Transparency Guideline for the Relationship Between Corporate Activities and Patient Organizations
Main Text
Japan Pharmaceutical Manufacturers Association
(Established March 14, 2012; Effective April 1, 2012)
(Revised February 22, 2017; Effective April 1, 2017)
(Revised September 25, 2017; effective April 1, 2018)
(Revised May 25, 2022; effective May 25, 2022)
The purpose of these guidelines is to ensure transparency in member companies’ relationships with patient organizations through their activities, thereby fostering broad public understanding that such activities contribute to the operations and development of patient organizations while upholding high ethical standards and mutual understanding that respect the independence of patient organizations.
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Member companies shall formulate their own “Guidelines on Transparency in Relationships with Patient Organizations” based on these Transparency Guidelines and adopt them as their own standards of conduct.
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“Patient organizations” are defined as patient and family support groups and patient advocacy groups that are primarily composed of patients, their families, and their supporters; represent the voices of patients; provide mutual support to patients and their families; and aim to improve the healthcare environment. In principle, these organizations have roles and objectives defined by their articles of incorporation or bylaws. However, the criteria for determining whether an organization qualifies as a “patient organization” are left to the discretion of the member company.Furthermore, the criteria for selecting organizations to which member companies provide funding or support shall be based on the judgment of the member companies.
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It is desirable for a company’s “Guidelines on Transparency in Relationships with Patient Organizations” to include the following statements.
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Member Companies’ Stance
Relationships with patient organizations must respect the independence of such organizations and ensure transparency. To ensure transparency, member companies must disclose their involvement and, regarding financial support, enter into a written contract or agreement regarding the purpose, content, and other details prior to the commencement of activities, and maintain records of such arrangements.Furthermore, all activities conducted by member companies with patient organizations must comply with the following documents established by the Japan Pharmaceutical Manufacturers Association (hereinafter referred to as “JPMA”):“JPMA Corporate Conduct Charter,” “JPMA Compliance Program Guidelines,” “JPMA Code of Practice,” “Transparency Guideline for the Relation between Corporate Activities and Medical Institutions, etc.,” and “Guidelines on Collaboration with Patient Organizations,” as well as the spirit of these guidelines.
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Scope and Content of Disclosure
Member companies shall disclose details regarding patient organizations to which they have provided direct or indirect funding, or for which they have provided services—such as compensation for tasks requested by the member company.-
Direct Financial Contributions
(Scope)
Donations, membership and supporting membership fees, sponsorship fees, advertising fees, etc.
(Content)
The names of patient organizations that received direct financial support and the amounts for each expense category shall be listed. However, the classification of expense categories shall be at the discretion of the member company. -
Indirect Financial Support
(Scope)
Expenses associated with lectures, briefings, training sessions, etc., hosted or co-hosted by the company for the purpose of supporting patient organizations
Expenses incurred by outsourcing to external vendors in connection with support for patient organizations
(Details)
List the names of the patient organizations that received indirect funding and the total amount of indirect funding provided. Note that it is not necessary to break down the information by patient organization or expense category. -
Honoraria, etc., for requests from member companies
(Scope)
Speaker fees, manuscript writing and supervision fees, research expenses, and fees for commissioned advisors, etc.
(Details)
List the names of patient organizations that received requests from member companies and the amounts for each expense category. However, the classification of expense categories is at the discretion of the member company. -
Other
(Scope)
Provision of Labor Services
(Details)
List the names of the patient organizations to which services were provided.
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Disclosure Timing
Member companies shall disclose information regarding financial contributions and other support for the previous fiscal year via their own websites or other means after each company has announced its financial results.