The Neglected Dimension of Global Security A Framework for Countering Infectious-Disease Crises

Transcription

1 Special Report The Neglected Dimension of Global Security A Framework for Countering Infectious-Disease Crises Peter Sands, M.P.A., Carmen Mundaca-Shah, M.D., Dr.P.H., and Victor J. Dzau, M.D. Pandemics and epidemics have ravaged human societies throughout history. The plague, cholera, and smallpox killed tens of millions of people and destroyed civilizations. In the past 100 years, the Spanish Flu of and HIV AIDS caused the deaths of nearly 100 million people. Advances in medicine have transformed our defenses against the threat of infectious disease. Better hygiene, antibiotics, diagnostics, and vaccines have given us far more effective tools for preventing and responding to outbreaks. Yet the severe acute respiratory syndrome (SARS), the Middle East respiratory syndrome (MERS), and the recent West African Ebola outbreak show that we cannot be complacent (Fig. 1). Infectiousdisease outbreaks that turn into epidemics and potential pandemics can cause massive loss of life and huge economic disruption. Indeed, Ebola demonstrated how ill-prepared we are for such infectious-disease crises. There were failures at almost every level. Identifying the outbreak in the community and raising alerts took too long. Local health systems were quickly overwhelmed. Response teams did not adequately engage communities and deepened distrust in health authorities. The international response was slow, cumbersome, and poorly coordinated. Rapid diagnostics, protective equipment, effective therapeutics, and a vaccine were lacking. Ultimately, the crisis was contained, thanks to the courage and commitment of medical staff and communities on the ground and a massive deployment of international resources. Yet the cost in human lives and economic and social disruption was far greater than it should have been. In this context, the Commission on a Global Health Risk Framework for the Future was initiated in the spring of Eight sponsors came together to support the initiative. The U.S. National Academy of Medicine provided leadership and guidance. An International Oversight Group comprising 12 leaders in science, business, and government was established to set up and guide the Commission. Severe acute respiratory syndrome (SARS) Started in China Zika virus Yap Island, Federated States of Micronesia Cholera Zimbabwe Cholera Haiti Zika virus French Polynesia Ebola Outbreaks in West Africa Brazil and Colombia Chikungunya Outbreaks H1N1 influenza Pandemic Chikungunya Outbreaks Measles Democratic Republic of Congo Middle East respiratory syndrome (MERS) Outbreaks Figure 1. Major Emerging and Reemerging Infectious-Disease Outbreaks, Epidemics, and Pandemics, 2002 through n engl j med 374;13 nejm.org March 31,

2 The Commission itself comprised 17 members from 12 countries on 5 continents and included clinicians, scientists, social researchers, policy experts, industry leaders, financiers, and community leaders (see the roster and the Commission s full report in the Supplementary Appendix, available with the full text of this article at NEJM.org). We were tasked with providing recommendations on creating an effective global architecture for recognizing and mitigating the threat of epidemic infectious diseases. Four key features characterized our work: independence the remit, membership, and processes of the Commission were designed to ensure independence from individual governments, international agencies, and other stakeholders; forwardlooking focus the goal was not to analyze what went wrong with Ebola, but to devise recommendations for the future, drawing lessons not just from Ebola, but from previous outbreaks, including SARS, MERS, and the H1N1 influenza and HIV AIDS pandemics; comprehensiveness the Commission was tasked with considering every aspect of an effective framework for preparedness, detection, and response to infectiousdisease threats, ranging from models of international governance to local skills and infrastructure requirements, and with assessing implications for scientific research and development and define the financing requirements; and timeliness the Commission was asked to complete its work within 6 months to enable its recommendations to inform policy initiatives in To tackle such a broad agenda so quickly, we held 11 days of public meetings in Washington, Hong Kong, Accra, and London, with the participation of more than 250 experts from various fields, followed by extensive consultations with experts from government, industry, civil society organizations (CSOs), the United Nations (UN), the World Health Organization (WHO), and the World Bank. We drew extensively on prior work and, without compromising the Commission s independence, connected with other relevant initiatives, such as the UN High Level Panel on Global Response to Health Crises, the WHO Ebola Interim Assessment Panel, the World Bank initiative on pandemic financing, and the Independent Panel on the Global Response to Ebola convened by Harvard and the London School of Hygiene and Tropical Medicine. Overview of Recommendations The Commission s report includes 26 recommendations for concrete actions to be taken within specific timeframes. They are designed to work together as a comprehensive, coherent framework to counter the threat of infectious-disease crises. The recommendations (Table 1) fall into four categories. Three recommendations aim to ensure that the global community implements the proposed framework, commits the financial resources required, and monitors progress. Ten recommendations are directed at reinforcing national public health capabilities and infrastructure, such as disease-surveillance systems and laboratory networks. These are designed to work as a package: clarifying what needs to be done, ensuring accountability and transparency through rigorous external assessment, and providing the incentives and financial resources required. They also stress the importance of community engagement in pandemic preparedness and response. Ten recommendations aim to strengthen the WHO s leadership role in coordinating global preparedness and response, working with other UN agencies, regional organizations, and nonstate actors including CSOs and the private sector. These recommendations also cover mobilization of international financial resources for pandemic response. And three recommendations are aimed at enhancing our scientific armory against infectious disease, including prioritization, mobilization, and deployment of significantly greater resources and harmonization of development and regulatory-approval processes. These recommendations encompass substantial changes to organizational structure and roles, new and modified processes and mechanisms, and new financial arrangements. Taken together, they create a global framework that would protect the world far better against infectious-disease threats. Investing in Pandemic Preparedness The Commission s report makes the case for greater investment in countering infectiousdisease threats, arguing that potential pandemics should be considered not just as important health risks but as major threats to the global economy and global security. The key lies in how the issue 1282 n engl j med 374;13 nejm.org March 31, 2016

3 Special Report Table 1. Summary of the Commission s Recommendations.* Chapter Recommendations 2 The Case for Investing in Pandemic Preparedness 3 Strengthening Public Health as the Foundation of the Health System and First Line of Defense 4 Strengthening the Global and Regional System for Outbreak Preparedness, Alert, and Response 5 Accelerating Research and Development to Counter the Threat of Infectious Disease The G7, G20, and UN should commit to the following actions: A.1: Implementing framework set out in this report and embodied in Rec. B.1 D.3. A.2: Mobilizing incremental financial resources required ($4.5 billion/yr). A.3: Monitoring progress of implementation by an independent assessment in 2017 and every 3 yr there after. B.1: WHO and member states should develop an agreed-on, precise definition and benchmarks for national core capabilities, and functioning, based on IHR and other efforts (GHSA and OIE Terrestrial Animal Health Code). B.2: WHO should devise a regular, independent, transparent, and objective assessment mechanism to evaluate country performance against benchmarks defined in Rec. B.1. B.3: All countries should commit to participate in external assessment process (Rec. B.2), including publication of results. B.4: WB, bilateral, and multilateral donors should declare that related funding will be conditional on a country s participation in external assessment process (Rec B.2). B.5: IMF should include pandemic preparedness in its economic and policy assessments of individual countries, based on outcomes of the external assessment of national core capacities. B.6: Countries should develop plans to achieve and maintain benchmark core capacities by mid-2017 (target to achieve full compliance with the benchmarks by 2020). B.7: WHO should provide technical support to fill countries gaps in core capacities and achieve benchmark performance. B.8: National governments should develop domestic resourcing plans to finance improvement and maintenance of core capacities as set out in plans (Rec. B.6). B.9: WB should convene other multilateral donors to secure financial support for lower-middle-income and low-income countries in delivering plans (Rec. B.6). B.10: UNSG should work with the WHO and other parts of the UN system to develop strategies for sustaining health system capabilities and infrastructure in fragile and failed states and in war zones, to the extent possible. C.1: WHO should create a CHEPR to lead the global effort toward outbreak preparedness and response. This center should be governed by an independent TGB. C.2: WHA should agree to an appropriate increase in WHO member states core contributions to provide sustainable financing for the CHEPR. C.3: WHO should create and fund a sustainable contingency fund of $100 million through one-off contributions or commitments proportional to assessed contributions from member states. C.4: UN and WHO should establish clear mechanisms for coordination and escalation in health crises. C.5: WHO should work with existing formal and informal regional and subregional networks to strengthen linkages and coordination among neighboring countries. C.6: WHO and national governments should enhance means of cooperation with nonstate actors. C.7: WHO should establish a mechanism to generate a daily high-priority watch list of outbreaks with potential to become PHEICs. List to be communicated to NFPs daily and to the public weekly. C.8: WHA should agree on new mechanisms for holding governments publicly accountable for performance under the IHR and broader GHRF, including protocols for avoiding delays in data and alerts and unnecessary restrictions on trade or travel. C.9: WB should establish the PEF as a rapidly deployable source of funds to support pandemic response. C.10: IMF should ensure capability to provide budgetary support to governments raising alerts of outbreaks. D.1: WHO should establish an independent PPDC, accountable to the TGB, to galvanize acceleration of relevant R&D, define priorities, and mobilize and allocate resources. D.2: WHO should work with global R&D stakeholders to catalyze the commitment of $1 billion/yr to maintain a portfolio of projects coordinated by the PPDC. D.3: PPDC should convene regulatory agencies, industry stakeholders, and research organizations to commit to the following actions: Adopting R&D approaches during crises that maintain consistently high scientific standards. Defining protocols and approaches to engage local scientists and community members in the conduct of research. Agreeing on ways to expedite medical product approval, manufacture, and distribution. * The Commission s full report is available at NEJM.org. CHEPR denotes Center for Health Emergency Preparedness and Response, G7 Group of 7 countries, G20 Group of 20 countries, GHRF Global Health Risk Framework, GHSA Global Health Security Agenda, IHR International Health Regulations, IMF International Monetary Fund, NFP National Focal Point, OIE World Organization for Animal Health, PEF Pandemic Emergency Facility, PHEIC Public Health Emergency of International Concern, PPDC Pandemic Product Development Committee, R&D research and development, Rec. recommendation, TGB Technical Governing Board, UN United Nations, UNSG UN Secretary General, WB World Bank, WHA World Health Assembly, and WHO World Health Organization. n engl j med 374;13 nejm.org March 31,

4 is framed. If outbreaks are framed as a health issue, spending on preventing and preparing for them pales against more pressing and visible health priorities. Governments find it difficult to justify spending money on avoiding relatively low-probability crises, and the private sector foresees relatively little return on such investments. Yet when the issue is framed as one of security or threat to human lives, it seems remarkable how little we spend. Pandemics arguably pose more of a threat to human lives than war, terrorism, or natural disasters. Framed as a risk to economic growth and stability, the danger is equally stark. Both the intrinsic dynamics of infectious-disease outbreaks and the behavioral and policy responses can have immense economic impact. Although we cannot know with any certainty the probability of future epidemics, let alone pandemics, nor estimate with precision their likely impact, the case for greater investment is compelling. The rate of emergence of new infectious diseases appears to be increasing. As a result of increased population, and consequently greater human wildlife interaction and increased livestock production, there is greater probability of zoonotic transmission. In addition, everincreasing global trade and travel increase the potential for outbreaks of new or resurgent pathogens to turn into epidemics or pandemics. Globalization drives economic growth but also facilitates the spread of contagion. And in our media-connected world, fear spreads even more quickly than infections. Fueled by television and social media, fears of infectious diseases, whether rational or unwarranted, drive behavior and policy changes, triggering travel bans, quarantines, and blocks on trade that can quickly escalate beyond what is scientifically justified. So though medical advances are helping us contain the loss of life from infectious-disease outbreaks, our vulnerability to economic damage seems magnified. The Commission s analysis suggests that expected economic losses from potential pandemics could amount to around $60 billion per year. Implementing our recommendations, by contrast, would cost about $4.5 billion per year. This figure has three elements: the cost of upgrading public health systems in low- and middle-income countries, which our report puts close to $3.4 billion per year; the cost of enhancing the WHO s pandemic prevention and response capabilities and of financing the WHO and World Bank contingency funds, which we assume to be $130 million to $155 million per year; and a proposed incremental investment in research and development of $1 billion per year. Incremental worldwide expenditures of $4.5 billion per year are substantial. When government budgets are stretched and trade-offs are difficult, such investments might seem difficult to justify. Yet given the scale of the risks posed by potential pandemics, the better question might be why we re not spending this money already. From a global-security perspective, what we re proposing is a tiny fraction of the more than $1 trillion spent every year on military defense. Every government needs to recognize that protecting its people from infectious-disease threats is an integral part of national security. From an economic-risk perspective, the proposed investment is a small fraction of what we spend to prevent financial crises. For example, the latest regulation to make big banks safer, known as Total Loss-Absorbing Capacity, will cost an estimated $17 billion per year. From both relative and return-on-investment perspectives, the investment case looks compelling. We accept that there are huge uncertainties about the scale of the threat from infectious diseases, but the risks of investing too much or too little are asymmetric. If we overinvest, we will spend more on shoring up our defenses against infectious-disease outbreaks than strictly necessary. Yet it is hard to see that as wasted money, since these investments will help us achieve other critical health objectives. For example, strengthening national public health and primary care systems will help us tackle endemic diseases such as tuberculosis and malaria more effectively and detect the emergence of antimicrobial-resistant pathogens more swiftly. On the other hand, if we underinvest, we open the door to potential catastrophe. Strengthening Public Health National public health capabilities are an integral part of an effective health system and the first line of defense against infectious-disease outbreaks. Yet in many countries they suffer from underinvestment. Even in wealthy countries, public health is often given relatively low priority n engl j med 374;13 nejm.org March 31, 2016

5 Special Report In poor countries, there are frequently substantial gaps in skills, systems, and infrastructure. Previous efforts to galvanize increased investment in public health capabilities and infrastructure after SARS and again after H1N1 have had limited effects. For example, according to their own assessments, more than two thirds of countries are less than fully compliant with the requirements of the International Health Regulations (IHR). Rigorous external assessments would undoubtedly have even more sobering results. The Commission s report argues that reinforcing public health capabilities should be a top priority. It sets out 10 interrelated recommendations to make this happen. Six aspects of our approach are worth highlighting. First, national public health capabilities should be assessed rigorously, objectively, and transparently, against clearly defined benchmarks. Selfassessment of adherence to insufficiently precise IHR requirements is inadequate. To identify and prioritize gaps and hold governments accountable, we need a mechanism more akin to the World Bank s Doing Business report or the Financial Action Task Force s Mutual Evaluations. The pilot peer assessments conducted under the Global Health Security Agenda initiative provide a useful model. Second, national governments should be held accountable for their own public health performance. Ensuring health security should be seen as part of a government s fundamental duty to protect its people. So national governments must commit to building and maintaining stronger public health capacities. Third, we should focus on sustainable funding for public health. On the basis of World Bank analyses, our report suggests that we face a funding gap of $1.9 billion to $3.4 billion. The Commission believes that high-income and uppermiddle-income countries should commit to funding their public health systems from domestic resources. Lower-middle-income and low-income countries should work with development partners to agree on the appropriate balance of domestic resources and international support but, wherever possible, should seek a path toward full domestic resourcing to ensure ownership and sustainability. Fourth, specific strategies are needed for fragile and failed states and war zones. Where local governments cannot or will not deliver what is required, the WHO and the World Bank, working with the rest of the UN system, need to devise strategies to sustain at least minimum public health capacities, since outbreaks are most likely to occur and gain momentum in such situations. Fifth, appropriate incentives should be implemented. For example, the Commission recommends that the International Monetary Fund include pandemic preparedness in its assessments of countries economic performance and policy. Such evaluation will enable financial markets to take better account of such risks, which in turn will increase the incentives to mitigate them. Finally, priority should be given to community engagement. Engaged communities can be highly effective in detecting outbreaks and, as was demonstrated with Ebola, are a prerequisite for effective response. Yet too often, community engagement has been an afterthought poorly researched, left until too late, and clumsily executed. Building stronger public health systems takes political leadership, persistence, and patience, since the capacity takes time to create, and the benefits avoidance of bad outcomes are often invisible. Yet countries such as Uganda have demonstrated that even where funds are scarce, substantial improvements can be made. Strengthening Global and Regional Systems Effective national public health systems represent the first line of defense against potential pandemics, but global and regional capabilities and coordination are also essential. Here, too, the recent Ebola outbreak revealed weaknesses. The international response was slow to mobilize and poorly coordinated. Our report sets out 10 recommendations to address these flaws. Most focus on the role, capabilities, and resourcing of the WHO. The Commission believes the WHO must take leadership within the international system in preparing and responding to potential pandemics but must do so much more effectively. The report recommends establishing a Center for Health Emergency Preparedness and Response (CHEPR) building on the recommendations of the WHO Ebola Interim Assessment Panel and the actions that the WHO s director-general has already taken to integrate and reinforce the orga- n engl j med 374;13 nejm.org March 31,

6 nization s emergency-response capabilities. The Commission also recommends that this center be guided and overseen by an external Technical Governing Board that provides oversight and a degree of political insulation to the CHEPR. That board, under the chairmanship of the director-general, should be composed of experts independent of and drawn from outside the WHO, on the basis of technical expertise. Among other tasks, this board would advise the director-general on when to declare a Public Health Emergency of International Concern (PHEIC). To ensure adequate and committed funding for the CHEPR, the Commission proposes increasing member states assessed contributions. The Commission also supports the establishment of the WHO s proposed $100 million Contingency Fund for Emergencies but believes it should be financed through one-off contributions proportional to assessed contributions rather than through voluntary contributions. Leading pandemic preparedness and response must be a core priority for the WHO and therefore needs adequate and committed funding. Prompt alerts and rapid dissemination of relevant data are essential to effective outbreak response. Yet too often, alerts are delayed or data suppressed by officials fearful of the economic and political consequences. To normalize infectious-disease alerts, the WHO should send member states daily updates listing outbreaks with the potential to become PHEICs and should post weekly summaries online. To further encourage use of early alerts, the WHO should reinforce the protocols for holding governments publicly accountable for delays and for imposing excessive trade and travel restrictions. The Commission s objective is to make the WHO stronger and more effective in taking the lead in pandemic preparedness and response. Member states will have to give the directorgeneral the resources and power to lead. Given the imminent succession process, member states should also consider carefully the qualities and authority of the next director-general. We need the WHO to be swift and decisive, with the resources and capability to lead other agencies in executing outbreak response and the authority to hold national governments to account. These responsibilities require strong, visible, empowered leadership from the director-general. There are also changes required beyond the WHO, including better coordination of international responses and across the UN system. Failures of coordination undermined the response to Ebola. The WHO needs to establish more effective communication and collaboration mechanisms with the rest of the UN system, including escalation arrangements when a pandemic evolves into a broader humanitarian crisis. The WHO should also formalize coordination efforts with regional organizations and nonstate actors such as the private sector and nongovernmental organizations. The Commission supports the creation of the World Bank s Pandemic Emergency Facility as a mechanism to enable rapid deployment of funds as a complement to the WHO Contingency Fund for Emergencies and before broader contributions are mobilized. If innovative insurance and capital-market mechanisms can be demonstrated to be both economically viable and practical, they could potentially represent attractive new sources of funds. Though clearly politically challenging to implement, binding contingent commitments from donor governments represent an economical and flexible alternative. Accelerating Research and Development Science can provide the weapons to combat infectious disease. But there are many gaps in our armory, as Ebola and other outbreaks have shown, ranging from vaccine development and capacity, diagnostic tools, therapeutics, and protective equipment to anthropological research. Relying on the disparate efforts of the research-and-development community academia, government, industry, and civil society has not worked. The coordination mechanisms and commercial incentives are too weak. Moreover, the processes for product development and approval are too slow, complex, and costly to enable sufficiently swift scientific responses to a serious outbreak. To rectify these deficiencies, our report offers three recommendations. The first is the creation of a new Pandemic Product Development Committee to prioritize, coordinate, and oversee research and development in this arena; this committee should be held accountable by the technical board described above. The chair of the committee should be appointed by the WHO s director-general with the rest of its membership consisting of international technical experts. The committee 1286 n engl j med 374;13 nejm.org March 31, 2016

7 Special Report would operate independently of the WHO, making decisions on the basis of members advice. This proposal builds on the work the WHO has already initiated to identify priority pathogens. Second, $1 billion per year should be mobilized for research and development on infectious diseases, to be deployed under the guidance of the product development committee. The funds would come from several sources, including contributions from governments and foundations, research-and-development budgets devoted to national security, private-sector investments, and potentially new sources of private funding outside the health sector. Third, agreements should be secured on expediting approval, manufacturing, and distribution, including harmonization of clinical protocols, streamlining of regulatory approvals, and better mechanisms for community engagement. We recognize that securing an additional $1 billion per year will be enormously challenging, given other demands on government, philanthropic, and academic budgets and the difficulties of making a commercial case. Yet viewed from the perspective of the global community, the case for such incremental investment is compelling, considering the scale of the risks to human lives and livelihoods. Conclusions The Commission s recommendations constitute a comprehensive framework for countering the risk of infectious-disease crises. Inevitably, there will be debate as to whether implementing only some will suffice. But policy frameworks are most effective when the elements complement each other; partial implementation is much less effective. Moreover, investment in prevention and preparation is worth much more than spending on response, and the best response is a wellprepared one. The battle against infectiousdisease outbreaks will be fought on the ground within specific communities and will be won only if these communities are fully engaged, but science is our most powerful weapon in combating infectious diseases, and the development of tools such as vaccines and diagnostics must begin before a crisis occurs. Otherwise, the delay in deploying such tools effectively will cost the world many lives and livelihoods. We must reinforce international mechanisms for leading, coordinating, and providing resources for the response to infectious-disease crises by strengthening WHO capabilities, improving coordination with the rest of the UN system, and creating contingency financing mechanisms through the WHO and the World Bank. Yet we should avoid the temptation to see such international initiatives as the complete answer. To substantially reduce the risks to humanity and human prosperity, we must catalyze the building of stronger national public health capabilities and infrastructure, even in failed and fragile states, and do so in a way that establishes effective community engagement. We do not underestimate the challenges in achieving this goal, since it requires leadership at multiple levels and sustained financing. Yet it must be the top priority. Neither do we underestimate the challenges of mobilizing additional funds for research and development or of achieving greater harmonization and efficiency in development and approval processes. Yet ultimately, we depend on science to enable us to counter potential pandemics. So we need to find the money and make our processes less complex and cumbersome. Infectious disease represents one of the most potent risks facing humankind. Few events could cause such loss of life and damage to livelihoods. Yet the global community spends relatively little in protecting humankind from the threat of pandemics. As compared with our position vis-à-vis other threats to human and economic security, such as war, terrorism, nuclear disaster, and financial crises, we are underinvested and underprepared. Pandemics are the neglected dimension of global security. Before the memories of Ebola fade, we should heed the wake-up call that tragedy represents. Global health security is a public good: making each of us safer depends on making us all safer; gaps in one community s defenses are gaps in all our defenses. Global leaders can commit to making the world safer by implementing the framework created by the Commission s recommendations. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. From the Commission on a Global Health Risk Framework for the Future (P.S., C.M.-S., V.J.D.); the Mossavar Rahmani Center for Business and Government, Harvard Kennedy School, Cambridge, MA (P.S.); and the National Academy of Medicine, Washington, DC (C.M.-S., V.J.D.). This article was published on January 13, 2016, at NEJM.org. DOI: /NEJMsr Copyright 2016 Massachusetts Medical Society. n engl j med 374;13 nejm.org March 31,