徳増有治

医療分野でのイノベーションの実現に向けて
Toward the realization of innovation in the healthcare sector
経済産業省 大臣官房審議官
（産業技術担当）
徳増 有治
Yuji Tokumasu
Deputy Director-General
for Industrial Science and Technology Policy,
Ministry of Economy, Trade and Industry
自律的イノベーションを阻害している市場の構造的要因
Structural factors inhibiting the self-sustaining innovation in the market
１．国の財政支出を安定化させるために、
投資意欲のある市場そのものの発展を阻害
Inhibition of the spontaneous growth to an attractive market for
Investors, for the purpose of stabilization of government spending
２．行政的対応による公的管理のため
科学技術の進歩、社会環境変化等への対応の遅れ
Slow response to the progress in scientific technology and
changes in the social environment, due to bureaucratic responses in
public management
３．公定価格、情報開示の遅れのため、
コストの削減意欲、質の向上意欲の阻害
Reduced motivation to cost reduction and quality improvement,
due to official prices and the delay in information disclosure
医療費の推移
3
自律的イノベーションを阻害している市場の構造的要因
Structural factors inhibiting the self-sustaining innovation in the market
１．国の財政支出を安定化させるために、
投資意欲のある市場そのものの発展を阻害
Inhibition of the spontaneous growth to an attractive market for
Investors, for the purpose of stabilization of government spending
２．行政的対応による公的管理のため
科学技術の進歩、社会環境変化等への対応の遅れ
Slow response to the progress in scientific technology and
changes in the social environment, due to bureaucratic responses in
public management
３．公定価格、情報開示の遅れのため、
コストの削減意欲、質の向上意欲の阻害
Reduced motivation to cost reduction and quality improvement,
due to official prices and the delay in information disclosure
４．均質が優先されることによる競争的環境の阻害
Inhibition of competition, due to a preference for homogeneity
５．旧来的技術、手法、考え方に対する旧来的安全規制のため、
Conventional safety regulations for conventional technologies,
methods and thinking, resulting in:
○ 科学技術の急速な進展や社会情勢変化に対応した
効用とリスクのバランスの欠如
Lack of a balance between risks and benefits that responds to
the rapid progress of scientific technology and changes in the social
situation
○ ベンチャー企業や、市場のない新規技術（再生医療等）に対する
経営実態や社会的（国民的）意義に対する配慮の欠如
Lack of consideration for the business status and the social
(national) meanings of venture companies and new technologies
without markets (such as regenerative medicine)
The Trend of Bio-venture
•
•
•
•
日本のバイオベンチャーは５００社を超える規模にまで拡大。
Japanese bio-venture will expand to more than 500 corporations.
バイオ関連分野に対する新規投資先社数は増加傾向。
The number of corporations associated with bio related sector to be newly
invested has an increased trend.
図４ バイオベンチャー企業数の海外比較
図３ バイオベンチャーの企業数推移
Chart 4 Comparison of Numbers of Bio-venture
Corporations in the World
Chart 3 Transition of the Numbers of Bio-venture
Corporations
Number of Corporation
600
531
464
500
387
400
304
300
333
Source: “The Bioindustry Infrastructure Project Report for the year 2002”
図５ ＩＴ、バイオ関連新規投資先推移（社数比率）
254
Chart 5 Transition of IT and Bio Related New
Investment (Comparison of Numbers of Corporations)
212
200
102 116
132
150 167
60%
50%
100
0
ＩＴ関連
バイオ／医療／ヘルスケア
40%
年度
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Source: “The Bio Venture Statistical Survey 2005”,
the Japan Biondustry Association
30%
20%
10%
0%
98年
99年
00年
01年
02年
03年
04年
05年
Source: “Investment Trend Survey including Venture Capital”, VEC
6
創薬分野におけるベンチャーへの期待
Expectations for Venture in the Drug Discovery Sector
•
In the USA, on contrary to the number of new drugs placed onto the market by major pharmaceutical
corporations, the number of approval of new drugs produced by bio-venture corporations has
continued to be increased, and its number of releases exceeded that of major corporations.
The role of venture corporations has been enhanced in the innovative seeds development where there
are high risks, which major pharmaceutical corporations have difficulty in being involved, as drug
discovery becomes more advanced and complicated.
•
Chart 7 Big Pharma’s and Biotech’s R&D Budget and Number of
Chart 6 Number of Corporations and Its Structure
Releases in the USA
in relation to the Origin of New Medical Product
Ｒ＆Ｄ費用
ＦＤＡ新規化合物
認可数（件）
（ｂｉlｌ＄）
R&D 費用（Big pharma)
R&D 費用（Biotech)
Component Development
70
米国
33
フランス
5
23
60
0
日本
7
その他
スペイン
3
スイス
3
オランダ
2
英国
20
40
0
15
0
0
3
30
製薬企業
ベンチャー企業
1
ベンチャーは増
加
20
4
4
イタリア
25
2
5
韓国
大手製薬は減少
50
0
8
30
認可件数（Biotech)
0
22
ドイツ
認可件数（Big pharma)
10
1
5
10
0
10
20
30
40
50
60
Source: Report by the Office of
Pharmaceutical Industry Research
0
1998
1999
2000
2001
2002
2003
2004
0
2005 年
（Source ：Ernst & Young Beyond Borders Global Biotechnology Report 2006）
7
バイオベンチャーを巡る厳しい状況（投資環境）
Difficult Conditions Surrounding Bio-venture (Investment Climate)
•
In comparison to Europe and the USA, Japanese venture capital
investment climate is extremely weak.
図６ ベンチャーキャピタル投資額の対ＧＤＰ比率の国際比較
（２０００～２００３年）
Chart 6 International Comparison of Venture Capital
Investment in comparison to GDP Ratios
図７ 日米欧のベンチャーキャピタルの投資残高の推移
Chart 7 Transition of Remaining Venture Capital
Investment Value in Europe, the USA, and Japan
(％)
Note 1: Investment in the early stage and expansion stage
Note 2: Japan and Korea take the values from 1998 to 2001, and Iceland
takes the values from 2000 to 2002.
Source ：OECD「OECD Science, Technology and Industry Scoreboard 2005」
Note 1: 107 yen/dollar conversions for the USA.
Note 2: 139 yen/euro conversions for Europe.
Source: “Investment Trend Survey including Venture Capital
(the year 2005)”
8
バイオベンチャーを巡る厳しい状況（アライアンス）
Difficult Conditions Surrounding Bio-venture (Alliance)
•
•
In comparison to Europe and the USA, the alliances of major pharmaceutical corporations and
bio-venture corporations in Japan are weak.
The expenditure on research funds from Japan to overseas institutions is especially large in the
pharmaceutical industry.
Chart 11 Transition of Number of Alliances by Major
Pharmaceutical Corporations in Europe, the USA, and Japan
Chart 12 Percentage of Development
Funds to Overseas, Outside the Company
プラスチック製品工業
0.7%
電子部品・デバイス工業
1.1%
情報通信業
1.3%
機械工業
2.5%
サービス業
2.8%
その他の工業
3.3%
化学工業
3.3%
食品工業
0.7%
非鉄金属工業
0.7%
電気・ガス・熱供給・水道
業
0.7%
その他
4.3%
医薬品工業
36.4%
電気機械器具工業
3.6%
精密機械工業
6.5%
輸送用機械工業
15.1%
情報通信機械器具工
業
16.9%
Source: Created by the Ministry of Economy, Trade and Industry
from “The Scientific Technology Development Study Report
(annual)”, the Ministry of Internal Affairs and Communications
9
•
In order to stimulate Japanese economy, creating technological innovation by
strengthening industrial technologies and utilizing seeds of technology for actual
application and commercialization in the market through research and
development is a pressing issue.
The issue is that advanced scientific technology and its achievements are not
applied into business. (Presence of “Valley of Death”)
On “Valley of Death”
~ From the materials presented by NIST* at a OECD Workshop”
The Wall of Nonsense
Why is it so tall?
Why is it so stiff?
To begin with, why is a wall necessary here?
→ Unfortunately, no one can understand!
←Easy
資金調達の容易さ
•
ﾍﾞﾝﾁｬｰｷﾔﾋﾟﾀﾙ
エンジェル
Difficult→
The Valley
of
Death
Because it is difficult to determine whether a
specific technology can be commercialized or
not in the development and scale-up phase
between
“basic
study
phase”
and
“release”, funding is not easy. The gap
between the research phase and release is
recognized to be an issue as “The Valley of
Death” in the USA as well.
“死の谷”
Basic Study
Development, Scale-up
Release
* NIST: National Institute of Standards and Technology
１
10
The Flow to Realize Institutional Reforms in Medical Care and Health Industries
Life Science Summit (April 2006)
Indicate the importance of clinical trial reformation
and promotion of health industries based on the
collaboration of industry, government, and academia.
Life Science Federation of LDP Diet Members declares
their initiative in clinical trial reformation.
Economic Growth Strategy Outline (July 2006)
As well as promoting research and development of medical
products and equipment, the infrastructure to deliver them promptly
to citizens is necessary, and communication between public and
private sectors will be carried out proactively in order to actualize
these objectives.
Life Science Federation of LDP Diet Members
Chairman Omi, Acting Chairman Tanigaki, and Secretary-general Hosoda
August 2006, establishment of a special committee on clinical trial
reformation
December, a resolution on activation of clinical trial and clinical researches,
acceleration of approval examinations, and establishment of
communication between public and private sectors is adopted.
Group on Regeneration
Medicine of Diet Members
December 2006, proposes a legislation
by members on the conversion of one’s
own cells
Japan Association of
Bioindustries Executives
(JABEX)/JBA
Release an interim report on
proposals for the enhancement
of the clinical trial system and
acceleration
of
approval
examinations in December 2006
Policy Speech by Prime Minister Abe (September 2006)
○ Submit “Innovation 25”, a
long-term strategic guideline
on medicine, etc., which will
contribute to growth.
Execution.
Council for Science and Technology Policy,
Cabinet Office (December 2006)
Provide an opinion on the activation of clinical trial and clinical
researches and acceleration of approval examinations
(promotion of regeneration medicine) to the government as an
institutional reform that leads to application of research and
development.
Examination starts at
Council on Fiscal and
Economic Policy
Elimination of complete
regulations, transition to
the growth strategy
Establishment of “Communication for Innovative
Drug Discovery between Public and Private
Sectors” (January 2007)
Hold the Second Communication between Public and
Private Sectors (April 2007)
Formulate the Five-year Strategy for Innovative Drug
Discovery
Formulate government policies
Promote institutional reforms
Ensure policy effectiveness
○Transfer the policy focus on
medical and nursing care to
prevention and promote “New
Health Frontier Strategy” to
increase healthy life expectancy.
Measures and Policies presented by Prime
Minister Abe (January 2007)
○Support for development of medical products that
have drastic effects and reformation of regulations
in the medical industry are necessary.
○Formulation of “New Health Frontier Strategy”.
Japan Science and
Technology Agency
December 2006, proposes the
reformation of clinical trial
system
Examination of Innovation 25
starts (November 2006)
Doubled number of PMDA
judges (January 2007)
Revision of the Pharmaceutical Act in
regard to regeneration medicine
(March 2007)
Establishment of “New Health
Frontier Strategy Council”
(November 2006)
Overview of Five-year Strategy to Create Innovative Medical Products and Equipment
Provide the world’s most advanced medical
products and equipment to citizens
Have the pharmaceutical and medical equipment
industries be a driving force of Japan’s growth
April 2007
MEXT
◎MHLW
METI
Measures and Policies aiming for Japan-lead Development and Simultaneous Worldwide
Development including Japan
①Concentrated Input of Research
Funds
• Prioritize and expand budgets
related to medical products and
equipment
• Establish an industry-governmentacademia
organization
to
coordinate research sectors to be
emphasized
• Examine the expansion and
enhancement of a research and
development tax system
②Development of Venture
Corporations and so on
• Expand research funds
• Share institutions and equipment
and so on
• Establish a support system for
corporatization, utilize experienced
personnel, improve consultation
services, etc.
• Examine a possibility of support for
examination charges
• Examine measures to promote the
provision of medical equipment
⑦Communication
between Public
and Private
Sectors
③ Improvement of Clinical Research and Clinical
Trial Conditions
⑤ Acceleration of Examination Processes and
Improvement of Examination Quality
•
Promote international joint clinical trials
•
•
Establish “Medical Care Cluster” which precedes
clinical researches by close collaborations of
industries, government and academia, lead by
national advanced specialized medical institutions,
in regard to diseases that greatly impact citizens
Shorten the period by the release of a new drug
by 2.5 years (eliminate the drug lag)
•
Double the number of judges and improve their
quality (increased by 236 people over 3 years)
•
Clarify the approval examination procedure and
standards and improve the operation of GCP
•
Establish a bridge-building research center, a
regeneration medicine center, and a clinical
research system
•
Create guidance for international joint clinical
trials and carry out consultations of preferential
clinical trials
•
Have a center of clinical trials, establish network and
utilize IT for clinical trials, involving medical care
clusters
•
Discuss about the introduction of joint clinical trial
consultations among examining authorities in
Europe, the USA, and Japan
•
Train and recruit personnel who support medical
doctors and clinical researches
•
•
Take measures to improve the evaluation of clinical
performance of medical doctors and so on
Promote streamlining and simplification of
examinations of clinical trials and approval while
maintaining safety of medical equipment
•
Improve and train judges for medical equipment
•
Promote the appropriate regulation for clinical
researches
•
Improve the operation of medical equipment
GCP
④Collaboration in Asia
• Promote joint researches on important diseases
• Joint researches on application methods of data
collected in East Asia
Strengthen the collaboration among related
Ministries, research institutions, and industries.
⑥Appropriate Evaluation of Innovation
Examine more appropriate evaluations of
innovative products in the NHI drug price
scheme and so on
Have periodical communication between
public and private sectors
12
Great achievements in basic studies are not applied to medical
care researches and actual scenes.
○Many research papers are published in relation to the basic study sector, but the number of research
papers published is extremely small in the clinical sector.
The Number of Judges in Examining Authorities
USA: 2200
France: 900
UK: 690
Japan (New): About 430
Japan: 190
Acquisition of
Regulatory Science
Quality and Quantity of
Science
Germany: 1100
Safety Level
世界初の上市から、各国での上市までのイメージ
Illustration of the Process from the First Release in the World to Releases in Each Country
Large Amount of Time
European Countries and the USA
Japan
Disadvantages to citizens and inhibition of
their selections
Increased burden on citizens and increased
medical service fees
↓
Loss of economic efficiency and increased
non-released products
Scientific Safety
to be Ensured
4 years
Cost Required for Examination
1.5 years
Cost Required for Examination
Cost Required for
Examination
The First
Release
(Approval) in
the World
Time Required for Examination
Safety Level
世界初の上市から、各国での上市までのイメージ
Illustration of the Process from the First Release in the World to Releases in Each Country
Number and quality of judges
(Medical doctor, statistic,
engineering, etc.)
Quality and quantity of
science at examinations are
the parameters
Approval
Scientific Safety
to be Ensured
Ｘ
In particular, regeneration
medicine and advanced
medical equipment/device
1.5 years
4 years
Relinquish
ment
Time Required for Examination
Basic Concept of Technology Development to Promote Bridging
between Basic Studies and Clinical Researches
Basic
Study
Basic
Study
Basic Study
Basic Study
R&D Phase
Bridge-building
Study
Portfolios for Promoting
Bridge-building Studies
Research for Practical Application
③ Demonstration Study for
Regulatory Science Support
Study for
Scientific
Regulation &
Examination
Basic Study
② Initiative Study
Large-scale Clinical Research
(Drug discovery, Diagnosis,
Regeneration, Treatment)
① Bridge-building Study PJ
Establishment of
Regulatory
Science
Development
of Innovative
Medical
Technology