What is this “PREP Act” that has entered our vocabulary this past week?
Several terms that were foreign to most just a couple of months ago are now becoming mainstream. Social Distancing. Congregate Settings. Sustained Community Transmission. Prep Act. And even proper personal hygiene for some.
I have been discussing the need for many to read and understand the complexities and pitfalls of this federal law for a few years. The PREP Act[i] or “Public Readiness and Emergency Preparedness Act” was the product of President Bush 43 and his Health and Human Services (HHS) agency.
The PREP Act was passed in December of 2005. Most of the emphasis for this act was born upon the federal government’s response to the Anthrax scare immediately after 9/11.
The Public Readiness and Emergency Preparedness Act (PREP Act) added new legal authorities to the Public Health Service (PHS) Act to provide liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics. It also added authority to establish a program to compensate eligible individuals who suffer injuries from administration or use of products covered by the PREP Act’s immunity provisions. [ii]
The first reading of this legislation would lend the reader to think that the act was reasonable. Think again. Promoting the Act as being similar to the NVICP, compensating persons for injuries and at the same time, sneaking freedom and liberty restrictions into our lives.
The Act would continue to be amended by legislation and by Executive Orders by Bush 43 and Obama.
The Act did create a CounterMeasures Compensation Fund and mechanism to award damages to those who suffered injury or death by any of the declared countermeasures by the Secretary of HHS.
What is not mentioned in this summary page provided by HHS is the scary and very concerning legal powerful granted to the Secretary of HHS and further to the local and state health departments?
Hidden in the Act is subsection (7) under declarations by the Secretary of HHS.
(7) JUDICIAL REVIEW.-No court of the United States, or of any State, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Secretary under this subsection.[iii]
Now, how to interpret this? In the Declarations subsection, whereas the Secretary of HHS has sole power to decide which counter measure or measures used to combat an epidemic or pandemic, the manufacturer of the said countermeasure will receive immunity from liability resulting in injury or death. And there is NO Court system in the land that can override this provision.
There have been seven (7) declarations of Countermeasures covered by the PREP Act. Countermeasures can include vaccines, drugs, or medical devices to be used against chemical, biological, radiological, and nuclear (CBRN) agents of terrorism, epidemics, and pandemics.[iv]
The covered Countermeasures include anthrax, Ebola, Zika, and now, the Secretary of HHS has begun the process of adding Coronavirus vaccines as a covered measure. This process started in early February 2020. With a period of soliciting public comment, and waiting for the development of a vaccine, the declaration if approved will be ready to add the vaccine sometime in early 2021 or later.
Isolation and Quarantine Provisions.
The Act clarifies that the Secretary of HHS and her designees have the authority to declare a national or regional public health emergency. With declaration comes, the authority to quarantine person(s) who are deemed infected or suspected of being affected. Also those who refuse any mandatory countermeasure may also be subject to isolation or home quarantine. This provision allows state and local health authorities to isolate and quarantine suspected persons.
What is not known is whether or not anyone rejecting a countermeasure and has shown to be asymptomatic, can they or when will they be able to return to normal activity?
In many states, the Governor has sought or is seeking a public health declaration by the state to use National Guard troops. This gets troubling for many. To me, the first step will be using the troops to help deliver medicines and food plus providing transport to medical facilities for those who need medical care. It is the second and third steps that might be an issue for some.
The PREP Act dovetails into a federal response designed to be enhanced by the President’s declaration of the Stafford Act which provides funding for any natural disaster and now for the first time, President Trump signed a declaration to allow funding to combat the Coronavirus pandemic.
We are witnessing the PREP Act in action for the first time since its passage in 2005. No one really knows the extent of the law and how it will affect everyone in the United States, short term and long term. Most of the media has not even discussed the details of the PREP Act and how it will affect the general public.
There is a lot of speculation that we might see Martial Law across all states. It has been many years since Martial Law was declared for parts of the United States. The Federal Government has used “State of Emergency” instead of martial law during Hurricane Katrina in certain sections of New Orleans, or in the case of searching for the Boston bombers.
The martial law concept in the United States is closely tied with the right of habeas corpus, which is in essence the right to a hearing on lawful imprisonment, or more broadly, the supervision of law enforcement by the judiciary. The ability to suspend habeas corpus is related to the imposition of martial law. Article 1, Section 9 of the US Constitution states, "The Privilege of the Writ of Habeas Corpus shall not be suspended, unless when in Cases of Rebellion or Invasion the public Safety may require it." The distinction must be made as clear as that between martial law and military justice: deployment of troops does not necessarily mean that the civil courts cannot function, and that is one of the keys, as the Supreme Court noted, to martial law.[v]
In United States law, martial law is limited by several court decisions that were handed down between the American Civil War and World War II. In 1878, Congress passed the Posse Comitatus Act, which forbids military involvement in domestic law enforcement without congressional approval.[vi]
So what happens to those who are injured from a countermeasure as declared by the Secretary of HHS?
CounterMeasures Injury Compensation Program
In 2010, President Obama signed into law the Counter Measures Injury Compensation Program (CICP) to enhance the existing PREP Act compensation function. The CICP is administered directly by the Health Resources and Services Administration (HRSA). This federal agency is also tasked with the administration of the National Vaccine Injury Compensation Program (NVICP) or Vaccine Court.
Over the course of the last couple of years, I have contacted HRSA officials to discuss some issues in the NVICP. I can usually get someone to talk with me via a phone call. When the topic turns to CICP, the tone changes and the official now states, “send me an email and I will review it.”
The CICP is problematic in so many ways. First, the statute of limitations is only one (1) year versus three (3) years for injury in the NVICP. Second, the Program does not reimburse any medical expert fees or attorney fees. Basically you are on your own, just filling out a petition form and submitting to HRSA.
Third, there is no appeals process within a court system. Can’t appeal the decision to the Federal Circuit Court of Appeals nor to the US Supreme Court. Fourth, all decisions are NOT public so they are not subject to public inspection.
Thus the public will not know what type of countermeasures are causing what type of injury. Several FOIA requests by journalists including several requests I’ve filed over the course of the last five years, seeking documents and materials of decisions have been refused by HRSA.
Fifth, the funding source for all compensation awards is a direct appropriation from Congress. The annual budget of HHS/HRSA does not provide any detail in the annual amounts awarded as damages.
Finally, the public is not made aware of this compensation program except for the website. The NVICP is promoted on the VIS statement. The CICP is not. It is unknown if the Secretary of HHS upon approval of any declaration will provide some material to the person receiving the countermeasure about the CICP.
The entire process of the enactment of the PREP Act is very fluid, changing day to day. States are responding differently. This is our country’s first chance to take the car out for a spin. Is it a well- defined European sedan or is it a jalopy?
We need to remain calm, we need to be vigilant. Take care of each of your family members, reach out to your neighbors to see how they are doing. Check upon the elderly, watch some reruns on TV, read more books, and play some Yahtzee.
and the upcoming The Vaccine Court 2.0 to be released in paperback August 2020