The Department of Health and Human Services (HHS) issued an amendment to the Public Readiness and Emergency Preparedness (PREP) Act to increase access to covered countermeasures during the COVID-19 public health emergency (PHE) (press release).
In general, the amendment defines covered countermeasures used to combat COVID-19, such as diagnostics, therapeutics, vaccines, and respiratory devices, and adds individuals that may order or administer such covered countermeasures to the covered persons who are afforded liability protections under the PREP Act.
Additional highlights from the amendment follow:
- Covered Persons – On p. 16, HHS details that covered persons are those individuals who are afforded liability protections under the PREP Act, including manufacturers, distributors, program planners, and qualified persons. Under the amendment, HHS add any individual authorized to prescribe, administer, deliver, distribute, or dispense the covered countermeasures to the definition of a “qualified person.” The following authorities are granted under the extension of covered persons:
- Covered Countermeasures – HHS defines covered countermeasures as the following
- Any antiviral, drug, biologic, diagnostic, device, respiratory protective device, or vaccine manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, or treat COVID-19 or the transmission of COVID-19, or limit the harm of COVID-19;
- A product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described above;
- A product or technology intended to enhance the use or effect of a product described above; or
- Any device used in the administration of any such product, and all components and constituent materials of any such product.
- Limitation on Distribution – HHS details that liability protections are only afforded to covered persons for recommended activities that involved the following covered countermeasures:
- Covered countermeasures that are related to any present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda or understanding, or other federal agreements;
- Covered countermeasures that received licensure or emergency use authorization (EUA) from the Food and Drug Administration; or are permitted for use under an investigational new drug application (INDA) or Investigational Device Exemption; and
- Respiratory protective devices approved by the National Institute for Occupational Safety and Health (NIOSH);
- Effective Time Period – HHS establishes that the liability protections for any respiratory protective device approved by NISOH begin on March 27, 2020 and extend through October 1, 2024, and liability protections for all other covered countermeasures begin on February 4, 2020 and extend through October 1, 2024. For vaccine countermeasures, liability protections begin on August 24, 2020 and extend through the final day of the Declaration of Emergency or October 1, 2024, whichever occurs first.