EFPIA Day 2022 Press Conference
Five Strategies to Enhance the Attractiveness of the Japanese Market

6 Oct 2022
Chair of EFPIA Japan
Takahiko Iwaya1

Overview of the European Federation of Pharmaceutical Industries andAssociations (EFPIA) Japan

Percentage of the total sales ofEFPIA Japan member
companies in the ethical drug
market in Japan 1)

Establishment

2002 (converted to general incorporated
association in 2022)

Overview

EFPIA Japan is comprised of European R&Doriented pharmaceutical companies
operating in Japan. Its mission is tocontribute to healthcare and patients inJapan through fast introduction ofinnovative medicines and vaccines. It aims
to strengthen dialogue with policy makers
to improve healthcare in Japan.

Member

23 companies (as of September 2022)

Board companies

AstraZeneca K.K.

Bayer Yakuhin, Ltd.

GlaxoSmithKline K.K.

Janssen Pharmaceutical K.K.

Merck Biopharma Co., Ltd

Nippon Boehringer Ingelheim Co., Ltd.

Novartis Pharma K.K.

Novo Nordisk Pharma Ltd.

Sanofi K.K.

UCB Japan Co., Ltd.

26%
Proportion of new drugs
launched by EFPIA Japanmember companies among
new drugs launched recently inJapan 2)

28%1) Approximately 2.8 trillion yen (EFPIA Japan 2021)
2) 46 components (EFPIA Japan 2019 – 21)2

We are concerned that policies biased toward drug cost reduction may
cause recurrence of a drug lag, resulting in deterioration of the quality of
medical care, and induce a negative cycle
Number of companies with drug development programs affected by thedrastic pricing reform in 2018 and associated market environment changes
1)

Termination

Delayed launch

Number of projects under clinicaldevelopment (In clinical trial phase toNDA submission) 2)

800
686

700
600
0%

10%

500
40%

40%

400
60%

50%

300
200

187

100YesNoNo Response

4 out of 10 companies decided totermination of launchYesNoNo Response

6 out of 6 companies who answered “Yes ”
Answer: Increased compared to that before
the Drastic Reform0Japan

1) Survey on 10 EFPIA Japan member companies on the Board (September 2022)
2) Survey in all EFPIA Japan member companies (September 2022)- Aggregated those who answered to both “Number of projects in Japan” and “Number of global projects” of under clinical development status (from clinical trial to NDAsubmission) in development pipeline.

Global3

To deliver innovative drugs to people in Japan, regardless of the origin
country of the drug, it is essential to establish an ecosystem for thepharmaceutical industry and increase the attractiveness of the market
Three factors for making Japan an attractive market
Development ofinnovative diagnostic
tech and treatment

Creation andpromotion ofinnovation

Access toinnovatice techand treatment

PharmaceuticalIndustry
Ecosystem

Improved
health byprevention,diagnosis, andtreatment

R&D and regulatory environment that drives innovation"Sustaining universal healthcare" while "driving
innovation"

Quality and efficiency of healthcareAppropriate
assessment ofinnovation

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EFPIA Japan executes five strategies toward the establishment of thepharmaceutical industry's ecosystem
Improve R&D and regulatory environment

Sustain universal healthcare while securing reward for innovationin the pharmaceutical sector

Contribute to health literacy enhancement

Build cost-effectiveness assessment approach that does not impede accessUtilize innovative technologies, incl. regenerative medicine, cell and gene therapy,
and digital technology, and develop necessary talent5Improvement of R&D and regulatory environment is necessary to deliver
the latest innovations to the people in Japan without delay from the USand Europe
Improvement of R&D and regulatory environment to promote the creation of innovative drugs

Development of an open ecosystem in Japan
Establish an international “open Japanese ecosystem ” regardless of the origin ofseeds from academia ventures or the nationality of pharmaceutical companies thatdevelop and obtain approval.

Establishment of sites for promotion ofcollaboration between Clinical Research Core
Hospitals and the industry side
To realize efficient clinical trial operations
Discuss, for example, the introduction of DCT, improvement of case accrual capacity,and aggregation of IRBs.

Introduction of a new drug approval system
based on key results from confirmatory clinical
trialsIntroduce a system to start new drug approval review based on major results ofconfirmatory clinical studies that have already been introduced in the U.S., andshorten the time from formal approval application to approval.

Establishment of a forum for discussion topromote industry-government-academia
collaboration in the development of highly
innovative drugs
Enhancement of technical support systems for academia by the government,
provide opportunities for industry-government-academia collaborative discussions
from the stage of considering regulatory requirements and development guidelines

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Japan needs to increase the market attractiveness by improving the drug
pricing system as the Japanese market is becoming less of a priority
among EFPIA member companies
Attractive drug pricing system to increase
market priority

Lower priority of the Japanese market
Change in priority of Japanese market relative toother markets after the fundamental drug pricing
reform655•

Secure high predictability that encourage investment in
R&D of new drugs•Grant incentives for first launches in Japan ahead of theworld•

Protect drug prices for new drugs during the patent period
in line with the US and Euro•

Maintain the current system that allows prompt NHI pricelisting and reimbursement after regulatory approval

4332210

Systems and regulations for referenceof future considerations

00

Increased

Slightly higher

No change

Slightly lower•

Official margin•

Reimbursement at purchase price•

Reference pricing•“Reimbursement ” like UK VAPS *LoweredSurvey in 10 EFPIA Japan member companies on the Board (September 2022), Unit: Number ofcompanies, n = 10*Voluntary Scheme for Branded Medicines Pricing and Access7

By providing appropriate information and supporting patients, we facilitate
patient health literacy and behavioral changes to promote efficient healthcare
resource utilization
Information activities to increase patientawareness

PASE - Patient Support Activities

List of health information websites provided by EFPIA member
companies
http://efpia.jp/healthliteracy/index.html

Interviews with vaccine experts

http://efpia.jp/healthliteracy_interview_article_1/index.html"PASE (Patient Advocacy Support by EFPIA Japan)" is a patient group support
project established in 2017 by EFPIA Japan. As part of the project, we provide
PASE AWARD to offer grants to organizations contributing to the advancementof patient advocacy activities. 2022 marks the fifth time of the PASE AWARD.

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We will make recommendations for a cost-effectiveness assessment system toappropriately reflect the diverse values of pharmaceutical products
Concerns•

Evaluation based on the incremental costeffectiveness ratio (ICER) alone•

Therapeutics for rare diseases are also subjectto CEA•

Potential use of CEA for decision making forreimbursement•Potential impact on patient access to latest
quality care, which is currently ensured inJapan and we can be proud of

EFPIA-J_HTA_Viewpoint_2020Jan_vf_JP.pdf

Ideal CEA systems

Evaluation of social and ethicalcontributions and indirect economic
effects of pharmaceuticals from a longterm perspective

Ensuring transparency with involvementof all parties

Utilization of cost-effectivenessassessments as a supplement to thedrug price system, not for decision
making for reimbursement9

To improve the quality of healthcare, we will support the utilization of
cutting-edge medical care such as gene therapy and regenerative
medicine and digital technologies by sharing knowledge in Europe anddeveloping human resources in Japan.
Leveraging digital technologies and data
through the Pharmaceutical Lifecycle

Application of innovative medical care••

Enhanced understanding of
disease and treatment
New Approaches toDelivering the Best
Medicines to Patients

•
•
•

•

•
•

Patient selfmanagement withcontinuous feedbackand communication
Enhanced managementof adverse reactions
Evaluation of Medicinal
Products Based on
Real-World Data

Further understanding ofpatient needs
Improvements in Clinical
Trial Design
Accumulation of data
during the study•••••

siryou4-2-8.pdf (kantei.go.jp)

Support patient care
Provision of information tohealthcare professionals
Realization of personalizedmedicine•

Automated safety andquality testing
Accurate understandingof demand
Tracking until delivery
to patients

The use of digital technologies and data in the medicine lifecycle
http://efpia.jp/healthliteracy_digital-health/index.html

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EFPIA seeks “Ideal Future” for people’s health and society in Japan incollaboration with diverse stakeholders
Ideal Future State
Increase public health awareness leading to improved disease prevention, earlier
diagnosis and treatment, thus extending healthy life expectancy

A society in which each person can live life to full despite illness or disability, and inwhich all citizens can live in harmony with each other
Safe and effective medicines developed around the world are available
in Japan without delay from other countries
All citizens should have equal access to the latest medical care and can lead healthy
lives without delay from other countries

11Thank you

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