Discussion
Figure 13 4 outlines which criteria and thematic factors were explicitly stated or implied as contributing to the EC recommendation to the WHO DG.
Figure 1Outlines which criteria and thematic factors were explicitly stated or implied as contributing to the Emergency Committee recommendation to the WHO Director-General. COVID-19, coronavirus disease-2019; EVD, Ebola virus disease; H1N1, influenza A; MERS, Middle East respiratory syndrome; PHEIC, Public Health Emergency of International Concern.
We find considerable inconsistency in statements issued by the EC regarding their determination of whether the IHR criteria for a PHEIC have been met. The ECs did not always require each of the three conditions to be met in order to recommend that a PHEIC should be declared. During the first Zika EC meeting when a PHEIC was recommended, there was no explicit mention of a risk of international spread nor did the EC state that a coordinated, international response was required. In contrast, the EC determined the yellow fever outbreaks in 2016 did not constitute a PHEIC even though they stated the outbreaks posed a public health risk to other States through international spread and indicated that enhanced international support was needed.3
When the ECs did reference specific PHEIC criteria, they were often inconsistent in their interpretation of whether the criteria were met. For example, for some events (H1N1, polio and the West Africa EVD outbreak) ECs interpreted the criterion of ‘requiring a coordinated international response’ to mean that the event required such coordination, but did necessitate that on-going coordination be enhanced or improved in order for the criterion to be met. In contrast, for the ninth DRC EVD outbreak, the EC argued that while the ‘response should be supported by the entire international community’ implying the need for a coordinated international response, a PHEIC was not necessary because the existing response was ‘rapid and comprehensive’ and there was reason to believe the outbreak could be brought under control. Similarly, for the 10th DRC EVD outbreak, in earlier meetings, the Committee noted ‘[t]he government of the Democratic Republic of Congo, WHO, and partners must intensify the current response’ indicating a coordinated international response was underway; however, the EC did not acknowledge that the criterion of a coordinated international response was met until the forth EC meeting on 17 July 2019.3
The criterion for determining if an event is considered extraordinary was also interpreted inconsistently. For both H1N1 and Zika, insufficient knowledge about the virus was cited as a factor in these situations being deemed extraordinary events. In contrast, the EC s never stated that MERS-CoV and COVID-19 (both outbreaks resulting from novel viruses for which there were significant gaps in knowledge of disease aetiology) constituted an extraordinary event.3
ECs varied in their interpretation of and the supporting evidence used to assess the criterion of there being a risk of international spread. The EC was inconsistent in whether it required that international spread to have already occurred vs there simply being risk that spread could occur in order for this criterion to be met. In some cases (H1N1, polio, West Africa EVD, yellow fever, ninth DRC EVD outbreak, 10th DRC EVD outbreak), the EC noted the threat of international spread when a disease involved sustained human-to-human or community transmission. However, despite the absence of sustained human-to-human transmission, the EC considered MERS-CoV outbreak to have a risk of international spread stating ‘the possibility of international spread remains of concern’ on 4 February 2015. For polio, an impending mass gathering, the Hajj, was used as rationale to continue a PHEIC declaration due to the risk it posed for international spread. However, for MERS-CoV, the EC did not note that they considered the Hajj a factor that contributed to the risk of international spread. The upcoming Olympics were also acknowledged during Zika EC meetings and it was recognised that mass gatherings can pose additional risks to international spread. It was ultimately deemed that with proper public health control measures, the risk of the Olympics contributing to international spread was negligible, and therefore, not factored into this criterion.3
By design, this study only reviewed the official statements of EC meetings to identify and analyse the rationale provided and determine if PHEIC criteria were present or absent. Most, but not all, EC meetings were followed by a press conference where the DG and the chair of the EC provided a verbal report of the meeting and answer questions posed by journalists. While these press conferences often allowed for further clarification of the EC decision, whether or not additional, clarifying information was relayed at press conferences was often contingent on the types of questions that happened to be asked by member of the press. As a result, these conferences cannot be viewed as a replacement for EC reports as a vehicle for explaining the rationale used by the EC in deciding whether an event met each of IHR criteria for a PHEIC declaration. To ensure there is complete understanding of the analysis and decision-making of the EC, the official reports of the EC should contain all of the necessary information regarding which IHR criteria were determined to have been. Transparency in this IHR process must be prioritised and, therefore, the official EC statements must provide a clear indication of how each of the three IHR criteria were deemed to have been met and include all the relevant information necessary to justify the decision to recommend declaration (or not) of a PHEIC.
Lack of consistency and clarity regarding the EC and the WHO DG’s decision-making contributes to ongoing concerns about a lack of transparency in the PHEIC process and other public disagreements with PHEIC declarations.9 Though ECs may have discussed each outbreak with greater clarity and consistency than what was publicly reported, it is important that the public representation of the EC’s rationale be fully articulated so that Member States and outside observers have a full record of the EC’s decision-making process. Lack of transparency surrounding the EC process has been a continuous point of contention for public health experts who noted the original reticence of WHO to disclose the identity of EC members following the H1N1 EC deliberations.22
Similarly, it is important that the EC’s recommendations are seen as consistent with the expectations of the IHR.
We recommend that in future convenings, the EC standardise their reviews of events to specifically address whether the event met each of the three criteria and to list corresponding evidence to support the presence/absence of each criterion. In addition, the EC should offer detailed explanation of how they interpreted the criteria. In order to standardise the EC review process and ensure explanations are provided to clearly justify decisions on PHEIC declarations and non-declarations, EC members should undergo further training regarding the authorities and decision-making criteria established by the IHR, a sentiment that is shared by other public health and international law experts.22 Notably, global health law experts have not been part of the composition of ECs.3 4 Adding legal expertise to future EC deliberations will help to resolve confusion about the IHR criteria and promote consistency with previous decisions.
Going forward, the WHO should, in consultation with member states and legal experts, develop clear guidelines to aid ECs in interpreting PHEIC criteria. In particular, there seems to be confusion among EC members as to whether the ‘risk of international spread’ criterion has to involve documented international spread. The IHRs do not specify that international spread must have already occurred and it would likely be against the spirit of the IHRs, which aim to reduce international spread of infectious diseases, for the ECs to need to wait until international spread has occurred in order to declare a PHEIC.1
The makeup of the EC is ill-equipped to address political and social considerations. While these considerations are important and relevant factors to take into account when responding to an outbreak, the IHR does not provide the ECs with the authority to consider the political and social implications. The ECs should disavow including these concerns in their deliberations and ensure that they only consider the available technical evidence on whether the three core criteria have or have not been met when determining if the event constitutes a PHEIC. Other avenues should be used to account for the political and social considerations as they are a necessary component of ensuring a robust and successful response to a health emergency. Box 1 provides a summary of the recommendations outlined in this paper.
Box 1Summary of recommendations
Emergency Committees (ECs) should standardise their review of an outbreak to specifically address whether the event met each of the criteria for a Public Health Emergency of International Concern (PHEIC); the outbreak should constitute as an extraordinary event, be a public health risk to other Member States though international spread of disease, and require a coordinated, international response.
WHO should include global health law experts in the composition of future EC meetings to ensure proper legal advice on the International Health Regulations criteria can be shared with EC members and properly applied during the decision-making process.
WHO, Member States and legal experts should develop clear guidelines to aid ECs in interpreting PHEIC criteria.
ECs should only consider the available technical evidence of events when determine if criteria for a PHEIC are met rather than incorporating additional considerations in the deliberations such as the political implications.
The EC should endeavour to provide clear and consistent statements outlining the decision-making process for PHEIC declarations. This would include a standardised statement reviewing their discussions and listing evidence to support their determination of the presence or absence of each PHEIC criterion.
With more consistency and transparency in EC justifications, there could be a better understanding on how the EC and the WHO DG reach their decision on whether an event should be considered a PHEIC. Similarly, as previous PHEIC determinations are often reviewed to compare the decision-making processes between public health events, a more structured approach should be provided that explicitly states what criteria were met and how the EC determined that each criterion was satisfied. This approach will remove some ambiguity and enable the international community to gain further insight into the EC’s thought process and their recommendations on whether to declare a PHEIC.
It is essential for PHEIC declarations to be made based on science, not politics. In recent convenings, ECs have seemed reluctant to recommend a PHEIC declaration, noting the potential for countries to respond with trade and travel measures that could harm response to the health event.3 23 Though concerns that countries may pursue harmful measures to stop the importation of disease are legitimate,24 the decision-making process established by the IHR does not accommodate these political considerations.1 The ECs should review the potential public health impact of the event and limit their decision-making to a technical assessment of each event. The WHO should address separately, outside of the PHEIC declaration process, the problem of Member States taking actions that are inconsistent with WHO recommendations and place unnecessary travel and trade restrictions on affected countries, which would be detrimental to both the country and the response efforts.
PHEIC declarations are not the entire focus of the IHR. The Regulations also require countries to develop capacities to detect and report potential PHEICs.1 If there is a lack of understanding of the rationale that EC uses to recommend PHEIC declarations, or if PHEIC declarations are seen to be political, it could undermine confidence in the IHR. Though the IHR are instruments of law, their impact depends on countries’ willingness to comply. It is essential for future compliance with the IHR that the WHO, ECs and Member States interpret the framework as written. If the Regulations are thought to be inadequate in supporting assessment and response to international public health emergencies, then a revision of the IHR may be necessary. Following the EC’s recommendation to declare the on-going COVID-19 epidemic a PHEIC, the WHO DG expressed frustration with the binary decision-making set up by the IHRs and suggested that a tiered decision-making tool, with an intermediary measure, may be more useful to gauge the level of emergency posed by health events.3 Such a suggestion would likely require a revision of the IHR, as the decision instrument contained in Annex 2 does not accommodate a multi-phase declaration.