ࡱ> jlghi%` >bjbj"x"x 8@@5~vvvvvvvR;R;R;8;&<Ӈp=p="===>>>FHHHHHH$Chbl!vL@>>L@L@lvv==CCCL@dv=v=FCL@FCC2wvvd}== p 'TR;@$\z.D0Ӈz Al \d}d} v}>Z>@C%?4Y?>>>ll@Cd>>>ӇL@L@L@L@.#$.#vvvvvv Optional Content for Module 1: Introduction to International Health Regulations PurposeTo provide the participants with an introduction to international health regulations. Learning ObjectivesAt 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 management system The purpose and scope of International Health 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  HYPERLINK "http://en.wikipedia.org/wiki/France" \o "France" France in  HYPERLINK "http://en.wikipedia.org/wiki/1851" \o "1851" 1851. From  HYPERLINK "http://en.wikipedia.org/wiki/1851" \o "1851" 1851 to  HYPERLINK "http://en.wikipedia.org/wiki/1938" \o "1938" 1938 fourteen conferences were held. The International Sanitary Conferences were the first international conventions organized in  HYPERLINK "http://en.wikipedia.org/wiki/Europe" \o "Europe" Europe to deal with the arrival and spread of pestilent diseases, particularly  HYPERLINK "http://en.wikipedia.org/wiki/Cholera" \o "Cholera" 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 PHEIC  Compliance with IHR (2005) implies that all member States must have implemented at 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: seriousness of the public health impact of the public health event; unusual or unexpected nature of the event; 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. Decision InstrumentIn order to provide concrete examples of criteria to be used for decision-making, Annex 2 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. 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 laboratories The resolution defines essential information: 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 capacityThe direct consequence of this requirement is that countries must perform an inventory of country laboratory capacity according to 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 requirementsAt the country level, requirements for compliance with the regulations can be summarized as follows: 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 statesThe regulations will provide real benefits to the Member States. These benefits include: 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 timeframeIn 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. IHR (2005) reporting requirements make it necessary for countries to develop laboratory capacity to meet the needs of the surveillance and reporting activities.     TRAINER GUIDE PAGE  PAGE 1 Introduction to International Health Regulations % Optional Content Sheet   PQRS[| = > մ{{p]VN?8 hdhdhi5CJOJQJ^JaJh = > N\kd$$IfTl0" tl644 laytdTd$If^gdil$Ifgddl$ & F =z$@&If^`zgdil> ^ _ j k 6 = > ? 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