Topics Held "Meeting of Code Administration Managers and Practitioners for 2021

Prior to the meeting, Satoshi Tanaka, Chairperson of the Pharmaceutical Association of Japan Code Compliance Promotion Committee, stated the basic policy of the Committee for FY2021: "The Code Compliance Promotion Committee is committed to ensuring that member companies comply not only with relevant laws and regulations but also with voluntary codes, including the Pharmaceutical Association of Japan Code of Practice, and fulfill their social responsibilities with high ethical standards as members of life-related industries. The Committee's basic policy is to "support 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 of Japan (PAL) Code of Practice and other voluntary codes," and its key tasks are "support member companies in promoting compliance," "promote appropriate information disclosure based on transparency guidelines," "respond to guidelines regarding sales information provision activities for ethical drugs," "cooperate with the government, JFPMA, IFPMA, and other related organizations in Japan and overseas," and "promote the collection, use and disclosure of information. The outline of "Cooperation with domestic and foreign related organizations, collection, dissemination and feedback of information" was introduced.

The Committee also explained that, following the release of the "FY2020 Report on the Monitoring of Marketing Information Provision Activities" on August 18, 2021, the Committee issued a letter of notification to its member companies on August 24, titled "Compliance with the Pharmaceutical Manufacturers Association Code" and requested that member companies carefully read the report and this letter of notification and comply with the Code. The member companies were requested to read the report and the letter carefully and comply with the Code.

(5) Measures for the Month to Promote Understanding of the Code

Mr. Toshiyuki Yamano, Chairperson of the Code Compliance Promotion Committee, explained the measures for the Code Understanding Promotion Month in FY2021.

He began by explaining that the theme for FY2021 is "Meeting Society's Expectations through Sincere Actions" and the subtitle is "Thinking in the Current Era. As background for setting the subtitle, he stated that there were "serious problems concerning the stable supply of pharmaceuticals, etc., triggered by inadequate manufacturing management" and "major changes in the environment brought about by the global spread of the new coronavirus.

He then explained that the poster design was based on the motif of a "flapping bird" to represent the image of moving forward into the future, and that the names of all member companies (73 companies) were included to signify the sense of unity as a pharmaceutical cooperative to meet the expectations of society.

Mr. Keita Nohara, Advertising Guidance Officer, Supervisory Guidance and Narcotics Control Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare, gave a lecture titled "The 'Sales Information Provision Activity Monitoring Project'".

Mr. Nohara gave an overview of the "FY2020 Report on the Monitoring of Sales Information Provision Activities," and explained the main points of the report, highlighting major cases of questionable reporting. He explained that the key points of "cases of failure to disclose matters related to conflicts of interest" were that the sponsoring company had not requested disclosure of conflicts of interest (COI) and that the sponsoring company had not been able to confirm the slides of the presenters. The sponsors were requested to "ask the speakers to disclose their COI appropriately and accurately," "check whether the COI is disclosed in the presentation materials," and "check whether the COI between the speakers and the sponsor company is disclosed appropriately and accurately.

He also explained that he had communicated to the target companies to alert them to "cases that cannot be said to be provision of sales information subject to the monitoring project" and "cases that are not worthy of guidance by publishing in the case studies, but we would like them to be careful," although they were not included in the monitoring project report, and to help them in their future activities. He stated that if there are similar cases in the future, he may provide guidance by publishing them in the casebook on the grounds that these alerts have not been utilized.

Mr. Tokuo Tanaka, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), expressed his appreciation for the participation in this meeting of code management officers and code practitioners, and thanked the special speaker, Mr. Kata Futa Nohara, Advertising Supervisor. 　He then reported on the following three points.

First, he mentioned the "FY2020 Monitoring Report on Sales Information Provision Activities," which was issued on August 18, and reported that the quality of information provision has improved due to the increase in online interviews with medical professionals and the increased attendance of senior staff and academic staff as a result of the Corona disaster, On the other hand, he stated that it was very disappointing that inappropriate information provision was still pointed out this time.

Secondly, he reported that two member companies were disciplined at the September 16 general meeting of the PharmaCorp Standing Committee and that, in response, the committee was asked to re-enforce the "Basic Approach to Support for Clinical Research by Pharmaceutical Companies," a notice issued in 2014 by the PharmaCorp.