Legal expert shares lessons from pandemic vaccine campaign

May 26, 2010 (CIDRAP News) – Legal issues that came into play during the H1N1 flu pandemic provided a useful look at how laws can help ease the availability of the vaccine, but in some instances can work against immunization efforts, according to a legal expert who has analyzed events that unfolded over the past year.

Encouraging the production of the vaccine while addressing public fears about immunization requires a delicate balance, Wendy E. Parmet, JD, wrote today in the New England Journal of Medicine. Parmet is a professor at Northeastern University School of Law in Boston.

Acknowledging the fragile market for vaccines, since the 1976 swine flu vaccine program Congress has connected liability protection for vaccine makers with a compensation system for patients, she wrote, referring to the National Childhood Vaccine Injury Act, which set up a special vaccine court to streamline claims and quickly compensate injured patients.

When the H5N1 avian influenza threat focused efforts on pandemic preparedness, Congress, with the 2005 passage of the Public Readiness and Emergency Preparedness (PREP) Act, combined tort immunity with no-fault compensation for injured patients, she added. The provisions take effect when federal officials declare a public health emergency.

While the PREP Act, along with Food and Drug Administration (FDA) emergency provisions, removed legal obstacles to the rapid production and distribution of the pandemic vaccine, "the effect of these laws on the public's willingness to be vaccinated, however, is uncertain," Parmet maintained.

She wrote that during a 2003 smallpox vaccination campaign, doubts about compensation eroded uptake in healthcare workers, and during the H1N1 pandemic vaccine campaign, critics charged that the PREP Act's broader reach was a sign that the government overplayed the pandemic risk to benefit the vaccine industry.

Some states have passed laws to address the public's vaccine suspicions related to the use of the vaccine preservative thimerosal. Parmet cited Washington state's suspension of its law limiting thimerosal content in vaccines when the pandemic vaccine was in short supply during the fall months. "A local health official reported that this move may have discouraged healthcare providers and patients from getting vaccinated," she wrote.

Mandates for schoolchildren and healthcare workers have had some success in increasing vaccination rates while allowing those who are most strongly opposed to opt out, Parmet noted. However, more coercive measures, such as New York state's emergency law requiring healthcare workers to receive flu shots, created an outcry that stirred up bad publicity and doubts in the public's mind about the vaccine.

When vaccine shortages exist, mandates may not work and could even backfire, she asserted. "Certainly, media reports about healthcare workers going to court to avoid vaccination are not apt to inspire the public's faith in vaccines."

Parmet urged lawmakers to tread carefully when considering legal solutions to vaccine challenges during future pandemics: "The more difficult task is to use those laws with a light enough touch so that they do not undermine the population's willingness to bare their arms."

Parmet WE. Pandemic vaccines—the legal landscape. N Engl J Med 2010 May 27;362(21):1949-52 [Full text]

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