Transparency Guideline for the Relationship between Corporate Activities and Patient Groups
Guidelines for Collaboration with Patient Organizations
Japan Pharmaceutical Manufacturers Association
(Formulated January 16, 2013, Implemented April 1, 2013)
(Revised February 22, 2017, Implemented April 1, 2017)
(Revised September 25, 2017, Implemented April 1, 2018)
(Revised May 25, 2022, Implemented May 25, 2022)
The mission of research-based pharmaceutical companies is to continuously The mission of research-based pharmaceutical companies is to contribute to the improvement of health and medical care for people around the world through the continuous creation and stable supply of innovative new medicines, and to help realize a society in which people can live healthy and comfortable lives.
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 actively and continuously working 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.
JPMA 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 with integrity.
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Mutual Understanding
Member companies shall work with patient groups based on mutual understanding, respecting each party's views and judgment. -
Building Relationships of 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. -
Respect for Independence of Patient Groups
Member companies will respect the autonomy and independence of patient groups with respect to their policies and operations. -
Ensuring Transparency
Member companies shall disclose appropriate information regarding the financial and other support they provide to patient groups in accordance with the "Transparency Guideline for the Relationship between Corporate Activities and Patient Groups. -
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. -
Appropriate Provision of Information
Member companies shall provide information to patient groups in accordance with relevant laws and regulations. -
Prohibition of Product Advertisements and Promotions
Member companies shall not advertise or promote ethical drugs to patient groups. -
Prohibition of Exercising Influence
H-row member companies shall not influence the contents or statements of materials, publications, websites, or social networking sites created by patient groups for the benefit of the company. -
Encouraging Diversity of Funding Sources
H-row will not provide support that requires the member company to be the sole funder. Patient organizations are encouraged to seek funding for their activities from multiple sources. -
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. -
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.
Explanation of Terms
Patient Organization
Patient organizations in these Guidelines refer to "patient groups and patient support groups that are comprised mainly of patients, their families, and their supporters, that represent the voices of patients and their families, that support each other, and that aim to improve the medical treatment environment, and that have roles and objectives 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 Organizations
This refers to activities in which pharmaceutical companies and patient groups work together on an equal footing. The scope of activities ranges from exchange and support to shared problem-solving activities.
Financial support, etc.
This refers to direct financial support such as donations, indirect financial support for lectures, honoraria for lecturers, etc., and the provision of labor to patient groups. Please refer to the "Transparency Guideline for the Relationship between Corporate Activities and Patient Groups" for details.