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The Department of Health and Human Services on PREP

March 16, 2020 in HHS/FDA & Other Regulatory Life Sciences News by Denise Bell

The Department of Health and Human Services issued a declaration on March 16 under the Public Readiness and Emergency Preparedness (“PREP”) Act to provide immunity to liability for activities related to medical countermeasures against COVID-19. The declaration is effective retroactively to February 4, 2020. The notice will be published in the Federal Register March 17.

The declaration provides liability immunity to covered individuals and entities “against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures.” More specifically, the declaration covers “products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic or epidemic or against adverse events from these products.” The covered countermeasure must be a qualified or epidemic product, or security countermeasure, or a drug, biologic or device authorized for emergency use.

The declaration defines “Covered Persons” as “manufacturers, distributors, program planners and qualified persons, and their officials, agents, and employees, and the Unites States.” The declaration further defines “manufacturer,” “distributor,” “program planner,” and “qualified person.”