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January 4, 2009
The American public is under a federally declared public health emergency for anthrax, bacillus anthracis. This is the first declared public health emergency under the Public Readiness and Emergency Preparedness Act of 2005, and began quietly on October 1, 2008.
Key elements in the declaration state that pursuant to section 319F-3 of the Public Health Service Act, 42 U.S.C. 247d-6d, (this provision originating from the Public Readiness and Emergency Preparedness Act of 2005) the Secretary of Health and Human Services declares a public health emergency. The declared purpose and reason is “to provide targeted liability protections for anthrax countermeasures based on a credible risk that the threat of exposure to Bacillus anthracis and the resulting disease constitutes a public health emergency. . . .” The conclusion of the declaration reads:
Therefore, pursuant to section 319F-3(b) of the Act, I have determined there is a credible risk that the threat of exposure of B. anthracis and the resulting disease constitutes a public health emergency.
The declaration also sets a time period, in accordance with section 319F-3(b)(2)(B) of the Act, and beginning with the effective date of October 1, 2008, the declaration ends on December 31, 2015, with an additional year’s extension.
The declaration is made to effect immunity (specified in section 319F-3(a) of the Act), for a wide range of the population including drug manufacturers and others who “deploy” or “donate” countermeasures for anthrax. Interestingly, “program planners” are given immunity under this declaration. The glaring omission is the declaration of immunity for healthcare givers who actually administer the countermeasure, such as any antibiotics requiring administering by a healthcare provider for an anthrax infection.
A legal, yet also very political reason for this glaring omission is the U.S. Constitutional relationship between state and federal governments. Under our federalism form of government, state law in public health matters, including medical malpractice, is a state law area of jurisdiction, and cannot be preempted by the federal government without an express directive from Congress, or other specific criteria, including that the federal government has “field preemption” because they regulate almost all of the activity in that field (which is far from the case with medical liability). Congress also does not like to encroach on state sovereignty by making a habit of preemption, so the political will has to be fairly high to preempt state law, which is not the case here.
Why, you might ask, does Congress not wish to preempt state liability for the sake of medical care providers on the front lines of a bioterrorism attack or a pandemic? It could be simply that the political will is not there; or more sinister, that the tort lawyers are lobbying hard to avoid preempting their way of life and source of income. My cynical side has to conclude the latter.
But there are other significant aspects of this “first” in the declaration. For the first time, a public health declaration has been made as a matter of “national security”. In the early days following the anthrax attacks of fall 2008, the U.S. Department of Justice refused to recognize public health threats as matters of national security in existing law which allowed federal actions. Specifically, in this declaration, it reads:
B. anthracis and multi-drug-resistant B. anthracis present a material threat against the United States population, sufficient to affect national security; [emphasis added]
So for the next six or seven years, the U.S. will be under a declared, recognized, public health emergency for legal immunity for the deployment of countermeasures. Whether each state will take action to protect its own healthcare givers who administer the countermeasures is yet to be seen, or exactly what is a state’s responsibility in the context of “national security” without federal preemption? But nonetheless, a landmark has been passed, where the federal government has formally recognized a public health emergency as a threat that may affect national security.
To see the federal announcement of the declaration go to:
http://edocket.access.gpo.gov/2008/E8-23547.htm
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