Federal declaration provides limited immunity to heath care workers in COVID-19 care

The federal PREP law provides for a type of limited liability for healthcare workers under a declaration by the Secretary of HHS.  On March 17, 2020, the Declaration activating that provision was issued by the Secretary.  Excerpts are provided below.  Full-text link: https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-05484.pdf

“Under the Declaration Covered Persons who are afforded liability immunity are ‘‘manufacturers,’’ ‘‘distributors,’’ ‘‘program planners,’’ ‘‘qualified persons,’’ and their officials, agents, and employees, as those terms are defined in the PREP Act and the United States. In addition, I have determined that the following additional persons are qualified persons:

(a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and 15202 Federal Register/ Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices volunteers, following a Declaration of an emergency;

(b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act; and

(c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. “

The “covered countermeasures” mentioned in the Declaration include:

Covered Countermeasures are 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. Covered Countermeasures must be ‘‘qualified pandemic or epidemic products,’’ or ‘‘security countermeasures,’’ or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.

The scope is further defined as:

I have determined that liability immunity is afforded to Covered Persons only for Recommended Activities involving Covered Countermeasures that are related to:

(a) Present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements; or

(b) 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. As used in this Declaration, the terms Authority Having Jurisdiction and Declaration of Emergency have the following meanings:

The Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority.

Until further clarification is issued, this is all legalese — consult your system attorney until then.

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