What Does the Monkeypox Outbreak Tell Us about Global Health Governance? Critical Remarks on the New WHO Declaration of Public Health Emergency of International Concern

On 23 July 2022, the Director-General of the World Health Organisation (“WHO”) declared that the outbreak of monkeypox constitutes a public health emergency of international concern (“PHEIC”). Under Art. 1 of the 2005 International Health Regulations (“IHRs”), a PHEIC means “an extraordinary event which is determined […] (i) to constitute a public health risk to other States through the international spread of disease and (ii) to potentially require a coordinated international response”. This act represents the culmination of the collective surveillance system established by the IHRs, as it means that a global health threat has been identified and, therefore, States Parties must adopt the necessary countermeasures, keeping with temporary recommendations issued by the Director-General under Art. 15 IHRs.

Against this backdrop, the present post is aimed at highlighting some critical issues related not only to the PHEIC declaration but, more generally, to global health governance, as designed by the IHRs and the WHO Constitution (see Gostin, p. 175 ff.; Negri; Greco). If States will not effectively take into consideration these issues, both by amending the IHRs and strengthening the existing normative framework, one may wonder whether the WHO architecture can effectively address current public health challenges. Some authors took a rather sceptical view in this respect (see Benvenisti).

Background

On 11 May 2022, through the Event Information Site for National IHR Focal Points (“EIS”) – the digital platform created for sharing available information and knowledge concerning health events – the WHO Secretariat alerted States Parties to the IHRs to the monkeypox outbreak. At the same time, it urged them to make an immediate effort to cooperate and tackle the virus, providing them technical guidance on laboratory testing, clinical management and infection prevention and control, vaccines and immunisation. This kind of initiative is not new, as the WHO is an international organisation whose action is mandated to be science-based. In this context, technical standards and guidelines are the usual instruments by which it exercises its “epistemic authority” (see Klabbers).

On 23 June 2022, as the number of cases started increasing, the Director-General decided to convene the Emergency Committee under Art. 48 IHRs, to assess whether the outbreak constituted a PHEIC and, if so, to provide views on potential temporary recommendations. Thus, the Committee had to assess the epidemiological situation: it noted that, as of May 2022, 3,040 cases in 47 countries had been reported to the WHO. At the time, however, there were few hospitalisations, one death in an immunocompromised individual and ten cases of infection among healthcare workers. Although, during the proceedings, some members had expressed a different view, the Committee concluded, by consensus, that the monkeypox outbreak did not constitute a PHEIC. Nonetheless, it acknowledged that the event was of an “emergency nature”, such as to require a joint effort of collaboration and mutual assistance within the meaning of Art. 44 (on the scope of this obligation, see Cinà et al.).

Convened again on 21 July 2022, the Emergency Committee found itself internally divided and was unable to reach a consensus regarding its advice. This outcome resembles a sort of scientific non liquet and may lead one to speculate on the possible violation of Article 48 IHRs, which provides that “at the request of the Director-General [the Emergency Committee] shall provide its views” (emphasis added).

Some members took the view that the multi-country outbreak of monkeypox met all the three criteria defining a PHEIC. In addition – they argued –, the trend of several factors should have led to a negative assessment of the future scenario, including the morbidity rate, the number of cases reported globally (partly underestimated), the increasing number of countries affected, the need to protect communities of people most affected by the disease, and the potential future consequences for health services. Other members pointed out that the overall epidemiological situation had not substantially changed since the first meeting of the Emergency Committee, that the greatest burden of the outbreak has been concentrated in 12 countries in Europe and the Americas, with no evidence of an exponential increase in the number of cases, and that the most affected communities of homosexual, bisexual and other men who have sex with men (MSM) could be protected with targeted measures.

Against such a puzzling background, the Director-General autonomously determined that the monkeypox outbreak constitutes a PHEIC and, consequently, issued temporary recommendations.

Critical Remarks

1. Scientific Uncertainty and the WHO Director-General’s Precautionary Approach. Since the entry into force of the revised IHRs, there have been six declarations of PHEIC in relation to the swine flu pandemic (2009), the re-emergence of wild poliovirus in some countries (2014), the Ebola epidemic in West Africa (2014-2016), the Zika virus outbreak (2016), the Ebola Kivu outbreak in Congo (2018-2019) and COVID-19 (2020). In the case at hand, however, the Director-General made his determination based on a precautionary approach due to the “complexities and uncertainties associated with this public health event”. If the lack of full scientific certainty prevented the Emergency Committee from reaching a consensus, it could not provide a reason for postponing the adoption of measures aimed at preventing serious harm.

Indeed, the Director-General’s autonomy is grounded in the IHRs: according to Arts. 12(4)(c) and 48, the Emergency Committee is a technical advisory body that expresses an authoritative yet non-binding opinion. Moreover, under Art. 12 IHRs, the Director-General is the only authority competent to declare a PHEIC, as further clarified in Art. 49, which states that “[t]he views of the Emergency Committee shall be forwarded to the Director-General for consideration. The Director-General shall make the final determination on these matters”. This is an almost unique case in the law of international organisations, where a single official exercises a power with potentially generalised effects.

The Director General’s initiative can also be read – in a post-pandemic world – as a sign of the increased attention to epidemic risks, which leads to declare a state of emergency even in the presence of scientific evidence that is still provisional and necessarily incomplete, also to avert criticism of inaction.

2. Definition of PHEIC and the (Scientific?) Role of the Emergency Committee. A second issue deserving attention concerns the Emergency Committee’s mandate and the criteria that should guide its functioning. According to the members in favour of a PHEIC declaration, this act would have the advantage of heightening the level of general awareness and alert as well as political commitment and financial resources available to tackle the public health event. On the other hand, according to those against it, the declaration would have entailed the risk of stigma, marginalisation and discrimination against the most affected MSM communities, while it would not necessarily have fostered capacity building for surveillance, laboratory research and response. In addition, the technical action undertaken by the WHO could have adequately addressed the new threat.

Despite the author’s best efforts, it is difficult to see how considerations of a blatant political nature can fit within the Emergency Committee’s technical mandate, whose sole task is to assess the existence of a PHEIC based on the three criteria required by the IHRs. This is not the first time that this shortcoming has affected the authority of the Emergency Committee (see Eccleston-Turner).

3. “To Declare or Not to Declare, That is the Question”. The difficulties that emerged within the Emergency Committee and the consequent initiative taken by the Director-General once again confirm the inadequacy of a risk assessment system capable of reading the infinite variety of health events based on a purely binary logic: emergency or non-emergency. This is a critical point repeatedly highlighted in the literature (see Fidler; Patel-George; Pavone), which can only be solved by introducing a more nuanced system of warnings according to differentiated risk scenarios (Burci, p. 212). In this sense militates the draft amendment submitted by the United States to the 75th World Health Assembly (WHA), which will be discussed at the next session in 2023 (see Behrendt-Müller).

4. Globalisation, Interdependence and Collective Health Security. Monkeypox is an infectious disease transmissible from human to human and caused by a zoonotic virus first identified in 1958, whose ability to infect humans has been known since the early years of the new millennium (see Hutin et al.). While it is endemic in certain areas of West and Central Africa, where it finds host species in monkeys and other animals, it is experiencing an unprecedented spread in Europe and other regions, where its circulation had never before been documented.

Given that initial cases had no epidemiological links to areas historically affected by the disease, such a scenario suggests – in the words of the WHO – that “undetected transmission might have been ongoing for some time in those countries” and that “monkeypox virus activity has been neglected and not well controlled for years in countries in the WHO African Region”. In this context, a relationship of strict interdependence among countries clearly emerges insofar as the effective (in)capacity of one State to detect and control a health threat is destined to jeopardise collective security. Therefore, that each State can effectively exercise such control represents a general interest of the international community.

5. Zoonotic Health Threats and Prevention Obligations. Like SARS, MERS, swine flu, Ebola and COVID-19, monkeypox is also the result of a zoonotic spill over. The frequency with which this phenomenon occurs has long highlighted the need for prevention obligations to play a role in global health law, where, to date, there are regulatory gaps on this point. In fact, the IHRs contain no real obligation to prevent a health risk from arising, merely requiring States to prevent the international spread of disease once it occurs and has been identified. The IHRs are based on the outdated assumption that disease outbreaks, epidemics and pandemics represent so-called “acts of God”, which means that they are natural events entirely outside human control. From this perspective, States can do nothing but prepare for and respond when such an event occurs so as to control and mitigate its negative impact. However, modern epidemiology has shown that social, environmental and animal health factors are systematically associated with the occurrence of public health events. In this light, it becomes crucial that States undertake preventive actions (see Viñuales et al.; Villarreal). A certain degree of awareness seems to be emerging during the negotiations to conclude a new WHO convention on pandemic prevention, preparedness and response (p. 11).

Conclusions

What has been pointed out above shows that not a few shortcomings affect the governance of international health emergencies. They undermine the WHO’s legitimacy insofar as they impair its effectiveness in protecting the health of all peoples, as stated by the Preamble of the WHO Constitution. First, while a renewed awareness of its role is a development for WHO to be welcomed, in the post-pandemic world an increased attention for health threats should not translate into anxiety, which risks undermining the alert value of PHEIC declarations.

Second, it is crucial to define more clearly the perimeter of the Emergency Committee’s mandate, whose scientific advice is needed to assess the factual elements underlying the definition of PHEIC. Within the framework designed by the IHRs, there is room for political and strategic considerations, but these fall within the competences of the Director-General and the WHO Secretariat.

Third, the binary nature of the PHEIC declaration is one of the main obstacles to the effective functioning of the collective surveillance mechanism. A graded risk assessment system would shield the WHO from criticisms of excessive caution or alarmism. Forth, health threats make territorial boundaries a purely abstract concept, revealing the interdependence underlying global health security. The architecture designed by the IHR originated from this awareness. However, the monkeypox epidemic confirms that the persistent difficulties some countries have been facing in developing the necessary core capacities undermines the effectiveness of the system.

Lastly, the vast majority of recent health threats is the result of zoonotic spill over. This situation points out the need to address social, environmental and animal health factors commonly associated with the emergence of these events. However, the existing regulatory framework does not provide for positive obligations of deep prevention.