Brady Collins
The Public Readiness and Emergency Preparedness (PREP) Act provides broad immunity from state and federal liability for clinicians prescribing the COVID vaccine, even off-label. The PREP Act has been applied during the COVID-19 pandemic to expedite the manufacture, distribution, and use of medical devices and drugs by providing immunity from liability under federal and state law. In the context of COVID-19 vaccinations, the PREP Act declarations have granted regulatory flexibility and new authorities to pharmacists, student pharmacists, and pharmacy technicians. For example, certain Georgia-licensed pharmacists and pharmacy interns have been authorized to administer COVID-19 vaccinations to persons aged three or older. However, it is important to note that the PREP Act immunity is not absolute or automatic and is subject to certain limitations and exceptions.
| Characteristics | Values |
|---|---|
| What is the PREP Act? | The Public Readiness and Emergency Preparedness Act (PREP Act) |
| Who does it apply to? | Georgia-licensed pharmacists and pharmacy interns acting under the supervision of a Georgia-licensed pharmacist |
| Who does it protect? | It provides broad immunity from state and federal liability for "covered persons" |
| Who are "covered persons"? | Anyone involved in the manufacture, distribution, and use of medical devices and drugs |
| Who decides when the PREP Act applies? | The Secretary of the U.S. Department of Health and Human Services (HHS) |
| When was the PREP Act invoked for COVID-19? | March 17, 2020 |
| What vaccines does it apply to? | Any ACIP-recommended vaccine |
| What ages does it apply to? | Persons ages 3 or older |
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What You'll Learn
The PREP Act provides broad immunity from state and federal liability
The Public Readiness and Emergency Preparedness (PREP) Act is a federal law that provides broad immunity from state and federal liability in times of public health emergencies, such as the COVID-19 pandemic. The PREP Act aims to expedite the manufacture, distribution, and use of medical devices and drugs, including vaccines, by offering liability protection to "covered persons" involved in the process. This protection applies to claims arising from the administration or use of "covered countermeasures," which can include vaccines.
In the context of COVID-19, the Secretary of the U.S. Department of Health and Human Services (HHS) issued an emergency declaration, triggering the PREP Act's immunity provisions. HHS has issued guidance and declarations authorising certain licensed pharmacists and pharmacy interns to order and administer COVID-19 vaccinations to individuals aged three or older. This authorisation extends to ACIP-recommended vaccines for persons aged three through eighteen.
The PREP Act's liability protections are significant, providing regulatory flexibility and new authorities to pharmacists and pharmacy professionals. However, it is important to note that the statutory immunity offered by the PREP Act is not absolute or automatic. While it provides broad immunity, some court decisions have narrowed its protection, and immunity is not guaranteed. The HHS has issued an advisory opinion stating that the PREP Act immunity should be interpreted broadly, but it is not binding on HHS or federal courts and does not have the force of law.
Furthermore, clinicians prescribing the COVID-19 vaccine, even off-label, can benefit from the PREP Act's liability protections. This additional layer of protection can shield them from malpractice lawsuits, as long as they follow accepted standards of care and guidance from relevant medical associations or state guidelines. Nonetheless, it is essential for pediatricians and other clinicians to review their malpractice insurance coverage to ensure they are protected under the PREP Act's provisions.
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PREP Act immunity is not absolute or automatic
The Public Readiness and Emergency Preparedness (PREP) Act grants broad immunity from liability to Big Pharma, distributors, hospitals, clinics, doctors, pharmacists, and paramedics whenever the government declares a health emergency. The PREP Act provides immunity from tort liability to certain individuals and entities for claims of loss caused, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures in response to COVID-19. However, it's important to note that PREP Act immunity is not absolute or automatic.
The PREP Act immunity has limitations. It does not cover claims for death or serious physical injury caused by willful misconduct. While the act provides broad immunity, it does not provide immunity from liability for "willful misconduct". The advisory opinion reiterates that immunity under the PREP Act is not absolute. There is no immunity against federal enforcement actions brought by the federal government, be they civil, criminal, or administrative. Additionally, there is no immunity against suit and liability for claims for equitable relief under federal law.
The PREP Act immunity is limited to claims for personal injury or damage to property. The immunity covers "covered persons" who are those who manufacture, test, develop, distribute, administer, or use "covered countermeasures", including "qualified persons". Qualified persons are licensed health professionals or other individuals authorized to prescribe, administer, or dispense such countermeasures. The PREP Act immunity can be extended by public agencies, including local, city, state, or federal agencies with legal responsibility in the health crisis response, such as law enforcement or public health officials.
While the PREP Act provides broad immunity from state and federal liability, it is not guaranteed and may be vulnerable in the future. Some court decisions have narrowed its protection, and there have been numerous lawsuits challenging the immunity granted under the act and seeking compensation for those harmed. The PREP Act has been considered by many legal experts to be clearly unconstitutional, violating citizens' Fifth Amendment right to due process.
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PREP Act declarations grant regulatory flexibility to pharmacists
The Public Readiness and Emergency Preparedness (PREP) Act grants broad immunity from liability to pharmacists and other healthcare providers whenever the government declares a health emergency. The PREP Act declarations grant regulatory flexibility to pharmacists by authorizing them to order and administer vaccines and COVID-19 tests to individuals as young as three years old. This includes both FDA-authorized and FDA-licensed vaccines.
In Georgia, for example, the PREP Act declaration authorizes certain Georgia-licensed pharmacists to order and administer ACIP-recommended vaccines to persons aged 3 to 18 years. This declaration also covers pharmacy interns acting under the supervision of a Georgia-licensed pharmacist. Similarly, pharmacy interns in Georgia are granted the authority to administer FDA-authorized or FDA-licensed COVID-19 vaccines to persons aged three and above.
The PREP Act provides liability protection to pharmacists, shielding them from legal consequences in the event of adverse outcomes from vaccine administration. This flexibility is intended to facilitate the rapid deployment of vaccines and treatments during public health emergencies. However, the PREP Act has faced criticism and legal challenges due to concerns about the broad immunity it grants to healthcare providers and the potential denial of hearing rights to injured parties.
While the PREP Act currently remains in effect, there are ongoing debates and legislative efforts to repeal or amend it to address these concerns. The act has been extended until December 31, 2029, but its constitutionality is still under question, with some legal experts and legislators advocating for its dismantling.
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PREP Act authorisations apply to Georgia-licensed pharmacists
The Public Readiness and Emergency Preparedness (PREP) Act provides broad immunity from liability for those administering vaccines during a public health emergency. The PREP Act authorisations do apply to Georgia-licensed pharmacists, as well as pharmacy interns acting under the supervision of a Georgia-licensed pharmacist.
On April 8, the HHS issued a PREP Act declaration authorising licensed pharmacists to order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorised through Emergency Use Authorization (EUA). This declaration was further clarified on May 19 by the General Counsel for the HHS Office of the Secretary, who emphasised its preemption of conflicting local and state regulations.
On August 19, the HHS issued a Third Amendment to the Declaration under the PREP Act, authorising certain state-licensed pharmacists to order and administer any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages 3 through 18 per ACIP's standard immunization schedule. This amendment was also clarified by the General Counsel for the HHS Office of the Secretary on October 22, who reiterated the inclusion of epinephrine in the PREP Act as a covered countermeasure.
Georgia-licensed pharmacists are granted the authority to order and administer any ACIP-recommended vaccine to persons aged 3 to 18 years. They are also covered under the liability protections of the PREP Act. However, it is important to note that a Vaccine Protocol Agreement is still required for pharmacists to order and administer adult vaccines in Georgia.
The PREP Act provides an additional layer of protection for clinicians prescribing the COVID vaccine, even if it is off-label. While it offers broad immunity from state and federal liability, some court decisions have narrowed its protection, and immunity is not guaranteed.
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PREP Act and malpractice law
The Public Readiness and Emergency Preparedness (PREP) Act provides broad immunity from state and federal liability for "'covered persons' using 'covered countermeasures'. In the context of the COVID-19 pandemic, this has been interpreted to include the manufacturing and administering of a COVID-19 vaccine.
However, this immunity is not absolute and has been challenged in medical malpractice cases. For example, in Goins v. Saint Elizabeth Medical Center, Inc., the plaintiff sued a physician and his practice group for medical malpractice after experiencing unusual blood sugar swings following her second dose of the Moderna COVID-19 vaccine. The plaintiff alleged that the physician negligently performed an endoscopy and biopsy to rule out a pancreatic tumour, which was potentially a reaction to the COVID-19 vaccine. The Sixth Circuit Court affirmed the lower court's denial of the motion to dismiss, finding that the allegations did not clearly tie the claimed medical malpractice to any vaccine-related medical care.
In another case, the Sixth Circuit Court held that a physician failed to show that he performed an endoscopy and biopsy to address a side effect of the COVID-19 vaccine for the purposes of claiming immunity under the PREP Act. The court found that there must be some plausible factual allegation that the COVID-19 vaccine caused the underlying symptoms for immunity to apply.
These cases highlight that while the PREP Act can provide immunity from liability for claims related to the use of covered countermeasures, it does not necessarily extend to medical malpractice claims that are not clearly tied to the use of those countermeasures. Clinicians prescribing the COVID-19 vaccine may have two layers of protection: malpractice coverage and the PREP Act. However, it is important to note that immunity under the PREP Act is not guaranteed and may be vulnerable in the future, as court decisions have narrowed its protection.
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Frequently asked questions
The PREP Act, or the Public Readiness and Emergency Preparedness Act, provides broad immunity from state and federal liability in times of epidemics and pandemics. It expedites the manufacture, distribution, and use of medical devices and drugs.
The PREP Act provides liability protection to certain state-licensed pharmacists and pharmacy interns to administer vaccines to persons aged three or older. The specific vaccines that can be administered vary by state.
The requirements for pharmacists and pharmacy interns to be covered under the PREP Act are determined by the U.S. Department of Health and Human Services (HHS). The specific requirements may vary depending on the state and the type of vaccine being administered.
