An analysis of International Health Regulations Emergency Committees and Public Health Emergency of International Concern Designations

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Title:

An analysis of International Health Regulations Emergency Committees and Public Health Emergency of International Concern Designations

Authors:

Lucia Mullen; Christina Potter; Lawrence O Gostin; Anita Cicero; Jennifer B Nuzzo

Date posted:

June 16, 2020

Publication type:

Article

Publication:

BMJ Global Health

DOI:

10.1136/bmjgh-2020-002502

See also:

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Introduction:

In the aftermath of severe acute respiratory syndrome (SARS) outbreak, the WHO fundamentally revised the International Health Regulations (IHR), which entered into force in 2007. The 196 States Parties to the IHR recognised that certain public health events pose a significant risk to the global community and should be designated as a Public Health Emergency of International Concern (PHEIC). Under Article I of the IHR, a PHEIC is defined by three criteria: an extraordinary event which ‘constitute[s] a public health risk to other States through international spread of disease and…potentially require[s] a coordinated international response.’ The IHR (Annex 2) provides a ‘decision instrument’ that guides States Parties as to which health events have the potential to become PHEICs, thus requiring reporting to WHO. [Annex 2 of the IHR provides a decision instrument for States Parties to assess which events detected by national surveillance systems would require notification to the WHO. This includes a single case of smallpox, poliomyelitis due to wild-type poliovirus, human influenza caused by a new subtype and SARS. Other health events that have the potential to cause international public health concerns or serious impact trigger an algorithm to determine if notification to WHO is required. Criteria for this algorithm include determining if the event is serious, unusual or unexpected, has a significant risk of international spread, or poses a significant risk of international travel or trade restrictions. If two of the criteria are true, then notification to WHO is required under the IHR]. The IHR also empowers the WHO Director-General (DG) to convene an Emergency Committee (EC) which consists of international experts brought together on an ad-hoc basis. The EC provides their advice on whether the current situation should be considered a PHEIC, and what Temporary Recommendations should be given to Member States to bolster the response and control the outbreak. Ultimately, however, the WHO DG has sole authority to declare a PHEIC and make Temporary Recommendations for Member States to follow.¹

The WHO’s decision-making under the IHR has come under intense scrutiny, especially its decision whether to declare a PHEIC. Global commissions, for example, strongly criticised the organisation for waiting 4 months after international spread of Ebola virus disease (EVD) in West Africa (2014–2016) before declaring an emergency.2 During the ongoing EVD outbreak in the Democratic Republic of Congo (DRC), the EC met a total of six times but did not declare a PHEIC until the fourth convocation, more than 11 months after the outbreak began.^{3 4} Most recently, the WHO’s judgement in response to coronavirus disease-2019 (COVID-19) has been questioned. The WHO DG first convened the EC on January 22, but announced it had insufficient data from China to arrive at a decision. The following day, the EC was almost equally divided, but ultimately said it was too early to declare a PHEIC. Seven days later, on 30 January 2020 during the second EC meeting, the DG declared a PHEIC. The WHO DG openly stated that the IHR should be reformed to allow intermediate levels for declaring an emergency, suggesting that an all or nothing standard hindered EC decision-making.^{3 5}

Experts have urged WHO to clarify how decisions should be reached,^6–8as well as proposing greater transparency in the EC decision-making process to better understand why the Committee recommended or did not recommend a PHEIC declaration.⁹ Overall, the IHR EC decision-making process is open to considerable interpretation.¹⁰ In addition, the WHO DG has raised concerns about the negative impacts that PHEIC declarations may trigger, especially travel and trade restrictions.^{3 5}

To date, there has yet to be a comprehensive analysis of EC recommendations and WHO DG decision-making regarding PHEIC declarations. To describe how the EC and the WHO DG relied on and interpreted these criteria in previous decisions to declare or not to declare PHEICs, we examined the EC’s decision-making in all instances where it has met from when the revised IHR entered into force in 2007. We summarised and categorised the justifications offered by the EC, identified the criteria used in each situation and compared these to criteria for PHEICs outlined by the IHR. Based on this analysis, we offer important recommendations for increasing transparency and consistency in EC recommendations and PHEIC decision-making. Adoption of these regulations would strengthen IHR decision-making and WHO legitimacy in responding to major outbreaks.