The IHR and the Pandemic Treaty

Parts I, II, and III of The Geneva Files documented the man, the moment, and the money — the selection of Director-General Tedros Adhanom Ghebreyesus, the institutional posture of the World Health Organization during the early pandemic period, and the funding architecture that constrains the institution's independence. Part IV documents the legal instruments through which the WHO exercises authority. The International Health Regulations of 2005 are the principal binding instrument of international health law, obligating 196 States Parties to specific conduct in the event of a public health emergency. The 2024 amendments to those regulations expanded the WHO Director-General's authority to declare a new and higher category of alarm. The Pandemic Agreement adopted in May 2025 is only the second binding health treaty in the WHO's seventy-seven-year history. Together these three instruments constitute the legal architecture of the WHO's authority over its member states. This Part documents that architecture, documents the specific mechanism through which the architecture has, in the case of the United States, operated at the edge of and arguably beyond constitutional authority, and documents the United States' formal rejection in 2025 of the expansion of that architecture.

The question this Part examines is one the previous three Parts have approached structurally and that this Part addresses directly. By what authority does the World Health Organization — an institution led by an unelected Director-General, funded predominantly by earmarked voluntary contributions from a small number of major donors, and governed by a World Health Assembly in which the United States holds one vote of 194 — influence the health policy of the United States? The answer the documentary record establishes is structural. The WHO's authority over the United States operated, during the pandemic period, through three mechanisms: the legal-instrument mechanism of the International Health Regulations; the alignment mechanism through which U.S. federal agencies adopted WHO determinations as the triggering events for their own domestic actions; and the normative mechanism through which WHO guidance became, in the information environment documented in the companion Fauci Files series, the authoritative standard against which dissent was measured. Each mechanism is documented. None required a vote of the American people or their elected representatives.

What follows is the documentary record.

The Instrument — What the IHR Actually Is

The International Health Regulations are not a metaphor for international cooperation. They are a binding instrument of international law. The current version, the International Health Regulations (2005), was adopted by the World Health Assembly on May 23, 2005 and entered into force on June 15, 2007. The regulations bind 196 States Parties — the 194 WHO member states plus the Holy See and Liechtenstein. The United States became bound by the IHR (2005) in 2007.

The legal mechanism through which the IHR binds states is the distinguishing feature of the instrument, and the feature most consequential for the constitutional question this Part examines. The IHR were not adopted as a treaty requiring signature and ratification by each member state through that state's own constitutional process. They were adopted as regulations under Articles 21 and 22 of the WHO Constitution. The distinction is not technical. It is the entire structural question.

Under the WHO Constitution, regulations adopted by the World Health Assembly enter into force for all member states automatically, following a notice period after adoption, unless an individual member state affirmatively notifies the Director-General that it rejects the regulation or accepts it subject to reservations. This is the opt-out mechanism. A WHO member state does not need to affirmatively accept an IHR amendment for the amendment to bind it. The amendment binds the member state automatically unless the member state takes affirmative action to reject it within the notice window.

The contrast with the United States' constitutional treaty framework is direct. Under Article II, Section 2 of the United States Constitution, the President has the power to make treaties "by and with the Advice and Consent of the Senate," provided two-thirds of the Senators present concur. A treaty does not bind the United States until the Senate has consented by a two-thirds vote and the President has ratified. The constitutional framework requires affirmative supermajority consent. The IHR opt-out mechanism requires no consent at all — only the absence of timely rejection.

The IHR opt-out mechanism requires no affirmative consent. An amendment binds the United States automatically unless the United States takes affirmative action to reject it.

When the United States agreed to be bound by the IHR (2005) in 2007, it did so with a reservation: that aspects of IHR implementation would be subject to the United States' federal system, in which certain health authorities are reserved to the states. The reservation acknowledged the constitutional tension. It did not resolve it. The structural mechanism through which IHR amendments enter into force without Senate ratification — the opt-out mechanism — remained the operative framework. The Congressional Research Service, in its June 2024 analysis of the IHR amendments, documented this framework directly: regulations adopted by the World Health Assembly "enter into force for all States Parties automatically following a notice period after WHA adoption, unless an individual Member State notifies the DG that it wishes to reject or modify its obligations under such regulations."

The Trigger — PHEIC and the American Response

The operational core of the IHR is the Public Health Emergency of International Concern. The PHEIC is the formal determination, made by the WHO Director-General on the advice of an Emergency Committee convened under the IHR, that an extraordinary event constitutes a public health risk to other states through the international spread of disease and potentially requires a coordinated international response. The PHEIC determination is the trigger that activates the IHR's operational machinery.

The documentary record of the COVID-19 PHEIC and the American response to it is the clearest available illustration of how the WHO's determinations operated as the triggering events for United States domestic action. The sequence is documented in the Federal Register.

On January 30, 2020, the WHO Director-General, on the advice of the IHR Emergency Committee convened for the second time, declared the COVID-19 outbreak a Public Health Emergency of International Concern. On January 31, 2020 — one day later — United States Secretary of Health and Human Services Alex Azar declared a public health emergency for the United States pursuant to Section 319 of the Public Health Service Act, 42 U.S.C. 247d. On March 11, 2020, the WHO publicly characterized COVID-19 as a pandemic. On March 13, 2020, the President of the United States declared the COVID-19 outbreak a national emergency.

The legal architecture of this sequence is precise, and the precision matters. The United States did not declare its public health emergency because the WHO declared a PHEIC, in the sense of a binding legal obligation. The U.S. declaration was made under the U.S. Secretary's own statutory authority under Section 319 of the Public Health Service Act. The U.S. declaration was, in the formal legal sense, an independent domestic action.

But the timing is the documentary record. The WHO declared the PHEIC on January 30. The United States declared its public health emergency on January 31. The WHO characterized COVID-19 as a pandemic on March 11. The United States declared a national emergency on March 13. The WHO determination preceded, by one to two days in each case, the corresponding U.S. determination. The U.S. domestic action was, as a documented matter of sequence, calibrated to the WHO determination. The Federal Register documents acknowledging the COVID-19 emergency open, in document after document, with the recitation of the WHO's January 30 PHEIC declaration as the framing event, followed by the U.S. declaration as the responsive action.

The structural significance is not that the United States was legally compelled to act by the WHO. It is that the WHO's determination functioned, in operational practice, as the authoritative event around which the U.S. domestic emergency architecture organized itself. The WHO Director-General — an unelected official, accountable to no American electorate, leading an institution whose funding and posture this series has documented — made a determination on January 30, 2020 that became the framing event for the most consequential domestic emergency declarations in the recent history of the United States.

The Alignment — How WHO Guidance Became American Policy

The PHEIC determination was the formal trigger. The deeper mechanism through which the WHO influenced American health policy operated below the level of formal legal obligation. It operated through alignment — the adoption by U.S. federal agencies of WHO guidance, WHO definitions, and WHO standards as the basis for U.S. domestic policy, without any formal legal requirement that the agencies do so.

The documented examples are specific. When the Centers for Disease Control and Prevention established the criteria for which vaccines would be accepted for international travelers entering the United States, the accepted vaccines included, by the CDC's own published guidance, vaccines on the WHO Emergency Use Listing — the WHO's own authorization mechanism — in addition to FDA-approved and FDA-authorized vaccines. The WHO's authorization determination was incorporated directly into U.S. border-entry policy. A vaccine the WHO had listed, but which the FDA had not independently authorized, was accepted for entry into the United States on the strength of the WHO determination.

The case-definition mechanism operated similarly. The WHO's case definitions for COVID-19 — the criteria for what counted as a confirmed case, a probable case, a COVID-19 death — substantially shaped the parallel definitions adopted by the CDC and used in U.S. surveillance and reporting. The naming convention itself — "COVID-19" for the disease, "SARS-CoV-2" for the virus — was a WHO determination, announced by the WHO in February 2020, that the entire U.S. governmental and medical apparatus adopted.

The treatment and public-health guidance mechanism operated through the normative authority the WHO's determinations carried. WHO guidance on masking, on distancing, on the classification of the virus's transmissibility, on the appropriate public-health response — this guidance was not binding on the United States in the formal legal sense. But it carried, in the information environment documented in Part IV of the companion Fauci Files series, the normative authority of the world's preeminent international health body. WHO guidance became the standard against which U.S. domestic guidance was measured, and against which dissent from U.S. domestic guidance was characterized as dissent from international scientific consensus.

The structural point is the one this series has documented from a different angle in each Part. The WHO's January 14, 2020 transmission of the Chinese authorities' finding of no clear evidence of human-to-human transmission — documented in Part II of this series — became, through this same alignment mechanism, an input into the early U.S. assessment of the outbreak. The institution whose early-pandemic posture Part II documented as substantially aligned with Chinese governmental preferences was the same institution whose determinations the U.S. federal apparatus adopted as authoritative.

The 2024 Amendments — Expanding the Authority

The COVID-19 pandemic exposed, in the assessment of the WHO and a substantial portion of its member states, gaps in the IHR framework. The principal gap was definitional: when COVID-19 emerged, the IHR did not define a "pandemic," and the WHO had no formal mechanism, beyond the PHEIC, to declare the highest level of global health alarm. The institutional response was a package of amendments to the IHR, negotiated over approximately two years and adopted by the Seventy-Seventh World Health Assembly through Resolution WHA77.17 on June 1, 2024.

The amendments' principal substantive change was the creation, through amendments to IHR Articles 1 and 12, of a new category: the "pandemic emergency." The pandemic emergency is defined as the highest level of global alarm available to the WHO Director-General — a tier above the PHEIC, triggered when a PHEIC involving a communicable disease has arisen that is characterized by wide geographic spread, the overwhelming of health systems, socioeconomic disruption, and the need for a whole-of-government and whole-of-society response. The Director-General determines the pandemic emergency on the advice of an Emergency Committee.

The second principal change was the requirement, through a revised Article 4, that each State Party "designate or establish a National IHR Authority" responsible for coordinating the implementation of the regulations across the entire national government rather than confining IHR implementation to a single national health agency. The National IHR Authority requirement is, in the assessment of the legal commentary documented in this series' research, a structural mechanism for embedding IHR implementation across the whole of a member state's government.

The amendments were adopted by consensus — meaning without a formal recorded vote against. The United States, at the time of the June 2024 adoption, was a WHO member state and did not, at the moment of adoption, reject the amendments. The amendments were set to enter into force on September 19, 2025, for all States Parties that had not affirmatively rejected them. Under the opt-out mechanism documented above, the amendments would have become binding on the United States automatically — absent affirmative U.S. rejection — notwithstanding that they had never been submitted to the United States Senate for the advice and consent that the Constitution requires for treaties.

The Pandemic Agreement — The Second Treaty

Parallel to the IHR amendments, and negotiated over the same period, was the more ambitious instrument: the WHO Pandemic Agreement. Where the IHR amendments modified an existing regulatory instrument, the Pandemic Agreement was negotiated as a new standalone treaty under Article 19 of the WHO Constitution — the same constitutional provision under which the WHO's only prior treaty, the 2003 Framework Convention on Tobacco Control, had been adopted.

The Pandemic Agreement's negotiation history is documented. The negotiations were launched by WHO member states in 2021, conducted through an Intergovernmental Negotiating Body, and proceeded through a "Zero Draft" published February 1, 2023 and successive revisions. The negotiations failed to reach conclusion before the May 2024 World Health Assembly. The Intergovernmental Negotiating Body's mandate was extended, and the negotiations continued through the early hours of April 16, 2025, when member states reached consensus on a final text. The Seventy-Eighth World Health Assembly adopted the Pandemic Agreement by consensus on May 20, 2025, through Resolution WHA78.1.

The Agreement is, in the assessment of the legal commentary, only the second legally binding health treaty in the WHO's seventy-seven-year history. Its substantive provisions include a "One Health" approach recognizing the animal-origin pathway of approximately seventy-five percent of emerging infectious diseases; commitments to equitable access to pandemic-related health products; and the framework for a Pathogen Access and Benefit-Sharing system. The Pathogen Access and Benefit-Sharing system — the mechanism by which member states would share pathogen samples and genetic-sequence data in exchange for access to resulting vaccines and therapeutics — was deferred to a separate annex, to be negotiated and presented to the Seventy-Ninth World Health Assembly in May 2026. Until the annex is adopted, the Agreement does not open for signature. The Agreement enters into force after sixty ratifications.

The structural distinction between the Pandemic Agreement and the IHR amendments is the constitutional crux. The Pandemic Agreement, as a treaty adopted under Article 19, requires affirmative ratification by each member state "in accordance with its constitutional processes." For the United States, that would mean Senate advice and consent by a two-thirds vote. The Agreement could not bind the United States through the opt-out mechanism. It would require the affirmative supermajority consent the Constitution demands. The IHR amendments, by contrast, operated through the opt-out mechanism and would have bound the United States automatically absent affirmative rejection.

This distinction is the reason the United States' 2025 actions took two different forms for the two instruments — an affirmative rejection for the IHR amendments, and a withdrawal from negotiations for the Pandemic Agreement.

The American Rejection — 2025

The documented sequence of United States actions toward the WHO architecture in 2025 is the institutional record of a member state withdrawing from the legal framework this Part has documented.

On January 20, 2025, on the first day of the second Trump administration, the President signed an executive order beginning the twelve-month process of withdrawing the United States from the World Health Organization. The United States was, at the time, by a substantial margin the WHO's largest single financial contributor. The withdrawal also directed the Secretary of State to cease U.S. participation in the Pandemic Agreement negotiations. The U.S. negotiators left the Pandemic Agreement discussions. When the Agreement was adopted on May 20, 2025, the United States — having withdrawn from the WHO and from the negotiations — was not party to it and would not be bound by it.

The IHR amendments required a separate action, and the reason is the opt-out mechanism. The United States had been a WHO member state when the amendments were adopted in June 2024. Under the opt-out mechanism, the amendments would become binding on the United States on September 19, 2025 — the entry-into-force date — unless the United States affirmatively rejected them before the deadline. The U.S. withdrawal from the WHO, by itself, did not automatically reject the amendments; the amendments were on track to bind the United States regardless of the withdrawal unless affirmatively rejected.

On July 18, 2025, one day before the July 19 deadline, United States Secretary of Health and Human Services Robert F. Kennedy Jr. and Secretary of State Marco Rubio issued a joint statement formally rejecting the 2024 IHR amendments. The joint statement's characterization of the amendments was direct.

Terminology throughout the 2024 amendments is vague and broad, risking WHO-coordinated international responses that focus on political issues like solidarity, rather than rapid and effective actions. The proposed amendments to the International Health Regulations open the door to the kind of narrative management, propaganda, and censorship that we saw during the COVID pandemic. Joint Statement of HHS and State Department — July 18, 2025

The joint statement framed the rejection as a defense of American sovereignty and constitutional self-governance. The HHS press release characterized the amended IHR as conferring on the WHO "the ability to order global lockdowns, travel restrictions, or any other measures it sees fit to respond to nebulous 'potential public health risks.'"

The characterization is, in the assessment of the documentary record, contested in part. Defenders of the IHR amendments — including Professor Lawrence Gostin of Georgetown University, director of the O'Neill Institute for National and Global Health and a longtime participant in WHO governance — have argued that the amendments do not override national sovereignty, that Article 3 of the IHR expressly preserves each State Party's "sovereign right to legislate and to implement legislation in pursuance of their health policies," and that a PHEIC or pandemic-emergency declaration does not automatically impose lockdowns, travel restrictions, or quarantine requirements on any state. Gostin characterized the U.S. rejection as leaving the United States "less safe and less secure," and noted that many of the IHR amendments had been "sought after by the United States" during the negotiation process to advance global health security.

The honest distinction the documentary record supports is this. The amendments do not, by their text, confer on the WHO Director-General the legal authority to order an American lockdown. The U.S. Secretary's characterization, read at its most literal, overstates the formal legal effect of the amendments. But the structural concern the rejection articulated is not principally about the formal legal text. It is about the mechanism — the opt-out mechanism through which IHR amendments bind the United States without the Senate's advice and consent, and the alignment mechanism through which WHO determinations became, during the COVID-19 period, the framing events and authoritative standards for U.S. domestic policy. On the structural concern, as distinct from the literal characterization, the documentary record this Part has assembled is substantial.

The Authority Question

The question this Part set out to examine was direct: by what authority does the World Health Organization influence the health policy of the United States? The documentary record supports a precise answer.

The WHO does not possess, and has never possessed, the formal legal authority to dictate United States domestic health policy. No WHO determination can, by its own legal force, compel an American to be vaccinated, close an American business, or mandate an American behavior. The formal legal authority over American health policy resides, under the United States Constitution, with the federal government in its enumerated powers, with the states in their reserved police powers, and ultimately with the American people and their elected representatives.

But the documentary record establishes that formal legal authority is not the only mechanism through which influence operates. The WHO influenced American health policy during the pandemic period through three documented mechanisms, none of which required the consent of the American people or their elected representatives.

The first mechanism was the legal-instrument mechanism. The IHR bind the United States through the opt-out framework, under which amendments enter into force automatically absent affirmative rejection, without the Senate advice and consent that the Constitution requires for treaties. The 2024 amendments would have bound the United States by this mechanism had the United States not affirmatively rejected them one day before the deadline.

The second mechanism was the alignment mechanism. U.S. federal agencies adopted WHO determinations — the PHEIC declaration, the pandemic characterization, the case definitions, the Emergency Use Listing, the disease nomenclature — as the triggering events and authoritative standards for U.S. domestic policy. The adoption was not legally compelled. It was institutional practice. But its operational effect was that WHO determinations made by unelected officials became the framing events for the most consequential U.S. domestic health actions in recent history.

The third mechanism was the normative mechanism. WHO guidance carried, in the information environment documented in the companion Fauci Files series, the normative authority of international scientific consensus. Dissent from U.S. domestic guidance that aligned with WHO guidance was characterized, in that information environment, as dissent from international scientific consensus itself. The institution whose early-pandemic posture Part II of this series documented as substantially aligned with Chinese governmental preferences became the authoritative standard against which American dissent was measured.

The WHO does not possess the legal authority to dictate American health policy. It did not need to. Three mechanisms of influence operated without the consent of the American people or their elected representatives.

The structural finding across the three mechanisms is consistent with the structural findings of the preceding three Parts of this series. The WHO's influence over American health policy operated not through formal legal authority — which the institution does not possess — but through institutional mechanisms that bypassed the constitutional architecture of consent. The IHR opt-out mechanism bypassed the Senate's treaty-ratification role. The alignment mechanism bypassed the question of whether U.S. agencies should independently assess the determinations of an institution whose posture and funding this series has documented. The normative mechanism bypassed the open scientific debate that the information environment, had it functioned as the constitutional design contemplates, would have produced.

The Pattern Across Four Parts

Read together, Parts I through IV of The Geneva Files document the institutional architecture of the World Health Organization in its full operational scope.

Part I documented the selection of a Director-General whose path to office included contested disease-classification practices as a national health minister, an African Union endorsement secured under Robert Mugabe's chairmanship, and Chinese diplomatic support.

Part II documented the institutional posture of the WHO during the early pandemic period — the January 14 transmission of the Chinese authorities' findings, the delayed PHEIC declaration, the Beijing praise, the Munich framing — that the Independent Panel characterized as "too cautious" and reflective of "an evident desire to maintain good relations with the Chinese government."

Part III documented the funding architecture — the shift from member-state assessed contributions to donor-directed voluntary contributions, and the $5.5 billion in earmarked Gates Foundation grants — that constrains the institution's independence.

Part IV has documented the legal instruments — the IHR, the 2024 amendments, the Pandemic Agreement — through which the institution exercises authority over its member states, and the three mechanisms through which the institution influenced American health policy without the formal legal authority to do so.

The pattern across the four Parts is structural and consistent. An institution led by a Director-General selected through the process Part I documented; postured as Part II documented; funded as Part III documented; exercising authority through the instruments Part IV has documented. At each stage, the institution operated through mechanisms that attenuated the accountability the institution's formal governance structure nominally provides. The Director-General is nominally accountable to the World Health Assembly; the funding architecture documented in Part III constrains that accountability. The IHR are nominally binding only by member-state consent; the opt-out mechanism documented in Part IV attenuates that consent. The institution's guidance is nominally advisory; the alignment and normative mechanisms documented in Part IV gave it operational authority over American policy that no advisory body's guidance would ordinarily carry.

The next and final Part of this series — Part V, The Origin Investigation — will examine the WHO-convened study mission to Wuhan in January and February 2021, the conflicts of interest among its members, the WHO's institutional handling of the pandemic origin question, and whether the institution is structurally capable of investigating a question in which one of its most consequential member states has a documented interest in a particular answer. Part VI — The Reckoning — will provide the structural assessment that the documentary record across all six Parts establishes.

What This Part Establishes

This Part has documented a legal architecture and a set of influence mechanisms. It has not, deliberately, made certain claims that the documentary record does not support.

It has not established that the WHO possesses the legal authority to dictate United States domestic health policy. The documentary record establishes the opposite: the WHO possesses no such formal authority, and the formal authority over American health policy resides with the constitutional institutions of the United States. The structural concern documented in this Part is not that the WHO holds formal authority it should not hold, but that it has exercised influence through mechanisms that operate outside the constitutional architecture of consent.

It has not established that the IHR amendments, by their text, authorize the WHO to order American lockdowns. The U.S. Secretary's July 2025 characterization to that effect overstates the literal legal effect of the amendments, which by their text preserve the sovereign right of each State Party to legislate its own health policy. The structural concern is not the literal text but the opt-out mechanism through which IHR amendments bind the United States without Senate ratification, and the alignment mechanism through which WHO determinations became authoritative for U.S. policy.

It has not established that international health cooperation is, in itself, illegitimate or undesirable. The case for binding international coordination in the face of transnational pandemic threats — articulated by Professor Gostin and others — is a serious case grounded in the genuine reality that pathogens do not respect national borders. The structural concern documented in this Part is not that international health cooperation is wrong, but that the specific mechanisms through which the WHO's authority operates over the United States have attenuated the constitutional architecture of consent in ways that warrant the scrutiny this Part has applied.

What this Part does establish is that the World Health Organization influenced American health policy during the pandemic period through three documented mechanisms — the legal-instrument mechanism of the IHR opt-out framework, the alignment mechanism through which U.S. agencies adopted WHO determinations as authoritative, and the normative mechanism through which WHO guidance became the standard against which dissent was measured — none of which required the consent of the American people or their elected representatives; that the 2024 IHR amendments would have bound the United States automatically through the opt-out mechanism had the United States not affirmatively rejected them on July 18, 2025; that the Pandemic Agreement adopted in May 2025, as a treaty requiring ratification, could bind the United States only through the Senate advice and consent the Constitution requires, which is why the United States withdrew from its negotiation rather than relying on the opt-out mechanism; and that the structural concern these mechanisms raise — the attenuation of the constitutional architecture of consent — is a concern the documentary record substantially supports, distinct from the contested literal characterizations that have attended the political debate.

The documentary record speaks. The institution whose authority this Part has documented exercised influence over American health policy through mechanisms that the constitutional architecture of the United States did not design and does not readily accommodate. The United States, in 2025, withdrew from that architecture. Whether the withdrawal was wise — whether the United States is, as Professor Gostin argued, "less safe and less secure" outside the WHO framework, or whether it is, as the U.S. Secretaries argued, more secure in its constitutional sovereignty — is a question on which the documentary record permits reasonable disagreement. What the documentary record does not permit is the claim that the WHO's influence over American health policy operated entirely within the constitutional architecture of consent. It did not. The mechanisms this Part has documented operated, in specific and consequential ways, outside that architecture.