Breakthroughs Blog: USAID

On May 16, with negotiations over fiscal year 2023 (FY23) appropriations underway on Capitol Hill, the Global Health Technologies Coalition (GHTC) hosted congressional staff and coalition members for a virtual briefing on the Supporting Innovative Global Health Technologies (SIGHT) Fund—a proposal for a new $250 million appropriations line in the FY23 State, Foreign Operations, and Related Programs bill dedicated to global health research and development (R&D) at the US Agency for International Development (USAID).Emily Conron, senior US policy and advocacy officer for GHTC, kicked things off with a presentation on the basics of the SIGHT Fund and the challenges it is designed to solve. She noted how 15 years ago, USAID spent about 8 percent of its global health funding on innovation, but that while USAID’s global health budget has doubled in that time, spending on innovation has not kept pace, dropping to less than 5 percent as a share of global health investment. She also emphasized that the pace of global health progress in the future will depend on the reversal of these investment trends today, with more resources urgently needed for R&D: “Today's global health tools like antiretrovirals for HIV/AIDS, oral rehydration therapy to save lives from diarrheal diseases, vaccines that have dramatically reduced child mortality globally—these tools are the product of robust R&D investments begun decades ago….We need to invest proactively today to ensure continued progress in global health in the years to come, and establishing the SIGHT Fund with an initial investment of $250 million dollars—which I should note is a level of investment representing less than 3 percent of all current US spending on global health—could really catalyze the development of tools that accelerate progress against emerging and enduring global health challenges. This would save US taxpayer dollars, maximize the impact of our programs, and ultimately improve and save lives around the world.” Rachel Cohen, regional executive director of the Drugs for Neglected Diseases initiative (DNDi), North America, followed with the perspective of a leading global health product development partnership on why the SIGHT Fund could be transformative for global health innovation. She described previous R&D partnerships DNDi has had with USAID, but how budget limitations cut this promising work short—work that a new source of dedicated innovation funding could be tapped to continue. USAID’s disease-focused programs, with their limited funding, “shouldn't have to make these kinds of trade-offs—between critical funding for service delivery and funding for the next generation of lifesaving tools,” Rachel noted. “That's why DNDi is supporting the SIGHT Fund and why we need a mechanism that perhaps could be more crosscutting and catalytic.” She noted how the fund could complement work advanced by other US agencies, ensuring that promising innovations do not languish in the dreaded R&D “valley of death” when early-stage R&D funding often drops off: “One important example of this would be, for example, to take some of the funding that NIH, the National Institute of Allergy and Infectious Diseases, is funding for broad-spectrum antiviral drug discovery,” she shared. “Once those tools are perhaps ready for clinical trials, USAID could fund the development of broad-spectrum and spectrum antivirals for a range of viral pathogens of pandemic potential.” She also noted new R&D areas the fund could support, such as funding “in a more transformative way the R&D needs of infants and young children, ensuring gender-responsive R&D, or addressing the health consequences of the climate crisis.” Another innovator perspective was shared by Dr. Anand Anandkumar, co-founder and chief executive officer of Bugworks Research Inc. Anand shared background on the growing crisis of antimicrobial resistance (AMR), a global threat Bugworks is combatting through the development of novel broad-spectrum antibiotics designed to be affordable and accessible globally. “We all know from the experience of COVID that none of us is safe until everyone is safe—these are global problems requiring global solutions,” he reflected. “This [SIGHT Fund] could actually fill in a lot of key global gaps and make the United States a leader in connecting and finding solutions that are important globally.” He shared a helpful image of a triangle to describe three interconnected gaps in the current global innovation ecosystem he believes the SIGHT Fund could help address. “One axis of the triangle is support funding of clinical development for phase 2 and 3 with an eye on LMICs [low- and middle-income countries],” he said. “There are already fascinating programs like CARB-X that have created a good pipeline to phase 1, fascinating programs like GARDP out of DNDi that are trying to support phase 2 and phase 3, and AMR Action Fund, that are trying to support phase 2 and phase 3—but that valley is a complex valley. It needs more support.”“Number two, USAID, through the SIGHT Fund, can build clinical trial capacities on the ground in LMICs,” he noted. “You have patient population that have multidrug resistance, a very rich patient population—that’s the right place to do clinical trials, to find out how your drugs are going to work on the worst, difficult patients, but they [LMICs] don’t have capacities.” “And third and last point: a fund like SIGHT could actually bring regulators together, take lessons from COVID, and accelerate these highly needed treatments for unmet population,” he concluded. “So one vertex of the triangle is supporting clinical development to plug the phase 2, phase 3 gap, one vertex is creating clinical trial capacities where it matters the most in LMICs, and the third is regulatory harmonization.” The final intervention was made by Dave Milestone, former acting director of the USAID Center for Innovation and Impact, who shared what he experienced leading innovation activities during his tenure at USAID and why that has made him a supporter of the SIGHT Fund proposal today. “We know that there's a need for innovation,” Dave shared. “We're slowing our progress toward the achievement of our health SDGs [Sustainable Development Goals]. If we just go with sort of the status quo today, even if we deploy all the existing solutions that we have, there's a number of studies that say that we would still fall short. We need innovation. We need new local solutions. We need new partners, and we need to start with local problem solvers to make sure that we're identifying those right problems and then engaging the global R&D community to address those needs.” Dave described several successful innovation partnerships from his time at USAID, including Grand Challenges, which crowded in new thinkers and problem solvers to address leading challenges such maternal and child health, Ebola, and Zika. But he noted that many of these partnerships, while very successful, were short term and ad hoc. “USAID funding for R&D and innovation isn't institutionalized. It's not consistent. It's not long term,” he emphasized. “We should think about a more strategic, holistic approach,” which he noted includes, but is not limited to, the level of funding: “It's also about crowding in the right skill sets and mindsets to how we work with innovation…bringing in the sort of people who understand the practice of innovation, who have portfolio management expertise. These are new skill sets and mindsets that should come with the [establishment of the] SIGHT Fund at USAID.” He concluded with a strong call to action: “If our goal is to end the need for foreign aid, then we need to do this. The status quo isn't cutting it, and we need to be prepared to solve tomorrow's problems with tomorrow's solutions—and the SIGHT Fund is an important step in that right direction.”Jamie Bay Nishi, executive director of GHTC, finished the event by leading a question and answer session with the speakers, in which they emphasized the far-reaching impact that $250 million in new annual funding could have, how the fund could improve USAID’s responsiveness during health emergencies like COVID-19, and how it could advance not only discrete global health innovations, but also innovate the practice of R&D, strengthening the capacity of global partners to lead this work. On this last topic, Rachel offered an inspiring closing point: “If COVID has taught us nothing, it's that …this whole concept that ‘trickle-down innovation’ is going to work—I think we have all been disavowed of that myth. By that, I mean [the belief that] all the innovation happening in high-income countries…[will, with enough good will] eventually make their way to low- and middle-income countries.” She emphasized that “the model of the future needs to be—especially for diseases that are highly prevalent in low- and middle-income countries—driven by the incredible innovation capacity that exists in those countries. But that cannot happen if all the money is flowing only to organizations and academic institutions that are based in high-income countries. We just have to break that cycle…[and] make sure that the experts, the scientists, the clinicians, and the policymakers from low- and middle-income countries are helping to set the priorities, to make the decisions, to allocate the resources, and ultimately to drive the innovation agenda of the future.” You can watch the recording of the full session below, and learn more about the SIGHT Fund here. 

Last Friday, President Joe Biden signed into law a $1.5 trillion spending bill that will fund the US government through the remainder of fiscal year 2022 (FY22), which began October 1, 2021, and concludes in September. The outcome followed months of tense negotiations by Congress—which had passed a series of temporary funding measures, known as continuing resolutions, to keep the government funded at FY21 levels since the start of this fiscal year—and last-minute maneuvering to try to pair annual spending with emergency aid for Ukraine and the COVID-19 response domestically and globally.While the bill ultimately included welcome boosts across key agency programs that fund global health and medical research, summarized below, in very disappointing news, emergency funding for COVID-19—including $4.5 billion for the global response—was stripped from the final package at the 11th hour due to disagreements on how to cover costs. This leaves an uncertain path ahead for the Biden administration to execute its COVID-19 plan, as previously appropriated funds for the domestic and global response are nearly depleted—raising the prospect of having to halt ongoing government-sponsored COVID-19 research trials, among other impacts. House Democrats have promised to advance a stand-alone COVID-19 emergency funding package, which could provide an influx of urgently needed funds, but it’s unclear whether such legislation could gain the 60 votes needed in the Senate since Republicans are demanding any new bill be paid for via offsets of unspent funds, a requirement many Democrats are opposed to.Below GHTC takes a detailed look at the spending bill and its impact on accounts that finance global health research and development (R&D) programming.State and Foreign OperationsThe final spending bill included $9.8 billion in funding for Global Health Programs at the State Department and US Agency for International Development (USAID), which represents an increase of $630 million, or 6.9 percent, over FY21 enacted levels. The vast majority—$510 million—of that increase is designated for global health security programming at USAID, a 268 percent increase over FY21 funding. This funding includes a $100 million allocation for the Coalition for Epidemic Preparedness Innovations (CEPI) to support vaccine development for potentially epidemic threats, which is both welcome news and higher than the $50 million pledge for this fiscal year announced by USAID Administrator Samantha Power at the CEPI pledging summit just a few days prior.Beyond global health security, the remainder of the increase—$130 million—was spread across other global health accounts. The tuberculosis and maternal and child health program lines at USAID received the largest increases at $52 million (16.3 percent) and $34.5 billion (4 percent) respectively, while nutrition, malaria, and neglected tropical diseases were each increased by $5 million and vulnerable children was increased by $2.5 million. USAID’s HIV/AIDS and family planning lines received flat funding compared to last fiscal year while the President’s Emergency Plan for AIDS Relief, or PEPFAR, under the State Department, was boosted by $20 million (0.5 percent). No global health-related accounts at USAID or State saw their funding cut. In other important news, in the joint explanatory statement accompanying the bill, Congress included language, for which GHTC advocated, directing USAID to develop and publicly release a new multi-year strategy on health R&D detailing its goals and how it plans to invest across health areas. USAID’s current health R&D strategy runs through 2022, so the fulfillment of this congressional directive will help ensure continuity and that research remains a priority for USAID’s global health programming.While it was positive to see Congress provide a major funding boost for health security programming and some modest increases to other global health accounts, overall, these funding increases fell short of what many advocates had hoped for, and in many cases what the House and Senate bill drafts released in 2021 had proposed. The COVID-19 pandemic has increased both the challenges and costs of operating health and research programs worldwide, so this funding package, even with increases, fails to match the scale of today’s expanding needs.Health and Human ServicesThe spending bill provided much larger, but uneven, increases across Department of Health and Human Services (HHS) subagencies and programs that support global health R&D. The National Institutes of Health (NIH) received $44.96 billion in funding, representing a $2 billion, or 4.7 percent, increase over FY21 levels. This included an increase of $253.1 million, or 4.2 percent, for the National Institute of Allergy and Infectious Diseases and a $2.8 million, or 3.4 percent, increase for the Fogarty International Center, which works to strengthen research capacity in low- and middle-income countries.Meanwhile, the Biomedical Advanced Research and Development Authority (BARDA)—an agency that supports development of medical countermeasures against health threats and a central player in COVID-19 R&D through then Operation Warp Speed—received a significant funding boost from Congress. It was appropriated $745 million in funding, a $148 million, or 24.9 percent, increase over the prior fiscal year. This funding envelope supports the agency’s entire research portfolio, which covers chemical, nuclear, radiological, and biological threats—both man-made and naturally occurring—so it is at the agency’s discretion to determine what of this funding it ultimately spends on R&D for naturally occurring health threats, including emerging infectious diseases, pandemic influenza, and antimicrobial resistance. Congress included in the bill’s accompanying joint explanatory statement language requested by GHTC expressing support for BARDA to expand its work on naturally occurring threats and provide more detailed reporting on such spending.The Centers for Disease Control and Prevention (CDC), which is a smaller but still important player in supporting global health R&D, received overall funding of $8.5 billion, a $582.4 million, or 7.4 percent, increase from the prior year. Within that, the Center for Global Health received a $54 million, or 9.1 percent, increase, with 93 percent of that increase designated for the global public health protection line focused on health security and the remainder spread across accounts funding global immunization, HIV/AIDS, tuberculosis, and parasitic diseases and malaria. The National Center for Emerging and Zoonotic Infectious Diseases, which funds select R&D for diagnostics and vaccines against infectious diseases, received a $45 million, or 6.9 percent, increase over FY21 enacted levels. These CDC increases were seen by many advocates as disappointing compared to evident needs. Challenges faced by the agency during the COVID-19 pandemic have underscored the need for a more significant influx of funding for this historically under-resourced agency to modernize its systems and improve staff retention.In addition to providing increases for the three HHS agencies above, Congress appropriated $1 billion for HHS to set up a new Advanced Research Projects Agency for Health, modeled after the Defense Advanced Research Projects Agency, to speed development of medical breakthroughs by funding high-risk, innovative projects. This funding was far lower than the $6.5 billion requested by the Biden administration and interestingly was designated to HHS to establish the agency under the Office of the HHS Secretary, rather than within NIH as the Biden administration and some congressional leaders had proposed. GHTC has pushed for this proposed agency to focus on poverty-related and neglected diseases, as a key area of market failure by industry; however, it remains unclear what health areas this new agency will initially prioritize as it is stood up.While FY22 was a bit of a mixed bag for global health R&D, with important increases across some programs but other areas falling short, advocates are already gearing up for the budget battle ahead for FY23, with the Biden administration expected to release its FY23 budget proposal soon.

Many experts have speculated that 2022 could bring the end of this acute stage of the COVID-19 pandemic. But if this proves true, what our new normal will be, and whether we’ll be better prepared for future crises, will depend on the decisions that our policymakers make in the months ahead. As 2022 begins, here are some of the top policy issues GHTC will be tracking.1. Will we achieve targets to vaccinate the world and what curveballs will COVID-19 still throw our way?What trajectory the pandemic will take in 2022 will depend in significant part on how successful efforts are to vaccinate the world. Last year, world leaders coalesced around a goal of vaccinating at least 70 percent of the world’s population by mid-2022, with an interim goal of vaccinating at least 40 percent of people in each country by the end of 2021. But a number of cascading challenges—from unexpected manufacturing disruptions with key suppliers to surging demand for booster shots in wealthy nations—slowed global efforts. As the year drew to a close, more than 90 countries missed the interim target, with many of the poorest nations in sub-Saharan Africa stuck at single digit vaccination rates. In a glimmer of positive news, the COVAX global vaccine facility delivered a record number of vaccine doses in December, hopefully setting a positive trend for the months ahead. Yet it remains clear there is much lost ground to make up as the year kicks off. Reaching the 70 percent target will require a significant influx of resources to boost manufacturing and overcome on-the-ground delivery and administration challenges, as well as continue research to respond to variants and deliver second generation vaccines better suited for distribution in low-resource settings. While leaders of the world’s richest nations have pledged their support for this global goal, few additional commitments of resources have materialized and nearly three-quarters of promised dose donations have yet to be shipped as of December. GHTC will be watching closely in 2022—particularly as President Joe Biden is expected to host a follow-up COVID-19 summit in March—to see whether the world embraces new urgency and accountability to close these gaps. As we’ve seen with the delta and omicron variants, COVID-19 could also still throw some unexpected curveballs our way that could upend existing efforts. 2. Will reams of recommendations turn into meaningful multilateral reforms?One might call 2021 the year of recommendations as several eminent groups, including the Global Preparedness Monitoring Board, the Independent Panel for Pandemic Preparedness and Response, and the G20 High Level Independent Panel on Financing the Global Commons for Pandemic Preparedness and Response, issued reports recommending actions to reduce the world’s vulnerability to pandemic threats. This included several significant proposed reforms to the existing multilateral architecture, including establishing a new Global Health Threats Council to elevate preparedness to the highest level of political leadership, creating a new financial intermediary fund or financing facility at the World Bank to support countries in strengthening their preparedness capacity and to finance surge response during a crisis, making permanent a structure like the Access to COVID-19 Tools Accelerator (ACT-A) to support end-to-end product development for epidemic threats, and advancing a pandemic treaty or framework convention on health preparedness to reform or build upon existing International Health Regulations. Now it remains to be seen whether 2022 will turn into a year of action to make these reforms a reality. GHTC has long advocated that research and development (R&D) is an essential pillar of health preparedness. As these discussions advance, we will be monitoring closely to see how ACT-A evolves and pushing for any such international agreement or financial fund to support countries in strengthening their research and manufacturing capacity.3. Will the US COVID-19 spending spigot still flow in 2022?During the first year of the pandemic, policymakers in Congress seemed willing to throw unlimited money at the problem, passing a series of huge emergency spending bills to finance response efforts and cushion the pandemic’s reverberating economic impacts in the United States—though money for the international response was slower to arrive and lower than advocates and experts recommended. Now that we’re nearly two years into this crisis, many are asking whether Congress has hit pandemic spending fatigue or whether the spigot will still flow. The last major emergency supplemental funding package—the American Rescue Plan Act (ARPA)—was signed in March 2021, more than ten months ago. But the need for additional resources seems as acute as ever as 2022 begins. On the domestic front, omicron is overwhelming US hospital systems and fueling increased demand for tests and boosters, while on the global front, reports are the US Agency for International Development (USAID) is fast running out of resources, as it has already spent or earmarked most of the money it received through ARPA to support global vaccination and response efforts—just as a significant influx of vaccine doses are finally arriving in partner countries and the international response is entering its most operationally intensive phase yet.Political observers are now watching closely whether Congress will put together a new emergency funding package, possibly pairing it with the regular fiscal year (FY) 2022 spending bills that it must pass before the continuing resolution now funding the government expires on February 18. As these talks advance, global health advocates are pushing for any such package to include substantial resources to replenish the coffers of USAID, the State Department, and the Centers for Disease Control and Prevention (CDC) to lead the international response.4. How exactly will the United States build back better for global health innovation?While congressional policymakers spent 2021 largely in emergency response mode, as the new year begins, many are looking to the future of how we can strengthen US agency programs for health preparedness, as well as build upon the research successes and gaps illuminated by COVID-19. Several pieces of legislation are expected to advance this year, which could significantly transform our health innovation infrastructure.For example, the Senate Health, Education, Labor and Pensions Committee is formulating a new pandemic preparedness bill that will look at retooling and refining the capabilities of several Health and Human Services agencies, potentially including the Biomedical Advanced Research and Development Authority (BARDA). This federal agency, which is responsible for developing medical countermeasures against health threats, went from obscurity to a household name during the pandemic as it was entrusted with an influx of emergency funding more than 40 times its annual appropriated levels to advance COVID-19 vaccines, treatments, and tests. GHTC has long advocated for Congress to provide dedicated funding for BARDA to grow its R&D activities for naturally occurring health threats, including emerging infectious diseases (EIDs), antimicrobial resistance, and pandemic influenza. Much of the agency’s work on EIDs has been funded via unsustainable “boom and bust” cycles of emergency funding appropriated only after a crisis has begun. This pandemic preparedness legislation opens fresh opportunity for Congress to authorize such a permanent funding line to fuel sustainable, proactive preparedness research.Additionally, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) are advancing bipartisan legislation dubbed Cures 2.0, a follow-up to their 2016 21st Century Cures Act, which among other things would authorize a new Advanced Research Projects Agency for Health (ARPA-H). Modeled after the Defense Advanced Research Projects Agency, this new federal agency would seek to speed the development of medical innovations by funding high-risk, high-reward projects not likely to be advanced by traditional commercial research activities. Given this goal, the agency’s work could encompass research on poverty-related and neglected diseases, a recognized area of market failure. But at the moment, ARPA-H is more of rough concept than a fleshed-out proposal. As Cures 2.0 advances, much will need to be worked out as to what the agency’s research scope will actually include; whether it will be housed within the National Institutes of Health as President Biden has proposed or as a separate entity as some stakeholders have advocated for; and how much money congressional appropriators will be willing to pony up for this new unproven agency.Alongside these legislative efforts, GHTC has also recently unveiled a proposal for the creation of a new catalytic fund at USAID to drive global health innovation, called the Supporting Innovative Global Health Technologies (SIGHT) Fund. Such a fund would allow USAID to supercharge its existing work to advance inclusive innovations for low-resource settings, as well as reverse a declining trend in the agency’s spending on R&D as a proportion of its global health budget. As the year continues, GHTC will seek to advance this proposal with policymakers in Congress and the agency.5. Will calls to decolonize global health be codified into policy and practice?Calls to decolonize global health gained steam last year as the world bore witness to the gross inequities in access to COVID-19 vaccines and other tools between rich and poor nations, and here in the United States, the Black Lives Matter movement forced Americans to reckon with our nation’s history of racism past and present. While many leaders in the global health and development field now recognize the need to correct long-standing power imbalances rooted in the colonial era, individual organizations—from nongovernmental organizations to international institutions to development agencies—are grappling with how to translate this goal into policy and practice. Here in the United States, new USAID Administrator Samantha Power, in one of her first public addresses in November, laid out her vision for a new era of “inclusive development” at USAID. This included targets to direct at least a quarter of USAID funding to local partners within the next four years and by the end of the decade to have 50 percent of USAID programming have in place “local communities in the lead” who are responsible for codesigning, implementing, and evaluating programs. As 2022 continues, the global health community will be watching closely how Administrator Power’s vision leads to concrete changes in programs and practices at the agency.6. Will funding for other global health areas grow to match evolving needs?Much has been documented about how the COVID-19 pandemic has set back progress in other areas of global health, from disrupting routine immunization programs and reliable access to HIV and tuberculosis drugs to increasing the cost and complications of conducting research and clinical trials. The common refrain from health practitioners is that more resources are needed not just to respond directly to COVID-19, but to shore up other vital global health programs to protect fragile progress. Here in the United States, we’ll be watching whether congressional appropriators take this need to heart in 2022 as they finalize FY 2022 spending bills and begin work on FY 2023. Outside of programs focused on health security, most global health-related funding lines at the CDC, State Department, and USAID have been flat-funded in recent years, in practice decreasing their purchasing power as COVID-19 has only increased the cost of doing business. As every country worldwide is feeling the weight of the latest omicron-fueled surge, the first few days of 2022 have unfortunately felt much like “2020, two.” But as the year continues, it is our hope the pandemic will turn a corner and that policymakers will embrace lessons learned from this crisis to ultimately usher in a healthier, safer, and more equitable world for all.