Executive Summary
The COVID-19 pandemic exposed persistent weaknesses in global health governance, particularly in preparedness, equity, and accountability, and in May 2025 the WHO Pandemic Agreement was adopted to address these systemic gaps through a binding international framework. The reforms since 2020 represent the most ambitious restructuring of global health architecture in two decades, spanning treaty law, surveillance rules, and dedicated financing. However, two compounding forces now threaten the architecture's effectiveness: an unresolved operational annex on pathogen access, and the US withdrawal from WHO.
- Health system operators: Audit organizational pandemic response plans against the new IHR "pandemic emergency" alert tier, which entered into force in September 2025, and assess whether supplier contracts include provisions triggered at that threshold.
- Risk officers/investors: Price in the Pathogen Access and Benefit-Sharing (PABS) negotiation outcome as a swing variable for vaccine manufacturing strategy; the annex was unresolved at the May 2026 World Health Assembly and remains the treaty's central implementation risk.
- Policy/government stakeholders: Monitor the Pandemic Fund's fourth call for proposals, targeting the highest-risk countries, as the primary mechanism for closing LMICs' surveillance and laboratory gaps that no treaty provision can substitute for.
The post-COVID reform cycle has produced more binding legal architecture than any prior generation of health governance, but the gap between paper commitments and operational capacity is widening faster than ratification timelines can close.
Key Findings
- The 2024 IHR amendments entered into force in September 2025, introducing a new "pandemic emergency" alert tier that materially upgrades the global early-warning system for the first time since 2005.
- The WHO Pandemic Agreement, adopted in May 2025, is the first binding pandemic treaty in WHO history, but its operational core, the Pathogen Access and Benefit-Sharing annex, remained unresolved at the May 2026 World Health Assembly, creating a procedural bottleneck that delays the treaty's central equity mechanism.
- The Pandemic Fund, established in September 2022, has mobilized a portfolio of nearly $11.5 billion across 128 countries, but demand for preparedness financing exceeds available supply by more than sixfold, signaling that the current funding model cannot close the structural gap without a step-change in sovereign contributions.
- The US withdrawal from WHO in January 2025 removed the organization's largest single financial contributor and creates an expanding capability gap in surveillance networks, disease modeling, and outbreak coordination that no current actor has committed to replace.
- The 100-day vaccine-development target is not yet achievable, and the 2025 outbreak year, encompassing mpox, H5N1, Ebola, Marburg, Rift Valley Fever, Chikungunya, and measles, demonstrated that detection, coordination, and access gaps remain operational rather than merely theoretical.
The Architecture Of Reform: Three Pillars Adopted Since 2020
The post-COVID reform cycle rests on three distinct but interlocking instruments. The first is the 2024 IHR amendments, the second is the 2025 Pandemic Agreement, and the third is the Pandemic Fund's catalytic financing model. Each addresses a different failure mode from the COVID-19 crisis, and each is operating under different levels of constraint.
Two major developments now define the next era of global health governance: the 2024 amendments to the International Health Regulations and the 2025 WHO Pandemic Agreement, both crafted through multi-year negotiations under WHO and aimed at correcting systemic failures revealed by the pandemic while embedding equity, transparency, and legal authority into global health responses.
The IHR amendments, which entered into force on September 19, 2025, address the operational failures most visible during COVID-19: slow alert escalation, weak national coordination authorities, and insufficient data-sharing norms. On June 1, 2024, the World Health Assembly reached consensus on a package of amendments to the 2005 International Health Regulations; while the IHR remain the only near-universal legal framework for preventing and addressing the international spread of disease, the amendments emphasize equity and solidarity and potentially shift the IHR from a purely technical instrument to one addressing inherently political issues. This shift from technocratic to political framing is an analytical signal that the IHR amendments may face compliance resistance where national political incentives diverge from reporting obligations.
The Pandemic Agreement, adopted by the 78th World Health Assembly on May 20, 2025, adds a layer above the IHR. Adopted by 124 countries at the 78th World Health Assembly in May 2025, the WHO Pandemic Agreement is the second major legally binding treaty negotiated under Article 19 of the WHO Constitution, following the 2003 Framework Convention on Tobacco Control, and was born out of three years of negotiations aimed at addressing structural inequities and governance failures in the global COVID-19 response.
The agreement mandates timely and fair distribution of diagnostics, vaccines, and therapeutics for low- and middle-income countries, and establishes a newly envisioned Global Supply Chain and Logistics Network to coordinate rapid, affordable access to health products during emergencies.
Both instruments spill directly into economic policy: the new alert tiers and mandatory reporting requirements translate directly into commercial risk for pharmaceutical manufacturers, medical supply chains, and airline operators that face potential travel and trade restrictions under the upgraded PHEIC and "pandemic emergency" framework. Governments that ratify both instruments are accepting constraints on sovereign economic decisions in exchange for access to multilateral surge capacity.
Where The Architecture Fails: Equity, Enforcement, And The Pabs Deadlock
The structural gap that most directly threatens the pandemic preparedness system is not funding volume, but distributional mechanics. The PABS mechanism, which would require pharmaceutical manufacturers to share a portion of vaccines, diagnostics, and therapeutics produced under the new Pandemic Agreement, remains unresolved. According to China CDC Weekly analysis published in January 2026, the agreement establishes a PABS System anchored in principles of equity, solidarity, and human rights, but operational ambiguities, particularly in defining pathogen scope, integrating traditional knowledge, enforcing manufacturer obligations, and coordinating with existing multilateral frameworks like the Convention on Biological Diversity and the Nagoya Protocol, pose significant implementation risks.
What is not being reported: The PABS deadlock receives less attention than the treaty's headline adoption, but it is the mechanism through which low-income countries agreed to share pathogen samples rapidly. If the annex remains unresolved, the incentive for rapid sharing is removed and the entire early-warning architecture becomes contingent on political goodwill rather than legal obligation. This is a materially different risk profile than the treaty's headline framing suggests.
The peer-reviewed literature identifies a scoping gap on top of the legal one. Persistent gaps in governance (limited enforceability, fragmented coordination), equity (inequitable access to medical countermeasures), capacity (technology transfer and financing), and accountability have been identified across the post-COVID reform period. According to a November 2025 scoping review published in the International Journal of Environmental Research and Public Health, the WHO Pandemic Agreement faces critical legal, governance, and equity challenges that must be addressed for it to effectively strengthen global health security, with the treaty's success dependent on implementation of key provisions, particularly the unresolved PABS mechanism, and on sustained investment in equitable and resilient health systems.
The financing gap has a concrete number. Across the first three Pandemic Fund calls for proposals, countries requested more than six times the available funding. This is not an expression of polite ambition; it is a direct measurement of unmet preparedness infrastructure demand. The Pandemic Fund's own Strategic Plan, covering 2024-29, identifies three programmatic priorities: strengthening surveillance, laboratory systems, and the health workforce, supported by investments in National Public Health Institutes and regional and global networks. These are the same three systems that failed most visibly in 2020. As of mid-2026, they remain underbuilt in sub-Saharan Africa and South Asia, where sub-Saharan Africa has received nearly 44% of all grants allocated, followed by Latin America and the Caribbean at 16%.
Short-term gain, long-term cost: The Pandemic Fund's catalytic model, which requires co-financing from recipient countries and multilateral development banks, improves efficiency but also means the highest-burden countries, those least able to mobilize domestic co-investment, receive proportionally less support. The Fund's board agreed to launch a targeted funding round in March 2026 specifically to support high-risk, high-need countries that have not yet received Pandemic Fund support, many of which are in fragile situations. This fourth round represents a corrective adjustment, but it does not resolve the structural tension between catalytic financing logic and fragile-state context.
The Us Withdrawal Variable And Geopolitical Fragmentation Risk
The United States' withdrawal from WHO, initiated in January 2025, is not a parallel development to the reform agenda; it directly undermines it through three mechanisms. First, it removes the largest single financial contributor from an institution whose budget is now stretched across expanded IHR and Pandemic Agreement mandates. The USA's financing accounted for 19.77% and 13.96% of WHO expenditures in 2022 and 2023 respectively, with the country contributing an impressive USD 1.284 billion in the 2022-23 biennium.
Second, the US withdrawal spills into the surveillance domain by breaking the CDC-WHO technical co-production relationship that has historically been the operational backbone of outbreak detection. The US is already preventing CDC employees from co-authoring papers with WHO staff, disrupting mechanisms for addressing transnational health threats. This is not a symbolic gesture; CDC-WHO collaboration on genomic sequencing, H5N1 monitoring, and laboratory network maintenance generated public goods that no replacement mechanism currently provides.
Third, the US is not a party to the 2025 Pandemic Agreement, meaning the PABS annex negotiations, the Global Supply Chain and Logistics Network, and the Coordinating Financial Mechanism for the agreement all proceed without the country that historically financed the largest share of global health infrastructure. In January 2025, President Trump signed an executive order withdrawing from WHO, citing issues including mismanagement during COVID-19 and a disproportionate financial burden. These are real governance grievances, and the scoping review literature confirms some of the accountability failures. The governance case for reform is not wrong; the question is whether unilateral exit accelerates or retards the structural corrections the treaty system is attempting.
Coalition fracture point: The global pandemic preparedness coalition is not a unitary actor. The PABS divide between approximately 100 LMICs demanding mandatory benefit sharing and high-income country pharmaceutical producers resisting binding allocation represents the most moderate-to-high confidence fracture point in the entire architecture. If the annex fails to produce a legally binding agreement, the Pandemic Agreement's Article 19 authority becomes a framework without its operational engine, and the incentive for rapid pathogen sharing dissolves.
The broader geopolitical and economic implications are mutually reinforcing. WHO budget constraints compound the IHR's new monitoring requirements, which require technical assistance to countries establishing National IHR Authorities. Reduced US engagement weakens the PABS negotiating environment by removing a major pharmaceutical producer country from the table. And weaker PABS outcomes reduce the incentive for LMICs to invest in the kind of rapid-reporting infrastructure that the Pandemic Fund is simultaneously trying to finance.
Key Assumptions
| Assumption | Supporting Evidence | Falsifying Evidence | Impact if Wrong | Monitoring Metric |
|---|---|---|---|---|
| IHR amendments will be implemented by most member states now that they have entered into force | WHO September 2025 announcement confirming entry into force for 196 States Parties; National IHR Authority mandates now active | Evidence of large-scale opt-outs or persistent non-reporting by major transit hubs, particularly in Southeast Asia | Early warning system degrades to pre-2024 sensitivity; pandemic emergency alert tier becomes unenforceable | WHO annual IHR States Parties Self-Assessment Annual Reporting Tool (SPAR) scores, published by WHO each December |
| The PABS annex will reach a negotiated outcome, even if weaker than LMICs demand | Three years of WHO negotiation momentum; May 2026 WHA deadline creates political cost for indefinite failure | A second failed WHA deadline with no fallback mechanism; bloc fragmentation preventing consensus formation | LMICs reduce pathogen sample sharing speed and volume, degrading global surveillance | WHO IGWG session reports, published quarterly through 2026 |
| The Pandemic Fund will sustain and expand its donor base without US government contributions | Over two dozen sovereign contributors have pledged funds; EU and member states are the largest contributor bloc; fourth call launched April 2026 | Major donor withdrawal following domestic budget pressure; Japan, Germany, or EU reducing pledges | Portfolio growth stalls; high-risk country round unfunded; 6:1 demand-to-supply ratio worsens | Pandemic Fund Governing Board meeting communiques, issued after each board session |
| 100-day vaccine development targets will be achievable within a 5-year horizon for prototype pathogens | CEPI and IPPS mission frameworks remain active; targeted therapeutics pipeline exists | Continued R&D budget cuts at scale; no new manufacturing capacity in LMICs; PABS annex failure removing incentive to share pathogen samples | Next pandemic response defaults to 12-18 month development timeline, as in COVID-19 | IPPS 100 Days Mission annual scorecard, published by the International Pandemic Preparedness Secretariat |
Counterarguments
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The treaty architecture may represent a paper advance rather than an operational one: The strongest challenge to the reform narrative is that the IHR amendments and Pandemic Agreement both rely on state compliance mechanisms that were already present in 2005 and still failed during COVID-19. While the IHR remain the only near-universal legal framework for preventing and addressing the international spread of disease, the 2024 amendments potentially deflect attention from the need for deeper structural reforms rather than resolving them. If states lacked the political will to report early in 2020 under the pre-existing IHR framework, adding a "pandemic emergency" alert tier does not address the political economy of early disclosure, which punishes countries with travel bans and economic sanctions for transparency.
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The Pandemic Fund's catalytic model systematically underserves the highest-risk countries: The six-to-one demand-to-supply ratio is evidence that the catalytic model is producing efficient allocation but insufficient volume. The co-financing requirement, which makes each Pandemic Fund dollar leverage additional domestic and development bank resources, works well in lower-middle-income countries with functional ministries of finance. It works poorly in fragile states, where the 2026 fourth round is being targeted. Demand continues to exceed available resources, meaning the countries most moderate-to-high confidence to be the origin point of the next pandemic remain the most underserved by the financing architecture designed to prevent it.
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The US withdrawal effect on surveillance may materialize faster than the treaty architecture can compensate: The peer-reviewed literature identifies a specific mechanism: the US is already preventing CDC employees from co-authoring papers with WHO staff, disrupting mechanisms for addressing transnational health threats. The 100 Days Mission report flags that major reductions in global health and research budgets in 2025 have exposed structural vulnerabilities, disrupted development pipelines, and weakened preparedness. These are current-tense operational degradations, not future risks. The combination means the reform cycle's surveillance pillar may be contracting in real terms even as the legal framework is being strengthened.
Indicators To Watch
| Indicator | Current State | Warning Threshold | Time Horizon |
|---|---|---|---|
| PABS annex negotiation status at WHO IGWG | Unresolved at May 2026 WHA deadline; IGWG continued | Second consecutive missed WHA deadline with no interim agreement | 6-12 months |
| Pandemic Fund fourth call for proposals funding level | Launched April 2026 targeting highest-risk countries | Less than 50% of targeted fragile-state countries receive approved projects within 12 months of launch | 12 months |
| National IHR Authority establishment rate | IHR amendments entered force September 2025; National IHR Authority mandates now active | Fewer than 60% of WHO member states report established authorities at December 2026 SPAR reporting cycle | 6 months |
| 100 Days Mission scorecard for diagnostics and therapeutics | Fifth implementation report (January 2026) found target not yet achievable | No measurable improvement in diagnostics pipeline benchmarks in the sixth scorecard | 12-18 months |
| US bilateral health security spending post-WHO withdrawal | CDC co-authoring with WHO suspended; bilateral programs under review | Formal cessation of USAID global health security bilateral programs in more than 20 countries | 3-6 months |
Near-term watch list: (1) WHO IGWG PABS negotiating session (Q3 2026), which will signal whether a limited annex text can be tabled before the 79th WHA special session deadline, the most consequential single outcome for the treaty's operational credibility; (2) Pandemic Fund fourth call for proposals results (Q4 2026), which will show whether the targeted fragile-state mechanism can close the coverage gap for the highest-risk origin countries; (3) G7 France Presidency health security deliverables (full year 2026), which the 100 Days Mission fifth report identifies as the decisive political window for coordinating therapeutics development financing across CEPI and national R&D agencies.
Decision Relevance
Scenario A (~55%): Reform architecture holds with partial PABS resolution and sustained Pandemic Fund growth. The PABS annex produces a limited but operational agreement, the Pandemic Fund's fourth round reaches high-risk countries, and IHR National Authorities are established in most member states by end-2026. If you advise on global health policy or supply-chain continuity planning in health-exposed sectors, this scenario calls for alignment of organizational pandemic protocols with the new IHR "pandemic emergency" alert tier now, before the next activation event forces reactive compliance. If you lack direct health-sector exposure, treat this as the baseline against which any deterioration in the indicators above should be measured.
Scenario B (~30%): PABS annex failure produces a treaty with a missing operational engine. A second missed WHA deadline on PABS leaves the Pandemic Agreement in force but without the equity mechanism that motivated LMIC ratification. Pathogen sharing slows, and the 100-day target becomes structurally unreachable because the incentive architecture for rapid disclosure has been removed. If you have pharmaceutical manufacturing or vaccine development exposure, this scenario materially increases the probability that the next pandemic response defaults to the 12-18 month timeline of COVID-19 rather than a reformed 100-day model. Begin stress-testing supply agreements for extended emergency duration. If you are a policy stakeholder, the PABS failure scenario creates an opening for bilateral frameworks (direct country-manufacturer agreements) to substitute for the multilateral one, with equity implications that are moderate-to-high confidence to be severe for lower-income markets.
Scenario C (~15%): US re-engagement with WHO or bilateral health security architecture replaces multilateral gaps. The US negotiates a re-entry framework or establishes a parallel bilateral surveillance and financing structure that compensates for WHO budget reduction. If you are evaluating public-private partnership opportunities in global health security infrastructure, this scenario opens significant investment potential in diagnostics manufacturing, laboratory network expansion, and digital surveillance platforms, particularly in Sub-Saharan Africa and Southeast Asia where the infrastructure gap is largest.
Analytical Limitations
- The PABS annex negotiation was ongoing at the time of this assessment, and its outcome, whether a binding text, an interim arrangement, or a failure, will materially alter the Pandemic Agreement's operational profile. This assessment cannot predict that outcome.
- US domestic political decisions on bilateral health security spending, CDC operational scope, and re-engagement with WHO-affiliated bodies are not publicly documented at the granularity required to model precise capability degradation timelines. The current-tense disruptions (CDC co-authoring suspension, program reviews) are confirmed, but their cumulative quantitative effect on surveillance sensitivity is not yet measurable.
- Country-level IHR compliance data from the SPAR tool lags by approximately 12-18 months, meaning the first real signal on National IHR Authority establishment rates will not be available until late 2026 or early 2027.
- The 100 Days Mission scorecard uses benchmarks developed under prior R&D investment assumptions. The 2025 budget reductions may have shifted those baselines in ways not yet reflected in the fifth implementation report, meaning the diagnostics and therapeutics gap may be larger than current scoring indicates.
- Evidence on LMIC domestic health budget trajectories is fragmented across country-specific reporting cycles and is not consolidated in any real-time data series, limiting the ability to verify whether Pandemic Fund co-financing assumptions remain achievable for the highest-burden countries.
Sources & Evidence Base
- Ungraded
- UngradedIncreasing capacity for pandemic preparedness - WOAH - Asia
rr-asia.woah.org
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- Ungraded