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)　3　衛生医療用品への公平なアクセス、政府間機関/国際機関との協力

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報告書の全文の3回目です。
Working Group on Amendments to the International Health Regulations (2005) (who.int)

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。　　IHR(2005)厚労省 (mhlw.go.jp)
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。

PART II – INFORMATION AND PUBLIC HEALTH RESPONSE 【採決で合意】

第2部 情報と公衆衛生の対応

Article 13 Public health response, including equitable access to relevant health products 　第13条　公衆衛生上の対応(関連する衛生医療用品への公平なアクセスを含む) 【採決で合意】

1. Each State Party shall develop, strengthen and maintain, as soon as possible but no later than five years from the entry into force of these Regulations for that State Party, the core capacityies to prevent, prepare for, and respond promptly and effectively to public health risks and public health emergencies of international concern, including a pandemic emergency, including in fragile and humanitarian settings, as set out in Annex 1. WHO shall publish, in consultation with Member States, guidelines to support States Parties in the development of public health response core capacities.
各締約国は、公衆衛生上のリスク及び国際的に懸念される公衆衛生上の緊急事態(パンデミックの緊急事態と、附属書1に定める脆弱かつ人道的な状況を含む)を防止し、これに備え、迅速かつ効果的に対応するための中核的能力を、可能な限り速やかに、遅くとも、本規則の施行から5年以内に策定し、強化し、維持する。WHOは、加盟国と協議の上、締約国が公衆衛生対応の中核的能力を開発することを支援するためのガイドラインを公表する。

2. Following the assessment referred to in paragraph 2 Part A of Annex 1, a State Party may report to WHO on the basis of a justified need and an implementation plan and, in so doing, obtain an extension of two years in which to fulfil the obligation in paragraph 1 of this Article. In exceptional circumstances and supported by a new implementation plan, the State Party may request a further extension not exceeding two years from the Director-General, who shall make the decision, taking into account the technical advice of the Review Committee. After the period mentioned in paragraph 1 of this Article, the State Party that has obtained an extension shall report annually to WHO on progress made towards the full implementation.
締約国は、附属書1の2第A部に規定する評価の後、やむを得ない事情と実施計画をWHOに報告したうえで、本規約の1の規定に定められる義務の履行の２年間の延長が認めれる。また、新たな実施計画がある場合は、例外的に、さらに2年を超えない延長の許可を求めることができ、事務局長は再検討委員会の技術的助言を考慮して決定する。本規約の1に規定する期間の経過後、延長を得た締約国は、完全な実施に向けた進捗状況について毎年WHOに報告する。

3. At the request of a State Party or following its acceptance of an offer by WHO, WHO shall collaborate in the response to public health risks and other events by providing technical guidance and assistance and by assessing the effectiveness of the control measures in place, including the mobilization of international teams of experts for on-site assistance, when necessary.
締約国が要請又はWHOの申し出を受諾した場合、WHOは、公衆衛生上のリスクその他の事象に対応するために、技術的指導及び援助、現地での管理措置の評価、現地支援のための国際専門家チームの動員を行う。

4. If WHO, in consultation with the States Parties concerned as provided in Article 12, determines that a public health emergency of international concern, including a pandemic emergency, is occurring, it may offer, in addition to the support indicated in paragraph 3 of this Article, further assistance to the State(s) Party(ies), including an assessment of the severity of the international risk and the adequacy of control measures. Such collaboration may include the offer to mobilize international assistance in order to support the national authorities in conducting and coordinating on-site assessments. When requested by the State Party, WHO shall provide information supporting such an offer.
第12条に規定する関係締約国との協議において、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が発生していると決定した場合、WHOは、本条3に規定する支援に加えて、締約国に対し、国際的リスク度と管理措置の的確性の評価を含む更なる支援を提供する。このような協力は、各国の責任当局が現地評価を実施し調整するのにむけた国際的支援の動員を含み、締約国の要請にこたえる情報を提供する。

5. When requested by WHO, States Parties should provide, to the extent possible, support to WHO-coordinated response activities.
締約国は、WHOが要請した場合、可能なかぎり、WHOが調整した対応活動を支持するべきである。

6．When requested, WHO shall provide appropriate guidance and assistance to other States Parties affected or threatened by the public health emergency of international concern, including a pandemic emergency.
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あるか、あるいは、その可能性のある他の締約国に対し、WHOは、要請に応じて、適切な指導及び援助を提供する。

7. WHO shall support States Parties and coordinate international response activities during public health emergencies of international concern, including pandemic emergencies, after their determination pursuant to Article 12 of these Regulations.
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ある締約国が第12条の規定に基づく決定を行った場合、WHOは、締約国を支援し、国際的な対応活動を調整する。

8. 【議長団が2024.5.20更新を提示】WHO shall facilitate and, subject to Article 57, work to remove barriers to timely and equitable access by States Parties to relevant health products after the determination of a public health emergency of international concern, including a pandemic emergency, based on public health risks and needs. To that effect, the Director-General shall:
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が決定された場合、WHOは、公衆衛生上のリスク及びニーズに基づき、締約国が関連する保健医療用品を適時、公平に入手できるよう、第57条に従いそれを妨げないよう働きかける。そのため、事務局長は以下を行う。
8. 【議長団が更新し2024.5.18スクリーンに掲示】WHO shall facilitate, and work to [remove] barriers to, timely and equitable [global] access by States Parties to relevant health products after the determination of a public health emergency of international concern, including a pandemic emergency, based on public health risks and needs. To that effect, the Director-General shall: INSERT REF to ART 57 (ie would read …and, subject to Art 57, work to remove barriers…) : RESERVE: ALT  留保

(a) conduct, and periodically review and update, assessments of the public health needs, as well as of the availability and accessibility including affordability of relevant health products for the public health response; publish such assessments; and consider the available assessments while issuing, modifying, extending or terminating recommendations pursuant to Articles 15, 16, 17, 18, and 49 of these Regulations;
公衆衛生上のニーズ、その状況に応じた保健医療用品の利用状況及び適正価格を含む入手可能性の評価を行い、定期的に見直し、更新をする。また、それを公表すること。また、本規則第15条、第16条、第17条、第18条、および第49条に基づく勧告の発出、修正、延長、終了について評価、検討する。
(a) 【議長団が更新し2024.5.18スクリーンに掲示】conduct, and periodically review and update, assessments of the public health needs, as well as of the availability and accessibility including affordability of relevant health products for the public health response; publish such assessments; and consider the available assessments while issuing, modifying, extending or terminating [temporary] recommendations pursuant to Articles 15, [16,] 17, 18, and 49 of these Regulations;
公衆衛生上のニーズ、並びに公衆衛生上の対応のための関連保健医療用品の入手可能性及び入手のしやすさ(価格を含む)の評価し、かつ、定期的に見直し更新し、公表する。利用可能な評価を検討して、第15条、第16条、第17条、第18条、第49条に基づく[暫定的]勧告を発行、修正、延長、または終了する。

(b) make use of WHO-coordinated mechanisms, or facilitate their establishment, in consultation with States Parties, as necessary, and coordinate, as appropriate, with other allocation and distribution mechanisms and networks that facilitate timely and equitable access to relevant health products based on public health needs.
締約国と協議するなかで、WHOの調整能を使い、あるいはその確立を促進し、必要性に応じ、また配分や流通機能、流通網を適宜調整し、公衆衛生のニーズに基づいた衛生医療用品の適時、公平な分配を促進する。
(b) 【議長団が更新し2024.5.18スクリーンに掲示】make use of WHO-coordinated mechanisms, [or facilitate their establishment as needed DEL], and coordinate, as appropriate, with other allocation and distribution mechanisms and networks that facilitate [, and minimize [all] barriers to, timely and] equitable [and unobstructed DEL / RETAIN] access to relevant health products based on public health needs [in consultation with States Parties];CLEAN (b) make use of WHO-coordinated mechanisms, [or facilitate their establishment [, in consultation with States Parties,] as [necessary] [needed,]] and coordinate, as appropriate, with other allocation and distribution mechanisms and networks that facilitate timely and equitable access to relevant health products based on public health needs[, and, in consultation with States Parties, facilitate their establishment, as needed]
WHOが調整する機構を利用し[または必要に応じてDELの設立を促進し]、また、適宜、分配、配分を支援する機構やネットワークと協力し［そして、（締約国と検討した上で）公衆衛生のニーズに基づく関連する保健医療用品の適時で公平で［DEL/囲い込みのない］入手を妨げる障害を最小化する］。

(c) collaborate through relevant WHO coordinated and other networks and mechanisms in the implementation of this aArticle to support States Parties, upon their request, in scaling-up scaling up and geographically diversifying the production of relevant health products, as appropriate, subject to Article 2 of these Regulations, and in accordance with relevant international law;
本条の実施に当たっては、WHOが調整するその他のネットワーク及び機構を通じて協力し、締約国の要請に応じて、適切に、この規則第２条に従い、かつ、関連する国際法に従って、関連する保健医療用品の生産規模を拡大し、地理的に多様化することを支援する。
(c) 【議長団が更新し2024.5.18スクリーンに掲示】 collaborate with relevant stakeholders [1 ] [ in the implementation of this article and] to support States Parties, upon their request, in scaling-up and [geographically] diversifying, as appropriate and in accordance with relevant international law, the production of relevant health products; DEL]
[本条の実施に当たっては]締約国の要請により、関連する保健医療用品の生産を促し、[地理的に]多様化するよう支援する際、適宜、また関連する国際法に従い、関連する利害関係者＊と協力する；DEL]
CLEAN (c) collaborate [through relevant [WHO coordinated] [and other] networks and mechanisms] [with relevant stakeholders＊ DEL] in the implementation of this article to support States Parties, upon their request, in scaling-up and geographically diversifying, as appropriate[, subject to Article 2 of these Regulations,] and in accordance with relevant international law, the production of relevant health products;
CLEAN (c) 締約国の要請に応じて、関連する保健医療用品の生産の規模拡大及び地理的多様化をはかって締約国を支援するために本条を実施するにあたっては、適宜、 [第2条に従い]また、関連する国際法に従って、[WHOが調整する][また他の]ネットワーク及び機構を通じて] [関連する利害関係者＊DEL]と協力する。
＊：stakeholders means international, inter-governmental organizations and non- state actors in accordance with FENSA / DEL ]利害関係者とは、FENSA / DELに準拠した国際的、政府間組織、および非国家主体を意味する。
FENSA：Framework of Engagement with Non-State Actors　　非国家主体の契約枠組み
非国家主体：国家から完全にまたは部分的に独立した、影響力をもつ個人やグループ

(d) share with a State Party, upon its request, the product dossier related to a specific relevant health product, as provided to WHO by the manufacturer for approval and where the manufacturer has consented, within 30 days of receiving such request, for the purpose of facilitating regulatory evaluation and authorization by the State Party.; and
締約国が規制上の評価及び認可を促進する目的で、製造業者が承認のためにWHOに提供した特定の関連保健医療製品に関する製品関係書類の共有をもとめ、また、製造業者がそれに同意した場合には、当該要請から30日以内に、共有する。かつ。
(d) 【議長団が更新し2024.5.18スクリーンに掲示】 RETAIN BUREAU TEXT　議長団のテキストを使用　share with a State Party, upon its request, the product dossier related to a specific relevant health product, as provided to WHO by the manufacturer for approval and where the manufacturer has consented, within 30 days of receiving such request, for the purpose of facilitating regulatory evaluation and authorization by the State Party.
製造業者が承認のためにWHOに提供した特定の関連保健医療用品に関する製品関係書類を、締約国が規制上の評価及び認可を容易にする目的で要請した場合、製造業者から同意を得て、締約国の要請から30日以内に締約国と共有する。

(e) support States Parties, upon their request, and, as appropriate, subject to Article 2 of these Regulations, through relevant WHO-coordinated and other networks and mechanisms, pursuant to subparagraph 8(c) of this paragraph Article, to strengthen local production of quality assured relevant health products; and facilitate the voluntary transfer of technology, know-how and expertise on mutually agreed terms,1 , including for research and development purposes.
締約国の要請に応じて、また、適宜、本規則第2条に従い、WHOによる調整その他の機構や組織を通じて、そして、本項第8(c)項に従い、品質が保証された関連保健医療用品の現地生産を強化する。研究開発目的を含め、相互に合意した条件＊で、技術、ノウハウ、専門知識の自発的な移転を促進する。
＊：For greater certainty, the reference to voluntary transfer of technology, know-how and expertise on mutually agreed terms is without prejudice to other measures that States Parties may take, consistent with the rights, obligations, and flexibilities that Members of the World Trade Organization have under the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), including those reaffirmed by the Doha Declaration on the TRIPS Agreement and Public Health.
より明確には、相互に合意した条件での技術、ノウハウ及び専門知識の自発的な移転は、締約国がとり得る他の措置を損なうものではない。すなわち、公衆衛生に関するドーハ宣言で再確認されたものを含む、知的所有権の貿易関連の側面に関する協定(TRIPS)の規定に基づいて世界貿易機関(WTO)加盟国が有する権利、義務及び柔軟性をそこなうものではない。
【議長団が更新し2024.5.18スクリーンに掲示】RETAIN BUREAU TEXT [(e) support States Parties, upon their request, and, as appropriate, in collaboration with relevant stakeholders, pursuant to sub-paragraph (c) of this paragraph, to strengthen local production; achieve quality assurance [through] [for the DEL] evaluation and regulatory approval of locally manufactured relevant health products; and facilitate [any other measures relevant for the full implementation of this provision] [the [[voluntary] DEL] transfer of technology, know-how and expertise [[on mutually agreed terms] DEL] [2 ], including for research and development purposes. DEL] DEL] DEL] ALT [(e) support States Parties, upon their request, and, as appropriate, subject to Article 2 of these Regulations, in collaboration [with] [through] relevant [[WHO-coordinated] [and other international] networks and mechanisms] [stakeholders], pursuant to sub-paragraph (c) of this paragraph, to strengthen local production [of quality assured relevant health products]; achieve quality assurance through evaluation and regulatory approval of locally manufactured relevant health products; and facilitate the [voluntary] transfer of technology, know-how and expertise [on mutually agreed terms], including for research and development purposes [, including technology licensing agreements on mutually agreed terms].

9.【議長団が2024.5.20更新を提示】 Pursuant to paragraph 5 of this Article and paragraph 1 of Article 44 of these Regulations, and upon request of other States Parties or WHO, States Parties shall undertake, subject to applicable law and available resources, to collaborate with, and assist each other and to support WHO-coordinated response activities, including through:
本条の５と第44条の１に従い、また、他の締約国又はWHOの要請に応じて、締約国は、適用法令及び利用可能な資源に従い、相互に協力し助け合い、以下に示すWHOが調整する対応活動を支援する。

(a) supporting WHO in implementing actions outlined in this Article
本条に定める措置のWHOによる実施を支援する。
(b) engaging with and encouraging relevant stakeholders operating in their respective jurisdictions, to facilitate equitable access to relevant health products for responding to a public health emergency of international concern, including a pandemic emergency; and
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処する衛生医療用品が公平に入手できるよう、各領域で活動している関連する利害関係者と連携し推進する。
(c) publishing, as appropriate, relevant terms of their research and development agreements for relevant health products related to promoting equitable access to such products during a public health emergency of international concern, including a pandemic emergency.
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の際に、衛生医療用品の公平な入手の促進に関係する研究開発に関する合意関連条件を　適宜公開する。

9. 【議長団が更新し2024年5月18日スクリーン掲示】Pursuant to paragraph 5 of this Article and paragraph 1 of Article 44 of these Regulations, and upon request of other States Parties or WHO, States Parties shall undertake, subject to applicable law and available resources, to collaborate with, and assist each other and to support WHO-coordinated response activities, including through: (a) supporting WHO in implementing actions outlined in this Article; (b) engaging with and encouraging relevant stakeholders operating in their respective jurisdictions, to facilitate equitable access to relevant health products for responding to a public health emergency of international concern, including a pandemic emergency; (c) publishing, as appropriate, relevant terms of their [government-funded] research and development agreements for relevant health products related to promoting equitable access to such products during a public health emergency of international concern, including a pandemic emergency. DEL para 9.a, 9.b, 9.c: DEL para9.c: (and without prejudice to this request, prefer “their” to “government funded”) Article 14 Cooperation of WHO with intergovernmental organizations and international bodie.

Article 14 Cooperation of WHO with intergovernmental organizations and international bodies 第14条 WHOの政府間機関及び国際機関との協力

1. WHO shall cooperate and coordinate its activities, as appropriate, with other competent intergovernmental organizations or international bodies in the implementation of these Regulations, including through the conclusion of agreements and other similar arrangements.
2. In cases in which notification or verification of, or response to, an event is primarily within the competence of other intergovernmental organizations or international bodies, WHO shall coordinate its activities with such organizations or bodies in order to ensure the application of adequate measures for the protection of public health.
3. Notwithstanding the foregoing, nothing in these Regulations shall preclude or limit the provision by WHO of advice, support, or technical or other assistance for public health purposes