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
1
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
2
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
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
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
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 influenzalike illness starting March 18,
2009
•
Mexican authorities initially
assumed this surge to be a “lateseason 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
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
WHO Pandemic Influenza Phases
Current Pandemic Influenza Phase (as of June 15, 2009): Phase 6
8
WHO Pandemic Influenza Phases
World Health Organization Pandemic Influenza Phases (2009)
Pandemic
Influenza Phase
Characterization of Phase
Public 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
9
WHO Confirmed Cases: 2009 H1N1 Flu
10
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
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
12
2009 H1N1 Flu Case Updates– June 17, 2009
Mexico: 6,241 laboratory
confirmed human cases of
infection, including 108 deaths
(Source: WHO)
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
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
2009 H1N1 Flu – U.S. Cases
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
15
U.S. Cases of 2009 H1N1 Flu – May 7
HI
AK
Legend
No confirmed cases
>1 confirmed case(s)
>10 confirmed cases
>50 confirmed cases
Last Updated: May 7, 2009
Source: CDC http://www.cdc.gov/h1n1flu/
U.S. Cases of 2009 H1N1 Flu – May 27
HI
AK
Legend
No confirmed cases
>1 confirmed case(s)
>10 confirmed cases
Last Updated: May 27, 2009
Source: CDC http://www.cdc.gov/h1n1flu/
>50 confirmed cases
17
U.S. Cases of 2009 H1N1 Flu – June 17
HI
AK
Legend
No confirmed cases
>1 confirmed cases)
>10 confirmed cases
Last Updated: June 17, 2009
Source: CDC http://www.cdc.gov/h1n1flu/
>50 confirmed cases
18
Public Health Law in Real Time
Legal Triage
19
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
20
Assessing the Legal Environment in
Emergencies
Treaties
Compacts
Cases
Constitutions
Types of
Laws
Policies
Regulations
21
Statutes
The Convergence of Governments
During Major Emergencies
International
National
Community
Government
City
State
Tribal
County
22
The Convergence of Partners During
Major Emergencies
Emergency
Management
Private
Industries
Public
Health
Partners
NGOs
Hospitals
23
Environment
Law
Enforcement
National
Security
The Convergence of Actors
During Major Emergencies
Military
Volunteers
Health
Administrators
Public Health
Officials
Actors
Health Care
Workers
24
Lab
Directors
Law
Enforcers
Federal
Agents
Legal Triage
Government
Laws
Legal Triage
in PHEs –
Public health
law in realtime
Partners
Actors
25
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.
26
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.
27
State of Emergency
Once an emergency has
been declared, the legal
landscape changes.
28
Emergency Declarations
How the legal landscape changes depends
on the type of emergency declared
29
Multiple Levels of Emergency Declarations
International
Federal
WHO
PHEIC
State
Local
Emergency
Public
or
Health
Disaster
Emergency
Emergency
Public
or
Health
“HHS”
“FEMA”
Public
Emergency
Health
Emergency
Disaster Emergency
30
Emergency
Declarations
By Intl Govs
Multiple Levels of Emergency Declarations
International Govts Emergency Declarations
International W.H.O. Public Health
Emergency of International Concern (PHEIC)
Federal “DHHS” public health emergency
Federal “FEMA” emergency
State public health emergency
State emergency or disaster
Local public health emergency
Local emergency or disaster
Public health authorities and powers, actors, liabilities, immunities, and
other critical legal issues vary depending on the declared emergency
31
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)
32
States That Define “Emergency”
HI
WA
VT NH
AK
MT
ME
ND
MN
OR
ID
SD
WI
WY
UT
CA
AZ
PA
IA
NE
NV
IL
CO
KS
OK
NM
MO
KY
NJ
DE
MD
DC
NC
AR
SC
AL
GA
LA
FL
“Emergency” or similar term
defined in state statutes - 39
Data Current as of April 1, 2008
WV VA
TN
MS
TX
OH
IN
MA
RI
CT
NY
MI
PR - (Puerto Rico)
VI - (U.S. Virgin Islands)
33
“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
States That Define “Disaster”
HI
WA
VT NH
AK
MT
ME
ND
MN
OR
ID
SD
WI
WY
CA
IL
UT
AZ
PA
IA
NE
NV
CO
KS
OK
NM
MO
KY
NJ
DE
MD
DC
NC
AR
SC
AL
GA
LA
FL
“Disaster” or similar term
defined in state statutes - 42
Data Current as of April 1, 2008
WV VA
TN
MS
TX
OH
IN
MA
RI
CT
NY
MI
PR - (Puerto Rico)
VI - (U.S. Virgin Islands)
35
“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 manmade 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)
36
States That Define
“Public Health Emergency”
HI
WA
VT NH
AK
MT
ME
ND
MN
OR
ID
SD
WI
WY
CA
UT
AZ
PA
IA
NE
NV
IL
CO
KS
OK
NM
MO
KY
NJ
DE
MD
DC
NC
AR
SC
AL
GA
LA
FL
“Public health emergency”
or similar term defined in
state statutes - 26
Data Current as of April 1, 2008
WV VA
TN
MS
TX
OH
IN
MA
RI
CT
NY
MI
PR - (Puerto Rico)
VI - (U.S. Virgin Islands)
37
“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
 Natural disaster
 Appearance of a novel
or previously controlled
or eradicated infectious
agent or biological
toxin
 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
Emergency Powers - MSEHPA
Individuals are
bestowed special
protections and
entitlements
Government is
vested with
specific, expedited
powers to facilitate
emergency
responses
Hospital
privileging
requirements
may be
waived
Volunteer
responders
may be
protected from
civil liability
40
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
41
Massachusetts State Senate Chamber
States That Define “Public Health
Emergency” and “Emergency” or “Disaster”
HI
WA
VT NH
AK
MT
ME
ND
MN
OR
ID
SD
WI
WY
CA
UT
AZ
PA
IA
NE
NV
IL
CO
KS
OK
NM
MO
KY
“Emergency”, “disaster”, and
“public health emergency” (or
similar terms) defined in state
Statutes - 27
Data Current as of April 1, 2008
WV VA
NJ
DE
MD
DC
NC
TN
AR
SC
MS
TX
OH
IN
MA
RI
CT
NY
MI
AL
GA
LA
FL
PR - (Puerto Rico)
VI - (U.S. Virgin Islands)
42
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
43
Dilemmas of Dual (or Duel)
Declarations: Maryland
Assignment of Powers in Maryland:
 Emergency: Maryland Department of
Emergency Management
 Public Health Emergency: Maryland
Department of Health and Mental
Hygiene
44
Emergency, Disaster, and Public Health
Declarations in Response to H1N1
HI
AK
Sonoma County
Alameda County
San Francisco
San Mateo County
San Bernardino County
Ventura County
Los Angeles County
LEGEND
Federal DHHS Public Health
Emergency Declaration
Emergency Declaration
American Samoa
(U.S. Territory)
Disaster Declaration
Public Health Emergency Declaration
Emergency and Public Health Emergency Declarations
Localities Declaring Emergencies/Disasters/Public
Health Emergencies
Last Updated: June 17, 2009
45
State H1N1 Emergency Declarations Timeline
VA
2
3
CA
52
3
OH
State
54
46
4
TX
Days after WHO
Declared PHEIC
(Days)
Duration of
Emergency
Declaration (Days)
31
WI
5
51
NE
5
51
7
IA
0
Ongoing Emergency
Declaration
30
10
*WHO PHEIC Declared
April 24, 2009
20
30
40
50
Duration of Emergency Declaration (Days)
46
60
Proliferation of Emergency Legal
Issues During Legal Triage
Quarantine and
Isolation
International
Trade Barriers
Legal
Triage
International
Travel Restrictions
Global Allocation of
Antivirals
47
Legal Triage Challenges: 2009 H1N1 Flu
1. Quarantine Powers
2.

Hong Kong, China

Quarantine of 71 Mexican nationals
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
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
•
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
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
Allocation of Available Antivirals
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
International Trade Restrictions
Ban of live pig and pork imports
•
Russia, China, and Ecuador:
banned pork products from
Mexico and U.S.
•
WTO SPS Agreement: allows
countries to suspend imports of
food for health and safety reasons
•
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
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]
53
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
54
Use of Revised IHRs
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
55
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
56