Philip Kenol

It has been nearly eight years since antimicrobial resistance (AMR) gained political attention at the highest levels. At the United Nations (UN) High-Level Meeting (HLM) on AMR in 2016, countries vowed to take a coordinated approach to address the root causes of AMR. Now, close to a decade later, progress has been uneven at best. While many countries have tried to tackle the issue by developing their own national action plans, fewer than a fifth of these plans are funded or implemented. And while annual global funding for antibiotic research and development (R&D) increased by 25 percent since 2017, access remains a challenge, as many new antibiotics never get registered and remain unaffordable in low- and middle-income countries (LMICs).On September 26, the UN is hosting a second HLM, aimed at accelerating multisectoral global, regional, and national action to address AMR. Will this be the moment where key global decision-makers generate lasting political momentum to make meaningful progress addressing this silent pandemic?Renewed sense of urgency to address AMR and invest in R&DThe upcoming meeting will occur amid a sense of renewed urgency around addressing AMR. A recent Lancet report highlights that drug-resistant pathogens could cause more than 39 million deaths over the next 25 years, forecasting that AMR deaths will increase steadily in the coming decades if remediation measures are not in place.A study by the Global Research on Antimicrobial Resistance Project predicts that AMR mortality will increase by 70 percent by 2050 and notes that the most impactful way to prevent this outcome is through improving access to effective antibiotics, particularly in LMICs, where the burden of disease continues to be the greatest. The study also suggests that the traditional model of drug development may not be sustainable for antibiotics, as most new products never reach key populations in LMICs because they are not able to overcome regulatory challenges and remain too expensive. Unless access and affordability are assured, the global mortality burden from resistant bacterial infections will continue unabated. Ensuring there are political commitments to strengthen the AMR R&D ecosystem will be crucial in realizing progress.2024: The year of AMR?The good news is that, in many ways, 2024 has already been the year of AMR. In May, the World Health Organization (WHO) delegates approved a resolution to accelerate national and global responses on AMR, with many of them highlighting it as a crucial building block for the HLM this fall.The resolution welcomes WHO’s strategic and operational priorities to address drug-resistant bacterial infections in the human health sector, including strengthening R&D to support the creation of new tools to combat AMR and replenish the shockingly waning pipeline.AMR has also continued to feature in G7 and G20 discussions, and member states are largely expected to include provisions focused on combating the silent pandemic in political outcome documents later this fall, including recognizing the need for new investments in research and greater support to initiatives like the Global AMR R&D Hub.Political declaration: Commitments on a path forwardSo, what constitutes success for the HLM on AMR? Much of it comes down to the commitments and pledges made in the political declaration that will be adopted by delegates. The good news is that the final draft includes some strong targets, including one to reduce global deaths from bacterial AMR by ten percent by 2030. Countries are also pledging to develop their national action plans by 2030, of which 60 percent would need to be adequately funded by the deadline (compared to the roughly 20 percent which are to date).Perhaps most notable though is the request for the Quadripartite—which is comprised of WHO, the World Organization for Animal Health, the UN Food and Agriculture Organization, and the UN Environment Programme—to establish an Independent Panel on Evidence for Action. The panel would serve a key function by supporting member states’ decision-making with regular guidance on the trends of science, data, and evidence across AMR-related sectors.R&D is also a central pillar in the declaration, with member states recognizing the need for increased public-health-driven R&D and the role of public-private partnerships like the Global Antibiotic Research & Development Partnership and the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator. The text encourages the use of push and pull incentives to spur R&D while ensuring mechanisms are in place for equitable access. Countries are called upon to develop and incentivize the adoption of manufacturing standards, promote the transfer of technology and know-how, encourage research, and undertake measures to address the growing shortage of researchers and medical specialists.It is worth celebrating the inclusion of several numeric targets, as many past political outcome documents coming out of UN health-focused high-level meetings did not feature such specific and explicit provisions and pledges. However, while the political declaration offers a good framework for making bigger shifts in the fight against the silent pandemic and ensuring a more explicit focus on equitable access to health technologies to fight AMR, additional funding and research targets would have led to an even stronger outcome, as targets lead to better transparency and accountability.What’s next?Member states are largely expected to adopt the political declaration on Thursday without much controversy. The question is: what’s next? There will certainly be opportunities to further advance the work on AMR in other forums, such as the G7 and G20, as well as at the AMR ministerial in Saudi Arabia in November. The AMR political declaration includes a commitment by countries to raise $100 million to aid implementation of national action plans, and follow-through on the principles and targets will be key in the months (and years) ahead, especially with the next AMR meeting not scheduled until 2029. The 79th UN General Assembly will be a pivotal moment to garner the high-level political commitment needed to ensure sustained focus on the ongoing challenges around AMR and to shift from dialogue to action to combat the silent pandemic.

Last week, rain clouds gathered over Geneva as delegates from all over the world completed their annual pilgrimage to the World Health Assembly (WHA), the World Health Organization’s (WHO’s) annual forum for the 194 member states. The somber background reflected the mood heading into the meeting, as many were expecting this year’s gathering to be a washout. A visibly weary WHO Director-General Dr. Tedros Adhanom Ghebreyesus expressed his disappointment on the opening day that negotiations on a pandemic accord had not been completed in time for a WHA vote. Representatives also expected contentious fights over sexual and reproductive health and geopolitical conflicts, such as the ones in Ukraine and Gaza, to spill over into the proceedings, freezing debate and derailing possible progress on agenda items ranging from climate and health to universal health coverage. Yet, despite some serious bumps in the road, WHA also showcased that any multilateral system obituary is premature and that multilateralism can still deliver the necessary change we need to advance the global health agenda.   WHA approves new IHR amendments, resets timeline for pandemic agreement negotiationsAll eyes were on whether member states could come together to finalize the negotiations around the pandemic accord, a proposed convention to address some of the shortcomings exposed during the COVID-19 pandemic, as well as amendments to the International Health Regulations (IHR), an existing framework that codifies member state and WHO responsibilities in preparing for and responding to a public health emergency.  Heading into WHA, many stakeholders waited with bated breath to see if member states could bring both these processes across the finish line. Unfortunately, despite two long years of grueling negotiations, countries were unable to forge sufficient consensus to approve the pandemic accord. Instead, countries agreed to extend the mandate of the intergovernmental negotiating body, which coordinates the deliberation process for another year, providing additional time to reach compromises around the most contentious issues (financing, technology transfer—the process by which knowledge is transferred from the originator of a technology to other manufacturers to support the diffusion of health technologies into additional markets—, and a proposed access- and benefit-sharing system, which would pair commitments by countries around the sharing of pathogen samples and sequencing data with commitments from manufacturers to set aside a dedicated portion of their products for equitable distribution during health emergencies).  Nonetheless, member states notched a desperately needed win in reaching consensus on amendments to the IHR, achieving an agreement in the final hours of WHA. The consensus takes on added significance given that country representatives were not only in a race against time but also against fast-eroding trust in multilateralism, which was deeply fractured by the pandemic and subsequent geopolitical conflicts. The amendments to these technical rules, last revised in 2005 following the SARS outbreak, represent the first significant change in international law in the aftermath of the COVID-19 pandemic. While there were many changes to the IHR, one that stands out the most is that the added provisions include a commitment to solidarity and equity on strengthening access to medical products and to financing, including specific text that directs countries to promote research and development (R&D) and strengthen local production of quality, safe, and effective relevant health products. The previous IHR did not include any mention of R&D or the need to ensure equitable access to new tools.   WHA reinvigorates maternal and child health agenda  Progress was also made on a couple of other fronts in Geneva. Alarmed by the stagnation of progress in reducing maternal and child mortality, member states passed a critical resolution committing to specific actions to prevent the deaths of women, babies, and children.The resolution, led by Somalia and other cosponsors, commits countries to tackle the leading causes of maternal and child deaths, particularly in the hardest-hit nations. In it, countries agreed to improve access to maternal health services, including sexual and reproductive services, and comprehensive child health services through stronger primary health care and expanded access to emergency services. It also urges countries to develop and invest in tools that enable access to essential quality medicines for pregnant women, lactating women, mothers, and newborns and calls on WHO to strengthen and expand collaborative efforts, such as those promoted by WHO technical departments and the Global Accelerator for Pediatric formulations, or GAP-f, network, for facilitating better access to medicines for children. The WHA resolution marks WHO’s first significant action on maternal mortality in nearly a decade, following the adoption of the Global Strategy for Women’s, Children’s and Adolescents’ Health in 2015. Antimicrobial resistance in the spotlight  Antimicrobial resistance (AMR) also was in the spotlight in Geneva. With the United Nations High-Level Meeting (UN HLM) on AMR taking place in New York in September and a high-level ministerial meeting in Saudi Arabia in November, this year has been supercharged with attention on the issue, with WHA featuring numerous AMR events, roundtables, and initiatives.  Delegates approved a resolution to accelerate national and global responses on AMR, with many of them highlighting it as a crucial building block for the meetings in the fall. The resolution welcomes WHO’s strategic and operational priorities to address drug-resistant bacterial infections in the human health sector, which include prevention of infections; universal access to affordable, quality diagnosis and appropriate treatment of infections; strategic information, science and innovation; and effective governance and financing of the human health sector response to AMR.  The resolution also calls on member states to support investments in R&D for new tools to combat AMR and replenish the shockingly waning pipeline, to strengthen the capacities and standards of laboratories, and to participate in the WHO’s Global Antimicrobial Resistance and Use Surveillance System, or GLASS.While WHA did ultimately feature some contentious moments, especially around the geopolitics of Ukraine and Gaza, and major pushback on sexual and reproductive health, the latter almost derailing the adoption of several key decisions, the wins on IHR, maternal and child health, and AMR will have reverberations beyond WHA. Delegates hope that these wins will provide the necessary momentum to continue to make progress on the pandemic accord and at the UN HLM on AMR in the fall.  

Over the course of the COVID-19 pandemic, more than 1 billion vaccine doses were delivered to the world’s poorest countries via the World Health Organization (WHO)-backed COVAX vaccine sharing scheme. While much attention has gone to evaluating the successes and shortcomings of this effort in the wake of the pandemic, far less has been directed towards the WHO program that helped facilitate the introduction of these vaccines and other technologies by certifying their safety and efficacy—a program that deserves equally nuanced examination.  For decades, the WHO prequalification (PQ) program has played an essential role in accelerating access to health products in low- and middle-income countries (LMICs) by reviewing their safety, efficacy, and quality. It is a stamp of approval that clears the way for multilateral agencies to procure drugs, vaccines, diagnostics, and vector control products, and it guides emerging regulatory agencies that might otherwise lack the capacity to conduct independent reviews. But despite the program’s critical role in the global health ecosystem, it has been plagued by both operational and procedural challenges that create unnecessary delays. External stakeholders highlight pain points in the PQ programThat paradox is on full display in an independent evaluation released last fall of the WHO Department of Regulation and Prequalification, which oversees the PQ program. The assessment lauds the PQ program’s successes in expanding global access to products, especially during the COVID-19 pandemic; however, it also highlights the need for increased communication and collaboration between the PQ department and key stakeholders in the public health ecosystem, including product developers, national regulatory authorities, procurers, and other WHO departments. It also notes how manufacturers who apply for PQ are especially keen to have more visibility into PQ decision timelines and roadmaps for the release of related technical standards and guidelines. Stakeholders also unanimously highlighted the limited resourcing at WHO headquarters as a key constraint across the PQ department. According to the evaluation, the department’s resources have remained stable between 2018 and 2022 (from 114 staff members in December 2019 to 115 in December 2022). However, the scope and the workload across all teams have increased substantially over the same period. This assessment echoes recommendations from a 2022 report from GHTC and the Duke Global Health Innovation Center, which also urged PQ to increase visibility into anticipated timelines for decision gates throughout the review process so developers can better anticipate communication and decision-making. The report also recommended that the PQ program be more transparent in publicly disclosing information on how it is performing against these targets, as well as provide access to regularly updated public databases with complete milestone information on all prequalified products. Moving towards greater efficiency and transparency Fortunately, recent moves by WHO suggest the agency is beginning to take this feedback seriously and pursue remedies. Alongside the release of the evaluation, WHO announced the forthcoming launch of a new electronic portal for processing PQ applications. The portal promises a one-stop shop for applicants to file applications and relevant documents, receive status notifications, and track and respond to requests—offering them a real-time picture of their application status. This portal should also drive major efficiency improvements, as applications are currently processed manually, meaning that WHO staff handled the more than 1,000 PQ applications received in 2022 without automated support mechanisms. For national regulatory agencies, particularly those involved in WHO’s Collaborative Registration Processes—which allow for regulators to rely on evaluations carried out by WHO and other participating stringent regulatory authorities to accelerate their regulatory decision-making—, the portal provides a single location where they can also access all relevant information and documents in tandem with WHO. Importantly, the portal will also capture process-related milestones in greater detail and integrate with the WHO website, which we hope will allow PQ to improve reporting and transparency. While, unfortunately, the intended January 2024 launch of the portal has been delayed to the second quarter of the year, the rollout of the portal should be a welcome step toward a more effective, efficient, and transparent PQ program. A new path forward for novel products?Alongside pursuing operational improvements to processing applications, it is also vital that WHO reevaluate the PQ process itself to ameliorate bottlenecks that delay access to critically needed new technologies. Our 2022 report identified the interplay between the PQ process and the release of WHO treatment and use guidelines as one such process area ripe for change. Currently, WHO PQ procedure states that before a product can complete the PQ process and be listed, the product must already be featured in published WHO policy guidelines that recommend its use in clinical practice or public health policy. Stakeholders with whom we spoke identified this sequence as an obstacle and a source of delay for the PQ of novel products since the committees that develop guidelines, which operate outside the PQ process, will not release them until the clinical data upon which the guidelines are based are formally published in peer-reviewed literature, which can often take some time. During the COVID-19 pandemic, WHO proved these functions could occur more flexibly and in parallel. For example, WHO released regularly updated “living guidelines” for COVID-19 therapeutics as new clinical evidence emerged and, in 2022, released interim guidance for novel shorter-course treatments for drug-resistant tuberculosis. WHO PQ also initiated and advanced PQ review of the COVID-19 antiviral known by the brand name Paxlovid before related guidance was released, ultimately announcing the PQ of the product on the same day as the living guidelines for COVID-19 therapeutics were updated to recommend its use. There is an opportunity for WHO to more broadly adopt lessons from this experience by both expanding the use of interim or living guidelines and redefining the process for prequalifying novel products so PQ and guidelines development can occur more in parallel. We hope PQ will pursue this opportunity with haste, as it could be a potential game changer and significantly reduce the timelines for product evaluation, helping products ultimately reach patients faster. We also urge member states to adopt policy changes and provide the PQ program with the resources it needs to meet its growing scope and demands. Despite some of its constraints, the PQ program remains a key cog in the global health ecosystem and an important driver of improved product access. There are indications that WHO and other key stakeholders have realized that changes must be made, as the current structures are weighing down the program's ability to quickly facilitate access to critical technologies, especially novel products. By implementing changes to make the application and review process more user-friendly and efficient and the procedure itself more streamlined, we believe the program can better deliver on its mission to make high-quality essential medical products available to all who urgently need them.

2024 will be a pivotal year for global health. With a record number of national elections, including one in the United States, many multiyear global health architecture reform processes are set to come to a close, and with several major replenishment and resource mobilization campaigns taking place, there is a palpable sense of “now or never” permeating global health discussions.  The World Health Organization (WHO) Executive Board (EB) meeting, which serves as the kickoff to the multilateral calendar, served as the first test on whether stakeholders could come together to ensure that progress continues. While the week offered welcome moments of political support for research and development (R&D), there is a sense that leaders have not yet met the moment to get the world back on track toward achieving the Sustainable Development Goals (SDGs).  Here are some key reflections from a busy week in Geneva:  Deadline looms over pandemic accord and International Health Regulations processes  As in previous years, the WHO’s role in global health emergencies was a central topic at the EB. Just weeks before the fourth anniversary of the COVID-19 pandemic, delegates received a new update from WHO on strengthening the global architecture for Health Emergency Prevention, Preparedness, Response and Resilience, which focused on the need for sustained political leadership and financing to drive the reform agenda forward. And while not on the official EB agenda, the work of amending the International Health Regulations (IHR) and finalizing a pandemic accord also loomed large. Little of the debate focused on specific proposals of these deliberations, though advancing access to medical countermeasures, vaccine equity, and regionally distributed manufacturing all got mentioned during these sessions. Instead, member states zeroed in on the process itself, with delegates seeking to inject a new sense of urgency to finalizing deliberations and adhering to the May deadline. Despite this, Poland became the first country to publicly question the feasibility of the current timeline, calling for a possible extension, signaling that there is also trepidation around how much progress can be achieved with limited negotiation days. The sessions on health emergencies also became the platform for geopolitical proxy battles, with the Russia and Ukraine and Israel and Palestine conflicts spilling over into the global health security debates. Several heated exchanges nearly derailed proceedings, and much airtime was spent addressing grievances.Tuberculosis, immunization, and neglected tropical disease reports highlight setbacksMultiple sessions during the week highlighted the continued disruption in healthcare caused by the pandemic. Despite reaching the midpoint in implementation of the SDGs, global progress remains off track in many key areas. This includes the fight against tuberculosis and neglected tropical diseases, which the WHO highlighted as requiring a renewed focus from member states.  The importance of investing in local production, strengthening laboratory capacity, and ensuring new tools are better adapted to the communities they are meant to serve were all key themes that came out of these sessions.Routine immunization levels are also still lagging behind pre-pandemic rates, with uneven progress regionally.  In its report to the EB, the WHO has documented that the current progress is not enough to meet targets set in the WHO’s Immunization Agenda for 2030. Low- and middle-income countries spoke of the cost of vaccinations as a major financial burden and challenge.  Yet there were notes of optimism too: 2024 is also expected to be a major year for immunization, with the rollout of two new malaria vaccines and two new polio vaccines, bringing the world closer to eradicating some of the planet’s deadliest diseases. Antimicrobial resistance shifts into bigger focus With the UN High Level Meeting on Antimicrobic Resistance (AMR) scheduled later this year and the WHO’s global action plan on AMR coming to an end in 2025, AMR was expected to be a prominent topic at this year’s meeting. While it made its way back on to the official agenda, it unfortunately did not receive as much attention as anticipated, with the agenda item being pushed late into the evening on Friday.  Member states ultimately advanced a resolution sponsored by Thailand which calls on member states to support R&D for new tools to combat AMR, to strengthen the capacities and standards of laboratories, and to participate in the WHO’s Global Antimicrobial Resistance and Use Surveillance System (GLASS), though several countries also wished to discuss the decision further ahead of the World Health Assembly (WHA) in May where it will be up for formal adoption. In his remarks on the topic, WHO Director-General Dr. Tedros Adhanom Ghebreyesus echoed the calls for stronger surveillance; the development of new vaccines, diagnostics, and antimicrobials; and measures to make these interventions accessible and affordable. New resource mobilization push for WHO  EB members supported the proposal for an investor round to raise funds for WHO, which would likely be held in November, with uncharacteristic enthusiasm last week. The WHO Working Group on Sustainable Financing’s report to the 2023 WHA highlighted that WHO’s budget is “up to 86% dependent on generous donors” and that only “roughly 14% of WHO’s finances are truly predictable”. The future effectiveness of WHO will depend on changing how the agency is funded. Progress has been made to increase the percentage of assessed contributions received in the form of member state dues, but far more flexibility and predictability in voluntary contributions will be needed to meet this moment. The idea of a WHO investment round, similar to those hosted by the Global Fund and Gavi, the Vaccine Alliance was accepted in principle by last year’s WHA. Dr. Tedros was charged by member states to provide a framework and justification at this year’s EB, and he delivered his investment case.  The investment framework is closely aligned with WHO’s 14th General Program of Work and the new strategic roadmap for the agency, but this WHO resource campaign will also have to compete with a number of replenishments set for this year, including for Gavi, as well as a resource push for the World Bank Pandemic Fund. This year feels like a make-or-break moment for the SDGs and the 2030 agenda. Yet the EB felt too much like business as usual, with ambition getting bogged down in a bloated agenda, geopolitical battles, and the minutia of internal processes. The urgency highlighted by several delegates on EB topics was not matched in the action or the commitments countries made in Geneva last week. While the EB did not jeopardize the potential of many processes moving forward, it did too little to contribute to the necessary forward momentum we will need to achieve the ambitious agenda set out by global leaders.  

Geneva is back! For the first time since the beginning of the COVID-19 pandemic, delegates from both World Health Organization (WHO) member states and civil society felt as if this World Health Assembly (WHA) marked a return to normal. In fact, given an almost unprecedented number of side events and meetings and the sheer volume of delegates swarming around the usual spheres of influence, including the United Nations Palais and the Intercontinental Hotel (and beyond), this year saw a massive surge in engagement and energy for this important milestone on the multilateral calendar. Here are some of the top takeaways from the week:1. WHA maintains constraints on civil society engagement.As civil society delegates descended on Geneva, the question that hung in the air was would non-state actors be able to meaningfully engage in this year’s assembly? Would we see improvement after we saw access further curtailed at the Executive Board (EB)? The answer was largely no. Over the past year, new protocols and structural changes have been put in place at WHO meetings, which have limited delegation size and left civil society sometimes literally on the outside looking in. As was the case at EB earlier in the year, in order to counter the ballooning number of agenda items, WHO maintained constraints on statements—an action that has hit non-state actors particularly hard. WHO forced civil society organizations to come together and develop single constituency statements for certain agenda items, further diluting specific technical feedback from a diverse set of voices as various WHO-accredited institutions tried to reconcile diverging views into a single, cohesive communication. In fact, in some cases, WHO pushed even further this time, as separate constituencies were forced to further consolidate, creating the almost impossible task of reconciling stakeholders with vastly diverging views. ⁦@WHO⁩ has sliced the already small NSA section for Committee A on #UHC in half at #WHA76. Press access is important but so is inclusive CSO participation. Don’t shut us out! pic.twitter.com/MnLOf4H2Dm— Elisha Dunn-Georgiou (@elisha_dg) May 22, 2023 It is disappointing to see no positive improvement for non-state actors after a horrendous EB experience. This underscores the likelihood that some of these restrictions may become the new normal and that without a concerted effort that involves member states advocating for the meaningful participation of civil society, these challenges will persist. 2. Geopolitics derails debate on WHO’s work in health emergencies.While we got a preview of this at the EB, the geopolitical fights reached a new crescendo at this year’s assembly. Much of the debate surrounding WHO’s role in health emergencies was derailed by several testy exchanges between western and Russia delegations on the current war in Ukraine. Many speakers retooled their interventions to primarily focus on the war, giving little airtime to other substantive issues covered under that agenda item. While not on the official agenda of this assembly—meaning no decisions would be made this year—the pandemic accord also remained a central topic of discourse during the week among both member states and advocates in Geneva.A draft from the Intergovernmental Negotiating Body (INB) leaked during WHA, and the new 42-page document provides member states with several text options to consider. It is generally a compilation of feedback and suggestions made on the zero draft released in February.The latest version, which comes on the heels of a number of largely member state-only deliberations and technical consultations on specific chapters with a wider group of stakeholders, has changed significantly. The previously strong language that set robust conditions on public research and development (R&D) funds for price transparency and technology transfer, among other measures, has been dropped or diluted. The new text still contains references linking access to pathogen samples or genomic data with the sharing of “benefits” from health products produced as a result, something that the pharmaceutical industry has strictly opposed.  Member states now face a big test as there is growing skepticism that differences can be reconciled by the next WHA, which is when the accord was set to be voted on. Some have voiced concerns over the process itself. The representative from Jamaica said the rush to complete the accord puts small island states at a disadvantage, preventing them from fully participating and contributing to the final document.3. Implementation of the clinical trials resolution remains discussion point despite not being on official agenda.During the session on global health emergencies, member states were set to follow up on the EB debate regarding implementation of last year’s clinical trials resolution, but the topic received little airtime from country delegates. A few leaders did underscore the need for greater clinical trial capacity in low- and middle-income countries, but few specifics were covered during the parliamentary debate. Outside of the official proceedings, there was certainly a focus on the topic as several organizations discussed implementation during side events throughout the week. In a big win for the advocacy community, WHO’s new Chief Scientist, Dr. Jeremy Farrar, publicly committed to including in clinical trial guidance being developed by WHO later this year an entire section that focuses on vulnerable populations, including pregnant individuals and children.4. Diagnostics resolution passes as UHC debate is overtaken by noncommunicable diseases.As was the case at the EB, universal health coverage (UHC) is back on the map, having featured heavily at this year's assembly. While the topic overall received substantive airtime, there was little focus on the role of research and innovation in achieving UHC, and much of the discussion centered around addressing noncommunicable diseases. However, in a win for the R&D community, WHO member states passed a resolution on strengthening diagnostics capacity. The resolution urges member states to address a range of diagnostic challenges, including increasing local production capacity, streamlining regulatory approaches, and addressing access barriers. It also calls on them to increase investment in diagnostic R&D and provide more systemic funding of capacity-strengthening infrastructure for diagnostics, as well as urges WHO to enact specific technical changes to facilitate and catalyze diagnostic development.  All eyes are now on the G2O and the United Nations High-Level Meetings this fall, where advocates hope to shift the focus towards creating greater political will and ensuring follow-through. While this WHA official agenda did not prominently feature research, it was encouraging to see R&D continue to play a prominent role in both informal and technical discussions throughout the week. With growing momentum, our community must now capitalize on all the work from the past year and seize upcoming opportunities to reshape the global architecture to accelerate health breakthroughs.

As is tradition, the World Health Organization (WHO) Executive Board (EB) kicked off what promises to be another packed multilateral calendar. While much has remained the same, this year’s forum also ushered in noteworthy shifts in deliberations, dynamics, and dialogue that advocates should be aware of. Here are GHTC’s top takeaways from the week: 1. EB shrinks space for civil society engagement. As civil society delegates entered the halls of WHO for the EB for the first time since 2020, they were confronted with a harsh reality: The ability for non-state actors to meaningfully participate in these meetings is at an all-time low. New protocols had been introduced limiting delegation size and physical and structural changes put in place that left civil society literally on the outside looking in. Gone are the days when civil society could be physically present in the assembly room to follow the proceedings. Instead, advocates were relegated to a small, hot, and stuffy overflow room, more akin to a small press room, located far away from the official proceedings, hampering their ability to connect with officials and country delegates, which is often the most valuable part of the week. As EB participation and the number of agenda items have ballooned, WHO has also imposed new constraints on civil society statements, which have hit non-state actors particularly hard. WHO has tried to force civil society organizations to come together and develop single constituency statements for certain agenda items, a challenge that often further dilutes specific technical feedback from a diverse set of voices as various WHO-accredited institutions try to reconcile diverging views into a single, cohesive communication. Individual interventions are now reduced to just one minute, and they must be uploaded to a WHO database prior to the start of that agenda item. Apart from the challenge of distilling feedback and technical input down to around 100 words, the requirement to upload in advance prohibits advocates from rebutting issues that arise during debate or meaningfully influencing the decision making in real time. Other United Nations (UN) agencies, such as the World Trade Organization and the World Intellectual Property Organization have far more robust and meaningful civil society engagement processes that could serve as better models for WHO to emulate. 2. Debate on WHO’s work in health emergencies goes into the next round. Global politics tend to spill over into the parliamentary debates at EB, and this year was no different with the war in Ukraine creating serious tension between western allies and Russia. Much of the debate surrounding WHO’s role in health emergencies was derailed by several testy back-and-forths between delegations, leading to disruptions and little progress on key agenda items. A new ten-point proposal from WHO Director-General Dr. Tedros Adhanom Ghebreyesus to improve preparedness and response to health emergencies also received mixed reviews from WHO member states, with many warning the WHO secretariat not to move ahead of member states and the already ongoing processes to amend the International Health Regulations and negotiate a pandemic accord.  The latter did make waves at this EB, as the WHO Intergovernmental Negotiating Body (INB) published a “zero-draft,” that included a few surprises. The draft features some strong, equity-focused language, as well as calls for building and strengthening country regulatory, manufacturing, and innovative research and development (R&D) capacities for pandemic-related products. Surprisingly, it also features numerous callouts and provisions focused on intellectual property, including incentivizing relevant transfers of technology and know-how, forcing manufacturers that receive public funding to disclose prices for pandemic-related products, and time-bound waivers on medical countermeasures that can accelerate or scale up manufacturing, signaling the key battlegrounds for upcoming negotiations.  The biggest stunner, though, is a brand-new section focused on creating a new WHO Pathogen Access and Benefit-Sharing System (the “PABS System”) that would collect and equitably distribute a portion of all globally produced vaccines and other medical products during pandemics. According to the draft, 10 percent of total global production of pandemic products would be allocated to WHO, with half donated and half bought at an “accessible” price. Now, deliberations on the specific provisions will begin in earnest ahead of the World Health Assembly (WHA) in May, with the INB hosting two meetings in the next few months to debate individual chapters of the draft.  3. Implementation of the clinical trials resolution enters its next phase as member states argue about scope. Member states also debated the implementation of last year’s clinical trials resolution during the session on global health emergencies. Delegates noted the progress WHO had made over the past year in leading consultations and mapping the current clinical trial networks landscape. A few countries underscored the importance of inclusiveness and equity and called for greater technical support from WHO. On the contrary, in response to a WHO proposal to develop a complementary self-assessment tool to measure the maturity of the clinical trial ecosystem at national and international levels, the United States and United Kingdom instead urged the WHO secretariat to keep its focus limited to the scope of the actual resolution until more progress is achieved. The WHO is now set to move forward with a process to develop draft guidelines for clinical trials, with the help of experts and member states, that is expected to be in place by WHA. 4. Universal health coverage (UHC) reemerges as a priority from COVID-19 slumber. In 2019, UHC was the “it” topic of global health. It featured prominently on the agenda of WHO meetings and the UN held a high-level meeting on the subject to advance a new framework to achieve the Sustainable Development Goals. Then came the pandemic, and focus and attention on the topic slipped. This year, UHC is back on the map, having featured heavily at this year's EB.  During the broader discussion on UHC, WHO member states highlighted the importance of primary health care and health system strengthening, as well as considered and ultimately passed a resolution on strengthening diagnostics capacity. The resolution urges member states to address a range of diagnostic issues, including increasing local production, streamlining regulatory approaches, and addressing access barriers. It also calls for greater investment in diagnostic R&D and more systemic funding of capacity-building infrastructure for diagnostics, as well as urges WHO to enact specific technical changes to facilitate and catalyze diagnostic development.  The next couple of months will continue to deliver multilateral developments at a breakneck pace, and given the interlinkages between the many multilateral processes underway, it will be vital for advocates to understand the full landscape of possible changes to the global health architecture. While the dynamics may be shifting, it is encouraging to see that the research agenda is present throughout these different dialogues, both in Geneva and beyond.