Transparency Guidelines

Transparency Guidelines for Corporate Activities Involving Medical Institutions

The mission of pharmaceutical companies is to contribute to the advancement of medicine and people’s health through continued research and development for new drug discovery and stable drug supply. To this end, as expressed in its Business Philosophy, “Helping people lead healthier, happier lives,” Nippon Shinyaku engages in various forms of collaboration with universities and other research organizations, numerous healthcare institutions, and experts in medicine and pharmacology, including basic research, clinical studies, post-marketing verification of efficacy and safety, diffusion of information for appropriate drug use, and donation.
While such collaboration is essential for pharmaceutical companies, there is today growing societal demand that movements of money involved therein be appropriately managed and be made more transparent.
In response, the Japan Pharmaceutical Manufacturers Association (JPMA), an industrial organization for pharmaceutical companies, has adopted the “Transparency Guideline for the Relation between Corporate Activities and Medical Institutions” so that its corporate members will increase transparency in their collaboration with outside parties as mentioned above and that they and the pharmaceutical industry as a whole will gain greater trust from society. As a JPMA member, Nippon Shinyaku has drawn up its own transparency guidelines based on the JPMA Guideline as the company’s criteria of action to “earn the trust of society” as stated in the Management Policy.

Basic Policy

The publication of the Guidelines and related information disclosure conform to related industrial standards, such as the JPMA Charter of Corporate Behavior, the JPMA Compliance Program Guidelines, and the JPMA Code of Practice, as well as the spirit of these standards.
The purpose of the Guidelines is to ensure transparency in the company’s relationship with medical institutions, thereby promoting understanding among the general public that the company contributes to the development of medicine, pharmacology, and other life sciences and that it pursues its corporate activities while guaranteeing high ethical standards.

Publication Method and Period

Actual flows of funds during each fiscal year (from April 1 to the last day of March of the subsequent year) are published within a year from the end of the fiscal year via the company’s website and other means.

Published items of information

A. Expenses for research and development

Expenses for research and development include expenses required for research, surveys, and so forth that are conducted in compliance with public regulations and guidelines, such as the Clinical Trial Act and the GCP/GVP/GPSP ministerial orders as defined under the Pharmaceutical and Medical Device Act.
Nippon Shinyaku discloses information on funds provided as indicated below, along with the total annual sums of the items.

・Specified clinical trial expense (*1)Name and other particulars (*2) of recipient institutions
: __ cases, __ yen
・Ethical Guidelines-based research expense (*3)Name of recipient institutions (*4): __ cases, __ yen
・Non-clinical research expense (*5)Name of recipient institutions (*4)
・Clinical trial expenseName of recipient institutions (*4): __ cases, __ yen
・Post-manufacturing/marketing clinical trial expenseName of recipient institutions (*4): __ cases, __ yen
・Side effect/infection case reporting expenseName of recipient institutions (*4): __ cases, __ yen
・Post-manufacturing/marketing investigation expenseName of recipient institutions (*4): __ cases, __ yen
・Other expensesTotal annual sums
  • (*1) The term “specified clinical trial expense” refers to the expense paid based on a specified clinical research contract as defined under the Clinical Trial Act.
  • (*2) As “other particulars,” clinical trial identification codes, recipient organizations, medical institutions conducting the research, the names of principal investigators, and the like are disclosed.
  • (*3) The “Ethical Guidelines” in “Ethical Guidelines-based research expense” refer to the “Ethical Guidelines for Medical and Health Research Involving Human Subjects.”
  • (*4) As the term “recipient institutions,” the names of institutions, organizations within the institutions, and the affiliations, titles, and names of individuals involved are disclosed based on a contract.
  • (*5) The term “non-clinical research expense” refers to the expense required for research other than specified clinical trials, Ethical Guidelines-based research, clinical trials, and post-manufacturing/marketing investigations, such as basic research and pharmaceutical studies.
B. Expenses for scientific research promotion

Incentive donations made to promote scientific research or assist research, general donations, donations made to support the organizations of scientific conferences and other meetings, co-sponsorship of scientific conferences and other events
Information on funds provided is disclosed as indicated below, along with the total annual sums of the items.

・Incentive donations__ University __ Laboratory: __ cases, __ yen
・General donations__ University (__ Foundation): __ cases, __ yen
・Donations for scientific conferencesThe __th Convention of __ Society (__ Regional Conference, __ Study Group)
: __ yen
・Co-sponsorshipThe __th Convention of __ Society __ Seminar: __ yen

(*Including information whose disclosure is mandatory under the Clinical Trial Act)

C. Honorariums and fees

Expenses paid for lectures, the authorship or editorial supervision of articles, and consulting and other commissioned services undertaken to provide scientific information on the company’s pharmaceutical products and medical/pharmacological subjects and in connection with research and development
Information on funds provided is disclosed as indicated below, along with the total annual sums of the items.

・Lecturer’s honorariums__ University (__ Hospital) __ Department, Prof.(Dr.) __
: __ cases, __ yen
・Authorship/supervision fees__ University (__ Hospital) __ Department, Prof.(Dr.) __
: __ cases, __ yen
・Consulting and other commissioned services__ University (__ Hospital) __ Department, Prof.(Dr.) __
: __ cases, __ yen

(*Including information whose disclosure is mandatory under the Clinical Trial Act)

D. Expenses for information provision

Expenses for providing information on the company’s pharmaceutical products and medical/pharmacological subjects to healthcare professionals through lectures, information meetings, and the like

・Expenses for lectures and meetingsNumber of events per year, total annual sum
・Expenses for medical/pharmacological literatureTotal annual sum
E. Other expenses

Socially customary entertainment expenses

・Entertainment expensesTotal annual sum

〈 Reference 〉
Transparency Guideline for the Relation between Corporate Activities and Medical Institutions (JPMA)

Transparency Guidelines for Corporate Activities Involving Patient Associations

To fulfill their mission to contribute to the advancement of medicine and people’s health (and realize patient-participatory healthcare, in particular) through continued research and development for new drug discovery and stable drug supply, pharmaceutical companies are required to understand and adequately respond to the needs and difficulties that patients and their families encounter with regard to pharmaceutical drugs under all circumstances. Accordingly, pharmaceutical companies have been increasing the number of opportunities to collaborate with associations that represent patients of specific diseases and their families. At the same time, the need for transparency in interactions between pharmaceutical companies and patient associations has been growing so as to gain society’s fair understanding.
In such a situation, the Japan Pharmaceutical Manufacturers Association (JPMA), an industrial organization for pharmaceutical companies, has adopted the “Transparency Guideline for the Relation between Corporate Activities and Patient Associations” so that its corporate members will increase transparency in their collaboration with patient associations and that they and the pharmaceutical industry as a whole will gain greater trust from society. As a JPMA member, Nippon Shinyaku has drawn up its own transparency guidelines based on the JPMA Guideline as the company’s criteria of action.
The term “patient associations” in the guidelines refers to organizations mainly comprising patients, their families, and their supporters and established for the roles and purposes defined in principle under their articles of association or regulations, publicly representing the voices of patients, offering mutual support among patients and families, and working toward the betterment of care and treatment.

Basic Policy

The publication of the Guidelines and related information disclosure conform to related industrial standards, such as the JPMA Charter of Corporate Behavior, the JPMA Compliance Program Guidelines, the JPMA Code of Practice, the Transparency Guideline for the Relation between Corporate Activities and Medical Institutions, and the Guidelines for Collaboration with Patient Associations, as well as the spirit of these standards.
The purpose of the Guidelines is to ensure transparency in the company’s relationship with patient associations in its activities, thereby promoting the understanding of the general public that the company thus contributes to the operation and development of patient associations while guaranteeing high ethical standards and mutual understanding that respect the independence of patient associations.

Publication Method and Period

Actual flows of funds during each fiscal year (from April 1 to the last day of March of the subsequent year) are published within a year from the end of the fiscal year via the company’s website and other means.

Published items of information

Nippon Shinyaku discloses information on the funds it directly and indirectly provides to patient associations, rewards for services rendered at the company’s request, and patient associations that render services to the company.

(1) Directly provided funds

Including:

  • Donations, regular/supporting membership fees, co-sponsorship, advertising expenses

Information:

  • Names of direct recipient patient associations, sum per cost item
(2) Indirectly provided funds

Including:

  • ・Expenses for company-sponsored or co-sponsored lectures, information meetings, workshops, etc. organized to support patient organizations
  • ・Expenses for services commissioned to external service providers in connection with support for patient associations

Information:

  • Names of indirect recipient patient associations, total sum of indirectly provided funds
(3) Rewards for services rendered at the company’s request

Including:

  • Honorariums and fees for lecturers, authors/editorial supervisors, investigators, advisors

Information:

  • Names of patient associations rendering services at the company’s request and sum per cost item
(4) Others

Including:

  • Services rendered to the company

Information:

  • Names of patient associations rendering services

〈 Reference 〉
Transparency Guideline for the Relation between Corporate Activities and Patient Associations (JPMA)