Earlier this month, in response to the end of the COVID-19 public health emergency, the Department of Health and Human Services (“HHS”) issued the Eleventh Amendment to the declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for medical countermeasures against COVID-19. The PREP Act allows the Secretary of HHS to provide liability immunity, through a declaration, to certain individuals and entities against claims associated with the manufacture, distribution, administration, or use of certain defined medical products or devices, referred to as countermeasures.

HHS originally announced this PREP Act declaration in January 2020 in response to the COVID-19 pandemic (the “Declaration”).  The Declaration has been amended at various points throughout the pandemic.  This latest amendment makes several different updates:

  • extends the effective date of the Declaration through December 31, 2024.
  • ensures coverage to FDA-approved or emergency-use-authorized (“EUA”) COVID-19 vaccines, products, or devices regardless of any government distribution or purchase agreements associated with those vaccines, products, or devices and regardless of any government emergency declarations.
  • clarifies that the Declaration applies to the burden on health care providers due to simultaneously occurring COVID-19 infections and seasonal flu infections.
  • ensures that the Declaration continues to apply to licensed pharmacist to order and administer and to pharmacy interns and technicians to administer COVID-19 vaccines, flu vaccines, and COVID-19 tests regardless of any government distribution or purchase agreements and regardless of any government emergency declarations. 

In announcing the amendment related to the coverage of pharmacy employees to administer vaccines and tests, HHS pointed out that “the majority of Americans have received their COVID-19 vaccines and tests from a pharmacy” and that “nearly 90 percent of Americans lived within five miles of a community pharmacy” as of last year.

The Secretary of HHS, Xavier Becerra, explained that the declaration was being amended and not canceled, despite the end of the public health emergency, because “COVID-19 continues to present a credible risk of a future public health emergency” and “continued coverage under the PREP Act . . . is intended to prepare for and mitigate that credible risk.”

The full, as-amended text of the Declaration can be found in the Federal Register

Reed Smith will continue to follow developments associated with the end of the COVID-19 public health emergency.  If you have questions about the recent amendments to the Declaration or any other responses to the end of the public health emergency, please reach out to the health care attorneys at Reed Smith.