By Alexandra Finch, LLB, LLM; Sam Halabi, JD, MPhil; Lawrence O. Gostin, JD, LLD (Hon)

O’Neill Institute for National and Global Health Law, Georgetown University Law Center

Introduction

In May, Member States of the World Health Organization (WHO) will decide whether to adopt reforms to the International Health Regulations (2005) (IHR) which have the potential to transform how the world prepares for and responds to pandemic threats. If given full political backing, these reforms might spare us from the devastating impacts of future pandemics. However, skeptics could derail the Geneva negotiations, calling attention to the short timeframe for finalizing negotiations. The timeline for the Working Group on Amendments to the IHR (WGIHR) to fulfill its mandate has been described as a “mad sprint,” and States Parties were given just four months to propose amendments to the IHR. The same governments are simultaneously negotiating a new pandemic agreement through an Intergovernmental Negotiating Body (INB). The goal is to have the World Health Assembly (WHA, WHO’s governing body) adopt both reforms in late May. 

To be sure, the process for negotiating multilateral treaties can be protracted, extending over years or even decades. But relatively recent multilateral agreements covering a wide range of matters have been negotiated over a shorter period. More importantly, the gravity of circumstances accompanying the COVID-19 pandemic and the likelihood of an imminent new or reemerging pathogen posing a similar or worse threat were explicitly stated as justifications for the WHA’s timeline. But perhaps most importantly, the IHR contains a relatively detailed process for amendment, the whole of which has been respected in letter and spirit by WHO. 

Damaging mis- and dis-information has been swirling around the reform processes, often falsely stating that states will lose their sovereign right to set domestic health policy. There is also distrust of international institutions, including WHO, even though the organization is the “directing and co-ordinating authority on international health work” under the WHO Constitution, which has the status of a treaty. 

In this blog post, we provide a systematic analysis of the legality and  prudence of the WHA’s amendment process. We conclude that States Parties have enjoyed the time required under the IHR to properly consider the proposed amendments once submitted; indeed, States Parties have received far more time than minimally required and given to consider past amendments.

The IHR: A Brief Overview

Articles 21 and 22 of WHO’s Constitution confer upon the WHA the authority to adopt regulations “designed to prevent the international spread of disease” which, after adoption by the WHA, enter into force for all WHO Member States that do not affirmatively opt out of them within a specified time period. This is an extraordinary power to make international law because it is an “opt-out” process, compared to much of international law which requires states to affirmatively consent to be bound, or “opt-in.” It was pursuant to these constitutional powers that the first International Sanitary Regulations were adopted in 1951 covering six notifiable diseases. In 1969, the 22nd WHA renamed Regulations as the International Health Regulations and excluded louse-borne typhus and relapsing fever, leaving only cholera, plague, smallpox, and yellow fever within the scope of the Regulations. Revisions to the Regulations in 1973 concerned cholera and revisions in 1981 removed smallpox owing to its global eradication. 

The 2005 revisions, adopted following the multi-country SARS outbreaks, represented a significant expansion of the core capacity and reporting measures envisioned. As the 1969 Regulations only applied to a small handful of diseases, they proved inadequate to respond to global health challenges of the 21st century, including biosecurity risks, emerging zoonotic diseases, and other health hazards. Adopting an ‘all-hazards’ approach, the IHR now serves “to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade,” and is the only extant binding international instrument on pandemic prevention, preparedness, and response.

With 196 States Parties, including all 194 WHO Member States, the Holy See and Liechtenstein, the IHR (2005) is one of the world’s most widely adopted treaties. 

Post-COVID-19 Amendments to the IHR

The COVID-19 pandemic represented the greatest challenge to the IHR. States had failed to build sufficient public health capacities, failed to comply with timely and full notification and verification requirements, implemented discriminatory public health measures that unduly restricted travel and trade, and failed to protect human rights in pandemic response. At the same time, gaps in the IHR were made evident, including a lack of transparency in Emergency Committee determinations, limited accountability for core capacity self-reporting, limited obligations for the sharing of public health information including genomic sequencing data, and, most prominently, the inability of the IHR to ensure the equitable distribution of pandemic response products.

In light of these challenges, the 75th WHA in 2022 decided to strengthen the instrument and formally commenced the amendment process envisioned under Article 55 of the IHR. Article 55 provides in full:

1. Amendments to these Regulations may be proposed by any State Party or by the Director-General. Such proposals for amendments shall be submitted to the Health Assembly for its consideration.
2. The text of any proposed amendment shall be communicated to all States Parties by the Director-General at least four months before the Health Assembly at which it is proposed for consideration. 
3. Amendments to these Regulations adopted by the Health Assembly pursuant to this Article shall come into force for all States Parties on the same terms, and subject to the same rights and obligations, as provided for in Article 22 of the Constitution of the World Health Organization and Articles 59 to 64 of these Regulations, subject to the periods provided for in those Articles with respect to amendments to these Regulations (emphasis added, as amended by the WHA in 2022).

As the WHA at which the amendments will be considered begins on May 27, 2024, the relevant deadline for the communication of any proposed amendments to the IHR was January 27, 2024. In the timeline below, we show that WHO complied with Article 55 para. 2 in letter and spirit.

The first proposals to amend the IHR were submitted by the United States on January 18, 2022. On 20 January 2022, the Director-General formally communicated the text of these proposed amendments to all IHR State Parties. Six days later the Executive Board urged Member States and relevant regional economic integration organizations to consider potential targeted amendments to the IHR while bearing in mind the need for coherence between that process and the parallel process to develop a new pandemic agreement. 

To oversee and consider targeted proposals to amend the IHR, the 2022 WHA established the WGIHR, comprised of all 196 States Parties to the IHR (including all WHO Member States, the Holy See, and Liechtenstein), the European Union, the Observer Delegation of Palestine, and invited non-state actors. The WGIHR is functionally a specialized committee of the WHA in accordance with Rule 41 of the Rules of Procedure of the Health Assembly and is tasked with considering and making recommendations to the WHA on matters assigned to it consistent with the Executive Board’s decision.

The WHA also invited proposed amendments to be submitted by September 30, 2022, which the Director-General would then communicate to all States Parties without delay. It requested the WGIHR to convene its organizational meeting no later than November 15, 2022 and to coordinate with the INB on the pandemic agreement, recognizing the overlap of concerns between the two negotiation processes. The Assembly then took a separate decision to adopt amendments to IHR Article 59 and related articles which would accelerate the time that the amended Regulations would come into force for States Parties from two years to one year from their adoption.

Ultimately, over 300 amendments were proposed by 15 states (some were submitted on behalf of regional organizations while one was submitted on behalf of governments in one WHO region), indicating widespread desire to revise the IHR. These proposals include provisions that would strengthen WHO’s power to collect and use outbreak information from unofficial channels without corollary verification requirements, introduce a new intermediate or regional outbreak alert level before the legal criteria for a public health emergency of international concern are met, establish an implementation committee and a new financing mechanism to support public health capacity building, and introduce new obligations to facilitate equitable access to health products, technologies, and know-how. While there is a degree of overlap between the topics under consideration by the WGIHR and the INB, amendments to the IHR have the advantage of coming into effect automatically for any WHO Member State that does not opt out. The INB and WGIHR have also met in joint session several times to reduce duplication and ensure coherence between the instruments.

The WGIHR held its first meeting in November 2022. On November 16, 2022, the WHO Secretariat circulated all proposed amendments to all IHR States Parties which were published online in addition to an article-by-article compilation of the proposed amendments on February 6, 2023. The WGIHR has since met several times to discuss the proposed amendments in sessions set out in Table 1 below. After each meeting, the WHO Secretariat communicated meeting outcomes to all IHR States Parties.

On the WGIHR’s fifth meeting in October 2023, the Co-chairs noted that it appeared unlikely that the final package of amendments would be ready by January 2024. Thereafter all members, being all IHR States Parties, agreed to continue to work on the proposals until May 2024 and for the Director-General to submit the agreed package of amendments to the WHA. 

Table 1: Meetings of the WGIHR
Meeting	Date
First meeting of the WGIHR	November 14–15, 2022
Second meeting of the WGIHR	February 20–24, 2023
Third meeting of the WGIHR	April 17–20, 2023
Joint plenary meetings of the INB/WGIHR	July 21 and 24, 2023
Fourth meeting of the WGIHR	July 24–28, 2023
Fifth meeting of the WGIHR	October 2–6, 2023
Sixth meeting of the WGIHR	December 7–8, 2023
Seventh meeting of the WGIHR	February 5–9, 2024
Joint plenary meeting of the INB/WGIHR	February 23, 2024
Resumed seventh meeting of the WGIHR on Equity	March 8, 2024

Legal Analysis of the Pace of Negotiations

As a multilateral treaty, interpretation of the IHR is governed by Article 31 of the Vienna Convention on the Law of Treaties which requires that the instrument be interpreted in good faith in accordance with the ordinary meaning given to its terms in their context and in the light of its object and purpose. 

On a plain reading of the article, the Director-General complied with Article 55 para. 2: the Director-General circulated the original amendment proposals submitted by IHR States Parties in November 2022 and published them online along with the article-by-article compilation before the WGIHR’s second meeting in February 2023. The temporal requirement was fulfilled at least 4 months – here at the earliest 17 months – before the May 2024 WHA, providing sufficient time for all 196 IHR States Parties to properly consider the proposed amendments. The ordinary meaning of the temporal requirement in Article 55 para. 2 does not require that the final version of those same amendments be submitted to IHR States Parties by that time. Indeed, such an implied requirement would contradict the explicit text of Article 55 para. 2 specifying “proposed” amendments.

Further, it is common practice for states to negotiate the final text of international agreements up to the point of voting whether or not to adopt them. An alleged IHR requirement on circulating only final and not proposed, draft amendments to all IHR States Parties would foreclose that possibility. Typically all WHO Member States have the ability to provide input into resolutions and decisions of the WHA;, a requirement only that all IHR States Parties see a final version of proposed amendments for which they have no opportunity to provide input would be at odds with the typical and customary practice of the WHA. An ordinary reading of Article 55 as a whole would not presume this unusual exception without explicit language that the circulated amendments must be in their final form, language that Article 55 para. 2 does not include.

That those original proposed amendments were considered and then further developed by a working group composed of all 196 IHR States Parties is relevant. There is no precedent for the application of Article 55 para. 2 to amendments proposed by a subdivision of the WHA. Nonetheless, in this case the WHO Secretariat has complied with the Article in both letter and spirit. All 196 IHR States Parties were kept continuously apprised of both the original proposed amendments and amendments developed by the WGIHR drafting group by virtue of their representation on the WGIHR, and the outcomes were communicated to all States Parties by the Secretariat after each WGIHR meeting. Having initially complied with the communication deadline for proposed amendments in November 2022, the WGIHR was able to continue its work up until the 2024 WHA, as agreed to by all IHR States Parties, and properly coordinate with the parallel INB process. 

There is precedent for this approach in the negotiation of the previous IHR. Dr. Ashley Bloomfield, co-chair of the WGIHR, assured WGIHR members during their fifth meeting that when the existing IHR were negotiated, “the final meeting finished on the weekend before the WHA started – at 4 am on a Saturday morning.” These final changes were not considered ‘new proposals’ but discussions and negotiations upon the proposed amendments. 

While the process has moved quickly and negotiators will likely be considering the amendments right up until the May 2024 deadline given the breadth of the proposals, the ongoing negotiations have not been in breach of the timeframes required under the IHR. To the contrary, by calling for and circulating all proposed amendments by the end of 2022, IHR States Parties have had the appropriate time to fully consider the proposed amendments while ensuring coherence with the parallel INB negotiations. The urgency for these reforms is not arbitrary, as experts and the Director-General have warned that the next health emergency may be imminent and the extant global governance system for pandemics is ill-equipped.

The COVID-19 pandemic taught us that no nation is safe unless all are safe. One might say the same thing for equitable allocation of medical countermeasures like diagnostics, vaccines, and therapeutics. All this requires global cooperation and mutual solidarity. That can only happen if we strengthen international instruments and the institutions that oversee them. The sheer gravity of preparing for the next pandemic creates urgent circumstances for the world’s most important health emergency agreement to be strengthened without delay. But even if those circumstances did not weigh on this round of amendments, WHO still would have met the letter and spirit of what Article 55 contemplates and more.

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Disclaimer: Professor Lawrence O. Gostin is the director of the WHO Collaborating Center on National and Global Health Law and a member of WHO’s IHR Review Committee.