Report of the Advisory Panel for Promotion of Medical Ventures(Summary)Report of the Advisory Panel for Promotion of Medical Ventures (Summary)Innovation is a key trigger for Japan’s economic growth in the future. A venture company is a driving force whichholds the key for success in innovation. And, progress in drugs and medical devices is an “investment for thefuture.”
This report is compiled to provide guiding principles for MHLW’s policy for medical ventures.
※ Medical ventures = Venture companies for drugs, medical devices, and cellular and tissue-based products

Ⅰ. Importance and necessity of promotion of medical ventures◆ There is a very high growth potential in healthcare.
・Healthcare is a huge growing market across the world.
・There is a need to respond to issues, such as, the extension of healthy life expectancy and building of a sustainable healthcare
system, within the country.
◆ Venture companies play a central part in the innovation of drugs and medical devices in the future.
・While specialization proceeds in mega pharma in the US & EU, many new drugs are being developed by venture companies.
・Cutting-edge technologies used in different fields are increasingly put to use for the development of medical devices, etc.
・ While our basic research and manufacturing technology are advanced, medical ventures play limited roles in Japan.
◆ Promotion of medical ventures is an urgent issue for Japan.
・ In view of trends in drug development, widespread use of generic drugs, and others, promotion of medical ventures is a pressingmatter.

◆ Three types of Medical ventures

Grow by itself

Acquired by large company

Enter from different industry１

Ⅱ. Issues for promotion of Medical ventures
Characteristics of medical ventures
The following characteristics of Medical ventures
present a host of challenges➀➁③④

Medical innovation requires a high level ofscience and technology and accompanies highrisks for development.
Development and approval take an extremely
long time and require an enormous amount ofmoney.

Regulations on medicines, pharmaceuticals andpublic insurance may become barriers to entry. It
is important to have a good understanding on
them.
Training new entrepreneurs requires a long timeand costs.

Japan’s strengths & weaknesses
For Japanese medical ventures to improve their capitalefficiency, they should look into the possibility ofexpanding into foreign markets

Advantages
・There are many world-classseeds in universities and research
institutions.
・Clinical research is widelypracticed in hospitals.

Disadvantages
・There are few entrepreneurs,
and it is difficult to secure
human resources for ventures.
・Venture capital investment isscarce, and funding support isweak.
・Human & capital networks
with foreign countries are weak.

・Many small & medium-sizedcompanies have advanced
manufacturing technologies.

・Approval process of drugs &medical devices is accelerated (e.g.
regenerative medical products)

・Venture companies are notconsidered in the medicalsystem and others.
・Successful cases of medicalventures are very few.
2If strengths can be utilized and weaknesses can be overcome, the importance of promoting medical ventures
and the potential of their growth are great.

Ⅲ. Promotion measures for medical ventures“The Goal”
Medical ventures lead innovation
Enhancement of healthcare standards
in Japan & the world
Contribution to economic growth in Japan“The Vision”
To be the center of innovation
Japan will become a country with the bestbusiness environment in the world.
To produce a virtuous cycle of innovation
Japan will accelerate a virtuous cycle ofinnovation (R&D ↔ Business).

◆ “Three principles” & “Three pillars” of promotion measures＜Three principles (paradigm shift＞＜Three pillars＞

From Regulation To Development
Proper regulation from the venture business point of viewSupport from MHLW

From Cautious To Speedy
Promotion measures with a sense of urgency

From Macro To Micro
Provision of support according to thecharacteristics of each company
3◆ Specific measures taken in line with “three pillars”①＜First pillar - Establishment of systems that foster “ecosystems” of medical ventures＞

Basicresearch◆New system forearlier approvalof innovative
medical devices◆Newconsultation
system undercollaboration
betweenpharmaceuticalaffairs and publicinsurance

Clinicalresearch

Approval◆Review of the drug
& medical device
pricing system (forpublic insurance)
・Proper pricing
corresponding to thecharacteristics of venturecompanies
・Proper pricing of innovation
where price premiums havefailed to cover adequately
・Proper pricing for high costs
involved in R&Ds andproduction

Sales

PMS

Export◆Support for postmarketing surveillance(PMS)◆Support for
global businesses

・Promotion of PMS thatutilizes IT clinical data, etc.

international
consultation systemfor pharmaceuticalaffairs

・Improvement of thedisease registryfor ”Clinical Innovation
Network”
・Reduction of financial
costs involved in PMS

・Establishment of・Build-up of clinicalevidence based on
local needs, etc.
4◆ Specific measures taken in line with “three pillars”②＜Second pillar – Development of human resources for “ecosystems” and provide places
for interaction＞
Matching between
ventures and large
companies, etc.

Interaction andmobility of humanresources

Promotion ofexpansion to newfrontiers
Creativity toconnect globally

EcoSystem

Supply of mentors andintroduction system
Development of humanresource for high level
R&D and global business

Invention-friendly
environment＜Third pillar - Organizational support by “all MHLW”＞
Establish a “Strategy Office for Supporting Ventures ” in MHLW

Establish a “Support Office forCommercialization of Seeds by
Small-scale Enterprises” in PMDA

Establish a “Venture Support
Department” in ClinicalResearch Core Centers

PDCA cycle forpromotionmeasures ofmedicalventures5