted into a Centre for Emergency Preparedness & Response (CEPR) with unified command and control authority. (Rec. 7)  WHO should establish a Centre for Emergency Preparedness & Response that integrates its outbreak control and humanitarian functions. (Rec. 11) An independent board should oversee the Centre and provide an annual global health security report to the WHA and UN GA. (Rec. 12)  Create contingency fund for rapid response  By the end of 2016, WHO should create a sustainable contingency fund of US$100 million to support rapid deployment of emergency response capabilities. (Rec. C.3)  No recommendation.  WHO should establish a contingency fund for emergency response, managed by the CEPR. Member States should provide at least US$300 million in financing. (Rec. 20)  Member States and partners should contribute to a contingency fund in support of outbreak response, with a minimum target capitalization of US$100 million. (Rec. 8)  Communications & outbreak monitoring  WHO should generate a high-priority ‘watch list’ of outbreaks, released daily to national focal points and weekly to the public. (Rec. C.7)  Responsibility for declaring a PHEIC should be delegated to a transparent and politically protected WHO standing committee. (Rec. 4)  WHO must re-establish itself as the authoritative body for health emergencies, capable of rapidly and accurately informing governments and the public about the severity and extent of an outbreak. (Rec. 14)  The IHR Review Committee should consider the creation of an intermediate level of emergency to alert the international community at an earlier stage of a health crisis before it becomes a global threat. (Rec. 5)  * LO Gostin and others, ‘Toward a Common Secure Future: Four Global Commissions in the Wake of Ebola’ (2016) 13 PLoS Medicine 1, 6, tbl 5. TABLE 1 Four global commissions to advance global governance—WHO emergency operations and response   CGHRF  Harvard/LSHTM  UN panel  WHO interim assessment  Independent centre for preparedness & response  WHO should create a Centre for Health Emergency Preparedness & Response (CHEPR), governed by an independent Technical Governing Board, to coordinate global outbreak preparedness and response. (Rec. C.1)  WHO should create a unified Centre for Emergency Preparedness & Response with clear responsibility, adequate capacity, and strong lines of accountability. (Rec. 3)  WHO’s Program for Outbreaks & Emergency Management should be converted into a Centre for Emergency Preparedness & Response (CEPR) with unified command and control authority. (Rec. 7)  WHO should establish a Centre for Emergency Preparedness & Response that integrates its outbreak control and humanitarian functions. (Rec. 11) An independent board should oversee the Centre and provide an annual global health security report to the WHA and UN GA. (Rec. 12)  Create contingency fund for rapid response  By the end of 2016, WHO should create a sustainable contingency fund of US$100 million to support rapid deployment of emergency response capabilities. (Rec. C.3)  No recommendation.  WHO should establish a contingency fund for emergency response, managed by the CEPR. Member States should provide at least US$300 million in financing. (Rec. 20)  Member States and partners should contribute to a contingency fund in support of outbreak response, with a minimum target capitalization of US$100 million. (Rec. 8)  Communications & outbreak monitoring  WHO should generate a high-priority ‘watch list’ of outbreaks, released daily to national focal points and weekly to the public. (Rec. C.7)  Responsibility for declaring a PHEIC should be delegated to a transparent and politically protected WHO standing committee. (Rec. 4)  WHO must re-establish itself as the authoritative body for health emergencies, capable of rapidly and accurately informing governments and the public about the severity and extent of an outbreak. (Rec. 14)  The IHR Review Committee should consider the creation of an intermediate level of emergency to alert the international community at an earlier stage of a health crisis before it becomes a global threat. (Rec. 5)    CGHRF  Harvard/LSHTM  UN panel  WHO interim assessment  Independent centre for preparedness & response  WHO should create a Centre for Health Emergency Preparedness & Response (CHEPR), governed by an independent Technical Governing Board, to coordinate global outbreak preparedness and response. (Rec. C.1)  WHO should create a unified Centre for Emergency Preparedness & Response with clear responsibility, adequate capacity, and strong lines of accountability. (Rec. 3)  WHO’s Program for Outbreaks & Emergency Management should be converted into a Centre for Emergency Preparedness & Response (CEPR) with unified command and control authority. (Rec. 7)  WHO should establish a Centre for Emergency Preparedness & Response that integrates its outbreak control and humanitarian functions. (Rec. 11) An independent board should oversee the Centre and provide an annual global health security report to the WHA and UN GA. (Rec. 12)  Create contingency fund for rapid response  By the end of 2016, WHO should create a sustainable contingency fund of US$100 million to support rapid deployment of emergency response capabilities. (Rec. C.3)  No recommendation.  WHO should establish a contingency fund for emergency response, managed by the CEPR. Member States should provide at least US$300 million in financing. (Rec. 20)  Member States and partners should contribute to a contingency fund in support of outbreak response, with a minimum target capitalization of US$100 million. (Rec. 8)  Communications & outbreak monitoring  WHO should generate a high-priority ‘watch list’ of outbreaks, released daily to national focal points and weekly to the public. (Rec. C.7)  Responsibility for declaring a PHEIC should be delegated to a transparent and politically protected WHO standing committee. (Rec. 4)  WHO must re-establish itself as the authoritative body for health emergencies, capable of rapidly and accurately informing governments and the public about the severity and extent of an outbreak. (Rec. 14)  The IHR Review Committee should consider the creation of an intermediate level of emergency to alert the international community at an earlier stage of a health crisis before it becomes a global threat. (Rec. 5)  * LO Gostin and others, ‘Toward a Common Secure Future: Four Global Commissions in the Wake of Ebola’ (2016) 13 PLoS Medicine 1, 6, tbl 5. Economic modelling, of course, is an inexact science, but historical experience points to devastating economic losses from epidemics—often from human irrationality rather than nature. Health crises trigger overreactions such as travel or trade restrictions and unnecessary quarantines. The 2002/03 SARS outbreak was not a great killer and lasted just eight months, but resulted in >USD$40 billion in economic losses, mostly in Canada and China.12 During the 2015 MERS-CoV outbreak, tourism in the Republic of Korea plummeted by 40–60%, requiring a government stimulus package of USD$19 billion.13 Three poor West African countries suffered USD$2.2 billion loses due to Ebola, with a 10% drop in GDP.14 Short-term economic impacts from Zika are estimated at USD$3.5 billion, but falsely assume a swift, effective response.15 What makes these economic models and historical precedent chilling is they are expected (not speculative) economic losses. Scientists cannot tell which epidemics will strike, but they can predict with assuredness that disastrous outbreaks will materialize, based on historical trends and currently circulating pathogens. Yet, despite the certainty and magnitude of the threat, the global community has significantly underestimated and underinvested in pandemic threats. CGHRF recommended an annual incremental investment of $4.5 billion—65 cents per person—to strengthen global preparedness, what I will call a ‘security dividend’. This modest investment, and probably more, would be needed to make the world far safer and more prosperous going forward. Although economists project staggering economic losses, multilateral organizations rarely incorporate disease vulnerability into official assessments of economic growth and stability—including the World Bank itself, the International Monetary Fund (IMF), and the Organization of Economic Cooperation and Development (OECD). Similarly, private sector analysts, such as ratings agencies and investment banks, fail to calculate economic losses from epidemics. The failure of macroeconomic forecasting to take account of infectious diseases helps explain why governments significantly underestimate the risks and underinvest in preparedness and response. The IMF, for example, could incorporate epidemic preparedness into its macroeconomic stability evaluations. Because governments rely on IMF assessments for access to credit, political leaders would have a marked incentive to invest. Likewise, the World Bank’s Pandemic Emergency Facility and regional development banks could provide funding contingent upon states building robust systems for emergency preparedness.16 Recently, economists offered hard-headed data inputs for capturing pandemic risks, with the aim of spurring greater investment.17 Transforming incentives for risk preparedness, therefore, is feasible as well as cost-effective. We cannot continue with the status quo, where governments and international institutions pay close attention to infectious disease threats only when they are at their peak and then return to complacency until the next major outbreak. To reinforce and sustain international focus, funding, and action, it is crucial that pandemics rise to the level of ‘high politics’, becoming standing agenda items for political actors in critical forums such as the G7, G20, and the United Nations Security Council. The WHO needs to become the global health leader envisaged in its constitution, but that it has rarely achieved. The ‘security dividend’ is more than justified by the data presented above. Yet, the investment in preparing for the next infectious disease outbreak pales in comparison to threats governments take far more seriously, such as terrorism, mass migration, or banking system failures. There continues to be a major disconnect between investments in preparedness and the actual humanitarian and economic harms that ensue from epidemics. Political leaders need to rethink their economic and political priorities, focusing on three fundamental reforms: national health systems, WHO and United Nations leadership, and research and development. Before briefly explaining why these reforms would vastly improve global health security, it is worth reflecting on the governing framework for epidemic preparedness. III. INTERNATIONAL HEALTH REGULATIONS: DOES THE RULE OF LAW MEAN ANYTHING? Does the rule of law mean anything in international affairs? In theory, states consent to rules under which they will be bound. Governments are supposed to comply with the norms created by international law, but in global health law, in particular, they incessantly flout the rules.18 Originating in 1892 as the International Sanitary Convention, the International Health Regulations (IHR) set the governing framework for global health security. The World Health Assembly fundamentally revised the IHR in 2005, now comprising 196 States Parties.19 The modernisation expanded the regulations’ scope beyond a few historic diseases (cholera, plague, and yellow fever) to cover the full range of global health threats irrespective of their origin or source. It empowers the WHO Director-General to convene an ‘emergency committee’ and declare a ‘public health emergency of international concern’ (PHEIC).20 States Parties are bound to meet standards, known as ‘minimum core capacity requirements’, to avert and respond to detect, assess, report, and respond to a potential PHEIC.21 Despite being minimum standards, however, state non-compliance is the norm. Most states missed the initial 2012 reporting requirement and WHO extended the deadline to 2016 for all 81 states that requested extensions. Only 64 states reported meeting core capacities, while 48 failed even to respond, representing a compliance rate of just over 30%.22 Even this low compliance level may be an overestimate because self-assessments are unreliable without independent validation. When the Director-General declares a PHEIC, she is required to issue temporary recommendations guiding States Parties on the health measures they should take.23 She is also empowered to make recommendations when the threat level does not rise to a PHEIC, as it did with MERS and yellow fever. Although technically non-binding, WHO recommendations are embedded within a treaty, with expectations that governments will abide by evidence-based norms. Yet they rarely do. WHO recommendations often target the most affected countries, specifying the public health actions needed—for example, surveillance, contact tracing, health advisories, and health care. Low-income countries may not have ample resources to comply with WHO recommendations, or simply lack the political will. For its part, WHO recommendations rarely come with funding to build capacities. And although the regulations call on States Parties to assist lower income countries with capacity building, such funding is sporadic at best. Recommendations may advise affected states not to employ coercive measures, but governments follow their political instincts in the midst of a health crisis. Among the most common measures are quarantines or cordon sanitaire (a guarded line preventing anyone from leaving an infected geographic area). Directly contravening WHO Ebola recommendations, Liberia deployed soldiers and police in riot gear, blocking roads and waterways in its capital city, Monrovia, a sprawling slum with tens of thousands of inhabitants. The government’s overreaction sparked anger, protest and violence. Not only did the government seed distrust in public health, but also exacerbated existing hazards such as food scarcity and reduced access to medicines and health care.24 The WHO also makes recommendations to States Parties beyond affected regions, calling on them to exercise restraint. Yet the history of PHEICs demonstrates that governments and the private sector flagrantly ignore WHO recommendations by implementing travel and trade restrictions. For example, despite no scientific evidence linking pork to Influenza H1N1, 20 countries banned meat from Mexico, Canada, and the USA. China and Russia, two of the world’s largest pork importers, ceased imports from affected countries. Egypt culled 40,000 pigs, which impacted the Coptic Christian minority almost exclusively, widely thought to be a discriminatory measure.25 During Ebola, >30 countries erected travel barriers contrary to WHO guidance—closing borders, restricting travel, limiting visas, and screening passengers.26 (Earlier, during SARS, China implemented mass fever screening at airports, finding virtually no true positive cases). State-run and private airlines halted flights to and from affected countries. In the USA, several states, including New York and New Jersey, imposed 21-day quarantines on health care workers returning from treating Ebola patients,27 exacerbating deep-seated impediments to humanitarian assistance. Congresspersons called for a total travel ban, while the US Centers for Disease Control and Prevention (CDC) implemented health questionnaires and fever screening at major airports. While States Parties widely ignored WHO recommendations, the Director-General did not publicly identify or reprimand a single government for defying IHR norms. The Organization neither offered governments incentives to comply nor imposed consequences for failing to do so. In short, the IHR was a governing framework in name only. At the same time, the USA led an initiative largely circumventing the WHO. A. Global Health Security Agenda The Global Health Security Agenda (GHSA), launched in February 2014 with USD$1.1 billion, has more than 50 partners (Fig 1), with a mission strikingly similar to the IHR: to build countries’ capacity to create a world safe and secure from infectious diseases and elevating global health security as a national and global priority.28 While the IHR relies on subjective self-assessments, the GHSA has a rigorous external evaluation tool to validate core health system capacities.29 Figure 1 View largeDownload slide Countries participating in GHSA Figure 1 View largeDownload slide Countries participating in GHSA The GHSA could offer a model for strengthening health systems, containing ‘Action Packages’ requiring planning and indicators, evaluated through a peer assessment process. GHSA however stands outside the IHR framework, thus lacking the international legitimacy of a WHO-led process. However, as explained in the next section, the WHO adopted many of the GHSA’s evaluative criteria and independent assessment methods to improve IHR core capacities. Understanding that national health systems are the foundation for global health security, in the next section, I consider how to build those systems to rapidly detect and respond to novel infections before they become health hazards for the region and the world. I underscore the links between the IHR and GHSA, as well as the United Nations Sustainable Development target of universal health coverage by 2020. IV. NATIONAL HEALTH SYSTEMS: THE FOUNDATION OF SECURITY Fast-spreading novel infections are diverse, demanding resilient health systems. With globalization drawing us closer in time and space, what happens in one corner of the globe can affect what happens in another, often rapidly. Building a resilient health system, therefore, benefits not only the country, but also the region and globally. Robust and sustainable health systems are an indispensable prerequisite for global health security. Using a range of available tools, including those outlined in this section, is critical to health system strengthening. A. WHO’s International Health Regulations The WHO Constitution places the right to health at the centre of it is mission, ‘the health of all people is fundamental to the attainment of peace and security and is dependent upon the fullest co-operation of individuals and States’.30 WHO’s IHR provide an important vehicle to achieving global health security and supporting health system strengthening. The IHR’s core capacities include a health workforce, laboratories, data systems, and risk communication to identify and contain threats before they cross national borders. As discussed above, WHO has traditionally measured health capacities by allowing states to conduct annual self-assessments, which all four major Global Commissions on Ebola criticized.31 However, WHO took an important step in February 2016, borrowing from the GHSA. The Organization established the Joint External Evaluation (JEE) Tool, to be conducted every 5 years, to better evaluate IHR capacities. The World Health Assembly recommended transitioning ‘from exclusive self-evaluation to approaches that combine self-evaluation, peer review and voluntary external evaluations involving a combination of domestic and independent experts’.32 The JEE incorporates GHSA criteria, while adding those specifically required under the IHR. Countries can request a JEE mission to identify priority health system and support national preparedness.33 Each country’s results will be made public, with a color-coding scheme to delineate implementation levels for each capacity. Until governments achieve a high degree of compliance, however, WHO should plan more frequent external assessments, rather than waiting a half-a-decade. Community participation should also be a critical component of assessments. It is worth noting that a major weakness of WHO’s new mechanism is that it is voluntary, reflecting state sovereignty concerns, which can undermine support for IHR implementation. Moreover, considering that political leaders are more likely to cooperate if they view external evaluations as a pathway to funding and technical support, WHO should not simply give countries a pass/fail grade, but rather constructively partner with governments. Ensuring compliance, therefore, requires creative incentives, technical and financial support, and transparency. When it comes to mobilizing financial support, additional measures may be needed to ensure higher-income countries achieve and maintain IHR core capacities. Core capacity financing requires the international community to close an investment gap of $3.4 billion per year.34 As discussed above, the IMF’s macroeconomic stability evaluations should incorporate pandemic preparedness and support IHR implementation. Similarly, the World Bank’s Pandemic Emergency Facility—along with regional development banks—could condition disbursements based on governments’ IHR compliance. What is more, WHO and the World Bank should develop a financial plan, with targets for national and international contributions. Additional financing mechanisms could be modelled on the Global Fund for AIDS, Tuberculosis and Malaria, with the World Bank and WHO hosting periodic donor investment and replenishment conferences. Achieving resilient health systems is a shared national/global responsibility. By 2017, every government should develop and publish concrete plans to achieve IHR core capacities by 2020. B. Sustainable Development Target: Universal Health Coverage by 2020 High-quality Universal Health Coverage (UHC) is needed for managing outbreaks as well as meeting a broad range of health needs. As outbreaks stretch existing resources, resilient systems are designed to ensure surge capacity in health emergencies. The United Nations Sustainable Development Goals (SDGs) include a goal to ensure healthy lives and promote well-being for all at all ages (Goal 3). Importantly, the goal contains explicit targets for controlling infectious diseases and for Universal Health Coverage (UHC) by 2030. Throughout, the SDGs stress equity, which is vital to building strong health systems because outbreaks often emerge in marginalized communities and then rapidly spread.35 Recent public health crises have demonstrated that national health systems are crucial in ensuring health security at the national and global level. Losing sight of this critical link exacerbates the threat. Using all available tools to achieve pandemic preparedness also requires reaching the SDG targets. In particular, by the end of 2030, all states should achieve the SDG target of universal health coverage. V. WHO AS THE GLOBAL HEALTH LEADER: ‘THE PIVOT’ TO THE UNITED NATIONS While national health systems are foundational to health security, so too is a global health system with a strong highly-functioning institutional leader.36 Infectious diseases transcend borders, rapidly spreading to neighbouring countries and regions. WHO’s Constitution unmistakably establishes the agency as the premier global health leader, acting as ‘the directing and coordinating authority on international health work’ (Article 2). Its democratic mandate includes 194 Member States, among the largest of any intergovernmental organization. WHO ought to have the funding and political clout to manage logistics, deploy medical personnel and equipment, and mobilize assistance for outbreak response and humanitarian needs. Yet, WHO’s budget is only one-quarter the size of the US CDC, about the equivalent of a major hospital in a high-income country.37 There is a cavernous mismatch between what the world expects of WHO and its funding levels. More concerning, is that Members’ assessed contributions have remained frozen for 15 years. More than 80% of its budget is funded through discretionary contributions, usually earmarked to reflect the donor priorities, not WHO’s;38 WHO has clearly lost control of its own agenda. The emergence of global foundations and public/private partnerships—the Bill & Melinda Gates Foundation, GAVI Alliance, and the Global Fund to Fight HIV/AIDS, TB and Malaria—coupled with WHO’s deficient performance, have led the international community to question the Organization’s ability to lead.39 The Ebola epidemic in particular unmasked major deficiencies as the Director-General delayed for four months before declaring a PHEIC. Although the Regional Office of Africa (AFRO) issued urgent messages to headquarters about the epidemic’s gravity, many calls for action ‘either did not reach senior leaders or senior leaders did not recognize their significance’.40 Medicines Sans Frontières noted that ‘[t]here was little sharing of information’ and failure ‘to oversee technical and operational support’.41 David Nabarro, who led the UN Mission for Ebola Emergency Response (UNMEER), chaired a WHO Advisory Group following Ebola and concluded that WHO clearly lacked the technical operational capabilities to fulfil its mandate.42 Accepting the top-level recommendations of the four Global Commissions, the Nabarro report proposed, and the Organization accepted, establishing a Programme for Outbreaks and Emergencies. The World Health Assembly approved a USD$494 million budget for 2016/17, along with a $100 million emergency contingency fund.43 Both funding targets are wholly incommensurate with its worldwide mandate. But even these low targets are under-funded: WHO has secured only about one-quarter of resources needed for the new emergency programme’s start-up costs,44 and an abysmal USD$1.12 million for the USD$100 million contingency fund.45 In addition to funding deficits, WHO has struggled to coordinate with other UN agencies, regional networks, and non-state actors, leaving politically powerful countries to take the lead in ramping up and coordinating international action. For example, during Ebola, the USA allocated over $1 billion to the global effort, while spearheading a historic Security Council resolution calling the epidemic a threat to international peace and security.46 A. ‘The Pivot’ to the United Nations Political clout is critical in mobilizing resources and accelerating international action, which WHO has lacked. For this reason, in times when an infectious disease intensifies reaching the level of a humanitarian disaster, the locus of responsibility should pivot from WHO to the United Nations. The major UN organs (Secretary-General, Security Council, and General Assembly), as well as the UN Health Cluster, have the political leverage and authority to stiffen political resolve and coordinate diverse actors.47 The UN Emergency Relief Coordinator should be charged with making the determination on shifting the leadership responsibility to the UN system. The UN criteria for the highest emergency level (Level 3 emergency) (Fig. 2) should be applied, including the scale of the epidemic, the degree of economic impact, and the threat for political destabilization.48 Considering the complexity of public health humanitarian crises, the UN Inter-Agency Standing Committee would be responsible for devising the procedures for UN inter-agency coordination of humanitarian assistance. Figure 2 View largeDownload slide Five criteria for determining Level 3 emergencies Figure 2 View largeDownload slide Five criteria for determining Level 3 emergencies Beyond the ‘pivot’, the United Nations should have a permanent mandate on global health security. The UN Secretary General’s High Level Panel on the Global Response to Health Crises proposed a standing committee within the General Assembly,49 while the Independent Panel on the Global Response to Ebola proposed a similar committee at the Security Council.50 Given the diverse tools at the UN System’s disposal, a UN-level response can bring the legitimacy and political resolve that WHO has not been able to garner. As Richard Holbrooke, US UN Ambassador, once stated: ‘if a country loses so many of its resources in fighting a disease which takes down a third of its population, it’s going to be destabilized, so it is a security issue’.51 Consequently, when a public health crisis threatens the international community, United Nations’ leadership should become prominent. To do so otherwise could have catastrophic effects. If such a ‘pivot’ to the UN system takes place, it will be important not to undermine the global health authority granted to WHO in 1948. Chronic scarcity of funding and weak responses to outbreaks, however, provide justification for higher level political support by the UN in an emergency that could spin out of control. It is crucial, therefore, that in bringing the UN into the mix of global health security, WHO and other UN agencies work in harmony and with a common purpose.52 VI. RESEARCH AND DEVELOPMENT: BIOLOGICAL COUNTERMEASURES Recent outbreaks such as Ebola and Zika unveiled major deficiencies in the availability of effective medical products. Preparedness and response to infectious disease outbreaks require rapid development and deployment of ‘effective and fit-for-purpose tools and technologies, such as vaccines, drugs, diagnostics, personal protective equipment (PPE), and medical devices’.53 The challenges underlying R&D deficiencies are often directly attributable to the low priority placed on ‘episodic infections’ by the private and public sectors. A coherent research and development (R&D) strategy is needed to counteract existing marked disincentives to innovation for episodic diseases. The CGHRF proposed an international coordinating entity; sustainable investments; convergence of diverse regulatory pathways; and access to intellectual property, data, and biological samples—ensuring rigorous scientific standards.54 Moreover, community participation is vital to the introduction of novel products. Multiple stakeholders—governments, academics, industry, and civil society—should identify and lead R&D priorities. Designing and implementing new R&D approaches require the participation of the private sector, including the pharmaceutical industry.55 Likewise, understanding the importance of protecting the interests of the most vulnerable is critical to averting epidemics and improving global health. Therefore, both the private sector and public health advocates and their communities need to be engaged from the start. WHO is well positioned to lead and coordinate these efforts. After all, the organization has a long history of carrying out multi-stakeholder initiatives, including those using public–private partnerships (PPPs). In 1993, the World Health Assembly stressed the importance of engaging all relevant sectors, including non-governmental organizations and the private sector, for implementing national strategies for health for all.56 This collaborative approach between private and public actors is needed in a globalized world with multiple stakeholders. R&D is one key example of how this transnational and cross-sectoral arrangement could be useful. PPPs could facilitate R&D incentives for the industry to improve therapeutic countermeasures, including vaccines, diagnostics, and treatment.57 PPPs could also assist developing countries in building R&D capacities for medical countermeasures, while fostering South-South cooperation. If PPPs are to operate successfully, however, it will be important to ensure good governance, including community engagement, transparency, and accountability. Governance is often identified as an obstacle to effective collaboration with the private, for-profit sector.58 Accordingly, WHO should establish a Pandemic Product Development Committee (PPDC), comprised of independent, high-level experts in discovery, development, regulatory approval, and medical product manufacturing. To streamline and expedite product research and delivery, the PPDC would set priorities for pathogens that pose an enhanced risk, mobilize resources, coordinate across sectors and actors, reduce redundancy, and minimize cost. Such an R&D preparedness strategy would require significantly greater investment, specifically, USD$1 billion new funding annually for at least 15 years. The PPDC would promote regulatory convergence; pre-approval of clinical trial designs; mechanisms to manage intellectual property, data sharing, and product liability; and expedite vaccine manufacture, stockpiling, and distribution. Well-funded and coordinated R&D is vital to prevent major outbreaks and mitigate their impacts on human health. Given the complexity of promoting R&D for averting pandemics and promoting health equity, WHO should establish the normative and operational framework to accelerate research and trial design, converge regulatory pathways, and promote equitable access.59 VII. THE SECURITY DIVIDEND The world has become increasingly interconnected, with considerable interdependence among countries. The modern challenge for global health security is to foster effective international cooperation. With globalization, countries are forced to integrate global health threats and strategies as integral to foreign policy.60 No country acting alone can mitigate health threats. Beyond international cooperation among states, it is also vital to work across sectors and disciplines. Health security does not take place in a vacuum but also requires cooperative arrangements with such national and international regimes as agriculture, energy, trade, and the environment. In addition to health professionals, Ebola taught us that an effective response requires anthropology, architects, engineers, and other disciplines. The need for a security dividend calls for exactly this approach. Ultimately, to secure our common future, the world needs sustained investment and leadership on a global scale. As recommended by the Global Health Risk Framework Commission, what this requires is a ‘security dividend’, both financial and institutional, to remake the global health security system. Financially, a modest investment of USD$4.5 billion (or 65 cents per person) per year could fill major funding gaps in financing R&D, strengthening national health systems, and the necessary global coordination to avert these public health threats, while fundamental reform of WHO would help fulfil its mandate. Closing the health security financing gap requires shared national and international responsibilities. Governments have a duty to their inhabitants to invest in health systems within their capacities. International donors and multilateral organizations should fill those capacity gaps. The World Bank, the Global Fund, and the International Monetary Fund can play a critical role in securing the USD$4.5 billion required.61 The Global Health Risk Commission lays out a concrete plan that involves focusing financing mobilization in the areas of national capacity building to respond to infectious disease outbreaks and increase resilience of national health systems; supporting global and regional coordination, preparedness, and response; and fostering research and development, including the delivery of resulting products (eg vaccines and therapeutics).62 Importantly, the strategy includes supporting emergency response funds, particularly WHO’s Contingency Fund for Emergencies (CFE) of USD$100 million and the World Bank’s Pandemic Emergency Financing Facility (PEF) of USD$1 billion to ‘provide financial resources for global health emergencies to allow for the rapid deployment of equipment, medications, and human resources’.63 If the international community fully recognizes the vast economic, social, and political costs of epidemics, it will become clear that sustainable financing and strong governance are vital to enhance prevention, detection, and response. A security dividend would yield enormous gains in human wellbeing, economic prosperity, and international cooperation. The author is Director of the World Health Organization Collaborating Centre on Public Health Law and Human Rights, and also serves on major WHO expert committees. He was a commissioner on the Harvard/London School of Hygiene and Tropical Medicine Independent Panel on the Global Response to Ebola and on the Commission on a Global Health Risk Framework for the Future. Footnotes 1 D Lucey and LO Gostin, ‘The Emerging Zika Pandemic: Enhancing Preparedness’ (2016) 315 JAMA 865. 2 D Lucey and LO Gostin, ‘A Yellow Fever Epidemic: A New Global Health Emergency?’ (2016) 315 JAMA 2661. 3 JS Malik Peiris and others, ‘Interventions to Reduce Zoonotic and Pandemic Risks from Avian Influenza in Asia’ (2016) 16 Lancet Infectious Diseases 252. 4 For pandemics in the past and contemporary history, see H Zinsser, Rats, lice and history (The Atlantic Monthly Press 1935). Also see WH McNeill, Plagues and peoples (Anchor 1976). 5 United Nations General Assembly ‘High-level Declaration on Antimicrobial Resistance’ (2016) accessed 27 September 2016. 6 LO Gostin and EA Friedman, ‘A Retrospective and Prospective Analysis of the West African Ebola Virus Disease Epidemic: Robust National Health Systems at the Foundation and an Empowered WHO at the Apex’ (2015) 385 Lancet 1902. 7 DL Heymann and others, ‘Global Health Security: The Wider Lessons from the West African Ebola Virus Disease Epidemic’ (2015) 385 Lancet 1884. 8 More discussion on global health security, see AT Price-Smith, The Health of Nations: Infectious Disease, Environmental Change, and their Effects on National Security and Development (MIT Press 2001). Also see C McInnes and K Lee, Global Health and International Relations (Polity 2012) and S Elbe, Security and Global Health (Polity 2010). 9 Commission on a Global Health Risk Framework for the Future, The Neglected Dimensions of Global Security: A Framework to Counter Infectious Disease Crises (National Academies Press 2016). 10 V Fan, L Summers and D Jamison, ‘The Inclusive Cost of Pandemic Influenza Risk’ (2016) National Bureau of Economic Research 14. 11 OB Jonas, ‘Pandemic Risk’ (2013) The World Bank Group, 2 accessed 27 September 2016. 12 World Health Organization ‘Summary Table of SARS Cases by Country’ (1 November 2002–7 August 2003). accessed 27 September 2016. 13 A Gale, ‘South Korea MERS Outbreak is Over, Government Says’ (27 July 2015) Wall Street Journal. accessed 27 September 2016. 14 The World Bank Group, ‘The Economic Impact of the 2014 Ebola Epidemic: Short and Medium Term Estimates for West Africa’, (27 October 2014) 2–3. 15 The World Bank Group, ‘The Short-term Economic Costs of Zika in Latin America and the Caribbean’ (2016) accessed 27 September 2016. 16 The World Bank Group ‘Pandemic Emergency Facility’ (2016). accessed 27 September 2016. 17 P Sands and others, ‘Assessment of Economic Vulnerability to Infectious Disease Crises’ (2016) Lancet. accessed 27 September 2016. 18 LO Gostin, Global Health Law (Harvard University Press 2014). Relevant discussion also see DP Fidler, International Law and Infectious Diseases (OUP 1999) and O Aginam, Global Health Governance: International Law and Public Health in a Divided World (University of Toronto Press 2005). A recent observation, see SE Davies and B Bennett, ‘A Gendered Human Rights Analysis of Ebola and Zika: Locating Gender in Global Health Emergencies’ (2016) 92(5) International Affairs 1041. 19 LO Gostin and R Katz, ‘The International Health Regulations: The Governing Framework for Global Health Security’ (2016) 94(2) Milbank Quarterly 264. For more discussion on the IHR (2005), see DP Fidler, ‘From International Sanitary Conventions to Global Health Security: The New International Health Regulations’ (2005) 4(2) Chinese JIL 325. 20 International Health Regulations [IHR] (2005), 23 May 2005, art 12. 21 See ibid annex 1. 22 WHO, WHO Implementation of the International Health Regulations (2005): Report of the Review Committee on Second Extensions for Establishing National Public Health Capacities on IHR Implementation: Report by the Director-General (27 March 2015), accessed 27 September 2016. 23 IHR (n 20) art 15. 24 N Onishi, ‘Clashes Erupt as Liberia Sets an Ebola Quarantine’ New York Times (20 August 2014). accessed 27 September 2016. 25 LO Gostin, ‘Influenza A(H1N1) and Pandemic Preparedness Under the Rule of International Law’ (2009) 301 JAMA 2376. 26 N Thompson and I Torre, ‘Ebola Virus: Countries with Travel Restrictions in Place’ (4 November 2014) accessed 27 September 2016. 27 JM Drazen and others, ‘Ebola and Quarantine’ (20 November 2014) 371 New England Journal of Medicine 2029. 28 Data Source: Country Roadmaps, Where the Global Health Security Agenda is Active, available at https://ghsagenda.org/where-shsa.html (Updated as of 11 August 2016). The Figure is created by the author with mapchart.net. 29 US Centers for Disease Control and Prevention ‘Global Health Security Agenda’. accessed 27 September 2016. 30 Constitution of the World Health Organization (22 July 1946), 14 UNTS 185, preamble. 31 LO Gostin and others, ‘Toward a Common Secure Future: Four Global Commissions in the Wake of Ebola’ (2016) 13 PLoS Medicine 1. 32 World Health Organization ‘The IHR Review Committee on Second Extensions for Establishing National Public Health Capacities and on IHR Implementation’ (WHA 68/22 Add.1). 33 Global Capacities Alert and Response (GCR), ‘IHR (2005) Monitoring and Evaluation Framework Joint External Evaluation Tool’ accessed 21 March 2017. 34 ibid. 35 United Nations, ‘Sustainable Development Knowledge Platforms’ (2015). accessed 27 September 2016. 36 LO Gostin and EA Friedman, ‘Reimagining WHO: Leadership and Action for a New Director-General’ (2017) The Lancet, Published Online 26 January 2017 accessed 21 March 2017. 37 LO Gostin, D Sridhar and D Hougendobler, ‘The Normative Authority of the World Health Organization’ (2015) 129(7) Public Health 854. 38 World Health Organization, ‘Assessed Contributions’ accessed 27 September 2016. 39 For more discussion on the WHO’s function and dysfunction, see M Freeman, S Hawkes and B Bennett (eds), Law and Global Health: Current Legal Issues, vol 16 (OUP 2014). 40 World Health Organization, ‘Report of the Ebola Interim Assessment Panel’ (July 2015) 21. 41 Medicine Sans Frontières [MSF], ‘Pushed to the Limit and Beyond: A Year into the Largest Ever Ebola Outbreak’ (2015) 8–9. 42 World Health Organization, ‘Advisory Group on Reform of WHO’s Work in Outbreaks and Emergencies Second Report’ (18 January 2016) 10. 43 World Health Organization, ‘World Health Assembly Agrees New Health Emergencies Programme’, (25 May 2016) accessed 27 September 2016. 44 World Health Organization, ‘Donor Centre’ accessed 27 September 2016. 45 World Health Organization, ‘Contingency Fund for Emergencies’ accessed 27 September 2016. 46 The White House Office of the Press Secretary ‘U.S. Response to the Ebola Epidemic in West Africa’ (16 September 2014). accessed 27 September 2016. 47 See Gostin and others (n 31) 9. 48 ibid. 49 High-level Panel on the Global Response to Health Crises, ‘Protecting Humanity from Future Health Crises Report of the High-level Panel on the Global Response to Health Crises’ (25 January 2016), Rec 26. 50 S Moon, D Sridhar and MA Pate, ‘Will Ebola Change the Game? Ten Essential Reforms before the Next Pandemic. The Report of the Harvard-LSHTM Independent Panel on the Global Response to Ebola’ (2015) 386 The Lancet 2284. 51 R Holbrooke, ‘The Age of AIDS: Interview with Richard Holbrooke’ Frontline (7 March 2005) accessed 27 September 2016. 52 Data Source: the UN Inter-Agency Standing Committee, Humanitarian System-Wide Emergency Activation: Definition and Procedure, available at https://interagencystandingcommittee.org/node/2564 The Figure is created by the author. 53 Commission on a Global Health Risk Framework for the Future (n 9) 69. 54 See ibid. 55 See World Health Organization, ‘Investing in health: A summary of the findings of the Commission on Macroeconomics and Health’ (20 December 2001) accessed 27 September 2016. 56 See WHO (Resolution of the Forty-Sixth World Health Assembly) ‘Health development in a changing world: a call for collective action’ (Geneva 12 May 1993) WHA46.17¶5(2) accessed 27 September 2016. 57 See P Puska, ‘Nutrition and Mortality: The Finnish Experience’ (2000) 55(4) Acta Cardiologica 213. 58 See World Health Organization, ‘Closing the Gap in a Generation: Health Equity through Action on the Social Determinants of Health. Final Report of the Commission on Social Determinants of Health’ (Geneva 2008) 23 accessed 27 September 2016. See also K Buse and A Waxman, ‘Public-Private Health Partnerships: A Strategy for WHO’ (2001) 79(8) Bulletin of the World Health Organization 748. 59 For more discussion on global cooperation to fight infectious diseases, see M Zacher and TJ Keefe, The Politics of Global Health Governance: United by Contagion (Springer 2008). 60 See ML Gagnon and R Labonté, ‘Understanding How and Why Health is Integrated into Foreign Policy-a Case Study of Health is Global, a UK Government Strategy 2008–2013’ (2013) 9(1) Globalization and health 24. 61 See Commission on a Global Health Risk Framework for the Future (n 9) 17. 62 See ibid 85–87. 63 ibid 10. © The Author 2017. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals.permissions@oup.com TI - Our Shared Vulnerability to Dangerous Pathogens JF - Medical Law Review DO - 10.1093/medlaw/fwx016 DA - 2017-04-01 UR - https://www.deepdyve.com/lp/oxford-university-press/our-shared-vulnerability-to-dangerous-pathogens-6UL3VMeq12 SP - 185 EP - 199 VL - 25 IS - 2 DP - DeepDyve ER -