# The 2009 Influenza Pandemic: Selected Legal Issues > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/crs%3AR40560 ## Record - **Collection:** Congressional research report - **Document type:** CRS Report - **Published:** October 29, 2009 - **Citation:** R40560 ## Text The 2009 Influenza Pandemic: Selected Legal Issues (name redacted), Coordinator Legislative Attorney (name redacted), Coordinator Legislative Attorney October 29, 2009 Congressional Research Service 7-.... www.crs.gov R40560 CRS Report for Congress Prepared for Members and Committees of Congress The 2009 Influenza Pandemic: Selected Legal Issues Summary 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, which indicates the start of an actual pandemic. This change reflected 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 could change. This report provides a brief overview of selected legal issues including emergency measures, civil rights, liability issues, and employment issues. There are a number of emergency measures which may help to contain or ameliorate an infectious disease outbreak. The Public Health Service Act, the Federal Food, Drug, and Cosmetic Act, the National Emergencies Act, and the Stafford Act contain authorities that allow the Secretary of Health and Human Services or the President to take certain actions during emergencies or disasters. While the primary authority for quarantine 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 issues recommendations regarding such activities as school closures and vaccination programs. States and local governments have the authority to initiate emergency measures such as mandatory vaccination orders and certain nonpharmaceutical interventions such as school closures, which may lessen the spread of an infectious disease. The International Health Regulations adopted by the WHO in 2005 provide a framework for international cooperation against infectious disease threats. The use of these emergency measures to contain the 2009 influenza pandemic may raise a classic civil rights issue: to what extent can an individual’s liberty be curtailed to advance the common good? The U.S. Constitution and federal civil rights laws provide for individual due process and equal protection rights as well as a right to privacy, but these rights are balanced against the needs of the community. Liability issues may become particularly important during the 2009 influenza pandemic. The Public 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 state laws 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 an influenza pandemic, since, if individuals fear losing their employment or their wages, compliance with public health measures such as social distancing and isolation or quarantine may suffer. It would seem possible for a court to conclude that the isolation or quarantine of individuals during a pandemic serves the public good and that the termination of individuals who are isolated or quarantined violates public policy. Employees may also have some job protection under the Family and Medical Leave Act. Congressional Research Service The 2009 Influenza Pandemic: Selected Legal Issues Contents Introduction ................................................................................................................................1 Emergency Measures ..................................................................................................................1 Emergency Authorities ..........................................................................................................1 Public Health Emergency Authorities ..............................................................................1 National Emergencies Act Declarations ...........................................................................2 Stafford Act Declarations ................................................................................................3 Section 1135 Waivers or Modifications ...........................................................................4 Emergency Use Authorizations (for Unapproved Countermeasures) ................................6 International Health Regulations (IHR) .................................................................................7 Overview of the IHR.......................................................................................................7 Declaration of a “Public Health Emergency of International Concern”.............................8 Quarantine and Isolation Authority...................................................................................... 10 Federal Authorities........................................................................................................ 10 Federal and State Coordination...................................................................................... 11 Proposed Federal Regulations ....................................................................................... 12 Border Entry Issues ............................................................................................................ 13 Inadmissibility of Infected Aliens .................................................................................. 13 Border Quarantines of Citizens or Aliens....................................................................... 13 Closing the Border ........................................................................................................ 14 Airlines and Travel Restrictions .......................................................................................... 14 Airline Corporate Policies ............................................................................................. 14 Public Health “Do Not Board” List ............................................................................... 15 Federal Airspace Authority............................................................................................ 15 School Closures .................................................................................................................. 16 Vaccinations.............................................................................................................................. 19 Background ........................................................................................................................ 19 Allocation of Vaccines ........................................................................................................ 20 Overview ...................................................................................................................... 20 Selected Federal Actions Prior to 2009 .......................................................................... 20 Federal Actions After Emergence of Influenza A(H1N1) ............................................... 21 Legal Issues .................................................................................................................. 23 Mandatory Vaccinations ...................................................................................................... 24 History and Precedent ................................................................................................... 24 Health Care Workers and Mandatory Vaccinations ........................................................ 25 Vaccination Orders During a Public Health Emergency ................................................. 26 Model State Emergency Health Powers Act................................................................... 27 Role of the Federal Government.................................................................................... 27 Civil Rights............................................................................................................................... 28 Introduction ........................................................................................................................ 28 Constitutional Rights to Due Process and Equal Protection.................................................. 29 Federal Nondiscrimination Laws......................................................................................... 31 Section 504 of the Rehabilitation Act ............................................................................ 31 The Americans With Disabilities Act (ADA) ................................................................. 32 The Air Carrier Access Act............................................................................................ 34 Liability Issues.......................................................................................................................... 35 The Public Readiness and Emergency Preparedness Act (PREP Act) ................................... 35 Congressional Research Service The 2009 Influenza Pandemic: Selected Legal Issues Civil Liability of Volunteers and Volunteer Health Professionals.......................................... 36 Volunteer Protection Acts .............................................................................................. 36 Liability Protection During a State of Emergency .......................................................... 37 Emergency Mutual Aid Agreements .............................................................................. 38 Employment Issues ................................................................................................................... 38 Introduction ........................................................................................................................ 38 Wrongful Discharge in Violation of Public Policy ............................................................... 40 The Family and Medical Leave Act ..................................................................................... 42 Overview of Family and Medical Leave Rights ............................................................. 42 State and Federal Laws Providing Employment Protections........................................... 44 Contacts Author Contact Information ...................................................................................................... 45 Congressional Research Service The 2009 Influenza Pandemic: Selected Legal Issues 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 reflected 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. Emergency Measures Emergency Authorities3 Public Health Emergency Authorities In response to public health threats, the Secretary of the Department of Health and Human Services (HHS) can provide a considerable degree of assistance to states through the Secretary’s general, non-emergency authorities. For example, upon the request of a state health official, and without the involvement of the President, the Centers for Disease Control and Prevention (CDC) can provide financial and technical assistance to states for outbreak investigation and disease control activities. These activities are carried out under the Secretary’s general authority to assist states at 42 U.S.C. §§ 243(c) and 247b. There are also a number of authorities in the Public Health Service (PHS) Act that allow the Secretary of HHS to take certain actions in the face of a “public health emergency.” The principal authority is in Section 319 of the PHS Act, 42 U.S.C. § 247d(a), which states that If the Secretary determines, after consultation with such public health officials as may be necessary, that—(1) a disease or disorder presents a public health emergency; or (2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2).4 1 Dr. Margaret Chan, Director-General of the World Health organization, “World Now at the Start of 2009 Influenza Pandemic,” http://www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html. 2 For information on the pandemic status and U.S. government actions, see http://www.cdc.gov/swineflu/, http://www.dhs.gov/xprepresp/programs/swine-flu.shtm, and http://www.flu.gov. See also CRS Report R40554, The 2009 Influenza Pandemic: An Overview, by (name redacted) and (name redacted). 3 This section was written by (name redacted) and (name redacted). 4 The Secretary is required to provide written notice of determinations under this section to Congress within 48 hours, but is not required to publish notice of such determinations in the Federal Register. 42 U.S.C. § 247d(a). Congressional Research Service 1 The 2009 Influenza Pandemic: Selected Legal Issues The then-Acting HHS Secretary issued a nationwide public health emergency declaration in response to human infections from the influenza A(H1N1) virus on April 26, 2009.5 Making such a determination enables the Secretary to take three types of actions that can be especially useful for dealing with an emerging influenza outbreak. First, such a determination authorizes the Secretary to draw from a special emergency fund. 6 Second, it is one of three events that can lead to the issuance of Emergency Use Authorizations under the Federal Food, Drug, and Cosmetic Act to allow for the use of unapproved medical treatments and tests, under specified conditions, if needed during an incident.7 Third, if there is a concurrent declaration pursuant to either the Stafford Act8 or the National Emergencies Act,9 the Secretary is authorized to waive or modify temporarily certain administrative requirements under Section 1135 of the Social Security Act, 10 as necessary to ensure that sufficient healthcare items and services are available to meet the needs of individuals enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP), and that providers of such services in good faith who are unable to comply with certain statutory requirements are exempted from sanctions for noncompliance, absent fraud or abuse. With respect to the 2009 influenza pandemic, and pursuant to the Secretary’s declaration of a public health emergency under Section 319 of the PHS Act, the Public Health Emergency Fund is available (but is currently unfunded);11 certain Emergency Use Authorizations have been granted by FDA;12 and, once the President declared a national emergency under the National Emergencies Act, the Secretary authorized waivers and modifications under Section 1135 of the Social Security Act.13 National Emergencies Act Declarations The National Emergencies Act (NEA)14 authorizes the President to declare a national emergency and activate existing statutory provisions that authorize the exercise of special or extraordinary power. The NEA does not provide any specific emergency authority on its own, but relies upon emergency authorities provided in other statutes. For example, a national emergency declaration under the NEA could authorize the Secretary of HHS to deploy officers in the Commissioned Corps of the Public Health Service to agencies outside of HHS in response to an urgent or emergency public health care need. Emergency statutory provisions are not activated automatically, but must be specifically identified in the President’s declaration before they may be given effect. 5 This determination, which would have expired after 90 days, was renewed by HHS Secretary Kathleen Sebelius on July 24 at http://www.hhs.gov/secretary/phe_swh1n1.html. It was again renewed on October 1, 2009, for an additional 90 days at http://www.flu.gov/professional/federal/h1n1emergency100109.html. 6 The Public Health Emergency Fund does not currently have any monies available. For more information, see CRS Report RL33579, The Public Health and Medical Response to Disasters: Federal Authority and Funding, by (name red acted). 7 See infra at “Emergency Use Authorizations (for Unapproved Countermeasures).” 8 42 U.S.C. § 5121 et seq. 9 50 U.S.C. § 1601 et seq. 10 42 U.S.C. § 1320b-5. 11 See supra note 6. 12 See infra at “Emergency Use Authorizations (for Unapproved Countermeasures).” 13 See infra at “National Emergencies Act Declarations” and “Section 1135 Waivers or Modifications.” 14 42 U.S.C. § 1601 et seq. For more information on the National Emergencies Act, and declarations made under it, see CRS Report 98-505, National Emergency Powers, by (name redacted). Congressional Research Service 2 The 2009 Influenza Pandemic: Selected Legal Issues President Barack Obama declared a state of national emergency pursuant to the National Emergencies Act on October 23, 2009.15 Specifically, the President proclaimed that because “the rapid increase in illness across the nation may overburden health care resources and ... the temporary waiver of certain standard Federal requirements may be warranted in order to enable U.S. health care facilities to implement emergency operations plans, the 2009 H1N1 influenza pandemic in the United States constitutes a national emergency.” The President further authorized the Secretary of HHS to “exercise the authority under section 1135 of the Social Security Act to temporarily waive or modify certain requirements of the Medicare, Medicaid, and State Children’s Health Insurance programs and of the Health Insurance Portability and Accountability Act Privacy Rule throughout the duration of the public health emergency declared in response to the 2009 H1N1 influenza pandemic.” Stafford Act Declarations A presidential declaration under the Stafford Act triggers federal emergency authorities that are independent of the Secretary’s public health emergency authorities. Declarations under the Stafford Act fall into two categories: emergency declarations and major disaster declarations. As of this point in time, there have been no Stafford Act declarations pertaining to the 2009 influenza pandemic. 16 A presidential emergency declaration under the Stafford Act authorizes the President to direct federal agencies to support state and local emergency assistance activities; coordinate disaster relief provided by federal and non-federal organizations; provide technical and advisory assistance to state and local governments; provide emergency assistance through federal agencies; remove debris through grants to state and local governments; provide assistance to individuals and households for temporary housing and uninsured personal needs; and assist state and local governments in the distribution of medicine, food, and consumables.17 The total amount of assistance available is limited in an emergency declaration to $5 million, “unless the President determines that there is a continuing need; Congress must be notified if the $5 million ceiling is breached.”18 Emergency declarations under the Stafford Act in the event of an outbreak of infectious disease are not unprecedented. In 2000, the detection of West Nile virus in New York and New Jersey 15 The text of the President’s Proclamation, “Declaration of a National Emergency with Respect to the 2009 H1N1 Influenza Pandemic” may be viewed at http://www.whitehouse.gov/the-press-office/declaration-a-national-emergencywith-respect-2009-h1n1-influenza-pandemic-0. 16 Whether a Stafford Act declaration is appropriate for a pandemic incident may be the subject of some debate. Compare Kevin Robillard, Officials Say Swine Flu Vaccine is Coming, CQ HOMELAND SECURITY, July 9, 2009 (quoting DHS Secretary Janet Napolitano as observing that “the [Stafford] act and the flu do not match up well.”) with Comments of DHS Deputy Secretary Jane Holl Lute, U.S. Congress, House Committee on Homeland Security, Beyond Readiness: An Examination of the Current Status and Future Outlook of the National Response to Pandemic Influenza, 111th Cong., 1st sess., July 29, 2009 (indicating that DHS has planned for contingencies in which the Stafford Act is invoked in response to a pandemic). 17 42 U.S.C. § 5192. Although there are currently significant stockpiles of antiviral medications, if there are large numbers of individuals infected with H1N1, the demand for antivirals, potential vaccines, and other medical supplies such as ventilators may exceed the supply. This potential imbalance has led to recommendations for priorities for medical resources for certain categories of individuals. For a discussion of these recommendations see CRS Report RL33381, The Americans with Disabilities Act (ADA): Allocation of Scarce Medical Resources During a Pandemic, by (name redacted). 18 42 U.S.C. § 5193(b). See also CRS Report RL33053, Federal Stafford Act Disaster Assistance: Presidential Declarations, Eligible Activities, and Funding, by (name redacted), at 13-15. Congressional Research Service 3 The 2009 Influenza Pandemic: Selected Legal Issues 19 was used as the basis of an emergency declaration under the Stafford Act. However, there may be uncertainty regarding whether a flu pandemic, or any outbreak of infectious disease, would be eligible for major disaster assistance under the Stafford Act. 20 A major disaster declaration authorizes the President to offer all the assistance authorized under an emergency declaration, and further authorizes funds for the repair and restoration of federal facilities, unemployment assistance, emergency grants to assist low-income migrant and seasonal farm workers, food coupons and distribution, relocation assistance, crisis counseling assistance and training, community disaster loans, emergency communications, and emergency public transportation.21 Additionally, the total amount of assistance provided in a major disaster declaration is not subject to a ceiling in the same way as under an emergency declaration. The authority of the President to declare a major disaster under the Stafford Act in response to a flu pandemic may be subject to some debate and likely depends upon whether a flu pandemic would qualify as a “natural catastrophe” under the Stafford Act. FEMA has historically excluded biological incidents from major disaster declarations under the Stafford Act, but executive policy under the Bush administration appeared to consider biological incidents, or at least flu pandemics, 22 to be eligible for major disaster assistance. Although there are differences between the types and amounts of assistance that are authorized by an emergency or major disaster declaration, either declaration would activate the Secretary’s waiver or modification authority,23 if concurrent with a public health emergency declaration. There have been no declarations issued under the Stafford Act with respect to the current pandemic. Section 1135 Waivers or Modifications Section 1135 of the Social Security Act was added by Section 143 of P.L. 107-188, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, to authorize the HHS Secretary to waive certain regulatory requirements related to the provision of health care services when the President has declared an emergency or major disaster pursuant to either the NEA or the Stafford Act, and the Secretary of HHS has declared a public health emergency. Waivers under Section 1135 involve administrative requirements principally relating to reimbursement through the Medicare and Medicaid programs, in order to facilitate the provision of health care items and services by providers in an emergency area subject to the concurrent declarations.24 An emergency area and an emergency period are defined in Section 1135 as the geographic area in 19 CRS Report RL33579, The Public Health and Medical Response to Disasters: Federal Authority and Funding, by (name redacted), at n.11 and accompanying text; and 65 Fed. Reg. 63589, 67747. 20 See CRS Report RL33579, The Public Health and Medical Response to Disasters: Federal Authority and Funding, by (name redacted), at 10-11. For a more detailed discussionsee CRS Report RL34724, Would an Influenza Pandemic Qualify as a Major Disaster Under the Stafford Act?, by (name redacted). 21 42 U.S.C. §§ 5172-5187. 22 HOMELAND SECURITY COUNCIL, Implementation Plan for the National Strategy for Pandemic Influenza, at http://www.whitehouse.gov/homeland/nspi_implementation.pdf. This document “describes more than 300 critical actions, many of which have already been initiated, to address the threat of pandemic influenza.” See, also, CRS Report RL34724, Would an Influenza Pandemic Qualify as a Major Disaster Under the Stafford Act?, by (name redacted). 23 See infra at “Section 1135 Waivers or Modifications.” 24 42 U.S.C. § 1320b-5(b). Congressional Research Service 4 The 2009 Influenza Pandemic: Selected Legal Issues which and time period during which there exists an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Stafford Act concurrently with a public health emergency declared by the Secretary pursuant to Section 319 of the PHS Act.25 If Section 1135 conditions are met, then health care facilities may ask the Secretary for “1135 waivers” in response to particular needs within the geographic and temporal areas of the emergency declarations. Generally, these waivers and modifications may assist patients who must be relocated due to the inaccessibility of health care facilities in the emergency area, allow beneficiaries to receive services despite having lost their documentation of eligibility, and allow providers to provide services in alternate temporary facilities. Specifically, the Secretary may take some or all of the following actions: • waive conditions of participation, certification requirements, program participation, and pre-approval requirements under Medicare, Medicaid, or the Children’s Health Insurance Program;26 • permit health care providers to provide care under Medicare, Medicaid, or the Children’s Health Insurance Program, even if they are not licensed by the state with jurisdiction over the emergency area;27 • waive sanctions under the Emergency Medical Treatment and Active Labor Act (EMTALA) for certain transfers or redirections of patients away from hospital emergency rooms;28 • waive sanctions for violations of the Stark law, which prohibits certain selfreferrals by physicians;29 • extend deadlines and other timetables for required activities;30 • waive limitations on payments under Medicare Advantage for care and services provided by out-of-network providers;31 or • waive sanctions and penalties for violations of the HIPAA Privacy Rule such as the use of protected health information for hospital directories, the disclosure of protected health information to patients’ families and friends, the distribution of health care providers’ and insurers’ privacy policies to patients, and individuals’ rights to request restrictions, privacy restrictions, or confidential communications.32 25 Section 1135(g), 42 U.S.C. §1320b-5(g). 42 U.S.C. § 1320b-5(b)(1). 27 42 U.S.C. § 1320b-5(b)(2). Providers must have equivalent licensing in another state and must not be affirmatively excluded from practicing in the emergency area. 28 42 U.S.C. § 1320b-5(b)(3). In the event of a pandemic infectious disease, patients can be relocated pursuant to a state’s pandemic preparedness plan, if one exists. 42 U.S.C. § 1320b-5(b)(3)(B)(ii). For more information on EMTALA’s requirements, see CRS Report RS22738, EMTALA: Access to Emergency Medical Care, by (name reda cted). 29 42 U.S.C. § 1320b-5(b)(4). For more information on the Stark law, see CRS Report RS22743, Health Care Fraud and Abuse Laws Covering Medicare and Medicaid: An Overview, by Jennifer Staman, at 3-5. 30 42 U.S.C. § 1320b-5(b)(5). 31 42 U.S.C. § 1320b-5(b)(6). 32 42 U.S.C. § 1320b-5(b)(7). For more information on HIPAA enforcement, see CRS Report RL33989, Enforcement of the HIPAA Privacy and Security Rules, by (name redacted). 26 Congressional Research Service 5 The 2009 Influenza Pandemic: Selected Legal Issues These waivers and modifications may be retroactively applied by the Secretary to the beginning of the period during which the concurrent declarations were in effect, and will generally remain in effect until the underlying emergency declarations end, or 60 days have elapsed since the date on which notice of the waivers or modifications was published.33 On October 27, 2009, HHS Secretary Sebelius invoked Section 1135 to waive or modify the provisions described above, but only to the extent determined necessary or appropriate by the Centers for Medicare and Medicaid Services. 34 The invocation of Section 1135 covers the period from October 23, 2009, until expressly revoked, or such time as either the NEA declaration or the PHE declaration is terminated. The one exception to this general rule is the waiver of HIPAA privacy provisions, which is limited to those hospitals that have disaster protocols in operation, and will only apply during the 72 hours following a hospital’s implementation of its disaster protocol. Emergency Use Authorizations (for Unapproved Countermeasures) Under Section 564 of the Federal Food, Drug, and Cosmetic Act (FFDCA), the Secretary may declare that an emergency exists which justifies the expedited use of certain medical countermeasures (1) on the basis of a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency; (2) on the basis of a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency; or (3) on the basis of a “determination by the Secretary [of HHS] of a public health emergency under Section 247d of Title 42 that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents.” Although a declaration under Section 564 of the FFDCA may be based on the declaration of a public health emergency under Section 319 of the PHSA, the two are distinct. An FFDCA emergency declaration lasts up to a year, but can be renewed. 35 Upon a declaration under Section 564, the FDA commissioner may authorize the emergency use of a drug, device, or biological product during the effective period of the declaration. 36 An Emergency Use Authorization (EUA) may apply to a product that is not currently approved for commercial use by the Food and Drug Administration (FDA).37 Alternatively, the subject of an EUA may already be an FDA-approved product, but the emergency use justifying the EUA may be one that is not presently approved by the FDA. 38 For example, a drug may be approved for use in the adult population but not for use in children, in which case an EUA may sanction its use by 33 42 U.S.C. § 1320b-5(e)(1). The Secretary may extend the effect of any waivers or modifications in 60-day increments. 42 U.S.C. § 1320b-5(e)(2). 34 HHS Secretary, “Waiver or Modification of Requirements Under Section 1135 of the Social Security Act,” Oct. 27, 2009, available at http://www.flu.gov/professional/federal/h1n1_1135waiver_10272009.html. 35 21 U.S.C. § 360bbb-3(b)(2). The HHS Secretary must publish “each declaration, determination, advance notice of termination, and renewal” in the Federal Register. 21 U.S.C. § 360bbb-3(b)(4). 36 21 U.S.C. § 360bbb-3(a)(1). The authority to issue EUAs statutorily resides with the HHS Secretary, but has been administratively delegated to the FDA commissioner. See 21 U.S.C. § 393(d)(2) and FDA, Staff Manual Guide 1410.10. 37 21 U.S.C. § 360bbb-3(a)(2)(A). 38 21 U.S.C. § 360bbb-3(a)(2)(B). Congressional Research Service 6 The 2009 Influenza Pandemic: Selected Legal Issues children. A drug may also be approved only for a specific disease, in which case an EUA may permit the drug’s use for treating different conditions. The issuance of an EUA must also be supported by a number of findings.39 First, the FDA commissioner must conclude that the underlying agent for which the emergency declaration was made can cause a serious or life-threatening disease or condition. Second, the commissioner must conclude, based on available scientific evidence, that (1) it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the disease or condition or that the product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a product authorized for emergency use40 and (2) it is reasonable to believe that the known and potential benefits of the product outweigh its known and potential risks. Third, the commissioner must conclude that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition. Finally, the commissioner must conclude that any other criteria for EUAs, which are prescribed in regulation, are met. On April 27, 2009, the FDA issued four Emergency Use Authorizations in response to requests from the CDC to make available certain drugs, diagnostic tests, and respiratory protection devices for the response to the H1N1 influenza outbreak. 41 In July of 2009, emergency use of a second unapproved diagnostic test was authorized,42 in August of 2009, the FDA authorized the emergency use of an H1N1 diagnostic test “to detect the virus in [American] troops serving overseas,” and on October 23, 2009, the FDA authorized the emergency use of intravenous antiviral Peramivir for H1N1 influenza for certain patients and in certain settings. 43 International Health Regulations (IHR)44 Overview of the IHR In May 2005, the World Health Assembly adopted a revision of its 1969 International Health Regulations, giving a new mandate to the World Health Organization (WHO) and member states to increase their respective roles and responsibilities for the protection of international public health.45 The IHR(1969) had focused on just three diseases (cholera, plague, and yellow fever). In 39 21 U.S.C. § 360bbb-3(c). In making these findings, the commissioner must consult with the directors of the National Institutes of Health and the Centers for Disease Control and Prevention prior to issuing the EUA. 40 For example, Vaccinia Immune Globulin (VIG) may be used to treat complications that result from smallpox vaccinations. See CDC, Smallpox Vaccination – Vaccine Immune Globulin, available at http://www.bt.cdc.gov/training/ smallpoxvaccine/reactions/vig.html. 41 See statement of Joshua M. Sharfstein, Acting Commissioner, FDA, before the Committee on Energy and Commerce, Subcommittee on Health, April 30, 2009, 111th Cong., 1st sess. Washington, D.C. See also the CDC’s website at http://www.cdc.gov/h1n1flu/eua/. 42 See FDA, “FDA Authorizes Emergency Use of Another Test for 2009 H1N1 Influenza Virus,” press release, July 24, 2009, http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm. 43 FDA, “FDA Authorizes Emergency Use of H1N1 Test for U.S. Troops Serving Overseas,” press release, Aug. 25, 2009, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm180153.htm. See also the FDA press release regarding Peramivir at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187813.htm. 44 This section was written by (name redacted), Legislative Attorney. 45 Fifty-eighth World Health Assembly, agenda item 13.1, Revision of the International Health Regulations, May 23, 2005, at http://www.who.int/csr/ihr/en/. Congressional Research Service 7 The 2009 Influenza Pandemic: Selected Legal Issues addition, compliance of State Parties46 with the IHR(1969) was uneven, a result of, among other things, resource limitations in poorer countries, and political factors, such as the reluctance to announce the presence of a contagious disease within one’s borders and face economic and other consequences.47 The IHR(2005), which entered into force in June 2007, have broadened the scope of the 1969 regulations by addressing existing, new, and re-emergent diseases, as well as emergencies caused by non-infectious disease agents.48 The IHR(2005) also include provisions regarding designated national points of contact, definitions of core public health capacities, disease control measures such as quarantine and border controls, and others. The IHR(2005) require WHO to recommend, and State Parties to use, control measures that are no more restrictive than necessary to achieve the desired level of health protection. The IHR were agreed upon by a consensus process among the member states, and represent a balance between sovereign rights and a commitment to work together to prevent the international spread of disease. The IHR(2005) are binding on all WHO member states as of June 15, 2007, except for those that have rejected the regulations or submitted reservations.49 While the IHR(2005) contain mechanisms such as negotiation and arbitration to assist States Parties in reaching mutually acceptable solutions where disputes arise, ultimately IHR(2005) do not provide an enforcement mechanism to compel compliance with WHO provisions.50 The United States accepted the IHR(2005) with three reservations, including the reservation that it will implement the IHR(2005) in line with U.S. principles of federalism. 51 Within five years of the entry into force date, State Parties must complete development of public health infrastructure that ensures full compliance with the regulations. Declaration of a “Public Health Emergency of International Concern” On April 25, 2009, WHO Director-General Dr. Margaret Chan, upon the advice of the Emergency Committee, declared that the influenza A(H1N1) virus outbreak constituted a “Public Health Emergency of International Concern” under the IHR(2005).52 This influenza outbreak marked the first time under the IHR(2005) that the Director-General convened the Emergency Committee and determined that a “Public Health Emergency of International Concern” existed. Article 12(1) of the IHR(2005) authorizes the WHO Director-General to make such a declaration, and Article 1 of the IHR(2005) defines a “Public Health Emergency of International Concern” as “an extraordinary event which is determined ... (i) to constitute a public health risk to other States through the international spread of disease and (ii) to potentially require a coordinated international response.” 46 “State Party” is the name for WHO member states that have agreed to be bound by the IHR. M.G. Baker and D.P. Fidler, “Global Public Health Surveillance under New International Health Regulations,” Emerging Infectious Diseases, vol. 12, no. 7, July 2006, at http://www.cdc.gov/ncidod/EID/vol12no07/05-1497.htm. 48 The full text of the IHR 2005 may be found at http://www.who.int/csr/ihr/IHR_2005_en.pdf. 49 IHR(2005), Article 59.2. 50 IHR, Article 56. 47 51 HHS Secretary Michael Leavitt announced the acceptance of the IHR(2005) by the United States on December 13, 2006. See News Release at http://www.pandemicflu.gov/plan/federal/index.html. 52 WHO, Statement by the WHO Director-General on Influenza A (H1N1), April 25, 2009, available at http://www.who.int/mediacentre/news/statements/2009/h1n1_20090425/en/index.html. Congressional Research Service 8 The 2009 Influenza Pandemic: Selected Legal Issues WHO Recommendations Under the IHR(2005), if the WHO Director-General declares a “Public Health Emergency of International Concern,” then the Director-General must issue temporary recommendations which will depend upon the nature of the threat (Article 15(1)). The IHR(2005) do not preclude State Parties from implementing measures that achieve a greater level of health protection than WHO temporary recommendations, provided that such measures are (1) otherwise consistent with the IHR(2005), and (2) not more restrictive of international trade and travel, and not more invasive or intrusive to persons, than reasonably available alternatives that would achieve the appropriate level of health protection (Article 43(1)). Following the declaration of a “Public Health Emergency of International Concern” on April 25, 2009, the Director-General recommended that “all countries should intensify surveillance for unusual outbreaks of influenza-like illness and severe pneumonia.”53 The Director-General, however, did not recommend any travel or trade restrictions. On June 11, 2009, the WHO Director-General announced that the scientific criteria for an influenza pandemic had been met with regard to the influenza A(H1N1) virus, so that the WHO pandemic alert level was raised from 5 to 6.54 Again, no travel, border closures, or trade restrictions were recommended. International Response to WHO Recommendations The WHO advised that travel restrictions would have “very little effect on stopping the virus from spreading, but would be highly disruptive to the travel community.”55 Despite this recommendation, some countries, such as China and several South American countries, implemented outright travel bans to or from Mexico. Other countries interrupted sales of pork products from the United States, disregarding a WHO determination, confirmed by scientists, that cooked pork does not transmit the virus.56 According to the IHR(2005), State Parties may apply measures that affect travel, even if not recommended by the Director-General.57 However, such measures must be no more restrictive of travel, or more intrusive to persons, than reasonably available alternatives that would achieve the appropriate level of health protection. Thus, State Parties are not supposed to bar the entry of a conveyance for public health reasons, but rather are to manage a public health threat through isolation, quarantine, disinfection, or other such applicable methods.58 If a State Party implements additional health measures significantly interfering with international traffic, the public health 53 Id. Dr. Margaret Chan, Director-General of the World Health organization, “World Now at the Start of 2009 Influenza Pandemic,” http://www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html. 55 WHO, Epidemic and pandemic alert and response (EPR)/ Travel: is it safe to travel? Available at http://www.who.int/csr/disease/swineflu/frequently_asked_questions/travel/en/index.html. See also CRS Report R40588, The 2009 Influenza Pandemic: U.S. Responses to Global Human Cases , by (name redacted). 56 Rebecca Katz, “Use of Revised International Health Regulations During Influenza A(H1N1) Epidemic, 2009,” 15 EMERG INFECT DIS. 1165-1170 (August 2009). 57 IHR, Article 42, “Additional Health Measures.” In addition, despite scientific evidence that eating pork does not cause influenza, a number of countries banned pork products. See CRS Report R40575, Potential Farm Sector Effects of 2009 H1N1 “Swine Flu”: Questions and Answers, by (name redacted), for a discussion of international responses to restrictions on pork products following the influenza A(H1N1) outbreak. 58 IHR, Article 28.1, “Ships and aircraft at points of entry.” 54 Congressional Research Service 9 The 2009 Influenza Pandemic: Selected Legal Issues rationale and relevant scientific information for the measures must be provided to WHO. The WHO will then share the information with State Parties and institute procedures to find a mutually acceptable solution.59 Ultimately, however, the IHR(2005) do not provide an enforcement mechanism to compel compliance with WHO recommendations.60 Quarantine and Isolation Authority61 Federal Authorities Although the terms are often used interchangeably, quarantine and isolation are two distinct concepts. Quarantine typically refers to the “(s)eparation of individuals who have been exposed to an infection but are not yet ill from others who have not been exposed to the transmissible infection.”62 Isolation refers to the “(s)eparation of infected individuals from those who are not infected.”63 Primary quarantine authority typically resides with state health departments and health officials; however, the federal government has jurisdiction over interstate and border quarantine. Federal quarantine and isolation authority may be found in Section 361 of the Public Health Service Act, 42 U.S.C. § 264, wherein Congress has given the Secretary of HHS the authority to make and enforce regulations necessary “to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.”64 While also providing the Secretary with broad authority to apprehend, detain, or conditionally release a person, the law limits the Secretary’s authority to the communicable diseases published in an Executive Order of the President. 65 Executive Order 13295 lists the communicable diseases for which this quarantine authority may be exercised, and specifically includes influenza viruses which have the potential to cause a pandemic. 66 In 2000, the Secretary of HHS transferred certain authorities, including interstate 59 IHR, Article 43, “Additional Health Measures.” While the IHR(2005) do not include an enforcement mechanism for State Parties that fail to comply with their provisions, the WHO considers the potential consequences of noncompliance within the global community, especially in economic terms, to be a powerful compliance tool. The IHR(2005) (Article 56) contain a dispute settlement mechanism to resolve conflicts which may arise among State Parties when applying or interpreting the regulations, including options such as negotiation, mediation, conciliation, or arbitration, or referral to the Director-General of WHO, if agreed to by all the parties to the dispute. 60 Lawrence O. Gostin, “Influenza A(H1N1) and Pandemic Preparedness Under the Rule of International Law,” 301 JAMA 2376-2378 (June 10, 2009). 61 This section was written by (name redacted), Legislative Attorney. For a detailed discussion of quarantine and isolation, see CRS Report RL33201, Federal and State Quarantine and Isolation Authority, by (name redact ed) and (name redacted). 62 Homeland Security Council, National Strategy for Pandemic Influenza: Implementation Plan (GPO May 2006). For a discussion of the history of quarantines in the United States see Felice Batlan, “Law in the Time of Cholera: Disease, State Power, and Quarantines Past and Future,” 80 TEMP. L. REV. 53 (2007). 63 Homeland Security Council, National Strategy for Pandemic Influenza: Implementation Plan (GPO May 2006). 64 42 U.S.C. § 264(a). Violation of federal quarantine and isolation regulations is a criminal misdemeanor, punishable by fine and/or imprisonment, 42 U.S.C. § 271. 65 42 U.S.C. § 264(b). 66 See also E.O. 13375, April, 2005, which amended E.O. 13295. The diseases listed are cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, severe acute respiratory syndrome (SARS), and influenza viruses which have the potential to cause a pandemic. Other new threats would have to be added to E.O. 13295 in order to be “quarantinable diseases.” Congressional Research Service 10 The 2009 Influenza Pandemic: Selected Legal Issues quarantine authority, to the Director of the CDC.67 Both interstate and foreign quarantine measures are now carried out by CDC’s Division of Global Migration and Quarantine. 68 HHS also works closely with the Department of Homeland Security (DHS) and its agencies. HHS and DHS signed a memorandum of understanding in 2005 that sets forth specific cooperation mechanisms to implement their respective statutory responsibilities for quarantine and other public health measures.69 DHS has three agencies that may aid CDC in its enforcement of quarantine rules and regulations pursuant to 42 U.S.C. § 268(b). They are U.S. Customs and Border Protection, U.S. Immigration and Customs Enforcement, and the United States Coast Guard. In addition to DHS, CDC may also rely on other federal law enforcement agencies and state and local law enforcement agencies. Federal and State Coordination While the federal government has authority to authorize quarantine and isolation under certain circumstances, it should be noted that the primary authority for quarantine and isolation exists at the state level as an exercise of the state’s police power. States conduct these activities in accordance with their particular laws and policies. 70 CDC acknowledges this deference to state authority as follows: In general, CDC defers to the state and local health authorities in their primary use of their own separate quarantine powers. Based upon long experience and collaborative working relationships with our state and local partners, CDC continues to anticipate the need to use this federal authority to quarantine an exposed person only in rare situations, such as events at ports of entry or in similar time-sensitive settings.71 Section 311 of the PHS Act72 provides for federal-state cooperative activities to enforce quarantines. The federal government may help states and localities enforce their quarantines and 67 42 C.F.R. Part 70. Regulations regarding quarantine upon entry into the United States from foreign countries are also administered by the CDC, see 42 C.F.R. Part 71. 68 See CDC Division of Global Migration and Quarantine home page at http://www.cdc.gov/ncidod/dq/index.htm. 69 http://www.dhs.gov/xnews/testimony/testimony_1181229544211.shtm. 70 A new development in the law relating to quarantine is the possible use of self-imposed or home quarantines. States may need to consider whether their ability to impose quarantine also includes the authorities necessary to support a population asked to voluntarily stay at home for a period of time. Federal and state authorities generally provide for the care of persons mandatorily quarantined, but voluntary home-quarantine situations may pose new issues. See Steven D. Gravely, et al., Emergency Preparedness and Response: Legal Issues in a Changing World, 17 THE HEALTH LAWYER 1 (June 2005). 71 Q&A on Executive Order 13295, available at http://www.cdc.gov/ncidod/dq/ qa_influenza_amendment_to_eo_13295.htm. The complexities of this shared power have been noted. One analysis observed that “When it comes to the exercise of isolation and quarantine powers, reality tends to be messier than the conceptual realm. Public health officials need clear lines of authority in emergency situations, often the moments when isolation and quarantine might be required. Unfortunately, confusion about which level of government should take the lead often occurs, thus revealing the ability of quarantine powers to spotlight difficulties federalism poses for public health.” David P. Fidler, Lawrence O. Gostin, and Howard Markel, “Through the Quarantine Looking Glass: DrugResistant Tuberculosis and Public Health Governance, Law and Ethics,” 35 J. OF LAW, MEDICINE & ETHICS 616 (2007). Another commentator has noted that “Given the variation in due process rights in connection with quarantine, which may be afforded under federal and state law, one can foresee the possibility of considerable conflict.” Felice Batlan, “Law in the Time of Cholera: Disease, State Power, and Quarantines Past and Future,” 80 TEMP. L. REV. 53, 119 (2007). 72 42 U.S.C. § 243. Congressional Research Service 11 The 2009 Influenza Pandemic: Selected Legal Issues other health regulations and, in turn, may accept state and local assistance in enforcing federal quarantines. The federal government may also assist with or take over the management of an intrastate incident if requested by a state or if the federal government determines local efforts are inadequate. 73 Under the authority of 42 U.S.C. § 97, the Secretary of HHS may request the aid of U.S. Customs and Border Protection, Coast Guard, and military officers in the execution of quarantines imposed by states on vessels coming into ports. Proposed Federal Regulations The CDC, on November 22, 2005, announced proposed changes to its quarantine regulations at 42 C.F.R. Parts 70 and 71.74 These proposed regulations have not been finalized, but Congress subsequently mandated that they be promulgated by June 10, 2009.75 These changes will constitute the first significant revision of the regulations in Parts 70 and 71 in 25 years. The proposed changes are an outgrowth of the CDC’s experience during the spread of Severe Acute Respiratory Syndrome (SARS) in 2003, when the agency experienced difficulties locating and contacting airline passengers who might have been exposed to SARS during their travels. In announcing the proposed regulations, then CDC Director Julie Gerberding said, “[t]hese updated regulations are necessary to expedite and improve CDC operations by facilitating contact tracing and prompting immediate medical follow up of potentially infected passengers and their contacts.”76 The proposed regulations would expand reporting requirements for ill passengers77 on board flights and ships arriving from foreign countries. They would also require airlines and ocean liners to maintain passenger and crew lists with detailed contact information and to submit these lists electronically to CDC upon request.78 The lists would be used to notify passengers of their suspected exposure if a sick person were not identified until after the travelers had dispersed from an arriving carrier. The proposed regulations address the due process rights of passengers who might be subjected to quarantine after suspected exposure to disease; the regulations also provide for an appeal process. 79 73 42 U.S.C. § 264 (c) and 42 C.F.R. § 70.2. See 70 Fed. Reg. 71892 (November 30, 2005), http://www.cdc.gov/ncidod/dq/nprm/. These proposed regulations were available for a 60-day comment period, which was extended for an additional 30 days, closing on March 1, 2006. See 71 Fed. Reg. 4544 (January 27, 2006), proposed Section 70.20 and 71.23 of 42 C.F.R. 75 Section 121(c) of P.L. 110-392 states: “Not later than 240 days after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate regulations to update the current interstate and foreign quarantine regulations found in parts 70 and 71 of Title 42, Code of Federal Regulations.” 76 “CDC Proposes Modernizing Control of Communicable Disease Regulation, USA,” Medical News Today, November 23, 2005, at http://www.medicalnewstoday.com/medicalnews.php?newsid=34042. Since the SARS outbreak, the CDC has increased its quarantine stations nationwide from 8 to 20. See http://www.cdc.gov/ncidod/dq/ index.htm. 77 The definition of ill person would be expanded to include anyone who has a fever of at least 100.4 degrees plus one of the following: severe bleeding, jaundice, or severe, persistent cough accompanied by bloody sputum, or respiratory distress. (Section 70.1 of proposed regulations). 74 78 Id. The lists, in electronic format, would have to be kept for 60 days after arrival, and be able to be submitted within 12 hours of a CDC request. The lists would include names, contact information and seat assignments. 79 Proposed section 70.20 and 71.23 of 42 CFR. Congressional Research Service 12 The 2009 Influenza Pandemic: Selected Legal Issues Border Entry Issues 80 Inadmissibility of Infected Aliens Those most easily excluded from the United States are aliens already infected with the influenza A(H1N1) virus. The Immigration and Nationality Act (INA) specifically bars aliens who are determined to have “a communicable disease of public health significance,” from receiving visas and admission into the United States.81 “A communicable disease of public health significance” is defined by the Secretary of Health and Human Services by regulation.82 Although the regulatory definition does not specifically include influenza A(H1N1), it does include, by reference, communicable diseases as listed in a Presidential Executive Order issued pursuant to section 361(b) of the Public Health Service Act.83 The relevant order, Executive Order 13295, as amended by Executive Order 13375, specifies “[i]nfluenza caused by novel or reemergent influenza viruses that are causing, or have the potential to cause, a pandemic” as a communicable disease for purposes of section 361(b). 84 Thus, for purposes of the INA, the influenza A(H1N1) virus is a ground for inadmissibility into the United States. Of course, this law only applies to aliens, not citizens, and prior to inadmissibility being triggered, the alien must be diagnosed with the influenza A(H1N1) virus.85 These considerations could therefore prevent this provision from being the most effective means to interdict individuals infected with the influenza A(H1N1) virus from entering the country. Border Quarantines of Citizens or Aliens There are currently no legal provisions that can exclude American citizens from the United States solely because of an infection with a communicable disease. The primary means to prevent infected citizens from introducing these diseases into the United States is to place them into quarantine or isolation at the border rather than deny them entry outright. As noted above, the Secretary has the authority to promulgate regulations to prevent the entry and spread of communicable diseases from foreign countries into the United States. The implementing regulations at 42 C.F.R. Part 71 specify that when there is reason to believe an arriving person is infected with “any communicable disease listed in an Executive Order, as provided under section 361(b) of the Public Service Act,” the person may be isolated, quarantined, or placed under surveillance or disinfected if deemed necessary to prevent the introduction of the communicable disease. 86 “Influenza caused by novel or reemergent influenza viruses that are causing, or have the potential to cause, a pandemic” is one such disease that can warrant quarantine. 87 80 This section was written by Yule Kim, Legislative Attorney. INA § 212(a)(1), 8 U.S.C. §1182(a)(1) (Any alien who is determined (in accordance with regulations prescribed by the Secretary of Health and Human Services) to have a communicable disease of public health significance…is inadmissible). 82 42 C.F.R. § 34.2(b). 83 42 U.S.C. § 264. 84 Exec. Order No. 13295, 68 FR 17255 (April 4, 2003) as amended by Exec. Order. No. 13375, 70 FR 17299 (April 1, 2005). 85 As a practical matter, there is not currently a real-time test that could be used to determine whether an apparently ill person is infected with this virus. Tests currently available require a day or more to perform. 81 86 42 C.F.R. § 71.32. Exec. Order No. 13295, 68 FR 17255 (April 4, 2003) as amended by Exec. Order. No. 13375, 70 FR 17299 (April 1, (continued...) 87 Congressional Research Service 13 The 2009 Influenza Pandemic: Selected Legal Issues Closing the Border The most drastic measure discussed so far is “to close the borders.” Presumably, this would entail a blanket bar on all aliens and citizens seeking entry into the United States regardless of their health. There appear to be no laws specifically authorizing an executive agency to take such action. However, Congress could presumably enact a law to do so, at least with regard to aliens, because the Supreme Court has long recognized “the power to expel or exclude aliens as a fundamental sovereign attribute that is largely immune from judicial control. 88 However, United States citizens cannot be barred from entering the United States.89 Thus, if Congress were to theoretically “close the borders,” it could do so only by excluding aliens. In the absence of an act of Congress, it may be possible for the President to “close the borders” to aliens by Executive Order. However, this course of action appears to be fraught with legal and practical challenges, which would likely result in extensive litigation. Because Congress has not given the President authority to conduct blanket closings of borders, it would appear that the President could do so only if the exclusion power is one where he has concurrent authority with Congress.90 Although this exclusion power is characterized as a power “exercised by the Government’s political departments largely immune from judicial control,”91 the President appears to have rarely exercised any authority within this realm outside of the authority expressly delegated by an act of Congress. Considering the rather extensive inadmissibility regime codified within the Immigration and Nationality Act, it would appear unlikely that the President can exercise this power without express congressional authorization. Airlines and Travel Restrictions92 Airline Corporate Policies Generally, airlines are under no legal obligation to provide transportation simply because a person has a valid ticket. As a matter of corporate policy, airlines have inserted clauses into their “contract of carriage” reserving the right to deny transportation to any ticketed passenger who presents himself or herself in a condition that may adversely affect the safety and/or security of the flight, its crew, or the other passengers. For example, Midwest Airlines’ “contract of carriage” specifically authorizes the refusal of transportation or removal from a flight if the passenger’s: age, mental or physical condition, disability or impairment is such that the passenger would need excessive or unusual assistance in the event of an emergency or to take care of his/her physical needs in flight.93 (...continued) 2005). 88 Shaughnessy v. United States ex rel. Mezei, 345 U.S. 206, 210 (1953). See also Chae Chan Ping v. United States, 130 U.S. 581, 609 (1889) (Chinese Exclusion Case) (Bradley, J., concurring). 89 United States v. Wong Kim Ark, 169 U.S. 649, 653 (1898) (holding that a person born in the United States could not be excluded from the country by the Chinese Exclusion Act); Perez v. United States, 502 F. Supp. 2d 301, 306 (N.D.N.Y. 2006). 90 Youngstown Sheet and Tube Co. v. Sawyer, 343 U.S. 579, 637 (1952) (Jackson, J., concurring). 91 Meizei, 345 U.S. at 210. 92 This section was written by (name redacted), Legislative Attorney. Congressional Research Service 14 The 2009 Influenza Pandemic: Selected Legal Issues Thus, it is conceivable that a person presenting himself or herself for air travel with symptoms of illness could be denied the right to board.94 Application and interpretation of this provision appears to be at the sole discretion of the air carrier. Should an individual be refused transportation, he or she may, depending on the terms of the “contract of carriage,” be eligible for a refund for any unused portion of the ticket purchased minus any taxes or applicable service fees. CDC has issued interim guidance to assist airline crew in identifying passengers who may be infected with influenza A(H1N1).95 This guidance provides that any passengers with certain symptoms should be reported immediately to the CDC quarantine station in the airport where the plane is expected to land. Public Health “Do Not Board” List Federal agencies have developed a new travel restriction tool to prevent the spread of communicable diseases of public health significance. 96 The public health Do Not Board (DNB) list was developed by the Department of Homeland Security (DHS) and the CDC, and made operational in June 2007.97 The DNB list enables domestic and international health officials to request that persons with communicable diseases who meet specific criteria and pose a serious threat to the public be restricted from boarding commercial aircraft departing from or arriving in the United States. The list provides a new tool for management of emerging public health threats when local public health efforts are not sufficient to keep people with certain contagious diseases from boarding commercial flights.98 Federal Airspace Authority In addition to the legal authority over individual passengers, the federal government possesses the legal authority to regulate and control the navigable airspace of the United States. The notion that every nation has absolute and exclusive sovereignty over the airspace above its defined territory is a hallmark aviation principle that has been recognized by international agreements dating back (...continued) 93 See Midwest Airlines, Contract of Carriage, available at, http://www.midwestairlines.com/uploadedFiles/ Travel_Tools/Travel_Policies/ContractofCarriage_20081222.pdf 94 Airlines also have general authority to refuse to board passengers with communicable diseases under certain circumstances pursuant to Air Carrier Access Act of 1986 (ACAA) regulations. See 49 U.S.C. § 41705, 14 C.F.R. § 382.51. Decisions to deny passengers scheduled to fly must be based on “reasonable judgment that relies on current medical knowledge or on the best available objective evidence,” that the individual poses a direct threat to the health and safety of others. See, discussion, infra at “Federal Nondiscrimination Laws”, regarding the application of federal nondiscrimination laws, including the nondiscrimination provisions of the ACAA. 95 http://www.cdc.gov/h1n1flu/aircrew.htm 96 For a summary of recent actions taken by DHS and the CDC to improve procedures to restrict persons with serious communicable diseases who intend to travel despite medical advice, see Government Accountability Office, Public Health and Border Security: HHS and DHS Should Further Strengthen Their Ability to Respond to TB Incidents. GAO09-58. Washington, D.C: October, 2008. 97 CDC. Federal Air Travel Restrictions for Public Health Purposes—United States, June 2007-May 2008, MMWR 2008 Sep. 19; 57 (37): 1009-12, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5737a1.htm. 98 The list, which applies to all citizens and foreign nationals, appears to have been developed under the general authority of the Aviation and Transportation Security Act of 2001, at 49 U.S.C. § 114(f) and (h). Congressional Research Service 15 The 2009 Influenza Pandemic: Selected Legal Issues to the 1919 Convention for the Regulation of Aerial Navigation. 99 The United States Congress has, by statute, delegated the legal authority over airspace regulation to the Administrator of the Federal Aviation Administration (FAA).100 Pursuant to this authority, it appears that the FAA can prevent airplanes from entering the airspace of the United States if they originate from a country experiencing incidents of communicable disease (e.g., airplane from Mexico to any airport in the United States). Similarly, the FAA could deny airspace access to any airplane originating in the United States whose intention it is to operate into a country experiencing incidents of communicable disease (e.g., an airplane from any domestic airport to Mexico). Finally, the FAA can prevent aircraft originating in third countries from utilizing the airspace of the United States to travel to a country experiencing incidents of communicable disease (e.g., airplane originating in Canada destined for Mexico). School Closures101 Since children tend to be more susceptible than adults to infection and are responsible for more secondary transmission,102 studies have suggested that community-wide school closures may help mitigate the impact of an influenza pandemic.103 The Centers for Disease Control and Prevention (CDC), in interim pre-pandemic planning guidance, included school closures as a tool for mitigation of a pandemic and, in some cases, the period of closure could be as long as 12 weeks.104 During the spring 2009 H1N1 influenza outbreak over 700 schools closed for varying lengths of time. 105 However, additional information on the virus led to less use of school closures. CDC issued revised guidance on May 5, 2009, and noted that new information, indicating the 99 Convention for the Regulation of Aerial Navigation, Oct. 13, 1919, Art. 1, 11 L.N.T.S. 173, 190. 49 U.S.C. § 40103 (2006). 101 This section was written by (name redacted), Legislative Attorney. For more information on the school closure issue see CRS Report R40554, The 2009 Influenza Pandemic: An Overview, by (name redacted) and (name redac ted). 102 U.S. Department of Education, H1N1 Flu and U.S. Schools: Answers to Frequently Asked Questions, http://www.ed.gov/admins/lead/safety/emergencyplan/pandemic/guidance/flu-faqs.pdf. 103 Centers for Disease Control and Prevention, Interim Pre-pandemic Planning Guidance: Community Strategy for Pandemic Influenza Mitigation in the United States, at 27. http://www.pandemicflu.gov/plan/community/ community_mitigation.pdf. Other school policies may also have an effect on the spread of an influenza virus. The National Association of State Boards of Education (NASBE) updated its statement on influenza and school preparedness to suggest that “[s]tates may want to consider adding the flu vaccination to the list of mandatory immunizations children are required to have to attend school.” http://www.nasbe.org/index.php/file-repository?func= startdown&id=887. 104 Centers for Disease Control and Prevention, Interim Pre-pandemic Planning Guidance: Community Strategy for Pandemic Influenza Mitigation in the United States, http://www.pandemicflu.gov/plan/community/ community_mitigation.pdf. CDC has also issued guidance relating to higher education. See http://www.cdc.gov/ h1n1flu/guidance/guidelines_colleges.htm. 105 The U.S. Department of Education responded to the spring 2009 H1N1 outbreak by holding a conference call on school closures with state and district education officials, http://www.ed.gov/admins/lead/safety/emergencyplan/ pandemic/guidance/trans042709.pdf; publishing guidance, U.S. Department of Education, H1N1 Flu and U.S. Schools: Answers to Frequently Asked Questions, http://www.ed.gov/admins/lead/safety/emergencyplan/pandemic/guidance/flufaqs.pdf, http://www.pandemicflu.gov/plan/school/index.html; and other information, http://www.ed.gov/admins/lead/ safety/emergencyplan/pandemic/guidance/flu-faqs.pdf, http://rems.ed.gov/index.cfm?event= PandemicPreparedns4Schools. In addition, President Obama originally called for school closures if there were students ill with the influenza A(H1N1) virus, http://www.whitehouse.gov/blog/09/04/30/The-Presidents-Remarks-on-H1N1. As of May 5, 2009, 726 schools out of more than 100,000 nationwide were closed due to the outbreak. Frank Wolfe, “NASBE: Schools Should Consider Mandatory Flu Shots,” 42 Education Daily No. 83, at 3 (May 6, 2009). 100 Congressional Research Service 16 The 2009 Influenza Pandemic: Selected Legal Issues disease severity was similar to that of seasonal influenza, warranted revision of the original recommendation.106 On August 7, 2009, CDC issued new guidelines for elementary and secondary schools to help decrease the spread of flu among students and school staff.107 This guidance emphasizes that “[t]he decision to dismiss students should be made locally and should balance the goal of reducing the number of people who become seriously ill or die from influenza with the goal of minimizing social disruption and safety risks to children sometimes associated with school dismissal.”108 The recommended school responses are staying home when sick for at least 24 hours after a fever, separating ill students and staff, using hand hygiene, routinely cleaning commonly touched surfaces, treating high-risk students and staff early, and considering selective school dismissals.109 If the flu appears to be causing more severe disease, other additional measures may be recommended, including active screening for fevers, advising high-risk students and staff to stay home, advising students with ill household members to stay home, and school dismissals.110 WHO has issued similar advice relating to schools, noting that “[e]xperience to date has demonstrated the role of schools in amplifying transmission of the pandemic virus, both within schools and into the wider community.”111 CDC and the Department of Education (ED) have established a school dismissal monitoring system in order to track school dismissals.112 During testimony before the Senate Committee on Homeland Security and Government Affairs on October 21, 2009, Secretary Duncan stated that from August 3 through October 9, 501 schools had closed for at least one day. 113 In addition, ED has provided recommendations to help schools maintain the continuity of learning both for individuals or small groups of students and for large groups of students disrupted by school dismissals or large numbers of faculty absences. 114 106 The updated guidance recommended that schools not close for suspected or confirmed cases of influenza A(H1N1) unless the number of faculty or students absent interferes with the school’s ability to function. In addition, it was recommended that the schools that were closed reopen. http://www.cdc.gov/h1n1flu/K12_dismissal.htm; http://www.cdc.gov/h1n1flu/mitigation.htm. 107 http://www.flu.gov/plan/school/schoolguidance.html; http://www.flu.gov/plan/school/k12techreport.html. See also “Preparing for the Flu (Including 2009 H1N1 Flu): A Communication Toolkit for Schools (Grades K-12),” http://www.flu.gov/plan/school/toolkit.html. Separate updated guidance for child care settings will be issued. 108 http://www.flu.gov/plan/school/schoolguidance.html. School closures have a direct economic cost due to worker absenteeism, including absenteeism by health care workers. A study by the Brookings Institute found that closing all the schools in the U.S. for four weeks could cost between $10 billion and $47 billion dollars and lead to a reduction of 6% to 19% in key health care personnel. Howard Lempel, Ross A. Hammond, Joshua M. Epstein, “Economic Cost and Health Care Workforce Effects of School Closures in the U.S.,” Center on Social and Economics Dynamics Working Paper No. 55 (September 30, 2009), http://www.brookings.edu/papers/2009/ 0930_school_closure_lempel_hammond_epstein.aspx. 109 Id. 110 Id. 111 WHO, “Measures in School Settings,” Pandemic (H1N1) 2009 Briefing Note 10, http://www.who.int/csr/disease/ swineflu/notes/h1n1_school_measures_20090911/en/index.html. 112 http://www.cdc.gov/h1n1flu/schools/dismissal_form/index.htm. 113 H1N1 Flu: Monitoring the Nation’s Response: Hearings Before the Senate Committee on Homeland Security and Government Affairs, 111th Cong. (2009) (Testimony of Secretary Arne Duncan) at http://hsgac.senate.gov/public/ index.cfm?FuseAction=Hearings.Hearing&Hearing_ID=cbe5331e-19ab-41d5-bffe-7610f97708f0. 114 “Preparing for the Flu: Department of Education Recommendations to Ensure the Continuity of Learning for Schools(K-12) During Extended Student Absence or School Dismissal,” http://www.ed.gov/admins/lead/safety/ emergencyplan/pandemic/guidance/continuity-recs.pdf. CDC also has issued guidance for institutions of higher (continued...) Congressional Research Service 17 The 2009 Influenza Pandemic: Selected Legal Issues School closures may spawn numerous policy issues including when and how long schools should be closed; how schools can comply with standardized testing requirements; and whether school meals programs should continue. 115 However, school closures also raise legal issues. The main question is who has the legal authority to institute a school closure. A CDC-requested study of state legal authorities to close schools found that school closure is legally possible in most jurisdictions during both routine and emergency situations.116 The study also indicated that state authority for closure may be vested at various levels of government and in different departments, generally the state or local education agencies or state or local departments of health. 117 However, if there is a state or local declaration of emergency, the authority to close schools shifts to the state emergency management agencies in most jurisdictions.118 These varying laws may create legal controversies over who has the authority to make the school closure decision. In addition, there could be legal challenges to whatever school closure decision is made, particularly if the duration of a school closing is lengthy. Issues may also arise regarding whether school employees will be paid for the time the schools are closed.119 Other legal issues regarding school closures may be raised under the Individuals with Disabilities Education Act (IDEA). 120 IDEA requires that states receiving IDEA funding provide children with disabilities a free appropriate public education (FAPE).121 Although IDEA does not specifically address school closures due to a pandemic, the Department of Education has stated that schools must be careful not to discriminate on the basis of disability when providing educational services.122 ED noted that if schools are closed due to H1N1 and no educational services are provided to any children, services do not have to be provided to children with disabilities. However, if services are provided to the general student body, students with disabilities must have (...continued) education regarding responses to H1N1. Like the guidance for elementary and secondary schools, the higher education guidance contains two main sets of recommendations: (1) recommendations which assume that H1N1 has a severity similar to the spring/summer outbreak, and (2) recommendations to consider if the disease becomes more severe. These recommendations parallel those for elementary and secondary school but also address issues relating to the close living conditions experienced in college dormitories. “CDC Guidance for Responses to Influenza for Institutions of Higher Education during the 2009-2010 Academic Year,” http://www.cdc.gov/h1n1flu/institutions/guidance/. 115 For a discussion of these issues and others see U.S. Department of Education, H1N1 Flu and U.S. Schools: Answers to Frequently Asked Questions, http://www.ed.gov/admins/lead/safety/emergencyplan/pandemic/guidance/flu-faqs.pdf; http://www.pandemicflu.gov/plan/school/index.html. 116 James G. Hodge, Jr., Dhrubajyoti Bhattacharya, and Jennifer Gray, “Legal Preparedness for School Closures in Response to Pandemic Influenza and Other Emergencies,” http://www.pandemicflu.gov/plan/school/ schoolclosures.pdf. This study was summarized in James G. Hodge, Jr. “The Legal Landscape for School Closures in Response to Pandemic Flu or Other Public Health Threats,” 7 Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 45 (2009). 117 See James G. Hodge, Jr. “The Legal Landscape for School Closures in Response to Pandemic Flu or Other Public Health Threats,” 7 Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 45 (2009), http://www.prepare.pitt.edu/pdf/school-closures.pdf. 118 Id. at 49. “The ability of departments of health and education in nonemergencies to close schools is largely supplanted by the legal authority of state emergency management agencies during declared emergencies in 98% of the jurisdictions studied.” 119 http://www.law.com/jsp/tx/PubArticleTX.jsp?id=1202430362015&slreturn=1. 120 20 U.S.C. §1400 et seq. 121 For a more detailed discussion of IDEA see CRS Report R40690, The Individuals with Disabilities Education Act (IDEA): Statutory Provisions and Recent Legal Issues, by (name redacted). 122 “Guidance on Flexibility and Waivers for SEAs, LEAs, Postsecondary Institutions, and Other Grantee and Program Participants,” http://www.ed.gov/admins/lead/safety/emergencyplan/pandemic/index.html. Congressional Research Service 18 The 2009 Influenza Pandemic: Selected Legal Issues equal access to these opportunities.123 ED also observed that compensatory services may need to be provided for a student with a disability in certain circumstances. 124 Vaccinations Background125 Vaccination with a matched strain of influenza virus is considered the most effective measure to prevent severe illness from flu. 126 Since influenza viruses continuously change, creating a matched strain is not possible until a virus is circulating. The production of a vaccine is time consuming, and the vaccine will become available in phases, not all at one time. When the vaccine is first produced, it is likely that the demand for the H1N1 vaccine will be greater than the supply.127 The first doses have become available but due to manufacturing issues, there is not as much vaccine currently available as was anticipated. 128 It should be noted that a mass vaccination campaign presents an array of challenges, including how to transport vaccines safely, redistribute vaccines, track vaccinations, and monitor adverse effects.129 Vaccines may be mandated in some circumstances; however, except for the Department of Defense and with respect to immigration, it is generally a matter of state, rather than federal, authority. 130 The current federal plans for a possible pandemic flu vaccination campaign in the fall assume that any such campaign would be voluntary.131 123 Id. Id. 125 This section was written by (name redacted). 124 126 For a more detailed discussion of vaccine development, licensing, and use see CRS Report R40554, The 2009 Influenza Pandemic: An Overview, by (name redacted) and (name redacted). 127 http://www.who.int/csr/disease/swineflu/frequently_asked_questions/vaccine_preparedness/production_availability/ en/index.html. CDC has stated that “We do not expect that there will be a shortage of novel H1N1 vaccine, but flu vaccine availability and demand can be unpredictable and there is some possibility that initially, the vaccine will be available in limited quantities.” “CDC Novel H1N1 Vaccination Planning Q&A,” http://www.cdc.gov/h1n1flu/ vaccination/statelocal/qa.htm. 128 http://www.cdc.gov/h1n1flu/vaccination/vaccinesupply.htm. 129 Trust for America’s Health, H1N1 Challenges Ahead, http://healthyamericans.org/reports/h1n1/ TFAH2009challengesahead.pdf. 130 CRS Report RS21414, Mandatory Vaccinations: Precedent and Current Laws, by (name redacted); CRS Report RL34708, Religious Exemptions for Mandatory Health Care Programs: A Legal Analysis, by Cynthia Brougher; CRS Report R40570, Immigration Policies and Issues on Health-Related Grounds for Exclusion, by (name re dacted) and (name redacted). 131 “With the new H1N1 virus continuing to cause illness, hospitalizations and deaths in the US during the normally flu-free summer months and some uncertainty about what the upcoming flu season might bring, CDC’s Advisory Committee on Immunization Practices has taken an important step in preparations for a voluntary novel H1N1 vaccination effort to counter a possibly severe upcoming flu season.” CDC, Novel H1N1 Vaccination Recommendations, at http://www.cdc.gov/h1n1flu/vaccination/acip.htm. Congressional Research Service 19 The 2009 Influenza Pandemic: Selected Legal Issues Allocation of Vaccines132 Overview To implement the voluntary mass vaccination campaign, the federal government has purchased the vaccine and a blended public- and private-sector distribution approach is being used.133 The federal government provides guidance to the states and localities on how the vaccine should be allocated but actual allocation decisions would be made at the state and local levels. CDC has stated, however, that “State and local health departments are strongly encouraged to adhere to national guidelines on vaccine prioritization. Uniformity in prioritizing vaccine is considered a significant national interest. There may be instances where specific local needs should be taken into consideration when implementing prioritization, but deviation from national guidelines should be minimized.”134 States have generally been following this guidance. 135 Selected Federal Actions Prior to 2009 The federal government examined the issue of how to set priorities for scarce resources, including vaccines, prior to the current H1N1 pandemic.136 The 2005 Homeland Security Council Implementation Plan, 137 as supplemented by the two-year summary implementation plan, required HHS with the Department of Homeland Security (DHS) to make priority recommendations for access to pre-pandemic and pandemic influenza vaccines. 138 The recommendations were to reflect the pandemic response goals as well as maintaining national security. 139 On December 14, 2006, HHS issued a request for information (RFI) in the Federal Register asking for “input on pandemic influenza vaccine prioritization considerations from all interested and affected parties.”140 In addition, the RFI indicated that limiting transmission may be an objective. The federal interagency working group used the input gained from this RFI to issue draft guidance on October 17, 2007.141 After consideration of comments, HHS and the Department of Homeland Security issued final guidance on July 23, 2008, in the form of a report entitled “Guidance on Allocating and Targeting 132 This section was written by (name redacted). It should be noted that allocation of other medical resources such as hospital beds and medical equipment may be necessary in certain circumstances. For a discussion of these issues see “Mass Medical Care with Scarce Resources,” http://www.ahrq.gov/prep/mmcessentials/; “State and Local Pandemic Influenza Preparedness: Medical Surge,” http://oig.hhs.gov/oei/reports/oei-02-08-00210.pdf. 133 CDC, Clinician Outreach and Communication Activity (COCA), conference call on H1N1 vaccine, July 15, 2009, transcript and presentation at http://emergency.cdc.gov/coca/callinfo.asp. 134 CDC Novel N1N1 Vaccination Planning Q & A, http://www.cdc.gov/h1n1flu/vaccination/statelocal/qa.htm. 135 For a state by state listing of vaccine priorities see http://www.astho.org/h1n1-vaccineprioritization.aspx. 136 For a detailed examination of the federal actions see CRS Report RL33381, The Americans with Disabilities Act (ADA): Allocation of Scarce Medical Resources During a Pandemic, by (name redacted). 137 National Strategy for Pandemic Influenza, November 2005, at http://www.flu.gov/plan/federal/index.html#national. 138 Id. “Implementation Plan Two Year Summary” Section 6.1.14.1. 139 Id. These goals are reducing health, societal, and economic impacts and maintaining national and homeland security, and public values. 140 71 Fed.Reg. 75252 (December 14, 2006). 141 “Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine,” http://www.pandemicflu.gov/vaccine/ prioritization.html. Congressional Research Service 20 The 2009 Influenza Pandemic: Selected Legal Issues Pandemic Influenza Vaccine.”142 The guidance creates tiers for coverage, and varies the vaccination priority depending on the severity of the pandemic. Since pandemics that have higher case fatality rates are more likely to disrupt essential services, threaten public order and homeland security, and disrupt supply chains, individuals who are necessary for these functions would receive a higher priority in a severe pandemic. Conversely, individuals with high-risk conditions making them more vulnerable to serious illness would receive greater priority in a less severe pandemic. 143 The guidance gives its highest rank to deployed forces, critical health care workers, fire and police, and pregnant women, infants, and toddlers. The importance of maintaining homeland and national security is highlighted and the guidance recognizes the following objectives as the most important: • protecting those who are essential to the pandemic response and providing care for persons who are ill, • protecting those who maintain essential community services, • protecting children, and • protecting workers who are at greater risk of infection due to their job.144 However, the guidance also recognizes that the plans must be flexible because “the guidance may be modified based on the status of vaccine technology, the characteristics of pandemic illness, and risk groups for severe disease—factors that will remain unknown until a pandemic actually occurs.”145 Federal Actions After Emergence of Influenza A(H1N1) On July 8, 2009, CDC issued recommendations for state and local planning for a pandemic flu vaccination program.146 These recommendations again emphasized that changing data may change the target populations.147 The CDC recommendations noted that immunization of military forces may be appropriate given the current circumstances but did not address the military in its allocation discussion. The CDC focused only on the vaccination of civilian populations under the authority of CDC and state and local health departments.148 142 U.S. Department of Health and Human Services, U.S. Department of Homeland Security, “Guidance on Allocating and Targeting Pandemic Influenza Vaccine,” (July 23, 2008) http://www.hhs.gov/news/press/2008pres/07/ 20080723a.html. 143 Id. at 10-11. 144 Id. at 3. 145 Id. at 1. 146 http://www.cdc.gov/h1n1flu/vaccination/statelocal/planning.htm. 147 CDC recommended the following groups be targeted first for vaccines: students and staff associated with schools and children at or over six months and staff in child care centers (vaccinated at schools and child care centers); pregnant women, children six months to four years old, new parents and household contacts of children (vaccinated at providers’ offices and community clinics); adults under 65 years old with medical conditions that increase the risk of complications from flu (vaccinated at work settings, community clinics, pharmacies, providers’ offices); and health care workers and emergency services sectors personnel (vaccinated at work settings, providers’ offices). http://www.cdc.gov/h1n1flu/vaccination/statelocal/planning.htm. 148 http://www.cdc.gov/h1n1flu/vaccination/statelocal/planning.htm. Congressional Research Service 21 The 2009 Influenza Pandemic: Selected Legal Issues On July 29, 2009, the CDC’s Advisory Committee on Immunization Practices (ACIP) met to make recommendations on H1N1 vaccine priorities. The ACIP recommendations generally track those issued on July 8 by CDC for planning purposes and list the following target groups: • pregnant women, • household and caregiver contacts of children younger than 6 months of age (e.g., parents, siblings, and daycare providers), • health care and emergency medical services personnel, • persons from 6 months through 24 years of age, and • persons aged 25 through 64 years who have medical conditions associated with a higher risk of influenza complications.149 The groups recommended for priority vaccination by the ACIP total approximately 159 million people in the United States.150 If there is a shortage of vaccine, the ACIP recommends that the following groups receive the vaccine first: • pregnant women, • people who live with or care for children younger than six months of age, • health care and emergency services personnel with direct patient contact, • children six months through four years old, and • children 5 through 18 years old who have chronic medical conditions.151 During the press briefing, the ACIP noted that it recommends that 83% of the population be vaccinated for seasonal influenza, but less than 40% are actually vaccinated each year. The demand for the H1N1 vaccine is uncertain because not everyone who is in a priority group may choose to get the vaccine. Hence, with more vaccine potentially available to lower tiers in the priority groupings, ACIP noted in the press briefing that it may be possible that the more limited target groups might not be used. 152 Similarly, CDC stated that a vaccine shortage is not expected; however, availability and demand are unpredictable, thus it is possible that priority groups may be needed. 153 CDC observed that the ACIP recommendations “leave room for flexibility at the local level depending on the local vaccine supply situation.”154 As the vaccination campaign has begun, CDC emphasizes that the state and local providers “should be aware of and follow any additional guidance provided by their state or local health departments. If no additional guidance is provided at the state or local level, providers should vaccinate among the initial target group populations on a first come, first served basis.”155 149 http://www.cdc.gov/h1n1flu/vaccination/clinicians_qa.htm. Id. 151 http://www.cdc.gov/media/pressrel/2009/r090729b.htm. 152 http://www.cdc.gov/media/transcripts/2009/t090729b.htm. 153 http://www.cdc.gov/h1n1flu/vaccination/statelocal/qa.htm. 154 Id. 155 http://www.cdc.gov/h1n1flu/vaccination/clinicians_qa.htm. 150 Congressional Research Service 22 The 2009 Influenza Pandemic: Selected Legal Issues Legal Issues The allocation of scarce pandemic vaccine could raise several legal issues. If an individual has an adverse response to the vaccine, there may be liability issues. However, HHS Secretary Kathleen Sebelius issued a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act)156 that waives vaccine liability, except for willful misconduct, for the United States, and for manufacturers; distributors; program planners; persons who prescribe, administer, or dispense the countermeasure; and employees of any of the above. This declaration would also make funds available under a vaccine compensation fund.157 Constitutional due process and equal protection issues as well as civil rights issues might also be raised concerning vaccine allocation if a particular covered group was adversely impacted by the vaccine allocation plan. 158 More specifically, issues regarding the Americans with Disabilities Act (ADA) 159 could be raised. However, vaccine allocation plans that are based on a determination that an individual not receive a vaccine because the vaccine would not be effective given his or her health situation would be unlikely to raise ADA concerns, because the determination would be based on a medical determination of treatment. Similarly, the mere fact that a decision would have a disparate impact on individuals with disabilities would not necessarily be sufficient to violate the nondiscrimination mandates.160 Other potential legal issues could arise concerning state and local decisions about vaccine allocation. Questions may occur about defining subgroups within priority groups. For example, how is a “health care worker” to be defined? Once the groups are defined, issues may arise concerning how vaccination sites will ensure that individuals are within the priority group. For example, would an individual have to “prove” that he or she had a medical condition that increased risk from the flu?161 What form would this proof have to take? Would there be potential liability issues for health care providers if they do not follow guidance concerning who is to be vaccinated? Would vaccinations be provided for illegal aliens who are within the priority groups? Finally, if there is possible liability for individuals or state or local agencies making these decisions, should there be any legal protections available to limit liability? The CDC “H1N1 Clinicians Questions and Answers” provides guidance for a vaccination provider who is faced with requests for vaccination from individuals not in the initial target group. CDC notes that some providers may have enough doses of vaccine to meet the demand from all patients but, if this is not the case, “the provider may wish to explain their local plan and rationale for vaccination among the initial target groups and ask others to wait to get vaccinated later.” CDC emphasized that “the decision regarding who should get vaccinated is one that should 156 42 U.S.C. § 247d-6d, 247d-6e. For a more detailed discussion of this issue see the subsequent discussion of the PREP Act, and CRS Report RS22327, Pandemic Flu and Medical Biodefense Countermeasure Liability Limitation, by (name redacted) and (name re dacted). 158 For a more detailed discussion see the subsequent discussion civil rights issues and CRS Report RL33381, The Americans with Disabilities Act (ADA): Allocation of Scarce Medical Resources During a Pandemic, by (name reda cted). 159 42 U.S.C. §12101 et seq. 160 Alexander v. Choate, 469 U.S. 287 (1985). 157 161 CDC states that “[t]here will be no federal requirements for vaccinators to require documentation of priority group status such as doctor’s note documenting pregnancy or risk status.” http://www.cdc.gov/h1n1flu/vaccination/statelocal/ qa.htm. Congressional Research Service 23 The 2009 Influenza Pandemic: Selected Legal Issues be made between the provider and the patient, weighing whether there are sufficient doses available for those at greatest risk for infection and serious complications as well as the likelihood that patients turned away will come back for vaccine at a later date.”162 This guidance places the decision between the provider and the patient. It does not directly address the potential liability issue for a provider when an individual who was in a priority group is unable to get vaccinated because of the vaccination of individuals not in the priority group, and this priority group individual suffers adverse consequences due to the lack of timely vaccination. However, a provider who weighs the factors suggested by CDC and makes an individualized determination, most likely would not be found liable to another individual who was unable to obtain vaccination. In addition, the burden of proof for the plaintiff in this scenario would be a difficult one. Mandatory Vaccinations163 History and Precedent Historically, the preservation of the public health has been the primary responsibility of state and local governments, and the authority to enact laws relevant to the protection of the public health derives from the state’s general police powers.164 With respect to the preservation of the public health in cases of communicable disease outbreaks, these powers may include the enactment of mandatory vaccination laws. 165 Every state has a law requiring children to be vaccinated before they enroll in a public or private school.166 All states also allow medical exemptions from school vaccination requirements for those whose immune systems are compromised, who are allergic to vaccines, or have other medical contraindications to vaccines, and many states also provide exemptions for religious or philosophical reasons.167 Various state laws also require vaccination against hepatitis B and meningococcal disease for incoming college and university students.168 Jacobson v. Massachusetts169 is the seminal case regarding a state’s or municipality’s authority to institute a mandatory vaccination program as an exercise of its police powers. In Jacobson, the Supreme Court upheld a Massachusetts law that gave municipal boards of health the authority to require the vaccination of persons over the age of 21 against smallpox, and determined that the vaccination program instituted in the City of Cambridge had “a real and substantial relation to the protection of the public health and safety.”170 In upholding the law, the Court noted that “the 162 http://www.cdc.gov/h1n1flu/vaccination/clinicians_qa.htm. This section was written by (name redacted), Legislative Attorney. For a detailed discussion see CRS Report RS21414, Mandatory Vaccinations: Precedent and Current Laws, by (name redacted). 164 See The People v. Robertson, 134 N.E. 815, 817 (1922). 165 Starting with the smallpox vaccine, vaccines have been used to halt the spread of disease for over 200 years. Donald A. Henderson & Bernard Moss, Smallpox and Vaccinia, VACCINES 74, 75 (Stanley A. Plotkin & Walter A. Orenstein eds., 3d ed. 1999). 166 For a more detailed discussion of these issues see CRS Report RS21414, Mandatory Vaccinations: Precedent and Current Laws, by (name redacted). 167 National Conference of State Legislatures, States with Religious and Philosophical Exemptions from School Immunization Requirements, updated June, 2009, at http://www.ncsl.org/Default.aspx?TabId=14376. 168 See the Immunization Action Coalition website state charts at http://www.immunize.org/laws/hepbcollege.asp and http://www.immunize.org/laws/menin.asp. 169 197 U.S. 11 (1905). 170 Id. at 31. The Massachusetts statute in question read as follows: “Boards of health, if in their opinion it is necessary for public health or safety, shall require and enforce the vaccination and revaccination of all the inhabitants of their (continued...) 163 Congressional Research Service 24 The 2009 Influenza Pandemic: Selected Legal Issues police power of a State must be held to embrace, at least, such reasonable regulations established directly by legislative enactment as will protect the public health and the public safety.”171 The Court added that such laws were within the full discretion of the state, and that federal powers with respect to such laws extended only to ensure that the state laws did not “contravene the Constitution of the United States or infringe any right granted or secured by that instrument.”172 In the context of the current H1N1 pandemic, mandatory vaccination issues are less likely to arise than allocation issues, since it is unlikely that there would be sufficient vaccine available to vaccinate the entire population, particularly in the early stages of vaccine availability. 173 Health Care Workers and Mandatory Vaccinations A number of states have laws requiring employees of certain health care facilities, such as nursing homes, to be vaccinated against diseases such as measles, mumps and rubella. Such laws, which vary widely, generally contain opt-out provisions where a vaccine is medically contraindicated or if the vaccine is against the individual’s religious or philosophical beliefs.174 A few states have laws pertaining to influenza vaccination of health care workers, and most that do provide for voluntary influenza immunization programs and staff education measures for employees; however, a few states have mandatory requirements for influenza vaccinations for health care workers.175 For example, Alabama has a law requiring that employees of nursing homes receive an annual vaccination against the influenza virus, unless the vaccine is medically contraindicated, or the vaccine is against the individual’s religious beliefs, or if the individual refuses the vaccine after being fully informed of the health risks of not being immunized. 176 In August 2009, the New York State Health Department amended its regulations to require that health care workers at hospitals, in home health care agencies, and in hospice care be immunized against influenza viruses as a precondition to employment and on an annual basis.177 This regulation, issued on an emergency basis, did not permit any exceptions to the influenza vaccination mandate except for medical contraindications. Lawsuits were filed challenging the regulation’s validity, and on October 16, 2009, a state judge issued a temporary restraining order suspending its application to New York health care workers.178 However, on October 22, 2009, (...continued) towns, and shall provide them with the means of free vaccination. Whoever refuses or neglects to comply with such requirement shall forfeit five dollars.” M.G.L.A. c. 111, § 181 (2004). 171 Id. at 25. 172 Id. 173 For a discussion of issues raised by the allocation of vaccine see preceding section of this report, “Allocation of Vaccines,” and CRS Report RL33381, The Americans with Disabilities Act (ADA): Allocation of Scarce Medical Resources During a Pandemic, by (name redacted). 174 Lindley, Megan C. et al., Assessing State Immunization Requirements for Healthcare Workers and Patients, Am J Prev Med 2007;32(6): 459-465. 175 The CDC maintains a continuously updated online database of state laws pertaining to vaccination requirements at http://www.cdc.gov/vaccines/vac-gen/laws/state-reqs.htm. 176 ALA. CODE § 22-21-10. 177 This regulation could apply to the influenza A(H1N1) virus if a vaccine becomes available in sufficient supply. The text of the regulation may be viewed at http://www.health.state.ny.us/regulations/emergency/. See also a press release issued by New York State Health Commissioner Richard F. Daines at http://www.health.state.ny.us/press/releases/ 2009/2009-09-24_health_care_worker_vaccine_daines_oped.htm. 178 The temporary restraining order issued by state Supreme Court Judge Thomas J. McNamara, may be accessed at http://op.bna.com/hl.nsf/r?Open=sfak-7wvsxh. This order requires the parties to return to court for a hearing on (continued...) Congressional Research Service 25 The 2009 Influenza Pandemic: Selected Legal Issues Governor David A. Paterson announced the suspension of the flu shot mandate for health care employees due to the current shortage of both the seasonal flu vaccine and the influenza A(H1N1) vaccine.179 In the private sector, employers can require health care workers to be vaccinated against communicable diseases as a condition of employment, unless a state law applies which permits employees to opt out. 180 Virginia Mason Medical Center in Seattle, WA, became the first hospital in the nation, in 2004, to make vaccination a condition of employment for all its employees. Within three years, the hospital reported 98% staff coverage, except for 2% of the staff who refused for medical or religious reasons, and, because of their refusal, were required to wear surgical masks when in the hospital. 181 In 2008, the Department of Defense (DOD) issued a policy directive requiring “all civilian health care personnel who provide direct patient care in DoD military treatment facilities to be immunized against seasonal influenza infection each year as a condition of employment, unless there is a documented medical or religious reason not to be immunized.”182 Vaccination Orders During a Public Health Emergency Many states also have laws providing for mandatory vaccinations during a public health emergency or outbreak of a communicable disease.183 Generally, the power to order such actions rests with the governor of the state or with a state health officer. For example, a governor may have the power to supplement the state’s existing compulsory vaccination programs and institute additional programs in the event of a civil defense emergency period.184 Or, a state health officer may, upon declaration of a public health emergency, order an individual to be vaccinated “for communicable diseases that have significant morbidity or mortality and present a severe danger to public health.”185 In addition, exemptions are generally provided for medical reasons or where (...continued) October 30, 2009. 179 See press release at http://www.ny.gov/governor/press/press_1022094.html. 180 See Vaccination of Healthcare Workers for H1N1 and Other Communicable Diseases, American Federation of Teachers, Frequently Asked Questions, at http://www.aft.org/healthcare/download/FAQ%20-%20H1N1.pdf. This FAQ notes that the Joint Commission requires accredited organizations to offer influenza vaccinations to staff, including those with close patient contact, as a condition of accreditation. 181 Manning, Anita., Hospitals Shoot for Employees to Get Flu Vaccine, September 16, 2007, at http://www.usatoday.com/news/health/2007-09-16-flu-doctors_N.htm. A union dispute regarding the flu shot mandate resulted in an exemption for union employees, but all other hospital employees are covered. 182 Department of Defense/Joint Forces, HA Policy: 08-005, Policy for Mandatory Seasonal Influenza Immunization for Civilian Health Care Personnel Who Provide Direct Patient Care in Department of Defense Military Treatment Facilities, April 4, 2008, available at http://mhs.osd.mil/Content/docs/pdfs/policies/2008/08-005.pdf. 183 Following the then-Acting HHS Secretary’s public health emergency declaration on April 26, 2009, a number of states issued their own statewide or territorial emergency declarations relating to the H1N1 influenza outbreak. See the continuously updated list of such states and territories at http://www.astho.org/h1n1-emergency.aspx. 184 HAW. REV. STAT. § 128-8 (2008). In Arizona, the Governor, during a state of emergency or state of war emergency in which there is an occurrence or the imminent threat of smallpox or other highly contagious and highly fatal disease, may “issue orders that mandate treatment or vaccination of persons who are diagnosed with illness resulting from exposure or who are reasonably believed to have been exposed or who may reasonably be expected to be exposed.” ARIZ. REV. STAT. § 36-787 (2009). 185 FLA. STAT. § 381.00315 (2008). Congressional Research Service 26 The 2009 Influenza Pandemic: Selected Legal Issues objections are based on religion or conscience.186 However, if a person refuses to be vaccinated, he or she may be quarantined during the public health emergency giving rise to the vaccination order. The legality of a particular mandatory vaccination program will hinge upon balancing the severity of the public health emergency with the effectiveness and safety of the vaccine involved, and the availability of less intrusive methods of dealing with the situation. For example, dealing with the introduction of smallpox by a terrorist might involve the use of national security powers and involve some consequential restrictions on individual civil liberties. However, most programs for protecting the public health also recognize and protect constitutional rights to personal liberties, such as freedom from physical restraint, bodily invasion, or the right to refuse medical treatment.187 Model State Emergency Health Powers Act In addition to the current laws, many states have considered and have passed some or all of the provisions set forth in the Model State Emergency Health Powers Act (Model Act).188 The Model Act was drafted by The Center for Law and the Public’s Health at Georgetown and Johns Hopkins Universities. 189 It seeks to “grant public health powers to state and local public health authorities to ensure strong, effective, and timely planning, prevention, and response mechanisms to public health emergencies (including bioterrorism) while also respecting individual rights.” With respect to vaccinations, the Model Act includes provisions similar to the current laws discussed above. Under the Model Act, during a public health emergency, the appropriate public health authority would be authorized to “vaccinate persons as protection against infectious disease and to prevent the spread of contagious or possibly contagious disease.” The Model Act requires that the vaccine be administered by a qualified person authorized by the public health authority, and that the vaccine “not be such as is reasonably likely to lead to serious harm to the affected individual.” The Model Act recognizes that individuals may be unable or unwilling to undergo vaccination “for reasons of health, religion, or conscience,” and provides that such individuals may be subject to quarantine to prevent the spread of a contagious or possibly contagious disease. 190 Role of the Federal Government Federal jurisdiction over public health matters derives from the Commerce Clause, which states that Congress shall have the power “[t]o regulate Commerce with foreign Nations, and among the 186 See, eg., CONN. GEN. STAT. § 19a-222 (2009) (exemption for physician’s determination of sickness); VA. CODE ANN. § 32.1-48 (2009) (vaccination waived if detrimental to person’s health, as certified by a physician); WIS. STAT. § 252.041 (2008) (vaccination may be refused for reasons of religion or conscience). See also, CRS Report RL34708, Religious Exemptions for Mandatory Health Care Programs: A Legal Analysis, by Cynthia Brougher. 187 Mariner, Wendy K. et al., Jacobson v Massachusetts: It’s Not Your Great-Great-Grandfather’s Public Health Law, AM J PUB HEALTH, 2005;95(4):581-90. 188 The Center for Law and the Public’s Health tracks state legislative activity relating to the Model Act at http://www.publichealthlaw.net/Resources/Modellaws.htm#MSEHPA. According to James G. Hodge Jr., Executive Director of the Center for Law and the Public’s Health, 44 states have introduced legislation based on the Model Act and 38 states have adopted some parts of it. Marcia Coyle, “Legal Issues Swell If Swine Flu Spreads,” The National Law Journal (May 4, 2009), available at http://law.com/jsp/nlj/PubArticleNLJ.jsp?id=1202430383777& Legal_Issues_Swell_If_Swine_Flu_Spreads&slreturn=1 189 The text of the Center’s Model State Emergency Health Powers Act from 2001 is available at http://www.publichealthlaw.net/ModelLaws/index.php. 190 Id. See Section 604 of the Model Act for provisions relating to quarantine. Congressional Research Service 27 The 2009 Influenza Pandemic: Selected Legal Issues several States.”191 Thus, under the Public Health Service Act, the Secretary of Health and Human Services has authority to make and enforce regulations necessary “to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.”192 With regard to foreign countries, the Secretary has the power to restrict the entry of groups of aliens for public health reasons.193 This power includes the authority to issue vaccination requirements for immigrants seeking entry into the United States.194 With regard to interstate commerce, the Public Health Service Act deals primarily with the use of quarantine measures to halt the spread of certain communicable diseases.195 The Public Health Service Act does not specifically authorize any mandatory vaccination programs; nor do there appear to be any regulations regarding the implementation of a mandatory vaccination program at the federal level during a public health emergency. As noted above, state and local governments have the primary responsibility for protecting the public health, and this has been reflected in the enactment of the various state laws authorizing mandatory vaccination procedures during a public health emergency. Any federal civilian mandatory vaccination program applicable to the general public would likely be limited to areas of existing federal jurisdiction, i.e., interstate and foreign commerce, similar to the federal quarantine authority. 196 Aliens seeking admission to the United States, for example, are already required to show proof of required vaccinations.197 This limitation on federal jurisdiction acknowledges that states have the primary responsibility for protecting the public health, but that under certain circumstances, federal intervention may be necessary. Civil Rights198 Introduction Infectious diseases, such as the 2009 influenza pandemic, may raise a classic civil rights issue: to what extent can an individual’s liberty be curtailed to advance the common good?199 The United 191 U.S. CONST. art. I, § 8. 42 U.S.C. 264(a). Originally, the statute conferred this authority on the Surgeon General; however, pursuant to Reorganization Plan No. 3 of 1966, all statutory powers and functions of the Surgeon General were transferred to the Secretary. 193 8 U.S.C. § 1182. 194 Currently, vaccines recommended by the Advisory Committee on Immunization Practices for the general U.S. population are also required for immigrants who seek permanent residence in the United States, and people currently living in the United States who seek to adjust their status to become permanent residents. See the CDC Division of Global Migration and Quarantine website for information on vaccination requirements for immigrants at http://www.cdc.gov/ncidod/dq/diseases.htm#vaccine, and a recent CDC Federal Register notice seeking comment, “Criteria for Vaccination Requirements for U.S. Immigration Purposes,” 74 Fed. Reg. 15986 (April 8, 2009). For further information about health-related grounds for exclusion of immigrants see CRS Report R40570, Immigration Policies and Issues on Health-Related Grounds for Exclusion, by (name redacted) and (name redacted). 195 See 42 C.F.R. Parts 70 (interstate matters) and 71 (foreign arrivals). 196 It has been suggested that in the case of a serious outbreak of a communicable disease, the federal government might enact policies to encourage vaccinations or place restrictions on those who refuse. Bureau of Justice Assistance, U.S. Department of Justice, The Role of Law Enforcement in Public Health Emergencies, September, 2006 at 19. 197 8 U.S.C. § 1182(a)(1)(A). 198 This section was written by (name redacted), Legislative Attorney. 192 Congressional Research Service 28 The 2009 Influenza Pandemic: Selected Legal Issues States Constitution and federal civil rights laws provide for individual due process and equal protection rights as well as a right to privacy, but these rights are balanced against the needs of the community. With the advance of medical treatments in recent years, especially the use of antibiotics, the civil rights of the individual with a contagious disease have been emphasized. However, classic public health measures such as quarantine, isolation, and contact tracing are, nevertheless, available in appropriate situations and, as new or resurgent diseases have become less treatable, some of these classic public health measures have been increasingly used. Therefore, the issue of how to balance these various interests in a modern culture that is sensitive to issues of individual rights has become critical.200 Constitutional Rights to Due Process and Equal Protection Constitutional rights to due process and equal protection may be implicated by the imposition of a quarantine or isolation order.201 The Fifth and Fourteenth Amendments prohibit governments at all levels from depriving individuals of any constitutionally protected liberty interest without due process of law. What process may be due under certain circumstances is generally determined by balancing the individual’s interest at stake against the governmental interest served by the restraints, determining whether the measures are reasonably calculated to achieve the government’s aims,202 and deciding whether the least restrictive means have been employed to further that interest. (...continued) 199 For a discussion of balancing individual legal rights and responsibility and communal objectives, see Institute of Medicine, Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations (September 2009). 200 For a detailed discussion of constitutional issues relating to quarantine see Michelle A. Daubert, “Pandemic Fears and Contemporar [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/crs%3AR40560. Public record. Not legal advice.