On December 9, 2020, the Department of Health and Human Services (HHS) Secretary Alex Azar issued a new notice of declaration under the Public Readiness and Emergency Preparedness (PREP) Act (the Declaration) to provide limited immunity for activities related to countermeasures against marburgvirus and/or Marburg Disease. 85 FR 79198-01. The Declaration is effective as of November 25, 2020.
The Declaration notes that Marburg Disease is a severe and often fatal illness in humans caused by marburgviruses, which are in the same family as the Ebola virus. Marburg Disease is highly infectious, can cause hemorrhagic fever, and has a fatality rate of approximately 88%. Person-to-person transmission can occur via direct contact with droplets of body fluids from infected persons or contact with equipment and other objects contaminated with infectious blood or tissues. Similar to Ebola virus outbreaks, marburgvirus has been determined to have the potential to be a threat to U.S. public health security. There have been previous Marburg outbreaks, most recently in 2014 and 2017, and the U.S. government has been focused on the development of relevant countermeasures over the past decade.
Since the enactment of the statute in 2005, the PREP Act has been used to address previous hemorrhagic fever outbreaks, most notably with Ebola in 2014. The marburgvirus Declaration is substantially similar to previous PREP Act declarations and also to Secretary Azar’s original March 17, 2020 COVID-19 PREP Act Declaration (85 FR 15198). In brief, the Declaration extends immunity from liability under the PREP Act to “Covered Persons” who engage in “Recommended Activities” involving “Covered Countermeasures,” subject to certain limitations. With two exceptions, the provisions of the marburgvirus Declaration are functionally identical to those of the original COVID-19 Declaration. First, the marburgvirus Declaration (Section I) refers to marburgvirus as a “credible risk” that “may in the future constitute a public health emergency.” This contrasts with the COVID-19 declaration, which determined that COVID-19 constituted a current public health emergency. Of note, the PREP Act grants the HHS secretary the authority to issue a declaration both for current and future threats to health. 42 U.S.C. § 247(d)-6(d)(b)(1). Second, the marburgvirus Declaration expands the definition of Covered Countermeasures (Section VI) to include “countermeasures for adverse effects of [other Covered Countermeasures], and countermeasures that otherwise limit the harm caused by the health threat.”
Notably, the marburgvirus Declaration does not adopt any of the significant additions and expansions that Secretary Azar’s December 3, 2020 Fourth Amendment to the COVID-19 Declaration implemented and, again, is more reflective of previous hemorrhagic fever declarations. For example, the marburgvirus Declaration’s definition of Covered Persons (Section V) does not include the expanded discussion of pharmacists that was recently added to the corresponding section of the COVID-19 Declaration. Likewise, the marburgvirus Declaration currently limits liability protection to Recommended Activities that are related to (1) present or future federal agreements or (2) activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a declaration of an emergency. In contrast, the currently operative COVID-19 Declaration additionally affords liability protection as to certain Covered Countermeasures that are licensed, approved, cleared, or authorized by the Food and Drug Administration or approved by the National Institute for Occupational Safety and Health, absent any federal agreement or action by the Authority Having Jurisdiction.
Given the almost exclusive focus on COVID-19, the issuance of the marburgvirus Declaration is certainly interesting — and it likely caught a number of people off-guard. And while it reflects past PREP Act declarations, the Marburgvirus Declaration is not as expansive as that in place extending PREP Act immunity to covered persons providing covered COVID-19 countermeasures. As such, entities hoping to rely on the PREP Act for the provision of Marburgvirus countermeasures should pay particular attention to this new Declaration and avoid making any assumptions regarding coverage based on the more expansive nature of the COVID-19 Declaration, as amended.
Additional information on the PREP Act and the COVID-19 Declaration is available at Faegre Drinker’s Coronavirus Resource Center.