Topics Meeting of Code Administration Managers and Practitioners for FY2023

Prior to the meeting, Ms. Chika Hirata, Chairperson of the JPMA Code Compliance 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 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 JPMA Code of Practice and other voluntary codes.

Mr. Go Matsumura, Chairperson of the Code Compliance 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 Chairperson's Notice. 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 the Committee had issued the "Guideline Workshops Code Compliance" to member companies on August 23, 2022 in response to the release of the "FY2022 Report on the Monitoring of Activities to Provide Sales Information" on August 21, 2023, and requested 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 JPMA Code.

Practice Member Hiroaki Mizoguchi of the Code Compliance Committee gave an overview of the concept of "action," the definition of "action" (JPMA's "action" is to request member companies to voluntarily make improvements), 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 "Casebook of Actions" in FY2022 and the viewpoints of the actions taken were explained.

Lastly, the JPMA was requested to promptly share with the JPMA the fact that a member company reported to a government agency about an act by a member company in violation of the JPMA Code of Practice, as it may be a violation of laws and regulations.

Mr. Takashi Tamada, a member of the Code Compliance Committee, explained the measures to be taken during the Code Compliance 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 "All for Patients", as patients and people who desire good health are the destination of actions that meet 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 poster's electronic media, and included a collection of examples of inspection items and an introduction to the JPMA Code of Practice Explanation document.

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 their 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.

Mr. Yoshiyuki Ishida, JPMA's Executive Director, expressed his appreciation for the participation of code administrators and code practitioners in this meeting, and thanked Mr. Furue, the special speaker.

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.