Transcript IHR - Erasmus Observatory on Health Law

IHR
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An Overview of the International
Health Regulations
And the Pandemic Influenza Preparedness
Framework
Professor Allyn Taylor
Georgetown Law
IHR Implementation Course
Learning Objectives
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At the end of this session, you will:
• Have a broad understanding of the history of international efforts to
control the global spread of infectious diseases; and
• Have an understanding of the underlying rationale, structure and key
provisions of IHR (2005), including:
• Objective and scope
• Significant obligations of States Parties
• Major responsibilities of WHO
• Have an understanding of the impact of the IHR on state practice
and some of the major limitations of the IHR as a legal instrument.
• Have a broad understanding of the 2011 Pandemic Influenza
Preparedness (PIP) Framework and how this agreement may
influence future implementation of IHR.
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Outline of the Lecture
1.
Introduction
2.
History of international cooperation to
control the global spread of infectious
diseases
3.
The globalization of infectious diseases
and the road to the IHR (2005)
4.
Overview of IHR (2005)
5.
Key obligations of States Parties under
the IHR (2005)
6.
Major responsibilities of WHO under the
IHR (2005)
7.
Conclusion of IHR and 2011 PIP
Framework
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Slide 2 of 30
Introduction: History of International Efforts to Control the
Global Spread of Infectious Diseases
Venetian Trading Ships, 17th Century
Source: Museo Correr, Venice / Erich Lessing / Art Resource,
available at
http://www.saudiaramcoworld.com/issue/200802/east.meets.w
est.in.venice.htm (last visited Feb. 10, 2010).
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Trade in a Seaport of the
Mediterranean About the Time of
Marco Polo
Source: Giclee Print, available at
http://italophiles.com/marcopolo.htm (courtesy
of allposters.com) (last visited Feb. 10, 2010).
Slide 3 of 30
History of International Efforts to Control the Global
Spread of Infectious Diseases: Black Death
Source: Decameron Web (a project of the Italian Studies Department’s
Virtual Humanities Lab at Brown University), Trade Routes that Brought
the Plague to Italy, available at
http://www.brown.edu/Departments/Italian_Studies/dweb/images/plagu
e/plague_routes.jpg (last visited Feb. 6, 2010)
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Etching by Paulus Furst of
Nuremburg, Germany,
1956
Slide 4 of 30
History of International Efforts: Smallpox spreads to
the Americas in the 16th Century
Mexican Emperor Montezuma II receiving
Cortés and the Spanish in 1518.
Source: Available at http://reformation.org/mexicans.html
(last visited Feb. 10, 2010).
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Aztec smallpox victims in the Sixteenth Century
Source: Historia De Las Cosas de Nueva Espana, Volume 4,
Book 12, Lam. cliii, plate 114. Peabody Museum of
Archaeology and Ethnology, Harvard University.
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History of International Efforts: 1918 Spanish Influenza
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Slide 6 of 30
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History of International Organization for Infectious
Disease Control
In 1851, the first International
Sanitary Conference is held in
Paris to draft uniform
quarantine measures for all
Mediterranean ports
1825
1850
1875
In 1838, the Conseil Supérieur de Santé
(Superior Council of Health) of
Constantinople is established to supervise
the sanitary regulation of the Turkish port
in order to prevent the spread of cholera
between Asia to Europe
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In 1902, the
International
Sanitary
Bureau of the
Americas is
formed
1900
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In 1923, the
Health
Organization
of the
League of
Nations is
formed
1925
In 1907, the
Parisian L’Office
International
D’Hygiene
Publique is
established
1950
In 1948, the
World Health
Organization is
established
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History of International Organization for Infectious Disease
Control: WHO and the International Health Regulations
In 1969,
WHO
adopts the
International
Health
Regulations
In 1948, the
World Health
Organization
(WHO) is
established
1950
1960
In 1951, WHO
adopts the
International
Sanitary
Regulations
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1970
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In 2005,
the new
IHR are
adopted
1980
1990
2000
In 1981, the IHR
are amended to
include only 3
diseases.
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The Road to the Adoption of the IHR (2005): The
Globalization of Infectious Diseases
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The Road to the Adoption of the IHR (2005): Globalization
of Infectious Diseases
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The Road to the Adoption of the New IHR (2005):
Globalization Highlights Weaknesses of the Old IHR (1969)
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IHR (1969):
• Applied directly to only 3
diseases (cholera,
plague and yellow fever).
• Emphasized sanitary
conditions, services and
procedures to be
maintained at frontiers
and borders.
• Were routinely ignored
by States Parties.
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Slide 11 of 30
The Road to the New IHR (2005): SARS and the
Emergence of Global Health Security Concerns
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Overview of the IHR (2005): Legal Significance of
WHO Regulations
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• IHR (2005) were adopted by World
Health Assembly in May 2005 and
entered into force in June 2007.
• IHR (2005) were adopted pursuant
WHO Constitution Article 21
regulatory authority.
• Regulations automatically enter
into force and are binding
international law for all Member
States, except those that notify the
WHO Director-General.
• National ratification is not required.
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Slide 13 of 30
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Overview of IHR (2005): Basic Legal Characteristics
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• Global scope of IHR (2005): Today the Regulations are legally
binding upon 194 states worldwide.
• More countries are States Parties to the IHR (2005) than there are Members of
the United Nations.
• IHR (2005) are legally binding upon the entire national
government:
• The IHR (2005) are legal obligation of the entire national government, not just
one ministry or sub-division.
• States Parties to IHR (2005) have a legal obligation to
implement all commitments contained in the Regulations:
• IHR commitments are subject to immediate implementation.
• One exception: there is a five year phase-in until 2012 for technical core
capacities development. (Annex 1)
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Overview of IHR (2005): Underlying Purpose and
Paradigm Shift
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The purpose and scope of these Regulations is to
prevent, protect against, control, and provide public
health responses to the international spread of disease
in ways commensurate with and restricted to public
health risks, while avoiding unnecessary interference
with international traffic and trade. (Article 2)
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Overview of the IHR (2005): Revolutionary Approach to
Global Infectious Disease Control
Core Provisions
IHR (1969)
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IHR (2005)
Scope
Cholera, plague and yellow
fever.
Apply to any broadly defined “event.” An “event”
must be reported to WHO when it may constitute a
“Public Health Emergency of International Concern”
(PHEIC).
Communication and
Notification
National health
administration reports to
WHO within 24 hours.
A designated National IHR Focal Point must report
potential PHEIC to WHO within 24 hours. There is a
range of other reporting obligations.
National Capacity
Disease inspection and
controls at points of entry.
Core capacity requirements for surveillance and
response as well as disease inspection and controls
at points of entry.
Global Coordination
No mechanism for global
coordination.
WHO to provide global coordination of PHEIC,
including dissemination of information necessary to
enable response to public health risk.
Reporting and
Verification
Self-reporting from States
Parties.
In addition to state self-reporting, WHO may request
additional information and consider information from
other States Parties and non-official sources.
Human Rights
Silent.
Mandates implementation of IHR with full respect for
human rights, human dignity and fundamental
freedoms.
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Overview of the IHR (2005): Broad Scope
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Event: “a manifestation of disease or an occurrence that
creates the potential for disease.”
Disease: “an Illness or medical condition, irrespective of
origin or source, that presents or could present significant
harm to humans.”
Event may be:
•
•
•
Biological/infectious, chemical, radio-nuclear;
Known or unknown, emerging or re-emerging; or
Transmissible by vectors, persons, goods, environment, etc.
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Overview of the IHR (2005): State Parties’ Obligations
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The IHR (2005) establish 6 main tasks that States Parties must undertake:
1) Establish a National IHR focal point which is available all of the time for official
information exchange with WHO;
2) Provide a range of information to WHO, including the occurrence of events which
may constitute a Public Health Emergency of International Concern (PHEIC);
3) Develop and ensure certain minimum core national surveillance and response
capacities;
4) Implement point of entry provisions;
5) Limit the imposition of excessive measures on international trade and protect
human rights; and
6) Comply with duties of international cooperation.
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(1) National Obligations under IHR (2005):
National IHR Focal Points
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•
States Parties must designate or establish a National IHR Focal Point that is
available at all times for communication with WHO IHR Contact Points. (Article
4.1 and 4.2)
•
The National IHR Focal Point is also responsible for disseminating information
nationally. (Article 4.2) The Focal Point must ensure coordination among all
relevant ministries and sectors of the State Party government.
•
The National IHR Focal Point is designed to facilitate rapid sharing of surveillance
information. By linking national IHR focal points through WHO, IHR (2005)
establishes a global network that improves the real-time flow of surveillance
information and responses from the local to the global level and also among
States Parties.
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(2) National Obligations Under IHR (2005): Notification and
Public Health Emergencies of International Concern (PHEIC)
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States Parties have a duty to notify potential PHEIC to WHO in a timely manner.
Always Notifiable Events
Potentially Notifiable Events
WHO must be immediately notified of
Assess these events using the Annex 2 decision
these, irrespective of the context in which algorithm to determine whether to notify WHO.
they occur.
Events including:
A single case of:
Cholera;
Smallpox;
Pneumonic plague;
Poliomyelitis (via wild type poliovirus);
Yellow fever;
Human influenza caused by a new
Viral hemorrhagic fevers;
subtype;
Other epidemic-prone diseases of special national
Severe acute respiratory syndrome
or regional concern;
(SARS).
Other biological, radiological or chemical events
when the events “have demonstrated the ability to
cause serious public health impact and to spread
rapidly internationally.”
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Is an Event Notifiable as a Potential Public Health
Emergency of International Concern? Decision Instrument
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Criteria for potentially notifiable
events:
(1) Is the public health impact of the event
serious?
(2) Is the event unusual or unexpected?
(3) Is there a significant risk of
international spread?
(4) Is there a significant risk of
international travel or trade restrictions?
If the answer is "yes" to any two of
these questions, States Parties are
required to notify the event within 24
hours to WHO.
WHO makes the final determination
if a PHEIC exists.
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Slide 21 of 30
IHR (2005) Reporting Duties: Timeliness and Scope
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•
National-level assessments of events, to determine if they are potential PHEICs, with the
decision instrument must be completed within 48 hours. States Parties must report potential
PHEIC to WHO within 24 hours of assessment and respond to requests for verification from
WHO within 24 hours. (Annex 1, Articles 6.1 and 10.2)
•
Following reporting of an event that may constitute a PHEIC, States Parties must continue to
communicate to WHO timely and detailed information on the event and health measures (e.g.,
quarantine) that are implemented in response. WHO must also be informed within 48 hours of
the implementation of additional health measures that interfere with international trade and
travel, unless the WHO Director-General has recommended such measures. (Articles 6.1, 43.3)
•
States Parties should consult with WHO on appropriate health measures for events that do not
meet the criteria for formal notification, but may still be of public health relevance. (Article 8)
•
States Parties, as far as is practicable, must inform WHO
within 24 hours of receipt of evidence of any public health
risk identified outside their territories that may cause
international disease spread, as manifested by exported
or imported human cases, through vectors that may carry
infection or contamination, or contaminated goods.
Image Source: http://www.libforall.org/photos/Global%20Network%20Web%20Image.02.JPG
(Article 9.2)
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(3) National Obligations under IHR (2005): Surveillance
and Response Capacities (Annex 1)
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States Parties must strengthen and maintain the capacity to rapidly detect, report
and respond to public health risks and PHEIC.
Source: M. Baker & D. Fidler, Global Public Health Surveilliance under New International Health Regulations 12 (7) Emerging Infectious Diseases (2006)
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(4) National Obligations Under IHR (2005): Provisions
Related to Points of Entry
•
Routine and emergency public health measures and required health
documents at points of entry are necessary to:
(i) ensure that conveyances and facilities at airports, ports and
ground crossings are kept free from sources of infection; and
(ii) mitigate the potential for international spread of disease.
•
States Parties are required to designate airports and ports and may
designate certain ground crossings to develop the capacities
provided for in Annex 1 of the IHR (2005).
•
States Parties are required to identify the competent authorities to
carry out:
(i) development of core capacities at designated points of entry;
and
(ii) implementation at points of entry of appropriate levels of
hygiene and sanitation, including effective vector, rodent and
environment control measures and procedures.
•
WHO has developed an assessment tool to assist countries in
assessing core capacities at designated airports, ports and ground
crossings.
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(5) National Obligations Under IHR (2005): Limitation of
Excessive Measures on Trade, Travelers and Persons
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•
Discouraging States Parties from implementing "excessive” measures is a crucial
aspect of the IHR (2005). Unjustified health measures have important economic and
human rights implications, and undermine national implementation of the IHR (2005).
•
The IHR (2005) recognizes that states have, in accordance with international law ,
the sovereign right to legislate and implement legislation in pursuance of their health
policies. However, the IHR incorporate a variety of mechanisms to discourage
unjustified imposition of excessive measures on trade, travel and persons.
•
In general, the Regulations do not preclude states from implementing health
measures, in accordance with international law, in response to public health risks
that achieve the same or greater protection of WHO recommendations as long as the
measures meet requirements of principle (i.e., based on scientific principles, not
more restrictive of international traffic and nor more intrusive or persons than
reasonably available alternatives) and process (notifications to WHO) (Article 43).
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Limitations on Imposition of Excessive Measures:
Protection of Human Rights under IHR (2005)
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• The first principle of the IHR (2005) requires full
respect for dignity, human rights and fundamental
freedoms of persons. (Article 3.1)
• The IHR (2005) include multiple provisions that
are protective of the interests of individuals who
may be subject to public health measures. Such
provisions include:
•
•
•
Health measures relating to entry of travelers within the
territory of state (e.g., medical exams, vaccination or other
prophylaxis) (Article 31);
Treatment of travelers (respect for gender, socio-cultural,
ethnic and religious concerns as well as provision of basic
conditions, including: adequate food, water and
accommodation) (Article 32); and
Treatment of personal data. (Article 45)
Source: denvergov.org
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(6) National Obligations Under IHR (2005): International
Cooperation and Assistance
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States Parties are required to collaborate with each other,
to the extent possible, in:
• Detecting, assessing and responding to events under the IHR
(2005);
• Providing or facilitating technical cooperation and logistical
support;
• Mobilizing financial resources to facilitate implementation of IHR
(2005); and
• Formulating proposed laws and other legal and administrative
provisions for the implementation of the IHR (2005). (Article 44)
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WHO’s Major Responsibilities Under IHR (2005)
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• Coordinate global surveillance and assessment of significant public health
risks and disseminate public health information to States Parties.
• Determine whether particular events constitute a PHEIC (with advice from
external experts).
• Develop and recommend measures for use by States Parties during a
PHEIC (after consultation with external experts).
• Provide direct support to States Parties by:
•
•
•
supporting states in assessing and strengthening their core public health capacities
for surveillance and response and at designated ports of entry;
mobilizing financial resources to support developing countries in strengthening such core
public health capacities; and
providing technical assistance to states in their responses to PHEIC.
• Monitor and evaluate implementation of IHR (2005) and adopt technical
guidelines to address evolving needs.
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WHO to help countries
managing events
• WHO Temporary and Standing Recommendations
• WHO Regional Alert and Response teams
• Train countries’ NFPs and WHO contact points for event
management
• New WHO Global Event Management System
• Expand Global Outbreak and
Alert Response Network
GOARN and other specialized
and regional support networks
• Develop new tools and standard
operating procedures
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WHO system of Global Outbreak Alert and
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Response Network GOARN Operations
Event
Intelligence
Official, State
sources
Verification
WHO HQ, Regional & Country
Offices, Collaborators
and experts
Risk Assessment
Response
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Global Outbreak Alert
and Response Network
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IHR (2005) – A Triumph of Global Health Governance Over
State Sovereignty?
Lessons from H1N1 (2009)
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May 2011 Report of the Review Committee on the
Functioning of the IHR in Relation to Pandemic (H1N1)
2009: The Limitations of Global Governance
•
•
•
The IHR helped make the world better prepared to cope with public – health
emergencies.
The core national and local capacities called for in the IHR are not yet fully
operational and are not now on a path to timely implementation worldwide.
The world is ill-prepared to respond to a severe influenza pandemic or to any
similarly global, sustained and threatening public-health emergency.
[Source, Report of the Review Committee on the Functioning of the IHR (2005)
and on Pandemic Influenza A (H1N1) 2009, WHA A64/10 (May 2011)]
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IHR (2005) and the Underdevelopment of Core
Surveillance Capacities: The Limitations of Global
Health Governance
•
66% (128) State Parties responded to a recent questionnaire on their
progress:
– Only 58% of respondents have developed national plans to meet core
capacity requirements; and
– Only 10% of respondents have fully established capacities as envisaged
by the IHR.
•
Anecdotally, WHO officials report that WHO does not receive timely
notifications of potential PHEIC:
– On average, WHO receives 2-3 reports of potential PHEIC per month.
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Global Influenza Surveillance
Network (GISN)
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• WHO's Global
Influenza
Surveillance and
Response System
– 136 National
Influenza Centers
(NICs)
– 6 WHO Collaborating
Centers (CCs) and 4
Essential Regulatory
Laboratories (ERLs)
– 12 WHO H5
Reference
Laboratories (ad hoc
internal network)
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Source: WHO Global Health Observatory Map Gallery
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Indonesia, GISN and Virus Sharing I
•
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In December 2006 Indonesia
announces that it will no
longer share virus samples of
H5N1 in an effort to force a
fundamental restructuring of
GISN
Source: WHO Global Health Observatory Map Gallery
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Market-Based Structural Challenges to
Equitable Access to Vaccines
•
–
For decades the only major purchasers of seasonal influenza vaccines have generally been
high-income countries led by the United States, the United Kingdom, Australia, Japan, France
and Canada
Consequence is that bulk of manufacturing capacity is in 9 countries.
Many high-income nations have secured advanced purchase agreements with vaccine
producers
–
–
•
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Lack of demand for seasonal influenza vaccine limits overall vaccine production
capacity
–
•
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Consequence: LMICS do not have access until needs of high-income countries met and well
after pandemic has commenced
Overcoming this hurdle requires rescinding and renegotiating agreements contrary to interests
of high-income countries
Existing vaccine production relies upon a diverse array of pubic and private actors with
considerably different interests and priorities:
–
–
–
34 companies in 19 countries control the world’s entire influenza production capacity (2009)
As of 2011 total annual capacity is 876 million doses with 7 largest companies controlling 64%
of the stock
WHO has launched a new plan to increase supply in developing countries, but progress to
expand capacity and production slow.
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WHO Pandemic Influenza Preparedness Framework for IHR
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Sharing of Influenza Viruses and Access to Vaccines and
Other Benefits (2011)
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 Objective (Art. 2) to improve pandemic
preparedness and response by
strengthening the WHO global influenza
and response systems (GISR) “with the
objective of a fair, transparent, equitable,
efficient, effective system for, on an equal
footing:
 (i) the sharing of H5N1 and other
influenza viruses with human pandemic
potential: and
 (ii) access to vaccines and sharing of
other benefits.“
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Source: denvergov.org
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WHO Pandemic Influenza Preparedness Framework:
Key Features
 Member States should share samples with WHO in a
rapid, systematic and timely manner
 By doing so, they agree to onwards transfer and use,
subject to provisions of the ‘Standard Material Transfer
Agreements’
 Directs WHO Director-General to put in place a
traceability mechanism in order to track in real time and
report movements of samples into, within and outside of
WHO system.
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WHO Pandemic Influenza Preparedness Framework:
Key Features of PIP Benefit Sharing System
 The Framework establishes a benefit sharing system that aims
to:
 Provide pandemic surveillance and risk assessment and early
warning information to all countries.
 Provide benefits, including capacity building in pandemic influenza
surveillance and prioritize benefits such as access to antiviral
medications and vaccines to developing countries and particularly
affected countries.
 Capacity building through technical assistance and transfer of
technology, skills, know-how and expanded vaccine production
capacity.
 Concrete provisions:
 DG to establish an a stockpile of 150 million doses of H5N1 vaccines
and other influenza virus vaccines and antiviral medications.
 Influenza vaccine, diagnostic and pharmaceutical manufacturers
using the WHO GISRS will make an annual partnership contribution
to WHO for improving global pandemic influenza response
equivalent to 50% of the operating costs of the network.
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WHO Pandemic Influenza Preparedness Framework:
Equitable benefit sharing?
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 States should urge pharmaceutical companies to set aside a portion of
each production cycle to developing countries
 States should urge manufacturers to implement tiered pricing, taking into
account the economic situation of each country to increase affordability
 States should urge pharmaceutical companies to transfer technologies to
the benefit of developing countries
 States and other stakeholders are encouraged to consider making
donations and in kind contributions for improving global preparedness and
response
 States are urged to continue and increase their support to strengthen
laboratory and surveillance capacity particularly in developing countries by
providing adequate financial and technical support
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WHO Pandemic Influenza Preparedness Framework:
Standard Material Transfer Agreements (SMTA)
 Two types:
 SMTA 1: used to govern transfers within the WHO
GISRS.
 SMTA 2: used to govern onwards transfers from
WHO to entities outside the system (i.e.
pharmaceutical industry).
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Standard Material Transfer Agreement II (SMTA II)
How much remains to be
negotiated?
Articles on: liability and
indemnity, warranties,
duration, termination,
governing law and
dispute resolution all
remain simply ‘to be
agreed by the parties,’
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WHO Pandemic Influenza Preparedness Framework
and Global Infectious Disease Surveillance:
Final Remarks
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