Revision of the
World Health Organization's International Health Regulations
By David P. Fidler
Recent global infectious disease crises, particularly
the 2003 outbreak of Severe Acute Respiratory
Syndrome (SARS)  and the 2004 epidemic of avian influenza A
 have elevated the importance of international
public health cooperation. Heightened efforts
in this area involve reform of the existing
international legal framework for infectious
disease control. In January 2004, the World
Health Organization (WHO) released an interim
draft of the revised International Health Regulations
(Interim IHR Draft).
 This Insight describes the Interim
IHR Draft and the changes proposed in it for
international law on infectious disease control.
Background on the International Health Regulations
WHO originally adopted the International
Health Regulations (IHR or Regulations) as the
International Sanitary Regulations in 1951.
Article 21 of the WHO Constitution (1948) empowers
the World Health Assembly (the main policy-making
organ of WHO) to adopt "regulations" concerning,
among other things, infectious disease control;
and the World Health Assembly adopted the International
Sanitary Regulations under this authority in
order to consolidate in one instrument the many
international sanitary conventions negotiated
since the late nineteenth century.
 WHO changed the name of the Regulations
to the IHR in 1969 and last revised them in
1983 when it removed smallpox from the IHR's
list of diseases. Under Article 22 of the WHO
Constitution, Assembly-adopted regulations are
binding on all WHO member states except those
that notify the Director-General of rejection
or reservations within a specified time.
The IHR's purpose is to ensure maximum
security against the international spread of
disease with minimum interference with world
traffic (IHR, Foreword). To achieve maximum
security against international disease spread,
the IHR requires, among other things, WHO members
to (1) notify WHO of outbreaks of specific diseases
subject to the Regulations (originally six diseases,
reduced to three by 1983); and (2) maintain
certain public health capabilities at points
of international entry and exit (e.g., the capability
to de-rat ships or disinsect aircraft).
To ensure minimum interference with world
traffic, the IHR impose maximum measures that
WHO members can apply to travelers and trade
coming from other WHO members affected by outbreaks
of diseases subject to the Regulations. These
measures are based on the best available scientific
evidence and are designed to justify rational
and effective responses from WHO members to
outbreaks in other countries.
Revision of the IHR
In 1995, the World Health Assembly instructed
the WHO Secretariat to begin the process of
revising the IHR.
 The first half of the 1990s had seen
increasing public health concern about "emerging
and re-emerging infectious diseases,"  and this alarm included the realization
that the IHR no longer provided an adequate
international legal framework to deal with the
mounting microbial threats. Identified weaknesses
of the IHR included (1) their application to
only three infectious diseases (cholera, plague
and yellow fever); (2) the failure of WHO members
to notify outbreaks of the diseases subject
to the Regulations; (3) WHO's inability to use
information about outbreaks it received from
non-governmental sources; and (4) the frequency
with which WHO members applied excessive and
irrational measures to the trade and travel
of other WHO members suffering from outbreaks.
In February 1998, WHO released a provisional
draft of revised Regulations, but this draft
did not meet with widespread approval among
WHO members.  Between 1998 and 2003, the IHR
revision process continued but was obscured
by other developments in international law and
public health, such as the battle concerning
the effect of pharmaceutical patent protection
under the World Trade Organization's Agreement
on Trade-Related Aspects of Intellectual Property
Rights on access to essential medicines, especially
access to antiretrovirals for AIDS treatment
in developing countries.
The SARS outbreak of 2003 accelerated
the IHR revision process because the outbreak
underscored the need for a new international
legal framework for infectious disease control.
In May 2003, the World Health Assembly instructed
the WHO Secretariat to complete the revision
of the IHR and to present the World Health Assembly
with the final draft for approval at its 2005
 Six months later the WHO released the
Interim IHR Draft for governmental and non-governmental
review and comments.
The Interim IHR Draft
The Interim IHR Draft is composed of a
Foreword and nine parts containing 55 articles.
In addition, the Interim IHR Draft has ten annexes
that form an integral part of Draft's rules.
This Insight will only describe key substantive
changes being proposed in the Interim IHR Draft
and will not engage in detailed analysis of
the text. More detailed analyses of the Interim
IHR Draft are available in other documents. 
A revolutionary proposal
The existing IHR follow an international
legal approach to infectious disease control
that can be traced back to the mid-nineteenth
century origins of diplomacy on infectious disease
threats. The Interim IHR Draft breaks radically
with the traditional approach in a number of
respects, and these radical breaks illustrate
the extent to which the WHO is responding to
the nature of infectious disease threats in
the globalized world of the twenty-first century.
Scope of the proposed regime: From specific
infectious diseases to public health risks
The traditional approach, embodied in
the IHR, has been to address specific infectious
disease threats, such as cholera, plague and
yellow fever. The Interim IHR Draft proposes
instead an approach that differs significantly
from the IHR in two respects.
First, the IHR (and the international
sanitary conventions that preceded them) addressed
only infectious diseases. The Interim IHR Draft
defines, by contrast, "disease" to mean "an
illness that presents a risk of significant
harm to humans caused by biological, chemical
or radiological sources" (Article 1.1). This
definition reflects the impact of the threat
posed by weapons of mass destruction and expands
the IHR's scope to cover areas never before
incorporated in this regime.
Second, the Interim IHR Draft abandons
a disease-specific approach for a more flexible
strategy based on "public health risks," defined
as events "posing a serious and direct threat
to the health of human populations" (Article
1.1). The emergence of new infectious disease
threats, such as SARS, makes a disease-specific
approach too inflexible, as illustrated by the
legal irrelevance of the IHR to the SARS and
avian influenza outbreaks. By gearing the regime
for new public health risks that might appear,
WHO hopes to make the legal framework relevant
and responsive to whatever public health threats
may emerge in the future.
Same end, radically new means
The Interim IHR Draft adopts essentially
the same purpose as the existing IHR, but seeks
to achieve this purpose through radically different
rules. To achieve the purpose of providing security
against the international spread of disease
while avoiding unnecessary interference with
 the Interim IHR Draft proposes five
First, the Interim IHR Draft obliges WHO
members to develop and maintain the capacity
to detect, report and respond effectively to
public health risks and events potentially constituting
public health emergencies of international concern
(Articles 4.1 and 10.1). Annex 1 of the Interim
IHR Draft lays out the core capacities WHO members
should develop and maintain for surveillance
and response. No such intrusive duties appeared
in the traditional international law on infectious
Second, the Interim IHR Draft requires
WHO members to notify WHO of all "events potentially
constituting a public health emergency of international
concern" (Article 5.1). The traditional approach
only required that WHO members notify WHO of
outbreaks of specific infectious diseases listed
in the Regulations. The Interim IHR Draft proposes,
thus, a significant expansion in the scope of
surveillance and notification duties for WHO
The concept of "events potentially constituting
a public health emergency of international concern"
is not defined,  but the Interim IHR Draft contains a "decision
instrument" to guide WHO members (Annex 2).
A "yes" answer to any two of the following four
questions means that an event potentially constitutes
a public health emergency of international concern
that the WHO member must notify to WHO: (1)
Is the public health impact of the event serious?
(2) Is the event unusual or unexpected? (3)
Is there a significant risk of international
spread? (4) Is there a risk of restrictions
on international travel or trade?
Third, the Interim IHR Draft allows WHO
"to take into account reports from sources other
than notifications or consultations and validate
these reports" (Article 7.1). This provision
also represents a radical break from the traditional
approach under which WHO's surveillance efforts
were restricted to information provided only
by governments. WHO's ability to collect and
use non-governmental sources of epidemiological
information is a powerful public health tool,
as illustrated in the SARS outbreak. 
Fourth, the Interim IHR Draft empowers
WHO to determine, independently, whether an
event constitutes a public health emergency
of international concern (Article 9.1). This
proposal increases WHO's power vis-à-vis its
members because it authorizes WHO to make judgments
about events transpiring in the territories
of its members.
 Again, nothing approaching this proposal
appeared in the IHR or the earlier international
Fifth, the Interim IHR Draft authorizes
WHO to prevent or reduce the international spread
of disease and minimize interference with world
traffic by making (1) temporary recommendations,
in the event WHO determines that a public health
emergency of international concern is occurring
(Article 11); and (2) standing recommendations
with respect to specific, ongoing public health
risks (Article 12).
 The Interim IHR Draft's abandonment
of the disease-specific approach means that
the disease-specific "maximum measures" strategy
used in the IHR cannot continue in a regime
with an expanded scope. The Interim IHR Draft
creates, thus, new legal powers for WHO to issue
recommendations on how WHO members should handle
public health risks and public health emergencies
of international concern.
Other provisions in the Interim IHR Draft
attempt to bolster the importance of WHO temporary
and standing recommendations by prohibiting
measures taken against world traffic that are
not recommended by WHO or authorized by other
applicable international agreements.  The Interim IHR Draft also empowers WHO to request "the cessation
of measures applied by States in excess of the
measures it has recommended, or of inappropriate
measures" and the full implementation of recommended
measures (Article 35).
Other new proposed provisions
National IHR Focal Point. The Interim
IHR Draft requires each WHO member to designate
a National IHR Focal Point that "shall remain
accessible at all times by WHO for urgent communications"
(Article 3.1). According to the Interim IHR
Draft, the National IHR Focal Point "will play
a central role in the notification of potential
public health emergencies of international concern
and in communications with WHO including, when
required, the implementation of event-specific
temporary recommendations issued by the Organization"
Human Rights. The Interim IHR Draft contains
a new provision, Article 36, on human rights
the likes of which never appeared in the traditional
approach. Article 36.1 provides that the Regulations
shall not prejudice rights persons have under
applicable international agreements which provide
for, or protect, the rights of persons. Article
36.2 states that "[n]o invasive medical examination,
vaccination or prophylaxis under these Regulations
shall be carried out on travelers without their
prior express informed consent."
Process of Amending Annexes. The Interim
IHR Draft proposes that WHO's Executive Board
may approve amendments to annexes by consensus,
and such amendments become binding on WHO members
pursuant to Articles 21 and 22 of the WHO Constitution
(Article 46.2). The Executive Board is composed
of 32 individuals selected from the member states
who are technically qualified in the field of
health. The Board's main functions are to advise
the World Health Assembly and give effect to
Assembly decisions. This provision potentially
clashes with Article 21 of the WHO Constitution,
which provides that the World Health Assembly
(not the Executive Board) shall adopt regulations.
Dispute Settlement. The Interim IHR Draft
eliminates the option that WHO members can submit
disputes concerning the IHR's interpretation
or application to the International Court of
Justice. It replaces that procedure with the
option to submit disputes to arbitration in
accordance with the Permanent Court of Arbitration
Optional Rules for Arbitrating Disputes Between
States (Article 47.3).
The Interim IHR Draft's Future
Currently, the Interim IHR Draft is being
reviewed by WHO members, which are providing
comments to the WHO Secretariat. Based on these
comments, the WHO Secretariat will revise the
Interim IHR Draft for consideration at formal
intergovernmental negotiations to take place
in the fall of 2004. The hope is that the intergovernmental
negotiations can produce a final draft of the
revised IHR that may be presented to the World
Health Assembly for adoption in May 2005.
About the Author:
David P. Fidler is Professor of Law and Ira
C. Batman Faculty Fellow, Indiana University
School of Law, and Senior Faculty, Center for
the Law and the Public's Health, Georgetown
and Johns Hopkins Universities. He is currently
a Visiting Senior Research Scholar at the Centre
for International Studies, University of Oxford.
 On the history of international law on infectious
disease control between 1851 and 1951, see
David P. Fidler, International Law and Infectious
Diseases (1999), Chapter 2.
 World Health Assembly, Revision and Updating
of the International Health Regulations,
WHA48.7, May 12, 1995.
 The WHO's World Health Report for 1996 was, for
example, devoted to the "global crisis" of
emerging and re-emerging infectious diseases.
See World Health Organization, World
Health Report 1996: Fighting Disease, Fostering
 For analysis of the February 1998 provisional
draft, see Fidler, supra note 4, at
 World Health Assembly, Revision of the International
Health Regulations, WHA56.28, May 28,
 Article 2 of the Interim IHR Draft provides:
"The purpose of the International Health Regulations
(hereinafter the "IHR" or "Regulations") is
to provide security against the international
spread of disease while avoiding unnecessary
interference with international traffic."
 The Interim IHR Draft only defines "event,"
which "means a manifestation of disease or
an occurrence that creates a potential for
disease" (Article 1.1).
 The proposal in Article 7.1 of the Interim IHR
Draft would, if adopted, embed in international
law a policy of approval for WHO use of non-governmental
information in global surveillance, which
had been provided on two individual occasions
by the World Health Assembly. See World
Health Assembly, Global Health Security:
Epidemic Alert and Response, WHA54.14,
May 21, 2001; and World Health Assembly, Revision
of the International Health Regulations,
WHA56.28, May 28, 2003.
 Annex 3 details the procedure through which
WHO would exercise this power.
 Annex 3 contains the procedure for the issuance
of temporary recommendations, and Annex 10
the procedure for standing recommendations.
 See, e.g., Interim IHR Draft, Articles
19.2, 21.1, 21.2, 23.1, 24, 26, 27.2. See
also Article 34, which provides that "States
should make every effort not to impose measures
exceeding those recommended by WHO under these
The purpose of ASIL Insights is to provide
concise and informed background for developments
of interest to the international community.
The American Society of International
Law does not take positions on substantive
issues, including the ones discussed
in this Insight.