10

Summary of Conclusions and Recommendations

The global vision that has brought improved travel and trade and increased interdependency among countries also calls for a common vision of health around the world. All countries are vulnerable to the ever-present threats of infectious disease, outbreaks, and epidemics. At the same time, there are opportunities for shared innovation and universal purpose as many countries that suffer from similar disease burdens strive to develop best practices and strong health systems for their citizens.

Throughout this consensus study, the committee emphasized the need for a more holistic examination of problems and challenges in global health. Such an approach applies not only to issues of global health security but also to the external factors that influence health security, such as the building of general capacity in countries and the creation of strong societies that foster stability, healthy lifestyles, and accessible economic opportunities. Unless core capacities and strong health systems are developed around the world, the global risk of infectious disease will continue to threaten the health and security of the United States. Beyond the imperative of addressing infectious disease threats, it is necessary to understand the fundamental connection between health and economic prosperity. In addition to the economic costs of responding to infectious disease outbreaks, the increasing prevalence of chronic or noncommunicable diseases (NCDs) has negatively affected global economies—compromising societal gains in life expectancy, productivity, and overall quality of life (WEF, 2017).

Many countries currently face the dual burden of a rapid increase in NCDs, such as cardiovascular disease (CVD) and cancer, and the continuing need to eliminate infectious diseases, such as malaria and tuberculosis

(TB), in addition to the priority of reducing the burden of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). Moreover, some countries are considered to bear a triple burden, as traumatic injury has been found to be the second leading cause of premature death in young men after HIV/AIDS (Marquez and Farrington, 2013). Combined, these three disease burdens can stall the progress of a country’s development and significantly affect its ability to become a strong trading partner or a business or travel destination. The cost of productivity losses associated with disability, unplanned absences, and increased accidents can be as much as 400 percent higher than the cost of treatment (WEF, 2010). Research also shows that investors are less likely to enter markets where the labor force suffers a heavy disease burden (Bloom et al., 2004). Human capital clearly contributes significantly to economic growth, and it follows that having a healthy population is critical for economic prosperity. This point has been demonstrated in recent years: between 2000 and 2011, 24 percent of income growth in low- and middle-income countries (LMICs) resulted from improvements in health (Jamison et al., 2013).

The root causes of all three of these health burdens are often linked by such underlying social factors as poverty, education, and location (Frenk and Gómez-Dantés, 2016; Marmot, 2005). This commonality suggests that methods for prevention are linked as well, and the tools used to prevent one burden can help to prevent the others, emphasizing the need for holistic examination of programs. Over the last few decades, the United States has demonstrated remarkable leadership in global health. Notable progress has been achieved by such initiatives as The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the President’s Malaria Initiative (PMI), as well as the nation’s commitment to such multilateral organizations as the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund); Gavi, the Vaccine Alliance; and, more recently, the Global Health Security Agenda (GHSA). Similarly, progress has been achieved by efforts to combat antimicrobial resistance (AMR) at the national and international levels. Against the backdrop of an influential legacy on the global health stage, the new U.S. administration faces the choice of whether or not to ensure that the gains won with billions of U.S. dollars, years of dedication, and strong programs are sustained and poised for further growth.

CHANGING THE WAY THE UNITED STATES ENGAGES

The committee has focused this report where it believes the United States can have the most immediate and substantial effect despite the limited resources available. Throughout the report, the committee has highlighted four priority areas that demand continued attention from U.S. global health investment within a two-pronged approach of securing against

global threats (areas 1 and 2), and promoting productivity and economic growth in other countries (areas 3 and 4):

1. achieving global health security (including addressing pandemics and AMR)
2. maintaining a sustained response to the continuous threats of communicable diseases such as HIV/AIDS, TB, and malaria
3. saving and improving the lives of women and children
4. promoting cardiovascular health and preventing cancer

In addition, the committee has underscored the imperative to change the way the United States does business in global health, highlighting an immediate need to focus on ensuring protection against global threats and enhancing productivity and economic growth in all countries. To these ends, a more systematic, proactive, and integrated approach is needed that includes long-range planning and vision; greater application of rigor and measurement in achieving return on investment; and cooperation with all global health partners to leverage the respective strengths of each, including the advancement of innovation through the private sector and political commitment to achieving global goals on the part of national governments and multilateral partners. This shift in approach places the focus on prevention and preparedness, with a vision of investing in cross-cutting infrastructure in three areas: catalyzing innovation in health systems through medical product development and digital health, enabling more flexible financing mechanisms to fund global health programs, and maintaining U.S. global health leadership internationally. The outcome of this approach will be resilient countries with positive health outcomes, resulting in turn in robust trade partners, safer travel destinations, and more active collaborators in preventing and controlling global health problems that affect citizens in every country, at every income level.

SECURING AGAINST GLOBAL THREATS

Many laudable public health successes have been achieved at the global, regional, national, and community levels. However, the world continues to evolve, and public health measures must change accordingly. The global community is no safer from infectious disease today than it was 20 years ago when the Institute of Medicine report America’s Vital Interest in Global Health (IOM, 1997) was written. The U.S. Army recently estimated that if a severe infectious disease pandemic were to occur today, the number of U.S. fatalities could be almost double the total number of battlefield fatalities sustained in all of the nation’s wars since the American Revolution (GAO, 2017). Poverty and climate change have led to greater risk of mosquito-

borne illness in the southern United States (Hotez et al., 2014); AMR has been elevated to a global crisis by the United Nations (UN) (UN, 2016); and the largest outbreak of influenza A (H7N9) to date is currently occurring in China (Iuliano et al., 2017). The risk of transnational outbreaks may be greater today than ever before given recent dramatic increases in international trade and travel, urbanization, and population density, as well as critical biodiversity loss worldwide. Strong public health infrastructure is essential to combat these threats successfully wherever they may emerge. While the burden of infectious diseases rests predominantly with low-income countries, where limited resources and weak health care systems are unable to control and prevent them, these are global threats that can significantly affect any country, including the United States, and that need to be understood as a threat to U.S. national security.

As noted above, the costs of infectious diseases extend beyond human suffering and mortality through indirect impacts on economies. In just a few short months, for example, the 2003 outbreak of severe acute respiratory syndrome (SARS) cost the world between $30 and $54 billion (Fan, 2003; World Bank, 2013). During the Ebola outbreak, which involved just four domestic cases, the United States spent $1.1 billion on domestic response (Epstein et al., 2015)—120 percent of the annual public health and health care preparedness budget for state and local health department and hospital capacity.¹ Between October 2014 and December 2015, $119 million was spent just on domestic migration and quarantine activities, such as airport screening and follow-up of potentially sick passengers, costing an average of more than $4,000 per passenger (CDC, 2016).² And direct costs for just two Ebola patients treated at the specialty center in Nebraska were estimated at more than $1 million (Gold, 2014).

Looking forward, a moderate influenza pandemic³ is projected to cost the world $570 billion annually in terms of income loss and mortality (Fan et al., 2016) with some estimates as high as $2 trillion (Burns et al., 2008). Furthermore, the threat of AMR continues to grow because of poor stewardship, weak surveillance systems, and a lack of second-line therapeutics in the development pipeline. And in addition to naturally occurring threats is the potential for terrorist use of man-made biological weapons. Regardless of whether epidemics or biosecurity threats originate naturally or through

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¹ This percentage was calculated by using fiscal year 2016 Public Health Emergency Preparedness program funding ($660 million) and Hospital Preparedness Program funding ($255 million) as the preparedness amounts. See Chapter 3 for more details.

² During this timeframe, 29,000 people were monitored following screening at five major U.S. international airports. The monitoring included follow-up for 21 days, and a check and report Ebola kit including a thermometer, a prepaid cell phone, and educational materials.

³ A “moderate” influenza pandemic is defined as one in which global output is reduced by more than 2 percent.

human engineering, it is critical for the United States to recognize the severity of these threats and take proactive measures to build capacities and establish sustainable and cost-effective infrastructure to combat them.

Coordination of International Health Emergency Response

As experienced during the Ebola outbreak in 2014, the U.S. population’s indifference to remote diseases can quickly turn to panic when even a single suspected case is reported within U.S. borders. The U.S. government implements extreme, government-wide responses to such occurrences—costing tremendous amounts of time and money—in a piecemeal, reactive fashion that can actually impede swift and efficient action, delaying response and discouraging private-sector involvement. While multiple agencies can bring unique expertise to a U.S. government–led response, it is difficult to execute a coordinated emergency plan in the midst of a crisis without a clear chain of command, a dedicated budget, and designated leadership. There is a need for a framework to guide international response to public health emergencies, similar to the domestic National Response Framework. While the Obama administration attempted this level of coordination on the fly with the creation of an Ebola czar, it would be more effective to consider the need for coordination in advance.

In addition to coordination, rapid access to funds during a response is of paramount importance to mobilizing assets and implementing needed interventions. After 7 months of disagreement and delay in fulfilling President Obama’s request for $1.9 billion in Zika funding, Congress finally approved $1.1 billion with the passing of H.R. 5243⁴ (Wexler et al., 2016). Before this approval was secured, agencies were forced to shift funds from other accounts for Zika-related activities, including by borrowing money from the Ebola supplemental funding and from the U.S. Centers for Disease Control and Prevention’s (CDC’s) state-level emergency public health care preparedness account (Epstein and Lister, 2016; Kodjak, 2016). While the appropriate focus is on prevention and preparedness, some level of response will always be necessary. To enable swift and rapid response when necessary, the committee supports the creation of a public health emergency response fund, to be used only in declared health emergencies.

Finally, the development of needed vaccines, therapeutic agents, and diagnostics is severely inadequate to enable the United States and the world to respond effectively to these global health threats. Currently, product development for response to pandemic and bioterror threats depends on the interagency Public Health Emergency Medical Countermeasures Enterprise, which is limited by annual appropriations and dependent on the goodwill

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⁴ Zika Response Appropriations Act, H.R. 5243. 2016.

of industry partners. Adequately protecting U.S. citizens requires long-term planning and vision that enables the development of strong and comprehensive capabilities to detect and diagnose pandemic threats wherever they occur, ensure the availability of needed medical products, reduce the risk of transmission, and properly treat and care for infected patients here in the United States. A critical medical product development fund supporting long-term, stable research and development through the engagement of industry, academia, and other partners would ensure the development of critical drugs, vaccines, and diagnostics.

Preparedness and Capacity Building for Global Health Security

Public health infrastructure in most countries, including the United States, is extremely underresourced or nonexistent, making levels of preparedness, even for everyday emergencies, decades behind where they should be and allowing for significant risks when a disaster does strike. Funding levels for U.S. health preparedness have been severely reduced since the Public Health Security and Bioterrorism Response Act was enacted in 2002. A dual focus on health preparedness at home and abroad is essential to reduce the risk of outbreaks and the transmission of infectious disease to U.S. citizens. To this end, it is necessary to build core preparedness capacities and public health infrastructure in the United States and in LMICs, supported by such partnerships as the GHSA.

While a portion of the Ebola supplemental funding was directed toward nonspecific capacity building over 5 years, the sustainability of funding thereafter is unclear. This sustainability is also vulnerable to new or reemerging diseases; Ebola funding was the first coffer proposed to be tapped upon the emergence of Zika (Epstein and Lister, 2016). By contrast, a sustained level of investment in multidisciplinary One Health systems⁵ can result in $15 billion in annual expected benefits from the prevention of mild pandemics and other major outbreaks (World Bank, 2012). Assuming that improved systems could detect and control even half of incipient pandemics, the rates of return are well above those on nearly all other public spending and private capital markets (World Bank, 2012), making this capacity building a smart investment. Enabling the right institutional capacity to reduce health risks, respond to emergencies, and innovate to improve the actions taken can dramatically improve the prevention and control of and response to health threats. At the same time, it is essen-

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⁵ Defined as the funding needed to bring major zoonotic disease prevention and control systems in developing countries up to World Organisation for Animal Health and World Health Organization standards. The World Bank report estimates that the required investments range from $1.9 billion to $3.4 billion per year.

tial to remain engaged and coordinated with domestic and international stakeholders, including the World Health Organization (WHO), the UN Secretary-General’s Committee on AMR, and the GHSA.

Recommendation 1: Improve International Emergency Response Coordination

Recommendation 2: Combat Antimicrobial Resistance

Recommendation 3: Build Public Health Capacity in Low- and Middle-Income Countries

Maintaining a Sustained Response to Continuous Threats: HIV/AIDS, Tuberculosis, and Malaria

Considerable successes have been achieved in slowing the advancement of HIV/AIDS, TB, and malaria worldwide, as evidenced by the millions of lives saved. However, these diseases are continuing health threats that can jeopardize global security and inflict a high cost on the economies of the countries in which they are prevalent. As of the end of 2015, there remained more than 36.7 million people living with HIV/AIDS globally (UNAIDS, 2015b), and there were more than 1.1 million deaths from AIDS (UNAIDS, 2015a). In 2015, 1.4 million people died from TB (WHO, 2016b), and 429,000 people died from malaria (WHO, 2016d). Complacency toward these diseases can lead to severe risk and harm for the entire global community, as all three are capable of developing strains resistant to currently available treatments. Should that occur, an even more lethal resurgence of these diseases would likely take place, threatening all progress made on these diseases in previous decades.

HIV/AIDS

PEPFAR has played a key role in successfully slowing the HIV/AIDS epidemic globally since 2003, reducing new infections, and helping to save millions of lives around the world (PEPFAR, 2017). In addition to this progress on its primary goal, studies have shown that the countries in which PEPFAR is active had better opinions of the United States (Daschle and Frist, 2015) and also saw 13 percent increase in employment rates among men compared to non-PEPFAR countries (Wagner et al., 2015).

As a truly bipartisan, collaborative program that has undergone transitions and shifts throughout the last 15 years, PEPFAR has adapted its focus to changes in the HIV/AIDS epidemic from that of a highly lethal, rapidly spreading emergency to one that requires sustaining care while targeting at-risk populations. Yet this work is far from finished, as 2 million new HIV infections still occur each year, and millions are without access to treatment (PEPFAR, 2017). The next phase of PEPFAR will continue to require cross-sector and data-driven efforts to dramatically reduce the number of new HIV infections and AIDS-related deaths globally by 2030. However it will also rely on continued and expanded partnerships with the private sector and communities. A promising example is PEPFAR’s multidisciplinary Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe women (DREAMS) partnership, which focuses on lowering rates of HIV infection in young women by addressing multiple factors outside of the health sector that affect rates of infection (e.g., enabling and encouraging them to stay in school, addressing gender-based violence, and changing community norms). Given the substantial reduction in the costs of drugs used to treat HIV/AIDS, the increased involvement of private-sector partnerships, and the effect of treatment on preventing new infections, program ownership should continue shifting to host countries where possible. PEPFAR also should leverage its existing structures and platforms to address other priority health issues for its HIV-infected patient population, based on country needs.

Recommendation 4: Envision the Next Generation of PEPFAR

Tuberculosis

Unfortunately, TB has not shown the same progress in treatment and prevention as HIV/AIDS and has been a historically underfunded disease. In 2015, there were 10.4 million new cases of TB and 1.4 million attributable deaths (WHO, 2016b). Further complicating efforts to combat this disease is the rapid rise of multidrug-resistant strains of TB (MDR-TB). The current available drug regimens for TB, MDR-TB, and a more severe extensively drug-resistant TB (XDR-TB) are lengthy and complex and frequently have low success rates (WHO, 2016b). Furthermore, treatment for MDR-TB and XDR-TB can cost 100 times as much as treatment for nonresistant TB (Laurence et al., 2015; Nieburg et al., 2015; Pooran et al., 2013). With few drugs available to treat MDR-TB and XDR-TB and little progress on new treatment options, TB and its drug-resistant strains pose a growing threat to the health and health security of all countries, including the United States. TB has been a priority for the United States since passage of the Foreign Service Act of 1961, and in 2010 the U.S. Agency for International Development (USAID) laid out a sweeping strategy⁶ for combating global TB. Of the $4 billion authorized over 5 years to implement this strategy, however, only 40 percent was ever appropriated. The U.S. government’s underprioritization of TB undercuts its capability to reduce the global burden of disease. Accordingly, the U.S. government should reevaluate its investment in and strategies for combating TB.

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⁶ See Lantos-Hyde United States Government Tuberculosis Strategy.

Recommendation 5: Confront the Threat of Tuberculosis

Malaria

Commensurate with the dedicated investment in combating malaria by the global community are tremendous successes in preventing and controlling the disease, with an estimated 41 percent reduction in incidence since 2000 and a 62 percent reduction in mortality rates globally (WHO, 2016d). This progress has been possible in large part because of increases in programmatic and financial support—from $100 million in 2000 (WHO, 2013) to $2.9 billion in 2015 (WHO, 2016d;). Through PMI and the Global Fund, which accounted for an estimated 35 percent of global funding for malaria efforts in 2015, the United States has, both directly and indirectly, been a major contributor to this success (WHO, 2016d). While the investment in malaria may appear costly, a cost–benefit analysis modeling the effect of global reduction and elimination of the disease found that the net gains in economic output would be worth $208.6 billion (Purdy et al., 2013).

As a result of these investments, elimination of malaria has become a realistic goal for many countries. Some countries can now declare themselves malaria-free, a welcome status for not only healthier communities but also healthier economies. Additionally, since 2006, all 15 PMI countries have seen up to 50 percent reductions in child mortality due to malaria infection (USAID, 2014). However, malaria still imposes a major burden of disease, with 212 million cases occurring in 2015 (WHO, 2016d), further imposing a financial burden on families and country economies. Malaria can cost families 25 percent of their income through lost days of work and prevention and treatment costs, and since 2000, average annual costs to sub-Saharan Africa totaled nearly $300 million simply for case management (UNICEF, 2004; WHO, 2015a). Given these high costs to individuals and countries and the threat of drug-resistant strains, a sustained, dedicated focus on malaria should continue.

Recommendation 6: Sustain Progress toward Malaria Elimination

ENHANCING PRODUCTIVITY AND ECONOMIC GROWTH

The general health and well-being of other countries, including their burden of NCDs such as CVD and cancer, may at first glance not appear to be the top priority of donor countries such as the United States. However, investing in countries’ prosperity and stability can result in greater order and predictability in the world, as well as promote U.S. health and prosperity and create more reliable and durable global partners. Premature death and disability stemming from NCDs coalesce to contribute to decreased productivity, decreased gross domestic product, and overall higher costs of health care because existing health systems are not designed to care for chronic disease in an integrated and holistic fashion (OECD, 2011).

As prevention is always less costly than treatment, efforts to prevent premature death and disability from NCDs ideally begin at birth and continue across an individual’s life course. Cost-effective investments made during a child’s early years can mitigate deleterious effects of poverty and social inequality, often resulting in long-lasting gains through adulthood. Healthy behaviors formed during childhood also can have long-term effects. Interventions carried out during the very early years can even translate into lifelong benefits in terms of labor market participation, earnings, and economic growth, generating returns of up to 25 percent (Gertler et al., 2014). Furthermore, the private sector has a clear interest in preventing NCDs as globalization continues to encourage international travel and trade. Multinational companies have workforces in many regions of the world and have interests in a productive and capable employee base, which also results in societies that are attractive places to locate their businesses.

Saving and Improving the Lives of Women and Children

Remarkable strides have been made in reducing mortality among women and children worldwide. Through the launch of the Ending Preventable Maternal and Child Death initiative, USAID has saved the lives of 46 million children and 200,000 women since 2008 (USAID, 2017). Yet global mortality rates for both mothers and children under 5 are still unacceptably high, with maternal mortality at 216 deaths per 100,000 births and child mortality at 41 deaths per 1,000 live births. As a result, each

year 5.9 million children die before their fifth birthday (WHO, 2016a), and an estimated 303,000 women die from causes related to pregnancy and childbirth (WHO, 2016c). The majority of these deaths are preventable through interventions whose effectiveness is supported by extremely strong evidence, but challenges remain around how to scale up these interventions. Accelerating investments in cost-effective, evidence-based interventions is critical to sustain the progress made thus far and further avoid preventable deaths of infants, children, adolescents, and pregnant and lactating women.

Recommendation 7: Improve Survival in Women and Children

The committee found that while continued investment in the survival agenda is critical, it is only part of the challenge. Without proper progress in development in the first 1,000 days of life, many adverse consequences resulting from disease and malnutrition can follow a child through life. Strong neurological evidence demonstrates long-term mental and physical effects of such early risk factors as poor nutrition, lack of nurturing care, and lack of immunizations (Sudfeld et al., 2015). In LMICs, extreme poverty and stunting causes 250 million children (43 percent) younger than 5 fail to reach their developmental potential (Black et al., 2017). Building empowering, nurturing, and cognitively enriching environments (which include responsive and emotionally supportive parenting, opportunities for play and learning, and support for early education) for vulnerable children under 5 and their mothers requires an agenda that incorporates the health, education, and social services sectors. Thus, a thrive agenda is an important focal point for investment in addition to the existing survival agenda.

Recommendation 8: Ensure Healthy and Productive Lives for Women and Children

Promoting Cardiovascular Health and Preventing Cancer

NCDs such as CVD, chronic obstructive pulmonary disease, and lung cancer kill 40 million people globally each year, almost three-quarters of whom are in LMICs (WHO, 2015b). Of these deaths, 17 million are considered “premature.” The annual global cost of CVD alone is estimated to rise to more than $1 trillion in 2030 (Reddy et al., 2016). Additionally, more people are dying from cancer in LMICs than from AIDS, TB, and malaria combined, with the total annual cost in 2010 approximated at $1.16 trillion⁷—more than 2 percent of total global gross domestic product (Stewart and Wild, 2014). Between 30 and 50 percent of cancer deaths are preventable through prevention, early detection, and treatment. This means that more than 2.4 million annual deaths are avoidable, with an approximate $100–$200 billion in global economic savings to be achieved (Stewart and Wild, 2014). Yet many health care systems in these countries are not designed to manage NCDs, and they have difficulty integrating various platforms across disease types. The lack of a properly trained workforce and of the effective population-level policies described in Chapter 6 is also a challenge for LMICs, and indeed for countries at all income levels. With

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⁷ This figure is the sum of the costs of prevention and treatment, plus the annual economic value of disability-adjusted life years (DALYs) lost as a result of cancer. This value fails to estimate longer-term costs to families and the costs that patients and families attribute to human suffering.

conditions across the NCD spectrum also affecting populations in the United States, this is a clear area for shared innovation to tackle common problems. Greater awareness of successful interventions and best practices for combating CVD, cancer, and other NCDs can reduce duplication and allow for more rapid information exchange, leading more quickly to solutions.

Unfortunately, many efforts to combat NCDs are incorporated into other programs as an afterthought, and there is no overall coordination mechanism or strategy for a global focus on these diseases. However, U.S. programs have established strong networks and knowledge bases in many countries through decades of global health efforts by various agencies, through such program areas as PEPFAR and maternal and child health efforts. These existing platforms can serve as opportunities in which to integrate prevention and treatment efforts for NCDs. Additionally, as noted earlier, recent years have seen strong interest from the private sector in addressing the global burden of these diseases because of their clear effects on workforce productivity; however, there is no synergy among private-sector efforts across countries or health systems. The knowledge base acquired by U.S. agencies and programs should be leveraged and paired with private-sector interest and community-level commitment to mobilize and coordinate high-impact, evidence-based interventions that can be applied in all countries. Absent such concerted efforts, these diseases will continue to result in high rates of premature death and lost productivity, reversing the recent gains in and trends toward improved economic growth and stability in many countries.

Recommendation 9: Promote Cardiovascular Health and Prevent Cancer

• Immunize for vaccine-preventable cancers (specifically human papilloma virus and hepatitis B vaccines).

MAXIMIZING RETURNS ON INVESTMENTS

The committee identified opportunities for changing the way the United States operates in the arena of global health and finances relevant programs to maximize the returns on U.S. investments through improved health outcomes and cost-effectiveness. If the United States can transition from its traditional siloed and reactive approach to global health to a more proactive, systematic, and sustainable approach, the committee believes U.S. investments will have an even more significant positive impact on the four priority areas outlined in this report—achieving global health security, maintaining a sustained response to the continuous threats of communicable diseases, saving and improving the lives of women and children, and promoting cardiovascular health and preventing cancer. To maximize the returns on investments in these four areas and achieve better health outcomes and more effective use of funding, the United States will need to

• catalyze innovation through the accelerated development of both medical products and integrated digital health infrastructure;
• employ more nimble and flexible financing mechanisms to leverage new partners and funders in global health; and
• maintain U.S. status and influence as a world leader in global health while adhering to evidence-based science and economics, measurement, and accountability.

Catalyze Innovation

Achieving the improvements in global health called for by numerous previous reports will require changing the way global health business is conducted to better enable innovation. Given the multisectoral nature of health, simply addressing individual challenges in a singular, siloed manner will never solve the overall problem. Challenges in the development process for vaccines and drugs to prevent and treat infectious and neglected diseases have plagued researchers and developers since before HIV/AIDS captured the world’s attention in the 1980s. Additionally, health systems in LMICs are typically underresourced and lack basic infrastructure, making it difficult to provide all types of care and public health protections, such as surveillance or access to specialty care. Unless researchers, regulators, health providers, and private-sector partners are encouraged to think more creatively to solve these complex problems and enable changes in current processes, new and innovative models will be difficult to achieve. The com-

mittee believes that the creation of an environment that enables innovation can accelerate the development of critical medical products and make it possible to augment public health services through technology such that they can be provided in a more sustainable manner.

Development of Medical Products

Global health priorities will be difficult to achieve without safe and effective drugs, vaccines, diagnostics, and devices. The private sector is an essential player, together with academia, civil society, and government, in ensuring that required products are developed and manufactured. However, the markets for many global health products are uncertain or risky, making it difficult for private-sector development and manufacturing partners to justify their shareholders’ investments. For example, industry considers investments in innovations to address unpredictable and fast-moving pandemics high-risk, especially given the experience of several firms with investing millions of dollars in the development of vaccines against SARS and Ebola only to find that the government was no longer interested in these products (Ebola Vaccine Team B, 2016; Osterholm and Olshaker, 2017). Through regulatory or market incentives, the U.S. government can reduce or share the burden of development costs and risks with industry, effectively “pushing” a product through the pipeline. Similarly, the U.S. government can reduce market risk (creating market “pull”) by increasing the certainty, speed, or volume of the purchase of products. In the absence of these push and pull interventions, the United States and other governments risk spending far more than is necessary to prevent, detect, respond to, and treat disease outbreaks by using suboptimal tools.

In addition to market forces, human and institutional capacity for research and development (R&D) underpins the ability of the private sector, academia, civil society, and governments to develop priority technologies. This R&D capacity is needed in countries where outbreaks begin and disease burdens are high. Helping to build the capacity for LMICs to conduct clinical trials using their own workforces and facilities is both more efficient and more cost-effective than trying to export foreign human capacity and technical infrastructure for every disease outbreak. The necessary capacity includes laboratory capacity, the ability to collect baseline data on disease burden, and an appropriately trained research-competent workforce. Building this capacity also enables sustainability and encourages innovation by creating environments in which local researchers can solve local problems. The U.S. government has an opportunity to streamline processes, reduce costs, and create more appropriate incentives that will enable industry, academia, and others to contribute to the development of priority innovations for global health.

Recommendation 10: Accelerate the Development of Medical Products

Development of Integrated Digital Health Infrastructure

Digital health efforts have shown promise in reducing costs and promoting health across the United States and the globe. However, many such investments have been siloed and shortsighted in their approach, often focusing on single diseases or sectors and missing opportunities to develop a sustainable, integrated platform. Growing mobile and internet connectivity worldwide, along with positive disruptive advances in the information and communications technology sector, provide a timely opportunity for the United States to reexamine its investment and development approaches to digital health efforts in other countries. A renewed focus should include goals of reducing fragmentation, improving integration of programs, and maximizing reusability to improve returns on investments. An emphasis on health systems innovation through technical assistance and public–private partnerships in digital health can lead to better care and more effective care delivery at lower cost.

Given the proliferation of digital health applications and platforms in countries across the world, created by public- and private-sector players alike, there is a need for a common digital health framework that can be applied to different country contexts, allowing for easier replication of best practices and information sharing. At the country level, cross-cutting digital health platforms should be interoperable and yet adaptable to local requirements and sovereignty. Such platforms should address each country’s health care priorities during steady-state times, thereby incentivizing country coinvestment and ownership, while at the same time serving as a resilient system to facilitate controlled sharing of data across countries, thereby enhancing surveillance, coordinated responses, and delivery of services during an emergency. The U.S. government has the opportunity to leverage government content expertise and private-sector talent to build on recent and ongoing efforts, including legislation⁸ aimed at improving and integrating efforts to incorporate internet access into education, development, and economic growth programs. Digital health efforts can be woven into each of those sectors with a holistic and cross-cutting perspective. New and existing U.S. investments should be buttressed by cross-cutting platforms and should assist in making these technological advances available to

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⁸ Digital Global Access Policy Act of 2017, H.R. 600, 115th Congress.

interested countries to improve their own health systems in a manner that is interoperable and scalable for future-minded solutions.

Recommendation 11: Improve Digital Health Infrastructure

Employ More Nimble and Flexible Financing Mechanisms

In the changing landscape of globalization and growth in middle-income countries, traditional aid models are also changing. As a global health leader, the United States should adapt its spending accordingly. Current U.S. global health financing is focused largely on immediate disease-specific priorities. This financial support is seen as development and humanitarian assistance for strategic partner countries. Instead, programs should focus on long-term goals of building global health systems and platforms that are disease-agnostic and can respond rapidly and flexibly to emerging threats that potentially impact the entire world, including the United States. There are innovative mechanisms for making present funds more effective, and opportunities exist for creative partnerships with new players and investors to develop better programs and goals. Existing plat-

forms such as PEPFAR can be augmented through public–private partnerships to improve health outcomes in countries, such as efforts made in the last decade on generic drugs and strengthening of supply chains (Waning et al., 2010). There is also potential in incentivizing the private sector to invest in global health, both for social benefit and for positive long-term business outcomes. Governments can crowd-in additional funding sources by increasing the demand for goods through public funds, and sharing risk in various ways, which then catalyzes private investment that would not have otherwise taken place (Powers and Butterfield, 2014). Overall, by conducting more strategic and systematic assessments, the U.S. government can make long-term investments in global health that contribute to global public goods rather than short-term expenditures. These long-term investments should maintain a focus on global health security; disease prevention and control; cross-cutting health systems innovation; and R&D for essential vaccines, drugs, diagnostics, and devices.

In addition to pursuing more systematic spending, the United States needs to consider that many countries continue to grow economically, and their needs will change from direct support for the procurement of drugs, diagnostics, and other commodities to technical support and sustainable financing from multiple sources. Thinking more strategically about how to help growing middle-income countries transition out of bilateral aid programs and optimize their use of domestic resources in a sustainable way will be an important future role of the United States. Assisting interested countries in structuring debt ratios and tax initiatives, along with implementing other innovative mechanisms, can build stronger and more holistic health systems and provide multiple returns on investments. The U.S. government should review the wide variety of mechanisms that have been implemented by partners around the world as it explores options for expanding and diversifying U.S. global health funding to increase its effectiveness.

Recommendation 12: Transition Investments Toward Global Public Goods

Recommendation 13: Optimize Resources Through Smart Financing

Maintain U.S. Global Health Leadership

Finally, given the extremely interconnected nature of the world today, it is critical for the United States to continue to be a leader in global health. Adequately protecting U.S. citizens at home and abroad requires not only investment in U.S. infrastructure, but also continued awareness of global issues and active engagement in the international global health arena. There have been continuing calls for management and operational reforms of WHO, and while the committee agrees on the need for reform, it also recognizes that WHO performs many essential functions—for example, setting such standards as International Health Regulations. In addition, many other UN agencies and international organizations and partnerships

formed in the last few decades are crucial in providing support to countries around the world. The success of all of these multilateral entities, such as the Global Fund, will help the U.S. government accomplish its global health goals and maximize its returns on investments.

Many of the events and elements of the changing global health landscape described throughout this report have created an environment for a centralized and comprehensive strategy for U.S. global health diplomacy. The United States has an opportunity to solidify its leadership and take a more deliberate foreign policy approach, including the creation of a system to support a more sustainable global health workforce in the United States. The limited number of noncareer health appointments currently available abroad are ad hoc and do not facilitate institutional knowledge or a promising career track for health professionals. Also needed is better bidirectional communication between health and diplomacy professionals and increased cross-disciplinary training. Greater flexibility for U.S. health professionals to work abroad, with emphasis on country and cultural competence and understanding, can allow for better sharing of information and more coordinated response during an outbreak or other emergency. It also could enable long-term partnerships focused on developing cures for such diseases as HIV/AIDS and cancer. Strengthening relations with countries through a strong, centralized office of global health diplomacy can create a coordinating health role for U.S. embassies while also improving situational awareness and networking with other sectors connected to health, such as finance and energy.

Recommendation 14: Commit to Continued Global Health Leadership

A BLUEPRINT FOR ACTION

The committee’s 14 recommendations are directed toward a wide range of U.S. government entities. In Table 10-1, the recommendations pertinent to each entity are summarized to form a blueprint for action to achieve global health security and enhance productivity and economic growth worldwide.

TABLE 10-1 Report Recommendations Outlined by Entity

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