Biodefense and Emergency Use Authorization: Different Originations, Purposes, and Evolutionary Paths of Institutions in the United States and South Korea
Abstract Background: Historical institutionalism (HI) determines that institutions have been transformed by a pattern of punctuated evolution due to exogenous shocks. Although scholars frequently emphasize the role of agency - endogenous factors – when it comes to institutional changes, but the HI analytic narratives still remain in the meso-level analysis in the context of structure and agency. This article provides domestic and policy-level accounts of where biodefense institutions of the United States and South Korea come from, seeing through emergency-use-authorization (EUA) policy, and how the EUA policies have evolved by employing the policy-learning concepts through the Event-related Policy Change Model. Results: By employing the Birkland’s model, this article complements the limitation of the meso-level analysis in addressing that the 2001 Amerithrax and the 2015 Middle East Respiratory Syndrome (MERS) outbreak rooted originations and purposes of the biodefense respectively. Since the crisis, a new post-crisis agenda in society contributed to establishing new domestic coalition, which begin to act as endogenous driving forces that institutionalize new biodefense institutions and even reinforce them through path dependent way when the institutions evolved. Therefore, EUA policy cores (Post-Exposure Prophylaxis (PEP) in the United States and Non-Pharmaceutical Intervention (NPI) in South Korea keep strengthened during the policy revisions. Conclusions: The United States and South Korea have different originations and purposes of biodefense, which are institutions evolving through self-reinforce dependent way based on the lessons learned from past crises. In sum, under the homeland security biodefense institution, the US EUA focuses on the development of specialized, unlicensed PEP in response to public health emergencies; on the other hand, under the disease containment-centric biodefense institution, the Korean EUA is specialized to conduct NPI missions in response to public health emergencies.