Use of Unapproved Medical Countermeasures During Public Health Emergencies: Comparing the United States and South Korea



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Biodefense includes the implementation of various activities related to biological warfare, bioterrorism, biosurveillance, emergency preparedness, and medical countermeasure (MCM) development. According to the narratives of historical institutionalism (HI), biodefense is an institution that has transformed by following a pattern of punctuated evolution due to exogenous shocks. However, other scholars criticize the meso-level analysis of the HI school of thought and emphasize the role of agency (endogenous factors) in institutional changes. This dissertation provides domestic-level, detailed accounts of how the biodefense institutions of the United States and South Korea have evolved by employing Thomas Birkland’s Event-Related Policy Change Model. According to Birkland’s model, the Emergency Use Authorization (EUA) policy, one of the representative biodefense policies, was legislated in the United States based on the lessons learned from Amerithrax in 2001, while Korea’s policy was based on the lessons learned from the Middle East Respiratory Syndrome (MERS) outbreak in 2015. Due to these divergent lessons arising from different focusing events (critical junctures), the US EUA stresses homeland security policy and follows an evolutionary path of strengthening post-exposure prophylaxis (PEP) missions. On the other hand, the Korean EUA pursues disease containment missions and follows an evolutionary path of strengthening diagnostic capabilities. Finally, the different features of the EUA policies in the two countries are the result of different testing outcomes during the early phase of the COVID-19 pandemic. This dissertation examines why the homeland security-centric US EUA struggled to integrate with other public health systems to support large-scale testing missions. Furthermore, policy recommendations for the United States, South Korea, and other countries pursuing an EUA policy are proposed.