The 2024 Amendments to the International Health Regulations: A New Era for Global Health Law in Pandemic Preparedness and Response?

Abstract

On June 1, 2024, the World Health Assembly reached consensus on a package of amendments to the 2005 International Health Regulations (IHR). These amendments follow nearly two decades of implementation and an intensive multilateral process prompted by the global struggle against COVID-19. This article critically examines whether the amended IHR reflect lessons learned from the pandemic, potentially ushering in a new era for global health law in pandemic preparedness and response, or if they deflect attention from the need for deeper structural reforms. While the IHR remain the only near-universal legal framework for preventing and addressing the international spread of disease, these amendments emphasize equity and solidarity, and potentially shift the IHR from a technical instrument to one focusing on inherently political issues. This analysis examines key IHR amendments and their implications for the future of global health law, particularly in the context of equity, financing, and implementation.

Introduction

On June 1, 2024, the World Health Assembly reached consensus on a package of amendments to the 2005 International Health Regulations (IHR).¹ This decision follows nearly two decades of implementing the IHR in their current form and an intensive multilateral process to amend them, prompted by the global struggle against COVID-19.² It remains to be seen if this moment will be a transformative one for global health governance. Do the amended IHR reflect lessons learned from the pandemic, ushering in a new era for global health law in pandemic preparedness and response?³ Or do they amount to a red herring, deflecting the international community’s focus from the need for deep and structural reforms to ensure a just and fair international legal landscape?⁴

Time will be the final arbiter. The bottom line is that the Regulations — first adopted by the World Health Assembly in 1951 — remain the world’s only international legal framework for preventing and addressing the international spread of disease, in particular infectious diseases. Even if ongoing negotiations in WHO for a new pandemic instrument succeed, the IHR will likely be the only instrument with near-universal implementation.⁵ An instrument of global health law par excellence, antecedents of the IHR predate the World Health Organization (WHO) itself, and reflect longstanding recognition by states that international public health cooperation is necessary in an era of interconnected travel and trade,⁶ and even more so nowadays with increasing risks of zoonotic diseases and spillover events.⁷

The specifics of how the IHR can best foster such cooperation and effectively thwart public health emergencies have evolved, as noted by Gostin in Global Health Law, through an incremental process of review and reform in the wake of successive health crises.⁸ This is not unique to global health law; crises often catalyze change in many areas of international law.⁹ As the product of recurring crises, the Regulations have been both a cornerstone and a work in progress in the realm of global health law.

The IHR: An Instrument in Flux

When the IHR were last revised in 2005, Fidler and Gostin heralded the instrument — adopted under Article 21 of WHO’s Constitution — as “an historic development for international law and public health.”¹⁰ Negotiations to revise the prior regulations began in earnest in the mid-1990s and accelerated in the wake of the 2003 Severe Acute Respiratory Syndrome (SARS) outbreak.¹¹ The revisions were driven by the realization that states needed a new framework to detect and respond to novel disease threats like SARS and to enhance domestic capacities to prevent, detect, and respond to such events in a timely and effective manner when they arise.¹² If new obligations for event detection, alert, and response were among the hallmarks of the IHR revisions at the turn of the millennium, the amendments approved in 2024 bring to the fore more deep-rooted issues of equity and solidarity in pandemic preparedness and response.

The 2024 Amendments to the International Health Regulations

Despite the repeated critiques of the ineffectiveness of the IHR in past emergencies, including the COVID-19 pandemic,¹³ IHR States Parties have, until recently, shown little interest in revising the Regulations.¹⁴ The latest impetus for amending the IHR came from the United States, reluctant to embark in uncertain negotiations for a new pandemic instrument and preferring to strengthen an existing instrument that better aligned with its political priorities.

In May 2022, the World Health Assembly adopted an initial set of technical amendments to the IHR’s final clauses, as proposed by the United States for the purpose of accelerating the entry into force of future amendments. The Health Assembly also invited IHR States Parties to propose further “targeted” amendments by September 30, 2022.¹⁵ This unusual approach to frontloading proposals before negotiations began led to a mass of over 300 amendments proposed or endorsed by over 100 States Parties.¹⁶ Despite the Health Assembly’s narrow mandate to focus on “targeted amendments,” a large coalition of developing countries submitted far-reaching proposals on equity, particularly in access to health products, financing, and assistance. Consequently, it became clear at the outset of negotiations that the nature of the IHR could shift from what was perceived as a technical and operational tool into a regulatory and political instrument to prioritize equity in pandemic prevention and response.¹⁷

After fifteen months of negotiation, the Working Group on Amendments to the IHR adopted a small fraction of the amendments proposed.¹⁸ This limited result reflects what could be agreed politically, within a limited timeframe, and what was considered a priority.¹⁹ Despite previous criticism, this outcome implicitly validated the structure and approach of the IHR. While the perception of the IHR as a technical instrument familiar to operational agencies in States Parties likely played a role in orienting the negotiations towards a focused and limited outcome, the amendments nonetheless aim to incrementally strengthen IHR implementation and better integrate equity across its provisions.

The Amendments Adopted Aim to Strengthen IHR Implementation

Many adopted amendments build on or fine-tune existing provisions. For instance, through amendments to Articles 1 and 12, the WHO Director-General may now determine a “pandemic emergency” where a particularly diffuse and acute public health emergency of international concern (PHEIC) has arisen, and the PHEIC is a communicable disease.²⁰ Responding to concerns that WHO lacked the authority to declare a “pandemic,” the determination of a “pandemic emergency” may trigger substantial legal consequences under a future pandemic agreement, for instance in relation to pathogen access and benefit-sharing,²¹ although at present this is largely uncertain.

Other amendments aim to strengthen the implementation of the IHR at multiple levels of governance. A revised Article 4, for instance, now requires States Parties to establish or designate a “National IHR Authority” with the responsibility for coordinating national implementation. This new designation seeks to overcome the confinement of coordinating responsibility in the national health agency, which has proven problematic in many countries, especially during acute emergencies.²² Beyond this National IHR Authority, the revised Annex 1 expands upon the “core capacities” to prevent, detect, prepare and respond to public health risks and PHEICs while maintaining the existing distribution of responsibilities among local and national authorities and avoiding equity conditionalities for maintaining those capacities.²³ At the multilateral level, a new intergovernmental implementation committee and a related advisory subcommittee have been established under Article 54 bis to strengthen IHR implementation through mutual learning and cooperation with a facilitative and consultative approach.²⁴ While this new organ is not meant as a compliance and accountability mechanism, it fills a yawning governance gap in the IHR, which lacked a dedicated implementation review body and could only rely on limited time and attention to address IHR implementation during the World Health Assembly’s annual session.

The Amendments Adopted to Center the IHR on Equity

The biggest changes within the amended IHR may well be the insertion of equity into the fabric of the IHR through multiple provisions — though in many cases, these new equity-related obligations are imposed upon WHO and not on IHR States Parties. They include:

• • A revised Article 13 now requires the WHO Secretariat to facilitate access to health products during a PHEIC or pandemic emergency, with States Parties bearing supportive obligations qualified by references to applicable law and available resources.²⁵

• • Strengthened obligations of collaboration and assistance in Article 44 now establish a commitment to promote and facilitate sustainable financing of national capacities, mostly for the benefit of developing countries, but qualify these commitments once again by references to applicable law and available resources.²⁶

• • A new coordinating financial mechanism under the authority of the Health Assembly is provided for by a new Article 44 bis, with this mechanism expected to identify and mobilize financial resources, although this provision falls short of establishing a new fund as originally demanded by developing countries.²⁷

Even with these qualifications, the 2024 amendments introduce some important innovations in the political, normative, and institutional structure of the IHR. While positive, there is a risk that the “equity and solidarity” provisions may lead to a further politicization of the IHR and affect their operational functions, both regarding the role of WHO, which risks becoming quasi-regulatory, and in terms of increased expectations from countries in return for their cooperation.

The Next Ten Years of Global Health Law

Looking ahead, these 2024 amendments are likely to have implications for the future of global health law. Gostin and Taylor previously defined “global health law” as encompassing the “legal norms, processes, and institutions needed to create the conditions for people throughout the world to attain the highest possible level of physical and mental health.”²⁸ Global health law can shape the conditions needed to achieve this public health ideal by stimulating investment in research and development, mobilizing resources, setting priorities, monitoring progress, creating incentives, and enforcing standards.²⁹ In light of the foregoing, a fundamental question remains: to what extent do the 2024 amendments to the IHR bring us closer to this ideal?

The amendments are unlikely to solve the suite of problems in global health governance highlighted by the COVID-19 pandemic. The changes that aim to center the IHR on equity simply do not go far enough to redress the huge gulfs which exist in capacity and resources between countries, nor do they go far enough in seeking to ensure equitable access to medicines during the next health emergency. Indeed, Article 13(8) of the amended IHR, which requires WHO to “facilitate, and work to remove barriers to, timely and equitable access by States Parties to relevant health products,” may prove to be a poisoned chalice, as the Organization does not have sufficient authority to address the full suite of complexities in access to health products, which encompass intellectual property, financing, transfer of technology, the relative purchasing power of developing and developed countries, and the excesses of the global capitalist system. If the inequities of past health emergencies again present themselves in the future, the WHO, as the duty bearer regarding equitable access under the IHR, may find itself backed into a difficult corner: obligated to remove barriers to access, but without all of the tools to make that access a reality.

Yet, while the current IHR amendments may not revolutionize pandemic preparedness and response, particularly on issues of equity, they may serve as a benchmark for future iterations of the IHR or for resolutions of the World Health Assembly regarding its interpretation and understandings. Through the inclusion of provisions regarding equity, financing, and implementation, the international community may have moved the center of gravity of the IHR away from the purely technocratic and into the political arena, centralizing these ideas as core elements of the Regulations moving forward. The IHR amendments will also likely drive momentum for further negotiations of the pandemic agreement.³⁰ With equity now a core feature of the IHR, delegates of the Intergovernmental Negotiating Body can look to the adopted amendments to frame their proposals for a pandemic agreement that will aim at synergy and an overall strengthened equity dimension to pandemic preparedness and response³¹

Put simply, it is unlikely that any future amendments will remove or water down established language regarding collaboration and assistance, equity, financing, and implementation. Indeed, it is hoped that any future understandings or amendments seek to strengthen these provisions, and the present text of the amended IHR provides a suitable foundation for future negotiations.³² However, hope can be a dangerous thing. In Greek mythology, hope was the only thing left in Pandora’s box, after she had opened it and unleashed all of the evils from the Gods onto mankind.³³ It may be the case that the inclusion of overtly political language, especially that which does not actually attribute responsibility where it ought to be placed, or empower key actors to address these political questions, has opened Pandora’s box. Much will depend on the implementation of the IHR amendments that will enter into force in September 2025.

Conclusion

The 2024 amendments to the IHR represent a rare moment in global health governance. While these changes may not fully address the extensive challenges highlighted by the COVID-19 pandemic, particularly in terms of equity, they mark a significant shift toward integrating political considerations into the IHR framework. By embedding provisions for equity, financing, and implementation, the amendments move the IHR beyond a purely technical instrument, potentially setting a new standard for future global health agreements. However, the true impact of these amendments will depend on their effective implementation and the international community’s commitment to addressing the underlying issues of inequity in global health. The IHR, thus fortified, continue to be a cornerstone of international public health cooperation, but much will hinge on how these new provisions are operationalized in practice.