Transparency Guideline for the Relationship Between Corporate Activities and Patient Organizations
Guidelines on Collaboration with Patient Organizations
Japan Pharmaceutical Manufacturers Association
(Established January 16, 2013; Effective April 1, 2013)
(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 mission of a research-based pharmaceutical company is to contribute to improving the health and medical care of people worldwide through the continuous creation and stable supply of innovative new drugs, thereby helping to realize a healthy and livable society.
In recent years, the importance of “patient-centered care” has been recognized, and initiatives aimed at realizing this concept have been discussed and implemented in various sectors.As pharmaceutical companies, in order to fulfill the above mission, we recognize the need to understand and address the needs and concerns of patients and their families in every situation where patients interact with pharmaceuticals—from the drug discovery stage through to the promotion of appropriate use and safety measures during the post-marketing phase. Consequently, opportunities for active and ongoing collaboration with patient organizations are increasing.
Against this backdrop, member companies formulated the “Guidelines on Collaboration with Patient Organizations” in 2013 to ensure that, in all forms of collaboration with patient organizations, they act with integrity and high ethical standards; respect the independence of patient organizations; and strive to achieve a thorough mutual understanding of the purpose and content of such collaboration.
Subsequently, at the APEC Business Ethics Forum held in Japan (Tokyo) in 2018, the “Guidelines for Ethical Partnerships in Japan” were adopted, based on the principles of “putting patients first,”“supporting ethical research and technological innovation,” “ensuring neutrality and ethical conduct,” and “promoting transparency and accountability.”
The Japan Pharmaceutical Manufacturers Association will continuously review these guidelines to make them more accessible and relevant to the times, and member companies collaborating with patient organizations will continue to use these guidelines as a reference to formulate and faithfully implement their own guidelines for collaboration with patient organizations.
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Mutual Understanding
Member companies will engage in collaboration with patient organizations based on mutual understanding, respecting each other’s perspectives and judgments. -
Building Trust
Member companies will build relationships of trust with patient organizations on an equal footing and fulfill their respective roles toward achieving common goals. -
Respect for the Independence of Patient Organizations
member companies will respect the autonomy and independence of patient organizations regarding their policy directions and operations. -
Ensuring Transparency
member companies will appropriately disclose information regarding financial support and other assistance provided to patient organizations in accordance with the “Transparency Guideline for Relationships Between Corporate Activities and Patient Organizations.” -
Written Agreements
Member companies shall enter into written contracts or agreements regarding the objectives and details of collaborative activities and funding provided to patient organizations prior to implementation, and shall maintain records of such agreements. -
Proper Provision of Information
Member companies shall provide information to patient organizations in accordance with relevant laws, regulations, and other applicable rules. -
Prohibition on Advertising and Promotion of Products
Member companies shall not advertise or promote prescription drugs to patient organizations. -
Prohibition on Exercising Influence
member companies shall not exert influence over the content of materials, publications, websites, or social media posts created by patient organizations for the benefit of the company. -
Encouragement of Diverse Funding Sources
member companies will not provide support on the condition that they be the sole funding source. They encourage patient organizations to secure funding for their activities from multiple sources. -
Appropriate Support
Member companies will limit their support for patient organizations to an appropriate level and scope. With regard to meetings and other events organized by patient organizations, they will provide appropriate support only after confirming that such support is commensurate with the purpose of the event. -
Management and Protection of Personal Information
member companies will respect the privacy of patients and patient advocates in their collaboration with patient organizations, comply with the Act on the Protection of Personal Information and other relevant laws and regulations, and properly manage and protect personal information obtained through collaborative activities.
Explanation of terms
Patient Organization
For the purposes of these Guidelines, “patient organizations” refer to “organizations composed primarily of patients, their families, and their supporters, which represent the voices of patients, provide mutual support to patients and their families, aim to improve the healthcare environment, and, in principle, have roles and objectives defined by their articles of incorporation or bylaws.” However, this definition applies regardless of whether the organization has legal personality or its form of establishment.
Collaboration with Patient Organizations
This refers to pharmaceutical companies and patient organizations working together as equals. It encompasses a wide range of activities, from exchange and support to initiatives aimed at solving shared challenges.
Financial Support, etc.
This refers to direct financial support such as donations; indirect financial support associated with events such as lectures; honoraria such as speaker fees; and the provision of labor services to patient organizations. Please refer to the scope of disclosure in the “Transparency Guideline for Relationships Between Corporate Activities and Patient Organizations.”