H.R. 4388: PREP Repeal Act

This bill, known as the PREP Repeal Act, aims to repeal specific provisions of the Public Health Service Act that currently provide liability protections to pharmaceutical manufacturers and other entities during public health emergencies. The key elements of the bill are outlined below:

Background Context

The bill addresses two sections of the Public Health Service Act - sections 319F–3 and 319F–4. These sections, known as the Public Readiness and Emergency Preparedness (PREP) Act, were designed to give liability immunity to pharmaceutical companies and others involved in developing and distributing medical products in the event of a health emergency, such as a pandemic.

Findings

The sponsors of the bill indicate several key findings:

• Liability protections can reduce public trust and accountability during health crises.
• Access to legal redress for harm is a fundamental aspect of justice.
• The PREP Act may be seen as promoting regulatory capture, where manufacturers benefit at the expense of individual rights.

Repeal of Liability Immunity

The bill proposes the repeal of:

• Section 319F–3, which provides immunity for entities against claims related to pandemic products.
• Section 319F–4, which pertains to the Covered Countermeasure Process Fund, a fund established to support the development and distribution of pandemic products.

Impact on Legal Redress

The repeal will restore the ability for individuals to seek compensation for injuries or harm caused by drugs, medical devices, and other products that were previously covered under the liability protections of the PREP Act.

Rescission of Fund Balances

The bill also calls for the rescinding of any unobligated balances in the Covered Countermeasure Process Fund as it existed prior to the enactment of this legislation.

Preservation of Existing Rights

This legislation aims to clarify that it will not impede individuals' rights to pursue civil actions or remedies under existing Federal or State laws for injuries arising from the use of drugs, devices, or other medical countermeasures.

Application of the Act

The provisions of this bill will apply to any legal actions or claims that are either pending at the time of enactment or that are initiated after the enactment date.

Severability Clause

The bill includes a severability clause, ensuring that if any part of this legislation is found to be invalid, the remaining provisions will still remain in effect.

Relevant Companies

• PFE (Pfizer Inc.) - As a leading pharmaceutical company involved in vaccine development, Pfizer could face increased legal liability if the immunity protections are repealed.
• MRNA (Moderna, Inc.) - Known for its mRNA technology, particularly in regards to COVID-19 vaccines, Moderna may be significantly impacted by changes in liability laws.
• JNJ (Johnson & Johnson) - With a broad portfolio of medical products, including vaccines, J&J might also see an increase in potential liabilities following this bill's enactment.
• AZN (AstraZeneca PLC) - As a player in the vaccine market, AstraZeneca could also be affected by the potential repeal of liability protection.