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PREP Act Questions and Answers

The following is intended to address an overview of the PREP Act and frequently asked questions from the manufacturing industry, the healthcare community, and state and local government officials.  It is not an exhaustive review of the PREP Act’s provisions in all contexts or a protocol for the HHS’s implementation of the PREP Act.  In addition, other legal protections may be available at the federal, state, and local government level.

The Public Readiness and Emergency Preparedness Act (PREP Act):

  • adds new legal authorities to the Public Health Service (PHS) Act
  • provides liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics
  • adds authority to establish a program to compensate eligible individuals who suffer injuries from administration or use of products covered by the PREP Act’s immunity provisions

The PREP Act authorizes the Secretary of the Department of Health and Human Services (Secretary) (HHS) to issue a PREP Act Declaration (“Declaration”) that provides immunity from liability for any loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined in the Declaration to constitute a present or credible risk of a future public health emergency.

Liability Immunity and Compensation

In general, the liability immunity applies to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of medical countermeasures described in a Declaration. The only statutory exception to this immunity is for actions or failures to act that constitute willful misconduct.

The PREP Act also authorizes a United States Treasury fund that compensates eligible individuals for serious physical injuries or deaths directly caused by administration or use of a countermeasure covered by the Declaration.

PREP Declaration

A Declaration includes:

  • A determination that a disease or health condition or threat to health constitutes a public health emergency, or that there is a credible risk that it will in the future constitute an emergency;
  • The category of diseases, health conditions, or health threats for which administration and use of the countermeasure is recommended. During the time period covered by the Declaration, it is presumed that the recommended countermeasure;
  • The effective time period (the Secretary may specify an extended time period for manufacturers to dispose of the countermeasure and for others to cease administration and use of the countermeasure);
  • The population of individuals receiving the countermeasure and the geographic area of administration and use of the countermeasure for which immunity from liability is in effect for program planners and qualified persons (manufacturers and distributors are provided liability immunity regardless of who receives the countermeasure or where it is administered or used);
  • Limitations (if any) on the geographic area or areas for which immunity is in effect with respect to administration or use of the countermeasure;
  • Limitations (if any) on the means of distribution;
  • Any additional persons identified as qualified to prescribe, dispense, or administer the countermeasure; and
  • Any other limitations or conditions.


Immunity means that courts must dismiss claims brought against any entity or individual covered by the PREP Act.  Claims that courts must dismiss include claims for any loss that is related to any stage of design, development, testing, manufacture, labeling, distribution, formulation, labeling, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing or use of a countermeasure recommended in a Declaration.  This includes, but is not limited to, claims for:

  • death;
  • physical, mental, or emotional injury, illness, disability, or condition or fear of any such injury, illness, disability, or condition;
  • any need for medical monitoring; or
  • property damage or loss, including business interruption loss.

The only exception is for claims of willful misconduct.  (See Question: Are There Any Limitations on Immunity From Liability?).

Claims and Compensation

The PREP Act authorized a “Covered Countermeasures Process Fund” to compensate eligible individuals who suffer injuries as the direct result of a countermeasure administered or used under the Declaration.  Funds must be appropriated by Congress into this account to pay claims.  If funds are appropriated, compensation for serious physical injuries may then be available to eligible requesters under the HRSA’s Countermeasures Injury Compensation Program (CICP).  Requests for Benefits must be made to HRSA’s CICP.

Serious physical injury means an injury that warranted hospitalization (whether or not the person was actually hospitalized) or that led to a significant loss of function or disability.  The CICP pays reasonable and necessary medical benefits, and/or lost wages for eligible injured countermeasure recipients.  Death benefits may also be available to certain survivors of eligible individuals who died as a direct result of the administration or use of a covered countermeasure.

The CICP is payer of last resort, so benefits are reduced by the amounts payable by all other public and private third-party payers (such as health insurance and workers’ compensation).  The regulations implementing the CICP are at 42 CFR part 110.


On November 21, 2012, the Appellate Division of the New York Supreme Court in Parker v. St. Lawrence County Public Health Department, 102 A.D.3d 140 (2012) upheld PREP Act protections for a county that conducted a school based vaccination clinic in response to the H1N1 outbreak.

During the clinic, a nurse employed by St. Lawrence County inadvertently vaccinated a kindergartener in the absence of parental informed consent.  The child's mother filed suit, arguing that the county had committed negligence and battery.  The county moved to dismiss the complaint on the basis that the claim was preempted under the PREP Act.  The lower court denied the defendant's motion to dismiss, asserting that the PREP Act was not intended by Congress to protect against claims arising from failure to obtain informed consent. The county appealed and the United States submitted an amicus brief supporting the county.

The appellate court dismissed the plaintiff's claims, finding that the federal PREP Act preempted the claims under state law and that the breadth of liability immunity provided under the PREP Act precluded the plaintiff's claims of negligence and battery.  The court noted the alternative remedy provided by the countermeasure injury compensation program and the possibility of a federal cause of action for willful misconduct claims.

The period for appeal of the case has expired.

In another case, Kehler v. Hood, 2012 WL 1945952 (E.D.Mo.), plaintiffs alleged that the physician and her employing hospital were negligent in failing to obtain the adult patient’s informed consent and a consult from a specialist prior to the administration of the vaccination, which resulted in a severe case of transverse myelitis to the patient, and  loss of consortium to the spouse.  Defendants then brought third party product liability/failure to warn claims against the manufacturer.

The parties did not dispute that the manufacturer, was protected by the PREP Act, nor did they allege that it engaged in willful misconduct.  As a result, the federal Eastern District Court of Missouri dismissed the claim against the manufacturer.  Finding that it had no jurisdiction over plaintiffs’ remaining claims, the federal court remanded the case to state court for further consideration of the plaintiffs’ claims.


The PREP Act Declaration as amended will apply to any activities related to a federal agreement through December 31, 2024, for administration of medical countermeasures or vaccines, treatments and tests procured by the federal government. The end of the PHE does not affect this coverage.

The PREP Act Declaration as amended also applies to manufacturing, distribution, administration and use of licensed COVID-19 vaccines, approved or cleared in vitro diagnostics and other devices, NIOSH approved respiratory protection devices, and all products under Emergency Use Authorization, regardless of any federal agreement or emergency declaration, through December 31, 2024.

In addition, the Secretary amended the PREP Act declaration to authorize pharmacists to continue to administer COVID-19 and seasonal influenza vaccines to individuals aged three and above and order and administer COVID-19 tests in accordance with an FDA license, approval, or authorization, through December 31, 2024.