Posted 09 December 2014
By Alexander Gaffney, RAC
The US Department of Health and Human Services (DHHS) is providing a gift to manufacturers of prospective vaccines meant to protect patients against the Ebola virus: Protection from legal liability.
In an announcement in the 9 December 2014 edition of the Federal Register, DHHS said it was issuing a new declaration that would "provide liability protection for activities related to Ebola virus disease vaccines consistent with the terms of the declaration."
Protection from legal liability is a major concern for vaccine manufacturers, whose products are administered to a large number of patients of different ages and health statuses. Even remarkably safe products can cause problems in a very small subset of patients, which becomes almost certain to happen when a vaccine is administered to tens of thousands—or even millions—of patients.
For ordinary vaccines, the US government offers legal protection through its National Vaccine Injury Compensation Program (NVICP) and a unique vaccine claims court system, both of which are funded through a tax assessed on vaccines.
For more background on this process, please see our explanation of a piece of vaccine liability legislation passed into law in June 2013.
But in emergency situations, the US government operates on a slightly different system. Under the Public Readiness and Emergency Preparedness (PREP) Act of 2005, DHHS is allowed to declare that a certain product is immune from liability as long as it is administered or used as a medical countermeasure in a specific patient population.
DHHS said it would use this same authority to allow all use of Ebola vaccines—barring, of course, "willful misconduct"—without concern to legal liability.
The liability waiver extends "without geographic limitation," DHHS noted, and is in effect for the next 12 months.
To date, no such vaccine products have been approved or made available for use through the US Food and Drug Administration's (FDA) Emergency Use Authorization (EUA) process, so for now DHHS' declaration seems anticipatory and intended to promote further research and development in this area.
Federal Register notice