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What it does 

The Public Readiness and Emergency Preparedness (PREP) Act, passed in 2005, provides immunity from legal liability for claims related to the administration of countermeasures (i.e. vaccines) against certain diseases. The statute authorizes the Secretary of the Department of Health and Human Services (DHHS) to issue a declaration granting liability immunity with regard to a specific disease or health threat, after determining that the disease or threat constitutes a public health emergency or presents a credible risk of causing such an emergency.

This Declaration (FR 82 10365), effective August 1, 2016, extends the PREP Act liability shield to countermeasures related specifically to Zika virus:

  • The Secretary of DHHS has determined that there is a credible risk that Zika virus may create a public health emergency in the future.
  • As required by the PREP Act, the Secretary of DDHS has considered the desirability of encouraging the design, development, manufacture, distribution, etc. of Zika virus vaccines/countermeasures before extending liability protections.
  • Individuals protected from liability include the manufacturers and distributers of Zika vaccines, government program planners, and any person authorized by law to prescribe, administer, or dispense countermeasures.
  • The Secretary has extended liability protection related to the manufacture, testing, development, distribution, administration, and use of the following Zika vaccine types:

(1) Whole-particle inactivated virus vaccines

(2) Live-attenuated vaccines

(3) mRNA vaccines

(4) DNA vaccines

(5) Subunit vaccines

(6) Peptide vaccines

(7) Virus like particles vaccines

(8) Nanoparticle vaccines.

  • The Declaration bars lawsuits that allege negligence in creating the vaccine on the part of manufacturers, or negligence in administering vaccines on the part of health care providers. The Declaration also bars injury claims related to the operation of a vaccine distribution site (for example, slip-and-fall injuries at a distribution center). Immunity does not extend to willful misconduct.
  • Liability immunity is in effect for 24 months from the effective date of the Declaration. An additional 12 months of liability protection is extended to return the vaccine to manufacturers after the emergency declaration has expired.
  • Individuals who sustain serious physical injury as a direct result of using Zika countermeasures may be eligible to receive benefits from the Countermeasures Injury Compensation Program (CICP). Individuals who want to receive benefits from CICP must support their claims with “compelling, reliable, valid, medical and scientific evidence” that the Zika vaccine/countermeasure directly caused their injuries.
Relevant Science 

Zika virus is a mosquito-borne virus in the same family as West Nile virus, dengue, and yellow fever virus. The disease is transmitted primarily through the bite of infected Aedes mosquitos, but transmission through sexual contact and blood transfusion is also possible.

Most people who contract the disease exhibit no symptoms; others present mild symptoms such as mild fever, rash, joint pain, conjunctivitis, headache, and malaise. Symptoms usually last from two to seven days. There is currently no vaccine for Zika virus, and no effective antiviral treatment exists. The disease is usually mild, however, and typically requires no more than bedrest and administration of over-the-counter medicines to relieve symptoms.

Although the disease is usually not life-threatening, Zika virus has been linked to certain serious health complications. Zika has been associated with congenital brain defects in infants, including microcephaly (stunted brain development, which can lead to cognitive impairments and related problems), if a woman is infected with the virus while pregnant. Zika may also trigger Guillain-Barre Syndrome, a disorder which causes the body’s immune system to attack its own nerves. Guillain-Barre Syndrome causes temporary muscle weakness and paralysis, and may lead to permanent and/or life-threatening complications. According to the World Health Organization (WHO), “[i]ntense efforts are continuing to investigate the link between Zika virus and a range of neurological disorders.”

Background 

The Public Readiness and Emergency Preparedness (PREP) Act was first passed in 2005. The objective of the law is to facilitate and incentivize development of drugs and vaccines in times of public health emergency, by protecting drug manufacturers from financial liability associated with rushing new drugs to market. The statute gives the Department of Health and Human Services the ability to declare that a particular disease presents or could cause a public health emergency, and may extend liability immunity to individuals and entities developing countermeasures for that specific disease. 

Endorsements & Opposition 

At present, there have not been any publicly reported endorsements of or opposition to the specific PREP Act declaration extending liability protections to Zika virus vaccines.

However, the PREP Act as a whole is controversial as a liability shield for pharmaceutical companies. Proponents of the statute believe that it incentivizes companies to develop and market drugs in response to a public health emergency by decreasing the risk of lawsuit. Opponents say that the PREP Act gives too much protection to drug companies, allowing them to market potentially unsafe products; they also claim that the compensation system denies consumers adequate remedy for injuries sustained as a result of receiving unsafe drugs.

Endorsement:

  • Former Senator Bill Frist: This concept “strikes a reasonable balance where those who are harmed will be fairly compensated and life-saving products will be available in ample supply to protect and treat as many Americans as possible.”

Opposition:

  • Former Senator Edward Kennedy: “Without a real compensation program, the liability protection … provides a Christmas present to the drug industry and bag of coal to everyday Americans.”
  • The Association of Trial Lawyers: “At a time when we see the egregious things that are being done by major drug companies, the last thing in the world that the consumer needs is immunity for drug manufacturers to act with impunity.”
Status 

This Declaration is effective as of August 1, 2016. 

Primary Author 
Cole Wilhelmi, JD/MA Candidate
Editor(s) 
Jenny Wang, JD/MA Candidate; Aubrey Incorvaia, MPP
Recommended Citation 

Duke SciPol, “Declaration Under the Public Readiness and Emergency Preparedness Act for Zika Virus Vaccines (DHHS Notice)” available at http://scipol.duke.edu/content/declaration-under-public-readiness-and-emergency-preparedness-act-zika-virus-vaccines-dhhs (5/23/17).

License 
Creative Commons License This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Please distribute widely but give credit to Duke SciPol and the primary author(s) listed above, linking back to this page if possible.