Public Readiness and Emergency Preparedness Act
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The Public Readiness and Emergency Preparedness Act (PREPA), passed by the
United States Congress The United States Congress is the legislature of the federal government of the United States. It is Bicameralism, bicameral, composed of a lower body, the United States House of Representatives, House of Representatives, and an upper body, ...
and signed into law by
President of the United States The president of the United States (POTUS) is the head of state and head of government of the United States of America. The president directs the Federal government of the United States#Executive branch, executive branch of the Federal gove ...
George W. Bush in December 2005 (as part of ), is a controversial
tort A tort is a civil wrong that causes a claimant to suffer loss or harm, resulting in legal liability for the person who commits the tortious act. Tort law can be contrasted with criminal law, which deals with criminal wrongs that are punishable ...
liability shield intended to protect
vaccine A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified.
manufacturers from financial risk in the event of a declared
public health Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the det ...
emergency. The part of PREPA that actually affords such protection is now codified at . The act specifically affords to drug makers immunity from actions 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. PREPA strengthens and consolidates the oversight of litigation against
pharmaceutical A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and ...
companies under the purview of the
secretary A secretary, administrative professional, administrative assistant, executive assistant, administrative officer, administrative support specialist, clerk, military assistant, management assistant, office secretary, or personal assistant is a ...
of
Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is ...
(HHS). PREPA provides $3.8 billion for
pandemic A pandemic () is an epidemic of an infectious disease that has spread across a large region, for instance multiple continents or worldwide, affecting a substantial number of individuals. A widespread endemic disease with a stable number of in ...
influenza Influenza, commonly known as "the flu", is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These symptom ...
preparedness to protect
public health Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the det ...
in the case of a
pandemic A pandemic () is an epidemic of an infectious disease that has spread across a large region, for instance multiple continents or worldwide, affecting a substantial number of individuals. A widespread endemic disease with a stable number of in ...
disease A disease is a particular abnormal condition that negatively affects the structure or function of all or part of an organism, and that is not immediately due to any external injury. Diseases are often known to be medical conditions that a ...
outbreak. Vaccine manufacturers
lobbied In politics, lobbying, persuasion or interest representation is the act of lawfully attempting to influence the actions, policies, or decisions of government officials, most often legislators or members of regulatory agencies. Lobbying, which ...
for the legislation, which would effectively override state vaccine safety laws in the case of an emergency declaration by HHS, by making clear they would not produce new vaccines unless the legislation was enacted. During and in the aftermath of the 2020–21
COVID-19 pandemic in the United States The COVID-19 pandemic in the United States is a part of the worldwide pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In the United States, it has resulted in confir ...
, PREPA is being invoked in a variety of lawsuits, many involving skilled nursing or assisted living facilities where COVID-19 countermeasures including the administration or non-administration of vaccines is said to have resulted in or contributed to resident deaths. Although PREPA was around for more than 15 years, prior to COVID-19, the act's defensive application in litigation was not widespread, but now the application of the act is being included more frequently in a variety of COVID-19 related lawsuits, including Shareholder Derivative Litigation.


Legislative process

Legislative leaders
Senator A senate is a deliberative assembly, often the upper house or chamber of a bicameral legislature. The name comes from the ancient Roman Senate (Latin: ''Senatus''), so-called as an assembly of the senior (Latin: ''senex'' meaning "the el ...
Bill Frist William Harrison Frist (born February 22, 1952) is an American physician, businessman, and politician who served as a United States Senator from Tennessee from 1995 to 2007. A member of the Republican Party, he also served as Senate Majority Lea ...
and
Congressman A Member of Congress (MOC) is a person who has been appointed or elected and inducted into an official body called a congress, typically to represent a particular constituency in a legislature. The term member of parliament (MP) is an equivalen ...
Dennis Hastert John Dennis Hastert (; born January 2, 1942) is an American former politician and convicted felon who represented from 1987 to 2007 and served as the 51st speaker of the United States House of Representatives from 1999 to 2007. The longest-se ...
were among the backers of PREPA legislation. Rep.
Nathan Deal John Nathan Deal (born August 25, 1942) is an American lawyer and politician who served as the 82nd governor of Georgia from 2011 to 2019. He was elected to the United States House of Representatives as a member of the Democratic Party in 1992 a ...
spoke on the House floor in support of the bill, calling it "absolutely critical legislation". It was added to the final version of a
Department of Defense Department of Defence or Department of Defense may refer to: Current departments of defence * Department of Defence (Australia) * Department of National Defence (Canada) * Department of Defence (Ireland) * Department of National Defense (Philipp ...
-
appropriations bill An appropriation, also known as supply bill or spending bill, is a proposed law that authorizes the expenditure of government funds. It is a bill that sets money aside for specific spending. In some democracies, approval of the legislature is ne ...

H.R. 2863
while the bill was negotiated between the Senate and the House of Representatives.H.R.2863 - Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, 2006: Actions
. ''United States Congress''. December 30, 2005.
On December 19, 2005, the appropriations bill with the PREPA legislation was approved by the House of Representatives in a vote o
308–106
with 2 voting Present and 18 not voting. On December 22, it was approved by the Senate in a vote o
93–0
with 7 not voting. President Bush signed the bill into law on December 30.


Funding

Of the $3.8 billion earmarked for pandemic preparedness, $350 million is slated for improvement of state and local preparedness. HHS will use most of the balance on "core preparedness activities", such as developing vaccines and stockpiling antiviral drugs. Under PREPA, an HHS emergency declaration will trigger establishment of a fund for "timely, uniform, and adequate compensation" program for vaccine injuries, but no funding provisions for such purposes were included in its language.


Liability protection and consolidation of oversight

PREPA was designed specifically to encourage rapid production of vaccines to protect American citizens in case of a potential public health threat. However, the primary effects of the legislation hinge on liability protections for drug companies, under provisions intended to remove financial risk barriers for any new vaccines that need to be rushed to market in case of an emergency. Under PREPA, the HHS secretary will have primary responsibility for making decisions on whether or not to declare an emergency that would justify removing financial risk barriers, which otherwise would cause a prudent manufacturer to exercise caution. Pursuant to such an emergency declaration, liability protection would extend to doctors and other individuals and organizations involved with countermeasures, which may include any medical product to prevent, treat, mitigate, or diagnose an
epidemic An epidemic (from Greek ἐπί ''epi'' "upon or above" and δῆμος ''demos'' "people") is the rapid spread of disease to a large number of patients among a given population within an area in a short period of time. Epidemics of infectious ...
. The act does not list any criteria for determining the existence of an emergency, but it does specify that any such declaration would have to list the diseases, populations, and geographic areas covered and when the emergency would end. PREPA removes the right to a jury trial for persons injured by a covered vaccine, unless a plaintiff can provide clear evidence of willful misconduct that resulted in death or serious physical injury. The act instructs the HHS secretary to write regulations "that further restrict the scope of actions or omissions by a covered person" that constitute willful misconduct. A plaintiff whose claim is subject to PREPA can sue the defendant only in the
United States District Court for the District of Columbia The United States District Court for the District of Columbia (in case citations, D.D.C.) is a federal district court in the District of Columbia. It also occasionally handles (jointly with the United States District Court for the District ...
. For such a civil action, PREPA requires the
complaint In legal terminology, a complaint is any formal legal document that sets out the facts and legal reasons (see: cause of action) that the filing party or parties (the plaintiff(s)) believes are sufficient to support a claim against the party ...
to be pleaded with particularity, verified under oath by the plaintiff, and accompanied by an affidavit from a non-treating physician to explain how the covered countermeasure injured the plaintiff, as well as relevant medical records. In the event of an emergency declared by HHS, Federal law would preempt all state provisions related to pandemic emergency preparedness, and would supersede any state provision governing vaccines. PREPA applies to any drug, vaccine, or biological product that the HHS secretary deems a "covered countermeasure," or that the secretary decides is a public health situation that could become an emergency at some point in the future, whether or not there is a specific relationship to a dangerous pandemic or
bioterrorism Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents are bacteria, viruses, insects, fungi, and/or toxins, and may be in a naturally occurring or a human-modified form, in much the same ...
. By invoking provisions of PREPA, the HHS secretary can wield broad authority to declare an emergency, which in turn would trigger drug company immunity from liability at any time, thereby conferring upon drug companies legal immunity for harm caused by their misconduct. The immunity that could be conferred on drug and vaccine manufacturers can be applied regardless of wrongdoing by affected drug companies.


Definitions

The PREPA defines terms such as covered countermeasure and qualified pandemic or epidemic product in terms related to the
Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of ...
of 1938, specifically section 201(g) drugs and section 201(h) medical devices. The definitions of security countermeasure and biological product are related only internally. PREPA covers many kinds of LOSS, including # death; # physical, mental, or emotional injury, illness, disability, or condition; # fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and # loss of or damage to property, including business interruption loss.


Opposition

Numerous consumer organizations vigorously opposed the legislation, including A-CHAMP,
Eagle Forum Eagle Forum is a conservative interest group in the United States founded by Phyllis Schlafly in 1972 and is the parent organization that also includes the Eagle Forum Education and Legal Defense Fund and the Eagle Forum PAC. The Eagle Forum has ...
, and
Public Citizen Public Citizen is a non-profit, progressive consumer rights advocacy group and think tank based in Washington, D.C., United States, with a branch in Austin, Texas. Lobbying efforts Public Citizen advocates before all three branches of the Unit ...
, as well as first responder organizations representing nurses, firemen and veterans. A-CHAMP ran a series of full page advertisements in various publications in opposition to PREPA. Because the legislation delegates broad legislative power to the executive branch of government, opponents view it as a violation of fundamental principles of the U.S. Constitution. Senator
Edward Kennedy Edward Moore Kennedy (February 22, 1932 – August 25, 2009) was an American lawyer and politician who served as a United States senator from Massachusetts for almost 47 years, from 1962 until his death in 2009. A member of the Democratic ...
issued a statement demanding repeal of the PREPA legislation, while condemning the liability provisions as a giveaway to the drug industry.Kennedy, Edward (2005).
Statement
. ''United States Senate''.
Kennedy said the bill makes it "essentially impossible" for injured parties to sue for damages, and that the measure allows common diseases to be used as a reason to activate the liability shield. Kennedy also notes that one of the drug companies that lobbied for PREPA is Sanofi Pasteur, which is under
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) investigation for being connected to at least five cases of
Guillain–Barré syndrome Guillain–Barré syndrome (GBS) is a rapid-onset muscle weakness caused by the immune system damaging the peripheral nervous system. Typically, both sides of the body are involved, and the initial symptoms are changes in sensation or pain oft ...
caused by its meningococcal vaccine. When the PREPA legislation was presented, its broad liability shields, its potential for undermining state vaccine laws, and its consolidation of responsibility within the executive branch were misrepresented in Congress and media, according to critics, who note that it was portrayed instead as primarily concerned with preparations to combat the avian flu. Opponents also contended that PREPA would contribute to the potential for abuse of discretion by the George W. Bush Administration, which was generally perceived as friendly to the drug industry. In particular, critics were concerned about the possibility that state laws banning thimerosal containing vaccines (TCVs) may be preempted. If the HHS secretary designates that a vaccine is a covered countermeasure, thimerosal (a mercury containing preservative) can be used in the vaccine, even in states that have enacted such bans.


See also

*
Vaccines for the New Millennium Act Vaccines for the New Millennium Act was a bill introduced by Senator John Kerry (D-MA) and Rep. Nancy Pelosi (D-CA) in the 107th Congress in 2001. The bill would have provided tax credits to private sector companies working on vaccines for some of ...


References


External links


GallatinNewsExaminer.com
- 'Hastert, Frist said to rig bill for drug firms: Frist denies protection was added in secret', Bill Theobald,
Gannett News Service Gannett Co., Inc. () is an American mass media holding company headquartered in McLean, Virginia, in the Washington, D.C., metropolitan area.Pitt.edu
- 'Vaccine liability law changes proposed by Democrats', Chris Buell, '' Jurist Legal News & Research'',
University of Pittsburgh The University of Pittsburgh (Pitt) is a public state-related research university in Pittsburgh, Pennsylvania. The university is composed of 17 undergraduate and graduate schools and colleges at its urban Pittsburgh campus, home to the univers ...
School of Law (February 15, 2006)
Senate.gov
- 'Harkin Calls on Frist and Hastert to Repeal "Dead of Night" Vaccine Liability Provision and Enact Real Protections (February 15, 2006)
SLWeekly.com
- 'Side Effects: Leavitt’s new power to limit suits against pharmaceutical companies has some critics feeling a bit ill', Louis Godfrey, ''
Salt Lake City Weekly ''Salt Lake City Weekly'' (usually shortened to ''City Weekly'') is a free alternative weekly tabloid-paged newspaper published in Salt Lake City, Utah. It began as ''Private Eye''. ''City Weekly'' is published and dated for every Thursday by ...
'' (February 9, 2006)
SMMirror.com
- 'Allowing the Drug Companies to Poison Our Children' (editorial), Lewis Seiler and Dan Hamburg, ''
Santa Monica Mirror The ''Santa Monica Mirror'' is a weekly community newspaper which covers Santa Monica,. It circulates around 10,000 copies weekly according to their website. The Mirror focuses on local happenings, events, sports, and arts. The Mirror also has ...
'' (March 30, 2006)
UMN.edu
- 'Pandemic funding, liability shield clear Congress' (December 28, 2005) {{vaccines Vaccination law United States federal health legislation Acts of the 109th United States Congress Disaster preparedness in the United States Vaccination in the United States Drug policy of the United States