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AIDS VACCINE INJURY COMPENSATION TRUST FUND

Executive Summary

AIDS VACCINE INJURY COMPENSATION TRUST FUND would be established under legislation (HR 5893) introduced by Rep. Stark (D-Calif.) on Aug. 12. Money for the trust fund would come from manufacturers in the form of a performance bond for HIV vaccines in clinical trials that are listed in an AIDS Vaccine Injury Table. Once a vaccine is approved, manufacturers would pay an excise tax. The Secretary of HHS, in consultation with an AIDS Vaccine Task Force to be established under the bill, would determine the appropriate amount of the bond and excise tax. In an Aug. 19 press release, Stark said "several major pharmaceutical companies reportedly have excellent ideas for anti- HIV vaccines, but won't test these drugs in clinical trials" because they fear liability lawsuits if there are adverse side effects to their vaccines. Stark's bill is intended to create a no-fault compensation system and limit a company's liability in the event of an adverse reaction. The trust fund would be similar to that provided in the Childhood Vaccine Compensation Act, but would also cover vaccines in clinical trials. One year after enactment of the bill and at three month- periods thereafter, the HHS Secretary is to review the number of awards of compensation and the amounts of compensation made to petitioners for HIV vaccine-related injuries and deaths. Congress would be notified if "the total amount of awards made by the end of these periods...is likely to exceed the amount of funds contained in the trust fund," the bill states. Six months after notification of Congress the program would be put on hold until there was a sufficient increase in the performance bond or excise tax to cover the awards. Entitled the "National AIDS Vaccine Development and Compensation Act of 1992," the bill would establish a program to "achieve optimal prevention of AIDS through immunization." The director of the program would coordinate AIDS vaccine research activities carried out through the National Institutes of Health, the Centers for Disease Control, FDA's Center for Biologics Evaluation and Research, the Department of Defense and the Agency for International Development. Under the compensation program, anyone who had an adverse reaction involving injury, illness, disability or death from receiving an HIV vaccine could file a petition to the United States Claims Court for compensation. The HHS Secretary would publish the petition in the Federal Register to solicit comments. The petition would be reviewed by a special master of the court who would make a determination on the petition, in most cases within 240 days of the petition filing. No person could file an action against a vaccine administrator or manufacturer without first filing a petition for compensation. If the individual is not satisfied by the special master's decision on the petition, he or she could then file civil action for HIV vaccine-related injuries or deaths. However, the bill specifies that no vaccine manufacturer will be liable in a civil action from "unavoidable" side effects or for injuries "solely due to the manufacturer's failure to provide direct warnings to the injured party...of the potential dangers resulting from the administration of the vaccine." Further, an individual may not seek punitive damages unless the manufacturer engaged in "fraud or intentional and wrongful withholding of information" either during the approval process or relating to safety or efficacy after approval, or "other criminal or illegal activity relating to the safety and effectiveness of vaccines." The AIDS Vaccine Injury Table would be established by the director of the compensation program one year after enactment of the bill. The table would contain a list of HIV vaccines, a list of disabilities, illnesses, conditions and deaths resulting from administration of the vaccines, and the time period in which such adverse reactions must occur after administration of the vaccine.
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