Zulekha Tasneem

The COVID-19 pandemic has underscored how vital the research and development (R&D) of medical countermeasures is to prevent and combat global health threats. The record-breaking speed at which vaccines, therapeutics, diagnostics, and other tools were developed proved a triumph of modern science. Yet, the pandemic also exposed clear and persistent gaps in our R&D preparedness ecosystem. Absent a crisis, R&D for health preparedness has historically been on the back burner or excluded from preemptive planning to develop local, regional, and global capacities necessary to effectively combat emerging infectious diseases and other health threats. Funding for advanced R&D of medical countermeasures has remained insufficient. And global health security leaders need to crystallize a vision of how to integrate R&D into a broader global preparedness framework. To build a world better equipped to prevent and respond to health threats, we need a more fit-for-purpose, resilient pandemic R&D ecosystem. To achieve that, we must pursue three key areas of reform, as well as recognize the need for these initiatives to support one another:1. Identifying R&D gaps with a strong evidence baseTo solve a problem, you must first understand the nature of it. When COVID-19 hit, not only were there no clear global mechanisms to coordinate and galvanize research efforts to develop vaccines, drugs, and other tools to fight the disease, but we also clearly lacked an understanding and evidence base for what existing R&D and manufacturing capacities existed at a country and regional level, how they could be leveraged to quickly respond to the crisis, and, most importantly, what the major gaps were. While World Health Organization (WHO) frameworks like the International Health Regulations (IHR) and various assessment tools and scorecards existed to help nations assess their health preparedness, none of them sought to comprehensively track R&D readiness metrics. The lack of regionally distributed R&D capabilities deepened inequities in the response, leaving low- and middle-income countries (LMICs) struggling to access the fruits of science, including key supplies and medical countermeasures.As we strive to build a more equity-driven response to future pandemic threats, a stronger evidence base of country-specific data is key to enabling LMICs to highlight and articulate their specific R&D capacity gaps. This will allow for better prioritization of long-term investment in local R&D capacity, ultimately ensuring better access to medical countermeasures. Fortunately, the Global Health Security Agenda (GHSA) exists as a ready-made platform that could support LMICs in both identifying and articulating their R&D capacity gaps and financing needs. GHSA’s new R&D Task Force is in the process of building a metrics tool that countries could utilize to assess and score their pandemic R&D readiness. Through leveraging that evidence base, countries can build a road map for longer-term reforms and a stronger case to guide the allocation and prioritization of future investments in preparedness.2. Developing sustainable financing mechanismsHealth experts from around the world have warned for years that countries, regional bodies, and global institutions must invest more in critical capacities to prevent, detect, and respond to epidemic and pandemic threats. Yet for years, funding for health preparedness, including R&D, has faced a boom-and-bust cycle, with funding surging during a crisis and then subsiding in the aftermath, as funders lose focus on addressing long-term capacity infrastructure. That’s why it is critical, as we consider reforms and new initiatives to strengthen the global health security architecture, that we advance new, more sustainable funding mechanisms to complement national budgets to fill identified preparedness capacity gaps. The proposed Financial Intermediary Fund (FIF) for Pandemic Prevention, Preparedness and Response, which will be housed at the World Bank, is one such exciting prospect. It could address major funding gaps to help LMICs strengthen R&D capabilities. The FIF should be leveraged for investment in coordinated surveillance and rapid development, manufacturing, and equitable delivery of medical countermeasures essential to controlling epidemics and pandemics in every region. While initial resources may be limited, the FIF should seek to bolster all stages of end-to-end product development, ensuring that every country can access the tools and technologies they need to mitigate health threats. The FIF is meant to be a supplementary, long-term fund that will eventually incentivize increased country investments. Integrating a focus on research and innovation within the FIF’s funding priorities from the start is essential to close local and regional R&D capacity gaps. As planning around governance of the FIF advances, GHSA should be given a participatory or coordinating role in this body to help align financing decisions with articulated R&D capacity gaps. 3. Advancing long-term reforms to global governanceAlongside addressing country-specific gaps, reforms must be pursued at a global level to incorporate R&D capacities—including surveillance, laboratory infrastructure, clinical trial, manufacturing, regulatory capabilities, pharmacovigilance, and supply chain management—into international health preparedness and response frameworks. Currently, there is no global framework or process to assess and strengthen national and global R&D readiness within coordinating mechanisms for health security; R&D is not explicitly part of WHO’s IHR or the Joint External Evaluation (JEE).The global community is currently advancing processes to reform the IHR and JEE. As part of that reform, WHO member states should incorporate new indicators into the IHR/JEE designed to specifically assess R&D capabilities, drawing on ideas generated by the GHSA R&D Task Force’s voluntary assessment tool. WHO should also ensure strong linkages between gaps identified and financing directed by the FIF. Additionally, as member states pursue development of a potential new pandemic framework, it is critical that R&D is incorporated as a central pillar to enhance the coordination of research, delineate roles, and ensure clear parameters and standards to facilitate both the development of and access to new tools. The pandemic has shown that systemic gaps continue to stymie the rollout of new technologies to all people, everywhere—perpetuating gross power imbalances between high- and low-income nations and exacerbating entrenched inequalities that have left significant portions of the world’s population without access to lifesaving tools. As we enter year three of the pandemic, it is essential that we do not fall victim to pandemic fatigue, and we seize this moment to enact substantial, meaningful, and coordinated systems change to ensure the world is better equipped to detect, prevent, and respond to pandemic threats. This includes enshrining R&D in global frameworks, securing new sustainable financing for building research capacity, and ensuring that these investments are made based on robust evidence and key metrics that allow countries and global stakeholders to prioritize their preparedness investments. If we fail to make the transformational changes, we will not be ready for the next pandemic. 

At GHTC, we get to read stories every day about incredible innovations in global health. Most of the technologies we see are inventive, some are revolutionary, and a few are so unusual, one might think they were ripped from the pages of a science fiction novel. Now, we’re testing how well you know these global health technologies with our annual Halloween game: the TRICK or TREATment quiz.For each question, we will present a description of a global health technology. Choose TREATment if you believe this innovation exists and has market approval. Choose TRICK if you think we are trying to pull one over on you and, instead, the product is still in development or is just a figment of our imagination.  Loading...(function(i,s,o,g,r,a,m){var ql=document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if(ql){if(ql.length){for(var k=0;k

Last month, G20 health ministers convened for their annual summit to address today’s greatest challenges to global health. As usual, they concluded with a new health declaration, which this year included language in support of multilateral cooperation to end the COVID-19 pandemic and improve access to COVID-19 medical countermeasures. It also recommits to health priorities like combating antimicrobial resistance (AMR), preparing for health emergencies, and achieving universal health coverage (UHC), and provides a framework to prioritize these global health challenges through the lens of equitable access and research and development (R&D) coordination. These seem to be powerful commitments, but where do they fit in context? In this Breakthroughs Blog, we look back on commitments from previous years to reflect on how the declarations have evolved and what they have been missing.Reflecting on five years of ministerial commitments Since the first G20 health ministers’ meeting in 2017, the health declarations have been a powerful platform for confronting long-standing global health challenges and adapting to new ones. While some topics such as AMR, health emergencies, and UHC have been featured repeatedly over the past five years in hopes of achieving equitable quality of and access to care, the declarations have also been used to react in real time to urgent crises such as COVID-19. Here are some key takeaways that help us understand where we’ve been:  Antimicrobial resistance Since 2017, the G20 health ministers have remained consistently committed to combating AMR through international collaboration. R&D has been a critical component of AMR commitments since the establishment of the Global AMR R&D Hub, an independent initiative to identify research gaps and align funders that was launched in 2018 following a call from G20 health ministers the prior year. Health ministers continue to recognize the urgent need for sustained R&D to accelerate the development of safe, effective, and affordable antimicrobials and partnerships to maintain the global supply of existing antimicrobials. Additionally, these health commitments also focus on surveillance and data sharing. Specifically, the World Health Organization (WHO) Global Antimicrobial Resistance Surveillance System (GLASS) Report was a step toward increasing the systematic collection of quality data on antimicrobial sales, consumption, and resistance to understand and mitigate the risks posed by AMR. Though AMR continues to be a focal point and some important initiatives have been launched, it is crucial that health ministers follow through on their agreed-upon proposals.Health emergencies While pledges to combat health emergencies and improve global health security were made prior to COVID-19, this issue has now taken center stage for G20 health ministers. Many of the pledges made in the 2020 health declaration focused on COVID-19 and discussed the adverse effects the pandemic is having on other health areas. Health ministers also recognize the importance of R&D to address infectious diseases with epidemic and pandemic potential. This past month, they put R&D at the core of the G20 agenda with a focus on the Access to COVID-19 Tools Accelerator, new pandemic preparedness initiatives, and reinvestment in existing programs. In 2019, much of the messaging and commitments were similarly focused on containing the Ebola outbreak in the Democratic Republic of the Congo. Along with pledges focused on specific health emergencies, the G20 health ministers have maintained yearly commitments to international cooperation and health systems strengthening under WHO guidance and in accordance with the International Health Regulations (IHR), both critical components of global health security. Despite reaffirming the need for strong health systems and compliance with the IHR as essential for health preparedness, health ministers have fallen short or been unable to secure commitments to the sustainable financing necessary for prevention and response. The lack of sustainable financing has translated into a lack of capacity, particularly in low- and middle-income countries, and left WHO and other multilateral institutions without adequate resources to mitigate pandemic threats. Recognizing these limitations, in January 2021, the G20 established a High-Level Independent Panel (HLIP) that worked at breakneck speed to propose actionable solutions for reliable and sustainable financing of the global commons for pandemic prevention, preparedness, and response by June 2021.Universal health coverage G20 health ministers have consistently recognized that UHC will be best achieved through strengthening health systems and promoting international collaboration, especially through sharing data, exchanging best practices, and sustainable financing. Their commitments reflect the multifaceted elements foundational to achieving UHC including primary care; health care workforce capacity; nutrition; immunization; and water, sanitation, and hygiene, as well as R&D and equitable access to medicines and health services. Health ministers have recognized and articulated the continued need for global investment in those areas, while also emphasizing that countries need to develop their own pathways toward the achievement of UHC by accounting for national contexts and priorities through engagement with civil society and the private sector. Despite consistently reaffirming their commitment to UHC, G20 countries have made few pledges shaping tangible action.The missing wheel for the road aheadFor the past five years, G20 health ministers have agreed on powerful language in their declarations—and yet each year, with a few notable exceptions, progress has rarely been made beyond a stamped paper. Unsurprisingly, the most recent declaration includes strong language on COVID-19, AMR, UHC, and health emergencies, but outside of pandemic financing, it is not connected to a plan to meet those pledges. It is unfortunate that the standard has become all talk and no action. But this month, G20 leaders can set a new course. Following the G20 health ministers’ meeting last month, the G20 heads of state will convene for their annual summit later this month. Together, the heads of state have an opportunity to fulfill the vision set forth by their health ministers; follow through with specific HLIP recommendations on how to fill gaps in pandemic preparedness, prevention, and response; and ultimately set a new standard of combining commitments with tangible action for future G20 health-related meetings.

The Biden administration has proposed a new, cutting-edge research entity that has the potential to benefit global health the way the Defense Advanced Research Projects Agency (DARPA)—the research agency behind the internet, GPS, and self-driving cars—benefited the rest of society. This proposal, the Advanced Research Projects Agency for Health (ARPA-H), could lead to transformative health innovations for neglected diseases and address gaps caused by market failures, ultimately bolstering global health research and development (R&D). What is ARPA-H? Initial proposals from the Biden administration and allies in Congress have described ARPA-H as a driver of scientific breakthroughs for innovations to prevent, detect, and treat diseases that will be housed within the National Institutes of Health (NIH). The idea for ARPA-H was originally conceived by the Suzanne Wright Foundation, a pancreatic cancer advocacy organization, which outlined a Health Advanced Research Projects Agency that would focus on overcoming market failures by de-risking investments from the private sector. Now that the proposal has been taken into the mainstream by the Biden administration and biomedical R&D champions like Representatives Diana DeGette (D-CO) and Fred Upton (R-MI), advocates hope this mandate of addressing market failures might also encompass global health issues including HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases. The scope of research to be conducted under ARPA-H has not yet been set in stone, even though the president’s fiscal year 2022 (FY22) budget request lists as initial focus areas cancer, diabetes, and Alzheimer’s in its $6.5 billion request for the agency. NIH has organized listening sessions, including one for allergies, infectious diseases, and global health, to further discuss the potential research areas for ARPA-H.  To promote high-risk, high-reward research, ARPA-H will likely be modeled after DARPA, which has a flat and nimble organizational structure and a large budget with limited oversight. In contrast to NIH’s sometimes slow-moving peer review process and multiyear grants, DARPA utilizes program managers who make unilateral funding decisions based on research milestones achieved. If the agency is stood up, GHTC supports an ARPA-H funding framework that is similar to DARPA, as it could enable easy, flexible collaborations with product development partnerships—nonprofit partnerships that address public health goals.The Biden administration’s proposal to house ARPA-H within NIH has raised concerns among some advocates and skeptics that this could limit its flexibility and independence, two critical aspects of the ambitious high-risk, high-reward ARPA-H agenda. An additional concern is that placement within NIH could eventually limit growth of top-line funding available for other NIH institutes and centers, and the lack of clarity regarding the scope of focus areas for research has created hesitancy among congressional appropriators to fund the full $6.5 billion proposed. However, if ARPA-H is created with the flexibility and independence of DARPA, and its funding is additive so as not to diminish work on any other NIH program, the agency holds great promise for global health innovations. Global health potential With the right influence from advocates, ARPA-H has the potential to advance research that could benefit the lives of people living in impoverished and underprivileged communities worldwide. Poverty-related and neglected diseases (PRNDs) affecting these communities remain inadequately addressed by the market, as they offer little commercial incentive for the private sector to invest in developing medical products to diagnose, treat, or prevent them. The lessons of the COVID-19 pandemic highlight the need to address gaps in existing PRNDs as their impacts are exacerbated during health emergencies. With a focus on PRNDs, ARPA-H could make a substantial impact toward developing innovations to address the world’s most overlooked diseases.GHTC is not the only stakeholder that recognizes the global health potential for ARPA-H. During a Senate budget hearing for FY22 on NIH, Dr. Francis Collins, NIH’s director, said that one focus for ARPA-H could be the development of a universal vaccine that protects against the ten most common infectious diseases in a single shot. The opportunity for further influencing the scope and mission of ARPA-H remains open. Just recently, Representatives DeGette and Upton, lead sponsors of the landmark 21st Century Cures Act of 2016 who are now developing a follow-up bill, issued a request for information on the possible authorization of ARPA-H in their bill, with questions including, “To ensure it has the biggest impact, on what activities or areas should ARPA-H focus?” In response, GHTC submitted feedback advocating for a focus on PRNDs, including HIV/AIDS, tuberculosis, malaria, and neglected tropical diseases, as well as antimicrobial resistance, arguing that a focus on these areas of historic market failures holds the greatest potential for ARPA-H’s societal impact. ARPA-H could produce transformative health innovations in chronically underfunded areas. If the agency is authorized, GHTC and other advocates should encourage lawmakers to ensure R&D for PRNDs is prioritized. The innovations that result could yield additional advancements across the entire field of biomedical R&D, improving health for all.