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GHTC submitted written testimony to the House appropriations subcommittees with jurisdiction over the US Agency for International Development and Department of State and the Department of Health and Human Services and its subagencies, urging these subcommittees to sustain and protect global health R&D funding in the fiscal year 2023 (FY23) budget.

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. The World Health Assembly (WHA) convened last week and concluded with several decisions affecting the global health architecture. The Assembly adopted a decision to bolster sustainable financing at the World Health Organization (WHO) by raising “assessed contributions,” or mandatory member fees, to cover 50 percent of the organization’s base budget by 2030, alongside steps to increase the agency’s efficiency. Proposals to immediately reform the International Health Regulations—which govern countries’ obligations to report and respond to pathogens that could lead to global public health emergencies—were not adopted due to member state disagreement, but the Assembly established an extended consultation process for future reforms and set a timeline for their implementation. Member states also discussed the ongoing negotiations around a pandemic instrument, which are being driven by an intergovernmental negotiating body formed last year, but any specific decisions will likely be at next year’s WHA at the earliest.Rising cases of monkeypox—confirmed in 19 countries since early May—have driven interest in the existing range of vaccines and treatments that could be used to offer protection against the outbreak. The monkeypox virus, which causes a usually mild infection, is closely related to the smallpox virus—and smallpox vaccines appear up to 85 percent effective in preventing monkeypox, according to WHO. There are two available smallpox vaccines: Bavarian Nordic’s Jynneos, also known as Imvamune or Imvanex, which has US approval for prevention of smallpox and monkeypox and European Union approval for smallpox but ability to be prescribed off-label for monkeypox, and Emergent Biosolutions’ ACAM2000, which has US approval for people at high risk for smallpox infection and no European Union authorization. While symptoms of monkeypox often resolve on their own within two to four weeks, there are also smallpox antivirals that may be considered for use.On Wednesday, Pfizer committed to provide its patented medicines and vaccines already available in the United States and Europe at a not-for-profit price to 45 lower-income countries. The deal, announced during last week’s World Economic Forum, includes 23 medicines and vaccines for infectious diseases, some cancers, and rare and inflammatory diseases, as well as future products. The initiative also includes Paxlovid, Pfizer’s oral antiviral treatment for COVID-19. Rwanda, Ghana, Malawi, Senegal, and Uganda are the first five countries to commit to join the accord, which will help inform rollout in all 27 low-income countries and 18 lower-middle-income countries that have transitioned from low to lower-middle-income classification in the past ten years. Pfizer says the initiative will be paired with improvements in diagnostics capacity and distribution infrastructure to improve access, as well as technical assistance for health worker training and expedited regulatory processes for entry of the new medicines.

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 following statement—from Global Health Council, supported by the Global Health Technologies Coalition—was delivered at the 75th World Health Assembly on agenda items 14.5: Immunization Agenda 2030; 14.6 Infection prevention and control; and 14.7 Global road map on defeating meningitis by 2030.The COVID-19 pandemic has overwhelmed immunization infrastructure and workforce, impacted the global supply chain, increased the incidence of antimicrobial resistance (AMR), and derailed gains made in immunization campaigns around the world.We therefore call on WHO and member states to:Focus on the full spectrum of innovations that support immunization programs. Support implementation research and the development of formal feedback loops to monitor follow-up of recommendations made by groups such as the WHO Strategic Advisory Group of Experts on Immunization. Strengthen manufacturing capacities in low-and-middle-income countries.Invest in scaling up access to WASH in healthcare facilities as an essential part of infection prevention and control and combating AMR.