Similar declarations have been put into effect in recent years to address Zika virus, Ebola virus, anthrax and influenza pandemics.
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:
- was administered during the period of the declaration;
- was administered for the category of diseases specified in the declaration; and
- was administered to an individual in the population of a geographic area as specified in the declaration.
Similar declarations have been put into effect in recent years to address Zika virus, Ebola virus, anthrax and influenza pandemics. The COVID-19 declaration addresses a public health emergency that continues to have a more real and immediate impact on daily life than any of the previous pandemics.
Who Are Covered Persons?
Covered Persons under the declaration include manufacturers, distributors, program planners and other qualified persons. Qualified persons include licensed health professionals or any person authorized to prescribe, administer or dispense Covered Countermeasures. “Covered Persons” is intended to broadly cover each step of the supply chain from product manufacturers to healthcare practitioners who administer or dispense products to the individual patient.
What Are Covered Countermeasures?
Covered Countermeasures include drugs, devices or biologics to diagnose, mitigate, prevent, treat or cure diseases resulting from the COVID-19 pandemic. Covered Countermeasures also include drugs, devices or biologics intended to treat, diagnose or prevent a serious or life-threatening disease caused by such a drug (addressing risks of adverse events from a countermeasure), as well as a product or technology intended to enhance the use or effect of a countermeasure. This declaration only addresses liability for use of products that are otherwise legally marketed in the United States. In other words, Covered Countermeasures must be approved, cleared or licensed under an applicable section of the Federal Food, Drug & Cosmetic Act (drugs or devices) or the Public Health Service Act (biologics), or authorized for emergency use under Section 564, 564A or 564B of the FFDCA.
Covered Countermeasures also includes security countermeasures, which are drugs, devices or biologics determined by the Secretary of the Department of Health and Human Services to be a priority to diagnose, prevent or treat any harm from any biological agent determined to be a material threat by the Secretary of Homeland Security. A security countermeasure may also be a Covered Countermeasure if it may reasonably be determined to qualify for approval or licensing within 10 years of the HHS determination that procurement of the countermeasure is appropriate.
What Activities Are Covered?
Liability immunity applies to a broad definition of “administration” activities and distribution. With respect to distribution, immunity applies to Covered Persons for activities related to (a) present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding or other federal agreements; or (b) activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a declaration of an emergency.
“Authorities Having Jurisdiction” is broadly defined to include federal, state, local and tribal authorities and organizations acting on behalf of those government entities. This broad definition empowers state and local authorities to make decisions how Covered Countermeasures can best be distributed in their jurisdictions.
Administration of a Covered Countermeasure also broadly includes:
- Physical provision of countermeasures to recipients;
- Activities and decision directly relating to public and private delivery, distribution and dispensing of countermeasures;
- Management and operation of countermeasure programs; and
- Management and operation of locations for the purpose of distributing and dispensing countermeasures.
While there are some limits on the scope of “administration,” this is meant to include not just immunity for those who physically administer the countermeasure, but also those involved in distribution, dispensing and management of programs for distribution.
Administration to Whom, When and Where?
The liability immunity is in effect with respect to countermeasures administered to or used by any individuals. There is no geographic limitation on use or administration, and immunity could apply to use outside the United States where U.S. law applies. The immunity is in effect through October 1, 2024, or the final day the emergency declaration is in effect.
Countermeasures Injury Compensation Program (CICP)
As permitted under the PREP Act, the declaration invokes the Countermeasure Injury Compensation Program, which provides benefits to eligible individuals who sustain a serious physical injury or die as a direct result of administration or use of a Covered Countermeasure. Direct causation requires “compelling, reliable, valid, medical, and scientific evidence.” The program is intended to provide compensation to individuals who, but for the PREP Act immunity, could have recovered for injuries caused by a Covered Countermeasure.
Conclusion
By providing liability immunity to manufacturers, distributors, program planners and healthcare professionals for administration of drugs and devices aimed at countering the COVID-19 pandemic, the government takes another step toward expediting development and availability of potentially life-saving treatments and preventative measures to bring the COVID-19 pandemic under control.
About Duane Morris
Duane Morris has created a COVID-19 Strategy Team to help organizations plan, respond to and address this fast-moving situation. Contact your Duane Morris attorney for more information. Prior Alerts on the topic are available on the team’s webpage.
For More Information
If you have any questions about this Alert, please contact Patrick C. Gallagher, Ph.D., Frederick R. Ball, Justin M. L. Stern, any of the attorneys in our Life Sciences and Medical Technologies Industry Group, any members of the COVID-19 Strategy Team or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.