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12 Apr 2023 @ Europe House / Online

1Internal【Opening】
16:00-16:10

Opening Remarks

Mr. Hubertus von Baumbach, President of EFPIA (video)
Mr. Takahiko Iwaya, Chair of EFPIA Japan【Part1 Lectures about Initiatives encouraging innovation】
From Industry
16:10-16:25
16:25-16:40
From Government
16:40-16:55
16:55-17:10(1) Opening the future with the powerof innovation

Ms. Kanako Kikuchi, Board Member of EFPIA Japan(2) Opportunities to enhance Japan’s
global market attractivenessMr. Paul Hudson, Chief Executive Officer, Sanofi(1) EU’s vision for innovation

Mr. Jean-Eric Paquet, EU ambassador(2) Policies of promoting innovation inJapanMr. Shinichi Isa, State Minister of MHLW (video)<Formation Change>【Part2 Dialogues; “The importance of continuously seeking for innovations and expectations for the future”】
17:15-17:55(40 min)【Closing】
17:55-18:00

Moderator: someone professional
Panelist 1. Patient
Panelist 2. HCP
Panelist 3. Government
Panelist 4. Industry

Ms. Naomi Sakurai, Japan Federation of Cancer Patient Groups
Dr. Watanabe, Director of Japan Medical Association
Mr. Katsufumi Jo, Assistant Vice Minister of MHLW
Mr. Kasper Bødker Mejlvang, Board Member of EFPIA Japan

Closing Remarks

Mr. Takahiko Iwaya, Chair of EFPIA Japan

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Opening Remarks
Mr. Hubertus von Baumbach, Chief Executive Officer, C. H. Boehringer Sohn AG & Co. KG (Video Message)
Mr. Takahiko Iwaya, President and Representative Director, Sanofi K.K.

President of EFPIA
Chair of EFPIA Japan
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Part 1 Lectures
Lectures about Initiatives encouraging innovation

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EU Japan Health Innovation Forum 2023
- Opening the future with the power of innovation -April 12, 2023

Kanako KIKUCHIEFPIA Japan Board Member
Representative Director and President, UCB Japan Co., Ltd.
5InternalEFPIA Japan is delivering patient-centered innovations
Establishment: 2002 (became a general incorporated associationin 2022)
Overview: EFPIA Japan is comprised of European R&D-oriented
pharmaceutical companies operating in Japan. Our mission is tocontribute to healthcare and patients in Japan through the early
introduction of innovative medicines and vaccines, and we aim
to strengthen dialogue with policymakers to improve healthcarein Japan.
Membership: 23 companies (as of April 2023)
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.

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

26%
Proportion of new drugs
launched by EFPIA Japanmember companies
among new drugs launchedrecently in Japan 2)28%1) Approximately 2.8 trillion yen (EFPIA Japan 2021)
2) 46 components (EFPIA Japan 2019 – 21)

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What EFPIA Japan thinks about innovations are:
 Patients' voices are a source of innovation
 Healthcare innovation aims to:• Bring hope to patients and change & save lives of patients andtheir families• Extend healthy life expectancy, energize society, andcontribute to better communities• Make science and medical practice to progress Each one, even one who is supporting others, may
become a patient one day.

• Stakeholders should understand each other and help to create
innovations

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EFPIA Japan executes the five strategies to continue creating innovations
and bring them to patientsDrive pharmaceutical innovations while sustaining universal healthcare
Be engaged in the development of cost-effectiveness assessment processes
that ensure patient access
Promote the improvement of R&D and regulatory environments
Support the enhancement of health literacy
Leverage innovative technologies such as regenerative medicine, gene/cell therapy,
and digital and develop talent8Internal

Drugs & Vaccines innovations in Japan
1. Do innovations occur spontaneously?
2. How can patients access innovations?

(JP)_EFPIA_HTA_Viewpoint-2019Jan.pdf

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Drugs & Vaccines innovations in Japan1. Do innovations occur spontaneously?
 Suitable infrastructures and regulations are needed

Agile regulatory frame in line with international standard and ready toaddress/review new technologies
 Appropriate financial conditions are required: Costs? OR Investment?
Let's think about the total benefits that society may gain
• Innovations will protect people suffering from new diseases or currently uncurable diseases• The percentage of pharmaceutical products in the total national healthcare spending has beenaround 20% as direct cost but also help to save overall HC cost

2. How can patients access innovations?

A patient-friendly system must be built to help patients benefit from theinnovations they need while maintaining Universal Healthcare System(JP)_EFPIA_HTA_Viewpoint-2019Jan.pdf

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An innovation-friendly environment must be built
through:
Building an open ecosystem that fits Japan
Introducing an International harmonized regulatory
system that starts NDA review based on the topline

Industry

Patients

Government

Academia

results of confirmatory clinical trials
Creating opportunities that encourage collaboration
between clinical research core hospitals andpharmaceutical companies
Creating opportunities to discuss how to promoteindustry-government-academia collaborations in thedevelopment of innovative new drugs
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EFPIA Japan promotes the creation of an environment where thepatient's voice can be heard: Patient Advocacy Support by EFPIA Japan (PASE)
PASE (Patient Advocacy Support by EFPIA Japan):
EFPIA Japan's patient group support project
launched in 2017
Overview: PASE encourages patient groups to act
more energetically and make policymakers reflect
patients' voices in the healthcare system in Japan,
thereby improving the healthcare environment
surrounding patients.
PASE Awards: Every year, EFPIA Japan provides
grants to organizations contributing to theadvancement of patient rights advocacy activities.
Education to patients about disease, treatments, etc.

The 5th PASE Award at EFPIA Day 2022
Source: Kibo-no-Kai, an award winner
EFPIA JAPAN | PASE - Patient support activities

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EFPIA Japan believes that cost-effectiveness analysis
system should ensures patient access
EFPIA's viewpoint: Four principles of cost-effectiveness analysis (CEA)
EFPIA has significant experience in the application of HTA in European markets. EFPIA suggests the following four
principles for CEA system in Japan.

1. Should not be used for reimbursement determination in order to protect patients'access
2. Should be used as a complementary tool for the system of drug pricing andreimbursement
3. Evaluate ethical and social value of pharmaceuticals from a long-term perspective
4. Involve all stakeholders in comprehensive evaluation to secure transparency(JP)_EFPIA_HTA_Viewpoint-2019Jan.pdf
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Decreased priority of the Japanese market may affectthe launch of new drugs in Japan
Discontinue, postpone or delay product launch in Japan
Change in priority of the Japanese market vs othercountries after the fundamental reform of the drug
pricing system
Unit: Number of companies, n = 1065543322• Decreases in the NHI price at the initial listing,revisions in the future, and their predictability• Need for developing products only for Japan(due to the 2-week prescription limit for newlylaunched drugs)• Influence on other countries like China where
Japan's NHI prices are referred to as pricing
data

1000

高くなった
Increased

やや高くなった
Slightly higher

変わらないNo change

やや低くなった
Slightly lower低くなった
LoweredSource: Survey on 10 EFPIA Japan board companies (September 2022)

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For global pharmaceutical companies to bring innovative newdrugs to Japanese patients as soon as possible, Japan needs tohave a supportive drug pricing system


Maintain the current system that ensures prompt NHI listing andreimbursement following the NDA approval;

Evaluate the value of innovative drugs appropriately;Provide incentives for launching new drugs in Japan earlier than othercountries;

Have a high predictability;

Be sustainable

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Summary: EFPIA sees the following challenges as opportunities and willcontinue to engage in dialogue with various stakeholders
Creating an environment that promotes innovation
Building a patient-friendly system to help patients benefit from the innovations
they need
Being engaged in the development of Cost-Effectiveness Assessment processes
that ensure patient access
Building a drug pricing system that rewards and incentivizes innovation so as tosupport the stable delivery of innovative new drugs to Japanese patients

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Thank you17

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EU Japan Health Innovation Forum 2023- Opportunities to enhance Japan’s global market attractiveness -April 12, 2023

Paul HUDSON

Chief Executive Officer, Sanofi
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EU’s vision for innovation
EU’s power for innovation and DX
for people, patients and innovation
Jean-Eric Paquet
Ambassador of the European Union to Japan
EU-Japan Health Innovation ForumInternal

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Part 2 Dialogues“The importance of continuously seeking for innovations
and expectations for the future”

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Closing Remarks
Mr. Takahiko Iwaya, President and Representative Director, Sanofi K.K.

Chair of EFPIA Japan33

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The END

See you again!
終了

ありがとうございました。

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