The process of determining whether a Public Health Emergencies of International Concern (PHEIC) exists and should be declared has drawn increasing criticism over the past few years with allegations that it is more political than technical. Delaying declaration, where appropriate, means that the opportunity of garnering international solidarity and necessary resources in the early phases of epidemics, when public health measures may be more effective, is lost. A reform agenda aimed at enhancing WHO/Emergency Committee transparency and objectivity for the PHEIC declaration process is required

Durrheim, David N.

Gostin, Lawrence O.

Moodley, Keymanthri

English

Georgetown Law Scholarly Commons

Georgetown University Law Center Scholarship @ GEORGETOWN LAW 2020 When does a major outbreak become a Public Health Emergency of International Concern? David N. Durrheim Lawrence O. Gostin Keymanthri Moodley   This paper can be downloaded free of charge from: https://scholarship.law.georgetown.edu/facpub/2268 https://ssrn.com/abstract=3608012  This open-access article is brought to you by the Georgetown Law Library. Posted with permission of the author. Follow this and additional works at: https://scholarship.law.georgetown.edu/facpub  Part of the Health Law and Policy Commons, and the International Humanitarian Law Commons Commentwww.thelancet.com/infection   Published online May 19, 2020   https://doi.org/10.1016/S1473-3099(20)30401-1 1When does a major outbreak become a Public Health Emergency of International Concern?Could the pandemic of the century have been averted? The process by which WHO decides whether to declare a Public Health Emergency of International Concern (PHEIC) under the International Health Regulations has drawn criticism. Reports have condemned the 4-month delay by WHO after the international spread of Ebola in west Africa before declaring a PHEIC.1 The Democratic Republic of the Congo, now experiencing the second largest Ebola outbreak in recorded history, notified WHO of the outbreak on Aug 1, 2018, but WHO required four Emergency Committee meetings, including on Oct 17, 2018 (216 confirmed cases, 139 deaths, and 64% case fatality ratio), and April 12 and June 14, 2019 (four confirmed cases in Uganda). Justifying their response, the Emergency Committee said that “the cluster of cases in Uganda is not unexpected”.2 A PHEIC was finally declared at the fourth Emergency Committee meeting on July 17, 2019 (2501 cases and 1668 deaths), almost a year after initial notification. The International Health Regulations3 do not require actual international spread, only a high potential for that spread, and thus the criteria for a PHEIC had already been met by the second Emergency Committee meeting.4 Notably, the PHEIC declaration coincided with increased resourcing and international focus, leading to a major reduction in Ebola cases.Global health scholars have criticised the Emergency Committee process as lacking transparency, using “irrelevant considerations, undue influence and political interference”,5 and delaying declaration when International Health Regulations criteria have been met. The coronavirus disease 2019 (COVID-19) outbreak originating in China and reported to WHO on Dec 31, 2019, suggests that little has changed. The PHEIC declaration for COVID-19 occurred well after most public health experts had concluded that this outbreak posed a major international threat. At the first Emergency Committee meeting on Jan 22, 2020 (309 cases and six deaths reported in mainland China; five confirmed cases in four countries or territories), the Emergency Committee said it did not have key facts from China. It extended the meeting to the next day, when cases had risen to 571, with 17 deaths and ten cases in seven other countries or territories. Yet, the Emergency Committee could not achieve consensus, and the Director-General concluded that the outbreak was “an emergency in China, but it had not yet become a global health emergency”.6Again, the process appeared “more political than technical”, as a Lancet Editorial described Ebola in the Democratic Republic of Congo, adding that “the committee seems to have favoured local protectiveness over global galvanising”.7 By the time the Emergency Committee declared a PHEIC for COVID-19 on Jan 30, 2020, 7736 cases and 179 deaths had been confirmed in mainland China, with 107 cases confirmed in 21 other countries.Delays in declaring a PHEIC could have serious detrimental consequences, lulling governments and donors into a false sense of security, because they could reason that if WHO does not consider the situation an international emergency, then it does not require a surge response.The legal definition of a PHEIC is clear, as “an extraordinary event that may constitute a public health risk to other countries through international spread of disease and may require an international coordinated response.”3 The purpose of the declaration is to focus international attention on acute public health risks that “require coordinated mobilisation of extraordinary resources by the inter national community” for prevention and response.3 The PHEIC process requires urgent reform. First, the all-or-nothing nature of the assessment generates confusion. We therefore propose a multilevel PHEIC process with each level defined by objective epidemiological criteria and paired with specific readiness actions. Level 1 PHEIC alert should indicate a high risk outbreak in a single country, with the potential for international spread requiring concerted public health efforts to contain and manage it locally. Level 2 PHEIC should imply that multiple countries have had importations and that limited spread has occurred in those countries. Level 3 PHEIC would indicate large clusters in multiple countries, with evidence of ongoing local transmission. This tiering would provide less ambiguous risk signalling, while also encouraging For the situation reports on Ebola in the Democratic Republic of the Congo see https://www.who.int/emergencies/diseases/ebola/drc-2019/situation-reportsFor the London School of Hygiene & Tropical Medicine’s COVID-19 tracker see https://vac-lshtm.shinyapps.io/ncov_tracker/Lancet Infect Dis 2020Published Online May 19, 2020 https://doi.org/10.1016/ S1473-3099(20)30401-1Comment2 www.thelancet.com/infection   Published online May 19, 2020   https://doi.org/10.1016/S1473-3099(20)30401-1See Online for appendixearlier, proportionate public health measures when they are most effective.Second, WHO should convene an expert consensus meeting to establish objective, evidence-based epi-demiological and containment criteria to transparently guide its decision making processes. The draft algorithm under Annex 2 of the International Health Regulations8 (appendix) already includes critical elements, but there are also subjective considerations, such as restraints on international travel and trade. The algorithm contains perverse relative weightings, treating the five categories as equivalent.The clear purpose of a PHEIC declaration is to catalyse timely evidence-based action, to spur increased inter-national funding and support, and to limit the public health and societal impacts of emerging and re-emerging disease risks. In the aftermath of the COVID-19 pandemic, International Health Regulation reform must be an ethical imperative for more rapid and effective responses to novel infectious diseases.We declare no competing interests.*David N Durrheim, Laurence O Gostin, Keymanthri Moodleydavid.durrheim@newcastle.edu.auSchool of Medicine and Public Health, University of Newcastle, Callaghan, NSW 2308, Australia (DND); O’Neill Institute for National and Global Health Law, Georgetown University, Washington, DC, USA (LOG); and Centre for Medical Ethics and Law, Stellenbosch University, Stellenbosch, South Africa (KM)1 Gostin LO, Tomori O, Wibulpolprasert S, et al. Toward a common secure future: four global commissions in the wake of Ebola. PLoS Med 2016; 13: e1002042.2 WHO. 2019. Statement on the meeting of the International Health Regulations (2005) Emergency Committee for Ebola virus disease in the Democratic Republic of the Congo. June 14, 2019. https://www.who.int/news-room/detail/14-06-2019-statement-on-the-meeting-of-the-international-health-regulations-(2005)-emergency-committee-for-ebola-virus-disease-in-the-democratic-republic-of-the-congo (accessed May 13, 2020).3  WHO. 2005. International Health Regulations (2005), 3rd edition. 2016. https://www.who.int/ihr/publications/9789241580496/en/ (accessed May 7, 2020).4 Tomori O, Durrheim DN, Gostin L, Kavanagh MM. Ebola in North Kivu, DR Congo—is it an undeclared public health emergency of international concern (PHEIC)? Travel Med Infect Dis 2019; 29: 1–3.5 Eccleston-Turner M, Kamradt-Scott A. Transparency in IHR emergency committee decision making: the case for reform. BMJ Glob Hlth 2019; 4: e001618.6 WHO. 2020. Statement on the meeting of the International Health Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus (2019-nCoV). Jan 23, 2020. https://www.who.int/news-room/detail/23-01-2020-statement-on-the-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov) (accessed May 13, 2020). 7 The Lancet. The politics of PHEIC. Lancet 2019; 393: 2470.8 WHO. 2005. Annex 2 of the International Health Regulations. https://www.who.int/ihr/annex_2/en/ (accessed May 13, 2020).

When does a major outbreak become a Public Health Emergency of International Concern?

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When does a major outbreak become a Public Health Emergency of International Concern?

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