PREP Act and COVID-19: Limiting Liability for Medical Countermeasures [Updated March 19, 2021]   [open pdf - 692KB]

From the Document: "To encourage the expeditious development and deployment of medical countermeasures during a public health emergency, the Public Readiness and Emergency Preparedness Act (PREP Act [hyperlink]) 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 [hyperlink]), 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. [...] Federal laws such as the PREP Act may preempt [hyperlink] state tort laws--as well as other state and federal laws-- in certain contexts. Preemptive federal legislation displaces [hyperlink] 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 [hyperlink] to ensure that potentially life-saving countermeasures will be efficiently developed, deployed, and administered. This Sidebar reviews the structure of the PREP Act and the HHS Declaration to explain the scope of this liability immunity as it applies to COVID-19 countermeasures."

Report Number:
CRS Legal Sidebar, LSB10443
Public Domain
Retrieved From:
Congressional Research Service: https://crsreports.congress.gov/
Media Type:
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