Biodefense and emergency use authorization: different originations, purposes, and evolutionary paths of institutions in the United States and South Korea

Abstract

Background Emergency-use-authorization (EUA) is the representative biodefense policy that allows the use of unlicensed medical countermeasures or off-label use of approved medical countermeasures in response to public health emergencies. This article aims to determine why the EUA policies of the United States and South Korea produced drastically different outcomes during the COVID-19 pandemic, and how these outcomes were determined by the originations and evolutionary paths of the two policies. Method Historical institutionalism (HI) explains institutional changes—that is, how the institution is born and how it evolves—based on the concept of path dependency. However, the HI analytical narratives remain at the meso level of analysis in the context of structure and agency. This article discusses domestic and policy-level factors related to the origination of the biodefense institutions in the United States and South Korea using policy-learning concepts with the Event-related Policy Change Model. Results The 2001 anthrax letter attack (Amerithrax) and the 2015 Middle East Respiratory Syndrome (MERS) outbreak prompted the establishment of biodefense institutions in the United States and South Korea, respectively. Due to the different departure points and the mechanism of path dependency, the two countries’ EUAs evolved in different ways—the United States EUA reinforced the Post-Exposure Prophylaxis (PEP) function, while the South Korea EUA strengthened the Non-Pharmaceutical Intervention (NPI) function. Conclusions The evolution and outcomes of the two EUAs are different because both policies were born out of different needs. The United States EUA is primarily oriented toward protecting homeland security against CBRN (chemical, biological, radiological, and nuclear) threats, whereas the South Korea EUA is specifically designed for disease prevention against infectious disease outbreak.

The Red Flag of Emergency Use Authorization (Eua)

“…The incompetence and negligence of the top leaders are key factors that have worsened the pandemic. However, this article argues that if the EUA policy is omitted as an independent variable, scholars could fall victim to the omitted variable bias (King, Keohane and Verba 1994). In order to illustrate the effectiveness of EUA during the COVID-19 pandemic—how EUA policy integrates with other supportive public health policies—this article introduces three factors: bio-surveillance, lab-partnership, and insurance system.…”

“…In the context of historical institutionalism, the U.S. biodefense system's pursuit of homeland security benefits was rooted in lessons learned from 9/11 and the 2001 Anthrax letter attacks, while the Korean biodefense system's pursuit of public health benefits, particularly in disease containment missions, was rooted in lessons learned from the 2015 Middle East Respiratory Syndrome (MERS) outbreak. Therefore, the EUA policy in each country reflected the features of their biodefense institutions: under the homeland security-centric U.S. biodefense, the U.S. EUA policy was much more focused on the mass treatment scenario (e.g., large-scale post-exposure prophylaxis (PEP) missions) using vaccines or therapeutic drugs in the case of bioterrorism or biowarfare, whereas under the public healthcentric Korean biodefense, the Korean EUA was designed to facilitate large-scale testing missions using in-vitro diagnostic kits (testing kits) in the case of infectious disease outbreak (Kim 2021). Consequently, the Korean EUA policy was easy to integrate with other public health systems supporting large-scale testing practices, especially public health surveillance, laboratory partnerships, and insurance systems.…”

“…According to the Birkland model, lessons learned from the 2001 Amerithrax increased the public attention to a new agenda highlighting ‘preparedness and response’ against bioterrorism, and facilitated the mobilization of a homeland security group (department of homeland security) in the United States. To overcome the limitation of meso‐level analysis in historical institutionalism, Kim (2022) adopts the Birkland model to demonstrate the dynamic of structure and agency in South Korea's institutional change; lessons learned from the 2015 MERS outbreak fostered public attention to a new agenda highlighting “disease containment” to cut the chain reaction of disease transmission, and facilitate the mobilization of a public health group (epidemiologists in the Korea Center for Disease Control and Prevention, KCDC).…”

“…Therefore, the bottom line of the U.S. EUA policy is “homeland security,” although the “emergency preparedness” domain from Hurricane Katrina in 2005) and the “disease control and prevention” domain by the H1N1 pandemic in 2009) are built up over the “homeland security” domain. Similarly, South Korea has built up a new “radioactive containment” domain over the previous “disease containment” domain (Kim 2022). Due to the policies’ different evolutionary origins, the U.S. EUA still gave more weight to counter‐CBRN activities and objectives during the COVID‐19 pandemic, while the Korean EUA focused on diagnostic capabilities, enabling superlative disease containment missions.…”

The Korean 3T Practice: New Biosurveillance Model Utilizing New Information Technology and Digital Tools (Preprint)

“…Disasters (eg, pandemic or 9/11 terrorism) often provide lessons that a country can learn from; these disasters are focusing events that lead to the adoption of new policies due to the increased attention on a new agenda and for the mobilization of interest groups [24,25]. Indeed, after the 2015 MERS outbreak, disease containment and epidemiology became the center of the public health policy agenda in Korea, which highlights nonpharmaceutical interventions in considering how to build effective "diagnose and detect" capabilities to break the chain reaction of infectious disease transmissions [26]. Therefore, the lessons learned from the 2015 MERS experiences affected all public health-related areas in Korea and laid the groundwork for the institutionalization of the post-MERS Korea public health systems to function efficiently during the COVID-19 pandemic [27].…”