ABA Health eSource
December 2007 Volume 4 Number 4

The Revised International Health Regulations: An Historical Overview and an Analysis of Modern Application
 by Rita-Marie A. Brady, JD, MPH, Emerging Leader Program Fellow, Centers for Disease Control and Prevention, Atlanta, GA
(The author would like to acknowledge and thank Rachel Weiss, JD for her editorial assistance and insight. The contents of this article should not be construed to represent any determination or policy of the Centers for Disease Control and Prevention or the US Department of Health and Human Services.)

Rita-Marie A. BradyIntroduction

On May 23, 2005, the World Health Organization (WHO) officially adopted the revised International Health Regulation1 which entered into force earlier this year and provides an international legal mechanism to address the public health response to the global spread of disease.2 This discussion will examine the implementation and application history of the International Health Regulations, describe the objectives of the revised International Health Regulations, and highlight some of the questions surrounding its future use.

The International Health Regulations: A Brief History of Implementation and Application

The history of the International Health Regulations began during the cholera epidemics sweeping through Europe between 1830 through 1857. These epidemics led to the 1851 International Sanitary Conference held in Paris, where states formally recognized that infectious diseases extended beyond designated national and state boundaries.3 A series of conventions were drafted following the Paris Conference, the most significant of which was the International Sanitary Convention written during the 1892 International Sanitary Conference in Venice.4 The Venice Conference was a significant milestone because it was the first occasion to develop an "international network of scientists and policy makers devoted to the global control of infectious diseases" ultimately creating the World Health Organization (WHO).5

The formation of the WHO was the result of a unanimous vote by the 50 delegates at the San Francisco United Nations Conference in 1945 who determined that "a single global health organization should be founded and recognized as an essential component of the postwar international system."6 WHO's constitution7 was signed in New York City a year later and was ratified in 1948.8 The responsibility of the newly founded organization was to "foster and coordinate public health campaigns around the world ... by spearheading cooperation between nations forming national health agencies."9

In keeping with its ambitious mandate, WHO offered an expansive definition of health, to include not just disease eradication, but also holistic health promotion.10 WHO made use of new medical advancements and technologies, emphasized human rights doctrines, and enjoyed the support of the United Nations.11.12 Member states adopted the International Sanitary Regulations (ISR) in 1951 and one of WHO's early missions was to fight infectious diseases.13 In 1969, the ISR was renamed the International Health Regulations (IHR) and later underwent modifications in 1973 and 1981, followed by revisions in 2005.14 The IHR represented, once it entered into force, "the first legally binding international set of regulations adopted by WHO member states."15 The binding force of the IHR centered on soft law principles discussed below.

The function of the original International Health Regulations [hereafter referred to as "IHR (1969)"] was to "ensure maximum security against the international spread of disease with a minimum interference with world traffic,"16 by requiring member states to notify WHO of listed diseases and for WHO to monitor for such diseases after receiving notification.17 The IHR (1969) was composed of four requirements: (1) notification by the state if the specified disease occurs; (2) imposition of hygiene measures at all ports of entry and points of transit (i.e., conducting inspections, providing potable water and clean food, etc.); (3) issuance of optional health certificates for travelers journeying from infected to non-infected areas; and (4) permitting the health measures to encompass the maximum permissible to international traffic "which a state may require for the protection of its territory."18

Despite its good intentions, the IHR (1969) was difficult to enforce. Because guidelines and policies created by WHO are considered "soft law," and not legally binding, some member states failed to comply with directives.19 20 Further complicating matters, because the IHR (1969) promoted action within the state, but not between states, there was little impetus for states to work together for the global good.21

In his research on international law and public health, David Fidler, of Indiana University School of Law, has argued that the early sanitary conventions did not follow the established pattern of customary international law, formed "when States exhibit general and consistent State practice accompanied by opino juris."22 Legal scholars have suggested that the IHR (1969) satisfies the generality criterion because, in essence, "WHO membership represents virtually the whole international community."23 However, scholars have maintained that the "inconsistent application of the IHR24 and the lack on the part of many WHO member states of any sense of legal obligation"25 do not support the element of consistency. These concerns surrounding enforcement and customary law led to WHO's decision to revise the instrument in 2005.

The 2005 Revised International Health Regulations

In addition to concerns over the legal weight and enforceability of the IHR (1969), the World Health Assembly (WHA), WHO's principal decision-making body,26 determined that global outbreaks of diseases not specified in the original regulations and the inadequate handling of those unlisted infectious diseases required changes to the IHR (1969).27 WHO adopted a series of resolutions28 and convened an inter-governmental work group, ultimately adopting the revised International Health Regulations [hereafter referred to as "IHR (2005)"] on May 23, 2005.29 The IHR (2005) became legally binding in 2007 on States Party to the instrument without rejections or reservations.30 31

The IHR (2005) was drafted 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 risks, and which avoid unnecessary interference with traffic and trade."32 WHO has identified five notable changes to the IHR (1969) pertaining to notification, establishing national IHR focal points and points of contact, definitions of member states' basic public health capacities, recommended measures, and procedures for garnering independent advice pertaining to the IHR (2005) implementation.33

The IHR (2005) has expanded on many of the requirements of the original IHR (1969). For example, each State Party is required to provide notification within 24 hours "of all events which may constitute a public health emergency of international concern," or a PHEIC.34 The 2005 IHR includes a list of diseases that automatically constitute a PHEIC, such as smallpox or influenza with new subtypes.35

Legal scholars have cautioned that the regulations' new broad definition could provide a loophole, allowing member states "an excuse not to report specific infectious diseases."36 Another concern is whether the IHR (2005) makes allowances for the legal systems of the States Party to it. Specifically, the United States has concerns about its ability to comply without reservations because of the limitations of federalism.37 Legal scholar Lawrence Gostin has acknowledged that the greatest hope for success with the revised regulations "lies in a balanced use of hard law, making health rules binding, and soft law, creating incentives to internalize health norms."38 This balance is particularly relevant as the IHR (2005) are put into practice within the context of emerging global health concerns.

Future Applications and Implications of the IHR (2005)

The objectives of the original IHR (1969) have expanded, but the IHR (2005) shares the original's objective of maximum protection with minimum disruption.39 At the core of this objective is the enforcement power of WHO. Under the new regulations, WHO has access to outside consultation and review power.40 WHO can enter a country only upon invitation, not if it suspects a hidden epidemic.41 Former European Commissioner for Health and Consumer Protection, David Byrne, who served as a WHO Special Envoy for the drafting of the revised regulations, acknowledged that the IHR's (2005) effectiveness ultimately rests in the hard laws of the states that apply it, supporting Gostin's emphasis on the need to balance hard and soft law.

Byrne, a proponent of the IHR (2005), has recognized that the most effective recourse against a non-compliant state occurs when each member state exercises "its own sovereign powers to protect itself—by closing down travel from that location, or closing down trade...."42 Further, Byrne has noted that not all nations are WHO members,43 which could pose difficulties in garnering transparent information. Officials are concerned, for example, that managing an avian influenza outbreak might be difficult if it were to develop in a Southeast Asian nation like Myanmar, which is not a WHO member.44

According to David Fidler, the primary practical issues facing the application of the IHR (2005) are cost and funding.45 Article 5 Section 4 of the IHR (2005) requires that WHO "shall collect information regarding events through its surveillance activities and assess their potential to cause international disease spread."46 Within five years of the 2005 IHR's entry into force (which occurred on June 15, 2007), Section 1 requires the States Party "develop, strengthen, or maintain" their surveillance instruments.47 However, scholars have raised concerns about the ability, or lack thereof of poor or developing countries to comply with regulations, not for lack of intent, but for lack of resources.48 WHO has indicated that it will provide logistical and collaborative aid, but makes no reference to monetary assistance,49 which would be crucial to the developing world in the event of a disease pandemic. Byrne has maintained, however, that one of the greatest strengths of the IHR (2005) is that it promotes "international pressure" to facilitate capacity building for functions such as the infrastructure that surveillance requires.50

Another consideration in the application of the new regulations is that they allow for "the application of time-limited measures restricting international trade and travel" in the event of a health emergency of international concern,51 raising the question of whether WHO would be able to show strength at an organizational level. Byrne noted that the lack of codified sanctions does not "rob the IHR [(2005)] of its teeth,"52 maintaining that "... each individual Member State has its own sovereign power to protect itself [which] exerts pressure on everybody to play the game properly."53

Conclusion

The borders of the globe have changed since the early Sanitary Conferences that spurred the creation of the original IHR (1969), but microorganisms and pathogens continue follow "trade and travel" and new borders remain permeable to disease.54 Consequently, now that the IHR (2005) has entered into force it is important to look to the instrument's history as well as its future use to appreciate its current application as a legal mechanism to address global disease.

1 World Health Organization [WHO], Frequently Asked Questions about the International Health Regulations, http://www.who.int/csr/ihr/howtheywork/faq/en/print.html (last visited November 14, 2007).
2 WHO, Entry Into Force of the IHR (2005): Are you Prepared?, http://www.who.int/csr/ihr/prepare/en/index.html (last visited November 14, 2007).
3 WHO, International Health Regulations Revision Project, Global Crisis-Global Solutions: Managing Public Health Emergencies of International Concern through the Revised International Health Regulations, WHO/CDS/CSR/GAR/2002.4, 1-18, at 1-2 (2002).
4 Id., at 1.
5 Alexandra Minna Stern & Howard Merkel, International Efforts to Control Infectious Disease, 1851 to the Present, 292, 1475, 1474-1479, JAMA (2004).
6 Id.
7 WHO's constitution is accessible from: http://whqlibdoc.who.int/hist/official_records/constitution.pdf (last visited November 15, 2007).
8 Id.
9 Id.
10 The World Health Organization defined health "not just as the amelioration of disease but also, more positively and profoundly, as the promotion of the universal physical, mental, and social well being."
11 The UN which recognized the importance of health to the objectives of security and peace.
12 Id.
13 Id.
14 WHO, Global Crisis-Global Solutions, WHO/CDS/CSR/GAR/2002.4 at 2.
15 Id.
16 WHO, Frequently Asked Questions about the International Health Regulations, http://www.who.int/csr/ihr/howtheywork/faq/en/print.html (last visited November 15, 2007).
17 The initial draft included cholera, plague, yellow fever, smallpox, relapsing fever, and typhus, but the final IHR (1969) listed only cholera, plague, and yellow fever as notifiable diseases. IHR (1969) accessible from: http://www.who.int/csr/ihr/ihr1969.pdf (last visited November 16, 2007).
18 Id. and Lawrence O. Gostin, International Infectious Disease Law: Revision of the World Health Organization's International Health Regulations, 291, JAMA, 2623-2627, at 2624.
19 E.g., not requiring certificates for HIV and other non-listed diseases or failing to report diseases promptly to the WHO.
20 Id.
21 Id at 288.
22 David P. Fidler, International Law and Infectious Diseases, 98-99, 104 Clarendon Press (1999). (Fidler defines opino juris as the legal obligation to "general and consistent state practice.")
23 Id. at 100.
24 See Lawrence O. Gostin, International Infectious Disease Law: Revision of the World Health Organization's International Health Regulations, 291, JAMA, 2623-2627, at 2624 (2004). (The examples often cited for inconsistent application is the varied treatment of "cholera in Peru, plague in India, and Ebola hemorrhagic fever in Zaire" in terms of reporting standards.)
25 See Gostin, International Infectious Disease Law: Revision of the World Health Organization's International Health Regulations, 291, JAMA, 2623-2627, at 2626. (This is particularly evidenced in the responses of both China and Canada in the wake of SARS outbreaks in their respective countries, when "China delayed notification to the WHO, and Ontario Canada, resisted WHO travel advisories.")
2 6 Alexandra Minna Stern & Howard Merkel, International Efforts to Control Infectious Disease, at 1477, JAMA (2004).
27 Gostin, International Infectious Disease Law: Revision of the World Health Organization's International Health Regulations, 291, JAMA, 2623-2627, at 2624 (2004).
28 World Health Assembly [WHA] 54.14: Global Health Security Epidemic Alert and Response in 2001 and resolution WHA 56.28: Revision of the International Health Regulations.
29 WHO, Frequently Asked Questions about the International Health Regulations, http://www.who.int/csr/ihr/howtheywork/faq/en/print.html (last visited October 15, 2007).
30 In the context of international law, Black's Law Dictionary defines a reservation to an international treaty as, "the establishment of a limiting condition or qualification...upon [a nation's] signing or ratifying a treaty, that its willingness to become a party to the treaty is conditioned on certain additional terms that will limit the effect of the treaty in some way." Black's Law Dictionary, 607 (Second Pocket Edition, 2001).
31 Id.
32 WHA, Revision of the International Health Regulations, WHA58.3, 1-60 at 9 (23 May 2005).
33 WHO, Frequently Asked Questions about the International Health Regulations, http://www.who.int/csr/ihr/howtheywork/faq/en/print.html (last visited October 15, 2005); WHA, Revision of the International Health Regulations, WHA58.3, 1-60 (23 May 2005).
34 WHA, Revision of the International Health Regulations, WHA58.3, at 11 (2005).
35 WHA, Revision of the International Health Regulations, WHA58.3, at See also, Michael G. Baker & David P. Fidler, Global Public Health Surveillance und New International Health Regulations, 12(7), Emerging Infectious Disease, 1058-1065, at 1059 (describing diseases requiring identification and the assessment instrument model).
36 Lawrence O. Gostin, The International Health Regulation and Beyond, 4, The Lancet, 606-607, at 606 (2004).
37 Michael G. Baker & David P. Fidler, Global Public Health Surveillance und New International Health Regulations, 12(7), Emerging Infectious Disease, 1058-1065, at 1063.
38 Gostin, International Infectious Disease Law: Revision of the World Health Organization's International Health Regulations, 291, JAMA, 2623-2627, at 2627.
39 WHA, Revision of the International Health Regulations, WHA58.3, 1-60 at 9 (23 May 2005).
40 Id.
41 Mary Ann Liebert & David Byrne, Profile: Interview with David Byrne: WHO Special Envoy on the Revision of the International Health Regulation, and Former European Commissioner for Health and Consumer Protection, 3, Biosecurity and Bioterrorism, 193 -197, at 195 (2005).
42 Id.
43 Id.
44 Id.
45 Laurie Garrett, a public health scholar and Senior Fellow for Global Health at the Council on Foreign Relations, notes in her work on avian flu- that the WHO budget in 2005 was $400 million, of which only a portion is allocated for an influenza response. (Garrett provides the annual budget of the New York City health department, over $1.2 billion, as a point of comparison.) Laurie Garrett, The Next Pandemic, 84, Foreign Affairs, 3-23, at 22 (2005).
46 WHA, Revision of the International Health Regulations, WHA58.3, 1-60 at 11 (23 May 2005).
47 Id.
48 Gostin, International Infectious Disease Law: Revision of the World Health Organization's International Health Regulations, 291, JAMA, 2623-2627, at 2627.
49 WHO, Frequently Asked Questions about the International Health Regulations, http://www.who.int/csr/ihr/howtheywork/faq/en/print.html (last visited October 15, 2005); World Health Assembly.
50 Liebert & Byrne, Profile, Biosecurity and Bioterrorism, at 195.
51 WHO, Frequently Asked Questions about the International Health Regulations, http://www.who.int/csr/ihr/howtheywork/faq/en/print.html (last visited October 15, 2005).
52 Liebert & Byrne, Profile, Biosecurity and Bioterrorism, at 195 (2005).
53 Id.
54 Stern & Merkel, International Efforts to Control Infectious Disease, at 1477, JAMA (2004).