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Bioshield Legislation Fails to Adequately Address Liability, Patent Issues, Study Finds By Marina Malenic WASHINGTON — The U.S. Project Bioshield legislation does not adequately address patents, liability and other issues while pledging government incentives to the drug industry for research and development of antidotes to various chemical and biological weapons, the Chemical and Biological Arms Control Institute said in a report released last week (see GSN, July 21). Although Bioshield addresses some barriers to industry involvement in vaccine development, the study identifies a number of remaining difficulties. These include: v The legislation does not call for a coordinating body. It is generally assumed that the responsibility would fall to the Health and Human Services Department, but Bioshield is not specific; v The allocation of $5.6 billion over 10 years may not be sufficient to address the need and the threat. The Congressional Budget Office determined that it would cost $8 billion to carry out Project Bioshield’s goals; and v Bioshield allocates financing for “significant biological countermeasures,” but never defines them. In addition to these shortcomings, Bioshield does not address liability issues or patents, according to the study, and the working group offered the following suggestions: v Immunity should be provided for biodefense vaccine manufacturers in which the government assumes complete responsibility for liability, to be applied only when vaccines are administered during emergencies or crisis situations — including the dispensing of vaccines following an act of terrorism; v Strict limits on liability under any future legislation; v Use of provisions from the 30-day moratorium on lawsuits against airlines after the terrorism attacks of Sept. 11, 2001 as a temporary measure until protection legislation is enacted; v An executive order to protect pharmaceutical companies from liability issues. Bioshield passed the U.S. Senate unanimously (see GSN, May 20). Even before its passage, however, the bill’s original co-sponsors, Joseph Lieberman (D-Conn.) and Orrin Hatch (R-Utah), were preparing a second version to address patent and liability issues. Bioshield II, as the expected legislation is known, would provide tax incentives and address liability concerns to make it profitable for the private sector to invest in research and development of bioterrorism countermeasures, said Hatch spokesman Adam Eggen. Like the earlier legislation, Bioshield II is expected to target research on pathogens that have the potential to be made into weapons, according to Eggen.
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