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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.

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. World leaders convened virtually Thursday for a second Global COVID-19 Summit to accelerate collective efforts in the global pandemic response, pledging about $3.1 billion in new 2022 funding along with commitments to bolster availability of COVID-19 tools. The funding commitments, though falling short of the goal of $10 billion for vaccinations and $3 billion for therapeutics and oxygen, included more than $2 billion in funding for the immediate COVID-19 response and $962 million for a new pandemic preparedness and global health security fund to be established at the World Bank. The United States, which cohosted the summit alongside Belize, Germany, Indonesia, and Senegal, also announced a new National Institutes of Health licensing agreement to share technologies with the World Health Organization’s COVID-19 Technology Access Pool and the Medicines Patent Pool to support the development of therapeutics, early-stage vaccines, and diagnostic tools.The Coalition for Epidemic Preparedness Innovations (CEPI) will provide up to $19.3 million to support development of a “variant-proof” COVID-19 vaccine by an international consortium consisting of Bharat Biotech, the University of Sydney, and ExcellGene SA. The funding will support preclinical and clinical proof of concept for an adjuvanted subunit vaccine candidate—including immunogen design, preclinical studies, manufacturing process development, and a phase 1 clinical trial—with the goal of providing broad protection against all known SARS-CoV-2 variants of concern as well as future variants of the virus. The project could contribute to long-term control of COVID-19, according to CEPI, and the partnership has committed to achieving equitable access to any outputs of the project.A World Trade Organization (WTO) proposal to temporarily waive patent protections on COVID-19 vaccines is receiving tepid reactions from members ahead of a long-delayed ministerial conference set for June. The current compromise proposal would ease some existing barriers to issuing compulsory licenses for patents on COVID-19 vaccines, but also introduces new impediments, including a condition requiring countries to list each patent they intend to waive. The deal is a result of discussions between the European Union, United States, South Africa, and India, following the original proposal by South Africa and India presented in 2020, which sought to not only waive intellectual property protections on patents, but also trade secrets, copyrights, and industrial designs, for treatments, tests, and vaccines. WTO member states expressed mixed views at a recent meeting of the Council on Trade-Related Aspects of Intellectual Property, or TRIPS, ultimately leaving the fate of the proposal uncertain.

GHTC delivered the following statement, on the 75th World Health Assembly (WHA) agenda item 14.3 Global strategy for tuberculosis research and innovation, on May 13, 2022 at the US Department of Health and Human Services (HHS) WHA stakeholder listening session:Thank you for the opportunity to provide feedback on the global strategy for tuberculosis research and innovation. To reverse the impact of the pandemic, avert preventable deaths, and put the world on track to end tuberculosis (TB), essential TB services must be restored as a matter of urgency, and more domestic and international resources need to be mobilized. It is also critical that the development and uptake of new technologies is part of that investment. The Treatment Action Group reported TB research and development investment of US$915 million in 2020, far below the 2018 UN high-level meeting target of at least US$2 billion per year. Annual funding for TB research needs to more than double to reach the global target.Therefore, GHTC calls on the United States to:Support research capacity globally to expand the pipeline of new and equitably accessible TB tools, especially true point-of-care molecular diagnostics, new antibiotic regimens, and vaccines.Address the unmet needs in translational research for TB. The pandemic has demonstrated that rapid sharing of data helps accelerate research and discovery. Some countries have already made strides by using common protocols coordinated through the Regional Prospective Observational Research for Tuberculosis (RePORT) network and contributed data and biospecimens to the platform. The United States should continue to push for additional coordination and collaboration through these platforms.Address the drug-resistant TB crisis and close persistent gaps in diagnosis and treatment access and care. The United States should work with the World Health Organization and member states to ensure that the process for including new technologies to fight drug resistant TB on the essential medicines and diagnostics lists and other guidelines is streamlined. 

GHTC delivered the following statement, on the 75th World Health Assembly (WHA) agenda item 14.5 Immunization Agenda 2030, on May 13, 2022 at the US Department of Health and Human Services (HHS) WHA stakeholder listening session:Thank you once again for the opportunity to provide feedback on this important agenda item. Many recent scientific and multilateral agency reports and publications suggest that overall, immunization took a step backward in the past two years. Despite the tireless efforts of countless immunization program staff and health workers to ensure the availability of vaccination services, vaccination coverage globally fell for the first time in a decade. The COVID-19 pandemic has overwhelmed immunization infrastructure and workforce, impacted the global supply chain, increased the incidence of antimicrobial resistance, and derailed gains made in immunization campaigns around the world. Therefore, GHTC calls on the United States to:    Focus on the full spectrum of innovations that support immunization programs. The near term will inevitably be dominated by a continuing focus on COVID-19 vaccine rollouts. Nevertheless, it is vital that these activities are also leveraged to strengthen vaccine manufacturing capacities to address a broader range of health areas. This also includes storage, administration, and coadministration with other health interventions as well as novel service delivery, including focused “test & vaccinate” strategies as recently recommended by the Gavi board.  Support the development of formal feedback loops to monitor follow up and implementation of recommendations made by the WHO Strategic Advisory Group of Experts on Immunization and other regional immunization technical advisory groups.  Accelerate and expand the COVAX facility research and development agenda to advance next-generation COVID-19 vaccines, including “variant-proof” COVID-19 vaccines and shots that could provide wide protection against coronaviruses, vaccines with optimized dosing, and vaccines more suitable for delivery in low-resource settings. World leaders must also do everything in their power to correct the shameful lack of equitable access to these lifesaving tools.