Preparing for and responding to public health emergencies involving medical countermeasures raise often complex legal challenges and questions among response stakeholders at the local, state, and federal levels. This includes concerns about emergency legal authorities, liability, emergency use of regulated medical products, and regulations that might enhance or hinder public health response goals. In this article, lawyers from the U.S. Department of Health and Human Services’ Office of the General Counsel , Centers for Disease Control and Prevention , and Food (...) and Drug Administration discuss federal legal tools that are critical to enhancing MCM legal preparedness for public health emergencies, with an emphasis on the legal mechanisms that can be used to facilitate the emergency use of countermeasures. Specifically, the authors describe the Public Readiness and Emergency Preparedness Act and Emergency Use Authorization authority, outlining the conditions under which these tools can be utilized and providing examples of how they have supported both pre-event and intra-event activities. (shrink)

Since the anthrax attacks of 2001 and the severe acute respiratory syndrome outbreak of 2003, significant efforts have been made to develop and revise a range of legal tools designed to strengthen public health emergency responses. The 2009 H1N1 pandemic provided an unprecedented opportunity to implement and exercise many of these mechanisms. At the global level, the World Health Organization declared a public health emergency of international concern pursuant to the revised International Health Regulations [IHR ], and many governments declared (...) national or regional emergencies. At the U.S. federal level, the Secretary of Health and Human Services made public health emergency and Public Readiness and Emergency Preparedness Act declarations. In addition, the Food and Drug Administration issued Emergency Use Authorizations, and President Obama declared a National Emergency. Select state and local governments also declared emergencies. (shrink)

Since the anthrax attacks of 2001 and the severe acute respiratory syndrome outbreak of 2003, significant efforts have been made to develop and revise a range of legal tools designed to strengthen public health emergency responses. The 2009 H1N1 pandemic provided an unprecedented opportunity to implement and exercise many of these mechanisms. At the global level, the World Health Organization declared a public health emergency of international concern pursuant to the revised International Health Regulations [IHR ], and many governments declared (...) national or regional emergencies. At the U.S. federal level, the Secretary of Health and Human Services made public health emergency and Public Readiness and Emergency Preparedness Act declarations. In addition, the Food and Drug Administration issued Emergency Use Authorizations, and President Obama declared a National Emergency. Select state and local governments also declared emergencies. (shrink)

Law can greatly facilitate responses to public health emergencies, including naturally-occurring infectious disease outbreaks and intentional or accidental exposures to chemical, biological, radiological, or nuclear agents. At the federal level, the Secretary of the Department of Health and Human Services, as the lead for federal public health and medical responses to public health emergencies and incidents, has a range of authorities to support federal, state, tribal, local, and territorial responses. For example, under the Public Health Service Act, the Secretary may (...) provide temporary assistance to States to meet health emergency needs or deploy medicine and supplies from the Strategic National Stockpile. The Secretary also may determine that a disease or disorder presents a public health emergency, which may be the first step in triggering other critical legal authorities for response.Since the 2001 anthrax attacks, one focus of public health preparedness has been on developing, distributing, and rapidly dispensing medical countermeasures for CBRN emergencies and pandemics. (shrink)

Pandemics challenge the law and often highlight its strengths or expose its limits. The novel strain of influenza A virus that emerged in the spring of 2009 and rapidly spread around the globe was no exception. The H1N1 pandemic prompted the first significant application of a number of international legal and policy mechanisms that have been developed in the last decade to respond to this kind of event. Furthermore, it presented a considerable test for public health systems at all levels, (...) from global to local.Although initial predictions forecasting high morbidity and mortality from this virus overestimated its eventual impact, the human toll of the pandemic was nevertheless significant. The World Health Organization reported approximately 1.5 million people were infected worldwide in 214 countries, resulting in over 25,000 confirmed deaths, but the actual health impact of the outbreak was certainly much higher. (shrink)

Pandemics challenge the law and often highlight its strengths or expose its limits. The novel strain of influenza A virus that emerged in the spring of 2009 and rapidly spread around the globe was no exception. The H1N1 pandemic prompted the first significant application of a number of international legal and policy mechanisms that have been developed in the last decade to respond to this kind of event. Furthermore, it presented a considerable test for public health systems at all levels, (...) from global to local.Although initial predictions forecasting high morbidity and mortality from this virus overestimated its eventual impact, the human toll of the pandemic was nevertheless significant. The World Health Organization reported approximately 1.5 million people were infected worldwide in 214 countries, resulting in over 25,000 confirmed deaths, but the actual health impact of the outbreak was certainly much higher. (shrink)