Health Policy and Initiatives

Globalization has transformed the marketplace for medicines in recent decades, giving rise to new threats including the poor traceability of global supply chains, counterfeit and substandard medicines, and antibacterial resistance. Aware that public drug authorities must cooperate to meet the emerging challenges of modern medicines regulation, the U.S. Food and Drug Administration (FDA) has been discussing with counterpart agencies abroad creating a "global coalition of regulators." Yet a coalition alone is not enough; the devil, as always, will be in the details. In pursuit of this goal, the FDA and partner medicines regulatory agencies should design a coalition with five distinct features: narrow scope, to promote realistic goals; flexibility, to adapt to future circumstances; selective membership, to maximize like­mindedness, particularly in the early stages; nongovernmental (NGO) participation, to leverage the capacities of both NGOs and for-profit corporations; and institutional partnerships, to orchestrate the activities of other regulatory organizations. Medicines Oversight Is Increasingly Complex in a Global Context Since the early 1990s, firms and products have proliferated in the global drug market, leading to stiffer competition and pressures to improve productivity. Drug companies have adapted by outsourcing a large share of services to other countries. Their reliance on tens of thousands of foreign subcontractors has resulted in an acutely segmented supply chain. Medicines may be processed, packaged, sold, and resold multiple times before reaching consumers. For regulators, it can be difficult to ensure the safety of drugs before they hit pharmacy shelves. As a result, the global supply is vulnerable to a host of threats that can have deadly consequences. In 2007 and 2008, fraudulent doses of heparin, imported from China, killed at least 149 Americans. Even when the effects are not fatal, adulterated therapies can intensify illness, introduce new health concerns, or lead to costly delays in recovery. Such cases of deadly or ineffective medicines will likely become more frequent in the absence of more effective global regulation. For national regulatory authorities, enforcing a safe and secure medicines sector is no longer a singularly domestic undertaking. The FDA, for instance, is supposed to regulate products destined for the U.S. market originating in roughly 300,000 manufacturing facilities located in over 150 countries. But neither the FDA nor any other national regulatory authority has the capacity to fulfill this remit on its own. According to a 2010 U.S. Government Accountability Office report, it would take the FDA eighteen years to inspect all registered manufacturing firms in China just once. This point underscores the fact that most foreign facilities have never received a single inspection from the FDA, and never will, if the status quo persists. Tackling these concerns requires strong multilateral cooperation among national regulatory agencies. To this end, a handful of international institutions and initiatives populate the regulatory space. These include the Pharmaceutical Inspection Cooperation Scheme (PIC/S), International Conference on Harmonization (ICH), and International Pharmaceutical Regulators Forum (IPRF). These schemes operate within specific, technical mandates and, since they perform their respective tasks well, should not be the focus of unnecessary reforms. At the same time, such specialized entities leave critical areas of regulation unattended. What has been missing from the institutional landscape is a high-level, strategic body capable of coordinating these and other existing regulatory approaches, closing the policy gaps among them, and proposing solutions to emerging challenges not currently addressed. Doing so would also empower a body to assume responsibility for new and pressing commitments, including harmonizing medicines standards, establishing coordinated monitoring systems, and building capacity in countries that need it most. How to Design a Global Coalition of Regulators As the world's premier national regulatory body for medicines (and food), the U.S. FDA is ideally positioned to facilitate a multilateral coalition composed of heads of medicines agencies. Yet the success of any such institution hinges on its initial design. Getting it right the first time is critical, since institutions are notoriously resistant to change. More than a few regulatory arrangements have been hobbled by design flaws. A case in point is the International Organization of Securities Commissions, a network of domestic securities authorities that has struggled to harmonize standards because its large membership (124 agencies) and consensus decision-making rules impede cooperation. To improve the odds of success, the FDA and its counterparts should incorporate five design features into a coalition of medicines regulators: Narrow scope. The global coalition should identify select issues it could reasonably address with the resources and expertise at its disposal, and where it can add value. When it comes to medical products, top priorities include: harmonizing standards; increasing monitoring capabilities in jurisdictions where the production of drugs is burgeoning, such as China and India; and helping to build capacity in countries with weaker regulatory authorities. Only after the coalition has begun to attain these objectives should it consider expanding its remit to other issues, such as tackling barriers to generic drug access or scaling up the FDA's Secure Supply Chain pilot program—a voluntary initiative that expedites the entry of imported drugs for firms meeting designated security criteria. Flexibility. The supply chain for medicines will evolve in unexpected ways, as will the policy preferences of national medicines agencies. Therefore, it is important to design a coalition that can adapt its mission, membership, and mandate to future circumstances. First, coalition members should pursue soft approaches rather than treaty-based solutions because they are easier to negotiate, even if rules become "harder," or more detailed, over time. Examples of soft law are principles, action plans, and recommendations, such as those published by the Financial Action Task Force. Second, if decisions cannot be reached by consensus, a majoritarian voting system would help overcome obstacles to action and improve responsiveness. Electing members to the governing board, adopting a strategic plan, or urgently responding to a public health crisis are different scenarios in which voting may prove useful. Third, building mechanisms for self-evaluation beyond annual reports, such as requiring the coalition to renew its mandate every five years, can encourage its members to revisit and revise institutional goals. Selective membership. Initially, the coalition should maintain a selective membership of approximately twenty jurisdictions representing willing and capable regulatory leaders. This modest size will allow members to more easily identify actionable goals while accelerating plans to meet them. Meanwhile, the coalition should consider its future target membership, in order to forecast preferences down the line. This means that even if the body is mainly composed of advanced market democracies, it should from the outset also include rising powers integral to the global medicines trade and its regulation. The cast of members should encompass the Group of Seven (G7), including the European Union; a handful of (non-G7) industrialized countries that have shown leadership in global regulation, including Australia, Ireland, the Netherlands, and Singapore; and critical rising powers, namely Brazil, China, India, South Africa, Nigeria, and Indonesia. Once established, the coalition should open its doors to any country committed to upholding high domestic health standards and assuming part of the global regulatory burden. Nongovernmental participation. Full membership in the coalition should be limited to national regulatory agencies, since they represent the public interest. Still, nonstate actors possess unique capacities in global regulation, which the coalition should leverage. For example, firms are best suited to monitor their own supply chains. Likewise, NGOs bring an independent voice to policy debates and can serve as effective watchdogs. The best option would be to institutionalize participation of industry actors and NGOs within the coalition, as observers or affiliate members. Regulators would retain ultimate authority, but the coalition would regularly draw on their input. Criteria for firms should include contributions to drug innovations and a strong commitment to pharmacovigilance—detection, analysis, and prevention of adverse drug effects. Criteria for NGOs should involve evidence-based philanthropic work and a record of consumer advocacy. Limiting firm and NGO involvement to five members apiece would allow leaders to hear diverse opinions without undermining public interest. An alternative option is to establish a parallel network, detached from the coalition, to set standards and undertake activities complementing the coalition's work. Institutional partnerships. Finally, the coalition should avoid the pitfall of assuming the entire regulatory burden itself. Rather than trying to replace regulatory bodies that are working well, the coalition should aim to steer, shape, or "orchestrate" their work. This can be done through formal or informal partnerships, whereby the coalition either coordinates its activities with organizations that implement programs or realizes common goals by lending financial and political support, such as through grants, office space, joint forums, or high-level endorsements. Such measures might eventually involve regional harmonization efforts (e.g., African Medicines Regulatory Harmonization program) or relevant private standard-setting bodies (e.g., Health Level Seven International, which focuses on electronic health information). Initially, however, coalition leaders should collaborate with organizations that share similar memberships, such as the Summit of Heads of Medicines Regulatory Agencies, a forum for exchanging information. This would minimize policy differences and provide a testing ground for future partnerships. Building consensus to launch a coalition should not present any major obstacles as the FDA and foreign counterpart agencies are already exploring plans to create a new global regulatory authority. Nonetheless, implementing these policy proposals will require political dexterity. The coalition must provide a clear path to membership for developing countries that initially remain outside the body. One option is to create tiers of membership linked to regulatory capacity, establishing criteria for graduation and mobilizing development assistance to help countries do so. Similarly, nonstate actors will expect a clear and fair set of criteria for their participation. Failing to meet these demands may reduce the strategic role of the coalition and diminish its legitimacy. Moreover, consumer groups may argue that collaboration with the private sector exposes policymakers to regulatory capture, as agencies place private interests above public interests. However, historical lessons from many sectors suggest that regulatory capture is more likely when regulators interact with firms on their own terms and within their own bureaucracies, without the transparency afforded by participation of peer agencies. These five recommendations are no panacea. Still, they should vastly improve the existing patchwork of disjointed institutions sprawled across the regulatory landscape. More important, they represent a critical first step toward a strategic and nimble network of medicines regulatory authorities, capable of harnessing the strengths of current efforts while also creating new rules to ensure the security of the global supply chain. A global coalition of regulators, buffered by these prescriptions, would enhance consumers' confidence in their medicines, reduce cases of counterfeit and substandard drugs entering the global supply chain, and potentially save taxpayers money by leveraging the resources of other countries and institutions. The stakes are high, given the growing risk to public health. But so, too, are the incentives and opportunities for cooperation, because all countries—and all people—rely on a supply of safe medicine.

Overview Over the past decade, the Global Fund's presence in China has left behind a deeply mixed legacy. Although the Fund's money has made important contributions to China's fight against AIDS, TB, and malaria, as well as its domestic health governance in ideational, institutional, and policy domains, it is associated with uneven progress in grant performance, low value for money, unintended effects on civil society–building, and enduring challenges to scaling-up and sustainability. In this International Institutions and Global Governance program Working Paper, CFR Senior Fellow Yanzhong Huang and Jia Ping, chief executive director of the Health Governance Initiative, argue that the mixed legacy has important implications for global health governance, the Fund's future financing model, and China's handling of its own public health challenges. Download the Chinese translation of this report [PDF].

The foreign policy community has largely ignored the unfolding revolution in biology, leaving its supervision to traditional scientific bodies, and, in rare cases, law enforcement agencies. This is a tremendous mistake. New technologies and genetic tools now allow biologists to manufacture living organisms, give viruses and bacteria capacities not found in nature, and push the boundaries of evolution in ways unimaginable less than a decade ago. Moreover, the costs of genetically decoding and modifying pathogens have plummeted since 2000, from billions of dollars to only a few thousand. Policymakers urgently need to work with diplomatic, law enforcement, disease surveillance, and global trade leadership worldwide to simultaneously regulate and deter malevolent or careless abuse of the new biology, while promoting its beneficial applications to medicine, science, and technology innovation. The New Revolutions in Biology Two revolutions are unfolding in biology, giving scientists the ability to turn existing germs into more dangerous ones with gained functional characteristics, and to synthesize new life forms entirely. The gain-of-function (GOF) revolution has been brought starkly to light by recent influenza experiments. Fearing various forms of bird flu viruses might naturally evolve into pandemic strains that could kill millions of people, the Animal Influenza Lab of China's Harbin Veterinary Research Institute used new biology techniques in 2013 to manufacture 127 previously nonexistent types of influenza viruses, five of which spread through the air between guinea pigs, indicating they might transmit casually from person to person. The Chinese virus-makers were not the first to manufacture killer microbes for the ostensible purpose of imagining what could emerge from natural evolution. In 2012, scientists in Wisconsin and the Netherlands manipulated the genes of H5N1 bird flu viruses, turning what in nature are bird-to-bird influenzas into forms of the virus that could spread through the air between ferrets—lab stand-ins for human beings. A second revolution—synthetic biology—exploits gene-sequencing technology that makes it cheap, fast, and easy to decipher DNA codes. Companies offer "bricks," or sections of genetic sequences, which can be purchased to build novel genomes, like stacking Legos. With GOF and synthetic biology, scientists are no longer mere observers of life but its creators, engaged in a cheap, fast-paced, multinational collaboration that is decoding all life forms, identifying their interesting "bricks," and exchanging them in real time, via the Internet. The Unfolding Problems While the new biology is racing pell-mell into a twenty-first century of biocreation, national and international surveillance and regulatory systems are bogged down in an outdated disease and counter-bioterrorism approach, focused on old-fashioned "select agent" lists of germs and toxins. Since the anthrax mailings of 2001, the U.S. Congress has appropriated hundreds of billions of dollars to develop technologies aimed at such antiquated lists. Meanwhile, the private sector worldwide is largely unregulated and unobserved. The U.S. and Dutch GOF flu experiments spawned debate between virologists and experts in public health and biosecurity, resulting in a set of U.S. National Institutes of Health guidelines for dual-use research of concern (DURC) on avian influenza. But as the Chinese creation of flu viruses demonstrates, unilateral U.S. guidelines offer no protection against overseas synthesis of dangerous new life forms. Moreover, U.S. biologists argue that domestic "overregulation" of GOF and synthetic biology work puts the country at an economic and scientific disadvantage compared to competition in Europe, Asia, and Latin America. DURC poses some immeasurable, but potentially high-impact, threats for state or nonstate terrorism. The more immediate risk is the unintended release of pathogens, with potential to harm humans, livestock, agriculture, or the environs. There is negligible oversight in any country over potential DURC executed in low-security labs, such as those found in high schools, colleges, and most private sector facilities. Since 9/11 there has been an exponential proliferation of biosafety level-3 (BSL-3) and -4 (BSL-4) laboratories worldwide—by definition, DURC-potential facilities—in which special pathogens, such as killer influenzas, Ebola, and smallpox, are stored and studied. Since 2003, more than one hundred human-exposure accidents involving deadly microbes have occurred in such U.S. labs. No uniform international or regional standards or definitions exist of laboratory security, safety, or protocols for DURC. What Needs to Be Done There is no consensus among science and security experts regarding which dual-use research weighs on the side of social benefit, versus that which poses significant danger to mankind. If left to self-supervise, scientists typically opt for a deregulated working environment. But policymakers need to reframe the issue and not leave risk assessment and response solely in the hands of the scientific community. Policy recommendations include the following: The U.S. Department of State (DOS) and the Department of Health and Human Services (HHS) should collaborate with international partners to harmonize global laboratory and biosecurity standards. DOS and HHS should work closely with the European Union, Organization of American States, African Union, and Association of Southeast Asian Nations to promulgate clear definitions of BSL-3 and BSL-4 labs, standards for biosecurity, pathogen storage, limits on GOF research, and screening of shared novel genetic sequences. Setting equivalent regulatory standards worldwide will minimize the risk that one well-regulated country's scientific pursuit is stifled while another's surges forward in the absence of government caution. A model for emulation might be the Codex Alimentarius, established by the Food and Agriculture Organization and the World Health Organization (WHO) in 1963 to standardize all food-safety guidelines worldwide. The Centers for Disease Control and Prevention (CDC) and the FBI should shift away from a "special pathogens" approach to one of monitoring and enforcement. A select-list approach offers false security, and by definition misses all novel threats. The CDC and FBI should work closely with the WHO, Interpol, the European Center for Disease Control, and analogous agencies worldwide to identify who is working on newly created or genetically augmented organisms, and to assess their threats. The Biological Weapons Convention process can serve as a multilateral basis for this conversation, but discreet, bilateral, and regional discussion is likely to prove more fruitful. The Department of Commerce, Animal and Plant Health Inspection Service (APHIS), and the Office of the U.S. Trade Representative should create a regulatory framework appropriate to the DURC conundrum. In an era when emailed gene sequences render test-tube transport obsolete, the proper boundaries of export are difficult to define. Overregulation risks stifling science. A model for regulation might draw from the experiences of the International Plant Protection Convention and APHIS' engagement via the agency's International Services. Many nucleotide distribution centers already monitor "sequences of concern" for Internet traffic in genomes, demanding special information on individuals seeking pathogen-related genetic details—an approach that should be embraced for government application. Private biotech companies and "biobrick" distributors should assign biosecurity tags to all man-made products. Trade in genomic sequences should be transparent and traceable, featuring insertion of nucleotide tags that can be monitored. Tagging is already mandated for genetically modified crops, and it can be implemented for man-made or commercially traded significant biobricks. The industry should self-finance necessary monitoring and enforcement of standards of practice, and permit unrestricted government inspection in the event of breakdowns in biosafety or lab security. Congress should restore disease-surveillance and response funds to the CDC and the U.S. Department of Agriculture (USDA). Such funds to the CDC have been cut by 25 percent—about $1 billion—since 2010 and further diminished by 5.1 percent under sequestration, including the loss of fifty thousand state, territorial, city, and county public health officers. CDC and USDA have been cut so severely that they have no reprogrammable funds. Both organizations should have sufficient funding and scientific capacity to ensure that if a pathogen is deliberately or accidentally released, systems of identification, containment, and response are in place that can eliminate or minimize the risks to humans, livestock, crops, and the environment. Any cost-benefit analysis strongly supports these modest expenditures, as release of foot-and-mouth disease would cost the U.S. livestock industry $14 billion a year; GOF research is calculated to increase the risk of human infection two-hundred-fold; and the World Bank estimates a virulent influenza pandemic would cost the world economy $3 trillion. The United States should fund the WHO's response capacity, leading a donor $100 million annual special support for the next five years. Facing tough budgetary constraints, the WHO has cut its 2014–2016 crisis-response budget by more than half and shifted outbreak responsibilities to the country level. But only thirty-five countries meet surveillance-capacity standards set by the International Health Regulations. The WHO's World Health Assembly of 194 nations aspires to country self-reliance in IHR compliance, but a bridge in support is needed to get poorer nations to that goal, and keep the WHO disease response program alive. The United States should take the lead; pick up most of that $100 million tab for FY14, rally other wealthy public donors and commit to provision of a portion of the bridge funds thereafter, diminishing annually as self-reliance grows, and zeroing out by the end of 2019. At no additional cost beyond restoration of now-sequestered monies, Congress should sustain the U.S. Agency for International Development PREDICT Project, which has trained fifteen hundred people worldwide to date and discovered two hundred previously unknown viruses. In general the academic, institutional, and commercial science sectors bridle at all forms of external regulation and argue that outsiders cannot comprehend their needs, innovations, and safety measures. As with genetic engineering in the 1970s and nuclear physics in the mid–twentieth century, scientists are wrong to insist that general society has no right to be wary of their efforts, or to insist on oversight. Concerns in poorer countries that the United States and Europe will use DURC regulation to hold them back are not entirely groundless. It is imperative that wealthy nations assist them in developing their research, biosecurity, and surveillance capacities, and not use the dual-use issue as an inappropriately applied obstacle to scientists' work visas and immigration. Although the combined impact of these recommendations will not entirely eliminate DURC-related biological threats, the resulting raised levels of governments' awareness, readiness, and response capacities would both vastly improve the prevention of disease and outbreaks, and minimize the health, economic, political, and environmental damage caused by a deliberate or accidental release of synthesized or GOF-altered organisms. Read Laurie Garrett's related article in the November/December 2013 issue of Foreign Affairs, "Biology's Brave New World."

This page is part of the multimedia Global Governance Monitor. Scope of the Challenge Despite medical advances and improvements in sanitation, water supply, nutrition, housing, and education, poor health continues to plague many countries in the world today. Infectious diseases kill approximately fifteen million people each year, and more than four million die from AIDS, malaria, or tuberculosis alone. A disproportionate share of this suffering occurs in developing countries. New threats, such as severe acute respiratory syndrome (SARS) and recombinant flu strains, continue to arise. Meanwhile, health conditions traditional to wealthier nations—including tobacco consumption, obesity, diabetes, and other noncommunicable diseases (NCDs)—are increasingly prevalent in the developing world. Global public health continues to be undermined by negative environmental, political, and economic factors from pollution to violent conflict to limited food production, and even a new, man-made threat—the specter of biological attacks. The expansive and evolving nature of global health challenges exerts constant pressure on national governments charged with safeguarding citizens' health and on the international institutions engaged in controlling the cross-border spread of disease and curbing dangers from noncommunicable diseases. Public health actors are generally motivated by a mix of development, humanitarian, economic, and security interests. Public attention to global health has grown at an unprecedented pace over the past half century. A surge in both funding and staffing has helped successfully eradicate smallpox, decrease AIDS mortality, and raise average global life expectancy from forty to sixty-five years. The shift has rightly been called a public health revolution. The surge in funding has spawned numerous organizations dedicated to improving public health worldwide. Some, though, have overlapping mandates, and coordination efforts are at times limited. Additionally, programs focused on alleviating specific diseases can often siphon resources from local infrastructure and reduce comprehensive health services. More needs to be done to coordinate actors and improve coherence across the global health landscape. Through centralized fora like the World Health Organization (WHO), countries should clarify priorities for the global health agenda, allocate more attention to health-related needs, advocate for greater accountability among nongovernmental organizations, and improve the monitoring and evaluation of global health initiatives. Meanwhile, as the global economic slump continues to linger, international institutions need to help ensure sustained financing for global health, improve alignment of recipient- and donor-country priorities, increase harmonization of multiple donor efforts, and engage the private sector to help mitigate persistent inequities in the development and delivery of resources to meet global public health challenges. Strengths & Weaknesses Overall assessment: Unprecedented focus and funding, yet anarchic The institutional landscape for global health is more populated, diverse, and better resourced than it was twenty years ago. The traditional multinational institutions that first dominated after World War II—primarily the World Health Organization (WHO)—have been joined by a panoply of new multilateral initiatives, public-private partnerships, foundations, faith-based organizations, and nongovernmental organizations. Yet the effectiveness of this increase in players and resources is often diluted by an uncoordinated and incoherent system. The WHO remains the primary organization involved in global health, responsible for health-related activities within the United Nations (UN). It plays a leadership role, spearheading research, policy, and country-level training and support. But the array of new players with expertise on global health is staggering. Within the UN, the Joint United Nations Program on HIV/AIDS (UNAIDS) and the UN Children's Fund (UNICEF) focus on particular global health issues. Other international organizations and programs with at least a partial mandate to address global health matters include the Food and Agriculture Organization (FAO), World Trade Organization (WTO), International Labor Organization (ILO), UN Environment Program (UNEP), and the World Bank. Multilateral funding mechanisms have also appeared, such as the Global Alliance for Vaccines and Immunization (GAVI), and the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund). Regional organizations, including the European Union (EU), the Association of Southeast Asian Nations (ASEAN), the African Union (AU), and the Pan American Health Organization (PAHO)—have also become players in global health. Their combined work has strengthened systems, ensured universal health accessibility, and facilitated dialogue among member states, international institutions, and nonstate actors. Meanwhile, donor governments have launched major bilateral global health efforts (such as the U.S. President's Emergency Plan for AIDS Relief, or PEPFAR), and a growing number of departments, including military and security agencies (such as the U.S. Department of Defense), have become involved in global health. All these official actors share space with a burgeoning number of nongovernmental organizations (NGOs), faith-based organizations, and foundations dedicated to advancing global health. A rise in global health initiatives has accompanied this proliferation of actors. Three of the eight UN Millennium Development Goals (MDGs) focus squarely on health objectives, and another four relate to the social determinants of health. The Group of Eight (G8) now regularly places public health on its annual summit agenda, and the new Group of Twenty (G20) prioritized global health at its 2011 summit in France. In 2000, the UN Security Council declared HIV/AIDS a threat to international peace and security. The multilateral Health Eight (H8)—a group of eight organizations working on global health issues—was also established to coordinate global health initiatives and determine uniform international health priorities. In all, more than forty bilateral donors, twenty-five UN agencies, twenty global and regional funds, and ninety global initiatives target health activities and assistance. This institutional richness creates huge coordination challenges, not least for developing countries on the receiving end of outside attention. As a partial response, the International Health Partnership and related activities (the so-called IHP+) seeks to coordinate the activities and funding commitments of outside actors around country-led strategies. New treaties have been negotiated to help strengthen aspects of the global health regime. The revised International Health Regulations (IHR 2005) established rules and processes that allow the WHO and its member states to identify and respond to international public health emergencies more effectively. The regulations require state parties to report significant disease events and to develop and maintain core public health surveillance and response capacities. Similarly, the Framework Convention on Tobacco Control (FCTC), adopted by the WHO in 2003, is the first international convention under Article 19 of the WHO Constitution. It has helped to mobilize an unprecedented, worldwide anti-tobacco movement. In addition, the Global Code of Practice on the International Recruitment of Health Personnel [PDF], adopted by the WHO in 2010, aims to mitigate the imbalances of health workers between developed and developing countries. Much-needed funding has also increased. International financial support for global health efforts ballooned from $5.6 billion in 1990 to over $27 billion in 2010, thanks in part to the development of innovative financing mechanisms. Of special note is the prominent role that NGOs, including philanthropic foundations and private corporations, play in championing and financing public health programs. The Bill and Melinda Gates Foundation, in particular, provides approximately 5 percent of all funding for global health assistance. This surge in resources has contributed to several notable successes, including expanded access to medicines, improved disease detection, and growing community participation. Despite this progress, several significant weaknesses are apparent. First, inadequate coordination and leadership threaten the efficacy of today's global health institutions. Although effective coordinating bodies have sprung up, much of the activity in the field of global health reflects poorly integrated, donor-driven, disease-specific initiatives, often with weak accountability. Such a patchwork has led one prominent scholar to describe the system not as a regime, but as a loosely configured complex. Second, increases in funding and the proliferation of organizations and initiatives have not adequately addressed continued health disparities between affluent and poor countries. Many of the benefits derived from globalization have disproportionately accrued to wealthy countries, leaving poor nations vulnerable to acute and chronic health threats. Given these challenges, progress toward achieving the health-related MDGs—including a 75 percent reduction in maternal mortality between 1990 and 2015—has been slow. Additional weaknesses in global health governance include inadequate disease surveillance, inequitable access to vaccines and other essential medicines, a focus on single diseases rather than public health systems, and comparatively little donor attention and resources devoted to noncommunicable diseases. Moving forward, the United States and stakeholders worldwide face three main challenges: first, to reinvigorate the resources needed to address an expanding agenda; second, to minimize health disparities between rich and poor countries; and, third, to correct an absence of coordination and leadership. Targeting noncommunicable diseases: Growing awareness, but still too little Noncommunicable diseases have traditionally received little attention from the international community, yet they pose an important and growing threat to public health. In 2008, the World Health Organization (WHO) reported that chronic, noncommunicable diseases are the leading cause of death globally, despite being mostly preventable. As a result, the WHO is increasing its efforts to target noncommunicable diseases around the world. Traditionally, noncommunicable disease—cardiovascular problems, diabetes, cancer, and chronic respiratory illness, to name a few—have been considered diseases of affluence because they reflect ill health resulting from improved living standards. Today, their prevalence is more global. They correspond to shifts in diet and nutritional standards as well as to aging, because older populations have higher levels of cardiovascular disease and cancer. Although noncommunicable diseases remain the leading cause of death in the West, risk factors stemming from tobacco and alcohol consumption, unhealthy diets, and physical inactivity are increasingly driving mortality rates in poor countries, hampering socioeconomic conditions for growth and development. In the South Pacific region, for instance, noncommunicable diseases account for 75 percent of annual fatalities. In countries with a burgeoning middle class—namely, India and China—food consumption patterns have changed in favor of a higher protein-filled diet, but this has been accompanied by a massive increase in per capita consumption of salt, sugar, and trans fats, which contribute to the onset of noncommunicable diseases. Aware of the growing threat, the WHO created the Global Strategy on Diet, Physical Activity, and Health [PDF] (DPAS) in 2004, aimed at raising awareness and reducing the health risk factors associated with sedentary lifestyles and a poor diet. The DPAS has engaged relevant figures around the world, including national governments, private actors, and United Nations agencies—such as the Food and Agricultural Organization (FAO) and the Codex Alimentarius Commission—to promote awareness of the harmful effects of poor lifestyle choices and to incorporate health policies at the country level. Implementation, however, has been slow as the WHO also continues to allocate a substantial amount of resources to a multitude of other international health concerns. This is especially so among low- and middle-income countries, where noncommunicable diseases compete for resources allocated to prevalent infectious diseases. The DPAS also prompted controversy from companies concerned about adopting restrictions on marketing certain food and beverage products. The WHO has also begun to focus on obesity and alcohol consumption. For the latter, based on consultations with states, it has drafted a global strategy [PDF] on harmful use of alcohol. In January 2010, the WHO executive board adopted a resolution recommending the World Health Assembly adopt this strategy. On obesity, the WHO has recognized the problem as growing and in some countries acute. Its efforts, however, are limited to advocacy and the collection and analysis of relevant data. In some cases, it has joined forces with regional organizations. One such example is the European Union (EU), which adopted measures to counteract obesity (drafted by the WHO regional office for Europe) within the EU Charter. The private sector has started to take a more active role in responding to the noncommunicable epidemic. Companies like Pepsi and Nestle are making efforts to limit sugar, salt, trans fats, and net calories in their food and drink products. According to Derek Yach, Pepsi's director of global health policy, major companies are also showing leadership [PDF] in developing products based on organic ingredients and using their marketing capital to promote a healthy lifestyle and diet. Despite roadblocks, significant progress has also been made in rallying global support against tobacco. The WHO's most significant achievement has been the Framework Convention on Tobacco Control (FCTC)—the first convention adopted under Article 19 of the WHO Constitution—which came into force in 2005 and as of 2010 has more than 160 state parties. The FCTC requires signatories to restrict the influence of the tobacco industry on national health policies and ensure that safeguards are in place to protect the public from secondhand smoke. Other provisions include limiting or banning advertising and ensuring clear health warnings on tobacco products. The WHO has developed guidelines for meeting obligations and provided assistance to enable implementation. According to the WHO, most parties have "passed or are renewing and strengthening national legislation and policies" related to the treaty. That said, raw figures point to an uphill battle on tobacco use. Given rising populations in developing countries, overall tobacco use is increasing and efforts to curtail it remain underdeveloped. Further showing its commitment to combat NCDs, in September 2011, the United Nations held its first Noncommunicable Disease Summit to address the threat posed by NCDs within developing, low-, and middle-income countries (LMICs). Although the summit presented an opportunity for NCDs to gain prominence within the global health community, the lack of outcome disappointed many public health experts who had hoped for concrete and time-specific goals to reduce the prevalence of NCDs. This conference was part of the World Health Organization's 2008-2013 Action Plan [PDF] for the Global Strategy for the Prevention and Control of Noncommunicable Diseases. Continuing the battle against HIV/AIDS: Unprecedented support, but still inadequate Responding to the Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) pandemic has been a critical challenge for nearly three decades. In 1986, the World Health Organization (WHO) created the Global Program on AIDS (GPA). Initially, GPA—and the Joint United Nations Program on HIV/AIDS—tried to create national AIDS commissions in every country, run at the highest levels of government. These strategies, however, were not effective in stemming the growth of the pandemic. In 1996, research showed the efficacy of highly active antiretroviral therapy (HAART), marking a turning point in the HIV/AIDS pandemic. By 1999, the HIV battle shifted away from prevention toward treatment, and in particular to getting HAART into poor countries. This prompted attacks on provisions of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on the grounds that the high cost of patented HAART—then averaging from $10,000 to $20,000 per patient annually—was immoral. Accordingly, Merck initiated efforts to promote universal access to HIV treatment, and later the William J. Clinton Foundation negotiated dramatic price reductions and generic manufacturing of antiretroviral drugs (ARVs). The efforts have brought the annual cost of treatment to less than $300 per patient. Further reductions are expected. Multilateral action on the disease accelerated in 2001, with a groundbreaking UN declaration that instructed all countries to fight HIV/AIDS through prevention, treatment, and long-term care. This new attention spurred the establishment of the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund) at the Genoa Summit of the Group of Eight (G8) in 2001. Along with the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and World Bank's Multi-Country HIV/AIDS Program (MAP) for Africa, the Global Fund has been an important advocate of prevention, counseling, care, and treatment programs. But economic difficulties in major donor countries have intensified debates about how best to spend existing resources in the face of increasing demand. After committing to help achieve "universal access" to HIV treatment—defined as ten million people by 2010—and to double aid for health and poverty reduction to $50 billion per year, the G8 backed off its pledge and restated its goal in June 2011 as fifteen million people by 2015. Despite these setbacks, funding for HIV/AIDS has suffered the least from contracted foreign aid budgets. A record 1.4 million began treatment in 2010, reflecting the continued increase in access to care for HIV/AIDS. Private actors have helped bridge some of the gaps in financing. Sustained efforts by foundations, faith-based organizations, and nongovernmental organizations, for example, have been critical in achieving the yearly decrease in new infections globally. Independent organizations, such as the International AIDS Vaccine Initiative and the Global HIV Vaccine Enterprise, have also contributed to the effort of developing an HIV vaccine. Growing evidence, however, indicates that prevention efforts have been too limited. HIV incidence in the United States rose by nearly 50 percent between 2005 and 2009. The large numbers of new infections globally each year—2.5 million in 2011—are increasing the number of people in need of ARVs, even as the availability of ARVs stagnates or declines. Intravenous drug users continue to be at high risk, and antinarcotics politics complicate prevention. In Africa, Asia, and Eastern Europe, blood supplies remain unsafe and syringes are often reused. Furthermore, failure to tightly integrate tuberculosis and HIV diagnosis and treatment has sparked a tuberculosis pandemic, marked by increasing rates of drug-resistance in tuberculosis strains. In response, the Joint United Nations Program on HIV/AIDS has called for a "prevention revolution" [PDF] to halve the number of infections by 2015. Secretary-General Ban Ki-moon hailed an overall global decline in HIV infections in the 2011 Report on AIDS. At the release of the report, the UN also launched its third major initiative to fight HIV/AIDS that set a target of zero new infections and zero AIDS-related deaths by 2015. However, Secretary-General Ban Ki-moon acknowledged financial hurdles, noting that resources to fund AIDS relief plateaued at $16 billion in 2007. In May 2009, the World Bank published an independent evaluation of its $2.46 billion HIV/AIDS portfolio, which included 106 projects in sixty-two countries. A quarter of the programs were deemed unsatisfactory or moderately unsatisfactory. The report concluded that the World Bank had underinvested in prevention programs for high-risk groups, inadequately monitored projects, and overestimated the capacity of nongovernmental organizations to design and implement AIDS interventions. The report recommended bolstering health ministries and civil society organizations, as well as more diligently monitoring and evaluating. Over the past five years, life-saving drugs have been made more available by a factor of one hundred due to increased donor funds; defiance of HIV drug patents by the governments of Brazil, Thailand, and South Africa; and continued activism by civil society groups. New initiatives and medicine also show promise. A new study of a microbicide gel showed that the treatment could stop HIV transmission to women in 39 and 54 percent of cases. Additionally, in July 2010, federal researchers released findings of antibodies that were effective at neutralizing 90 percent of HIV strains that lead to AIDS, inspiring optimism that a vaccine might soon be achieved. In addition, the Medicines Patent Pool was set up in July 2008 and aims to increase access to treatment by promoting price reductions of existing antiretroviral drugs, stimulating the production of newer first- and second-line drugs and increasing the number of generic producers of these medicines. The first major agreement between a pharmaceutical company and the Patent Pool was finalized in July 2011, with assistance from the United Nations. Recently, Johnson and Johnson agreed not to enforce its patents on darunavir, a common retroviral, amid calls for other HIV medicines to be added to the Patent Pool. UNAIDS also enacted Treatment 2.0 [PDF], a new approach to simplify treatment and increase access to medicine, in order to decrease costs, reduce the burden on health systems, and improve the quality of life for people living with HIV. Modeling suggests that, compared with current treatment approaches, Treatment 2.0 could avert an additional 10 million deaths by 2025. Still, two broad challenges persist. First, the demand for ARVs far exceeds the supply. Approximately 5.2 million [PDF] people have accessed HIV treatment in low and middle-income countries, up 30 percent from 2009, but more than double that need treatment immediately. Furthermore, price reductions for treatment have been negotiated for only a small subset of drugs, while newer, simpler, and more palatable formulations remain unaffordable in most high-prevalence countries, including Swaziland and Botswana. Finding a balance between market-driven innovation that creates new drugs and the imperative to ensure access to HIV/AIDS medicine and vaccines in low- and middle-income countries remains elusive. With that said, international efforts, led by UNAIDS, to provide universal access to HIV treatment by 2015 remain on track. Management of acute pandemics: Testing surveillance and alert systems; response systems under stress Pandemic preparedness requires a standardized outbreak alert system linked to concrete actions by national and local health authorities. In 2000, the World Health Organization (WHO) established the Global Outbreak Alert and Response Network (GOARN)—a decentralized network of technical experts and regional surveillance programs from the United Nations, civil society partners, and academic centers—designed to detect and coordinate the response to disease outbreaks. The WHO also established a six-level pandemic alert system for influenza based on the geographic spread of the disease and its human transmissibility. This system, however, has been criticized for failing to consider the severity of each virus, to link threat levels to tangible actions, and to harmonize existing country alert systems. By contrast, the U.S. alert system has five threat levels that correspond to deaths from infection, but fails to consider human-to-human transmission or geographic spread. Efforts to improve and synchronize the alert systems are underway, and will ideally convey the severity of infection, risk of death, geographic spread, and contagiousness in a combined metric, as well as suggest clear actions linked to threat levels. Following the severe acute respiratory syndrome (SARS) and h2N1 (avian flu) outbreaks, the WHO redoubled efforts to modernize its surveillance and warning systems. In 2007, WHO member states adopted the International Health Regulations (IHRs) for pandemic preparedness and response. The regulations have helped facilitate coordination among states, but pandemic management is still relatively haphazard. The revised IHRs require governments to report public health emergencies of international concern to the WHO within twenty-four hours, permit use of nongovernmental disease detection data to supplement government data, and obligate countries to improve their capacity to respond to health crises. The revisions—which require all signatories to comply with core surveillance and response capacity requirements by 2012—are legally binding but contain no provisions for enforcement. Country compliance with the IHRs has been mixed. In the 2009 H1N1 (swine flu) outbreak, Mexico exceeded IHR obligations by implementing a rapid domestic response, communicating with neighboring states and the WHO, and sharing viral samples with other national and multinational health authorities. Unfortunately, Indonesia performed less admirably during the various h2N1 (avian flu) outbreaks. Even after the revised IHRs went into force, Indonesia refused to report new cases. Fearing that multinational corporations would use the samples to develop a vaccine (and turn a profit by selling it back to affected countries), the Indonesian minister of health justified his refusal to share samples by invoking "viral sovereignty"—the principle that infectious diseases belong to the countries in which they are discovered endemic. This is a troubling principle that could undercut timely international cooperation and monitoring in future crises. The episode underscored the need for mechanisms to persuade recalcitrant states to cooperate on critical matters of global health. But the WHO has also been criticized for sounding false alarm bells. Critics have attacked its handling of the 2009 H1N1 pandemic for causing undue panic. The Council of Europe investigated [PDF] the WHO on grounds of misconduct, finding that the WHO exaggerated the dangers of the pandemic and above all lacked transparency throughout the process. The WHO was also under investigation by the Review Committee established under the revised IHRs for its use of the revised regulations and its overall actions during the 2009 pandemic. The committee ultimately concluded that the adoption of IHR 2005 helped make the world better prepared to cope with public health emergencies, even though the core national and local capacities called for in the IHR are incomplete and nonexistent in many regions around the world. Disputes over intellectual property protection are another major obstacle to combating acute pandemics. Emerging market countries—notably Indonesia, Thailand, China, India, Brazil, and Malaysia—have criticized the World Trade Organization's (WTO's) Trade-Related Aspects of Intellectual Property Rights (TRIPS) provisions, which are frequently blamed for drug and vaccine pricing that keeps some medicines out of the reach of much of the world's population. Since the Doha Declaration in 2001, the same criticisms have been levied against the European Union, United States, and Japan to insert enhanced intellectual property provisions into trade agreements, most notably the Anti-Counterfeiting Trade Agreement. Addressing neglected tropical and other infectious diseases: Growing attention, but still addressed weakly The global health agenda has not adequately focused on some of the infectious diseases that continue to plague, debilitate, and kill millions in the developing world. Diarrheal and enteric diseases include some types of hepatitis, salmonella, cholera, typhoid, and an array of other viral, bacterial, and parasitic pathogens. They remain the second-leading cause of fatality for children, killing nearly 1.7 million every year, and are the greatest contributor to childhood malnutrition. Worldwide, diarrheal diseases account for 4 percent of all deaths and 5 percent of health-related disabilities. Yet, unlike HIV/AIDS, these diseases pose no serious threats to the national interests of powerful countries, perhaps accounting for the neglect. Relative to the global impact of these diseases, funding and dedicated advocates have been lacking historically. The situation, however, is improving. The Bill and Melinda Gates Foundation is investing in research and development for new treatments, along with improved delivery for existing interventions, such as making vaccine distribution and administration less costly. The foundation is also trying to promote and implement structural solutions, such as improved access to fresh water, sanitation systems, and nutrition. Advances have also been made in vaccination, with the Global Alliance for Vaccines and Immunizations leading the way. In July 2011, the United Nations Foundation and GAVI pledged $4.3 billion toward vaccinating 250 million children by the year 2020. These vaccines will help protect against a variety of preventable, life-threatening diseases, including vaccines against diarrhea and pneumonia, which are not readily available to children in developing countries. Vaccine pledges are a significant step toward ensuring comprehensive global childhood immunization, which is one of the most cost-effective and sustainable methods for improving health worldwide. Another subset of problematic infections is known as neglected tropical diseases (NTDs). NTDs thrive in specific climates, are often linked with impoverished environments, and tend to be spread by insects, contaminated water, or infested soil. They currently affect more than one billion [PDF] of the world's poorest people, many of whom suffer from multiple NTDs. In the past few years, great strides have been made in understanding the complexity and character of NTDs. Their direct link to poverty has led the World Health Organization (WHO) to consider poverty control [PDF] part of its global health strategy. The WHO has also launched a comprehensive Preventive Chemotherapy and Transmission Control (PCT) program that works with national governments to train health specialists and advocate disease control measures. In partnership with the WHO, numerous NGOs have begun to develop initiatives to eradicate and eliminate NTDs. The Carter Center, for instance, has helped eradicate Guinea worm in some twenty countries and eliminate onchocerciasis (river blindness) in much of the Americas. The Gates Foundation has also prioritized NTDs. In addition, the Mectizan Donation Program, established by Merck in 1987, began donating mectizan for treatment of onchocerciasis, and Merck has since partnered with GlaxoSmithKline to provide albendazole to treat lymphatic filariasis (elephantiasis) in coinfected individuals. As part of its new Global Health Initiative (GHI), the U.S. government has pledged to increase funding for research and treatment of NTDs, and it plans to increase funding from $15 million in 2006 to $155 million in 2011. Targeted diseases include trachoma, schistosomiasis, onchocerciasis, lymphatic filariasis, and soil-transmitted helminthiases. However, this new focus on NTDs and other initiatives, combined with the effects of the economic crisis in donor countries, has meant the potential shift of resources away from other health efforts. NTDs are starting to make their way onto the global health agenda, but the crux of the problem is in delivering [PDF] needed medications and therapies to affected communities and addressing infrastructure issues. For the most part, NTD drugs are inexpensive, but serious supply shortages and distribution challenges persist. Additionally, financing to purchase existing drugs is often limited. Despite commitments by the donor community and the Group of Eight, these tropical infections and their underlying causes will need additional, sustained focus and funding. Managing biosecurity: Rudimentary mechanisms The international community continues to lag in its efforts to deter—and prepare for—the use of biological weapons. Existing governance mechanisms reflect Cold War concerns about state proliferation of weapons, rather than the threat of terrorism by nonstate actors. The stakes of such negligence are high. Depending on the severity of the pathogen, a biological agent deployed as a weapon—whether improvised or stolen—could conceivably kill millions, bring global commerce to a grinding halt, and have lingering effects for generations. Smaller-scale attacks, like the 2001 anthrax scare, can cause widespread panic and disruption, even when the death toll is relatively low. Managing biological weapons is made more complex by the nature of the threat. Even if existing multilateral agreements were entirely effective, biological agents cannot be managed without local controls and cooperation among nonstate actors. Most biological agents are manufactured and housed in the private sector (particularly in laboratories, hospitals, and universities), which requires enhanced coordination with each of type of facility. Inspections are all the more difficult because the equipment, materials, and agents used for weapons are often also appropriate for legitimate commercial use. Despite calls from United Nations (UN) secretary-general Kofi Annan in 2006, no global forum convenes all the relevant actors to promote a dialogue on safeguards for biological agents. Moreover, the rapid dissemination of weapons-manufacturing information and the ease with which materials can be obtained have rendered the threat of biological weapons more diffuse. Over the last decade, it has become simpler to manipulate viral and bacterial genes to increase their harmfulness and transmissibility. A movement is also growing that promotes in-house production of life forms and open-source sharing of biological "recipes" online. On the positive side, arrangements to counter the threats of biological weapons have emerged. These include UN Security Council Resolution 1540, which obligates UN member states to prohibit nonstate actors from acquiring, pursuing, or obtaining weapons of mass destruction. Additionally, the Global Health Security Initiative, which is an informal partnership among national health ministries from eight countries (including the United States), the European Commission, and the World Health Organization (WHO) seeks to strengthen global preparedness against biological threats. The reporting requirements of the revised IHRs now apply to acts of biological terrorism, and Interpol has bolstered its efforts to prevent bioterrorism. In the United States, the Obama administration has released a National Strategy for Countering Biological Threats and a first-of-its-kind National Health Security Strategy. Under the leadership of WHO, the international community increasingly recognizes the importance of public health surveillance and intervention capabilities in countering the biological weapons threat. The WHO's Global Outbreak and Response Network(GOARN) is part of a global early warning and surveillance network that can identify unusual disease events rapidly, although it does not provide specific response protocols. The main international legal instruments relevant to combating bioattacks at the global level remain the 1925 Geneva Protocol and the 1972 Biological and Toxin Weapons Convention (BTWC), both of which ban states from using biological weapons but are widely considered inadequate and flawed. The Geneva Protocol prohibits use of biological weapons in warfare, but lacks [PDF] any institutional capacity to monitor compliance. The BTWC goes further in banning development, production, acquisition, and stockpiling of biological weapons but also lacks the rigorous system of inspections that would be necessary for monitoring compliance. Efforts to add a protocol to the BTWC, which would address this shortcoming by establishing a mechanism for information exchange and routine inspections of facilities, have failed. Currently, only about half of BTWC signatories submit voluntary monitoring reports. Unlike the nuclear and chemical weapons regimes, the BTWC lacks a permanent institutional structure that could help implement the convention and promote peaceful use of biotechnology. It includes a provision whereby a state party can appeal to the UN Security Council to enforce the convention against an alleged violator; however, no state has yet done so. The BTWC has an Implementation Support Unit (ISU), but it has a limited mandate and a staff of only three. Discussions on modernizing the BTWC—through new lab safety standards, new reporting requirements, increased enforcement of safety measures, and bolstering of the ISU—have failed to translate into concrete revisions of the convention. Nearly ten years after the 2001 U.S. anthrax attacks, controversy continues to surround the Federal Bureau of Investigation's handling of the matter, indicating the need for greater U.S. government—as well as global—attention to biosecurity issues. It will be imperative at the Seventh Review Conference of the BTWC in December 2011, to agree on new security standards for laboratories that work with high-risk agents and enforce standards more rigorously. Yet such steps are fraught with technical and practical complexities. These include how to define potential biological agents, how to surmount the financial and legal burdens associated with implementation, and how to balance these goals with other objectives, such as development of medical countermeasures and disease surveillance. Developing health systems in poor countries: Minimal progress Poor countries often suffer from inadequate health systems. These weaknesses typically include shortages of health professionals, chronic underfunding, dilapidated or nonexistent infrastructure, and a persistent lack of access to essential medicines, including vaccines. Margaret Chan, director general of the World Health Organization (WHO), has identified weak health systems as the greatest threat to global health goals. Although most countries have adopted the principle of health as a fundamental human right, too few developing nations have actually strengthened their health systems. A significant portion of global health financing today is dedicated to vertical, disease-specific programs and initiatives. These include the President's Emergency Plan for AIDS Relief (PEFPAR), the President's Malaria Initiative (PMI), the Global Fund for AIDS, Tuberculosis, and Malaria (Global Fund), and several Bill and Melinda Gates Foundation initiatives. PEPFAR alone is contributing $48 billion to research, care, prevention, and treatment of HIV over a period of five years. In 2011 President Obama's proposed budget included almost $7 billion for PEPFAR, representing a 1.8 percent increase on the previous year. However, according to some activists, this increase actually represents a 'step backwards' due to increasing demand for treatment and inflation. Furthermore, additional focus has been placed toward improving MDGs 4 and 5 relating to maternal and child health. A 2010 MDG Summit and a 2010 G8 Summit further committed to providing additional funding to support childbirth, maternity, and early childhood health. But such programs often reflect donor priorities rather than local needs and are often independent, uncoordinated, and unaccountable, either to their intended beneficiaries or to taxpayers. Rather than respond to host country requests, donors often impose their own funding priorities, and programs tend to be poorly integrated into local public health systems. Funders and implementers have a vested interest in minimizing failures, and host countries are wary of holding donors to account for fear of driving away badly needed resources. What accountability exists comes in the form of self-regulation, uneven oversight from funders, and monitoring by (typically overstretched) health ministries in host countries. In sum, incentives for honest evaluations are few. Some argue for greater coordination between vertical—or disease-specific—and horizontal programming. One initiative, known as fifteen by 2015, aims to reallocate 15 percent of current funding by 2015. Meanwhile, President Obama in 2009 launched the Global Health Initiative (GHI), which targets health systems as well as single diseases. In March 2011, the Obama Administration released the GHI Strategy Document [PDF], illuminating key aspects of the GHI approach and strategy. The report emphasized shifting U.S. health to an impact-based approach and focusing on areas where large, substantial health gains can be achieved. Unfortunately, health systems in most developing countries depend on volatile donor funds. In 2006, donors supplied more than 40 percent of health system funds in eight African countries; many more African nations rely on external funding for more than 30 percent of their budgets. Donor support for health systems is critical, but donors must beware of generating negative, unintended consequences. Governments receiving development assistance for health tend to invest 43 percent fewer of their own resources for health-related activities according to a Lancet study. To combat this risk, donors' governments will need to expand their country-level monitoring of how assistance impacts healthcare. The emigration of qualified health professionals can also undermine health systems. The WHO warns that countries with fewer than 2.3 health professionals per thousand inhabitants will struggle to provide essential primary care services. The relevant figures for Africa and Southeast Asia are 1.3 and 1.7, respectively. Most low- and middle-income countries train far too few health professionals annually, and many locals who are trained immigrate to countries with higher salaries and better working conditions. For example, between 1993 and 2002, half of the doctors and one-third of all nurses educated in Ghana emigrated immediately. According to Michael Clemens at the Center for Global Development, 15 percent of registered nurses and 30 percent of doctors from sub-Saharan African work outside the continent. There is no easy solution to this brain drain. Restricting health worker emigration is not logistically feasible, and everyone has the right to pursue a better life. In May 2010, the World Health Assembly adopted the Global Code of Practice on the International Recruitment of Health Personnel [PDF] that aims to balance the interests of health workers with those of countries that lose them and receive them. Another initiative, the Global Health Workforce Alliance, seeks to develop country coordination and a code of ethical international recruitment. A few attempts have been made to regulate migration of health professionals at national and regional levels. South Africa and the United Kingdom signed a Memorandum of Understanding (MOU) in 2003, in which the UK agreed to ethical recruitment practices, technical assistance, partnerships between hospitals, and time-limited placements of staff trained in South Africa. Countries in the Caribbean established uniform professional qualification standards for health workers and created a common market that permits their free movement in the region. Pending rigorous assessments, these approaches may provide models for developing countries. Facilitating access to vaccines: Record progress, but more attention needed Vaccines are often effective in preventing disease. The H1N1 (swine flu) pandemic revealed how rapidly a vaccine could be developed and manufactured on a large scale with the support of major developed economies. Nonetheless, the 2009 scare also highlighted critical gaps in financing and in the equitable distribution of much-needed vaccines around the world. International efforts to control disease through vaccination are not new. In 1974, the World Health Organization (WHO) launched the Expanded Program on Immunization (EPI) to help vaccinate children in developing countries. Since 1970, the program has provided regular vaccinations through regional WHO branches. The most successful WHO achievement has been on smallpox, which in 1979 became the first infectious disease to be eradicated. More recently, international commitment has been jumpstarted by a joint WHO-United Nations Children's Fund initiative, the Global Immunization Vision and Strategy (GIVS), which looks to increase vaccine coverage by 2015 to meet the Millennium Development Goals [PDF]. According to the WHO's flagship publication on the issue, the last decade showed remarkable progress for vaccines. Some 120 vaccine products are now on the market, and eighty more are in the late stages of research and development. Moreover, scientific improvements (such as adjuvant compounds) have extended short supplies more than tenfold by stimulating the immune systems of recipients, making them more likely to ward off targeted infectious diseases (measles, polio, diphtheria, and the like). Newer vaccines—like those recently adopted to combat meningitis and pneumonia are becoming more effective and cheaper to produce and disseminate. Financing for vaccines has increased dramatically in the last few years, due partly to innovative financing and partly to new contributions. Most recently, at the 2010 World Economic Forum, the Bill and Melinda Gates Foundation announced a pledge of $10 billion over the next decade for research, development, and delivery of vaccines for poor countries. Such new financing has helped alleviate some shortfalls, but more funds are needed. According to the United Nations, national governments support about 40 percent of the costs for routine immunizations. For many developing countries, sustaining this commitment will be difficult. Multilateral funding is not enough to close the gap. The Global Alliance for Vaccines and Immunizations (GAVI) was able to overcome its $4.3 billion funding shortfall in June 2011 at its first pledging conference. The pledges bring GAVI's total available resources for the period 2011 to 2015 to $7.6 billion. Yet, the pharmaceutical industry relies on a handful of firms to produce all the vaccines needed to meet global demand. Declining profitability from production suggests the need for stronger manufacturer incentives. In response, the Center for Global Development, in partnership with public and private donors, helped promote the Advance Market Commitments (AMCs) for Vaccines. These firm commitments from multilateral donors incentivize manufacturers to develop vaccines that might otherwise be ignored. GAVI's Advance Market Commitment is piloting a new vaccine for pneumococcal disease (a common cause of pneumonia), though it has been criticized for protracted distribution timelines, and even accused of coercing developing countries to accept the new vaccine instead of an existing, less expensive alternative. Another innovative financing mechanism launched by GAVI (with the World Bank as treasurer) is the International Finance Facility for Immunization (IFFIm). The mechanism makes use of pledges to issue bonds that generate readily available cash for immunization needs. To date, it has raised $5.9 billion in pledges to be paid over twenty years. Inequities in access to resources for pandemic management unfortunately persist. The 2009 swine flu outbreak is the most recent reminder. At first, access to H1N1 vaccine was largely restricted to high-income countries. Almost a year elapsed between the emergence of H1N1 in North America and the first population-based distribution of H1N1 vaccines in Africa. By the spring of 2010, the pandemic had petered out in high-income countries, which were then willing to donate unused stocks to poor countries. Additionally, negotiations on sharing viruses and the benefits from their use have not progressed. Multilateral talks have been deadlocked, which only increases the challenge of vaccine distribution, particularly in developing countries. Progress in developing vaccines for pandemics also continues to be a major challenge. Established in 1996, the International AIDS Vaccine Initiative (IAVI) develops and assesses candidate HIV vaccines and addresses previous impediments to developing vaccines. To date, IAVI has six vaccines in early-stage clinical trials in eleven countries. GlaxoSmithKline and the PATH Malaria Vaccine Initiative (MVI) have been working toward a vaccine targeted for infants and children in sub-Saharan Africa since 2001. The vaccine, known as RTSS is in the final stage of trials and, if results remain positive, will be ready for distribution by 2015. Ensuring effective and sustainable financing: Significant progress, but uncertain future and fragmented focus Development assistance for global health more than doubled between 2001 and 2007. The budget reached [PDF] $27 billion in 2010, fueled primarily by new financing mechanisms, though the growth rate has plateaued in the wake of the financial crisis. The current regime, however, may be neither sustainable nor appropriate given the lingering effects of the global recession, escalating deficits, domestic healthcare shortfalls in developed countries, shifting priorities, and a greater donor focus on climate change. The multitude of health actors does raise awareness and funding for global health, but activity lacks coordination and monitoring. Of the five largest financing mechanisms, one is bilateral (the President's Emergency Plan for AIDS Relief, or PEPFAR), one is multilateral (the World Bank), one is a private foundation (the Bill and Melinda Gates Foundation), and two are public-private partnerships (the Global Alliance for Vaccines and Immunizations, or GAVI, and the Global Fund to Fight AIDS, Tuberculosis and Malaria, or Global Fund). Perhaps the biggest challenge is identifying sustainable, predictable, and adaptable funding streams. Most international health financing comes from national governments, which are unpredictable from year to year and complicate long-term, strategic approaches. As a result, efforts taken to increase funding from national governments for domestic health priorities must continue as they have in Rwanda, India, China, and Indonesia. In principle, the donor community has committed to work with developing countries to implement the 2005 Paris Declaration, a set of guidelines to improve the effectiveness of development assistance. The emphasis is on developing country priority-setting, aligning donor funds to grantee agendas, harmonizing donor initiatives, monitoring program results, and establishing accountability between donors and recipients. A recent study of the declaration's impact, however, found that only 45 percent of development aid arrived on time and that many development programs continued to undermine local program work. In 2011, the Busan Outcome Document [PDF] of the High-Level Forum on Aid Effectiveness recommitted governments to the Paris Declaration's core principles of strengthening country ownership and developing partnerships and, for the first time, included emerging countries such as the BRICS as well as civil society organizations and private funders. However, despite monitoring mechanisms such as the 2011 Survey on Monitoring the Paris Declaration, many original goals of the Paris Declaration have not been met. In 2007, several initiatives were launched to enhance coordination among major donors. The International Health Partnership and related initiatives (IHP+) aims to expand on the Paris Declaration principles and provide recipient governments with a greater stake, by focusing donor assistance on a centralized national health plan and budget. Similarly, the Health Eight (H8) partnership brings together eight major health organizations (the World Health Organization, United Nations Children's Fund, United Nations Population Fund, United Nations Joint Program on HIV/AIDS, Global Fund, GAVI, the Gates Foundation, and the World Bank) to strengthen efforts toward achieving the Millennium Development Goals (MDGs). Progress, however, remains mixed. The 2011 MDG report indicated [PDF] that nutrition, universal primary education, and child mortality were in danger of falling short of their 2015 targets. In early 2011, WHO Director General Margaret Chan highlighted "serious funding shortfalls" in a speech addressing how to more effectively use existing financing. Continued economic difficulties in major donor countries have intensified the debate about how best to spend increasingly scarce resources. While the global financial crisis did not freeze increases in health funding, it has slowed its growth—from 13 percent annually in 2004 to 2008 to 6 percent in 2009 and 2010. Given that major new financing is unlikely in the near term, progress in providing health services in developing countries will require efficiencies in existing assistance levels, including through better alignment of donor and recipient priorities, enhanced coordination among the largest programs and institutions, rational divisions of labor at the national and local levels to reduce redundant services, and an improved evidence base to identify cost-effective interventions. Some innovative financing approaches exist. The intergovernmental group UNITAID seeks to improve treatments for HIV/AIDS, malaria, and tuberculosis (primarily in low-income countries) through more affordable mechanisms. Since 2006, UNITAID has also committed more than $955 million [PDF] to partners worldwide. Additionally, in March 2010, the Millennium Foundation launched Massive Good to help raise more funds for UNITAID. The initiative centers on the travel industry, giving anyone who buys an airline ticket online the option to donate to UNITAID. By November of 2011, however, the campaign was discontinued. The International Finance Facility for Immunization of GAVI, mentioned earlier, was also innovative in raising quick cash for global health needs. U.S. and International Global Health Policy Issues Should the United States develop an integrated, coherent global health strategy? Yes: An integrated approach is necessary in today's interconnected world. Programs that focus on a wide range of diseases and help bolster other countries' health infrastructures are the only way to combat the litany of global health threats. Efforts will be ineffective without supporting national health systems, and funding must be given to programmatic issues that focus on maternal and child health to prevent diseases before they start. President Obama's Global Health Initiative—with its goals to improve health systems and fight diseases in coordination—is a step in the right direction but if it falls short, then it must be replaced with a coherent alternative. Important single-issue programs will remain a significant portion of the budget, but the strategy on the whole will be more flexible and more capable of addressing multiple issues—not only disease, but human rights, women's rights, country ownership of health issues, and international health governance as well. No: A broad strategy takes away focus and funding from what single-issue programs already do well. The President's Emergency Plan for AIDS Relief (PEPFAR) and the President's Malaria Initiative have succeeded because of their relatively narrow focus, and the guarantee that funding would go directly to combating the targeted disease. Also, a mandate on a single disease does not mean that a program does not have an integrated approach. In PEPFAR's case, for example, efforts have involved childcare, hiring additional healthcare workers, and addressing the challenges of food and nutrition in addition to direct treatment. If single-issue programs are embedded in a broader strategy, there is no guarantee that such an integrated approach to disease will result, and critics contend that PEPFAR may end up competing with other diseases and issues for funding. In the end, a single comprehensive program with a large budget may face more funding challenges than multiple, smaller, single-issue programs where less money can have a more direct effect. Should the United States push for a broader institutional focus to combat noncommunicable diseases (NCD) across the globe? Yes: In 2008, the World Health Organization (WHO) reported that chronic, noncommunicable diseases are the leading cause of death globally, despite being mostly preventable. As a result, the United States should join forces with the WHO in increasing its efforts to target noncommunicable diseases around the world. Noncommunicable diseases also remain the leading cause of death in the West, as risk factors stemming from tobacco and alcohol consumption, unhealthy diets, and physical inactivity are increasingly driving mortality rates. In the United States alone, NCDs and other chronic diseases such as stroke account for 70 percent of deaths, limit the activities of tens of millions more Americans, and cost the U.S. economy over 1.5 trillion annually. According to the U.S. State Department, six strategies need to be implemented by the United States in order to curb the growth of NCDs in the United States and across the globe: collaboration across policy sectors, prioritizing high-impact and affordable strategies, knowledge sharing, greater scale and geographic spread for NCD programs, and an enhanced media presence. No: Unlike illnesses caused by a mosquito, a virus or an infection, noncommunicable diseases (NCD) are linked to factors like food, tobacco, environmental pollution and a lack of exercise. Therefore, many people believe that NCDs are developed as a result of irresponsible personal choices, and thus governmental money should not be allocated towards alleviating these self-inflicted diseases. In addition, the U.S. budget has little room to fund initiatives targeting the elimination of NCDs as the financial crisis drags on and should prioritize more pressing issues. At the same time, others believe that the private sector, such as the recent initiatives launched by Pepsi and Nestle to limit sugars, is a more efficient and cost-effective medium to prevent the spread of NCDs in the United States and abroad. Should the G20 assume leadership in setting the global health agenda for the donor community? Yes: In September 2009, the Group of Twenty (G20) replaced the Group of Eight (G8) as the world's premier economic forum, raising speculation that the G20 would become the steering group for other areas, including global health. Some proponents of the change note that the G20 includes developing countries—including South Africa, India, Brazil, and China—with health concerns not currently represented by the G8. Others note that the G8 has been neglecting its health agenda since the global recession. If the G8 continues to wane [PDF] in momentum and legitimacy, the G20 might become a natural forum for setting the global health agenda, ensuring the involvement of important nontraditional donors, and play a role beyond donor coordination. In 2004, the WHO's assistant director general outlined [PDF] three areas where G20 engagement would benefit the global health agenda: drawing attention to country and regional health crises; raising awareness for neglected health priorities; and holding leaders accountable for their health commitments. No: The G8 remains the source of the overwhelming majority of official development assistance, including global health, and thus should remain the focal point for such efforts. The G8 also has a consistent record of prioritizing global health over the past decade, even if G8 members have sometimes failed to follow through on financial commitments. In the absence of firm leadership from the World Health Organization, the G8 has routinely driven the agenda for response mechanisms needed to address the most pressing global health problems. In 2001, G8 leaders supported the creation of the Global Fund to Fight AIDS, Tuberculosis and Malaria, backed initiatives to relieve debt in developing countries, and endorsed Kofi Annan's call to fight infectious diseases at a rate of $7 to 10 billion annually. In 2005, the G8 summit held at Gleneagles, Scotland, promised "universal access" to HIV treatment—defined as 10 million people by 2010—and a doubling of aid for health and poverty reduction to $50 billion per year. These impressive commitments have proven difficult to recreate in the G20, which has to balance the interests of a larger and more diverse membership. While commitments were not met on time due to the financial crisis, the G20 is even more unlikely to build such unified pledges from its membership and ensure follow through. Should the United States ratify the World Health Organization Framework Convention on Tobacco Control? Yes: The World Health Organization Framework Convention on Tobacco Control (FCTC) is the first international treaty adopted under Article 19 of the WHO Constitutive Act. It views tobacco use as a global problem that demands coordinated solutions, and seeks to reduce both supply and demand for tobacco products by limiting advertising and indoor smoking, encouraging states to raise tobacco taxes, placing prominent warnings on cigarette packages, and preventing smuggling. According to the Centers for Disease Control and Prevention (CDC), more deaths occur annually due to tobacco use than by all deaths from human immuno-deficiency virus (HIV), illegal drug use, motor vehicle injuries, suicides, and murders combined. All state parties to the FCTC are required to harmonize their national tobacco regulations to certain minimum standards. Former president George W. Bush signed the FCTC in 2004, but the U.S. Senate has not yet ratified it. The WHO argues that ratification could give further strength to existing domestic efforts to reduce tobacco use and exposure, which according to the Centers for Disease Control and Prevention causes approximately 443,000 deaths annually, and is the leading cause of preventable death in the United States. The FCTC would provide an additional opportunity for the United States to lead by example. As a nonparty, the United States cannot participate in implementing and shaping the FCTC. No: Since its entry into force in 2005, the FCTC has encountered problems related to national implementation. Of the nearly 174 parties to the treaty, only a handful have enacted full indoor smoking bans. In short, the success of the convention remains unproven and tobacco use is still a leading preventable cause of death worldwide. Some critics add that FCTC goals could be accomplished by national governments on their own and that the most effective way to achieve anti-tobacco goals like those in the FCTC is through domestic regulation. Finally, given the enormous size of the U.S. tobacco industry, ratification requirements for strict regulations in tobacco-growing U.S. states could also translate to job losses. Should the United States maintain its leadership role in promoting intellectual property rights for pharmaceuticals? Yes: Intellectual property rights give the pharmaceutical industry incentives to innovate, research, and develop new medicines. Without protection from the United States Trade Representative [PDF], the industry would not be able to pay for developing new drugs and conducting clinical trials. Moreover, the debate between intellectual property rights and health equity distracts from a discussion of the real obstacles to universal access to essential medicines, which include weak financing, procurement, and distribution systems in many countries. The vast majority of drugs on the essential medicines list is already off patent and has been for years. Patent pooling for essential medicines is therefore unlikely to improve access. No: U.S. regulations supporting intellectual property deprive access to essential medicines, particularly for new drugs needed in pandemic emergencies either through local manufacturing or parallel importing. Preferential trade policies shackle medical innovation and protect monopolies that do not favor fair competition and pricing. In essence, policies that prevent developing countries from importing generics more cheaply or manufacturing drugs locally raise concerns about health equity and justice. Some experts have argued for a more nuanced approach that balances the protections offered by patents with more robust public health considerations within the intellectual property system. Recent Developments January 2014: India eradicates polio India reported 741 cases of polio in 2009—making it the country with the highest number of reported cases of the disease in the world at that time. It has now been three years since the last reported case was a patient who contracted polio in 2011. Several factors contributed to India's success including the use of a bivalent oral polio vaccine beginning in 2010 and the tailoring of vaccine delivery campaigns to particular areas of the country. The Indian government also integrated these strategies with a "holistic approach" into community health work with initiatives to encourage local adoption of regular hand-washing and other critical hygiene and sanitation practices. September 2013: Global Health Investment Fund JPMorgan Chase & Co. and the Bill & Melinda Gates Foundation partnered to launch the Global Health Investment Fund in September 2013. The Fund will provide individual and institutional investors with the chance "to finance late-stage global health technologies" that could prove to be lifesaving in developing countries. It has already procured $94 million in pledged funds to date from a combination of groups including the Children's Investment Fund Foundation, Grand Challenges Canada, and the German Ministry for Economic Cooperation and Development. June 2013: New coronavirus spreads The novel coronavirus (nCoV), responsible for the emergence of the Middle East Respiratory Syndrome, also known as MERS, has spread from Saudi Arabia, where it originated in June 2012, to six other countries including France, Italy, and the United Kingdom. The virus has infected fifty-four people to date, over half of whom have died. MERS is genetically related to the Severe Acute Respiratory Syndrome (SARS), which killed about 774 people in a global epidemic in 2003. However, a total of eight thousand people were infected with SARS at that time, underscoring concern over the high mortality rate of MERS. At the closing of the sixty-sixth World Health Assembly, WHO Director General Margaret Chan warned state regulators over the new threat. "Any new disease that is emerging faster than our understanding is never under control," said Chan. "These are alarm bells and we must respond. The novel coronavirus is not a problem that any single affected country can keep to itself or manage all by itself." From June 4-9, a joint mission between the Saudi government and World Health Organization met in Riyadh to assess the disease's patterns of transmission. May 2013: Price cut for cervical cancer vaccines Cervical cancer vaccines for poor countries will now cost less than $5 per dose, under an agreement negotiated between the GAVI Alliance and two major pharmaceutical firms that produce human papillomavirus (HPV) vaccines, Merck and GlaxoSmithKline. More than 85 percent of women who die from cervical cancer each year reside in low-income countries, where vaccines are far too expensive for most people to afford. The reduced cost of the vaccines, which run about $130 per dose in the United States, will allow millions of girls to protect themselves against deadly strains of HPV. While the price cut will apply first to demonstration sites in Africa and Southeast Asia, the GAVI Alliance aims to make the reduced price available to 30 million girls worldwide by 2020. May 2013: Deadly bird flu rattles China A new strain of deadly bird flu rattled China in the spring of 2013. A total of 129 people were infected and 32 of those who contracted the disease died, as of mid 2013. The new virus, H7N9, largely affects poultry but spreads more easily to humans than previous bird flus. Moreover, Chinese authorities and health experts suspect that human-to-human transmission already has taken place. While officials from the World Health Organization and U.S. Centers for Disease Control and Prevention emphasize the lack of evidence for an imminent pandemic, there is no certainty that the virus could not mutate, causing widespread contagion. April 2013: 5.5 billion pledged to eradicate polio The World Health Organization (WHO) and partner groups affiliated with the Global Polio Eradication Initiative (GPEI) released a $5.5 billion vaccination and monitoring plan to eradicate polio within the next five years. Funders have already pledged three-fourths of the total cost: the Bill & Melinda Gates Foundation agreed to give $1.8 billion; a handful of donor governments—including Britain, Germany, Nigeria, Norway, and Pakistan—offered just over $2 billion; and a small assembly of private foundations has supplied an additional $335 million. Since the mid-1980s, when polio eradication efforts began in earnest, the incidence of the disease has dropped to record lows. The disease is now endemic in only three states—Afghanistan, Pakistan, and Nigeria—with a mere nineteen cases reported so far in 2013. The plan calls for vaccinating over 250 million children where the disease still lingers, as well as establishing monitoring and surveillance systems in over seventy countries. "After millennia battling polio," said WHO Director-General Margaret Chan, "this plan puts us within sight of the endgame." April 2013: India rejects patent protection for drugmaker The Indian Supreme Court rejected patent protection for Glivec, a major cancer drug produced by Swiss drugmaker Novartis. The ruling paves the way for local Indian manufacturers to continue providing cheap generics to large swaths of the developing world. India is one of the world's leading producers of generic medicines, and as such has received credit for broadening access to life-saving drugs for millions of people. Whereas Glivec can cost up to $70,000 per year, for instance, an Indian generic version of the drug can cost as little as $2,500 per year. Options for Strengthening the Global Public Health Regime Introduction U.S. and international action is needed to ensure aggressive pursuit of health agendas, improved representation of health issues in international fora, and increased coordination between donors and recipients. These recommendations reflect the views of Stewart M. Patrick, director of the program on international institutions and global governance, and Laurie A. Garrett, senior fellow for global health. Strengthen commitment toward development goals As the global economic slump lingers, and as the United States and Europe confront sovereign debt challenges, it has become virtually certain that most health-related United Nations Millennium Development Goals (MDG) will fail to achieve their desired targets. While President Obama addressed these concerns in his speech at the 2010 MDG review summit, it is unknown as of yet whether his promise for more effective U.S. leadership and his call for greater global participation in development will be fruitful. The United States and other world actors should avoid the temptation either to give up on the MDGs or to spin the breakdown of the 2015 target as a success. Instead, they should set a realistically achievable 2020 target with definite strategy and clear financing. The lessons of the first MDG project need to be applied to future endeavors, and the United States can take a lead role. Include global health on G20 agenda Global economic realities have forced the rise of the Group of Twenty (G20) over the Group of Eight (G8) as the most prominent forum for multilateral cooperation on financial and economic issues. Over time, the G20 agenda should gradually expand to address global health issues. To date, the new grouping has focused overwhelmingly (and understandably) on the response to the economic crisis, leaving health and broader development matters to the G8. Going forward, the G8 will likely retain an important role as a forum for major donor countries, including mobilizing major pledges of health-related development assistance. At the same time, the G20 offers an important forum for engaging an emerging set of nontraditional donors—including China, India, and Brazil—in forging global agreement on standards of development cooperation. As evidenced by the meeting of health ministers from Brazil, Russia, India, China, and South Africa (BRICS) in Beijing in July 2011 where those nations pledged support, emerging nations are increasingly active in developing countries. The G20 would serve as an ideal forum to leverage their support and integrate their efforts into a global strategy drawing on developed and emerging nations alike. The G20 also offers an opportunity to extend multilateral cooperation well beyond the limits of foreign assistance. Expand the evidence base for health interventions Disappointingly, only limited monitoring, evaluation, and reporting on global health programs and interventions have been undertaken to date. Little is therefore known about nonmedical interventions, models of care, and program implementation. The United States should insist on an empirical assessment of all global health programs to improve the evidence base for the efficacy of interventions and encourage its development partners to do the same. Programs should collect and report process indicators as well as data on outcomes. Partners should be encouraged to conduct implementation research and share results to better capitalize on successes and learn from mistakes. A recent Lancet article showed disappointing effectiveness in major child health campaigns in West Africa led by UNICEF, highlighting the need for regular monitoring and evaluation of health programs. Strengthen regional approaches and cooperation on health Although regional organizations have over the past fifteen years begun to engage in health issues, their efforts remain uneven. Some regions, such as Latin America and Europe have strong systems, while others are far too weak. This often means continued reliance on global structures and initiatives that limit rapid and effective response to health emergencies. Global health initiatives should help build and employ regional capacity, tapping the strengths of existing regional organizations where possible to reinforce and consolidate ongoing efforts and to develop more inclusive objectives. For example, some experts advocated shifting more control of avian influenza outbreaks away from the World Health Organization and toward the Asia-Pacific Economic Cooperation forum and the Association of Southeast Asian Nations, which have the regional clout, political trust, and financial capacity necessary to manage vaccine stockpiles and encourage viral sharing for pandemics concentrated in the Asia region. Anticipate effects of climate change on health Countries and international institutions need to understand the impact of climate change on global health and prepare for the anticipated consequences. As weather patterns change, major storm events multiply and temperatures increase, likely triggering an increase in instances of drowning and heat stroke. These will add pressure to the emergency response mechanisms of even the most developed countries. Food insecurity and changing patterns of infectious disease (such as malaria) will also tax health systems. In some cases, population relocation may often be the only viable preventive option. In 2008, the World Health Organization's (WHO's) World Health Day focused on the health implications of climate change, but much more research and negotiation are needed to generate the necessary knowledge, infrastructure, agreements, and institutions to prepare for the health effects of climate change. The potentially devastating correlation between climate and health can be seen with the Somalia famine in which crop failure as part of prolonged drought has given rise to a cholera epidemic and has contributed to nearly 50 percent of the population suffering from acute malnutrition. Strengthen the International Health Regulations to prevent pandemics The revised International Health Regulations (IHRs) aim to bolster global pandemic preparedness and response among 194 state parties, both in the interest of public health and to minimize interruptions to global travel and commerce. The regulations have helped facilitate international coordination, but pandemic management is still haphazard. The United States should work to further strengthen the IHRs and harmonize pandemic alert systems. Country compliance with the IHRs has been mixed, underscoring the need for additional mechanisms to persuade recalcitrant states to cooperate and ease the flow of crucial information and viral samples for potential pandemic emergencies. Develop a new pharmaceutical R&D and patent regime outside the WTO The World Trade Organization (WTO) is no longer at the forefront of discussions on intellectual property issues related to health. The Doha Round of trade negotiations invested little time on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provisions or on intellectual property right issues more broadly. The international health community should shift its attention toward trade agreements through TRIPS+ provisions and non-WTO forums that include intergovernmental negotiations on benefit sharing and virus sharing. These new mechanisms will help bolster research and development and use external funding to price essential medicines affordably. Become self-sustaining in meeting U.S. domestic health worker demand The most recent estimates indicate that approximately 25 percent of all doctors in the United States are foreign trained, and 66 percent of these are from low and middle-income countries. According to an Association of American Medical Colleges (AAMC) report, the United States will reach a shortage of 91,500 doctors by 2020. The AAMC predicts Americans will need an additional 45,000 primary care physicians and 46,000 surgeons and medical specialists. These estimates are higher than previously expected and is the combined result of an aging baby boom generation and increasing health care costs. The demand for healthcare workers will only increase now that the U.S. health reform bill has passed, putting thirty to fifty million more citizens on insurance or public rolls in the United States. The United States, arguably the best in the world at professional health training and tertiary education, should set a target for self-sufficiency in the education of health professionals. Building this capacity plays to a major U.S. strength.

Overview Yanzhong Huang examines China's and India's participation in three dimensions of global health governance (GHG): health-related foreign assistance, the development and implementation of global health rules, and the ideational foundations of their participation. Overall, both countries are increasingly active in participating in GHG, but they not only fail to shoulder significantly more responsibilities in GHG but also fail to offer a viable, sustainable alternative to the existing governance paradigm. Future directions and effectiveness of their participation will ultimately be determined by the dynamics of the ongoing global power shift and the two countries' ability to address domestic health challenges.