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Microsoft word - prep act.doc

H1N1 Influenza and Immunity under Public Readiness and Emergency Preparedness Act
Prepared by Office of General Counsel
Texas Department of State Health Services (DSHS)
(August 31, 2009)

ISSUE: What immunity exists under the PREP Act concerning H1N1 influenza?
ANSWER: The federal Public Readiness and Emergency Preparedness (PREP) Act, 42 United
States Code sec. 247d-6d, and declarations issued by the secretary of the US Department of
Health and Human Services (HHS) create immunity from tort liability for “covered persons”
who are involved in the administration and use of H1N1 influenza vaccine; H1N1 pandemic
antivirals (Tamiflu and Relenza); and pandemic influenza diagnostics, personal respiratory
protection devices, and respiratory support devices (covered countermeasures).
DISCUSSION: See one page summary concerning immunity under the PREP Act for a general
discussion of the Act and emergency use authorizations (EUA). As of August 2009 the HHS
secretary has issued the following declarations for H1N1 influenza covered countermeasures.
(Declarations are found at www.hhs.gov/disasters/discussion/planners/prepact/ and should be
reviewed for details.)
Vaccine: Countermeasures are 2009 H1N1 influenza vaccine and associated adjuvants; time
period extends through March 31, 2013 during pre-pandemic and pandemic times; immunity for
the covered persons below; covers injury to persons who use vaccine or to whom vaccine is
administered; and no geographic limitations.
Influenza antivirals: Countermeasure is H1N1 influenza antiviral drugs (Tamiflu and Relenza);
time period is through December 31, 2015 for antivirals administered or used in accordance with
federal requirements and through the time of an emergency declaration; immunity for the
covered persons below; covers injury to persons who receive an antiviral during a declared
emergency or under an EUA; and no geographic limitations. Additional covered persons are ones
who prescribe, administer, deliver, distribute, or dispense antivirals during declared emergency
and persons authorized to prescribe, administer, or dispense antivirals under law or an EUA.
Devices: Countermeasures are pandemic influenza diagnostics, personal respiratory protection
devices, and respiratory support devices; time period is through December 31, 2015 for devices
administered or used in accordance with federal requirements and through the time of an
emergency declaration; immunity for the covered persons below; covers injury to persons who
receive a device during a declared emergency or under an EUA; and no geographic limitations.
Additional covered persons are ones who prescribe, administer, deliver, distribute, or dispense
devices during declared emergency and persons authorized to prescribe, administer, or dispense
devices under law or an EUA.
A covered person is a: 1) manufacturer of a countermeasure; 2) distributor of a countermeasure;
3) public or private program planner (including state or local government) who supervises or
administers a program using a countermeasure; 4) qualified person authorized under state law to
prescribe, administer, or dispense a countermeasure; or 5) official, agent, or employee of a
person or entity described in 1-4.

Source: http://www.bcms.org/PDF/PREP%20Immunity.pdf

Pii: s0015-0282(01)02929-6

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Date this summary statement was written:

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