「世界保健機関（WHO)パンデミック
インフルエンザ事前対策枠組み」
パンデミックインフルエンザプリペアドネス（PIP)
フレームワークを例に、国際的感染症対策における病原体確保と名古屋議定書対応について

2021年3月16日
1

本講演の内容は演者の個人的意見を含むものであり、組織、団体を代表した意見や見解ではないことをご了承ください。

出典：厚生労働省 https://www.mhlw.go.jp/content/10906000/000547042.pdf

新型インフルエンザワクチンの生産

新型インフルエンザワクチンの細胞培養法ワクチン実生産施設整備等推進事業の資料より抜粋
出典： https://www.mhlw.go.jp/content/10906000/000547043.pdf

WHO総会（WHA)

PIP

PIP
フレームワークWHO総会決議64.5
WHA64.5 Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits
The Sixty-fourth World Health Assembly,Having considered the report of the Open-Ended Working Group of Member States on Pandemic Influenza
Preparedness: sharing of influenza viruses and access to vaccines and other benefits;2
Acknowledging the work of the Co-Chairs and the Bureau of the Open-Ended Working Group; Welcoming theoutcome of the Open-Ended Working Group of Member States on Pandemic Influenza Preparedness: sharing ofinfluenza viruses and access to vaccines and other benefits in elaborating the Pandemic Influenza Preparedness
Framework for sharing of influenza viruses and access to vaccines and other benefits (the “Pandemic Influenza
Preparedness Framework”); Recognizing the role of industry as an important contributor to technology innovationand transfer in addressing the challenges of pandemic influenza preparedness and response,
1. ADOPTS, in accordance with Article 23 of the WHO Constitution, the Pandemic Influenza Preparedness Framework,
including its annexes;
2. URGES Member States:(1) to implement the Pandemic Influenza Preparedness Framework;(2) to support actively the wide implementation of the Pandemic Influenza Preparedness Framework, and to consider
providing adequate resources for its implementation;
3. CALLS UPON relevant stakeholders to give priority to implementing the Pandemic Influenza Preparedness
Framework;
4. REQUESTS the Director-General, in consultation with the Advisory Group:(1) to implement the Pandemic Influenza Preparedness Framework;(2) to monitor and review the operation of the Pandemic Influenza Preparedness Framework and all of its
components, in accordance with its provisions;(3) to report, on a biennial basis, to the World Health Assembly, through the Executive Board, on progress in theimplementation of this resolution.
(Tenth plenary meeting, 24 May 2011 – Committee A, third report)Pandemic influenza preparedness Framework
for the sharing of influenza viruses
and access to vaccines and other benefits
The objective of the Pandemic Influenza Preparedness
Framework is to improve pandemic influenza
preparedness and response, and strengthen theprotection against the pandemic influenza by improving
and strengthening the WHO global influenza surveillance
and response system (“WHO GISRS”),
with the objective of a fair, transparent, equitable,efficient, effective system for, on an equal footing:(i) the sharing of H5N1 and other influenza viruses withhuman pandemic potential;

and(ii) access to vaccines and sharing of other benefits.

出典： https://www.who.int/images/default-source/departments/global-influenza-programme/gisrs-map-2020.png?sfvrsn=e8108a0b_2

4.1 Pandemic influenza preparedness
biological materials or PIP biological materials“PIP biological materials”, for the purposes of this Framework(and its appended Standard Material Transfer Agreements(SMTAs) and terms of reference (TORs)) and the Influenza
Virus Tracking Mechanism (IVTM), includes
human clinical specimens, virus isolates of wild type human
H5N1 and other influenza viruses with human pandemic
potential;
and modified viruses prepared from H5N1 and/or otherinfluenza viruses with human pandemic potential developed by
WHO GISRS laboratories, these being candidate vaccine
viruses generated by reverse genetics and/or high growth reassortment.
Also included in “PIP biological materials” are RNA extracted
from wild-type H5N1 and other human influenza viruses withhuman pandemic potential and cDNA that encompass theentire coding region of one or more viral genes.

Genetic sequences• “Genetic sequences” means the order of nucleotides foundin a molecule of DNA or RNA. They contain the genetic
information that determines the biological characteristics ofan organism or a virus.

OPERATIONAL EXEMPTION
1 OPERATIONAL EXEMPTION: materials shared within the WHO
GISRS or with other laboratories specifically for non-commercial
public health uses including surveillance activities, diagnostic
applications, and quality assurance, are not handled as PIP
Biological Materials. Their onward transfer for purposes other thanthose specified in the terms of reference of National Influenza
Centres, WHO Collaborating Centres, Essential Regulatory
Laboratories and H5 Reference Laboratories is not allowed under
this operational exemption.

パンデミックインフルエンザ事前対策(PIP)枠組み
ワクチン生産候補
ウイルス株の生成

SMTA 2
プレパンデミック／
パンデミックウイルス
採取→分与

年間パートナーシップ
分担金(APC)

ワクチンの寄付、頒布

パンデミックの際
ワクチン8%寄附+ 2%安価頒与

115.4 Standard Material Transfer Agreements
5.4.1 The Standard Material Transfer
Agreement 1 (SMTA 1) in Annex 1 will be used
to cover all transfers of PIP biological materials
within the WHO GISRS for the duration of its
applicability.
5.4.2 The Director-General will, using theStandard Material Transfer Agreement 2(SMTA 2) in Annex 2, enter into agreementswith entities outside the WHO GISRS.
Such agreements will cover all transfers of PIP
biological materials to recipients for theirduration.

IFPMA: 国際製薬団体連合会（International Federation of Pharmaceutical Manufacturers & Associations）
IVS-ITF: Influenza Vaccine Supply (IVS) International Task Force (ITF)
製薬協： 日本製薬工業協会（JPMA)日ワ協：日本ワクチン産業協会（JAVI)PIC/MAT締結？

2019-2020年季節性インフルエンザワクチンWHO推奨株
egg based quadrivalent vaccines
for use in the 2019-2020 northern hemisphere influenza season• an A/Brisbane/02/2018 (H1N1)pdm09-like virus;• an A/Kansas/14/2017 (H3N2)-like virus; *• a B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage); and• a B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage).

2020-2021年季節性インフルエンザワクチン
選定検討候補株の状況

A/Guangdong-Maonan/SWL 1536/2019
・ Requested clarification on 28 February 2020
・ CNIC confirmation email on April 2020
A/Paris/2554/2019
・Request clarification on 22 April 2020
・MTA reported complete on 17 June 2020

2020-2021年季節性インフルエンザワクチンWHO推奨株

Egg-based Vaccines• an A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-likevirus;• an A/Hong Kong/2671/2019 (H3N2)-like virus;• a B/Washington/02/2019 (B/Victoria lineage)-like virus; and• a B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.
Cell- or recombinant-based Vaccines• an A/Hawaii/70/2019 (H1N1)pdm09-like virus;• an A/Hong Kong/45/2019 (H3N2)-like virus;• a B/Washington/02/2019 (B/Victoria lineage)-like virus; and• a B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.

2021-2022年季節性インフルエンザワクチンWHO推奨株
Egg-based Vaccines• an A/Victoria/2570/2019 (H1N1)pdm09-like virus;• an A/Cambodia/e0826360/2020 (H3N2)-like virus;• a B/Washington/02/2019 (B/Victoria lineage)-like virus; and• a B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.
Cell- or recombinant-based Vaccines• an A/Wisconsin/588/2019 (H1N1)pdm09-like virus;• an A/Cambodia/e0826360/2020 (H3N2)-like virus;• a B/Washington/02/2019 (B/Victoria lineage)-like virus; and• a B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.

インフルエンザワクチン名古屋議定書対応に関する動向• WHO総会でインフルエンザワクチンへの影響が継続議論されている• 本邦では指針にパンデミック及び季節性インフルエンザの取り扱いが規定

2012年

WHOの専門家会議によるPIP*1アドバイザリーグループがパンデミックインフルエンザについて、 PIPフレームワークでの拠出金またはワクチン備蓄での対応を決定。
2017年5月18日 本邦 「遺伝資源の取得の機会及びその利用から生ずる利益の公正かつ衡平な配分に関する指針」 発出
2017年5月22日 本邦の名古屋議定書批准手続き完了 （同年8月20日発効）
2018年5月
第71回WHO総会 ： WHOはPIPFに季節性インフルエンザワクチンを含めるかどうかと、 遺伝子配列情報を生物資源として含めるかどうかについて、 慎重な分析を行うことを求めた。GISRS他においてウイルス株の共有の状況報告を求めた。
2019年5月
国際製薬団体連合会 （IFPMA） よりWHOに季節性インフルエンザワクチンで名古屋議定書による影響としてインフルエンザウイルスサンプル共有の遅れや拒否が発生したことと、 ワクチンのタイムリーな供給ができなくなることから公衆衛生への重大な悪影響を及ぼすこと、 GISRSネットワークを通じた最適なワクチン開発に支障が出ることなどを書面で提出。
2020年2月
インフルエンザウイルス株共有の報告書
2020年5月
第73回WHO総会*1 PIP(F)：Pandemic Influenza Preparedness(Framework)*2GISRS：Global Influenza Surveillance and Response System

23

WHOが提示したアプローチ案
1

現行のPIP枠組文書を維持→季節性は議定書の範疇で取扱い

2

PIP枠組文書を季節性に拡張→PIP枠組文書の「専門的な国際文書」該当が前提
2A

PIP-BM(biomaterials)の定義修正

2B

季節性に関する章／附属書追加

3

GISRSを 「専門的な国際文書」 として位置付け→WHO:GISRSの70年の実績をアピール

4

全ての病原体等に係る新規枠組みの策定

2018年10月 PIP諮問会議 ：◆ 「専門的な国際文書」 要件協議の早期解決は見込み薄⇒未解決の状態で最善のアプローチを決めるのは困難◆現時点でPIP枠組文書を季節性に拡張すべきではない24

WHO執行理事会(EB144) [2019/01/24～02/01]（季節性）インフルエンザウイルス共有への影響•GISRS等との喫緊の連携：
季節性インフルエンザウイルス共有に関する課題及び不確実性が何であるか•
インフルエンザウイルスの共有に影響が生じた事例の監視 ：議定書又は国内措置等の施行による影響•PIP枠組文書附属書2の文言修正：
PI P-BM間接利用者 （開発支援機関等） にも利益配分要求へ•議定書施行による公衆衛生への影響について、分野横断的な性質を考慮し、W H O全体で加盟国の状況報告

25

EB148(2021年1月25-26日)における討議
発言国：Austria（EU), China, Indonesia, USA, India, Ghana, UAE, Bangladesh,Russia, Argentina, Monaco, Canada, Switzerland, Brazil, Japan.

i. Pathogen sharing and Accessii. Benefit sharingiii. Public Health Implications• COVID-19 Laboratory network• Bio Hub : pilot voluntary program• CBD 2021 : Global multilateral treaty

Pandemic preparedness出典： https://www.mhlw.go.jp/content/10900000/000747950.pdf

CEPIが資金提供しているCOVID-19関係の開発•••••••••

University of Oxford and Astrazeneca ChAdOx1 Phase 3
Moderna, Inc. Nucleic acid Phase 3
Novavax, Inc. Recombinant protein nanoparticle technology Phase 3
Inovio Pharmaceuticals Nucleic acid Phase 1/2
Cure Vac Nucleic acid Phase 3
Clover Biopharmaceuticals Phase 1
University of Hong Kong Live attenuated vaccine Preclinical
Biological E Limited Protein Antigen Phase 1/2
SK bioscience Recombinant protein Preclinical• Instiitut Pasteur, Themis Bioscience, University of Pittsburgh Measles vector
Development Discontinued• University of Queensland Recombinant protein Development Discontinued
出典： https://cepi.net/research_dev/our-portfolio/
2021年3月5日にアクセスした情報

ご清聴ありがとうございました。

Article 4. Relationship with International Agreements and Instruments••••

1. The provisions of this Protocol shall not affect the rights and obligationsof any Party deriving from any existing international agreement, except
where the exercise of those rights and obligations would cause a serious
damage or threat to biological diversity. This paragraph is not intended tocreate a hierarchy between this Protocol and other international instruments.
2. Nothing in this Protocol shall prevent the Parties from developing andimplementing other relevant international agreements, including otherspecialized access and benefit-sharing agreements, provided that they aresupportive of and do not run counter to the objectives of the Convention
and this Protocol.
3. This Protocol shall be implemented in a mutually supportive manner withother international instruments relevant to this Protocol. Due regard shouldbe paid to useful and relevant ongoing work or practices under suchinternational instruments and relevant international organizations, provided
that they are supportive of and do not run counter to the objectives of theConvention and this Protocol.
4. This Protocol is the instrument for the implementation of the access andbenefit-sharing provisions of the Convention. Where a specializedinternational access and benefit-sharing instrument applies that is
consistent with, and does not run counter to the objectives of theConvention and this Protocol, this Protocol does not apply for the Party or
Parties to the specialized instrument in respect of the specific genetic
resource covered by and for the purpose of the specialized instrument.

Article 8. Special Considerations••••

In the development and implementation of its access and benefitsharing legislation or regulatory requirements, each Party shall:(a) Create conditions to promote and encourage research which
contributes to the conservation and sustainable use of biologicaldiversity, particularly in developing countries, including throughsimplified measures on access for non-commercial research
purposes, taking into account the need to address a change of intent
for such research;(b) Pay due regard to cases of present or imminent emergencies thatthreaten or damage human, animal or plant health, as determinednationally or internationally. Parties may take into consideration theneed for expeditious access to genetic resources and expeditious
fair and equitable sharing of benefits arising out of the use of suchgenetic resources, including access to affordable treatments by
those in need, especially in developing countries;(c) Consider the importance of genetic resources for food andagriculture and their special role for food security.