Regulatory Delivery Lessons From COVID-19 Responses

The COVID-19 pandemic is still very much ongoing. Given how little is known about the epidemiology of the virus, as well as the medical and economic challenges that the pandemic presents, this might be only the beginning of a protracted crisis. This means that trying to learn lessons from the first months of the crisis is as acutely needed as it is difficult. I attempt here to tentatively outline some key issues and challenges that have confronted governments across Europe, North America, and to a lesser extent East Asia. These challenges to date have laid bare not only governments’ sometimes inadequate risk management and lack of preparedness, but also some shortcomings when overly rigid regulations and existing administrative structures that have been built up in “good times” suddenly create barriers to emergency response. The initial stages of the pandemic response—or actually, the absence of such a response—in Europe and North America in January and early February of this year provide examples of how not to handle risk communication and manage public expectations. Communication is difficult when surrounded by uncertainty, and especially when confronted with hard-to-predict “fat tail” risks. But conveying excessive and unfounded certainty is also bound to backfire. Many governments initially downplayed the seriousness of the risk—for example, insisting that using face masks was unnecessary—issuing statements that were later contradicted by new evidence and the harsh reality of the virus’s spread. Governments issued early messages intended to avoid public panic, but these messages did not necessarily work. For example, hoarding occurred in spite of reassuring messages. Issuing messages that were later disproven probably led to a significant loss of credibility for many public authorities. In a crisis, credibility matters immensely because governments need to be able to persuade entire populations to comply with demanding distancing or stay-at-home measures and to cope with serious hardship. Governmental credibility and legitimacy matter considerably but, in the initial response to the pandemic, they were sometimes lost carelessly. Managing uncertainty is always difficult. In the face of previous viral outbreaks, some governments—the French government, for instance, with H1N1—have reacted strongly, only to have an outbreak turn out to be less severe than expected. Such experiences have led to decreased preparedness in many countries, as governments and citizens are wary of overreaction. Effectively communicating risk and uncertainty, as well as getting the public to understand and accept regulatory and policy tradeoffs, remains difficult. The sudden spread of the recent coronavirus pandemic, along with the difficulties in coping with a large population of asymptomatic but contagious cases, has created urgent needs and an overwhelming demand for supplies, intensive care unit beds, protective equipment, and ventilators. In light of these challenges, the Organization for Economic Cooperation and Development (OECD) recently published a paper providing an overview of the regulatory challenges of the COVID-19 crisis. As highlighted in the OECD paper, rigid rules about which laboratories may conduct testing related to human epidemics have resulted in considerable testing capacity left unused. This is the case in France and Italy, even though testing there has ramped up significantly. In the United States, the U.S. Food and Drug Administration’s demanding approval process for testing methods created similarly harmful delays. Successful testing and tracing approaches need reliable antibody tests, and developing antibody tests requires increased diagnostic testing capacity. Exempting adequately staffed and equipped laboratories from existing regulations could therefore make a positive difference in addressing this serious issue. In addition, governments could have done better in facing the spike in demand for the hydro-alcoholic solution used for hand sanitizer, given that its basic ingredients are commonly available. The manufacturing and sale of sanitizer, however, is subject to tight regulations. Some countries already allowed pharmacies to produce and sell sanitizers, but in other countries, such as France, allowing production required changing existing regulations. Likewise, in the United States, a double layer of regulatory approval made market entry difficult for new suppliers of face masks. As in the European Union (EU), suppliers first must obtain third-party certification, but in the United States, suppliers require additional registration with the National Institute of Occupational Safety and Health. These are prime examples of how pre-pandemic regulations were written or construed too broadly in the early days of the pandemic. Biocide regulation in the EU, for instance, is designed to ensure that professional sanitizers are safe and effective—not to make basic hand hygiene more difficult in a global health crisis. Other regulations, such as the two-step approval required for face masks, have burdened manufacturers with extra steps that have limited or undemonstrated additional value, especially in a time of emergency. Excessively broad rules, combined with lack of discretion in their application, led to the harmful loss of time and opportunity, as well as eventual emergency changes. The crisis also has revealed major issues around public procurement. The United States has seen chaotic, competing procurement efforts, pitting federal and state governments against each other. Early on in the crisis, France and other countries were unable to replenish stocks of face masks and other supplies because of strict adherence to rigorous public procurement rules. The OECD has recommended revising public procurement legislation to ensure better preparedness for emergency situations. Enforcement and compliance efforts are also central to the response to the pandemic. Here, too, recurrent weaknesses appear—but attempts at developing innovative responses emerge as well. For instance, ensuring that masks on the market conform to certain standards has been a serious challenge. To avoid the risk of contagion, many regulatory and third-party inspections have been suspended, with only the highest-risk controls performed. As a result, high quality risk-assessment has become even more important, as has the development and use of technology to facilitate remote audits and conduct inspections without site visits. The regulation and enforcement of physical distancing requirements, stay-at-home orders, and other measures imposed on individuals and businesses have frequently lacked focus on risks and outcomes. These broad measures have failed to target specific behavior that creates contagion risks. They also do not effectively educate the public about safe conduct, and they pay excessive attention to formal requirements such as paperwork. These measures may also be informed by downright bias. Interestingly, both policing data, where available, and mobility data collected by Google and Apple suggest that compliance with distancing measures has been high in Southern European countries, sometimes more so than in Northern countries. These data provide additional evidence that prevailing cultural stereotypes about European countries’ regulatory compliance are generally fallacious. Physical distancing guidance and regulations requiring sick workers to stay home will be consistently followed only to the extent that economic survival does not necessitate that individuals go to work when sick. If governments or employers fail to provide adequate provisions for sick leave, many people will come to work, even when they are at significant risk of spreading the disease. The OECD therefore recommends ensuring adequate paid sick leave or similar income compensation. Other administrative issues to date relate to health system management. In some cases, politicians have failed to heed warnings that an emergency was in fact present, leading to delayed awareness of local cases and contagion. Administrative failures also demonstrate how even high-performing health systems are not designed to react to signals from general practitioners and are not equipped to detect and manage clusters of cases that do not match known treatment trajectories. Several health systems have also experienced serious difficulties in managing hospital capacity across private and public sectors, with some hospitals overwhelmed, others underused, and many of their administrative structures not prepared for the emergency situation. These challenges highlight issues long-known by experts but rarely perceived by the general public, namely the fragmentation of regulatory responsibilities, lack of integration of information systems, limited resources, and underdeveloped risk assessment methods. Furthermore, many of the issues, concepts, and best practices long discussed in regulatory policy and public administration have proven relevant during the crisis. The COVID-19 pandemic has demonstrated the importance of focusing on risk assessment, integrating and managing information, ensuring that regulatory requirements do not create unnecessary barriers, avoiding procedural “heaviness” that hinders responsiveness, and communicating effectively with the public. International cooperation has been difficult, and countries have initially failed to avoid others’ mistakes. Moving forward, learning from others’ experiences is essential to ensure that the next steps of pandemic response, as well as the economic recovery, are handled better