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1 1 (February 28, 2023)

handle is hein.crs/goveksm0001 and id is 1 raw text is: Con gressionaI AResearch Servic The PREP Act and COVID-19, Part 2: The PREP Act Declaration for COVID-19 Countermeasures Updated February 28, 2023 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). Part 1 of this two-part Sidebar reviews the structure of the PREP Act and provides an overview of the CICP. This second part examines the HHS Declaration related to the COVID-19 pandemic in detail and discusses the scope of the PREP Act's liability immunity as it applies to COVID-19 countermeasures. It also discusses the effective time periods for PREP Act immunity and how they will apply after the Biden Administration's announcement of its intention to terminate, on May 11, 2023, the federal public health emergency declared under Section 319 of the Public Health Service Act (the Section 319 PHE). HHS's COVID-19 Declaration and Amendments On March 10, 2020, the Secretary invoked the PREP Act and determined that COVID-19 constitutes a public health emergency. The HHS Declaration authorizes PREP Act immunity for the manufacture, testing, development, distribution, administration, and use of covered countermeasures. (These activities, however, must either relate to present or future federal contracts, or be part of the public health response to COVID-19 authorized by an authority having jurisdiction, such as federal, state, Tribal, or local Congressional Research Service https://crsreports.congress.gov LSB10730 CRS Legal Sidebar Prepared for Members and Committees of Congress

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