The 9th Nikkei FT Communicable Diseases ConferenceTokyo Communicable Diseases Statement 2022
Table of Contents
0. Introduction

An Emergency Recommendation - Ideal Command Post for the Fight Against Communicable Diseases

1. Preparing for the Next Pandemic: Issues Around COVID-19 and Actions Required
1-1. Functions Required of Japan’s Command Post
1-2. R&D for Vaccines, Therapeutics, and Diagnostics - To Achieve the 100 Days Mission
1-3. Crisis Response for Communicable Diseases, Etc. With Active Participation by Consenting Citizens

2. Contributing to Global Health - For Japan to Play a Leading Role in Times of Crisis
2-1. Tuberculosis, Malaria, Neglected Tropical Diseases, Nutrition, and Immunization- Innovations from Industry-Government-Academia Collaboration Stemmingfrom the COVID-19 Experience
2-2. Cooperation Among Developed Countries in the Fight Against AMR
2-3. Expectations for Japan Regarding UHC - What to Do in Advance of the G7 Summit in Hiroshima

3. Conclusive Words

4. Appendix<Reference Material> Summary of the 9th Nikkei FT Communicable Diseases Conference Special Sessions/ Breakout Sessions

1

0. Introduction

The ninth round of the annual Nikkei FT Communicable Diseases Conference, which started in 2014, wasrecently held. Each year, the conference brings together key players from different sectors and countries todiscuss the never-ending battle between humanity and communicable diseases and to propose public-private
partnership (P3) projects to address the issues.
Japan faced the peak of COVID-19 during the seventh wave in August 2022, and the recent conference
was held amid concerns about an eighth wave. Using remote access technology developed during the
pandemic, key players in the fight against communicable diseases from industry, academia, government andthe private sector gathered for the conference in Tokyo's Meguro Ward on 15 and 16 November 2022. Somewere invited to attend as audience members, and the event was streamed online.
<Issues related to COVID-19>
It has been almost three years since COVID-19 began ravaging the world in early 2020. The cumulative
number of people infected worldwide since October 2021 has increased by about 400 million to a total of
642 million, and the number of deaths has increased by about 1.6 million to a total of 6.6 million (as of 29
November 2022). In Japan, the cumulative number of infections is 24.68 million (as of 29 November 2022),
and the cumulative number of deaths is approximately 49,600 (same period), an increase of approximately
22.9 million and 30,000, respectively, since October 2021. Although COVID-19 posed a serious threat to thelives of citizens around the world, including Japan, and to socio-economic activities, information sharing
about the disease, advances in medical technology, and weakened variants have contributed to the lifting ofrestrictions on activities and containment in Japan and countries around the world.
During the fifth wave in August 2021 (Delta variant), Japan faced a crisis with the collapse of its healthcare
system. The seventh wave in August 2022 (Omicron BA.5 variant) shamefully caused the largest number of
infections worldwide, and medical crises continued to occur. Participants at this latest conference, following
a renewed and thorough investigation of the response to COVID-19 in Japan, strongly recognised that thelack of a command post function was at the root of the problem. As a result, an emergency recommendationon the ideal command post for communicable disease control was developed as an essential and effective
measure against the pandemic and communicable diseases. Achieving the contents of this recommendation
through the joint efforts of industry, academia, government and the private sector would ensure the safety of
citizens. The creation of strong medical and social systems should also contribute to the global fight against
communicable diseases for future pandemics. We encourage you to read last year's Tokyo Communicable
Diseases Statement 2021, Measures Against COVID-19 in Japan, and the Yokohama Communicable
Diseases Statement 2020 (see 7th Nikkei FT Communicable Diseases Conference Statement).

<Other P3 related to communicable diseases>
Along with the measures against COVID-19, progress and further development of other P3 projects that2

had been discussed and recommended by this conference since 2014 were addressed. Through discussions
on equal footing for the wide range of stakeholders from industry, academia, government, and private sectors,
participants of the conference reaffirmed the need and effectiveness of P3 projects to better tackle
communicable diseases that threaten human health and economic activities.
AIDS issues were also newly raised and discussed at the conference. This elevated the conference as aforum to discuss three of the world's major communicable diseases, namely tuberculosis and malaria, bothof which had been discussed at previous Nikkei FT Communicable Diseases Conferences, and now AIDS.
Communicable diseases caused by bacteria with antimicrobial resistance (AMR), which are being continually
addressed by the Group of Seven (G7), were also discussed and concrete proposals for pull incentives for thedevelopment of new drugs were made. This conference in 2022 was a major step forward as a place to makeP3 project proposals to take concrete action in a comprehensive way against the communicable diseases
facing humanity, with the participation of a wide range of stakeholders from industry, academia, government
and the private sector.
<The Tokyo Communicable Diseases Statement 2022>
At the end of the conference, participants agreed on the Tokyo Communicable Diseases Declaration 2022,
which included a proposal to establish a command post to combat pandemics and communicable diseases.
The results of this conference will be reported at government meetings, disseminated online andcommunicated through the media. The statement will be released not only in Japan, but widely around theworld, including Asia, Africa and international institutions. It is hoped that the mutual understanding that will
result will encourage Japan to become even more involved in the global fight against communicable diseases
in the future.
Please refer to previous statements listed below for details of Nikkei FT Communicable Diseases
Conferences discussions to date.
https://cdc.nikkei.com/pdf/archive/statement/ja/8thnfc_statement2021_ja.pdf
https://cdc.nikkei.com/pdf/archive/statement/ja/7thnfc_statement2020_ja.pdf
https://cdc.nikkei.com/pdf/archive/statement/ja/statement2019_ja.pdf
https://cdc.nikkei.com/pdf/archive/statement/ja/statement2018_ja.pdf
https://cdc.nikkei.com/pdf/archive/statement/ja/okinawastatement2017_ja.pdf
https://cdc.nikkei.com/pdf/archive/statement/ja/3rdnac_tokyo2016_statement_jp.pdf
https://cdc.nikkei.com/pdf/archive/statement/ja/OkinawaCommunicableDiseasesStatement2015.pdf
https://cdc.nikkei.com/pdf/archive/statement/ja/OkinawaCommunicableDiseasesStatement2014.pdf*Information including position titles in the statements reflect the latest version at that time3

An Emergency Recommendation - Ideal Command Post for the Fight Against
Communicable Diseases[Background of the emergency recommendation]<Issues revealed by COVID-19>● Roles and authority of government and experts were not clearly defined. The expert advisory groupmade over 80 recommendations along with supporting evidence, in spite of many restrictions.
However, there is room for improvement over quality and timing of recommendations due to constraints
on human resources and time. Roles and authority of the expert advisory group including with regard
to exemption of liabilities were also unclear.
● Development of diagnostics, vaccines, and therapeutics as a concerted effort by government, industry andacademia was delayed because the overall status of R&D underway in Japan was hard to see and there
was no structure to conduct researches and clinical trials while handling the pandemic.
● Issues included insufficient planning and proposing of measures (policies) against communicablediseases, not enough experts available for crisis management, and no structure in place forcooperation among experts in many areas including epidemiology, engineering, IT, AI, economics,
laws and regulations, and ethics. There was also an inability to use experts in risk communication andsocial marketing to convey to the public any policies decided by the government.
<Background of the emergency recommendation made by the conference>● Amidst the issues above and others, the government is expected to establish an agency in the cabinet forcommunicable disease crisis management in FY2023 as a command post, followed by establishmentof a new expert organization. Over the past three years, participants of the Nikkei FT Communicable
Diseases Conference have contributed in various ways regarding COVID-19 both in Japan and abroad.
Based on such experience, an emergency recommendation is made for an ideal command post in
both emergency situations and normal times so that the government can create the best command
post.
[Ideal command post: In emergency situations (proposed)]Command Post
Agency in the cabinet for communicable disease crisis management**Create a system to enable inspection
based on records on a periodic basis tosee whether the three parties have beenfunctioning properly.

(Prime minister/ relevant minister(s)/ chief medical officer)

A. Final decision-making, execution,

ProposedmeasuresD. Survey and research necessary for
proposing and readjusting measures as
required according to the status of thepandemic

Cooperativerole

MHLW Communicable Diseases
Control Division

β: Conventionally, F
was handled bycorporations, but thecommand post could
potentially request the
networks to do soRequest β

Periodicexchange of
opinions

Make
proposal

Government to carry out, taking full
responsibility with advice from experts oncommunicable diseases, risk communication,and social marketing

α: Conventionally, D and
E were handled only bylimited experts, but thecommand post could
potentially request the
networks to do so

C. Grasping an overall picture ofongoing surveys, R&D (D.F)

follow-up of communicable diseasemeasures (policies）

Make
proposalRequest α

B. Communication within Japanand abroad

F. R&D for vaccines,
therapeutics, and diagnostics

E. Evaluation of risks

Measures recommending unit (D,E)

Network of experts*

Members: a new expert organization at the core including medical institutions
and organizations with experience in communicable disease control, experts incrisis management and disaster medicine, human resources in local governments
involved in communicable disease control, and experts in socioeconomics, laws andregulations, ethics, IT, AI, engineering, risk communication, and social marketing4

R&D unit (F)R&D-related network*

Members: include medical institutions involved in R&D for vaccines,
therapeutics, and diagnostics, regulatory authorities, corporations,experts, and the Japan Agency for Medical Research and Development(AMED)

[Details of the ideal command post: In emergency situations (proposed)]● Government side above the dotted line, experts side below. The ideal state in an emergency involves
three parties: the agency in the cabinet for communicable disease crisis management that is thecommand post made up of the prime minister, relevant ministers, and the chief medical officer who is thehead of the medical field; network of experts and the R&D-related network comprised of various
experts and corporations; and the MHLW Communicable Diseases Control Division.
● Measures recommending unit (network of experts): consists of various experts, conducting D. survey
and research necessary to propose and readjust measures as required according to the status of thepandemic, and with E. evaluation of risks, propose measures for communicable disease control tothe command post. With D in particular, although the expert advisory group were compelled to revise
measures according to the status of the COVID-19 pandemic, for which surveying and researching wasessential, they could not afford such surveys and researches at all.
● R&D unit (R&D-related network): made up of medical institutions involved in R&D for vaccines,
therapeutics, and diagnostics, regulatory authorities, corporations, experts, and relevant institutions,promoting F. R&D for vaccines, therapeutics, and diagnostics.
● Command post (agency in the cabinet for communicable disease crisis management): the mostimportant role is A. final decision-making, execution, follow-up of communicable disease control,
including whether or not to adopt the measures proposed by the network of experts. They will also
receive advice based on data analysis by experts on communicable diseases, risk communication, andsocial marketing regarding measures adopted, and encourage citizens to participate with B.
communication after dutifully gaining consent of society. With regard to survey and R&D conductedduring D and F, they will also need to C. grasp the overall picture of ongoing survey and R&D. R&D
of companies developing diagnostics, vaccines, and therapeutics and R&D of Japan Agency for
Medical Research and Development (AMED) needs to be understood in a centralized way.
● Cooperative role (the MHLW Communicable Diseases Control Division): coordinate collaboration
between the government and experts.
● Up until now, only limited experts dealt with D and E at their own expense, and experts and companies
handled F on their own accord. Going forward, the government may request them to do certain
surveys or researches depending on the situation of the pandemic that Japan faces at any given moment.
For R&D as well, the government could also request certain diagnostics or therapeutics to be
developed.
● Up until now, decisions regarding communicable disease control tended to be made centering on Tokyo.
But in rural areas, status of the pandemic and available structures for medical and nursing careprovision vary among local governments. Network of experts must include people involved incommunicable disease control in local governments so that the situation in rural areas can be known.
This ideal state for emergency situations should be required both on a prefectural and municipality
level.
● A system should be created for inspection based on records from time to time to ensure legitimacy of
the ideal state during emergency situations by checking if the three parties were functioning properly.

5[Ideal command post: In normal times (proposed)]*Put a third-party review committee in place toinspect whether the management agency, networks,
and the ideal state are functioning properly fromvarious angles based on records.

Command Post

Agency in the cabinet for communicable disease crisis management*

Periodicexchange of
opinions

Cooperativerole

MHLW Communicable Diseases
Control Division and others

RequestSpread awareness of communicable diseases withthe advice of experts on communicable diseases,
risk communication, and social marketing.
Strengthen ability of medical institutions to respondto communicable diseases.

Establish a structure for drug
discovery and conducting clinicalstudies, secure medical equipment andsupplies, and consider regulations for
emergency medicine.

MakeproposalCreate laws, secure financial resources,develop human resources, establish a
network of experts and one for R&Drelated individuals.

Increase the surge capacityof institutions involved in
spreading awareness ofcommunicable diseases.

Make
proposalRequest(Prime minister/ relevant minister(s)/ chief medical officer)

Establish a structure for clinical trials, establish andstrengthen ability (of human resources, bases) to procure
and manufacture raw materials and resources.

International relations, create a network ofexperts, assess risks related to communicablediseases, plan and propose strategies
Strategy planning unit (D,E)

R&D unit (F)Network of experts*

Members: a new expert organization at the core including medical institutions
and organizations with experience in communicable disease control, experts incrisis management and disaster medicine, human resources in local governments
involved in communicable disease control, and experts in socioeconomics, laws
and regulations, ethics, IT, AI, engineering, risk communication, and social
marketing

R&D-related network*

Members: include medical institutions involved in R&D for
vaccines, therapeutics, and diagnostics, regulatory authorities,
corporations, experts, and the AMED

[Details of the ideal command post: In normal times (proposed)]<Establish the structure>● Prepare for the next pandemic, with relevant parties agreeing in advance upon the ideal state inemergency situations.
● Set up the same type of command post on both a prefectural and municipality level as well.
● Establish a structure to support the network of experts and the R&D-related network.
<Train and secure human resources to play an active role both in Japan and abroad>● Foster individuals in communicable diseases, public health and hygiene, epidemiology, disaster medicine,crisis management, data analysis, R&D, laws and regulations, ethics, risk communication, and social
marketing. Register them in a database.
● Strengthen the foundation for research, and also train researchers to contribute to planning and proposing
measures during communicable diseases crises.
● Training human resources generally occurred individually among organizations, but organizations withexperience in human resource development should handle it comprehensively for crisis management andcommunicable disease control in a cross-sectional way throughout Japan.
<Strengthen surge capacity>● Surge capacity should be strengthened for elevated states in emergency situations, for medical institutions,health centers, related organizations, and supply chains for medical equipment and supplies, fullyusing public funding, private funds, and other sources.
<Ensure legitimacy>● After the crisis is contained, a third-party review committee should be set up to assess the three parties
and their proper functioning based on records, with a high level of transparency through adequate
discussions among various stakeholders.
6<Contribute globally>● Commit to antimicrobial resistance (AMR), communicable disease control against tuberculosis andsexually transmitted diseases, and strengthen UHC to support such measures in advance during
opportunities on a global scale such as G7 gatherings.
[Conditions for the success of command post functions]
So as not to end up like the proverbial phrase, “have the form but not the spirit,” the following
conditions should be met for success:● Secure financial resources and place appropriate human resources in the command post so that it
functions both in emergency situations and in normal times.
● So that the command post and network of experts fulfill their function, train and secure humanresources in industry, government, and academia.
[What is anticipated with the establishment of a command post]
By setting up a functioning, ideal command post in emergency situations and in normal times as declaredin the emergency recommendation:(1) Communicable disease control can be practically and resourcefully implemented, minimizing theeffects communicable diseases have on Japan’s socioeconomic activities and leading to economic
growth in Japan.
(2) The 100 Days Mission announced at the G7 Summit and speedy deployment of vaccines,
therapeutics, and diagnostics made in Japan become achievable. This would allow socioeconomic
activities to resume soonest, further strengthen Japan’s position in a prominent state internationally, andcontribute to global society.
(3) Make use of Japan’s limited resources, use tax funds efficiently and resourcefully, leading to consent
among citizens.
(4) First establish the crisis management structure for communicable disease crises that will help in themedium term to create an all-hazards crisis management structure to respond to all types of
emergencies, including natural disasters, nuclear accidents, transport accidents, crime, terrorism,
conflict, and war.
[The 100 Days Mission and Japan’s contribution]<The 100 Days Mission>
The 100 Days Mission was announced in June 2021 at the Group of Seven (G7) industrialized nations
summit. The 100 Days Mission is an initiative to make diagnostics, vaccine approval, and treatment methods
available within 100 days of the World Health Organization (WHO) declaring a public health emergency ofinternational concern. With the 100 Days Mission, access to and delivery of such diagnostics, vaccines, andtherapeutics throughout the world, including to low-income countries, is also a goal.
<Issues faced by Japan>
In Japan, even with promising seeds in basic research, a shortage of human resources to use them came tolight, and cooperation among government, industry, and academia was insufficient. Industry input had a hardtime reaching the government. Leadership of the country to pull various sectors together was also lacking.
Japan therefore lost its chance to deploy diagnostics, vaccines, and therapeutics for COVID-19 in a timely
manner to its own people, not to mention contribute globally.

7

<Actions required>(1) Efforts in the past were separated for different diseases such as tuberculosis and malaria, but COVID-19
became an incentive to reaffirm gravity of communicable diseases, showing the need for collective
initiatives against them.
(2) To achieve the 100 Days Mission and for Japan to take the lead in communicable diseases crises, handle
human resource development across organizations throughout Japan collectively, instead of companies
and organizations training human resources individually. It is important to develop human resources
both comprehensively throughout Japan and in cooperation with other countries so that Japan candispatch human resources able to play a vital role in international-level decision-making forcommunicable disease control to international institutions and organizations.
(3) Strengthen manufacturing bases for vaccines in normal times so that diagnostics, therapeutics, andvaccines developed in Japan and abroad for emergency situations can be manufactured in Japan anddistributed globally. Supply chains should also be established in Japan for raw materials and resources.
(4) Establish a structure to provide diagnostics and rapid test agents which are Japan’s strengths inparticular, not only domestically but to other countries, and to make them available for use by thecommunity instead of just by medical institutions. Also make technology such as Japan’s digital-based
diagnostic imaging available for diagnosing and testing.
(5) Promote international coherence for pharmaceutical regulations.
<What is anticipated by achieving the 100 Days Mission>
By achieving the 100 Days Mission, Japan will become more highly regarded in the field of communicablediseases, and will be counted on to contribute to global society.
[Crisis response for communicable diseases, etc. with active participation by consenting citizens]<What behavioral science and social marketing shows>● For citizens to understand concepts behind each other’s behaviors and agree for the most part on
directionality of measures regarding communicable diseases measures, it is effective to use knowledge
from behavioral science such as social marketing, and to exchange opinions and communicate
information appropriately.
● Once a certain level of agreement has been reached, it is important for state and local governments tochange the communicator of information and what is being conveyed, depending on the target and natureof the desired behavior.
● By doing so, consent among the people will increase, and by changing their own behavior, they can cometo feel value in themselves and society which can lead to efficacy of measures.
<Dilemmas faced by society>
At the start of the pandemic in 2020, information available was extremely limited and people feared theunknown disease, so it was easy to see what society would do. But as the pandemic prolonged, information
about the communicable disease became known and people accumulated experiences. Perspectives on
COVID-19 diversified driven by individual values and experiences, and directionality of society as a wholebecame unclear.
<Actions required>
Short-term:(1) Reach a certain level of agreement regarding an exit strategy for COVID-19. For that, prepare a forum
for dialogue among citizens, decision makers, and experts. Related parties including civil groups,
NPOs, universities and other academia would host. Initially, several local governments would hold the8discussions by segment, and spread out from there.
(2) Make practical guidelines for using behavioral science and social marketing.
Medium-term:(1) To elevate efficacy of state and local government measures, foster experts in behavioral science andsocial marketing. Secure funding to do so.
(2) Consider development of a digital platform such as an app that can be used in normal times, anddiverted in emergency situations. (Assume utilization online as a remote, non-contact, distribution-type
digital dialogue/ communication tool)[Expectations on the government for the G7 Summit in Hiroshima]
Unlike last time, messages that Japan can communicate globally at the G7 in Hiroshima are not necessarily
clear.
Importance of measures against communicable diseases is being recognized due to COVID-19, and theneed for global society as a whole to commit to crisis management for communicable diseases overall, notonly tuberculosis, malaria, and AIDS, should be highlighted.
● Foster human resources who can get an overall view of measures against communicable diseases● Create a structure for international clinical trials● Achieve the 100 Days Mission, etc.

9

1. Preparing for the Next Pandemic:
Issues Around COVID-19 and Actions Required
1-1. Functions Required of Japan’s Command Post
[Background and issues]
The Japanese government set up various expert advisory groups to obtain advice regarding COVID-19.
In February 2020, the Novel Coronavirus Expert Meeting was created consisting mostly of experts incommunicable diseases and medicine. In July 2020, the Subcommittee on Novel Coronavirus Disease
Control was formed that included not only specialists in public health and communicable diseases but alsoin economics, as well as local government heads. The Ministry of Health, Labour and Welfare also created
the COVID-19 Advisory Board consisting of experts in public health, communicable diseases, andmedicine for advice regarding measures against communicable diseases.
Despite various restrictions placed on expert advisory groups, they provided advice for more than 80
measures along with supporting data and evidence on various different topics. The government thenadopted many of those recommended measures. As a result, the mortality rate in Japan was lower comparedto other nations, and numbers for severe cases and deaths were kept low. However, with human resource
and time constraints, there was a limit to quantity and quality of proposals and amendments for measures.
Roles and authority of the expert advisory group including with regard to exemption of liabilities were also
unclear.
With regard to planning and executing measures against communicable diseases, the number of experts
available to take on communicable diseases, public health, epidemiology, and crisis management wasinsufficient, and a structure for cooperation among experts in other areas including data analysis
engineering, information technology (IT), artificial intelligence (AI), economics, laws and regulations, andethics was not in place. Ability was also lacking to make use of experts in risk communication and social
marketing that could convey to the public any policies set forth by the government.
Furthermore, overall status of the R&D taking place in Japan was not known, and because a structure
was not in place to conduct research and clinical trials while handling the pandemic, development of
diagnostics, vaccines, and therapeutics that was newly needed for measures against COVID-19 as aconcerted effort among government, industry and academia was delayed.
Amidst such issues, the government will set up an agency in the cabinet for communicable disease crisis
management in FY2023 to strengthen the command post function for the response to communicabledisease emergencies. In FY2024, the Communicable Diseases Control Division (tentative) will be launchedwithin the Ministry of Health, Labour, and Welfare. To provide high-quality scientific expertise regarding
communicable diseases to the government, the National Institute of Infectious Diseases and the National
Center for Global Health and Medicine will merge in FY2025 to make a new expert organization (newindependent legal entity).
Participants of the Nikkei FT Communicable Diseases Conference over the past three years since thestart of the COVID-19 pandemic have contributed in various ways both in Japan and abroad. Based on such10

experience, an emergency recommendation is made for the ideal command post in both emergency
situations and in normal times (proposed) so that the government can create the best command post.
[Ideal command post: In emergency situations (proposed)]
The ideal state in a communicable disease emergency involves three parties: the agency in the cabinet forcommunicable disease crisis management that is the command post made up of the prime minister, relevant
ministers, and the chief medical officer who is the head of the medical field; network of experts and the
R&D-related network comprised of various experts and corporations; and the MHLW Communicable
Diseases Control Division.
■ Function of the three parties in emergency situations(1) Measures recommending unit (network of experts): consists of various experts, conducting D. survey
and research necessary for proposing and readjusting measures as required according to the status of thepandemic, and upon E. evaluation of risks, proposes measures for communicable disease control to thecommand post. With D in particular, although the expert advisory group were compelled to revise
measures according to the status of the COVID-19 pandemic, for which surveying and researching wasessential, they could not afford such surveys and researches at all.
R&D unit (R&D-related network): made up of medical institutions involved in R&D for vaccines,
therapeutics, and diagnostics, regulatory authorities, corporations, experts, and relevant institutions,promoting F. R&D for vaccines, therapeutics, and diagnostics.
(2) Command post (agency in the cabinet for communicable disease crisis management): the mostimportant role is A. final decision-making, execution, follow-up of communicable disease control,
including whether or not to adopt the measures proposed by the network of experts. In addition, advice
by experts is to be received on communicable diseases, risk communication, and social marketing
regarding measures adopted, and B. communication is to be dutifully made with citizens. Regarding thesurvey and R&D conducted with D and F, C. grasping the overall picture of ongoing survey and R&D
also becomes necessary. R&D of companies developing diagnostics, vaccines, and therapeutics andR&D of Japan Agency for Medical Research and Development (AMED) need to be understood in acentralized way.
(3) Cooperative role (the MHLW Communicable Diseases Control Division): coordinate collaboration
between the government and experts.
Up until now, only limited experts dealt with D and E at their own expense, and experts and companies
handled F on their own accord. Going forward, the government may request them to do certain surveys andresearch depending on the situation of the pandemic that Japan faces at any given moment. For R&D also,
the government could request certain diagnostics or therapeutics to be developed.
■ Up until now, decisions regarding communicable disease control tended to be made centering on Tokyo.
But in rural areas, status of the pandemic and available structures for medical and nursing care provision vary
among local governments. Network of experts must include people involved in communicable disease control
in local governments so that the situation in rural areas can be known. This ideal state for emergency
11

situations should be required both on a prefectural and municipality level.
■ A system should be created for inspection based on records to ensure legitimacy of the ideal state during
emergency situations by checking if the three parties were functioning properly. In particular, it must betransparent on whether or not measures for communicable diseases proposed by the network of experts wereadopted. In normal times, a third-party review committee should be set up to assess with a high level oftransparency based on records whether the three parties are functioning.
[Ideal command post: In normal times (proposed)]
The ideal state during emergency situations should be agreed upon in advance mainly by three parties, i.e.,
the agency in the cabinet for communicable disease crisis management, a network of experts and the R&Drelated network, and the MHLW Communicable Diseases Control Division.
■ Function of the three parties in normal times(1) Strategy planning unit (network of experts): strengthen commitment to antimicrobial resistance (AMR),
communicable disease control against tuberculosis and sexually transmitted diseases, and UHC to
support such measures during opportunities on a global scale such as G7 gatherings where international
relations can be built. Establish a network for various experts in Japan to cooperate in emergency
situations and conduct information exchange on a regular basis. Gather information on communicablediseases occurring outside of Japan and make risk assessments and plan strategies. Then as necessary,
propose measures against communicable diseases and strategy plans.
R&D unit (R&D-related network): establish a structure for clinical trials in advance so that speedy clinicalstudies can be conducted both in Japan and abroad during emergency situations in communicable diseasecrises. Diversify procurement routes and strengthen supply chains in advance so that raw materials andresources necessary for manufacturing diagnostics, vaccines, and therapeutics, and vaccines can be procuredin emergency situations. Also strengthen establishment of bases necessary for manufacturing and fostering
human resources. Then, propose R&D as necessary.
(2) Command post (agency in the cabinet for communicable disease crisis management): prepare laws,
secure financial resources, and develop human resources for times of crisis in communicable disease
emergencies. Establish the network of experts and the R&D-related network so that they function in
emergency situations. Make preparations to strengthen surge capacity for elevated states in emergency
situations for related organizations such as medical institutions and health centers, and promote
activities that are easy to understand when informing the public about communicable diseases, fully
utilizing private sector and other funding.
(3) Cooperative role (the MHLW Communicable Diseases Control Division): coordinate collaboration
between the government and experts.
[What is anticipated with the establishment of a command post]■ For the command post to function successfully, it must (1) secure financial resources and position
appropriate human resources in the command post for proper functioning both in emergency situations andin normal times, and (2) foster human resources strategically within industry, government, and academia so12that the command post and network of experts function as they should.
■ By setting up a functioning, ideal command post in emergency situations and in normal times as declaredin the emergency recommendation, the following can be anticipated:(1) Communicable disease control can be practically and resourcefully implemented, minimizing theeffects communicable diseases pose on Japan’s socioeconomic activities, which can be expected to leadto economic growth in Japan.
(2) The 100 Days Mission announced at the G7 Summit and speedy deployment of vaccines, therapeutics,
and diagnostics made in Japan become achievable. This can be expected to allow socioeconomic
activities to resume at the fastest possible time and lead to economic growth for Japan.
(3) Make use of Japan’s limited resources, use tax funds efficiently and resourcefully, leading to consent
among citizens.
(4) First establish the crisis management structure for communicable disease crises that will help in themedium term to create an all-hazards crisis management structure to respond to all types of
emergencies, including natural disasters, nuclear accidents, transport accidents, crime, terrorism,
conflict, and war.

1-2. R&D for Vaccines, Therapeutics, and Diagnostics - To Achieve the 100 Days Mission[Background]
R&D for diagnostics, vaccines, and therapeutics for COVID-19 progressed at an unprecedented speed.
However, if diagnostics and vaccines were available even faster, the number of cases and deaths would belower and could lead to a faster end to spread of the disease with less socioeconomic effect.
The 100 Days Mission was announced in June 2021 at the Group of Seven (G7) industrialized nations
summit held in the U.K. It aims to achieve deployment of medical countermeasures (MCM) including
medicine for crisis response such as diagnostics (Dx), vaccines (Vx), and therapeutics (Tx) within 100 daysof the World Health Organization (WHO) declaring a public health emergency of international concern. Withthe 100 Days Mission, assuring equal access and delivery (A&D) of MCM throughout the world, including
low-income countries, is also a goal. To achieve the 100 Days Mission, 25 actionable recommendations weremade at the G7 Summit in the U.K. for governments, industry, philanthropic organizations, civil society andinternational organizations to take. At present, the secretariat for the 100 Days Mission is temporarily set up
in the U.K., monitoring progress of the 25 actionable recommendations.
Japan will host the G7 Summit in 2023. Japan must gain a diplomatic perspective on how it can contributeto achieving the 100 Day Mission. Taking into account a lack of its own COVID-19 vaccine at present, Japan
must also take a domestic affairs perspective on how it can strengthen its pharmaceutical industry structure
to contribute to the 100 Days Mission.
The Nikkei FT Communicable Diseases Conference was an opportunity to discuss issues facing Japan in13

achieving the 100 Days Mission and preparing for future pandemics, and what contributions can be madeand the actions required by industry, academia and government from their respective standpoints, all putting
into consideration Japan’s inability to provide diagnostics to the world in the early stages of COVID-19 andthe lack at present of its own developed and deployed vaccines and therapeutics.
[Issues]
R&D in Japan for MCM against COVID-19 faced many issues. First, risk assessment of communicablediseases showing what pathogens led to pandemics was not sufficiently being conducted during normal times,
and participation in global intelligence was also insufficient, which caused a delay in moving forward. There
was also no system in place for centralized information gathering regarding where and what kind of R&D
was taking place. Clinical development took too much time since platforms were not in place to conductclinical trials of therapeutics and vaccines for communicable diseases, especially a structure for conducting
a large-scaled placebo-controlled clinical study on a global scale for vaccines. Though medical institutions
designated for communicable diseases who treat patients are expected to play a central role in clinical studies
for communicable disease therapeutics, they do not have sufficient human resources and facilities especiallyduring a pandemic, which caused R&D functions to be weak. With no structure in place to guarantee profit
such as with pull incentives, vaccines as a business means poor profitability and predictability for companies
in Japan, making it difficult for them to maintain manufacturing bases, raw materials, resources, and humanresources. Supply chains for raw materials and resources in particular rely on overseas sources, andprocurement itself becomes difficult in times of communicable disease crises.
In light of these issues, the Japanese government approved the Strategy for Strengthening the Vaccine
Development and Production System in June 2021. Based on this strategy, the government established theStrategic Center of Biomedical Advanced Vaccine Research and Development for Preparedness andResponse (SCARDA) within the Japan Agency for Medical Research and Development (AMED). At
SCARDA, R&D for vaccines and new modalities and formation of a global top-class R&D base for vaccine
development are taking place.
However, strengthening strategy for the development and manufacturing structure applies only for
vaccines, not for diagnostics and therapeutics. Also, SCARDA in its current scope is limited to R&D only,
and the steps before and after that, i.e. upstream information gathering to downstream regulatory,
manufacturing, stockpiling, distribution, and other areas, are not included. For Japanese corporations to truly
contribute to the 100 Days Mission, domestic structure must be strengthened further. In collaboration withsuch activities, the Japanese government should take the following action to promote R&D of MCM in Japan
toward achieving the 100 Days Mission.
[Actions required]
Efforts in R&D of communicable diseases so far have mainly been separated for differing diseases suchas tuberculosis and malaria, but COVID-19 became an incentive to reaffirm gravity of communicablediseases including emerging diseases. Initiatives against communicable diseases collectively are necessary.
(1) Strengthen the domestic structure including human resources development
Strengthen domestic structure - link with industry and security policies - Human resources are key in emergency responses to public health crises and addressing the 100 Days
14

Mission. Fostering human resources has conventionally taken place individually among companies andorganizations, but human resource development should be handled uniformly across sectors throughout
Japan. At the same time, since response by Japan by itself has limits, it is important to cooperate withother countries in an organic and agile manner. It is important to develop human resources bothcomprehensively throughout Japan and in cooperation with other countries so that Japan can dispatch
human resources able to play a vital role in international-level decision-making for communicable disease
control to international institutions and organizations.
- To realize the 100 Days Mission and speed up A&D, as well as to strengthen the structure forcommunicable disease control in emergency situations, the government is to formulate policies andstrategies comprehensively including for diagnostics and therapeutics. In doing so, MCM is a field thatmust be addressed as a nation from the perspective of national security despite its poor marketability innormal times. Therefore, it is key to establish industrial policies for MCM (MCM policies), have thegovernment lead formation of a market for MCM, and prepare a business environment for corporations.
- As an example, the government should create an MCM fund over multiple fiscal years that would
guarantee business certainty for companies. Such measures to provide incentives for corporations arebeing carried out in the defense and semiconductor industries. The government should apply the samemeasures for corporate development that are being utilized in such industries for the MCM field as well.
- As MCM policies rest on several government agencies such as the Ministry of Health, Labour andWelfare and the Ministry of Economics, Trade and Industry, the agency in the cabinet for communicabledisease crisis management to be newly established should take charge in integrating MCM policies of thegovernment, coordinating with the National Security Council.
Promote cooperation with the Asian region- Japan is in an advantageous position within Asia geopolitically and from an international strategy
perspective. The fact that many pandemics in the past have originated in Asia makes it significantly
meaningful to focus on covering Asia. Including cooperating with the ASEAN Center for Public Health
Emergencies and Emerging Diseases (ACPHEED), cooperation and collaboration with Asia on mattersfrom R&D of MCM to its manufacturing, supply, and access, are put into consideration.
- For example, a structure could be created for international cooperation in clinical trials mainly in the
Asian region, strengthening of manufacturing capabilities in Asian countries can be promoted throughtechnical transfer and other methods, and regulatory coherence within the Asian region can be arranged inadvance. Japanese corporations can study how to enable such entry into Asian countries in advancethrough cooperation among industry, academia, government, and private sectors.
- At the same time, it is difficult for the MCM value chain to be complete by a single country. We also mustrid ourselves of the concept to complete it all within Japan, and consider how to promote cooperation withother countries organically for critical points within the value chain.
(2) Formulate specific actions
By delving into discussions among industry, government and academia cooperation including the15government, analyzing gaps in achieving the 100 Days Mission and identifying issues as well as setting
future goals and creating specific action plans to achieve them can be accomplished.
To prevent, prepare, and respond to communicable disease crises can be considered to be a business
opportunity for Japanese corporations. It is necessary to be speedy and strategic accordingly. While placing
weight on health and economic security during emergency situations in Japan, policies, strategies, and an
even more specific action plan should be created in advance through cooperation with the Japan International
Cooperation Agency (JICA), etc. as to how to undergo international collaboration and cooperation.
R&D- The role that start-up companies play in R&D for MCM is significant. However, when looking at the
global market, Japan’s bio startups do not necessarily have a strong presence, so developing such startups
should be further promoted.
- In recent years, the trend has been for not one major corporation to take charge of everything from R&D
to manufacturing of MCM, but rather for several companies to share the work by processes in a horizontal
division of labor. In developing startups, it is necessary in Japan for a perspective to encourage bio
startups becoming actively incorporated into MCM value chains horizontally.
Clinical trials and drugs regulations- Japanese pharmaceutical companies and bio startups should take initiatives in advance so that they areable to conduct international joint clinical trials on a global scale during emergency situations.
Specifically, a network should be established for global clinical trials for vaccines and a structure createdfor endemic areas to participate in clinical trials.
- So that international joint clinical trials can be conducted globally in emergency situations, and based on
their results, vaccines and therapeutics can be approved in each country and region, it is necessary to
promote coherence of regulations in advance.
Manufacturing and Procurement- Manufacturing and procurement of MCM are also important. In addition to strengthening R&D ofpharmaceutical companies, it is therefore important to strengthen manufacturing capability of companies
including contract manufacturing organizations (CMO) for vaccines, therapeutics, and diagnostics. It isnecessary in that case to check all processes, from securing raw materials and resources to mass
manufacturing, development and approval, and supply. Methods for development, manufacturing, andsupply to be carried out efficiently, effectively and rapidly should be considered and prepared. There isalso a need for policies that will establish a mechanism for joint procurement between Japan and places
such as the Biomedical Advanced Research and Development Authority (BARDA) in the U.S. and the
Health Emergency Preparedness and Response Authority (HERA) in Europe.
- It is important to strengthen manufacturing bases for vaccines in Japan in advance so that diagnostics,
therapeutics, and vaccines developed in Japan and abroad for emergency situations can be manufactured
in Japan and distributed globally through cooperation with BARDA, HERA, and similar entities in Asian
countries. Supply chains should also be established in Japan for raw materials and resources.
- Specific measures should be created for pull incentives, where the government purchases and stockpiles
16vaccines and therapeutics manufactured by companies so they can secure profits, or provide vaccines
through the framework of official development assistance (ODA).
- The policy for stockpiling MCM that reflect the purchasing pattern of the Japanese government is notstandardized, and is insufficient for guaranteeing companies’ business certainty. The government should
clarify the perception of threats in Japan and also raise certainty for the business of companies bystandardizing its stockpile criteria for MCM.
(3) 100 Days Mission - Therapeutics, diagnostics - While discussions around vaccine R&D continue internationally and in Japan, the same cannot be said fortherapeutics and diagnostics. Japan is strong in development of diagnostics and rapid test agents, so the
GHIT Fund and others should be utilized to take on international leadership and role in coordination toachieve the 100 Days Mission for diagnostics.
- Establish a structure to provide diagnostics and rapid test agents which are Japan’s strengths in particular,
not only domestically but to other countries, and to make them available for use by the community insteadof just by medical institutions. Also make technology such as Japan’s digital-based diagnostic imaging
available for diagnosing and testing.
(4) Access and delivery (A&D)- Japanese corporations possess technology contributing to vaccines for easy management and use indeveloping countries, such as technology for administering intradermal and intranasal immunization. The
development of vaccines is suited for A&D in developing countries, since the vaccines do not require lowtemperatures in transport and storage like mRNA vaccines do. Japan should also consider the developmentof effective vaccines from an A&D perspective.
(5) Funding needs and procurement methods- To achieve the 100 Days Mission and A&D, analyze what funding is required in which part, and thecurrent status and gaps, while discussing funding needs and procurement methods to create an action plan.
Funding does not need to be limited to sources in Japan when doing so. Funding also needs to beconsidered from international organizations such as the Coalition for Epidemic Preparedness Innovation(CEPI) as well as venture capital (VC) in Japan and abroad. At the same time, startups and pharmaceuticalcompanies in Japan should participate in the overall global R&D ecosystem and also consider ways tobring funding into Japan from abroad.

1-3. Crisis Response for Communicable Diseases, Etc. With Active Participation by Consenting Citizens[What behavioral science and social marketing shows]For citizens to understand concepts behind each other’s behaviors and agree for the most part on
directionality of measures regarding communicable diseases measures, it is effective to use knowledge
from behavioral science such as social marketing, and to exchange opinions and communicate information
appropriately.
Once a certain level of agreement has been reached, it is important for state and local governments to17change the communicator of information and what is being conveyed, depending on the target and nature of
the desired behavior. By doing so, consent among the people will increase, and by changing their own
behavior, they can come to feel value in themselves and society which can lead to efficacy of measures.
[Dilemmas faced by society]
At the start of the pandemic in 2020, information available was extremely limited and people feared theunknown disease, so it was easy to see what society would do. But as the pandemic prolonged, information
about the communicable disease became known and people accumulated experiences. Perspectives on
COVID-19 diversified driven by individual values and experiences, and directionality of society as a wholebecame unclear.
Many measures have been taken by state and local governments to encourage behavior change amongindividuals and participation by citizens. For example, the model for stages of behavior change was utilized
for vaccinations in Sumida Ward, Tokyo, which encouraged citizens to participate and led to a high rate ofvaccination at an early stage.
Tokyo Metropolis set up the Tokyo Center for Infectious Disease Control and Prevention (iCDC) in
October 2020. Since its establishment, the Tokyo iCDC has conducted PR, public information gathering,and dialogue continuously as part of risk communication activities. Surveys among citizens have been
conducted seven times so far, and interviews with single parents as well as other segment bases have been
selected for group interviews. Results have been shared with the governor and relevant departments, andreflected into measures.
There have been cases where citizens themselves, and not the government, led efforts with theirawareness of issues. In Okinawa, the Okinawa Yagumai Project was set up by young volunteers, and the
COVID-19 Task Force Okinawa was created among volunteers from the prefecture’s medical, economic,
welfare, and educational sectors.
While such activity took place among certain parts of Japan, the country as a whole cannot be perceived
as successfully having created a mechanism functioning sufficiently in leading to behavior change amongindividuals and society through communication. The country as a whole was unable to overcome hurdles
and issues as seen below.
(1) The medical system was unable to provide regular treatment as it worked to save as many lives as
possible during the pandemic, and patients are being forced to choose a different option under thecircumstances. In the latter phase of the pandemic, opinions emerged that suggest a conflicting structure
between the economy and the medical system, making medical providers choose whether to prioritize
COVID treatment or regular medicine.
(2) Various types of testing were conducted, but with a break in communication and a lack of consent fromregional communities, several testing options had issues of efficacy. For example, issues arose withtests targeting individuals working in red light districts when incentive for testing was insufficient andwhen testing got a bad reputation. Wastewater surveillance met issues with reputation and its horizontal
expansion to other areas was difficult.
(3) Japan faced great difficulty communicating information in the unprecedented crisis. Especially at the
beginning of the pandemic, the spread of misinformation, when the nature of the virus and treatment
methods were not known, was a problem. How to communicate information and elevate literacy of thereceiving end of the information became issues.
(4) The government created COCOA, a contact tracing app, but because it was made so that no information18

on individuals could be collected, it was not effectively linked to other related systems, making it
unsuccessful as an app to confirm status of the pandemic. As a result, a PDCA cycle did not result andefficacy as an app did not come to fruition.
[Actions required]<Short-term>(1) Reach a certain level of agreement regarding an exit strategy for COVID-19. For that, prepare a forum
for dialogue among citizens, decision makers, and experts. Related parties including civil groups,
NPOs, universities and other academia to host. Initially, several local governments would hold thediscussions, and spread out from there.
(2) Make practical guidelines for using behavioral science and social marketing.
<Medium-term>(1) To increase implementation of state and local government measures, foster experts in behavioral scienceand social marketing. Secure funding to do so.
(2) Consider development of a digital platform such as an app that can be used in normal times, anddiverted in emergency situations. (Assume utilization online as a remote, non-contact, distribution-type
digital dialogue/ communication tool)19

2. Contributing to Global Health- For Japan to Play a Leading Role in Times of Crisis
2-1. Tuberculosis, Malaria, Neglected Tropical Diseases, Nutrition, and Immunization- Innovations from Industry-Government-Academia Collaboration Stemmingfrom the COVID-19 Experience
Awareness is growing regarding the need for measures against existing communicable diseases, such as
tuberculosis, malaria and neglected tropical diseases (NTD), and not just COVID-19. Consortiums fortuberculosis and malaria have continued to be active after the Nikkei FT Communicable Diseases
Conference held last November. An NTD consortium was also newly established to have many
deliberations, and portion related to nutrition and immunity was newly created this time. During thesession, each consortium presented results of deliberations, and reported on recommendations to be made at
the G7 Summit to be held in Japan next year.
The tuberculosis consortium explained the target set by WHO to reduce tuberculosis cases by 80% anddeaths by 90% by 2030 in line with SDGs. Activities by industry, academia, and government to prevent the
spread of diseases in Africa and Asia, as well as technological development and deployment oftherapeutics, test agents, etc. toward achieving the target, were reported on. Specifically, Eiken Chemical’s
TB LAMP test agent was approved by the WHO and is deployed in six countries through budget from the
Global Fund. Nipro’s genetic test agent for multi-drug resistant tuberculosis and others have also received
WHO approval. Otsuka Pharmaceutical’s new therapeutics for multi-drug resistant tuberculosis are being
used in over 120 countries worldwide, and a pediatric formulation has been approved in Europe in 2021. It
appears in the WHO’s Essential Medicines List. Konica Minolta’s diagnostic imaging equipment using
artificial intelligence (AI) and Fuji Film’s super compact x-ray equipment have also been made available,
examples that products created by Japanese corporations are preventing infections in communities.
The Ministry of Foreign Affairs explained the policy of the Japanese government to allocate up to USD
1.08 billion over the next three years toward ending the three major infectious diseases including
tuberculosis by 2030. It also reported that as the host of the G7 Summit in 2023, Japan will make proposals
in three areas, namely (1) create a global health architecture related to health equipment, (2) lead efforts
toward achieving universal health coverage, and (3) innovation.
From the NTD consortium, measures being taken that target 20 infectious diseases were presented. It
was emphasized that three pillars are necessary for measures against communicable diseases: (1) combat
poverty; (2) strengthen measures for public health; and (3) gain public support for R&D. It was pointed outthat Japan is in a very advantageous position. A case example was given with topical medicine for jigger
infestations developed by Saraya, which is scheduled to be approved for Kenya shortly and deployed as
early as next year. Even as R&D for therapeutics is progressing, a structure to provide the medicine swiftlyto patients remains an issue. It was also reported that recommendations on access and delivery of test
agents and therapeutics were made in advance of next year’s G7 Summit.

20

Information was also provided on action being taken by the malaria consortium in the fields of vector
control, diagnosis, and drug discovery through cooperation among Japan’s industry, academia, andgovernment. According to the Asian task force, Sysmex’s diagnostic tool XN-31 received regulatory
approval in Japan in 2020 and gained insurance coverage by 2021. Eiken Chemical’s LAMP test wasapproved in 2021 as one of several diagnostic standards for Japan, then gained approval for Europe inAugust 2022. Both companies are conducting performance evaluation tests for commercialization at
Mahidol University, a base for clinical research overseas under the National Center for Global Health andMedicine (NCGM). It was also explained that Neopharma Japan is conducting clinical research to develop
therapeutics.
The African task force reported that to handle the presence of asymptomatic patients and mosquitos thatcan resist pesticides, which both cause spread of communicable diseases in the Lake Victoria area of Kenya
located on the eastern side of Africa, they aim for comprehensive extermination efforts such as mass drug
administration and mosquito control. Finally, the African business consortium reported on the start of an
integrated approach against malnutrition, anemia, and malaria by a cross-industry, co-creation project(Sysmex, The Ajinomoto Foundation, NEC) to improve maternal and child health and nutrition in the
Republic of Ghana. It was pointed out that going forward, coordinating and expansion with internationalorganizations on results by the task force need to be addressed.
Specific activities and initiatives were introduced for nutrition and immunity after an explanation of the
aim to heighten comprehensive ability of measures against communicable diseases through food culture
and fermentation nutritional technology that are strongholds of Japan. The Ajinomoto Foundation is
working to improve nutritional status in Ghana through food, and examples of initiatives to prevent
developmental disorders were presented. It was pointed out that leveraging the latest technologies such asdata analysis with AI and surveillance would be key going forward.

2-2. Cooperation Among Developed Countries in the Fight Against AMR
The annual number of deaths from communicable diseases caused by bacterias with antimicrobial
resistance (AMR) (in 2019) was reported to be 1.27 million, more than that for AIDS and for malaria. In
Japan as well, it is estimated that approximately 8,000 people have died from a mere two types of bacteriaswith AMR. On the other hand, new development of antimicrobial drugs for treating communicable diseases
caused by bacterias with AMR is significantly decreasing because of the difficulty in R&D, its high cost,and low profitability. Even if the drugs were to become available, use would be limited from the standpointof it being discouraged to prevent bacterial resistance, with little promise of ensuring profit based on sales
quantity and sufficient return on investment. Major pharmaceutical companies are continuing to exit the
antimicrobial drug market or are selling the business. Aiming to secure profitability through assistance after
a drug is approved and by creating pull incentives for continuous support of R&D, the AMR consortium
was formed as the fifth consortium for the Asia Africa Medical Innovation Consortium (AMIC). The
consortium released a document in March 2021 proposing to the government the implementation of asystem for pull incentives in the antimicrobial drug market and initiated activities to recommend it.
At the conference, it was reported that the consortium submitted a proposal to the Minister of Foreign21

Affairs and the Minister of Health, Labour and Welfare prepared in advance of the 2023 G7 Summit inHiroshima. An official from the Federal Ministry of Health of this year’s host country, Germany, explainedthat all countries agreed to strengthen the surveillance system and raise awareness regarding the use of
antimicrobial drugs, and the importance of promoting innovation for the R&D of new drugs. The U.K.
indicated that they have employed pull incentives and confirmed a certain level of effectiveness, expressing
hope for Japan as the next host country to set milestones toward achieving the incentives system.
The clinical forefront spoke about the presence of antimicrobial drugs as a condition of modern medicine
such as advanced surgery and chemotherapy, and reported that antimicrobial resistance is a big issue in thethree major communicable diseases as well. The corporate side spoke of pull incentives enabling a preventionof linking the dosage of antimicrobial drugs with sales, allowing for proper amounts to be used and a certain
level of manufacturing quantity to become foreseeable. This heightens economic predictability and thesuggestion by many of an environment being created allowing more investment for companies that willdevelop antimicrobial and other drugs to treat communicable diseases. In Japan, a budget for pull incentives
has been added to the appropriations request for the next fiscal year, and discussions were held regarding thesource of funding. The proposal by the consortium estimates 20-80 billion yen in total per drug (with payment
period of ten years, two to eight billion yen per year), and discussions were held regarding the amount to beborne by Japan in terms of fair share in which countries contribute a share amount that is equally fair basedon GDP or other measure, referencing recent academic studies.
The government reported that work is taking place on revising Japan’s action plan formulated in 2016, inconsideration of the achievement status for antimicrobial drugs dosage and other numerical targets. It wasalso revealed that the next plan is to be completed within FY2022, and AMR is being given weight in theagenda for next year’s G7 Summit. To achieve implementation of pull incentives and for efficacy of AMR
measures, all agreed that deployment of the next plan should be made clear and Japan must show leadershipat the G7 and that the consortium would fulfill its role.

2-3. Expectations for Japan Regarding UHC - What to Do in Advance of the G7 Summit in Hiroshima
Universal health coverage (UHC) is a comprehensive policy concept that aims for all people to have accessto effective and quality health services without financial hardship. To achieve UHC, access in three areas
must be improved, namely physical access to medical institutions and medicine, economic access for medical
fees, and social access including language and customs. The U.N.’s sustainable development goals (SDGs)
aim to achieve UHC by 2030.
UHC is the foundation for measures against communicable diseases, such as tuberculosis and malaria.
[Background and issues]
Japan’s universal health insurance started in 1961, achieving UHC at an early stage. At the 2016 Summit
in Ise-Shima, host country Japan made the promotion of UHC the main theme for the first time at a G7
Summit. Japan has supported the promotion of UHC in Asia, Africa, etc. and has led the international debate.
COVID-19 has seriously affected countries with a weak health system in particular. Vaccine inequality,
etc. arose between developed countries and developing countries. Many people are unable to receive basic
medical services, and poverty has spread.
22

Developing countries have especially been deeply impacted. For example, low income countries have adeclining rate of vaccinations. In 57 low income countries supported by Gavi, the Vaccine Alliance, the rateof children receiving immunizations decreased by 5 percentage points to 77% since the start of the pandemic.
Even in Japan where UHC has been achieved, weaknesses in crisis management came to light. Healthcenters and local health research facilities that are bases for primary care played a part in measures againstclusters with backward active epidemiological surveys. But as the structure for medical provision emphasized
nursing care and supporting daily life for the elderly, preparation for treating acute illnesses including
communicable diseases was not sufficient, leading to severe strain in medical care. There was no system
functioning to immediately gather information pertaining those infected, and a delay in development ofdomestic vaccines and therapeutics revealed a serious problem with crisis management. We need to be awarethat Japan is not in a position of superiority internationally in terms of crisis management.
Diseases such as tuberculosis and malaria continue to be widespread in countries around the world, andthe silent pandemic associated with AMR is also spreading. However, now having experienced COVID-19
for three years, political momentum for UHC on a global scale is not being maintained and in fact, is starting
to wane.
Japan as the host of the 2023 G7 Summit is now in a position to lead this debate on UHC.
[Actions required]
Propose projects, at the G7 Summit in May 2023, for helping solve issues that participating countries sharewithin the large framework of UHC. To do so, recommend policies incorporating logistics and distribution
for the 100 Days Mission. Use this to share specific case examples with the international community forprevention and preparedness for UHC.

3. Conclusive Words
As the COVID-19 pandemic continues for three years around the world, each person from the medical
front, corporations, government, and expert organizations participating in the Nikkei FT Communicable
Diseases Conference possesses experience having closely dealt with communicable diseases from theirrespective positions. It is now important for the government to seize the opportunity to strengthen its
function as the command post for communicable diseases to communicate and utilize the on-siteexperience gained. The emergency recommendation incorporated in the statement at this time is a proposalby the conference embodying such in detail. Participants of the ninth round of the Nikkei FTCommunicable Diseases Conference agreed to this statement.
End

23

4. Appendix
The Nikkei FT Communicable Diseases Conference conducted an awareness survey online regarding
COVID-19 in August 2022 on 1,000 men and women aged 20 to 69.
The main points of the results are outlined below:(Edited based on presentation material by Professor Yoko Uryuhara of Doshisha University who supervised
and analyzed the survey)(Hesitation to vaccinate, intention to vaccinate next time)● Seventy-three percent of respondents did not hesitate to vaccinate for the first and second doses.
● Those who did not hesitate were more likely than those who did to➢ believed that vaccination was effective in preventing infection and severity of disease.
➢ expected the vaccine to be effective in preventing serious infections, even if there were adverse
reactions.
● Among 854 individuals who received at least the first dose, 56.5% intended to get another (plan to or
have already booked second vaccination).
● The degree of convincing with previous vaccination, external behavioral were statistically significant
for the intention to vaccinate next time, indicating that the higher the degree of convincing, the higher theintention to vaccinate next time.
< Degree of convincing in infection control behaviour (Voluntary infection control behaviour) >● Degree of convincing in voluntary infection control behavior: mean 5.61 (7-point scale).
● The most highly convinced (very convincing ~ fairly convincing) were “washing hands and gargling
when going home” (87.3%), “regular ventilation” (86.4%) and “staying away from crowds and being
aware of social distance” (84.9%).
< Degree of convincing in infection control behaviour (vaccination behaviour). >● Degree of convincing in vaccination behavior: mean 5.11 (7-point scale).
● Even those with a high degree of convinced about vaccination thought that adverse reactions were hard todeal with. It was suggested that the key is to raise awareness that the vaccine is expected to prevent serious
disease, even if there are adverse reactions, and to avoid misleading people into thinking that adverse
reactions are more serious than the symptoms of infection.
<Degree of convincing with infection control behaviour (external behavioural restrictions)>● Degree of convincing in external behavioural restrictions: mean 4.86.
<Degree of convincing with infection control behaviour (lack of systems in place)>● Degree of convincing in lack of systems in place: mean 4.06 (7-point scale).
●The highest rate of non-conviction was 'hoaxes and misinformation on social networking sites' (39.0%)
followed by effect on treatment of illnesses other than COVID-19 (31.4%) and inability to be tested when24

spread of diseases was at high levels (29.7%).
<Messengers to increase conviction>● Messengers to increase conviction need to vary according to the behaviour they want to encourage.
● Influence of 'family and friends' in all behaviours.
● Messengers to increase conviction for Voluntary infectious behaviour: infectious disease professionals >family and friends● Messengers to increase conviction for Vaccination behaviour: infectious disease experts > heads of local
government > managers in the organization > family and friends● Messengers to increase conviction for External behavioural restrictions: infectious disease professionals> family and friends● Messengers to increase conviction regarding Lack of systems: politicians > Ministry of Health, Labourand Welfare and other government > Community influencers > Family and friends<Information to increase conviction>● The content of the transmission to increase conviction need to vary according to the behaviour they wantto encourage.
● Information to increase conviction for voluntary infection behaviour: information on scientific evidence,various examples of people who have behaved.
● Information to increase conviction for vaccination behaviour Information clearly stating what thedisadvantages are of not vaccinating.
● Information to increase conviction for external restrictions on action: Information that makes them proud
to behave, information that aligns the politician's actions with the demands of the people.
● Information to increase conviction regarding lack of system: Information that makes them proud tobehave, information that aligns the politician's actions with the demands of the people, and informationthat shows specifically how they should act.
<Message to increase conviction>● The message to increase conviction need to vary according to the behaviour they want to encourage.
● Message to increase conviction for voluntary infectious behaviour: gain frame, peer effects.
● Message to increase conviction for vaccination behaviour: scientific efficacy, gain frames and social norms.
● Message to increase conviction for external action restrictions: loss frames.
● Message to increase conviction for lack of systems: loss frame, peer effects.
<Measures to increase conviction>● Common measures desired by people to increase their conviction were the establishment of local centerswhere they could easily ask about infection control behaviours, and a system to visualize the real situationin each hospital and health center.
● Measures to increase conviction for voluntary infectious behaviour: a mechanism for visualizing andpublicizing the results achieved by citizens working together.
● Measures to increase conviction for vaccination behaviour: a system for everyone to share and utilize goodpractice on outstanding initiatives of communities.
● Measures to increase conviction for external restrictions on action: mechanisms for people taking infection
25

control behaviours to gain qualifications.
● Measures to increase conviction for lack of systems: mechanism for people' s representatives to participate
in national and municipal meetings on infectious disease control.

The 9th Nikkei FT Communicable Diseases Conference
Organizer
Nikkei Inc.
Co-organizers
THE FINANCIAL TIMES LTD,
Supporters
CABINET OFFICE, Office of Hideyo Noguchi Africa Prize, Ministry of Foreign Affairs,
Ministry of Health, Labour and Welfare, Ministry of Economy, Trade and Industry,
Ministry of Education, Culture, Sports, Science and Technology
In association with
Mitsubishi UFJ Research and Consulting Co., Ltd., Nikkei Business Publications, Inc.
Special Sponsors
The Japan Pharmaceutical Manufacturers Association (JPMA), Alfresa Corporation,
Daiichi Sankyo Co., Ltd., FUMAKILLA Limited, Gilead Sciences K.K., ICheck, KM Biologics,
Moderna Japan Co., Ltd., Pfizer Japan Inc.,The Research Foundation for Microbial Diseases of Osaka University, Saraya Co., Ltd., SHIONOGI,
Takeda Pharmaceutical Company Limited
Sponsors
AAIC Consulting Pte. Ltd., Eiken Chemical Co., Ltd.,
Global Health Innovative Technology Fund(GHIT Fund), Mitsubishi Tanabe Pharma Corporation, MSD
K.K., NIPRO CORPORATION, Okura. Co., Ltd, Sumitomo Mitsui Trust Asset Management Co., Ltd,
Sumitomo Pharma Co., Ltd., SYSMEX CORPORATION
26

<Reference Material>
Summary of the 9th Nikkei FT Communicable Diseases Conference Special Sessions / Breakout
Sessions■ Special Session 1 (Daiichi Sankyo Co., Ltd.): Issues in vaccine development and new challenges for
future pandemics
Vaccine development progressed at an unprecedented speed around the world against the COVID-19
pandemic crisis. Including initiatives with new technology in mRNA vaccines, Europe and the United States
had been preparing for new diseases in advance. In the United States, vaccine development was underway
by the industry, government, and academia under strong leadership and large-scaled public funding as anational project. As a result, pharmaceutical and biotechnology companies in Europe and the United States
deployed vaccines in only eleven months after genome sequencing.
In contrast, Japan’s pharmaceutical and biotechnology companies have been late in deploying domestic
vaccines.
Vaccines are positioned as an important strategic resource for national security while also being aneffective defensive measure against communicable diseases. To respond to a pandemic, R&D andtechnological development ability that enable domestic manufacturing under a command post functioning ina nation with strong leadership are essential. To prepare for emergency situations in the form of future
pandemics, issues uncovered by COVID-19 must be reviewed so that initiatives can be taken in advance byindustry, government, and academia to overcome those issues. To date, vaccine manufacturers in Japan have
not had opportunities to mutually share issues with the government and discuss ways to resolve those issues.
As this is a factor in the delay of vaccine development in Japan, a structure for government and private sectors
to continuously hold dialogue must be newly established, and initiatives taken to resolve issues on a regularbasis, as essential actions for speedy vaccine development and manufacturing when a pandemic hits.
The Japanese government approved the Strategy for Strengthening the Vaccine Development andProduction System in June 2021. As part of this strategy, the government established the Strategic Center ofBiomedical Advanced Vaccine Research and Development for Preparedness and Response (SCARDA)
within the Japan Agency for Medical Research and Development (AMED) in March 2022, proceeding todevelop a base for academia. Going forward, it is important that public funding for fundamental research incommunicable diseases and vaccines are heavily invested in advance, that academia and corporations tocooperate, and that efforts are made for technological development and fostering human resources.
It is also essential to create a structure in advance for vaccine businesses to function, and to establish
policies that will help pharmaceutical and biotechnology companies in Japan, with the government requestingdevelopment of vaccines for priority diseases and buying up developed vaccines as stockpile. Additionally,
as it was difficult for large-scaled international joint clinical trials to be conducted globally by Japanesepharmaceutical and biotechnology companies, a network should be established for global clinical trials for
vaccines and coherence of regulations promoted in advance. It is believed a scheme for academia to analyze
samples from patients collected in clinical trials at an early stage and evaluate efficacy of vaccines must be
considered.
It is vital to aim for the creation of a new vaccine ecosystem in the medium- to long-term with continuous
effort by industry, government, and academia so that development of vaccines in Japan can start with urgency
when future pandemics strike and for speedy provision to citizens.

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■ Special Session 2 (Pfizer Japan Inc.): Accelerating R&D for manufacturing novel vaccine withmRNA technology in Japan~ Think through experiences of COVID-19 and a perspective of Global-Health ~The latest pandemic has made it clear that global cooperation and candid partnerships are essential in thedevelopment and manufacturing of superior vaccines, and that the fight against communicable diseases
should be one for which the entire world unites.
German startup BioNTech and U.S. company Pfizer have been cooperating on developing influenza
mRNA vaccines since 2018, and the vaccine they developed for COVID-19 can be said to be a result ofopen innovation. mRNA technology which was the basis for the creation was developed by Katalin Karikofrom Hungary, but researchers from Japan also played a part. Vaccines are manufactured by a network thatspans the globe, with ingredients for manufacture originating in many countries throughout the world.
It is of course important to have a structure in place for vaccines to be developed solely in Japan, but toachieve initiatives like the 100 Days Mission, Japan will need to be actively involved in global networks
and be expected to play a part in making vaccines. However, Japanese corporations will need to have acertain level of ability to do so. An element of national security is contained in vaccines for pandemics that
may arise in the future. Establishing domestic manufacturing bases in advance will allow Japan tocontribute in international cooperation in an emergency situation.
The latest pandemic has made it evident what is essential in vaccine development. First there is agility, or
speedy decision-making. Companies that succeeded in developing vaccines first made decisions early every
time it was necessary, including making heavy prior investments knowing the risks, and action was taken
just as early for development, manufacture, and requesting regulatory approval.
Also, development should not be random but rather conducted after the target product profile for R&D isidentified, and it is important to have a structure in place in advance for vaccine clinical trials to take place
in a speedy manner.
A voluminous amount of data was created related to the mRNA vaccine. It will also be important to havea structure in place to analyze and share such real-world data and be able to monitor efficacy and safety ofvaccines.

■ Special Session 3 (ICheck): Infectious disease screening: Considerations for the post-COVID era
How will initiatives globally to end a pandemic benefit future society? Research outcome for cholera,
which to this day causes two million fatalities every year, is being accumulated over the past 40 years
toward its eradication, and leading-edge research work has been presented regarding everything from themechanism of outbreaks to the predicting of pandemics, with data including sea surface temperature,humidity, and human density utilizing satellites. That knowledge combines analysis of virus present inregional community’s sewage found through drainage surveillance with risk forecasting to project the
number of COVID-19 cases.
Meanwhile, with concentrated populations in cities and proceeding global warming, we are faced with asituation in which the threat of new diseases and how to prepare for them must be dealt with globally.
Reflecting on past experience alone will be insufficient, and we will need to take a foresight approach in28

unity throughout the world leveraging artificial intelligence (AI) and addressing several scenarios and how
to manage them.
The pandemic in Japan peaked at 600,000 cases during the fifth COVID-19 wave in the summer of 2021.
It was then that private corporation ICheck singlehandedly provided a package distributing 200,000 rapid
antigen tests kits along with free PCR testing and online diagnosis. They also communicated and educatedonline proper understanding and decision-making, and such activities as a package were widely acceptedby society. ICheck analyze that raising awareness of testing on an individual-level basis and encouraging
speedy action was one of several factors that led to a relatively early end to the wave. From the UnitedStates, a status report was made on conditions including a low rate of booster shots and stockpilingbehavior leading to a strain in medical care, as well as lack of medical supplies and daily items. Opinions
were expressed that Japan was a good case to follow in educating the public which led to suppressed spreadof the disease.
Many citizens voluntarily taking the rapid testing and the results being reflected into their mobile devices
could potentially lead to predicting outbreaks in the future geopolitically. With the 100 Days Mission
initiative globally to significantly reduce the time it takes to develop vaccines and therapeutics for new
communicable diseases, the area that Japan can contribute to the most is with testing, and hopes wereexpressed that it would continue leveraging that strength.

■ Special Session 4 (Moderna Japan Co., Ltd.): What is needed to be ready for the next pandemic?
The role of industry-government-academia cooperation
The COVID-19 pandemic provided us with various knowledge into emerging diseases. The
compatibility between pharmaceuticals and communicable diseases is one of them. Various available
antiviral and anti-inflammatory medication were tested, but a lot of time was required to determine theproper method of use.
On the other hand, development at an early stage was achieved with positive results by the mRNA
vaccine. The decline in number of deaths with the spread of the vaccine is evident from WHO data.
Non-pharmaceutical intervention in the form of calls to stay-at-home were effective. Japan’s response to
COVID-19, that is stay-at-home measures at the outset such as declaring a state of emergency and strategy
to suppress spreading of the disease through aggressive vaccination after development of vaccines, wasconsequently a success. Meanwhile, strain on the medical system was an enormous problem.
Through such experience, the first thing we must address is swift vaccine development and expanding
manufacturing and provision. For example, vaccine development should be accelerated for the 15 priority
pathogens identified by the WHO (COVID-19, Ebola virus, malaria, etc.), and a system should be in place
to conduct Phase 3 studies in no time during a pandemic.
Establishing a system for manufacturing and providing vaccines is also key. For rapid provision, amanufacturing base should be created in each of the five continents. The plants should manufacture various
therapeutics using mRNA technology even in normal times, and ideas to keep the production line runningat all times is important.
It is also true that a factor in the strain on the medical system was an uneven distribution of medical29

resources. We could perhaps refer to the Fukushima model for a solution. This model divides medical
institutions into four levels such as severe, mild, etc., and patients are transported depending on the severityof their symptoms. By sending patients to the relevant hospital based on changes in condition, efficiency inthe use of medical resources was made possible.
Mankind has experienced numerous pandemics. And pandemics are a certainty in the future. It isessential that industry, government, academia, and private sectors throughout the world cooperate inpreparation.

■ Special Session 5 (Gilead Sciences K.K.):
Strategies to end AIDS epidemic - multisector approaches as key enablers
AIDS was once considered the same as death, but now there are various drugs and treatment, allowing
HIV positive patients to live long. However, there are still 1.5 million new infections each year around theworld, and 650,000 people die an AIDS-related death.
In such conditions, the Joint United Nations Programme on HIV/AIDS (UNAIDS) is targeting the
reduction of new infections and deaths to 370,000 and 250,000, respectively, by 2025. The specific strategy
is to achieve “95-95-95.” This means 95% or more of individuals with HIV will be aware of their status,
out of which 95% or more will receive proper treatment, and a further 95% or more out of that will achieve
viral suppression. HIV patients for which viruses are no longer detected (U: Undetectable) will not be able
to sexually transmit the disease (U: Untransmittable). This scientific fact is known as U=U. In Japan, after
the spread of COVID-19, the number of tests conducted for HIV at health centers significantly decreased,
and restrictions of the medical system made the time between HIV transmissions diagnosis and start oftreatment very long, preventing achieving the first and second 95’s.
To see an end to the spread of AIDS, a 4-pillar strategy with a combination of U=U, promotion of
testing, and the use of condoms, as well as the use of PrEP, would be effective. PrEP is pre-exposure
prophylaxis against HIV, intended for use by individuals at high risk for contracting HIV. It is highly
effective, and PrEP at present is approved in many countries as a preventive measures against HIV. Japan
should also rush to approve it.
It is expected that the AIDS prevention guidelines in Japan which are the backbone of AIDS measures
will be revised shortly. A structure to treat HIV positive patients has been established, and it will be
important to prevent HIV along with other sexually transmitted diseases. To do so, mail-in testing, selftesting, and new methods such as PrEP should be spread and utilized, along with making target individuals
for testing and prevention the key population, enhancing AIDS measures that take into consideration their
viewpoints.
Development of drugs to cure HIV is also progressing. With HIV, viruses remain latent in immune cells,
and since infection occurs continuously, it is a difficult disease to cure. Treatment is therefore being
considered that would reactivate the latent viruses and proceed to remove those infected cells. There is apromising method that would combine the three elements of immunomodulating drugs, neutralizing
antibodies, and therapeutic vaccines.
To end the spread of AIDS in Japan, initiatives by various sectors under government leadership, withsociety at the core, is anticipated.
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■ Special Session 6 (The Japan Pharmaceutical Manufacturers Association):
Establishing a Drug Discovery Ecosystem for Infectious Disease Area
~ Focusing on Cooperation among Industry, Government, and Academia ~COVID-19 infections spread quickly around the world since it emerged, but companies overseas
developed highly effective vaccines at an unprecedented speed of under one year since the start of thepandemic. Behind this speed were continuous R&D support from the government, a high level of drug
discovery ability, and speedy cooperation with major pharmaceutical companies and bio startups. To
prepare for the next pandemic, Japan should also have such an environment ready, so that it can meet
expectations it will succeed in constantly bringing about new drugs in the realm of communicable diseases.
With such problem awareness in mind, the government prepared in March 2022 a tentative list of priority
diseases for communicable diseases that require securing the use of MCM such as medicine and medical
equipment, that will serve as countermeasures for public health emergencies. The list includes 5 categories,
for diseases based on whether they are completely unknown so far, new diseases that are related to ones
that existed in the past like with COVID-19, diseases caused by bacterias with antimicrobial resistance(AMR), and other such groupings. Eight diseases were selected from among them and policies were formed
to provide MCM R&D assistance and to stockpile, etc.
During the session, opinions were exchanged among industry, government, and academia as to how best
investment and support should be provided for academia and bio startups that bear the seeds ofrevolutionary new drugs, in order to support the initial stages of drug discovery. Discussion was also heldon pull incentives that could contribute to predictability in the antimicrobial drugs business as requirementsthat would make such investment and support fruitful. The clinical forefront offered opinion that local
medical institutions providing care for infected patients also need human resources and facilities to engage
in R&D. The venture capital side noted the importance in possessing technology that can be utilized otherthan for communicable diseases and in support for the creation of drug discovery seeds that will lead tocontinuous creation of startups, in light of the field of communicable diseases being generally difficult toinvest in due to the unpredictability in demand and economic uncertainty.
Through discussions regarding drug discovery for communicable diseases, it was agreed that creating asystem for pull incentives to raise certainty for businesses is vital. Also, creating a favorable cycle in theform of a drug discovery ecosystem is necessary by fostering drug discovery seeds for academia and bio
startups by supporting venture capitals, and by institutional investors investing in startups that become
listed or in major pharmaceutical companies that tie up with or acquire startups. Toward that end, fostering
human resources to link various value chains is urgent, and it was unanimously agreed that it was important
to elevate awareness of the value that discovery of drugs for communicable diseases would create withtherapeutics including antimicrobial drugs, not only financially but also in terms of social value.

■ Breakout Session A (Takeda Pharmaceutical Company Limited):
Challenges and proposals for developing and producing vaccines made in Japan in preparation for
unpredictable pandemic
With the spread of COVID-19, Takeda Pharmaceutical made the decision to import Moderna’s mRNA
vaccine to develop and supply it for Japan, and also develop, manufacture, and supply a vaccine from31

Novavax’s protein-based vaccine. The Novavax vaccine was authorized for use in Japan in April 2022.
Authorization gained for manufacture and sale of the Moderna vaccine was transferred to Moderna Japan inAugust 2022.
Takeda had considered creating a vaccine in-house, but believed their utmost contribution would be to
make any promising vaccine elsewhere in the world available in Japan soonest so that vaccination in Japan
could start at the earliest possible time. Takeda Pharmaceutical has been developing and manufacturing
vaccines since 1946 for commercialization in Japan, and such efforts led to the early collaborations with
Moderna and Novavax.
Viruses mutate and cause changes in the infection and pathogen just as they did with COVID-19. It takes
an enormous toll for manufacturing bases to continue developing vaccines for mutating diseases. Since
procurement of raw materials rests on competing in global competition for the resources, public-private
partnerships need to be enhanced. Being able to respond in emergency situations requires preparation andcooperation, and expectation rests on the government’s command post functions.
To achieve the 100 Days Mission, it is important to stockpile vaccines and prototype vaccines* on aregular basis. To be of help not only for those in Japan but worldwide, manufacturing capabilities should be
reinforced and prepared in advance.
R&D and establishment of a manufacture system for vaccines, which are biopharmaceuticals, require anenormous amount of investment, which is difficult for private corporations alone to cover. Long-term
support by the government, including push incentives in the form of aid for R&D, and pull incentives suchas purchase of product after it is approved and immunization plans, along with partnerships with othercompanies becomes vital. The importance in creating a business environment where innovation is rewarded
in normal times is significant.
In preparation for the post-pandemic stage for a virus where the end of the pandemic is near, it isessential to raise the rate of vaccinations, and to maintain a perspective for the pandemic to not recur. It is
important to lower the economic burden through immunization plans for the vaccines, and to enable anenvironment for as many people as possible to get vaccinated by giving them more choices in vaccines
through improvements in currently available products as well as development of new vaccines.
*Prototype vaccine: a mock-up vaccine for speedy development and manufacture of a vaccine in apandemic, for the future virus assuming changes to its strain■ Breakout Session B (The Research Foundation for Microbial Diseases of Osaka University):
Review infectious disease control in companies, applying learnings from COVID-19 pandemic
Learnings from COVID-19 spanning a long period should be incorporated into the business continuity
plan (BCP) formulated by a company for the event of a disaster or other emergency. The focus of BCPs
created by many companies rests on assuring continuity of business that assumes natural disasters such as
earthquakes and flooding, and what to do if business is in fact interrupted. Taking the experiences we haveundergone over many stages since the original state of disarray faced in the wake of the COVID-19 pandemic,
it is urgent that action to be taken is incorporated that assumes new pandemics in the future. For unforeseen
pandemics going forward, a system enabling access to accurate information in a speedy manner is crucial in
addition to maintaining risk communication with employees ahead of time.
What has changed with COVID-19 in terms of health management is that the head of companies have32

become apt in decision-making to prioritize employee health over costs for the company, as evidenced byworkplace vaccinations. Efforts in health management taking into consideration the health of employees
throughout the supply chain are also starting to emerge.
The aging population of employees is sounding an alarm as an issue going forward. Analyses suggest that
one of the factors to be so is that labor productivity in Japan is at a level only 60% compared with the UnitedStates or France, leading to unresolved health issues of workers. In particular, it is important to put measuresin place against infections caused by bacteria such as Helicobacter pylori linked to cancer which is the top
cause of deaths among groups middle-aged and over, and to incorporate testing and vaccination for rubella(5th phase immunization) into health exams for men born between April 2, 1962 and April 1, 1979 when
immunizations were suspended, so that women desiring pregnancy can work in a safe health environment. It
was emphasized that companies are tasked with creating an environment for employees to work energeticallytoward the future.
Having experienced the COVID-19 pandemic, it has become clear that measures are necessary that exceed
conventional health management expectations in terms of compliance with laws and regulations, safety
consideration obligations, and corporate social responsibility. The message delivered was that companies
should move forward in implementing such measures taking them as investment for the future, not as costs.

■ Breakout Session C (FUMAKILLA Limited):
Personal care as a control of mosquito-borne diseases: Protect people’s lives using mosquito
insecticides and repellents.
The number of deaths from mosquito-borne malaria has decreased since 2000 with the spread of mosquito
nets and therapeutics, but the rate of decrease has been leveling off since 2015. Diseases other than malaria
such as zika and dengue are spreading worldwide and regions requiring measures against mosquito-borne
diseases are only increasing.
The first choice in mosquito extermination is the use of pesticides. In areas where infections spread, themunicipality is usually in charge of extermination activities, but in private spaces, residents are forced tohandle it themselves. And when economic activity increases globally, the number of people traveling abroad
rises. It is essential that they do not become infected abroad, and do not bring the disease back to their country.
The Centers for Disease Control and Prevention (CDC) in the U.S. recommend use of insect repellents
containing deet and picaridin, mosquito coils, and aerosol sprays as highly effective means to control
mosquito-borne diseases when traveling to tropical regions.
FUMAKILLA offers single-spray mosquito insecticide and battery-operated mosquito repellent as evenmore effective mosquito-repelling items. One spray of the former item offers long-lasting repelling effects asa very effective means against mosquitos in a household situation. The battery-operated item is suited for use
during outdoor activities. FUMAKILLA also offers the single spray insecticide in Indonesia, wheremosquitoes have roughly five times the resistance against insecticides as mosquitos in Japan, by adjusting
the amount and method of use. A problem is with a large number of countries where regulations restrict
mosquito insecticides. FUMAKILLA asserts the need to break down these barriers to spread the effectivenessof the latest insecticides to protect the lives of those in need of such items.
In addition to enrichment and dissemination of mosquito insecticides, public awareness activities including
proper use of insecticides are indispensable to educate people, particularly children, who are unaware that amosquito bite can cause disease. In Asia where forest malaria is a problem, workers at rubber plantations
33

learned and spread the fact that infections can be prevented by applying repellent. The key is for companies
developing highly effective personal care products to play an important role in carrying out public
measures along with spreading awareness for individual behavior with a bottom- up approach.

■ Breakout Session D (Saraya Co., Ltd.): Jigger infestation in Kenya; WHO NTDs road map
Jigger infestation is an infectious disease in which a female sand flea, a type of parasite and flea, burrows
itself into skin, especially tips of the toes and under the feet, laying eggs and causing pain, itching, andinflammation of the affected area. It can lead to complications such as abscesses, gangrene, and tetanus, anddeath may result in the worst case. The affected area may also become deformed causing difficulty walking,and bad appearance that can also be caused may lead to discrimination. It is found in most tropical andsubtropical regions throughout the world, with 4% of the population in Kenya affected and approximately 20
million people in North and South America at risk of infection. It is closely associated with the issue ofpoverty, and the WHO added soil-transmitted helminth to the list of neglected tropical diseases (NTDs),
launching a road map to control jigger infestations.
The status in Kenya was explained as an example at the breakout session. Sufficient effectiveness is notevident with current antiparasitic drugs for jiggers, such as ivermectin. A continuous regimen for two weeks
applying potassium permanganate to the affected area then treating with various oils is recommended, butwith limited medical access in the region, information is not sufficiently disseminated. Prevention is also
limited to traditional methods using coconut oil, and the reporting revealed that effective prevention andtreatment were not being achieved.
Meanwhile, Japanese universities and corporations are working toward controlling jiggers. Nagasaki
University is currently working on-site in the region, aiming to bring the morbidity rate down to 1% or lessin five years. They are getting results with their efforts to strengthen the surveillance system for detecting
and reporting jigger infestations, improve patient diagnosis and treatment ability of local health workers andvolunteers, and help citizens change behavior such as maintaining sanitary feet.
Saraya succeeded in developing a topical liquid for jiggers that is more effective and convenient for use.
It has already received approval locally and is anticipated to be available next year, with preparations
underway for manufacturing in Saraya’s Uganda factory. Results Japan continues working to provide washedsecond-hand shoes locally, delivering 17,000 pairs weighing a total of 10 tons to individuals being treatedwith jiggers.

■ Breakout Session E (SHIONOGI): Issues and next action on the access of anti-AMR agents to
global countries
The process in developing AMR (antimicrobial resistance) therapeutics is extremely difficult. In addition
to international coherence not in place for regulations, clinical studies for patients with infectious diseases
caused by multi-drug resistant bacteria in particular cost an exorbitant amount. This is due to the fact that inaddition to frequency of those patients being low, identifying multi-drug resistance is complex, withpatients prone to becoming severely affected. Patients are then less likely to agree to participation, causing
a severely low figure of individuals in contrast to the number of screenings that are taking place.
34Forming a sound market is also not an easy task. Even after therapeutics for infectious diseases caused
by multi-drug resistant bacteria are introduced into the market, they must be administered with the correct
dosage continually, but only to individuals who are identified as suffering from those diseases or are
regarded as highly likely to be afflicted. Follow-up of patients, including susceptibility surveillance, is also
challenging. Such is the background surrounding companies selling antimicrobial drugs in the U.S. as oflate going bankrupt or being acquired at a price that fails to gain returns on money invested intodevelopment.
In considering global access, we have to face reality that anti-AMR agents are not available to not only
low and middle income countries, but even to high income countries. Therapeutics not being available inhigh income countries is due to the fact that in addition to cases in each country being limited, the market isalso limited due to strict limitations regarding proper usage, with no incentive to make up for it, causing
limited profit for companies. Meanwhile, many people are dying from AMR in low income countries. It isextremely difficult to create an environment to have AMR patients accurately identified and takeappropriate dosages. In addition, response to regulations, data follow-up, and managing supply chains ineach country are also difficult.
In June 2022, Shionogi entered into a three-way partnership with the Global Antibiotic Research &Development Partnership (GARDP) and the Clinton Health Access Initiative, Inc. (CHAI) based in the
U.S., and also signed a technology transfer license agreement with GARDP. Access to Shionogi’s
antimicrobial drug “cefiderocol” was expanded to 135 low and middle income countries around the world
and a portion of high income countries. GARDP enters into supply licenses with generic manufacturers forthe manufacture and sale of cefiderocol.
There is a growing tendency in developed countries to implement pull incentives. For example in the
U.K., a subscription-based payment model was started in June 2022. The model puts antimicrobial drugprescription amounts aside, with the government offering a fixed payment for development by companies,
and the government, in exchange for it, is able to obtain the necessary antimicrobial drugs in times of need,with cefiderocol being eligible for the program.
Momentum is building in Japan as well to implement pull incentives. A trial program is being planned inwhich the Ministry of Health, Labour and Welfare guarantees a certain amount of payment to companies,
with 1.8 billion yen being included into the FY2023 budget estimate.
Development of anti-AMR agents, which involves difficulty in conducting clinical trials, also carryelements that make a global, harmonized approach more reasonable than an individual country basis. Major
developed countries will need to cooperate and take action to provide smooth global development andaccess with pull incentives. Japan is expected to take leadership at the G7 Summit in 2023 and commanddiscussions toward implementation of pull incentives based on cooperation by G7 countries.

■ Breakout Session F (KM Biologics): Development of inactivated vaccine for COVID-19~ A vaccine that meets the needs of post pandemic era ~KM Biologics of the Meiji Group, in collaboration with Meiji Seika, a pharmaceuticals segment of thesame group, is working on initiatives in the field of communicable diseases. The two companies are currently
joining forces, aiming to achieve a domestic vaccine against COVID-19 (code name: KD-414).
Several types of vaccines against COVID-19, such as the new type mRNA vaccine, viral vector vaccine,and long-established types of inactivated vaccine, have been commercialized and vaccination is taking place35

around the world. One such vaccine, the KD-414 being developed by KM Biologics, is an inactivated vaccinewith an extensive track record such as for the influenza vaccine and DPT-IPV.
KM Biologics started clinical studies on humans ten months after starting development of KD-414.
Phase 1/2 study to assess safety and Phase 2/3 study to assess safety and immunogenicity on more test
subjects were conducted, and it was confirmed that immunogenicity (antibody level) heightened for test
subjects the younger they were, and safety was high in the same way as conventional inactivated vaccines.
Currently, 1,500 adult cases are subjects of Phase 3 study in Japan and the Philippines for approved
vaccines and KD-414, to compare their immunogenicity and safety. KM Biologics is also in the middle ofdeveloping pediatric KD-414 for children and currently in Japan, 600 pediatric test subjects are undergoing
Phase 2/3 study to test immunogenicity and safety, with Phase 3 study also scheduled going forward. With
the results of these clinical studies, application for approval in Japan is expected to occur in April throughJune 2023. In addition, the company plans to hold discussions with the government towardcommercialization of an inactivated vaccine for the strain currently spreading, and a combination vaccine
for the seasonal flu and COVID-19.
And to prepare for the next pandemic, their policy is to cooperate with the government and academia towork on initiatives including R&D of new vaccines in cooperation with academia, development of vaccines
against priority diseases designated by the government, and preparing manufacturing bases that can beconverted to government-led facilities in emergency situations, etc.

36