COMPANY

TOP MESSAGE

The history of the successive revisions to the Fair Competition Code for Pharmaceutical Industry and JPMA Code of Practice obviously correlates with the history of compliance scandals and disgraceful actions on the part of pharmaceutical companies at the center of such scandals. Although the pharmaceutical industry has strived to restore society’s trust after such events, inappropriate activities still continue.
Under such circumstances, the Ministry of Health, Labor and Welfare (MHLW) has been rapidly promoting preventive measures, such as the enactment of the Clinical Research Act (2018), the execution of the Guidelines on the Sales-related Information Provision Activities (“MHLW’s Promotion Guidelines”) (2019), reinforcement of MHLW’s monitoring activities for advertisement (2019) and the planned revision of the Pharmaceutical and Medical Device Act (2019).
Pharma Integrity (“PhI”) Inc. is a consulting company founded by experts who are well-experienced in compliance who support pharmaceutical companies to adapt to such a rapidly-changing environment.
As an “Integrity Partner”, we are here to give our support to your business. We are committed to contribute to development of the pharmaceutical industry.

March, 2019

Pharma Integrity Inc.

Yoshihiko Otoguro

Representative Director

Company Profile

Company Name	Pharma Integrity Inc.
Date of Establishment	March 5, 2019
Representative Director	Yoshihiko Otoguro
Location	Shinjuku Center Building 49F, 1-25-1 Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan

Our Strength

1. Deep understanding of pharmaceutical businesses

We have a deep understanding of how business is done in the pharmaceutical industry, which is essential to provide effective support for our clients.
All of PhI’s consultants have extensive work experience in the pharmaceutical industry and have a profound understanding of the business.

2. Accumulated know-how about compliance

Our compliance know-how is based on broad industry experience and is definitely helpful for our clients.

3. Extensive experiences in industry associations

Industry associations are very important in the pharmaceutical industry. Reading relevant law texts is not enough to understand the essence of the regulations in the industry.
All of PhI’s consultants have extensive experience in industry associations and have profound practical knowledge about how the regulations are implemented.

4. Expertise on legal norms

Many rules in the pharmaceutical industry are entrusted to self-regulation by industry associations but the ultimate basis for business operations is based on legal norms.
PhI has the expertise of an international lawyer on hand, specializing in the pharmaceutical industry. Our lawyer works as a consultant and has professional knowledge and expertise about legal norms including the current situation and the latest changes and current situation regarding the relevant laws.

5. Close network with external experts

PhI can offer clients a wide range of services with expertise and has the resources to call upon other experts where necessary.
PhI closely cooperates with experts including law firms to resolve complex issues.

MEMBERS

Yoshihiko Otoguro
1994	Glaxo SmithKline KK (“GSK”) (previously Japan Glaxo KK), Academic Department
2003	GSK, Branch Manager in Kanagawa Prefecture
2010	GSK, Head of Business Compliance Department JFTC Headquarters, Administrative Member
2011	JPMA Code Compliance Committee, Permanent Member
2014	JFTC, Administrative Member at Headquarters
2015	EFPIA Japan, Chairman at Corporate Ethics Division
2016	Compliance consultant for pharmaceutical companies
March 2019	Pharma Integrity Inc., Representative Director
June 2019	Advisor for Governance and Legal Committee of EFPIA (The European Federation of Pharmaceutical Industries and Associations) Japan

Keijiro Minegishi
1982	Japan Glaxo KK, Sales Department
2005	GSK, Business Compliance Department The Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry
	-Administrative Vice Chairman, Hokkaido Branch -Administrative Vice Chairman, Kita-Kanto Branch -Administrative Vice Chairman, Minami-Kanto Branch -Administrative Member, Tohoku Branch -Administrative Member, Chubu Branch
2010	Compliance consultant for pharmaceutical companies
March 2019	Pharma Integrity Inc., Senior Consultant and Director

Yohei Kijima
2012	Licensed Lawyer (Tokyo Bar Association)
2013	Eisai Co., Ltd., Legal Department
2015	Licensed Lawyer (New York, USA)
2017	CSL Behring KK., Head of Legal and Compliance Department
January 2019	Shin-Yotsuya Law Office
January 2019	Advisor for the Compliance Research Group of Japan Pharmaceutical Industry Legal Affairs Association (“IHOKEN”)
March 2019	Pharma Integrity Inc., Senior Consultant and Director
April 2021	GI&T Law Office, LC
March 2022	Shin-Yotsuya Law Office

Executive Adviser

Tokuo Tanaka
1983	Takeda Pharmaceutical Company Limited (“Takeda”)
1993	Institute for Health Economics and Policy (General Incorporate Foundation), Dispatched Head of Business Planning Department
2006	Takeda, Medicine Sales Headquarters, Branch Manager at Kyoto Prefecture
2010	Takeda, Medicine Sales Headquarters, Branch Manager at Yokohama Area
2013	The Japan Pharmaceutical Manufacturers Association (JPMA), Managing Director
2014	MR Education & Accreditation Center of Japan (Public Interest Incorporated Foundation), Director
2014	Kyoto Pharmaceutical University (Educational Corporation), Councilor
2018	Japan Medical Management Practice Association (General Incorporate Foundation), Director
2019	MR Education & Accreditation Center of Japan (Public Interest Incorporated Foundation), Executive Director
2022	Academy of Next Generation in Pharmacy (General Incorporate Foundation), Director
October 2022	Pharma Integrity Inc., Executive Adviser
May 2023	Kyoto Pharmaceutical University (Educational Corporation), Director

Expert Partner

In addition to the consultation services above, PhI expertise on hand from several expert partners who have experience not only as sales managers at major pharmaceutical companies but also have experience at compliance departments (including experience as the Administrative Chairman at JFTC Branches). We will offer the most suitable consultant(s) to deal with the task depending on your specific requests.