Public Readiness and Emergency Preparedness Act
Encyclopedia
The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress
and signed into law by President of the United States
George W. Bush
in December, 2005, is a controversial tort
liability shield intended to protect vaccine
manufacturers from financial risk in the event of a declared public health
emergency. The act specifically affords to drug makers immunity from potential financial liability for clinical trials of avian influenza vaccine at the discretion of the Executive branch of government. PREPA strengthens and consolidates the oversight of litigation against pharmaceutical companies under the purview of the secretary of Health and Human Services (HHS), a position then held by Mike Leavitt (now Kathleen Sebelius
). PREPA provides $3.8 billion for pandemic
influenza
preparedness to protect public health
in the case of a pandemic
disease
outbreak.
Vaccine manufacturers lobbied
for the legislation, which would effectively preempt 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.
and Congressman Dennis Hastert
were among the backers of PREPA legislation, which was tacked onto the end of a defense-spending bill (HR 2863).
, but no funding provisions for such purposes were included in its language.
.
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.http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liability.html
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.
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
.
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.
, and Public Citizen
, 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 delegaties broad legislative power to the executive branch of government, opponents view it as a violation of fundamental principles of the US Constitution
.
Senator Edward Kennedy
issued a statement demanding repeal of the PREPA legislation, while condemning the liability provisions as a giveaway to the drug industry.http://kennedy.senate.gov/~kennedy/statements/05/12/2005C22413.html 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
(FDA) investigation for being connected to at least five cases of Guillain-Barré syndrome
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 branchwere 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 contend that PREPA may contribute to the potential for abuse of discretion by the current George W. Bush Administration
, which is generally perceived as friendly to the drug industry. In particular, critics are 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.
United States Congress
The United States Congress is the bicameral legislature of the federal government of the United States, consisting of the Senate and the House of Representatives. The Congress meets in the United States Capitol in Washington, D.C....
and signed into law by President of the United States
President of the United States
The President of the United States of America is the head of state and head of government of the United States. The president leads the executive branch of the federal government and is the commander-in-chief of the United States Armed Forces....
George W. Bush
George W. Bush
George Walker Bush is an American politician who served as the 43rd President of the United States, from 2001 to 2009. Before that, he was the 46th Governor of Texas, having served from 1995 to 2000....
in December, 2005, is a controversial tort
Tort
A tort, in common law jurisdictions, is a wrong that involves a breach of a civil duty owed to someone else. It is differentiated from a crime, which involves a breach of a duty owed to society in general...
liability shield intended to protect vaccine
Vaccine
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
manufacturers from financial risk in the event of a declared public health
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" . It is concerned with threats to health based on population health...
emergency. The act specifically affords to drug makers immunity from potential financial liability for clinical trials of avian influenza vaccine at the discretion of the Executive branch of government. PREPA strengthens and consolidates the oversight of litigation against pharmaceutical companies under the purview of the secretary of Health and Human Services (HHS), a position then held by Mike Leavitt (now Kathleen Sebelius
Kathleen Sebelius
Kathleen Sebelius is an American politician currently serving as the 21st Secretary of Health and Human Services. She was the second female Governor of Kansas from 2003 to 2009, the Democratic respondent to the 2008 State of the Union address, and chair-emerita of the Democratic Governors...
). PREPA provides $3.8 billion for pandemic
Pandemic
A pandemic is an epidemic of infectious disease that is spreading through human populations across a large region; for instance multiple continents, or even worldwide. A widespread endemic disease that is stable in terms of how many people are getting sick from it is not a pandemic...
influenza
Influenza
Influenza, commonly referred to as the flu, is an infectious disease caused by RNA viruses of the family Orthomyxoviridae , that affects birds and mammals...
preparedness to protect public health
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" . It is concerned with threats to health based on population health...
in the case of a pandemic
Pandemic
A pandemic is an epidemic of infectious disease that is spreading through human populations across a large region; for instance multiple continents, or even worldwide. A widespread endemic disease that is stable in terms of how many people are getting sick from it is not a pandemic...
disease
Disease
A disease is an abnormal condition affecting the body of an organism. It is often construed to be a medical condition associated with specific symptoms and signs. It may be caused by external factors, such as infectious disease, or it may be caused by internal dysfunctions, such as autoimmune...
outbreak.
Vaccine manufacturers lobbied
Lobbying
Lobbying is the act of attempting to influence decisions made by officials in the government, most often legislators or members of regulatory agencies. Lobbying is done by various people or groups, from private-sector individuals or corporations, fellow legislators or government officials, or...
for the legislation, which would effectively preempt 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.
Legislative process
Legislative leaders Senator Bill FristBill Frist
William Harrison "Bill" Frist, Sr. is an American physician, businessman, and politician. He began his career as an heir and major stockholder to the for-profit hospital chain of Hospital Corporation of America. Frist later served two terms as a Republican United States Senator representing...
and Congressman Dennis Hastert
Dennis Hastert
John Dennis "Denny" Hastert was the 59th Speaker of the House serving from 1999 to 2007. He represented as a Republican for twenty years, 1987 to 2007.He is the longest-serving Republican Speaker in history...
were among the backers of PREPA legislation, which was tacked onto the end of a defense-spending bill (HR 2863).
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 injuriesVaccine injury
A vaccine injury is an injury caused by vaccination.Allegations of vaccine injuries in recent decades have appeared in litigation in the United States. Some families have won substantial awards from sympathetic juries, even though most public health officials believed that the claims of 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 epidemicEpidemic
In epidemiology, an epidemic , occurs when new cases of a certain disease, in a given human population, and during a given period, substantially exceed what is expected based on recent experience...
.
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.http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liability.html
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.
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
Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents are bacteria, viruses, or toxins, and may be in a naturally occurring or a human-modified form. For the use of this method in warfare, see biological warfare.-Definition:According to the...
.
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.
Opposition
Numerous consumer organizations vigorously opposed the legislation, including A-CHAMP, Eagle ForumEagle 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 been primarily focused on social issues; it describes...
, and Public Citizen
Public Citizen
Public Citizen is a non-profit, consumer rights advocacy group based in Washington, D.C., United States, with a branch in Austin, Texas. Public Citizen was founded by Ralph Nader in 1971, headed for 26 years by Joan Claybrook, and is now headed by Robert Weissman.-Lobbying Efforts:Public Citizen...
, 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 delegaties broad legislative power to the executive branch of government, opponents view it as a violation of fundamental principles of the US Constitution
United States Constitution
The Constitution of the United States is the supreme law of the United States of America. It is the framework for the organization of the United States government and for the relationship of the federal government with the states, citizens, and all people within the United States.The first three...
.
Senator Edward Kennedy
Ted Kennedy
Edward Moore "Ted" Kennedy was a United States Senator from Massachusetts and a member of the Democratic Party. Serving almost 47 years, he was the second most senior member of the Senate when he died and is the fourth-longest-serving senator in United States history...
issued a statement demanding repeal of the PREPA legislation, while condemning the liability provisions as a giveaway to the drug industry.http://kennedy.senate.gov/~kennedy/statements/05/12/2005C22413.html 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
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) investigation for being connected to at least five cases of Guillain-Barré syndrome
Guillain-Barré syndrome
Guillain–Barré syndrome , sometimes called Landry's paralysis, is an acute inflammatory demyelinating polyneuropathy , a disorder affecting the peripheral nervous system. Ascending paralysis, weakness beginning in the feet and hands and migrating towards the trunk, is the most typical symptom...
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 branchwere 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 contend that PREPA may contribute to the potential for abuse of discretion by the current George W. Bush Administration
George W. Bush administration
The presidency of George W. Bush began on January 20, 2001, when he was inaugurated as the 43rd President of the United States of America. The oldest son of former president George H. W. Bush, George W...
, which is generally perceived as friendly to the drug industry. In particular, critics are 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
Ethylmercury
Ethylmercury is a cation composed of an ethyl group bound to a mercury centre; its chemical formula is C2H5Hg+...
containing preservative) can be used in the vaccine, even in states that have enacted such bans.
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 (February 9, 2006)
- Pitt.edu - 'Vaccine liability law changes proposed by Democrats', Chris Buell, Jurist Legal News & Research, University of PittsburghUniversity of PittsburghThe University of Pittsburgh, commonly referred to as Pitt, is a state-related research university located in Pittsburgh, Pennsylvania, United States. Founded as Pittsburgh Academy in 1787 on what was then the American frontier, Pitt is one of the oldest continuously chartered institutions of...
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 WeeklySalt Lake City WeeklySalt Lake City Weekly is a free alternative weekly tabloid-paged newspaper published in Salt Lake City, Utah. It began its life as the Private Eye. City Weekly is published and dated for every Thursday by Copperfield Publishing Inc...
(February 9, 2006) - SMMirror.com - 'Allowing the Drug Companies to Poison Our Children' (editorial), Lewis Seiler and Dan Hamburg, Santa Monica MirrorSanta Monica MirrorThe Santa Monica Mirror is a weekly community newspaper which covers Santa Monica, Brentwood, Pacific Palisades, Venice, and Marina del Rey in the U.S. state of California. It circulates around 22,000 subscriptions weekly. The Mirror focuses on local happenings, events, sports, and arts...
(March 30, 2006) - UMN.edu - 'Pandemic funding, liability shield clear Congress' (December 28, 2005)