On May 9, 2023, Secretary Becerra signed the 11th amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures. The Secretary issues this amendment to clarify that COVID-19 continues to pose a credible risk of a future public health emergency, add two new limitations on distribution, extend the time period of coverage for certain Covered Countermeasures and Covered Persons, clarify the time period of coverage for Covered Persons authorized under the Declaration, and extend the duration of the Declaration to December 31, 2024.
The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims:
* of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions
* determined by the Secretary to constitute a present, or credible risk of a future public health emergency
* to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures
A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.
The end of the COVID-19 Public Health Emergency Declaration does not automatically terminate PREP Act coverage. To learn more, view our COVID-19 PREP Act FAQs.
Continues:
https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx
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