HHS Issues PREP Act Declaration Covering Ebola Vaccines
The U.S. Department of Health and Human Services (“HHS”) published a declaration today under the Public Readiness and Emergency Preparedness (“PREP”) Act covering activities relating to three Ebola vaccine candidates that are currently in development. The declaration went into effect on December 3, 2014 and extends liability protection to manufacturers, distributors, program planners, and qualified persons who prescribe, administer, or dispense the vaccine candidates identified in the declaration when distributed in connection with a federal contract, grant, or other agreement, or as directed in a public health emergency. The declaration represents another significant step in the federal government’s response to the Ebola outbreak in West Africa, following recent actions taken by HHS and the Defense Threat Reduction Agency to fund the development of Ebola countermeasures and related products and services.
The PREP Act was originally enacted in 2005 to address liability concerns raised by the use and distribution of countermeasures for pandemic Influenza viruses. Under the PREP Act, the Secretary of HHS is generally authorized to provide covered individuals and entities with protection from suit and liability under federal and state law for losses related to the administration or use of specifically identified countermeasures after determining that a disease, condition, or other threat constitutes a present or credible risk of a future public health emergency. The Secretary must define the scope of protections afforded by each declaration, including the countermeasures, geographic areas, subject populations, time periods, and means of distribution covered by the declaration. Since its original enactment, the PREP Act has been used to issue declarations covering various countermeasures for pandemic Influenza viruses, including medical devices designed to detect or treat pandemic Influenza viruses, Acute Radiation Syndrome, Smallpox, Botulism, Anthrax, and now Ebola virus.
The protection afforded by a PREP Act declaration is valuable to covered individuals and entities because a declaration generally allows them to assert immunity from suit, rather than litigate entitlement to reimbursement as may be required under other forms of liability protection, such as insurance or indemnification for unusually hazardous risks under Public Law 85-804. However, every PREP Act declaration to date has limited the potential scope of this protection by covering the administration or use of covered countermeasures only when they are distributed in connection with a federal contract, grant, or other agreement, or as directed in a public health emergency. In addition, PREP Act declarations do not offer protection for claims arising under foreign law or brought in a foreign court, which is of particular relevance to declarations targeting activities conducted primarily overseas. PREP Act declarations also do not protect willful misconduct causing death or serious physical injury, which is defined to exclude certain regulated and directed activities in circumstances described in the Act.
The Ebola declaration covers the manufacture, testing, development, distribution, physical administration, and use of the vaccine candidates identified in the declaration. Other than vaccine candidates that are obtained for the Strategic National Stockpile, which are statutorily protected through their distribution or release, the declaration will protect covered activities for a two-year period. The declaration contains no geographic limitation and broadly defines the subject population, explicitly extending protection from liability to the administration of the vaccine candidates, prescription of doses, and related management and operational decisions in West Africa, including liability for security decisions made at vaccine administration sites and premises liability.
The Secretary of HHS has encouraged other countries to implement similar liability protections to facilitate a global response to the Ebola outbreak. The World Health Organization also pushed for liability protections at an emergency meeting held earlier this year.