Topics Held "Meeting of Code Administration Managers and Practitioners for 2023

Prior to the meeting, Ms. Chika Hirata, Chairperson of the Pharmaceutical Association of Japan Code Compliance Promotion Committee, introduced the basic policy of the Committee for FY2023 and an overview of the four key issues. She then encouraged the participating code administrators and practitioners to take the information and tools shared and discussed at the meeting back to their member companies and make effective use of them.

＜Basic Policy
The Code Compliance Promotion Committee supports member companies in fulfilling their social responsibilities with high ethical standards as members of the life-related industry by complying with relevant laws and regulations as well as the Pharmaceutical Manufacturers Association Code of Practice and other voluntary codes.

Mr. Go Matsumura, Chairperson of the Code Compliance Promotion Committee, reconfirmed the "Request for Prevention of Erroneous Dissemination of Information on In-house Drugs Prior to Approval" issued on April 18, 2023 as a notice by the Chairperson of the Committee. In particular, he reminded the Committee of the need to thoroughly implement measures to prevent misdelivery of information to outsourcing companies and to conduct inspections of such companies.

The Committee also explained that, following the release of the "FY2022 Report on the Monitoring of Activities to Provide Sales Information" on August 21, 2023, the Committee issued a "Request for Thorough Compliance with the Pharmaceutical Manufacturers Association Code" to each member company on August 23, requesting member companies to review the report and correctly understand the Guidelines for Activities to Provide Sales Information. The Committee requested member companies to review the report and correctly understand the Guidelines for Activities to Provide Marketing Information, as well as to comply with the Pharmaceutical Manufacturers Association Code.

Mr. Hiroaki Mizoguchi, working member of the Code Compliance Promotion Committee, gave an overview of the concept of "action," the definition of "action" (the "action" of the Pharmaceutical Manufacturers Association of Japan is to request voluntary improvement from member companies), the level of action, and the criteria for determining the level of action.

In addition, an overview of the two cases of action newly added to the "Case Studies of Actions" in FY2022 and the viewpoints of the actions taken were also explained.

Lastly, the committee requested member companies to promptly share the fact of their reports with the Pharmaceutical Manufacturers Association of Japan (PMAJ) in the event that a member company reports an act in violation of the PMAJ Code of Practice to a government agency as a possible violation of laws and regulations.

Mr. Takashi Tamada, a member of the Code Compliance Promotion Committee, explained the measures to be taken during the Code Understanding Promotion Month in FY2023.

First, the theme for FY2023 was decided to be "meeting society's expectations through sincere actions" for the third consecutive year since FY2021, as it was highly evaluated by member companies in questionnaires, etc. The sub-theme was "Everything is for patients" because patients and people who wish for their health are beyond our actions to meet their expectations as a member of a company involved in life-related business. The sub-theme was "All for Patients" because patients and people who wish for their health are beyond our actions to meet their expectations as a life-related company, and this was reflected in the poster design.

The presentation continued with an explanation of the poster display and inspection items, as well as the electronic media for the poster. A collection of case studies of inspection items and the MHLW Code of Practice explanatory materials were also introduced.

Mr. Michiaki Furue, Advertising Guidance Officer, Monitoring and Guidance and Narcotics Control Division, Ministry of Health, Labour and Welfare, gave a lecture titled "The 'Monitoring Project for Sales Information Provision Activities'".

After explaining the background and overview of the "Project for Monitoring Sales Information Provision Activities of Ethical Drugs," Mr. Furue gave an overview of the results of the "FY2022 Report on the Project for Monitoring Sales Information Provision Activities," stating that while the opportunities for providing information are expected to have increased compared to FY2021, the fact that the number of inappropriate cases and items in FY2022 has not increased is understood to be due to the efforts of each company. He stated that he understood that the fact that there was no increase in inappropriate cases/items in FY2022 was due to the efforts of each company.

He then highlighted the main cases of questionable reports and explained the key points. He explained the importance of taking measures to deal with cases where not only individual medical representatives (MRs) but also organizational efforts are questionable, and also pointed out that both companies that were pointed out in the surveillance project in FY2022 and those that were not were not aware of any cases of questionable reporting. He also stated that it is important for both companies that were subjected to the surveillance project in FY2022 and those that were not to continuously inspect their internal systems, etc., with reference to the cases of questionable reports.

Yoshiyuki Ishida, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), expressed his appreciation for the participation of code administrators and code practitioners in the meeting and thanked Mr. Furue, the special speaker, for his presentation.

He then presented three directions for future Code compliance efforts, first, appropriate responses to risks newly identified in recent activities, second, accurate understanding of the guidelines in sales information provision activities, and third, further efforts in sharing information held by the Compliance Department within the company. He concluded his message with the hope that the promotion of the above will lead to compliance with the Code.