Earlier this month, in response to the end of the COVID-19 public health emergency, the Department of Health and Human Services (“HHS”) issued the Eleventh Amendment to the declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for medical countermeasures against COVID-19. The PREP Act allows the Secretary of HHS to provide liability immunity, through a declaration, to certain individuals and entities against claims associated with the manufacture, distribution, administration, or use of certain defined medical products or devices, referred to as countermeasures.
HHS originally announced this PREP Act declaration in January 2020 in response to the COVID-19 pandemic (the “Declaration”). The Declaration has been amended at various points throughout the pandemic. This latest amendment makes several different updates:Continue Reading HHS Amends and Extends COVID-19 PREP Act Declaration