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

The Quality Management System Organization Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Facilities & Safety International Health Regulations

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 International Health Regulations

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 International Health Regulations

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 International Health Regulations

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” International Health Regulations

Decision Instrument Annex 2 of the Regulations is an instrument that directs States to notify WHO of events that may constitute a PHEIC International Health Regulations

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? International Health Regulations

Core Capacity Requirements Countries 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 International Health Regulations

Capacities at three levels the local community level intermediate public health response levels at the national level International Health Regulations

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. International Health Regulations

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 International Health Regulations

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. International Health Regulations

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

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) International Health Regulations

Core requirements in a nutshell (1) 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 An IHR national laboratory coordinator to ensure the coordination of the laboratory system International Health Regulations

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) International Health Regulations

WHO Office in Lyon 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 International Health Regulations

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/ International Health Regulations

Purchasing & Inventory Information Management Occurrence Management Organization Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Facilities & Safety Questions? Comments? International Health Regulations