American Journal of Law & Medicine

Ebola Again Shows the International Health Regulations Are Broken: What Can Be Done Differently to Prepare for the Next Epidemic?

Epidemics are among the greatest threats to humanity, and the International Health Regulations are the world's key legal instrument for addressing this threat. Since their revision in 2005, the IHR have faced two big tests: the 2009 H1N1 influenza pandemic and the 2014 Ebola epidemic in West Africa. Both exposed major shortcomings of the IHR, and both offered profound lessons for the future.

The objective of this Article is twofold. First, we seek to compare the lessons learned from HIN1 and Ebola for reforming the IHR in order to test the hypothesis that they are similar. Second, we seek to examine the barriers to implementing these lessons and to identify' strategies for overcoming those barriers.

We find that the lessons from H1N1 and Ebola are indeed similar, and that opportunities to act on lessons from HINI were woefully missed. We identify many political barriers to global collective action and implementation of lessons for the IHR. On that basis, we describe strategies to overcome these barriers, which will hopefully be deployed now to reform the IHR before the policy window following Ebola closes, and before the inevitable next epidemic comes. The emerging threat of the Zika virus underscores that we have no time to waste.

  I. INTRODUCTION
 II. THE INTERNATIONAL HEALTH REGULATIONS
     A. HISTORY
     B. STRUCTURE AND CONTENT
        1. NATIONAL PUBLIC HEALTH CAPACITIES
        2. NOTIFICATION AND SHARING OF INFORMATION
        3. THE WHO'S ASSESSMENT, DECLARATIONS, AND RECOMMENDATIONS
        4. PERMISSIBLE HEALTH MEASURES
III. THE H1N1 AND EBOLA OUTBREAKS
     A. THE 2009 H1N1 PANDEMIC
     B. THE 2014 EBOLA EPIDEMIC
 IV. LESSONS FROM HINI AND EBOLA FOR THE IHR
     A. COUNTRIES' PUBLIC HEALTH CAPACITIES
     B. NOTIFICATION AND INFORMATION SHARING
     C. WHO'S ASSESSMENT, DECLARATIONS, AND RECOMMENDATIONS
     D. PERMISSIBLE HEALTH MEASURES
  V. THE POLITICS OF INACTION
     A. ACTOR POWER
     B. IDEAS
     C. POLITICAL CONTEXTS
     D. ISSUE CHARACTERISTICS
 VI. CONCLUSION AND STRATEGIES FOR OVERCOMING INACTION

I. INTRODUCTION

Infectious disease outbreaks are among the greatest threats to humanity. (1) Dramatic changes in livestock and agricultural production, population density, mobility, and human-animal interaction are increasing the risk of large-scale epidemics and pandemics. (2) Experts have suggested there is a one percent chance for a severe global pandemic to occur in any given year. (3) This risk is linked to potentially catastrophic consequences. The 1918 influenza pandemic, for example, killed fifty to one hundred million people and caused widespread social and economic disruption. (4) It has been estimated that under today's circumstances, a flu pandemic could cut world economic activity by almost five percent (5) and that the annual expected loss from potential pandemics is more than sixty billion USD. (6) All this makes insurers now see pandemics as the top extreme risk to their industry, above economic depression and terrorism. (7)

Fortunately, the world has the International Health Regulations ("IHR"). (8) Revised in 2005, this legally-binding international treaty provides a framework for preventing the cross-border spread of disease. It has the potential to mobilize collective action for reducing the risk of large-scale disease outbreaks and the impact of those that do occur. Yet, the two big tests of the revised IHR have questioned the extent to which this potential has been realized. After the 2009 H1N1 influenza pandemic, it was widely agreed that the IHR had major weaknesses and needed to be strengthened. (9) Now, following the 2014 Ebola epidemic in West Africa, the situation appears very much the same. Again, it seems there is widespread agreement that the IHR suffers from several major shortcomings and that transformative changes are needed. (10) This may all sound reasonable, but there is concern that the lessons from Ebola are similar to the lessons from H1N1, such that we have failed to act on what was previously learned and are now merely restating old lessons. This suggests that to achieve real change, we need to take lessons one step further and ask about the implementation of the lessons themselves; about the political barriers to action and the strategies needed to overcome them. The emerging threat of the Zika virus underscores that we have no time to waste."

The objective of this Article is twofold. First, we seek to compare the lessons from H1N1 and Ebola head on, in order to test the hypothesis that the lessons are similar and to examine the most important similarities and differences. Second, we seek to examine the barriers to implementing these lessons and to identify strategies for overcoming the barriers and effectively implementing IHR reform proposals. Parts II and III introduce the IHR and the H1N1 and Ebola outbreaks, respectively. Part IV analyzes the operation of the IHR during those outbreaks and the lessons learned from each. Part V examines the barriers to implementing lessons learned, and the final section concludes with strategies to overcome them.

II. THE INTERNATIONAL HEALTH REGULATIONS

A. History

The current IHR has a long pedigree. Travel and trade measures to stop the spread of infectious diseases were imposed as early as in the fourteenth century. (12) At that time, the city of Dubrovnik (then known as Ragusa) required ships coming from infected, or suspected to be infected, sites to stay at anchor for thirty days before docking. (13) The isolation period for land travellers was 40 days, corresponding to the term "quarantine." (14)

More coordinated efforts to stem the international spread of disease began in the mid-1800s, chiefly in the form of international sanitary conferences, with the first one taking place in Paris in 1851. (15) These conferences were held mainly out of fear that diseases from Asia and the Middle East would spread to Europe and North America. (16) Over the next 100 years, several international sanitary conventions were adopted and became part of international law. (17) International institutions were also established, including the Pan-American Sanitary Bureau (1902) and l'Office International d'Hygiene Publique (1907). (18) These agreements and institutions were part of what has been called the "classical regime" governing global disease outbreaks. (19) This regime had two basic components: (1) obligations on state parties to "notify each other about outbreaks of specified infectious diseases in their territories"; and (2) obligations to "limit disease-prevention measures that restricted international travel and trade to those based on scientific evidence and public health principles." (20)

After the establishment of the World Health Organization ("WHO") in 1948, it took only three years before its plenary governing body--the World Health Assembly--adopted the International Sanitary Regulations ("ISR"). (21) The ISR were established under the authority of Articles 21 and 22 of the WHO constitution, which allowed the WHO to make regulations on "sanitary and quarantine requirements and other procedures designed to prevent the international spread of disease." (22) The 1951 ISR brought together the pre-existing twelve conventions and related agreements into one binding legal framework overseen by the WHO. (23) In 1969, the ISR changed its name to the International Health Regulations (24) and was narrowed in scope from six to four diseases; a scope that was further narrowed in 1981 to only include cholera, plague, and yellow fever. (25) In the period from 1951 to the outbreak of severe acute respiratory syndrome ("SARS") in 2002, the classical regime became "marginalized" and limitations of the ISR/IHR became increasingly evident. (26) One obvious shortcoming was the exclusive emphasis on three diseases. (27) Another was the lack of accountability and enforcement mechanisms to promote states' compliance with the Regulations. (28) It was also a problem that the IHR only allowed the WHO to act on epidemiological evidence provided by its member states rather than independent scientists, research centers, civil society organizations, or news media. (29)

Ever increasing appreciation of these limitations led the World Health Assembly to formally initiate an IHR revision process in 1995. (30) This decision was motivated by the 1994 plague outbreak in India; the 1995 Ebola outbreak in what was formerly Zaire; and, more fundamentally, an increasing sensitivity to the transnational risks arising from the greater interconnectedness of globalization and to the link between infectious diseases and national security. (31)

Even so, the IHR revision process moved slowly for a long time. It had lasted seven years when an unusual form of respiratory illness started to emerge in the Guangdong Province of China in November, 2002. (32) This was the beginning of the SARS outbreak; an outbreak widely seen as the trigger of the final push towards the most recent IHR reforms. (33) The SARS outbreak demonstrated to the world the many shortcomings of the old IHR. (34) In particular, SARS was not caused by any of the three pathogens covered by the IHR, (35) and it took months before the full scale of the outbreak was acknowledged because the Chinese government initially refused to cooperate with the WHO. (36)

The new IHR were eventually adopted by the World Health Assembly in 2005. Five key shortcomings of the 1969 IHR had then been addressed. First, the scope of the IHR had been expanded from the three pathogens to cover the broader terms of "event," "public health risk," and "public health emergency of international concern" ("PHEIC"). (37) Second, the new IHR came with obligations on state parties to develop minimum core public health capacities. (38) Third, the new IHR allowed the WHO to access and use information from non-governmental sources. (39) Fourth, the WHO Director-General was authorized to declare PHEICs and to issue recommendations on how state parties are to address such emergencies. (40) And finally, the new IHR explicitly required States to respect human rights in their implementation of the Regulations. (41)

The IHR entered into force on June 15, 2007, for the 191 states that had not made reservations to them. As of February 2016, there were 196 state parties to the IHR, including all WHO member states. (42)

B. Structure and Content

The purpose of the IHR is 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." (43) Simply put, the aim is to maximize protection against public health risks while minimizing interference with travel and trade. The components of the IHR can be categorized in several ways. (44) What follows is a simple categorization that is roughly aligned with the chain of events in the case of a PHEIC.

1. National Public Health Capacities

The IHR require state parties to develop, strengthen, and maintain two types of national public health capacities. One is core capacities to detect, notify, and report events. (45) The other is core capacities to respond promptly and effectively to public health risks and PHEICs. (46) These capacities cover a wide range of surveillance, preparedness, and response activities, such as mapping of potential hazards, stockpiling medicines, and establishment of adequate laboratory services. (47)

Under the new IHR, state parties are required to report on their implementation of the IHR to the World Health Assembly, (48) and the Assembly decided in 2008 that this should be done on a yearly basis. (49)

Although the IHR entered into force in 2007, state parties did not have to meet the public health capacity requirements until 2012. (50) The parties could also request two extensions of two years. (51) While the IHR urge state parties to collaborate and provide technical and financial support, (52) they do not specify any enforceable obligations to do so or provide for any pooled financing mechanism to facilitate this kind of support.

2. Notification and Sharing of Information

The IHR require state parties to notify the WHO of all events that may constitute a PHEIC within its territory. (53) A PHEIC is defined as an extraordinary event that is determined to both constitute a "public health risk to other States through the international spread of disease," and "to potentially require a coordinated international response." (54) An "event," more generally, is defined as a "manifestation of disease or an occurrence that creates a potential for disease." (55)

The IHR provide state parties with a decision instrument for assessing whether an event may constitute a PHEIC. (56) Central to this instrument are four questions: (1) is the public health impact of the event serious?; (2) is the event unusual or unexpected?; (3) is there a significant risk of international spread?; and (4) is there a significant risk of international travel and trade restrictions? If a state party identifies an event that may constitute a PHEIC, the State must notify the WHO within twenty-four hours. (57) Moreover, if a state party has evidence of such an event, it is required to provide the WHO with "all relevant public health information." (58)

State parties are also obligated to respond to requests from the WHO seeking to verify the existence of an event that may constitute a PHEIC. (59) Beyond these obligations, the IHR provide an explicit option for consultations between a state party and the WHO in the case of events occurring within its territory that do not require notification. (60)

3. The WHO's Assessment, Declarations, and Recommendations

According to the IHR. the WHO should verify and assess notifications and other relevant information. (61) The WHO is supposed to primarily act in collaboration with state parties in whose territory the event is occurring. (62)

A new feature of the 2005 IHR is that the WHO may consider information from sources other than state notifications or consultations. (63) This means that the WHO can access and use information from non-governmental sources, including health workers, civil society organizations, and news media. In these cases, the IHR requires that the WHO request verification from the state party in whose territory the event is allegedly occurring. (64) The WHO cannot act on any non-governmental information before it has tried to obtain such verification.

The IHR also authorize the WHO Director-General to declare a PHEIC. (65) Before doing so, the Director-General must consult with the state party in whose territory the event arises (66) and obtain the advice of an Emergency Committee, (67) which is a temporary committee of experts established by the Director-General.

For situations in which a PHEIC has been declared, the IHR give the WHO's Director-General the power to issue temporary recommendations. (68) These recommendations may include health measures to be implemented by the state party in whose territory the event is occurring, or by other parties. (69) An equally important class of recommendations includes those advising against specific health measures. (70)

4. Permissible Health Measures

The IHR impose a range of limitations on the health measures state parties can implement. (71) These constraints are primarily motivated by concerns for travel, trade, and human rights. With regard to travelers, state parties cannot generally require invasive medical examination, vaccination, or other prophylaxis as a condition of entry, (72) and state parties are required to respect travelers' dignity, human rights, and fundamental freedoms. (73) In addition, the IHR require that any health measures be applied in a "transparent and non-discriminatory manner." (74)

The IHR also impose restrictions on the "additional health measures" state parties can pursue. (75) For these measures to be permitted, they must meet a number of conditions specified in Article 43. In particular, the additional measures are not to be more restrictive of international traffic nor more invasive or intrusive to persons than reasonably available alternatives that would achieve the appropriate level of health protection. The IHR require state parties to base their determination of whether to implement additional health measures upon scientific principles, available evidence and information, and specific guidance or advice from the WHO. (76) A state party implementing an additional measure that significantly interferes with international traffic is required to inform the WHO within forty-eight hours of implementation about this measure and its health rationale, unless covered by a temporary or standing recommendation. (77) The WHO may then request that the state party concerned reconsider the application of the measure, (78) and any state party impacted by an additional measure may request consultation with the implementing state party. (79) However, there are no strong enforcement mechanisms compelling states to actually do so.

III. THE H1N1 AND EBOLA OUTBREAKS

The 2009 H1N1 pandemic was the first influenza pandemic of the twenty-first century and the first major test for the new IHR. The second big test came in 2014, with the largest Ebola outbreak ever recorded. This outbreak is technically not considered a pandemic, as nearly all cases originated in one region of the world.

A. THE 2009 HINI PANDEMIC

In February and early March 2009, the first cases of what was to become the 2009 H1N1 pandemic appeared in Mexico. (80) In mid-March, Mexican authorities detected an unusual increase in the number of cases of influenza-like illness, (81) and in early April, enhanced surveillance detected an emerging outbreak in the village of La Gloria, Veracruz. (82) The Pan American Health Organization's ("PAHO") surveillance system identified the associated increase in media attention surrounding the outbreak and requested further information from Mexico's National IHR Focal Point. (83) In response, the Focal Point completed a risk assessment using the IHR decision instrument and "reported that [the La Gloria event] might constitute a Public Health Emergency of International Concern." (84)

By this time, the virus had already spread outside Mexico. (85) On April 23, it was confirmed that viruses found in Mexico and California were "genetically identical," and the Mexican authorities immediately reported this information to the WHO. (86) A WHO Emergency Committee convened for the first time on April 25, and later that day, Dr. Margaret Chan, WHO's Director-General, declared a PHEIC. (87)

The virus continued to spread within Mexico, the United States, and beyond. On June 11, 2009, Dr. Chan declared that an influenza pandemic was underway. (88) Over the next year, more than 214 countries and territories reported laboratory-confirmed cases of H1N1. (89) Finally, on August 10, 2010, Dr. Chan announced that the world was moving into H1N1's post-pandemic period. (90) Estimates of total H1N1 cases globally range from several tens of millions to 200 million. (91) While there were around 18,500 laboratory-confirmed deaths worldwide, modeling has suggested overall mortality of more than fifteen times that figure. (92)

B. THE 2014 EBOLA EPIDEMIC

The 2014 Ebola epidemic in West Africa began with a toddler in the remote village of Meliandou in Guinea. (93) The boy developed a fever on December 26, 2013, and died a few days later. (94) For nearly three months, the virus spread as a mysterious disease. (95) While local health officials at first suspected cholera, microscopic examination of patient samples concluded that the unknown disease was different. (96) Further investigations were conducted by the Guinean Ministry of Health, Medecins Sans Frontieres ("MSF"), and the WHO. (97) Eventually, the diagnosis of Ebola was confirmed by the Institut Pasteur in France on March 22, 2014. (98) The Guinean government notified the WHO the same day, and the WHO publicly announced the outbreak the day after. (99)

In the following months, the virus spread throughout Guinea, Liberia, and Sierra Leone--the three countries that would become most affected. (100) In this period, there were numerous warnings from early responders. MSF stated in late March that the outbreak was "unprecedented" with a spread "never before seen. …

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