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President Bush said Tuesday that granting vaccine manufacturers protection from civil lawsuits would go a long way to spur the development of medicine needed to fight a potential pandemic. “In the past three decades, the number of vaccine manufacturers in America has plummeted, as the industry has been flooded with lawsuits,” Bush said. “Today, there is only one manufacturer in the United States that can produce influenza vaccine.” Not everyone agrees with Bush’s reasoning. Officials have pointed out what they consider more significant reasons for the small number of flu vaccine producers worldwide. Bush proposed the protection on Tuesday as he outlined a national strategy for dealing with a possible flu pandemic, including billions of dollars to buy and stockpile vaccines. Bush made a similar lawsuit indemnification argument last year when a shortage of flu vaccine became an issue in the presidential election. British regulators had suspended the license of a company that makes vaccine for the U.S. market, and, as a result, the United States received about half of the supply that officials had anticipated. Anthony Fauci, the infectious disease chief at the National Institutes of Health, told The Associated Press last year that more significant issues are the low-profit margin vaccines provide, unpredictable demand and the complexity of the manufacturing process. The trade association for trial lawyers cited Fauci’s comments on Tuesday when criticizing the president’s proposal as a “huge giveaway to drug companies that are making record-breaking profits.” “If he was really interested in protecting the public, he would not call for the elimination of these important legal protections,” said Chris Mather, communications director for the Association of Trial Lawyers of America. “And his claims that lawsuits are keeping these companies out of the business is just plain wrong.” Several bills have been introduced in Congress that are designed to enhance the ability of the United States to thwart or diminish a pandemic. Two weeks ago, the Senate’s health committee approved a bill that said the “manufacturer, distributor or administrator” of a pandemic product shall be immune from lawsuits caused by the dispensing of that product. The legislation gives the secretary for the Health and Human Services Department authority to designate which products are necessary for fighting an epidemic or pandemic. The Senate has not yet approved the bill, but it is expected to begin debate on it within the next two weeks. Republicans on the House Energy and Commerce Committee have also said they’re interested in taking up legislation that would improve pandemic preparedness, and No. 2 on their list of priorities was providing liability protection to increase vaccine manufacturing and distribution capacity. The federal government administers a compensation program for people injured by certain vaccines, such as those for tetanus, measles and polio. Just last year, Congress added the annual flu shot to the program. People who believe they have been injured by a covered vaccine can file a claim against the Health and Human Services Department in the U.S. Court of Federal Claims. If found eligible, they can recover compensation for medical expenses. Often, awards exceed $1 million, and a fact sheet about the program on the Justice Department Web site says that “costly litigation against drug manufacturers and health professionals who administer vaccines has virtually ceased.” The trade group representing drug makers applauded Bush’s call for liability protection. No medicine is risk-free, and it’s certain that a pandemic flu vaccine would be rushed to production once shown to be effective. “Companies should not be forced to balance the need of finding an effective vaccine for this potentially devastating pandemic against the certain knowledge that trial lawyers will pursue claims exploiting the inherent risks of vaccine development,” said Billy Tauzin, president and CEO of The Pharmaceutical Research and Manufacturers of America. Copyright 2005 Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten or redistributed.

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