1. 1 2009 H1N1 (Swine) Flu and Principles of Legal Triage James G. Hodge, Jr., J.D., LL.M. Professor, Johns Hopkins Bloomberg School of Public Health; Executive Director, Centers for Law & the Publics Health: A Collaborative at Johns Hopkins and Georgetown Universities

2. 2 Principal Objectives Brief Update on 2009 H1N1 Flu International and National Responses Legal Environment Concerning Declarations of Public Health Emergencies Principles of Legal Triage Legal Triage re: Global Health Issues Concerning 2009 H1N1 Flu

3. 3 Brief Disclaimer Information in this presentation is current through June 17, 2009 @ 12:30 p.m. EST, unless indicated otherwise As additional facts develop related to the spread of H1N1 influenza or legal responses, analyses presented herein will change as well 3

4. 4 2009 H1N1 Flu Epidemiology Contagious respiratory disease that commonly originates from pigs and is caused by a type-A influenza The current strain is a new variation of an H1N1 virus, which includes a mix of human and animal versions, and thus defined as novel This strain is particularly dangerous because it can spread from human to human instead of from animals to humans H1N1 may continue to mutate, making it more difficult to treat and combat due to potential lack of immunity 4

5. 5 2009 H1N1 Flu Epidemiology Symptoms of H1N1 are similar to the common flu: Fever Lethargy, Lack of appetite, Coughing, runny nose, sore throat Occasional nausea, vomiting, diarrhea H1N1 is transmissible in ways similar to common flu: coughs, sneezes, touching contaminated surfaces 5

6. 6 2009 H1N1 Flu Epidemiology This novel strain of H1N1 was first detected in Mexico City, where surveillance began picking up a surge in cases of influenza- like illness starting March 18, 2009 Mexican authorities initially assumed this surge to be a late- season flu until April 21 when a CDC alert regarding two isolated cases was reported The first H1N1 flu death (39 year old female) occurred on April 13, 2009 in Mexico 6

7. 7 2009 H1N1 Flu: Recognition April 25, 2009: WHO Director General, Dr. Margaret Chan, declares first-ever public health emergency of international concern pursuant to the International Health Regulations (2007) 7

8. 8 WHO Pandemic Influenza Phases Current Pandemic Influenza Phase (as of June 15, 2009): Phase 6 8

9. 9 WHO Pandemic Influenza Phases World Health Organization Pandemic Influenza Phases (2009) Pandemic Influenza Phase Characterization of PhasePublic Health Goals Phase 3 Human infection(s) with a new subtype, but no human-to-human spread, or at most rare instances of spread to a close contact Ensure rapid characterization of the new virus subtype and early detection, notification and response to additional cases Phase 4 Small cluster(s) with limited human-to-human transmission but spread is highly localized, suggesting that the virus is not well adapted to human Contain the new virus within limited foci or delay spread to gain time to implement preparedness measures, including vaccine development Phase 5 Larger cluster(s) but human-to-human spread still localized, suggesting that the virus is becoming increasingly better adapted to humans, but may not yet be fully transmissible (substantial pandemic risk) Maximize efforts to contain or delay spread, to possibly avert a pandemic, and to gain time to implement pandemic response measures Phase 6 Pandemic increased and sustained transmission in general population Minimize the impact of the pandemic

10. 10 WHO Confirmed Cases: 2009 H1N1 Flu 10

11. 11 2009 H1N1 Flu: Recognition April 26, 2009: U.S. DHHS Acting Secretary, Charles Johnson, declares a public health emergency Via the Public Health Service Act, 42 U.S.C. § 247d Allows federal, state, and local agencies to utilize federal resources to prevent and mitigate H1N1 flu 11

12. 12 2009 H1N1 Flu: U.S. Response April 27, 2009 - President Barack Obama: We are closely monitoring the emerging cases of swine flu in the United States. And this is obviously a cause for concern and requires a heightened state of alert. But it's not a cause for alarm. National Academy of Sciences Speech: April 27, 2009

13. 13 2009 H1N1 Flu Case Updates– June 17, 2009 Mexico: Mexico: 6,241 laboratory confirmed human cases of infection, including 108 deaths (Source: WHO) United States United States: 11,855 laboratory confirmed human cases, including 44 deaths (Source: CDC) Source: PAHO (June 17, 2009): http://new.paho.org/hq/images/stories/AD/HSD/CD/Epidemic_Alert_ and_Response/MAPS/influenza_a_h1n1_map_eng_june16.jpg 13

14. 14 2009 H1N1 Flu – CDC Briefing CDC Briefing May 5, 2009: The good news is this virus does not seem to be as severe as we once thought it could be based on the very early studies in Mexico Kathleen Sebelius, DHHS Secretary [W]e're still in that period of major uncertainty Dr. David Besser (CDC Acting-Director) 2009 H1N1 vaccine to be developed in anticipation of Fall 2009 flu season 14

15. 15 2009 H1N1 Flu – U.S. Cases 15 CDC. Number of confirmed (N = 394) and probable (N = 414) cases of novel influenza A (H1N1) virus infection with known dates of illness onset --- United States, March 28--May 4, 2009

16. Last Updated: May 7, 2009 Source: CDC Source: CDC http://www.cdc.gov/h1n1flu/http://www.cdc.gov/h1n1flu/HI AK U.S. Cases of 2009 H1N1 Flu – May 7 >10 confirmed cases Legend >1 confirmed case(s) No confirmed cases >50 confirmed cases

17. 17 Last Updated: May 27, 2009 Source: CDC Source: CDC http://www.cdc.gov/h1n1flu/http://www.cdc.gov/h1n1flu/ >10 confirmed cases Legend >1 confirmed case(s) No confirmed cases >50 confirmed cases HI AK U.S. Cases of 2009 H1N1 Flu – May 27

18. 18 U.S. Cases of 2009 H1N1 Flu – June 17 Last Updated: June 17, 2009 Source: CDC Source: CDC http://www.cdc.gov/h1n1flu/http://www.cdc.gov/h1n1flu/ >10 confirmed cases Legend >1 confirmed cases) No confirmed cases >50 confirmed cases HI AK

19. 19 Public Health Law in Real Time Legal Triage

20. 20 Assessing the Role of Law in Emergencies Laws pervade emergency responses at every level of government : They determine what constitutes a public health or other emergency They help create the infrastructure through which emergencies are detected, prevented, and addressed They authorize the performance (or nonperformance) of various emergency responses by a host of actors They determine the extent of responsibility for potential or actual harms that arise during emergencies

21. 21 Assessing the Legal Environment in Emergencies Types of Laws TreatiesConstitutions Statutes RegulationsPolicies Cases Compacts

22. 22 The Convergence of Governments During Major Emergencies Govern- ment InternationalNational State TribalCounty City Community

23. 23 The Convergence of Partners During Major Emergencies Partners Public Health Environment Law Enforcement National Security HospitalsNGOs Private Industries Emergency Management

24. 24 The Convergence of Actors During Major Emergencies Actors Public Health Officials Lab Directors Law Enforcers Federal Agents Health Care Workers Health Administrators VolunteersMilitary

25. 25 Legal Triage Government Partners Actors Laws Legal Triage in PHEs – Public health law in real- time

26. 26 Legal Triage Legal triage refers to the efforts of legal actors and others to construct a favorable legal environment during emergencies through a prioritization of issues and solutions that facilitate legitimate public health responses Hodge, JG, Anderson, ED. Principles and practice of legal triage during public health emergencies. NYU Ann. Surv. Am. L. 2008; 64(2): 249-291.

27. 27 Legal Triage Legal actors and others must be prepared to: assess and monitor changing legal norms during emergencies ; identify legal issues that may facilitate or impede public health responses as they arise; develop innovative, responsive legal solutions to reported barriers to public health responses; explain legal conclusions through tailored communications to planners and affected persons; and consistently revisit the utility, efficacy, and ethicality of legal guidance.

28. 28 State of Emergency Once an emergency has been declared, the legal landscape changes.

29. 29 Emergency Declarations How the legal landscape changes depends on the type of emergency declared

30. 30 Multiple Levels of Emergency Declarations Local State Federal Emergency or Disaster Public Health Emergency or Disaster Public Health Emergency FEMA Emergency HHS Public Health Emergency International WHO PHEIC Emergency Declarations By Intl Govs

31. 31 Multiple Levels of Emergency Declarations Local emergency or disaster Local public health emergency State emergency or disaster State public health emergency Federal FEMA emergency Federal DHHS public health emergency Public health authorities and powers, actors, liabilities, immunities, and other critical legal issues vary depending on the declared emergency International W.H.O. Public Health Emergency of International Concern (PHEIC) International Govts Emergency Declarations

32. 32 Emergency Declarations in the U.S.– State Approaches Before 9/11: Existing state legal infrastructures focused on general emergency or disaster responses All hazards approach After 9/11: Reforms of emergency laws in many states are reformed to address public health emergencies Based in part on the Centers Model State Emergency Health Powers Act (MSEHPA)

33. 33 States That Define Emergency HI AK CA OR WA ID MT TX SD WY NV OK KS NE CO NM AZ UT ND SC MN WI IA MO AR LA VA NC GA FL AL MS IL WV KY TN NY PA IN OH MI DE NJ CT RI MA ME DC MD NHVT PR - (Puerto Rico) VI - (U.S. Virgin Islands) Emergency or similar term defined in state statutes - 39 Data Current as of April 1, 2008

34. Emergency Defined - Florida Emergency" is defined as any occurrence, or threat thereof, whether natural, technological, or manmade, in war or in peace, which results or may result in substantial injury or harm to the population or substantial damage to or loss of property. F.S.A. § 252.34(3) (2005). 34

35. 35 States That Define Disaster HI AK CA OR WA ID MT TX SD WY NV OK KS NE CO NM AZ UT ND SC MN WI IA MO AR LA VA NC GA FL AL MS IL WV KY TN NY PA IN OH MI DE NJ CT RI MA ME DC MD NHVT PR - (Puerto Rico) VI - (U.S. Virgin Islands) Disaster or similar term defined in state statutes - 42 Data Current as of April 1, 2008

36. 36 Disaster Defined - Texas "Disaster" means the occurrence or imminent threat of widespread or severe damage, injury, or loss of life or property resulting from a natural or man- made cause, including fire, flood, earthquake, wind, storm, wave action, oil spill or other water contamination, volcanic activity, epidemic, air contamination, blight, drought, infestation, explosion, riot, hostile military or paramilitary action, other public calamity requiring emergency action, or energy emergency. Tex. Govt Code Ann. § 418.004(1), (3) (Vernon 2003)

37. 37 States That Define Public Health Emergency HI AK CA OR WA ID MT TX SD WY NV OK KS NE CO NM AZ UT ND SC MN WI IA MO AR LA VA NC GA FL AL MS IL WV KY TN NY PA IN OH MI DE NJ CT RI MA ME DC MD NHVT PR - (Puerto Rico) VI - (U.S. Virgin Islands) Public health emergency or similar term defined in state statutes - 26 Data Current as of April 1, 2008

38. Public Health Emergency Defined - MSEHPA Public health emergency: An occurrence or imminent threat of an illness or health condition that (1) is believed to be caused by any of the following: Bioterrorism Appearance of a novel or previously controlled or eradicated infectious agent or biological toxin Natural disaster Chemical attack or accidental release Nuclear attack or accident; and 38

39. Public Health Emergency Defined - MSEHPA (2) poses a high probability of any of the following harms occurring in a large number of the affected population: Death Serious or long-term disability Widespread exposure to infectious or toxic agent posing significant risk of substantial future harm 39

40. 40 Emergency Powers - MSEHPA Government is vested with specific, expedited powers to facilitate emergency responses Individuals are bestowed special protections and entitlements Hospital privileging requirements may be waived Volunteer responders may be protected from civil liability

41. 41 Massachusetts Legislative Activity April 29, 2009: Massachusetts Senate unanimously passed a pandemic flu preparation bill Allows the public health commissioner in a public health emergency to close or evacuate buildings, enter private property for investigations, and quarantine individuals Requires a registry for volunteers that would be activated in an emergency Fines of up to $1,000 for failure to comply with public health orders Massachusetts State Senate Chamber 41

42. 42 States That Define Public Health Emergency and Emergency or Disaster HI AK CA OR WA ID MT TX SD WY NV OK KS NE CO NM AZ UT ND SC MN WI IA MO AR LA VA NC GA FL AL MS IL WV KY TN NY PA IN OH MI DE NJ CT RI MA ME DC MD NHVT PR - (Puerto Rico) VI - (U.S. Virgin Islands) Emergency, disaster, and public health emergency (or similar terms) defined in state Statutes - 27 Data Current as of April 1, 2008

43. 43 Dilemmas of Dual (or Duel) Declarations Triggering of distinct powers and responsibilities under each declaration Assignments of powers to different governmental agencies (e.g., public health agency vs. emergency management agency) lead to overlapping priorities Widely divergent responses and decisions on key issues Compounded in national emergencies when federal, state, and local authorities seek to respond to their specifically-declared emergencies

44. 44 Dilemmas of Dual (or Duel) Declarations : Maryland Assignment of Powers in Maryland: Emergency: Maryland Department of Emergency Management Emergency: Maryland Department of Emergency Management Public Health Emergency: Maryland Department of Health and Mental Hygiene Public Health Emergency: Maryland Department of Health and Mental Hygiene

45. 45 Localities Declaring Emergencies/Disasters/Public Health Emergencies Emergency, Disaster, and Public Health Declarations in Response to H1N1 Los Angeles County Last Updated: June 17, 2009 Disaster Declaration Emergency Declaration Public Health Emergency Declaration Federal DHHS Public Health Emergency Declaration LEGEND Emergency and Public Health Emergency Declarations San Mateo County San Bernardino County Alameda County Sonoma County American Samoa (U.S. Territory) Ventura County San Francisco HI AK

46. 46 State H1N1 Emergency Declarations Timeline *WHO PHEIC Declared April 24, 2009 Ongoing Emergency Declaration

47. 47 Proliferation of Emergency Legal Issues During Legal Triage Global Allocation of Antivirals Quarantine and Isolation International Trade Barriers International Travel Restrictions Legal Triage

48. 48 Legal Triage Challenges: 2009 H1N1 Flu 1.Quarantine Powers Hong Kong, China Quarantine of 71 Mexican nationals 2.International Travel Restrictions Restricted travel to Mexico and U.S. 3.Allocation of Available Antivirals 4.International Trade Restrictions Restricted trade of pork products with Mexico, U.S., and Canada 48

49. 49 International Quarantine Powers Hong Kong: isolation of 71 Mexicans Mexican Foreign Minister Patricia Espinosa: countrymen placed under quarantine despite showing no signs of swine flu… and having no contact with those infected Mexicos President Felipe Calderón:countries acting out of ignorance and disinformation and taking repressive, discriminatory measures. "The task we have carried out was intended purely for the safety of the public and our city.- Liang Banmiam, Chinese Health Bureau Spokesman 49

50. 50 International Travel Restrictions Travel Restrictions Argentina, Peru, Ecuador, and Cuba suspended flights to Mexico China suspended flights from Mexico to Shanghai and Xinhua UN Secretary-General Ban Ki-moon: asked governments to reverse trade and travel restrictions unless they have a clear scientific basis for doing so [S]uch restrictions are unlikely to prevent the spread of the disease while disrupting the functioning of the world community. – David Navarro, Senior UN Coordinator for Influenza 50

51. 51 Allocation of Available Antivirals WHO DG Dr. Margaret Chan called for more donations of antiviral drugs to global stock More antivirals are needed to prepare a global response to the spread of H1N1 now and in the future Pharmaceutical companies may be willing to donate over possibility of outsourcing products Relenza: GlaxoSmithKline, England Tamiflu: Roche AG, Switzerland 51

52. 52 International Trade Restrictions Ban of live pig and pork imports Russia, China, and Ecuador: Russia, China, and Ecuador: banned pork products from Mexico and U.S. WTO SPS Agreement: WTO SPS Agreement: allows countries to suspend imports of food for health and safety reasons WTO: WTO: No justification for the imposition of trade restrictions on account of 2009 H1N1 Flu U.S. Meat Export Federation: recent bans have cut U.S. pork exports 8-10% 52

53. 53 Use of Revised International Health Regulations (IHRs) (2007)* Planning Provisions that member states are required to follow: Establishing a National IHR Focal Point for communication with WHO Meeting core capacity requirement for disease surveillance Timely reporting to WHO of any incident that might be considered a PHEIC Responding to additional requests for information from WHO Notification March 18, 2009: Mexico alerts authorities in a timely fashion to an unusual number of cases of influenza-like illness Authorities notify PAHO according to recommendations in IHR Focal Points of a potential PHEIC * Katz R. Use of revised international health regulations during influenza A (H1N1) epidemic. Emerg Infect Dis. 2009 Aug; [Epub ahead of print]

54. 54 Use of Revised IHRs Determination of a PHEIC Following announcement of PHEIC, WHO proposes that nations increase their active surveillance for unusual outbreaks of influenza-like illness Ongoing Communication WHO maintains constant contact with the National IHR Focal Points PAHO coordinates communications between the U.S., Mexico, and Canada National IHR Focal Points globally supply daily reports of confirmed and suspected cases to WHO WHO communicates with all member states through the National IHR Focal Points and online to share recommendations for action

55. 55 Coordinated Response WHO, PAHO, and CDC experts meet in Mexico to support Mexicos efforts in all facets of surveillance, mitigation, and response to H1N1 and report daily to WHO and PAHO WHO and PAHO arrange ~490,000 treatments to be shipped to Mexico and other countries in the Americas The U.S. and other countries with confirmed cases share isolates and sequences of the virus with the international community Pandemic Phases WHO Emergency Committee convenes several times, recommending increases in WHO pandemic phase levels due to changing circumstances, eventually increasing to Phase 6 as the virus spreads globally Use of Revised IHRs

56. 56 2009 H1N1 (Swine Flu) Information For updated information on swine flu, please visit: Centers H1N1 (Swine Flu) Legal Preparedness and Response: http://www.publichealthlaw.net/Projects/swinefluphl.php WHO: http://www.who.int/csr/disease/swineflu/en/index.htmlhttp://www.who.int/csr/disease/swineflu/en/index.html Special thanks to Craig Jaques, Centers Researcher, for his research and contributions to this presentation