HHS Provides Liability Shield for Coronavirus Countermeasures

Regulatory NewsRegulatory News
| 13 March 2020 | By Michael Mezher 

The federal government is granting companies protection from liability for medical and security countermeasures against coronavirus disease (COVID-19), according to a declaration, signed by Health and Human Services Secretary Alex Azar, to be published in the Federal Register on Tuesday 17 March.
The authority to grant liability immunity for countermeasures stems from the 2005 Public Readiness and Emergency Preparedness Act (PREP Act). Similar declarations have been made for other public health emergencies, including the Ebola and Zika virus outbreaks in recent years.
Specifically, the protection from liability shields “covered persons” including manufacturers, distributors and program planners from “any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures,” except in cases of willful misconduct.
Countermeasures covered under the declaration include drugs, biologics and medical devices used to diagnose, prevent, treat or mitigate a pandemic or epidemic disease. The declaration also covers drugs, biologics and medical devices intended “to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition” caused by such products, as well as products meant to enhance usage of another countermeasure.
Security countermeasures are defined as products determined by the HHS Secretary to be a necessary to protect public health, and include products intended to be used against material threats and those protect against “adverse health consequences or death.”
To be covered by the declaration, countermeasures must be approved, cleared, licensed or authorized for emergency use by the US Food and Drug Administration (FDA). Products being studied under an investigational new drug application (IND) or investigational device exemption (IDE) are also covered by the declaration when they are the “object of research for possible use” as a pandemic or epidemic product.
Security countermeasures may also qualify for liability immunity “if [they] may reasonably be determined to qualify for approval or licensing within 10 years after the Department’s determination that procurement of the countermeasure is appropriate.”
The declaration is retroactive, and once published, will be effective from 4 February 2020 through 1 October 2024.
Federal Register Notice


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