By Lisa Schnirring
December 11, 2024
Source: CIDRAP
Photo / Image Source: Unsplash,
US Department of Health and Human Services (HHS) Secretary Xavier Becerra today signed the 12th amendment to the declaration under the Public Readiness and Emergency Preparedness (PREP) Act (PREP) Act for COVID-19 countermeasures, a step that provides liability immunity through December 31, 2029.
The declaration provides immunity, except for willful misconduct, for certain claims, including loss caused by or related to administration or use of countermeasures to diseases, threats, or conditions, according to information from the Administration for Strategic Preparedness and Response (ASPR), which is part of HHS.
Present or credible risk
The immunity applies to situations deemed by the HHS secretary as a present or credible risk of a future public health emergency. It also applies to groups or individuals involved in development, production, testing, distribution, and administration of countermeasures.
The PREP Act was enacted in 2005 to help protect pharmaceutical companies from financial risk in the event of a declared public health emergency. The act also provides funding for pandemic influenza preparedness. ASPR notes that the PREP Act declaration is different from and not dependent on other emergency declarations.
Similar PREP Act declarations are currently in effect for countermeasures against a range of other biological or chemical threats, including mpox and other orthopox viruses, viral hemorrhagic fevers such as Ebola, nerve agents and insecticides, Zika virus, pandemic flu, anthrax, acute radiation syndrome, and botulinum toxin.
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