20080701s00019p44.pdf
CMAJ • JULY 1, 2008 • 179(1)
© 2008 Canadian Medical Association or its licensors
44
Analysis CMAJ•JAMC
The International Health Regulations, the principle doc-ument governing the response to public health emer-gencies that pose an international threat, were revised
in 2005 and became binding international law on June 15,
2007.1 These new regulations, unanimously approved by the
World Health Assembly, differ in important ways from previ-
ous versions (Table 1) and represent a major step forward in
protecting global public health security.2,3 Despite their impor-
tance, countries will face several challenges to implementing
the regulations. Many developing countries lack the capacity
to detect and respond to public health emergencies, and devel-
oped countries may choose to act unilaterally. Decentralized
states such as Canada will also face specific challenges to im-
plementation. In May 2008, the Auditor General of Canada is-
sued a report highlighting areas in which Canada has had diffi-
culty complying with the new regulations.4
In this article, we describe how the regulations provide
new guidance to member states on preparing for and respond-
ing to public health emergencies, some of the challenges to
compliance with the regulations, and Canada’s role in helping
to ensure their successful implementation.
Features of the revised regulations
The goal of the revised International Health Regulations are
to protect against the international spread of epidemics and
other public health emergencies without unnecessary interfer-
ence with international travel and trade. To achieve this ob-
jective, the regulations provide new guidance to membe
states on several matters (Figure 1). The fundamental premise
of the regulations is that preparation and early detection and
esponse are essential to protect against global health emer-
gencies. The regulations therefore require member states to
assess their core capacity for effective public health surveil-
lance and response within 2 years and meet requirements fo
core capacity within the subsequent 3 years.5
Ensuring that public health emergencies are reported in a
timely manner to the World Health Organization (WHO) is a
priority of the new regulations. The previous version of the reg-
ulations covered only 3 specific diseases: plague, cholera and
yellow fever (Table 1).6 The revised regulations instead intro-
duce the concept of a “public health emergency of international
concern.” To assist countries in determining what events should
e reported, the new regulations provide a mechanism to evalu-
ate whether events are potential international threats.3,7 Membe
states are required, within 48 hours, to assess any event occur-
ing within their te
itory and to determine whether it may be a
public health emergency using an algorithm (see Appendix 1,
available online at www.cmaj.ca/cgi/content/full/179/1
44/DC1).8 An out
eak of certain diseases, such as SARS (se-
vere acute respiratory syndrome), will always be considered a
potential public health emergency of international concern.
Recognizing the importance of a rapid response, the new
egulations require that member states report potential public
health emergencies to WHO within 24 hours after they have
identified and assessed them. Member states must also desig-
nate a “National Focal Point” for communication with WHO.
Unlike in the previous regulations, initial notification of WHO
can be made on a confidential basis. The new regulations also
allow WHO to consider unofficial “reports from sources othe
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Kumanan Wilson MD MSc, Ba
ara von Tigerstrom LLB PhD, Christopher McDougall MA
@@ See related editorial by Attaran, page 9
Protecting global health security through the International
Health Regulations: requirements and challenges
From the Ottawa Health Research Institute and Department of Medicine
(Wilson), University of Ottawa, Ottawa, Ont.; the University of
Saskatchewan College of Law (von Tigerstrom), Saskatoon, Sask.; and the
Department of Health Policy, Management and Evaluation (McDougall),
University of Toronto, Toronto, Ont.
Published at www.cmaj.ca on June 12, 2008.
Key points
• The revised International Health Regulations are designed
to protect against the international spread of public health
emergencies without unnecessary interference with inter-
national travel and trade.
• The regulations require member states to develop national
surveillance and response systems.
• The regulations describe how international health emer-
gencies are to be identified, reported and managed.
• The implementation of the regulations faces several chal-
lenges, including lack of capacity in developing countries,
the risk of independent action in developed countries and
poor coordination between federal and regional govern-
ments in decentralized countries.
• Canada can lead the way by demonstrating its compliance
with the regulations and by championing their implemen-
tation in developing countries.
CMAJ • JULY 1, 2008 • XXXXXXXXXX
Analysis
than notifications or consultations.” This means that, if gov-
ernment officials in a member state delay reporting a potential
public health emergency, WHO can use information from un-
official sources that may be available by email or the Internet,
for example, to assess the situation. WHO will consult with
the member state concerned and attempt to obtain verification
efore taking any action; however, it can share the information
with other member states, and even directly with the public in
some situations. These alternatives for gathering information
are important, because the regulations do not describe penal-
ties for member states that fail to report, or for that matter fail
to comply with the regulations in other respects.
In addition to protecting public health, another important
goal of the regulations is to prevent unnecessary economic
harm. In the event of a possible health emergency, countries
may be anxious to close their borders to protect their popula-
tions. Premature or unjustified closing of borders, however,
can have serious negative economic consequences. During
out
eaks of cholera in the 1990s in Peru and eastern Africa,
other countries banned imports of fish and other food prod-
ucts from the affected areas and restricted the entry of trav-
ellers from Peru, despite clear advice from WHO that there
was no justification for such measures. Peru estimated trade
losses for the year of the out
eak at over US$770 million.9,10
In 1994 India was hit with extensive restrictions on travel and
trade during a localized out
eak of plague, again contrary to
WHO advice; the estimated cost to India’s economy was
more than US$2 billion.9
To limit economic damages from public health emergen-
cies effectively, a multifaceted approach is necessary.11 The
new regulations attempt to prevent unnecessary interference
with international travel and trade by making WHO the pri-
mary a
iter on decisions related to controlling public health
threats. Once WHO has received information about an event,
the Director-General of WHO is responsible for determining,
on the advice of an expert committee, whether the event con-
stitutes a “public health emergency of international concern”
and, if so, what temporary recommendations will be issued to
guide member states in their control efforts. Recommenda-
tions must take into consideration the views of the affected
country, scientific principles and evidence, the least intrusive
measures that would provide protection, and relevant interna-
tional agreements. Examples of temporary recommendations
include requiring medical examinations or vaccinations, quar-
antine or isolation of individuals or goods, or denial of entry.
Member states are not limited to these recommendations.
However, if they put in place measures that exceed those rec-
ommended, they must comply with a set of conditions.
Challenges to compliance
The revised International Health Regulations have been criti-
cized for subordinating health concerns to security and eco-
nomic concerns.12 They have also been described as overem-
phasizing surveillance,13 not placing enough emphasis on
assistance for developing countries13 and lacking a legal
mechanism to ensure compliance.14
Despite these criticisms, the new regulations were unani-
mously approved by the WHO member states. All membe
states are bound by their requirements unless they specifically
objected to them by the end of XXXXXXXXXXAs of Fe
uary 2008, no
member states had rejected the regulations, 188 had designated
National Focal Points, 76 had already conducted an assessment
of their national core capacities, and 50 had nominated individ-
uals to the International Health Regulations Roster of Experts.16
A number of countries, including Australia, Syria, Finland,
Sweden, Columbia, France, Georgia and Germany, have al-
eady recognized the regulations as domestic law or have incor-
porated elements of the agreement into their national health
legislation.17 A number of other countries, including Argentina,
Spain, Brazil, South Africa and the European Community,
have passed administrative regulations that cite the new Inter-
national Health Regulations. Still other countries, including the
United Kingdom,18 are considering “all-hazards” approaches to
the reform of their public health legislation.
In spite of these efforts and the recognition of the impor-
tance of the regulations, several factors may prevent full na-
tional compliance. This is particularly true when compliance
may leave countries, or regions within countries, vulnerable.
Limited capacity in developing countries
Developed countries have a considerable interest in the regu-
lations succeeding. Many developed countries will likely be
geographically removed from areas in which public health
emergencies, such as an influenza pandemic, may develop. It
is in their interest that countries in high-risk regions comply
with the regulations, to provide an early warning so that the
developed countries can take appropriate measures to protect
their populations.12
For many developing countries, however, early detection
and reporting of a public health emergency may be of little
Table 1: Major differences between the new International
Health Regulations and previous versions*
Previous regulations New regulations
Focus was on 3 diseases
(cholera, plague, yellow
fever)
Focus is on all “public health
emergencies of international
concernӠ
Regulations defined
measures that member
states could take
The World Health Organization
(WHO) makes recommendations
on measures that can be taken;
member states can exceed the
ecommended measures if they
comply with the conditions
Limited surveillance and
esponse obligations
More extensive surveillance and
esponse obligations
Mandatory reporting of
cases and automatic
sharing of information
with other member states
Mandatory reporting of
potential public health
emergencies of international
concern; WHO may use and
share information from
unofficial sources
*The previous regulations were issued in 1969 and updated in 1981. The
new regulations were revised in 2005 and came into force in June 2007.
†Events that (a) may constitute a public health risk to other member states
through the international spread of disease and/or (b) may require a
coordinated international response.1
CMAJ • JULY 1, 2008 • XXXXXXXXXX
Analysis
enefit if the country lacks the capacity to control the out-
eak in its early stages. Early reporting could also trigge
apid closing of international borders to travel and trade,
which could be devastating to their economies. Furthermore,
investment in surveillance infrastructure, as required by the
egulations, may divert scarce resources away from areas of
public health that have a greater need, such as the treatment
and control of tuberculosis, malaria and HIV/AIDS.12,19
Noncompliance by less developed countries will reduce the
likelihood of controlling public health