The Entry into Force of the Amendments to WHO’s International Health Regulations

Introduction

The International Health Regulations (IHR) are, for the moment, the sole global binding legal instrument in force for the prevention and control of the international spread of disease.  They are the successor of the pre-WHO international sanitary agreements that were taken over by the newly established WHO and replaced by a single regulation originally adopted in 1951.  The IHR were partially revised in 1969 and overhauled with an entirely new approach in 2005; they have been in force since 2007 for the 194 WHO member states, as well as for two non-member states, the Holy See and Switzerland. The World Health Assembly (WHA), at its latest session in May 2025, has requested the Director-General (DG) to invite Palestine to join the IHR as the third non-member state.

The legal status of the Regulations is based on Articles 21 and 22 of the WHO Constitution.  The Regulations enter into force automatically for all WHO member states within a prescribed deadline, except for those that object or file a reservation.  I wrote separately about the structure, object and approach of the IHR (see here and here), in particular how they are triggered by events that may escalate into a public health emergency of international concern (PHEIC) declared by the WHO Director-General and I refer interested readers to those sources in order to keep this post short. For a recent analysis of the legal nature of regulations, see here.

Challenges and criticism

The current IHR have been tested in several PHEICs since 2007 and been frequently criticized on the basis of allegations ranging from low levels of compliance, the ineffectiveness of WHO as the “manager” of the Regulations, the lack of an accountability mechanism, excessive politicization of what should be a technical and operational instrument, and too much discretion for states parties (see critical reviews here and here).  The COVID-19 pandemic was a particularly challenging crisis for the IHR and WHO.  The perception of a governance and legal gap, and of the inadequacy of the IHR for guiding the international response to a long-term destabilizing crisis, prompted the initiative by a sizable group of countries in 2021 towards a “pandemic treaty” that would fill the gaps of the Regulations.  The agreement was adopted by the WHA in May 2025.  Still, despite the frequent criticism of the IHR and the awareness of their limits and flaws, there was always a strong opposition among WHO member states – fully shared by the WHO secretariat – against amending them further for fear of a political process that may not improve their effectiveness.  The response to criticism was a call for more resources for WHO, more commitment and solidarity from states parties, and the development of soft supportive tools by the WHO Secretariat.

The amendment process

The possibility of amending the IHR, instead of or alongside negotiating a new treaty, was being discussed within WHO’s governance with considerable ambivalence and confusion: both on the political implications of either instrument, as well as the motives behind the various proposals. And yet, the United States – which had been openly hostile to the idea of a new treaty – broke the prevailing dogma about the “untouchability” of the text and in January 2022 changed the political discourse overnight by proposing a set of substantial amendments to the Regulations. With only four months to consider those proposals, the WHA in May 2002 adopted a limited sets of amendments to the final clauses of the IHR as a kind of low-hanging fruit to shorten the period for entry into force of future amendments from 24 to 12 months. 

At the same time, confirming the strategic impact of the US initiative, the Assembly launched a process involving all WHO member states to negotiate “targeted amendments” to the IHR and requested that proposed amendments be submitted by September 2022.  Frontloading proposals before a negotiation even begins is an unusual approach in multilateral diplomacy and it probably prompted developing countries, that were pushing for the equity and solidarity that was visibly lacking during the COVID-19 pandemic, to propose far-reaching changes to the technical and operational nature of the IHR.  These included equitable access to medical countermeasures, a financial mechanism to support developing countries in health emergency preparedness and response, and a multilateral mechanism linking access to pathogens and genetic sequences with the equitable sharing of benefits arising from their utilization.  This dynamic was also prompted by the unusual parallel negotiations of the IHR amendments and the pandemic agreement.  Despite their different objects and purposes, that parallelism encouraged many delegations to place similar proposals in both instruments for tactical reasons and led to difficult and sometimes metaphysical discussions in both negotiating forums about placement of certain topics and overall normative design.  

In broad approximation, the main fault lines in both negotiations were the prioritization of security against a future pandemic for developed countries versus equity as the absolute priority for developing countries.  Even though those two objectives are not mutually exclusive and should actually be complementary, the deep mistrust between developed and developing countries resulted in entrenched and uncompromising positions that led both processes to the brink of failure several times.  However, while the negotiation of the pandemic agreement was relatively more open to observers and characterized by the development of subsequent drafts posted on the WHO’s website that mapped the dynamics of the negotiation, the work on the IHR amendments took place behind closed doors with the only publicly available draft issued one month before the 2024 WHA. A draft which the WHA nevertheless managed to adopt on 1 June 2024 after some last-minute compromises reached during the session of the Assembly. 

The outcome

The amendments eventually adopted by the WHA are a fraction of those initially proposed by Member States and mostly remain within the technical and managerial scope of the IHR as agreed in 2005, with the notable exceptions explained below. Again with broad approximations, the amendments fall under three categories:

1) Technical amendments

Some amendments are arguably more “technical”, remain within the existing frame of the IHR (2005) and aim at strengthening or clarifying it. The most visible is the addition of “pandemic emergency” as the ultimate level of alert in extreme situations triggered by outbreaks of communicable diseases.  As in the case of a PHEIC, also a pandemic emergency will be declared by the DG on the advice of an Emergency Committee composed of individual experts.  This is potentially a heavy responsibility on the DG’s shoulders in view of the political implications of declaring on his/her authority the highest level of health emergency.  A small but important amendment is also the requirement for states parties to establish a National IHR Authority that should secure coordination of IHR implementation across the government rather than confining it to an often weak national health agency. Unsurprisingly, the amendments also addressed the need to harmonize health documentation necessary for international travel in response to the chaotic adoption of uncoordinated and often inconsistent documentary requirements during the COVID-19 pandemic, as well as to explicitly provide for digital documents in order to “future-proof” the IHR. Finally, the amendments added clarity and details to the so-called “core capacities” that each state party has to maintain in order to detect and control disease outbreaks that may spread internationally.

2) Equitable access to health products and financing

The political requests for the inclusion of equity in the IHR as a fundamental principle of global health governance eventually focused on two main issues: equitable access to health products and financing. Article 13 was substantially amended by requesting WHO to carry out a broad range of functions to foster preparedness during a pandemic emergency including assessing availability and accessibility of health products, facilitating equitable access and supporting States Parties in diversifying their production. States Parties play a supporting role, and their obligations are qualified by subjecting them to national law and available resources. Placing emphasis on WHO rather than States Parties may have been tactically useful for reaching consensus and may promote complementarity with the Pandemic Agreement, but it has already been criticized for not adding anything new to what the Secretariat is already doing in its technical cooperation programmes. Financing to support developing countries in IHR implementation, as the main form of international assistance and cooperation, was included in Article 44 and a new Article 44bis that establishes a Coordinating Financial Mechanism. The outcome did not meet the expectations of developing countries that initially insisted on a proper funding mechanism, a request strongly opposed by all developed countries.  The gist of the amendments is to create an enabling environment to facilitate mobilization and access to financing from non-WHO sources and much will depend on the process to establish the mechanism, the politics surrounding it and on the commitment of donors.

3) Committee for the Implementation of the IHR

One of the most significant changes, of an institutional nature, is the creation through a new Article 54bis of a “States Parties Committee for the Implementation” of the IHR as a kind of “conference of the parties” of the Regulations.  This new body fills a glaring governance and accountability gap in the 2005 IHR, whereby the sole monitoring mechanism was a general annual report by the DG to the WHA, and the short and crowded annual sessions of the Assembly did not leave enough time for a dedicated discussion on the implementation of the IHR. The approach of the 2005 IHR was not an oversight but a conscious decision by WHO Member States to “depoliticize” the management of health emergencies by largely delegating it to the WHO Secretariat.  However, the lack of an institutional forum within WHO facilitated the creation of political networks bypassing WHO’s governance such as the Global Health Security Agenda.  Despite initial expectations by the USA and the European Union, the new Committee – open to all states parties – is not really a compliance mechanism but rather a facilitative and consultative body, “non-adversarial, non-punitive, assistive and transparent…” with the aim of “promoting and supporting learning, exchange of best practices and cooperation among States Parties…” (Article 54bis paragraph 1 and 1(a)).  Though some observers (myself included) saw the outcome as a missed opportunity, what matters in the end is creating a political environment that fosters the effectiveness of the Regulations through confidence-building, mutual learning and cooperation, and from this perspective the Committee is potentially a major step forward.

Relationship between the amended IHR and the WHO pandemic agreement

The IHR and the WHO pandemic agreement address different issues and have different functions and scope.  The IHR purport to be an operational instrument with a scope limited to preparedness, detection of disease outbreaks and containment of their international spread.  The pandemic agreement has a more ambitious scope, covering the whole “ideal cycle” of a pandemic from primary prevention to preparedness and equitable cooperation in response.  Notwithstanding these differences, there was a clear intention on the part of negotiators to ensure synergy and complementarity between the two instruments that, if implemented effectively and cooperatively, can constitute the main components of an overall international legal regime on global health security. A number of positive interactions have indeed materialized that should hopefully avoid conflicts and major gaps. The most striking is the fact that a pandemic emergency triggers a number of obligations for the parties to the pandemic agreement, most notably an unqualified obligation for their pharmaceutical manufacturers under Article 12 to make available to WHO a defined percentage of their production for collective distribution based on needs.  However, there is no institutionalized mechanism under the agreement for declaring a pandemic emergency, and the agreement implicitly defers to the authority of the DG to declare a pandemic emergency under the IHR. Consequently, a unilateral decision by the DG, which does not raise direct legal consequences for the parties to the IHR, instead automatically triggers several obligations for the parties to a separate agreement that play no formal role in the establishment of the triggering condition. As noted above, such an unusual arrangement carries the risk of politicizing the IHR process to declare a pandemic emergency, with states putting pressure on the DG against the risk of reputational and economic consequences. 

A second significant development is the fact that, faced with parallel and very similar coordinating financial mechanisms established under both instruments, Article 18 of the pandemic agreement decided that the IHR coordinating financial mechanism shall be utilized as the corresponding mechanism for the implementation of the agreement in a manner determined by the Conference of the Parties. The WHA resolution that adopted the IHR amendments also decided that “future instruments on public health emergencies or [pandemics], adopted pursuant to the Constitution of the World Health Organization, may utilize” the IHR mechanism. Even though many institutional aspects will have to be clarified in terms of decision-making and accountability, WHO may be moving towards a single financial arrangement servicing multiple international instruments, a rough equivalent of the Global Environmental Facility for global health security.

Entry into force and next steps

The 2022 amendments entered into force on 31 May 2025 and the 2024 amendments (adopted under the new accelerated regime) on 19 September 2025.  The current status unfortunately does not give full justice to the frequent statement that one of the advantages of a WHO regulation as compared to a convention is a bias towards universality and a globally uniform normative landscape facilitated by the “opt-out” mechanism in Article 22 of the Constitution.  The situation has instead been complicated by a number of rejections.  Four states parties (Iran, the Netherlands, New Zealand and Slovakia) rejected the 2022 amendments; thus the 2024 amendments will enter into force for them in September 2026.  More significantly, 11 states parties (Argentina, Austria, Brazil, Canada, Czech Republic, Germany, Israel, Italy, the Netherlands, the Philippines and the USA) have rejected the 2024 amendments.  Some of the rejections (e.g. Brazil, Canada and Germany) are declaredly temporary and motivated by the need to fulfill their respective constitutional requirements, typically parliamentary approval, before those countries can legitimately assume new international obligations.  Other rejections, however, in particular those by Argentina, Israel, Italy and the USA, appear politically motivated and more permanent until and unless they are withdrawn.  But also in the case of temporary rejections, it is not a foregone conclusion that parliaments will approve the amendments, considering for example that several European countries have moved politically to the right and adopted increasingly sovereigntist and nationalist positions.  The current scenario creates for the time being uncertainty and inconsistency as to applicable obligations, acceptance by rejecting states of an enhanced role for WHO under Articles 13 and 44 with related financial implications, as well as participation in the coordinating financial mechanism and the new Implementation Committee.  The latter is comprised of all states parties, but arguably not of those that through their rejection do not (yet) recognize the existence of this new body. 

Conclusions

Even though the controversies surrounding the pandemic agreement have attracted the attention of most global health scholars, the IHR continue to provide the main normative bulwark against the increasing frequency of transboundary disease outbreaks and their importance should not be underestimated. The 2024 amendments, albeit limited and “conservative”, may strengthen the effectiveness of the Regulations as our main line of defense—provided they secure sustained political and financial commitment and eventually reach the universality of participation that constitutes one of their main advantages.