“Enacted
in December 2005, the PREP Act authorizes the Secretary of HHS
(Secretary) to issue a declaration (called a PREP Act declaration) that
provides immunity from tort liability (except
for willful misconduct) for claims of loss caused, arising out of,
relating to, or resulting from administration or use of countermeasures
to diseases, threats and conditions determined by the Secretary to
constitute a present, or credible risk of a future
public health emergency to entities and individuals involved in the
development, manufacture, testing, distribution, administration, and use
of such countermeasures.” (link)
A PREP Act declaration is specifically for the purpose of providing
immunity from tort liability, and is different from, and not dependent
on, other emergency declarations.
Under the HHS Notification, the PREP Act has been modified: “The amended Section VII adds that PREP Act liability protections also extend
to Covered Persons for Recommended Activities that are related to any Covered Countermeasure that is:
- licensed, approved, cleared, or authorized by the Food and Drug Administration (FDA) (or that is permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the Federal Food, Drug, and Cosmetic (FD&C) Act or Public Health Service (PHS) Act to treat, diagnose, cure, prevent, mitigate or limit the harm from COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom; (link)
The attachment of a liability or tort waiver to only cover FDA approved therapeutics likely
explains a shift amid the medical community to stop patients treatment
due to coverage restrictions on their malpractice insurance.
Additionally, Big Pharma
-the group who controls NIH- wouldn’t make as much money if their
mandatory vaccines had a less costly alternative. So there’s that.
The PREP
Act offers hospitals blanket financial liability protection in treating
C19 patients only if the hospitals follow the approved protocol; if
hospitals treat
only with CDC, FDA approved countermeasures, i.e. NIH approved measures,
they keep the liability shield. Any hospital deviating from the
protocol loses the PREP Act C19 liability shield, it seems. Again,
follow the money.
I can’t see any other reason hospitals would fight so hard to block
dying patients last-chance medical requests for an FDA approved drug
used off-label but not EUA’d for C19. It might explain the hospital’s
use of the term “human guinea pig”.
This is from a brief outline of the current PREP Act applied to C19 treatments. Ivermectin is not a "covered countermeasure” by this
definition.
“Fourth, the medical product at issue must be a covered
countermeasure. The PREP Act specifies four types of covered
countermeasures: (i) a qualified “pandemic or epidemic product”; (ii) a
“security countermeasure”; (iii) a drug, biological product,or
device that the U.S. Food and Drug Administration (FDA)has authorized
for emergency use; and (iv) a “respiratory protective device” that is
approved by the National Institute for Occupational Safety and Health
(NIOSH).”
