INTERNATIONAL HEALTH REGULATIONS
***********************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>
[1]
Date: 20 May 2005
From: Stephen Apatow <s.m.apatow@humanitarian.net>
Source: Environment News Service [edited]
<http://www.ens-newswire.com/ens/may2005/2005-05-20-01.asp>
World health officials agree to report all major disease outbreaks
-----------------------------------------------
Health ministers and senior officials from 192 countries today [20 May 2005]
agreed to new rules requiring all major public health events of international
concern to be reported to the World Health Organization (WHO). Up until now,
outbreaks of only 3 diseases -- cholera, plague and
yellow fever -- had to be notified to the WHO, but not world's biggest fear:
the start of a global flu pandemic.
The revised International Health Regulations adopted today [20 May 2005]
at the World Health Assembly mean that the WHO will be notified of all major
disease outbreaks, and also notified of suspected bio-terrorism events, such
as the deliberate release of biological pathogens.
The revised regulations require the WHO to assist its members in responding
to such threats and provide a basis for greater international cooperation
in this field. The new rules should come into force in 2007.
International cooperation against infectious disease outbreaks will be strengthened
by the new notification rules, said Markos Kyprianou, European Commissioner
for Health and Consumer Protection. Severe Acute Respiratory Syndrome (SARS)
in 2003 has shown how quickly infectious diseases can spread around the globe,
he said.
Kyprianou said, "The drive to strengthen international cooperation against
future epidemics complements our efforts to reinforce Europe's defenses against
disease. The quicker we are alerted to a disease outbreak, the greater the
chances we can successfully contain it."
"If international cooperation can help stop an epidemic before it really
gets started, the whole world will be better off as a result," he said.
The International Health Regulations were adopted in 1969, and have been
updated twice since then, in 1973 and 1981.
In May 2003, the World Health Assembly agreed to launch a review of the regulations.
The European Commission and the 25 EU member states have played a central
role in negotiating the revision to the regulations agreed by the World Health
Assembly today Kyprianou said.
A system of Europe-wide surveillance and an early warning and response system
against infectious disease has been operational in the European Union since
1998, but now the EU is acting to reinforce its own defenses against infectious
diseases. Later this month [May 2005] in Stockholm, a new EU agency, the
European Centre for Disease Prevention and Control (ECDC), will be officially
launched.
On 27 May [2005], Commissioner Kyprianou, the Swedish Minister for Public
Health and Social Services, Morgan Johansson, and Minister Mars Di Bartolomeo,
on behalf of the Luxembourg Presidency, will inaugurate the ECDC. The inauguration
ceremony will be held at the Karolinska Institute in Stockholm.
This new EU agency will reinforce and develop Europe's disease surveillance
system and will also provide EU policy makers with authoritative scientific
advice on new and emerging health threats.
U.S. Secretary of Health and Human Services Mike Leavitt put the prevention
of a global flu pandemic at the top of his priority list and told reporters
at a briefing in Geneva that implementing the U.S. plan for HIV/AIDS relief
in 15 focus nations is another important U.S. concern.
Completing the eradication of polio worldwide, improving the response to
bioterrorism and developing a better global system for communicating health
information were also cited as priorities.
Leavitt's concerns about a global flu pandemic arise from the widespread
outbreak of bird flu now plaguing 11 Asian nations. Hundreds of millions
of birds have been destroyed to prevent further spread of the H5N1 flu virus.
This strain has also caused illness among about 90 people.
"What concerns us greatly is the fact that there is virtually no human immunity
to this particular strain," Leavitt said. "We're working feverishly to develop
a vaccine. The vaccine is now in clinical trials."
U.S. health officials acknowledged that the vaccine in development might
not provide complete protection from a still-unknown mutation of the H5N1
strain of bird flu virus that could spread among humans and set a pandemic
in motion.
Still, they said, the vaccine now being manufactured provides a head start
should the need arise to develop massive numbers of doses for use in response
to a global pandemic.
Dr. Julie Gerberding, who heads the U.S. Centers for Disease Control and
Prevention, told reporters, "We agree that the question is not if a pandemic
will occur, it is when will the pandemic will occur."
"We don't know when, but right now, the situation that we see in South East
Asia is one that is characterized by a very large amount of virus circulating
widely among poultry and waterfowl and evidence of transmission to people
with a very bad outcome," Gerberding said. "So it is a very
virulent, deadly form of the virus, and we can't afford to take the chance
that this is the one that will become more transmissible to people, so we're
taking all the steps now that we can to try to prevent it from evolving,
but also to be prepared to contain it if it should emerge and protect people
more broadly if that becomes necessary."
The World Health Assembly continues through 25 May 2005.
--
Stephen M. Apatow
President, Director of Research and Development
Humanitarian Resource Institute
<http://www.humanitarian.net>
<s.m.apatow@humanitarian.net>
******
[2]
Date: 21 May 2005
From: ProMED-mail <promed@promedmail.org>
Source: Medical News Today [edited]
<http://www.medicalnewstoday.com/medicalnews.php?newsid=24869#>
Stronger global defenses against epidemics: EU Commissioner welcomes new
WHO agreement
-----------------------------------------------
Markos Kyprianou, European Commissioner for Health and Consumer Protection,
has welcomed the agreement reached at the World Health Assembly today [21
May 2005] to strengthen international cooperation against infectious disease
outbreaks. SARS in 2003 has shown how quickly infectious diseases can spread
around the globe. Health ministers and senior officials from 192 countries
agreed to new rules requiring all major public health events of international
concern to be reported to the World Health Organization (WHO). This would
include major disease outbreaks and also suspected
"bio-terrorism" events (i.e. the deliberate release of biological pathogens).
Cooperation in responding to such events will also be strengthened by the
revised International Health Regulations (IHR) adopted
today. The EU has helped lead the drive to strengthen the IHR. In 2003, the
European Commission was given a mandate to negotiate for this in the WHO
(see IP/03/1282). The EU is also acting to reinforce its own defenses against
infectious diseases. On 27 May 2005 in Stockholm, a new EU agency, the European
Centre for Disease Prevention and Control (ECDC), will be officially launched.
Health and Consumer Protection Commissioner Markos Kyprianou said: "The drive
to strengthen international cooperation against future epidemics complements
our efforts to reinforce Europe's defenses against disease. The quicker we
are alerted to a disease outbreak the greater the chances we can
successfully contain it. If international cooperation can help stop an epidemic
before it really gets started, the whole world will be better off as a result."
The IHR were adopted in 1969 and have been updated twice since then (in 1973
and 1981). In May 2003, the World Health Assembly agreed to launch a review.
The European Commission and the 25 EU Member States have played a central
role in negotiating the revision to the IHR agreed to by the World
Health Assembly today.
Up until now, outbreaks of only 3 diseases -- cholera, plague and yellow
fever -- had to be notified to the WHO. The revised IHR requires national
authorities to notify the WHO of all major public health threats with the
potential to spread. They also require the WHO to assist its members in responding
to such threats and provide a basis for greater international cooperation
in this field. The new rules should come into force in 2007.
European Centre for Disease Prevention and Control
A system of Europe-wide surveillance and an early warning and response system
against infectious disease has been operational in the EU since 1998 (see
MEMO/03/155).
On 27 May [2005], Commissioner Kyprianou, the Swedish Minister for Public
Health and Social Services, Morgan Johansson, and Minister Mars Di Bartolomeo,
on behalf of the Luxembourg Presidency, will inaugurate the European Centre
for Disease Prevention and Control (ECDC). This new EU agency will reinforce
and develop Europe's disease surveillance system. It will also provide EU
policy makers with authoritative scientific advice on new and emerging health
threats. The inauguration ceremony will be held at the Karolinska Institute
in Stockholm.
Further Information
For further information on the EU cooperation against health threats see:
<http://europa.eu.int/comm/health/ph_threats/threats_en.htm>.
--
ProMED-mail
<promed@promedmail.org>
[Acceptance of the revised International Health Regulations (IHR) by the
World Health Assembly (WHA) has been long awaited. While full implementation
is not mandated until 2007, one hopes that earlier implementation will be
effected.
The text of the draft of the revised IHR that was passed by the WHA can be
found at:
<http://www.who.int/gb/ebwha/pdf_files/WHA58/A58_4-en.pdf>.
Supporting documents that were presented to the WHO included a report by
the Secretariat
<http://www.who.int/gb/ebwha/pdf_files/WHA58/A58_41-en.pdf>,
a revision commenting on a member state abstention on articles 7 and 44
<http://www.who.int/gb/ebwha/pdf_files/WHA58/A58_41-en.pdf>,
and proposed changes to the Health Part of the Aircraft General Declaration
as recommended by the Intergovernmental Working Group on Revision of the
IHR at the 2nd session in February 2005
<http://www.who.int/gb/ebwha/pdf_files/WHA58/A58_41Add2-en.pdf>.
(This section addresses the required reporting of suspected illnesses of
international import from airline crews if such illness is observed in passengers
or crew members on a commercial airline flight and reads:
"The following signs and symptoms in a passenger or crew member appearing
obviously unwell, other than those resulting from airsickness or injury,
should be regarded as a reason to suspect the existence of an infectious
disease. The signs and symptoms of illness as described below, as well as
any deaths occurring during the flight, must be reported to the designated
public health authority at destination:
(a) fever accompanied by:
(i) extreme weakness (prostration);
(ii) decreased consciousness;
(iii) glandular swelling;
(iv) yellow color of skin and eyes (jaundice);
(v) persistent cough or shortness of breath;
(vi) unusual bleeding;
(vii) paralysis.
(b) with or without fever:
(i) recent skin rash or eruption;
(ii) persistent or severe vomiting;
(iii) persistent or severe diarrhea;
(iv) convulsion.")
These new regulations markedly expand mandated international collaboration
with respect to disease surveillance, international reporting of disease
occurrence, and investigation and control of outbreaks through international
collaboration.
Article 6 on Notification (page 11) mandates member States to "assess events
occurring within its territory by using the decision instrument in Annex
2. Each State Party shall notify WHO, by the most efficient means of
communication available, by way of the National IHR Focal Point, and within
24 hours of assessment of public health information, of all events which
may constitute a public health emergency of international concern within
its territory in accordance with the decision instrument, as well as any
health measure implemented in response to those events. If the notification
received by WHO involves the competency of the International Atomic Energy
Agency (IAEA), WHO shall immediately notify the IAEA."
Annex 2 (pages 45 - 47) provides a algorithm to be used in the decision tree
for what constitutes a public health emergency of international concern.
The diseases specifically singled out for immediate notification
have been markedly expanded from the preexisting IHR and include: smallpox,
poliomyelitis due to wild-type poliovirus, human influenza caused by a new
subtype and severe acute respiratory syndrome (SARS). It also highlights
any event of potential international public health concern, including those
of unknown causes or sources and those involving other events or diseases
than those listed above; and an event involving the following diseases shall
also lead to the utilization of the algorithm, because they have demonstrated
the ability to cause serious public health impact to spread rapidly internationally:
cholera, pneumonic plague, yellow fever, viral hemorrhagic fevers (Ebola,
Lassa, Marburg), West Nile fever, other diseases that are of special national
or regional concern, e.g. dengue fever, Rift Valley fever, and meningococcal
disease.
Examples of a "suggested" (but not binding) use of the decision tree
for what events should be reported immediately is presented as part of Annex
2:
"Does the event meet at least 2 of the following criteria?
I. Is the public health impact of the event serious?
1. Is the number of cases and/or number of deaths for this type of event
large for the given place, time or population?
2. Has the event the potential to have a high public health impact?
The following are examples of circumstances that contribute to high public
health impact:
- Event caused by a pathogen with high potential to cause epidemic
(infectiousness of the agent, high case fatality, multiple transmission routes
or healthy carrier).
- Indication of treatment failure (new or emerging antibiotic
resistance, vaccine failure, antidote resistance or failure).
- Event represents a significant public health risk even if
no or very few human cases have yet been identified.
- Cases reported among health staff.
- The population at risk is especially vulnerable (refugees,
low level of immunization, children, elderly, low immunity, undernourished,
etc.).
- Concomitant factors that may hinder or delay the public health
response (natural catastrophes, armed conflicts, unfavorable weather conditions,
multiple foci in the State Party).
- Event in an area with high population density.
- Spread of toxic, infectious or otherwise hazardous materials
that may be occurring naturally or otherwise that have contaminated or have
the potential to contaminate a population and/or a large geographical area.
3. Is external assistance needed to detect, investigate, respond and control
the current event, or prevent new cases?
The following are examples of when assistance may be required:
- Inadequate human, financial, material or technical resources,
in particular:
- Insufficient laboratory or epidemiological capacity to investigate
the event (equipment, personnel, financial resources)
- Insufficient antidotes, drugs and/or vaccine and/or protective
equipment, decontamination equipment, or supportive equipment to cover estimated
needs
- Existing surveillance system is inadequate to detect new cases
in a timely manner.
Is the Public Health impact of the event serious?
Answer "yes" if you have answered "yes" to questions 1, 2 or 3 above.
II. Is the event unusual or unexpected?
4. Is the event unusual?
The following are examples of unusual events:
- The event is caused by an unknown agent or the source, vehicle,
route of transmission is unusual or unknown.
- Evolution of cases more severe than expected (including morbidity
or case-fatality) or with unusual symptoms.
- Occurrence of the event itself unusual for the area, season
or population.
5. Is the event unexpected from a public health perspective?
The following are examples of unexpected events:
- Event caused by a disease/agent that had already been eliminated
or eradicated from the State Party or not previously reported.
Is the event unusual or unexpected?
Answer "yes" if you have answered "yes" to questions 4 or 5 above.
III. Is there a significant risk of international spread?
6. Is there evidence of an epidemiological link to similar events in other
States?
7. Is there any factor that should alert us to the potential for cross border
movement of the agent, vehicle or host?
The following are examples of circumstances that may predispose to international
spread:
- Where there is evidence of local spread, an index case (or
other linked cases) with a history within the previous month of:
- international travel (or time equivalent to the incubation
period if the pathogen is known)
- participation in an international gathering (pilgrimage, sports
event, conference, etc.)
- close contact with an international traveler or a highly mobile
population.
- Event caused by an environmental contamination that has the
potential to spread across international borders.
- Event in an area of intense international traffic with limited
capacity for sanitary control or environmental detection or decontamination.
Is there a significant risk of international spread?
Answer "yes" if you have answered "yes" to questions 6 or 7 above.
IV. Is there a significant risk of international travel or trade restrictions?
8. Have similar events in the past resulted in international restriction
on trade and/or travel?
9. Is the source suspected or known to be a food product, water or any other
good that might be contaminated that has been exported/imported to/from other
States?
10. Has the event occurred in association with an international gathering
or in an area of intense international tourism?
11. Has the event caused requests for more information by foreign officials
or international media?
Is there a significant risk of international trade or travel restrictions?
Answer "yes" if you have answered "yes" to questions 8, 9, 10 or 11 above.
States Parties that answer "yes" to the question whether the event meets
any 2 of the 4 criteria (I-IV) above, shall notify WHO under Article 6 of
the International Health Regulations."
Article 9 (page 12) supports the use of unofficial reports on the part of
WHO, which has been in practice since passed by the WHA during the SARS outbreak
in May 2003.
With respect to verification of such unofficial reports of outbreaks, Article
10 (page 13) has the following provision:
"4. If the State Party does not accept the offer of collaboration, WHO may,
when justified by the magnitude of the public health risk, share with other
States Parties the information available to it whilst encouraging the State
Party to accept the offer of collaboration by WHO, taking into account the
views of the State Party concerned."
With respect to dissemination of information received by WHO, Article 11
(pages 13 and 14) has the following provision:
4. When information received by WHO under paragraph 2 of this Article is
made available to States Parties in accordance with these Regulations, WHO
may also make it available to the public if other information about the same
event has already become publicly available and there is a need for the dissemination
of authoritative and independent information."
This provision should permit WHO to put out clarifications when there are
reports appearing in the lay press or on publicly available listserves, such
as ProMED-mail.
With respect to differences of opinion between WHO and a member State on
what constitutes a public health emergency, the IRH permits the Director
General to establish an expert committee composed of experts from the IHR
Expert Roster and representation of the member State to review the situation
(description of this committee, composition, terms of reference and procedures
can be found in Articles 47, 48 and 489 pages 32-33). This section
provides for a formal process of public review and discussion of possible
differences of opinion on what constitutes a public health emergency.
Hopefully, these new IHRs will lead to more rapid international notification
and more rapid investigation and control of disease outbreaks, keeping in
mind that we do live in a global village, and these communicable diseases
have not required Visas to cross borders, extending the geographic boundaries
of outbreaks. - Mod.MPP]
[see also:
1998
----
International Health Regulations (05) 19981006.1977
Official secrets and public health (02) 19980625.1180
International health regulations (04) 19980208.0254
International health regulations, revisions (02) 19980127.0189
International health regulations, revisions 19980124.0177
1997
----
International Health Regulations revisions 19970731.1598
Infected area, definition 19970723.1542]
.............................mpp/msp/mpp
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