title: Notes and comments "High and dry?" The Public Readiness and Emergency Preparedness Act and liability protection for pharmaceutical manufacturers.
abstract: In an era filled with fears of bioterrorism, Congress approved the Public Readiness and Emergency Preparedness Act (PREPA) to encourage development of vaccines and other countermeasures. By providing pharmaceutical manufacturers with protection from liability for potential side effects, Congress has attempted to motivate manufacturers to produce a national stockpile of countermeasures. As part of PREPA, the government established a compensatory system intended to provide compensation to persons injured by countermeasures used during a public health emergency. Although the Act provides for a compensation fund, it fails to allocate monies for that fund. Thus, in the absence of further congressional action, PREPA will not provide compensation to those injured by countermeasures. Failing to assure the American public of a compensation program constitutes bad public policy and risks inspiring potential vaccinees to refuse necessary drugs. Additionally, arguments as to the constitutionality of the Act exist should Congress fail to adequately fund the program, and the existence of those arguments undermines the purpose of the Act--namely to assure pharmaceutical manufacturers that they will not be sued into oblivion should they attempt to aid national pandemic protection. In addition to detailing both the Act and the statutory precedent for congressional attempts to spur biodefense, this Article addresses important issues of healthcare, tort, and constitutional law that will continue to manifest themselves in this new era of bioterrorism.
authors.affiliation: University of Notre Dame, USA.
authors.forename: B Kurt
authors.initials: BK
authors.lastname: Copper
mesh_terms: D023482:Bioterrorism / Q000331:legislation & jurisprudence* / Q000517:prevention & control; D002961:Civil Rights / Q000191:economics / Q000331:legislation & jurisprudence*; D003140:Communicable Disease Control / Q000191:economics / Q000331:legislation & jurisprudence*; D035881:Compensation and Redress / Q000331:legislation & jurisprudence*; D004189:Disaster Planning / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005380:Financing, Government; D006801:Humans; D016365:Liability, Legal / Q000191:economics*; D011057:Politics; D016312:Treatment Refusal; D014481:United States; D014612:Vaccines / Q000009:adverse effects*
chemical_list: D014612:Vaccines