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Strategies for implementing the new International Health

Regulations in federal countries


Kumanan Wilson,a Christopher McDougall,b David P Fidler c & Harvey Lazar d

Abstract The International Health Regulations (IHR), the principal legal instrument guiding the international management of public
health emergencies, have recently undergone an extensive revision process. The revised regulations, referred to as the IHR (2005),
were unanimously approved in May 2005 by all Member States of the World Health Assembly (WHA) and came into effect on 15 June
2007. The IHR (2005) reflect a modernization of the international communitys approach to public health and an acknowledgement of
the importance of establishing an effective international strategy to manage emergencies that threaten global health security.
The success of the IHR as a new approach to combating such threats will ultimately be determined by the ability of countries to
live up to the obligations they assumed in approving the new international strategy. However, doing so may be particularly challenging
for decentralized countries, specifically those with federal systems of government. Although the IHR (2005) are the product of an
agreement among national governments, they cover a wide range of matters, some of which may not fall fully under the constitutional
jurisdiction of the national government within many federations. This tension between the separation of powers within federal systems
of government and the requirements of an evolving global public health governance regime may undermine national efforts towards
compliance and could ultimately jeopardize the regimes success.
We hosted a workshop to examine how federal countries could address some of the challenges they may face in implementing
the IHR (2005). We present here a series of recommendations, synthesized from the workshop proceedings, on strategies that these
countries might pursue to improve their ability to comply with the revised IHR.

Bulletin of the World Health Organization 2008;86:215220.

Une traduction en franais de ce rsum figure la fin de larticle. Al final del artculo se facilita una traduccin al espaol. .

The revised International Health Regu- health governance, with the protection to public health events.7 When com-
lations (IHR) represent a dramatic new of the international community from bined, the required capacities constitute
approach to combating public health public health threats granted priority a blueprint for a comprehensive, fully-
emergencies.1 However, the success of the over national sovereignty in certain integrated, public health emergency
IHR may be impeded because of prob- circumstances.6 Some of the more dra- detection and response system.
lems federal countries may experience in matic examples of this shift in approach The IHR outline core capacity
meeting their requirements.2,3 Founded include: new requirements for coun- requirements for designated airports,
on a series of sanitary conventions dat- tries to report on potential public health ports and ground crossings. These re-
ing back to the mid 19th century, the emergencies within 24 hours; WHO au- quirements should not be problematic
recently revised IHR aim to guide the thority to use nongovernmental sources for most federal countries to implement
response of Member States to public of information for surveillance pur- since international points of entry
health emergencies, with a particular poses; and the ability of WHO to issue normally fall under the jurisdiction of
focus on preventing the international public health recommendations such as national governments. Potential com-
spread of disease without unnecessary those regarding travel, with or without pliance problems, however, can emerge
disruption of trade or travel. Recogni- the consent of potentially affected States with regard to those core capacities
tion of the limitations of previous ver- Parties.13 A further major innovation over which federal governments may
sions, as well as growing awareness of in the new IHR is the detailed re- not have explicit jurisdiction. For ex-
the increased threat of infectious dis- quirement for States Parties to develop ample, surveillance powers may fall to
eases in an ever-more interconnected multilevel capacities (referred to as core the regional (such as state, provincial
world, prompted an extensive revision capacity requirements) to effectively or cantonal) level of government in
process which began in 1995 and con- manage public health threats (Table 1). many federal countries. Federal gov-
cluded with unanimous approval of the The revised IHR impose on all WHO ernments may not have the authority
new agreement in May 2005.4,5 Member States the explicit obligation to to implement local level surveillance
The IHR (2005) reflect a substan- develop, strengthen, and maintain the or guarantee the transfer of epidemio-
tial change in approach to international capacity to detect, report and respond logical data from local to national levels

a
Department of Medicine, University of Toronto, Toronto, ON, Canada.
b
Department of Health Policy Management and Evaluation, University of Toronto, Toronto, ON, Canada.
c
School of Law, Indiana University, Bloomington, IN, United States of America.
d
Centre for Global Studies, University of Victoria, Victoria, BC, Canada.
Correspondence to Kumanan Wilson (e-mail: kumanan.wilson@uhn.on.ca).
doi:10.2471/BLT.07.042838
(Submitted: 3 April 2007 Revised version received: 11 September 2007 Accepted: 18 September 2007 Published online: 20 December 2007 )

Bulletin of the World Health Organization | March 2008, 86 (3) 215


Policy and practice
International Health Regulations implementation strategies Kumanan Wilson et al.

Table 1. Core capacities for surveillance and response

Obligations of States Local level Intermediate level National level


Parties to IHR (2005)
Core capacities to detect unusual public health to evaluate and verify to assess within 48h all domestic
events epidemiological data urgent events by consolidating input
to report key epidemiological to implement additional control from and disseminating information to
information to relevant measures as necessary relevant sectors of the administration
intermediate and national to report to national authorities to report the results of assessments as
authorities required within 24h to WHO through
to immediately implement a national focal point (NFP) which
primary control measures must be accessible at all times for
communications

Points of entry to provide and maintain facilities and expertise to conduct inspection (of goods and conveyances) and interview,
capacities diagnosis and treatment (of travellers) at designated points of entry

Cross-cutting to conduct 24h/7day surveillance and inspection, reporting, notification, verification, response, and collaboration
capacities with domestic and international public health authorities
to develop and maintain trained specialized personnel and facilities for health data collection, laboratory investigation
and operational/logistical support (including communication, transportation and supply chain), and detailed national
public health emergency plans that specify multi-sectoral response teams
to implement the regulations and conduct of public health interventions with full respect for the dignity, human
rights, and fundamental freedoms of persons (and as guided by the UN Charter and WHO Constitution)
to assess existing national capacities to comply with the terms of the IHR (2005) within 2 years (and to achieve full
compliance within 5 years) of the entry into force of the agreement
Capacity-building in for WHO and State Parties to assist in the development of public health capacities everywhere, including the
low-resource countries provision of technical cooperation and logistical support, as well as the mobilization of financial resources to facilitate
implementation of the IHR

IHR, International Health Regulations; PHEIC, public health emergencies of international concern.

to meet IHR (2005) requirements. Implementation in federal determine the appropriate approach for
Compounding matters is the fact that federal countries, the following funda-
countries mental questions need to be answered:
voluntary compliance from the local
level cannot be presumed due to re- Addressing the domestic governance (1) To what extent can federal countries
source limitations at this level or fear of challenges created by an increasingly ensure compliance with the IHR within
economic consequences related to early demanding global public health regime the context of a decentralized approach
reporting of potential emergencies. is not a simple task. While all countries to public health? (2) If federal countries
The potential difficulty in reconcil- share an interest in addressing global adopt more centralized approaches to
ing federal systems of government with public health emergencies through the public health, how should they manage
the IHR (2005) is illustrated by a revised IHR, they differ in important the potential negative impacts of such
request made by the United States of ways that will have an impact on the reforms on their relationships with
America for an article declaring that it viability of various strategies to imple- regional and local public health authori-
ment the agreement. Every country has ties? (3) In either case, how coercive are
would implement the regulations in
a unique governance system, as well as federal governments justified in being
a manner that is most consistent with
a legal framework (constitutional or towards regional governments to ensure
its federal system of government.8 The
otherwise) that places limitations on that the coordination of public health
rejection of the USAs request suggests the design of policies and practices.
that other federal countries did not view necessary for compliance with the IHR
Countries also have unique histories,
their systems of government as an insur- takes place?
including experiences with public
mountable obstacle to implementation health emergencies and acceptance of
of the IHR (2005).9 To the contrary, national government intervention. In
Governance options
the unanimous approval of the IHR some federal countries, India for ex- To effectively implement the IHR, federal
(2005) by all members of the World ample, it may be considered more ac- governments will need to take steps to
Health Assembly, including its fed- ceptable for national governments to either centralize governance, or at the
eral countries, is evidence of a global intervene in local issues, particularly if minimum, increase harmonization of
recognition of the importance of the that intervention brings much needed public health policy and practice at the
agreement as well as of the general will- resources to manage public health level of regional government. The latter
ingness of States Parties to take measures threats. will require creating a structure whereby
to overcome domestic obstacles to its No one set of policy options will regional governments are encouraged to
implementation. be appropriate for all federations. To develop the appropriate local public health

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Policy and practice
Kumanan Wilson et al. International Health Regulations implementation strategies

capacity and pass necessary public health Box 1. Key messages from symposium
legislation that will allow the country to
meet IHR requirements. Federal govern- Participants in the symposium included senior public health experts from, but not officially
ments have different instruments they representing, the following: Australia, Canada, China, France (China and France are examples
can utilize to achieve these goals. These of decentralized unitary countries), India, the Russia Federation, Senegal (as a general
representative of regional governance in Africa), the United States of America and WHO.
include direct legislation within the area of The views, opinions and conclusions expressed in this paper do not necessarily reflect those of
public health, legislation within a parallel WHO or participating countries.
area that covers the matters of interest, Each of the countries involved had uniquely different experiences with implementing the
funding arrangements, the use of intergov- International Health Regulations (IHR). Australia, Canada and the USA were confronted with the
ernmental agreements, and the issuance challenge that authority over several of the core capacity requirements was primarily located
of national guidelines. Each of these has at the state or province level. Each of these countries has potential mechanisms by which
advantages and disadvantages and it is im- these powers could be centralized, although such a process may be contrary to the history of
portant to identify the combination of in- federalism within that country and could be viewed as harmful to the integrity of the public health
struments that can optimize the likelihood system.
of successful compliance with the IHR The intention of these countries is to manage these issues through collaborative approaches
while mitigating its potential harms such as harmonization of legislation, funding arrangements and memoranda of understanding.
Brazil, India and the Russian Federation have systems in which necessary legislative authority
(Box 1). exists at the federal level and regional governments are dependent on central governments
for funding, which allows conditions to be attached to funding. These countries have more
Legislation governance mechanisms by which to implement the IHR although public health capacity at the
Among the options available to federal local or regional level remains a critical issue. The representative from Senegal identified the
governments, the legislative approach is need for coordination of governance not just within each country but also with adjacent countries
with which borders are often crossed in daily activities and from which diseases could spread.
likely to be considered one of the most
intrusive, or least respectful, of regional
sovereignty. But it may also be one of
the most effective mechanisms for the mechanisms through which federal gov- to its citizens or to the international
implementation of the IHR (2005). ernments can gain the needed legisla- community.
The ability of a national or federal gov- tive authority. In Canada, for example, An intriguing and controversial
ernment to exploit this option will in the criminal law power has been used approach to establishing a legislative
many cases depend on the allocation by the federal government to regulate basis for federal authority to intervene
of powers in the constitution. If the in public health.10 In the USA, the during public health emergencies is
federal government has clear constitu- federal governments tax and spending through the use of security powers. This
tional jurisdiction, it could pass legisla- powers and its ability to regulate in- is an option that has been considered by
tion imposing requirements on local or terstate commerce provide the oppor- the United States and Australia, which
regional public health authorities. This tunity to extend its influence in many has recently enacted legislation that
legislation could provide for surveillance public health matters.11 The constitu- links public health surveillance with
capacity development at the regional tions of some federal countries also con- national security.14,15
level, compulsory reporting of public tain variations of a supremacy clause The securitization of public health
health threats and allow for federal in- whereby conflicts between regional and has implications that need to be care-
tervention in public health emergencies. federal legislation (including treaty law) fully considered. 1618 A primary ad-
The IHR (2005) decision instrument are resolved in favour of federal law.12 vantage is that it could provide the
for identifying a public health emer- The use of these alternative ap- federal government with the necessary
gency of international concern (PHEIC) proaches must be considered with par- powers to take aggressive action early
could be adopted as a federal test for ticular caution. The expansion of fed- in a public health emergency. Including
jurisdiction for the latter issue: if a pub- eral authority into an area not other- public health as an essential component
lic health emergency is found to be of wise constitutionally enumerated runs of security also raises the profile and
international concern according to the the risk of being viewed as a power visibility of the former, which may in
algorithm contained in the instrument, grab, and could damage essential col- turn result in increased resources for
then the federal government would au- laborative intergovernmental relation- population health. However, securitiza-
tomatically have jurisdiction over the ships. Moreover, unilateral assertions of tion is in direct opposition to the funda-
matter. India, for example, has proposed federal authority, whatever the legal mental ethos of public health based on
new legislation that explicitly provides grounds, are unlikely to be effective in collaboration. It also necessarily makes
the federal government with authority the absence of regional cooperation, public health concerns secondary to
over a WHO-declared PHEIC. and could, in the worst case, generate security concerns, and so public health
The constitutions of many coun- animosity sufficient to seriously im- emergencies could ultimately fall under
tries, however, are silent on the alloca- pair responses during a public health the authority of security officials as op-
tion of public health powers between emergency.13 Thus such measures and posed to public health officials.
levels of government, with the result in approaches should only be considered Importantly, the consideration of
most cases being concurrent jurisdic- once other less intrusive alternatives any legislative approach must also respect
tional authority for activities related to have failed, and only when a federal other aspects of a nations constitution,
the IHR. On the other hand, parallel government judges that its lack of legis- notably human rights provisions. Respect
constitutional powers often provide lative authority poses a significant threat for human rights is also explicitly made

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Policy and practice
International Health Regulations implementation strategies Kumanan Wilson et al.

obligatory under the IHR (2005), which Canadian federal and provincial authori- Conclusion
requires that domestic implementation be ties have been considering the use of an
guided by the UN Charter, the WHO MOU related to data transfer, based on We have presented several governance
Constitution, and with full respect for the PHEIC algorithm proposed in the strategies that federal countries could
the dignity, human rights, and funda- decision-making instrument in Annex 2 consider when determining how to
mental freedoms of persons.19 of the IHR (2005). Australia has devel- comply with the revised IHR (summary
in Table 2). Our recommendations are
oped an intergovernmental agreement
intended for federal governments but
Funding power to outline the mechanism by which an
may also be useful for decentralized
Ultimately legislative authority at the emergency will be declared.20 However,
countries with unitary systems of gov-
federal level is meaningless without in the absence of additional funding ar-
ernment. While in these countries the
necessary capacity at the regional or local rangements or compensation plans, such
central government always has a legisla-
levels. Moreover, strengthening public agreements could be difficult to enforce. tive option, the importance of maintain-
health capacity to meet the require- Tensions are likely to arise when regional ing effective collaborative relationships
ments of the IHR (2005) will require governments are faced with the actual should encourage the consideration of
significant resource commitments in decision to report a public health emer- other approaches.
most countries. One way to achieve gency which could risk damage to the There is no single solution to the
enhanced capacity, while ensuring that local economy. One approach to diffusing challenges faced by federal States Parties
local and regional authorities transfer such tensions would be to pursue inter- to the revised IHR. In all likelihood,
relevant public health information to governmental agreements for the creation a combination of strategies based on
national governments, is through con- of independent bodies to oversee public specific circumstances will have to be
ditional funding arrangements. These health activities (during emergencies and developed for each country. However, a
would most likely involve agreements otherwise) that could act at arms length couple of over-arching themes emerged
between federal and local or regional of government. The degree of autonomy from the proceedings of our workshop.
governments to share the costs of de- of such organizations will be dependent First, we expect the greatest challenges
veloping surveillance infrastructure in upon the legislative framework within to occur in meeting the surveillance,
exchange for guaranteed transfer of which they must operate as well as the reporting and response requirements of
epidemiological information to the na- source of their funding. the IHR. The revised IHR require that
tional level. From a political perspective, a single body within every country has
such an arrangement may be viewed as National guidelines the responsibility to communicate to
less intrusive than a legislative approach. Another minimally intrusive approach WHO about potential PHEIC. Assum-
It also has the potential to achieve the is the creation of national guidelines ing this will be a federal agency, the most
same or better results on the ground, with regard, for example, to the stan- effective mechanism by which to ensure
particularly when there is a large finan- dardization of data collection, storage it has the required information would
cial asymmetry between national and and reporting. Regional and national be to incorporate the Annex 2 decision
regional governments. However, some instrument either into legislation or an
data standardization remains a major
regional governments may still regard MOU between federal and regional
obstacle in most countries, where there
the attachment of conditions to federal governments. If and when a potential
is a need to develop compatible, if not
dollars as coercive and could potentially PHEIC is detected, the federal agency
fully-integrated, information technol-
restrict the optimal use of these dollars must possess sufficient authority to as-
ogy platforms for the collection, analy- sess and acquire all available pertinent
at the local level. This is particularly true sis and communication of information information so as to meet the IHR
in developing countries dealing with during a public health emergency. reporting requirements. Second, ongo-
the burden of multiple public health Guidelines, while not binding, could be ing challenges such as surveillance at the
threats, such as HIV, tuberculosis and used to encourage such harmonization local level are likely to be handled better
malaria, which they are already insuffi- and could lead to increased coopera- through more collaborative approaches
ciently resourced to manage. tion from local governments if they are that combine conditional funding to
invited to participate in the process of develop capacity with intergovernmental
Intergovernmental agreements guideline formulation. Another ad- agreements to formalize relationships
Another less intrusive option than legisla- vantage of guidelines, as compared to and responsibilities. National guidelines
tion is the creation of formal negotiated legislation, is that they can be rapidly could be used for matters in which stan-
agreements between different levels of modified to remain current with chang- dardization of practices is sought.
governments. These would be mutually ing technologies and evolving public Whatever the combination of strat-
agreed upon and would therefore respect health science and practice. Guidelines egies used, their ultimate success will
jurisdictional boundaries. Memoranda are most likely to be effective if used in depend crucially on the development
of Understanding (MOU) could be par- combination with another strategy, in of appropriate public health capacity
ticularly effective for issues such as data particular conditional funding arrange- at all levels of government, as well as
transfer and could be used to formalize ments. For example, the Pandemic and effective working relationships between
funding arrangements. They might also All-Hazards Preparedness Act in the the various stakeholders. Furthermore,
establish the level of authority the federal USA provides an example of how devolution of public health activities
government would have in the event of a federal funding to states can be made or powers to nongovernmental entities,
regional public health emergency of pos- contingent on meeting federal stan- for example in the form of privatization,
sible national or international concern. dards.21 can make agreements between govern-

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Kumanan Wilson et al. International Health Regulations implementation strategies

Table 2. Summary of governance strategies

Governance Advantages Disadvantages Potential area of use


strategies
Legislation enforceable dependent on existence of authority to oversee and guide
clear designation of roles and appropriate constitutional authority response to a PHEIC
responsibilities may damage relations with other mechanism to ensure transfer of
clear lines of accountability levels of government epidemiological data to national level
inflexible

Funding enforceable may be changed unilaterally by surveillance capacity development


arrangements links capacity development to national government in combination with meeting IHR
governance strategy may be viewed as coercive reporting requirements
respects constitutional boundaries creates some ambiguity as to
accountability
Agreements respects constitutional boundaries limits to enforceability mechanism to ensure transfer of
epidemiological data to national level
Guidelines respects constitutional boundaries least enforceable standardization of data
flexible

IHR, International Health Regulations; PHEIC, public health emergencies of international concern.

ments meaningless and threatens to be ineffective in promoting compliance Agency of Canada, Canadian Interna-
undermine compliance with the IHR with the IHR (2005). tional Development Agency and the
by limiting the ability of countries to International Development Research
gather and aggregate public health Acknowledgements Centre. Dr Wilson is supported by the
information.22,23 Any implementation The symposium was supported by Canadian Institutes of Health Research.
strategy that does not take these factors funding from the Canadian Institutes
into serious consideration is likely to of Health Research, Public Health Competing interests: None declared.

Rsum
Stratgies de mise en uvre du nouveau rglement sanitaire international dans les Etats fdraux
Le Rglement sanitaire international (RSI), principal instrument systme fdral de gouvernement. Si le RSI (2005) est le fruit
juridique guidant la prise en charge internationale des urgences dun accord entre gouvernements nationaux, il couvre une grande
de sant publique, a rcemment fait lobjet dun processus de varit de questions, dont certaines ne relvent pas totalement
rvision approfondi. Le rglement rvis, appel RSI (2005), a t du gouvernement national dans nombre de fdrations. Cette
approuv lunanimit en mai 2005 par tous les Etats Membres tension entre la sparation des pouvoirs au sein des systmes
de lAssemble mondiale de la Sant (WHA), puis est entr en de gouvernement fdraux et les exigences dun rgime de
vigueur le 15 juin 2007. Le RSI (2005) reflte la modernisation de gouvernance sanitaire mondiale en volution pourrait saper
lapproche de la sant publique par la communaut internationale les efforts au niveau national pour respecter le rglement et
et la reconnaissance de limportance dune stratgie internationale finalement remettre en cause le succs de cette gouvernance.
efficace pour faire face aux situations durgence qui menacent la Nous avons accueilli un atelier charg dexaminer comment
scurit sanitaire mondiale. les Etats fdraux pourraient rpondre certaines de difficults
Le succs du RSI, en tant que nouvelle approche pour quils risquent de rencontrer dans lapplication du RSI (2005).
combattre ces menaces, sera conditionn en dernier ressort par Nous prsentons dans cet article une srie de recommandations,
la capacit des pays sacquitter des obligations auxquelles ils formules partir des actes de latelier, sur les stratgies que
se sont soumis en approuvant la nouvelle stratgie internationale. pourraient suivre ces pays pour amliorer leur capacit respecter
Nanmoins, respecter ces obligations risque dtre particulirement le RSI rvis.
difficile pour les pays dcentraliss, notamment ceux dots dun

Resumen
Estrategias para aplicar el nuevo Reglamento Sanitario Internacional en los pases federales
El Reglamento Sanitario Internacional (RSI), que constituye el de la Asamblea Mundial de la Salud y entr en vigor el 15 de
principal instrumento jurdico disponible para dirigir la gestin junio de 2007. El RSI (2005) refleja el enfoque ms moderno que
internacional de las emergencias de salud pblica, ha sido aplica a la salud pblica la comunidad internacional, as como el
objeto recientemente de un extenso proceso de revisin. El reconocimiento de la importancia que reviste el establecimiento
Reglamento revisado, conocido como RSI (2005), fue aprobado de una estrategia internacional eficaz para controlar las
por unanimidad en mayo de 2005 por todos los Estados Miembros emergencias que amenazan la seguridad sanitaria mundial.

Bulletin of the World Health Organization | March 2008, 86 (3) 219


Policy and practice
International Health Regulations implementation strategies Kumanan Wilson et al.

El xito del RSI como una nueva perspectiva para combatir gobierno y las exigencias de las nuevas formas de gobernanza de
esas amenazas depender en ltimo trmino de la capacidad la salud pblica mundial puede minar los esfuerzos nacionales
de los pases para cumplir las obligaciones que asumieron al encaminados a garantizar el cumplimiento de las medidas
aprobar la nueva estrategia internacional. Sin embargo, ello propuestas y a la larga podra poner en peligro el xito de esas
puede representar una tarea especialmente ardua para los pases medidas.
descentralizados, sobre todo para los que cuentan con sistemas Organizamos un taller para estudiar de qu manera podran
federales de gobierno. Aunque es fruto de un acuerdo entre los pases federales afrontar algunos de los desafos que puede
gobiernos nacionales, el RSI (2005) abarca una amplia gama de plantear la aplicacin del RSI (2005). Presentamos aqu una serie de
asuntos que pueden quedar fuera de la jurisdiccin constitucional recomendaciones, sintetizadas a partir de lo discutido en el taller, sobre
del gobierno nacional en muchas federaciones. Ese conflicto entre las estrategias que podran adoptar esos pases a fin de mejorar su
la separacin de poderes que se da en los sistemas federales de capacidad para cumplir lo dispuesto en el RSI revisado.



.
2005

. )2005(
2005 /
2007 / 15
.

.
2005


.

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