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1 1 (April 13, 2022)

handle is hein.crs/govehge0001 and id is 1 raw text is: Congressional_______ R a esearch Service The PREP Act and COVID-19, Part 1: Statutory Authority to Limit Liability for Medical Countermeasures Updated April 13, 2022 To encourage the expeditious development and deployment of medical countermeasures during a public health emergency, the Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (HHS) to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. In a declaration effective February 4, 2020 (the HHS Declaration), the Secretary of HHS (the Secretary) invoked the PREP Act and declared Coronavirus Disease 2019 (COVID-19) to be a public health emergency warranting liability protections for covered countermeasures. Under the HHS Declaration and its amendments, covered persons are generally immune from legal liability (i.e., they cannot be sued for money damages in court) for losses relating to the administration or use of covered countermeasures against COVID-19. The sole exception to PREP Act immunity is for death or serious physical injury caused by willful misconduct. However, individuals who die or suffer serious injuries directly caused by the administration of covered countermeasures may be eligible to receive compensation through the Countermeasures Injury Compensation Program (CICP). Courts have characterized PREP Act immunity as sweeping. It applies to all types of legal claims under state and federal law. For example, under state tort law, individuals who suffer injuries caused by the intentional or negligent acts or omissions of another person may generally sue that person to recover monetary compensation. Thus, in the health care context, if a health care provider negligently administers a drug or device that causes a foreseeable injury to a patient, the injured person may be able to sue the provider for compensation under state tort law. Federal laws such as the PREP Act may preempt state tort laws-as well as other state and federal laws- in certain contexts. Preemptive federal legislation displaces state law to alter the usual liability rules or immunize certain individuals from liability. In the PREP Act, Congress made the judgment that, in the context of a public health emergency, immunizing certain persons and entities from liability was necessary to ensure that potentially life-saving countermeasures will be efficiently developed, deployed, and administered. Congressional Research Service https://crsreports.congress.gov LSB10443 CRS Legal Sidebar Prepared for Members and Committees of Congress

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