保健医療科学

2021

Vol.70 No.1 p.2－12

Topics: Recent topics in public health in Japan 2021

＜ Review ＞
Health research policy and systems in Japan: A review focusedon the Health, Labour and Welfare Sciences Research Grants
TAKEMURA Shinji 1-3)
1)Department of Health Policy and Technology Assessment, National Institute of Public Health
Program Officer, Research Program on Health Security Control and Research Program on
Rare and Intractable Diseases, Health, Labour and Welfare Sciences Research Grants
3)
Health Sciences Division, Ministerʼs Secretariat, Ministry of Health, Labour and Welfare
2)

Abstract
In this article, the history of the development and the current status and issues of the Health, Labourand Welfare Sciences Research Grants (HLWSRG) under the jurisdiction of the Ministry of Health, Labourand Welfare (MHLW), which supports health research policies and systems in Japan, are reviewed, and its
future direction is also discussed.
The HLWSRG was initiated in 1951. The objectives of the HLWSRG are to ensure the science-based
promotion of policies and to improve the technological level related to health and medical care, welfare,environmental sanitation, and occupational safety and health in Japan. The HLWSRG especially promotes“mission-oriented research” that can solve various problems by utilizing evidence obtained from research
for the policies of the MHLW and by monitoring and evaluating the results of the policies through research.
Since the enactment of the Healthcare Policy in 2014 and the foundation of the Japan Agency for Medical
Research and Development (AMED) in 2015, previous researches implemented by the HLWSRG werecategorized into “policy research” and “practical research.” Policy research under the jurisdiction of the
HLWSRG is aimed to conduct studies to establish scientific evidence for policymaking, studies on the promotion and assessment of policies, and the technological development of products other than drugs andmedical devices, whereas practical research under the jurisdiction of AMED is aimed to elucidate pathogenesis and pathophysiology and to develop innovative diagnostic and treatment methods.
The HLWSRG consists of 27 research programs including medical ICT and artificial intelligence, global
health, children, youth and families, cancer, cardiovascular diseases and diabetes mellitus, rare and intractable diseases, dementia, infectious diseases, occupational safety and health, food safety, regulatory science,
health security control, etc. In FY2019, the budget of the HLWSRG was 8.90 billion yen, and the number of
research projects was 644.
Each program is managed by the division of the MHLW that is in charge of the relevant policy. This enables the promotion of mission-oriented research, in which each division conducts its own research program
to solve the problems identified in policy planning and implementation and utilizes the evidence obtained
from the program for policymaking. On the other hands, the Health Sciences Council, which is an advisory
body for the promotion of health research, and the Health Sciences Division of the MHLW, which carries
out the comprehensive planning and coordination of health research, are established to improve the systemof promoting the HLWSRG as a whole. They built a mechanism to promote mission-oriented research by

Corresponding author: TAKEMURA Shinji
2-3-6 Minami, Wako, Saitama 351-0197, Japan.
Tel: 048-458-6166
Fax: 048-469-3875
E-mail: takemura.s.aa@niph.go.jp

2

J. Natl. Inst. Public Health, 70 (1) : 2021

Health research policy and systems in Japan: A review focused on the Health, Labour and Welfare Sciences Research Grants
formulating common criteria for assessment of the research proposal and for the interim and ex-post evaluation of the research project, and by setting a unified format for the Funding Opportunity Announcement inwhich objectives, expected results, and requirements for the research project were specified. This enables
determination of whether or not the proposal is worth being adopted, the project is worth being continued,
and the project was successful.
The National Institute of Public Health (NIPH) has contributed to the development of the HLWSRG.
First, the NIPH operates the MHLW Grants System, which registers the products of all the research projects of HLWSRG , and allows them to be viewed and searched on the web. Second, the NIPH has a roleas the funding agency for the Research Program on Health Security Control and the Research Program on
Rare and Intractable Diseases, replacing the MHLW.
The HLWSRG has funded many mission-oriented research projects and has produced many research results. In the next step, however, it is necessary to evaluate the extent to which applying them has improved
the level of national health and welfare. In other words, it is necessary to evaluate the outcomes that can beachieved by utilizing the research results as outputs.
keywords: health research, research utilization, funding agency, evidence-based health policy, implementation science(accepted for publication, November 25, 2020)

I. Introduction
In Japan, there are several funding systems for healthresearch including the Health, Labour and Welfare Sciences Research Grants (hereinafter, “HLWSRG”) under thejurisdiction of the Ministry of Health, Labour and Welfare(hereinafter, “MHLW”). The HLWSRG was established in
1951 and has developed to date with an expanded budget
and scope of research. Many research projects have been
carried out to date, producing abundant research results andcontributing to the improvement of the health and medical
system of Japan and the quality of life of the Japanese people.
Most countries have their funding systems or funding
agencies (FAs) for health research, e.g., the National Institutes of Health (NIH) in the United States and the Medical
Research Council (MRC) in the United Kingdom. In Japan,
the Grants-in-Aid for Scientific Research (KAKEN), which
is a competitive research funding system covering all aspects of scientific research under the jurisdiction of the
Ministry of Education, Culture, Sports, Science and Technology, also provides grants for health research. Although
KAKEN mainly promotes research based on the researchers’ interests, the HLWSRG promotes “mission-oriented
research” that contributes to the establishment of evidence
and advances in science and technology necessary to tackle
various policy issues concerning the nation’s health andmedical care, welfare, environmental sanitation, and occupational safety and health [1,2]. Accordingly, the HLWSRG
has focused on the direct utilization of research results inclinical practice and policymaking. Such a competitive research funding system is unique, and the lessons learned

from the operation of the HLWSRG may also be useful forother countries and other systems.
In this article, the history of the development and thecurrent status and issues of the HLWSRG, which supports
health research policies and systems in Japan, are reviewed,
and its future direction is also discussed.

II. History of the Health, Labour and Welfare
Sciences Research Grants
A Japanese research grant system, including health research, was initiated in 1918 by the then Ministry of Education, Science and Culture [3], and it still continues as KAKEN. The Health Sciences Research Grants, the predecessorof HLWSRG, was initiated in 1951 with funding transferredfrom the then Ministry of Education to the then Ministry of
Health and Welfare [4]. In 2001, the Ministry of Health andWelfare and the Ministry of Labour were merged to form
the MHLW, and the Health Sciences Research Grants was
renamed the Health, Labour and Welfare Sciences Research
Grants (HLWSRG) in 2002.
Since it was launched, the HLWSRG has provided support to research projects aimed at solving health problems
that have a significant impact on the Japanese people. These
projects include research on Minamata disease in 1956 [5],research on thalidomide-related abnormalities in 1963 [4,5],
research on itai-itai disease in Toyama Prefecture in 1963
[4,6], research on Niigata mercury poisoning in 1965 [4,6],
research on subacute myelo-optico-neuropathy (SMON) in
1969 [5], and epidemiological research on PCB contamination in breast milk in 1972 [4]. These projects determinedthe causes of these diseases and provided research re-

J. Natl. Inst. Public Health, 70 (1) : 2021

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TAKEMURA Shinji
sults that contributed to the treatment of patients. These
research projects excellently characterize the HLWSRG,
aimed to carry out its “mission” of solving health problems.
Although the aforementioned research projects wereconducted by principal investigators and research teams
designated by the MHLW, the HLWSRG accepts proposals
from researchers by public offering and allocates research
grants to selected proposals in principle. Research on
non-communicable diseases has been conducted since 1952[5]. Projects subsequently launched were cancer researchin 1963 [5,6], research into the development of new medical
technologies in 1964 [5,6], and research on intractable andrare diseases in 1972 [5-7], all with the aim of elucidating
the causes of diseases and establishing methods to diagnose, treat and prevent them.
The HLWSRG has not only been involved in elucidating
the causes of diseases and developing medical technologies
as described above, but also in studies aimed at solvingsocial issues related to health and medical care. The HLWSRG has specifically made various recommendations byconducting research on issues of high public concern, suchas a study on the criteria for determining brain death thatstarted in 1983 [4,5], research on end-of-life care in 1984 [4],etc.
The MHLW set up the post of the Science and Technology Councilor in the Minister’s Secretariat in 1958 [5], asa department responsible for the overall planning and coordination of science and technology policies including the
HLWSRG, followed by the Health Sciences Division [8] in1988.
As described above, the HLWSRG has produced abundantresults needed to solve various health problems. However,research programs consisting of multiple research projects
were operated separately according to the disease typesuch as cancer or intractable and rare diseases; therefore,a fundamental strategy for the promotion of health-relatedscience and technology had not been established. For thisreason, the Health Sciences Conference, consisting of the
Minister of Health and Welfare and experts, was establishedin November 1986. Thereafter, in 1997, the Health Sciences Council was established as a development of the Health
Sciences Conference to review important matters related
to science and technology in the administration by the Ministry of Health and Welfare. The Research Planning Subcommittee (presently the Science and Technology Subcommittee) was established as a subordinate body of the Health
Sciences Council to discuss matters related to the planningand assessment of health sciences research [9]. In 1999,
the Health Sciences Council presented the following basic
concepts for the promotion of health sciences research:(1) promotion of health sciences research (implementation

4of a wide range of research from basic to clinical research,and promotion of translational research); (2) promotion ofevidence-based medicine; (3) promotion of data sharing inconsideration of personal information; and (4) improvementof the health research system from social and ethical viewpoints [9].
In 2005, the Science and Technology Subcommittee ofthe Health Sciences Council presented policies to further
clarify the role of health research as mission-oriented
research: to prioritize research that is useful to protect
people’s health and to promote research with specific andevaluable objectives to be achieved [10]. It was also decided
to transfer the administration of research grant allocation,
which had been carried out by MHLW, to external FAs.
Accordingly, starting in FY2006, some of the HLWSRG research programs had to be entrusted to research institutes
affiliated with the MHLW, including the National Institute of
Public Health (hereinafter, “NIPH”) and the National Institute of Health Sciences.
In 2010, the MHLW formulated guidelines for the assessment of scientific research and development [11], anddeveloped appropriate and effective systems to assess research programs, research projects, research institutes, andresearchers related to the MHLW.
Although the HLWSRG had been supporting various
research contributing to the improvement of the nation’s
health and welfare, the development of drugs and medical
devices had become the most important issue. A five-year
strategy for the creation of innovative drugs and medical
devices [12] was therefore formulated by the MHLW, theMinistry of Education, Culture, Sports, Science and Technology, and the Ministry of Economy, Trade and Industry in
2007, followed by a five-year strategy for medical innovation[13] by the Cabinet Secretariat in 2012. In accordance withthese strategies, the intensive infusion of research funds,
the cultivation of venture companies, the improvement of
the necessary system for conducting clinical research andclinical trials, and the promotion of cooperation between thegovernment and the private sector was accomplished. In
addition, to further develop these strategies, the Healthcare
Policy [14] was formulated by the Cabinet in 2014.
The basic principles of the Healthcare Policy are as follows [14]:(1) To provide people with medical care using the world’s
best technologies, by promoting integrated medical
R&D activities, from basic R&D to R&D focused onpractical uses, and by facilitating the practical application of the results of these activities.
(2) To contribute to Japan’s economic growth while
helping to improve the quality of medical care abroad
by promoting the creation and overseas expansion of

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Health research policy and systems in Japan: A review focused on the Health, Labour and Welfare Sciences Research Grants
industries that contribute to the establishment of a society in which people enjoy long and healthy lives.
This policy covered the period between FY2014 andFY2019 in the first term, and a new 5-year second term of
the Healthcare Policy [15] began in 2020. On the basis of
this policy, the Japan Agency for Medical Research and Development (hereinafter referred to as “AMED”) was founded in 2015. It promotes top–down research by unifying themanagement of the research and development budget in the
medical field, which had previously been under the jurisdiction of multiple ministries including the MHLW, the Ministry of Education, Culture, Sports, Science and Technology,
the Ministry of Economy, Trade and Industry, and so on.
In the Healthcare Policy, research of each ministry wereconsolidated into some integrated projects so that they
can be managed in a unified way, and their own KPIs (keyperformance indicators) were set to be achieved for them.
In the first term, nine integrated projects were launched,which included drug discovery & development, medical
device development, translational & clinical research corecenters, regenerative medicine, genomic medicine, cancer, psychiatric and neurological disorders, emerging andre-emerging infectious diseases, and rare and intractablediseases. In the second term, integrated projects were reorganized into six projects including project for advanced drug
discovery and development, project for medical device andhealthcare, project for regenerative/cellular medicine andgene therapies, project for genome and health related data,
project for basic medical research, and project for seeds development and research base.
Since the enactment of the Healthcare Policy in 2014 andthe foundation of AMED in 2015, the framework of healthresearch of the MHLW has changed significantly. Previous
researches had been categorized into “policy research”
and “practical research,” with the former falling under thejurisdiction of the MHLW, called HLWSRG, and the latter
under AMED. Policy research under the jurisdiction of the
HLWSRG is aimed to conduct studies to establish scientificevidence for policymaking (e.g., epidemiological studies),
studies on the promotion and assessment of policies, andthe technological development of products other than drugs
and medical devices, whereas practical research is aimed toelucidate pathogenesis and pathophysiology and to develop
innovative diagnostic and treatment methods [16].
Policy research and practical research are conductedsystematically through joint cooperation. For example, eachdivision of the MHLW is involved in the planning and progress management of the research programs and projects
conducted by AMED. The research results produced by
AMED are also utilized in the HLWSRG, the seeds obtainedby HLWSRG are developed by AMED. The Health Scienc-

es Division also plays a vital role in the overall coordination
between the HLWSRG and AMED.

III. Outline of the Health, Labour and Welfare Sciences Research Grants
1. Framework of the HLWSRG
The objectives of the HLWSRG are to ensure science-based promotion of policies and to improve the technological level of health and medical care, welfare, environmental sanitation, and occupational safety and health inJapan. The HLWSRG also promotes original or pioneeringresearch as well as research on issues with a high social demand, while creating a competitive research environment.
The HLWSRG also promotes “mission-oriented research”
that can solve various problems by utilizing evidence obtained by research for the policies under the jurisdiction of
the MHLW and by monitoring and evaluating the results ofthe policies through the research.
The HLWSRG consists of 27 research programs, andeach program is divided into three research areas, as shownin Table 1. Although the HLWSRG as a whole is administered by the Health Sciences Division, each program ismanaged by the division in charge of the relevant policy, e.g.,
Table 1 List of research areas and programs of the HLWSRG
Research Area of Administration and Policy
Research Program on Policy Planning and Evaluation
Research Program on Statistics and Information
Research Program on Medical ICT and Artificial Intelligence
Research Program on Ethical, Legal and Social Issues
Research Program on Policies for Global Health Issues
Special Research Program
Research Area of Diseases and Disabilities
Health Research Program on Children, Youth and Families
Research Program for Promotion of Cancer Control Programs
Comprehensive Research Program on Life-Style Related Diseases including Cardiovascular Diseases and Diabetes Mellitus
Comprehensive Research Program for Women's Healthcare
Research Program on Rare and Intractable Diseases
Research Program on Renal Diseases
Research Program on Immunologic and Allergic Diseases
Research Program on Transplant Medicine
Research Program on Chronic Pain
Comprehensive Research Program on Aging and HealthResearch Program on Dementia
Comprehensive Research Program on Disability Health andWelfareResearch Program on Emerging and Re-emerging Infectious
Diseases and Immunization
Research Program on HIV/AIDS
Policy Research Program for Hepatitis Measures
Research Area of Health and Safety
Research Program on Region Medical
Research Program on Occupational Safety and HealthResearch Program on Food Safety
Research Program on Regulatory Science of Pharmaceuticals
and Medical Devices
Research Program on Risk of Chemical Substances
Research Program on Health Security Control

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TAKEMURA Shinji
the Research Program for Promotion of Cancer Control
Programs is managed by the Cancer and Disease Control
Division. This enables the promotion of mission-oriented
research whereby each division conducts its own research
program to solve the problems identified by policy planningand implementation and utilizes the evidence obtained fromthe research program for policymaking.
2. Annual schedule of the HLWSRG
In general, the HLWSRG allocates research funds to research projects every year in April, because the Japanese
fiscal year starts in April.
Every fiscal year, a “Research Program Implementation
Policy” of HLWSRG is formulated, in which the research
projects to be promoted with priority and those to be newly
implemented are set by the division in charge of each research program. The Health Sciences Division coordinatesand compiles them, and the Science and Technology Subcommittee of the Health Sciences Council then evaluates
and approves them. The “Research Program Implementation Policy” of the HLWSRG is then published in May of theyear before the relevant fiscal year.
In accordance with this policy, each division preparesa “Funding Opportunity Announcement” for the new research projects. The Health Sciences Division coordinatesand compiles them, and the Science and Technology Subcommittee then reviews and approves them. The Funding
Opportunity Announcement is then promulgated, and proposals for each research project are invited in Decemberof the same year. From January to March of the next year,
each proposal is evaluated by the assessment committee,
and decisions are made on whether or not to adopt a proposal. When a proposal is adopted, the research project may
be initiated in April.
3. Funding Opportunity Announcement of the HLWSRG
Since the HLWSRG is designated to promote “mission-oriented research,” most of the research projects havea predetermined theme. A researcher develops a researchplan that is consistent with the theme and submits a proposal. However, themes of research projects under theprevious Funding Opportunity Announcement have sometimes been vague, making it difficult to achieve consensus
between the researcher who proposed the plan for the
research project and the division that managed the research
project, often leading to failure to achieve research results
useful for policymaking [17]. For this reason, since 2016,
the Funding Opportunity Announcement has taken a unified
format containing descriptions on each research project
specified as follows:(1) The theme of the research project (The objectives,

6

contents, and expected results of the research project
are specified.)(2) Objectives (The goals of the research project and thedeadlines to achieve them are described.)(3) Expected results (The products of the research project, e.g., guidelines, manuals, and evidences on theeffectiveness of the health and medical care are specified.)(4) Requirements for conducting the research project(The requirements for the researcher, research team,etc., to achieve the objectives of the research project,including the participation of experts specializing in theacademic fields related to the research project in the
research team, cooperation with the users and beneficiaries of the results of the research project, etc. aredescribed)(5) Other conditions (The available funds for the research
project, the scheduled research period (at least one fiscal year, but up to three fiscal years as a general rule),
and the number of proposals to be newly adopted aredescribed.)
It enables appropriate evaluation of the research projectby specifying the contents of the Funding Opportunity Announcement as described above. The details are as follows:(1) It enables determination of whether or not a proposal
is worth adopting by assessing whether it is likely toachieve the objectives and expected results and whether it satisfies the requirements to achieve the objectives;(2) While the research project is ongoing, it enables determination of whether or not it is worth continuingwith a research project by assessing to what extent theobjectives and expected results have been achieved,
and whether the objectives and expected results arelikely to be achieved based on the progress to date;(3) At the time of completing the research project, it enables determination of whether or not a research project was successful by assessing whether the objectives
and expected results have been achieved.
4. Assessment of the HLWSRG for research proposals
and projects
Proposals for research projects will be evaluated by theassessment committee established for each research program. The number of the assessment committee members
is 10 to 15 as a rule. The members of the assessment committee are assigned to each proposal (research plan) andthey review it. At the assessment committee meeting, asummary of the rates and comments for each proposal fromthe committee members is presented, and proposals to be
adopted are then determined after the discussion.

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Health research policy and systems in Japan: A review focused on the Health, Labour and Welfare Sciences Research Grants
The assessment criteria for research proposals in the
HLWSRG are as follows: significance; expansibility; originality/novelty; feasibility/efficiency; researchers’ qualifications and institutional capacity; applicability to policy;
administrative urgency; and securing efficient and effective
operations. These criteria are common for all research programs. These criteria are also not markedly different fromthose of FAs in other countries (e.g., the NIH in the UnitedStates and the MRC in the United Kingdom) [18].
The HLWSRG does not only require assessment to determine whether a proposal should be adopted, but alsointerim evaluation and ex-post evaluation of a research proj-

ect that was adopted. The interim evaluation is performed
every fiscal year if the research period is ≥2 years, todetermine whether or not to continue the project by evaluating the progress of the research to date and the future
research plan. The ex-post evaluation is performed after
completion of the research period to determine whether the
research project has been successful and how the research
results can be used for policymaking.
The specific criteria for the assessment, interim evaluation, and ex-post evaluation are as shown in Table 2, 3, and 4,
respectively [11]:Table 2 List of criteria for assessment of the research
proposal of the HLWSRG [11]Table 3 List of criteria for interim evaluation of theresearch project of the HLWSRG [11](1) Criteria from expert and academic viewpoints- Significance (Is the proposal useful in the field of health, labour,and welfare sciences?)- Expansibility (Will it be possible to produce research resultsthat are useful for promotion and development in the field ofhealth, labour, and welfare sciences based on the proposal?)- Originality/novelty (Is the proposal original/novel?)- Feasibility/efficiency of the research objectives (Are the objectives for each fiscal year of the research period clearly described in the proposal? Is the proposal feasible? Is it likely to
conduct the proposal efficiently?)- Researchers' qualifications and institutional capacity (Is the
proposal feasible in terms of the research achievements ofthe principal investigator and researchers, composition of theresearch team, and facilities at the research institute? Are epidemiological and biostatistical experts involved in the researchteam?)(1) Criteria from expert and academic viewpoints- Extent of achievement of the objectives and expected results (Isthe research proceeding as originally planned?)- Validity and efficiency of the future research plan (Are there
any problems to proceed with future research? If yes, is it necessary to change the contents or other aspects of the research
project? If so, how should these be changed or corrected?)- Ability to continue the research project (Is it possible to continue the research and achieve the intended objectives in viewof the composition of the research team, their capabilities, andthe facilities at the research institute? If any changes need tobe made to the composition of the research team, how should
it be made?)(2) Criteria from policy and administrative viewpoints- Applicability to policy (Is the proposal significant as publicresearch? Are the research results to be capable of being produced by the proposal likely to be utilized directly on policymaking or used indirectly as a reference in the process of policy formation? Are the research results expected to bring any
indirect spillover effects? Is the use of the research results inpolicymaking specifically and clearly indicated in the proposal?
Does the proposal have a high social and economic impact?)- Administrative urgency(3) Criteria from the perspective of securing efficient and effective operations- Is the proposal effectively and efficiently planned?
- Can the proposal not be replaced by the other private research?
- Is coordination with and utilization of the other public and private research sufficiently described in the proposal? (Is there
any room to improve the efficiency and effectiveness of the
proposal by utilizing the other public and private research andthe results of past research or by planning a joint research project?)(2) Criteria from policy and administrative viewpoints (same as
Table 2)
(3) Criteria from the perspective of securing efficient and effective operations (same as Table 2)

Table 4 List of criteria for the ex-post evaluation of
the research project of the HLWSRG [11](1) Criteria from expert and academic viewpoints- Extent of achievement of the objectives and expected results(Have the intended objectives been achieved? If no, what is the
problem?)- Academic, international, and social significance of the research
results (How significant are the research results from academic, international, and social viewpoints?)- Expansibility of the research results (Are the research results
expansible to future research?)- Efficiency of the research (Has the research project been conducted efficiently?)(2) Criteria from policy and administrative viewpoints (same as
Table 2)(3) Criteria from the perspective of securing efficient and effective operations- Has the research project been conducted effectively and efficiently?
(4) Criteria from the viewpoints of an easy-to-understand explanation and dissemination to the public- Are the results and significance of the research explained tothe public in an easy-to-understand manner?
- Are the researchers and the research institute supposed tomake sufficient efforts to disseminate the research results?

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TAKEMURA Shinji

IV. Performance of the Health, Labour andWelfare Sciences Research Grants
1. Budget of the HLWSRG
Figure 1 shows the changes over time in the budget allocated to the HLWSRG and AMED by the MHLW. It should
be noted that the budget shown here does not represent
the entire budget of AMED, because other ministries havealso allocated budgets to AMED. Figure 2 shows the number of research projects funded by the HLWSRG. Both thebudget and the number of research projects increased in
FY2002 and FY2009 to approximately 50 billion yen and
1,600, respectively. After the establishment of the AMEDin FY2015, the budget has hovered around 7 to 8 billion yen
and the number of research projects has hovered around600. In FY2019, the budget of the HLWSRG was 8.90 billion
yen, and the number of research projects was 644. Also, theresearch budget allocated to the AMED by the MHLW was
43.27 billion yen.
Table 5 shows the proportion of budget allocated to eachresearch area and each research program funded by the HLWSRG in FY2019. More than half of the budget was allocated to the Research Area of Diseases and Disabilities. The
research program that the largest budget was allocated to
was on Rare and Intractable Diseases, followed by Medical
ICT and Artificial Intelligence.
(billion yen)
60
50

30
20

Budget allocated to the HLWSRG

2019

2018

2017

2016

2015

2014

2013

2012

2011

2010

2009

2008

2007

2006

2005

2004

2003

2002

2001

10

Budget allocated to the AMED

Fig1 1.Budget
Budgetallocatedallocated toto theAMED
FiguretheHLWSRG
HLWSRGand
andAMED
by theof Health,LabourLabourand Welfare
byMinistry
the Ministryof Health,and Welfare
1,600

1,200
1,000
800
600
400

2019

2018

2017

2016

2015

2014

2013

2012

2011

2010

2009

2008

2007

2006

2005

2004

2003

2002

2001

200

Figure 2 Number of research projects funded by theFig 2. Number of research projects funded by the
HLWSRGHLWSRG

8

%
18.4%
3.0%
0.2%
12.5%
0.1%
0.3%
2.3%
62.6%
2.5%
10.6%
4.6%
0.4%
13.7%
0.4%
0.6%
0.3%
0.7%
3.3%
1.0%
4.7%
10.0%
7.1%
2.7%
19.0%
2.9%
0.8%
6.8%
1.9%
3.8%
2.8%
100.0%

Budget(million yen)
1.0 ～ 2.9
3.0 ～ 4.9
5.0 ～ 6.9
7.0 ～ 9.9
10.0 ～ 14.9
15.0 ～ 19.9
20.0 ～ 29.9
30.0 ～
Total

Number of projects
51
95
62
138
114
61
68
55
644

%
7.9%
14.8%
9.6%
21.4%
17.7%
9.5%
10.6%
8.5%
100.0%

Table 6 shows the distribution of budget allocated to eachresearch project in FY2019. Around 32% of the research
projects were allocated a budget of <7 million yen, around
54% received <10 million yen, and around 81% received<20 million yen.

1,400

0

Name of Area/Program
Administration and Policy
Policy Planning and Evaluation
Statistics and Information
Medical ICT and Artificial Intelligence
Ethical, Legal and Social Issues
Policies for Global Health Issues
Special Research Program
Diseases and Disabilities
Children, Youth and Families
Cancer Control
Life-Style Related Diseases including Cardiovascular
Diseases and Diabetes Mellitus
Women’s Healthcare
Rare and Intractable Diseases
Renal Diseases
Immunologic and Allergic Diseases
Transplant Medicine
Chronic Pain
Aging and Health
Dementia
Disability Health and Welfare
Emerging and Re-emerging Infectious Diseases and
Immunization
HIV/AIDS
Hepatitis Measures
Health and Safety
Region Medical
Occupational Safety and Health
Food Safety
Regulatory Science of Pharmaceuticals and Medical
Devices
Risk of Chemical Substances
Health Security Control
Total

Table 6 Distribution of the budget allocated to eachresearch project of the HLWSRG in FY2019

40

0

Table 5 The proportion of the budget allocated to eachresearch area and program of the HLWSRG
in FY2019

2. Products of the HLWSRG
The principal investigator of a research project must
submit an annual research report for each fiscal year and a
final research report for the final fiscal year if the research
period is longer than one year. The principal investigator of

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Health research policy and systems in Japan: A review focused on the Health, Labour and Welfare Sciences Research Grants
the research project must also report on the “administrative
effects” for 5 years after the end of the research period.
The “administrative effects” obtained through the project
include the number of original articles, other papers, conference presentations, patents to be applied for and granted,
findings used for policymaking, and activities for publicawareness.
The products of all the research projects, including research reports and administrative effects, are registered in
the MHLW Grants System (https://mhlw-grants.niph.go.jp/
index.html) operated by the NIPH. This database started
operation in 1997 for the purpose of disclosing the research
results of the HLWSRG widely to the public [19]. This database can be viewed and searched on the web, and it is a
useful tool for disseminating research results and promoting their utilization for policymaking.

V. Contribution of the National Institute of
Public Health to the development of the
Health, Labour and Welfare Sciences Research Grants
The NIPH is a research institute affiliated with the
MHLW. The mission of the NIPH is to perform educationand training of personnel engaged in public health, environmental health, and social welfare and to conduct research inthese areas. As for the duties related to the HLWSRG, the
NIPH operates the MHLW Grants System described above,and plays a role as the FA for some of the research programs. The NIPH became the FA for the Research Programon Health Security Control in 2006 and for the Research
Program on Rare and Intractable Diseases in 2010, replacing the MHLW.
The FA at the NIPH is responsible for the assessmentof research proposals and the progress management ofresearch projects [20]. A program director and a program
officer are instituted in the FA to implement the following
operations:(1) Assessment of research proposals, including the selection of assessment committee members, holding ofcommittee meetings, summarization of the ratings andcomments by committee members, and the provisionof information and reports to the committee, etc.
(2) Progress management of research projects, including
attendance at project meetings, hearings with principal
investigators, site visits to research facilities, etc.
The FA activities of the NIPH have contributed to thedevelopment of the HLWSRG. Firstly, as with the Research
Program on Health Security Control, the NIPH has developed the format of the Funding Opportunity Announcementthat consists of objectives, expected results, and require-ments for the research project since 2013, ahead of otherresearch programs in the HLWSRG. Then it was suggested
that they are useful for the assessment of research proposals and the progress management of research projects [17].
Second, as with the Research Program on Rare and Intractable Diseases, it was required for each research projectto set the goals to be studied, and the annual submission ofprogress reports was made mandatory for each project toimplement progress management effectively and efficiently.
As a result, diagnostic criteria and clinical practice guidelines of many rare and intractable diseases were developedor revised [7].

VI. Conclusions
Since 1951, the HLWSRG has funded many mission-oriented research projects aimed to solve various problems
concerning the nation’s health and medical care, welfare,environmental sanitation, and occupational safety andhealth, and it has produced many research results. Initially,
the HLWSRG started with research programs on non-communicable diseases, cancer, and new medical technologies.
The scope of research was then expanded to handle 27
research programs at present. This is because the policy
issues related to health and welfare have increased and become widespread year after year, suggesting that research
programs that contribute to policymaking have been added one after another in response to the increasing policy
issues. For example, as the Research Program on Renal
Diseases was launched in 2009, the Research Programon Chronic Pain in 2011, the Comprehensive Research
Program for Women’s Healthcare in 2015, the Research
Program on Medical ICT and Artificial Intelligence in 2016,
and the Research Program on Ethical, Legal and Social Issues in 2017, the HLWSRG has quickly responded to newly
emerging health issues and policy issues and has plannedand conducted new research programs.
The HLWSRG has achieved the expected results presented by the Funding Opportunity Announcement, suchas guidelines, manuals, and evidence of the effectiveness ofthe health and medical care program, and these results havebeen utilized in clinical practice and policymaking. In thenext step, however, it is necessary to evaluate the extent
to which these have improved the level of national healthand welfare by using the results in the years following theend of the period of the research project. In other words,
it is necessary to evaluate the outcomes that could be produced by utilizing the research results as outputs. However,
several issues need to be addressed to evaluate the outcomes of research projects. For one thing, it is necessary
to define the relationship between the output achieved by

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TAKEMURA Shinji
the research project and the outcome such as the improved
level of health and welfare. It is difficult to assume that theoutput of a single research project alone will improve theoutcome unless the output is extremely significant. It issuggested that, in most cases, a group of outputs obtained
through multiple research projects are related to an outcome. In addition, an outcome, such as the level of healthand welfare, is strongly influenced by other factors than the
results of research projects and research programs.
Another point is that it is the role of the policymaker, notof the researcher, to relate the output of a research projectto the outcome. Even if a researcher produces an excellent
output, it will not relate to an outcome unless the policymaker makes good use of it. It is therefore necessary tostrengthen mutual collaboration between researchers andpolicymakers even after the research period, and then to
consider how the results obtained from the current researchshould be utilized to improve the outcome in the future.

Conflicts of Interest
The authors declare that there are no conflicts of interest
regarding the publication of this article.

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TAKEMURA Shinji＜総説＞
日本の健康関連研究開発の政策と制度―厚生労働科学研究費補助金を中心に―
武村真治 1-3）
1）

国立保健医療科学院政策技術評価研究部

2）

厚生労働科学研究費補助金（健康安全・危機管理対策総合研究事業，難治性疾患政策研究事業）研究事業推進官

3）

厚生労働省大臣官房厚生科学課

抄録
本稿では，日本の健康関連研究開発を支える「厚生労働科学研究費補助金」の発展の経緯，現状と課題を概観し，今後の方向性を考察する．
厚生労働科学研究費補助金は，国民の保健医療，福祉，生活衛生，労働安全衛生等に関し，行政
施策の科学的な推進を確保し，技術水準の向上を図ることを目的として，1951年から実施されている．
2014年の健康・医療戦略の制定，2015年の日本医療研究開発機構（AMED）の設立によって，これまでの厚生労働科学研究費補助金の研究は「政策研究」と「実用化研究」に分割された．厚生労働省が所管する政策研究では，各種政策立案，基準策定等のための基礎資料や科学的根拠を得るための研究，
各種政策の推進，評価に関する研究，医療分野以外の各種政策に関係する技術開発に関する研究を実施し，AMEDが所管する実用化研究では，病因・病態の解明，革新的な診断・治療法の開発を実施している．
厚生労働科学研究費補助金は，医療ICT・AI，国際保健，母子保健，がん，循環器疾患・糖尿病，難病，
認知症，感染症，労働安全衛生，食品安全，レギュラトリーサイエンス，健康危機管理など，27の研究事業で構成され，2019年度は約89億円の予算で644の研究課題が実施された．各研究事業は関連する政策を担当する厚生労働省の課室によって所管され，各課室が政策立案・実施において把握した課題を解決するための研究を設定し，その成果を政策に反映させる，というMission-oriented Researchを推進している．また大臣官房厚生科学課は厚生労働科学研究費補助金の総合的企画・調整を実施し，研究課題の事前・中間・事後評価の評価基準の設定，公募要項の様式（目標，求められる成果，採択条件）の統一化など，制度の改善に取り組んでいる．
国立保健医療科学院は「厚生労働科学研究成果データベース」の運営主体として，厚生労働科学研
究費補助金の研究成果をウェブ上で公開している．また健康安全・危機管理対策総合研究事業，難治性疾患政策研究事業の研究費配分機関として，研究課題の評価や進捗管理を実施している．
厚生労働科学研究費補助金はこれまで多くの研究成果を産出してきたが，今後はそれらの成果（アウトプット）によって国民の健康や福祉の水準（アウトカム）がどの程度改善したか，を評価する必要がある．
キーワード：医学研究，研究利用，ファンディングエージェンシー，エビデンスに基づく健康政策，
実装科学

12

J. Natl. Inst. Public Health, 70 (1) : 2021