Public Readiness and Emergency Preparedness Act (PREP Act)Updated: December 23, 2022
The Public Readiness and Emergency Preparedness (PREP) Act extends legal authority to the Public Health Service (PHS) Act to provide immunity from liability related to the manufacturing, testing, development, distribution, administration and use of medical measures against the following:
- Chemical and biological agents of terrorism
- Radiological and nuclear agents of terrorism
- Disease epidemics and pandemics
- Other events deemed as public health emergencies
Immunity from liability means that courts must dismiss any claims that are brought against any individual, organization, or other entity that is covered by the PREP Act. The only time that immunity for these measures is not provided under the PREP Act is for failures or deliberate actions that constitute willful misconduct on the part of entities providing covered countermeasures.
The PREP Act authorizes the secretary of the Department of Health and Human services (HHS) to issue a declaration to provide immunity from any liability claims for loss caused by countermeasures against disease outbreaks and other public health emergencies or health threats. These countermeasures can include:
- Medical equipment and supplies
- Medical staff and other employees
The PREP Act also established a program to compensate any individuals who suffer injuries, death, or other adverse effects from the use of products, like vaccines or medications, covered by the immunity provisions outlined in the Act. This is provided through a fund in the United States Treasury to eligible individuals who have sustained serious physical injury or death directly caused by the use of a measure covered by declaration of the PREP Act.
History of the PREP Act
The PREP Act was first developed in December 2005 to amend the Public Health Service Act, to address liability immunity for organizations that make products that are used in an emergency, and to create a compensation program for anyone accidentally injured due to those products. In March 2013, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) was enacted to allow the emergency use of approved products such as medications, as well as those held for emergency use. It also extended the definition of which pandemic and epidemic products may be covered under a PREP Act Declaration, to include products intended to enhance the use or effect of a drug, device or biologic product used against a pandemic or epidemic. Since its development, the PREP Act has been enacted several times, including during the H1N1 pandemic in 2009.
What does the PREP Act cover?
There are four main categories of entities that are protected under the PREP Act. These include:
- Persons Covered: these may include manufacturers, and those involved in the planning and administration of programs that distribute countermeasures. Any U.S. agents, officials, and employees of any of these agencies are considered covered persons.
- Activities Covered: these include the development, manufacturing, testing, distribution, administration, and use of countermeasures.
- Countermeasures Covered: these can include medications, vaccines, or medical devices used against any chemical, biological, nuclear or radiological agents of terrorism or pandemics.
- Claims Covered: these include death, injury (physical, mental, or emotional), illness, disability, or the fear of any of these conditions. Protection from liability also covers claims for loss or damage to property, including the interruption of business.
What Information is included in a PREP Act Declaration?
When a PREP Act is declared, there are several components that are included in the Declaration. These include:
- A determination that a health condition, disease, or health threat constitutes a public health emergency, or that there is a credible risk that it will constitute an emergency in the future.
- A recommendation for the manufacture, development, testing, distribution, or administration of one or more covered countermeasures.
- The recommended category for the disease, health condition or health threat for which use of countermeasure is recommended.
- The effective time period; this may be extended for manufacturers to dispose of additional countermeasures, and for others to stop the administration and use of countermeasures.
- The population that will receive the countermeasures.
- The geographic area where the countermeasures will be administered and used, and where immunity from liability is in effect (this only applies for program planners and qualified persons; those who manufacture and distribute countermeasures are immune from liability regardless of where the countermeasure is used or who receives it).
- Any limitations on the geographic area where immunity is in effect.
- Any limitations on how the countermeasures will be distributed.
- Any other persons identified as being qualified to prescribe, dispense, or administer countermeasures.
- Any other conditions or limitations.
What will it do to help during the Corona outbreak?
Before a Declaration under the PREP Act can be issued, the HHS Secretary must determine that a disease or other health condition constitutes a public health emergency, or that there is a credible risk that the health threat may constitute an emergency. On Jan. 31, 2020, a Declaration was issued for COVID-19. The HHS Secretary determined that COVID-19 constituted a public health emergency that necessitated a Declaration under the PREP Act. This outbreak is a significant threat to public health, and requires a coordinated and sustained response by the government so that the virus can be contained.
In February 2020, a Notice of Declaration was made under the PREP Act to call for medical countermeasures against COVID-19. This Declaration will be effective from Feb. 4, 2020 to Oct. 1, 2025. The Declaration provides protection to the following:
- Countermeasures: any antiviral or other drug, any diagnostic, any vaccine, or any other device used to diagnose, treat, prevent, cure or mitigate COVID-19.
- Activities: the manufacture, development, testing, distribution, and administration of the countermeasures covered by the Declaration.
- Persons: those who manufacture and/or distribute countermeasures; program planners, qualified persons, and their officials and employees, and additional persons who are connected to the covered countermeasures.
Under the PREP Act, organizations throughout the United States will be working to provide medications and other treatments, necessary staff and equipment, and other resources as needed to help control the spread of COVID-19 and provide care for those who have been affected, while protecting those providing these resources from liability.