As Suspected HHS Secretary Will Continue Immunity to Liability Under the PREP Act

This has all been about protecting the pharmaceutical companies and not about public health

HHS Secretary Becerra Issued a Letter to Governors on April 14, 2023 Renewing the COVID-19 PHE

Source: https://www.hhs.gov/about/news/2023/04/14/letter-us-governors-hhs-secretary-xavier-becerra-renewing-covid-19-public-health-emergency.html

The PREP Act Provides Immunity from Liability

The PREP Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December 2005 is a controversial tort liability shield intended to protect vaccine manufacturers from financial risk in the event of a declared public health emergency.

The Public Readiness and Emergency Preparedness Act (PREP Act):

• adds new legal authorities to the Public Health Service (PHS) Act

• provides liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics

• adds authority to establish a program to compensate eligible individuals who suffer injuries from administration or use of products covered by the PREP Act’s immunity provisions

The PREP Act authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. The declaration provides immunity* from liability (except for willful misconduct) for claims:

• of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions

• determined by the Secretary to constitute a present, or credible risk of a future public health emergency

• to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.

*Immunity means that courts must dismiss claims brought against any entity or individual covered by the PREP Act. Claims that courts must dismiss include claims for any loss that is related to any stage of design, development, testing, manufacture, labeling, distribution, formulation, labeling, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing or use of a countermeasure recommended in a Declaration. This includes, but is not limited to, claims for:

• death;

• physical, mental, or emotional injury, illness, disability, or condition or fear of any such injury, illness, disability, or condition;

• any need for medical monitoring; or

• property damage or loss, including business interruption loss.

The end of the PHE does not automatically terminate PREP Act coverage for activities related to COVID-19 Countermeasures.  Manufacturers, distributors, public and private entities conducting countermeasure programs and providers authorized under state law or by the Secretary’s PREP Act declaration for COVID -19 countermeasures are covered (subject to the terms of the Act and the declaration):

• For all activities related to a federal agreement through October 1, 2024 (for example, a federal contract for procurement and distribution of vaccines or treatments, provider agreement; memorandum of understanding, etc.)

Thus, under the terms of the current PREP Act declaration for COVID -19 countermeasures, PREP Act coverage will end if the PHE and all other emergency declarations end, AND there is no federal agreement relevant to the activity.

A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.