Pursuant to the Public Readiness and Emergency Preparedness (PREP) Act, the Department of Health and Human Services (HHS) has declared COVID-19 a public health emergency. Pursuant to this Declaration, certain qualifying individuals and entities are now afforded tort liability immunity from any loss caused, arising out of, relating to, or resulting from administration or use of countermeasures against COVID-19. See 85 FR 15198 (HHS March 17, 2020); 42 U.S.C. §247d-6d. The PREP Act’s broad immunity does not extend to acts of willful misconduct.
Under the PREP Act, immunity is granted to those individuals who qualify as “Covered Persons” and are providing “Covered Countermeasures” as those terms are defined in the Act.
Defining Covered Persons
The PREP Act defines a “Covered Person” to include manufacturers, distributors, program planners and other qualified persons, and broadly defines each entity as follows:
- Manufacturer: A supplier or licenser of any product, intellectual property, service, research tool, or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure
- Distributor: A person or entity engaged in the distribution of drugs, biologics or devices, including but not limited to manufacturers, repackers, common carriers, contract carriers, air carriers, own-label distributors, private-label distributors, jobbers, brokers, warehouses and wholesale drug warehouses, independent wholesale drug traders and retail pharmacies
- Program Planner: A person or entity (including a municipality or municipal employee) who supervises or administers a “Covered Countermeasure” program, including any person or entity who “establishes requirements, provides policy guidance, or supplies technical or scientific advice or assistance or provides a facility to administer or use a Covered Countermeasure in accordance with the Secretary’s Declaration;”
- Qualified Person: A licensed health professional or other person authorized to “prescribe, administer, or dispense Covered Countermeasures.”
42 U.S.C.A. § 247d-6d(i)(2)(B)(i),(ii),(3),(4).
Due to the expansiveness of these definitions, a number of individuals and companies may qualify as a “Covered Person” under the PREP Act. Whether they can avail themselves of the tort immunity conferred under the Declaration, however, also is dependent upon whether they are manufacturing or distributing “Covered Countermeasures” as defined by the PREP Act, as well as the manner in which they are doing so.
Defining “Covered Countermeasures”
A “Covered Countermeasure” under the PREP Act consists of any antiviral, drug, biologic, diagnostic, device, and/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. 85 FR 15202. 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 Federal Food, Drug, and Cosmetic Act, and the Public Health Service Act. Id. at 15199; see also, e.g., 42 U.S.C.A. § 247d-6d; 21 U.S.C.A. § 360bbb-4b; 21 U.S.C.A. § 321; 42 U.S.C.A. § 262.
Limitations on Types of Activities
Finally, the PREP Act limits the immunity protection to Covered Persons to a defined set of circumstances and activities. Specifically, liability immunity is afforded to the manufacture, testing, development, distribution, administration and use of the Covered Countermeasures, but only to the extent such activities 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.
The Declaration’s broad language and the PREP Act’s definitions bring a wide variety of products and services under the Declaration’s immunity umbrella. Indeed, if a product does fall within the Declaration’s ambit, the immunity extends retroactively from February 4, 2020 to October 1, 2024.
As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.