WHOパンデミック協定採択見送り 知的財産権放棄議論から意見対立は技術移転やワクチン、治療薬及び診断薬配分の仕組みへ



スイス・ジュネーブで2024年5月27日から6月1日まで開催されていた世界保健機関(WHO)の第77回年次総会(World Health Assembly)は、その最終日、「WHOパンデミック協定」(WHO pandemic agreement)案の採択を見送ることを決定しました(2024.06.01 WHO press release: World Health Assembly agreement reached on wide-ranging, decisive package of amendments to improve the International Health Regulations And sets date for finalizing negotiations on a proposed Pandemic Agreement 参照)。


この「WHOパンデミック協定」案は、COVID-19パンデミックへの対応において国際社会(WHO)が連帯と公平性を示すことができなかったことを踏まえ、WHO CA+の作成のための政府間交渉会議(INB:Intergovernmental Negotiating Body)の設置が2021年12月に決定され、2022年2月に最初のINBが開催されて以来、今回のWHO総会において成果物を提出することを目指して政府間での交渉が行われてきました。

しかし、INBでの交渉妥結には至らず(A/INB/9 (Resumed session and drafting group)参照)、今回の総会の会期中においても各国間で協議が重ねられましたが、やはり意見の隔たりが埋まらなかったようです。

INBの成果として総会に提出された報告書には、5月24日正午(現地時間)時点でのテキスト案が添付されることとなりました(2024.05.28 A/INB/9/5 Report of the meeting及び 2024.05.27 WHA77/A77_10: Intergovernmental Negotiating Body to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response 参照)。



さて、以前に当ブログで紹介した「WHO CA+」のゼロ ドラフトには、医薬品等へのアクセスに知的財産はネガティブな効果についての懸念があることを前提とした記載が盛り込まれていましたが(2023.02.20ブログ記事「パンデミックの予防、準備、対応に関するWHO条約、協定、その他の国際文書「WHO CA+」の合意に向けた政府間交渉の基礎となるゼロ ドラフト」参照)、今回の総会に提出された報告書に添付された協定テキスト案ではどのような内容となっていたのでしょうか。




– ハイライトなしのテキスト:収束に至らなかったテキスト
– [括弧]内のテキスト:見解が分かれたテキスト



「WHO CA+」のゼロドラフトから修正され、ネガティブな効果についての記載は無くなっています。

The Parties to the WHO Pandemic Agreement…


14. Recognizing that intellectual property protection is important for the development of new medicines and recognizing the concerns about its effects on prices, and recalling that the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) [and its flexibilities] does not, and should not, prevent Member States from taking measures to protect public health,

NOTE: Subject to consistency with related articles in this Agreement.

14. 知的財産権の保護が新薬の開発にとって重要であることを認識し、その価格への影響に関する懸念を認識し、知的財産権の貿易関連の側面に関する協定(TRIPS協定)[及びその柔軟性]が、加盟国が公衆衛生を保護するための措置をとることを妨げるものではなく、また妨げるべきではないことを想起し、

[(New para. 14 bis) Emphasizing the need to improve access to quality, safe, effective and affordable
medicines and other health technologies, inter alia, through building capacity for local production,
especially in developing countries [and notably least developed countries and small island developing
states], technology transfer [on voluntary and mutually agreed terms] and cooperation, and other

14bis. 特に、開発途上国(特に後発開発途上国及び小島嶼開発途上国)における現地生産能力の構築、技術移転(自主的かつ相互に合意された条件による)及び協力、ならびにその他のイニシアティブを通じて、質の高い、安全で効果的かつ安価な医薬品及びその他の保健技術へのアクセスを改善する必要性を強調し、

…Have agreed as follows: 




Article 11. Transfer of technology and know-how for the production of pandemic-related health products

1. Each Party shall, in order to enable the sustainable and geographically diversified production of pandemic-related health products for the attainment of the objective of this Agreement, as appropriate:


(a) Promote and otherwise facilitate or incentivize transfer of technology, skills and [know-how] [which may include know-how, as appropriate,] on [voluntary and mutually agreed terms, without prejudice to other measures a Party might take,] for pandemic-related health products, in particular for the benefit of developing countries [and for technologies that have received public/government funding for their development], through a variety of measures such as licensing, capacity building, relationship facilitating, incentives or conditions linked to research and development, procurement or other funding, regulatory policies, and/or fiscal policies;

パンデミックに関連する保健製品、特に開発途上国の利益となるような技術、技能及び[ノウハウ] [適切な場合には、ノウハウを含むことができる]の移転を、ライセンス供与、能力開発、関係の促進、研究開発、調達その他の資金、規制政策、及び/又は財政政策に関連するインセンティブ又は条件といった様々な措置を通じて、[締約国が取り得る他の措置を損なうことなく、自主的かつ相互に合意された条件で]促進し、又はインセンティブを与える;

note: it is to be recalled that the chapeau of article 22 on “Cooperation in the scientific, technical, and legal fields and provision of related expertise” of the FCTC when dealing with transfer of technology, stated the following:

“1. The Parties shall cooperate directly or through competent international bodies to strengthen their capacity to fulfill the obligations arising from this Convention, taking into account the needs of developing country Parties and Parties with economies in transition. Such cooperation shall promote the transfer of technical, scientific and legal expertise and technology, as mutually agreed, to establish and strengthen national tobacco control strategies, plans and programmes aiming at, inter alia:”

Also, the PIP Framework uses similar terminology under article 16:

“6.13.3 Technology transfer should be conducted in a manner consistent with applicable national laws and international laws and obligations, facilitated progressively over time, on mutually agreed terms, and be suitable to the…”

note: another option would be to add a definition on “transfer of technology”, either:

1. Wherever the term transfer of technology is used in this agreement, it implies the transfer takes place under terms and conditions which are conducive to successful transfer;


2. Technology transfer is the process of sharing knowledge, skills, innovations, and technologies between governments, organizations, or institutions to ensure scientific and technological developments are available to those who need them.


3. When transfer of technology, including through licensing agreements, is referred to in this Agreement, such reference is generally understood to concern transfer of technology consensually negotiated and accepted among the parties. It is recognized that transfer of technology also may take place pursuant to domestic legislation or regulation of WHO members, provided that such legislation or regulation and actions taken pursuant to it is consistent with relevant international norms regarding intellectual property.

Member State proposed footnote for VMAT: For greater certainty, for the purposes of this Agreement references to the transfer of technology or know-how on voluntary and mutually agreed terms are without prejudice to other measures that Parties may take consistent with the rights, obligations, and flexibilities that WTO Members have under the provisions of the TRIPS Agreement, including those reaffirmed by the Doha Declaration on the TRIPS Agreement and Public Health.


note: on “know-how”, we can add a footnote:

For the purpose of this agreement, the transfer of technology includes the transfer of know-how [required to consistently manufacture and control the resulting product according to international standards].

(b) [Seek to] make available licences on a non-exclusive, worldwide and transparent basis and for the benefit of developing countries for government-owned pandemic-related technologies, in accordance with national or domestic, and international law and urge private rights holders to do the same;


(c) [seek to ensure/take measures to ensure] timely publication of the terms of its licensing agreements relevant to promoting timely and equitable global access to pandemic-related health technologies, in accordance with applicable law and policies, and shall encourage private rights holders to do the same;


(d) [Encourage / urge / request] holders of relevant patents or licenses for the production of pandemic-related health products to [forgo or otherwise] charge reasonable royalties in particular to developing country manufacturers during a pandemic emergency, with the aim to increase the availability and affordability of such products to populations in need;


(e) Promote the transfer of relevant technology and related [knowledge and skills] for pandemic-related health products by private rights holders, to established regional or global technology transfer hubs, coordinated by WHO, or other mechanisms or networks; and


Note: pending resolution of discussion on VMAT and use of term ‘know-how’ as per the footnotes above.

(f) Urge manufacturers within its jurisdiction to [voluntarily] share information, in accordance with national law and policies, during pandemic emergencies, that is relevant to the production of pandemic-related health products with appropriate third parties, [when the lack of such information prevents or hinders those parties] who do not have [that]/[the] information for the urgent manufacturing of such products that is necessary to respond to the pandemic.



Alt(f) Urge manufacturers within its jurisdiction to [voluntarily] share information, [in accordance with national law and policies,] during pandemic emergencies, [relevant to]/[necessary for] the production of pandemic-related health products.


2. Each Party shall provide, within its capabilities and subject to available resources and applicable law, support for capacity-building, especially to local, subregional and/or regional developing country manufacturers [in / from developing countries], for the implementation of this Article.


3. Each Party shall [consider supporting], within the existing framework of relevant international and regional organizations, appropriate time-bound measures to accelerate or scale up the manufacturing of pandemic-related health products, to the extent necessary to increase the availability, accessibility and affordability of pandemic-related health products during pandemic emergencies.


4. The Parties that are World Trade Organization (WTO) members reaffirm that they have the right to use, to the full, the TRIPS Agreement and the Doha Declaration on the TRIPS Agreement and Public Health of 2001, which provide flexibility to protect public health including in future pandemics. The Parties respect the use of the TRIPS flexibilities that are consistent with the TRIPS Agreement [and shall not exercise any direct or indirect pressure [to that effect (DEL)] [to discourage the use of such flexibilities].


5. The Parties shall, in collaboration with WHO, identify, assess and, as appropriate, strengthen and [/or] develop [multilateral] mechanisms that promote and facilitate the transfer of technology with a view to increasing access to pandemic-related products, particularly in developing countries, including through the pooling of intellectual property, [know-how] and data and transparent, non-exclusive licensing. Such mechanisms may, where appropriate, be coordinated by the WHO, in collaboration with other relevant mechanisms and organizations, enabling equal participation of manufacturers from developing countries.


6. Each Party should review and consider amending, as appropriate, its national and/or domestic legislation with a view to [using the flexibilities referred to in paragraph 4 and] ensuring that it is able to implement this Article in a timely and effective manner.




Article 12 Pathogen Access and Benefit-Sharing System

1. Recognizing the sovereign right of States over their biological resources and the importance of collective action to mitigate public health risks, and underscoring the importance of promoting the rapid, and timely sharing of materials and sequence information on pathogens with pandemic potential, to be covered by the instrument, pursuant to paragraph 2 (hereafter PABS Materials and Sequence Information) and, on an equal footing, the rapid, timely, fair and equitable sharing of benefits [covered by the PABS System] [arising from the sharing] of PABS Materials and Sequence Information, for public health purposes [taking into account] / [in accordance with] relevant national, domestic, and [applicable] international laws].

自国の生物資源に対する国家の主権的権利と、公衆衛生上のリスクを軽減するための集団行動の重要性を認識し、本制度の対象となるパンデミックの可能性のある病原体に関する物質と配列情報の迅速かつタイムリーな共有を促進することの重要性を強調する、 また、公衆衛生の目的のために、[PABS制度が対象とする][PABS物質及び配列情報の共有から生じる]利益の迅速、適時、公平かつ衡平な共有を、[国内法、国内法及び[適用される]国際法を考慮し]/[遵守して]促進することの重要性を強調する。

The Parties [hereby establish] a multilateral system for safe, transparent, and accountable, access and benefit sharing for pathogens with pandemic potential, the ‘WHO Pathogen Access and Benefit-Sharing System’ (PABS System). The PABS System shall be [administered,] coordinated and convened by WHO [working in cooperation with relevant stakeholders – Note: move to new paragraph 3h].


2. The provisions governing the PABS System, including definitions of pathogens with pandemic potential and PABS Materials and Sequence Information, modalities, legal nature, terms and conditions, and operational dimensions, shall be developed and agreed in an instrument in accordance with Chapter III (hereinafter the ‘PABS Instrument’). All elements of the PABS System shall come into operation simultaneously in accordance with the terms of the PABS Instrument. [The PABS Instrument shall come into force no earlier than the date on which the WHO Pandemic Agreement comes into force.]


3. The instrument referred to in paragraph 2, shall contain provisions regarding, inter alia, the following:


(a) access to PABS Materials and Sequence Information, and on an equal footing, the fair and equitable sharing of benefits [arising from sharing];

(b) modalities, terms and conditions on access and benefit sharing that provide legal certainty;

(c) implementation in a manner to strengthen, facilitate and accelerate research and innovation, as well as the fair and equitable sharing and distribution of benefits;

(d) implementation in a manner, complementary to, and not duplicative of, the Pandemic Influenza Preparedness Framework and other relevant access and benefit sharing instruments where applicable;

(e) implementation in accordance with national, domestic, and applicable international law, regulations, and standards, including as related to export control [and traceability of relevant pathogens] [and PABS Materials and Sequence Information], biosafety and biosecurity of pathogens, and data protection;

(f) robust [inclusive], transparent, and evidence-based governance, review, and accountability under the oversight of the parties to the Instrument, referred to in paragraph 2, including the consideration of a traceability mechanism [, as well as consistency with open access data];

NEW PARA: The provisions governing the PABS System shall be agreed such that they are consistent with, and do not run counter to the objectives of the Convention on Biological Diversity and its Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, with the aim to recognize the PABS System, [with respect to Parties to the Nagoya Protocol and] [once fully developed] [and operational], as a specialized international access and benefit-sharing instrument, within the meaning of paragraph 4 of Article 4 of the Nagoya Protocol [, taking into account relevant decisions of the Meeting of the Parties to the Nagoya Protocol, and noting that only Parties to the Nagoya Protocol and the PABS Instrument are bound thereby. (DEL / RETAIN)] [The PABS System shall be operationalized once the System is recognised as a specialized international access and benefit-sharing instrument. (DEL)]

PABSシステムを管理する規定は、PABSシステムを承認することを目的として、生物多様性条約及び遺伝資源へのアクセスとその利用から生じる利益の公正かつ衡平な配分に関する名古屋議定書の目的に合致し、反することのないように合意されなければならない、 [名古屋議定書の締約国に関し、] [一旦完全に開発され] [運用されれば]、名古屋議定書第 4 条第 4 項の意味における、専門化された国際的なアクセスと利益配分制度として承認することを目的とし、[ 名古屋議定書締約国会合の関連する決定を考慮し、名古屋議定書及び PABS 文書の締約国のみがこれに拘束されることに留意する。(名古屋議定書及びPABS文書の締約国のみが拘束されることに留意する。] [PABS制度は、本制度が専門化された国際的なアクセスと利益配分制度として承認され次第、運用を開始するものとする。(削除)] [PABS制度は、専門的な国際アクセスと利益配分制度として承認された時点で運用を開始する。

[alt(g) the provisions governing the PABS System shall be agreed in a specialised international access and benefit sharing instrument within the meaning of Paragraph 4 of Article 4 of the Nagoya Protocol.]

Note: suggestion to make this into separate paragraph (1bis or 3bis)

[Para 3(h) engagement with relevant stakeholders in accordance with norms and standards on WHO’s engagement with non-state actors.]

[Para 3(i) Development and implementation in a manner that is consistent with and does not run counter to the objectives of Article X of the Biological Toxin Weapons Convention;]

4. The PABS System, as set out in the Instrument referred to in paragraph 2, shall provide, inter alia, the following:


(a) The rapid [, voluntary,] and timely sharing of PABS Materials and Sequence Information, [informed by risk assessment,] including, [but not limited to,] through WHO coordinated laboratory networks, and relevant [and accountable] sequence databases [, the modalities, terms and conditions of which shall be agreed in legally binding contracts]; NOTE: Taking note of the unyellowing of this paragraph


(b) The fair, equitable and rapid, and timely sharing of benefits [free from disruptions (DEL / RETAIN)], both monetary and non-monetary, the modalities, terms and conditions, of which shall be set out in [a prior and informed consent and mutually agreed terms] legally binding contracts between the PABS system, administered by WHO, and [entities (DEL)] [users] that [voluntarily] decide to [use PABS Material and Information] [enter into such contracts, (DEL)] taking into account the different nature, [size and capabilities (DEL)] of such [entities (DEL)] [users], including the following:


[i. in the event of a PHEIC, contribution by manufacturers to WHO for allocation and distribution through the GSCL Network of reasonable real-time production in a range [of 3%–10% (DEL)] [of 10%–15%] of safe, quality, efficacious vaccines, therapeutics, and diagnostics needed during a PHEIC, on a free-of-charge basis or at not-for-profit prices. Such products shall be made available for use on the basis of public health risk and need, and upon request, with particular attention to the needs of developing countries. (DEL / RETAIN)]

PHEIC発生時には、GSCLネットワークを通じて、PHEIC発生時に必要とされる安全で、品質が高く、効果的なワクチン、治療薬、診断薬について、[3%~10%(DEL)] [10%~15%]の範囲で、合理的な生産量をリアルタイムで配分・分配するために、製造者 がWHOに無償又は非営利価格で拠出すること。このような製品は、公衆衛生のリスクと必要性に基づき、また、要請があれば、開発途上国のニ ーズに特に注意を払いながら、使用できるようにしなければならない。

[The Director General of WHO may initiate advance release of vaccines, therapeutics and diagnostics in paragraph (i) [to developing countries before PHEIC, (DEL)] to prevent outbreaks becoming PHEIC, [in developing countries] [in cases where concerned countries lack equitable access (DEL)] and/or for WHO stockpiles. Manufacturers shall comply with the DG’s request for advance release.]

WHO 事務局長は、PHEIC となるアウトブレイクを予防するため、(i)項のワクチン、治療薬、診断薬 の[PHEIC 前の開発途上国への(DEL)]事前放出を開始することができる。製造業者は、DG の事前放出の要請に応じなければならない。

ii. in the event of a pandemic emergency, contribution by manufacturers to WHO for allocation and distribution through the GSCL Network of [their] reasonable real-time production [at least 20% of real-time production, and no less than 10% of production provided free of charge, and 10% production at not-for-profit prices] [up to 20%] of safe, quality, efficacious vaccines, therapeutics, and diagnostics needed during pandemic emergency, on a free-of-charge basis or at [not-for-profit or affordable] prices, recognizing that flexibility is important in negotiating in the above referenced range with all manufacturers. Such products shall be made available for use on the basis of public health risk and need, [and] upon request, with particular attention to the needs of developing countries.


iii. Annual monetary contributions to the WHO from relevant commercial users of the PABS System, including relevant manufacturers of vaccines, therapeutics and diagnostics based on modalities, terms and conditions, to be defined according to paragraph 3 of this Article.


5. The PABS System shall include additional benefit sharing provisions which may include the granting to WHO, during a PHEIC and/or pandemic emergency, of royalty free, non-exclusive manufacturing licences that can be sub-licensed to manufacturers in developing countries for the production of vaccine therapeutics and/or diagnostics. Such additional benefits shall be defined in the PABS Instrument referred to in paragraph 2.


6. Each Party that has manufacturing facilities in its jurisdiction that produce vaccine, therapeutic and/or diagnostics for pathogens covered by the PABS Instrument, shall take appropriate measures to facilitate the manufacture and export of such products, in accordance with its national/domestic and relevant international law.


[6 bis.This Article is without prejudice to consideration of other elements for the effective operationalization of the PABS System for pathogens with pandemic potential and sequence information, in a fair, transparent, accountable and equitable manner. (RESERVE)]



「WHO CA+」のゼロドラフト第7条第4項には、知的財産権の放棄について規定されていましたが、その後、削除されたようです。パンデミックが起きた時に、知的財産権を放棄しても解決に進まないことが理解されたのでしょうか。知的財産権の放棄議論は、政治的な駆け引きの道具でしかなかったのかもしれません。交渉の焦点は、もっと具体的なパンデミック対策として、病原体アクセス、技術移転や、ワクチン、治療薬及び診断薬配分等に関する迅速かつ効果的なシステムの構築に関する建設的な議論へと移っているように思われます。