The PREP Act And COVID-19: Two Years Later

The Public Readiness and Emergency Preparedness Act (PREP Act) provides immunity from liability to certain entities and individuals for claims of loss that have a causal relationship to the administration or use of a Covered Countermeasure in the event the Secretary of Health and Human Services (HHS) makes a determination that a threat to health constitutes, or in the future may constitute, a public health emergency. On March 10, 2020, The Secretary of HHS issued a PREP Act Declaration, effective as of February 4, 2020, to provide liability immunity to "Covered Persons" who engage in "Recommended Activities" related to "Covered Countermeasures" against COVID-19 (COVID-19 Declaration). Since the COVID-19 Declaration, there have been ten amendments issued by the Secretary of the HHS, six advisory opinions from the HHS General Counsel, and seven additional guidances published by the HHS Secretary. This Advisory provides an overview of these amendments and guidances.