Public Readiness and Emergency Preparedness Act

1. 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

2. 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? Privileged Attorney Work Product

3. 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 Privileged Attorney Work Product

4. What is immunity? • No legal tort claim can be pursued in court • Federal or State Privileged Attorney Work Product

5. What is a tort? • A civil wrong • Other than a breach of contract • Recognized by the courts • Compensated by damages Privileged Attorney Work Product

6. 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. Privileged Attorney Work Product

7. 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 Privileged Attorney Work Product

8. 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. Privileged Attorney Work Product

9. Who is protected? • Covered persons • Manufacturers • Distributors • Program planners • “Qualified persons” • The United States • Officials, agents, and employees of any of the above Privileged Attorney Work Product

10. Program planners • State or local government agency (includes tribes) • State or local government employee • Or other person (private sector employer or community group) WHO… Privileged Attorney Work Product

11. 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 Privileged Attorney Work Product

12. “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 Privileged Attorney Work Product

13. 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 Privileged Attorney Work Product

14. 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. Privileged Attorney Work Product

15. 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) Privileged Attorney Work Product

16. 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 Privileged Attorney Work Product

17. 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 Privileged Attorney Work Product

18. 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) Privileged Attorney Work Product

19. 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 Privileged Attorney Work Product

20. 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 Privileged Attorney Work Product

21. 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 Privileged Attorney Work Product

22. 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/planners/prepact/index.html Privileged Attorney Work Product