Stop TB Japan Action Plan
July 1st, 2014
Ministry of Foreign Affairs
Ministry of Health, Labour and Welfare
Japan International Cooperation Agency
Japan Anti-Tuberculosis Association
Stop TB Partnership JapanThe Stop TB Japan Action Plan was formulated in response to “The Global Plan to Stop
TB 2006 – 2015” of WHO. WHO recently adopted a new global plan, “Global Strategy and Targets
for Tuberculosis Prevention, Care and Control after 2015”. We revised the plan with the aim ofachieving a state of low tuberculosis (TB) prevalence as early as possible, as well as contributing to
the goal of ending the global TB epidemic. Although the timeline of the revised Action Plan goes tothe end of 2020, reconsideration will be made as necessary, in accordance with the revisions of
WHO strategy.

I. BACKGROUND OF FORMULATION OF THE STOP TB JAPAN ACTION PLAN
1. TB is a chronic infectious disease such that once infected with its bacilli, the person carries alife-long risk of disease development. The spread of the disease respects no borders, and untiring
efforts under international cooperation and partnerships are indispensable for its elimination. Thus,
the Ministry of Foreign Affairs (MOFA), Ministry of Health, Labour Labor and Welfare (MHLW),
Japan International Cooperation Agency (JICA), Japan Anti-Tuberculosis Association (JATA), andStop TB Partnership Japan (STBJ) jointly announced the "Stop TB Japan Action Plan" on July 24,
2008, with the determination that the Japanese public and private sectors would actively engage ininternational efforts for TB control, calling for strengthening of international cooperation andpartnership.

2. The Action Plan was developed in 2008 with the objective of reducing TB deaths by 10%
worldwide, especially in Asia and Africa, through cooperation among Japan's public and private
sectors. It was based on the concept of “human security” that seeks to protect individuals exposedto a threat and to empowering individuals to make their own decisions and take action against thethreat. The Plan referred to the need for strengthening TB control in each country through bilateral
cooperation by JICA, for strengthening financial support to international organizations (e.g., theGlobal Fund to fight AIDS, Tuberculosis and Malaria (GFATM)), and involving Japanese NGOs inthese activities. Moreover, it clearly stated the importance of enhancing infrastructures forcultivating human resources for the national control program and for encouraging research
activities in those countries.

3. Since the start of the Plan, biannual meetings have been held to monitor implementation of the
Action Plan by each party, with discussions and information-sharing regarding such matters as
national budgets and TB control program activities. The meetings have contributed to ensuring
TB-related funding, including contributions to international organizations, and to implementing
bilateral cooperation projects by JICA and NGOs. These discussions also help deepen the parties’
understanding of the GFATM mechanism and involvement in it. Since the establishment of the
Action Plan, great progress in research and development of new anti-TB drugs, diagnostics, andvaccines has been made. (For details of the background and progress, see Attachment 1.)

II. TB SITUATION IN THE WORLD AND IN JAPAN
1. Global TB Situation
The global target to halt and begin to reverse the incidence of TB by 2015 has been
attained. Also, the target to reduce the mortality rate by 50% by 2015 compared with a baseline of1990 is expected to be accomplished. However, achieving the target of halving the prevalence rateof TB is more difficult.
WHO estimates that 8.6 million people developed TB and 1.3 million people died fromthe disease in 2012. In addition, an estimated 450,000 people developed multidrug-resistant(MDR)-TB, and 170,000 people died from MDR-TB.
Furthermore, one third of newly occurring TB cases remain undiagnosed, and it is anurgent problem that 3 million TB patients are not properly diagnosed or treated every year. In
addition to existing problems such as TB co-infected with HIV, new challenges include TB control
in children, reactivation and relapse of TB due to the aging population, and complications withdiabetes and cancer.

2. TB Situation in Japan
As of 2012, more 21,000 new TB patients are registered each year, making it a major infectious
disease domestically. The TB incidence rate in Japan (16.7 per 100,000 population in 2012) is four
to five times higher than that of western European countries, and Japan is still categorized as acountry with an intermediate burden of TB.
The majority of incident cases involve those with high risk, such as the elderly (morethan half of newly registered patients are 70 years or older), socioeconomically vulnerable people,
and those with medical risk due to an underlying disease. In general, the incidence rate in westernJapan is higher than in eastern Japan; however, the fact that major large cities have a higher
incidence than surrounding areas reflects the socioeconomic risk of TB in urban areas. Although the
influence of immigrants from high TB burden countries is smaller than that of western European
countries, it is increasing remarkably among young people and in some specific areas.
While both TB epidemiology and the circumstances for TB control are changing, it is ofmajor concern that citizens are generally losing interest in TB and that the provision of medical
services may be degraded due to doctors’ lack of experience with TB. (For details of the TB
situation throughout the world and in Japan, see Attachment 2.)

III. SUMMARY OF WHO'S NEW GLOBAL STRATEGYThe new global strategy declared by WHO in May 2014 is summarized as follows.
1. Vision and Goal: With the vision of the world free of TB, the following targets are set to end theglobal TB epidemic.
Milestone for 2025: 75% reduction in TB death (compared with 2015)
50% reduction in incidence rate (compared with 2015; below 55 TB cases per
100,000 population)
Target for 2035: 95% reduction in TB deaths (compared with 2015)
90% reduction in TB incidence rate (compared to 2015, i.e., below 10 TB cases
per 100,000 population)
2. Three pillars and components of bold, innovative New Strategy

WHO proposes to implement the works in the strategy under following three pillars.
① Integrated, patient-centered care and prevention-

Early diagnosis of TB including universal drug-susceptibility testing, and systematic
screening of contacts and high-risk groups-

Treatment of all people with TB including drug-resistant TB, and patient support-

Collaborative TB/HIV activities, and management of co-morbidities-

Preventive treatment of persons at high risk, and vaccinations against TB② Bold policies and supportive systems-

Political commitment with adequate resources for TB care and prevention-

Engagement of communities, civil society organizations, and public and private careproviders-

Universal health coverage policy, and regulatory frameworks for case notification,
vital registration, quality and rational use of medicines, and infection control-

Social protection, poverty alleviation and actions on other determinants of TB③ Intensified research and innovation-

Discovery, development and rapid uptake of new tools, interventions and strategies-

Research to optimize implementation and impact, and promote innovations

IV. CONTRIBUTIONS OF JAPAN TO ATTAINING GLOBAL TARGETS
In an effort to achieve WHO’s goal of ending the global TB epidemic, both the public and theprivate sectors of Japan contribute to the world by mobilizing their wisdom and technology, in
accordance with the concept of human security.
1. GoalWith a target of 10% reduction in TB deaths, public and private sectors work together to reduce the
TB mortality rate worldwide, especially in Asia and Africa.

2. Support for High Burden Countries through GFATM, WHO, and Bilateral Cooperation
The Government continues to contribute as a major donor to GFATM, in whose establishment
Japan played an important role.
The Government shall maintain commitment to TB control in high-burden countries
through WHO and JICA, and further expand and strengthen it. JICA shall continue its
cooperation in TB high-burden countries and international training programs in Japan as well as inthird countries with the goal of TB control in high-burden countries, in accordance with theGovernment’s policies such as Country Assistance Policies.
To implement the Government’s bilateral cooperation, JATA shall collaborate with JICA
in JICA’s TB-related cooperation, including projects in trust, dispatch of experts, and training
courses. The Government, JICA, and JATA shall promote and strengthen operational researchnecessary for more effective implementation of TB control, as well as research and development
such as the ongoing joint research program of Thailand and Japan.
Furthermore, JATA shall reinforce its current TB experts’ network with over 2200 alumni,
mostly from developing countries, who have attended international TB training courses in Japan.
STBJ shall play a leading role in the global Stop TB Partnership movement, in liaison with the StopTB Partnership based in Geneva and individual countries’ Partnerships.

3. Helping the World Attain Universal Health Coverage through TB Control
In order to realize universal health coverage (UHC), it is necessary to enhance accessibility to suchbasic health services as mother-and-child health, lifestyle-related disease control, and TB services.
Also, UHC and TB control should be complementary, as improvement in geographic and economic
access to medical services in UHC will also benefit TB control.
The Government, JICA, and JATA shall consider the possibility of providing international
cooperation and technical support toward the promotion of UHC, adapting to each country’s actual
situation, so that the TB control program and promotion of UHC generate synergistic effects.
Especially in Asian countries, it is highly possible that approaches based on Japan's experience may
be applied in such areas as developing patient support for medical fee payments and living (i.e.,
public insurance system and public support for fees), installment and maintenance of hardware
infrastructures, and establishment of laboratory network and medical information systems.

4. Forging Breakthroughs in Innovative Technology
In order to attain WHO's global target for 2035, innovative technological breakthroughs in various
fields (e.g., prevention, diagnosis, and treatment of TB) are needed. Japan has been leading theworld in studies on immunology, genetic engineering, biotechnology, drug-development technology,
and TB research. With its high-capacity TB research and its scientific and technological potential,
Japan will be able to contribute to a new series of breakthroughs in the field of TB.

In order to bring together the powers of Japan's science and technology, MHLW shallscale up comprehensive research and development for TB control, including new TB vaccines, newanti-TB drugs against MDR-TB, and new diagnostics, in line with discussions of the Panels of
Research and Development, Production, and Distribution of Section of Vaccination, Council for
Health and Welfare Science, and in Joint Meeting on Emerging and Re-emerging Infectious
Disease Control Promotion Project." Also, when TB studies are adopted in the Plan of Medical
Research Promotion stipulated by the Headquarters of Promotion of Health and Medical Care
Strategy, MHLW shall ensure necessary funding through the Japan Medical Research Development
Organization (planned to be established on April 1, 2015). Moreover, considering collaboration
with the Innovation Network Corporation of Japan (INCJ) and the Global Health Innovative
Technology (GHIT) Fund, it shall support further TB research and development.
Any promising innovative technology from the following specific areas of research anddevelopment should be supported with priority for its earliest practical application.
- New TB vaccine- Innovative medicine for short-term, effective treatment of MDR-TB- Simple, rapid, and accurate diagnostics of TB for point of care use- Research for diagnosis and treatment of latent TB infection (LTBI)- Establishment of biomarkers for innovative diagnostics and clinical trials

STBJ shall ensure that these technologies can be put practical use as quickly as possible.

5. Globalization of Japan's Technology and LeadershipJapan will lead in and contribute to attaining the goal of the global TB strategy by joint public andprivate efforts for global expansion of new anti-TB drugs, new TB vaccines, and new diagnostic
technologies developed in Japan, as well as digital X-ray technology. In such efforts, theGovernment actively supports the global expansion of new technologies of Japanese origin. For thispurpose, INCJ is expected to accelerate and expand its use in practice, as its mission is to discover
Japan's superb technologies and ideas and to introduce them to the world.
For TB, WHO requires an innovative system, due to limitations of the conventional
method based on sputum smear microscopy for symptomatic patients. In order to meet this need,public and private sectors should work together to introduce and expand the chest X-ray screeningsystem that has been widely applied in Japan and has proven so useful, as well as simple TB
diagnostics such as the LAMP method developed in Japan. For X-ray examinations, expansion andquality control of computerized radiography are important, due to its advantages of high-quality
images with low radiation dose exposure, low operating cost, and elimination of waste fluid
disposal causing environmental pollution. Furthermore, use of Japan's experience in quality control
of TB diagnosis and treatment by the TB Expert Committee of public health centers would be
utilized.
In order for innovations and technologies developed in Japan to be introduced and usedwidely in developing countries, it is necessary to build a system appropriate to each country. To
build an appropriate system, for example, operational research on their technical transfer orpractical use may be included in the international training courses conducted by JICA and JATA.

6. Forging GHIT and Other Creative and International Public-Private Partnerships
The GHIT Fund is a creative framework to maximize the use of knowledge on drug development
accumulated in Japan, through international public-private partnerships so that people indeveloping countries can overcome hardships caused by infectious diseases such as TB. MOFA,MHLW, JATA, and STBJ shall cooperate with GHIT with the necessary support so that it canachieve success as early as possible.

7. Roles of TB-related NGOs
NGOs (e.g., JATA, STBJ, AMDA, SHARE, and RESULTS JAPAN), in cooperation with
the Government, shall actively extend advocacy activities on the importance of worldwide TB
control towards achieving the global target. Also, they should endeavor to eliminate TB byengaging in actions against TB. The Government should cooperate closely with NGOs and support
their activities.

V. OVERCOMING TB IN JAPAN WHILE CONTRIBUTING TO WORLD CONTROL
Working to become a low-burden country by 2020
While pursuing the global target and contributing to worldwide TB control, Japan aims to become alow TB burden country (i.e., a country with an incidence rate of less than 10 per 100,000
population) by the 2020 Tokyo Olympics.

For this purpose, MHLW will implement thorough measures against TB by ensuring thenecessary budget and personnel and by revising "Prevention Guidelines of Control of TB as a
Designated Infectious Disease”, and Japan’s determination to achieve low prevalence by 2020should be publicly announced.
The JATA/Research Institute of Tuberculosis (RIT), Anti-Tuberculosis Women's Society,and other organizations related to TB control should make maximum efforts towards the target of
realizing a low TB burden state. Playing a leading role in these actions, RIT should provide
technical guidance and support for the Government, local governments, and public health centers
so that their fight against TB will be most effective.
STBJ should support the activities of TB-related organizations through enhancing publicawareness of TB and advocacy.
Priority should be given to the following issues in Japan.
1. Strengthen TB prevention for the elderly, high-risk groups, and danger groups*
2. Intensify treatment of LTBI.
3. Restructure medical care provision systems appropriate to local needs.
4. Promote research on new tools for TB control.
5. Cultivate human resources and address technical support.
6. Reinforce TB control in mega cities.
*People in specific occupations who are likely to spread infections once they develop the disease.

VI. IMPLEMENTING THE ACTION PLAN
1. Follow-up Meeting
For each party to monitor the progress of implementing the Action Plan, MOFA, MHLW, JICA,
JATA, and STBJ shall exchange views as necessary.

2. Cooperation with New Parties
Each of these five parties shall collaborate with other groups or organizations (e.g., Japan Medical
Development Organization, INCJ, GHIT Fund, Product Development Partnerships* (PDPs) such as
Aeras, business corporations, and STB Kansai) in support of the Action Plan, according to party
and partner standpoints.
*Public-private partnerships for developing medicines in developing countries

3. Promoting the Action Plan
STBJ monitors the progress of the Action Plan. The five parties cooperatively work toward fully
implementing the Plan, including funding issues.

Attachment 1

Stop TB Japan Action Plan and TB Control

1. History of formulating the Stop TB Japan Action Plan
In 2006, the WHO and Stop TB partnership in Geneva set a global target of reducing mortality andprevalence rates of TB by 50% by 2015, compared with the 1990 level in its Global Plan to Stop
TB 2006-2015, which was later revised as 2011-2015.
In March 2007, Mr. Winston Zulu, a patient from Zambia with the dual burden of AIDS
and TB, made a courtesy visit to Mr. Shinzo Abe, then Prime Minister of Japan (Abe’s first cabinet)
to discuss the current TB epidemic in Africa, the increasing need for TB control, and his
expectation of support from the Japanese Government. In addition, in November 2007, STBJ wasestablished, and in December the nonpartisan group “Stop TB Promotion Parliamentarian Union”
was founded to support STBJ.
In the fourth Tokyo International Conference on African Development (TICAD-IV) of
May 2008 and in the G8 summit in Toyako and Hokkaido of July 2008, it was stated thatstrengthening TB control and supporting WHO's global TB strategy were urgently needed in order
to attain the MDGs for health in the Yokohama Action Plan and in the Toyako Framework for
Action on Global Health - Conference Report of the health-advisory group.
On July 24, 2008, MOFA, MHLW, the Western Pacific Regional Office of WHO, JATA,
and STBJ cosponsored the international TB symposium "Toward TB Elimination in the World From Asia to Africa," where the "Stop TB Japan Action Plan" was announced by MOFA, MHLW,
JICA, JATA, and STBJ.

2. Progress of TB Control since the Announcement of the Stop TB Japan Action Plan
- Securing funding of TB Control (e.g., GFATM and TB control in Japan)
The Japanese government, as a major donor country of the GFATM, had contributed
USD $2,155,880,000 to GFATM by March 2014. MHLW has secured the budget for TB control,
including voluntary contributions to WHO, as well as for domestic TB control.

- Implementing bilateral cooperation
The Japanese government extended support to TB control in high TB burden countries,mainly in Asia and Africa (e.g., Indonesia, Cambodia, Myanmar, Bangladesh, Afghanistan, Kenya,
and Zambia) in the framework of bilateral technical cooperation and Grant Aid. Specifically, inIndonesia and Kenya, Japan has contributed to improving the quality of smear and culture
examinations for TB by introducing and intensifying the external quality assurance system for the
TB diagnostic centers, which is essential for TB diagnosis. In Zambia, Japan strengthened activities
against TB/HIV co-infection and developed a simple and rapid TB diagnostic tool that could be
used at low cost. In Myanmar, the assistance included the provision of anti-TB drugs, strengthening
TB control in urban areas and technical assistance in conducting a national TB prevalence survey.
In Cambodia, technical cooperation has been extended in three phases, lasting 13 years (1999 to2013); this assistance, along with Grant Aid, has resulted in reducing TB prevalence by half, forwhich WHO highly recognized the contribution of the Japanese Government.
In Afghanistan, assistance is being provided for constructing a hospital for patients with
TB and other infectious diseases, and for technical cooperation for the national TB control program.
In areas of the Philippines that were seriously hit by Typhoon Yolanda in November 2013, a survey
was conducted to determine its influence on the TB diagnosis capacity of health centers, andmicroscopes were provided based on the survey results.
In addition to international training courses in Japan, the third country training programs
were conducted in Egypt and Brazil to develop human resources for TB control. In Kenya, plansincluded sending a TB expert in July 2014 to improve the quality of recording and reportinglaboratory work and to intensify external quality assurance of these services under the ongoingadministrative devolution.

-NGOs’ Project Operation in Communities of Developing Countries
After the serious earthquake in Haiti, STBJ investigated its influence on TB control using
the grant scheme for NGOs by MOFA. In 2011 and 2012, based on the results of the investigation,
JAPAN RESULTS implemented a project for strengthening TB laboratories in collaboration with
the Haitian government, JATA, and STBJ and funded by the Japan platform's fund. In 2013, as a
joint project under the "public-private partnership for accelerated economic growth" under MOFA,“Data Collection Survey for Public Private Partnership Program on the evaluation of LAMP
method for diagnosis of tuberculosis” was conducted with the cooperation of JICA and Eiken
Chemical Co., Ltd., in collaboration with Japan RESULTS and RIT/JATA.

In Zambia, JATA contributed to improving the TB diagnostic capacity at health centersand strengthening TB controls in the community using community volunteers as treatment
supporters, through "Grant Assistance for Japanese NGO Projects" (2008 to 2012) and "JICA
Grassroots Grant Aid Project" (2012 to 2015). In the Philippines, JATA also extended technicalcooperation to improve TB control in urban pocket areas in Manila through "Grant Assistance forJapanese NGO Projects" (2008 to 2012) and "JICA Grassroots Grant Aid Project" (2012 to 2015).
Its contribution was highly recognized by the Embassy of Japan in the Philippines.
Furthermore, STBJ raised public awareness of TB using Indonesian shadow
puppets ”Wayang Kulit” funded by MOFA’s grant for the NGO project in Indonesia.

-Enhancing Commitment to GFATM Programs
In Afghanistan, the JICA office was appointed as the Principal Recipient. Sub-recipientswere the Japan-Nepal Health and Tuberculosis Research Association (JANTRA) in Nepal, which
was established with the support of JATA, and the Cambodia Anti-Tuberculosis Association, which
was established with the support of JATA and the Women's Society for TB Prevention. These
organizations contribute much to TB control by implementing GFATM programs in their countries.

-Progress in Developing New Anti-TB Drugs, Diagnostics, and Vaccines
Much progress has been made in research and development of anti-TB drugs, diagnostics,
and vaccines. Delamanid, a new anti-TB drug developed after 40 years, was developed by Otsuka
Pharmaceutical and was approved as a drug for MDR-TB by the Pharmaceutical Committee ofEuropean Commission in November 2013. In Japan, an application for manufacturing andmarketing the drug was submitted in March 2013, and approval is expected in the near future.
RIT/JATA has been involved in its pre-clinical drug evaluation study.
Eiken Chemical Co., Ltd., in collaboration with the Foundation for Innovative New
Diagnostics (FIND) in Geneva, developed the LAMP-TB method for simple, rapid TB diagnostics,
which is now being evaluated in 14 developing countries in order to receive endorsement from
WHO. As part of this project, LAMP-TB was evaluated in the Haiti project under MOFA’s
public-private partnership for accelerated economic growth.
The National Institute of Biomedical Innovation, Create Vaccine Co., Ltd. (establishedjointly by Sumitomo Dainippon Pharma and Japan BCG Manufacturing Co. Ltd., and funded by

INCJ), and Aeras (an international NPO based in Washington DC, promoting research anddevelopment of new TB vaccines in cooperation with research institutions or corporations invarious countries) agreed to work together to develop the first new TB vaccine in 90 years. Thisvaccine development is partially subsidized by the research fund of MHLW and by the GHIT Fund.
STBJ has coordinated the facilitation of these three projects.
RIT/JATA is conducting chemical-substance screening for developing anti-TB drugs
under concession from the Global Alliance for TB Drug Development (a New York based NGOthat promotes anti-TB drug development in a coalition of public and private institutions, academia,
and charities) and is funded by the GHIT Fund.

-New Framework Based on Public-Private Partnership
The GHIT Fund, a fund for the specific purpose of research and development ofpharmaceutical drugs for developing countries, was established by contributions from MOFA,MHLW, UNDP, the Bill and Melinda Gates Foundation, and Japan's five major pharmaceuticalcompanies. This fund aims to develop innovative medicines of Japanese origin through promoting
research and development collaboration between Japan and overseas countries. It targets AIDS, TB,
malaria, and other neglected tropical diseases. Great progress toward this target is highly expected
so that new drugs against such diseases will become readily available for poor people in developing
countries.

[Attachment 2]

Global TB Situation, 2012ChildrenHIV-positive
GlobalMDR-TB
TB(Age<15)

Incidence

8,600,000

1,100,000

450,000

530,000

Mortality

1,300,000

320,000

170,000

74,000

Number of HIV-positive TB, MDR-TB and Children are included in Global total.

TB incidence and patient detections by WHO region, 2012
Western

South-East

Eastern
AfricaThe
EuropeMediterranean

GlobalPacific

Asia

Mortality1)

115,000

501,000

480,000

104,000

40,00025,0001,260,000

Incidence

1,600,000

3,400,000

2,300,000

670,000

360,000

280,000

8,600,000

Total new cases

1,345,000

2,331,000

1,413,000

431,000

337,000

233,000

6,090,000

Undetected2)

16%

30%

39%

36%

6%

17%

29%

1)

Mortality：Includes deaths among HIV-positive TB cases

2)

Undetected： 1 – no. notified cases / estimated no. new cases

Reference：“WHO Global Tuberculosis Report 2013”

AmericasProjected acceleration in the decline of global tuberculosis incidence rates to target levels

Reference：“WHO Global strategy and targets for tuberculosis prevention, care and control after 2015”

TB Situation in Japan, 2012

No. of newly
21,283
registered patients
Incidence rate
16.7
(per 100,000 population)

No. of TB deaths

2,110● No. of newly registered TB patients by age group （（）: Proportion in %）Age > 39

40-49

50-59

60- 6970- 7980+

No. of newly

3,044

1,600

1,795

3,012

4,595

7,237

registered patients（14.3%）(7.5%)(8.4%)(14.2%)(21.6%)(34.0%)

5.6

9.1

11.5

16.3

33.7

81.0

Incidence rate
(per 100,000 population)● High-incidence areas
SpecialNagoyaOsaka City

Sakai City

Wards of
Kobe City

City

Tokyo
Metropolis

Incidence rate
42.7

27.9

25.4

24.4

24.3

(per 100,000 population)●No. of newly registered patients with risk factor （（）: Proportion in % per total cases）

Diabetes mellitus

3,036（14.3%）

Healthcare worker1)636（2.9%）

Unemployed / Day laborer2)

1,637（26.4%）

1)

Healthcare worker: Includes; clinical nurses, public health nurses, doctors, physical/occupational therapists,
laboratory technicians, radiology technologists.

2)

Unemployed/Day laborer: Excludes; entertainment workers, healthcare workers, other regular employees,
self-employed workers, home workers, and students. Number refers only to those aged 20-59 years..

Reference: Health Service Bureau, MHLW: Abstract of Annual Reports of Surveillance of Tuberculosis 2012