EFPIA Japan

Message from Chair of European Federation of PharmaceuticalIndustries and Associations, Japan (EFPIA Japan)
As a super-aging society, Japan must address increasingly diversified
healthcare needs, while also responding to urgent public health challenges
as a result of the COVID-19 pandemic.
EFPIA Japan is fully committed to providing innovative medications toimprove the health and quality of life (QOL) of patients in Japan. I am
honored and truly humbled to be appointed as Chair of EFPIA Japan andwill make the most of my experience working as a government official andin the pharmaceutical industry to help fulfill the mission of EFPIA Japan.
Established in April 2002, EFPIA Japan represents 23 R&D-based European pharmaceutical companies operating inJapan. Combined sales of its member companies account for about a third of the total pharmaceutical sales in theJapanese market and they generate about a third of all the new drugs launched recently in Japan. EFPIA Japan willcontinue working passionately in order to best contribute to healthcare and above all to support patients in Japanby delivering the expertise and insights of innovation-seeking European pharmaceutical companies.
EFPIA Japan is actively engaged in dialogue with the Japanese government and other stakeholders on important
topics such as healthcare reform to maintain the universal health insurance system in this super-aging society, newhealthcare models that incorporate digital technologies and community-based hospital-clinic collaboration andfinally early introduction of innovative treatments and vaccines.
In particular, we make contributions to the policy debate with the aim to achieve the following outcomes:⚫ Increase incentives for innovative treatments and vaccines to improve the quality of healthcare in Japan, andensure patient access to them⚫ Maintain the predictivity and stability of National Health Insurance drug prices and thereby encourage thedevelopment and introduction of new drug
⚫ Ensure that all business operations are conducted in accordance with legal, ethical, and compliancerequirement
Through policy recommendations to help achieve these outcomes and innovations by collaborative efforts of its
member companies, EFPIA Japan will continue to be committed to ensuring a stable supply of medicines andvaccines, and enhancing its contribution to patients in Japan amid this current public health emergency.

Takahiko Iwaya

2EFPIA Japan ChairEFPIA Japan Member Companies (Total 23 Companies)
Alexion Pharma G.K.

Genmab K.K.

Nippon Boehringer Ingelheim Co., Ltd.

AstraZeneca K.K.

GlaxoSmithKline K.K.

Nippon Medac Co., Ltd.

Bayer Yakuhin, Ltd.

Guerbet Japan K.K.

Novartis Pharma K.K.

Bracco Japan Co., Ltd.

Ipsen Co., Ltd.

Novo Nordisk Pharma Ltd.

CHUGAI PHARMACEUTICAL CO., LTD.

LEO Pharma K.K.

Nxera Pharma Japan Ltd.

CSL Behring K.K.

Lundbeck Japan K.K.

Sanofi K.K.

Ferring Pharmaceuticals Co., Ltd.

Merck Biopharma Co., Ltd.

UCB Japan Co., Ltd.

GE Healthcare Pharma Limited

NIHON SERVIER COMPANY LIMITED

Board MembersChair

Takahiko Iwaya(Sanofi K.K.)

Vice Chair

Takafumi Horii(AstraZeneca K.K.)

Kasper Bødker Mejivang(Novo Nordisk Pharma Ltd.)Paul Lirette(GlaxoSmithKline K.K.)

Leo Lee(Novartis Pharma K.K.)

Kanako Kikuchi(UCB Japan Co., Ltd.)Jan Stefan Scheld(Nippon Boehringer Ingelheim Co., Ltd.)

Ying Chen(Bayer Yakuhin, Ltd.)

Jeremy Grossas(Merck Biopharma Co., Ltd.)Board of Directors

Director General

Yoshiaki Aono

EFPIA in the Japanese Market
Employment by EFPIA
member companies (2022)

EFPIA Member Companies inJapan Sales (2022)

Number of Newly Listed Drugs(2022)

approx. 28,034
Source: EFPIA Japan figures

3

EFPIA Japan has identified the following four states as
its vision of the future:

Increase public healthawarenessThe society all people
live in harmony witheach othervision of thefuture
The society in whichsafe and effective
medicines areavailable in JapanThe society in which all
people have equal access tothe latest medicine

Increase public health awareness"Increased public health awareness leads to promotion of prevention, early detection, and early treatment ofdiseases, thereby extending healthy life expectancy;"

The society all people live in harmony with each other"All people live in harmony, allowing each individual to be oneself despite illness or disability;"

The society in which safe and effective medicines are available in Japan"Safe and effective pharmaceuticals are available in Japan without delay from other countries;"

The society in which all people have equal access to the latest medicine"All people have equal access to the latest medicine and lead healthy lives;"

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Five basic strategies to realize EFPIA Japan's four states as
its vision of the future
To realize EFPIA Japan's four states as its vision of the future, it aims to continuously strengthen thepharmaceutical industry in Japan and increase the market attractiveness based on its five basic strategies.
Further, to execute the strategies, EFPIA Japan will build a resilient organization, strengthen collaboration
between Japan and Europe, and make distinctive contributions to society.

1. Support the enhancement of health literacy
EFPIA Japan works with the government and the healthcare community to support thehealth literacy in patients, as healthcare recipients’ literacy and interest in health is an

important factor in improving the quality of healthcare.

2. Drive pharmaceutical innovation while sustaining universal

healthcare
While maintaining the advantages of the current healthcare system in Japan that allows
prompt price listing and reimbursement of new pharmaceuticals after regulatory
approval, it is necessary to build a sustainable system to balance the financial
sustainability and the market attractiveness. To this end, EFPIA Japan carries on in-depth
debates with stakeholders on incentivizing new drug launches in Japan ahead of theworld and on allowing more flexibility in the new drug evaluation processes.

3. Be engaged in the development of cost-effectiveness assessment
processes
The use of health technology assessment (HTA) based on cost-effectiveness as a priceadjustment tool after listing involves both scientific and operational challenges. EFPIA
Japan believes that an appraisal with the participation of physicians and patients isnecessary to appropriately evaluate the value of pharmaceuticals and address theshortfall of the current cost-effectiveness assessment system. EFPIA Japan is committed
to the development and realization of appropriate cost-effectiveness assessment
processes by reflecting solutions to the challenges faced by Europe ahead of Japan andincorporating the diverse value of pharmaceuticals.

54. Promote the improvement of R&D and regulatory environment
To enable Japan to remain internationally attractive and competitive in the developmentof innovative pharmaceuticals and vaccines, and ultimately ensure that the people inJapan continue to benefit from the latest innovations, EFPIA Japan regularly investigatesthe clinical trial environment, encourages networking of core clinical research hospitals,
promotes a risk-based approach, and facilitates decentralized clinical trials.

5. Leverage digital technologies and develop digital talent
To effectively allocate limited healthcare resources, it is necessary to correct
inefficiencies in healthcare. Digital technologies can play a significant role in this regard.
To utilize digital technologies to increase the healthcare efficiency, allocate healthcare
resources appropriately, and improve health outcomes, the government needs to takethe lead in forming a framework for digital technology use, including the development ofa data infrastructure and its incorporation into community healthcare. Further, talentswith both macro perspectives on the healthcare system and patient-oriented micro
perspectives, who can look ahead to the utilization of evolving technology seeds mayserve as a bridge between the pharmaceutical industry and society. To this end, EFPIA
Japan develops such talents in the industry building on the experiences in Europe.

6Organization
Board
Pricing & Economics Committee

Director General

EFPIA Japan Office

Yoshiaki Aono

Secretary General
Leon Ochiai

AuditorMina Nagaoka

Access Committee

Patient Committee

Vaccines Working TeamTechnical Committee

Blood Products Working Team

Governance & Legal Committee

Messaging & Advocacy Committee

Communications Committee

EFPIA Japan committee activities (September 2023)
EFPIA Japan is focusing on the following activities
1.

Put forth evidence-based policy recommendations to ensure appropriate reward for innovation andincentives for investment in research and development in the course of pricing reform discussions.

(Pricing and Economics Committee)
2.

Promote public-private dialogue on healthcare systems, including cost-effectiveness assessment aligned withthe pricing system, diagnosis procedure combination per-diem payment (DPC), cancer genomic profiling andcompanion diagnostics, and intractable disease control, to improve patient access to medicines and ensure
appropriate reward for innovation in the country. (Access Committee)

3.

Support the improvement of a healthcare environment for patients by encouraging the activation of patientgroup activities, so that their voices are appropriately reflected in the healthcare system. Strengthen
collaboration with patient groups in various disease areas through information exchanges and educational

opportunities. (Patient Committee)
4.

Contribute to improving the regulatory environment and the environment for executing drug development
and post-marketing activities in Japan and enhancing development and evaluation technologies to ensure
the availability of innovative medicines as quickly as possible with appropriate information and their safe useby patients. (Technical Committee)

75.

Contribute to the further enhancement of compliance and integrity in the pharmaceutical industry andenable member companies to respond flexibly to changes from legal, ethical, and compliance perspectives.
(Governance and Legal Committee)

6.

Develop and implement strategic advocacy plans in collaboration with other committees/working teams andother pharmaceutical industry bodies to advocate the importance of appropriate rewards for innovation andimprovement of the regulatory environment to ensure patient access to innovative medicines in the country
as quickly as possible. Create impactful and consistent messages that harmonize with allcommittees/working teams and promote EFPIA's policies. (Messaging and Advocacy Committee)

7.

Develop and execute effective communication activities to advance EFPIA Japan's positions and initiatives,enhance its presence, and promote policy advocacy, thereby facilitating stakeholders’ understanding.
(Communications Committee)

8.

Contribute to the public health of the country by introducing world-class innovative vaccines to Japan as
early as possible. Aiming to improve the predictability of the vaccine market in Japan, continue dialogue andcollaboration with government and academia, and put forth policy recommendations to policymakers on
regulations, including biological product standards and national assay, life-long immunization program, andawareness-raising on vaccination and infectious disease control. (Vaccines Working Team)

9.

Promote patient access and regulatory harmonization for blood products through dialogue with thegovernment. Enhance EFPIA Japan's presence and position as a trusted partner for blood law stakeholders.
(Blood Products Working Team)EFPIA Japan key activities in 2022
EFPIA Japan offers a patient group support program “PASE”
Patient Advocacy Support by EFPIA Japan (PASE) is ourinitiative to support further development of thehealthcare

environment

surrounding

patients

byencouraging revitalization of patient group activities inJapan so that their voice is appropriately reflected. We
will make our best efforts to ensure “patient-centeredhealthcare” in Japan by supporting patient groups that
contribute to development.
5th PASE award ceremony (October 5, 2022)

EFPIA Japan Office
Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488 (Office established in Sanofi K.K.)
Tel: 03-6301-4094
E-mail: info@efpia.jp URL: http://www.efpia.jp/(Updated in July 2024)