HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation

On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and deploying countermeasures to COVID-19.

The PREP Act grants tort liability immunity to manufacturers, developers, sellers, and prescribers of certain medical countermeasures during a public health emergency. In response to the COVID-19 pandemic, the Secretary of HHS issued a PREP Act declaration last month. The Act immunizes “covered persons,” with respect to all claims for loss arising out of the use or administration of a “covered countermeasure.” But the complexity of these defined terms makes it difficult for entities to determine whether they are protected. The new guidance clarifies the countermeasures, entities, and activities that are covered by the PREP Act declaration and expands protections in a way that encourages cooperation between private parties and public health agencies.

Read our Class Dismissed blog post.

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