The Public Readiness and Emergency Preparedness Act of 2005 (PREP Act)1 authorizes the secretary of the Department of Health and Human Services (HHS) to issue a declaration that provides immunity from tort liability for claims of loss caused by countermeasures (e.g., vaccines, drugs, products) against diseases or other threats of public health emergencies. The PREP Act added new authorities under the Public Health Service Act to address concerns about potential liability associated with the development and administration of countermeasures. (Download a printable PDF.)
The PREP Act confers immunity from liability on specified persons for certain activities related to covered countermeasures:
The PREP Act authorizes an emergency fund in the U.S. Treasury to provide compensation for injuries directly caused by administration or use of a countermeasure covered by the secretary’s declaration. The Countermeasures Injury Compensation Program (CICP) is administered by the Health Resources and Services Administration (HRSA).
A PREP Act declaration by the HHS secretary only provides immunity from liability for the persons, activities, and countermeasures specified in the declaration; it does not automatically protect everyone involved in any kind of medical response to an emergency. The act’s liability protections do not apply where the liability arose from willful misconduct. It also does not protect individuals who violate a person’s civil rights or who violate the Americans with Disabilities Act, among other exceptions stated in the act. The PREP Act does not confer any other immunities or liability protections. A PREP Act declaration is different from, and independent of, other federal emergency declarations. A separate public health emergency determination under Public Health Service Act Section 319 or another statute is not required to enable the PREP Act or for its immunities to take effect.2
Before issuing a PREP Act declaration, the secretary must determine that a disease, condition, or threat to health constitutes a public health emergency or a credible risk of a future public health emergency and find that the development of a countermeasure is desirable. The secretary then issues a PREP Act declaration that specifies, among other things3:
As of December 2011, there have been seven PREP Act declarations since the act’s passage, some which have been amended multiple times.4 The declarations have covered H5N1 and H1N1 pandemic influenza vaccine and antivirals and countermeasures for the following diseases: anthrax, botulism, pandemic influenza, smallpox, and acute radiation syndrome. A declaration for influenza antiviral Peramivir has expired; all others remain in effect.4
An interim final rule (IFR) governing the submission and review of claims to the CICP were issued by HRSA in October 2010. The IFR allows the CICP to begin evaluating request for benefits filed by individuals who sustained serious physical injuries as a direct result of the administration or use of covered countermeasures identified by the HHS secretary in declarations issued under the PREP Act.5 Claims must be filed within one year of administration or use of a covered countermeasure. Eligible countermeasures include certain influenza vaccines, antivirals, respiratory protection and support devices, and anything to identify, prevent, or treat smallpox, anthrax, botulinum toxin, and acute radiation syndrome.5 (Claims for injuries from seasonal influenza vaccine are administered through the National Vaccine Injury Compensation Program.)
The PREP Act has a direct impact on states because it provides a source of liability protection for governmental and private sector persons developing and administering approved countermeasures during a public health emergency. During the H1N1 outbreak, PREP Act declarations were issued for H1N1 vaccines, antivirals, and personal protective equipment. PREP Act declarations may also provide protections related to products authorized for use under an Emergency Use Authorization (EUA) under the Federal Food, Drug, and Cosmetic Act, which allow for the use of an unapproved medical product (drugs, biologics [e.g., vaccines], and devices [e.g., diagnostics]), or an unapproved use of an approved medical product, during a declared emergency.
Note: This document was compiled from June–December 2011 and reflects the laws and programs current then. It reflects only portions of the laws relevant to public health emergencies and is not intended to be exhaustive of all relevant legal authority. This resource is for informational purposes only and is not intended as a substitute for professional legal or other advice. The document was funded by CDC Award No. 1U38HM000454 to the Association of State and Territorial Health Officials; Subcontractor PI Elliott, Logan Circle Policy Group LLC.