Public Health Emergency of International Concern

A Public Health Emergency of International Concern (PHEIC) is a formal declaration by the World Health Organization (WHO) of "an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response", formulated when a situation arises that is "serious, sudden, unusual or unexpected", which "carries implications for public health beyond the affected State's national border" and "may require immediate international action".[1] Under the 2005 International Health Regulations (IHR), States have a legal duty to respond promptly to a PHEIC.[2]

Logo of the World Health Organization, the authority which declares PHEIC

The declaration is publicized by an Emergency Committee (EC) made up of international experts operating under the IHR (2005),[3] which was developed following the SARS outbreak of 2002/2003.[4] Between 2009 and 2019, there have been five PHEIC declarations:[5] the 2009 H1N1 (or swine flu) pandemic, the 2014 polio declaration, the 2014 outbreak of Ebola in Western Africa, the 2015–16 Zika virus epidemic[6] and, as of 17 July 2019, the 2018–19 Kivu Ebola epidemic.[7] The recommendations are temporary and require three-monthly reviews.[1]

SARS, smallpox, wild type poliomyelitis, and any new subtype of human influenza, are always a PHEIC and do not require an IHR decision to declare them as such.[8]

A PHEIC is not only confined to infectious diseases, and may cover an emergency caused by a chemical agent or a radio nuclear material.[9] It is a "call to action" and "last resort" measure.[10]

Most epidemics and emergencies will not gain public attention or fulfil the criteria to be a PHEIC.[10] ECs were not convened for the cholera outbreak in Haiti, chemical weapons use in Syria or the Fukushima nuclear disaster in Japan.[9][11] Of the outbreaks reported to the WHO for consideration of PHEIC declaration, the 2018–19 Kivu Ebola epidemic was declined for the third time on 14 June 2019, when the number of deaths from Ebola in the Democratic Republic of the Congo (DRC) had reached 1,405 by 11 June 2019 and when a couple of cases of Ebola in neighbouring Uganda had been confirmed.[12] In July 2019, following a confirmed case of Ebola in Goma, the capital of North Kivu, the reconvening of a fourth EC was announced.[13] The WHO officially announced it as a PHEIC on 17 July 2019[7][14] and as of 18 October 2019, it continues to be a PHEIC.[15]

Background

Surveillance and response systems exist for the early detection and effective response to contain the spread of disease. However, time delays still occur for two main reasons. The first is the delay between the first case and the confirmation of the outbreak by the healthcare system, allayed by good surveillance via data collection, evaluation, and organisation. The second is when there is a delay between the detection of the outbreak and widespread recognition and declaration of it as an international concern.[4] The declaration is promulgated by an Emergency Committee (EC) made up of international experts operating under the IHR (2005),[3] which was developed following the SARS outbreak of 2002/2003.[4] Between 2009 and 2016, there have been four PHEIC declarations.[5] The fifth was the 2018–19 Kivu Ebola epidemic which was announced on 17 July 2019.[7]

Under the 2005 International Health Regulations (IHR), States have a legal duty to respond promptly to a PHEIC.[2]

Definition

PHEIC is defined as;

an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response[16]

This definition designates a public health crisis of potentially global reach and implies a situation that is "serious, sudden, unusual or unexpected", which may necessitate immediate international action.[16][17]

It is a "call to action" and "last resort" measure.[10]

Reporting a potential concern

WHO Member States have 24 hours within which to report potential PHEIC events to the WHO.[8] It does not have to be a member State that reports a potential outbreak, hence reports to the WHO can also be received informally.[18] Under the IHR (2005), ways to detect, evaluate, notify and report events were ascertained by all countries in order to avoid PHEICs. The response to public health risks was also decided.[10]

The IHR decision algorithm assists WHO Member States in deciding whether a potential PHEIC exists and the WHO should be notified. The WHO should be notified if any two of the four following questions are affirmed:[8]

  • Is the public health impact of the event serious?
  • Is the event unusual or unexpected?
  • Is there a significant risk for international spread?
  • Is there a significant risk for international travel or trade restrictions?

The PHEIC criteria include a list of diseases that are always notifiable.[18] SARS, smallpox, wild type poliomyelitis and any new subtype of human influenza are always a PHEIC and do not require an IHR decision to declare them as such.[8]

Most epidemics will not gain public attention or fulfil the criteria to be a PHEIC.[10] EC's were not convened for the cholera outbreak in Haiti, chemical weapons use in Syria or the Fukushima nuclear disaster in Japan.[9][11]

Further assessment is required with diseases that are prone to pandemics including cholera, pneumonic plague, yellow fever, and viral hemorrhagic fevers.[11]

A declaration of a PHEIC may appear as an economic burden to the state facing the epidemic. Incentives to declare an epidemic are lacking and the PHEIC can be seen as placing limitations on trade in countries that are already struggling.[10]

Emergency Committee

In order to declare a PHEIC, the WHO Director-General is required to take into account factors which include the risk to human health and international spread as well as advice from an internationally made up committee of experts, the IHR EC, one of which should be an expert nominated by the State within whose region the event arises.[1] Rather than being a standing committee, the EC is created ad hoc.[19]

Until 2011, the names of IHR EC members were not publicly disclosed. These members are selected according to the disease in question and the nature of the event. The Director-General takes the EC's advice following their technical assessment of the crisis using legal criteria and a predetermined algorithm after a review of all available data on the event. Upon declaration, the EC then makes recommendations on what actions the Director-General and Member States should take to address the crisis.[19] The recommendations are temporary and require three-monthly reviews.[1]

Declarations
H1N1 influenza virus

2009 Swine flu declaration

On 26 April 2009,[20] more than one month after its first emergence,[4] the first PHEIC was declared when the H1N1 (or swine flu) pandemic was still in Phase Three.[2][21][22] On the same day, within three hours the WHO web site received almost two million visits, necessitating the pandemic's own dedicated pandemic influenza web site.[20] Of the first three outbreaks to be declared a PHEIC, H1N1 occurred in only three countries and was the least severe with the fastest response, probably because it was airborne.[4] Declaring H1N1 a PHEIC has therefore been argued as fuelling public fear.[11]

2014 Polio declaration

The second PHEIC was the 2014 polio declaration, issued in May 2014 with the resurgence of wild polio after its near-eradication, deemed "an extraordinary event".[23][24]

Global eradication was deemed to be at risk with small numbers of cases in Afghanistan, Pakistan, and Nigeria.[11]

In October 2019, continuing cases of wild polio in Pakistan and Afghanistan, in addition to new vaccine-derived cases in Africa and Asia, was reviewed and remains a PHEIC.[25]

2014 Ebola declaration

Confirmed cases of Ebola were being reported in Guinea and Liberia in March 2014 and Sierra Leone by May 2014. On Friday, 8 August 2014, following the occurrence of Ebola in the United States and Europe and with the already intense transmission ongoing in three other countries for months,[10] the WHO declared its third PHEIC in response to the outbreak of Ebola in Western Africa.[26] Later, one review showed that a direct impact of this epidemic on America escalated a PHEIC declaration.[4] It was the first PHEIC in a resource-poor setting.[10]

2016 Zika virus declaration

On 1 February 2016, the WHO declared its fourth PHEIC in response to clusters of microcephaly and Guillain–Barré syndrome in the Americas, which at the time were suspected to be associated with the ongoing 2015–16 Zika virus epidemic.[27] Later research and evidence bore out these concerns; in April, the WHO stated that "there is scientific consensus that Zika virus is a cause of microcephaly and Guillain–Barré syndrome."[28] This was the first time a PHEIC was declared for a mosquito‐borne disease.[11] This declaration was lifted on 18 November 2016.[29]

2018–19 Kivu Ebola declaration

In October 2018 and then later in April 2019, the WHO did not consider the 2018–19 Kivu Ebola epidemic to be a PHEIC.[30][31] The decision was controversial, with Michael Osterholm, director of the Center for Infectious Disease Research and Policy (CIDRAP) responding with disappointment and describing the situation as "an Ebola gas can sitting in DRC that's just waiting for a match to hit it",[32] while the WHO panel were unanimous that declaring it a PHEIC would not give any added benefit.[32] The advice against declaring a PHEIC in October 2018 and April 2019, despite the criteria for doing so appearing to be met on both occasions has led to the transparency of the IHR EC coming into question. The language used in the statements for the Kivu Ebola epidemic has been noted to be different. In October 2018, the EC stated "a PHEIC should not be declared at this time". However, in the 13 previously declined proposals for declaring a PHEIC, the resultant statements quoted "the conditions for a PHEIC are not currently met" and "does not constitute a PHEIC". In April 2019, they stated that "there is no added benefit to declaring a PHEIC at this stage", a notion that is not part of the PHEIC criteria laid down in the IHR.[19][33]

After confirmed cases of Ebola in neighbouring Uganda in June 2019, Tedros Adhanom, the Director-General of the WHO, announced that the third meeting of a group of experts would be held on 14 June 2019 to assess whether the Ebola spread had become a PHEIC.[34][35] The conclusion was that while the outbreak was a health emergency in the Democratic Republic of the Congo (DRC) and the region, it does not meet all the three criteria for a PHEIC.[36] Despite the number of deaths reaching 1,405 by 11 June 2019[12] and 1,440 by 17 June 2019, the reason for not declaring a PHIEC was that the overall risk of international spread was deemed to be low, and the risk of damaging the economy of the DRC high.[37] Adhanom also stated that declaring a PHEIC would be an inappropriate way to raise money for the epidemic.[38] Following a visit to the DRC in July 2019, Rory Stewart, the UK's DfID minister, called for the WHO to declare it an emergency.[39]

Acknowledging a high risk of spread to the capital of North Kivu, Goma, a call for a PHEIC declaration was published on 10 July 2019 in the Washington Post by Daniel Lucey and Ron Klain (the former US Ebola response coordinator). They stated that "in the absence of a trajectory toward extinguishing the outbreak, the opposite path—severe escalation—remains possible. The risk of the disease moving into nearby Goma, Congo—a city of 1 million residents with an international airport —or crossing into the massive refugee camps in South Sudan is mounting. With a limited number of vaccine doses remaining, either would be a catastrophe".[40][41] Four days later, on 14 July 2019, a case of Ebola was confirmed in Goma, which has an international airport and a highly mobile population. Subsequently, the WHO announced a reconvening of a fourth EC meeting[13] on 17 July 2019, when they officially announced it "a regional emergency, and by no means a global threat" and declared it as a PHEIC, without restrictions on trade or travel.[7][14][42] In response to the declaration, the president of the DRC, together with an expert committee led by a virologist, took responsibility for directly supervising action, while in protest of the declaration, health minister, Oly Ilunga Kalenga resigned.[43] A review of the PHEIC had been planned at a fifth meeting of the EC on 10 October 2019[44] and as of 18 October 2019, it continues to be a PHEIC.[15]

Response

In 2018, an examination of the first four declarations (2009–2016) showed that the WHO was noted to be more effective in responding to international health emergencies, and that the international system in dealing with these emergencies was "robust".[6]

Another review of the first four declarations, with the exception of wild polio, demonstrated that responses were varied. Severe outbreaks, or those that threatened larger numbers of people, did not receive a swift PHEIC declaration, and the study hypothesized that responses were quicker when American citizens were infected and when the emergencies did not coincide with holidays.[4]

Non-declarations
MERS-coronavirus

2013 MERS

PHEIC can also make the news when it is not invoked, as has been the case to date with MERS.[45][46] Originating in Saudi Arabia, MERS reached more than 24 countries and resulted in more than 580 deaths by 2015, although most cases were in hospital settings rather than sustained community spread. What constitutes a PHEIC has as a result, been unclear.[9]

Non-infectious events

PHEIC are not confined to only infectious diseases. It may cover events caused by chemical agents or radio nuclear materials.[9]

The emergence and spread of antimicrobial resistance, may debatably constitute a PHEIC.[47][48][49]

References
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