最新の IHR 修正案と現行IHRの比較

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関連記事：「最新のパンデミック条約草案」

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最新の IHR 修正案が2024年4月17日～23日の間に公開されました

(PDF link)
Proposed Bureau’s text for the eighth meeting of the Working Group on Amendments to the International Health Regulations (2005)

(link元)
WGIHR(Working Group on Amendments to the International Health Regulations (2005))
https://apps.who.int/gb/wgihr/

最新の IHR 修正案…正確には
「Working Group on Amendments to the International Health Regulations (2005) (WGIHR) Proposed Bureau’s text for Eighth WGIHR Meeting, 22–26 April 2024」
で、和訳すると
「国際衛生規則（2005年）の修正に関する作業部会（WGIHR）
2024年4月22日から26日に開催される第8回WGIHR会議の提案された事務局の文書」
の事です。

なお、現行のIHRこと、国際保健規則（2005年）の原文pdfはコチラ(P14からArticle 1)です。また第1回WGIHRで提案され主権剥奪として話題を呼んだ改正規則案の条項(Article)はコチラ(13A条項はP12)から確認できます。今回、13Aは丸ごと消えたようです。

折角なので「国際保健規則（2005年）」と「最新の IHR 修正案」の比較しやすいように、テキスト差分サイトに入力しましたのでご活用ください。
日本語で読みたい場合は、Google翻訳等をご活用ください。

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📗1-29条
https://web.archive.org/web/20240423145920/https://difff.jp/94suq.html

📗30-66条
https://web.archive.org/web/20240423150621/https://difff.jp/t5rtp.html

※翻訳で重くなるのを避ける為、二分割。

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補足：第一回の作業部会で提案された新条項13A。今回の提案で丸ごと消えたと思われる部分です。コチラのP12-13から引用。

NEW Article 13A WHO Led International Public Health Response
１．States Parties recognize WHO as the guidance and coordinating authority of international public health response during public health Emergency of International Concern and undertake to follow WHO’s recommendations in their international public health response.
２．WHO shall carry out an assessment of the availability and affordability of the heath products such as diagnostics, therapeutics, vaccines, personal and protective equipment and other tools required for responding to public health emergencies of international concern, including the potential increase in supply resulting form the surge and diversification of production and in cases of expected shortage of supply, WHO shall develop and allocation plan for health products so as to ensure equitable access to people of all States Parties.
３．WHO shall, in its allocation plan for health products, inter alia identify and prioritize the recipients of health products, including health workers, frontline workers and vulnerable populations, and determine the required quantity of health care products for effective distribution to the recipients across States Parties.
４．Upon request of WHO, States Parties with the production capacities shall undertake measures to scale up production of health products, including through diversification of production, technology transfer and capacity building especially in the developing countries.
５．Upon request of WHO, States Parties shall ensure the manufacturers within their territory supply the requested quantity of the health products to WHO or other States Parties as directed by WHO in a timely manner in order to ensure effective implementation of the allocation plan.
６．WHO shall develop and maintain a database containing details of the ingredients, components,design, know-how, manufacturing process, or any other information required to facilitate manufacturing of health products required for responding to the potential public health emergencies of international concern. Within two years of the entry into force of this provision, WHO shall develop this database for all PHEICs declared so far, including for the diseases identified in the IHR 1969.
７．In accordance with the provisions of these Regulations and in particular Article 13A (1), shall collaborate with other international organizations, and other stakeholders consistent with the provisions of FENSA, for responding to public health emergency of international concern. WHO shall report all its engagement with other stakeholders to the Health Assembly. The Director-general shall provide documents and information relating to such engagements upon request of States
Parties.

New Article 13A: Access to Health Products, Technologies and Know-How for Public Health Response
１．Immediately after the determination of a public health emergency of international concern under Article 12, the Director General shall make an immediate assessment of availability and affordability of required health products and make recommendations, including an allocation mechanism, to avoid any potential shortages of health products and technologies pursuant to Article 15 or 16 as appropriate.
２．States Parties shall co-operate with each other and WHO to comply with such recommendations pursuant to paragraph 1 and shall take measures to ensure timely availability and affordability of required health products such as diagnostics, therapeutics, vaccines, and other medical devices required for the effective response to a public health emergency of international concern.
３．States Parties shall provide, in their intellectual property laws and related laws and regulations,exemptions and limitations to the exclusive rights of intellectual property holders to facilitate the manufacture, export and import of the required health products, including their materials and components.
４．States Parties shall use or assign to potential manufacturers, especially from developing countries,on a non-exclusive basis, the rights over health product(s) or technology(ies), when the same is/are obtained in the course of research wholly or partially funded by public sources, and is/are identified as required health product(s) or technology(ies) to respond to a PHEIC, with a view to ensureequitable, timely availability and affordability through diversification of production.
５．Upon request of a State Party, other States Parties or WHO shall rapidly cooperate and share relevant regulatory dossiers submitted by manufacturers concerning safety and efficacy, and manufacturing and quality control processes, within 30 days. The dossiers received by a requesting State Party shall be solely used by their regulatory authorities and manufacturers designated by the requesting State Party for the purposes of accelerating the manufacture and supply of product(s) or technology(ies) as well as expediting their regulatory approval. Requesting State Party shall take measures to prevent designated manufacturer(s) from disclosing such information to a third-party(ies) except for the purposes of producing and supplying any materials or components to the manufacturer(s) under a contract with non-disclosure provisions.
６．WHO shall take measures to ensure availability and accessibility through the local production of required health products including:
a) develop and publish a list of required health products,
b) develop and publish specifications for the production of required health products,
c) develop appropriate regulatory guidelines for the rapid approval of health products of quality including development of immunogenicity co-relative protection (ICP) for vaccines,
d) establish a database of raw materials and their potential suppliers,
e) establish a repository for cell-lines to accelerate the production and regulatory of similar biotherapeutics products and vaccines,
f) review and regularly update WHO Listed Authorities so as to facilitate appropriate regulatory approvals,
g) any other measures required for the purposes of this provision.
７．The States Parties shall take measures to ensure that the activities of non-state actors, especially the manufacturers and those claiming associated intellectual property rights, do not conflict with the right to the highest attainable standard of health and these Regulations and are in compliance with measures taken by the WHO and the States Parties under this provision, which includes:
a) to comply with WHO recommended measures including allocation mechanism made pursuant to paragraph 1.
b) to donate a certain percentage of their production at the request of WHO.
c) to publish the pricing policy transparently.
d) to share the technologies, know-how for the diversification of production.
e) to deposit cell-lines or share other details required by WHO repositories or database established pursuant to paragraph 5.
f) to submit regulatory dossiers concerning safety and efficacy, and manufacturing and quality control processes, when called for by the States Parties or WHO.