International Health Regulations Amendments

International Health Regulations Amendments

Updated June 24, 2024
International Health Regulations Amendments
Background
discussions regarding IHR implementation, including the
Since 1980, outbreaks of new and long-standing infectious
absence of financing mechanisms and distribution networks
diseases have been occurring with increasing frequency and
for procuring and disseminating countermeasures in low-
intensity. In response, the World Health Assembly (WHA),
and middle-income countries (LMIC) and ensuring
the governing body of the World Health Organization
sovereign rights of States Parties. These and other issues
(WHO), has been amending the International Health
were addressed in the amendments, as summarized below.
Regulations (IHR)—a set of rules on global responses to
Sovereignty. While IHR amendments were being
public health emergencies. The IHR was most recently
deliberated, several Members expressed concern that
amended in June 2024. In January 2022, the United States
broadening the IHR might threaten U.S. sovereignty while
and several other States Parties proposed amendments to
numerous observers challenged that idea. Per Article 3,
the regulations. The 75th WHA agreed to establish a
States Parties have “the sovereign right to legislate and to
working group that would consolidate the proposals into a
implement legislation in pursuance of their health policies.”
revised IHR. The working group presented the proposals to
As such, a PHEIC declaration would not automatically
the 77th WHA, which debated and adopted agreed-upon
restrict travel or impose specific quarantine requirements,
amendments on June 1, 2024, as summarized below.
for example. Article 4, as amended, instructed States Parties
Several Members of Congress expressed concern that some
to designate or establish a National IHR Authority, “in
of the proposed amendments might encroach upon U.S.
accordance with its national law and context,” to coordinate
sovereignty. The State Department issued a press release in
June 2024 asserting that the amendments would “make
the implementation of the regulations.
the
global health security architecture stronger overall while
Equity. Early in the COVID-19 pandemic, LMIC struggled
maintaining full respect for sovereignty of individual
to gain access to novel therapeutics and vaccines to combat
states.” This In Focus addresses common questions
the disease. This phenomenon prompted intense debate
regarding the IHR, including the role of Congress.
about the equitable distribution of pandemic
countermeasures. Article 3, as amended, added the
International Health Regulations
promotion of “equity and solidarity” among the IHR (2005)
In 1969, WHA adopted the IHR to stop the spread of six
principles. Article 13, as amended, authorized WHO to
diseases (cholera, plague, yellow fever, smallpox, relapsing
“facilitate, and work to remove barriers to, timely and
fever, and typhus) through quarantine and other infectious
equitable access by States Parties to relevant health
disease control measures. The WHA has since amended the
products.” The article also directed the DG to support States
IHR several times. The 2005 edition, known as IHR (2005),
Parties in expanding and diversifying production of relevant
expanded methods for controlling infectious disease
health products, including by promoting research and
outbreaks beyond quarantine and broadened the type of
development and strengthening local production of relevant
public health events that would require international
health products. Per Article 13, the DG is permitted to
coordination. The regulations provide an overarching legal
“share with a State Party, upon its request, the product
framework that defines the rights and obligations of States
dossier related to a specific relevant health product, as
Parties, including the United States, in handling public
provided to WHO by the manufacturer for approval and
health events and emergencies that have the potential to
where the manufacturer has consented.”
cross borders. They also outline criteria for declaring a
public health emergency of international concern (PHEIC,
Financing. For many years, IHR proponents argued that a
described below) and requirements for States Parties to
funding mechanism was needed to support IHR
implementation in LMICs. (For more information on this
• report public health events,
issue, see CRS In Focus IF10022, The Global Health
• designate National IHR Focal Points for communication
Security Agenda (2014-2019) and International Health
with WHO, and
Regulations (2005)). The Global Health Security and
•
International Pandemic Prevention, Preparedness and
establish and maintain core capacities for surveillance
Response Act of 2022 authorized U.S. participation in a
and response.
Financial Intermediary Fund—later called the Pandemic
2024 Amendments to IHR (2005)
Fund—to support countries in IHR implementation, among
other things. Article 44, as amended, established a
In the first year of the COVID-19 pandemic, States Parties
Coordinating Financial Mechanism (CFM) to, inter alia, use
debated whether WHO had sufficient authority to
or conduct needs and funding gap analyses, and promote
investigate the origins of a potential PHEIC, particularly
sustainable financing for IHR implementation, including
when a State Party slowed the process (as China had). The
harmonizing existing funding streams and mobilizing new
United States and several other countries proposed
ones.
amendments to the IHR to address this and several other
related concerns. The proposal prompted broader
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International Health Regulations Amendments
Transparency and Accountability. Article 44, as
disease and other nomenclatures, diagnostic procedure
amended, specified that the DG shall report all its work on
standards, and safety, advertising, and labeling standards
expanding access to and funding for relevant products to
for pharmaceutical and other products. The WHA
the WHA, including through the CFM. Article 49, as
developed the IHR pursuant to this authority. Article 55 of
amended, instructed the DG to share with all States Parties
IHR (2005) authorized WHA to consider and adopt IHR
supporting evidence for determining and terminating a
amendments proposed by WHO States Parties.
PHEIC and the composition of the Emergency Committee
tasked with recommending whether the DG should declare
When did the United States become a party to the
a PHEIC.
IHR, and are the regulations a treaty?
In 1948, President Harry Truman signed into law a joint
Implementation. Discussions about IHR shortcomings also
resolution authorizing the President to accept U.S.
centered around its lack of any implementation mechanism.
membership in WHO, and to become party to the WHO
Article 54, as amended, established the IHR States Parties
Constitution. Under the WHO Constitution, States Parties
Committee to facilitate IHR implementation. The language
can adopt new conventions, agreements, and regulations
specifies that the committee shall be “non-adversarial,”
“
through a vote at WHA. New conventions and agreements
non-punitive,” and consultative in nature with the aim of
require a Member State to become party via signature and
promoting and supporting learning and cooperation among
ratification “in accordance with its constitutional processes”
States Parties, among other things.
as a standalone treaty. In contrast, regulations adopted by
Public Health Emergency of International Concern
WHA, and amendments thereto, enter into force for all
States Parties automatically following a notice period after
IHR amendments require the DG to determine whether a
WHA adoption, unless an individual Member State notifies
PHEIC constitutes a pandemic emergency (Article 12) and
the DG that it wishes to reject or modify its obligations
describe actions to be taken by States Parties in the event of
under such regulations. The United States agreed to be
a pandemic emergency. Following the emergence of an
bound by the obligations of IHR (2005) with the reservation
event that might be deemed a PHEIC, including a pandemic
that aspects of IHR implementation might be left to U.S.
emergency, the DG convenes an international team of
state governments rather than the federal government.
independent experts (Article 48) to analyze available
information on the event and consider the views of the State
How does WHO monitor IHR (2005)
Party where the event is occurring (Article 49). The team,
implementation?
called the Emergency Committee, makes recommendations
WHO monitors State Party progress through the issuance
to the DG on how to control the event and whether to
and analysis of self-assessment questionnaires known as
declare a PHEIC. The composition of each Emergency
Joint External Evaluations. Article 50 also established a
Committee varies per outbreak, though it is expected to
Review Committee, which among other things, was tasked
include at least one expert nominated by the State Party
with periodically reviewing IHR functions.
where the event is occurring. The IHR Emergency
Committee for COVID-19, for example, was composed of
How does WHO enforce IHR?
15 scientists from around the world, including China and
IHR (2005) does not provide WHO with enforcement
the United States. Though the DG usually follows the
authority. Instead, the regulations specify that
advice of Emergency Committees, the Director-General
implementation must follow national decisionmaking
makes final determinations on the event.
processes. If a WHO Member State asserts another is not
A PHEIC declaration alerts countries to implement national
adhering to IHR obligations, Article 43, as amended,
public health emergency plans. The regulations provide the
instructs the concerned Member State to raise the issue with
framework for the plans, which States Parties develop
the other Member State directly or through the DG. Unless
according to their national laws and policies. Should a
otherwise agreed to by the States Parties involved,
PHEIC be declared, countries may take a number of steps,
information shared during the consultation shall be kept
including heightening surveillance, reporting incidence of
confidential. A WHO Member State could also initiate
the relevant disease to WHO, and allocating resources for
dispute settlement procedures set out in Article 56. To date,
responses. Following the WHO PHEIC declaration for
no WHO Member State has ever invoked the Article 56
COVID-19, for example, then U.S. Department of Health
process against another Member State.
and Human Services (HHS) Secretary Alex Azar “declared
a public health emergency for the entire United States to aid
Does the executive branch require congressional
the nation’s healthcare community in responding to 2019
approval to propose or adopt IHR amendments?
novel coronavirus.” A declaration can also enable WHO to
The executive branch retains authority to introduce IHR
access funding from sources like the United Nations (U.N.)
amendments without congressional consent. If Congress
Central Emergency Response Fund and the Pandemic Fund
wishes to exercise greater control over U.S. proposals for or
administered by the World Bank.
positions on IHR amendments, it could consider requiring
the executive branch to notify and consult with Congress
Frequently Asked Questions
about such proposals. Congress could also consider placing
conditions on the use of appropriated funds or adopt a sense
How were the IHR adopted and amended?
of Congress provision expressing support for or concern
Article 21 of the WHO Constitution authorized the WHA to
about particular amendments.
adopt regulations for preventing the spread of infectious
diseases, including sanitary and quarantine requirements,
Tiaji Salaam-Blyther, Specialist in Global Health
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International Health Regulations Amendments

IF12139
Matthew C. Weed, Specialist in Foreign Policy Legislation

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https://crsreports.congress.gov | IF12139 · VERSION 4 · UPDATED