In conjunction with EUA (Emergency Use Authorization), the PREP Act is the legislation that enabled – and continues to perpetuate – the rollout and administration of mRNA “countermeasures” against Covid-19.
In this article I will discuss what the PREP Act says, how it was passed, what prominent politicians and legal experts said about it at the time, how it is related to Covid, and why I support efforts (1) calling for the HHS Secretary to immediately repeal the PREP Act emergency declaration for Covid, and (2) calling on legislators to repeal the law entirely.
What the PREP Act Says
The PREP Act is a long and convoluted piece of legislation. You can read the entire thing here:
This is a summary of the main sections of the law:
(a) Liability Protections
- Anyone defined as a “covered person” is immune from legal liability related to the use or administration of anything defined as a “covered countermeasure.”
A “covered person” includes (A) “the United States” or (B) any person or “entity” that manufactures, distributes, plans a program for, prescribes, administers, or dispenses a covered countermeasure, or an official, agent, or employee of any of the above.
A “covered countermeasure” includes any drug, biological product, or device that is authorized under Emergency Use Authorization or approved through any other legal pathway.
- Scope of claims for loss:
- The immunity applies to any claim related to death, actual or fear of physical, mental, or emotional injury, illness, disability, or condition; and loss of or damage to property, including business interruption loss.
- The immunity applies to any causal relation to any of the above types of loss related to the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of a covered countermeasure.
- The immunity applies only if a countermeasure was applied or used during the effective period of the emergency declaration for that countermeasure, and was used for the disease, population, and geographic area specified in the declaration.
- For manufacturers or distributors, the immunity applies to any population in any geographic area, without regard to the population or area specified in the emergency declaration for the countermeasure.
(b) Declaration by Secretary
- The HHS Secretary has the sole discretion to determine that a disease or other health condition or other threat to health constitutes a public health emergency, or that there is a credible risk for a future such emergency and, based on that determination, to make a declaration recommending the manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures, thereby activating the legal immunity described in section (a).
- In the emergency declaration, which is made by publishing it in the Federal Register, the secretary shall identify – with respect to the use of countermeasures – the category of threat, the period during which the threat is in effect, the population for which it is in effect, and the geographic area for which it is in effect.
- The period during which the emergency declaration is effective is flexible, depending on various determinations by the Secretary.
- The Secretary can change any aspect of the declaration of emergency without retroactively affecting the immunity granted under the declaration.
- The Secretary’s decision to issue an emergency declaration for immunity can be based on anything, including the “desirability of encouraging” the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, or licensing of a covered countermeasures
- No court – whether Federal or State – has subject matter jurisdiction to review any action by the Secretary related to the emergency declaration
- No State may pass or enforce any law that is different from or in conflict with anything related to the declaration of emergency or to anything related to the qualified persons or covered countermeasures.
(c) Definition of Willful Misconduct
(d) Exception to Immunity of Covered Persons
These two sections define the circumstances under which the PREP Act immunity does not apply. In general, the sole exception is defined as “an exclusive Federal cause of action against a covered person for death or serious physical injury caused by willful misconduct.”
The definition of “willful misconduct” is: “an act or omission taken intentionally to achieve a wrongful purpose; knowingly without legal or factual justification; and in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.” This is specifically defined as “a standard for liability that is more stringent than a standard of negligence in any form or recklessness.”
A plaintiff who tries to sue under this section has “the burden of proving by clear and convincing evidence willful misconduct.”
Hellbound and Down 