prop · GT03215 · 2006-09-15 00:00:00 — (a)in the case of a conveyance, a voyage between points of entry in the territories of more than one State, or a voyage between points of entry in the territory or territories of the same State if the conveyance has contacts with the territory of any other State on its voyage but only as regards those contacts; (b)in the case of a traveller, a voyage involving entry into the territory of a State other than the territory of the State in which that traveller commences the voyage; intrusive means possibly provoking discomfort through close or intimate contact or questioning; invasive means the puncture or incision of the skin or insertion of an instrument or foreign material into the body or the examination of a body cavity. For the purposes of these Regulations, examination of the ear, nose and mouth, temperature assessment using an ear, oral or cutaneous thermometer, or thermal imaging; inspection; auscultation; external palpation; retinoscopy; external collection of urine, faeces or samples; external measurement of blood pressure; and electrocardiography shall be considered to be non-invasive; isolation means separation of ill or contaminated persons or affected baggage, containers, conveyances, goods or postal parcels from others in such a as to prevent the spread of infection or contamination; examination means the preliminary assessment of a person by an authorized health worker or by a person under the direct supervision of the competent authority, to determine the persons health status and potential public health risk to others, and may include the scrutiny of health documents, and a physical examination when justified by the circumstances of the individual case; National IHR Focal Point means the national centre, designated by each State Party, which shall be accessible at all times for communications with WHO IHR Contact Points under these Regulations; Organization or WHO means the ; permanent has the meaning as determined in the national law of the State Party concerned; personal data means any information relating to an identified or identifiable natural person; point of entry means a passage for international entry or exit of travellers, baggage, cargo, containers, conveyances, goods and postal parcels as well as agencies and areas providing services to them on entry or exit; port means a seaport or a port on an inland body of water where ships on an international voyage arrive or depart; postal parcel means an addressed article or package carried internationally by postal or services; 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 (ii)to potentially require a coordinated international response; public health observation means the monitoring of the health status of a traveller over time for the purpose of determining the risk of disease transmission; public health risk means a likelihood of an event that may affect adversely the health of human populations, with an emphasis on one which may spread internationally or may present a serious and direct danger; quarantine means the restriction of activities and/or separation from others of suspect persons who are not ill or of suspect baggage, containers, conveyances or goods in such a as to prevent the possible spread of infection or contamination; recommendation and recommended refer to temporary or standing recommendations issued under these Regulations; reservoir means an animal, plant or substance in which an infectious agent normally lives and whose presence may constitute a public health risk; road vehicle means a ground transport vehicle other than a train; scientific evidence means information furnishing a level of proof based on the established and accepted methods of science; scientific principles means the accepted fundamental laws and facts of nature known through the methods of science; ship means a seagoing or inland navigation on an international voyage; standing recommendation means non-binding advice issued by WHO for specific ongoing public health risks pursuant to Article 16 regarding appropriate health measures for routine or periodic application needed to prevent or reduce the international spread of disease and minimize interference with international traffic; surveillance means the systematic ongoing collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary; suspect means those persons, baggage, cargo, containers, conveyances, goods or postal parcels considered by a State Party as having been exposed, or possibly exposed, to a public health risk and that could be a possible source of spread of disease; temporary recommendation means non-binding advice issued by WHO pursuant to Article 15 for application on a time-limited, risk-specific basis, in response to a public health emergency of international concern, so as to prevent or reduce the international spread of disease and minimize interference with international traffic; temporary has the meaning as determined in the national law of the State Party concerned; traveller means a natural person undertaking an international voyage; vector means an insect or other animal which normally transports an infectious agent that constitutes a public health risk; verification means the provision of information by a State Party to WHO confirming the status of an event within the territory or territories of that State Party; WHO IHR Contact Point means the unit within WHO which shall be accessible at all times for communications with the National IHR Focal Point. Unless otherwise specified or determined by the context, reference to these Regulations includes the annexes thereto. Article 2 Purpose and scope The purpose and scope of these Regulations are to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade. 1.The implementation of these Regulations shall be with full respect for the dignity, human rights and fundamental freedoms of persons. 2.The implementation of these Regulations shall be guided by the Charter of the United Nations and the Constitution of the . 3.The implementation of these Regulations shall be guided by the goal of their application for the protection of all people of the world from the international spread of disease. 4.States have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to legislate and to implement legislation in pursuance of their health policies. In doing so they should uphold the purpose of these Regulations. Article 4 Responsible authorities 1.Each State Party shall designate or establish a National IHR Focal Point and the authorities responsible within its respective jurisdiction for the implementation of health measures under these Regulations. 2.National IHR Focal Points shall be accessible at all times for communications with the WHO IHR Contact Points provided for in paragraph 3 of this Article. The functions of National IHR Focal Points shall include: (a)sending to WHO IHR Contact Points, on behalf of the State Party concerned, urgent communications concerning the implementation of these Regulations, in particular under Articles 6 to 12; and (b)disseminating information to, and consolidating input from, relevant sectors of the administration of the State Party concerned, including those responsible for surveillance and reporting, points of entry, public health services, clinics and hospitals and other government departments. 3.WHO shall designate IHR Contact Points, which shall be accessible at all times for communications with National IHR Focal Points. WHO IHR Contact Points shall send urgent communications concerning the implementation of these Regulations, in particular under Articles 6 to 12, to the National IHR Focal Point of the States Parties concerned. WHO IHR Contact Points may be designated by WHO at the headquarters or at the regional level of the Organization. 4.States Parties shall provide WHO with contact details of their National IHR Focal Point and WHO shall provide States Parties with contact details of WHO IHR Contact Points. These contact details shall be continuously updated and annually confirmed. WHO shall make available to all States Parties the contact details of National IHR Focal Points it receives pursuant to this Article. PART II INFORMATION AND PUBLIC HEALTH RESPONSE 1.Each State Party shall develop, strengthen and maintain, as soon as possible but no later than five years from the entry into force of these Regulations for that State Party, the capacity to detect, assess, notify and report events in accordance with these Regulations, as specified in 1. 2.Following the assessment referred to in paragraph 2, Part A of 1, a State Party may report to WHO on the basis of a justified need and an implementation plan and, in so doing, obtain an extension of two years in which to fulfil the obligation in paragraph 1 of this Article. In exceptional circumstances, and supported by a new implementation plan, the State Party may request a further extension not exceeding two years from the Director-General, who shall make the decision, taking into account the technical advice of the Committee established under Article 50 (hereinafter ). After the period mentioned in paragraph 1 of this Article, the State Party that has obtained an extension shall report annually to WHO on progress made towards the full implementation. 3.WHO shall assist States Parties, upon request, to develop, strengthen and maintain the capacities referred to in paragraph 1 of this Article. 4.WHO shall collect information regarding events through its surveillance activities and assess their potential to cause international disease spread and possible interference with international traffic. Information received by WHO under this paragraph shall be handled in accordance with Articles 11 and 45 where appropriate. 1.Each State Party shall assess events occurring within its territory by using the decision instrument in 2. Each State Party shall notify WHO, by the most efficient means of communication available, by way of the National IHR Focal Point, and within 24 hours of assessment of public health information, of all events which may constitute a public health emergency of international concern within its territory in accordance with the decision instrument, as well as any health measure implemented in response to those events. If the notification received by WHO involves the competency of the (), WHO shall immediately notify the . 2.Following a notification, a State Party shall continue to communicate to WHO timely, accurate and sufficiently detailed public health information available to it on the notified event, where possible including case definitions, laboratory results, source and type of the risk, number of cases and deaths, conditions affecting the spread of the disease and the health measures employed; and report, when necessary, the difficulties faced and support needed in responding to the potential public health emergency of international concern. Article 7 Information-sharing during unexpected or unusual public health events If a State Party has evidence of an unexpected or unusual public health event within its territory, irrespective of origin or source, which may constitute a public health emergency of international concern, it shall provide to WHO all relevant public health information. In such a case, the provisions of Article 6 shall apply in full. In the case of events occurring within its territory not requiring notification as provided in Article 6, in particular those events for which there is insufficient information available to complete the decision instrument, a State Party may nevertheless keep WHO advised thereof through the National IHR Focal Point and consult with WHO on appropriate health measures. Such communications shall be treated in accordance with paragraphs 2 to 4 of Article 11. The State Party in whose territory the event has occurred may request WHO assistance to assess any epidemiological evidence obtained by that State Party. Article 9 Other reports 1.WHO may take into account reports from sources other than notifications or consultations and shall assess these reports according to established epidemiological principles and then communicate information on the event to the State Party in whose territory the event is allegedly occurring. Before taking any action based on such reports, WHO shall consult with and attempt to obtain verification from the State Party in whose territory the event is allegedly occurring in accordance with the procedure set forth in Article 10. To this end, WHO shall make the information received available to the States Parties and only where it is duly justified may WHO maintain the confidentiality of the source. This information will be used in accordance with the procedure set forth in Article 11. 2.States Parties shall, as far as practicable, inform WHO within 24 hours of receipt of evidence of a public health risk identified outside their territory that may cause international disease spread, as manifested by exported or imported: (a)human cases; (b)vectors which carry infection or contamination; or (c)goods that are contaminated. 1.WHO shall request, in accordance with Article 9, verification from a State Party of reports from sources other than notifications or consultations of events which may constitute a public health emergency of international concern allegedly occurring in the States territory. In such cases, WHO shall inform the State Party concerned regarding the reports it is seeking to verify. 2.Pursuant to the foregoing paragraph and to Article 9, each State Party, when requested by WHO, shall verify and provide: (a)within 24 hours, an initial reply to, or acknowledgement of, the request from WHO; (b)within 24 hours, available public health information on the status of events referred to in WHOs request; and (c)information to WHO in the context of an assessment under Article 6, including relevant information as described in that Article. 3.When WHO receives information of an event that may constitute a public health emergency of international concern, it shall offer to collaborate with the State Party concerned in assessing the potential for international disease spread, possible interference with international traffic and the adequacy of control measures. Such activities may include collaboration with other standard-setting organizations and the offer to mobilize international assistance in order to support the national authorities in conducting and coordinating on-site assessments. When requested by the State Party, WHO shall provide information supporting such an offer. 4.If the State Party does not accept the offer of collaboration, WHO may, when justified by the magnitude of the public health risk, share with other States Parties the information available to it, whilst encouraging the State Party to accept the offer of collaboration by WHO, taking into account the views of the State Party concerned. Article 11 Provision of information by WHO 1.Subject to paragraph 2 of this Article, WHO shall send to all States Parties and, as appropriate, to relevant intergovernmental organizations, as soon as possible and by the most efficient means available, in confidence, such public health information which it has received under Articles 5 to 10 inclusive and which is necessary to enable States Parties to respond to a public health risk. WHO should communicate information to other States Parties that might help them in preventing the occurrence of similar incidents. 2.WHO shall use information received under Articles 6 and 8 and paragraph 2 of Article 9 for verification, assessment and assistance purposes under these Regulations and, unless otherwise agreed with the States Parties referred to in those provisions, shall not make this information generally available to other States Parties, until such time as: (a)the event is determined to constitute a public health emergency of international concern in accordance with Article 12; or (b)information evidencing the international spread of the infection or contamination has been confirmed by WHO in accordance with established epidemiological principles; or (c)there is evidence that: (i)control measures against the international spread are unlikely to succeed because of the nature of the contamination, disease agent, vector or reservoir; or (ii)the State Party lacks sufficient operational capacity to carry out necessary measures to prevent further spread of disease; or (d)the nature and scope of the international movement of travellers, baggage, cargo, containers, conveyances, goods or postal parcels that may be affected by the infection or contamination requires the immediate application of international control measures. 3.WHO shall consult with the State Party in whose territory the event is occurring as to its intent to make information available under this Article. 4.When information received by WHO under paragraph 2 of this Article is made available to States Parties in accordance with these Regulations, WHO may also make it available to the public if other information about the same event has already become publicly available and there is a need for the dissemination of authoritative and independent information. Article 12 Determination of a public health emergency of international concern 1.The Director-General shall determine, on the basis of the information received, in particular from the State Party within whose territory an event is occurring, whether an event constitutes a public health emergency of international concern in accordance with the criteria and the procedure set out in these Regulations. 2.If the Director-General considers, based on an assessment under these Regulations, that a public health emergency of international concern is occurring, the Director-General shall consult with the State Party in whose territory the event arises regarding this preliminary determination. If the Director- General and the State Party are in agreement regarding this determination, the Director-General shall, in accordance with the procedure set forth in Article 49, seek the views of the Committee established under Article 48 (hereinafter ) on appropriate temporary recommendations. 3.If, following the consultation in paragraph 2 above, the Director-General and the State Party in whose territory the event arises do not come to a consensus within 48 hours on whether the event constitutes a public health emergency of international concern, a determination shall be made in accordance with the procedure set forth in Article 49. 4.In determining whether an event constitutes a public health emergency of international concern, the Director-General shall consider: (a)information provided by the State Party; (b)the decision instrument contained in 2; (c)the advice of ; (d)scientific principles as well as the available scientific evidence and other relevant information; and (e)an assessment of the risk to human health, of the risk of international spread of disease and of the risk of interference with international traffic. 5.If the Director-General, following consultations with the State Party within whose territory the public health emergency of international concern has occurred, considers that a public health emergency of international concern has ended, the Director-General shall take a decision in accordance with the procedure set out in Article 49. Article 13 Public health response Each State Party shall develop, strengthen and maintain, as soon as possible but no later than five years from the entry into force of these Regulations for that State Party, the capacity to respond promptly and effectively to public health risks and public health emergencies of international concern as set out in 1. WHO shall publish, in consultation with Member States, guidelines to support States Parties in the development of public health response capacities. 2 Following the assessment referred to in paragraph 2, Part A of 1, a State Party may report to WHO on the basis of a justified need and an implementation plan and, in so doing, obtain an extension of two years in which to fulfil the obligation in paragraph 1 of this Article. In exceptional circumstances and supported by a new implementation plan, the State Party may request a further extension not exceeding two years from the Director-General, who shall make the decision, taking into account the technical advice of . After the period mentioned in paragraph 1 of this Article, the State Party that has obtained an extension shall report annually to WHO on progress made towards the full implementation. 3.At the request of a State Party, WHO shall collaborate in the response to public health risks and other events by providing technical guidance and assistance and by assessing the effectiveness of the control measures in place, including the mobilization of international teams of experts for on-site assistance, when necessary. 4.If WHO, in consultation with the States Parties concerned as provided in Article 12, determines that a public health emergency of international concern is occurring, it may offer, in addition to the support indicated in paragraph 3 of this Article, further assistance to the State Party, including an assessment of the severity of the international risk and the adequacy of control measures. Such collaboration may include the offer to mobilize international assistance in order to support the national authorities in conducting and coordinating on-site assessments. When requested by the State Party, WHO shall provide information supporting such an offer. 5.When requested by WHO, States Parties should provide, to the extent possible, support to WHO-coordinated response activities. 6.When requested, WHO shall provide appropriate guidance and assistance to other States Parties affected or threatened by the public health emergency of international concern. Article 14 Cooperation of WHO with intergovernmental organizations and international bodies 1.WHO shall cooperate and coordinate its activities, as appropriate, with other competent intergovernmental organizations or international bodies in the implementation of these Regulations, including through the conclusion of agreements and other similar arrangements. 2.In cases in which notification or verification of, or response to, an event is primarily within the competence of other intergovernmental organizations or international bodies, WHO shall coordinate its activities with such organizations or bodies in order to ensure the application of adequate measures for the protection of public health. 3.Notwithstanding the foregoing, nothing in these Regulations shall preclude or limit the provision by WHO of advice, support, or technical or other assistance for public health purposes. Article 15 Temporary recommendations If it has been determined in accordance with Article 12 that a public health emergency of international concern is occurring, the Director-General shall issue temporary recommendations in accordance with the procedure set out in Article 49. Such temporary recommendations may be