Marissa Chmiola

Malaria is one of the world’s oldest and deadliest diseases. Thanks to international efforts to develop and scale up prevention tools and treatments, significant gains have been made over the past few decades in fighting this dangerous disease. But challenges, such as growing drug and insecticide resistance and disruptions from COVID-19, have hampered control efforts. In 2021, there were 247 million malaria cases as cases have continued to rise between 2020 and 2021—indicating progress against the disease has stalled and underscoring the need for continued research and development of new tools.In recognition of World Malaria Day, test your knowledge of this deadly disease and the innovations being advanced to end malaria:

The ability of women to choose whether, when, and how many children to have is essential to advancing the health and well-being of women and their families. In fact, research shows that expanding global access to contraception could reduce maternal deaths by nearly one-third and child deaths by one-quarter. Yet today, 218 million women in low- and middle-income countries have an unmet need for modern contraceptives. New contraceptive innovations are urgently needed to help close this contraceptive gap, including tools that are suitable and convenient for women who live far from health care settings and multipurpose products that combine contraception with HIV prevention. In recognition of World Contraception Day, GHTC is testing our readers’ knowledge of the history of contraceptive innovation. Your challenge for each question below: Name that contraceptive method.

The 75th World Health Assembly (WHA) concluded on Saturday after seven intense days of debate and decision-making. While the Assembly took key actions to shape the leadership and financial future of the World Health Organization (WHO) and to strengthen coordinated regionally distributed clinical research, efforts to advance immediate substantive reforms to the world’s health preparedness framework sputtered, laying the grounds for a prolonged policy process ahead to make the world better prepared for future health threats.Here are our top takeaways from this year’s Assembly:1. WHA adopts landmark decision on sustainable financingIn a move many had anticipated leading into this year’s Assembly, member states adopted a landmark decision to gradually increase their assessed contributions, or membership dues, to WHO to reach 50 percent of the organization’s base budget by 2030. Today, assessed contributions represent just 16 percent of WHO’s budget, with the remainder of its funding derived from voluntary contributions that are often earmarked and unpredictable—a situation that has challenged the agency’s ability to plan strategically and respond effectively during crises. This decision means WHO will eventually receive a boost of roughly $600 million a year of predictable funds to its base budget, which in the words of its director-general will empower the agency to meet “expectations and truly fulfill our mandate as the world’s leading global health authority.” 2. WHO Director-General Dr. Tedros is reelected for second termWHA followed the old adage “don’t change horses in midstream,” voting to reelect Dr. Tedros Adhanom Ghebreyesus to serve another five-year term as WHO director-general. The former Ethiopian minister of health and foreign affairs, who has helmed the agency since July 2017, received the Assembly’s overwhelming endorsement, running unopposed. WHO director-generals can be reappointed only once, so Dr. Tedros should hold the position until August 2027, at which point the Assembly will need to choose a new agency leader. Under his leadership, WHO reshuffled the agency’s organizational structure, creating the Science Division, and GHTC will closely watch what other strategic shifts the director-general will make in his second term that could have implications on research and development (R&D).3. WHA fails to adopt immediate substantive reforms to preparedness framework, but establishes long-term processIn the meatiest of agenda items at this year’s Assembly, member states considered approaches to strengthen WHO and the world’s preparedness for health emergencies, including via potential changes to the International Health Regulations (IHR)—the current legal framework governing how countries are expected to respond to health threats. While going into the Assembly, a WHO working group had recommended that this year WHA establish a longer-term process for amending the IHR, while also immediately considering any proposed IHR amendments that were already tabled—and the United States came ready with a series of proposed IHR amendments that among other items would change requirements around countries notifying WHO of incidents—in the end, the Assembly decided not to adopt any immediate substantive changes to the IHR. Instead, it set in motion a long-term process, tasking the WHO working group with driving a two-year consultation and reform negotiation with member states, with the intent of having amendments voted upon at the 77th WHA in May 2024. Additionally, WHA also passed a companion resolution that halved from two years to one the time period for countries to implement IHR amendments, meaning if amendments are adopted in May 2024, then should be in force by May 2025. A separate but related process for countries to negotiate a new potential pandemic accord or instrument was not formally part of this year’s agenda but will continue via an Intergovernmental Negotiating Body, which will meet again next month.4. WHA passes resolution on strengthening clinical trialsMember states passed an important resolution, introduced by the United Kingdom and Argentina, to strengthen clinical trial research. The resolution urges countries to introduce grant conditions to encourage the use of standardized data protocols and mandate registration of trials via a WHO trial platform or other registry meeting its international standards. It also encourages measures to improve reporting of results, including negative results; promote sharing of prepublication results with regulatory bodies for rapid decision-making during health emergencies; and strengthen global coordination and clinical trial capacity in low- and middle-income countries. While it calls on individual member states to actually adopt the above changes at a local and regional level, it also requests that WHO convene stakeholders and provide guidance to facilitate implementation of the resolution principles.5. WHO takes small steps on other health issuesWhile much of the energy in Geneva was focused on WHO financing, IHR reforms, and pandemic preparedness, each year the Assembly addresses a huge range of agenda items from drug and alcohol abuse to nutrition, to progress on individual diseases and health conditions, and more. This year was no different. In addition to the headline-grabbing news, WHA also took other smaller actions of note and important to health R&D. It extended into 2030 its global strategy and plan of action on public health, innovation and intellectual property, a framework particularly relevant in the wake of COVID-19 that is intended to promote innovation and improve access to health technologies. In addition, it also heard progress reports on the global strategy for tuberculosis research and innovation, the road map on neglected tropical diseases, and implementation of the Immunization Agenda 2030 to improve global immunization coverage—all areas that, as GHTC emphasized in statements going into the Assembly, require enhanced investment in R&D. Unfortunately, these items did not come up until late in the Assembly, highlighting their lower priority in this year’s forum.

The 75th World Health Assembly (WHA) will kick off Sunday with delegates and limited civil society gathering in person in Geneva, Switzerland, for the first time since the pandemic was declared more than two years ago. While immediate COVID-19 response needs still remain a high priority, the conversation has also shifted to how to reform the global health architecture to better prepare for future health threats and how to reinvigorate the fight against other health challenges. Here are the top five issues GHTC will be tracking:1. Will WHO get a budget boost?Many experts have pointed to the World Health Organization’s (WHO) financial health as a key obstacle hindering the agency’s ability to plan strategically and respond effectively during crises. Over the past two decades, assessed member state contributions—or countries’ mandatory dues to WHO—have stagnated, today accounting for just 16 percent of the WHO budget. This has left the agency increasingly reliant on unpredictable, often earmarked voluntary contributions from wealthy countries and philanthropic donors. In January 2021, the WHO Executive Board (EB) tasked a new WHO Working Group on Sustainable Financing with remedying this problem. In late April, the group announced it had reached a consensus agreement to raise assessed contributions to cover 50 percent of WHO’s base budget by 2030, which would be linked to progress on WHO governance reforms. While this agreement is a positive signal of broad member state support, it still needs to be adopted at WHA, which is not a certainty. If approved, the first increases will take place next year and will hopefully usher in a more solid, sustainable financial future for WHO.2. What changes are ahead for WHO and the global preparedness architecture?Heading into WHA, several processes have begun unfolding that could fundamentally alter how WHO—and the world—prepares for and responds to health emergencies. At the 74th WHA and the November Special Session, member states established a new Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR) and an Intergovernmental Negotiating Body (INB) to advance a potential new pandemic treaty or instrument. While the INB is not expected to meet again until June, after holding a historic public hearing in April, the WGPR has released its draft report of recommendations for WHA consideration. Among other actions, the WGPR proposes independent evaluations to determine the future and evolution of new initiatives like the Access to COVID-19 Tools Accelerator, COVID-19 Technology Access Pool, mRNA vaccine hub, and BioHub pathogen sharing system and calls for member states to grow national and regional manufacturing capacity. Notably, the report also calls for a process to amend the International Health Regulations (IHR), the current legal framework that dictates member state responsibilities to prevent and combat disease outbreaks, urging this year’s assembly to adopt any amendments that are ready. The US government has already submitted its amendments for IHR reform for WHA consideration, but other resolutions from member states could still be forthcoming. It remains to be seen whether the assembly takes forward any amendments this year or pushes the process into 2023.Alongside IHR reform, we’ll also be watching whether WHA takes action to expand the Global Influenza Surveillance and Response System (GISRS), following a report presented at January’s EB that suggested GISRS be broadened to cover other respiratory viruses with epidemic and pandemic potential, building on the success of leveraging the system for the COVID-19 response. In the interim months between, the WHO Secretariat has engaged with stakeholders for feedback on this proposal, but it’s unclear whether WHA will vote on this proposal, and key questions remain as to how this expansion would align with other related initiatives like the WHO BioHub pathogen sharing system and requirements of the Nagoya Protocol, which governs the access and benefit-sharing provisions of biological sample sharing.3. How’s the progress report on TB innovation, NTDs, and immunization?While COVID-19 and health preparedness are consuming much of the political energy going into the 75th WHA, they are certainly not the only global health challenges the world is facing. This year’s assembly will also take up agenda items on the global strategy for tuberculosis (TB) research and innovation, the road map for neglected tropical diseases (NTDs), and Immunization Agenda 2030, which are all WHO-led health-area strategies that run through 2030. While the assembly is just expected to hear progress reports on these matters and interventions from member states and civil society, given the significant impact of COVID-19-related disruptions on many of these issues, it will be important to hear whether targets are on track, gauge the level of political will to reinvigorate efforts against these critical challenges, and see what concrete steps member states highlight as priority areas for WHO. In addition, the assembly is also expected to vote to extend the global strategy and plan of action on public health, innovation and intellectual property, which now runs through 2022, until 2030.4. Will a resolution drive changes in the way clinical trials are approached?While this matter has largely flown under the radar, the assembly is anticipated to consider a resolution introduced by the United Kingdom aimed at improving the quality of clinical trials. The intent of the resolution is to build on lessons learned from the COVID-19 pandemic, which drove a surge in funding for clinical research on COVID-19 tools, but also saw many trials that weren’t large enough or employed inconsistent protocols and outcome measurements across geographies, making it difficult to pool and compare data to turn conclusions into medical practice. Among other matters, the resolution urges countries to better coordinate research, standardize protocols, improve reporting on trial registration and results, and work to increase clinical trial capacity globally, particularly in low- and middle-income countries—though none of these actions are binding. It also requests WHO develop a global action plan to strengthen clinical trial practices to be presented for consideration at next year’s assembly.5. Will civil society engagement be satisfactory this year?During these past pandemic years, civil society has unfortunately experienced diminished opportunity to meaningfully engage in WHA and other WHO meetings as forums have turned virtual and agendas have become increasingly jam-packed. Last year and this year, WHO experimented with separate pre-WHA consultations for non-state actors (NSAs), which have left many participants dissatisfied as actual member state participation has been low and the mechanism is unclear for how feedback is transmitted to member states. This year, NSAs have been invited back to the Palais in person for the first time since the pandemic began, with passes limited for safety, and they are expected to be able to deliver interventions live before the assembly. Yet continued scheduling constraints often result in limited time for NSA interventions at best, or being excluded from speaking on certain agenda items altogether at worst. In addition, with few technical public consultations and little transparency around the status of negotiations on specific agenda items, NSAs are left with fewer vehicles to influence proceedings than in the past. We’ll be watching closely if this semi-return to normal engenders better opportunity for NSAs to have their voices heard and will continue to push for robust civil society involvement this year and beyond.

Malaria is one of the world’s oldest and deadliest diseases. Thanks to international efforts to develop and scale up prevention tools and treatments, significant gains have been made over the past few decades in fighting this dangerous disease. But challenges, such as growing drug and insecticide resistance and disruptions from COVID-19, have hampered control efforts. Unfortunately, in 2020, both malaria cases and deaths increased significantly from the prior year—indicating progress against the disease has stalled and underscoring the need for continued research and development of new tools.In recognition of #WorldMalariaDay, test your knowledge of this deadly disease and the innovations being advanced to #EndMalaria:

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.