Public Readiness and Emergency Preparedness Act

The Public Readiness and Emergency Preparedness Act (PREP Act) added new powers to the federal government under the Public Health Service (PHS) Act, and provides immunity from liability for the use of covered medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics. First enacted in 2005 and amended since then, the PREP Act further conferred authority for establishing a program to compensate eligible individuals who suffer injuries from administration or use of products which are immunized against liability by the immunity provisions in the PREP Act.

At least two decisions have upheld immunity for the administration of vaccines, under the PREP Act.

Conditions

The Secretary of HHS may declare a medical countermeasure based on one or more of the following:

• A qualified pandemic or epidemic product;
• A security countermeasure;
• An unapproved drug, biological product, or device used under an Emergency Use Authorization (EUA) issued by FDA;
• An approved drug, biological product, or device used pursuant to Federal law in conditions that are in consistent with its approval ; or
• An unapproved drug, biological product, or device, or an approved drug, biological product, or device intended for an unapproved use, that is intended for emergency use and shipped and held by a government agency or someone working on that agency’s behalf for use only when that use is authorized.

Declaration

The Declaration is by the Secretary of Health and Human Services. It is published in the Federal Register, but is effective upon signature rather than upon publication.