Transparency Guidelines for Relationships between Corporate Activities and Patient Groups Guidelines on Collaboration with Patient Organizations

Japan Pharmaceutical Manufacturers Association
(Formulated on January 16, 2013, Implemented on April 1, 2013)
(Revised on February 22, 2017, Implemented on April 1, 2017)
(Revised on September 25, 2017, Implemented on April 1, 2018)
(Revised on May 25, 2022, Implemented on May 25, 2022)

The mission of research-based pharmaceutical companies is to contribute to the improvement of health and healthcare of people around the world through the continuous creation and stable supply of innovative new medicines, thereby contributing to the realization of a healthy and comfortable society.
In recent years, the importance of "patient-participatory medicine" has been recognized, and efforts toward its realization have been considered and implemented in various fields. In order to fulfill the above mission, pharmaceutical companies recognize the need to understand and respond to the needs and concerns of patients and their families at every stage of the relationship between pharmaceutical products and patients, from the drug discovery stage to the promotion of appropriate use and safety measures for pharmaceutical products after marketing, and are increasingly working proactively and continuously with patient groups. In this context, member companies are increasingly collaborating with patient groups.
In this context, member companies established the "Guidelines for Collaboration with Patient Organizations" in 2013 to ensure that, in any collaboration with patient organizations, they act with high ethical standards and integrity, respect the independence of patient organizations, and strive to fully mutually understand the purpose and content of their collaboration with patient organizations. In 2013, the Japanese Ministry of Health, Labour and Welfare (MHLW) formulated the Guidelines for Collaboration with Patient Organizations.
Subsequently, at the APEC Business Ethics Forum held in Japan (Tokyo) in 2018, the APEC Business Ethics Forum stated that "patients are our top priority" and "we support ethical research and innovation in technology." The APEC Business Ethics Forum in Tokyo called for the establishment of a "Consensus Framework for Ethical Partnerships in Japan" based on the principles of "putting patients first," "supporting ethical research and innovation," "ensuring neutrality and ethical behavior," and "promoting transparency and accountability. The Japan Pharmaceutical Manufacturers Association (JPMA), the Japan Pharmaceutical Manufacturers Association (JMPIA), and the Japan Pharmaceutical Manufacturers Association for Healthcare Products (JPPHI) have declared the establishment of a "Consensus Framework for Ethical Collaboration in Japan" based on the principles of "ensuring ethical conduct" and "promoting transparency and accountability.
JCIA will continuously review these Guidelines to make them easier to understand and more in line with the times, and member companies that work with patient groups will continue to use these Guidelines as a reference to develop their own guidelines for working with patient groups and apply them in good faith.

  1. Mutual Understanding
    Member companies shall work with patient groups based on mutual understanding, respecting each party's views and judgment.
  2. Building Trust
    Member companies will build relationships of trust with patient groups on an equal footing and fulfill their respective roles toward the realization of common objectives.
  3. Respect for Independence of Patient Groups
    Member companies will respect the autonomy and independence of patient groups with respect to their policies and operations.
  4. Ensuring Transparency
    Member companies shall disclose appropriate information regarding the financial and other support they provide to patient groups in accordance with the "Guidelines for Transparency in the Relationship between Corporate Activities and Patient Groups.
  5. Agreements in writing, etc.
    Member companies shall exchange written contracts or agreements on the purpose and content of activities and funding for collaboration with patient groups prior to implementation, and shall keep records of such agreements.
  6. Appropriate Provision of Information
    Member companies shall provide information to patient groups in accordance with relevant laws and regulations.
  7. Prohibition of Product Advertisements and Promotions
    Member companies shall not advertise or promote ethical drugs to patient groups.
  8. Prohibition of Exercising Influence
    Member companies shall not influence the contents or statements of materials, publications, websites, or social networking services created by patient groups for the benefit of the company.
  9. Encouraging Diversity of Funding Sources
    Member companies will not provide support that requires them to be the sole source of funding. Patient organizations are encouraged to seek funding for their activities from multiple sources.
  10. Appropriate Support
    Member companies will limit their support of patient groups to an appropriate level and scope. We will provide appropriate support for meetings, etc. held by patient groups after confirming that they are appropriate for the purpose for which they are held.
  11. Management and Protection of Personal Information
    In collaboration with patient groups, member companies shall respect the privacy of patients and patient supporters, comply with relevant laws and regulations such as the Personal Information Protection Law, and properly manage and protect personal information obtained through collaborative activities.

The End

Explanation of Terms

Patient Organization

Patient groups referred to in these Guidelines are "patient groups and patient support groups that are mainly composed of patients, their families, and their supporters, that represent the voices of patients, support patients and their families, and aim to improve the medical treatment environment, and that have roles and purposes defined in their articles of incorporation or constitution, in principle. However, the existence of a legal entity and the form of establishment are not required.

Collaboration with Patient Groups

It means that pharmaceutical companies and patient groups work together on an equal footing. A wide range of activities, from exchange and support to activities aimed at solving shared issues.

Financial Support

The term "patient groups" refers to direct funding such as donations, indirect funding associated with lectures and other events, honoraria for lecturers and other rewards, and the provision of labor to patient groups. Please refer to the "Transparency Guidelines for the Relationship between Corporate Activities and Patient Organizations" public disclosure target.

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