2nd Nikkei Asian Conference
2015 Okinawa Communicable Disease Statement

Introduction
Outbreaks of communicable disease, such as avian influenza H7N9 and Ebola virus disease (EVD),
highlight the growing interconnectedness of nations. Internationally renowned experts incommunicable disease, both within and outside Japan, representatives of the private sector, andhigh-ranking government officials responsible for health gathered in Okinawa on January 16 and
17 for the Nikkei Communicable Diseases Okinawa Conference 2015. This gathering, organizedby Nikkei Inc., built upon the foundation of the inaugural Nikkei Communicable Diseases
Okinawa Conference, which took place in February 2014.
Conference participants reaffirmed the imminent threat posed by communicable disease
and the importance of stepping up efforts to address such threat. Discussions focused on
tuberculosis (TB) and EVD, as well as on Japan’s role in fighting such disease. Through an active
plenary panel and smaller group discussions, participants unanimously adopted this Statement,
which includes detailed action plans whose implementation is essential.

I. A Mounting Challenge
Asia, the world’s most populous continent, is poised to take the global lead in economic growth.
Japan engages in ever-deepening interaction with other Asian nations in economic, cultural, andscientific spheres. As an integral member of the Asian community, Japan is urged to work in close
collaboration and partnership with neighbouring countries to address the common challenges posedby the re-emergence and resurgence of communicable disease. Addressing such challenges is also
critical to Japan’s fulfilment of its responsibilities, given that increasing human mobility makes
communicable disease a major cross-border concern.

II. Japan’s Role and Okinawa’s Position
Participants at the Okinawa conference agreed that Japan has a significant role to play in the fightagainst communicable disease—in Asia and worldwide. They agreed, too, that fulfilling that role
will require close cooperation among government, industry, and academia.
Meanwhile, conference participants agreed to support the notion that Okinawa should be
an international center for research and development in the area of prevention and control ofcommunicable disease.

III. Action Plans

Action plans focused on 1) measures for combatting TB—a critical health problem across most of
Asia, and 2) EVD, which has become an endemic in West Africa and poses a threat in other regions.
Action plans detailed ways to introduce to the international community the new technologicalinnovations developed in Japan, such as new therapies or diagnostic kits, as well as how to makethem available for international public use.

1. Tuberculosis
1-1. Status and Issues
Tuberculosis is second-only to human immunodeficiency virus (HIV) among communicablediseases in terms of number of deaths. In 2013, some 9 million people contracted TB worldwide,
and 1.1 million people died of the disease. The number of people infected with TB worldwide is
declining gradually, but the disease remains widespread in developing nations of Africa and Asia.
Tuberculosis also continues to occur in Japan, at a higher rate than in most other industrialized
nations.
The emergence of multidrug-resistant strains of TB is a challenge for the international
community. Such strains have arisen partly as the result of the inappropriate use of anti-tubercular
drugs. As a result, the number of people who have contracted multidrug-resistant TB is growing.
Forestalling epidemics of TB depends on rapid, early detection of the disease as well as
the appropriate administration of effective drugs. The Stop Tuberculosis Japan Action Plan, createdin 2008, contains a useful blueprint for working systematically to prevent epidemics. The planunderwent revision in the follow-up to the 2014 Okinawa conference, and comprises part ofcurrent Japanese government policy for preventing the spread of communicable disease.

1-2. Loop-Mediated Isothermal Amplification
The Loop-mediated isothermal amplification (LAMP) method, a single tube technique for theamplification of DNA developed in Japan, facilitates rapid, easy detection of TB. LAMP is
potentially applicable to the detection of other diseases, and making it available in developing
nations could aid the fight against communicable disease in areas of greatest need. Government,
industry, and academia should promote the international deployment of LAMP by joining hands ingathering data for verifying the method’s efficacy and cost performance, and by identifying viableapproaches for LAMP’s distribution and use.

1-3. Quick, Simple Diagnosis of Drug-resistant Tuberculosis
Drug-resistant strains are the Achilles heel of efforts to fight TB. Curtailing the spread of
drug-resistant strains depends on the capacity of countries to identify resistance to different
anti-TB drugs accurately, quickly, and inexpensively. Multi-sector cooperation, namely

collaboration between government, private sector and academia, in promoting the international
deployment of LAMP will therefore be crucial in containing drug-resistant tuberculosis.

1-4. Asia-Wide Cooperation in Drug Approvals
In 2014, delamanid, which was developed in Japan, became the first new anti-TB drug to go on themarket in 40 years. Regulatory authorities in Japan and in Europe approved the drug for adults who
suffer from multidrug-resistant TB. Making delamanid available throughout Asia will require thesubmission of applications to relevant government authorities in each nation. Building aframework for international liaison in governmental, corporate, and academic sectors could speed
up that process while also ensuring safety. Japan’s Pharmaceuticals and Medical Devices Agency(PMDA) should spearhead initiatives for constructing such a framework.

1-5. Delamanid
Cultivating global awareness of delamanid’s promise will depend on supplementing corporate
work with joint initiatives by government, industry, and academia. Such initiatives must include
measures for amassing data to verify the drug’s efficacy, safety, and cost performance. The
Japanese Society for Tuberculosis and the Japan Anti-Tuberculosis Association (JATA) should leadthe evaluation of drug candidates, and Japan’s government and pharmaceutical industry should
enthusiastically support that evaluation work.
Cooperation with the World Health Organization (WHO) will also be necessary to share
the benefits of Japanese anti-TB drugs with developing nations. Japanese pharmaceuticals
companies must therefore work with the government, nonprofit organizations, and counterparts inother Asian nations to devise viable approaches for drug deployment.

1-6. Continuing Drug Development
Overcoming drug resistance and defeating TB will depend on the mobilization of multiple anti-TB
drugs of differing mechanisms. Such mobilization will require continuing work on anti-TB drugs,
despite the market for anti-TB drugs being commercially unattractive for the pharmaceuticalindustry. Promoting research on anti-TB drugs will require joint initiatives between public andprivate sectors, such as Japan’s Global Health Innovative Technology Fund (GHIT). Of additional
importance will be the mobilization of sufficient funding. Finally, international cooperation isessential to speeding work on anti-TB drugs. Japan’s government will launch the Agency for
Medical Research and Development (AMED) in spring 2015; collaborations between this agency
and organizations that participated in this conference should be further strengthened.

1-7. Asian Platforms for Clinical Trials

An anti-TB vaccine developed in Japan, which uses recombinant human parainfluenza virus type 2(rhPIV2), has shown exciting promise in animal testing. The vaccine, which induces mucosal
immunity, has exhibited greater effectiveness than the traditional Bacillus Calmette–Guérin (BCG)
vaccine in preventing infection and forestalling the onset of disease following infection. The world
currently lacks an effective tuberculosis vaccine for adults, and the Japanese vaccine candidate has
attracted international attention in that regard. Work on developing technology to support
commercial production of the vaccine is under way.
Japanese research on anti-TB and other vaccines gained momentum with the 2014
completion of a world-class facility for animal testing at the National Institute of Biomedical
Innovation’s Tsukuba Primate Research Center (TPRC). Nevertheless, work on anti-TB vaccines
suffers from the lack of a comprehensive clinical trial platform. Neither Japan nor any other Asian
nation has a framework for clinical trials comparable in size, for example, to the South African TB
Vaccine Initiative. Creating a large testing platform remains a pressing need in the development ofanti-TB vaccines and other agents while ensuring safety. Also pressing is the need for pan-Asian
cooperation in processing drug applications and approvals. Such cooperation will be crucial
ensuring appropriate, timely access to new vaccines and drugs.

2. Ebola
2-1. Status and Issues
The outbreak of EVD in West Africa during spring 2014 has infected more than 20,000 persons
and has claimed nearly 10,000 lives. Logging associated with economic development exposed
people to pathogens that lurked deep in West African forests, and road-building allowed EVD tospread quickly to cities. This outbreak of EVD is correlated to insufficient public awareness of theimportance of good sanitary practices and an inadequate network for providing primary healthcare.
The 2014 West African outbreak has made EVD a global health concern, illustrating thedanger of epidemics in other regions. As a result, Japan must address the threat of EVD in thecontext of global health care, as well as in the context of regional assistance for West Africa.

2-2. Favipiravir: Emergency Administration
The drug favipiravir, developed in Japan, received approval from the Japanese government inMarch 2014 for stockpiling against influenza epidemics. It is the world’s first antiviral agent togain approval based on the selective inhibition of viral RNA-dependent RNA polymerase. In
addition to favipiravir’s indication for influenza, the drug demonstrates potential effectivenessagainst EVD, Rift Valley fever, and other diseases caused by RNA viruses.
Humanitarian considerations dictate that Japan should make favipiravir available foremergency administration against high-mortality viral diseases, such as EVD. In December 2014,
France’s Institut National de la Santé et de la Recherche Médicale (INSERM) began conducting
clinical trials on favipiravir at an Ebola clinic in Guinea run by Médecins Sans Frontières. The trial
results could prompt the Guinean government to request supplies of favipiravir for administration
to Ebola patients, and Japan’s government and pharmaceutical industry must be prepared torespond appropriately.

2-3. Favipiravir: Platforms for Infection Experiments
Japanese work in establishing favipiravir’s efficacy against EVD has been hindered due to thedifficulty of securing data in Japan on EVD in primates. Japanese researchers have addressed the
problem by obtaining data from experiments conducted in the United States, but the lack of direct
engagement in such experiments has slowed progress of such research. To contribute more fully tothe fight against EVD and other diseases of international public concern, Japan should establish
domestic platforms for infection experiments. Such platforms must meet the highest, BSL-4
standards for biosafety levels, as defined by the U.S. Centers for Disease Control and Prevention.
Establishing platforms in Japan for infection experiments will need to include measures forreassuring the public about safety. Such measures will be most persuasive if led by objective third
parties, rather than by the pharmaceutical industry.

2-4. Favipiravir: New Indications
Researchers have reported findings that favipiravir is effective against multiple RNA viruses. The
agent has demonstrated in vitro efficacy in treating hemorrhaging caused by RNA viruses and intreating severe fever with thrombocytopenia syndrome (SFTS) contracted from ticks. Translating
those results into new indications for favipiravir will require a multi-sector approach involving thepharmaceutical industry, academia, and government—both within Asia and worldwide.

2-5. Favipiravir: Distribution and Stockpiling
Fulfilling the potential of favipiravir in the fight against EVD will depend in part on joint work bycompanies, government agencies, international agencies, universities, and nonprofit organizations.
That joint work needs to marshal data for nurturing an international consensus in regard to
favipiravir’s efficacy, safety, cost performance, and other benefits. Based on that consensus, theparties concerned need to work with World Health Organization (WHO) and other nations toestablish common recognition to develop viable approaches for stockpiling and distributing
favipiravir .

2-6. Public Health and Sanitation Systems

Japan needs to provide support focused directly on ending the Ebola outbreak in West African
nations and on preventing future outbreaks with support for upgrading public health and sanitation
systems in those and other developing nations. That support for systemic improvements should
include sharing expertise in combatting communicable disease, advanced medical technology, andexperience in providing universal health coverage. It should also include support for humandevelopment for developing countries.

2-7. Elevated Commitment to International Initiatives
As the Ebola outbreak abates, Japan must redouble its commitment to international initiatives
aimed at preventing epidemics of other diseases. These efforts should include cooperation withinternational agencies and with other nations to mobilize necessary resources.

3. Other Issues
The successful prevention of infection hinges greatly on a solid, widespread understanding of theissue, fostering good habits in regard to washing hands and sterilizing equipment and fixtures,
securing reliable access to clean water, and maintaining a pristine environment. A promising step
forward in that regard: All Asian nations now subscribe to the World Health Organization (WHO)guideline for preventing infections in hospitals and clinics by promoting rigorous hand washing.
The final two Asian nations to adopt the guideline, Laos and Myanmar, announced their adoption
at the Okinawa conference.
Additionally, fulfilling the conditions for preventing infection depends on proactive
cooperation among and between government agencies, schools and universities, and the private
sector. Japan can help to promote that cooperation by sharing its experiences withgovernment-academic-industrial interaction.

IV. Establishing A Consortium for Action Plan Implementation
Participants at the Okinawa conference reaffirmed their commitment to the fight against
communicable disease. They also emphasized the importance of cooperation between government,
industry, and academia, as well as the critical value of a long-term perspective on the developmentof medical technologies, including drugs and vaccines, and in fostering human resources in the
medical sector. Participants therefore unanimously agreed to establish a consortium to implement
the action plan that accompanies this Statement in cooperation with the Japan Agency for Medical
Research and Development (AMED). In addition, they have agreed that the 2016 conference
should be an occasion for reviewing the first-year performance of the consortium.

Conclusion

Through fruitful discussions, conference participants agreed that healthcare innovation developedin Japan should be introduced to the international society. Furthermore, they concluded that joint
efforts with other Asian countries and our global society are necessary for the fulfillment of theconsortium’s above-stated actions in fighting against communicable disease.