Lisa Schnirring
CIDRAP News
05/26/2010
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.
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