Fair Operating Practices Appropriate Relationships with Medical Institutions and Patient Organizations

Compliance with Promotion Code and MHLW Guidelines on Provision of Prescription Drug Marketing Information

In the Japan Pharmaceutical Manufacturers Association's Code of Practice (JPMA Code), for a pharmaceutical company, "promotion" is not so-called "sales promotion." Rather, it is defined as the provision, collection, and transmission of pharmaceutical information to and from healthcare professionals and the advancement of the proper use and spread of those ethical pharmaceuticals based on that information.
The Promotion Code for Prescription Drugs is a part of the Pharmaceutical Manufacturers Code and describes details of promotions conducted by member companies.
In accordance with the intent of the Promotion Code, we established the Mitsubishi Tanabe Pharma Promotion Code for Prescription Drugs to promote the appropriate use and dissemination of prescription drugs.
Following the application of the Guidelines for Sales Information Provision Activities for Ethical Drugs, which sets forth a standard for appropriate sales information provision activities for ethical drugs by the Ministry of Health, Labour and Welfare, we established an appropriate Promotion Supervisory Committee and an appropriate Promotion Supervisory Division as a system for verifying that the Company is properly conducting sales information provision activities. In addition to creating appropriate promotional tools, we will conduct routine monitoring and education on sales information provision activities to promote the proper use of prescription drugs.

Fair Competition Code of the Ethical Pharmaceutical Drugs Marketing Industry

The Fair Competition Code on Restrictions on Premium Offers in the Ethical Pharmaceutical Drugs Marketing Industry (hereafter the "Code") has been established in the prescription drug industry. The aim of the Code is to restrict unjustifiable premiums, such as money, goods, services, etc., provided as an inducement to engage in transactions so as to ensure autonomous and rational decisions (purchasing, prescribing) by healthcare professionals, etc., as well as fair competition among businesses. The Code has its legal basis in the Act against Unjustifiable Premiums and Misleading Representations.
In addition to the Code, restrictions (hereafter, the Notifications) are in place on various matters relating to premium offers in the ethical pharmaceutical industry, medical devices industry, and the clinical laboratories industry, based on Article 4 of the above act. The ethical pharmaceutical industry restricts premium offers through the Code and the Notifications.
The Mitsubishi Tanabe Pharma Group adheres strictly to the Code, the Notifications, respects the International Federation of Pharmaceutical Manufacturers and Associations' Code of Conduct (IFPMA Code), which was established by an organization that the Japan Pharmaceutical Manufacturers Association is a member of, and practices fair medical information activities. Respecting the spirit of the IFPMA Code, from 2019, we have prohibited the giving of personal gifts in the Treatment Guidelines for Medical Institutions.

Initiatives Related to Transparency with Medical Institutions and Patient Organizations

To support not only the discovery of innovative drugs but also the provision and collection of information for the purpose of appropriate drug usage, collaboration and alliances among pharmaceutical companies, universities, and medical institutions are indispensable. However, as these alliance activities become more common, there are increasing opportunities for medical institutions and healthcare professionals to be significantly involved with specific companies or products, and there could be concerns about the extent to which the judgment of these medical institutions and healthcare professionals is influenced by this situation.
Accordingly, in accordance with guidelines formulated by the Japan Pharmaceutical Manufacturers Association (JPMA), in July 2011 the Company formulated its guidelines for transparency in relationships with medical institutions, etc. In accordance with these guidelines, from fiscal 2012 we have followed a policy of releasing related information on the Company's website. This information includes payments to medical institutions as research and development expenses, etc., academic research support expenses, manuscript/writing fees, etc., information provision-related expenses, and hospitality and other expenses. The purpose of these initiatives is to secure a broad understanding from society in regard to the contribution made by the Company's business activities to progress in medicine, pharmacology, and the other life sciences and in regard to the Company's high ethical standards in its business activities. Of these, the Company is separately disclosing recipients, etc. for "research and development expenses," "academic research support expenses," and "manuscript/writing fees, etc." In addition, in August 2014 the Company formulated guidelines for managing conflicts of interest with medical and research institutions, etc. We have established principles for avoiding problems with conflicts of interest and a system for managing conflicts of interest, and we are working to operate this system in an appropriate manner.
In particular, in regard to scholarships and donations to domestic medical institutions, which are included in "research and development expenses, etc.," to secure transparency in April 2016 the Company started a system of publicly inviting applications on the Internet. Funding is provided after screening is conducted by a third-party unit.
In addition, in regard to relationships with patient organizations, first it is important for corporate activities to be based on a high level of ethical standards and mutual understanding with respect for the independence of patient organizations. On that basis, to secure a broad understanding from society in regard to our contribution to the activities and development of patient organizations, in accordance with the guidelines of the JPMA, in April 2013, we formulated our guidelines for transparency in relationships with patient organizations. From fiscal 2013 information regarding the funds and labor provided to these patient organizations is provided on the Company's website.
Furthermore, in regard to the provision of compensation or funds to doctors or to healthcare related institutions or organizations in Europe or the U.S., we are conducting information disclosure in an appropriate manner in accordance with guidelines and laws formulated in Europe and the U.S.