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GAO Report 2009 Pandemic Legal Issues

GAO Report 2009 Pandemic Legal Issues

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Published by AxXiom
Released Sept 1, 2009

Introduction
On June 11, in response to the global spread of a new strain of influenza, the World Health Organization (WHO) raised the level of influenza pandemic alert to phase 6, the highest level, which indicates the start of an actual pandemic.1 This change in alert level reflects the spread of the new virus, not its severity. In late April 2009, human cases of infection with a novel influenza A(H1N1) virus were identified. Since then, the virus has become widespread. Although currently
the pandemic is of moderate severity with the majority of patients experiencing mild symptoms and making a rapid and full recovery, the virus and its effects may change over time.2 This report provides a brief overview of selected legal issues including emergency measures, civil rights, liability issues, and employment issues.
Released Sept 1, 2009

Introduction
On June 11, in response to the global spread of a new strain of influenza, the World Health Organization (WHO) raised the level of influenza pandemic alert to phase 6, the highest level, which indicates the start of an actual pandemic.1 This change in alert level reflects the spread of the new virus, not its severity. In late April 2009, human cases of infection with a novel influenza A(H1N1) virus were identified. Since then, the virus has become widespread. Although currently
the pandemic is of moderate severity with the majority of patients experiencing mild symptoms and making a rapid and full recovery, the virus and its effects may change over time.2 This report provides a brief overview of selected legal issues including emergency measures, civil rights, liability issues, and employment issues.

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Published by: AxXiom on Oct 26, 2009
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CRS Report for Congress
Prepared for Members and Committees of Congress
The 2009 Influenza Pandemic:Selected Legal Issues
Kathleen S. Swendiman, Coordinator
Legislative Attorney
Nancy Lee Jones, Coordinator
Legislative AttorneySeptember 1, 2009
Congressional Research Service
7-5700www.crs.govR40560
 
The 2009 Influenza Pandemic: Selected Legal IssuesCongressional Research Service
Summary
On June 11, in response to the global spread of a new strain of influenza, the World HealthOrganization (WHO) raised the level of influenza pandemic alert to phase 6, which indicates thestart of an actual pandemic. This change reflects the spread of the new influenza A(H1N1) virus,not its severity. Although currently the pandemic is of moderate severity with the majority of patients experiencing mild symptoms and making a rapid and full recovery, this experience couldchange. This report provides a brief overview of selected legal issues including emergencymeasures, civil rights, liability issues, and employment issues.There are a number of emergency measures which may help to contain or ameliorate an infectiousdisease outbreak. The Public Health Service Act, the Federal Food, Drug, and Cosmetic Act, andthe Stafford Act contain authorities that allow the Secretary of Health and Human Services or thePresident to take certain actions during emergencies or disasters. While the primary authority forquarantine and isolation in the United States resides at the state level, the federal government has jurisdiction over interstate and border quarantine. The federal government also issuesrecommendations regarding such activities as school closures and vaccination programs. Statesand local governments have the authority to initiate emergency measures such as mandatoryvaccination orders and certain nonpharmaceutical interventions such as school closures, whichmay lessen the spread of an infectious disease. The International Health Regulations adopted bythe WHO in 2005 provide a framework for international cooperation against infectious diseasethreats.The use of these emergency measures to contain the 2009 influenza pandemic may raise a classiccivil rights issue: to what extent can an individual’s liberty be curtailed to advance the commongood? The U.S. Constitution and federal civil rights laws provide for individual due process andequal protection rights as well as a right to privacy, but these rights are balanced against the needsof the community.Liability issues may become particularly important during the 2009 influenza pandemic. ThePublic Readiness and Emergency Preparedness Act limits liability with respect to the use of countermeasures for pandemic flu or other public health threats. A patchwork of federal and statelaws generally protect volunteers, which may include volunteer health professionals (VHPs),under certain circumstances. Laws also provide liability protections specifically for VHPs.Questions relating to employment are among the most significant issues presented by aninfluenza pandemic, since, if individuals fear losing their employment or their wages, compliancewith public health measures such as social distancing and isolation or quarantine may suffer. Itwould seem possible for a court to conclude that the isolation or quarantine of individuals duringa pandemic serves the public good and that the termination of individuals who are isolated orquarantined violates public policy. Employees may also have some job protection under theFamily and Medical Leave Act.
 
The 2009 Influenza Pandemic: Selected Legal IssuesCongressional Research Service
Contents
Introduction................................................................................................................................1
 
Emergency Measures..................................................................................................................1
 
Emergency Authorities..........................................................................................................1
 
Public Health Emergency Authorities..............................................................................1
 
Stafford Act Declarations................................................................................................3
 
Emergency Use Authorizations (for Unapproved Countermeasures)................................5
 
International Health Regulations (IHR).................................................................................6
 
Overview of the IHR.......................................................................................................6
 
Declaration of a “Public Health Emergency of International Concern”.............................7
 
Quarantine and Isolation Authority........................................................................................9
 
Federal Authorities..........................................................................................................9
 
Federal and State Coordination......................................................................................10
 
Proposed Federal Regulations.......................................................................................11
 
Border Entry Issues ............................................................................................................11
 
Inadmissibility of Infected Aliens..................................................................................11
 
Border Quarantines of Citizens or Aliens.......................................................................12
 
Closing the Border........................................................................................................12
 
Airlines and Travel Restrictions..........................................................................................13
 
Airline Corporate Policies.............................................................................................13
 
Public Health “Do Not Board” List...............................................................................14
 
Federal Airspace Authority............................................................................................14
 
School Closures..................................................................................................................15
 
Vaccinations..............................................................................................................................17
 
Background........................................................................................................................17
 
Allocation of Vaccines........................................................................................................18
 
Overview......................................................................................................................18
 
Selected Federal Actions Prior to 2009..........................................................................18
 
Federal Actions After Emergence of Influenza A(H1N1)...............................................19
 
Legal Issues..................................................................................................................20
 
Mandatory Vaccinations......................................................................................................21
 
History and Precedent...................................................................................................21
 
Health Care Workers and Mandatory Vaccinations........................................................22
 
Vaccination Orders During a Public Health Emergency.................................................23
 
Model State Emergency Health Powers Act...................................................................24
 
Role of the Federal Government....................................................................................25
 
Civil Rights...............................................................................................................................26
 
Introduction........................................................................................................................26
 
Constitutional Rights to Due Process and Equal Protection..................................................26
 
Federal Nondiscrimination Laws.........................................................................................28
 
Section 504 of the Rehabilitation Act............................................................................28
 
The Americans With Disabilities Act.............................................................................29
 
The Air Carrier Access Act............................................................................................30
 
Liability Issues..........................................................................................................................31
 
The Public Readiness and Emergency Preparedness Act (PREP Act)...................................31
 
Civil Liability of Volunteers and Volunteer Health Professionals..........................................32
 
Volunteer Protection Acts..............................................................................................32
 

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