PREP Act – Coronavirus (COVID-19)

April 24, 2020August 31, 2020 by Duane Morris

Department of Health & Human Services Clarifies Broad Scope of Immunity Protection Under the PREP Act

The Department of Health & Human Services (HHS) has provided an omnibus advisory opinion in response to various requests for clarification of the scope of tort immunity provided by the declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act declaration provides immunity from tort liability for various persons, products and activities in response to COVID-19, as explained in our March 17, 2020, Alert. The Coronavirus Aid, Relief and Economic Security Act (CARES Act) subsequently expanded these protections.

To read the full text of this Duane Morris Alert, please visit the firm website.

April 13, 2020September 2, 2020 by Duane Morris

CARES Act Expands Immunity Protections for Covered Countermeasures and Healthcare Volunteers

As discussed in our March 18 Alert, the Secretary of Health and Human Services has issued a declaration authorizing drugs, devices and biologics used to treat or mitigate COVID-19 as covered countermeasures under the Public Readiness and Emergency Preparedness (PREP) Act. Following Secretary Azar’s declaration of a public health emergency, covered persons may obtain immunity under federal law for all claims arising from manufacturing, distributing or administering covered countermeasures, subject to the conditions laid out at 42 U.S.C. § 247d-6d, the declaration and other applicable regulations.

Subsequent to our previous Alert, President Trump signed into law the Coronavirus Aid, Relief and Economic Security Act (CARES Act), which expanded the covered countermeasure protections offered by the PREP Act.

To read the full text of this Duane Morris Alert, please visit the firm website.

April 13, 2020August 31, 2020 by Duane Morris

Webinar: How COVID-19 Is Affecting Life Sciences and Medical Technologies

Duane Morris will be hosting the webinar, “How COVID-19 Is Affecting Life Sciences and Medical Technologies,” on April 16, 2020, from 1:00 p.m. to 2:00 p.m. (Eastern).

Join Duane Morris attorneys for a discussion on how the life sciences and medical technologies industry is responding and adapting to the COVID-19 pandemic, including:

FDA’s Emergency Use Authorizations (EUAs) for devices and diagnostics testing policies
Public Readiness and Emergency Preparedness Act (PREP Act) immunity from liability
Implications on intellectual property, such as patent strategy, in biotechnology and pharmaceuticals
License and collaboration agreements in the wake of COVID-19

For more information and to register, please visit the firm website.

March 18, 2020August 31, 2020 by Duane Morris

Declaration Provides Immunity for Certain COVID-19 Pandemic Medical Countermeasure Activities

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.

To read the full text of this Duane Morris Alert, please visit the firm website.