Summary box.
On 19 September 2025, amendments to the International Health Regulations (IHR) will take effect, introducing the requirement for national IHR authorities to coordinate implementation of the Regulations at the national level.
This reform aims to overcome long-standing political and structural challenges, such as fragmented authority, limited legal mandates and weak intersectoral coordination, which have hindered IHR implementation.
While the amended Regulations allow flexibility in how these authorities are designated or established, their success will depend on resolving domestic governance constraints and ensuring senior-level political support.
To support this transition, WHO and States should collaborate to develop technical guidance that reflects diverse legal and constitutional contexts.
In June 2024, the World Health Assembly reached agreement on a package of amendments to the International Health Regulations (IHR) to enhance global epidemic and pandemic preparedness.1 The amendments come into force on 19 September 2025.2 Described by the WHO Director-General as a “historic opportunity to protect future generations from the impact of epidemics and pandemics, with a commitment to equity and solidarity,”3 the amendments must now be translated into national legal frameworks if they are to realise their full potential. In today’s post-Westphalian international legal order, sovereign States are accustomed to adjusting domestic legal frameworks to align with international commitments. The COVID-19 pandemic reinforced the urgency of this task, underscoring the need not only for legal preparedness but also for sustained political and financial support for the Regulations.4 As States prepare to implement the amendments and adapt their national laws, the newly introduced concept of national IHR authorities is likely to demand particular attention.
A new national authority?
Sovereign States have significant autonomy in how they structure their health systems and implement the Regulations. Several entities play a role at the various levels of governance since the existing Regulations came into force in 2007. These are referred to under Article 4 of the IHR by the encompassing term of ‘responsible authorities’.3 In its amended form, Article 4 now requires states to ‘establish or designate one or two entities to serve as national IHR authority and national IHR focal point as well as the authorities responsible within its respective jurisdiction for the implementation of health measures under these Regulations’.5 The focal point—well-known by public health professionals and clearly defined under Article 1 of the IHR since 2005—is the national centre maintaining constant communication between WHO IHR Contact Points and the State.3 Under Article 22, States are also required to identify ‘competent authorities’ tasked with the implementation and application of health measures under the Regulations at each designated point of entry.3 Other entities may be responsible for implementing specific IHR obligations. For instance, even before the 2024 amendments, Annex 6 required States to establish an authority responsible for issuing the vaccination and prophylaxis certificates and overseeing the administering centres.3 Likewise, some States have established Public Health Emergency Operations Centers (PHEOCs) to implement some IHR obligations. PHEOCs are not legally required under the Regulations, but are part of the IHR monitoring and evaluation framework.6
An attempt to overcome persistent challenges
The addition of the national IHR authority reflects States’ willingness to address long-standing challenges associated with existing responsible authorities. Although IHR focal points have been designated in nearly all states signed up to the IHR, they face difficulties related to intersectoral collaboration, limited access to information systems and insufficient domestic authority to report public health events to WHO.7 These issues are often exacerbated by resource constraints, communication barriers as well as political and bureaucratic barriers.
The need to ensure ‘that IHR national focal points are appropriately organized, resourced, and positioned within government, with sufficient seniority and authority, to meaningfully engage with all relevant sectors in crisis response,’ as well as the need to establish a national competent authority responsible for overall implementation of the IHR in each country—were both recommendations of the expert reviews assessing IHR performance during the COVID-19 pandemic.4 In 2022, these recommendations were pursued by 53 WHO Member States in their proposed amendments to Article 4 of the IHR. Member States of the Eurasian Economic Union and WHO African Region suggested language to reinforce the idea that the national IHR focal point should be established as a formal entity and adequately resourced to fulfil its mandate.8 In parallel, Switzerland proposed a ‘national competent authority responsible for overall implementation that will be recognized and held accountable for the focal point’s functionality and the delivery of other IHR obligations’.8 To provide technical input on the proposed amendments submitted by States, the WHO Director-General convened a committee of independent experts.9 In its report, the committee noted that the second set of proposed amendments to Article 4 would establish a new function—potentially fulfilled by a newly designated entity—charged with overseeing the implementation of all state obligations under the Regulations.10 It further suggested replacing the term ‘national IHR competent authority’ with that of ‘national authority’ to avoid confusion with the term ‘competent authority’ already defined in the IHR (2005).10 The committee also warned against the difficulty of holding such authority accountable for the overall implementation of the Regulations, citing practical difficulties in enforcing such a mandate. In line with the committee’s advice, in the final amendments approved by the World Health Assembly in 2024, States adopted the term ‘national IHR authority’ and removed references to the authority’s accountability.5
What are the new obligations of States regarding national IHR authorities?
Article 4 (1)(bis) of the amended IHR assigns to the national authority the broad function of coordinating the implementation of the IHR within the State’s jurisdiction.5 It also requires that the national authority be established through domestic legislative and/or administrative arrangements when appropriate.5 Future guidelines developed by the WHO, in collaboration with individual States, may help clarify the modalities for establishing or designating the national authority within domestic health and constitutional systems. Both the Swiss proposal and the committee’s report envisioned that national authorities would oversee the implementation of the IHR across sectors, elevating health issues to the highest level of government.8 10 To fulfil the spirit of this vision, national authorities will need to collaborate closely and partner with the various entities involved in IHR implementation. In federal or decentralised states, this includes coordination with subnational entities.11 Such coordination will hinge on the availability of adequate resources and personnel, and a legal mandate.
Under Article 4 of the amended IHR, States decided to leave open the option to choose between setting up one or two entities to fulfil the functions of the national authority and national focal point.5 Further, the terminology ‘designate or establish’ is intended to account for existing entities that might already serve or could be entrusted with these functions, which may well be exercised by the same entity. To give effect to the 2024 amendments, States will therefore need to assess existing entities within their jurisdiction and clearly define how they will interact with the newly established or designated authority. Once national authorities are established or designated, States will be required to share their contact details with the WHO as well as continuously update and confirm them annually.
What is needed for national IHR authorities to succeed?
National authorities offer a new tool for creating a more cohesive national framework for public health preparedness and response. By striving to confront siloed approaches, they aim to foster greater integration and cross-sectoral collaboration. However, if they are to succeed in this role, it is essential for national decision-makers to consider how these entities can effectively overcome the long-standing challenges faced by national IHR focal points. As noted above, the amended Regulations offer limited guidance on the structure or establishment of the national IHR authorities.5 This likely reflects both a respect for States’ sovereignty and the recognition of the diversity of constitutional and health system arrangements worldwide. Nevertheless, the challenges of intersectoral collaboration are well known, and existing frameworks offer valuable lessons. For example, the joint external evaluation tool for the IHR core capacities foresees the establishment of a multisectoral and multidisciplinary mechanism for the coordination and integration of relevant sectors in the implementation of the IHR.12 Similarly, the 2022–2026 one health joint action plan identified ‘enabling regulatory frameworks, investment and the institutionalization of intersectoral governance’ as one of its three change pathways.13 These initiatives and established practices in national cross-sectoral coordination will serve as valuable resources for establishing or designating national IHR authorities. In addition, States should take into account the political and financial dimensions of elevating health issues to high-level political agendas, as well as the need to ensure comprehensive oversight of the implementation of the Regulations across governments, and offer each other technical and financial support, as foreseen by Article 44, where help is needed. In the process of amending the Regulations, negotiators emphasised that States are obliged to cooperate in ‘the formulation of proposed laws and other legal and administrative provisions for the implementation of these Regulations’.5 This impetus offers an opportunity for States to confirm their vision for their own national IHR authority, while accelerating its realisation. Further, WHO’s normative authority and its role in the above initiatives puts the organisation and its regional offices in a unique position to spearhead this process. To turn this opportunity into a meaningful reality, it is crucial for WHO, individual States and other relevant stakeholders to identify strategies and develop guidance for reviewing existing structures, ensuring complementarity and granting the new national IHR authorities sufficient seniority and authority to overcome the persistent obstacles. This unified effort is critical as States that have signed up to the IHR turn their attention to implementing the 2024 amendments.
Footnotes
Funding: CA is employed by Resolve to Save Lives, which receives funding from multiple sources, none of which had any role in the writing of the manuscript or the decision to submit it for publication.
Handling editor: Mathuros Tipayamongkholgul
Patient consent for publication: Not applicable.
Ethics approval: Not applicable.
Provenance and peer review: Not commissioned; externally peer reviewed.
Data availability statement
There are no data in this work
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Data Availability Statement
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