The National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34) was enacted in the United States to reduce the potential financial liability of vaccine makers due to vaccine injury claims. The legislation was aimed at ensuring a stable market supply, and to provide cost-effective arbitration for vaccine injury claims. Under the NCVIA, the National Vaccine Injury Compensation Program (NVICP) was created to provide a federal no-fault system for compensating vaccine-related injuries or death by establishing a claim procedure involving the United States Court of Federal Claims and special masters. 1986 (MCMLXXXVI) was a common year starting on Wednesday of the Gregorian calendar. ... A vaccine is an antigenic preparation used to establish immunity to a disease. ... Vaccine injury is a term used in both medicine and law to designate alleged injuries sustained by individuals subsequent to having been vaccinated. ... Arbitration is a legal technique for the resolution of disputes outside the courts, wherein the parties to a dispute refer it to one or more persons (the arbitrators or arbitral tribunal), by whose decision (the award) they agree to be bound. ... The United States Court of Federal Claims is a special court created on October 1, 1982 by the U.S. Congress and headquartered in Washington, D.C.. By federal law, claims brought against the United States must be brought in this court; however, as this court is established under Article... A special master, in law, is an authority appointed by a judge to make sure that judicial orders are actually followed. ...

In the face of mounting potential liabilities that were rapidly increasing along with the number of mandated vaccines, the legislation was passed on behalf of pharmaceutical companies. Vaccine makers indicated they would cease production if their proposal for the NCVIA was not enacted.[1] Over the past two decades, the recommended vaccination schedule in the United States and elsewhere has grown rapidly and become more complicated as many new vaccines have been developed and marketed. ... A pharmaceutical company, or drug company, is a commercial business licensed to research, develop, market and/or distribute drugs, most commonly in the context of healthcare. ...

Escalating liability controversy

It has been estimated that the current potential vaccine injury liability, in the US alone, may total in the tens of billions of dollars. In light of the growing liability estimates and concern that the NCVIA may not provide an adequate legal shield, the pharmaceutical industry has escalated lobbying efforts, seeking additional protections through a series of new legislative proposals, including the Bioshield Two (Senate bill 1873), a pandemic vaccine act that would put drug companies beyond the reach of civil law. The bill would give the Secretary of the Department of Health and Human Services (DHHS) the absolute authority to decide whether a manufacturer violated laws mandating drug safety and would ban citizens from challenging his decision in the civil court system. This is a list of pharmaceutical and biotech companies that are major manufacturers on global or national markets : Abbott Laboratories Able Laboratories Akzo Nobel Allergan Almirall Prodesfarma Alphapharm Altana (previously Byk Gulden) ALZA, part of Johnson & Johnson Amgen AstraZeneca, formed from the merger of Astra AB and Zeneca Group PLC... The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (S. 1873), nicknamed Bioshield Two and sponsored by Senator Richard Burr (R-North Carolina), aims to shortcut safety testing for new vaccines and drugs in case of a pandemic, and to protect vaccine makers and the pharmaceutical industry from... The United States Department of Health and Human Services, often abbreviated HHS, is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. ... It has been suggested that this article or section be merged into lawsuit. ...

Opponents of the more draconian aspects of the NCVIA, realizing that outright repeal is unlikely in the near term, have sought to scale back certain financial protections for vaccine makers. Congressman Dan Burton, (R-IN), introduced a VICP reform bill which included a one-time look back provision to allow children, injured before 1997, to access the compensation program. Rep. ... 1997 (MCMXCVII) was a common year starting on Wednesday of the Gregorian calendar. ...

The case for limited liability

Public health safety, according to backers of the legislation, depends upon the financial viability of pharmaceutical companies, whose ability to produce sufficient supplies in a timely manner could be imperiled by civil litigation on behalf of vaccine injury victims that was mounting rapidly at the time of its passage. Vaccination against infectious illnesses provides protection against contagious diseases and afflictions which may cause permanent disability or even death. Vaccines have reduced morbidity caused by infectious disease; e.g., in the case of smallpox, mass vaccination programs have eradicated a once life-threatening illness. Civil litigation has at least three meanings. ... Vaccination is the process of administering weakened or dead pathogens to a healthy person or animal, with the intent of conferring immunity against a targeted form of a related disease agent. ... The term disease refers to an abnormal condition of an organism that impairs function. ... Look up disability in Wiktionary, the free dictionary. ... Smallpox (also known by the Latin names Variola or Variola vera) is a highly contagious disease unique to humans. ...

NCVIA provisions

Vaccine Adverse Event Reporting System

The NCVIA also mandates that all health care providers must report certain adverse events following vaccination to the Vaccine Adverse Event Reporting System (VAERS). Adverse effect, in medicine, is an abnormal, harmful, undesired and/or unintended side-effect, although not necessarily unexpected, which is obtained as the result of a therapy or other medical intervention, such as drug/chemotherapy, physical therapy, surgery, medical procedure, use of a medical device, etc. ... The Vaccine Adverse Event Reporting System is a United States program for vaccine safety, co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). ...

The NCVIA also established a committee from the Institute of Medicine (IOM) to review the existing literature on vaccine adverse events occurring after immunization, regardless of whether there was a direct link between events. The Institute of Medicine, a part of the National Academy of Sciences, is an American organization whose purpose is to provide national advice on issues relating to biomedical science, medicine, and health (National Academy of Sciences, n. ... A child being immunized against polio. ...

National Vaccine Program Office

As a result of the NCVIA, the National Vaccine Program Office (NVPO) was established within the DHHS. The NVPO is responsible for coordinating immunization-related activities between all DHHS agencies, including the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), National Institutes of Health (NIH) and the Health Resources and Services Administration (HRSA). The Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, is recognized as the leading United States agency for protecting the public health and safety of people. ... FDA logo The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States. ... The National Institutes of Health (NIH) is the primary agency of the United States government responsible for medical research. ... The Health Resources and Services Administration (HRSA), a division of the United States Department of Health and Human Services, envisions optimal health for all, supported by a health care system that assures access to comprehensive, culturally competent, quality care. ...

Vaccine Information Statements

The NCVIA requires all health care providers who administer vaccines containing diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, hepatitis B, Haemophilus influenzae type b and varicella must provide a Vaccine Information Statement (VIS) to the vaccine recipient, their parent or legal guardian prior to each dose. Tetanus is a medical condition characterized by a prolonged contraction of skeletal muscle fibers. ... Pertussis, also known as whooping cough, is a highly contagious disease caused by the bacterium Bordetella pertussis; a similar, milder disease is caused by B. parapertussis. ... Poliomyelitis (polio), or infantile paralysis, is a viral paralytic disease. ... Rubella (also known as epidemic roseola, German measles, liberty measles[1] or three-day measles) is a disease caused by the Rubella virus. ... Hepatitis B is a inflammation of the liver and is caused by the Hepatitis B virus (HBV), a member of the Hepadnavirus family[1] and one of hundreds of unrelated viral species which cause viral hepatitis. ... Binomial name Haemophilus influenzae (Lehmann & Neumann 1896) Winslow 1917 Haemophilus influenzae, formerly called Pfeiffers bacillus or Bacillus influenzae, is a non-motile Gram-negative coccobacillus first described in 1892 by Dr. Richard Pfeiffer during an influenza pandemic. ... Varicella is a Latin name for chickenpox. ...

A VIS must be given with every vaccination, including each dose in a multi-dose series. Each VIS contains a brief description of the disease, as well as the risks and benefits of the vaccine. Each VIS is developed by the CDC and distributed to state and local health departments as well as individual providers. For other uses, see Risk (disambiguation). ... For use in social policy, see the article social welfare. ...

References

• HRSA.gov - 'National Childhood Vaccine Injury Act: Vaccine Injury Table', United States Department of Health and Human Services (DHHS)
• HRSA.gov - 'Commonly Asked Questions About The National Vaccine Injury Compensation Program', DHHS (last updated December 18, 2002)

The United States Department of Health and Human Services, often abbreviated HHS, is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. ...

External links

• CDC.gov - 'Overview of Vaccine Safety', National Immunization Program
• Dekker.com - 'National Childhood Vaccine Injury Act of 1986'
• LSU.edu - 'Vaccine Law: National Childhood Vaccine Injury Act', Louisiana State University
• NVIC.org - National Vaccine Information Center
• PartnersForImmunization.org - 'National Partnership for Immunization: Promoting Immunization Across the Lifespan'
• VaccineSafety.edu - 'Institute for Vaccine Safety', Johns Hopkins University Bloomberg School of Public Health