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Infectious Disease Movement in a Borderless World: Workshop Summary 4 Global Public Health Governance and the Revised International Health Regulations OVERVIEW As globalization renders national and geographic boundaries increasingly permeable to pathogens, infectious disease control necessitates international cooperation and coordination. This became abundantly clear when severe acute respiratory syndrome (SARS) emerged in 2003, and it provided a powerful rationale for global public health governance, according to presenter David Heymann of the World Health Organization (WHO). In his contribution to this chapter, Heymann describes the process by which the International Health Regulations (IHR) were revised in the wake of the SARS epidemic and discusses two important challenges that have compromised implementation of IHR 2005: the suspension of polio vaccinations in northern Nigeria and the refusal of Indonesia to share samples of H5N1 influenza viruses collected in that country with the WHO (also discussed in a subsequent essay by Fidler; see below). “The global public health community has come a long way since the time of the 1918 influenza pandemic,” Heymann observes, as evidenced by the first full application of the IHR 2005 in response to influenza A (H1N1) in 2009. The procedures used by the WHO to declare this event a “public health emergency of international concern” (PHEIC), as stipulated by IHR 2005, are discussed in additional papers in this chapter by Chu et al. and Fidler. Despite this progress, until the issues surrounding the H5N1 virus sharing are resolved, the IHR 2005 “remain a valuable but potential framework within which to address infectious diseases across international borders,” Heymann asserts. Another challenge to IHR 2005 implementation involves its requirement for significant public health capacity-building, particularly with regard to infectious
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Infectious Disease Movement in a Borderless World: Workshop Summary disease surveillance. In their contribution to this chapter, speaker May Chu and WHO colleagues Heymann and Guénaël Rodier discuss the obligation of signatories to the IHR 2005 to develop the capacity to detect, assess, and report a possible PHEIC, and they describe steps being taken by the WHO to support progress toward this ambitious and crucial goal by member nations. Chu et al. note that countries may take a variety of routes to build surveillance capacity, including collaboration and networking with other member nations and nongovernmental organizations (NGOs) not limited to the WHO. They also consider the crucial role of information networks, such as the Global Outbreak Alert and Response Network (GOARN), coordinated by the WHO, in broadcasting timely disease alerts to the worldwide health community. The chapter’s third paper presents a view of the IHR 2005 from the perspective of the developing world. Workshop speaker Oyewale Tomori, of Redeemer’s University in Nigeria, notes that the successful implementation of the IHR 2005 depends on addressing the concerns of policy makers from resource-constrained countries. While some of these concerns are country- and region-specific, he states that “a large proportion of policy-makers in resource-constrained countries perceive that the emphasis of the IHR 2005 on the international spread of disease evinces little concern regarding the burden of infectious diseases on the nations in which they occur.” Tomori examines significant obstacles to implementing IHR 2005 in Africa, which include multiple barriers to the establishment of surveillance systems; lack of political will and commitment to global public health; barriers to sharing public health information among countries; and constraints imposed by donor agencies on funded projects. He also describes steps that could be taken to correct misperceptions of the IHR 2005 in Africa (and elsewhere) and to enable implementation of these regulations in resource-constrained countries. In his workshop presentation, David Fidler of Indiana University stated that the IHR 2005 represents a “radical departure from all previous uses of international law for public health purposes.” After examining the basis for this statement in his contribution to this chapter, Fidler explores a series of challenges that must be overcome if the IHR 2005 are to live up to their promise. His focus is Indonesia’s refusal to share H5N1 viral samples with the WHO’s H5N1 influenza surveillance team and the significance of this controversy to the implementation of IHR 2005 and to global public health governance in general. In 2006, Indonesia claimed “viral sovereignty” over samples of H5N1 collected within its borders and announced that it would not share them until the WHO and developed countries established an equitable means of sharing the benefits (e.g., vaccine) that could derive from such viruses. Proposals to use IHR 2005 as a means to force Indonesia to share the samples for global surveillance purposes have failed; Fidler notes that this incident highlights the important, yet ambiguous, position of health as a foreign policy issue and its broad implications for global public health governance.
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Infectious Disease Movement in a Borderless World: Workshop Summary The lack of effective international efforts to address many of the factors that encourage the emergence and spread of infectious diseases (e.g., migration, environmental change, antimicrobial resistance, and armed conflict) increases the potential significance of the IHR 2005 to the future of global health, Fidler argues. He notes that the emergence of influenza A (H1N1) has brought the IHR 2005 renewed political attention and appreciation of its value, and it has demonstrated the WHO’s ability to implement the regulations in a crisis. However, the IHR 2005 must weather far more severe crises than this epidemic to date, Fidler concludes, as well as a host of global trends that threaten to derail advances toward global public health governance. PUBLIC HEALTH, GLOBAL GOVERNANCE, AND THE REVISED INTERNATIONAL HEALTH REGULATIONS David Heymann, M.D.1 World Health Organization Communicating Disease Risk: Then and Now The 2003 outbreak of SARS was an event of singular importance in demonstrating the need for global public health governance. It began when a physician, who had treated patients with an unknown respiratory disease in the Guangdong Province of China, traveled to Hong Kong on February 21, 2003. From his visit to Hong Kong, the disease that was eventually named SARS began to spread around the world. When the WHO was alerted about the outbreak of an unknown respiratory disease in Hong Kong on March 12, there was only one way to provide 194 ministers of health throughout the world with the information about this threat simultaneously: a press release. It soon became clear that the message had been received: on March 14, the health ministries of Canada and Singapore reported to WHO that persons in their countries who had recently traveled to Hong Kong had a similar disease. Early Saturday morning, March 15, in Geneva, the WHO duty officer received a call from the Singapore health ministry. A medical doctor who had treated the patients in Singapore had traveled to the United States for a medical conference and was on a return flight to Frankfurt, Germany. WHO was asked to help this medical doctor get medical care in Frankfurt and this was accomplished. At the same time it became evident that the disease was spreading internationally, and, once again, the most effective method of communicating this recent development simultaneously was by press release—one that gave the disease a name, provided a case definition, 1 At the time of the workshop, Dr. Heymann was Assistant Director-General for Communicable Diseases and Representative of the Director-General for Polio Eradication at the World Health Organization; however, at the time of publication he is Chairman of the Health Protection Agency.
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Infectious Disease Movement in a Borderless World: Workshop Summary and brought it to the attention of international travelers and health workers alike. Clearly this was a less than desirable way to communicate critical information to ministers of health around the world. The fear was that the message would not spread as rapidly as necessary, particularly because it was a weekend. Five years later, in late October 2008, the revised IHR were in effect. At that time the ministry of health of Sudan reported an outbreak of Rift Valley fever. WHO, along with partners from the Office International des Epizooties2 (OIE) and the Food and Agriculture Organization of the United Nations3 (FAO), was requested by the government of Sudan to support the ministries of health and agriculture in investigation and containment activities. The risk assessment after the outbreak investigation raised great concern because livestock from Sudan, traded across the Red Sea into Yemen and Saudi Arabia, could have been carrying the Rift Valley fever virus. As these animals were being sacrificed during religious ceremonies, the risk of transmission of Rift Valley fever to humans was high. Unlike in 2003, at the time of the SARS outbreak, WHO was able to transmit information about the infectious disease threat directly and simultaneously to all 194 ministries of health because of the presence of an IHR4 focal point in each country who is on call 24 hours a day. Health ministers quickly received the information they needed for risk assessment, and they were able to report back to WHO or ask for further clarification electronically and in real time. Today, the IHR connect national focal points in countries with contact points at WHO regional offices and a universal event management system. The WHO regional offices enter epidemiological and other information necessary for risk analysis and management into this event management system that stores the information and makes it available as needed for risk analysis and management. Feedback to countries through a national IHR focal point completes the reporting link and, if countries require support in outbreak response, a request is transmitted back to the WHO. 2 The OIE is the intergovernmental organization responsible for improving animal health worldwide. The Office International des Epizooties was created through an international agreement signed on January 25, 1924. In May 2003, the office became the World Organisation for Animal Health but kept its historical acronym OIE. For more information, see http://www.oie.int/eng/OIE/en_about.htm?e1d1 (accessed March 30, 2009). 3 Achieving food security for all is at the heart of FAO’s efforts—to make sure people have regular access to enough high-quality food to lead active, healthy lives. FAO’s mandate is to raise levels of nutrition, improve agricultural productivity, better the lives of rural populations, and contribute to the growth of the world economy. For more information, see http://www.fao.org/about/mission-gov/en/ (accessed March 30, 2009). 4 The International Health Regulations (2005) represent a legally binding agreement that significantly contributes to international public health security by providing a new framework for the coordination of the management of events that may constitute a public health emergency of international concerns, and will improve the capacity of all countries to detect, assess, notify, and respond to public health threats. For more information, see http://www.who.int/csr/ihr/prepare/en/index.html (accessed March 30, 2009).
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Infectious Disease Movement in a Borderless World: Workshop Summary Revising the IHR The original IHR, established in 1969, were preceded by a long history of public health measures designed to control the spread of infectious diseases across borders (see Gushulak and MacPherson in Chapter 1). These efforts focused on four diseases: plague, cholera, yellow fever, and smallpox. In the case of the IHR (and the accompanying sanitation guidelines for seaports and airports), they attempted to strike a balance between ensuring maximum public health security against the international spread of these four infectious diseases with minimum interference in global commerce and trade. The original IHR were predicated on the notion that with appropriate measures at border posts it was possible to stop diseases from crossing international borders. Countries in which one of the four reportable diseases (three, after the eradication of smallpox) was occurring were required to notify WHO, and other countries were permitted to take specified measures at airports and seaports to prevent the entry of disease or disease vectors coming from these countries. As an example, when a country reported a yellow fever outbreak to WHO, a report of the infected area was published in the WHO Weekly Epidemiological Record. During the period between reporting and certifying that the outbreak was contained, countries could require yellow fever vaccination certificates from passengers arriving from the affected country. Recognizing that the world contains multiple and diverse infectious threats beyond these reportable diseases, and that advances in communications could be employed to detect and support the control of diseases that threatened to spread internationally, a decision was made in the mid-1990s to revise IHR. The revision process had two primary goals: to make use of modern communication technologies to understand where diseases were occurring and had the potential to spread, and to change the international norm for reporting infectious disease outbreaks so that countries were not only expected to report outbreaks, but also respected for doing so. Before 1996, WHO acted only when reports of infectious disease were received from affected countries. As the vision for the revision of the IHR became clear, the WHO began to work more proactively, both in detecting diseases that threatened to cross international borders and in more actively supporting countries in outbreak response should they so request. This vision led to the creation of the Global Public Health Information Network (GPHIN)5 by Health Canada, and the GOARN by the WHO and its technical partners. GPHIN, a web-crawling application,6 searches open sites on the World Wide Web for key words associated with infectious diseases, in multiple languages. It does a preliminary analysis of the 5 See http://www.who.int/csr/alertresponse/epidemicintelligence/en/. 6 A web crawler is a computer program that browses the World Wide Web in a methodical, automated manner. For more information, see http://en.wikipedia.org/wiki/Web_crawler (accessed March 30, 2009).
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Infectious Disease Movement in a Borderless World: Workshop Summary information collected and provides this information every 24 hours to the WHO, where it is verified as rapidly as possible through the WHO system. In 2000, WHO formalized GOARN and it is now able to mount coordinated international response to an infectious disease outbreak by linking its technical partners (institutions, organizations, and networks) with countries that request support.7 Figure 4-1 shows some of the current technical partners of GOARN throughout the world. GPHIN, and many other global surveillance partners of WHO, were in place when SARS first appeared. While still nameless, SARS was first identified in Asia by GPHIN and several other partners in global surveillance. WHO feared that these reports of an atypical pneumonia with high mortality signaled the beginning of an influenza pandemic because H5N1 was known, since 1997, to be present in that region of China. Within a period of a weeks after the first recognized case, GOARN mobilized more than 115 experts from 26 institutions and 17 countries to support infected countries in outbreak investigation, patient management, and outbreak containment. These experts, and others, exchanged epidemiological, laboratory, and clinical information about the outbreak in real time. WHO used this information to make recommendations on patient management and eventually issued travel recommendations in an attempt to curb, and eventually stop, the international spread of this newly recognized virus. The SARS outbreak was a turning point in international collaboration on infectious disease control, and many ministers of health became convinced that they must change the way they work together to fit this model. At the World Health Assembly (WHA) in May 2003, a resolution was passed by WHO member states that confirmed that WHO could receive and use infectious disease information from sources other than countries for risk assessment with the affected country in a confidential manner, and it also mandated reporting of a wider range of infectious diseases with potential for international spread rather than just yellow fever, cholera, and plague. This resolution helped increase the pace of the revision of the IHR and, in 2005, the revision process was completed with full endorsement by the WHA. The revised IHR enable more proactive surveillance for an event that could be considered a PHEIC, whether it be infectious, chemical, radiological, or food-related. With a core capacity strengthening requirement for countries in epidemiology and public health laboratory, the revised IHR will strengthen the ability of countries to detect and contain outbreaks at their source so that they do not have the opportunity to spread internationally. Figure 4-2 compares the major distinctions between the 1969 IHR and the 2005 revision. Specifically, the revised IHR mandate: Strengthened national core capacity for surveillance and control, including at border posts; 7 See http://www.who.int/csr/outbreaknetwork/en/.
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Infectious Disease Movement in a Borderless World: Workshop Summary FIGURE 4-1 Global Outbreak and Alert Network (GOARN): Institutions and members of partner networks. SOURCE: Reprinted with permission from WHO/GOARN.
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Infectious Disease Movement in a Borderless World: Workshop Summary FIGURE 4-2 Major distinctions between the IHR 1969 and the revised IHR 2005. SOURCE: Heymann (2008). Reporting of possible PHEICs (see Figure 4-3), and of four specific diseases even if only one case is identified: SARS, smallpox, avian influenza, and polio; Collective, proactive global collaboration for risk assessment and risk management; and Monitoring of implementation by the WHA. Global Governance and the Revised IHR Polio Eradication In 1988, polio was present in more than 125 countries, where it caused paralysis in approximately 1,000 children each day; and access to polio vaccine was inequitable between countries. Polio vaccine rapidly became available after 1988 in sufficient quantities for all countries and, by 2003, polio remained in only six countries: India, Pakistan, Afghanistan, Egypt, Niger, and Nigeria. Fewer than 1,000 children became paralyzed in the course of that entire year, and there was equitable access to vaccine. But during the latter part of 2003, rumors began circulating that polio vaccines were causing sterility in young girls. These rumors led to a suspension of polio vaccination in 2003 in northern Nigeria. The result was that the polio virus began to migrate with people from northern Nigeria as they crossed Islamic pilgrimage routes and Muslim trade routes throughout Africa. Polio virus from Nigeria traveled as far as Saudi
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Infectious Disease Movement in a Borderless World: Workshop Summary FIGURE 4-3 Requirements of the IHR 2005. SOURCE: Heymann (2008). Arabia, Yemen, and Indonesia, and polio returned to countries that had previously become polio free. In the first year after vaccinations ceased in northern Nigeria, it cost the Global Partnership on Polio Eradication an estimated $500 million to stop polio in reinfected African countries, as illustrated in Figure 4-4. Initial efforts to deal with this situation involved demonstrating that polio vaccines contained no impurities or hormones that could cause sterility in young girls. Vaccines were sent by the Nigerian government to WHO Collaborating Centers on polio in South Africa and India, and testing was overseen by experts from Nigeria. At the same time, an offer was made by the United Nations Children’s Fund (UNICEF) of polio vaccine manufactured in an Islamic country. WHO representatives, along with Ministry of Health officials, engaged in personal discussions with the governors of the northern Nigerian states who had ordered that polio vaccination be stopped. The governors convened groups of pediatricians to help them determine whether the risk was greater from vaccine or from polio, at a time when approximately 82 percent of all polio in the world was occurring in northern Nigeria. These concerns were also taken to the Organization of Islamic Conferences (OIC), whose members understood the importance of this issue in their own countries. The OIC heads of state discussed the importance of polio eradication in a plenary session at their summit in 2003 in Malaysia, and then passed a resolution to support polio eradication that has been reviewed each year since then at annual OIC minister of health meetings. Neither proof of vaccine safety nor political and religious advocacy were, however, enough to convince northern Nigeria to resume polio vaccination. The issue was then taken to the broader Islamic community that produced a series of religious
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Infectious Disease Movement in a Borderless World: Workshop Summary FIGURE 4-4 The international spread of polio from Nigeria, 2003-2005. SOURCE: Reprinted from WHO (2005) with permission from the World Health Organization. fatwas (declarations) and academic statements regarding the safety and importance of polio vaccination. One religious leader in particular, the late Imam Cheik Cisse of Senegal, was very active in northern Nigeria, traveling there to advocate for the importance of polio vaccination, vaccinating children himself as an example. As an additional measure, WHO convened an ad hoc expert advisory group on polio epidemiology and public health to determine if there were any evidence-based measures that could be recommended to stop the international spread of polio. This group concluded that evidence in the scientific literature supported the fact that polio-immune adults could carry the virus in their intestines for periods up to a month, that the polio virus therefore had the potential to be carried wherever persons from polio-infected areas traveled, and that a booster dose of oral polio vaccine could decrease the period the virus was carried. A recommendation was made that a booster dose of oral polio vaccine be provided for persons traveling from countries with polio. Saudi Arabia, where there had been imported polio from Nigeria, followed these recommendations and began requiring booster vaccination of Islamic pilgrims before they left their country if it was polio-infected, and also upon the arrival of the pilgrims in Saudi Arabia. These recommendations continue to stand and are being considered as standing recommendations under the IHR, where polio is one of those four diseases named that even one case requires reporting. Finally, resolutions were passed in the WHA regarding measures to be taken when polio spread internationally, and the most recent, in 2008, was widely reported
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Infectious Disease Movement in a Borderless World: Workshop Summary in the Nigerian press, leading in part to further engagement of Nigerian President Umaru Yar’Adua, who stated publicly that “[w]e will do everything humanly possible to ensure that polio is finally and totally eradicated from Nigeria.” Nevertheless, the polio virus continues to circulate in northern Nigeria. As of April 2009, 184 Nigerian children have been paralyzed from polio this year (WHO, 2009a). The polio virus also continues to spread to neighboring countries, and every aspect of global governance, including work within the framework of the IHR, continues to be used to stop its international spread. While polio vaccination has resumed in northern Nigeria, efforts have not yet been effective enough in reaching children to provide the level of herd immunity necessary to interrupt transmission. Once countries succeed in interrupting the transmission of polio worldwide, other risks to polio eradication will remain. The Sabin vaccine virus is able to revert to a wild form either through genetic recombination or reassortment. After eradication has been certified, a WHO group of advisers has concluded that it will therefore be necessary to stop the use of oral polio vaccine to minimize this risk, and countries continuing to vaccinate would have inactivated polio vaccine as an alternative. It remains to be seen whether the IHR will be used by member states in any way at the time of oral polio vaccine cessation to ensure that all countries stop its use simultaneously so that no country places others at risk. It likewise remains to be seen if the IHR will be used to address another post-eradication risk, destruction, or consolidation under high security of those polio viruses that remain stored in research and diagnostic laboratories. Thus, while the IHR provide a useful framework that enables international coordination for the prevention and control of infectious diseases, their use is not automatic. It depends rather on the collective will of WHO member states to use them as a framework to resolve public health issues, on a case-by-case basis. Influenza Pandemic Preparedness WHO facilitates the work of a network of 127 national influenza centers throughout the world that regularly provide seasonal influenza viruses to one of four WHO Collaborating Centers on influenza where genetic characterization is conducted (Figure 4-5). Results of sequencing are then used for a comparative risk analysis, and an annual recommendation is made for the composition of seasonal influenza vaccine. Once the recommendation is made as to which virus strains should comprise the next seasonal vaccine, it takes up to six months to prepare the vaccine for use. The global capacity for seasonal influenza vaccine production varies between 350 million and 500 million doses, far less than would be required to produce an influenza vaccine for a pandemic. The same network of laboratories also tracks potential pandemic influenza viruses. Figure 4-6 shows the geographic locations of human zoonotic infections
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Infectious Disease Movement in a Borderless World: Workshop Summary Political Problems Pile Up, Policy Questions Multiply Political Problems The manner in which the virus sharing controversy has evolved to date has revealed many political problems and policy questions that, so far, have not been adequately addressed. Politically, this controversy has put the existing inequity of benefit sharing starkly into focus, but effectively addressing inequities of all sorts has historically proven one of the most difficult foreign policy and diplomatic challenges. In addition, the controversy has illuminated the existing and growing gaps between the disease surveillance and response capabilities of developed and developing countries. In terms of the IHR 2005, the dispute has exposed that, for all their radical elements, the new regulations are very weak with respect to providing developing countries with assistance in improving their surveillance and response capabilities. The lack of any clearly identifiable strategy, supported by funding, to help developing countries meet their minimum core surveillance and response obligations under the IHR 2005 has also been made more glaring by the virus sharing controversy. These political problems point to a harsh message for global health policy— surveillance as the “center of gravity” for global health governance cannot hold without more robust efforts to address the “benefits” imbalance emphasized by the virus sharing controversy. Put another way, the continuation of the status quo will continue to erode the legitimacy of the IHR 2005 as a mechanism of global health governance. Policy Questions This controversy is also spawning many different policy questions that require answers. Most prominently, how the virus sharing-benefit sharing dispute will be resolved remains uncertain. Some press reports claimed that the intergovernmental negotiations in December 2008 made progress, but scrutiny of the key passages of the agreed document reveals no clear “meeting of the minds” on the fundamental problems at the heart of the dispute. For example, the document’s preamble noted that the WHO member states recognize that they “have a commitment to share on an equal footing H5N1 and other influenza viruses of human pandemic potential and the benefits considering these as equally important parts of the collective action for global health.” How exactly this recognition advances the diplomatic negotiations is not clear. The need for this single statement to include the concept of equality twice suggests continuing tension among WHO member states about which is more important for global health—virus sharing for surveillance, or benefit sharing for response capabilities.
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Infectious Disease Movement in a Borderless World: Workshop Summary The virus sharing controversy raises other important policy questions, including the following: How will the equity and legitimacy questions raised by the controversy affect the implementation of the IHR 2005? What assistance will be forthcoming for developing countries to help them implement their surveillance and response obligations under the IHR 2005? Without adequate assistance, will developing countries view the IHR 2005 increasingly through the lens of “viral sovereignty”? How will policy and governance responses to these challenges fare: With an expanding global health agenda, especially the challenge of integrating human and animal health systems? With increasing competition from other global political, economic, and environmental crises? In the context of anticipated global trends over the next 10-15 years (e.g., demographics of discord, mulitpolarity without multilateralism)? IHR 2005: Intent Versus Reality Rising concerns about the IHR 2005’s future focus attention on the growing gap between the intent of these regulations and the reality of their implementation. This section analyzes this gap by contrasting critical aspects of the intent behind the IHR 2005 with the lack of effective strategies to implement the regulations globally. The IHR 2005 as Health in Foreign Policy Those crafting the IHR 2005 intended this new regime to have the kind of foreign policy significance for countries that global health policies rarely achieve. This intent becomes clear when we see how the IHR 2005 were designed to service each of the four basic functions of foreign policy (Figure 4-11): Protecting national security (e.g., through military power and alliances); Achieving national economic well-being (e.g., through increasing exports of goods, services, and investment capital); Supporting development of strategically important countries and regions (e.g., through foreign and development assistance); and Fostering human dignity (e.g., through humanitarian assistance and human rights policies). Identifying these four functions of foreign policy does not mean that any country’s foreign policy necessarily follows each function or that pursuit of the
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Infectious Disease Movement in a Borderless World: Workshop Summary FIGURE 4-11 Foreign policy functions. functions is consistent. The four functions provide an analytical framework to assess how foreign policy reflects different issues, such as global health. The IHR 2005 were designed to connect to each function of foreign policy (Figure 4-12). The WHO conceptualized the IHR 2005 as a strategy for strengthening national and global health security against both naturally occurring infectious diseases and the use of biological, chemical, and radiological agents. Thus, the IHR 2005 hooked into the foreign policy priority of national security. The express purpose of the IHR 2005 speaks to the foreign policy interest in maintaining economic power and well-being by stating that the regulations seek to address international disease threats in ways that do not unnecessarily interfere with international trade and travel. In addition, the manner in which the IHR 2005 accomplishes this purpose mirrors almost exactly how the trade-health balance is managed in WTO agreements. The IHR 2005’s emphasis on the need for each country to develop and maintain core surveillance and response capacities connects directly to strategies that emphasize the importance of public health to development policies. Over the past decades, efforts to place public health at the heart of development thinking have elevated the importance of public health capabilities to overall development aims. The IHR 2005 integrates these ideas and gives them concrete form. Finally, the IHR 2005’s incorporation and application of human rights principles reflect the foreign policy function of fostering human dignity. Unlike the
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Infectious Disease Movement in a Borderless World: Workshop Summary FIGURE 4-12 The IHR 2005 and the functions of foreign policy. IHR 1969, the IHR 2005 reflects the human rights revolution in international law and global governance, and embeds the importance of maintaining human dignity in the midst of responding to disease threats, including public health emergencies of international concern. The IHR 2005 and “Great Debates” in Global Health Another way to sense the intent behind the IHR 2005 is to consider how this radically new global health governance regime relates to some of the “great debates” taking place in global health policy circles, including: Naturally occurring infectious diseases versus bioterrorism: The IHR 2005 recognize both threats as real and contain provisions that move countries toward building public health capabilities to handle both types of threats. Vertical versus horizontal programs: With their emphasis on the need to develop and sustain core public health capabilities, the IHR 2005 support the need to craft more policies and initiatives that move toward building horizontal, systemic capabilities. Multilateral versus bilateral efforts: The IHR 2005 clearly support multilateralism over bilateralism because the regulations represent one of the
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Infectious Disease Movement in a Borderless World: Workshop Summary most innovative multilateral governance regimes ever to be created in the context of global health. Levels of governance debates: In the debate about what level of governance— local, national, or global—deserves policy priority, the IHR 2005’s design and substance emphasizes the need to improve public health capabilities at each level of governance, reflecting the epidemiological interdependence that governments and international organizations face in this realm. How the IHR 2005 factors into these “great debates” in global health helps illustrate why this new global health governance regime has such importance for global health and for foreign policy in this area. The intent behind the IHR 2005 was not to create a regime that was merely technical, narrow, and apolitical. The intent was to produce and implement a regime that could raise the foreign policy importance of global health and be a transformative contribution to global health governance. The IHR 2005 and Other Governance Regimes This workshop has considered many “drivers” of disease emergence and spread, including trade, travel, migration, environmental change, antimicrobial resistance, and armed conflict. For many of these drivers of microbial emergence and spread, existing international governance regimes are weak and ineffective, particularly with respect to migration, environmental change, antimicrobial resistance, and armed conflict. The weakness of other governance mechanisms in this realm only reinforces the importance of the IHR 2005 as the global regime designed to strengthen the ability of the countries and the international community to prepare for, protect against, and respond to emerging and reemerging disease threats. This enhanced political significance for the IHR 2005 helps underscore the critical role the IHR 2005 have in the future of global health. IHR 2005 Implementation Realities Many presentations at this workshop have raised concerns about problems with the actual implementation of the IHR 2005. These implementation problems include the impact of the H5N1 virus sharing controversy and more general worries about the lack of any robust and funded strategy to assist developing countries to implement the IHR 2005 by the 2012 compliance deadline. I have also raised the concern that other global problems and crises, such as the global energy, food, climate change, and economic crises, have overshadowed the policy challenge of IHR 2005 implementation. In my work on the IHR 2005, I also sense a pervasive lack of understanding and urgency about the importance and the potential of the IHR 2005, which undermines prospects for effective implementation.
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Infectious Disease Movement in a Borderless World: Workshop Summary A disappointing example of this lack of understanding and urgency appeared the day before this workshop began, when the IOM released the recommendations for the Obama Administration on U.S. foreign policy and global health from the high-profile Committee on the U.S. Commitment to Global Health (2008) (committee). This committee called “on the next President to highlight health as a pillar of U.S. foreign policy” (emphasis in original) and presented the new President with its “ideas for the U.S. government’s role in global health under the leadership of a new administration” (IOM, 2008, pp. 1, 5). This report never even mentions the IHR 2005, let alone includes any recommendations concerning how the Obama Administration should handle IHRs 2005 implementation challenges. How such a high-powered, extensively briefed committee could produce peer-reviewed foreign policy recommendations on global health that fail to mention, even once, the IHR 2005 as relevant to U.S. foreign policy on global health is astonishing and, unfortunately, disappointing evidence of an apparent failure among the committee members and perhaps even the peer reviewers to appreciate the importance of the IHR 2005 to global health and U.S. foreign policy interests in this realm. Interestingly, and equally astonishing, the committee’s report fails to address, let alone make recommendations concerning, two potential threats that contributed significantly to global health becoming more important in U.S. foreign policy over the past 10-15 years—the threats of pandemic influenza and bioterrorism.20 The UN and the WHO have both emphasized the importance of addressing bioterrorism and pandemic influenza as part of global health activities. The IHR 2005 encompass both of these threats as part of how the regulations, by design, connect to foreign policy interests that countries, including the United States, have in global health. The United States has expended a great deal of foreign policy and diplomatic effort on addressing pandemic influenza and bioterrorism, and, in the event either of these threats emerges, the President of the United States and his national security and foreign policy teams would have to confront such developments. Yet, the committee never directly mentions either threat or provides any recommendations for the Obama Administration to improve how the United States addresses these global health challenges. The Influenza A (H1N1) Outbreak of 2009 Although it occurred after the workshop in December 2008, the outbreak of influenza A (H1N1) in April and May 2009 is very important to consider briefly in terms of the issues addressed at the workshop. Although, as of this writing, the 20 The report contains one mention of “[e]merging pandemic threats like bird flu” (IOM, 2008, p. 15) but no mention of pandemic influenza or all of the diplomatic and foreign policy activity that the threat of pandemic influenza has generated in the last few years.
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Infectious Disease Movement in a Borderless World: Workshop Summary outbreak had not fully run its course, five points should be made with respect to the outbreak’s relevance to the issues raised in this paper. The Importance of the IHR 2005 The influenza A (H1N1) outbreak triggered the first full-scale application of the IHR 2005 to a communicable disease threat, and, as such, was historic for a number of reasons: The novel H1N1 influenza virus was the first new pathogen to emerge since the IHR 2005 entered into force in 2007, and the IHR 2005’s direct application to the virus and its emergence underscored the value of the broader scope of the regulations. WHO took actions authorized under the IHR 2005 for the first time, including: convening the Emergency Committee established in the IHR 2005 (Article 48) to advise the WHO Director-General on whether the H1N1 virus and outbreak constituted a public health emergency of international concern; the Emergency Committee’s recommendation that the H1N1 outbreak did constitute a public health emergency of international concern; the WHO Director-General’s declaration under the IHR 2005 (Article 12) that a public health emergency of international concern existed; and the WHO Director-General’s issuance, with the advice of the Emergency Committee, of temporary recommendations under the IHR 2005 (Article 15) to guide state parties in responding to the H1N1 problem. Trade measures (e.g., import bans on pork products from affected countries) and measures taken against travelers from affected countries (e.g., quarantine measures China applied against Mexican nationals arriving in China from Mexico) were scrutinized for their compliance with rules in the IHR 2005. Under these rules, WHO issued statements that trade restrictions on pork products were not necessary from a public health perspective; and requested that China provide a justification for certain measures it was applying to Mexican nationals (see IHR 2005, Article 43(3)). The IHR 2005 and the WHO Pandemic Influenza Alert System Another interesting feature of the H1N1 outbreak was that the WHO Director-General used the Emergency Committee authorized under the IHR 2005 to advise her on whether to determine that the outbreak triggered higher pandemic alert
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Infectious Disease Movement in a Borderless World: Workshop Summary phases in the WHO’s pandemic influenza alert system, which she did twice in the last week of April 2009, ultimately raising the alert level from phase 3 to phase 5. Criticism of the decisions to elevate the pandemic alert phases mounted when the H1N1 virus did not exhibit severity in its effects in the vast majority of human cases. The lack of any criterion for the severity of an influenza virus’s impact in the pandemic alert system brought calls for changes in the system, and WHO announced it would undertake a review of the system in light of its use in the H1N1 outbreak. From the IHR 2005 perspective, the use of the Emergency Committee established under the IHR 2005 raises questions about the use of this Committee to advise on the pandemic influenza alert system. The IHR 2005 contain no references to the pandemic alert system, and the mandate of the Emergency Committee is limited to providing its views to the WHO Director-General on (1) whether an event constitutes a public health emergency of international concern; (2) whether to terminate a public health emergency of international concern; and (3) the proposed issuance, modification, extension, or termination of temporary recommendations (IHR 2005, Article 48(1)). In other words, the IHR 2005 do not authorize the Emergency Committee to advise the WHO Director-General on whether she should raise the alert phase under the pandemic alert system, which itself forms no part of the IHR 2005. The H1N1 Outbreak’s Impact on the Virus Sharing Controversy During the H1N1 outbreak, affected countries shared samples of the H1N1 virus with WHO and other countries (e.g., Mexico shared virus samples with Canada and the United States) without controversies. This pattern of behavior reinforced how critical timely sharing of virus samples is for national and global efforts to understand and manage a potentially dangerous outbreak of a new pathogen. How the sharing of H1N1 viruses for global surveillance and response purposes will affect the difficult, ongoing negotiations on sharing H5N1 virus samples is not clear, but the sharing of samples of the H1N1 virus might shift the terrain enough for more productive talks at the next negotiating session to emerge. The H1N1 Outbreak and Health as a Foreign Policy Issue The H1N1 outbreak also illustrates the elasticity that health exhibits as a foreign policy issue. The global energy, food, and economic crises that emerged in 2008 had pushed health issues down the list of foreign policy priorities until the H1N1 outbreak—another global health crisis—raised again the importance of health to foreign policy and diplomacy. And, when the H1N1 outbreak began to look more like an annual influenza epidemic rather than the dreaded 1918-1919 pandemic, the outbreak faded almost as quickly from political prominence as it had emerged.
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Infectious Disease Movement in a Borderless World: Workshop Summary The Failure to Emphasize the IHR 2005 in Global Health Proposals for the Obama Administration As noted earlier, the H1N1 outbreak revealed the importance of the IHR 2005 as a global health governance framework. The first global health problem the Obama Administration confronted involved a novel influenza virus handled globally through the IHR 2005. The outbreak helps highlight the failure of the Committee on U.S. Commitment to Global Health to give any serious emphasis to the threat of influenza epidemics or to the importance to the United States of the IHR 2005 in its highly touted report of December 2008. Conclusion The virus sharing controversy sparked by Indonesia has been a body blow to the trajectory of global health governance, and in particular the IHR 2005. This controversy has not been fatal to the prospects of the IHR 2005, as the H1N1 outbreak demonstrates. But, in reality, nothing in the way in which the controversy has unfolded hints that this episode has any silver linings for the IHR 2005’s future. In fact, as we attempt to look past the virus sharing controversy with the H1N1 outbeak in mind, we must acknowledge that the IHR 2005 face some rather daunting global trends: Epidemiological risks are expanding and accelerating, Incentives for political disagreements on how to handle such risks are increasing, Limitations on governance mechanisms, such as the IHR 2005 and WHO, are increasingly exposed, and Vulnerabilities of societies to pathogen politics are deepening. More positively, the H1N1 outbreak has brought the IHR 2005 renewed political attention and importance because the outbreak highlighted the value of the strategies embedded in the IHR 2005 and the capability of WHO to implement it in a crisis. The H1N1 virus’s comparatively mild impact did not, however, test the IHR 2005 as severely as a more virulent virus would have done. The IHR 2005’s relevance to the H1N1 outbreak demonstrates that the virus sharing controversy does not represent the beginning of the end for the IHR 2005, but this controversy and the H1N1 outbreak perhaps together signal the end of the beginning for the IHR 2005’s journey in global health, with potentially more difficult times ahead for the IHR 2005 as an innovative mechanism for global health governance.
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