International Health Regulations: amendments

The International Health Regulations (2005) (IHR) are a legally binding international instrument to which 196 States Parties, including all 194 Member States of the World Health Organization (WHO), are parties. The purpose of these Regulations is to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are restricted to public health risks and that avoid unnecessary interference with international traffic and trade.

In 1951, Member States of WHO adopted the first set of International Sanitary Regulations. They included mostly notification and quarantine provisions for outbreaks of six diseases: cholera, plague, relapsing fever, smallpox, typhus and yellow fever. These Regulations were revised in 1969 and adopted as the International Health Regulations (1969). Their purpose was “to ensure the maximum security against the international spread of diseases with a minimum interference with world traffic.” They were further amended in 1973 to include only four diseases (cholera, plague, smallpox and yellow fever). Then, after the eradication of smallpox in 1980, the Regulations included only three diseases: cholera, plague and yellow fever.

With the increase in international travel and trade, and the emergence, re-emergence and international spread of disease and other threats, the World Health Assembly called for a substantial revision to the IHR in 1995. This revision extended the IHR’s scope beyond any specific disease or manner of transmission to cover “illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans.”

Other additions included the obligations of States Parties to develop and maintain public health core capacities, to notify WHO of events that may constitute a public health emergency of international concern (PHEIC), and procedures by which the WHO Director-General could determine a PHEIC and issue temporary recommendations.

The revised IHR were adopted in 2005 and entered into force in June 2007.

WHO Member States, in light of the experience of the COVID-19 pandemic, agreed in 2022, through decision EB150(3), to consider potential amendments to the IHR, with the understanding that “such amendments should be limited in scope and address specific and clearly identified issues, challenges, including equity, technological or other developments, or gaps that could not effectively be addressed otherwise but are critical to supporting effective implementation and compliance of the International Health Regulations (2005), and their universal application for the protection of all people of the world from the international spread of disease in an equitable manner.”

In May 2022, the World Health Assembly decided to continue this work through the Working Group on Amendments to the International Health Regulations (2005) (WGIHR), and invited Member States to propose amendments to the IHR.

WHO Member States further asked the Director-General to convene a Review Committee to provide technical recommendations on the proposed amendments. The Review Committee held several meetings and submitted its report to the Director-General in January 2023, who shared it with the WGIHR.

There are 196 State Parties to the IHR: all 194 WHO Member States plus Liechtenstein and the Holy See. It is the 196 State Parties who are negotiating the proposed amendments to the IHR, through the WGHIR. The WGIHR operates as a subdivision of the World Health Assembly. The negotiations are facilitated by the WGIHR Bureau, which comprises representatives from each WHO region, including two co-chairs. As requested by Member States, the WHO Secretariat supports the WGIHR, including the Bureau, by convening its meetings and providing the WGIHR with services and facilities necessary for its work, as well as information and advice.

No, the proposed amendments to the IHR that have been submitted by States Parties, distributed to Member States and posted online are proposals under consideration by the WGIHR and, therefore, do not bear any international legal weight. In accordance with decision WHA75(9), the WGIHR is expected to present the package of proposed negotiated amendments to the Seventy-seventh World Health Assembly in May 2024 for its consideration. 

The latest working draft of the proposed amendments to the International Health Regulations can be found here:

• Working Group on Amendments to the International Health Regulations (2005)
• Proposed Bureau’s text for Eighth WGIHR Meeting, 22–26 April 2024

The package of proposed negotiated amendments will be submitted to the Seventy-seventh World Health Assembly in May 2024 for consideration, in accordance with Article 55 of the IHR. It is well established practice for the Health Assembly to work by consensus, although decision-making by vote is a legally available option.

No. WHO will have no ability to impose any health measure, including lockdowns or other restrictions, on the populations of any country. Among provisions of the IHR are the global public health alert function, and the framework and recommendations to support States Parties and the international community to respond to public health events, including outbreaks, epidemics and pandemics. 

According to the WHO Constitution, regulations adopted pursuant to Article 21 shall come into force for all Members after due notice has been given of their adoption by the World Health Assembly, except for such Members that notify the Director-General of rejection or reservations within the period stated in the notice.

Further, in accordance with Article 59(2) of the IHR, as amended in 2022 (and which will come into force generally on 31 May 2024), amendments to the IHR shall enter into force 12 months after the date of notification by the Director-General of the adoption of amendments. 

The IHR in Article 1 currently defines a public health emergency of international concern (PHEIC) as “an extraordinary event which is determined to constitute a public health risk to other States Parties through the international spread of disease and to potentially require a coordinated international response.” 

In accordance with Article 12(4) of the IHR, in determining whether an event constitutes a PHEIC, the Director-General shall, among other issues, consider the following:

• information provided by the State Party;
• the Emergency Committee’s advice;
• scientific principles, available scientific evidence and other relevant information; and
• an assessment of the risks to human health, international spread of disease and interference with international traffic.

The determination of a PHEIC serves as a global alert and, most importantly, it implies the issuance of Temporary Recommendations to States Parties – which, by definition, are not legally binding – to guide them in preparing for and responding to the PHEIC.

Under the IHR, Temporary Recommendations automatically expire three months after their issuance. Emergency Committees are, therefore, reconvened at least every three months to advise the WHO Director-General on whether the event continues to constitute a PHEIC, as well as on temporary recommendations to States Parties that the Director-General may continue to issue.

A statement of the Emergency Committee meeting is published on the WHO website after each Committee meeting.

Article 59 of the IHR, as amended, specifies how the length of time before amendments to the Regulations come into force. That duration is 12 months from when the WHO Director-General notifies States Parties that an amendment to the IHR has been adopted by the World Health Assembly.

Article 59 was amended by the Seventy-fifth World Health Assembly, as were conforming amendments to Articles 55, 61, 62 and 63 of the IHR (resolution WHA75.12 (2022)).

Each of these amendments come into force on 31 May 2024.

Further, Article 59, as amended, sets the period for rejection of, or reservation to, an amendment to these Regulations as 10 months from the date of the notification by the Director-General. Rejections or reservations to an amendment are allowed under Article 22 of the WHO Constitution. 

Yes. Provisions of Article 55 of the IHR, which set out who can propose amendments to the IHR, and when and how such proposals must be communicated to States Parties, have been met by the WHO Secretariat.

Article 55(1) of the IHR enables any State Party or the WHO Director-General to propose amendments to the IHR for consideration by the World Health Assembly. This has been applied to the WGIHR process.

Article 55(2) of the IHR further provides that the WHO Director-General shall communicate any proposed amendment to all States Parties at least four months before the World Health Assembly for consideration. This applies to any proposed IHR amendment submitted by a State Party or the WHO Director-General pursuant to Article 55(1). 

In fulfilling the Article 55(2) requirement, the WHO Secretariat circulated all proposals for amendments to the IHR on 16 November 2022, some 17 months before the Seventy-seventh World Health Assembly, which begins on 27 May 2024, when they are proposed for consideration.   

The World Health Assembly established the WGIHR, which operates as a subdivision of the Assembly and includes all 196 States Parties. As such, the WHO Secretariat has further exceeded the technical requirements of Article 55(2) by communicating not only the original 308 amendments, but also by communicating all proposed changes to these amendments developed by the WGIHR drafting group, to all 196 States Parties, after each WGIHR meeting. 

These communications to all States Parties occurred at the conclusion of each WGHIR meeting.

In sum, both the letter and the spirit of Article 55(2) have been met.

The letter of the provision was fulfilled, again, by the communication of 16 November 2022. This was well in advance of the four-month requirement. This notice maximized the time available for all States Parties for domestic and international consideration and coordination.

The spirit of the provision, which is to ensure that all States Parties have adequate time to consider and coordinate domestically and internationally on the proposed amendments in the run up to the Assembly, has been met. 

During a Special Session of the Health Assembly in December 2021, governments agreed to draft and negotiate a convention, agreement or other international instrument under WHO’s Constitution to strengthen pandemic prevention, preparedness and response. These negotiations are ongoing, led by the Intergovernmental Negotiating Body (INB), and a draft accord is to be presented to the World Health Assembly in 2024.

A new pandemic agreement could contain a provision on its relationship to other international instruments, including clarifying its complementarity with the IHR.

Article 57 of the IHR includes provisions regarding the relationships with other international agreements, including the possibility for State Parties to conclude special treaties or arrangements to facilitate the implementation of the IHR.

In establishing the INB, the World Health Assembly noted the “need for coherence and complementarity between the process of developing the new instrument and the ongoing work . . . with regard to implementation and strengthening of the IHR (2005).”

The  World Health Assembly also requested the WGIHR “to coordinate with the process of the [INB], by means that include regular coordination between the two respective Bureaus and alignment of meeting schedules and workplans, as both the International Health Regulations (2005) and the new instrument are expected to play central roles in pandemic prevention, preparedness and response in the future.”