Appendix E

• Jurisdiction: United States

Appendix E Language of the 2005 PREP Act Added in 2005 (Selected Portions of Pub. L. 109-148 Legislative History, December 2005)

Amending Public Health Service Act 319f-3. Targeted Liability Protections for Pandemic and Epidemic Products and Security Countermeasures (Emphasis Supplied)

(a) Liability Protections.—

(1) In general.—Subject to the other provisions of this section, a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure.
(2) Scope of claims for loss.—

(A) Loss.—For purposes of this section, the term 'loss' means any type of loss, including—

(i) death;
(ii) physical, mental, or emotional injury, illness, disability, or condition;
(iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and
(iv) loss of or damage to property, including business interruption loss.

Each of clauses (i) through (iv) applies without regard to the date of the occurrence, presentation, or discovery of the loss described in the clause.
(B) Scope.—The immunity under paragraph (1) applies to any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure.

(3) Certain conditions.—Subject to the other provisions of this section, immunity under paragraph (1) with respect to a covered countermeasure applies only if—

(A) the countermeasure was administered or used during the effective period of the declaration that was issued under subsection (b) with respect to the countermeasure;
(B) the countermeasure was administered or used for the category or categories of diseases, health conditions, or threats to health specified in the declaration; and
(C) in addition, in the case of a covered person who is a program planner or qualified person with respect to the administration or use of the countermeasure, the countermeasure

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