Five Legal Preparedness Challenges for Responding to Future Public Health Emergencies

Author:

Courtney Brooke

Abstract

Since the anthrax attacks of 2001 and the severe acute respiratory syndrome (SARS) outbreak of 2003, significant efforts have been made to develop and revise a range of legal tools designed to strengthen public health emergency responses. The 2009 H1N1 pandemic provided an unprecedented opportunity to implement and exercise many of these mechanisms. At the global level, the World Health Organization (WHO) declared a public health emergency of international concern (PHEIC) pursuant to the revised International Health Regulations [IHR (2005)], and many governments declared national or regional emergencies. At the U.S. federal level, the Secretary of Health and Human Services (HHS) made public health emergency and Public Readiness and Emergency Preparedness (PREP) Act declarations. In addition, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) (to allow the emergency use of certain antiviral medications, diagnostic tests, and respirators during the pandemic), and President Obama declared a National Emergency (to authorize the use of temporary waivers or modifications of certain federal requirements related to health care facility responses). Select state and local governments also declared emergencies.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference25 articles.

1. The Emergency Use Authorization of Peramivir for Treatment of 2009 H1N1 Influenza

2. “Assessing the Legal Standard of Care in Public Health Emergencies,”;Fink;JAMA,2010

3. 14. See, e.g., The Centers for Law and the Public's Health and National Conference of Commissioners on Uniform State Laws, supra note 1.

4. 10. For example, in advance of emergencies, it could be helpful for local health departments to have some visibility into nearly-final versions of EUAs (sometimes referred to as “pre-EUAs”) to become familiar with their conditions, as well as have access to dosing and crushing instructions for pediatric formulations. During a sudden-onset emergency, because EUAs are not issued until an emergency occurs, a responding public health department in a city with millions of residents would be required to review and interpret the EUAs conditions at the time of the emergency. It may then, under a very compressed timeframe, have to print and distribute a sufficient number of fact sheets for the EUA product for the impacted population. See, e.g., Institute of Medicine and Starr, and Carr, , supra note 8.

5. 23. “New Orleans Hospital Settles Post-Katrina Wrongful Death Lawsuit,” Insurance Journal, January 28, 2010 available at (last visited December 8, 2010); see Barrow, , supra note 22.

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