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.

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 Public’s Health: A Collaborative at Johns Hopkins and Georgetown Universities

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

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

2009 H1N1 Flu Epidemiology2009 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


• 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


• 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

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

WHO Pandemic Influenza PhasesWHO Pandemic Influenza Phases

Current Pandemic Influenza Phase (as of June 15, 2009): Phase 6

8

9

WHO Pandemic Influenza Phases

World Health Organization Pandemic Influenza Phases (2009)

Pandemic Influenza Phase Characterization of Phase Public Health Goals

Phase 3Human 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 6Pandemic increased and sustained transmission in general population

Minimize the impact of the pandemic

10

WHO Confirmed Cases: 2009 H1N1 FluWHO Confirmed Cases: 2009 H1N1 Flu

10

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

2009 H1N1 Flu: U.S. Response

April 27, 2009April 27, 2009 - President Barack - President Barack Obama: 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

2009 H1N1 Flu Case Updates– June 17, 20092009 H1N1 Flu Case Updates– June 17, 2009

MexicoMexico: : 6,241 laboratory confirmed human cases of infection, including 108 deaths (Source: WHO)

United StatesUnited 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

2009 H1N1 Flu – CDC Briefing2009 H1N1 Flu – CDC Briefing

CDC Briefing May 5, 2009: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

2009 H1N1 Flu – U.S. Cases2009 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

Last Updated: Last Updated: May 7, 2009May 7, 2009Source: CDC Source: CDC http://www.cdc.gov/h1n1flu/http://www.cdc.gov/h1n1flu/

HIHIAKAK

U.S. Cases of 2009 H1N1 Flu – May 7U.S. Cases of 2009 H1N1 Flu – May 7

>10 confirmed cases

Legend

>1 confirmed case(s)

No confirmed cases

>50 confirmed cases

17

Last Updated: Last Updated: May 27, 2009May 27, 2009Source: 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

HIHIAKAK

U.S. Cases of 2009 H1N1 Flu – May 27U.S. Cases of 2009 H1N1 Flu – May 27

18

U.S. Cases of 2009 H1N1 Flu – June 17U.S. Cases of 2009 H1N1 Flu – June 17

Last Updated: Last Updated: June 17, 2009June 17, 2009Source: 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

HIHIAKAK

19

Public Health Law in Real Time

Legal TriageLegal Triage

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

Assessing the Legal Environment in Emergencies

Compacts

Cases

Policies Regulations

Statutes

Constitutions

Treaties

Types of Laws

22

The Convergence of Governments During Major Emergencies

Community

City

County Tribal

State

National

International

Govern-ment

23

The Convergence of Partners During Major Emergencies

Emergency Management

Private Industries

NGOs

Hospitals

National Security

Law Enforcement

Environment

Public Health

Partners

24

The Convergence of Actors During Major Emergencies

Military

Volunteers

HealthAdministrators

Health CareWorkers

Federal Agents

Law Enforcers

Lab Directors

Public HealthOfficials

Actors

25

Legal Triage

Government

Partners

Actors

Laws

Legal Triage in PHEs – Public health law in real-time

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

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

State of Emergency

Once an emergency has

been declared, the legal

landscape changes.

29

Emergency Declarations

How the legal landscape changes depends on the type of emergency declared

30

Multiple Levels of Emergency Declarations

LocalLocal

StateState

FederalFederal

Emergency

or

Disaster

Public

Health

Emergency

Emergency

or

Disaster

Public

Health

Emergency

“FEMA”

Emergency

“HHS”

Public

Health

Emergency

InternationalInternational

WHO

PHEIC

Emergency

Declarations

By Intl Govs

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

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 Center’s Model State Emergency Health Powers Act (MSEHPA)

33

States That Define “Emergency”

HIHIAKAK

CACA

OROR

WAWA

IDID

MTMT

TXTX

SDSDWYWY

NVNV

OKOK

KSKS

NENE

COCO

NMNMAZAZ

UTUT

NDND

SCSC

MNMN

WIWI

IAIA

MOMO

ARAR

LALA

VAVA

NCNC

GAGA

FLFL

ALALMSMS

ILILWVWV

KYKY

TNTN

NYNY

PAPA

ININ OHOH

MIMI

DEDENJNJ

CTCTRIRI

MAMA

MEME

DCDCMDMD

NHNHVTVT

PR - PR - (Puerto Rico)(Puerto Rico)VI - VI - (U.S. Virgin Islands)(U.S. Virgin Islands)

““Emergency” or similar termEmergency” or similar termdefined in state statutes - 39defined in state statutes - 39

Data Current as of April 1, 2008

“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

States That Define “Disaster”

HIHIAKAK

CACA

OROR

WAWA

IDID

MTMT

TXTX

SDSDWYWY

NVNV

OKOK

KSKS

NENE

COCO

NMNMAZAZ

UTUT

NDND

SCSC

MNMN

WIWI

IAIA

MOMO

ARAR

LALA

VAVA

NCNC

GAGA

FLFL

ALALMSMS

ILILWVWV

KYKY

TNTN

NYNY

PAPA

ININ OHOH

MIMI

DEDENJNJ

CTCTRIRI

MAMA

MEME

DCDCMDMD

NHNHVTVT


““Disaster” or similar term Disaster” or similar term defined in state statutes - 42defined in state statutes - 42


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. Gov’t Code Ann. § 418.004(1), (3) (Vernon 2003)

37

States That Define “Public Health Emergency”

HIHIAKAK

CACA

OROR

WAWA

IDID

MTMT

TXTX

SDSDWYWY

NVNV

OKOK

KSKS

NENE

COCO

NMNMAZAZ

UTUT

NDND

SCSC

MNMN

WIWI

IAIA

MOMO

ARAR

LALA

VAVA

NCNC

GAGA

FLFL

ALALMSMS

ILILWVWV

KYKY

TNTN

NYNY

PAPA

ININ OHOH

MIMI

DEDENJNJ

CTCTRIRI

MAMA

MEME

DCDCMDMD

NHNHVTVT


““Public health emergency” Public health emergency” or similar term defined in or similar term defined in state statutes - 26state statutes - 26


“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

“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

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

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

States That Define “Public Health Emergency” and “Emergency” or “Disaster”

HIHIAKAK

CACA

OROR

WAWA

IDID

MTMT

TXTX

SDSDWYWY

NVNV

OKOK

KSKS

NENE

COCO

NMNMAZAZ

UTUT

NDND

SCSC

MNMN

WIWI

IAIA

MOMO

ARAR

LALA

VAVA

NCNC

GAGA

FLFL

ALALMSMS

ILILWVWV

KYKY

TNTN

NYNY

PAPA

ININ OHOH

MIMI

DEDENJNJ

CTCTRIRI

MAMA

MEME

DCDCMDMD

NHNHVTVT


““Emergency”, “disaster”, andEmergency”, “disaster”, and““public health emergency” (or public health emergency” (or similar terms) defined in state similar terms) defined in state Statutes - 27Statutes - 27


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

Dilemmas of Dual (or Duel) Declarations: Maryland

Assignment of Powers in Maryland:Assignment of Powers in Maryland:

Emergency: Emergency: Maryland Department of Maryland Department of

Emergency ManagementEmergency Management

Public Health Emergency: Public Health Emergency: Maryland Maryland

Department of Health and Mental Department of Health and Mental

HygieneHygiene

45

Localities Declaring Emergencies/Disasters/Public Health Emergencies

Emergency, Disaster, and Public Health Emergency, Disaster, and Public Health Declarations in Response to H1N1Declarations in Response to H1N1

Los Angeles County

Last Updated: June 17, 2009Last Updated: June 17, 2009

Disaster Declaration

Emergency Declaration

Public Health Emergency Declaration

Federal DHHS Public Health Emergency Declaration

LEGENDLEGEND

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

HIHIAKAK

46

State H1N1 Emergency Declarations TimelineState H1N1 Emergency Declarations Timeline

*WHO PHEIC Declared April 24, 2009

Ongoing Emergency Declaration

47

Proliferation of Emergency Legal Issues During Legal Triage

Global Allocation of Antivirals

Quarantine and Isolation

International Trade Barriers

International Travel Restrictions

LegalTriage

48

Legal Triage Challenges: 2009 H1N1 FluLegal Triage Challenges: 2009 H1N1 Flu

1.1. Quarantine PowersQuarantine Powers

Hong Kong, China

Quarantine of 71 Mexican nationals

2.2. International Travel Restrictions International Travel Restrictions

Restricted travel to Mexico and U.S.

3.3. Allocation of Available AntiviralsAllocation of Available Antivirals

4.4. International Trade RestrictionsInternational Trade Restrictions Restricted trade of pork products with Mexico, U.S.,

and Canada

48

49

International Quarantine PowersInternational Quarantine Powers

Hong Kong: isolation of 71 MexicansHong 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

• Mexico’s 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

International Travel RestrictionsInternational Travel Restrictions

Travel RestrictionsTravel 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

Allocation of Available AntiviralsAllocation of Available Antivirals

Allocation of Available AntiviralsAllocation 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

International Trade RestrictionsInternational Trade Restrictions

Ban of live pig and pork imports 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

Use of Revised International Health Use of Revised International Health Regulations (IHRs) (2007)*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

Use of Revised IHRsUse 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

Coordinated Response• WHO, PAHO, and CDC experts meet in Mexico to support

Mexico’s 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 IHRsUse of Revised IHRs

56

2009 H1N1 (Swine Flu) Information

For updated information on swine flu, please visit:

• Center’s H1N1 (Swine Flu) Legal Preparedness and Response:

http://www.publichealthlaw.net/Projects/swinefluphl.php

•WHO: http://www.who.int/csr/disease/swineflu/en/index.html

• Special thanks to Craig Jaques, Centers’ Researcher, for his research and contributions to this presentation

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.

Documents

h1n1 flu slide

h1n1 flu international

h1n1 swine flu

h1n1 flu death

spread of h1n1 influenza

h1n1 vaccine

humans h1n1

pandemic slide