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 | [email protected]. What you will learn. - PowerPoint PPT Presentation
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Public Readiness and Public Readiness and Emergency Preparedness Emergency Preparedness Act Act Strategic National Stockpile Strategic National Stockpile Training Summit Training Summit Atlanta, Georgia Atlanta, Georgia March 12, 2009 March 12, 2009 Joseph Foster Joseph Foster Office of the General Counsel Office of the General Counsel Department of Health and Human Services Department of Health and Human Services 404 639 7209 404 639 7209 | | [email protected]
Transcript
Public Readiness and Public Readiness and Emergency Preparedness ActEmergency Preparedness Act
Strategic National Stockpile Training SummitStrategic National Stockpile Training SummitAtlanta, GeorgiaAtlanta, GeorgiaMarch 12, 2009March 12, 2009
Joseph FosterJoseph FosterOffice of the General CounselOffice of the General CounselDepartment of Health and Human ServicesDepartment of Health and Human Services404 639 7209 404 639 7209 | | [email protected]
Privileged Attorney Work Product Privileged Attorney Work Product
What you will learnWhat you will learn
What is the PREP Act intended to do?What is the PREP Act intended to do?What is immunity?What is immunity?How is immunity triggered?How is immunity triggered?Who is protected?Who is protected?What types of products may be covered?What types of products may be covered?What are covered persons protected from?What are covered persons protected from?What are covered persons NOT protected from?What are covered persons NOT protected from?What about those who are injured?What about those who are injured?
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What is the PREP Act intended What is the PREP Act intended to do?to do?
Enacted to alleviate liability concernsEnacted to alleviate liability concerns
Authorizes the Secretary to issue a Authorizes the Secretary to issue a declaration providing immunity from tort declaration providing immunity from tort liabilityliability– Exception: willful misconductException: willful misconduct
Different from, and (mostly) independent Different from, and (mostly) independent of, other emergency declarationsof, other emergency declarations
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What is immunity?What is immunity?
No legal tort claim can be pursued in courtNo legal tort claim can be pursued in court
Federal or StateFederal or State
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What is a tort?What is a tort?
A civil wrongA civil wrong– Other than a breach of contractOther than a breach of contract– Recognized by the courtsRecognized by the courts– Compensated by damagesCompensated by damages
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How is immunity triggered?How is immunity triggered?
Declaration published in Federal RegisterDeclaration published in Federal RegisterPublished declarationsPublished declarations– H5N1, H2, H6, H7, and H9 pandemic influenza vaccineH5N1, H2, H6, H7, and H9 pandemic influenza vaccine– Anthrax countermeasuresAnthrax countermeasures– Botulism countermeasuresBotulism countermeasures– Pandemic antiviral countermeasuresPandemic antiviral countermeasures– Smallpox countermeasuresSmallpox countermeasures– Acute radiation syndrome countermeasuresAcute radiation syndrome countermeasures– Pandemic influenza diagnostics, personal respiratory Pandemic influenza diagnostics, personal respiratory
protection devices, and respiratory support devices.protection devices, and respiratory support devices.
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Declaration contentsDeclaration contents
Declaration includes:Declaration includes:– Determination of threat or credible riskDetermination of threat or credible risk– Recommendation for action (manufacture, testing, Recommendation for action (manufacture, testing,
use, etc.)use, etc.)– Category of diseases, health conditions or health Category of diseases, health conditions or health
threatsthreats– Effective time periodEffective time period– Receiving populationReceiving population– Geographic area of administrationGeographic area of administration– Limitations (geographic area, means of distribution)Limitations (geographic area, means of distribution)– Additional qualified personsAdditional qualified persons
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Pandemic influenza antivirals Pandemic influenza antivirals effective periodeffective period
With respect to Covered Countermeasures administered and used With respect to Covered Countermeasures administered and used in accordance with present or future Federal contracts, cooperative in accordance with present or future Federal contracts, cooperative agreements, grants, interagency agreements, or memoranda of agreements, grants, interagency agreements, or memoranda of understanding, the effective period of time of this Declaration understanding, the effective period of time of this Declaration commences on signature of the declaration and extends through commences on signature of the declaration and extends through December 31, 2015.December 31, 2015.
With respect to Covered Countermeasures administered and used With respect to Covered Countermeasures administered and used in accordance with the public health and medical response of the in accordance with the public health and medical response of the Authority Having Jurisdiction, the effective period of time of this Authority Having Jurisdiction, the effective period of time of this Declaration commences on the date of a declaration of an Declaration commences on the date of a declaration of an emergency and lasts through and includes the final day that the emergency and lasts through and includes the final day that the emergency declaration is in effect including any extensions thereof.emergency declaration is in effect including any extensions thereof.
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Who is protected?Who is protected?
Covered personsCovered persons– ManufacturersManufacturers– DistributorsDistributors– Program plannersProgram planners– ““Qualified persons”Qualified persons”– The United StatesThe United States– Officials, agents, and employees of any of the Officials, agents, and employees of any of the
aboveabove
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Program plannersProgram planners
State or local government agency State or local government agency (includes tribes)(includes tribes)
State or local government employeeState or local government employee
Or other person (private sector employer Or other person (private sector employer or community group) or community group)
WHO…WHO…
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Program plannersProgram planners
Supervises or administers a program to Supervises or administers a program to administer, dispense, distribute, provide, administer, dispense, distribute, provide, or use a countermeasure, including or use a countermeasure, including persons who:persons who:– Establish requirementsEstablish requirements– Provide policy guidanceProvide policy guidance– Supply technical or scientific advice or Supply technical or scientific advice or
assistanceassistance– Provide a facilityProvide a facility
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““Administration” definedAdministration” defined
Includes, but is not limited to, public and Includes, but is not limited to, public and private delivery, distribution, and private delivery, distribution, and dispensing activities relating to physical dispensing activities relating to physical administration of the Covered administration of the Covered Countermeasures to patients/recipients, Countermeasures to patients/recipients, management and operation of delivery management and operation of delivery systemssystems
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Qualified personsQualified persons
Licensed health professionalsLicensed health professionals
Other individuals authorized (by state law) Other individuals authorized (by state law) to prescribe, administer, or dispense to prescribe, administer, or dispense countermeasurescountermeasures
Other persons identified as “qualified” in Other persons identified as “qualified” in the Secretary’s declarationthe Secretary’s declaration
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Qualified persons as defined in Qualified persons as defined in anthrax declarationanthrax declaration
Any person who is authorized to prescribe, administer, deliver, Any person who is authorized to prescribe, administer, deliver, distribute or dispense Covered Countermeasures to Department of distribute or dispense Covered Countermeasures to Department of Defense military personnel and supporting civilian-employee and Defense military personnel and supporting civilian-employee and contractor personnel, contractor personnel,
Any person authorized in accordance with the public health and Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense Covered prescribe, administer, deliver, distribute or dispense Covered Countermeasures, and their officials, agents, employees, Countermeasures, and their officials, agents, employees, contractors and volunteers, following a declaration of an emergency, contractors and volunteers, following a declaration of an emergency, andand
Any person authorized to prescribe, administer, or dispense Any person authorized to prescribe, administer, or dispense Covered Countermeasures or who is otherwise authorized under an Covered Countermeasures or who is otherwise authorized under an Emergency Use Authorization, including, but not limited to Emergency Use Authorization, including, but not limited to Department of Defense military personnel and supporting civilian Department of Defense military personnel and supporting civilian employee and contractor personnel.employee and contractor personnel.
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What types of products are What types of products are covered?covered?
Covered countermeasuresCovered countermeasures– Qualified pandemic or epidemic productQualified pandemic or epidemic product– Security countermeasureSecurity countermeasure– Drug, biological product, or device authorized Drug, biological product, or device authorized
for emergency use (EUA)for emergency use (EUA)
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Qualified pandemic or epidemic Qualified pandemic or epidemic productproduct
Drug, biological product, or deviceDrug, biological product, or device– Approved, cleared, or licensedApproved, cleared, or licensed– Under an INDUnder an IND– Authorized as an EUAAuthorized as an EUA
ANDANDDiagnose, mitigate, prevent, treat, or to cure a Diagnose, mitigate, prevent, treat, or to cure a pandemic or epidemic; orpandemic or epidemic; orLimit the harm such pandemic or epidemic might Limit the harm such pandemic or epidemic might cause; orcause; orUse to diagnose, mitigate, prevent, treat, or cure Use to diagnose, mitigate, prevent, treat, or cure a condition caused by one of these productsa condition caused by one of these products
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Security countermeasureSecurity countermeasure
Drug, biological products, or deviceDrug, biological products, or device– Approved, cleared, or licensedApproved, cleared, or licensed– Authorized as an EUAAuthorized as an EUA– Will qualify for approval or licensing within 8 yearsWill qualify for approval or licensing within 8 years
ANDANDSecretary determines to be a priority to treat, identify, or Secretary determines to be a priority to treat, identify, or prevent harm from any biological, chemical, radiological, or prevent harm from any biological, chemical, radiological, or nuclear agent identified by DHS as a material threat or to nuclear agent identified by DHS as a material threat or to treat, identify, or prevent harm that may be caused by such treat, identify, or prevent harm that may be caused by such products; products;
ANDANDSecretary determines to be necessary to protect public healthSecretary determines to be necessary to protect public health
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What are covered persons What are covered persons protected from?protected from?
Any loss with any causal relationship to any Any loss with any causal relationship to any stage of development, distribution, stage of development, distribution, administration, or use of a countermeasureadministration, or use of a countermeasure– DeathDeath– Physical, mental, or emotional injury, illness, disability Physical, mental, or emotional injury, illness, disability
or conditionor condition– Fear of physical, mental, or emotional injury, illness, Fear of physical, mental, or emotional injury, illness,
disability, or conditiondisability, or condition– Any need for medical monitoringAny need for medical monitoring– Loss of or damage to property (including business Loss of or damage to property (including business
interruption)interruption)
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What are covered persons NOT What are covered persons NOT protected from?protected from?
Claims other than tort claimsClaims other than tort claims– Civil rights lawsCivil rights laws– ADAADA– Labor lawsLabor laws
Claims with no causal relationshipClaims with no causal relationshipClaims for activities outside the declarationClaims for activities outside the declaration– Effective dateEffective date– Geographic areaGeographic area
Claims filed in foreign courtsClaims filed in foreign courts– BUT events outside U.S. may be covered if claim filed BUT events outside U.S. may be covered if claim filed
in U.S. courtsin U.S. courts
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What are covered persons NOT What are covered persons NOT protected from?protected from?
Death or serious physical injury caused by willful Death or serious physical injury caused by willful misconductmisconductWillful misconduct is an act or omission taken:Willful misconduct is an act or omission taken:– Intentionally to achieve a wrongful purposeIntentionally to achieve a wrongful purpose
ANDAND– Knowingly without legal or factual justification Knowingly without legal or factual justification
ANDAND– In disregard of a known or obvious risk (highly In disregard of a known or obvious risk (highly
probable that the harm will outweigh the benefit)probable that the harm will outweigh the benefit)
Secretary shall by regulation further restrict what Secretary shall by regulation further restrict what constitutes willful misconductconstitutes willful misconduct
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What about those who are injured?What about those who are injured?
Compensation fund established upon issuance Compensation fund established upon issuance of a declarationof a declarationMust be appropriatedMust be appropriatedCompensation available for:Compensation available for:– Medical benefitsMedical benefits– Lost wagesLost wages– Death benefitsDeath benefits
Compensation reduced by insurance or workers’ Compensation reduced by insurance or workers’ compensationcompensationSubject to regulationsSubject to regulations
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If you don’t believe me…If you don’t believe me…
Sections 319F-3 and 319F-4 of the Public Sections 319F-3 and 319F-4 of the Public Health Service Act (42 USC §§ 247d-6d, Health Service Act (42 USC §§ 247d-6d, 247d-6e)247d-6e)
