Slide 1



Optional Content for Module 1:

Introduction to International Health Regulations

|Purpose |To provide the participants with an introduction to international health regulations. |

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

| |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 |

Brief History of International Health Regulations

|Role in quality |The purpose and scope of International Health |[pic] |

|management system |Regulations (IHR) is to prevent, protect 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 IHR 2005 |The first International Sanitary conference was organized by France in 1851. From 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. |

| | |

Major Changes in IHR (2005)

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

| |table: |

| | |

| |1969 |

| |2005 |

| | |

| |implement a control of travelers and goods when crossing borders and entering countries (e.g., need for appropriate vaccinations such |

| |as yellow fever) |

| |organize the containment of the risk at the source, so that risks do not escape control and spread out of the country. |

| | |

| |a list of epidemic-prone diseases to be specially controlled (smallpox, yellow fever, and cholera) |

| |report any event constituting a threat for the international community, whether caused by a disease or other sources such as chemical |

| |spill, or even a nuclear event. |

| | |

| |preset measures, which have to be adopted by all countries |

| |replaced by a more flexible set of adapted 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 reporting system |The new IHR (2005) broadens the scope of reporting requirements. It requires countries to report all major events that may constitute|

| |a Public Health Emergency of International 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). |

Public Health Emergency of International Concern

|Identification of a |Compliance with IHR (2005) implies that all member States must have implemented at national level the capacity to: |

|PHEIC |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: |

| |seriousness of the public health impact of the public health event; |

| |unusual or unexpected nature of the event; |

|[pic] |potential for the event to spread internationally; |

| |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. |

| |In order to provide concrete examples of criteria to be used for decision-making, Annex 2 in the resolution gives a schematic |

|Decision Instrument |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. |

Requirements of IHR

|Capacity requirements |The core Capacity Requirements mention that countries must have capacities “to detect, 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: |

| |Capacities at the local community level |

| |to detect events involving disease or death above expected levels; |

| |to report all available essential information immediately to the appropriate health response level; |

| |to implement preliminary control measures immediately. |

| | |

| |Capacities at intermediate public health response levels |

| |to confirm the status of reported events and support or implement additional control measures; and |

| |to assess reported events immediately and, if urgent, to report all essential information to the national level. |

| | |

| |Capacities at the national level |

| |-Capacities for assessment and notification: |

| |to assess all report of urgent events within 48 hours; and |

| |to notify WHO immediately (within 24 h assessing a PHEIC) through the National IHR Focal Point |

| |-Capacities for public health response: |

| |to determine the control measures; |

| |to provide support; |

| |to provide direct operational link, etc. |

| | |

|Role of diagnostic |The resolution defines essential information: |

|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 collecting and processing biological samples at the community level, and for |

| |addressing them as quickly as possible to the appropriate diagnostic laboratory. This requires: |

| | |

| |guidelines/regulations and an operational system for collection, packaging and shipment of samples; |

| |a list of laboratories designated for surveillance and response based on the priority threats with clear role and responsibilities of|

| |each laboratory; |

| |contractual agreements with high quality outside collaborating centers, when no corresponding domestic capacity is available. |

| | |

|Ensuring laboratory |The direct consequence of this requirement is that countries must perform an inventory of country laboratory capacity according to |

|capacity |major risks they could face as potential PHEIC. 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. |

New Formal Requirements for Countries

|Summary of national |At the country level, requirements for compliance with the regulations can be summarized 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 support |WHO will coordinate the provision of international assistance at the request of States 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 member |The regulations will provide real benefits to the Member States. These benefits include: |

|states | |

| |improvement of national and international surveillance; |

| |use of the current WHO system for detection and quick response to public health risks; |

| |use of modern communication tools; |

| |access to GOARN, a “one-stop shop” of global resources. |

|IHR timeframe |In May 2005 the World Health Assembly adopted the revised IHR, but decided in May 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. |

|[pic] |IHR (2005) reporting requirements make it necessary for countries to develop laboratory capacity to meet the needs of the |

| |surveillance and reporting activities. |

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