Public Readiness and
Emergency Preparedness Act
Strategic National Stockpile Training Summit
Atlanta, Georgia
March 12, 2009
Joseph Foster
Office of the General Counsel
Department of Health and Human Services
404 639 7209 | jfoster@cdc.gov
What you will learn
What is the PREP Act intended to do?
What is immunity?
How is immunity triggered?
Who is protected?
What types of products may be covered?
What are covered persons protected from?
What are covered persons NOT protected from?
What about those who are injured?
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What is the PREP Act intended
to do?
Enacted to alleviate liability concerns
Authorizes the Secretary to issue a
declaration providing immunity from tort
liability
– Exception: willful misconduct
Different from, and (mostly) independent
of, other emergency declarations
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What is immunity?
No legal tort claim can be pursued in court
Federal or State
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What is a tort?
A civil wrong
– Other than a breach of contract
– Recognized by the courts
– Compensated by damages
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How is immunity triggered?
Declaration published in Federal Register
Published declarations
– H5N1, H2, H6, H7, and H9 pandemic influenza
vaccine
– Anthrax countermeasures
– Botulism countermeasures
– Pandemic antiviral countermeasures
– Smallpox countermeasures
– Acute radiation syndrome countermeasures
– Pandemic influenza diagnostics, personal respiratory
protection devices, and respiratory support devices.
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Declaration contents
Declaration includes:
– Determination of threat or credible risk
– Recommendation for action (manufacture, testing,
use, etc.)
– Category of diseases, health conditions or health
threats
– Effective time period
– Receiving population
– Geographic area of administration
– Limitations (geographic area, means of distribution)
– Additional qualified persons
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Pandemic influenza antivirals
effective period
With respect to Covered Countermeasures administered and used
in accordance with present or future Federal contracts, cooperative
agreements, grants, interagency agreements, or memoranda of
understanding, the effective period of time of this Declaration
commences on signature of the declaration and extends through
December 31, 2015.
With respect to Covered Countermeasures administered and used
in accordance with the public health and medical response of the
Authority Having Jurisdiction, the effective period of time of this
Declaration commences on the date of a declaration of an
emergency and lasts through and includes the final day that the
emergency declaration is in effect including any extensions thereof.
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Who is protected?
Covered persons
– Manufacturers
– Distributors
– Program planners
– “Qualified persons”
– The United States
– Officials, agents, and employees of any of the
above
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Program planners
State or local government agency
(includes tribes)
State or local government employee
Or other person (private sector employer
or community group)
WHO…
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Program planners
Supervises or administers a program to
administer, dispense, distribute, provide,
or use a countermeasure, including
persons who:
– Establish requirements
– Provide policy guidance
– Supply technical or scientific advice or
assistance
– Provide a facility
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“Administration” defined
Includes, but is not limited to, public and
private delivery, distribution, and
dispensing activities relating to physical
administration of the Covered
Countermeasures to patients/recipients,
management and operation of delivery
systems
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Qualified persons
Licensed health professionals
Other individuals authorized (by state law)
to prescribe, administer, or dispense
countermeasures
Other persons identified as “qualified” in
the Secretary’s declaration
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Qualified persons as defined in
anthrax declaration
Any person who is authorized to prescribe, administer, deliver,
distribute or dispense Covered Countermeasures to Department of
Defense military personnel and supporting civilian-employee and
contractor personnel,
Any person authorized in accordance with the public health and
medical emergency response of the Authority Having Jurisdiction to
prescribe, administer, deliver, distribute or dispense Covered
Countermeasures, and their officials, agents, employees,
contractors and volunteers, following a declaration of an emergency,
and
Any person authorized to prescribe, administer, or dispense
Covered Countermeasures or who is otherwise authorized under an
Emergency Use Authorization, including, but not limited to
Department of Defense military personnel and supporting civilian
employee and contractor personnel.
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What types of products are
covered?
Covered countermeasures
– Qualified pandemic or epidemic product
– Security countermeasure
– Drug, biological product, or device authorized
for emergency use (EUA)
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Qualified pandemic or epidemic
product
Drug, biological product, or device
– Approved, cleared, or licensed
– Under an IND
– Authorized as an EUA
AND
Diagnose, mitigate, prevent, treat, or to cure a
pandemic or epidemic; or
Limit the harm such pandemic or epidemic might
cause; or
Use to diagnose, mitigate, prevent, treat, or cure
a condition caused by one of these products
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Security countermeasure
Drug, biological products, or device
– Approved, cleared, or licensed
– Authorized as an EUA
– Will qualify for approval or licensing within 8 years
AND
Secretary determines to be a priority to treat, identify, or
prevent harm from any biological, chemical, radiological,
or nuclear agent identified by DHS as a material threat or
to treat, identify, or prevent harm that may be caused by
such products;
AND
Secretary determines to be necessary to protect public
health
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What are covered persons
protected from?
Any loss with any causal relationship to any
stage of development, distribution,
administration, or use of a countermeasure
– Death
– Physical, mental, or emotional injury, illness, disability
or condition
– Fear of physical, mental, or emotional injury, illness,
disability, or condition
– Any need for medical monitoring
– Loss of or damage to property (including business
interruption)
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What are covered persons NOT
protected from?
Claims other than tort claims
– Civil rights laws
– ADA
– Labor laws
Claims with no causal relationship
Claims for activities outside the declaration
– Effective date
– Geographic area
Claims filed in foreign courts
– BUT events outside U.S. may be covered if claim filed
in U.S. courts
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What are covered persons NOT
protected from?
Death or serious physical injury caused by willful
misconduct
Willful misconduct is an act or omission taken:
– Intentionally to achieve a wrongful purpose
AND
– Knowingly without legal or factual justification
AND
– In disregard of a known or obvious risk (highly
probable that the harm will outweigh the benefit)
Secretary shall by regulation further restrict what
constitutes willful misconduct
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What about those who are injured?
Compensation fund established upon issuance
of a declaration
Must be appropriated
Compensation available for:
– Medical benefits
– Lost wages
– Death benefits
Compensation reduced by insurance or workers’
compensation
Subject to regulations
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If you don’t believe me…
Sections 319F-3 and 319F-4 of the Public
Health Service Act (42 USC §§ 247d-6d,
247d-6e)
http://www.hhs.gov/disasters/discussion/pl
anners/prepact/index.html
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