Key Benefits:
President of the Republic,
On the report of the Prime Minister and the Minister for Foreign and European Affairs,
Considering articles 52 to 55 of the Constitution;
Considering Act No. 48-814 of 13 May 1948 authorizing the ratification of the Constitution of the World Health Organization;
Having regard to the amended Decree No. 53-192 of 14 March 1953 concerning the ratification and publication of the international commitments undertaken by France;
In view of Decree No. 89-38 of 24 January 1989 on the publication of the International Health Regulations (1969) adopted by the twenty-second World Health Assembly in 1969 and amended by the twenty-sixth World Health Assembly in 1973 and by the thirty-fourth World Health Assembly in 1981 (all four appendices and four annexes), decreed:
The international health regulations (2005) adopted by the fifty-eighth World Health Assembly on 23 May 2005 will be published in the Official Journal of the French Republic.
The Prime Minister and the Minister for Foreign and European Affairs are responsible for the execution of this decree, which will be published in the Official Journal of the French Republic.
CINQUANTE-HUITIÈME ASSEMBLÉE MONDIALE
HEALTH
AGENDA ITEM 13.1
RÉVISION DU RÈGLEMENT SANITAIRE INTERNATIONAL
The fifty-eighth World Health Assembly,
Having considered the draft revised International Health Regulations (1);
Considering articles 2 (k), 21 (a) and 22 of the WHO Constitution;
Recalling the need to revise and update the International Health Regulations in WHA48.7 on the revision and updating of the International Health Regulations, WHA54.14 on global health safety: alert and action in the event of an outbreak, WHA55.16 on the natural presence, accidental release or deliberate use of chemical, biological or radionuclide health-related effects, WHA
Welcoming resolution 58/3 of the United Nations General Assembly on the intensification of capacity-building in the public health sector around the world, which underlines the importance of the International Health Regulations and urges high priority for its revision;
Affirming the continuing importance of the role of WHO in addressing epidemic and response to global public health events, in accordance with its mandate;
Stressing the continued importance of the International Health Regulations as a fundamental global instrument for the protection against the international spread of diseases;
Welcoming the success of the work of the intergovernmental working group on the revision of the International Health Regulations;
1. ADOPTED the revised International Health Regulations, now referred to as the International Health Regulations (2005), annexed to the present resolution;
2. Calls upon Member States and the Director General to fully implement the International Health Regulations (2005), in accordance with the object and scope set out in Article 2 and the principles defined in Article 3;
3. DECIDE, for the purposes of Article 54, paragraph 1, of the International Health Regulations (2005), that States Parties and the Director-General shall submit their first report to the sixty-first World Health Assembly and that, at that time, the Assembly of Health shall consider the schedule of subsequent reports and the first review of the operation of the Regulations in accordance with Article 54, paragraph 2;
4. DECIDE IN ORDER that, for the purposes of article 14, paragraph 1, of the International Health Regulations (2005), other intergovernmental organizations and relevant international bodies with which the WHO is required to cooperate and coordinate its activities, as the case may be, include: International Organization of the United Nations, International Labour Organization, Food and Agriculture Organization of the United Nations, International Atomic Energy Agency, International Civil Aviation Organization
5. INVITE INSTAMMENT les Etats membres :
1st to acquire, strengthen and maintain the capacity required under the International Health Regulations (2005) and to mobilize the necessary resources for this purpose;
2° to actively collaborate with each other and the WHO in accordance with the relevant provisions of the International Health Regulations (2005) to ensure its effective implementation;
3° to provide support to developing countries and countries with economies in transition, upon request for the acquisition, strengthening and maintenance of public health capacities required under the International Health Regulations (2005);
4° to take all appropriate measures, pending the entry into force of the International Health Regulations (2005), to promote the purpose and implementation of the Regulations, including the acquisition of the required public health capacities and the development of the necessary legal and administrative provisions, and in particular to initiate the process of introducing the use of the decision-making instrument set out in Annex 2;
6. Calls upon the Director General:
1° to promptly notify the adoption of the International Health Regulations (2005), in accordance with paragraph 1 of Article 65 of that Regulation;
2° to inform other relevant intergovernmental organizations or international bodies of the adoption of the International Health Regulations (2005) and, where appropriate, to cooperate with them in updating their standards, and to coordinate with them the activities of the WHO under the International Health Regulations (2005), in order to ensure the application of adequate measures for the protection of public health and the strengthening of the global public health action in the face of the international spread of diseases;
3° to transmit to the International Civil Aviation Organization (ICAO) the recommended amendments to the Health Issues Part of the General Aircraft Declaration (2) and, when the ICAO has completed its revision of the General Aircraft Declaration, to inform the Health Assembly and to include in Schedule 9 of the International Health Regulations (2005) the Health Matters Part of the General Aircraft Declaration as revised by the ICAO
4° to acquire and strengthen the WHO's capacity to fully and effectively carry out its functions under the International Health Regulations (2005), in particular through strategic health operations that provide support to countries for the screening and assessment of public health emergencies and for response to them;
5° to collaborate with the States Parties to the International Health Regulations (2005), as appropriate, including by providing or facilitating technical cooperation and logistical support;
6° to work with States Parties to the extent possible to mobilize financial resources to provide support to developing countries for the acquisition, strengthening and maintenance of the capacity required under the International Health Regulations (2005);
7° to develop, in consultation with Member States, guidelines for the application of health measures at land-based border crossings, in accordance with Article 29 of the International Health Regulations (2005);
8° to establish the Review Committee of the International Health Regulations (2005) in accordance with Article 50 of the said Regulations;
9° to take immediate action for the development of guidelines for the implementation and evaluation of the decision-making instrument contained in the International Health Regulations (2005), including the development of a procedure for the review of its operation, to be submitted to the Assembly of Health in accordance with section 54, paragraph 3, of that Regulation;
10° to take steps to establish a list of IHR experts and to apply in accordance with Article 47 of the International Health Regulations (2005).
INTERNATIONAL SANITICAL REGULATION (2005)
PART I
DEFINITIONS, OBJECT AND SCOPE,
RESPONSIBLE PRINCIPLES AND AUTORIES
Article 1
Definitions
1. For the purposes of the International Health Regulations (hereinafter referred to as the "IRSI" or "Rules"):
"aircraft" means an aircraft travelling internationally;
"airport" means an arrival and departure airport for international flights;
"affected" means persons, baggage, cargo, containers, means of transport, goods, postal parcels or human remains that are infected or contaminated, or that convey sources of infection or contamination, and thus constitute a risk to public health;
"entry" of a means of transport means:
(a) in the case of a sea vessel, arrival or anchorage in the defined area of a port;
(b) in the case of an aircraft, arrival at an airport;
(c) in the case of an inland navigation vessel carrying out an international voyage from arrival to an entry point;
(d) in the case of a train or road vehicle, from arrival to a point of entry;
"competent authority" means an authority responsible for the implementation and application of health measures taken under this Regulation;
"baggage" means the personal effects of a traveller;
"cargo" means goods transported in a means of transport or in a container;
"postal parcel" means an item or package with an address and transported by international postal or courier services;
"contamination" means the presence of an infectious or toxic agent or substance on the surface of the body of a person or animal, in or on a consumer product or on other inanimate objects, including means of transportation, that may constitute a risk to public health;
"container" means a transport equipment:
(a) having a perennial character and thus being sufficiently resistant to allow its repeated use;
(b) specially designed to facilitate the transport of goods, without load failure, by one or more modes of transport;
(c) equipped with devices that facilitate the handling of these devices, particularly when trans-shipment from one means of transport to another; and
(d) specially designed to be easy to fill and empty;
"decontamination" means a procedure that involves taking health measures to eliminate an infectious or toxic agent or substance on the surface of the body of a person or animal, in or on a consumer product or on other inanimate objects, including means of transport, that may constitute a risk to public health;
"departure" means, for a person, a baggage, a cargo, a means of transport or a commodity, the act of leaving a territory;
"deratization" means the procedure that involves taking health measures to control or eliminate rodent vectors of human diseases present in baggage, cargo, containers, means of transport, services, goods and postage parcels at the point of entry;
"disinfection" means the procedure that involves taking health measures to control or eliminate infectious agents present on the surface of the body of a person or animal or in or on baggage, cargo, containers, means of transport, goods and postal parcels by direct exposure to chemical or physical agents;
"disinsectisation" means the procedure that involves taking health measures to control or eliminate insect vectors of human diseases present in baggage, cargo, containers, means of transport, goods and postal parcels;
"Director General" means the Director General of the World Health Organization;
"personal data" means any information relating to an identified or identifiable natural person;
"scientific evidence" means information providing evidence based on established and accepted scientific methods;
"team" means persons on board a means of transport other than passengers;
"event" means a pathological manifestation or a fact that creates a risk of disease;
"medical examination" means the preliminary examination of a person by an authorized health officer or a person acting under the direct supervision of the competent authority, in order to determine whether the health status of that person poses a potential risk to public health; it may include the verification of health documents and a clinical examination if the circumstances so warrant;
"operating a means of transport" means the natural or legal person responsible for a means of transport, or his representative;
"infection" means the penetration and development or multiplication of an infectious agent in the body of people or animals that may constitute a risk to public health;
"inspection" means the examination by the competent authority or under its supervision of areas, baggage, containers, means of transport, installations, goods or postal parcels, as well as relevant information and documents, to determine whether there is a risk to public health;
"intrusive" means the embarrassment caused by close or intimate contact or close interrogation;
"invasive" means the effraction or cutaneous incision or the introduction of an instrument or foreign body into the body or examination of a cavity. For the purposes of this Regulation, the medical examination of the ear, nose or mouth, the taking of the temperature by means of an atrial, oral or skin contact thermometer, or by means of thermal imaging devices, the inspection, auscultation, external palpation, retinoscopy, the external collection of samples of urine, skeleton or its
"Isolation" means the removal of sick or contaminated persons or baggage, containers, means of transport, goods or postal parcels affected to prevent the spread of infection or contamination;
"free practice" means, for a vessel, authorization to enter a port, to embark on or disembark on boarding, unloading or loading cargo or provisions; for an aircraft, the authorization, after landing, to proceed with boarding or disembarking, unloading or loading of cargo or provisions; and, for a means of land transport, authorization, arrival, to proceed with boarding or disembarking, unloading or loading of cargo or provisions;
"healthy" means a person suffering or suffering from a physical disorder likely to pose a risk to public health;
"illness" means a human pathology or a condition, regardless of origin or source, having or likely to have significant adverse effects to the human being;
"goods" means tangible products, including animals and plants, transported during an international journey, especially to be used on a means of transport;
"health measure" means used to prevent the spread of disease or contamination; a health measure does not include enforcement or security measures;
"carriage means" means an aircraft, a vessel, a train, a road vehicle or any other means of transportation used for an international voyage;
"ship" means a sea ship or an inland navigation vessel that makes an international voyage;
"public health observation" means monitoring the health status of a traveller over time to determine the risk of disease transmission;
"Organization" or "WHO" means the World Health Organization;
"RSI contact point to WHO" means the service that, at any time, must be able to communicate with the RSI national focal point;
"entrance point" means a crossing point for the international entry or exit of passengers, baggage, cargo, containers, means of transport, goods and postal parcels as well as organizations and sectors providing services at the entrance or exit;
"RSI national focal point" means the national centre, designated by each State Party, which must be at any time in a position to communicate with RSI focal points to WHO for the purposes of this Regulation;
"port" means a seaport or an internal port where the ships on an international voyage arrive or depart;
"frontier" means a land entry point in a State Party, including a point used by road vehicles and trains;
"Scientific principles" means fundamental laws and facts accepted and known through scientific methods;
" quarantine" means the restriction of activities and/or the removal of suspected persons who are not ill or baggage, containers, means of transport or suspicious goods, so as to prevent the possible spread of infection or contamination;
"recommendation" and "recommended" refer to temporary or permanent recommendations issued under this Regulation;
"permanent recommendation" means the non-binding opinion issued by WHO under Article 16 concerning the systematic or periodic application of appropriate health measures in response to certain persistent risks to public health, in order to prevent or reduce the international spread of diseases by creating the minimum intrusions to international traffic;
"temporary recommendation" means the non-binding opinion issued by the WHO under Article 15 for the purposes of a time-limited and risk-based application to deal with an international public health emergency in order to prevent or reduce the international spread of diseases by creating the minimum intruder to international traffic;
"container" means an animal, plant or substance that normally hosts an infectious agent and whose presence may constitute a risk to public health;
"permanent residence" means in the sense determined by the internal law of the State Party concerned;
"provisional residence" means in the sense determined by the domestic law of the State Party concerned;
"risk for public health" means the probability of an event that can harm the health of human populations, particularly an event that can spread internationally or pose a serious and direct danger;
"monitoring" means the systematic and ongoing collection, compilation and analysis of public health data and the timely dissemination of public health information for the purpose of assessment and public health action, as appropriate;
" Suspects" means persons, baggage, cargo, containers, means of transport, goods or postal parcels that a State Party considers to have been exposed or may have been exposed to a risk to public health and may constitute a source of disease spread;
"international traffic" means the movement of people, baggage, cargo, containers, means of transport, goods or postal parcels that cross an international border, including international trade;
"International Public Health Emergency" means an extraordinary event to which it is determined, as set out in this Regulation:
(i) that it constitutes a risk to public health in other States because of the risk of international spread of diseases; and
ii) may require coordinated international action;
"vehicle" means an insect or any animal that normally carries an infectious agent that poses a risk to public health;
"land transport vehicle" means a motorized means of transport for ground transportation on an international journey, which includes trains, coaches, trucks and cars;
"road vehicle" means a ground transportation vehicle other than a train;
"audit" means the provision to the WHO by a State Party of information confirming an event on the territory or territories of that State Party;
"international travel" means:
(a) in the case of a means of transport, a journey between points of entry in the territories of more than one State, or a journey between points of entry located on the territory or territories of the same State if, during its journey, the means of transport is in contact with the territory of any other State, but only for such contacts;
(b) in the case of a traveller, a journey involving the entry into the territory of a State other than the territory of the State from which the traveler leaves;
"traveller" means a natural person who travels internationally;
"affected area" means a specific geographic location for which health measures were recommended by the WHO under this Regulation;
"Container loading zone" means a place or facility reserved for containers used in international traffic.
2. Unless otherwise provided or unless the context is opposed, any reference to this Regulation shall also refer to the annexes thereto.
Article 2
Purpose and scope
The purpose and scope of this Regulation is to prevent the international spread of disease, protect, control and respond to it through a public health action that is proportionate and limited to the risks it presents to public health, avoiding unnecessary barriers to international traffic and trade.
Article 3
Principles
1. This Regulation is implemented in full respect of the dignity of persons, human rights and fundamental freedoms.
2. The implementation of this Regulation is guided by the Charter of the United Nations and the Constitution of the World Health Organization.
3. The implementation of this Regulation is guided by the concern of its universal application to protect the entire world population from the international spread of diseases.
4. Pursuant to the Charter of the United Nations and the principles of international law, States have the sovereign right to legislate and enact legislation for the implementation of their health policies. In doing so, they must promote the purposes of this Regulation.
Article 4
Responsible authorities
1. Each State Party shall establish or designate a national focal point RSI and the authorities responsible, in its own jurisdiction, for the implementation of the sanitary measures provided for in this Regulation.
2. RSI national focal points must be at any time in a position to communicate with RSI contact points to the WHO referred to in paragraph 3 of this article. RSI National Focal Points will include:
(a) to address RSI points of contact to the WHO, on behalf of the State Party concerned, the urgent communications relating to the application of this Regulation, including those referred to in Articles 6 to 12; and
(b) to disseminate information to the relevant sectors of the administration of the State Party concerned, including the areas responsible for monitoring and reporting, entry points, public health services, clinics and hospitals and other public departments, and to collect the information provided by these sectors.
3. WHO designates RSI focal points that must be at any time in a position to communicate with RSI national focal points. RSI points of contact to WHO send urgent communications regarding the application of this Regulation, in particular the provisions of Articles 6 to 12, to the national RSI focal points of the States Parties concerned. WHO may designate RSI points of contact at United Nations Headquarters or at the regional level.
4. States Parties shall communicate to the WHO the coordinates of their national focal points RSI and WHO shall communicate to States Parties the coordinates of its RSI focal points. These coordinates are continuously updated and confirmed annually. WHO shall communicate to all States Parties the coordinates of the national RSI focal points that are communicated to it pursuant to this Article.
PART II
INFORMATION AND ACTION OF PUBLIC HEALTH
Article 5
Monitoring
1. Each State Party shall acquire, strengthen and maintain, as soon as possible but not later than five years after the entry into force of this Regulation with respect to that State Party, the capacity to detect, evaluate, notify and report events under this Regulation, as set out in Annex 1.
2. Following the assessment referred to in paragraph 2 of Annex 1, a State Party may report to the WHO on the basis of a justified need and action plan and, in so doing, obtain an additional two-year period to fulfil its obligation under paragraph 1 of this Article. In exceptional circumstances, and by submitting a new action plan, the State Party may request that the deadline be extended to the Director-General for a maximum of two years, taking into account the technical advice of the Committee established under Article 50 (hereinafter the "Review Committee"). After the period provided for in paragraph 1 of this article, the State Party that has obtained an additional period shall report annually to the WHO on the progress made in the full implementation.
3. WHO assists States Parties, at their request, to acquire, strengthen and maintain the capacities referred to in paragraph 1 of this Article.
4. The WHO collects information on events within its monitoring activities, and assesses the risk of the international spread of diseases that they involve and the obstacles to international traffic that they can create. The information received by the WHO under this paragraph shall be processed in accordance with the provisions of articles 11 and 45 as appropriate.
Article 6
Notification
1. Each State Party shall assess the events occurring in its territory by means of the decision-making instrument set out in Annex 2. Each State Party shall notify the WHO, through the most effective means of communication available to it, through the national focal point RSI and within twenty-four hours of the assessment of public health information, of any event in its territory that may constitute an international public health emergency under the decision-making instrument, as well as any health measures taken to deal with these events. If the notification received by the WHO relates to the competence of the International Atomic Energy Agency (IAEA), the WHO immediately informs the IAEA.
2. After a notification, the State Party continues to provide the WHO with accurate and sufficiently detailed public health information, where possible, including case definition, laboratory results, source and type of risk, number of cases and deaths, factors affecting the spread of the disease and the health measures used; and indicates, if necessary, the difficulties encountered and the help it needs to cope with the possible international public health emergency.
Article 7
Communication of information
in case of unexpected or unusual events
If a State Party has elements indicating the occurrence of an unexpected or unusual event in its territory, regardless of origin or source, which may constitute an international public health emergency, it shall provide the WHO with all relevant public health information. In this case, the provisions of section 6 apply fully.
Article 8
Consultation
In the event that events on its territory do not require the notification provided for in Article 6, in particular events for which it does not have sufficient information to use the decision-making instrument, a State Party may nevertheless keep the WHO informed through its national focal point RSI and consult the WHO on the health measures to be taken. These communications are governed by the provisions of paragraphs 2 to 4 of Article 11. The State Party in the territory of which the event occurred may ask the WHO to assist it in verifying the epidemiological information it was able to obtain.
Article 9
Other reports
1. WHO may take into account reports from sources other than notifications or consultations and assess such reports in accordance with established epidemiological principles; it then discloses information on the event in question to the State Party on whose territory this event is supposed to occur. Before taking any action on the basis of these reports, the WHO shall consult with the State Party on the territory of which the event is supposed to occur and shall endeavour to verify this information with it in accordance with the verification procedures defined in Article 10. To this end, the WHO makes the information received available to the States Parties, knowing that, only in cases where this is duly justified, the WHO can preserve the confidential nature of the source. This information is used in accordance with the procedure provided for in Article 11.
2. States Parties, to the extent possible, shall inform the WHO within 24 hours of receipt of data establishing the existence, outside their territory, of a risk identified for public health that may be at the origin of the international spread of diseases, attested by the export or import:
(a) Human cases;
(b) vectors of infection or contamination; or
(c) contaminated goods.
Article 10
Audit
1. The WHO, pursuant to Article 9, requests the State Party to verify reports from other sources than notifications or consultations, according to which events that may constitute an international public health emergency would occur in its territory. In such cases, the WHO shall inform the State Party concerned about the reports it seeks to verify.
2. In accordance with the provisions of the preceding paragraph and Article 9, each State Party, at the request of the WHO, shall conduct the necessary verifications and:
(a) provide within 24 hours a first response or an acknowledgement of receipt of the WHO request;
(b) provide within 24 hours the public health information available on the events referred to in the WHO request; and
(c) provide information to the WHO in the context of the Article 6 assessment, including the information described in this article.
3. When the WHO is informed of an event that could constitute an international public health emergency, it proposes to work with the State Party concerned to assess the risk of the international spread of diseases, the impetus to international traffic that could be created and the adequacy of the control measures. These activities may include collaboration with other standardization organizations and the offer to mobilize international assistance to assist national authorities in conducting and coordinating on-site assessments. At the request of the State Party, WHO provides information in support of this offer.
4. If the State Party does not accept the offer of collaboration, the WHO may, when justified by the magnitude of the risk to public health, communicate to other States Parties the information it has, while urging the State Party to accept the offer of collaboration of the WHO, taking into account the views of the State Party concerned.
Article 11
Communication of information by WHO
1. Subject to the provisions of paragraph 2 of this Article, WHO shall communicate to all States Parties and, as appropriate, to the relevant intergovernmental organizations, as soon as possible and by the most effective, confidential means, the public health information it has received in accordance with Articles 5 to 10 and which is necessary to enable States Parties to face a public health risk. WHO should provide other States Parties with information that could help prevent similar incidents.
2. The WHO shall use the information received pursuant to Articles 6 and 8 and paragraph 2 of Article 9 for verification, assessment and assistance under this Regulation and, unless otherwise agreed with the States Parties referred to in these provisions, it shall not generally communicate this information to other States Parties before:
(a) it is determined that the event constitutes an international public health emergency under Article 12; or
(b) information certifying the international spread of infection or contamination has been confirmed by the WHO in accordance with established epidemiological principles; or
(c) it is established that:
(i) measures against international spread are unlikely to result due to the nature of contamination, pathogen, vector or reservoir; or
(ii) the State Party does not have sufficient operational capacity to implement the necessary measures to prevent a further spread of the disease; or
(d) the nature and extent of the international movement of passengers, baggage, cargo, containers, means of transport, goods or postal parcels that may be affected by infection or contamination require the immediate implementation of international countermeasures.
3. The WHO shall consult with the State Party on whose territory the event occurred with respect to its intention to provide information under this article.
4. When communicating to States Parties, in accordance with this Regulation, information received under paragraph 2 of this Article, the WHO may also make this information public if further information concerning the same event has already been published and if the dissemination of reliable and independent information is required.
Article 12
Determination of the existence of an emergency
International Public Health
1. The Director-General shall determine, on the basis of the information he receives, in particular from the State Party in whose territory an event occurs, whether an event constitutes an international public health emergency under the criteria and procedure set out in this Regulation.
2. If the Director-General considers, on the basis of an assessment under this Regulation, that there is an international public health emergency, he shall consult with the State Party on the territory of which the event occurs with respect to this preliminary conclusion. If the Director General and the State Party agree with this conclusion, the Director General, following the procedure set out in Article 49, requests the views of the Committee established pursuant to Article 48 (hereinafter referred to as the "Emergency Committee") concerning the appropriate temporary recommendations.
3. If, following the consultation referred to in paragraph 2 above, the Director General and the State Party in whose territory the event occurs does not agree within 48 hours on whether the event constitutes an international public health emergency, a decision shall be taken in accordance with the procedure set out in Article 49.
4. To determine whether an event is an international public health emergency, the Director-General takes into account:
(a) information provided by the State Party;
(b) of the decision instrument set out in Appendix 2;
(c) in the opinion of the Emergency Committee;
(d) scientific principles and available scientific evidence and other relevant information; and
(e) an assessment of the risk to human health, the risk of international disease spread and the risk of intrusions to international traffic.
5. If the Director General, after consultation with the State Party on the territory of which the international public health emergency has occurred, considers that the international public health emergency has ended, it shall take a decision in accordance with the procedure set out in Article 49.
Article 13
Public health action
1. Each State Party shall acquire, strengthen and maintain, as soon as possible but not later than five years after the entry into force of this Regulation with respect to that State Party, the ability to react promptly and effectively in the event of a risk to public health and an international public health emergency in accordance with Annex 1. WHO publishes, in consultation with Member States, guidelines to assist States Parties to develop public health capacity.
2. Following the assessment referred to in paragraph 2 of Part A of Schedule 1, a State Party may report to the WHO on the basis of a justified need and action plan and, in so doing, obtain an additional two-year period to meet its obligation under paragraph 1 of this Article. In exceptional circumstances and with a new action plan, the State Party may request that the deadline be extended to the Director General for a maximum of two years, taking into account the technical advice of the Review Committee. After the period provided for in paragraph 1 of this article, the State Party that has obtained an additional period shall report annually to the WHO on the progress made in the full implementation.
3. At the request of a State Party, WHO is working together on public health risk action and other events by providing technical advice and assistance and assessing the effectiveness of the control measures put in place, including, where appropriate, by mobilizing international teams of experts to provide on-site assistance.
4. If the WHO, in consultation with the States Parties concerned in accordance with Article 12, establishes that there is an international public health emergency, it may offer, in addition to the support indicated in paragraph 3 of this Article, additional assistance to the State Party, including an assessment of the seriousness of international risk and the adequacy of measures to combat. It can, under this collaboration, provide international assistance to assist national authorities in conducting and coordinating on-site assessments. At the request of the State Party, WHO provides information in support of this offer.
5. At the request of the WHO, the States Parties shall, to the extent possible, support the WHO coordinated action.
6. At their request, WHO provides appropriate advice and assistance to other States Parties affected or threatened by the international public health emergency.
Article 14
WHO cooperation with organizations
intergovernmental bodies and international bodies
1. WHO cooperates and, where appropriate, coordinates its activities with other intergovernmental organizations and relevant international bodies for the implementation of these Regulations, including similar agreements and arrangements.
2. In the event that the notification or verification of an event, or the action taken to deal with it, is primarily within the competence of other intergovernmental organizations or international organizations, WHO coordinates its activities with these organizations or organizations for the purpose of implementing measures to protect public health.
3. Notwithstanding the above, no provision of this Regulation shall prevent or limit the provision by WHO of advice, support or technical or other assistance for public health purposes.
PART III
RECOMMENDATIONS
Article 15
Temporary recommendations
1. If it has been established, in accordance with Article 12, that there is an international public health emergency, the Director General shall issue temporary recommendations in accordance with the procedure set out in Article 49. These temporary recommendations may be amended or extended, as the case may be, especially after it has been determined that an international public health emergency has ceased, after which other temporary recommendations may be issued, as appropriate, for the purpose of preventing or detecting resurgence.
2. Temporary recommendations may relate to health measures to be implemented by the State Party in which the international public health emergency occurs, or by other States Parties, with regard to persons, baggage, cargo, containers, means of transport, goods and/or postal parcels to prevent or reduce the international spread of diseases and to avoid unnecessary interference with international traffic.
3. Temporary recommendations may be cancelled at any time in accordance with the procedure set out in Article 49 and automatically expire three months after publication. They may be amended or extended for additional periods of up to three months.
Temporary recommendations cannot be maintained beyond the Second World Health Assembly following the decision on the international public health emergency to which they relate.
Article 16
Permanent recommendations
WHO may make permanent recommendations for the systematic or periodic implementation of appropriate health measures, in accordance with Article 53. Such measures may be applied by States Parties in respect of persons, baggage, cargo, containers, means of transport, goods and/or postal packages in the event of persistent specific risks to public health in order to prevent or reduce the international spread of diseases and to avoid unnecessary obstacles to international traffic. The WHO may, under section 53, amend these recommendations or cancel them, if any.
Article 17
Criteria for recommendations
In formulating, modifying or cancelling temporary or permanent recommendations, the Director General shall take into account:
(a) views of States Parties directly concerned;
(b) the opinion of the Emergency Committee or Review Committee, as appropriate;
(c) scientific principles and available evidence and scientific information;
(d) health measures that, on the basis of an assessment of the risks appropriate to the situation, do not interfere with international traffic and trade and are not more intrusive to persons than other reasonably available measures that would ensure the health protection required;
(e) relevant international standards and instruments;
(f) activities of other relevant intergovernmental and international organizations; and
(g) other specific and appropriate information concerning the event.
With regard to temporary recommendations, the urgency of the situation may limit consideration by the Director-General of the elements referred to in subparagraphs (e) and (f) of this article.
Article 18
Recommendations on persons, baggage, cargo,
containers, means of transport, goods and postal parcels
1. WHO recommendations to States Parties regarding individuals may include the following advice:
- no specific health measures are recommended;
- review travel history in affected areas;
- examine the evidence that a medical examination and laboratory tests were conducted;
- require medical examinations;
- examining evidence of vaccinations or other prophylactic measures;
- require vaccination or prophylaxis;
- placing suspicious persons in public health observation;
- to quarantine suspects or apply other health measures to them;
- isolate or treat affected persons if necessary;
- search for contacts of suspected or affected persons;
- denying the entry of suspicious and affected persons;
- refuse the entry of unaffected persons into affected areas; and
- subject people from affected areas to screening and/or apply exit restrictions.
2. WHO recommendations to States Parties regarding baggage, cargo, containers, means of transport, goods and postal parcels may include the following advice:
- no specific health measures are recommended;
- examine the manifest and the itinerary;
- conduct inspections;
- examine evidence of the measures taken at the start or during transit to eliminate infection or contamination;
- carry out the handling of baggage, cargo, containers, means of transport, goods, postal parcels or human remains to eliminate infection or contamination, including vectors and tanks;
- apply specific health measures to ensure the safety of the handling and transport of human remains;
- isolate or quarantine;
- require, in the absence of effective processing or process, the seizure and destruction under control of baggage, cargo, containers, means of transport, infected, contaminated or suspected postal goods or parcels;
- and refuse to leave or enter.
PART IV
ITEMS
Article 19
General obligations
In addition to other obligations under this Regulation, each State Party shall:
(a) ensure that the capabilities set out in Schedule 1 for designated entry points are acquired within the time limits set out in Article 5, paragraph 1, and Article 13, paragraph 1,;
(b) specify the competent authorities at each designated entry point in its territory; and
(c) Provides to the WHO, to the extent possible when the WHO requests it to address a potential public health risk, relevant data on sources of infection or contamination, including vectors and tanks at its entry points, which may lead to the international spread of diseases.
Rule 20
Airports and ports
1. States Parties shall designate airports and ports to acquire and maintain the capacity set out in Annex 1.
2. States Parties shall ensure that certificates of exemption from ship health control and vessel health control certificates are issued in accordance with the requirements of Article 39 and the model in Annex 3.
3. Each State Party shall communicate to the WHO the list of ports authorized to propose:
(a) the issuance of ship health certificates and the provision of services referred to in Annexes 1 and 3; or
(b) only the issuance of certificates of exemption from ship health control; and
(c) the extension of the certificate of exemption from ship health control for a period of one month until the vessel arrives in the port to which the certificate may be delivered.
Each State Party shall inform the WHO of any changes in the status of the ports on the list. WHO publishes the information received under this paragraph.
4. The WHO may, at the request of the State Party concerned, do the necessary to certify, following an appropriate investigation, that an airport or port located in the territory of that State Party shall fulfil the conditions set out in paragraphs 1 and 3 of this article. WHO can periodically review these certifications, in consultation with the State Party.
5. WHO, in collaboration with relevant intergovernmental organizations and international bodies, develops and publishes the guidelines for the certification of airports and ports referred to in this article. WHO also publishes a list of certified airports and ports.
Article 21
Border posts
1. Where warranted in the light of public health, a State Party shall designate border crossings to acquire the capacity set out in Annex 1, taking into account:
(a) the volume and frequency of the various types of international traffic at border crossings that could be designated by a State Party in relation to other entry points; and
(b) the risks to public health in the areas from which international traffic originates, or that it passes, prior to its arrival at a particular border post.
2. States Parties with common borders should consider:
(a) conclude bilateral or multilateral agreements or arrangements concerning the prevention or control of the international transmission of diseases to border posts in accordance with Article 57; and
(b) to jointly designate adjacent border crossings for the capabilities described in Annex 1, in accordance with paragraph 1 of this Article.
Article 22
Role of competent authorities
1. The competent authorities:
(a) Ensure that baggage, cargo, containers, means of transport, postal goods and parcels and human remains from and from affected areas are maintained in such a state that they are free from sources of infection or contamination, including vectors and tanks;
(b) ensure, to the extent possible, that facilities used by passengers at ports of entry are maintained in good hygiene conditions and remain free from sources of infection or contamination, including vectors and tanks;
(c) Supervise the deratization, disinfection, decontamination or decontamination of baggage, cargo, containers, means of transport, goods, postal parcels and human remains or sanitary measures applied to persons, in accordance with this Regulation;
(d) notify operators of means of transport, as long as possible, of their intention to apply control measures to a means of transport, and provide, where appropriate, written information on the methods to be used;
(e) Supervise the hygienic removal and disposal of contaminated water or food, as well as human or animal excrements, waste water and any other contaminated material on board a means of transport;
(f) take all possible measures consistent with this Regulation to monitor and prevent the release by vessels of wastewater, waste, ballast water and other potentially pathogenic substances that may contaminate water from a port, river or canal, strait, lake or other international inland waterway;
(g) are responsible for the supervision of service providers for passengers, baggage, cargo, containers, means of transport, goods and postal parcels and human remains at ports of entry, including the conduct of medical inspections and examinations as required;
(h) provide effective emergency arrangements to deal with an unforeseen event affecting public health; and
(i) communicate with the RSI national focal point on relevant public health measures taken pursuant to this Regulation.
2. Health measures recommended by WHO for passengers, baggage, cargo, containers, means of transport, goods, postal parcels and human remains from an affected area may be applied again upon arrival if there are verifiable indications and/or evidence that the measures applied at the departure of the affected area have failed.
3. De-insectization, deratization, disinfection, decontamination and all other sanitary procedures are carried out in such a way as to avoid causing trauma and, as far as possible, discomfort to persons or damage to the environment that would affect public health, or damage to baggage, cargo, containers, means of transport, goods and postal parcels.
PART V
PUBLIC HEALTH MEASURES
Chapter I
General provisions
Article 23
Health measures on arrival and departure
1. Subject to applicable international agreements and relevant articles of this Regulation, a State Party may, for public health purposes, upon arrival or departure:
(a) for passengers:
(i) interrogate them about their destination in order to be able to contact them;
(ii) interrogate them about their route in order to verify whether they have stayed in an affected area or nearby, or their other potential contacts with an infection or contamination prior to their arrival, and verify the health documents of such travellers if required under this Regulation; and/or
(iii) require a non-invasive medical examination, i.e. the least intrusive examination possible to achieve the public health objective;
(b) require inspection of baggage, cargo, containers, means of transport, goods, postal parcels and human remains.
2. On the basis of evidence of the existence of a public health risk obtained by applying the measures provided for in paragraph 1 of this article or by other means, States Parties may apply additional health measures in accordance with this Regulation, and in particular with regard to a suspicious or affected traveller may, on a case-by-case basis, carry out the least intrusive and least invasive medical examination possible to achieve the public health objective of
3. Travellers shall not be subjected to any medical examination, vaccination or health or prophylactic measures under this Regulation without their express and informed consent, or that of their parents or guardians, having been obtained in advance, except in accordance with article 31, paragraph 2, and in accordance with the international legislation and obligations of the State Party.
4. Travellers who must be vaccinated or to whom a prophylactic measure must be proposed in the application of this Regulation, or their parents or guardians, are informed of any risk associated with vaccination or non-vaccination, and the use or non-use of the prophylactic measure in accordance with the legislation and international obligations of the State Party. States Parties shall inform doctors of this obligation in accordance with the legislation of the State Party.
5. Any medical examination, medical act, vaccination or other prophylaxis that involves a risk of disease transmission is performed on a traveller or is administered only in accordance with national and international safety standards and principles, to minimize this risk.
Chapter II
Special provisions applicable to means
transport and transport operators
Article 24
Transport operations
1. States Parties shall take all possible measures consistent with this Regulation to ensure that operators of means of transport:
(a) apply the health measures recommended by WHO and adopted by the State Party;
(b) inform travellers of the health measures recommended by WHO and adopted by the State Party for the purpose of their application on board; and
(c) maintain the means of transport that they are responsible for free from sources of infection or contamination, including vectors and tanks. The application of measures to eliminate sources of infection or contamination may be required if signs of their presence are found.
2. The special provisions applicable to means of transportation and to operators of means of transportation under this section are listed in Appendix 4. The specific measures applicable to means of transportation and to operators of means of transportation for vector-borne diseases are listed in Appendix 5.
Rule 25
Ships and aircraft in transit
Subject to the provisions of articles 27 and 43 or unless the applicable international agreements authorize it, no health measures shall be applied by a State Party:
(a) a vessel not coming from an affected area that borrows a canal or other seaway located in the territory of that State Party towards a port located in the territory of another State. Such a ship is authorized to board, under the supervision of the competent authority, fuel, water, food and provisions;
(b) a vessel that passes through waters under its jurisdiction without a stopover in a port or on the coast; neither
(c) to an aircraft in transit at an airport under its jurisdiction, such aircraft may nevertheless be confined to a particular area of the airport, without boarding or landing, or loading or unloading. However, such an aircraft is authorized to embark, under the supervision of the competent authority, on fuel, water, food and provisions.
Rule 26
Trucks, trains and coaches in transit
Subject to the provisions of Articles 27 and 43 or unless the applicable international agreements authorize it, no sanitary measures shall be applied to a civilian truck, train or coach from an affected area that passes through a territory without embarking or disembarking, or loading or unloading.
Rule 27
Means of transport affected
1. If clinical signs or symptoms and information based on facts or evidence that there is a risk to public health, including sources of infection and contamination, are discovered on a means of transport, the competent authority considers that the means of transport is affected and may:
(a) disinfect, decontaminate, decontaminate or decontaminate this means of transport, as appropriate, or enforce these measures under its supervision; and
(b) decide in each case the technique to be used to adequately control the risk to public health in accordance with these Regulations. If methods or materials are recommended by the WHO for these operations, they must be used, unless the competent authority considers that other methods are as safe and reliable.
The competent authority may take additional health measures, including isolating the means of transport, if necessary, to avoid the spread of a disease. These additional measures should be reported to the RSI national focal point.
2. If the competent authority at the point of entry is not in a position to apply the control measures prescribed by this Article, the means of transport affected may nevertheless be authorized to leave, provided that:
(a) the competent authority, at the time of departure, shall communicate to the competent authority at the next point of entry known to the data referred to in paragraph (b); and
(b) in the case of a vessel, the required signs and control measures shall be recorded in the vessel's health control certificate.
The means of transport in question is authorized to charge, under the supervision of the competent authority, fuel, water, food and supplies.
3. A means of transport that has been considered to be affected is no longer considered as such when the competent authority has acquired the conviction:
(a) that the measures referred to in paragraph 1 of this article have been effectively implemented; and
(b) that there is no condition on board that could pose a threat to public health.
Rule 28
Ships and aircraft at ports of entry
1. Subject to the provisions of section 43 or those of the applicable international agreements, a vessel or aircraft may not be prevented, for public health reasons, from stopping at a point of entry. However, if this entry point is not equipped to apply the sanitary measures provided for in this Regulation, an order may be given to the vessel or aircraft to continue its route, at its own risk, to the nearest appropriate entry point at its disposal, unless a technical problem makes this diversion dangerous.
2. Subject to the provisions of Article 43 or applicable international agreements, free practice may not be refused, for public health reasons, to a ship or aircraft by the States Parties; In particular, it cannot be prevented from embarking or disembarking, unloading or loading goods or supplies, or from embarking on fuel, water, food and provisions. States Parties may require the authorization of free practice to an inspection and, if a source of infection or contamination is discovered on board, disinfection, decontamination, decontamination, decontamination or deratization of the vessel or aircraft, or other measures necessary to prevent the spread of the infection or contamination.
3. Where possible, and subject to the provisions of the preceding paragraph, a State Party shall grant free practice to a ship or aircraft by radio or other means of communication where, based on information received from that ship or aircraft prior to arrival, the State Party considers that such arrival will not result in the introduction or spread of a disease.
4. The master of a vessel or the captain of an aircraft, or their representative shall inform the controllers of the port or airport as soon as possible prior to arrival at the port or airport of destination of any cases of indicative disease of an infectious nature, or evidence of the existence of a public health risk on board as soon as the master or commander is aware of such illness or public health risks. This information shall be transmitted immediately to the competent authority of the port or airport. In the event of an emergency, they shall be communicated directly by the master or commander to the competent authorities of the port or airport.
5. If, for reasons beyond the control of its captain or master, an aircraft or a suspicious or affected vessel lands elsewhere than on the scheduled airport, or is in a port other than the intended arrival port, the following provisions apply:
(a) the pilot-in-command of the aircraft or the master of the vessel, or any other person responsible for it, shall endeavour by all means to communicate promptly with the nearest competent authority;
(b) as soon as the competent authority has been informed of the landing or anchorage, it may apply the sanitary measures recommended by the WHO or other sanitary measures provided for in this Regulation;
(c) except where the urgency or requirements of communication with the competent authority require it, no traveller present on board the aircraft or vessel shall depart and no cargo shall be removed, unless the competent authority authorizes it; and
(d) Upon implementation of all sanitary measures prescribed by the competent authority, the aircraft or vessel may, with respect to these sanitary measures, continue its route either to the airport or to the port where it was to land or to wet or, if technical reasons prevent it, to a convenient airport or port.
6. Notwithstanding the provisions of this section, the master of a vessel or the captain of an aircraft may take all emergency measures that may be necessary to protect the health and safety of passengers. It shall inform the competent authority as soon as possible of any action taken under this paragraph.
Rule 29
Trucks, trains and civil buses
points of entry
The WHO, in consultation with the States Parties, develops guidelines for the application of sanitary measures to civilian trucks, trains and coaches at ports of entry and crossing a border crossing.
Chapter III
Special provisions for travellers
Rule 30
Travellers for public health observation
Subject to the provisions of Article 43 or unless the applicable international agreements authorize it, a suspicious traveller who is placed on observation for public health purposes upon arrival may be authorized to continue an international voyage if it is not an imminent risk to public health and if the State Party informs the competent authority at the point of entry to the intended arrival of the traveller, if it knows it. Upon arrival, the traveller presents himself to this authority.
Rule 31
Health measures related to passenger entry
1. The entry of a traveller into the territory of a State Party is not subject to invasive medical examination, vaccination or other prophylaxis. Subject to the provisions of Articles 32, 42 and 45, these Regulations do not prohibit States Parties from requiring medical examination, vaccination or other prophylaxis or proof of vaccination or other prophylaxis:
(a) where necessary to determine whether there is a risk to public health;
(b) as a condition of entry for any traveller seeking temporary or permanent residence;
(c) as a condition of entry for any traveller, pursuant to Article 43 or Annexes 6 and 7; or
(d) applicable under section 23.
2. If a traveller for whom a State Party may require a medical examination, vaccination or other prophylaxis under paragraph 1 of this article refuses to give consent, or refuses to provide the information or documents referred to in paragraph 1 (a) of Article 23, the State Party concerned may, subject to the provisions of Articles 32, 42 and 45, refuse entry to that traveller. If the existence of an imminent risk to public health is established, the State Party may, in accordance with its national legislation and to the extent necessary to combat this risk, oblige the traveller to, or advise him, in accordance with Article 23(3):
(a) undergo the least invasive and intrusive medical examination possible to achieve the intended public health objective;
(b) be vaccinated or subjected to another prophylaxis measure; or
(c) subject to additional established health measures to prevent or reduce the spread of the disease, including isolation, quarantine or observation for public health purposes.
Rule 32
Traveller processing
When applying the health measures provided for in this Regulation, States Parties shall treat travellers in a manner that respects their dignity and fundamental human rights in order to minimize any discomfort or discomfort that may be associated with these measures, including:
(a) treating all travellers with courtesy and respect;
(b) taking into account the sex of the person and the religious or socio-cultural concerns of travellers; and
(c) providing or making arrangements to provide travellers in quarantine or segregation, or subjected to medical examinations or other public health measures, food and water in sufficient quantity, adequate accommodation and clothing, protection for their baggage and other personal effects, appropriate medical treatment, means of communication if possible in a language they understand and any other appropriate assistance.
Chapter IV
Special provisions applicable to goods,
containers and containers
Rule 33
Goods in transit
Subject to the provisions of section 43 or unless the applicable international agreements authorize it, goods other than living animals that are in transit without transshipment are not subject to sanitary measures under this Regulation or retained for public health purposes.
Rule 34
Container containers and cargo areas
1. States Parties shall ensure, to the extent possible, that container loaders use, in international traffic, containers free from sources of infection or contamination, including vectors and tanks, especially during the shelling.
2. States Parties shall ensure, to the extent possible, that the container loading areas remain free from sources of infection or contamination, including vectors and tanks.
3. Where, in the opinion of the State Party, the volume of international container traffic is sufficiently important, the competent authorities shall take all possible measures consistent with this Regulation, including by conducting inspections, to assess the sanitary status of containers and container loading areas in order to ensure that the obligations set out in this Regulation are fulfilled.
4. To the extent possible, facilities are available in the container loading areas for inspection and isolation of containers.
5. Containers and container shippers are doing everything to avoid cross-contamination when loading multiple-use containers.
PART VI
SANITARY DOCUMENTS
Rule 35
General rule
No health document other than those provided for in this Regulation or by WHO recommendations is required in international traffic, provided that this section does not apply to travellers seeking temporary or permanent residence permits, nor does it apply to documents relating to the state of goods or cargo entering international trade required by applicable international agreements. The competent authority may require travellers to complete information forms on their contacts and health questionnaires, provided that the conditions set out in section 23.
Rule 36
Vaccination certificates
or other prophylaxis measures
1. Vaccines and prophylaxis measures administered to travellers pursuant to this Regulation or recommendations, and certificates thereof, shall be in accordance with the provisions of Schedule 6 and, where appropriate, Schedule 7 concerning certain diseases.
2. A traveller with a immunization certificate or certificate attesting to another prophylaxis measure issued in accordance with the provisions of Schedule 6 and, where applicable, of Schedule 7, may not be returned as a result of the disease covered by the certificate, even if it comes from an affected area, unless the competent authority has verifiable indications and/or evidence that the immunization or prophylaxis
Rule 37
Maritime Health Declaration
1. Before its first port of call in the territory of a State Party, the master of a ship shall ensure the state of health on board and, unless that State Party so requires, it shall fill and hand over to the competent authority of the port, upon arrival or before the arrival of the ship if the vessel is equipped with the necessary equipment and if the State Party requires that it be put on board the ship in advance, a Declaration against the vessel
2. The master or, if any, the on-board physician shall provide the competent authority with all information on the state of health on board during the international voyage.
3. The Marine Health Declaration must conform to the model set out in Appendix 8.
4. A State Party may decide:
(a) not requiring all ships upon arrival to submit the Marine Health Declaration; or
(b) require the submission of the Marine Health Declaration pursuant to a recommendation on vessels from affected areas or require vessels that may otherwise be carrying a source of infection or contamination.
The State Party shall inform the operators of ships or their representatives of these requirements.
Rule 38
Part of the General Aircraft Declaration
on health issues
1. In flight or landing on the first airport in the territory of a State Party, the pilot-in-command of an aircraft or his representative shall fulfil his or her best and shall give to the competent authority of that airport, unless that State Party so requires, the part of the General Declaration of Aircraft on sanitary matters, which shall be in accordance with the model set out in Annex 9.
2. The pilot-in-command of an aircraft or its representative shall provide the State Party with all information it requests on the state of health on board during the international voyage and on any health measures that may be applied to the aircraft.
3. A State Party may decide:
(a) not requiring all aircraft upon arrival to submit the portion of the General Aircraft Declaration on Health Issues; or
(b) require the submission of the portion of the General Aircraft Statement on Health Issues pursuant to a recommendation on aircraft from affected areas or require aircraft that may otherwise be carrying a source of infection or contamination.
The State Party shall inform aircraft operators or their representatives of these requirements.
Rule 39
Ship Health Control Certificates
1. Ship health certificates and ship health certificates are valid for up to six months. This validity period may be extended by one month if the required inspection or control measures cannot be carried out at the port.
2. If a certificate of exemption from ship health control or a valid ship health control certificate cannot be produced or if the existence on board a public health risk is established, the State Party may proceed as indicated in paragraph 1 of Article 27.
3. The certificates referred to in this section shall conform to the model in Appendix 3.
4. Whenever possible, the control measures are implemented when the vessel and the holds are empty. If the vessel is on ballast, they are carried out before loading.
5. When control measures are required and implemented satisfactorily, the competent authority shall issue a vessel health control certificate, in which signs and control measures are noted.
6. The competent authority may issue a certificate of exemption from ship health control in any port referred to in section 20 if it is satisfied that the vessel is free of infection and contamination, including vectors and tanks. Such a certificate is normally issued only if the vessel's inspection was carried out while the vessel and the holds were empty or contained only ballast or other equipment of such nature or arranged in such a way that a complete inspection of the holds was possible.
7. If the conditions under which the control measures are applied are such that, in the opinion of the competent authority of the port where the operation is carried out, a satisfactory result cannot be obtained, the competent authority shall include a note to that effect on the vessel's health control certificate.
PART VII
RIGHTS
Rule 40
Fees collected under sanitary measures
concerning travellers
1. Except for travellers seeking temporary or permanent residence authorization, and subject to paragraph 2 of this article, the State Party shall not receive other rights under this Regulation for the following public health protection measures:
(a) any medical examination provided for in this Regulation, or any further examination, which may be required by the State Party to ensure the health of the traveller examined;
(b) any immunization or other prophylaxis administered to a traveller upon arrival, which is not subject to a published prescription or has been subject to a prescription published less than ten days before the administration of immunization or other prophylaxis;
(c) appropriate isolation or quarantine measures imposed on a traveller;
(d) any certificate issued to the traveller stipulating the measures applied and the date of application; or
(e) any health measures concerning baggage accompanying passengers.
2. States Parties may collect rights for health measures other than those referred to in paragraph 1 of this article, including those applied primarily in the interest of the traveller.
3. If fees are collected for the application of these sanitary measures to travellers under this Regulation, there shall be only one tariff for each State Party, all of which:
(a) comply with this tariff;
(b) not exceed the actual cost of the service provided; and
(c) are collected irrespective of the nationality, domicile or place of residence of the passengers concerned.
4. The tariff, and any changes that may be made, is published at least ten days before the perception of any right contained therein.
5. Nothing in this Regulation shall prevent States Parties from seeking reimbursement of expenses incurred as a result of the sanitary measures referred to in paragraph 1 of this Article:
(a) to operators or owners of means of transport in respect of their employees; or
(b) to the insurers concerned.
6. Passengers or operators of means of transport may not be denied the possibility of leaving the territory of a State Party pending the settlement of the rights referred to in paragraphs 1 and 2 of this article.
Rule 41
Fees collected on baggage, cargo, containers, means of transport, goods or postal parcels
1. If fees are collected for the application of sanitary measures to baggage, cargo, containers, means of transport, goods or parcels under this Regulation, there shall be in each State Party only one tariff for such rights, all of which:
(a) comply with this tariff;
(b) not exceed the actual cost of the service provided; and
(c) are collected regardless of nationality, flag, registration or owner of baggage, cargo, containers, means of transport, goods or postal parcels. In particular, no distinction is made between luggage, cargo, containers, means of transport, goods or parcels of national and foreign postal goods.
2. The tariff, and any changes that may be made, is published at least ten days before the perception of any right contained therein.
PART VIII
GENERAL PROVISIONS
Rule 42
Implementation of health measures
Health measures taken under these Regulations are implemented and implemented without delay and implemented in a transparent and non-discriminatory manner.
Rule 43
Additional health measures
1. This Regulation does not prevent States Parties from applying, in order to address specific risks to public health or to international public health emergencies, health measures in accordance with their applicable national legislation and their obligations under international law which:
(a) provide an identical or higher level of health protection to WHO recommendations; or
(b) are also prohibited by Article 25, Article 26, paragraphs 1 and 2 of Article 28, Article 30, paragraph 1 (c) of Article 31 and Article 33;
provided that these measures are otherwise compatible with these Regulations.
These measures should not be more restrictive for international traffic or more intrusive or invasive for people than other reasonably applicable measures that would ensure the appropriate level of health protection.
2. States Parties shall base their decision to apply the sanitary measures referred to in paragraph 1 of this Article or the other sanitary measures referred to in paragraph 2 of Article 23, paragraph 1 of Article 27, paragraph 2 of Article 28 and paragraph 2 (c) of Article 31 on:
(a) scientific principles;
(b) available scientific evidence indicating a risk to human health or, if insufficient, available information, including from WHO and other relevant intergovernmental organizations and international bodies; and
(c) any specific advice or advice available from WHO.
3. A State Party that applies the additional health measures referred to in paragraph 1 of this article, which significantly hamper international traffic, shall provide the WHO with the public health reasons and scientific information that justify it. WHO communicates this information to other States Parties and communicates information on the health measures applied. For the purposes of this article, it is generally understood that the refusal to allow international travellers, baggage, cargo, containers, means of transport, goods and items assimilated, or to carry over twenty-four hours of their entry or departure.
4. After assessing the information provided pursuant to paragraphs 3 and 5 of this article and other relevant information, the WHO may request the State Party concerned to review the appropriateness of applying the measures.
5. A State Party that applies the additional health measures referred to in paragraphs 1 and 2 of this article that significantly impede international traffic shall inform the WHO, within 48 hours after their implementation, of these measures and their health justification unless they are subject to a temporary or permanent recommendation.
6. A State Party that applies a health measure under paragraph 1 or paragraph 2 of this article shall review it within three months, taking into account the WHO opinion and the criteria set out in paragraph 2 of this article.
7. Without prejudice to the rights conferred on it by article 56, any State Party that suffers the consequences of a measure taken under paragraph 1 or paragraph 2 of this article may request the State Party applying this measure to consult it to clarify scientific information and public health reasons behind the measure and to find an acceptable solution for both States Parties.
8. The provisions of this Article may apply to the implementation of measures concerning travellers taking part in important gatherings.
Rule 44
Collaboration and assistance
1. States Parties undertake to work together, to the extent possible, to:
(a) detect and assess events and deal with them in accordance with these Regulations;
(b) To ensure or facilitate technical cooperation and the provision of logistical support, in particular for the acquisition, strengthening and maintenance of public health capacities in accordance with these Regulations;
(c) mobilize financial resources to facilitate the implementation of their obligations under this Regulation; and
(d) to formulate bills and other legal and administrative provisions for the purposes of this Regulation.
2. WHO, to the extent possible, works with States Parties to:
(a) assess and assess their public health capacities to facilitate the effective implementation of these Regulations;
(b) Ensure or facilitate technical cooperation and the provision of logistical support to States Parties; and
(c) Mobilizing financial resources that will help developing countries acquire, strengthen and maintain the capacity set out in Annex 1.
3. Collaboration under this Article can be implemented at multiple levels, including bilaterally, through regional networks and WHO regional offices, and through intergovernmental organizations and international organizations.
Rule 45
Processing of personal data
1. Sanitary information collected or received by a State Party of another State Party or WHO pursuant to this Regulation and relating to an identified or identifiable person shall be held confidential and treated anonymously as provided for in national legislation.
2. Notwithstanding paragraph 1, States Parties may disclose and use personal data if necessary to assess and manage a public health risk, but States Parties, in accordance with national legislation, and WHO shall ensure that such data:
(a) be treated impartially and in accordance with legality and not used in a manner incompatible with that purpose;
(b) be adequate, relevant and do not exceed what is necessary for this purpose;
(c) be accurate and, where appropriate, updated; all reasonable arrangements shall be made to ensure that inaccurate or incomplete data are erased or corrected;
(d) not retained longer than necessary.
3. The WHO shall, to the extent possible, provide to the interested party who makes the request for the personal data referred to in this article, in an intelligible form, without delay or excessive costs, and, if necessary, make corrections.
Rule 46
Transport and handling of biological substances,
reagents and equipment used for diagnostic purposes
In accordance with national legislation and the applicable international guidelines, States Parties shall facilitate the transport, entry, exit, treatment and disposal of biological substances, diagnostic samples, reagents and other diagnostic materials for the verification and action required by this Regulation.
PART IX
RSI EXPERTS LIST,
URGENCE COMMITTEE AND EXAMEN COMMITTEE
Chapter I
List of RSI experts
Rule 47
Composition
The Director General shall prepare a list of experts from all relevant areas of competence (hereinafter referred to as the "IHR List"). Unless otherwise provided by this Regulation, the Director General shall appoint the members of the IHR List in accordance with the Regulations applicable to WHO Panels and Committees of Experts (hereinafter referred to as the "Regulation applicable to WHO Panels"). In addition, it appoints a member at the request of each State Party and, where appropriate, experts proposed by relevant intergovernmental organizations and regional economic integration organizations. The States Parties concerned shall communicate to the Director-General the qualifications and competence of each expert they propose. The Director General shall periodically inform States Parties and intergovernmental organizations and relevant regional economic integration organizations of the composition of the IHR List of Experts.
Chapter II
Emergency Committee
Rule 48
Mandate and composition
1. The Director General shall establish an Emergency Committee which, at the request of the Director General, shall give his opinion on:
(a) whether an event constitutes an international public health emergency;
(b) whether an international public health emergency has ended; and
(c) the proposal to issue, amend, extend or cancel temporary recommendations.
2. The Emergency Committee is composed of experts selected by the Director General from among the members of the IHR List of Experts and, where appropriate, other expert tables of the Organization. The Director General determines the duration of the membership's mandate to ensure continuity of the review of a particular event and its consequences. The Director General selects the members of the Emergency Committee on the basis of the skills and experience required for a particular session and with due regard to the principles of equitable geographical representation. At least one member of the Emergency Committee should be an expert designated by a State Party in whose territory the event occurs.
3. The Director General may, on his own initiative or at the request of the Emergency Committee, appoint one or more technical experts to advise the Committee.
Rule 49
Procedure
1. The Director General shall convene the meetings of the Emergency Committee by selecting several experts from among those referred to in paragraph 2 of Article 48, depending on the areas of competence and experience that best correspond to the specific event that is happening. For the purposes of this Article, the Emergency Committee's "meetings" may designate electronic teleconferences, videoconferences or communications.
2. The Director General shall communicate to the Emergency Committee the agenda and any relevant information regarding the event, including information provided by the States Parties, as well as any temporary recommendation that the Director General propose to make.
3. The Emergency Committee shall elect its Chairperson and, after each meeting, shall prepare a brief report on its deliberations and deliberations in which it shall include its views on possible recommendations.
4. The Director General invites the State Party on whose territory the event occurs to present its views to the Emergency Committee. To this end, the Director General informs him as long in advance as necessary of the date and agenda of the Emergency Committee meeting. However, the State Party concerned cannot request the adjournment of the meeting of the Emergency Committee to explain its views.
5. The opinion of the Emergency Committee shall be communicated to the Director General for consideration. The Director-General finally decides.
6. The Director General shall inform the States Parties of its decision to declare that there is an international public health emergency or that it has terminated and shall notify them of any health measures taken by the State Party concerned, any temporary recommendations and their modification, extension or cancellation, and the opinion of the Emergency Committee. It also informs of these temporary recommendations, including their modification, extension or cancellation, operators of means of transport, through the States Parties and relevant international bodies. It then disseminates this information and recommendations to the general public.
7. States Parties on whose territory the event occurred may propose to the Director-General that an international public health emergency and/or temporary recommendations be terminated and may present a briefing to the Emergency Committee.
Chapter III
The Review Committee
Rule 50
Mandate and composition
1. The Director General shall establish a Review Committee which shall perform the following functions:
(a) To make technical recommendations to the Director-General concerning amendments to this Regulation;
(b) provide the Director-General with technical advice on the permanent recommendations and any changes or cancellations thereof;
(c) provide technical advice to the Director-General on any matters before the Director-General concerning the operation of these Regulations.
2. The Review Committee shall be considered as an expert committee and shall be subject to the Regulations applicable to WHO expert tables, unless this section otherwise provides.
3. The members of the Review Committee are selected and appointed by the Director General from among the individuals listed on the IHR List of Experts and, where appropriate, from other expert tables of the Organization.
4. The Director General shall determine the number of members to be invited to a meeting of the Review Committee, as well as the date and duration of the meeting, and shall convene the Committee.
5. The Director General shall appoint the members of the Review Committee for the duration of the work of a session only.
6. The Director-General selects the members of the Review Committee on the basis of the principles of equitable geographical representation, gender parity, balanced representation of developed and developing countries, representation of different currents of thought, approaches and practical experiences in the various regions of the world, and appropriate interdisciplinary balance.
Rule 51
Conduct of work
1. The decisions of the Review Committee shall be taken by a majority of the members present and voting.
2. The Director General invites Member States, the United Nations and its specialized agencies and other relevant intergovernmental organizations or non-governmental organizations in official relations with the WHO to appoint representatives to attend the sessions of the Committee. These representatives may submit memorandums and, with the consent of the Chair, make statements on the topics under consideration. They don't have the right to vote.
Rule 52
Reports
1. For each session, the Review Committee shall prepare a report outlining its advice and advice. The report is approved by the Committee before the end of the session. These opinions and advice are not binding on the Organization and are presented in the form of advice addressed to the Director General. The text of the report cannot be amended without the Committee's consent.
2. If the findings of the Examining Committee are not unanimous, any member has the right to express one or more different professional opinions in an individual or group report, which indicates why a dissenting opinion is formulated and which is part of the Committee's report.
3. The report of the Committee is submitted to the Director General, who communicates the Committee's advice and advice to the Health Assembly or the Executive Council for consideration and action.
Rule 53
Procedure for standing recommendations
When the Director General considers that a permanent recommendation is necessary and appropriate in the face of a public health risk, he requests the views of the Review Committee. In addition to the relevant paragraphs of articles 50 to 52, the following provisions apply:
(a) the Director General or, through the Director General, States Parties may submit to the Review Committee proposals concerning the formulation, modification or cancellation of permanent recommendations;
(b) any State Party may submit to the Review Committee relevant information for consideration;
(c) the Director General may request any State Party, intergovernmental organization or non-governmental organization in official relations with the WHO to make available to the Review Committee the information available to them regarding the subject matter of the proposed permanent recommendations, as indicated by the Review Committee;
(d) the Director General may, at the request of the Review Committee or its own initiative, designate one or more technical experts to advise the Review Committee. These experts do not have the right to vote;
(e) reports containing the advice and advice of the Review Committee on standing recommendations are forwarded to the Director General for consideration and decision. The Director General shall communicate the advice and advice of the Review Committee to the Health Assembly;
(f) the Director-General shall communicate to the States Parties the standing recommendations, as well as any amendments made to them or their cancellation, including the views of the Review Committee;
(g) the Director General shall submit the standing recommendations to the next Health Assembly for consideration.
PART X
FINAL PROVISIONS
Rule 54
Reporting and review
1. The States Parties and the Director General shall report to the Assembly of Health on the application of this Regulation as decided by the Assembly of Health.
2. The Health Assembly shall periodically review the operation of these Regulations. For this purpose, it may seek advice from the Review Committee through the Director General. The first of these examinations shall be held no later than five years after this Regulation comes into force.
3. WHO conducts periodic studies to review and evaluate the operation of Appendix 2. The first of these reviews shall be undertaken no later than one year after this Regulation comes into force. The results of these reviews are submitted, as appropriate, to the Health Assembly.
Rule 55
Amendments
1. Any State Party or Director-General may propose amendments to this Regulation. These amendments are submitted to the Health Assembly for consideration.
2. The text of any proposed amendment shall be communicated to all States Parties by the Director General at least four months before the Assembly of Health to which this amendment is submitted for consideration.
3. Amendments to this Regulation adopted by the Health Assembly in accordance with this Article shall enter into force with respect to all States Parties under the same conditions and subject to the same rights and obligations as provided for in Article 22 of the WHO Constitution and to Articles 59 to 64 of this Regulation.
Rule 56
Settlement of disputes
1. If a dispute arises between two or more States Parties concerning the interpretation or application of this Regulation, the States Parties concerned shall first endeavour to resolve it by negotiation or by any other peaceful means of their choice, including by resorting to good offices or mediation of a third party or conciliation. In the event of failure, the parties to the dispute shall continue their efforts to reach a settlement.
2. If the dispute is not resolved by the means set out in paragraph 1 of this article, the States Parties concerned may agree to submit the dispute to the Director-General, who makes every effort to resolve it.
3. A State Party may at any time declare in writing to the Director General that it agrees to submit to compulsory arbitration all disputes concerning the interpretation or application of this Regulation to which it is a party or a specific dispute opposing it to any other State Party that accepts the same obligation. Arbitration shall take place in accordance with the Optional Rules of the Permanent Court of Arbitration for Disputes between two States in force on the date of application for arbitration. States Parties that have agreed to accept arbitration as binding accept the arbitral award as binding and final. The Director General shall inform the Health Assembly if necessary.
4. None of the provisions of this Regulation shall affect the right of States Parties under any international agreement to which they are parties to the dispute settlement mechanisms established by other intergovernmental organizations or under an international agreement.
5. In the event of a dispute between WHO and one or more States Parties with respect to the interpretation or application of this Regulation, the matter shall be referred to the Health Assembly.
Rule 57
Relationship with other international agreements
1. States Parties recognize that RSI and other relevant international agreements should be interpreted to ensure their compatibility. The IHR provisions do not affect the rights and obligations of States Parties arising from other international agreements.
2. Subject to paragraph 1 of this rule, no provision of this Regulation shall prohibit States Parties that have certain common interests as a result of their health, geographic, social or economic situation from entering into separate treaties or arrangements to facilitate the application of this Regulation, including with respect to:
(a) the direct and rapid exchange of information on public health between neighbouring territories of different States;
(b) sanitary measures applicable to international coastal traffic and international traffic in waters under their jurisdiction;
(c) Sanitary measures applicable in territories contiguous to different States on their common borders;
(d) the organization of the transport of affected persons or human remains affected by a specially adapted means of transport; and
(e) deratization, de-insectization, disinfection, decontamination or any other treatment designed to make goods free from pathogens.
3. Without prejudice to their obligations under this Regulation, States Parties that are members of a regional economic integration organization shall apply the common rules in force within that organization in the context of their mutual relations.
Rule 58
International health agreements and regulations
1. Subject to the provisions of Article 62 and the following exceptions, this Regulation shall replace between the States it binds and between those States and WHO the provisions of the following international health agreements and regulations:
(a) International health convention, signed in Paris on 21 June 1926;
(b) International Air Navigation Health Convention, signed at The Hague on 12 April 1933;
(c) International arrangement concerning the removal of health-care patents, signed in Paris on 22 December 1934;
(d) International arrangement concerning the abolition of consular visas on health patents, signed in Paris on 22 December 1934;
(e) Convention amending the International Health Convention of 21 June 1926, signed in Paris on 31 October 1938;
(f) 1944 international health convention amending the Convention of 21 June 1926, open for signature in Washington on 15 December 1944;
(g) 1944 International Air Navigation Convention amending the Convention of 12 April 1933, opened for signature in Washington on 15 December 1944;
(h) Protocol of 23 April 1946 extending the International Health Convention of 1944, signed in Washington;
(i) Protocol of 23 April 1946 extending the International Health Convention for Air Navigation of 1944, signed in Washington;
(j) International Health Regulations of 1951 and Additional Regulations of 1955, 1956, 1960, 1963 and 1965; and
(k) 1969 international health regulations and amendments of 1973 and 1981.
2. The Pan American Health Code, signed in Havana on 14 November 1924, remains in force, with the exception of articles 2, 9, 10, 11, 16 to 53, 61 and 62, to which the relevant provisions of paragraph 1 of this article apply.
Rule 59
Entry into force; deadline
to formulate a refusal or reservations
1. The period provided for in Article 22 of the WHO Constitution to refuse this Regulation or to amend it or to make reservations shall be eighteen months from the date of notification by the Director General of the adoption of this Regulation or of the said amendment to this Regulation by the Health Assembly. A refusal or reservation received by the Director General after the expiry of this period will be without effect.
2. These Regulations come into force twenty-four months after the notification date referred to in paragraph 1 of this section, except in respect of:
(a) a State that has refused the Regulation or an amendment to it in accordance with Article 61;
(b) a State that has made a reservation and in respect of which the Regulation comes into force as provided for in Article 62;
(c) a State that becomes a member of the WHO after the date of notification by the Director General referred to in paragraph 1 of this section and that is not already a party to this Regulation, in respect of which the Regulations come into force as provided for in Article 60; and
(d) a State not a WHO Member State, but accepts this Regulation and in respect of which it comes into force in accordance with Article 64, paragraph 1.
3. If a State is unable to adjust its national legislative and administrative provisions within the time limit provided for in paragraph 2 of this rule to bring them into full compliance with this Regulation, it shall forward to the Director-General within the time limit specified in paragraph 1 of this rule a declaration concerning the remaining adjustments and shall make such adjustments no later than twelve months after the entry into force of this Regulation in respect of that State Party.
Rule 60
New WHO Member States
Any State that becomes a Member of the WHO after the date of notification by the Director General referred to in paragraph 1 of Article 59, and that is not already a Party to these Regulations, may indicate that the Director General refuses or makes reservations within twelve months of the date of notification to the Director General after he became a Member of the WHO. Subject to the provisions of Articles 62 and 63, and except in case of refusal, this Regulation shall enter into force with respect to that State at the expiry of the period referred to above. This Regulation shall not enter into force in any case in respect of that State less than twenty-four months after the date of the notification referred to in paragraph 2 of Article 59.
Rule 61
Refus
If a State notify the Director General of its refusal of this Regulation or of an amendment to it within the time limit provided for in paragraph 1 of Article 59, this Regulation or the amendment concerned shall not enter into force with respect to that State. Any international health agreement or regulation referred to in article 58 to which that State is already a Party shall remain in force with respect to it.
Rule 62
Reservations
1. Any State may make reservations to the Regulation under this rule. Such reservations shall not be incompatible with the purpose and purpose of this Regulation.
2. Any reservation to this Regulation shall be notified to the Director General in accordance with the provisions of section 59, paragraph 1, and section 60, section 63, paragraph 1, or section 64, paragraph 1, as the case may be. A non-WHO State shall notify the Director General of any reservation it makes in its notification of acceptance of this Regulation. Any State that formulates reservations must convey its reasons to the Director-General.
3. A partial refusal of this Regulation or an amendment to it shall be equivalent to a reservation.
4. Pursuant to article 65, paragraph 2, the Director-General shall notify any reservation received under paragraph 2 of this article. Le Directeur général :
(a) if the reservation has been formulated prior to the entry into force of this Regulation, requests Member States that have not refused this Regulation to notify it within six months of any objection they would have to object to this reservation; or
(b) if the reservation has been formulated after the entry into force of this Regulation, requests the States Parties to notify it within six months of any objection they would have to object to this reservation.
States that formulate an objection to a reservation must indicate the reasons to the Director-General.
5. After this period, the Director-General shall notify all States Parties of objections received concerning reservations. If, at the end of the six-month period from the date of notification referred to in paragraph 4 of this article, a third of the States referred to in paragraph 4 of this article did not object to the reservation, the reservation shall be deemed to be accepted and this Regulation shall enter into force with respect to the reserving State, with the exception of the provisions subject to the reservation.
6. If at least one third of the States referred to in paragraph 4 of this article object to a reservation before the expiration of the six-month period from the date of notification referred to in paragraph 4 of this article, the Director-General shall notify the reserving State of the reservation so that the reserving State may consider withdrawing its reservation within three months of the date of notification to it by the Director-General.
7. The reserving State continues to fulfil all obligations relating to the purpose of the reservation it has accepted under an international health agreement or regulation referred to in article 58.
8. If the State author of a reservation does not withdraw the reservation within three months of the date of notification by the Director General referred to in paragraph 6 of this article, and if the State author of the reservation so requests, the Director General shall request the opinion of the Review Committee. The Review Committee shall inform the Director-General, as soon as possible and in accordance with the provisions of section 50, of the practical impact of the reservation on the application of this Regulation.
9. The Director General shall submit the reservation and notice of the Review Committee, if any, to the Health Assembly for consideration. If the Assembly of Health, by a simple majority vote, opposes the reservation on the ground that it is incompatible with the object and purpose of this Regulation, the reservation is not accepted and this Regulation comes into force only after it has withdrawn its reservation in accordance with Article 63. If the Assembly of Health accepts the reservation, this Regulation shall enter into force with respect to the reserving State with that reservation.
Rule 63
Withdrawal of a refusal and a reservation
1. A refusal under Article 61 may, at any time, be withdrawn by a State with a notification addressed to the Director General. In such a case, the Regulation shall enter into force with respect to that State on the date of receipt by the Director General of the notification, unless the State issues a reservation when it withdraws its refusal, in which case the Regulation shall enter into force as provided for in article 62. In no case shall the Regulations come into force with respect to that State before a period of twenty-four months after the date of notification referred to in paragraph 1 of Article 59.
2. Any or part of a reservation may at any time be withdrawn by the State Party concerned with a notification addressed to the Director General. In this case, the withdrawal shall take effect from the date of receipt by the Director-General of the notification.
Rule 64
States not WHO Members
1. States not Members of the WHO, but which are Parties to an international health agreement or regulations referred to in Article 58 or to which the Director General has notified the adoption of this Regulation by the World Health Assembly, may become Parties to it by notifying their acceptance to the Director General. Subject to the provisions of section 62, such acceptance shall take effect on the effective date of this Regulation or, if notified after that date, three months after the day on which such notification was received by the Director General.
2. WHO non-Member States that have become Parties to these Regulations may at any time denounce their participation in these Regulations by a notification addressed to the Director General; this denunciation takes effect six months after receipt of the notification. The State that has denounced its participation shall, from that time on, apply the provisions of any international health agreement or regulation referred to in article 58 to which it was previously a Party.
Rule 65
Notifications by the Director-General
1. The Director-General shall notify the adoption of this Regulation by the Health Assembly of all WHO Member States and associate members, as well as other Parties to any international health agreement or regulation referred to in Article 58.
2. The Director-General shall also notify these States, as well as any other State that has become a Party to this Regulation or to any amendment to this Regulation, of any notification received by the WHO pursuant to Articles 60 to 64 respectively, and of any decision taken by the Health Assembly pursuant to Article 62.
Rule 66
Authentic texts
1. The Arabic, Chinese, English, French, Russian and Spanish texts of this Regulation shall also be authentic. The original texts of these Regulations are deposited in the WHO archives.
2. Certified true copies of this Regulation shall be sent by the Director-General to all Associate Members and Members, as well as to other Parties to any international health agreement or regulation referred to in Article 58, with the notification provided in paragraph 1 of Article 59.
3. At the time of the entry into force of these Regulations, the Director-General shall transmit certified copies thereof to the Secretary-General of the United Nations for registration, in accordance with Article 102 of the Charter of the United Nations.
A N N E X E 1
A. - CAPACITY-BUILDING PRINCIPLES
FOR MONITORING AND ACTION
1. States Parties shall use existing national structures and resources with a view to developing the key capacities required under this Regulation to:
(a) their monitoring, reporting, reporting, verification, action and collaboration activities; and
(b) their activities relating to designated airports, ports and border crossings.
2. Each State Party shall, within two years after the entry into force of this Regulation with respect to that State Party, assess the capacity of existing national structures and resources to meet the minimum requirements of this Annex. As a result of this assessment, States Parties develop and implement action plans to ensure that these key capabilities are present and operate throughout their territory as stipulated in Article 5, paragraph 1, and Article 13, paragraph 1.
3. States Parties and WHO shall support, upon request, the evaluation, planning and implementation processes provided for in this annex.
4. At the local community level and/or at the primary level of public health action:
Capacity:
(a) to detect, in all areas of the State Party's territory, events involving morbidity or mortality above the expected levels for the period and the place in question; and
b) immediately disclose all essential data available at the appropriate level of health action. At the community level, communications are addressed to local health care institutions or appropriate health personnel. At the primary level of public health action, communications are addressed at the intermediate or national level, depending on the organic structures. For the purposes of this annex, the essential data include the following information: clinical descriptions, laboratory results, sources and types of risks, number of human cases and deaths, conditions affecting the spread of the disease and the health measures applied; and
(c) immediately apply preliminary control measures.
5. At the intermediate level of public health action:
Capacity:
(a) confirm the nature of the reported events and immediately support or implement additional control measures; and
(b) immediately assess the reported events and, if urgent, communicate all essential data at the national level. For the purposes of this annex, the criteria that determine the existence of an urgent event are its serious effects on public health and/or its unusual or unexpected character, with a high potential for spread.
6. National level
Evaluation and notification. Capacity:
(a) to assess in the forty-eight hours all urgent events reported; and
(b) immediately notify the WHO, through the national focal point RSI, when the assessment indicates that the event must be declared pursuant to Article 6, paragraph 1 and Annex 2, and provide the WHO with the information requested in Article 7 and Article 9, paragraph 2.
Public health action. Capacity:
(a) Quickly determine the necessary measures to prevent the spread at the national and international levels;
(b) provide support through the provision of specialized personnel, analysis at the sampling laboratory (at the national level or through the collaborating centres) and logistical assistance (material, supplies and transport);
(c) provide, where appropriate, on-site assistance to complement local investigations;
(d) To ensure a direct operational link with senior health and other officials to accelerate the approval and implementation of damping and fighting measures;
(e) direct liaison with other relevant departments;
(f) To ensure, through the most effective means of communication, the link with hospitals, clinics, airports, ports, border stations, laboratories and other key operational areas, to disseminate, on the territory of the State Party and on that of other States Parties, information and recommendations from the WHO regarding the events that have occurred;
(g) establish, implement and maintain a national emergency public health action plan, which includes the creation of multidisciplinary/multisectoral teams to respond to events that may constitute an international public health emergency; and
(h) ensure the measures that precede 24 hours a day.
B. - PRINCIPAL CAPACITIES REQUIRED OF AROPORTS,
SUSTAINABLE PORTS AND POSTS
1. Ongoing
Capacity:
(a) ensure access to an appropriate medical service, including diagnostic means located to enable the rapid examination and care of sick travellers; and provide adequate personnel, equipment and premises;
(b) to provide the necessary equipment and appropriate personnel to enable the transport of sick travellers to an appropriate medical service;
(c) provide the services of qualified personnel for the inspection of means of transport;
(d) ensure the hygiene of services used by passengers at the point of entry, including the provision of drinking water, restoration facilities, on-board restoration services and public toilets, as well as the provision of solid and liquid waste disposal services and other potentially at-risk areas, by conducting, as appropriate, inspection programmes; and
(e) to put in place to the extent that this is possible in practice a program led by qualified personnel to combat vectors and reservoirs at and near the entry points.
2. To address events that may constitute an international public health emergency
Capacity:
(a) Organize appropriate action by establishing and maintaining a public health emergency response plan, including the designation of a focal point and focal point focal point and public and other health agencies and services that are involved;
(b) ensure the examination and care of travellers or animals affected by agreements with local medical and veterinary services to allow their isolation and treatment and to provide any other support services that may be required;
(c) provide an appropriate space, separated from other travellers, for interviews with suspected or affected persons;
(d) ensure the examination and, if necessary, the quarantine of suspicious travellers, preferably in facilities away from the point of entry;
(e) apply the recommended measures to de-insect, de-ratize, disinfect, decontaminate or otherwise treat baggage, cargo, containers, means of transport, goods and postal parcels, including, if necessary, in places specially affected and equipped for this purpose;
(f) to subject passengers to arrival and departure at entrance and exit controls; and
(g) ensure access to appropriately protected special equipment and qualified personnel to allow the transfer of passengers who may be carrying a source of infection or contamination.
A N N E X E 2
DECISION INSTRUMENT PERMITTING ASSESSMENT AND NOTIFIC
EVENTS TO CONSTITUATE A PUBLIC HEALTH URGENT OF INTERNATIONAL
You can see the table in the OJ
n° 156 of 07/07/2007 text number 14
"Examples for the application of the decision instrument to the assessment and notification of events that may constitute an international public health emergency
The examples in this annex are not binding and are provided as an indication to assist in the interpretation of the criteria applicable to the instrument of decision. »
Does the event meet at least two of the following criteria?
I. - The impact of the event on public health
Are they serious?
1. Is the number of cases and/or number of deaths for this type of event high for the place, period or population considered?
yes
2. Is the event likely to have a significant impact on public health?
yes
Examples of circumstances that may have a significant impact on public health:
Event caused by a pathogen with high epidemic potential (agent infectiousness, high lethality, multiple or healthy transmission channels).
Indication of the failure of treatment (new or emerging antibiotic resistance, vaccine failure, antidotes resistance or antidotes failure).
The event is a significant risk to public health, although the number of cases identified in humans is zero or very low.
Cases reported among health personnel.
At-risk populations are particularly vulnerable (refugees, insufficient immunization coverage, children, older persons, immuno-primed, undernourished, etc.).
Concomiting factors that may interfere or delay public health action (natural disasters, armed conflicts, adverse weather conditions, multiple homes in the State Party).
The event occurs in a high population density area.
Propagation of toxic or infectious material or hazardous material for other reasons of natural or other origin that has contaminated or may contaminate a population and/or a large geographic area.
3. Is external assistance necessary to detect, study, contain and control the current event, or to avoid new cases?
yes
Examples of circumstances under which assistance may be required:
Insufficient human, financial, material or technical resources, in particular:
- insufficient laboratory or epidemiological means to study the event (material, personnel, financial resources);
- lack of antidotes, drugs and/or vaccines and/or protective equipment, decontamination or support to meet estimated needs;
- failure of the existing monitoring system to detect new cases in a timely manner.
Impact of the event
Are public health serious?
Reply "yes" if you answered "yes" to questions 1, 2 or 3 above.
II. - Is the event unusual or unexpected?
4. Is the event unusual?
yes
Examples of unusual events:
The event is caused by an unknown agent, or the source, vector, transmission path are unusual or unknown;
The evolution of cases is more serious than expected (including morbidity or lethality) or is accompanied by unusual symptoms;
The occurrence of the event is unusual for the area, season or population.
5. Is the event unexpected from a public health perspective?
yes
Examples of unexpected events:
The event is caused by a disease/agent that has already been eliminated or eradicated in the State Party or that has not been previously reported.
Is the event unusual or unexpected?
Reply "yes" if you answered "yes" to questions 4 or 5 above.
III. - Is there an important risk?
of international propagation?
6. Are there signs of epidemiological connection with similar events in other states?
yes
7. Is there any factor in fearing the possibility of a transboundary movement of the agent, the vector or the host?
yes
Examples of circumstances conducive to international spread:
When there are signs of local spread, an indicator case (or other cases associated with it) observed[s] the previous month:
- subject having made an international voyage during that period (or for a period equivalent to the incubation period if the pathogen is known); or
- subject having participated in an international gathering (e.g., pilgrimage, sports event, conference, etc.); or
- subject having had close contact with an international traveller or a very mobile population.
Event caused by contamination of the environment that may spread beyond international borders.
Events occurring in an intense international traffic area with limited capacity for health control, environmental detection or decontamination.
Is there an important risk of international spread?
Reply "yes" if you answered "yes" to questions 6 or 7 above.
IV. - Is there a significant risk of restrictions
international travel or exchange?
8. Did similar events in the past result in restrictions on international trade and/or travel?
yes
9. Do we understand or do we know that the source is a food product, water or any other goods that may be contaminated, that have been exported to other States or imported from other States?
yes
10. Has the event occurred as part of an international gathering or in an intense international tourism area?
yes
11. Did the event raise requests for additional information from foreign officials or international media?
yes
There is a significant risk of trade restrictions
or international travel?
Reply "yes" if you answered "yes" to questions 8, 9, 10 or 11 above.
States Parties that responded "yes" to the question of whether the event meets two of the four criteria (I-IV) set out above must send a notification to the WHO under Article 6 of the International Health Regulations.
You can see the table in the OJ
n° 156 of 07/07/2007 text number 14
You can see the table in the OJ
n° 156 of 07/07/2007 text number 14
A N N E X E 4
TECHNICAL REQUIREMENTS FOR TRANSPORT MEDITORIES AND EXPLANATORS
Section A
Transport operations
1. Transport operators will facilitate:
(a) inspections of cargo, containers and means of transport;
(b) medical examinations of persons present on board;
(c) the application of the other sanitary measures provided for in this Regulation; and
(d) the provision of public health information required by the State Party.
2. Operators of means of transport shall provide to the competent authority of the States Parties a valid certificate of exemption from health control, or ship health control, or a maritime declaration of health, or the sanitary part of the general declaration of aircraft, as required by this Regulation.
Section B
Transport
1. The measures applied under this Regulation to a baggage, cargo, container, conveyance or cargo will be implemented in such a way as to avoid any trauma or embarrassment to persons and any damage to baggage, cargo, container, means of transport or goods. The measures are applied, if possible and appropriate, when the means of transport and the holds are empty.
2. States Parties shall indicate in writing the measures applied to a cargo, container or means of transport, the processed parts, the methods used and the reasons for their application. This information is provided in writing to the person responsible for the aircraft and, in the case of a vessel, it is noted on the vessel's health control certificate. For other cargoes, containers or means of transport, States Parties shall submit this information in writing to shippers, consignees, carriers and the person responsible for the carriage or their agent.
A N N E X E 5
SPECIAL MEASURES CONCERNING MALADIES
VECTORIELLE TRANSMISSION
1. The WHO regularly publishes the list of areas from which any means of transport must be subject to de-insectization measures or other recommended vector control measures. These areas are defined in accordance with the procedures for temporary or permanent recommendations, as appropriate.
2. The means of transport leaving an entry point located in an area where vector control is recommended must be disinsected and maintained free of vectors. When the Organization advocates methods and materials for these operations, they must be used. The presence of vectors on transport and the control measures taken to eradicate them shall be recorded:
(a) in the case of an aircraft, in the health-related portion of the general aircraft declaration, unless the competent authority of the arrival airport grants an exemption to not complete that part;
(b) in the case of a vessel, on the vessel health certificate; and
(c) in the case of other means of transport, on a written certificate of treatment issued to the consignor, the consignee, the carrier and the person responsible for the carriage or their agent.
3. States Parties shall accept measures of de-insectization, deratization and other vector control measures applied to means of transport by other States, if the methods and materials recommended by the Organization have been used.
4. States Parties shall establish programmes to combat vectors that may carry an infectious agent that poses a risk to public health within a perimeter of not less than 400 metres from the areas of the facilities at the point of entry that are used for passenger operations, means of transport, containers, cargoes and postal parcels, or even more if the vectors present have a greater radius of action.
5. If a supplementary inspection is required to determine the success of the applied vector control measures, the competent authorities of the next port or airport port port port port port port port of call authorized to conduct such an inspection must be informed in advance by the competent authority who makes the request. In the case of a vessel, this inspection must be recorded on the ship's health certificate.
6. A means of transport is considered suspect and must be inspected to detect the presence of vectors or tanks:
(a) if there is a possible case of vector-borne disease on board;
(b) if a possible case of vector-borne illness occurred on board during an international voyage; or
(c) if this means of transport left an affected area while the vectors present on board could still be carrying disease.
7. A State Party may not prohibit the landing of an aircraft at an airport in its territory or the arrival of a ship if the control measures referred to in paragraph 3 of this annex or otherwise recommended by the Organization are applied. However, aircraft or vessels from an affected area may be required to land at airports or diverted to other ports specially designated for this purpose by the State Party.
8. A State Party may apply vector control measures to a means of transport from an area where vector-borne disease occurs if the vectors of this disease are present in its territory.
A N N E X E 6
VACCINATION, PROPHYLAXIA AND CERTIFICATES
1. Vaccines or other prophylactic agents referred to in Schedule 7 or recommended in this Regulation shall be of satisfactory quality; vaccines and prophylactic agents prescribed by WHO must be submitted for approval. Upon request, the State Party shall provide the WHO with appropriate evidence of the adequacy of vaccines and prophylactic agents administered in its territory under this Regulation.
2. Persons to whom vaccines or other prophylaxis are administered under this Regulation receive an international vaccination certificate or a certificate certifying the administration of a prophylaxis (hereinafter referred to as the "certificate") in accordance with the model in this Annex. This model must be scrupulously respected.
3. The certificates referred to in this annex are valid only if the vaccine or prophylactic agent used has been approved by WHO.
4. Certificates must be signed by the clinician - doctor or other registered health officer - who supervises the administration of the vaccine or prophylactic agent; they must also bear the official stamp of the authorized centre which, however, cannot be considered to be held as a place of signature.
5. Certificates must be completed in English or French in full; They can also be in another language.
6. Any correction or rature on certificates or omission of any of the requested information may result in their nullity.
7. Certificates are individual and should not be used in a collective capacity. Children must be provided with separate certificates.
8. When the certificate is issued to a child who does not know how to write, a parent or guardian must sign it instead. The signature of an illiterate must be replaced, as it is used in such cases, by its mark authenticated by a third party.
9. If the clinician responsible is of the opinion that vaccination or the administration of a prophylaxis is counter-indicated for medical reasons, he shall give the person concerned a duly motivated counter-indication certificate, written in English or French and, where applicable, in another language in addition to English or French, that the competent authorities of the arrival place must take into account. The responsible clinician and the competent authorities shall inform the person concerned of any risk associated with the non-vaccination or non-use of prophylaxis in accordance with the provisions of section 23, paragraph 4.
10. An equivalent document issued by the armed forces to an active member of these forces will be accepted instead of an international certificate conforming to the model in this annex:
(a) if it contains medical information essentially identical to those required in the model; and
(b) if it indicates in English or French, and if applicable in another language in addition to English or French, the nature and date of vaccination or administration of prophylaxis, and if issued in accordance with this paragraph.
International Immunization Certificate Model
or certificate certifying the administration of prophylaxis
We certify that [name] born, sex
and nationality, national identification document,
if the signature follows
was vaccinated or received prophylactic agents on the date indicated against:
(name of disease or affection)
in accordance with the International Health Regulations.
You can see the table in the OJ
n° 156 of 07/07/2007 text number 14
This certificate is valid only if the vaccine or prophylactic agent used has been approved by the World Health Organization.
This certificate must be signed by the clinician - doctor or other registered health officer - who supervises the administration of the vaccine or prophylactic agent; it must also bear the official stamp of the authorized centre which, however, cannot be considered to be held as a place of signature.
Any correction or rature on the certificate or omission of any of the requested information may result in its invalidity.
This certificate is valid until the date indicated for the vaccine or prophylactic agent administered. It must be fully established in English or French. The same certificate may also be established in another language, in addition to English or French.
A N N E X E 7
VACCINATION REQUIREMENTS
OR THE PROPHYLAXIA AGAINST MALADIES
1. In addition to any recommendations regarding vaccination or the administration of prophylaxis, the entry of travellers to a State Party may be subject to the presentation of evidence of vaccination or the administration of prophylaxis against the following diseases expressly designated by this Regulation:
Yellow fever
2. Considerations and requirements for yellow fever vaccination:
(a) For the purposes of this annex:
(i) the yellow fever incubation period is six days;
(ii) WHO-approved moor vaccines provide protection against infection that takes effect ten days after the vaccine is administered;
(iii) This protection lasts 10 years; and
(iv) the validity of a yellow fever vaccination certificate is ten years, beginning on the tenth day after the date of vaccination or, in the case of re-immunization during that ten-year period, from the date of re-accination.
(b) Yellow fever vaccination may be required from any traveller leaving an area in which the Organization has determined that there is a risk of yellow fever transmission.
(c) A traveller with an unsatisfactory amarile vaccination certificate may be allowed to leave, but the provisions of paragraph 2.(h) of this annex may be applied to the traveller upon arrival;
(d) A traveller with a valid yellow fever vaccination certificate must not be considered a suspect, even if it comes from an area in which the Organization has established that there is a risk of yellow fever transmission.
(e) In accordance with the provisions of Annex 6, paragraph 1, the amaril vaccine used shall be approved by the Organization.
(f) States Parties shall designate specific centres of amarile vaccination in their territory to ensure the quality and safety of the procedures and equipment used.
(g) Any person employed at a point of entry in an area in which the Organization has established that there is a risk of yellow fever transmission, as well as any member of the crew of a means of transport that uses this point of entry must be provided with a valid yellow fever vaccination certificate.
(h) A State Party in the territory of which yellow fever vectors are present may require a traveller from an area in which the Organization has established that there is a risk of yellow fever transmission either, if it is not able to present a valid certificate of amarile vaccination, quarantined for a maximum of six days from the date of the last possible exposure to the infection, unless its certificate of vaccination became valid for a period of time.
(i) Travellers in possession of an Amarile Vaccine Exemption Certificate signed by an authorized physician or a registered health officer may nevertheless be allowed to enter the territory, subject to the provisions of the preceding paragraph of this annex and provided that they have received information on protection against yellow fever vectors. Travellers who have not been quarantine may be required to report any febrile symptoms or other symptoms relevant to the competent authority and placed under supervision.
A N N E X E 8
MODEL DECLARATION MARITIME DE HEALTH
To be completed by the captains of ships from foreign ports and to be submitted to the competent authorities.
Presented at the port of Date:
Name of vessel or inland navigation vessel:
Registration number/IMO:
from to
(Nationality) (shipper vessel) Captain's name:
Gross yogurt:
Jauge (inland navigation panel)
Valid Certificate of Health Control/Exemption on board?
yes
Issued to Date:
New inspection required?
yes
Did the vessel/boat go to an affected area as defined by the WHO?
yes
Name of port and date of visit:
List of stopovers from the start of the trip (with indication of departure dates) or during the last 30 days, unless the trip lasts less than 30 days:
If requested by the competent authority of the port of arrival, list of crew members, passengers or other persons who have boarded the vessel/boat from the beginning of the international voyage or during the last 30 days, unless the voyage lasted less than 30 days, and name of all ports/country visited during that period (add the names in the table below):
(1) Name: 1° 2° 3°
(2) Name: 1° 2° 3°
(3) Name: 1° 2° 3°
Crew strength:
Number of passengers on board:
Health issues
1) Was there a death on board during the trip, other than by accident?
yes
If so, give the details in the table below.
Total number of deaths:
2) Are there any suspected cases of infectious disease on board or during the international voyage?
yes
If so, give the details in the table below.
(3) Has the total number of passengers sick during the trip been higher than normal/ expected number?
yes
What was the number of patients?
4) Are there patients on board?
yes
If so, give the details in the table below.
5) Has a doctor been consulted?
yes
If so, give details of the treatment or medical advice in the table below.
6) Do you have any knowledge of the existence of a condition that could cause an infection or the spread of a disease?
yes
If so, give the details in the table below.
7) Have any health measures (such as quarters, isolation, disinfection or decontamination) been taken on board?
yes
If yes, specify which location and date
8) Have they been found on board?
yes
If so, where did they board (to your knowledge)?
9) Is there a sick pet/animal on board?
yes
I declare that the information and answers contained in this health statement (including the table) are, to my knowledge, accurate and consistent with the truth.
Signed
Captain
Tentences
Edge doctor (if applicable)
Date:
Attachment to Marine Health Reporting Model
You can see the table in the OJ
n° 156 of 07/07/2007 text number 14
A N N E X E 9
THIS DOCUMENT PARTY OF THE GENERAL DECLARATION OF AERONEF PROMULGUED BY THE INTERNATIONAL ORGANIZATION OF CIVILE AVIATION (1)
Health Part
General Aircraft Reporting
Health statement
Cases of illness, excluding air injury or accidents (including people with symptoms or signs such as eruption, fever, chills, diarrhea), found on board or landed during the trip
Presence on other conditions that may cause the spread of a disease
Details relating to each insectization or other hygiene measure (place, date, time, method) practised during the flight. If there has been no insectization during the flight, please provide information on the most recent insectization
Signature (if necessary):
Member of the crew concerned
Eighth plenary meeting, 23 May 2005 A58/VR/8
Done in Paris, July 4, 2007.
Nicolas Sarkozy
By the President of the Republic:
The Prime Minister,
François Fillon
Minister for Foreign Affairs
and European,
Bernard Kouchner
