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U.S. Response: Liability Protection Needed for Project Bioshield, Industry Representatives Say By Mike Nartker The legislation would provide $6 billion over 10 years to create a market for new vaccines and treatments against biological agents to spur private industry research and development. The bill would also allow the government, during national emergencies, to release new treatments prior to Food and Drug Administration approval. Liability protection needs to be addressed for private industry to become more interested in developing new biological countermeasures, however, Frank Rapoport, a lawyer for the pharmaceutical company Aventis Pasteur, told the House Government Reform Committee. He said liability concerns were a “major obstacle” in National Institutes of Health efforts to find a company to develop a new anthrax vaccine. “The issue of the potential liability for any entity that provides, or performs research and development related to, biodefense countermeasures absolutely must be addressed in order to stimulate private sector interest in entering into agreements for such countermeasures,” Rapoport said in his prepared opening statement. There are previous instances where companies developing vaccines received liability protection, such as that offered by the Homeland Security Act to smallpox vaccine manufacturers, Avant Immunotherapeutics President Una Ryan said. “I believe I speak for most, if not all, of my colleagues in the industry when I say that unless we are protected from this risk to a fair and reasonable degree, we will not be able to participate in this national effort,” Ryan said in her prepared opening statement. U.S. biotechnology and pharmaceutical companies also have other concerns with Project Bioshield, in addition to the lack of liability protection, according to Ryan and Rapoport. For example, private industry needs to be assured that the market the U.S. government is seeking to create is adequate to meet the high costs of researching, developing and producing biological countermeasures, Ryan said. “Biotech companies will want to see a federal program of sufficient size to convince them that our effort can be funded throughout the life cycle, and that the risk we endure and success we achieve will be fairly compensated,” she said. Without a guarantee of a long-term U.S. government market, it will be difficult for companies to interest outside funding sources, Rapoport said. “Private industry simply must be assured that the government market will be in place for some reasonable period of time before it commits the massive resources necessary … to meet the demands of the newly created market,” Rapoport said. “Without such assurance, it will be all but impossible to generate interest from investors or lenders to allow for purely speculative (and truly enormous) capital expenditures,” he added. Washington needs to guarantee long-term sources of research and development funding, Ryan said, saying that the development of new countermeasures can take up to 10 years. There also needs to be “careful coordination” among the U.S. agencies that will be involved in biological defense research, including the Defense Department and NIH, she said. Of special concern is the new Homeland Security Department, which will oversee the procurement of new biological countermeasures, Ryan said. “This is a daunting task for a well-established organization, not to mention a brand-new department,” she said.
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