The Third Nikkei Asian Conference on Communicable Disease
Tokyo Communicable Diseases Statement 2016

Introduction
As economic globalization advances, Japan is becoming inextricably linked at all levels—
including the economic, social, and cultural—with the rest of the world, and most particularly
with Asia. As is clear from the emergence of the Zika virus, a new outbreak of the Ebola virus,
and global multidrug-resistant (MDR) communicable disease epidemics, the threat posed by ourhealth by communicable diseases has moved to the foreground as a major issue both
domestically and abroad. At the Kyushu Okinawa Summit held in July 2007, Japan launched theOkinawa Infectious Diseases Initiative, calling for global partnership in the fight against
communicable diseases. The first Nikkei Asian Conference on Communicable Disease(NACCD) in 2014 as well as the second Conference in 2015, were also held in Okinawa, and onApril 22–23, 2016, key figures working in the area of communicable diseases in the public andprivate sectors as well as government and academia gathered from more than 10 countries to takepart in the Third Nikkei Asian Conference in Tokyo. Participants reaffirmed the necessity andthe efficacy of addressing health-threatening communicable diseases through public-private
partnership (P3).
The conference also confirmed progress with and issues arising from (1) a P3 initiative for
packaging and disseminating Japanese medicines and diagnostic tools to Asia that was proposedby the Tuberculosis Working Group under the Asian Medical Innovation Consortium (AMIC)
formed at the recommendation of the Second NACCD held in January last year, and (2) Ebola
countermeasures being pursued in Guinea, West Africa that again package Japanese medicinesand diagnostic tools. Participants also discussed possibilities for new P3-based action oncommunicable diseases using Japanese technologies and services, and agreed on The Third
Nikkei Asian Conference on Communicable Disease: Tokyo Communicable Diseases Statement
2016. Combating MDR communicable diseases is also slated for discussion at the G7 Ise-Shima
Summit next month, with concern over communicable diseases growing. The Tokyo
Communicable Diseases Statement will be widely communicated not only in Japan but
throughout Asia and the rest of the world. Leveraging the deeper international understandingachieved accordingly, it will be incumbent upon Japan to demonstrate even stronger commitment
to the international community through measures to combat communicable diseases.
I. Report on Progress with Japan’s P3 Communicable Disease Programs since the SecondNACCD
Last year, a draft P3 MDR tuberculosis initiative developed through deliberations at the AMIC
Tuberculosis Working Group was presented to the Prime Minister’s Office and the relevant
government ministries and agencies. A P3 program is also underway in Japan in relation to theEbola virus as discussed at the Second NACCD. Progress with and issues arising from these two
initiatives were reported as follows.
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Tuberculosis
1. AMIC Tuberculosis Working Group P3 Initiative: Proposal made to Prime Minister’s Office
A P3 MDR tuberculosis (MDR-TB) initiative was proposed at the AMIC Tuberculosis WorkingGroup for providing MDR tubercular bacteria diagnostic tools and medicines as a package,engaging in empirical research in those Asian countries with tuberculosis incidence, andassisting them in eliminating tuberculosis. The plan was to implement the initiative on the basisof close partnership among the Japanese government; the governments, medical institutions anduniversities of the targeted Asian countries; and Japanese private enterprises, medical institutions
such as the Japan Anti-Tuberculosis Association, and universities.
More specifically, with assistance from the Japanese government and the cooperation of thetargeted Asian countries, tubercular patients would be screened using a simple, high-precision
genetic test (TB-LAMP, Eiken Chemical Co.) in place of a sputum examination using amicroscope, boosting the diagnostic rate for tubercular patients. A MDR genetic test(Genoscholar, Nipro Corporation) would then be used to produce a definite diagnosis of MDRTB. In accordance with these diagnoses, the first new MDR-TB drug to be approved in Japanand Europe in 40 years (delamanid, Otsuka Pharmaceutical Co., Ltd.) would be prescribed asappropriate to boost the curative effect and reduce the occurrence of MDR bacteria, helping tocontrol MDR-TB in the targeted countries.
2. Progress since Proposal to the Prime Minister’s OfficeSince appealing to the Prime Minister’s Office and the relevant government ministries andagencies, P3 projects have begun at various levels.
In Afghanistan, where the most progress has been made, TB-LAMP is already in use, andarrangements are currently being made to have Genoscholar included within the scope ofgovernment procurement. As of FY2016, TB-LAMP, Genoscholar and delamanid will beutilized in Phase 3 (2015–2018) of the Tuberculosis Control Project, a technical cooperation
project between the Japan International Cooperation Agency (JICA) and Afghanistan. As a newdrug, delamanid is currently going through Afghanistan’s drug approval process. As part of grant
aid for Afghanistan, Japan also implemented the Project for the Supply of Anti-TB Medicinesand Laboratory Consumables and the Development of Drug Management Systems inAfghanistan over November 2014–May 2015 and built the Afghan-Japan Communicable Disease Hospital (completed in August2013). Further work will be implemented in conjunction with these two existing initiatives.
In the Philippines, a program for the dissemination of a new TB diagnostic algorithm based onJapanese technologies (TB-LAMP and Genoscholar) that was adopted in February 2016 has now
been launched as a JICA Collaboration Program with the Private Sector for Disseminating
Japanese Technologies. JICA is in the process of dispatching healthcare policy advisors to thePhilippines, and consultations were held on January 21, 2016 between the Philippines’
Undersecretary of Health and the local Japanese embassy and JICA office. The next stage willentail considerations on the provision of delamanid, etc. On February 29, 2016, a joint publicprivate field survey was conducted by Japan’s Ministry of Health, Labour and Welfare (MHLW),
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JICA, Otsuka Pharmaceutical, Nipro, Eiken Chemical, and the Japan Anti-Tuberculosis
Association, with project preparations moving forward.
In Indonesia too, two JICA Collaboration Programs with the Private Sector for Disseminating
Japanese Technologies are currently underway: one promoting the dissemination of a system
supporting the medication compliance of tubercular patients (delamanid), adopted in July 2015,
and the other promoting the dissemination of tuberculosis diagnosis kits (Genoscholar), adopted
the same month.
In Myanmar, consultations have begun on the use of delamanid, TB-LAMP, and Genoscholar,etc., while Japan is also looking at introducing these technologies into Vietnam and othercountries.
In addition, Japan has begun exploring collaboration with the United States Agency forInternational Development (USAID), which is also combatting tuberculosis through P3 programs.
Ebola1. Ebola Plan since the Second NACCD
Following the Ebola outbreak in West Africa in 2014, a three-year project funded by a MHLW
scientific research grant was launched on novel strains of influenza and other emerging and reemerging communicable diseases at St Luke’s International University as of FY2014. Upon
receiving a request for assistance from the government of affected Guinea and a joint researchrequest from the French National Institute of Health and Medical Research (INSERM), Japan
immediately launched its first P3 project.
The project entails supplying LAMP-based diagnostic drugs and tools developed in Japan for theEbola virus (RT-LAMP, developed by Toshiba Medical Systems Corporation and Nagasaki
University) and conducting empirical tests in Guinea, as well as engaging in clinical research on
the efficacy of Favipiravir (Fujifilm Holdings Corporation, Toyama Chemical Co., Ltd.), an
influenza drug with a new mechanism of action, in treating Ebola. Favipiravir is an inhibitor ofRNA polymerase that is necessary for RNA virus proliferation, and it was hoped that it would
also be efficacious against Ebola. However, adding this new indication required adjusting theactual dosage and demonstrating the drug’s efficacy.
2. Progress since the Second NACCDIn December 2014, a proof-of-concept experiment (the JIKI clinical trial) was conducted withthe cooperation of INSERM, NGOs such as Médecins Sans Frontières, and the Guinean
government in order to plan clinical research demonstrating the efficacy and safety of Favipiravir
in treating Ebola. The outcome of the JIKI trial, which analyzed the results of treating 126
patients with the drug, was ultimately published in the March 1, 2016 issue of PLOS Medicine.
Important information was gleaned in terms of planning further clinical trials, such as that thedrug should be given to moderately rather than seriously infected patients, and that the frequencyof kidney damage and the amount of Ebola virus found in the bloodstream can be used as
prognostic biomarkers.
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On the diagnostic front, in April 2015, in response to a request from the Guinean government,
RT-LAMP, 3,000 specimens, and three diagnostic devices were passed on to Guinea via Japan’sMinistry of Foreign Affairs. A research team funded by an MHLW scientific research grant sent
personnel out to Guinea to implement a human resource development (HRD) program in relation
to RT-LAMP diagnostics and examinations.
Based on these P3 results, on October 5, 2015, the French Prime Minister, who was in Japan atthe time, signed a Collaborative Agreement to Enhance R&D on Ebola Virus Diseases (EVD)with St. Luke’s International University President Tsuguya Fukui in the Prime Minister’s Office,widening the scope of activity to pursue joint research on combating Ebola, cooperation in thecomprehensive analysis of results, and joint empirical research and HRD cooperation oncommunicable disease countermeasures in Africa. Data from the JIKI trial is currently being
analyzed, while research is underway on the pharmacokinetics of Favipiravir and the according
optimal prescription, with the results progressively reflected in JIKI trial follow-up research.
Research using animal models has now also begun toward developing an injectable solution andidentifying the optimal combined therapy.
Kyowa Hakko Kirin Co., Ltd., which was part of the MHLW scientific grant research team, isconducting screening research on antibodies neutralizing Ebola, while Toray Industries isdeveloping infection-protective garments, etc., and conducting empirical research in Guinea.
II. New Challenges and Solutions to ThemDiscussion at the Third NACCD revealed challenges that should be addressed toward furtherenhancing and expanding P3.
Tuberculosis
Closer partnership is required in supplying the targeted countries with TB-LAMP, Genoscholar
and delamanid as an MDR-TB package. Delivery of this MDR-TB package has been imperfectunder Japan’s current assistance regime, and more public-private partnership and coordination
are needed. The AMIC Tuberculosis Working Group must pursuer close public-private
information exchange and cooperation. Consideration also needs to be given to expanding thescope of those countries (four at present) targeted by P3 programs. HRD assistance should begiven in countries where empirical experiments are conducted, as well as assistance indeveloping guidelines for the treatment of communicable diseases.
Efforts should be made to have the results of empirical experiments published in academic
journals, etc., deepen the understanding of international institutions, and have information
garnered from research results listed in WHO recommendations and treatment guidelines.
Lobbying needs to be strengthened towards those international institutions handling procurement
in order to have TB-LAMP, Genoscholar, and delamanid supplied to TB high-burden countries.
At the same time, the relevant Japanese companies should work harder to reduce costs in order tosupply products to developing countries at a cheaper price. They must also not neglect to develop4

drug resistance diagnostics for more drugs and MDR-TB drugs with new mechanisms of action.
The Japanese government should also examine ways to assist this R&D.
Ebola
Clinical trials on RT-LAMP need to be properly concluded, information based on the results ofthat research supplied to the WHO and other relevant institutions in Japan and abroad, andconsideration given to having the information listed in Ebola guidelines, deploying diagnostic
devices and stockpiling diagnostic agents to deal with further outbreaks.
Information on Favipiravir needs to be provided in Japan and overseas, including analysis of thedata from the JIKI trial and follow-up research results. Based on the JIKI trial results a planshould be drawn up for clinical trials that prove the efficacy and safety of Favipiravir. An
injection form should also be developed premised on hospital treatment, and the effects in terms
of preventing Ebola infection demonstrated using animal models. Based on that clinical researchand experiment results, consideration must be given to emergency use when outbreaks occur andto clinical trials on adding a new Ebola indication. In terms of immediate tasks, the Guinean
government has requested that the drug be provided to address the new Ebola outbreak whichbegan in March.
Internationally, biodefense and counter bio-terrorism responses are being deployed to deal withhighly-virulent viruses. The Japanese government should recognize the importance of having themeans to protect the country and discuss the establishment of national stockpiles, etc., while also
bearing in mind the possible spread of such viruses to Asian countries.
Other
Communicable diseases were discussed at last year’s G7, and are also on the agenda for thisyear’s Ise-Shima Summit. Last year, antimicrobial resistance (AMR) was addressed as an area ofgrowing international concern, and in April 2016, the Japanese government too released an AMRAction Plan. AMR therefore needs to be added to items for discussion at the next NAACD.
P3
Based on deliberations at the Third NACCD, the following steps need to be actioned in order tofurther enhance P3 on communicable diseases.
A. Begin preparations for the establishment of a new clinical research center in Asia, taking into
consideration cultural and ethical aspects.
B. Look at enhancing the development of human resources able to operate at overseas clinicalresearch centers for communicable diseases, and at partnership with PMDA.
C. Build a drug and diagnostic agent approval system for Japan in conjunction with other Asian
countries and expedite investigations for approval of new indications.
D. Promote the development of human resources able to share information and negotiate withinternational institutions such as the WHO, the Global Fund and Gavi, the Vaccine Alliance.
E. Enhance and expand communicable disease research hubs in Japan.
F. Develop long-term P3 mechanisms.
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G. Promote the establishment of venture businesses that will accelerate the commercialization ofmedical innovations.
H. Strengthen partnerships with the WHO and other UN and international institutions (assistancefor listing in recommendations and treatment guidelines).
I. Strengthen partnership with NGOs (promoting empirical experiments, etc.)
J. Develop innovative and ongoing fund procurement mechanisms.
K. Further develop commodity procurement mechanisms, including stockpiling.
L. Use Japan’s experience to assist in enhancing medical and public hygiene systems,
communicable disease countermeasures and surveillance included (universal health coverage).
M. Promote participation in P3 by companies from other areas such as logistics and ICT that willcontribute to combating communicable diseases.
N. Strengthen collaboration with the government’s Conference for Government-Private Sector
Partnership on Combating Communicable Diseases in Developing Countries.
New Technology Seeds
New seed-level technologies developed in Japan with the potential to contribute to combating
communicable diseases in Asia were announced at the Third NACCD, attracting expressions ofstrong expectation from other Asian countries. The technologies will now need to be carefullyevaluated, companies and institutions invited to participate in consortia for promoting
communicable disease countermeasures, and considerations undertaken toward drawing up theseprojects as new P3 initiatives.
A. A new hepatitis vaccine and a new influenza vaccine based on a vaccinia virus vector (TokyoMetropolitan Institute of Medical Science)
B. A malaria diagnostic device (Sysmex Corporation), malaria vaccine (Osaka University) andtreatment drug (Eisai Co., Ltd.)C. Drugs treating infections caused by multi drug resistant (MDR) bacteria (Shionogi & Co.,Ltd.), vaccines treating and preventing the occurrence of the same (Daiichi-Sanko Co., Ltd.)D. Tuberculosis vaccine (National Institutes of Biomedical Innovation, Health and Nutrition)
E. New indications for Favipiravir beyond Ebola (Toyama University, Fujifilm Holdings
Corporation, Toyama Chemical Co., Ltd.)F. Technologies and services for combating communicable diseases, refrigerators, logistics,sterilization services, ICT, etc.
Subsequent progress with the above technologies will be reported as appropriate at the Fourth
Nikkei Asian Conference on Communicable Disease.
III. Conclusion
The Third Nikkei Asian Conference on Communicable Disease affirmed that concrete results arebeginning to emerge from P3 initiatives combating communicable diseases. It was confirmedthat initiatives have been formed for addressing MDR-TB and Ebola, with concrete steps
beginning to be taken, and results emerging in some areas. Participants also affirmed that adiverse range of seed-level technologies contributing to combating communicable disease in
Asia are being developed by Japanese companies and research institutes.
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At the same time, there are still many issues to address in further developing P3 initiatives. HRD
and building networks among the various stakeholders in and beyond Japan are particularlypressing tasks.
On April 21, 2016, the Japanese government launched the Conference for Government-Private
Sector Partnership on Combating Communicable Diseases in Developing Countries, comprisingrepresentatives from the relevant ministries and agencies, private firms and related associations,etc. The aim is for the public and private sectors to work together to contribute to international
efforts to combat communicable disease, with the Conference to develop specific policies for
deploying Japanese innovations in developing countries.
In relation to the strategies agreed at the Third NACCD, proposals need to be presented to theabove Conference particularly on themes that require a national-level approach to finding
solutions.
Regarding the NACCD, it would be important for AMIC, which was established by the Second
NACCD, to provide ongoing and progressive assistance to P3 initiatives, and for NACCD toengage in further efforts in conjunction with government initiatives such as the above. They
further agreed on the need to hold a Fourth Nikkei Asian Conference on Communicable Disease.

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