U.S. Proposals to Amend the International Health Regulations
Updated February 1, 2024
U.S. Proposals to Amend the International Health Regulations
Background
called the Emergency Committee, makes recommendations
Since 1980, outbreaks of new and long-standing infectious
to the Director-General on how to control the event and
diseases have been occurring with greater frequency and
whether to declare a PHEIC. The composition of each
causing higher numbers of human infections. The World
Emergency Committee varies per outbreak. The IHR
Health Assembly (WHA), the governing body of the World
Emergency Committee for Pneumonia Due to the Novel
Health Organization (WHO), has occasionally amended a
Coronavirus 2019-nCoV, for example, was composed of 15
long-standing set of rules called the International Health
scientists from around the world, including an official from
Regulations (IHR) to address this growing global threat. In
the U.S. Centers for Disease Control and Prevention
January 2022, the United States introduced amendments to
(CDC). Though the Director-General usually follows the
the Regulations that sought to broaden the ways in which
advice of Emergency Committees, the Director-General
WHO could respond to public health threats and increase
makes final determinations on the event.
the pace of such responses. Congressional deliberations of
these amendments focused on the potential implications of
A PHEIC declaration alerts countries to implement public
implementation and whether adoption of the amendments
health emergency responses, as outlined in IHR (2005). The
would require congressional consent since the United States
Regulations provide the framework for the response and
consented to be legally bound by the Regulations through
Member States develop their own implementation plans. In
an executive agreement. This In Focus addresses common
upholding IHR (2005), the Regulations specify that
questions regarding the IHR, including the role of Congress
Member States have “the sovereign right to legislate and to
and the status of U.S.-proposed amendments to the
implement legislation in pursuance of their health policies.”
Regulations.
As such, a PHEIC declaration does not automatically
restrict travel or impose specific quarantine requirements,
International Health Regulations
for example.
In 1969, WHA adopted the IHR to stop the spread of six
diseases (cholera, plague, yellow fever, smallpox, relapsing
Following a PHEIC declaration, countries may take a
fever, and typhus) through quarantine and other infectious
number of actions, including heightening surveillance,
disease control measures. The WHA amended the IHR
reporting incidence of the relevant disease to the WHO, and
several times, most comprehensively in 2005. The 2005
allocating resources for domestic or international responses.
edition, known as IHR (2005), expanded methods for
On behalf of the United States, former U.S. Department of
controlling infectious disease outbreaks beyond quarantine
Health and Human Services (HHS) Secretary Alex Azar,
and broadened the type of public health events that would
for example, “declared a public health emergency for the
require international coordination. The Regulations provide
entire United States to aid the nation’s healthcare
an overarching legal framework that defines the rights and
community in responding to 2019 novel coronavirus”
obligations of parties to the agreement (which includes the
following the WHO PHEIC declaration for Coronavirus
United States and all other WHO Member States) in
Disease 2019 (COVID-19). A declaration can also enable
handling public health events and emergencies that have the
WHO to access certain emergency funding during an
potential to cross borders. They also outline criteria for
outbreak, such as that provided through the United Nations
declaring a public health emergency of international
concern (PHEIC) and requirements for Member States to
(U.N.) Central Emergency Response Fund and the World
Bank Pandemic Emergency Financing Facility.
• report public health events;
• designate National IHR Focal Points for communication
Frequently Asked Questions
with WHO; and
•
How were the IHR adopted and amended?
establish and maintain core capacities for surveillance
and response.
Article 21 of the WHO Constitution authorizes WHA to
adopt regulations to prevent the spread of infectious
IHR (2005) compliance is measured through a self-
diseases, including sanitary and quarantine requirements,
assessment questionnaire that WHO sends to Member
disease and other nomenclatures, diagnostic procedure
States.
standards, and safety, advertising, and labeling standards
for pharmaceutical and other products. WHA developed the
Public Health Emergency of International Concern
IHR pursuant to this authority. Article 55 of IHR (2005)
Following the emergence of an event that might be deemed
authorizes WHA to consider and adopt IHR amendments
a PHEIC, the WHO Director-General convenes an
proposed by WHO Member States.
international team of independent experts to analyze
available information on the event and consider the views
of the State Party where the event is occurring. The team,
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U.S. Proposals to Amend the International Health Regulations
When did the United States become a party to the
Session of the WHO Executive Board in January 2022, the
IHR, and are the Regulations a treaty?
United States introduced amendments to IHR (2005) that
In 1948, Congress adopted legislation authorizing the
were expected to be considered at the 75th WHA in May
President to accept U.S. membership in WHO, and to
2022. The amendments introduced by the Biden
become party to the WHO Constitution. Under the WHO
Administration built on the aforementioned Roadmap,
Constitution, Member States can adopt new conventions,
congressional calls for strengthening IHR (2005)
agreements, and regulations through voting in WHA. New
compliance, and feedback from the WHO Working Group
conventions and agreements require a Member State to
on Strengthening WHO Preparedness and Response to
become party via signature and ratification “in accordance
Health Emergencies.
with its constitutional processes” as a standalone treaty. In
contrast, regulations adopted by WHA, and amendments
What amendments did the United States propose?
thereto, enter into force for all Member States automatically
The amendments were primarily aimed at expanding the
following a notice period after WHA adoption, unless an
capacity of WHO to respond to public health events,
individual Member State notifies the Director-General that
including to
it wishes to reject or modify its obligations under such
• permit WHO to develop an early warning system and
regulations. The United States agreed to be bound by the
to issue a public health alert for events that are not
obligations of IHR (2005) with the reservation that aspects
deemed a PHEIC;
of IHR implementation might be left to U.S. state
governments rather than the federal government.
• enable WHO to issue a PHEIC and other alerts should
a Member State where the event is occurring decline to
How does WHO monitor IHR (2005)
cooperate;
implementation?
• require the Member State that rejected WHO
IHR (2005) requires all Member States to have developed
consultation to provide a rationale for its decision;
minimum public health capacities to detect acute public
• permit a WHO Regional Director to declare a public
health events in a timely manner, assess and report to WHO
health emergency of regional concern;
through their National IHR Focal Point health events that
•
may constitute a PHEIC, and respond to public health risks
direct countries to provide WHO-convened experts
investigating a possible PHEIC “short term access to
and emergencies. WHO monitors State Party progress in
these areas through the issuance and analysis of self-
relevant sites ... in compliance with national law”; and
assessment questionnaires.
• establish a Compliance Committee to oversee and
report on global IHR (2005) compliance.
How does WHO enforce IHR?
As noted, IHR (2005) does not provide WHO with
What is the status of the U.S.-proposed
enforcement authority; instead, IHR (2005) specifies that
amendments?
implementation must follow national decisionmaking
The 75th WHA adopted the proposed amendment to shorten
processes. If a WHO Member State asserts another is not
the period of time in which countries could implement and
adhering to IHR obligations, that Member State may raise
object to any IHR amendments. The WHA also decided to
the issue with the other Member State, privately or during
establish a Working Group on IHR amendments “to discuss
WHA sessions. A WHO Member State could also initiate
targeted amendments to address specific and clearly
dispute settlement procedures set out in Article 56 of IHR
identified issues, challenges, including equity, technological
(2005). To date, no WHO Member State has ever invoked
or other developments, or gaps that could not effectively be
the Article 56 process against another Member State.
addressed otherwise but are critical to supporting effective
implementation and compliance of the International Health
Why did the United States propose amendments
Regulations.” The Working Group has received over 300
to IHR (2005)?
proposed amendments from 15 countries and stated that it
In the first year of the COVID-19 pandemic, the Trump
plans to propose a package of targeted amendments for
Administration criticized what it called WHO’s delayed
consideration at the 77th WHA in May 2024.
acknowledgement that COVID-19 was spreading via
human-to-human transmission and WHO’s inability to
Does the Administration require congressional
investigate fully the origins of the pandemic. Several
approval to propose or adopt IHR amendments?
Members of Congress also criticized the WHO response
The executive branch retains authority to introduce IHR
and called for a range of actions, including withdrawing
amendments without congressional consent. If Congress
from WHO, holding China accountable for failing to
wishes to exercise greater control over U.S. proposals for or
comply with IHR (2005) in a timely fashion, strengthening
positions on IHR amendments, it could consider requiring
WHO, and boosting global disease surveillance capacity
the Administration to notify and consult with Congress
within and outside of WHO. The Trump Administration,
about such proposals. Congress could also consider placing
after announcing in 2020 the intent to withdraw the United
conditions on the use of appropriated funds or enact a Sense
States from WHO, released a “WHO Roadmap” to
of Congress expressing support for or concern about
“strengthen the WHO by increasing accountability and its
particular amendments.
ability to be impartial and objective, [and] improve
transparency and its overall effectiveness, by providing it
Tiaji Salaam-Blyther, Acting Section Research Manager
with a more comprehensive set of tools that are fit-for-
Matthew C. Weed, Specialist in Foreign Policy Legislation
purpose to address new and emerging threats.” At the 150th
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U.S. Proposals to Amend the International Health Regulations
IF12139
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https://crsreports.congress.gov | IF12139 · VERSION 2 · UPDATED