Thanks BUSH for your hyped up BS war and you Dept of Homeland Security, which is run by the president, and all the POLICE POWERS and our LOSS of FREEDOM.
Can't balme Obama for this.
The PREP Act authorizes the Secretary of the Department of Health and Human Services ("Secretary") to issue a declaration ("PREP Act declaration") that provides immunity from tort liability (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures. A PREP Act declaration is specifically for the purpose of providing immunity from tort liability, and is different from, and not dependent on, other emergency declarations. The PREP Act also authorizes an emergency fund in the United States Treasury to provide compensation for injuries directly caused by administration or use of a countermeasure covered by the Secretary's declaration.
2. Who May be Afforded Immunity from Tort Liability Under a PREP Act Declaration?
The Secretary's declaration may provide liability immunity for covered persons involved in administration and use of a countermeasure recommended in the declaration. (See Question 6, below, "What Countermeasures May be Covered by Immunity From Liability?" for an explanation of what countermeasures may be covered by the declaration.) Covered persons may, at the Secretary's discretion, include:
• Manufacturers of countermeasures;
• Distributors of countermeasures;
• Program planners of countermeasures (i.e., individuals and entities involved in planning and administering programs for distribution of a countermeasure);
• Qualified persons who prescribe, administer, or dispense countermeasures (i.e., healthcare and other providers); and
• The United States.
Officials, agents, and employees of any of these entities or persons are also covered persons.
A person includes an individual, partnership, corporation, association, entity, or public or private corporation, including a Federal, State, or local government agency or department.
A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a covered countermeasure; and any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.
A distributor means a person or entity engaged in the distribution of drug, biologics, or devices, including but not limited to: manufacturers; repackagers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.
A program planner means a State or local government, including an Indian Tribe; a person employed by the State or local government; or other person (such as a private sector employer or community group) who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a countermeasure, including a person who establishes requirements, provides policy guidance, or supplies technical or scientific advice or assistance or provides a facility to administer or use a covered countermeasure in accordance with the Secretary's declaration.
A qualified person means a licensed health professional or other individual who is authorized to prescribe, administer, or dispense covered countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or a person within a category of persons identified as qualified in the Secretary's declaration.
For manufacturers and distributors, immunity applies without regard to whether the countermeasure is administered to, or used by, populations designated in the Secretary's declaration or whether such administration and use occurs in the geographic areas designated in the Secretary's declaration.
For program planners and qualified persons, immunity applies when the countermeasure is administered to or used by persons designated in the Secretary's declaration and in geographic areas designated in the Secretary's declaration, or when the program planner or qualified person reasonably could have believed that these conditions were met.
3. What Types of Losses Are Covered?
The PREP Act declaration provides immunity for any type of loss suffered by an individual who receives the countermeasure, including death; physical, mental, or emotional injury, illness, disability or condition; fear of physical, mental, or emotional injury illness, disability, or condition, including any need for medical monitoring; and loss of or damage to property, including business interruption, with any causal relationship to any to stage of development, distribution, administration or use of the countermeasure.
4. Are There Any Limitations on Immunity from Liability?
Immunity from liability is not available for death or serious physical injury caused by willful misconduct. An individual who would ordinarily be protected under the PREP Act can be sued for tort claims if he or she engages in willful misconduct. A serious physical injury is life-threatening, or results in or requires medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Immunity is not available for claims based on activities that fall outside the scope of the declaration. As described below ("When Does Immunity Under the PREP Act Become Available?"), the Secretary can specify the conditions under which the declaration will provide immunity from liability, including (but not limited to) the effective dates and geographic area for which immunity will be available. Claims related to administration and use of the countermeasures that are inconsistent with those conditions are not afforded liability immunity under the declaration.
Immunity is not available for claims of loss that do not allege a causal relationship to the administration or use of a covered countermeasure and are not in fact based on such a causal relationship. A causal relationship with administration and use under the PREP Act includes 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.
Immunity from liability also is not available under the PREP Act for claims filed under foreign law in courts outside the United States. Immunity may be available for claims filed under United States law in United States courts, even when based on events that took place outside the United States.
Immunity from liability is not available under the PREP Act for lawsuits other than tort claims. For example, a PREP Act declaration would not provide immunity for claims related to violations of civil rights laws, the Americans with Disabilities Act, labor laws, or other such claims that have no connection to a tort claim.
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