WHO　第77回総会　Provisional agenda item 13.3　　　国際保健規則(2005年)の改正に関する作業部会事務局長報告　(全文)　１　定義、目的、原則、責任当局

IHR(2005)改正はこれまで段階的に行われてきました。この報告書は2005年に作成されたIHR文書に、今回改正される部分を書き加える形でつくられています。この記事では、改正されない部分をグレー地（本来、引用表示として使用される）としています。
改正部分は４種類に分類されています。
１．過去に投票で合意(時期不明)
２．今回2024年5月20日にWGIHR(作業部会)議長団が提示
３．議長団が13(8)(e) と44(2 ter)(c)に関して更新(時期不明)
４．議長団が更新し2024年5月18日中央欧州夏時間16:00にスクリーン表示

それぞれの変更箇所で、「採決で合意」「議長団が2024.5．20更新を提示」「議長団が13(8)(e) 、44(2 ter)(c)に関して更新」「議長団が更新し2024.5.8にスクリーン掲示」と付記します。

これは、第77回世界保健総会において、国際保健規則 IHR（2005）の改正作業部会（WGIHR）から事務局長あてに提出された、文書（付録）とその議長団による注記である。
Working Group on Amendments to the International Health Regulations (2005) (who.int)

International health regulations

国際保健規則(2005年)の改正に関する作業部会議長団からの注記

1.      決定WHA75(9)(2022)により設置された国際保健規則(2005年)改正作業部会(以下「WGIHR」または「作業部会」)は、締約国が提出した国際保健規則(2005年)(以下「IHRまたは規則」)の改正に関するすべての提案および国際保健規則(2005年)の改正に関する検討委員会の報告を慎重に検討した。： Document A/WGIHR/2/5 (2023)
2.      WGIHRは、2022年11月14日から2024年5月24日までハイブリッド形式で開催された8回およびその後の会議で、規則改正に関するこれらの提案について議論し、改良した。（WGIHRの作業の詳細: https://apps.who.int/gb/wgihr/ (accessed 24 May 2024).
3.      WGIHRは、規制の対象を絞った改正に合意すると同時に、その権限に従って公平性の問題に取り組むことに向けて大きな進展を遂げた。：Decision EB150(3) (2022)
WGIHRは、政府間交渉機関事務局(INB)と緊密に協力し、特に、両事務局が検討している重要な共通問題の数を考慮しながら、パンデミックの予防、準備、対応についてのWHO条約、協定、その他の国際文書を、起草、交渉し、2つのプロセス間の一貫性と補完性を確保した。INBとWGIHRの2つの合同会議は、2023年7月21日と24日、2024年2月23日に開催された。
4.      WGIHRを代表して、議長団は、第77回世界保健総会での審議に向け、本文書(付録参照)を提出する。この文書は、完全に合意された改定案を示すものではなく、WGIHRの作業の現状及び進捗状況の概要を示すことを意図している。これは、原則的に合意された多くの修正案、合意に近い他の文書、および合意に達するためにさらなる作業が必要ないくつかの問題を含んでいる。原則的に合意された文書(附属書で緑色で強調表示)は、改定案の全体が最終決定されるまで暫定的なものとみなすべきである。
5.      議長団は、WGIHRは規則改正の合意案にこぎつけつつあり、プロセスを成功裡に終わらせたいという強い意欲があると感じている。WGIHR共同議長及び議長団の活動はとりあえず終了したが、我々は、第77回世界保健総会で合意された次のステップを支持する用意があり、決定された場合には、更なる議論を促進することも含む。

付録

議長団報告（BUREAU'S PROPOSED TEXT）2024年5月20日

INTERNATIONAL HEALTH REGULATIONS (2005)

PART I – DEFINITIONS, PURPOSE AND SCOPE, PRINCIPLES AND RESPONSIBLE AUTHORITIES

Article 1 Definitions   第１条　定義

1.      For the purposes of the International Health Regulations (hereinafter “the IHR” or “Regulations”):
“affected” means persons, baggage, cargo, containers, conveyances, goods, postal parcels or human remains that are infected or contaminated, or carry sources of infection or contamination, so as to constitute a public health risk;
“affected area” means a geographical location specifically for which health measures have been recommended by WHO under these Regulations;
“aircraft” means an aircraft making an international voyage;
“airport” means any airport where international flights arrive or depart;
“arrival” of a conveyance means:
(a) in the case of a seagoing vessel, arrival or anchoring 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 on an international voyage, arrival at a point of entry;
(d) in the case of a train or road vehicle, arrival at a point of entry; “baggage” means the personal effects of a traveller;
“cargo” means goods carried on a conveyance or in a container;
“competent authority” means an authority responsible for the implementation and application of health measures under these Regulations;
“container” means an article of transport equipment:
(a) of a permanent character and accordingly strong enough to be suitable for repeated use;
(b) specially designed to facilitate the carriage of goods by one or more modes of transport, without intermediate reloading;
(c) fitted with devices permitting its ready handling, particularly its transfer from one mode of transport to another; and
(d) specially designed as to be easy to fill and empty; Annex A77/9 5
“container loading area” means a place or facility set aside for containers used in international traffic;
“contamination” means the presence of an infectious or toxic agent or matter on a human or animal body surface, in or on a product prepared for consumption or on other inanimate objects, including conveyances, that may constitute a public health risk; “conveyance” means an aircraft, ship, train, road vehicle or other means of transport on an international voyage;
“conveyance operator” means a natural or legal person in charge of a conveyance or their agent; “crew” means persons on board a conveyance who are not passengers; “decontamination” means a procedure whereby health measures are taken to eliminate an infectious or toxic agent or matter on a human or animal body surface, in or on a product prepared for consumption or on other inanimate objects, including conveyances, that may constitute a public health risk;
“departure” means, for persons, baggage, cargo, conveyances or goods, the act of leaving a territory;
“deratting” means the procedure whereby health measures are taken to control or kill rodent vectors of human disease present in baggage, cargo, containers, conveyances, facilities, goods and postal parcels at the point of entry;
“Director-General” means the Director-General of the World Health Organization;
“disease” means an illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans;
“disinfection” means the procedure whereby health measures are taken to control or kill infectious agents on a human or animal body surface or in or on baggage, cargo, containers, conveyances, goods and postal parcels by direct exposure to chemical or physical agents;
“disinsection” means the procedure whereby health measures are taken to control or kill the insect vectors of human diseases present in baggage, cargo, containers, conveyances, goods and postal parcels;
“event” means a manifestation of disease or an occurrence that creates a potential for disease;
“free pratique” means permission for a ship to enter a port, embark or disembark, discharge or load cargo or stores; permission for an aircraft, after landing, to embark or disembark, discharge or load cargo or stores; and permission for a ground transport vehicle, upon arrival, to embark or disembark, discharge or load cargo or stores;
“goods” mean tangible products, including animals and plants, transported on an international voyage, including for utilization on board a conveyance;
“ground crossing” means a point of land entry in a State Party, including one utilized by road vehicles and trains　
“ground transport vehicle” means a motorized conveyance for overland transport on an international voyage, including trains, coaches, lorries and automobiles;
“health measure” means procedures applied to prevent the spread of disease or contamination; a health measure does not include law enforcement or security measures;
“ill person” means an individual suffering from or affected with a physical ailment that may pose a public health risk;
“infection” means the entry and development or multiplication of an infectious agent in the body of humans and animals that may constitute a public health risk;
“inspection” means the examination, by the competent authority or under its supervision, of areas, baggage, containers, conveyances, facilities, goods or postal parcels, including relevant data and documentation, to determine if a public health risk exists;
“international traffic” means the movement of persons, baggage, cargo, containers, conveyances, goods or postal parcels across an international border, including international trade;
“international voyage” means:
(a) in the case of a conveyance, a voyage between points of entry in the territories of more than one State, or a voyage between points of entry in the territory or territories of the same State if the conveyance has contacts with the territory of any other State on its voyage but only as regards those contacts;
(b) in the case of a traveller, a voyage involving entry into the territory of a State other than the territory of the State in which that traveller commences the voyage;
“intrusive” means possibly provoking discomfort through close or intimate contact or questioning;
“invasive” means the puncture or incision of the skin or insertion of an instrument or foreign material into the body or the examination of a body cavity. For the purposes of these Regulations, medical examination of the ear, nose and mouth, temperature assessment using an ear, oral or cutaneous thermometer, or thermal imaging; medical inspection; auscultation; external palpation; retinoscopy; external collection of urine, faeces or saliva samples; external measurement of blood pressure; and electrocardiography shall be considered to be non-invasive;
“isolation” means separation of ill or contaminated persons or affected baggage, containers, conveyances, goods or postal parcels from others in such a manner as to prevent the spread of infection or contamination;
“medical examination” means the preliminary assessment of a person by an authorized health worker or by a person under the direct supervision of the competent authority, to determine the person’s health status and potential public health risk to others, and may include the scrutiny of health documents, and a physical examination when justified by the circumstances of the individual case;

「国内IHR当局」【採決で合意し追加】

“National IHR Authority”
means the entity designated or established by the State Party at the national level to coordinate the implementation of these Regulations within the jurisdiction of the State Party;
「国内IHR当局」とは、締約国の管轄区域内で本規則の実施を調整するために、締約国が国家レベルで指定または設立する機関をいう。

“National IHR Focal Point” means the national centre, designated by each State Party, which shall be accessible at all times for communications with WHO IHR Contact Points under these Regulations; “Organization” or “WHO” means the World Health Organization;

「パンデミック緊急事態」【議長団が2024.5.20更新を提示】

“pandemic emergency” means a public health emergency of international concern that is caused by a communicable disease and:
「パンデミック緊急事態」とは、伝染病によって引き起こされる国際的に懸念される公衆衛生上の緊急事態を意味し、
(i) has, or is at high risk of having, wide geographical spread to and within multiple States; and
複数の国、地理的に広く広がっている、またはそのリスクが高く、
(ii) is exceeding, or is at high risk of exceeding, the capacity of health systems to respond in those States; and
かつ、その国の保健システムの対応能力を超えている、または超えるリスクが高く、
(iii) is causing, or is at high risk of causing, substantial social and/or economic disruption, including disruption to international traffic and trade; and
かつ、国際交通や貿易の混乱など、重大な社会的、経済的混乱を引き起こしている、または引き起こすリスクが高いため、
(iv) requires rapid, equitable and enhanced coordinated international action, with wholeof-government and whole-of-society approaches.
政府全体、社会全体のアプローチによる、迅速、公平、強化された協調的な国際行動が必要である事態

「パンデミック緊急事態」【議長団が更新し2024.5.18スクリーン掲示】

“pandemic emergency” means a public health emergency of international concern that is caused by a communicable disease and: 「パンデミック緊急事態」とは、伝染病によって引き起こされる国際的に懸念される公衆衛生上の緊急事態を意味し、
(i) has[, or is at high risk of having, DEL] wide geographical spread to and within multiple States; and
地理的に広く、複数の国内に広がっている、またはそのリスクが高く、DEL、かつ
(ii) is exceeding[, or is at high risk of exceeding, DEL] the capacity of health systems to respond in those States; and DEL
これらの国における保健システムの対応能力を超えている、またはそのリスクが高く、DEL、かつ
(iii) is causing[, or is at high risk of causing, DEL] substantial social and/or economic disruption, including disruption to international traffic and trade; and
国際的な交通や貿易の混乱を含む、重大な社会的および/または経済的混乱を引き起こしている、またはそのリスクが高く、DEL、かつ
(iv) requires rapid, equitable and enhanced coordinated international action, with whole-ofgovernment and whole-of-society approaches.
政府全体と社会全体のアプローチによる、迅速で公平かつ強化された協調的な国際的行動が必要な事態。

“permanent residence” has the meaning as determined in the national law of the State Party concerned;
“personal data” means any information relating to an identified or identifiable natural person;
“point of entry” means a passage for international entry or exit of travellers, baggage, cargo, containers, conveyances, goods and postal parcels as well as agencies and areas providing services to them on entry or exit;
“port” means a seaport or a port on an inland body of water where ships on an international voyage arrive or depart;
“postal parcel” means an addressed article or package carried internationally by postal or courier services;
“public health emergency of international concern” means an extraordinary event which is determined, as provided in these Regulations:
(i) to constitute a public health risk to other States through the international spread of disease;and
(ii) to potentially require a coordinated international response
“public health observation” means the monitoring of the health status of a traveller over time for the purpose of determining the risk of disease transmission;
“public health risk” means a likelihood of an event that may affect adversely the health of human populations, with an emphasis on one which may spread internationally or may present a serious and direct danger;
“quarantine” means the restriction of activities and/or separation from others of suspect persons who are not ill or of suspect baggage, containers, conveyances or goods in such a manner as to prevent the possible spread of infection or contamination;
“recommendation” and “recommended” refer to temporary or standing recommendations issued under these Regulations;

「関連健康用品」【議長団が2024.5.20に更新を提示】

“relevant health products” means medicines, vaccines, medical devices including
diagnostics, vector control products, personal protective equipment, decontamination products, assistive products, antidotes, cell- and gene-based therapies, and other health technologies, which are needed to respond to public health emergencies of international concern, including pandemic emergencies;
「関連健康用品」とは、医薬品、ワクチン、診断薬を含む医療品、媒介生物制御用品、個人用保護具、除染用品、福祉用具、解毒剤、細胞および遺伝子ベースの治療、およびその他の医療技術で、パンデミックの緊急事態を含む国際的に懸念される公衆衛生上の緊急事態に対応するために必要なもの。

「関連健康用品」【議長団が更新し2024.5.18スクリーン掲示】

“relevant health products” means health products, including medicines, vaccines, medical devices including diagnostics, personal protective equipment, decontamination products, assistive products, antidotes, cell- and gene-based therapies, and other health technologies, which are needed to respond to public health emergencies of international concern, including pandemic emergencies; RESERVE:
「関連健康品用品」とは、医薬品、ワクチン、診断薬を含む医療品、個人用保護具、除染用品、福祉用品、解毒剤、細胞および遺伝子ベースの治療、その他の医療技術を含む健康技術で、パンデミックの緊急事態を含む国際的に懸念される公衆衛生上の緊急事態に対応するために必要なもの：留保：

“reservoir” means an animal, plant or substance in which an infectious agent normally lives and whose presence may constitute a public health risk;
“road vehicle” means a ground transport vehicle other than a train;
“scientific evidence” means information furnishing a level of proof based on the established and accepted methods of science;
“scientific principles” means the accepted fundamental laws and facts of nature known through the methods of science;
“ship” means a seagoing or inland navigation vessel on an international voyage

「常設勧告」【採決で合意】

“standing recommendation” means non-binding advice issued by WHO for specific ongoing public health risks pursuant to Article 16 regarding appropriate health measures for routine or periodic application needed to prevent or reduce the international spread of disease and minimize interference with international traffic;
「常設勧告」とは、「特定の進行中の公衆衛生上のリスク」についてWHOが発行する拘束力のない助言、すなわち、第16条による、疾病の国際的な蔓延防止と軽減、国際交通への影響を最小限に抑えるために必要、適切な「日常的または継続的健康措置」

“surveillance” means the systematic ongoing collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary;
“suspect” means those persons, baggage, cargo, containers, conveyances, goods or postal parcels considered by a State Party as having been exposed, or possibly exposed, to a public health risk and that could be a possible source of spread of disease;

「臨時勧告」【採決で合意】

“temporary recommendation” means non-binding advice issued by WHO pursuant to Article 15 for application on a time-limited, risk-specific basis, in response to a public health emergency of international concern, so as to prevent or reduce the international spread of disease and minimize interference with international traffic;
「臨時勧告」とは、「国際的懸念となった公衆衛生の緊急事態」に対しWHOが発行する拘束力のない助言、すなわち、第15条に定めた、疾病の国際的な蔓延防止と軽減、国際交通への影響を最小限に抑えるなどのための、「期間限定の特定のリスクに対応した措置」

“temporary residence” has the meaning as determined in the national law of the State Party concerned;
“traveller” means a natural person undertaking an international voyage;
“vector” means an insect or other animal which normally transports an infectious agent that constitutes a public health risk;
“verification” means the provision of information by a State Party to WHO confirming the status of an event within the territory or territories of that State Party;
“WHO IHR Contact Point” means the unit within WHO which shall be accessible at all times for communications with the National IHR Focal Point. 2. Unless otherwise specified or determined by the context, reference to these Regulations includes the annexes thereto.

Article 2 Purpose and scope　第2条 目的及び範囲　【議長団が2024.5.20に更新を提示】

The purpose and scope of these Regulations are to prevent, prepare for, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risk and which avoid unnecessary interference with international traffic and trade.
本規則の目的は、疾患の国際的蔓延について、これを防止し、準備し、防御し、管理し、公衆衛生上のリスクに見合い、かつ限定した対応を提供し、国際的な交通及び貿易への不必要な干渉を回避することにある。

全く同じ文章を【議長団が更新し2024.5.18にスクリーン掲示】し、留保としています。

Article 3 Principles　第3条 原則　【採決で合意】

1. The implementation of these Regulations shall be with full respect for the dignity, human rights and fundamental freedoms of persons, and shall promote equity and solidarity.
本規則の実施にあたっては、人の尊厳、人権及び基本的自由を十分に尊重し、公平及び連帯を促進するものとする。　

2. The implementation of these Regulations shall be guided by the Charter of the United Nations and the Constitution of the World Health Organization.
この規則の実施にあったては、国際連合憲章及び世界保健機関憲章に従う。

3. The implementation of these Regulations shall be guided by the goal of their universal application for the protection of all people of the world from the international spread of disease.
この規則の実施にあたっては、疾病の国際的な蔓延から世界のすべての人々を保護するための普遍的な適用をその目標とする。

4. States have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to legislate and to implement legislation in pursuance of their health policies. In doing so, they should uphold the purpose of these Regulations.
国々は、国際連合憲章及び国際法の原則に従い、自国の保健政策に従って立法し施行する主権を有する。その際、本規則の趣旨を守らなければならない。

Article 4 Responsible authorities　第4条 責任当局 【採決で合意】

1.国内IHR当局（National IHR Authority）、国内IHR拠点（National IHR Authority）、責任当局（the authorities）の設置

Each State Party shall designate or establish, in accordance with its national law and context, one or two entities to serve as National IHR Authority and a National IHR Focal Point, and as well as the authorities responsible within its respective jurisdiction for the implementation of health measures under these Regulations.
各締約国は、自国の法律及び文脈に従い、国内IHR当局及び国内IHR拠点として機能する1つ又は2つの団体と、本規則に基づく保健措置の実施についての（自国の管轄区域内における）責任当局を指定又は設立する。
1 bis. The National IHR Authority shall coordinate the implementation of these Regulations within the jurisdiction of the State Party.
国内IHR当局は、締約国の管轄権の範囲内で本規則の実施を調整する。

2.国内IHR拠点の機能

National IHR Focal Points shall be accessible at all times for communications with the WHO IHR Contact Points provided for in paragraph 3 of this Article. The functions of National IHR Focal Points shall include:
国内IHR拠点は、本条第3項に規定するWHOのIHR連絡窓口に、常時、接触、連絡可能とする。国内IHR拠点の機能は、次のものを含む。
(a) sending to WHO IHR Contact Points, on behalf of the State Party concerned, urgent communications concerning the implementation of these Regulations, in particular under Articles 6 to 12; and
締約国を代表して、本規則、特に第6条から第12条の規定の実施に関する緊急通報をWHOのIHR連絡窓口へ送付。
(b) disseminating information to, and consolidating input from, relevant sectors of the administration of the State Party concerned, including those responsible for surveillance and reporting, points of entry, public health services, clinics and hospitals and other government departments.]
WHOからの情報の拡散と、締約国国内の監視及び報告義務のある関連部署（入国、公衆衛生サービス、診療所及び病院並びにその他の政府部門）からの情報の収集、集約
2 bis. States Parties shall take measures to implement paragraphs 1, 1 bis, and 2 of this Article, including, as appropriate, adjusting their domestic legislative and/or administrative arrangements. Annex A77/9 11
締約国は、この条の1及び2を実施するため、適宜、国内の立法および行政機関の調整を含む措置をとる。

3.WHOのIHR連絡窓口（IHR Contact Points）の機能

WHO shall designate IHR Contact Points, which shall be accessible at all times for communications with National IHR Focal Points. WHO IHR Contact Points shall send urgent communications concerning the implementation of these Regulations, in particular under Articles 6 to 12, to the National IHR Focal Point of the States Parties concerned. WHO IHR Contact Points may be designated by WHO at the headquarters or at the regional level of the Organization.
WHOは、常時、各国内のIHR拠点と連絡可能となるIHRの連絡窓口を指定する。WHOのIHR連絡窓口は、本規約、特に第6条から第12条の規定の実施に関する緊急通報を、締約国の国内IHR拠点に送付する。WHOのIHR連絡窓口は、WHO（本部または地域レベルで）が指定する。

4.国内IHR当局、国内IHR拠点、WHOのIHR連絡窓口の連携

States Parties shall provide WHO with contact details of their National IHR Authority and their National IHR Focal Point and WHO shall provide States Parties with contact details of WHO IHR Contact Points. These contact details shall be continuously updated and annually confirmed. WHO shall make the contact details available to all States Parties
締約国は、WHOに対し国内IHR当局及び国内IHR拠点の連絡先の詳細を提供し、WHOは、締約国に対しWHOのIHR連絡窓口の連絡先の詳細を提供する。これらの連絡先の詳細は、継続的に更新され、毎年確認し、WHOは、連絡先の詳細をすべての締約国が利用できるようにする。