Marissa Chmiola

The health ministers of G20 nations concluded their annual meeting last weekend with the adoption of an “outcome document” that includes welcome commitments to advance the research and development (R&D) of health products. While normally such a ministerial-level meeting would end with the release of a formal consensus communique, broader geopolitics derailed this process, with Russia and China opposing the inclusion of language condemning the Russian war of aggression against Ukraine. Below we break down what R&D commitments are included in the outcome document, why it matters, and where conversations are expected to go from here. What’s in the declaration? At the highest level, G20 nations made commitments to strengthen the global health architecture and “build more resilient, equitable, sustainable and inclusive health systems equipped to address ongoing global health challenges and future public health emergencies with equitable access to safe, effective, quality-assured and affordable vaccines, therapeutics, diagnostics, and other medical countermeasures.” They also reaffirmed their commitment to ending the epidemics of AIDS, tuberculosis, and malaria; achieving polio eradication; advancing universal health coverage (UHC) and the Sustainable Development Goals (SDGs); and tackling antimicrobial resistance (AMR). On the latter issue of AMR, the ministers vowed to strengthen R&D for AMR and further the development of novel antimicrobials. They welcomed the work of various international initiatives and GHTC members including the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Global Antibiotic Research and Development Partnership (GARDP) and voiced continued support for the Global AMR R&D Hub, which was established under the German G20 presidency to promote AMR R&D coordination. On the broader issue of R&D for pandemic prevention, preparedness, and response (PPPR), G20 leaders agreed to support a World Health Organization (WHO)-led consultative process to develop an interim (and potentially later permanent) medical countermeasures (MCMs) mechanism to coordinate the end-to-end R&D, manufacturing, procurement, and equitable delivery of MCMs during health emergencies. They advised that such a mechanism should consider a “network of networks” approach, building off existing international and regional partnerships, and should be coherent with the outcomes of ongoing efforts to amend the International Health Regulations (IHR) and advance a binding pandemic instrument. Additionally, the ministers underscored the need to strengthen local and regional R&D networks and manufacturing capabilities, especially in low- and middle-income countries, as well as voiced support for what many call the “100 Days Mission” to develop and make available safe and effective vaccines, therapeutics, and diagnostics within 100 days of the identification of a pandemic or epidemic threat. They also noted the importance of public-private R&D partnerships—calling out the contributions of GHTC members the Coalition for Epidemic Preparedness Innovations (CEPI), Medicines Patent Pool (MPP), and FIND—and technology transfer and knowledge sharing “on voluntary and mutually agreed terms.”Why it matters?  G20 nations currently conduct and fund the majority of the world’s health R&D. Thus, it is great to see G20 leaders reaffirm the importance of R&D to achieving UHC, SDGs, and PPPR and demonstrate political will to accelerate R&D efforts. However, the outcome document is short on specifics as to how G20 countries intend to operationalize their many promises, and it disappointingly includes no new funding targets or commitments.  Additionally, going into this year’s G20 cycle, many observers and health advocates also expected that the G20 under the Indian presidency would play a more active role in envisioning and detailing a specific proposal for the creation of an end-to-end MCMs mechanism or platform to succeed and build upon the Access to COVID-19 Tools Accelerator. Instead, the G20 simply promised to support a WHO-led consultative process to design an interim mechanism and punted it to the International Negotiating Body (INB) process for a pandemic instrument to determine the prospects for a permanent MCMs platform. What’s next? With G20 nations offering few specifics on a vision to reimagine the global health architecture and advance an MCMs platform, the focal point for change is now squarely within the separate but interrelated processes now underway to amend the IHR, advance a pandemic accord that will create a more comprehensive framework for how countries will prevent and respond to outbreaks, and design an interim MCMs platform. While these processes have been ongoing, the deliberations have been stymied as countries struggle to reach consensus around thorny R&D topics like access and benefit sharing, with some pushing for more aggressive legally binding commitments for transparency, conditions on public R&D funding, patent waivers, and new supply chain mechanisms for ensuring low- and middle-income countries access to medical countermeasures. Questions remain on the full scope of some of the processes, and how they will delineate which issues will be tackled where and with the target date of May 2024 for the adoption of an instrument rapidly approaching and the INB and IHR processes largely behind schedule, it remains to be seen what tangible changes for R&D can be realized. While it is impossible to know what exactly what the future of these negotiations hold, GHTC promises to continue to watch, weigh in, and report back in the months ahead as these interrelated processes unfold. Stay tuned! 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Scientists have discovered that a naturally occurring strain of bacteria could help reduce the transmission of malaria by stopping the development of parasites in a mosquito’s gut. The bacteria, TC1, was found by chance when GSK scientists noticed that one of their mosquito colonies had stopped becoming infected with malaria parasites and later identified TC1 as the cause. Researchers have since observed that the bacteria works by secreting a small molecule, called harmane, which inhibits the parasite’s growth and that can be ingested by mosquitoes if mixed with sugar or absorbed by contact, opening the possibility for it to be used as an abatement tool. A recent study found that the bacteria can reduce a mosquito’s parasitic load by up to 73 percent, and trials in Burkina Faso are ongoing to assess the intervention’s effectiveness and safety in real-world settings.An international team of researchers has identified a genetic variant among some people of African ancestry that is associated with them having naturally lower viral loads of HIV—thereby slowing their illness progression and lowering the risk of them transmitting the virus. According to the researchers, this is the first new genetic variant related to HIV infection discovered within the last nearly 30 years. Between 4 to 13 percent of people of African origin are thought to carry this variant, which was discovered through an analysis of the DNA of almost 4,000 people of African ancestry infected with HIV-1. The scientists now intend to continue studies to more fully understand how exactly this variant impacts HIV replication.Health experts are warning that dengue poses a danger to pregnant women, as new research has found that the disease can cause serious health complications for both mothers and their unborn babies. A recent study from the University of Surrey found that mild infection can make a pregnant individual 77 percent more likely to give birth before 32 weeks and can more than double the risk of the child being born with extremely low birth weight, which can affect brain development. This work builds on prior research that found pregnant women are three to four times more likely to die after becoming infected and 450 times more likely if their infection progresses into dengue hemorrhagic fever. There are currently no specific treatments for dengue, and existing vaccines are not recommended for pregnant women.

The US Agency for International Development (USAID) recently released a new five-year strategy to guide its global health research and development (R&D) efforts. Informed by the input of more than 150 stakeholders, the latest strategy continues the agency’s core focus on developing, introducing, and scaling up health technologies and approaches; advancing implementation science; and strengthening R&D systems while more intentionally embedding approaches of partnership, local leadership, monitoring and evaluation, and adaptive learning into its work.Why it matters:  The release of the strategy represents a renewed commitment by the agency to R&D. For more than 50 years, USAID has played a pivotal role in saving and improving lives around the world through its R&D programs. With its strong in-country presence, relationships with government and community leaders, and extensive knowledge of local context and development constraints, USAID is uniquely qualified to advance interventions that are affordable, accessible, scalable, and responsive to the needs of affected communities worldwide.What’s included: The strategy outlines a mission, vision, four objectives, 16 key actions, four approaches, and four principles that will guide its R&D work. View the slide deck below to get a summary overview.Our take: GHTC applauds USAID for developing this comprehensive strategy and for its inclusive design approach, which considered the input of a broad spectrum of US and global stakeholders. We are pleased to see this renewed commitment to R&D and the strategy’s increased emphasis on local leadership; inclusive innovation; and meeting the needs of women, children, and other vulnerable populations.

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.