The Public Readiness and Emergency Preparedness Act
The Prep Act was enacted by Congress in 2005 in response to the Avian Flu (42 U.S.C. § 247d-6d, 247d-6e). It was intended to encourage expeditious development of diagnostics, treatments, and/or vaccines (referred to as countermeasures) during a Public Health Emergency, by limiting legal liability relating to any injury or loss sustained in the administration of the countermeasure. It 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:
- Loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats, and conditions
- That are 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
To qualify for PREP immunity:
- The individual or entity must be a “covered person” who prescribes, dispenses, or administers covered countermeasures (including long-term care facilities).
- The legal claim must be for a “loss” which includes death; physical, mental or emotional injury; illness; disability or condition; fear of such injury including medical monitoring costs; and loss of or damage to property, including business interruption loss.
- The loss must have a “causal relationship” with the administration of a covered countermeasure.
- The medical product that caused the loss must be a “covered countermeasure” including vaccines, drugs, biological products, therapeutics, and devices (including masks and respirators) approved or otherwise authorized by the FDA.
What you should know:
Under the PREP Act, The Secretary of Health has primary responsibility for decisions, including declaration of an emergency, covered countermeasures, countermeasures injury table, and countermeasures injury compensation.
Under the PREP Act the Secretary of Health is given broad and vague authority to declare an emergency at any time. There are no established criteria for determining the existence of emergency. Any declaration, however, must articulate the disease(s), populations, and geographic areas covered, as well as the date the emergency declaration will end.
Under the PREP Act, in the event of a declared emergency Federal Law preempts all state provisions relating to pandemic emergency preparedness and would supersede any state provision governing vaccines.
Prep Act applies to any drug, vaccine, or other biological product deemed a “covered countermeasure” by the Secretary.
The PREP Act also allows application to any drug, vaccine, or other biological product that the Secretary deems a realistic emergency at some point in the future.
Read the current version of The PREP Act:
https://www.phe.gov/Preparedness/legal/prepact/Pages/4-PREP-Act.aspx
Other Sources:
Public Readiness and Emergency Preparedness Act (hhs.gov) The PREP Act and State https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx
Laws: COVID-19 in Long-Term Care Settings Update – Excelas (excelas1.com) https://excelas1.com/prep-act-and-state-laws-in-ltc-settings/
Salt Lake City Weekly – Side Effects (archive.org) https://web.archive.org/web/20060629171751/http:/www.slweekly.com/editorial/2006/cityweek_1_2006-02-09.cfm
