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| Journal of the New Zealand Medical Association,
14-December-2007, Vol 120 No 1267
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The new International Health Regulations: a
revolutionary change in global health security
Michael G Baker, Andrew M Forsyth
On 15 June 2007 the most comprehensive global agreement ever
developed for the management of emerging human health hazards came into force in
193 countries, including New Zealand. This agreement, the International Health
Regulations 2005 (IHR 2005) had been adopted by the World Health Assembly on 23
May 2005.1 A full copy of the Regulations is
available on the World Health Organization (WHO) website (http://www.who.int/csr/ihr/en/).
This paper briefly describes the reasons for revision of the
IHR, summarises the main changes, and describes what they mean for New
Zealand.
The IHR 2005 became binding international law for all member
states of the WHO 2 years after the formal notification of their adoption,
unless a state advised that they rejected them or made a reservation. New
Zealand was among the overwhelming majority of WHO member states that did not
lodge such an objection.
Only three countries tendered qualifications to the IHR
2005, and only in the case of the United States were these reservations
potentially important (the US reserved against the IHR 2005 to the extent that
it will give effect to the core capacities in accordance with its constitutional
arrangements for the demarcation of responsibilities between federal and state
governments).
The IHR 2005 is a vastly different agreement to the previous
version (IHR 1969) that it replaced.2 It
represents an historic development for international law on public
health.3 WHO began revising the IHR in
19954 and this work accelerated following
severe acute respiratory syndrome (SARS) in 2003. New Zealand participated
actively in the review process, including the formal inter-governmental
negotiating sessions in Geneva in 2004 and 2005.
The negotiation process saw some changes, notably: the
removal of explicit references to intentional releases of biological, chemical,
and radiological agents (though such events are still covered by wording in
Article 7); a reluctance from some quarters to rely solely on a risk assessment
process for identifying which events to notify to WHO; and concerns about the
costs of implementing the new regime. However, the core direction of the
revisions was accepted by all member states.
Reasons for changesUpdating the IHR has been driven by concerns about
increasing global health threats and the need to incorporate more effective
surveillance and control practices to combat these threats. Originally adopted
in 1951,5 and last substantially changed in
1969,6 the previous IHR (IHR1969) was
recognised as inadequate by the mid-1990s, if not
earlier.7
Like the new IHR, the IHR 1969 included articles on
notification of specified diseases, control measures, and provisions for
travellers, points of entry, and conveyances (aircraft, ships, trains, road
vehicles). However, the scope of the IHR 1969 was severely constrained as its
provisions applied to just three named diseases (cholera, plague, yellow fever)
and it had little flexibility for responding to other current and emerging
health threats such as pandemic influenza.
The experience with SARS in 2003 demonstrated the
inter-dependence of countries in the detection, assessment and management of
public health threats.8 There is considerable
evidence that the global spread of epidemics can only be inhibited by a rapid
and focused response.9 Although the response to
SARS has been hailed as a success for international collaboration in infectious
disease control, there were features of this disease that made it relatively
containable.10,11
Other transmissible diseases such as pandemic influenza will
be much harder to manage. Even for that disease, modelling work has shown that
it may be possible to contain an outbreak with geographically targeted
prophylaxis and social distancing. However, the effectiveness of these
containment measures still depends critically on rapid identification and
response.12,13
Global environmental and social changes may also be creating
conditions where new emerging diseases threats are more
likely.14,15 The high speed and steadily
growing volume of international traffic makes the threat of disease spread a
potentially greater risk than during the era of mass migration by sea when
previous forms of the IHR were first developed. One of the predicted
consequences of global climate change is an increase in the burden of emerging
infectious diseases.15
Globalisation more generally has created an environment
where international law and global governance approaches are being increasingly
considered.16
Table 1. Important features of the
International Health Regulations 2005
Figure 1. Decision instrument from the
International Health Regulations 2005 (simplified from Annex 2). Reproduced from
reference.17
 Main changes in the IHR 2005The stated purpose of the Regulations ...are to prevent,
protect against, control and provide a public health response to the
international spread of disease in ways that are commensurate with and
restricted to public health risk, and which avoid unnecessary interference with
international traffic and trade (Article 2). The IHR 2005 agreement
contains a wide range of new measures to support this goal (summarised in Table
1).
The most dramatic of these changes is the new surveillance
system this agreement establishes, which goes far beyond what the IHR 1969
contained.17 Where the previous IHR applied to
just three named diseases, the new IHR agreement is concerned with any public
health risk that may adversely affect the health of human populations.
To encapsulate this concept it defines a new legal event,
the Public Health Emergency of International Concern (PHEIC) which
...means an extraordinary event which is determined...(i) to constitute a
public health risk to other States through the international spread of disease
and (ii) to potentially require a coordinated international response
(Article 1). Under the IHR 2005, states are required to notify all events that
may constitute a PHEIC.
The IHR 2005 agreement (Annex 2) includes a risk-based
decision instrument that states are required to use in assessing events that may
represent a PHEIC (Figure 1). Under this framework, even a single case of
smallpox, polio, SARS, or human influenza caused by a new subtype would be
notifiable. Other diseases would be assessed according to four decision criteria
and would be notifiable if they met any two of these (Figure 1).
Where the previous IHR agreement focused exclusively on
formal notifications from WHO member states, the new Regulations specify that
WHO may use surveillance data from any available source, including media
reports. This important change is consistent with a more globalised world where
information of all kinds is often communicated fastest through unofficial
channels.18,19
As well as specifying responsibilities for surveillance,
response, and points of entry, the IHR 2005 also specify the capacities that
countries must develop to carry out these activities. The provisions for
regulating points of entry, conveyances, and travellers represent an important
updating of requirements, but are more evolutionary than revolutionary. The IHR
2005 agreement retains some of the ‘tried and true’ provisions from
the IHR 1969, such as vector control and pratique (permission for an
arriving craft to unload cargo or disembark travellers).
What the new IHR agreement means for New ZealandLike most international agreements, the IHR 2005 offers
important benefits for participating states, but inevitably there are
obligations and associated costs, including some loss of national
sovereignty.3
Probably the most important benefit from the new Regulations
is the greater level of global health security that will come from having a
coordinated global surveillance and response system for emerging health threats.
Because of the heightened risk of an influenza pandemic, the World Health
Assembly in May 2006 called upon member states to immediately comply with
relevant provisions of the IHR 2005 in relation to
influenza.20 There are also the benefits to
trade and commerce from having well standardised processes for managing borders,
conveyances, and travellers.21
The obligations of the IHR 2005 agreement include complying
with its processes and developing and maintaining specified capacities. These
capacities largely relate to surveillance, response, and points of entry.
Building these domestic public health capacities is likely to assist countries
to better manage routine and endemic health risks on an ongoing basis, as well
as helping them to identify and report potential PHEIC.
The IHR focal point for New Zealand is the Ministry of
Health where this function is performed primarily by the Office of the Director
of Public Health, including application of the Decision Instrument when
required. Few events in New Zealand are likely to meet the threshold for
assessment as a potential PHEIC. Far more common will be events that represent
evidence of a public health risk outside the territory of the reporting country
that may cause international disease spread. Such events include imported human
cases, vectors, and contaminated goods (Article 9). The IHR 2005 require New
Zealand to report such events to the WHO within 24 hours of receipt of such
evidence.
The new Regulations specify that states assess the ability
of existing national structures and resources to meet the minimum requirements
described in the IHR 2005 (Annex 1). This assessment may identify functional
areas where enhancements to existing public health capacities are warranted.
Where capacities require development, states are required to have a national
implementation plan to fully implement these capacities throughout their
territories, with a deadline of June 2012. The New Zealand Ministry of Health
plans to carry out this assessment prior to the June 2009 deadline specified in
the IHR 2005.
Under Article 59, states were also expected, by June 2007,
to have adjusted domestic legislation and administrative arrangements to make
them compatible with the IHR 2005. Many of the key elements of the Regulations
are already incorporated into New Zealand legislation, in particular the
quarantine provisions of the Health Act 1956. Some aspects of the new IHR regime
are implemented by administrative and other means. The primary vehicle for full
legislative compliance will be through the proposed Public Health Act, which
will replace the Health Act 1956.
The IHR 2005 agreement includes specific obligations for
states to collaborate with each other to improve the detection, assessment, and
response to PHEIC, and in building the capacities to achieve this goal (Article
44). There is an expectation that developed countries such as New Zealand will
support developing countries in these areas. Arguments have also been made for
supporting health service development more generally, rather than a specific
focus on sophisticated surveillance
systems.22
Clinicians in New Zealand will notice few immediate effects
of the IHR 2005. One visible change is that the “international certificate
of vaccination or revaccination against yellow fever” has been replaced by
the “international certificate of vaccination or prophylaxis”. In
keeping with the greater flexibility of the IHR 2005, clinicians filling in this
form will now need to specify, in the space provided, when the disease for which
the certificate applies is “yellow
fever”.23
The surveillance requirements of the IHR 2005 emphasise the
importance of swift recognition and reporting of public health risks at the
local level. Alert clinicians and laboratory scientists remain the cornerstone
of timely and sensitive surveillance of both familiar and unfamiliar diseases of
public health importance.24,25 It is important
that all health workers observing an unexpected or unusual health event,
particularly one which may spread or may present serious and direct danger,
report this immediately to their local medical officer of health.
ConclusionThe IHR 2005 is an important international agreement for
public health, scientific, and symbolic reasons. From a public health
perspective, it specifies and mandates processes and capacities to enable public
health surveillance and control measures to work. From a scientific perspective,
it embodies modern risk assessment and surveillance methodologies. From a
symbolic perspective, it articulates the view that the world is inter-dependent
when confronting global health threats.
The IHR 2005 agreement is not a panacea for global health
threats.3 It will not, for example, require
states to address the many underlying factors that give rise to emerging health
threats, such as global climate change. Its focus on new risks means that it
provides limited direct support for efforts to reduce established threats such
as HIV/AIDS, tuberculosis, and malaria. Nor does it address the growing global
burden of non-communicable diseases.26
There are important technical, resource, governance, legal,
and political obstacles to be overcome in implementing the IHR
2005.17 But there are also effective responses
to these barriers.17 With collective national
and international effort to implement these new Regulations, the IHR 2005 will
support greater global health security for all.
Competing interests: Both of the
authors have carried out short-term consultancies for the World Health
Organization, including work on the IHR 2005.
Author information: Michael Baker, Public
Health Physician, University of Otago, Wellington. Andrew Forsyth, Public Health
Legislation Review Team, Office of the Director of Public Health, Ministry of
Health, Wellington
Correspondence: Associate Professor Michael
Baker, Department of Public Health, University of Otago, Wellington, PO Box
7343, Wellington South. Fax: (04) 389 5319; email: michael.baker@otago.ac.nz
References:
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