The PHEIC mechanism is a tool designed to alert the globe to a new or spreading health emergency that may pose a concern to international travel and trade, and for which an internationally coordinated response may be required. In this chapter, we describe the roles of actors and process for declaring a PHEIC, providing clear and separate roles for state parties, the WHO DG, and the EC. In doing so, we lay out two of the central claims of this book. First, that the criteria to declare a PHEIC have been subject to broad interpretation by the EC beyond the legal text and mandate. Second, and linked to the first claim, that the EC is taking into account political considerations in decision making, a prerogative reserved for the DG, and in turn the DG has allowed this to occur. In the concluding section of this chapter, we outline the implications these two claims have on the good governance and legitimacy of the IHR and WHO.

Role of states that are party to the IHR

State obligations in respect of the PHEIC declaration are made up of two interlocking components: first, strengthening the national health system to be able to detect and assess emerging health threats rapidly; and second, making timely notifications to the WHO regarding potential PHEIC events. Under the IHR, state capacity becomes an issue of legitimate international concern, outlined at Articles 5 and 13, as well as Annex 1, and must correspondingly ‘generate accountability and responsibility akin to those arising from erga omnes obligations’. Adherence to these articles has been measured initially by voluntary self-reporting of compliance and subsequently through a Joint External Evaluation (JEE) of states’ capacities, a voluntary peer-review process of states’ current health emergencies infrastructure, although many states have yet to undergo this process.

The second duty of states that are party to the IHR is the actual reporting of events that may constitute a PHEIC. Article 6 raises the obligation for states to assess health events using the decision-making instrument found at Annex 2 (see Figure 2.1) of the IHR and to provide relevant notification to the WHO regarding a potential or actual health emergency within their territory, furnishing the WHO with accurate and timely information in an ongoing manner, following the initial notification of an event.

The PHEIC mechanism has been fraught with tension since it was first introduced in 2005, with the revisions to the IHR. As this book has shown, the declaration process and decision making underpinning a declaration are the source of many of the inconsistencies regarding the PHEIC.

In the wake of COVID-19, and the widespread failures of the global health architecture to manage disease transmission, many elements of the system will come under review, and likely reform. While it is too early to know the outcomes of such processes, it is likely that the IHR will be revised in some format in the coming years, or be replaced by, or replicate, a similar mechanism through the proposed ‘pandemic treaty’. We write this book to inform such discussions and demonstrate the need to ensure that any power bestowed upon the DG is exercised in a reasonable and proportional manner. In doing so we highlight the following arguments.

First, the PHEIC criteria, as laid out in the IHR, have been inconsistently applied by the DG and the EC throughout the history of PHEIC declarations and non-declarations. To this end, there have been PHEICs declared that do not appear to meet the objective criteria found at Article 1 (and nor did the EC describe these as such). Equally, there have been other events whereby the criteria appear to have been met, but no EC was convened by the DG, or an EC was called, and a PHEIC was not declared. Notably, while the convening of an EC remains the decision of the DG, the decision about declaring a PHEIC or not appears to be in practice at the discretion of the EC, rather than the DG simply taking advice from the EC. The role of the EC has thus grown in prominence, and through increased technocratization, the EC has been able to bolster its role within the IHR and governance of health emergencies, affording itself the option to consider social, economic and political interferences in the strict criteria for the PHEIC process.Indeed, as the PHEIC process has developed over successive outbreaks, it appears that there has been greater consideration of factors beyond the treaty criteria and, through continual use of such justifications for the PHEIC declaration the EC has been further empowered to depart from the three criteria for which it is allowed to advise the DG to declare a PHEIC:

International Sanitary Conferences

Modern-day international cooperation for the control of infectious disease began in 1851 with the first International Sanitary Conference (ISC). In these meetings, ten European (city) states and Turkey gathered to map out coordinated guidelines to minimize the effects of disease along trade routes, spurred on by a series of cholera outbreaks in the 18th and 19th centuries, which had devastated port cities. Importantly, their mandate was to establish mechanisms to reduce disease spread, and to do so with minimal interference with international trade – a balancing act that remains at the very heart of the current IHR. Conferences continued for almost a century, expanding membership of participating states, and topics covered. While the ISCs were progressive in respect to recognizing the need for international cooperation, they were hampered by the inability to agree to terms, and indeed differences in opinion about understanding disease transmission. This limited efforts to create common processes for outbreak response; a tension that continues to blight cooperation for health security 170 years later. Despite these setbacks, ISCs did identify key tools for international infectious disease control: the standardization of quarantine at points of entry; the reporting of outbreaks internationally; and public health capacities to respond to an epidemic. By the early 20th century, international health cooperation led to the development of intergovernmental organizations for health: the Office International d’Hygiène Publique (OHIP), the Health Organization of the League of Nations and the International Sanitary Bureau, the precursor to the Pan American Health Organization (PAHO).

Such international cooperation greatly expanded in the wake of the Second World War with the creation of the WHO, a key pillar of the post-war multilateral system. As part of this mandate, the World Health Assembly (WHA) (the legislative arm of the WHO) was granted the authority to adopt regulations concerning sanitary and quarantine requirements to prevent the international spread of disease. Such activity is structurally aligned to the Constitutional Functions of the Organization, which state that the WHO will ‘establish and maintain administrative and technical services as may be required including epidemiological and statistical services … and to stimulate work to eradicate epidemic, endemic and other diseases’.

On 30 January 2020, Dr Tedros Adhanom Ghebreyesus, Director General (DG) of the World Health Organization (WHO) declared the novel coronavirus outbreak (COVID-19) to be a Public Health Emergency of International Concern (PHEIC), using his authority derived from the International Health Regulations (IHR) (2005). The IHR are the singular binding legal treaty governing global health security. In his press conference, he stated:

He continued:

This statement helpfully highlights the key tensions within the PHEIC mechanism: is the PHEIC a tool of international law to be enacted whenever the objective criteria are met, or a political, normative device within the securitization of health to get governments to pay attention to a health emergency, or does the PHEIC fall ambiguously between the two? COVID-19 was declared a PHEIC on the recommendation of the IHR Emergency Committee (EC), advice accepted by the DG, which believed: that the outbreak was unusual or unprecedented; that it posed a public health risk to other states through the international spread of disease; and that it might require a coordinated international response. These are the three criteria for a PHEIC, as prescribed at Article 1 of the IHR.

Yet, beyond a legal instrument, DG Tedros recognized the extent of the normative power within the PHEIC mechanism. A week prior, DG Tedros had (upon the advice of the EC) delayed declaring COVID-19 a PHEIC, despite it appearing that the criteria to do so were met.

To date there have been six PHEIC declarations, as well as several other health emergencies that have been considered as potential PHEICs. These non-PHEIC events fall into two distinct categories: those considered by an EC, but not declared a PHEIC; and those for which an EC was never convened, but which objectively met the criteria for declaration. In this chapter we examine each of the health emergencies declared a PHEIC in turn, followed by the non-PHEIC events. In doing so we explore how the criteria to declare a PHEIC have been understood and applied by the DG and the EC, as well as the wider considerations that each of these actors might have taken into consideration when fulfilling their functions in respect of a PHEIC under the IHR. In doing so, we demonstrate the overarching findings of this book: that the criteria to declare a PHEIC have been subject to broad interpretation by the EC beyond the legal text, which have been subsequently improperly validated by the DG in accepting the advice of EC. We structure each section first with a background to the context of the health emergency, second with detailed analysis of the apparent PHEIC decision making, third with consideration of the TRs recommended, and finally with analysis of the additional lessons learned about the broader PHEIC, IHR process and global health security. In the analysis we centre on the initial declaration of the PHEIC, and only consider later EC meetings for each disease outbreak if they are a noteworthy change in advice provided or justification.

2009-H1N1

The United States (US) first reported cases of 2009-H1N1, a novel influenza virus with human pandemic potential, on 18 April 2009. By the end of April 2009, more than 1,300 suspect cases and approximately 84 deaths were attributed to the outbreak. Under Annex 2 of the IHR, notification by states to the WHO must occur if there is a positive response to two of four criteria, or if a health emergency is caused by poliomyelitis, smallpox, human influenza caused by a new subtype or SARS. In response to this notification, on 25 April the DG convened an EC, which recommended 2009-H1N1 to be declared the first PHEIC under the revised IHR.

Further to the case studies in the previous chapter, we also sought to understand whether the same inconsistencies were present in outbreaks that were not declared a PHEIC. Within this chapter we consider events for which the DG convened an EC, but which did not result in a PHEIC declaration and second, we also consider events the DG did not convene an EC for, despite the criteria appearing to be met. Considering these events enables us to have a clearer understanding of the use of executive discretion by the DG in regard to the PHEIC, particularly in respect of when an EC is convened, and the relationship between the DG and the EC. We find that multiple DGs failed to convene ECs to consider an event a potential PHEIC, despite the criteria to do so appearing to be met. We further show that the DG is unwilling to go against the advice provided by the EC, even when, as was the case with MERS-CoV, it was apparent that the criteria to declare a PHEIC had been met. This is unusual, given the advice of an EC is one of multiple considerations the DG needs to consider when determining whether a PHEIC declaration is warranted, and goes some way towards demonstrating the extent to which certain aspects of the DG role have been fettered away to the EC.

MERS-CoV

Middle East respiratory syndrome coronavirus (MERS-CoV) is a zoonotic virus, which is transferred to humans from camels. It was first reported to the WHO in 2012, and since then has been detected in 27 countries, and has led to at least 858 deaths and 2,494 reported cases, with an estimated 35% mortality rate. The majority of these have occurred in Saudi Arabia, although there was a notable outbreak in South Korea.

A considerable issue with the initial global response to MERS was the lack of clear and transparent information. For example, a case was detected in the UK in a passenger recently arriving from Saudi Arabia, after the initial analysis by Public Health England MERS was confirmed, the UK was obligated to report this case to the WHO under Article 6 of the IHR.