1 International Health Regulations (2005) and the Laboratory Role in Disease Surveillance.

1

International Health Regulations (2005) and the Laboratory Role in Disease Surveillance

International Health Regulations 2

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Brief History of the International Health Regulations (IHR)

1851: first International Sanitary Conference, Paris

1951: first International Sanitary Regulations (ISR) adopted by WHO member states

1969: ISR replaced and renamed the International Health Regulations (IHR)

1995: call for Revision of IHR

2005: IHR (2005) adopted by the World Health Assembly

2006: World Health Assembly vote that IHR (2005) will enter into force in June 2007


The purpose and scope of IHR

To prevent, protect against, control and provide a public health response to the international spread of disease

To establish a single code of procedures and practices for routine public health measures


Major Changes in IHR (2005) Widened scope: to report all major events, that may

constitute Public Health Emergency of International Concern (PHEIC)

Notification by designated National IHR Focal Points

National core capacities for detection and response

Real time event management system


Public Health Emergency of International Concern (PHEIC)

Definition (Article 1):“public health emergency of international concern means an extraordinary event which is determined, as provided in these Regulations:(i) to constitute a public health risk to other States through the international spread of disease and(ii) to potentially require a coordinated international response”


Decision InstrumentAnnex 2 of the Regulations is an instrument that directs States to notify WHO of events that may constitute a PHEIC


Is an event notifiable to WHO? Is the public health

impact of the event serious?

Is the event unusual or unexpected?

Is there a significant risk of international spread?

Is there a significant risk of international restrictions to travel and trade?


Core Capacity RequirementsCountries must have capacities “to detect, report and respond” to risks in general, and to those at international ports, airports and land crossings:

Annex 1A: core capacity requirements for surveillance and response

Annex 1B: core capacity requirements for designated airports, ports and ground crossing


Capacities at three levels

1. the local community level2. intermediate public health

response levels3. at the national level


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) – (h) to determine the control measures, to provide support, to provide direct operational link, etc.


National IHR Focal Points“the national centre, designated by each State Party which shall be accessible at all times for communication with WHO Contact Points” (Article 4)

National IHR Focal Point shall be accessible at all times for communications with WHO IHR Contact Points

WHO shall designate IHR Contact Points, which shall be accessible at all times for communications with National IHR Focal Points


Support for States Parties

WHO will coordinate the provision of international assistance at the request of States Parties, in support of activities

Through the Global Outbreak Alert and Response Network, the affected Member State will have access to over 120 network partners

When requested, WHO will work closely and confidentially with the affected Member State for verification and assessment of the risks, and organization of the response.


120 institutions and networks who pool resources for outbreak alert and response, and daily assessment of disease outbreaks

Rapid assistance (identification, verification and communication)

Global outbreak preparedness and response strategies

Global Outbreak Alert and Response Network A “network of networks”


Laboratory role in context of IHR “Laboratory” is quoted 6 times in the text, in 5

sections in IHR (2005)

Detection laboratory data to be reported - if available - as an early warning signal (annex 1)

Assessment of events (insufficient laboratory capacity = serious event) (annex 2)

Notification to WHO (continuous communication of laboratory results) (art. 6)

Response element (laboratory analysis of samples, domestically or through collaborating centres) (annex 1)

Recommendations by WHO with respect to the persons may include any laboratory analysis (art. 18)


Core requirements in a nutshell (1)

An IHR national laboratory coordinator to ensure the coordination of the laboratory system

Inventory of country laboratory capacity

Designation of laboratories for surveillance and response with clear role and responsibilities

Collection, packaging and shipment of samples

Collaboration with outside collaborating centers when no corresponding domestic capacity available


Core requirements in a nutshell (2)

Strong focus on quality assurance:

compliance of the reference laboratories with the internationally recognized standards

development of national quality assurance programs

successful participation in External Quality Assessment program(s)


a key component of WHO’s IHR Coordination Programme

a unique resource for WHO Regional and country Offices Provide Member States:

training for laboratory specialists laboratory quality assurance programmes laboratory standards and guidelines IHR laboratory capacity assessment tools surveillance systems strengthening

WHO Office in Lyon


IHR timeframe May 2005 World Health Assembly adopted the

revised IHR 15 June 2007 IHR entered into force and are

binding on 194 States Parties 2007-2009 Member States assess and improve

their national core capacities for surveillance and reporting

2012 the core capacities are in place and functioning

For more information visit: http://www.who.int/csr/ihr/en/


Questions?

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Organization Personnel Equipment

Purchasing &

Inventory

Process Control

Information Management

Documents&

Records

Occurrence Management Assessment

Process Improvement

Customer Service

Facilities &

Safety

1 International Health Regulations (2005) and the Laboratory Role in Disease Surveillance.

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