Public Readiness and Emergency Preparedness Act (PREP Act) for Pandemic Influenza Medical Countermeasures Utilization Protocol & Decision Tools

BACKGROUND

The Public Readiness and Emergency Preparedness Act (PREP Act) (Pub. L. 109-148), provides immunity from liability claims arising from administration and use of covered countermeasures to manufacturers, distributors, program planners and qualified persons involved in the administration and use of a covered countermeasure, as specified in a declaration by the Secretary of HHS [See section 319F-3 of the Public Health Service Act (42 U.S.C. §247d-6d)]. The exception to this immunity is willful misconduct acts by the covered persons.

HSC Pandemic Influenza Implementation Plan Action Item 6.1.11.2 states that HHS shall develop a protocol and decision tools for medical countermeasures to implement liability protections and compensation, as authorized by the PREP Act, within 6 months of the issuance of the Plan.  The protocol and decision tools are in fulfillment of that Action Item.

RESPONSIBLE PARTIES:

1. HHS/OPHEP in consultation with CDC, NIH, FDA, HHS/OGC, HHS/ASL, HHS/ASPA and countermeasure manufacturers is responsible for the following activities:
   1. Determination of pre-pandemic and pandemic conditions and countermeasures warranting utilization of the Prep Act.
   2. Preparation and publication of the PREP Act declaration and amendments for the covered countermeasures during pre-pandemic or pandemic periods.
   3. Preparation of the statutory-required report to Congress regarding the issuance of a PREP Act declaration or amendment.
   4. Publication of the PREP Act declaration or amendments for pre-pandemic or pandemic influenza for publication in Federal Register on behalf of the HHS Secretary.
2. Department of Treasury
   1. Establishment of the “Covered Compensation Process Fund.”

PROTOCOL & DECISION TOOLS:

1. HHS determines whether the global spread of a highly pathogenic animal or human influenza virus strain during interpandemic periods in humans and/or animals at a CDC pandemic alert phase three or higher constitutes a public health emergency or whether there is a credible risk that the circulation of a pre-pandemic or pandemic influenza virus strain may in the future constitute such an emergency or receives request for liability relief from manufacturers of countermeasures for pandemic influenza.
2. HHS determines what countermeasures including vaccines would be used to prevent or respond to a pandemic influenza emergency.
3. HHS considers the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of such countermeasures for pre-pandemic and pandemic periods.
4. HHS/OPHEP and HHS operating or staff divisions brief HHS Secretary that an emerging pandemic influenza threat may exist and whether there may be a need for liability protection as provided in the PREP Act.
5. HHS/OPHEP in consultation with other HHS operating or staff divisions prepares a PREP Act declaration based on the determinations in the following categories for administration of each covered pandemic countermeasure.
   1. Covered Countermeasures.
   2. Category of Disease.
   3. Population.
   4. Time period.
   5. Geographic area.
   6. Means of Distribution.
6. HHS/OPHEP consults with manufacturer of covered countermeasure regarding a reasonable period for the manufacturer to arrange for disposition of the covered countermeasure, including the return of such product to the manufacturer following the expiration of the effective time period.
7. HHS determines whether the covered countermeasure for pandemic influenza is in or will be purchased for or by the Strategic National Stockpile. If the covered countermeasure is the subject of a declaration under paragraph (1) at the time that it is obtained for the stockpile, then the effective period of such declaration shall include a period when the countermeasure is administered pursuant to a distribution or release from the stockpile.
8. HHS/OPHEP submits PREP Act declaration to HHS Secretary for approval on covered countermeasure.
9. HHS determines whether any part of the declaration falls under section 552(b) of title 5, United States Code, which is exempt to disclosure by the Act.
10. HHS issues a PREP Act declaration under section 319F-3 of the Act and publishes the declaration in the Federal Register.
11. HHS prepares and submits the statutorily-required report to Congress regarding the issuance of the PREP Act declaration within 30 days after making the declaration.
12. The Department of Treasury establishes an emergency fund designated as the “Covered Countermeasure Process Fund.”
13. During the effective time period for a pre-pandemic or pandemic emergency, HHS determines whether amendments are needed.
14. If amendments to the declaration are deemed necessary by HHS, then HHS issues the amendments to the PREP Act declaration and publishes the amendments in the Federal Register.
15. If amendments to the declaration are deemed necessary by HHS, then HHS prepares and submits the statutorily-required report to Congress regarding the issuance of the PREP Act declaration amendments within 30 days after making the declaration.
16. If funds are appropriated for the Covered Countermeasure Process Fund under subsection (a), then HHS provides compensation to an eligible individual for a covered injury directly caused by the administration or use of a covered countermeasure pursuant to the declaration in accordance with Public Law 109-148.