International Health Regulations: amendments

The International Health Regulations (known as IHR 2005, for the year of its most recent revision) are a legally binding international instrument to which 196 States Parties, including all 194 Member States of WHO, are committed. 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 issued 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 minimum core public health capacities and to notify WHO of events that may constitute a public health emergency of international concern (PHEIC), as well as procedures by which the Director-General could determine a PHEIC and issue temporary recommendations.

The revised IHR (2005) 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 to consider potential amendments to the IHR (2005), with the understanding that the entire instrument would not be reopened for negotiation: “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 Health Assembly decided to continue this work through the Working group on amendments to the IHR (WGIHR), and invited Member States to propose amendments to the IHR.

 

WHO Member States 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.

Since the IHR’s entry into force in 2007, the Director-General has convened a Review Committee on four other occasions: three times to provide technical recommendations on the functioning of the IHR during the H1N1 pandemic (2011), during the Ebola outbreak in West Africa (2016), and during the COVID-19 pandemic (2021), and once to provide technical recommendations on the second extension of the deadline to meet the core capacities under the IHR in 2014. A Review Committee’s functions (specified under Article 50 of the IHR, are to: a) make technical recommendations to the Director-General on proposed amendments to the IHR; b) provide technical advice to the Director-General with respect to standing recommendations; and c) provide technical advice to the Director-General on any matter referred to it by the Director-General.

 

Sixteen Member States, some on behalf of regional groups, submitted more than 300 proposed amendments, covering 33 of the 66 articles of the IHR, and five of its nine annexes; six new articles and two new annexes have been proposed. The proposed amendments were published online.

The proposed amendments address the following issues:

• purpose and scope
• principles
• responsible authorities
• notification
• verification
• information sharing
• risk assessment
• determination of a Public Health Emergency of International Concern and intermediate level of alert, including temporary recommendations and the convening and functioning of the Emergency Committee
• public health response, collaboration, and assistance
• health measures
• conveyances
• digitalization of health documents
• compliance and implementation.

 

As requested by Member States, the WHO Secretariat supports the WGIHR by convening its meetings and providing the WGIHR with services and facilities necessary for its work, as well as information and advice.

 

The first meeting of the WGIHR was convened on 14-15 November 2022. The WGIHR will propose a package of targeted amendments to the IHR for consideration by the Seventy-seventh World Health Assembly in 2024, in accordance with Article 55 of the IHR. The timeline for the WGIHR was agreed at its second meeting in February 2022.

 

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 accord could include 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 . . . particularly with regard to implementation and strengthening of the IHR (2005)”. The 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”.