Code Compliance
Code Compliance Promotion Committee
Interview with Mr. Ouchi, Chairperson

The mission of the Code Compliance Promotion Committee is to manage, administer, and disseminate information to ensure that the actions of member companies comply with relevant laws and regulations as well as voluntary standards such as the Pharmaceutical Manufacturers Association Code of Practice (COP). We believe that our activities to keep abreast of domestic and international regulations and industry trends in a timely manner and to promptly share necessary information will support the creation and maintenance of trust in the pharmaceutical industry, which in turn will directly lead to ensuring patient safety.

Especially since the establishment of the "Guidelines for Provision of Marketing Information on Ethical Drugs" in 2019, the form of information provision activities has changed significantly. In addition to the traditional face-to-face provision of information, webinars and online interviews are becoming more widespread, and the number of people responsible for providing information is expanding from MRs to MSLs and clinical development staff. In light of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code, the Pharmaceutical Manufacturers Association of Japan (PMAJ) has reorganized its framework to cover all those involved in promotion. We believe that the revised COP clarifies the point that the previous wording tended to be perceived as biased toward MRs. While the basic spirit remains the same, the clarification of the scope of the bearers is extremely significant.

At this point, the issue the committee considers is the degree of penetration of the COP. Even if the philosophy is shared, the degree of incorporation into actions differs from company to company, resulting in a situation in which the degree of compliance varies. It is important to fill in the gaps in understanding of COP through training and individual dialogue, showing specific examples.

Next, the impact of changes in promotion methods can be considered. Differences in devices themselves do not necessarily weaken promotion. However, new methods may cause unexpected oversights. In this regard, it is essential to work to increase the penetration of the revised COP.

Furthermore, the quality and compliance issues that have been pointed out in recent years are serious issues that affect the credibility of the industry as a whole. The Committee believes that the soundness of the industry is supported by the attitude of disclosing such incidents without concealment and promptly correcting them. We must enhance and maintain the credibility of the entire pharmaceutical industry through preventive measures.

The third pillar of the "Pharmaceutical Manufacturers Association of Japan Industry Vision 2035" is to "ensure ethics and transparency and become an industry trusted by society. As an organization that plays a central role in realizing this vision, the Committee has an urgent need to develop specific initiatives to foster and maintain public trust.

The most important issue for the time being is to ensure that the revised COP is well known to all. The message must be conveyed according to the understanding of member companies and medical professionals who are the recipients of the message, not according to the perception of those who convey it.

In addition, training is conducted every year for member company code management managers and code practice managers. In October, we are planning to hold a compliance-related kasuhara training for compliance managers and compliance practitioners. As for training, we interview member companies on a case-by-case basis regarding training deemed necessary.

In carrying out the activities of the Committee, it is necessary to continue to understand the actual activities of pharmaceutical companies and to identify issues. Through surveys of member companies, we will identify the factors that cause obstacles in the field and promptly provide necessary information and support.

In addition, as a contribution to "improving public literacy in health and medicine," as stated in the "Japan Pharmaceutical Manufacturers Association Industry Vision 2035," we will work to strengthen external collaboration and international communication, actively participating in IFPMA and other discussions, reflecting Japanese findings from the IFPMA Code revision stage, and developing a "consensus framework for ethical collaboration in Japan. In addition, we are playing a central role in the "Consensus Framework for Ethical Collaboration in Japan". We will also strive to deepen dialogue and exchange views with the Japan Medical Association and other related organizations.

In committee operations, as the number of personnel with diverse backgrounds increases, it is essential to strengthen education and accompanying support to ensure that the Code of Conduct is equally disseminated to new members.

We believe that the most reliable and efficient risk management is the development of a "fire prevention system," which will lead to the reassurance of patients and the maintenance of public trust. Through these efforts, we will move forward toward a future in which the pharmaceutical industry is truly recognized as "an industry trusted by society.

The structure and activities of the Code Compliance Promotion Committee are posted on the website of the Pharmaceutical Manufacturers Association of Japan. Please visit the website.

[Code Compliance Promotion Committee website]
Code Compliance Promotion Committee | Information from the Committee | Japan Pharmaceutical Manufacturers Association