As part of the U.S. government’s response to the COVID-19 pandemic, on March 10, 2020, the secretary of Health and Human Services (HHS) issued a declaration pursuant to the Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. § 247d-6d. This declaration activated immunity from personal injury, property damage, and other types of claims for companies and certain individuals who manufacture, distribute, or use “covered countermeasures”—certain drugs, devices, or components that may be used to treat COVID-19 patients or combat the COVID-19 pandemic. Since that time, the secretary has amended the declaration on four occasions. In addition, the HHS Office of the General Counsel (OGC) and the HHS Office of the Assistant Secretary for Health (OASH) have issued several advisory opinions and guidance documents setting forth their views on the breadth and application of the PREP Act for COVID-19.
The PREP Act Declaration for COVID-19 extends immunity for all but willful misconduct to the manufacture, testing, development, distribution, administration, and use of “covered countermeasures” by “covered persons.” Covered countermeasures include qualified pandemic or epidemic products; certain defined security countermeasures; drugs, devices, or biologics that are approved or cleared, or authorized by FDA for emergency use; and certain respiratory protective devices used to treat, diagnose, cure, prevent, or mitigate COVID-19 and their components. Covered persons included manufacturers, distributors, program planners, and other defined “qualified persons.” Qualified persons include any person authorized to prescribe, administer, deliver, distribute, or dispense a covered countermeasure in accordance with the public health and medical emergency response of a local, state, or federal agency with legal responsibility and authority for responding to COVID-19. The initial PREP Act declaration placed several limits on the immunity; notably, the immunity only extended to use of covered countermeasures “related to,” generally speaking, a federal contract or agreement, or activities authorized by a state, local, or tribal authority in accordance with its public health response to the COVID-19 pandemic.
The first amendment to the declaration, published on April 10, 2020, amended the declaration in light of the CARES Act. It extended the definition of “covered countermeasures” to include respiratory protective devices approved by the National Institute for Occupational Health and Safety.
The second amendment, dated June 4, 2020, amended the definition of “covered countermeasures” to clarify that they include qualified products that limit the harm that COVID-19 might cause.
Motivated by lower rates of child well visits (and therefore routine vaccinations) during the pandemic, on August 19, 2020, the secretary amended the declaration for a third time. This amendment broadened the definition of “qualified persons” to include state-licensed pharmacists and interns licensed or registered by their state board of pharmacy to administer certain vaccines to children recommended by the Advisory Committee on Immunization Practices. The secretary also clarified that the disease for which the secretary recommends using covered countermeasures is not only COVID-19 but also other diseases and threats that may have been caused by COVID-19, such as the decrease in the rate of routine childhood vaccinations.
In the fourth amendment, dated December 3, 2020, the secretary clarified that the declaration must be construed in accordance with OGC advisory opinions and that it incorporates OASH guidance documents. The secretary further amended the definition of “qualified persons” to include telehealth medicine crossing state lines and clarified that the definition of “covered countermeasures” in the declaration encompasses the full PREP Act definition. Notably, the secretary also removed the limitation in the initial PREP Act declaration on distribution and extended immunity to entirely private distribution channels. The secretary further clarified that PREP Act immunity can also apply to individuals choosing not to administer a covered countermeasure.
To date, the OGC has issued six advisory opinions and OASH has provided five guidance documents on the PREP Act declaration. Those opinions and guidance cover topics such as whether a person with a reasonable, but mistaken belief that she is administering a covered countermeasure can nonetheless retain immunity (answer: Yes, assuming other requirements are met), and in what circumstances a conscious decision not to administer a covered countermeasure can still give rise to PREP Act immunity.
The secretary has been regularly updating the PREP Act declaration and issuing interpretive opinions and guidance. Thus, it is important to check for recent developments when advising clients on PREP Act immunity.