COVID-19 The PREP Act and its Application to Health Care Providers and Entities
Who civil immunity is provided to:
- Manufacturers, distributors, program planners, qualified persons and their officials, agents, employees (as defined by the PREP Act) and the United States;
- Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction (i.e. as authorized by a state or local emergency order, etc.) to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures including their officials, agents, employees, contractors and volunteers following a Declaration of an emergency;
- Any person authorized to prescribe, administer, or dispense the covered counter measures or who is otherwise licensed to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act;
- Any persons authorized to prescribe, administer or dispense covered countermeasures in accordance with Section 564A of the FD&C act.
What are “covered countermeasures”:
- Any antiviral, drug, biologic, diagnostic or other device or any vaccine, used to treat, diagnose, cure prevent or mitigate COVID-19 or the transmission of SARS or any device used in the administration 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.
What activities are specifically provided civil immunity:
- Present or future federal contracts, cooperative agreements, grants other transactions, interagency agreements, memoranda of understating or other federal agreements;
- 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.
What actions are not provided civil immunity:
- Any willful misconduct;
- Actions not directly related to the treatment, diagnosis, cure, prevention or mitigation of COVID-19.
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