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Public Health Law Program | |||
2009 H1N1 Flu Legal Preparedness
Federal Legal Actions & Guidance U.S. Department of Health and Human Services, Determination that a Public Health Emergency Exists (April 26, 2009). U.S. Food and Drug Administration, FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans, (April 27, 2009). FDA has issued Emergency Use Authorizations, pursuant to its authority under the Project BioShield Act (42 U.S.C. § 247d-6b), to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the H1N1 Influenza virus. EUAs have been issued for oseltamivir (Tamiflu), zananivir (Relenza), the N95 respirator, and the swine flu test kit. More information is available at http://www.cdc.gov/h1n1flu/eua/fda_issuance_letters.htm. FEMA, Emergency Assistance for Human Influenza Pandemic State/Territorial Laws, Legal Actions, and Draft Orders Declarations of Emergency or Related Actions American Samoa California Florida Department of Health, Declaration of Public Health Emergency Supplemental Order #02, (May 5, 2009). Department of Health, Declaration of Public Health Emergency, (May 1, 2009). Maine Maryland Nebraska New York Ohio Texas Virginia Wisconsin Florida Massachusetts North Carolina Washington To assist in mass administration of H1N1 vaccine, states are evaluating their laws to determine individuals who are authorized to administer H1N1 vaccines. If necessary, states are amending legal provisions to extend legal authority to administer HlNl vaccine to persons who would not otherwise be permitted to administer vaccine. Three states provide examples: Massachusetts emergency regulation passed recently by the Public Health Council (to be effective upon filing with the Secretary of State) authorizing the Commissioner of Public Health to issue an order designating the persons who may administer H1N1 vaccine and the conditions under which the vaccine may be administered. To access the regulation, 105 CMR 700.003(H), please click here. Michigan statute authorizing physicians to delegate administration of vaccine to appropriately trained individuals. To access the statute, MCL 333.16215, please click here. Recently-amended Minnesota statute extending the authority of the Commissioner of Health to respond to requests of local officials by expanding the categories of persons authorized to administer vaccine. To access Minnesota Statutes section 144.4197 (2008) as amended by Minnesota Laws 2009, chapter 41, section 5, please click here. Texas Maine Insurance Commissioner, Health Insurance Emergency Planning & Procedures (Emergency Rule), (June 16, 2009). The State Bureau of Insurance issued an emergency preparedness rule "To ensure that all health insurance companies... are adequately prepared to deal with public health emergencies." Iowa The following draft order was provided by the Iowa Department of Public Health: Antiviral Shortage Order International Legal ActionsWorld Health Organization (WHO), Statement by WHO Director-General Dr. Margaret Chan, (April 25, 2009). The Director-General has determined that the outbreak of H1N1 Influenza constitutes a public health emergency of international concern, pursuant to the International Health Regulations. (posted 4/29/09) Australia Department of Health and Ageing, Australia Strengthens Border Surveillance for Swine Flu, (April 27, 2009). The Commonwealth Chief Medical Officer, Professor Jim Bishop, has authorized the strengthening of border surveillance at airports, including requiring the captains of all planes arriving from the Americas to report to the Australian Quarantine Inspection Service. (posted 4/29/09) Canada Public Health Agency of Canada, Government of Canada Provides Update on Prevention Measures Being Taken Regarding Human Swine Influenza, (April 28, 2009). This News Release details actions taken by the Canadian government, including activating the Government’s emergency Operations Centre. (posted 4/29/09) Costa Rica Presidente de la República Óscar Arias, Decretan Emergencia Sanitaria Nacional por Epidemia Humana de Fiebre Porcina, (April 28, 2009) (in Spanish). The President of the Republic of Costa Rica has declared a public health emergency. (posted 5/01/09) Mexico Presidente Felipe de Jesús Calderón Hinojosa, Decreto por el que se Ordenan Diversas Acciones en Materia de Salubridad General, para Prevenir, Controlar y Combatir la Existencia y Transmisión del Virus de Influenza Estacional Epidémica, (April 25, 2009) (in Spanish).. The President of Mexico has instructed the Ministry of Health to take action to control and combat H1N1 Influenza, including isolation of those identified as carrying the virus, and inspection of passengers. (posted 4/29/09) Secretario de Salud, José Ángel Córdova Villalobos, Suspensión de Clases en el Distrito Federal y el Estado de México por Influenza, (April 24, 2009)) (in Spanish). The Mexican Minister of Health has authorized the closure of schools in these jurisdictions. (posted 4/29/09) Secondary SourcesDavid Fidler, The Swine Flu Outbreak and International Law, 13 ASIL Insights (April 27, 2009). PresentationsU.S. Senate Committee on Homeland Security and Governmental Affairs held a hearing entitled “Swine Flu: Coordinating the Federal Response,” at 10:00 a.m. ET, on April 29, 2009, at the Dirksen Senate Office Building. A video archive of the hearing, featuring DHS Secretary Janet Napolitano and CDC Interim Deputy Director for Science and Public Health Program, Rear Admiral Anne Schuchat, is available at http://hsgac.senate.gov/public/index.cfm?Fuseaction=Hearings.Detail&HearingID=2a681099-9864-4f0d-b533-7dd2489f65ec. Disclaimer: Please note that this information is not legal advice. Any questions regarding the application of specific laws should be directed to your official legal counsel. Pandemic Influenza Legal Preparedness ToolsThe CDC Public Health Law Program recommends state, local, tribal, and territories consider implementing these tools to assess their legal preparedness for H1N1 and other influenza outbreaks.
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