UPDATING THE INTERNATIONAL HEALTH REGULATIONS: REVISING IHR DECISION INSTRUMENTS AND THE BINARY PHEIC DECLARATION SYSTEM.

• Author: Patel, Rupa R.
• Position: Public Health Emergency of International Concern

1. AN INCREASINGLY URGENT NEED FOR REFORM

   In 2005, in response to the 2002-2003 Severe Acute Respiratory Syndrome (SARS) pandemic, the World Health Assembly (1) adopted the International Health Regulations (IHR 2005). (2) The Regulations, which replace their predecessor from 1969, aimed to modernize global health threat monitoring, reporting, and response with the hopes of reducing morbidity, mortality, and socioeconomic repercussions. The IHR 2005 require its 196 States Parties to notify the World Health Organization (WHO) of "all events which may constitute a public health emergency of international concern." (3) To accomplish this goal, the IHR include two key components, Annex 1 and Annex 2, which rely sequentially on each other, to calculate a potential global health threat. Annex 1 obligates States Parties to have the capacity for disease surveillance, to conduct urgent report assessment within forty-eight hours, and to effectively minimize spread. Annex 2 is a decision instrument for States' National Focal Points (NFP) (4) to determine if an event is required to be reported to the WHO (/, e., is "notifiable"). All notifiable events must be reported within twenty-four hours if the threat meets two of four criteria. Once an event is reported, an Emergency Committee and the Director-General may declare a Public Health Emergency of International Concern (PHEIC), initiating a coordinated international response, including temporary recommendations such as trade travel restrictions to prevent international spread. Since 2009, the WHO has declared six PHEICs. (5)

   As the only legally binding instrument regarding international disease prevention and control, the IHR play a key role in global health security. When the IHR 2005 came into effect in June 2007, it was widely hoped that this new document would remedy some of the problems its predecessor encountered. The IHR 1969 was unable to account for emerging infectious diseases which spanned beyond the six quarantinable diseases it was bound to, nor did it adequately define a process for global action to minimize spread. (6) Yet less than two years after its adoption, the ineffectiveness of the IHR has been demonstrated by miscalculations during the Ebola and swine flu pandemics, as well as the current COVID-19 pandemic. These failures reveal similar limitations of the IHR 2005 to its predecessor in its inability to keep up with a dynamically changing environment, population growth and migration, emerging diseases, natural disasters, and other unpredictable situations. (7)

   The novel coronavirus, SARS-CoV-2, which causes COVID-19, has claimed over 2.5 million lives worldwide since December 2019. (8) The estimated death toll, thus far, is more than three thousand times higher than that of the SARS pandemic, (9) and is expected to grow in the face of continued poor pandemic control and the development of several viral variants. It is widely accepted that the WHO's declaration of a PHEIC on January 30, 2020, was a delayed response and resulted in valuable time lost to prevent international spread, deaths, and economic loss. (10) Many reasons have been cited for this delay, but noteworthy concerns directly tied to the IHR include: (1) unsatisfied and difficult to attain core capacity requirements for surveillance and response (Annex 1); (2) a lack of clarity within the health threat notification decision instrument (Annex 2); and (3) the binary nature of PHEIC declarations. This paper will focus on each concern in turn.

   The urgent need for IHR reform is evidenced by the expected annual increase in both the number and variety of threats requiring different detection system and responses. There is a roughly three percent chance that a pandemic could take place in any given year." In 2015, the WHO established a priority list for which diseases could become the next pandemic and required more research. (12) Dozens of diseases have been identified as threats over the last thirty years. (13) At least ten emerging and reemerging infectious diseases (14) (the majority of which have no efficacious curative or preventive solutions) are on the horizon and have the characteristics to result in outbreaks' (5) with serious global consequences, potentially wreaking more havoc than COVID-19. (16) In evaluating the severity of these potentially catastrophic diseases, analysts must look not only to the number of possible deaths, but also to the socioeconomic repercussions posed by an outbreak, which can be devastating and long lasting. (17) One potential pandemic disease has been labeled as "Disease X" to signify that scientists anticipate not knowing all the specific diseases that are to come. As the volume of threats to evaluate increases, it is increasingly important that the IHR have a high statistical probability of accurately identifying true threats to global health security, as well as identifying events which do not pose a global risk.

   Emerging infectious diseases are fostered by close interactions between (1) infectious agents or pathogens, (2) animal hosts and humans, and (3) the environment. They are increasingly driven by today's global urbanization, animal habitat encroachment, and the effects of climate change. (1) SARS, H1N1 influenza, and the novel coronavirus, classified as zoonotic diseases, are examples of how pathogens emerged from animal reservoirs to cause human catastrophe. These pandemics and several historical disease outbreaks emphasize how the equilibrium of these factors directly impacts future global health security. Climate change's impact on health can be seen in disturbances in the seasonal patterns and geographic locations of disease carrying insects {e.g., mosquitoes, ticks, and flies). These vectors have caused unusual patterns of Zika, dengue, malaria, West Nile, and other emerging diseases worldwide requiring state-of-the-art surveillance systems and response capacities. (19) Lastly, antimicrobial resistance, a byproduct of human behavior and our interconnectedness with animals and the environment, threatens our wellbeing in the context of a non-innovative antimicrobial development pipeline. The former remains absent from the IHR, further rendering the IHR insufficient to safeguard future international health security. Reforms must acknowledge the varied global health threats knocking at today's doorstop and the pace that they are arriving.

   The One Health Approach acknowledges the transdisciplinary view - the interconnectedness of humans, pathogens, animals, and the shared environment have a role in instigating emerging public health threats - and, thus , promotes linked disease surveillance and prevention efforts within these three areas. (20) One Health more precisely addresses prevention of zoonotic disease, antimicrobial resistance, effects of climate change, food safety, environmental contamination, and a wide-range of other public health threats. One Health's integration into IHR's components, such as national core capacity requirements for surveillance and response, would be beneficial to global health security. (21) Efforts have begun to include One Health approaches in pandemic response, (22) but further effort should be made to ensure this practice is commonplace, including by directly incorporating it into the IHR.

2. AN OVERARCHING OBSTACLE TO IHR COMPLIANCE- MEETING ANNEX 1 STANDARDS

   A key aspect of the IHR 2005 is the requirement that member countries meet certain domestic benchmarks regarding their healthcare capacity. Though sanitary conventions have long required that nations maintain certain disease monitoring capabilities at ports of entry, the IHR 2005 were innovative in obligating nations to meet minimum standards for domestic healthcare and health infrastructure. Annex 1 provides "minimum requirements" that States must meet in order to effectively detect and analyze possible health threats. Among these requirements are that the State "establish, operate and maintain a national public health emergency response plan" and "determine rapidly the control measures required to prevent domestic and international spread [of disease]." (23)

   Annex 1 's minimum standards are designed to ensure that every WHO Member State has the basic operational capacity to fulfil its obligations toward its own people and toward the international community. (24) The IHR 2005 envisioned the attainment of minimum standards for domestic health systems in all Member States by 2016 at the latest. (25) Despite these aspirations, the most recent survey of State compliance showed that twothirds failed to meet their Annex 1 obligations. (26) A recent review of 182 countries and their ability to respond to the COVID-19 pandemic revealed that countries' capacities to prevent, detect, and respond to outbreaks varied widely. Only half of the countries reviewed had adequate operational readiness or adequate response enabling functions (resources and coordination aptitude). (27)

   Failures to meet capacity benchmarks by States Parties are not indicative of widespread indifference toward global health security. Instead, it should be seen as a consequence of a lack of necessary funding to meet IHR requirements in many low-income nations - creating weak links in the global system. (28) When national funding for new projects is available, immediate concerns often take precedent over long-term projects to improve healthcare infrastructure. (29) In some instances, corruption and mismanagement worsen shortages. (30) The result is felt both at home and on the international stage. Domestically, residents of countries that fall below 1HR standards are less likely to receive adequate healthcare. (31) Internationally, the lack of infrastructure causes gaps in global health monitoring and increases the risk that a novel disease may develop and spread before it is detected. (32)

   Although funding is not the focus of this Essay, it is a key obstacle to IHR compliance for...