Mapp Biopharma nabs federal liability protection for Ebola drug
- Because Mapp Biopharmaceuticals is developing ZMapp, a treatment for Ebola, which is considered a "credible risk" to public health, it is protected by federal law from legal liability.
- The Public Readiness and Emergency Preparedness Act (PREP Act) of 2005, as modified by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013, is the legal basis for shielding drugmakers from legal liability.
- Products such as ZMapp could potentially be used under the "Emergency Use Authorization" clause of this law if an Ebola outbreak occurs.
It often comes down to a risk-benefit analysis. That is, which is a greater risk—an Ebola pandemic or individuals who either become sick or die as the result of an experimental medication that has not been fully tested before use.
The answer, at least for the Department of Health and Human Services (DHHS), is to avert the greater risk—the public health threat—and protect the company from legal liability. In doing so, the goal is to incentivize R&D in areas where entire communities or even the entire nation are at risk. So far, this law has been effective.
- Regulatory Affairs Professional Society HHS Says it Will Shield Maker of Ebola Therapy ZMapp from Legal Liability