The Public Readiness and Emergency Preparedness Act provides the Secretary of HHS authority to issue a declaration providing immunity to certain individuals and entities during a public health emergency.  On March 17, 2020, the U.S. Secretary of Health and Human Services published a Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 in the Federal Register.  The issuance of this declaration provides immunity to certain individuals and entities for liability against “all claims for loss caused by, or, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.”

Who is covered: The declaration provides immunity to “covered persons.”   Covered persons are “manufacturers”, “distributors,” “program planners,” qualified persons,” and their officials, agents, and employees.  The Secretary also designated persons authorized to “prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers” and those “authorized to perform an activity under an Emergency Use Authorization” under the Federal Food, Drug, and Cosmetic Act.  In appropriate circumstances, this will help innovative companies that create novel approaches to combat the coronavirus, along with the hospitals and medical personnel providing these medical interventions.

What is covered: “Covered Countermeasures” include “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.”  Importantly, these must be “qualified pandemic or epidemic products,” or “security countermeasures,” or “drugs, biological products, or devices authorized for investigational or emergency use.”

How broad is the immunity:  The Declaration provides that “a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the

administration to or use by an individual of a covered countermeasure.”  The liability immunity for Covered Countermeasures extends to October 1, 2024 and manufacturers will have an additional 12 months for the disposition of the Covered Countermeasures, and for Covered Persons to “take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures.”

The exception to this immunity is where claims involve “willful misconduct.”  The Declaration is effective retroactively to February 4, 2020.   While the Declaration is an important step in encouraging proactive measures to address the COVID-19 pandemic. Additional information about the Public Readiness and Emergency Preparedness Act may be found here.

Norton Rose Fulbright professionals are available to provide guidance regarding the Declaration or other queries related to the addressing this public health emergency.

The Health Law Pulse will continue to provide updates as more is known about this public health crisis.