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COPYRIGHT 2005 Health Law Institute
I. Introduction
Occurring against the backdrop of severe acute respiratory syndrome (SARS), avian influenza and fears of a global influenza pandemic, the revision of the International Health Regulations (IHR or Regulations) is one of the most significant developments in international health law in recent years. The previous Regulations, outdated and notoriously ineffective, have been comprehensively revised, providing a new legal framework for global infectious disease surveillance and control. In May 2005, the World Health Assembly adopted the revised IHR, which will be binding on WHO member states when they come into force in 2007. With major changes to the Regulations' scope, states' obligations, and the powers and duties of the World Health Organization (WHO), the revised IHR represent a landmark in the international legal framework relating to health. It has even been suggested that the revision can be seen as part of a transition to a new era in global health governance. (1)
One important change involves the way in which the revised IHR purport to govern or limit public health measures taken by individual states. The previous Regulations prescribed specific measures to be taken in response to diseases within their scope, and prohibited additional or "excessive" measures. The aim of this restriction was to achieve the main purpose of the IHR, "to ensure the maximum security against the international spread of diseases with a minimum interference with world traffic." (2) This objective remains important, but the means of achieving it have been dramatically changed. This difference and its implications are the main focus of this article. After reviewing the IHR and their revision, it will discuss the old and new approaches to restricting states' public health measures and balancing maximum security against minimum interference. The revisions to the relevant articles themselves will be examined, but these must also be considered in light of changes to other parts of the Regulations and the evolving global context, and in terms of the change they represent for the role of the IHR and their relationship with the rest of international law.
II. The International Health Regulations and their revision
A. The International Health Regulations (1969)
The IHR have long been, and remain, the only binding international legal instrument on global disease surveillance and control. They were adopted under the authority of the WHO Constitution, Article 21 of which provides that the World Health Assembly, the highest decision-making body of the WHO, may adopt regulations on matters including "sanitary and quarantine requirements and other procedures designed to prevent the international spread of disease". (3) According to Article 22 of the same instrument, such regulations are binding on WHO member states unless they advise the Director-General of their rejection or reservation. The IHR (1969) had earlier precursors: a series of International Sanitary Conventions adopted in the second half of the 19th century, later consolidated into the 1951 International Sanitary Regulations, renamed the International Health Regulations in 1969. (4) These Regulations, with only a few minor changes, have remained in place despite widespread and profound changes in the global environment relating to infectious diseases.
Like the earlier conventions upon which they were based, the IHR (1969) deal only with a limited set of specific diseases: plague, cholera and yellow fever. (5) In respect of those diseases, they require states to notify the WHO of any case of the disease within their territory (Article 3). The WHO must also be provided with further information during an epidemic (Article 6) and must be notified of measures taken by each state with respect to arrivals from infected areas and vaccination requirements (Article 8). This information is then to be shared by the WHO with the health administrations of all other member states (Article 11). With respect to each of the three diseases, the Regulations set out measures to be taken by states to prevent the spread of the disease (Part V, Chapters I, II, and III). Part III prescribes minimum standards for sanitation and public health facilities at air and sea ports. (6) Other provisions prescribe mandatory and permitted health measures, including restrictions to be imposed on inbound and outbound international travel or movement of goods (Part IV) and health certificate requirements (Part VI). Article 23 provides that the permitted measures are the maximum measures to be applied, and the application of certain measures or of measures in certain circumstances is specifically prohibited.
Although they were considered to be a "significant advance" at the time of their adoption, (7) the IHR proved to be of limited effectiveness. Several key weaknesses were perceived, as much within the WHO itself as by external critics. (8) First, the limited scope of the Regulations means that they have been of little or no relevance in most of the major contemporary global public health crises: responses to the HIV/AIDS pandemic, the SARS epidemic and the threat of an influenza pandemic have all fallen outside the scope of the IHR provisions. Second, the record of states' compliance with the IHR has been poor, both with respect to notifying the WHO of cases of diseases subject to the Regulations and in their application of excessive health measures beyond those permitted by the IHR. This is particularly worrying in conjunction with the third major weakness, which is that the WHO is required, under the existing IHR, to rely on official state notifications, despite the increasing amount of information now available from other sources. This not only limits the Organization's ability to respond in a timely and effective manner to new outbreaks, but is out of step with recent developments in global surveillance capacity. (9)
B. Revision of the International Health Regulations
The process to revise the IHR formally began in 1995 with a resolution of the World Health Assembly requesting the preparation of revised and updated IHR. (10) Discussion and consultation progressed over the following years, during which various possible concepts and approaches were explored. (11) The experience of the SARS epidemic in 2003 and growing fears of avian influenza and the next influenza pandemic provided the catalyst for renewed efforts. Although the death toll from SARS was low relative to other global health threats, it highlighted both the strengths and weaknesses of global infectious disease surveillance and control. As the "first severe and readily transmissible new disease to emerge in the 21st century", with an incubation period long enough to allow "spread via air travel between any two cities in the world", (12) it illustrated the challenges posed by one aspect of globalization: the increase in speed and volume of international travel that can result in a faster and more unpredictable spread of infectious disease. The significance of increased global interconnectedness through information and communications technology was also demonstrated, however, as mobile phones, text messaging, email and the internet played key roles in sharing information about the disease. (13) The importance of unofficial sources of information became clear as the WHO struggled to obtain the cooperation of the Chinese government. (14)
SARS "demonstrate[d] dramatically the global havoc that can be wreaked by a newly emerging infectious disease" (15) but also the importance of effective national and international surveillance and response to the ultimate impact of a global health threat. (16) Although the response to SARS was generally considered to be a success story for the WHO and the international community, the epidemic once again drew attention to the inadequacy of the IHR, (17) which were essentially irrelevant in the case of SARS as they have been for other major health threats. Against this backdrop and with a renewed sense of urgency, work continued on the revisions in 2003 and 2004. Drafts were released for comment in January 2004, (18) September 2004 (19) and January 2005, (20) each being revised in response to consultations and submissions by member states and other international organizations. After meetings of the Intergovernmental Working Group in November 2004 and February 2005, agreement was reached on a text of the revised IHR which was subsequently adopted by the World Health Assembly in May 2005. (21)
The stated objective of the revised IHR (2005) is very similar to that of the IHR (1969), with some subtle changes in its expression: "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 international traffic and trade" (Article 2). (22) However, the means of achieving this objective have changed significantly in a number of respects.
The scope of the revised IHR is much broader and is defined differently. As seen above, the IHR (1969) apply to a short and closed list of three diseases, and this was one of the key weaknesses perceived in the IHR. Early in the revision process it was proposed that the Regulations should require reporting of "a number of defined clinical syndromes", followed by reports of specific diseases once the diagnosis was confirmed. (23) After this approach was field tested, it was concluded that it "was not appropriate for use in the context of a regulatory framework." (24) Efforts then shifted to developing "criteria to define what constitutes a health emergency of international concern" (PHEIC), (25) a concept which ultimately was adopted as the main approach to defining the scope of the IHR (2005).
The central notification requirement in Article 6 requires states to notify the WHO of "all events which may constitute a public health emergency of international concern within [their] territory". The determination of whether such an event has occurred is to be undertaken using the "decision instrument" set out in Annex 2 of the IHR (2005). Annex 2 contains an "algorithm" (flow-chart diagram) with a series of questions. For any event detected by national surveillance that is of "potential" international concern, it must be asked: (1) whether its public health impact is serious; (2) whether it is unusual or unexpected; (3) whether there is a significant risk of international spread; and (4) whether there is a significant risk of international travel or trade restrictions. If any two of these questions receive an affirmative answer, the event must be notified to WHO. The second part of Annex 2 contains a series of examples to be used in application of each of the algorithm's four criteria. In addition, the Annex contains a list of diseases to which the algorithm must always be applied, presuming that they are always potentially of international concern. (26) It also contains a further list of diseases that must always be notified, presuming that any occurrence is both unusual or unexpected and serious, and thus a PHEIC. (27)
In cases where notification is not required, states "may nevertheless keep WHO advised", consult with it "on appropriate health measures", and request assistance in assessing epidemiological evidence (Article 8). Such consultation and prompt notification are encouraged by making all information received by WHO under Articles 6 and 8 confidential in the first instance, that is, it will not be shared with other member states until a PHEIC is confirmed or unless the risk is too great. (28) This is in contrast to the IHR (1969), which require all notifications and other relevant communications automatically to be shared with other states (Article 11).
Allowing for confidential provisional notification and consultation is the first of two key changes to deal with the problem of lack of compliance with notification obligations. The second is the provision of authority for the WHO to take into account "reports from sources other than notifications or consultations" in Article 9. As noted above, a variety of unofficial sources of information have become available with developments in information and communications technology, and are of growing importance in global surveillance, but the WHO's authority to use this information has been uncertain. (29) Article 9 allows the WHO to take account of, assess, and share information received from non-governmental sources. Where such information is received, it will consult with the state concerned and attempt to obtain verification before taking any action, but the information will be shared with other states in accordance with Article 11. States have an obligation under Article 10 to verify reports from other sources of an event potentially constituting a PHEIC by sharing certain information with WHO. Where reports of a potential PHEIC are received, the WHO will offer its assistance and collaboration, and if this offer is refused will share available information with other states. These provisions are designed to decrease the risk of non-compliance with notification obligations and deal with uncooperative governments, since governments know that information reaching the WHO from other sources can be used and disseminated. In addition, the WHO is authorized to release information directly to the public, rather to governments, in some cases. (30)
Although governments must use the decision instrument to determine whether to notify the WHO of disease events, the existence of a PHEIC is ultimately determined by the Director-General, in consultation with the state concerned and in the case of disagreement, on the advice of a new body called the Emergency Committee (Article 12). The Emergency Committee's role is to give its views to the Director-General on the existence and termination of a PHEIC and on any proposed temporary recommendations (Article 48), although the final determination on these matters is made by the Director-General (Article 49(5)). Once a PHEIC has been determined to exist, the Director-General will issue temporary recommendations which may include measures to be taken by the state in which the event is occurring and/or other states "to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic" (Article 15(2)). Standing recommendations may also be issued (Article 16), after taking the advice of a Review Committee (established and governed by Part IX, Chapter III). Articles 17 and 18 set out criteria for recommendations and a (non-exhaustive) range of possible recommendations.
Another major change in the IHR (2005) is the substantial expansion of the requirements for national public health capacities. The IHR (1969) contain a limited set of prescriptions for organization, equipment, facilities, and services required at national ports and airports (Part HI). The public health capacities demanded of member states in the IHR (2005) are much more ambitious, reflecting the realization that effective surveillance and response at the national level are ultimately the key to containing outbreaks. States must designate a "National IHR Focal Point" for communication with the WHO and authorities responsible for implementation of health measures (Article 4). Article 5 requires states to "develop, strengthen and maintain" surveillance capacities as set out in Annex 1. Each state party must first assess its capacity and then meet the Annex 1 requirements within five years (with a possibility of extension), with the WHO's assistance if requested. Article 13 sets out similar requirements in respect of public health response capacities. The WHO is to publish guidelines to support the development of public health response capacities, and will offer additional assistance and collaboration in response to public health risks and any PHEIC. Requirements for authorities and capacities at points of entry are set out in Part IV. Annex 1 contains a list of "core capacity requirements for surveillance and response" and "core capacity requirements for designated airports, ports and ground crossings".
Like the IHR (1969), the revised Regulations also set out a series of health measures that states may apply to travellers and goods, such as inspection or examination, vaccination, and documentation requirements (Parts V and VI). Part VIII contains general provisions which also deal with limits on health measures and their implementation. These provisions will be the focus of discussion below.
III. Restraining "excessive" or "additional" health measures
A. Why the concern with restraining measures?
As noted above, the IHR (1969) purport to limit the measures taken to prevent the spread of disease. This is one of the crucial aspects of the regime, although it has been largely ineffective. As expressed by the WHO:
The rationale for listing the maximum measures permissible is simple: if a template is not given for protective measures to be taken by other countries in an outbreak situation, then there is great risk of overreaction, which could be damaging to the affected country. Trade, travel and tourism might well suffer, with economic consequences that extend far beyond the measures necessary from a public health point of view. (31)
It is widely recognized that the risk of such disproportionate responses and the resulting economic harm provides a strong disincentive for states to notify outbreaks and cooperate with the WHO. From this perspective, restraining excessive measures is essential to achieving the IHR objective of "maximum security against the international spread of diseases with a minimum interference with world traffic". The two principles of "maximum security" and "minimum interference" are complementary, "[i]n theory ... integrated to form the overall international legal regime on infectious disease control". (32)
Concern with the economic impact of health measures is far from new. During the "Black Death" plague epidemics in medieval Europe, when quarantine measures began to be systematically applied to travellers and goods, "[o]nce cases of plague began to appear, local health authorities went to great lengths to play down its significance as long as possible to prevent the economic disaster that emergency health measures inflicted on a community"--this despite explicit recognition of "the reciprocal value of the free exchange of information". (33) Later, the nineteenth-century efforts to create an international regime dealing with infectious diseases are said to have been motivated primarily by concerns about the impact of quarantine measures on international trade. (34) In the transition from these precursor sanitary conventions to the IHR, the desire to minimize interference with trade continued to be a key objective.
The IHR (1969) attempt to restrain states' health measures, but they have generally failed to do so, due in part to a pattern of widespread non-compliance with the restrictions. (35) There have been many examples of measures being imposed and maintained despite being disproportionate to the risk or even entirely lacking scientific justification. (36) Among the most notorious examples is the international response to an outbreak of cholera in Peru in 1991. Despite clear statements from the WHO and the United States Centers for Disease Control (CDC) that there was no basis for travel or trade restrictions, the European Community (EC) and others began imposing import bans on fish and other perishable foods within weeks of the outbreak. Inspection requirements and other measures well in excess of WHO guidelines were also imposed; travellers from Peru were restricted or refused entry in some countries. Peru estimated trade losses for 1991 at over US$770 million. (37) Similarly, during a later cholera outbreak in East Africa, imports of fish from affected countries were banned by the EC, again despite WHO statements that this was not an appropriate response. (38) In 1994, a suspected outbreak of plague in Surat, India, was reported (formally to the WHO as well as in media reports). Local measures were immediately taken, there was no evidence of transmission to nor any confirmed cases in other cities, and the outbreak was declared over in a little more than a month. However, other countries responded with cancellation of flights, closing of borders to both goods and people, travel advisories, and even in some cases restrictions on Indian nationals residing abroad. Again in this case the WHO had advised that no travel or trade restrictions were appropriate, and in the same year other countries had reported larger numbers of plague cases without any measures being imposed. The estimated cost to the Indian economy was over US$2 billion. (39) Many other examples of disproportionate responses could be cited, including some trade bans based on risks of bovine spongiform encephalopathy (BSE) (40) or more recently avian influenza, (41) and entry restrictions imposed on individuals with HIV/AIDS. (42)
Although it is clear that excessive measures have been a major concern historically, one might ask whether this concern is still relevant in the current context and whether it is one that should be directly addressed by the revised IHR. There appear to be two main arguments to the contrary. The first is that the issue of compliance with notification obligations can be addressed in other ways, so we need not worry about restrictive measures as a disincentive to...
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