Abstract

Context: Regulatory approaches to COVID-19 vaccine authorizations varied substantially across countries. Facing a common public health threat, what accounts for regulatory variation? This study focuses on emergency pharmaceutical and vaccine regulatory procedures and whether and how regulators' emergency pharmaceutical regulatory procedures going into the pandemic shaped regulatory processes and decisions during the pandemic.

Methods: The authors conducted an analysis of seven high-impact national and international pharmaceutical regulators with case studies from Brazil, China, India, Russia, the United Kingdom, the United States, and the European Medicines Agency. The authors analyzed evidence from primary source executive and legislative branch regulations and statutes as well as national and international scientific and general press reporting; they also drew on the secondary analysis of scholars, practitioners, and international organizations.

Findings: Inherited emergency pharmaceutical and vaccine regulatory procedures substantially shaped COVID-19 vaccine regulation during the pandemic. Variation in the presence and content of emergency regulatory procedures affected the quality of pandemic regulatory processes, outcomes, and procedural updates and differentially empowered policy-making experts and elected politicians.

Conclusions: Emergency regulatory procedures affect key features of regulatory political economy and public health practices during crises. To improve future public health crisis responses, the authors provide policy recommendations for (1) establishing clear emergency pharmaceutical regulatory procedures, and (2) international collaboration.

Policy responses to the COVID-19 pandemic present unique opportunities to understand key features of health politics and policy, and their study can help improve policy making during future public health emergencies (Greer et al. 2021; Lynch and Gollust 2021; Oberlander 2020). Among other subjects, examinations of pandemic policy responses have emphasized the centrality of pharmaceuticals and vaccines, particularly product development and funding, regulatory authorization and approval, and production, procurement, distribution, and administration (Fernandez Lynch et al. 2021; Kesselheim et al. 2021; Thomson and Nachlis 2020). Analyses of the political economy of COVID-19 vaccines have generally highlighted themes central to the study of political economy, including issues of political influence, bureaucratic independence, regulatory capture, public-private partnerships, economic nationalism, and social inequality and equity (Fonseca et al. 2022).

In this article we emphasize an important but underappreciated component of the political economy of emergency responses generally, and of the COVID-19 pandemic policy response specifically, by examining emergency regulatory processes for approving drugs and vaccines. Theoretically, because new crises are often addressed using old laws and regulations—themselves designed to address not the present crisis, but either more general policy issues or the specific circumstances of earlier crises—inherited emergency regulatory procedures are central to how a new emergency like the COVID-19 pandemic is addressed. This core historical institutionalist dynamic, in which old policies shape present policy making, can be particularly influential during such emergencies, where swift policy making is required and an idealized policy-making approach of slowly and deliberately creating an optimal new policy from a blank slate is a remote possibility at best (Nachlis 2018). Substantively, given the centrality of vaccines and pharmaceuticals to the pandemic policy response, we focus on inherited emergency regulatory procedures for the authorization and approval of pharmaceuticals and vaccines.

We analyze seven high-impact national and international pharmaceutical regulatory bodies, with case studies drawn from Brazil, China, India, Russia, the United Kingdom, the United States, and the European Medicines Agency. We pay particular attention to the emergency regulatory procedures agencies had in place—if any—going into the pandemic as well as changes made to those processes to address the pandemic and provide clarity to regulatory pathways for vaccines as the public health emergency progressed. We examine the standard tensions of political economy that can arise between the preferences of scientific and policy-making experts in agencies and firms and the sometimes contrary political preferences of elected officials.

Overall, we find substantial variation in regulators' standing emergency procedures before the pandemic. Importantly, we find that this variation in prepandemic emergency pharmaceutical regulatory procedures corresponded with significant variation in regulators' approaches to the authorization and approval of COVID-19 vaccines during the pandemic, and, in many cases, to the political tensions surrounding vaccines. We show that during the frenzy and uncertainty of crises, inherited emergency regulatory procedures significantly shape the interactions between public actors and firms and between elected politicians and civil servants. Critically, emergency regulatory procedures substantially affect the relative balance of power across these groups. By placing emergency policy-making responses on either predictable or uncertain paths and by constraining or enabling elected officials' political interventions into the scientific and regulatory decisions made by public and private experts, these procedures materially affect features of crisis policy responses that can have significant consequences for public health. The pandemic experience therefore demonstrates not only the underappreciated importance of inherited emergency regulatory procedures but also that emergency regulatory procedures deeply shape dynamics central to political economy.

From this analysis we derive two sets of policy recommendations. First, we argue that national pharmaceutical regulatory authorities should establish clear emergency regulatory procedures, and we outline a set of dimensions on which they might focus their attentions. Second, we argue for increased international collaboration across key regulators on issues related to emergency pharmaceutical regulatory procedures.

The scope conditions of these policy recommendations—for establishing clear emergency regulatory procedures in advance of crises, and for international collaboration—are important, particularly given the difficulties of direct legal transplantation across venues. That is, because simply copying regulations across countries without adapting them to local legal, political, and institutional circumstances is unlikely to succeed, our recommendations are principally procedural rather than substantive (Berkowitz, Pistor, and Richard 2003; Engel and Weinshall 2022; Goldbach 2019). We argue that, as a procedural matter, countries should establish clear emergency regulatory procedures before crises arise and should seek out opportunities for international collaboration. As the literature on legal transplantation makes clear, though, the particular substantive forms that such regulations take will need to be sensitive to local legal, political, and institutional factors. Of course, it is certainly possible that such procedural recommendations, if pursued, could contribute to a process that ultimately yields substantive policy coordination, harmonization, and convergence over time, as has already occurred globally for pharmaceutical approval processes, for example (Pezzola and Sweet 2016; Vogel 1998), although not yet in related areas such as postmarketing regulation or emergency regulatory procedures. Here we simply provide procedural starting points that may, but need not necessarily, facilitate some downstream convergence.

Collectively, at minimum, these recommendations could help improve regulation during future emergencies. More broadly, these findings and recommendations show that an appreciation of emergency regulatory procedures can enhance scholars' understandings of the political economy of regulation and practitioners' efforts to successfully combat future public health emergencies.

Regulatory Procedures, Emergencies, and Political Economy

Crisis Political Economy

Emergencies require policy makers to respond quickly to new circumstances while maintaining sound policy-making standards and procedures. This requires procedures that properly balance different policy makers' competing approaches, particularly the democratic responsiveness that elected politicians provide and the technical rigor that civil servants provide. Emergencies are also key moments of historical contingency, as historical institutionalist scholarship emphasizes (Capoccia and Keleman 2007; Soifer 2012). Scholars of political economy similarly underscore the substantial uncertainty surrounding policy-making efforts occurring during these intense sui generis episodes (Shenai 2018). The analytic puzzle of crisis political economy, then, becomes a question of which factors fill this policy-making uncertainty and shape emergency policy responses.

A range of scholarship offers broad, overarching models of crisis political economy. Given emergencies' speed, complexity, and newness, some accounts find that policy-making uncertainty in emergencies can devolve into ad hoc approaches. Emergency “adhocracy” can yield procedural shortcomings that undermine policies' perceived legitimacy and can result in substantively suboptimal policies (Wallach 2015). Such ad hoc emergency responses often persist beyond their animating emergencies, a persistence variously characterized by different analysts as unnecessary and harmful government expansion, antidemocratic state-market collusion, irrational emergency ratcheting, or, alternatively, objectively necessary and normatively desirable moments of state-building (Ackerman 2006; Frymer, Gottschalk, and Johnson 2022; Higgs 1987).

More granularly, scholars emphasize a range of specific factors that consistently shape policy responses during crises. Chief among these are preexisting social, economic, demographic, and cultural inequalities, with a range of scholarship demonstrating that emergencies reflect and magnify existing dimensions of social stratification (Sledge et al. 2022; Willison et al. 2019). Beyond inequality, key domestic factors shaping emergency policy responses include private firms and issues of regulatory capture, public expertise and issues of bureaucratic and state autonomy, electoral and political incentives, public health infrastructure, political polarization, and, quite often, the tensions that can arise among elected politicians, expert civil servants, and private firms (Carpenter and Moss 2013; Wallach 2015). International dynamics further shaping crisis political economy include variation in levels of economic development, democratization, global integration, state capacity, regionalism, and issues of economic nationalism (Fonseca, Shadlen, and Bastos 2021). During the public health response to the COVID-19 pandemic, all of the dynamics above shaped outcomes (Fonseca et al. 2022; Greer et al. 2021).

Emergency Regulatory Procedures

Shaping these factors' roles across many cases is the broader historical institutionalist dynamic of new emergencies being addressed using old policies. Because emergencies are often unique and sudden, they make a slow and deliberate policy-making approach untenable, forcing policy makers to deploy whatever expedient tools appear to be available. For this reason, policies and regulations designed to address an earlier crisis or more general policy issue are often deployed later to combat a specific new crisis. Thus, the stronger and clearer the inherited emergency policies and regulations are, the easier it may become to combat a new crisis (Nachlis 2018).

Scholars of recent financial crises are particularly attentive to these dynamics. They lament the ad hoc approaches with which financial crises have been addressed and argue that it is essential to have rigorous emergency procedures on the books ex ante that allow for swift and flexible, and also rigorous and sound, policy responses. Scholars and leading financial regulators emphasize that it is best to have sound emergency regulatory procedures in place beforehand (Bernanke, Geithner, and Paulson 2019; Shenai 2018; Wallach 2015). This would allow for more predictable crisis operations, fewer procedural and substantive policy-making inefficiencies, fewer unanticipated tensions, and fewer policy-making errors.

Following this logic, we argue that inherited emergency regulatory procedures are an additional fundamental component of public health crisis responses. Because new crises are addressed using old policies, and because crisis responses require both swiftness and rigor, the presence, absence, and quality of standing emergency regulatory procedures can substantially shape crisis responses.

Standing emergency regulatory procedures also interact with other key concerns of crisis political economy, including by potentially (dis)empowering different elected and appointed policy makers. Broadly, emergency regulatory procedures can channel, harmonize, rationalize, and legitimize policy making during the uncertainty of crises. Emergency regulatory procedures can also allocate policy-making responsibility among political actors on contested issues, set responses on procedurally predictable paths, and help determine the procedural and substantive quality of crisis policy decisions. Over and above standard factors influencing crisis political economy, and also in conjunction with them, emergency regulatory procedures can significantly affect crisis policy responses and shape these key moments of historical contingency and policy uncertainty.

Cases

Case studies are drawn from seven major pharmaceutical regulatory bodies, including in Brazil, China, India, Russia, the United Kingdom, the United States, and the European Medicines Agency. These are all high-impact cases central to the study of pharmaceutical regulation and the COVID-19 pandemic, representing leading and influential regulators and large and influential countries, and providing variation on dimensions including region, economic development, and democratization. Evidence is drawn from primary source executive and legislative branch regulations and statutes, national and international scientific trade press and general interest media reporting, and the secondary analysis of scholars, practitioners, firms, and international organizations.1

We focus on the earliest vaccines taken up for regulatory review in each country. Regulators review only what firms ask them to review, so the earliest-reviewed products vary across countries based on market penetration and access, buying power, clinical trial standards, and vaccine nationalism. Importantly, these are the most probative cases of interest with respect to the political economy of drug regulation during the COVID-19 pandemic, as they occurred at the height of political pressures, procedural frenzy, and the sheer fog of crisis decision-making. They also set the stage for how the public and international community would approach particular authorization decisions, with implications for public health and perceptions of legitimacy.2

Case Studies of Emergency Vaccine Regulation during the COVID-19 Pandemic

The Political Economy of Pharmaceutical Regulation

Pharmaceutical regulators evaluate medical products, principally drugs and devices, for safety and efficacy. Prototypically, they rely on maintaining their reputations for expertise and credibility to sustain their policy-making independence and resist political intervention. Ideally, they base their decisions on compelling scientific data and clear regulatory standards and then transparently relay the processes and evidence underlying their decisions. They also generally embrace a risk-averse approach and fear the potential public opinion and public health costs of letting harmful products onto the market. In broad terms, the archetype for these structures (political independence and scientific credibility) and incentives (risk aversion) is the United States Food and Drug Administration (FDA). The FDA, often cast as the world's most powerful regulatory agency, provides a model reflected in other national and international pharmaceutical regulatory bodies, which are influenced by the FDA's structure and decisions (Carpenter 2010).

Case Studies

United States

The FDA sits within the Department of Health and Human Services under its secretary, with a commissioner appointed by the president. Although the commissioner and secretary can overturn decisions by the agency's staff, decisions of the FDA's internal and external scientific advisors are almost always followed, and no commissioner has ever been replaced because of a policy disagreement (Carpenter 2010).

A policy-making environment like the COVID-19 pandemic, however, in which a fast response to a devastating public health problem was required, could have upended the FDA's traditionally slow, deliberate, and rigorous approach. Notably, controversies in early to mid-2020 over the Emergency Use Authorizations (EUAs) for some COVID-19 therapeutics, including hydroxychloroquine, remdesivir, and convalescent plasma, drew criticism that there was insufficient data to support the safety and efficacy of the authorizations, insufficient transparency about the evidence and decision-making underlying the authorizations, and an appearance of political factors affecting regulatory decisions and agency public communications, namely substantial pressure from the Trump administration to quickly authorize therapeutics (Nachlis 2020; Patel, Kesselheim, and Darrow 2023; Thomson and Nachlis 2020). But when the FDA turned toward critical decisions about COVID-19 vaccines in late 2020, the agency—having learned from these earlier mistakes—successfully drew on its emergency powers to outline clear standards for authorizing COVID-19 vaccines and to insist on an evidentiary timeline that, contrary to the apparent wishes of President Trump, placed any prospective vaccine authorization after the November 2020 presidential election (Eban 2020).

These vaccine-related regulatory successes, in which the FDA maintained its independence, processes, and standards in the face of political pressure, derived in part from the agency arriving at the pandemic moment with a set of emergency authorization procedures already established. By 2007 the FDA had authority under section 564 of the Food, Drug, and Cosmetic Act to authorize emergency use of medical products where, based on the totality of evidence, (1) it is reasonable to believe that the product may be effective in treating the disease or condition identified in the public health emergency, and (2) the known and potential benefits of the product outweigh the known and potential risks, taking into consideration the threat posed by the disease in question (21 U.S.C. 360bbb-3(b)(1)(C)) (emphasis added). The FDA issued clarifying guidance in 2017 stating that the “may be effective” standard “provides for a lower level of evidence than the ‘effectiveness’ standard that FDA uses for product approvals”—which typically requires two well-controlled clinical trials—and that the level of evidence sufficient to meet this standard will be assessed on a case-by-case basis using a risk benefit analysis (FDA 2017; 21 U.S.C. 360bbb-3(f)(1), (g)).

In part responding to the concerns surrounding its earlier COVID-19 therapeutic EUAs, the FDA issued guidance specific to its decision-making process for COVID-19 vaccine candidate EUAs in October 2020 (Eban 2020; FDA 2020). This guidance describes the information that firms seeking an EUA for a COVID-19 vaccine should submit to the agency and clarifies the agency's position that “issuance of an EUA would require a determination by FDA that the vaccine's benefits outweigh its risks based on data from at least one well-designed Phase 3 clinical trial that demonstrates the vaccine's safety and efficacy in a clear and compelling manner” (emphasis added).This was broadly interpreted as defining a higher bar for vaccine EUAs than the general EUA standard of “may be effective.” It also specified that two months of follow-up data to phase III studies should be provided to assess safety, a much shorter time frame than typical for vaccines. Relying on this guidance, the FDA issued EUAs for vaccines from Pfizer, Moderna, and Johnson & Johnson, beginning in December 2020.

While the pandemic required the agency to use and modify its EUA process in unprecedented ways, and while that process remains imperfect, the presence of a robust set of emergency procedures going into the pandemic allowed the FDA to maintain rigor and processes fairly close to its standard operations by building on them for COVID-19 vaccines. Critically, this enabled the agency to resist substantial and repeated political pressures from President Trump to approve vaccines more quickly and with potentially less evidence before an election. The FDA's EUA procedures afforded scientific rigor, transparency, and political independence to the United States' COVID-19 vaccine authorization efforts, while maintaining necessary speed.

United Kingdom

The Medicines and Healthcare Regulatory Agency (MHRA) is the United Kingdom executive branch agency tasked with overseeing drugs, medical devices, and blood products (Richards and Hudson 2019). It is situated within the Department of Health, which is headed by the secretary of state for health and social care, a member of the prime minister's cabinet. The MHRA is led by a board whose members are appointed by Parliament, including a chief executive, but this board explicitly does not have any role in decision-making. Rather, control over MHRA processes and outcomes rests with career staff. Similar to the FDA, then, the MHRA is principally an independent scientific body whose decisions are left to expert scientific and regulatory staff.

The MHRA's pandemic political context was particularly complicated. Amid the pandemic, the UK's partial separation from the European Union (EU) via Brexit was scheduled for January 1, 2021. Although the UK could have relied on a vaccine approval by the European Medicines Agency (EMA) as a member of the EU—which it still was when it temporarily authorized the Pfizer/BioNTech vaccine on December 2, 2020—it was technically operating under an EU exception that allows local rules to take precedence during public health emergencies (Mahase 2020). Practically, the UK was also about to reassume full authority over authorizing medical products within its borders, likely leading to a greater emphasis on the MHRA to conduct its own review of vaccine data rather than relying on the EMA.

Despite these complications, the in-country politics of vaccines were relatively uncontroversial, with clear support for the MHRA decision-making process from Prime Minister Boris Johnson's government (BBC 2021). Given the domestic political support for the MHRA and its decision-making, and the looming UK/EU breakup underscoring the MHRA's centrality, political pressures—beyond the standard need for sound decision-making and the pandemic need for swift public access to beneficial products—appear to have been low.

Procedurally, like the United States, the MHRA entered the pandemic with both standard and emergency tracks for authorizing pharmaceuticals. Typically, drugs are granted Market Authorization in the UK after demonstrating the safety, efficacy, and quality of the product. Per 2012's regulation 174, the MHRA also may grant temporary authorization for the distribution of medical products in response to a public health emergency (Human Medicines Regulations 2012, SI 2012/1916, part 10, regulation 174). The UK updated this rule with regulation 174A in October 2020 to further provide that additional conditions may be placed on temporary authorizations to ensure that proper safeguards are in place for safe use of the product being authorized (Human Medicines (Coronavirus and Influenza) (Amendments) Regulations 2020, SI 2020/1125, part 6, regulation 174A). Although the temporary authorization standard is similar to standard market authorization, temporary authorization is granted for a year with additional obligations placed on the sponsor to conduct or finish additional research. Since its passage, 174A has been relied on for multiple vaccine approvals, beginning on December 2, 2020, with the Pfizer/BioNTech vaccine.

The United Kingdom, therefore, arrived at the pandemic moment with political incentives to underscore the credibility of its domestic pharmaceutical regulator, low political controversy about vaccination itself, and a credible independent regulatory body in possession of a standing set of sufficiently rigorous emergency procedures. As a result, the MHRA was able to straightforwardly rely on and update its Regulation 174 emergency procedures to combat the pandemic, exhibiting a procedural adaptability and rigor partially resting on standing credibility, independence, and already codified emergency procedures.

European Medicines Agency

The EMA is the EU body that regulates medical products. Originally formed to harmonize across national regulatory bodies rather than to replace them, the EMA is now Europe's principal pharmaceutical regulatory body. Its procedures and structure resemble the FDA, with the notable differences that: (a) it reviews requests from across member countries rather than a single country; (b) its decisions authorize marketing across member countries rather than in a single country; (c) its scientific review procedures distribute responsibility across experts from member countries rather than its own internal staff; and (d) its processes are somewhat less transparent (EMA 2023). The body's aggregative and distributed approach is in part intended to diffuse localized political pressures and harmonize regulatory and medical approaches across localities.

Similar to the UK's temporary authorization pathway, the EMA has a conditional marketing authorization (CMA) standard that allows for products, including vaccines, to gain market access without providing the standard amount of evidence necessary. CMAs come with specific requirements, including “completing ongoing or new studies or collecting additional data to confirm the medicine's risk-benefit balance remains positive” (EMA n.d., “Conditional”). Conditional authorization is granted for one year, at which time it can be renewed for another year, or it can be converted into a full authorization once any required studies have been completed that demonstrate that a drug's benefits outweigh its risks. Unlike the UK's expedited 174 pathway and the United States' expedited EUA pathway, which are predicated on the existence of a public health emergency, the EMA's conditional authorization is generally available for any drug that the agency deems is in the interest of public health “where the benefit of immediate availability of the medicine outweighs the risk inherent in the fact that additional data are still required.”

Given its broader ambit and more inclusive study eligibility criteria, the EMA has authorized more COVID-19 vaccines than national regulatory bodies have. To date, the EMA has authorized eight different COVID-19 vaccines, with five receiving conditional authorization before being granted full authorization later (EMA n.d., “COVID-19”). Importantly, it has done so by following existing CMA procedures and with relatively little political controversy, given its clear procedures and relative insulation (Cavaleri et al. 2021). Moreover, in the process, the EMA also built on its standing emergency regulations and strengthened them, particularly by deciding to proactively publish COVID-19 vaccine-related data as well as the agency's scientific assessments underlying its decisions (EMA 2020). In part because it already had clear emergency regulatory procedures in place before the pandemic, when the pandemic arrived the EMA was able to quickly, straightforwardly, and uncontroversially adopt significantly higher transparency standards than it had ordinarily used—all to meet the pandemic's particular need of public support for authorization decisions and authorized products.

Brazil

The Brazilian Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, or ANVISA) is tasked with overseeing the regulation of food, drugs, and medical devices in Brazil. ANVISA is an independent agency managed by a five-member board of directors, with connections to the Ministry of Health, which manages ANVISA through a management contract (Huynh-Ba and Sassi 2018). The Ministry of Health is as an independent administrative agency with a politically appointed head who serves at the behest of the president. This dynamic led to tensions in the COVID-19 pandemic, during which the Ministry of Health had four successive leaders. These dismissals and departures followed from tensions with President Jair Bolsonaro over Bolsonaro's preferred COVID-19 treatments (like hydroxychloroquine), general downplaying of the pandemic, and general opposition to the testing, approval, and distribution of COVID-19 vaccines (Fonseca, Shadlen, and Bastos 2021).

Two factors in Brazil further complicated a situation already driven by political tensions between political and regulatory leaders. First, local and regional governments are autonomous and can make their own rules related to public health, including purchasing vaccines and other treatments and supplies (Greer et al. 2022). During different periods of the pandemic, regional governments found themselves at odds with Bolsonaro, instituting public health measures to curb the spread of COVID-19 and purchasing vaccines and other countermeasures while the president downplayed the severity of the disease and announced that he would not take a vaccine (Fonseca, Shadlen, and Bastos 2021; Greer et al. 2022).

The second factor complicating Brazil's regulatory response was the absence of any clear emergency regulatory procedures going into the pandemic. Instead, once the pandemic began, the federal government enacted a law providing for emergency powers for ANVISA and the Ministry of Health, including emergency use authorizations as well as permits for importation of vaccines approved abroad. Against the president's wishes, as the pandemic progressed the Brazilian congress and regulatory officials passed a series of laws and regulations that provided for ever-increasing, and in some cases highly variable, emergency regulatory pathways (Fonseca, Shadlen, and Bastos 2021).3 Clear prepandemic emergency regulatory pathways may well have tempered such tensions and complexities.

The ad hoc nature of this emergency regulatory approach meant unpredictability and uncertainty for public health officials, firms, and citizens, and it produced criticisms from provaccine groups like vaccine makers, legislators, and public health officials on one side, and from antivaccine forces like President Bolsonaro and his supporters on the other. Although Brazil eventually caught up and, with fairly harmonized processes, granted emergency authorizations for CoronaVac, Oxford/AstraZeneca, and Janssen, and a temporary permit for the importation of the Sputnik vaccine, the process was less streamlined, more regionally variable, and more confusing and contested than it might have been.

India

In India, drugs and medical devices are approved by the drugs controller general, the head of the Central Drugs Standard Control Organization (CDSCO), a department in the Ministry of Health and Family Welfare in the Indian government's executive (Drugs and Cosmetics Rules, 1945, part IX § 94Iiii; CDSCO 2011). The agency and its standards are generally modeled after the British and American systems, with significant reforms in the past two decades after quality issues with generic drug manufacturers became apparent (Carpenter 2010, chap. 11; Eban 2019).

A 2008 amendment to India's Drugs and Cosmetics Act provided the CDSCO authority to grant emergency use authorization for a product during a pandemic or natural disaster if “in the public interest it is necessary or expedient so to do” (Drugs and Cosmetics Act of 1940 § 26B). During the COVID-19 pandemic, the CDSCO issued guidance on the development of COVID-19 vaccines (CDSCO 2020) as well as guidance providing for approval of COVID-19 vaccines for “Restricted Use in Emergency Situation” for vaccines that have already been approved for use in other countries or by the World Health Organization (WHO) and complete a bridging study in India (CDSCO 2021).

India's initial approvals of the COVID-19 vaccines Covaxin and Covishield were met with widespread skepticism from the scientific community because of the lack of data supporting the approvals and the lack of transparency surrounding the regulatory decision-making process (Pulla 2021). Covaxin was approved on January 3, 2021, while the phase III confirmatory study was still enrolling participants, before data confirming the vaccine's safety and efficacy was available, leading to the requirement that Covaxin recipients sign a consent form acknowledging that the vaccine was still being studied (Perappandan 2021). This decision appeared to go against the CDSCO's previously issued draft guidance stipulating a 50% effectiveness standard. Meanwhile, Covishield was granted approval based on phase III results but without a bridging study to evaluate efficacy among Indian adults as required by CDSCO guidance (Pulla 2021). These issues were not limited to emergency use. Questions have arisen as to whether Covaxin was granted full approval based on appropriate evidence after reporting surfaced about discrepancies in the reported number of participants in the trials relied on for approval as well as concerns with the clinical trial design, including approval of protocols for phase II and phase III trials before the trials from previous phases were completed (Silverman 2022).

It is plausible that the politics of vaccination in India, particularly vaccine nationalism, played a large role in the approval process—one in which, unlike in other cases, fairly clear ex ante emergency procedures were seemingly flouted during the crisis.4 It is unclear, though, whether and to what extent Prime Minister Narendra Modi or his government played a role in influencing regulatory decision-making itself. While Modi defended India's vaccine approvals and praised the creation of vaccines in India on nationalist grounds,5 this may have been in response to vaccine fearmongering by his opponents rather than or in addition to a pressure campaign to hastily grant market access to Indian-made vaccines (Sarkar 2021).

Despite India's preexisting statutory pathway for emergency use authorization and issuance of guidance to help steer the development and authorization of COVID-19 vaccines, India's COVID-19 approval process deviated from some standards, exhibited procedural variability, and lacked transparency regarding what evidence was relied on before issuing emergency use authorizations. The Indian case is therefore somewhat unique in that it exhibits standing emergency regulatory procedures going into the pandemic while also exhibiting some of the complexities and contestations that occurred in cases where no such procedures were in place. In this sense, the Indian case demonstrates that while our policy recommendations may be helpful in various ways, they are certainly not a panacea.

China

China's pharmaceutical regulator, the National Medical Products Administration (NMPA), shares many similarities with the FDA, after which it was largely modeled. Similar to the FDA, which emerged following public health controversies to consolidate bureaucratic powers and institutionalize itself in the early to mid-20th century, the NMPA's precursor, the China Food and Drug Administration (CFDA), was created for similar reasons in the early 21st century (Feng and Li 2021). Organized in 2013, the CFDA was further centralized, institutionalized, and modernized in 2018, when it was renamed the NMPA and placed under China's market-regulating agency, the State Administration for Market Supervision, which sits just under China's principal governing organ, the State Council. Although structurally and in some ways procedurally similar to the FDA, the NMPA exists in a Chinese governing system where the level of state party control through the State Council is high, and requirements for procedural regularity and transparency are more variable and discretionary (He, Shi, and Liu 2020).

China's NMPA has undergone many important changes to its regulation of pharmaceuticals in recent years, including significant reforms of its entire drug regulatory system (Xu et al. 2018). In response to concerns that drug and vaccine development and approval were too slow, China also passed legislation specifically aimed at accelerating vaccine R & D in 2019 (Wang and Shao 2021). Included in these 2019 reforms was the establishment of a variety of accelerated approval pathways similar to those employed by the FDA and EMA. One such pathway is conditional approval, which provides that drugs that are meant to treat fatal diseases may be granted conditional approval before phase III trials are completed if their clinical benefits over existing treatments can be “reasonably foreseen” (Yao et al. 2018).

The first COVID-19 vaccines granted marketing status in China—Sinovac/Coronavac and Sinopharm—were granted conditional approval (NMPA 2021). However, at the time when conditional approval was granted, the evidence that was relied on was unclear. Rather than releasing results of phase III studies or interim analyses, reports of trial results were largely “limited to government media reports and press releases” (Tanveer et al. 2022). These vague standards and the lack of transparency raised concerns from the global scientific community and generally made it difficult for experts to evaluate whether NMPA was following clear standards or succumbing to political pressure to ensure vaccines made it to market quickly.

China's particular policy-making approach, featuring a large and robust bureaucracy, low transparency, and high centralized governance, makes it difficult to analytically disaggregate regulatory and political influences on COVID-19 vaccine regulatory decision-making. On the one hand, preexisting emergency regulatory pathways and recently clarified and accelerated vaccine approval procedures certainly appear to have provided the government with recognized mechanisms for reviewing and approving COVID-19 vaccines, likely enhancing the efficiency, rigor, and procedural clarity of their review as well as decision quality and perceived legitimacy. But the serious lack of clarity and transparency regarding both the evidence supporting vaccine approvals and the decision-making process itself make it difficult to assess how emergency procedures interacted with political pressures.

Russia

Pharmaceuticals in Russia are regulated by a variety of agencies. While the Ministry of Health licenses pharmaceuticals, other agencies are tasked with ensuring the quality of drugs or regulating drug advertising (Klimenko et al. 2021). Russia's typical drug authorization process is broadly like those of other countries and regulators reviewed here. In standard cases, the Russian Ministry of Health reviews all available evidence of a drug's safety and effectiveness and authorizes its use if it determines that the benefits outweigh the risks (Chaplenko, Gildeeva, and Vlassov 2021). However, after the pandemic began, the Russian government issued emergency-use provisions via decree no. 441 on April 3, 2020, which allow for obtaining a temporary license for a medical product during a medical emergency, with the ability to place additional requirements on a product given a temporary license, including postapproval studies (Decree of the Government of the Russian Federation of April 3, 2020 N 441, as amended on July 26, 2020).

In apparent reliance on decree no. 441, Russia was the first country to approve a vaccine—Sputnik 5, on August 11, 2020. This approval was met with great fanfare domestically and skepticism internationally (FSSH 2020). While initial approval was granted with the stipulation that the Sputnik vaccine could not be used until phase III studies were completed (Cohen 2020), the fact that the approval came before such studies had been conducted to confirm safety and efficacy was met with widespread international criticism (Callaway 2020). At the time of approval, the vaccine had been tested in only 76 individuals, and results were not published or otherwise publicly available; nor were protocols for the forthcoming phase III studies.

Instead, early-stage data showing that participants who received doses of the vaccine had produced antibodies against the virus was relied on to grant a registration certificate, which represents full drug approval in Russia (Burki 2020). Moreover, despite the qualification that the vaccine could not be used until phase III studies were completed, Russian President Vladimir Putin made statements on its approval suggesting that the studies had demonstrated stable immunity (Isachenkov and Litvinova 2020) and that he hoped to “start a massive release of this vaccine soon” (Grove 2020).

Although subsequent data appears to show the vaccine is safe and effective (Nograndy 2021), by approving the product without establishing safety and effectiveness first, the Russian government ran the risk of undermining trust and exacerbating issues surrounding its highly irregular and nontransparent approval. This considerable lack of transparency, and the creation of an emergency pathway in an ad hoc and underspecified fashion, yielded substantial international skepticism of the Russian vaccine and relatively little international adoption of it, despite the Russian government's championing of the Russian vaccine (Stronsky 2021).

Implications and Policy Recommendations

Implications for Health Policy Scholars and Practitioners

Analysis of the political economy of regulation tends to focus on issues of regulatory capture, political influence, bureaucratic autonomy, economic nationalism, and social inequality. Each of these is, of course, central to understanding the political economy of regulation generally and the political economy of pharmaceutical and vaccine regulation specifically. With respect to the political economy of regulation during emergencies, however, the role of regulatory procedures themselves—particularly standing emergency regulatory procedures that are in place before the onset of a new crisis—has received less attention.

The importance of inherited emergency regulatory procedures, and the ways that inherited regulatory procedures interact with the demands of a new crisis, become quite clear when considering the political economy of vaccine regulation during the COVID-19 pandemic. During the pandemic, inherited emergency regulatory procedures, such as the FDA's EUA authorities, transformed from obscure regulatory pathways into front-page news whose features had the potential to help determine the course of a global pandemic.

The pandemic demonstrates not just that emergency regulatory procedures matter and that their importance may have been underappreciated before 2020 but also that they shape dynamics at the core of considerations of political economy. That is, emergency regulatory procedures affect interactions between political and market forces, and between elected politicians and civil servants. They also shape the relative balance of power across these groups, particularly by setting emergency policy-making responses on a predictable path for policy and market actors, and by constraining the influence of potentially suboptimal political intervention by elected officials in the expert scientific and regulatory decisions made by regulatory officials and firms. These procedures therefore materially affect the substance of crisis policy responses, with potentially significant public health and social welfare consequences.

Given the impacts that emergency regulatory procedures have on core tensions in political economy and key features of crisis policy responses, these procedures deserve attention from scholars and policy makers. This increased attentiveness could improve policy responses and enhance social welfare during future public health emergencies.

Policy Recommendations

The pandemic vaccine regulation experience suggests two related and straightforward sets of policy recommendations. The first broad recommendation is for national pharmaceutical regulatory authorities to establish clear emergency regulatory procedures ex ante. The second broad recommendation, which can help achieve the first, is for greater international communication and collaboration regarding emergency pharmaceutical regulatory procedures.

Establishing Clear Emergency Pharmaceutical Regulatory Procedures before Crises Occur

Leading regulators exhibited wide variety in the emergency regulatory procedures they had in place going into the COVID-19 pandemic, from robust procedures to none at all. Moving forward, it is important for regulatory bodies to put standing emergency regulatory procedures into place. Having emergency regulatory procedures in place before crises can increase regulatory clarity and predictability during crises, and thereby decrease policy-making tensions during crises that derive in part from unclear allocations of administrative policy-making power.

Beyond simply having established emergency regulatory procedures in place, regulatory bodies could focus their efforts on a few key dimensions to best help firms, policy makers, and the public. As a procedural matter, based on the case studies above, the following dimensions stand out as being particularly important to establish and/or clarify in emergency regulations. First, clear standards for acceptable amounts and kinds of evidence for emergency authorizations are important to address. Second, bodies could develop different evidentiary standards for different types of products—for example, it may be warranted to have different standards for population-wide vaccines than for specific drugs intended for small subpopulations. Third, regulators could establish different evidentiary standards for emergency scenarios of different magnitudes, temporal and geographic scopes, and speeds of onset and evolution. Fourth, regulatory bodies could address their standards for transparency, data sharing, and public notification; and fifth, they could address the processes by which emergency regulatory procedures can be amended. While countries' and regulators' specific approaches are likely to vary based on local legal, political, and institutional factors, as the literature on legal transplantation shows, as a procedural matter clear attentiveness to these key dimensions should be central to any such efforts (Berkowitz, Pistor, and Richard 2003; Engel and Weinshall 2022; Goldbach 2019).

Collaborating on Procedures across National and Supranational Regulatory Bodies

The second principal recommendation is for greater international communication and collaboration regarding emergency pharmaceutical regulatory procedures across national and supranational regulators. This, too, could substantially benefit firms, policy makers, and the public; this is also a procedural claim about the potential benefits of greater collaboration. While it is certainly possible that such collaboration could lead to convergence and harmonization over time, as with global pharmaceutical approval processes, such procedural collaboration may, but need not necessarily, facilitate downstream convergence across regulatory bodies facing different legal, political, and institutional contexts (Berkowitz, Pistor, and Richard 2003; Engel and Weinshall 2022; Goldbach 2019). The fact that there has already been convergence in the key area of approval, although not yet in the related areas of postmarketing regulation and emergency procedures, suggests that some additional movement in these latter areas may be possible (Pezzola and Sweet 2016; Vogel 1998).

Such collaboration could occur via the WHO as well as the International Coalition of Medicines Regulatory Authorities (ICMRA), with the assistance of private firms, particularly given the WHO's emphasis on norm setting, coordination, and technical cooperation (Ruger and Yach 2009). In fact, the WHO already rates national medical product regulators, with intensive research and regular updating. In the interest of facilitating convening and coordination around these issues, the WHO could therefore incorporate some scoring of specific emergency pharmaceutical regulatory procedures into its existing Global Benchmarking Tool. The WHO could collaborate with the ICMRA, regulators, and firms, the latter of which especially prefer predictable global regulatory procedures and which wield economic and political influence that could be deployed in favor of policy collaboration. Collaboration between the WHO, the ICMRA, regulators, and firms regarding emergency medical product regulatory procedures is therefore politically feasible and could yield real results.

These collaboration efforts could emphasize all the dimensions described above and yield the benefits of increased communication, decreased international tension, and better scientific decision-making. First, such efforts could increase communication, collaboration, understanding, and transparency across regulatory bodies, potentially allowing for best practices to diffuse across bodies (Engel and Weinshall 2022). This diffusion-induced potential increase in international consistency, predictability, and trust could also allow for the sharing of relevant trial data and the mutual acceptability of trial data and products from other countries, leading to faster and broader adoption of successful products. Second, with respect to international tensions, regulatory bodies may become better prepared to anticipate potential complications such as domestic unrest and economic nationalism, the likelihood of political intervention in scientific and regulatory processes, and the potential international consequences of spillover from peer countries' domestic processes and decisions. Collaboration might also dampen domestic citizenries' dissatisfactions relative to other countries they perceive as achieving better results during crises, thereby enhancing domestic political stability. Finally, these efforts could strengthen regulators vis-à-vis politicians, helping to promote sound medical science and regulatory decisions during crises. Consequently, firms' scientific achievements could be more likely to be judged meritoriously, yielding more consistently beneficial medical products for public use. Instead of economic nationalism and political meddling, product development in emergencies could increasingly rest on the expertise of private firms' innovations and public regulators' evaluations.

More broadly, improving emergency pharmaceutical regulatory procedures can potentially help increase the speed with which safe and effective salves are developed, authorized, legitimized, and administered during future emergencies. Appreciating the importance of emergency regulatory procedures can therefore bolster scholars' understandings of the political economy of regulation and practitioners' efforts to address future public health crises.

Acknowledgments

The authors thank the anonymous reviewers; guest editors Holly Jarman, Elize Massard da Fonseca, and Elizabeth King; and JHPPL Editor Jonathan Oberlander for their valuable feedback. The authors are also grateful to Sarah Feldman Rose and Jack Mirabella Thomson for their assistance with this article, and they thank Neha Agarwal for excellent research assistance.

Notes

1.

Methodologically, this approach entails formulating explanatory ideas and theory development by drawing attention to the important role of emergency regulatory procedures. Empirically and inferentially we employ cross-case analysis, within-case process tracing, and causal process observations.

2.

Two standard and important endogeneity-related points are worth addressing here. First, emergency regulatory procedures may be partially endogenous to macrolevel factors like economic development. Second, emergency regulatory procedures may be partially endogenous to a regulator's independence. Of course, it is likely that emergency regulatory procedures are partial functions of both. What we show here, though, is that over and above factors like economic development, and over and above regulatory independence, emergency regulatory procedures have considerable independent marginal effects on substantive policy outcomes during crises, and their presence or absence and high or low quality generally correspond to better and worse crisis policy-making processes and decisions. This is shown through variation across cases and within cases, making us confident that emergency regulatory procedures themselves merit attention. Emergency regulatory procedures are certainly not the only thing that matters, but they matter in important ways, including by affecting the balance of power across policy makers during crises and shaping the content of crisis responses.

3.

By spring 2021, three different pathways existed for COVID-19 vaccine authorizations in Brazil, including emergency use authorization, rolling review and full licensure, and a pathway allowing ANVISA to register some vaccines approved abroad.

4.

For example, as Science reports, “A member of India's ruling Hindu nationalist party tweeted he was shocked to learn that a UK vaccine had been approved while a homegrown vaccine lay ‘in the ditch’” (Pulla 2021).

5.

As Modi declared, “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India!” (Modi 2021).

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