The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) enhances emergency use authorities with respect to both approved and unapproved medical countermeasures (MCMs). PAHPRA authorities can also be critical to preserving tort liability protections for public health stakeholders, since these protections are often contingent upon appropriate authorizations for the MCMs utilized. This article details the evolution of emergency use authorities and liability protections, analyzes how these separate legal doctrines can intersect in practice, and discusses implications for facilitating preparedness and response activities and for protecting associated personnel.
The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) enhances emergency use authorities with respect to both approved and unapproved medical countermeasures (MCMs). PAHPRA authorities can also be critical to preserving tort liability protections for public health stakeholders, since these protections are often contingent upon appropriate authorizations for the MCMs utilized. This article details the evolution of emergency use authorities and liability protections, analyzes how these separate legal doctrines can intersect in practice, and discusses implications for facilitating preparedness and response activities and for protecting associated personnel.
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The HHS secretary interprets the PREP Act to provide that “when a declaration is in effect, the Act precludes, for example, liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct. Likewise, the Act precludes a liability claim relating to the management and operation of a countermeasure distribution program or site, such as a slip-and-fall injury or vehicle collision by a recipient receiving a countermeasure at a retail store serving as an administration or dispensing location that alleges, for example, lax security or chaotic crowd control. However, a liability claim alleging an injury occurring at the site that was not directly related to the countermeasure activities is not covered, such as a slip and fall with no direct connection to the countermeasure's administration or use. In each case, whether immunity is applicable will depend on the particular facts and circumstances.” Department of Health and Human Services. Pandemic Influenza Vaccines—Amendment. February28, 2012. 77 Fed Regist 13329-36 (March6, 2012).
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