In an effort to encourage development of drugs, devices and biologics useful for the treatment, diagnosis, and prevention of COVID-19 respiratory illness, the Secretary of Health and Human Services has issued a declaration providing statutory immunity under the Public Readiness and Emergency Preparedness (PREP) Act. This declaration is separate from the Public Health Emergency declared under Section 319 of the Public Health Service Act on January 31, 2020, and is a part of the continued effort by the federal government to expedite development and distribution of medical products that can address the COVID-19 pandemic.
Declaring a public health emergency under the PREP Act provides covered persons with immunity from liability under federal or state law for all claims arising from administration to or use by an individual of a Covered Countermeasure. Under the statute, 42 U.S.C. § 247d-6d, immunity applies if the medical countermeasure: