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FUMIMARO TAKAKU President The Japanese Association of Medical Sciences Honorary President Jichi Medical University
FUMIMARO TAKAKU President The Japanese Association of Medical Sciences Honorary President Jichi Medical University
The Issues facing Japanese Medicine Today
The Crisis of Hospital Medicine
The Crisis of Clinical Research
Other Medical Issues
Issues with Regime for Medical
Care Provision in Japan
Increase in the amount of work
Informed consent
Risk management
Increasing demands from
patients
Concern or anxiety about medical
accidents
Sharp decrease in QOL
Hospital Doctors’ Intention to go to Private
OECD Health Data 2012
Japan’s Medical System is seen as Top Class in International Evaluations
Japan １ ３ １８ Germany
USA
WHO OECD
General Evaluation
Equality for Access
Rates of Health Care Cost to GDP
Canada Outranks U.S. in healthcare Report Card Reuters Sep.28, 2009
The Conference Board of Canada
1 Japan A 2 Switzerland A 3 Italy A 4 Norway A 5 Sweden B 6 France B 7 Finland B 8 Germany B
Rank Country Grade
9 Australia B 10 Canada B 11 Netherlands C 12 Austria C 13 Ireland C 14 United Kingdom D 15 Denmark D 16 United States D
No. Working Hours Min
Working Hours Max
Working Hours
Average
Average arrival time
Average leaving time
Mon 42 12 24 12.6 8:34 20:46
Tue 42 11 26 13.9 8:01 21:12
Wed 42 10 26 13.2 8:33 21:14
Tur 42 12 26 13.1 8:17 21:19
Fri 40 10 26 12.9 8:18 21:03
Sat 29 2 24 5.1 8:35 14:40
Sun 28 3 24 7.0 10:19 16:32
Total - - - 77.8 per week
- -
Doctors’ Working Hours (4 Public Institutions in Kanagawa Prefecture)
Comparison by Country of Acute Phase Medical ｉｎCare Provision Regime (2009)
Averagelength of
hospital stay
No. beds per1000 popln .
No . doctorsper 100 beds
No. doctorsper 1000
popln .
No . nursingstaff per 100
beds
No. nursingstaff per 1000
popln .
日本 18.5 8.11 26.6 2.15 117.9 9.54ドイツ 7.5 5.66 64.3 3.64 194.1 10.98
フランス 5.2 3.47 94.3 3.27 236.5 8.21イギリス 6.8 2.68 101.0 2.71 361.3 9.68アメリカ 5.4 2.66 93.6 2.44 413.8 10.8
日本は，人工当たりの病床数が多く，人工当たりの医療従事者が少ないため，病床当たりの医療従事者数が低い水準となっており，また，平均在院日数が長い
ＪＡＰＡＮ
Ｊｅｒｍａｎｙ
Ｆｒａｎｃｅ
Ｂｒｉｔａｉｎ
Ｕｎｉｔｅｄ Ｓｔａｔｅｓ
②
Average of Britain, France and Germany
Comparison by Country of Doctors’ Working Hours Age group
Japan
Under 29
80 or over
60 or over
60 or over
60 or over
(Hours)
France B
ritain G
ermany
(Hospital doctors, includes full-time and part-time doctors)
（出典）医師･歯科医・看護師調査
Change in the Number of Doctors by Clinical Department (Where the number in 1994 is defined as 1.0)
○ Most Clinical Departments are seeing an increase trend in the number of doctors.
○ Even Obstetrics & Gynecology and Surgery, which were in a decrease trend, are shifting to an increase trend.
The Issues facing Japanese Medicine Today
The Crisis of Hospital Medicine
The Crisis of Clinical Research
Other Medical Issues
Issues with Regime for Medical
Care Provision in Japan
National Universities had been transformed into independent
administrative institutions
New Clinical Resident Training System
Medical students’ orientation toward specialist medicine
May end as an empty slogan...
Translational Research
Bench Bed
The Crisis for Medical Research
International Comparison of Numbers of Papers on Major Aspects of Basic and
Clinical Medicine Number of Papers on Basic Research Number of Papers on Clinical Research
Change in the Number of Students Who Graduated from the Faculty of Medicine at Tokyo University who
are Engaging in Basic Research
0
5
10
15
20
25
人数
卒業年
基礎系従事者数
社会科学・その他
研究所
大学
14
Number of people engaging in basic research
Social science or other Research institute University
1971 1973 1975 1977 1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999 2001 2003 2005 2007
Num
ber of people
Graduation Year
The Issues facing Japanese Medicine Today
The crisis of hospital medicine
The crisis of clinical research
Other Medical Issues
Issues with Regime for Medical
Care Provision in Japan
Other Medical Issues
Delay in the development and spread of Pharmacogenomics Delay in the development of monoclonal antibodies No regime to promote Translational Research has been
established Delay in clinical trials (No IND or IDE systems) Drug lag and Device lag
バイオ医薬品の研究開発の成果が減少傾向
The number of biopharmaceutical items being developed is on a downward trend, and it is necessary to strengthen the foundations for putting the outcomes of research to actual use
各国のバイオ医薬開発品目数
Pharmaprojects, PJB, 2007
ＪＡＰｈＭｅｄ
Japan
France
Germany
UK
United State
1996 2006
Government Spending on Life Science Research in Japan and the US
unit: 100 million yen
Source: Japan; Council for Science and Technology Policy, Cabinet Office, Government of Japan, 2005 US; Science and Engineering Indicators 2008, National Science Foundation, 2008
18
Other Medical Issues
Delay in the development and spread of Pharmacogenomics Delay in the development of monoclonal antibodies No regime to promote Translational Research has been
established Delay in clinical trials (No IND or IDE systems) Drug lag and Device lag
“Clinical Trials of new candidate drugs etc., based on the Pharmaceutical Affairs Act”
Approval and admission to Health insurance as a drug, etc. (Ministry of Health, Labour and Welfare)
Clinical tests and screening / permission (Pharmaceuticals and Medical Devices Agency)
Treatment as reiterative (Pharmaceutical Affairs Act)
Clinical trials by a company /
“investigator initiated” clinical trials
Notification of Advanced medicine etc. (Ministry of Health, Labour and Welfare ）
Application within institutions conducting clinical
research as a medical act (No spread to the entire country)
Notify Ministry of Health, Labour and Welfare or conduct medical acts
outside the restrictions of the Pharmaceutical Affairs Act
Developed mainly at universities and research institutes using
various funds
Development is commissioned (made into a business project with a sponsor)
“Clinical research using new candidate drugs etc. within institutions”
Research seeds (New candidate drug, etc.)
“Clinical trials” and “Clinical research” within institutions in Japan
Problems of Clinical Research in Japan
Other Medical Issues
Delay in the development and spread of Pharmacogenomics Delay in the development of monoclonal antibodies No regime to promote Translational Research has been
established Delay in clinical trials (No IND or IDE systems) Drug lag and Device lag
Results of the Device Lag Survey
2008年デバイスラグ調査（ACCJ 医療機器・IVD小委員会）
Index (Japan= 1.0)
0.0 0.5 1.0 1.5 2.0 2.5
USA
Europe
Japan
2.1x
2.0x
Index of available medical devices (Japan= 1.0)
2-1. Because of the situation in Japan, only approx. half of the medical devices from the US and Europe can be accessed
2-2. Reasons why application for approval is not (cannot be) made in Japan
Percentages of devices developed in USA applied for approval in Japan
Do not apply
%
Reason for not apply
High cost to Obtain an approval
Not enough market
Time lag to approval
others
High cost to operate
Low price Lack of resources
A Comparison of the International Market for Diagnostic Imaging Devices
GEヘルスケア
1999 2000 2001 2002 2003 2004 2005 2006
3TMR head 2003.Feb.Approval MHLW:711days
3TMR whole body 2005.Jan.Approval MHLW:445days
3TMR head 1999.Sep.Approval
FDA:81days
PET/CT 2001.Mar Approval
FDA:66days
PET/CT 2003.Dec.Approbal MHLW:526days
3TMR whole body 2002.Aug. Approval
FDA:30days
A Generation Gap in Products is Being Caused by the Slow Application/Approval Process
In Japan, products which are 2 or 3 generations behind the latest products are being used
⇒ A cause of unnecessary cost
Regarding medical devices which were approved in 2003 to 2006, it took on average 3.6 years longer to introduce them to the market in Japan than it did in Europe, and on average 3 years longer than it did in the United States.
In addition to the period for overall review being long, delays in starting
development and in clinical trials also contribute
Japanese patients cannot access the most advanced medical technology
（Newsweek, “Cutting-Edge Medicine”）
The Issues facing Japanese Medicine Today
The Crisis of Hospital Medicine
The Crisis of Clinical Research
Other Medical Issues
Issues with Regime for Medical
Care Provision in Japan
Primary, secondary and tertiary medical care are not functioning as a system
Free Access (FA)in Japan： （being able to access medical care whenever, wherever, and whoever you are) Problem is wherever .We need rules for where patients can be seen (except for emergency medicine)
FA is obstructing the functioning of the medical system
FA is disturbing hospital medicine
FA is obstructing efficient medicine and causing wastage in terms of medical costs
Is Medicine Functioning as a System in Japan?
Key (Reference) Hospital
Local hospital
Family doctor General Practioner
Family doctor General Practioner
Resident Resident Resident Resident
Local hospital Update
Update
Ideal Local Medical System
Basic Design of a New Specialist Medicine System
Subspecialty Specialist Medicine Digestive apparatus, Respiratory apparatus, Endocrine
metabolism, Kidney, Allergies, Gerontology, Circulation, Blood, Diabetes, Liver, Infectious diseases, Neurology,
Digestive surgery, Respiratory surgery, Cardiovascular surgery, Pediatric surgery, etc.
Basic Areas of Specialist Medicine
Clin
ical e
xamin
ation
Path
olo
gy P
lastic su
rgery
Rehab
ilitation
Em
erge
ncy
Rad
iograp
hy
Uro
logy
Ophth
almolo
gy O
rthopedic
s C
linic
al psyc
hiatry
Pediatric
s A
nesth
etic
s N
euro
surge
ry O
torh
inolaryn
golo
gy O
bs. &
Gyn
ecolo
gy Surge
ry D
erm
atolo
gy In
tern
al medic
ine
General
Practitioner (Tentative nam
e)
Issues with Medicine in Japan which should be resolved in the
Future Crisis of small and medium sized hospitals Shortage of Primary Care doctors Shortage of specialists capable of Providing primary
care services. Uneven distribution of doctors among clinical
departments or regions No regime for the provision of medical care has been
established Drug lag and Device lag
The End of My Presentation Thank You FUMIMARO TAKAKU President The Japanese Association of Medical Sciences. Honorary President Jichi Medical University .
Contact：03-3946-2121 e-mail:[email protected]
