HB2012

THE CONTEXT: The U.S. Secretary of Health & Human Services (Secretary) may authorize the introduction into interstate commerce, during the effective period of a declaration, of a drug, device or biological product intended for use in an actual or potential emergency. The Secretary may make a declaration of emergency or threat justifying emergency authorized use on the basis of: 1) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological or nuclear agent or agents; 2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States (U.S.) military forces, including personnel operating under the authority of various titles of attack with a biological, chemical, radiological or nuclear agent or agents; or an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S. military forces; 3) a determination by the Secretary that there is a public health emergency, or a significant potential for public health emergency, that affects, or has significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or 4) the identification of a material threat sufficient to affect national security or the health and security of U.S. citizens living abroad (21 U.S.C 360bbb-3). Health Care Entity means any of the following: 1) a licensed health care provider; 2) an entity that provides health care services through one or more licensed health care providers; 3) an entity that contracts to provide or pays for health care services; 4) a professional organization of licensed health care providers; 5) a utilization or quality control peer review organization; 6) a state health care provider; 7) a component of the statewide emergency medical services and trauma system; 8) a qualifying community health center; and 9) a committee or other organizational structure of a health care entity (A.R.S 36-2401).

WHAT THE BILL DID: The final vetoed version would prohibit an employer from requiring the administration of an emergency use product as defined in federal law to the employer's employees or as a condition of employment, prohibit a government entity or health care entity from requiring the administration of an emergency use product as defined in federal law, and define health care entity and government entity.

WHY IT MATTERED: The practical reason for this bill was to set a clear legal boundary for emergency use products instead of leaving the conduct unaddressed. It would prohibit an employer from requiring the administration of an emergency use product as defined in federal law to the employer's employees or as a condition of employment, and would also prohibit a government entity or health care entity from requiring the administration of an emergency use product as defined in federal law, rather than leave the current rule unchanged.