About IHOKEN
Outline of IHOKEN
The Japan Pharmaceutical Industry Legal Affairs Association (“IHOKEN”), established onApril 6, 1981, is the only organization that researches legal affairs surrounding pharmaceuticalcompanies and pharmaceutical-related companies. Its research extends from the various legal
areas relating to pharmaceutical companies and companies that produce medical devices,
regenerative medical products, and other pharmaceutical-related products, to compliance,
intellectual property, pharmaceutical regulations, clinical development, medical issues, andmore, and it currently has 363 registered individual members from 106 member companies.
The primary objective of IHOKEN is “to contribute to the improvement of national healthand welfare by promoting development in the pharmaceutical industry through conducting
research, gathering and exchanging information, and coordinating and cooperating with
relevant authorities and organizations to serve the needs of pharmaceutical companies andpharmaceutical-related companies, under the shared awareness of the association’s policy that
foster the development of “Legal Minds” of our members. IHOKEN also believes that one ofits key purposes is for its individual members to make efforts to enhance their capabilities as
professionals in legal affairs, compliance, intellectual property, pharmaceutical regulations,and related areas through mutual education on a wide range of topics relating to daily industry
affairs.
Annual membership fees from the member companies are the main source of revenue forthe administration of IHOKEN, which ensures its financial independence. At the same time,
IHOKEN coordinates with the Federation of Pharmaceutical Manufacturers’ Associations ofJapan (FPMAJ), the Japan Pharmaceutical Manufacturers Association (JPMA), and otherindustry organizations to jointly pursue the sound development of the pharmaceuticalindustry, its member companies, and other pharmaceutical companies one example of whichis IHOKEN’s cooperation with JPMA for the establishment of “the JPMA Compliance
Program Guideline.”

Administration of IHOKENIHOKEN’s operations are planned and managed by the Board of Directors (which consistsof elected directors and auditors), six committees, and one special committee, with clericalsupport from the Secretariat, in accordance with matters decided by the General Assembly,
IHOKEN’s main decision-making organ. IHOKEN has its headquarters in Tokyo, but also
has a Kansai branch to assist activities in the Kansai area particularly Osaka which is a centerfor pharmaceutical companies.

Directors and Auditors
Chairman

Hisahito Osuka

Alnylam Japan K.K.

Vice Chairman

Mitsutaka Okano

Daiichi Sankyo Co., Ltd

Vice Chairman

Yukihiko Okamura

Otsuka Medical Devices Co., Ltd.

Vice Chairman

Yoshitaka Saito

TAIYO Pharma Co., Ltd.

Vice Chairman

Satoshi Sawada

FUJIFILM Toyama Chemical Co., Ltd.

Chief Director

Kazuhide Ikeda

Shionogi Pharma Co., Ltd.

Director

Takaaki Ishii

Sumitomo Pharma Co., Ltd.

DirectorKinichi Enomoto

Pfizer Japan Inc.

DirectorHideki KatayamaOtsuka Pharmaceutical Factory, Inc.

Director

Yasushi Shimokawa

The Research Foundation for Microbial
Diseases of Osaka University

Director

Masakazu Nishiyachi

Chugai Pharmaceutical Co., Ltd.

Director

Keigo Baba

Maruho Co., Ltd.

Auditor

Tetsuri Kobayashi

Mochida Pharmaceutical Co., Ltd.

AuditorTakeshi Yamada

CSL Behring K.K.

Counselor
Yasunori Shibata

Former vice chairman of IHOKEN, Former secretary general ofIHOKEN, resigned from SANWA KAGAKU KENKYUSHO CO., LTD.

Research Groups, Monthly Meetings, Seminars in Practical Legal Affairs, and Journal“LEGAL MIND”
Registered members’ research activities are mainly coordinated through research groups.
With the formation of the “Medical Affairs and Clinical Development Research Group” inApril 2018, IHOKEN currently has 11 standing research groups in total nine groups in Tokyo,
two groups in Osaka, the Compliance Research Group based in Tokyo and Kansai, and aSpecial Research Group for revising the “Database of Pharmaceutical Contract Formats”.
Each registered member belongs to at least one of these research groups, and exchanges
knowledge and information and fosters its legal mind through research activities andcommunication with other members in the research group. Monthly meetings are held (i) toprovide an opportunity for each research group to present its results and (ii) to hear special
lectures delivered by experts from the industry, government, and academia. In 2017, IHOKEN
invited potential members to monthly meetings including the “IP Advance Month” topromote joining IHOKEN. As part of its efforts toward professional education in legal affairs,

compliance, intellectual property, pharmaceutical regulations, and other areas, IHOKEN
provides “Seminars in Practical Legal Affairs” nine times a year and gives opportunities forregistered members and other employees of the member companies to hear expert lectures.
The journal “LEGALMIND” also plays an important role in IHOKEN’s activities. The journal
publishes transcripts of the special lectures delivered at monthly meetings, reports of researchgroups, and other content, and is highly regarded internally and externally. The March 2018
issue of “LEGALMIND” was the 395th monthly issue including its predecessor publication,
the “IHOKEN NEWSLETTER.” Thirty-seven special issues of “LEGALMIND” have also
been published from time to time, including “Guideline for Compensation of Subjects’ Health
Injury in Clinical Studies” (2015). Commemorative books have been issued every five years
since IHOKEN’s establishment, the most recent of which was “History of the 40 Years ofIHOKEN” (2022).

About “IHOKEN GUIDE”
Every July, IHOKEN publishes the “IHOKEN GUIDE” in print and online, containing asummary of IHOKEN, a description of its activities, and other information. Readers who areconsidering joining IHOKEN are encouraged to refer to the “IHOKEN GUIDE.”