Coherent explanatory power to Back up historical institutionalism

The new HI literatures give more attention to endogenous factors but still remain limited to meso-level analysis which can hardly explain “how it actually changed?” To compensate for the lack of adequate descriptive power in explaining how political behaviors are shaped by the interaction of structure and agency, some scholars borrow the concept of policy-learning [28,29,30]. The learning process by which participants use information and knowledge to develop, test, and refine their beliefs becomes the center of academic debates [31,32,33,34].

Thomas Birkland developed a policy learning model illustrating how a society learns lessons from focusing events (exogenous shocks) that facilitate policy changes within the society (seeing Fig. 1). He emphasizes the emergence of policy domain as a learning result from focusing event. The policy domain is generally defined and studied as a component of the political system that is organized around substantive issues. Policy domains are largely socially constructed, varying with issues and politics, which leads to legislative enactment of major policy change [35]. Therefore, groups of congregated agencies (namely, society or the public) and the dynamic interactions among agencies such as conflicts and contests between agents (e.g., turf war) become the centers of institutional change. Birkland’s model contributes to explaining the role of exogenous shocks (critical junctures or focusing events) as facilitators for endogenous dynamics, which can increase public attention on a problem and lead to the emergence of a new policy domain resulting in policy changes [36].

Fig. 1

Event-Related Policy Adopting/Changing Process

This model effectively demonstrates the mutuality between structure and agent in addressing that once an exogenous shock triggers the emergence of new political agenda and political behaviors of agents, the endogenous forces lead to institutional changes; but the newly mobilized endogenous factors also perform a vital role of sustaining and reinforcing policy cores. Therefore, from the time a group is mobilized after a crisis, the group remains in the society and plays a significant role in strengthening policy cores (e.g., PEP and NPI) owing to the mechanism of self-reinforcement. The case study in the next chapter illustrates how a homeland security group was mobilized in the US after the 2001 Amerithrax and why the policy core (PEP) of the US EUA was strengthened by two policy revisions after Hurricane Katrina (2005) and the H1N1 pandemic (2009). Similarly, epidemiologists were mobilized in Korea after the 2015 MERS outbreak, and the policy core (NPI) of the Korean EUA was strengthened by a revision made due to the 2018 trade war with Japan.

Case study of the United States Twin focusing events (9/11 and Amerithrax) and a new agenda (counterterrorism)

The adoption of the homeland security policy domain dominated all areas and fields of the post-9/11 movement in the United States. The former Secretary of DHS under the Obama administration, Janet Napolitano, views, in retrospect, that Americans in 2001 - including both ordinary citizens and those in the highest levels of the US government - were seized by a national sense of paranoia and dread of terrorism [37]. The emergence of the homeland security domain in parallel with expanding counter-terrorism efforts mobilized the homeland security group. President G.W. Bush issued Executive Order 13228 on 8 October 2001, which established the Office of Homeland Security within the Executive Office of the President. Executive Order 13228 called for the coordination of US national efforts against terrorism threats and, consequently, contributed to the mobilization of the homeland security group.

Along with the increasing concerns of conventional terrorism threats emerging from 9/11, the 2001 anthrax letter attacks added a new concern of terrorists exploiting weapons of mass destruction (WMDs), especially with regards to biological weapons. Counterterrorism and WMD nonproliferation became the top priority for US policy agendas following 9/11 and Amerithrax in 2001. To protect the US homeland and population, it was deemed necessary to recognize emerging CBRN terrorism as a potential new type of public health threat. On 12 October 2001, Vice President Dick Cheney stated that it is “reasonable” to assume the anthrax attacks were linked to the 9/11 terrorist attacks, because al-Qaeda-trained operatives know “how to deploy and use these kinds of substances [weaponizable biological and chemical materials]” [38]. At a 15 October 2001 press conference, President George W. Bush stated that “there may be some possible link” between the anthrax-contained envelopes and Osama bin Laden, adding “I wouldn’t put it past him” [39].

Accompanying the increasingly political narratives concerning CBRN terrorism threats, the majority of the post-Amerithrax evaluations and investigations held critical reviews for all levels of the US public health emergency system and made policy recommendations for what should be done in such future scenarios with focuses on preparedness and response. For example, the US Defense Threat Reduction Agency (DTRA) and Center for Strategic and International Studies (CSIS) published a joint post-event analysis report. The US DTRA-CSIS report concludes that the 2001 anthrax letter attacks, along with the September 11th attacks, forced the United States to confront new threats –terrorism within the homeland and the proliferation of WMDs - thus assigning public health as a key element to US defense [40].

Homeland security group mobilized

The National Commission on Terrorist Attacks Upon the United States (also known as the 9/11 Commission) was established on 27 November 2002 by Public Law 107–306. The law directed the 9/11 Commission to investigate “facts and circumstances relating to the terrorist attacks of September 11, 2001,” including those relating to intelligence agencies, law enforcement agencies, diplomacy, immigration issues and border control, the flow of assets to terrorist organizations commercial aviation, the role of congressional oversight and resource allocation and other areas determined relevant by the Commission [39]. The post-9/11 counterterrorism efforts expanded in scope to include the non-traditional counter-terrorism disciplines and began to consolidate them to one name: homeland security. Finally, the Homeland Security Act of 2002 was enacted on 25 November 2002, which authorized the establishment of the US Department of Homeland Security (DHS). The Homeland Security Act is a historical milestone of US national security that mobilized resources and efforts across all levels of government to deal with terrorism threats. The Homeland Security Act of 2002 brought many responsibilities for public health preparedness and response within one department (DHS), which was composed of 180,000 personnel from 22 federal organizations.

The newly formed homeland security group embraced biodefense topics since its origin following Amerithrax. In other words, biodefense became one of core subjects of counterterrorism through homeland security efforts. On 12 June 2002, the Public Health Security and Bioterrorism Preparedness and Response Act (PL 107–188, 2002; also known as the Bioterrorism Act [41]) was signed into effect. The purpose of this law was to strengthen national preparedness for bioterrorism and other public health emergencies, giving much more weigh to security benefits over public health benefits. One of the most notable biodefense inventions created by the Bioterrorism Act was the concept of “Select Agents” to tighten control and restrict access to certain dangerous biological agents and toxins. Also, it established the Strategic National Stockpile (SNS) to maintain a stockpile of medical countermeasures and necessary supplies in the event of bioterrorism or another public health emergency [42].

Both the Public Health Security and Bioterrorism Preparedness and Response Act and Homeland Security Act of 2002 solidified the urgency of CBRN terrorism threats as the post-9/11 and post-Amerithrax homeland security domain overtook public health domains. The United States government immediately reacted to the September 11th and the anthrax letter attacks as one event, which lumped public health issues into homeland security benefits. The US General Accounting Office (GAO) released a post-Amerithrax evaluation report. Written for the US Senate, that emphasized the need to reinforce and expand the benefits of public health preparedness and rapid response. On the first page, the GAO report clearly states its purpose: “Because of [the Senate’s] interest in bioterrorism preparedness, you asked GAO to review the public health response to the anthrax incidents” [43].

Finally, President George W. Bush introduced homeland security as the new agenda of the United States government by issuing the Homeland Security Presidential Directive-10 (HSPD-10, or often called to Biodefense for the twenty-first Century) in April 2004. The Homeland Security Act of 2002 was enacted on November 2002, which authorized the establishment of the US Department of Homeland Security (DHS). The homeland security group was deeply involved with the discussion of idea about biodefense as well as the legislation of Project Bioshield Act as seeing the issuance of the Homeland Security Presidential Directive-10 (HSPD-10). The title of the HSPD-10 – Biodefense for the twenty-first Century – clearly signs that biodefense was initially subordinate to the homeland security domain. The overall tone of the HSPD-10 is, as the title of the document hints, a security-oriented narrative about defending the US territory and population against biological threats. The main sentence of the HSPD-10 announces that “the United States will continue to use all means necessary to prevent, protect against, and mitigate biological weapons attacks perpetrated against our homeland and our global interests” [44].

Biodefense and idea discussed

After the anthrax letter attacks of 2001, common themes of after-action reports and lessons learned analyses emphasized the need for reinforcing and expanding the benefits of “public health preparedness” and the importance of “rapid response” against chemical biological, radiological and nuclear (CBRN) threats [45, 46]. In terms of preparedness and response for national emergencies, particularly bioterrorism events, the mass use of post-exposure prophylaxis (PEP) emerged as key necessity to US biodefense [40]. Vaccines and PEP have quite different medical purposes. A vaccine is an ex-ante biological preparation administered before an actual infection in order to provide active acquired immunity to a particular infectious disease, while a PEP is an ex-post preventive medical treatment administered after expected exposure to a particular infectious disease in order to prevent becoming infected. During the anthrax letter attacks, an estimated 10,000 individuals, including postal workers, were potentially exposed to B. anthracis and advised to take PEPs to prevent inhalational anthrax. However, the US Center for Disease Control and Prevention (CDC) floundered when making a clear decision about the use of prophylaxis. The CDC should mandate specific public health actions, particularly for administration of antibiotic prophylaxis, but there were huge confusions and time-delays surrounding the CDC’s recommendations [47,48,49]. The United States did not develop emergency response and preparedness measures that strengthen the effectiveness and timeliness of dispensing antimicrobials and vaccines for PEP. Early on, the CDC recommended two antimicrobial prophylaxes – doxycycline and ciprofloxacin – as the post-event countermeasures. However, CDC later selected only doxycycline as a single MCM due to issues regarding efficacy, resistance, side effects, and cost [47].

Moreover, the initial post-exposure prophylaxis (PEP) program recommended 60 days of antimicrobial PEPs (either doxycycline or ciprofloxacin), but later the CDC issued an extended regimen for 40 additional days [47]. The extension was recommended with or without three doses of anthrax vaccine adsorbed (AVA) under an investigational new drug protocol as an extended PEP program [48]. The CDC, as the central federal agency for public health, failed to make timely and appropriate decisions about the use of antibiotic prophylaxis, which caused massive confusion for local-level public health practices during the emergency. Gursky, Inglesby, and O’Toole also point out that it was hard for the CDC as such a research organization to make timely and decisive operational actions at the local level under scientific uncertainties. The key uncertainty in this crisis was the use of post-exposure chemoprophylaxis, for which the CDC struggled to address because it is “a research-based organization, far removed from how public health is delivered” [50].

Legislation of the Project Bioshield Act & EUA

The prophylaxis-related issues became the center of lessons learned from the 2001 anthrax letter attack. Most post-event evaluations emphasize that the inefficient coordination between governmental levels resulted in delayed and inappropriate response actions. Particularly, the necessity of a central agency that can perform risk versus benefit-based decision making emerged with the issues relating to the use of prophylaxis. Finally, President George W. Bush signed the Project BioShield Act of 2004 into law, which facilitated the development of MCMs against CBRN agents. The Project BioShield Act was designed to strengthen public health emergency preparedness and response by ensuring the authority of the US government to develop, acquire, stockpile, and make available the medical countermeasures needed to protect the population against WMDs [51]. The implementation of Project Bioshield consists of three major duties: funding needed countermeasures, facilitating research and development, and facilitating the use of MCMs in an emergency; the Emergency Use Authorization (EUA) is one of three main pillars of this Project Bioshield [52]. The US EUA became a legal framework in which the Food and Drug Administration (FDA) is allowed to approve the use of unapproved new MCMs or new off-label indications for previously approved MCMs during a declared emergency.

Evolution of the EUA: PAHPA and PAHPRA

The Project Bioshield Act has evolved and revised via the Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA) after the Hurricane Katrina (2005) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) after the 2009 H1N1 pandemic. The experience of the Hurricane Katrina (2005) provides the United States the significant lessons to adopt the concept of “all-hazard emergency preparedness” integrating biodefense with public health areas [18]. The 2009 H1N1 global pandemic provided lessons that the US public health preparedness faces a lack of available testing tools as well as countermeasures for emerging infectious diseases [53]. Due to the different public health and security environments, the Bush’s administration’s biodefense strategy has focused on preparing for and responding to public health threats, the Obama’s biosecurity strategy gives the emphasis on prevention efforts [54]. The homeland security domain made by the Amerithrax began to embrace the concept of “emergency preparedness” by the PAHPA of 2006 after Hurricane Katrina and the concept of “disease control and prevention” by the PAHPRA of 2013 after the H1N1 influenza pandemic. Together with these two revisions, the scope of EUA policy broadened from CBRN terrorism threats to other types of threats such as naturally occurring and accidental events.

Although the scope of the EUA policy expanded in accordance with the PAHPA of 2006 and the PAHPRA of 2013, these two revisions of the EUA policy shared the same path of development with the policy core – the use of unlicensed MCMs as post exposure prophylaxis (PEP) which has kept in the baseline of the newly expanded EUA policies. Under the PAHPA of 2006, two EUA models for doxycycline – the US Postal Service and City Readiness Initiatives (CRI) – were granted. The EUA for doxycycline was combined with mass dispensing models through the US Postal Service and City Readiness Initiatives. These two doxycycline EUA models illustrated that the US biodefense community finally reached an important conclusion from the 2001 anthrax letter attacks: the need to strengthen mass dispensing of PEPs. CRI involves 72 major metropolitan areas and all 50 states, and primarily aims to develop the mass capabilities to provide PEP to 100% of the identified population within 48 h of notification to do so. The United States Postal Service (USPS) is one of the key players in the CRI plan because USPS can deliver antimicrobials (doxycycline hyclate tablets) in the case of an anthrax attack and its medical instructions to residential households within 48 h [55]. Therefore, as seeing Fig. 2, the EUA for doxycycline hyclate tablets, in conjunction with the CRI program, completed the mission of mass and timely distribution of PEPs.

Fig. 2

A Structure of the US Biodefense Institutions

The PAHPA of 2006 was reauthorized by the name of PAHPRA of 2013, and reinforced the mission of mass and timely dispensing of PEPs. The PEP programs for doxycycline such as City Readiness Initiatives are further reinforced by the emergency dispensing order and emergency use instruction (EUI) granted by the PAHPRA of 2013. Both the emergency dispensing order and EUI are advanced forms of the biodefense policy. The FDA explained that the emergency dispensing order authority can “strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of eligible, approved MCMs needed during public health emergencies without FDA needing to issue an Emergency Use Authorization” [56]. The EUI authority allows the CDC director to facilitate “the availability of streamlined information about the use of eligible, approved MCMs needed during public health emergencies without FDA needing to issue an Emergency Use Authorization” [56].

Case study of South Korea Focusing events (2015 MERS) and new agenda (disease containment)

A businessman returning from Bahrain on 4 May 2015 felt sick. Although the businessman visited three different hospitals, no medical professionals suspected that he may have been infected with Middle East Respiratory Syndrome (MERS). The businessman had just returned from a trip to the Middle East; by visiting so many hospitals while the businessman was contagious, he unknowingly infected many healthcare workers and patients with MERS. MERS-CoV, the virus that causes MERS, is a member of the coronaviridae family. Same as SARS-CoV-2 causing COVID-19, MERS-CoV features non-specific flu-like symptoms, asymptomatic, and pre-symptomatic transmission, which is hard to identify early. The invisible disease was rapidly spread in Korea by the two amplifiers – nosocomial infection and super-spreader.

First, the MERS outbreak became intensified by nosocomial infection within hospitals [57]. Nosocomial infections, referred to as healthcare-associated infections (HAI), are infections acquired during the process of receiving health care services. In general, hospitals are hubs for sick people who are vulnerable to any kind of infectious diseases. Hospitals unwittingly became the major routes or places of transmission for the 2015 MERS outbreak in South Korea. For example, 85 of the 186 confirmed MERS cases occurred among healthcare workers at Samsung Hospital, the largest general hospital in South Korea. Also, St. Mary’s Hospital in Pyeongtaek, one of the three hospitals visited by patient zero, became the most notorious virus breeding spot infecting 28 people. Second, super-spreaders became another disease amplifier of the MERS outbreak. The businessman (patient zero or index patient) started a chain reaction of disease transmission in multiple hospitals, rendering him a “super-spreader” [58]. This chain reaction of MERS infections further perpetuated transmission as those infected persons sought medical attention at other facilities. The Korea Society of Infectious Disease emphasized the role of five super-spreaders during the MERS outbreak. Case 1 (or patient zero) infected 28 people, case 14 infected 85 people, case 15 infected 6 people, case 16 infected 23 people, and case 76 infected 11 people. These five super-spreaders created 82.3% of the total confirmed cases – 153 cases of 186 total cases [59]. Due to nosocomial infections and super-spreader issues, Korean society descended into chaos; no one knew which hospitals were safe and no one knew who are infected and spread the disease. Containment of the invisible disease spread within society was the first priority for the Korean public health authority.

Mobilization of the public health group

The Korea National Assembly established a Special Committee for MERS Prevention in July 2015, which held congressional hearings nine times during the MERS outbreak. The main purpose of the Special Committee was to determine why mass infections were occurring in hospitals and what the ministries responsible for the MERS outbreak did to contain the outbreak. Directors and physicians at the hospitals where the MERS infection had occurred were summoned for hearings where they were asked about the results of epidemiological investigation into mass-infections at their hospitals [60, 61]. Finally, the Special Committee passed a resolution for “reforming national infection prevention and control system” and requested an investigation by the Board of Audit and Inspection (counterpart to the US General Accounting Office) in the Assembly plenary session in August [62]. Based on the Congressional resolution, the Korean government introduced a policy plan, “Measures to Reform National Infection Prevention and Control System for the Purpose of Immediate Response to Emerging Infectious Diseases.” Based on this plan, Korea Center for Disease Control and Prevention (KCDC)’s capabilities and authorities were expanded, and 24-h-a-day Emergency Operation Centers staffed by full-time epidemiologists were created in order to lead the initial response to reports of a new disease outbreak [63].Footnote 3

Idea discussed and emergence of disease containment

In 2016, the Ministry of Health and Welfare published the 2015 MERS Outbreak in the Republic of Korea: Learning From MERS, or simply the “2015 MERS White Paper.” According to this report, the 2015 MERS outbreak was terminated, not by new biomedical technologies, but by traditional disease prevention practices such as epidemiological investigations that identified sick patients who were isolated and exposed individuals who were quarantined [64]. In the absence of medical countermeasures for the treatment or prevention of MERS, non-pharmaceutical interventions (NPIs), such as contact tracing, isolation, and quarantine, became the foundation of South Korea’s public health response. Korea society leaned from the 2015 MERS outbreak that any delay in diagnosing, treating, and isolating an infected patient could unintentionally and unknowingly allow that patient to become a super-spreader. The Korea National Assembly concluded to add Article 34–2 (Disclosure of Information during Infectious Disease Emergency) of the Infectious Disease Control and Prevention Act. This legislation effort implies that accurate and timely diagnostic capabilities are key to identify cases who were infected and who need to be epidemiologically investigated. In other words, diagnostic capabilities are paired with epidemic investigation efforts and epidemic information disclosure policy which becomes the foundation of a new policy – 3 T practice (testing, tracing, and treatment) – later in the COVID-19 pandemic [65]. The Health and Welfare Committee of the National Assembly held a panel discussion on 27 August 2015 on how to reform the public health system to respond more effectively to pandemics. Panelists from government, academia, and private sectors discussed six topics, most of which were related to Korea’s diagnostic capabilities [66]. Also, the Korean Academy of Science and Technology held a round-table discussion with medical professionals about the MERS outbreak and future response plans on 1 July 2015. The participants emphasized the adoption of a US-style EUA policy is essential to identify and trace cases as early as possible [67].

EUA legislation in the Medical Device Act

To solve the super-spreader issue, South Korea public health authority adopted EUA policy, officially entitled The Emergency Use Authorization of In-Vitro Diagnostics for Infectious Disease. The South Korea government added two clauses regarding the emergency use of diagnostics within “Enforcement Regulations of the Medical Device Act.” Unlike the US EUA legislated in a stand-alone Bill (the Project Bioshield Act), the two clauses (Paragraph 7 of Article 10 and Paragraph 7 of Article 32)Footnote 4 were added in the “Enforcement Regulations of the Medical Device Act” as a legal basis for the emergency use of in-vitro diagnostic kits. According to this law, by commissioner of KCDC, the commissioner of KFDA issues the exemption of testing kit’s examination (authorizing emergency use or called to as EUA) in the case of a public health emergency defined in the Infectious Disease Control and Prevention Act. Because of the legal parameters of the Medical Device Act, the Korean EUA is only applicable to medical devices, such as in-vitro diagnostic (IVD) kits. In contrast to the US approach, which defines MCMs broadly, the Korean EUA cannot issue the use of novel vaccines or therapeutic drugs.Footnote 5

Evolution of the EUA: Zika and MERS in 2016, and radioactive contamination

Korea’s new EUA policy was first tested in 2016 following the emergence of Zika in South Korea. Among the 14 cases of ZIKV (Zika virus) infection in total from March to October 2016, 9 cases were confirmed by July [68]. On 12 August 2016, the KCDC announced the first issuance of an EUA, which was for MERS diagnostic kits and Zika diagnostic kits. Based on lessons from the 2015 MERS outbreak about the importance of large-scale testing, the Korean public health authority encouraged the private sector to actively participate in testing practice. Same as the purview of the US EUA expanded from bioterrorism to all-hazards, the purview of the Korean EUA also expanded; from infectious diseases to radioactive contamination along with a nuclear crisis in the neighboring country – Japan, as seeing Fig. 3. When a tsunami created a nuclear crisis at Fukushima, Japan in 2011, the world was reminded of the radioactive nightmare of the 1986 Chernobyl disaster. South Korea, as a neighboring country of Japan, paid highest attention to potential radioactivity-related issues and banned the import of Japanese seafood produced by the eight provinces near Fukushima. In May 2015, Japan initiated legal proceedings at the World Trade Organization (WTO), arguing that Korea’s import ban was unreasonable [69].

Fig. 3

A Structure of the South Korea Biodefense Institutions

As the conflict escalated, however, South Korea decided to appeal the ruling and maintain the ban. Also, the Medical Device Act was revised in 2018 to include the threat of a radiological emergency. Instead of legislating a new policy for radiation exposures medications such as iodine or anti-cancer drugs, the purview of the Korean EUA was expanded to include radioactive contamination under the Medical Device Act. The South Korean media raised suspicion that the Korean government aimed to exercise stricter rules for radioactive inspections to all importing products from Japan, as a countermeasure to the Japanese export restrictions [70]. It is worth noting that the Korean EUA was developed along the existing path emphasizing diagnosis (detection), a process of path dependency. Article 46–2 (Special Cases concerning Medical Devices in Cases of Infectious Disease Pandemic) clearly addresses its component of EUA policy that “respond[s] to [an] infectious disease pandemic under the Infectious Disease Control and Prevention Act or radiological emergencies under the Act on Physical Protection and Radiological Emergency” [71].