Public Readiness and Emergency Preparedness Act

The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December, 2005, is a controversial tort liability shield intended to protect vaccine manufacturers from financial risk in the event of a declared public health emergency. The act specifically affords to drug makers immunity from potential financial liability for clinical trials of avian influenza vaccine at the discretion of the Executive branch of government. PREPA strengthens and consolidates the oversight of litigation against pharmaceutical companies under the purview of the secretary of Health and Human Services (HHS). PREPA provides $3.8 billion for pandemic influenza preparedness to protect public health in the case of a pandemic disease outbreak. The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December, 2005, is a controversial tort liability shield intended to protect vaccine manufacturers from financial risk in the event of a declared public health emergency. The act specifically affords to drug makers immunity from potential financial liability for clinical trials of avian influenza vaccine at the discretion of the Executive branch of government. PREPA strengthens and consolidates the oversight of litigation against pharmaceutical companies under the purview of the secretary of Health and Human Services (HHS). PREPA provides $3.8 billion for pandemic influenza preparedness to protect public health in the case of a pandemic disease outbreak. Vaccine manufacturers lobbied for the legislation, which would effectively preempt state vaccine safety laws in the case of an emergency declaration by HHS, by making clear they would not produce new vaccines unless the legislation was enacted. Legislative leaders Senator Bill Frist and Congressman Dennis Hastert were among the backers of PREPA legislation, which was tacked onto the end of a defense-spending bill (HR 2863). Of the $3.8 billion earmarked for pandemic preparedness, $350 million is slated for improvement of state and local preparedness. HHS will use most of the balance on 'core preparedness activities,' such as developing vaccines and stockpiling antiviral drugs. Under PREPA, an HHS emergency declaration will trigger establishment of a fund for 'timely, uniform, and adequate compensation' program for vaccine injuries, but no funding provisions for such purposes were included in its language. PREPA was designed specifically to encourage rapid production of vaccines to protect American citizens in case of a potential public health threat. However, the primary effects of the legislation hinge on liability protections for drug companies, under provisions intended to remove financial risk barriers for any new vaccines that need to be rushed to market in case of an emergency. Under PREPA, the HHS secretary will have primary responsibility for making decisions on whether or not to declare an emergency that would justify removing financial risk barriers, which otherwise would cause a prudent manufacturer to exercise caution. Pursuant to such an emergency declaration, liability protection would extend to doctors and other individuals and organizations involved with countermeasures, which may include any medical product to prevent, treat, mitigate, or diagnose an epidemic. The act does not list any criteria for determining the existence of an emergency, but it does specify that any such declaration would have to list the diseases, populations, and geographic areas covered and when the emergency would end.