Japanese Government Strategyto Promote Pharmaceutical industry

Director of Health & Welfare Dept.Hiroyuki Kawabata

Health & Welfare Dept.

Abenomics – The Three Arrows

First Arrow : Aggressive Monetary Policy

Second Arrow: Flexible Fiscal Policy

Third Arrow : Growth Strategy

Overcome deflation

Over the next 10 years (annual average)

2% real growth

3% nominal growth

1

Abenomics Outcome

Real GDP growth rate

+2.4% per year (first quarter 2015)

+2.0% total (from fourth quarter 2012 to first quarter 2015)

Stock price

Up 100% since Abenomics started

Jobs to applicants ratio

High standard (1.17 as of April 2015)

2

Employee wage

Average wage (highest in 15 years)

Summer Bonus (highest in 23 years)

Unemployment

Down 0.61 million (2.19 million as of April 2015)

Ordinary company profits

Highest standard (17.6 trillion yen as of 2014 fourth quarter)

Tourism to Japan

13.4 million in 2014 (+ 29.4% compared to previous year)

JAPAN, 1.41

USA, 1.88

0

0.5

1

1.5

2

2.5

80 82 84 86 88 90 92 94 96 98 00 02 04 06 08 10 12

Birth Rate

JAPAN, 25.06

USA, 14.14

0

5

10

15

20

25

30

80 82 84 86 88 90 92 94 96 98 00 02 04 06 08 10 12

％

Elderly Population Percentage

出所： U.S. Census Bureau, OECD Health DataCenters for Disease Control 3

Aging Society

Key Word

Optimization of Healthcare Costs

4

To achieve a stable supply of high-quality drugs as well as optimization of healthcare costs, the Japanese government decided to increase the share of generic medicine from less than 50% to 80% in the near future.

Enhancement of Industry Competition

Greater industry-academia-government collaboration

Fair reward of innovation in insurance reimbursement price

Small or middle sized companies open innovation

Medical Product Development

IT Development

Low Molecular Medicine Biologics Biosimilars Ventures（Bio, Academia） Translational Research Global Clinical Trials CRO’s, SMO’s

Medical Development

Personalized Medical Treatment

Gene Therapy Regenerative Medicine Preventative Care

GovernmentStrategy

Budget, Taxation and Regulation

Patents Regulatory Science

Market Trends

M＆A Strategic partnership Production base Generic medicine

Lifestyle-related Diseases

Dementia Rare Diseases End-of-life Care Infectious Diseases

Change in Needs

Big Data Wearable Devices Remote Treatment Artificial Intelligence

Societal Changes

Population Composition Economic Trends Financial Conditions International

Competition

The Environment Surrounding the Pharmaceutical Industry

5

Ministry of Health, Labour and WelfareSeptember 4, 2015

厚生労働省Ministry of Health Labour and Welfare

ひと 、 く らし 、 みらいのために

厚生労働省Ministry of Health Labour and Welfare

ひと 、 く らし 、 みらいのために

Comprehensive Drug Industry Reinforcement Strategy～Drug Discovery with a View to Global Expansion～

(Overview version)

For people, for life, for the future

ReferenceEnglish

6

Background to Formulation of Comprehensive Drug Industry Reinforcement Strategy

O As a knowledge-intensive industry, the drug industry is vital to supporteconomic growth in Japan, a country with limited resources.

O The market environment changes due to further generic promotion havebeen immense. The ‘Honebuto Principles 2015’ incorporated the followingas well as new generic targets etc.

O To achieve a trinity of ‘enhancement of industry competitiveness’, ‘stablesupply of high-quality drugs to the nation’ and ‘optimization of healthcarecosts’ in the 80% generic drug era too, the MHLW shall formulate anurgent and focused comprehensive strategy to enhance thecompetitiveness of the drug industry.

* The Comprehensive Strategy shall be revised following a progress check mid-2017 when the timing of the achievement of the volume-based generic sharetarget of 80% or higher will be specified.

The necessary actions shall be considered for enhancing the global competitiveness of the drugindustry, as through assurance of the stable supply of basic drugs highly needed in clinical practice ofwhich the ongoing manufacture and marketing is required, promotion of innovation through drugdiscoveries that contribute to the growth strategy and fair assessment of genuinely effective newdrugs.

7

Drug Industry – Realities and Challenges

Key ItemsI Japan is one of the few global drug development basesII Drug development costs are soaring, but Japanese companies are small in scaleIII Many of the leading pharmaceutical companies rely on revenues from long-listed

products and a business shift is urgently neededIV The profitability of some basic drugs has deteriorated through successive price

revisions and measures to assure their stable supply are neededV The generic drug market includes many companies operating on a small scale, of which

structural reinforcement is a challenge

Drug sales of the world’s leading pharmaceutical companies (2014) No. of new drugs by major country of origin(2013: Top 100 products by global sales)

France: 4

Denmark: 6

U.K.: 6

Germany: 9

Others: 2

U.S.: 53

Shire

Allergan

Valean

t P

harm

aceuticals

Celgen

e

Mylan

Merck Sero

no

Daiich

i Sankyo

Baxter In

ternatio

nal

Bio

gen Id

ec

Otsu

ka Ho

ldin

gs

Actavis

Astellas P

harm

a

Bo

ehrin

ger Ingelh

eim

Takeda P

harm

aceutical

No

vo N

ord

isk

Bristo

l Myers Sq

uib

b

Bayer H

ealthcare

Eli Lilly

Teva Ph

armaceu

tical In

du

stries

Ab

bV

ie

Am

gen

Gilead

Sciences

AstraZen

eca

Glaxo

Smith

Klin

e

Joh

nso

n &

Joh

nso

n

Merck

Sano

fi

Ro

che

Pfize

r

No

vartis

Source:

Unit: $ 100 million

Source: Published by Cegedim Strategic Data K.K., Uto Brain Division ‘Pharma Future’8

Basic Concept of Comprehensive Drug Industry Reinforcement Strategy

Basic PhilosophyI Promotion of innovationII Realization of high-quality and efficient healthcareIII Restructuring of policies from the global perspective

II Realization of High-quality and Efficient Healthcare(1) Assurance of stable supply of basic drugs(2) Acceleration of generic use(3) Stabilization and modernization of distribution and promotion of appropriate

price formation

III Restructuring of Policies from the Global Perspective(1) Global support(2) Promotion of Global Regulatory Harmonization Strategy(3) Future image of the drug industry

I Promotion of Innovation(1) Revitalization of clinical research and trials etc.(2) Greater industry-academia-government collaboration (commercialization of

excellent seeds from universities)(3) Reward for innovation in insurance reimbursement prices

9

Priority I – (1) Revitalization of clinical research and trials etc.

Basic conceptO Implement measures necessary to establish a CIN or similar clinical development infrastructure

O Give priority support for areas of potential future expansion, such as genomic medicine, iPS cell-derived and similar drug discoveries, nucleic acid-based drugs and biodrugs

Provision of clinical development infrastructure and development of human resources• Create a clinical innovation network (CIN) (through actions including provision of the clinical

development infrastructure using disease registry data and development of biostatisticians incollaboration with pharmaceutical companies and core clinical research hospitals)

• Expand the access to research areas etc. through standardization of electronic medicalrecord data in medical institutions

• Implement measures to promote drug repositioning through promoting research to build upevidence for linking up existing drugs with rare diseases etc.

Support for areas of potential future expansion • Form an All Japan network to analyze the genome data collected. To promote personalized medicine, set

up bases centered on the National Centers (NCs) for accumulating all genome data etc. and deliver tomedical institutions the information obtained from analysis etc. of this data. At the same time establishan intra-Ministry framework for the design and planning of genomic medicine commercialization

• Intra-Ministry departments shall review the policy initiatives of the Headquarters for the Implementationof Genomic Medicine (provisional designation) and the outcomes shall be incorporated in the ‘cancercontrol acceleration plan’ to be formulated by the year-end and in disease control measures etc.

• In collaboration with the Ministry of Education, Culture, Sports, Science and Technology and the Ministryof Economy, Trade and Industry, prioritize the AMED-allocated R&D budget to give support foremost forresearch on iPS cell-derived and similar drug discoveries and nucleic acid-based drugs etc.

• Using GMP-compliant antibody drug manufacturing facilities, promote the development of humanresources conversant with biodrug R&D in pharmaceutical companies 10

Priority I – (2) Greater industry-academia-government collaboration (to commercialize excellent seeds from universities)

Basic conceptO Further encourage the commercialization of excellent seeds discovered by academic

establishments etc. through greater industry-academia-government collaboration and promotionof open innovation

O Promote industry-academia dialogue and implement the measures necessary for Japan to be agenuine drug discovery nation

Expansion of public-private dialogue• Add academia, AMED and PMDA as participants in the ‘public-private dialogue for innovative drug and

medical device discovery’, the forum for dialogue on government policies between senior industry and government officials.

• Only one meeting held from fiscal 2012 to 2014 – increase the frequency

Joint public-private drug development

・ Establish the framework for efficient conduct of clinical trials through the application of disease registrydata accumulated by NCs and the formation of an industry-academia-government consortium

・ Isolate the themes for the purpose of resolving Japan’s drug development bottleneck and aim to establisha framework for focused research on each one through the participation of academia, pharmaceuticalcompanies, NCs and other parties concerned and public-private co-funding including AMED

Promotion of research with an exit strategy, etc.

・ In principle, make the selection from AMED-selected research themes of those to transition to thecommercialization stage conditional upon undergoing PMDA regulatory strategy consultations

・ Collaborate with universities and the industry to establish new functions in the Drug Discovery SupportNetwork、such as expansion of the compound library and prediction of clinical benefit

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Priority I – (3) Reward for innovation in insurance reimbursement prices

Basic conceptO Fair reward of innovation in insurance reimbursement prices is vital for the

promotion of drug discovery innovationO Given that drug R&D is a long-term project, assurance of the predictability of reward is

also vital

Format for reward under drug pricing system• To assure an effective and efficient drug discovery cycle, review the format of the premium to

promote new drug discovery and eliminate off-label use• Proceed to review the format for the assessment of drugs eligible for the sakigake review

designation scheme and other innovative drugs in order to create a highly predictable drugprice assessment system consistent with the regulatory system and ensure properassessment of innovation in Japan

・

Improvement of distribution (promotion of single-product, single-price transactions)• Improve ethical drug distribution in view of the need for pricing commensurate with the

value of individual drugs (through single-product, single-price agreements) to rewardinnovation fairly in Japan’s drug pricing system under which drug prices are determined onthe basis of actual market prices

12

Priority II – (1) Assurance of stable supply of basic drugs etc.

Basic conceptO Continued excessive falls in the prices of basic drugs highly needed in clinical

practice of which the ongoing manufacture and marketing is required into thefuture, will jeopardise their ongoing supply to the market

O Assurance of the continued stable supply of these basic drugs is neededO The use of clearly effective and safe and reasonably priced drugs is conducive

to high-quality and efficient healthcare, and is vital

Promotion of use of reasonably-priced drugs• Review the modality for the promotion of the use of reasonably-priced drugs conducive to high-quality and

efficient healthcare

Drug pricing measures to assure the stable supply of ‘basic drugs’

Clarify the requirements and discuss the necessary drug pricing measures etc. including minimum-priced

products of which the supply is difficult to maintain (including repair of manufacturing facilities) andproducts formerly subject to the repricing of unprofitable products rule

13

Priority II – (2) Acceleration of generic use

Basic conceptO Accelerate generic use since this is vital for further reduction of the national burden

etc.O Implement further generic promotion measures to achieve the 80% generic drug

target. In conjunction, consider the sound expansion of the generic drug industry

Drug pricing and medical fees system• Review generic drug prices in terms of assurance of stable supply and reduction of the national burden etc.• Review the format for promotional measures under the medical and dispensing fee system

Review of generic drug manufacturing and marketing• Review the format for descriptions of multiple manufacturer co-developments• With ongoing consideration of the healthcare services required, revise the line-up of generic drug

specifications during fiscal 2015, since this is burdensome for corporate manufacturing and marketing andmedical institution and drug wholesaler inventory management etc.

Discuss countermeasures for the price listing of a very large number of generic drugs – e.g. 30 or soproducts per ingredient (original drug), in view of the concerns over the inventory burden on pharmaciesetc. and drug wholesalers and assurance of stable supply

Quality assurance measures• Promote unified quality assurance through coordination of scientific evaluations with tests and

inspections of distributed products and disseminate the information to healthcare professionals Increase the number of products subject to dissolution tests etc. in the ‘tests and inspections to assure

the quality of distributed products’• Aim to reinforce the PMDA Office of Manufacturing/Quality and Compliance to increase the number of on-

site audits of overseas manufacturing sites

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Priority II – (3) Stabilization and modernization of distribution and promotion of appropriate price formation

Basic conceptO Fair cost-sharing of distribution costs between the parties concerned is vital to maintain the

stable supply of prescription drugs, in time of disaster tooO Single-product, single-price transactions reflecting the value of individual drugs are paramount

for stabilization of distribution and appropriate price formationO Revision of the distribution system is vital for the rapid promotion of generic use in view of the

increase in distribution management costs and to assure stable supply

Further promotion of single-product, single-price negotiations

• At a time of environmental changes in the distribution of prescription drugs as the number of innovativedrugs and generic drugs increases, single-product, single-price transactions are vital to ensure the fairreward of the innovation of innovative drugs and stable distribution

Distribution modality based on further promotion of generic use

• Assure proper and efficient distribution of generic drugs, which will account for half the volume ofprescription drugs in circulation

• Make new barcode labelling including information on changes in the shelf-life and manufacturing number etc. compulsory for newly listed products

Distribution modality in response to market changes and societal demands

• Restructure the distribution model in response to changes in the revenue structure of distributors• To assure safety, discuss the drafting of domestic GDP compliant with PIC/S GDP• Formulate a schedule for the compulsory new barcode labelling incorporating information on changes

15

Priority III– (1) Global support

Basic conceptO As one of the few new drug discovery nations in the world, contribute to upgrading global health

and healthcare levels through the stable supply of high-quality drugsO The increase in the number of emergent nations etc. in the global drug market is significant and

cooperation with and support for these nations will also be conducive to the overseas expansionof Japan’s drug industry

Cooperation with and support for emergent nations etc.• Establish the infrastructure for the expansion of the drug industry to the respective region through

introducing high-quality diagnostic and therapeutic technologies and developing foreign healthcare-related human resources

• Establish cooperative relations with the health ministry and regulatory authorities of emergent anddeveloping nations and, with a view to the global expansion of Japanese drugs, hold dialogue and shareJapan’s knowledge with the other country on local issues, in liaison also with local Japanese businesses

• Give support to developing nations through training etc. in drug safety measures with the aim ofimproving the access of developing nations to strictly controlled drugs

Proper protection of intellectual property• Aim to establish high-level drug-related intellectual property protection systems in other countries

through global negotiations etc.

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Priority III– (2) Promotion of Global Regulatory Harmonization Strategy

Basic concept○ Promote initiatives based on the Global Regulatory Harmonization Strategy (formulated in June of

this year) clarifying the medium-to-long term vision and policy priorities○ Promote global dissemination, foremost to Asia, of Japan’s knowledge (regulatory science).

Revitalize the drug and medical device industry while contributing further to the improvement ofglobal health and hygiene

Proactive dissemination of data to the global community

• Establish the ‘Asian Pharmaceuticals and Medical Devices Regulatory Training Center’ in the PMDA to offer anopportunity for effective training in line with the needs of Asian regulatory authorities

Establishment of environment for first-in-the-world approval of innovative drugs and medicaldevices etc.

• Promote the sakigake review designation system, the creation of a clinical innovation network and regulatoryscience research with application of the big data from the PMDA ‘Regulatory Science Center’ (to be establishedin 2018)

Strategic initiatives per area with clarified priorities (drugs, medical devices and regenerativemedicine products)• Contribute to the establishment of pharmaceutical regulations for the Asia region as part of the tripartite

Japan-US-Europe global harmonization framework (ICH)➢ Short-term: Aim to establish an abridged review system in the leading ASEAN countries on a level with Europe and the US➢ Medium-to-long term: Promote joint clinical trials by selected domestic central training centers, and cooperation in reviews

Promotion of sustainable and consistent global regulatory harmonization and cooperation• Establish the MHLW/PMDA organizational framework, introduce a managerial system per country and region.

Implement strategy progress management and revisions17

Priority III – (3) Future image of drug industry (1)

O To date the Drug Industry Vision setting out the MHLW future image of the drug industry has been formulated at 5-yearly intervals,

O Alongside greater dialogue with the industry through the Public-Private Dialogue etc., a new Vision shall be drafted based on the changing situation (the 80% generic drug era), but the rapid changes in the market structure through acceleration of generic use may present issues such as the following.

Drug Industry Vision 2013

Issues concerning new drug manufacturers

• The discovery of globally expandable innovative drugs is the role expected of new drug manufacturers. Ata time when the ratio of long-listed products in the market is decreasing, it is suggested that in futurethose that were unable to discover new drugs may be forced into a business shift etc.

• Given the increase in drug R&D costs and the global expansion of business, it is suggested that Japan’snew drug manufacturers should also perhaps consider business upscaling through M&As etc.

• The importance of bioventures in the pharmaceutical industry is increasing. It is suggested that as well asrevising their research strategy, manufacturers analyze and consolidate the conditions necessary forestablishing bioventure ecosystems and that the public and private sectors collaborate in thedevelopment of Japanese bioventures

Future image of new drug manufacturers(three-directional)

Response to patient needs

‘Development of innovative drugs’‘Stable supply of drugs’

‘Contribution to economic growth’ ‘Dissemination of Japan-origin innovation’

Greater investment in services and human resources

Expansion to overseas markets

18

Priority III – (3) Future image of drug industry (2)

Issues concerning generic drug manufacturers

• In the immediate future, expansion of the generic drug market is expected ahead of the 80%generic share target. However, following the achievement of this target, there will be lessscope for generic promotion in Japan (market expansion)

• Therefore, although the market is in an expanding phase, it is suggested that generic drugmanufacturers look to the future at the present stage and review their status, includingconcentration and upsizing

* It is also expected that foreign business that have so far not entered the Japanesemarket will start to manufacture and market drugs for this market

Top 3 Japanese specialised generic drug manufacturers

Top 3 Japanese new drug

manufacturers

Total fiscal 2014 sales

Generic drug sales

Nichi-Iko

Sawai Pharmaceutical

Towa Pharmaceutical

Takeda Pharmaceutical

Astellas Pharma

Daiichi Sankyo

Teva (Ref.)

Source: From the corporate financial data* Teva: Global GE sales leader

Exchange rate $1 = ￥120 (rate used at time of financial results)

(100 million yen)

19

(Overview of) Comprehensive Drug Industry Reinforcement Strategy

○ Japan is one of the few new drug discovery nations in the world andthe knowledge-intensive drug industry has also been placed as a pillarof Japan’s growth industries within the ‘Japan Revitalization Strategy’and the ‘Healthcare and Medical Strategy’.

Background

I Promotion of innovation(1) Revitalization of clinical research and trials, etc.

• Creation of a clinical innovation network• Priority support for genomic medicine , iPS cell-derived and similar

drug discoveries, nucleic acid-based drugs and biodrugs etc.• Promotion of drug repositioning, as through research on evidence-

building to link up existing drugs with rare diseases etc.(2) Greater industry-academia-government collaboration

(commercialization of excellent seeds from universities)• Joint access to disease registry data based on an industry-academia-

government consortium• Promotion of use of regulatory strategy consultations on research

transitioning to the commercialization stage• Expansion of public-private dialogue

(3) Reward of innovation• Fair reward for innovation in insurance reimbursement prices• Improvement of distribution (promotion of single-product, single-

price transactions)

(1) Assurance of stable supply of basic drugs etc.• Clarify the requirements for ‘basic drugs’ and discuss the drug pricing

measures necessary etc.(2) Acceleration of generic use (= decline in ratio of long-listed

products)• Discuss the format for promotional measures under the medical and

dispensing fee system• Discuss drug prices in terms of assurance of stable supply and reduction

of the national burden• Review the line-up of specifications etc.• Discuss countermeasures for the NHI price listing of numerous generic

drugs for one ingredient(3) Stabilization and modernization of distribution

• Make new barcode labelling compulsory for generic drugs on listing• Formulate a schedule for the introduction of compulsory new barcode

labelling• Promote single- product, single -price transactions

II Realization of high-quality and efficient healthcare

○ To ‘achieve a trinity’ of ‘enhancement of industry competitiveness’,’stable supply of high-quality drugs to the nation’ and ‘optimization ofhealthcare costs’ in the ‘80% generic drug era’ an urgent and focusedcomprehensive strategy to enhance the competitiveness of the drugindustry shall be formulated.

III Restructuring of policies from the global perspective

(1) Global support・ Cooperation with and support for emergent nations

etc. with expanding markets due to populationincrease etc.

・ Aim to establish high-level intellectual propertyprotection system in each country throughinternational negotiations etc.

(2) Global Regulatory Harmonization Strategy・ Promotion of Global Regulatory Harmonization

Strategy (formulated in June this year)・ Global dissemination of Japan’s regulatory science• Establishment of ‘Asian Pharmaceuticals and

Medical Devices Regulatory Training Center’ inPMDA

(3) Future image of drug industry (issues)・ Development of potentially global-level new

drugs・ Business upscaling through M&As etc. ・ Business shift of manufacturers finding new

drug development difficult as the ratio of long-listed products declines

・ Concentration and upsizing of generic drug manufacturers

Stable supply of high-qualitydrugs to the nation

Optimization ofhealthcare costs

Enhancement of industry competitiveness

80% generic drug era

(To be revised mid-2017 following a progress check.)

MHLW release on September 4, 2015

20

平成２７年９月４日厚生労働省

厚生労働省Ministry of Health Labour and Welfare

ひと 、 く らし 、 みらいのために

厚生労働省Ministry of Health Labour and Welfare

ひと 、 く らし 、 みらいのために

医薬品産業強化総合戦略～グローバル展開を見据えた創薬～

（概要版）

参考資料日本語

21

医薬品産業強化総合戦略策定の背景

○知識集約型産業である医薬品産業は、資源の乏しい我が国にとって、経済成長を担う重要な産業

○後発医薬品の更なる使用促進による市場環境の変化は非常に大きく、「骨太の方針２０１５」には後発医薬品の新目標等と併せて、以下の内容が盛り込まれた

臨床上の必要性が高く将来にわたり継続的に製造販売されることが求められる基礎的

な医薬品の安定供給、成長戦略に資する創薬に係るイノベーションの推進、真に有効な新薬の適正な評価等を通じた医薬品産業の国際競争力強化に向けた必要な措置を検討する。

○「後発医薬品８０％時代」においても、「国民への良質な医薬品の安定供給」・「医療費の効率化」・ 「産業の競争力強化」を三位一体

で実現するため、厚生労働省は医薬品産業の競争力強化に向けた緊急的・集中実施的な総合戦略を策定する

（※）後発医薬品の数量シェア80％以上の目標の達成時期を具体的に決定する2017年（平成29年）央の際に、進捗状況を確認し総合戦略の見直しを行う 22

医薬品産業の現状と課題

主な現状と課題

Ⅰ 我が国は数少ないグローバルな医薬品開発の拠点の一角を占めている

Ⅱ 医薬品開発の費用は高騰する一方、日本企業の規模は小さいⅢ 多くの大手製薬企業が長期収載品に収益を依存しており、転換が急務Ⅳ 基礎的医薬品は、度重なる薬価改定で一部について採算が悪化、安定供給

策が必要Ⅴ 後発医薬品市場は、経営規模が小さい企業が多数存在し、体質強化が課題

23

医薬品産業強化総合戦略における基本的考え方

基本理念Ⅰ イノベーションの推進

Ⅱ 質の高い効率的な医療の実現Ⅲ グローバルな視点での政策の再構築

Ⅱ 質の高い効率的な医療の実現

①基礎的医薬品等の安定供給の確保②後発医薬品の使用の加速化③流通の安定化・近代化、適切な価格形成の促進

Ⅲ グローバルな視点での政策の再構築

①国際支援②国際薬事規制調和戦略の推進③医薬品産業の将来像

Ⅰ イノベーションの推進

①臨床研究・治験活性化等②産学官の連携強化（大学発優れたシーズの実用化）③保険償還価格におけるイノベーションの評価

24

重点項目Ⅰ−① 臨床研究・治験活性化等

基本的考え方○ CINなど臨床開発インフラの整備のために必要な措置を講じる○ ゲノム医療、iPS細胞等を用いた創薬、核酸医薬品、バイオ医薬品など今

後の進展が見込まれる分野へ重点的に支援

臨床開発インフラの整備、人材育成

・ クリニカル･イノベーション・ネットワーク（ＣＩＮ）の構築（疾患登録情報を活用した臨床開発インフラの整備、製薬企業と臨床研究中核病院との連携による生物統計家の育成などを通じ、臨床研究の質の確保に資する人材を育成）

・ 各医療機関の電子カルテデータの標準化を通じ、研究分野等への利用拡大を図る

・ 既存薬と希少疾病等を関連付けるためのエビデンス構築に係る研究を推進するなどドラッグ・リポジショニングを促進するための施策を実施

今後の進展が見込まれる分野への支援

・ ゲノム情報収集分析のためのオールジャパンのネットワークを形成。全ゲノム情報等の集積拠点を国立高度専門医療研究センター（NC）を中心とした拠点に整備し、集積した情報の解析等によって得られた情報を医療機関に提供することで個別化医療の推進を図るとともに、省内のゲノム医療実用化の企画、立案を行う体制を整備

・ ゲノム医療実現推進本部（仮称）の取組方針に基づき、省内各局で検討し、年内目途に策定する予定の「がん対策加速化プラン」や疾病対策等に検討の成果を盛り込む

・ iPS細胞等を用いた創薬や核酸医薬品等の研究支援をはじめとした、AMEDで配分される研究開発予算について、文部科学省、経済産業省と連携して重点化を推進する

・ ＧＭＰ準拠抗体医薬品製造施設を活用し、製薬企業におけるバイオ医薬品の製造・開発に精通した人材育成を推進 25

重点項目Ⅰ −② 産学官の連携強化（大学発優れたシーズの実用化）

基本的考え方○ 産学官の連携強化、オープンイノベーションの推進により、アカデミア等で

発見された優れたシーズの実用化の更なる促進を図る○ 産業界やアカデミアとの対話を促進し、真の創薬立国に必要な施策の遂

行を図る

官民対話の拡充

・ 産業界と行政のトップの政策対話の場である「革新的医薬品・医療機器創出のための官民対話」について、その参加者にアカデミア、ＡＭＥＤ、ＰＭＤＡを加える

・ 平成２４年度から２６年度にかけて年1回の開催だったが、開催頻度を増やす

官民共同による医薬品開発

・ ＮＣが蓄積した疾患登録情報を活用し、産学官がコンソーシアムを形成することで、効率的な治験実施体制を構築する

・ 日本の医薬品開発のボトルネックを解消するための課題を抽出し、その課題ごとに、アカデミア、製薬企業、NC等の関係者が参画し、ＡＭＥＤも含めた官民共同出資により、集中的に研究を推進する体制の構築を目指す

出口戦略を見据えた研究の推進等

・ AMEDが採択した研究課題のうち実用化段階に移行するものは、原則的にPMDAの薬事戦略相談を受けることを採択の条件とする

・ 創薬支援ネットワークにおいて、大学や産業界と連携し、化合物ライブラリの拡充や臨床効果予測などの新たな機能を構築する

26

重点項目Ⅰ−③ 保険償還価格におけるイノベーションの評価

基本的考え方○ 創薬に係るイノベーションを推進するため、保険償還価格でイノベーション

を適正に評価することが重要○ 医薬品の研究開発は長期間なことから、評価の予見性の確保も重要

薬価制度における評価のあり方

・ 創薬サイクルを効果的・効率的に回す観点から、新薬創出・適応外薬解消等促進加算制度のあり方について検討を行う

・ 薬事制度と一貫性があり予見性の高い薬価の評価制度を構築し、我が国において適切なイノベーションの評価が行われるよう、「先駆け審査指定制度」の対象となる医薬品など革新的な医薬品に係る評価のあり方について検討を進める

流通改善（単品単価取引の推進）

・ 市場実勢価格に基づき薬価が決定される我が国の薬価制度において、イノベーションを適正に評価するためには、個々の医薬品の価値に見合った価格が決定される（単品単価契約となっている）ことが必要であり、医療用医薬品の流通改善を図る

27

重点項目Ⅱ−① 基礎的医薬品等の安定供給の確保

基本的考え方○ 臨床上の必要性が高く将来にわたり継続的に製造販売されることが求め

られる「基礎的医薬品」については、過度の価格下落が続けば、今後、市場への継続な供給を行うことが困難となる

○ このような基礎的医薬品について、継続的な安定供給の確保が必要○ 有効性、安全性が明確で且つ安価な医薬品の利用は、質の高い効率的

な医療に資するものであり重要

安価な医薬品の使用促進

・ 安価で質の高い効率的な医療に資する医薬品の使用促進のあり方について検討する

「基礎的医薬品」の安定供給のための薬価上の措置

・ 最低薬価では供給の維持（製造設備の改修を含む）が困難な品目や以前に不採算品再算定を受けた品目も含め、基礎的医薬品の要件を明確にした上で、薬価上必要な措置などについて検討を行う

28

重点項目Ⅱ−② 後発医薬品の使用の加速化

基本的考え方○ 後発医薬品の使用促進は、国民負担の軽減等という観点から重要なた

め、加速化○ 後発医薬品80％という目標の実現に向け、引き続き使用促進策を講ず

る。その際、後発医薬品産業の健全な発展も念頭に施策を講ずる

薬価・診療報酬制度

・ 後発医薬品の薬価について、安定供給の確保と国民負担軽減等の観点からそのあり方について検討

・ 診療報酬・調剤報酬上の促進策の在り方について検討

後発医薬品の製造販売のあり方の検討

・ 複数企業による共同開発の記載に関するあり方の検討

・ 後発医薬品の規格揃えは、企業の製造販売や医療機関・医薬品卸業者における在庫管理等の負担となるため、必要な医療の確保を考慮しつつ、27年度中に見直しを行う

・ １つの成分（先発医薬品）に対し30数品目など非常に多くの後発医薬品が薬価基準に収載されることは、薬局等や医薬品卸売業者の在庫負担や安定供給への懸念となることから、対応策を検討

品質確保対策

・ 学術評価と流通品の試験検査を連動させた一元的な品質確保を推進するとともに、医療関係者に情報発信する

・ 「流通品の品質確保のための試験検査」における溶出試験等の検査対象品目数を拡充

・ 海外製造所の実地調査を増やすためPMDAの品質管理部門等の体制強化を目指す 29

重点項目Ⅱ−③ 流通の安定化・近代化、適切な価格形成の促進

基本的考え方○ 災害時も含めた医療用医薬品の安定的な供給の維持には関係者間の流通

コスト負担の公平性の確保が重要○ 流通の安定化、適切な価格形成を行うためには、個々の医薬品の価値を反

映した単品単価取引が最重要○ 急速な後発医薬品の使用促進には、流通管理コストの増加や安定供給のた

めの流通体制見直しが必要不可欠

単品単価交渉の更なる推進

・ 革新的医薬品、後発医薬品が増加する医療用医薬品の流通を取り巻く環境変化の中で、革新的医薬品のイノベーションの適正な評価、流通の安定化のためには、単品単価取引が必要不可欠

後発医薬品の更なる使用促進を踏まえた流通のあり方

・ 流通する医療用医薬品の数量の大半を占めることとなる後発医薬品の適正かつ効率的な流通の確保

・ 新規収載品目について、有効期限、製造番号などの変動情報を含んだ新バーコード表示を必須化

市場の変化や社会的要請に対応する流通のあり方

・ 流通当事者における収益構造の変化に対応した流通モデルの再構築を図る

・ 安全性確保の観点からPIC/SのGDPに準拠した国内GDPの策定の検討

・ 変動情報が盛り込まれた新バーコード表示の必須化に向けた工程表の策定 30

重点項目Ⅲ−① 国際支援

基本的考え方○ 世界で数少ない新薬創出国として、質の高い医薬品を安定的に供給する

ことにより世界の保健医療水準の向上に貢献○ 人口増等に伴い医薬品市場の伸びは新興国等が大きく、新興国等との協

力・支援は結果として我が国の医薬品産業の海外展開にも資する

新興国等との協力・支援

・ 高品質な診断・治療技術の紹介や海外の医療関連人材の育成を支援することにより、医薬品産業が当該地域へ進出するための環境整備を行う

・ 新興国・途上国等の保健省や規制当局との協力関係の構築を進め、我が国医薬品の国際展開に向け現地で抱えている課題について、現地日系企業とも連携しつつ、我が国における知見の共有も含め相手国との対話を実施

・ 医薬品安全対策の研修等を通じた途上国支援を行い、管理が厳格な医薬品について途上国でのアクセス向上を目指す

知的財産の適切な保護

・ 国際交渉等を通じて、各国において医薬品に関する知的財産が高い水準で保護される制度が設けられることを目指す

31

重点項目Ⅲ−② 国際薬事規制調和戦略の推進

基本的考え方○ 中長期的なビジョンや施策のプライオリティを明確化した国際薬事規制調和

戦略（本年６月策定）に基づく取組を推進○ 我が国の知見（レギュラトリーサイエンス）をアジアをはじめ世界に発信。

世界の保健衛生の向上に一層貢献しつつ、医薬品・医療機器産業を活性化

国際社会への積極的な情報発信

・ PMDAに「アジア医薬品・医療機器薬事トレーニングセンター」を設置し、アジア規制当局のニーズに応じた効果的なトレーニング機会を提供

世界に先駆けて革新的な医薬品、医療機器等が承認される環境の整備

・ 先駆け審査指定制度、クリニカル・イノベーション・ネットワークの構築、 PMDAの「レギュラトリーサイエンスセンター」（平成30年には設置）でのビッグデータを活用したレギュラトリーサイエンス研究の推進

プライオリティを明確化した分野別（医薬品、医療機器、再生医療等製品）の戦略的な取組・ 日米欧３極での国際調和の枠組み（ICH）の一角として、アジア地域の薬事規制の構築に貢献

➢ 短期：ASEAN主要国の簡略審査制度における欧米と同等の位置づけを目指す

➢ 中長期：中核トレーニング施設の国内からの選出による共同治験の推進、審査協力の推進

継続性・一貫性のある国際規制調和・国際協力の推進・ 厚労省・PMDAの組織体制を構築し、国・地域別の担当者制を導入｡戦略の進捗管理、見直しの実施

※

32

重点項目Ⅲ−③ 医薬品産業の将来像①

○ これまで概ね５年間隔で医薬品産業ビジョンを策定し、厚生労働省による医薬品産業の将来像を示してきた

○ 官民対話などを通じて業界と対話を重ねながら、今後も状況の変化（後発医薬品80％時代）に応じた新たなビジョンの作成を行っていくが、後発医薬品の使用促進の加速化により急激に市場構造が変化するなかで、以下のような論点があるのではないか

医薬品産業ビジョン2013

新薬メーカーの論点

・ 新薬メーカーに期待される役割は、グローバルに展開できる革新的医薬品を創出することであり、市場における長期収載品比率が減少する中で、今後に新薬創出ができなかった新薬メーカーについては、事業の転換等が迫られるのではないか

・ 医薬品の研究開発コストの増加やグローバルでの事業展開を考慮すると、日本の新薬メーカーもM＆A等による事業規模の拡大を視野に入れるべきではないか

・ 製薬産業におけるバイオベンチャーの重要性が高まっており、各メーカーが研究戦略の見直しを行うとともに、バイオベンチャーのエコシステム確立のために必要な条件を分析・整理した上で、官民一体となって我が国のバイオベンチャーの振興に取り組むべきではないか 33

重点項目Ⅲ−③ 医薬品産業の将来像②

後発医薬品メーカーの論点

・ 後発医薬品のシェア80％という目標に向け、当面は日本における後発医薬品市場の拡大が見込まれる。ただし、この目標の達成後には、国内における使用促進の余地（市場拡大の余地）は、これまでよりも小さいということでもある

・ そのため、市場が拡大する局面ではあるが、後発医薬品メーカーは今の段階から将来を見越して、集約化・大型化も含めそのあり方について検討することが必要ではないか

（※） これまで日本市場に参入していなかった海外の企業が日本市場向けの医薬品の製造販売を開始することも見込まれる

34

医薬品産業強化総合戦略（概要）

○ 我が国は世界で数少ない新薬創出国であり、知識集約型産業である医薬品産業は、「日本再興戦略」や「健康・医療戦略」においても我が国の成長産業の柱の一つとして位置づけられている。

背景

Ⅰ イノベーションの推進

①臨床研究・治験活性化等・クリニカル・イノベーション・ネットワークの構築・ゲノム医療、iPS細胞等を用いた創薬、核酸医薬品、バイオ医薬品などを重点的に支援

・既存薬と希少疾病等を関連付けるためのエビデンス構築に係る研究を推進するなどドラッグ・リポジショニングを促進

②産学官の連携強化（大学発優れたシーズの実用化）・産学官コンソーシアムによる疾患登録情報の共同活用・実用化段階に移行する研究の薬事戦略相談の活用促進・官民対話の拡充

③イノベーションの評価・保険償還価格でイノベーションを適正に評価・流通改善（単品単価取引の推進）

②後発医薬品の使用の加速化（＝長期収載品比率の減少）・診療報酬・調剤報酬上の促進策の在り方について検討・安定供給の確保と国民負担軽減の観点から薬価を検討・規格揃え等の見直し・品質確保対策の充実・１成分に対し多くの後発品が薬価収載されることへの対応策を検討

①基礎的医薬品等の安定供給の確保・「基礎的医薬品」の要件を明確にした上で、薬価上必要な措置などについて検討

③流通の安定化・近代化・新規収載時の後発品の新バーコード表示を必須化・新バーコード表示の必須化に向けた工程表の策定・単品単価取引の推進

Ⅱ 質の高い効率的な医療の実現

○ 「後発医薬品８０％時代」において、「国民への良質な医薬品の安定供給」・「医療費の効率化」・ 「産業の競争力強化」を三位一体で実現する

ため、医薬品産業の競争力強化に向けた緊急的・集中実施的な総合戦略を策定する。

Ⅲ グローバルな視点での政策の再構築

①国際支援・人口増等に伴い市場拡大する新興国等との協力・支援

・国際交渉等を通じて、各国で知的財産が高い水準で保護される制度が設けられることを目指す

②国際薬事規制調和戦略・国際薬事規制調和戦略（本年６月策定）を推進・日本のレギュラトリーサイエンスを世界へ発信・PMDAに「アジア医薬品・医療機器薬事トレーニングセンター」を設置

③医薬品産業の将来像（論点）・グローバルに展開できる新薬の創出・M＆A等による事業規模拡大・バイオベンチャーの活用

・長期収載品比率が減少する中で、新薬創出が困難なメーカーは事業転換

・後発医薬品メーカーの集約化・大型化

国民への良質な医薬品の安定供給

医療費の効率化 産業の競争力強化

後発医薬品80％時代

（2017年央に進捗状況を確認し総合戦略の見直しを行う。）

平成２７年９月４日公表厚生労働省