Guidelines for Transparency in the Relationship Between Corporate Activities and Medical Institutions

Guidelines for Transparency in the Relationship Between Corporate Activities and Medical Institutions

We have established the Kissei Code of Conduct and pursue business activities with the aim of contributing to the health of people around the world and to the advancement of medical care through the development and provision of highly original pharmaceuticals and outstanding products that contribute to health through diet. As a member of the life sciences industry with significant involvement in the lives and health of patients and the people of Japan and that exists under the universal healthcare insurance system, it is crucial that Japan’s pharmaceutical industry, more than any other industry, demonstrate transparency in its activities. In our aim to be an R&D-oriented pharmaceutical company that will earn even greater trust from society, we establish the Guidelines for Transparency in the Relationship Between Corporate Activities and Medical Institutions.

1. Our Approach to Transparency

We strive to ensure the transparency of the relationship between all our corporate activities and medical institutions, etc. in accordance with both the letter and the spirit of relevant guidelines, including those established by the Japan Pharmaceutical Manufacturers Association (JPMA), including the JPMA Charter of Corporate Behavior, JPMA Compliance Program/Guideline, and JPMA Code of Practice.

2. Method of Disclosure

Information is disclosed on the Company website.

3. Timing of Disclosure

Disclosures are made no later than one year after the end of each fiscal year.

4. Scope of Disclosure

A. Research and development expenses, etc.

Research and development expenses, etc. include expenses required for research, surveillance, etc. conducted based on official regulations such as the ministerial ordinances on good clinical practice, good vigilance practice, and good post-marketing study practice under the Clinical Trials Act and the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and various guidelines. Funds provided are disclosed as follows along with the total annual amount of each item.

(Note 1) “Specified clinical trial expenses” refers to expenses paid under contracts for specified clinical trials as defined in the Clinical Trials Act.

(Note 2) “Clinical trial ID No.,” “Recipient of funds,” “Name of medical institution conducting trial,” “Name of physician responsible for trial,” etc. will be disclosed.

(Note 3) “Ethical guidelines” in “Expenses for research based on ethical guidelines” refers to “Ethical Guidelines for Medical and Biological Research Involving Human Subjects” (Medical and Biological Research Guidelines)

(Note 4) For “Name of relevant institution, etc.,” “Name of relevant institution,” “Name of organization within relevant institution,” and “Affiliation, position, and name of individual” will be disclosed based on the contract.

(Note 5) “Nonclinical research expenses” refers to costs incurred for research other than specified clinical trials, research conducted under ethical guidelines, clinical trials, or post-marketing surveillance. This includes so-called “basic research” and “pharmaceutical formulation studies.”

B. Academic Research Grants

Scholarship donations and general donations made for such purposes as promoting academic research and supporting research, as well as donations and co-sponsorship expenses for academic conferences, etc. to support the costs of holding academic conferences
“Co-sponsorship expenses, etc. for academic conferences, etc.” include seminar co-hosting expenses, ad placement fees, and exhibition fees incidental to the holding of meetings.
Funds provided are disclosed as follows along with the total annual amount of each item.

(*This item also includes information subject to mandatory disclosure under the Clinical Trials Act)

C. Fees for Writing Manuscripts, Etc.

Expenses paid to provide scientific information, etc. on the medical and pharmaceutical sciences, including the Company’s pharmaceuticals, or as consideration for lectures and writing/supervision of manuscripts related to research and development, or for consulting and other outsourced services Funds provided are disclosed as follows along with the total annual amount of each item.

(*This item also includes information subject to mandatory disclosure under the Clinical Trials Act)

D. Expenses related to information provision

Expenses for seminars, briefings, etc., to provide healthcare professionals with information on the Company’s pharmaceuticals and on medicine and pharmacology

E. Other expenses

Expenses for hospitality, etc. provided as a social courtesy

5. Timing of application

These guidelines apply to payments in and after FY2023.

Established December 1, 2011
Revised April 1, 2024

Guidelines for Transparency in the Relationship Between Corporate Activities and Medical Institutions【PDF/131kb】

Guidelines for Collaboration with Patient Groups

We engage in business activities with the aim of contributing to the health of people around the world and to the advancement of medical care through the development and supply of outstanding products. In collaboration with patient groups, we act in good faith with high ethical standards and respect the independence of those groups. We also establish these guidelines for collaboration with patient groups to ensure full understanding of each other’s objectives and the contents of collaborations and to build appropriate relationships of trust.

1. Mutual Understanding

We collaborate with patient groups in the spirit of mutual understanding, respecting the views and judgments of the other party.

2. Building Relationships of Trust

We build relationships of trust with patient groups as equal partners and fulfill our role for the achievement of objectives we share with them.

3. Respect for the Independence of Patient Groups

We respect the autonomy and independence of the action policies and operation of patient groups.

4. Assurance of Transparency

We conduct appropriate disclosures of information about the financial and other support that we provide to patient groups in accordance with the Guidelines for Transparency in the Relationship Between Corporate Activities and Patient Groups.

5. Agreement in Writing, etc.

For collaborations with patient groups, we exchange written contracts or agreements in advance regarding the objectives, content, and other details of specific activities, funding, and other matters, and retain records of those matters.

6. Appropriate Information Provision

We provide information to patient groups in accordance with relevant laws and regulations.

7. Prohibition of Product Advertising and Promotion

We do not engage in any advertising or promotions that target patient groups.

8. Prohibition of Exertion of Influence

We do not exert any influence for our own benefit over the content of materials, publications, websites, or social media posts, or over statements or other expressions made by patient groups.

9. Recommendation of Diverse Funding Sources

We do not provide support on the condition that we will be the sole contributor of funding. We recommend that patient groups obtain funding for their activities from multiple sources of support.

10. Appropriate Support

We limit our support for patient groups to an appropriate level and scope. For any meetings held by patient groups, we provide appropriate support after first confirming that such meetings are in line with our values.

11. Management and Protection of Personal Information

In collaborations with patient groups, we comply with the Act on the Protection of Personal Information and other relevant laws and regulations. We also properly manage and protect the personal information of patients and patient advocates obtained through collaborative activities.

Guidelines for Collaboration with Patient Groups【PDF/104kb】

Guidelines for Transparency in the Relationship Between Corporate Activities and Patient Groups

We engage in business activities with the aim of contributing to the health of people around the world and to the advancement of medical care through the development and provision of outstanding products. By ensuring transparency in relationships with patient groups in our activities, we aim to promote broad understanding that our efforts contribute to the activities and advancement of patient groups while ensuring high ethical standards and mutual understanding. To this end, we establish these guidelines and implement them in good faith.

1. Our Approach to Transparency

We respect the independence of patient groups and strive to ensure the transparency of our relationships with such groups in accordance with both the letter and spirit of relevant guidelines established by the Japan Pharmaceutical Manufacturers Association (JPMA), including the JPMA Charter of Corporate Behavior, JPMA Compliance Program/Guideline, JPMA Code of Practice, Transparency Guideline for the Relation between Corporate Activities and Medical Institutions, and Guideline for Collaboration with Patient Organizations.

2. Method of Disclosure

We disclose funding provided, etc. in the previous fiscal year on the Company website and through other means after the announcement of financial results.

3. Scope and Details of Disclosure

We disclose payments that fall under 1) to 4) below.

1) Direct funding
Names of patient groups to which we provided direct funding and the amounts for each expense item
Scope: Donations, membership/supporting membership fees, sponsorship expenses, advertising expenses, etc.
Example

・AAA Group

2) Indirect funding
Names of patient organizations to which we provided indirect funding and total amount of indirect funding
Scope: Expenses associated with seminars, briefings, and workshops, etc., hosted or co-hosted by us for the purpose of supporting patient groups and expenses paid to external contractors in connection with the support of patient groups
Example

3) Honoraria for matters that we have requested
Names of patient groups to which we made requests and the amounts for each expense item
Scope: Honoraria for speakers, fees for writing/supervising manuscripts, surveillance fees, consultancy, and other commissioned service fees
Example

・AAA Group

4) Other
Names of patient groups to which the Company’s employees provided labor/services
Scope: Provision of labor/services
Example

Established April 1, 2013
Revised October 1, 2022

Guidelines for Transparency in the Relationship Between Corporate Activities and Patient Groups【PDF/109kb】