TRAINER GUIDE

Optional Content for Module 1:

Introduction to International Health Regulations

Purpose To provide the participants with an introduction to international health

regulations.

Learning At the end of this module, participants will be able to:

Objectives
 explain the main points of international health regulations;

 understand the requirements for quality and biosafety measures

and practices for compliance with the new regulations.

Content  Brief History of International Health Regulations

 Major Changes in IHR (2005)

 Public Health Emergency of International Concern

 Requirements of IHR
 New Formal Requirements for Countries

Introduction to International Health Regulations ● Optional Content Sheet 1

 TRAINER GUIDE

Brief History of International Health Regulations

Role in The purpose and scope of

quality International Health Regulations
management (IHR) is to prevent, protect
system against, control and provide a
public health response to the
international spread of disease and
to establish a single code of
procedures and practices for
routine public health measures.

Adoption of The first International Sanitary conference was organized by France in 1851. From
IHR 2005 1851 to 1938 fourteen conferences were held. The International Sanitary Conferences
were the first international conventions organized in Europe to deal with the arrival
and spread of pestilent diseases, particularly cholera.

The first international regulations were not put in place until the meeting of the World
Health Assembly in 1951. WHO member states approved the first International
Sanitary Regulations (ISR); the aim was to provide protection against the spread of six
infectious diseases - smallpox, typhoid fever, relapsing fever, yellow fever, cholera,
and plague - with a minimum of interference with world traffic. However compliance
with the Regulations has been only partially achieved. In 1969, the Regulations were
revised and renamed the International Health Regulations (IHR). Following further
amendments in 1974 and 1981, the IHR addressed only three diseases: cholera, plague
and yellow fever.

 In 1995, upon realization that the diseases being addressed were a very narrow
panel, revision of IHR was begun. The new IHR were adopted by the World
Health Assembly in 2005. In face of the growing threat of avian influenza in
several countries, the World Health Assembly decided to speed up the process
and voted in 2006 that IHR (2005) enter into force in June 2007. On June 15,
2007, IHR entered into force and are binding on 194 States Parties.

Introduction to International Health Regulations ● Optional Content Sheet 2

 TRAINER GUIDE

Major Changes in IHR (2005)

Major Three main points were changed in the new set of regulations, compared to text edited in
changes 1969. These changes are reflected in the table:

1969 2005

implement a control of travelers and goods organize the containment of the risk at the
when crossing borders and entering source, so that risks do not escape control
countries (e.g., need for appropriate and spread out of the country.
vaccinations such as yellow fever)

a list of epidemic-prone diseases to be report any event constituting a threat for

specially controlled (smallpox, yellow the international community, whether
fever, and cholera) caused by a disease or other sources such
as chemical spill, or even a nuclear event.

preset measures, which have to be adopted replaced by a more flexible set of adapted
by all countries responses according to the nature of the
event constituting the threat, that will be
implemented by countries with the help of
WHO and the international community

New The new IHR (2005) broadens the scope of reporting requirements. It requires countries to
reporting report all major events that may constitute a Public Health Emergency of International
system Concern (PHEIC). The reporting system has been completely updated, in order to ensure
both legal and binding aspects of the new procedure, and to also ensure the capacity of real
time management of the events at the source.

Reporting of the event to the international community must be done at country level
through the IHR national Focal Point, a national institution officially designated by
countries as the one and only means of communication between member state and WHO in
this respect.

In return, WHO will ensure the triggering of an international mechanism of assistance to the
country through activation of the Global Outbreak Assistance and Response Network
(GOARN).

Introduction to International Health Regulations ● Optional Content Sheet 3

 TRAINER GUIDE

Public Health Emergency of International Concern

Identification Compliance with IHR (2005) implies that all member States must have implemented at
of a PHEIC national level the capacity to:
 detect events that may constitute a threat to public health;
 determine if this could be a risk at an international level;
 organize a response in order to contain the event at the source.

The text of IHR (2005) provides a definition of a Public Health Emergency of International
Concern (PHEIC), and criteria to decide the necessity to report the event as a PHEIC.

“Public Health Emergency of International Concern” means an extraordinary event which

is determined, as provided in these Regulations:
 to constitute a public health risk to other States through the international spread of
disease, and
 to potentially require a coordinated international response.

The determination if the event constitutes a PHEIC is made on the basis of four criteria:
1. seriousness of the public health impact of the public health event;
2. unusual or unexpected nature of the event;
3. potential for the event to spread internationally;
4. risk that the event may result in restrictions to travel or trade.
Answering yes to any two of these questions will lead to obligation for the IHR Focal Point
to report the event to WHO as a PHEIC.

Decision
In order to provide concrete examples of criteria to be used for decision-making, Annex 2
Instrument in the resolution gives a schematic representation of using a decision tree based on four
criteria. This decision tree is called the Decision Instrument.
Diseases mentioned in this annex were designated as examples, but note that smallpox, a
new variant of avian influenza, wild type polio virus, and SARS infections mentioned in
the left-hand box must be declared as PHEIC as soon as they are identified. At the other
end of the spectrum are epidemic-prone diseases that occur as outbreaks at country level,
for which the four criteria must be applied before reporting as PHEIC. In the middle remain
events for which no cause or pathogen has been clearly identified, requiring the full
application of the decision algorithm.
Apart from the clear involvement of laboratories for the characterization of the four
diseases to be reported immediately, some uncertainties can be found in the resolution,
giving space for countries (national IHR Focal Points) to interpret the risks and conditions
before making a decision to report. As an example it is mentioned in the text that absence
of clear laboratory data should be taken as an enhancing risk factor for any event to be
considered as a PHEIC.

Introduction to International Health Regulations ● Optional Content Sheet 4

 TRAINER GUIDE

Requirements of IHR

Capacity The core Capacity Requirements mention that countries must have capacities “to detect,
requirements report and respond” to risks in general, and to those at international ports, airports and land
crossings, as defined in the resolution:
Annex 1A: core capacity requirements for surveillance and response
Annex 1B: core capacity requirements for designated airports, ports and ground crossing
Different levels in the surveillance system are defined and required capacities are clearly
listed as follows:
1. Capacities at the local community level
a. to detect events involving disease or death above expected levels;
b. to report all available essential information immediately to the appropriate health
response level;
c. to implement preliminary control measures immediately.

2. Capacities at intermediate public health response levels

a. to confirm the status of reported events and support or implement additional control
measures; and
b. to assess reported events immediately and, if urgent, to report all essential
information to the national level.

3. Capacities at the national level

-Capacities for assessment and notification:
a. to assess all report of urgent events within 48 hours; and
b. to notify WHO immediately (within 24 h assessing a PHEIC) through the National
IHR Focal Point
-Capacities for public health response:
a. to determine the control measures;
b. to provide support;
c. to provide direct operational link, etc.

Role of The resolution defines essential information:

diagnostic
laboratories “Essential information includes clinical descriptions, laboratory results, sources and type
of risk, numbers of human cases and deaths, conditions affecting the spread of the disease
and the health measures employed”.

Therefore the capacity to provide an accurate laboratory diagnostic should be available as

close as possible to the onset of the event. To achieve this, countries have to be ready for
Introduction to International Health Regulations ● Optional Content Sheet 5
 TRAINER GUIDE

collecting and processing biological samples at the community level, and for addressing
them as quickly as possible to the appropriate diagnostic laboratory. This requires:

1. guidelines/regulations and an operational system for collection, packaging and

shipment of samples;
2. a list of laboratories designated for surveillance and response based on the priority
threats with clear role and responsibilities of each laboratory;
3. contractual agreements with high quality outside collaborating centers, when no
corresponding domestic capacity is available.

Ensuring The direct consequence of this requirement is that countries must perform an inventory of
laboratory country laboratory capacity according to major risks they could face as potential PHEIC.
capacity Countries should develop a list of priority diseases, according to the IHR document, listing
the diseases for immediate reporting, and epidemic diseases or threats that are likely to
occur within the country and become of potential international concern. A list of diagnostic
tests to be performed and of laboratories with the appropriate capacities should be
developed accordingly, with external agreements with international centers if the
laboratory capacity is lacking in-country.

This will constitute a real challenge for countries, as they will need to produce laboratory
data accepted by the international community as reliable, and will also need to preserve
national sovereignty. On the other hand, countries must be able to trust the data coming
from other nations. The first step will be then to assess and strengthen the laboratory
system.

Core requirements for this strengthening will include:

 putting a strong focus on quality assurance;
 developing strategies to assure reference laboratory compliance with internationally
recognized standards;
 developing national quality assurance programs, including establishment of
internationally recognized external quality assessment (EQA)
 assuring the international community that appropriate biosafety requirements and
regulations in the manipulation of dangerous pathogens are being met

Appointing an IHR national laboratory coordinator at national level would ensure the
effective and efficient onset of the laboratory network.

Introduction to International Health Regulations ● Optional Content Sheet 6

 TRAINER GUIDE

New Formal Requirements for Countries

Summary of At the country level, requirements for compliance with the regulations can be summarized
national as follows:
requirements
 each State Party shall designate or establish a National IHR Focal Point;
 national IHR Focal Point shall be accessible at all times for communications with
WHO IHR Contact Points;
 the National Focal Point is not an individual; it is defined by Article 4 of the
regulations as “the national centre, designated by each State Party which shall be
accessible at all times for communication with WHO Contact Points under these
Regulations”;
 WHO shall designate IHR Contact Points, which shall be accessible at all times for
communications with National IHR Focal Points;
 all parties will provide each other with contact details.

WHO WHO will coordinate the provision of international assistance at the request of States
support Parties, and the affected Member State will have access to over 120 network partners,
through the Global Outbreak Alert and Response Network.

In case of uncertainty in the identification of the event, WHO will work closely and
confidentially with the affected Member State for verification and assessment of the risks,
and organization of the response.

Benefits to The regulations will provide real benefits to the Member States. These benefits include:
member
states 1. improvement of national and international surveillance;
2. use of the current WHO system for detection and quick response to public health risks;
3. use of modern communication tools;
4. access to GOARN, a “one-stop shop” of global resources.

IHR In May 2005 the World Health Assembly adopted the revised IHR, but decided in May
timeframe 2006 to accelerate the entry into force. On June 15, 2007, IHR entered into force and are
binding on 194 States Parties. Member States have from 2007 to 2009 to assess and
improve their national core capacities for surveillance and reporting, then in 2012 the core
capacities must be in place and functioning.

IHR (2005) reporting requirements make it necessary for countries to develop

laboratory capacity to meet the needs of the surveillance and reporting activities.

Introduction to International Health Regulations ● Optional Content Sheet 7