PREP Act (2005)

The Public Readiness and Emergency Preparedness (PREP) Act, passed in 2005, operates as the ultimate liability shield within the U.S. biodefense procurement framework.^[1] Designed to function in tandem with Project BioShield, the PREP Act grants sweeping tort liability immunity to individuals and entities—including pharmaceutical manufacturers, distributors, and administrators—involved in the development and deployment of medical countermeasures during a declared public health emergency.^[2] This statutory mechanism ensures that private capital can extract immense profits from government procurement without facing standard commercial risks associated with product defects or adverse health events.^[3] The statute provides that a covered person — manufacturers, distributors, programme planners, and those who prescribe, administer or dispense — shall be immune from suit and liability under Federal and State law once a declaration is issued, the sole exception being death or serious physical injury proximately caused by willful misconduct, which a claimant must prove by clear and convincing evidence.^[4] A compensation route exists under the adjacent section, but electing to accept compensation bars the individual from bringing an action, and the fund is not standing money — it operates only where amounts have by law been provided for it.^[5]