Topics The "2021 Meeting of Code Administration Managers and Practitioners" was held
The JPMA Code Compliance Committee held the "FY2021 Meeting of Code Administration Managers and Practitioners" on September 21, 2021. 2021 was held in an online format, as in 2020, in light of the Corona disaster. Code Administration Managers and Code Practitioners from 73 member companies participated in the meeting, which was conducted according to the program shown in Table 1, and proved to be a meaningful meeting. The following is a summary of the meeting.
Table 1 Program of the "FY2021 Meeting for Code Administration Managers and Practitioners
Opening remarks
Prior to the meeting, Satoshi Tanaka, Chairperson of the JPMA Code Compliance Committee, stated the basic policy of the Committee for FY2021: "The Code Compliance Committee is committed to ensuring that member companies comply not only with relevant laws and regulations but also with the JPMA Code of Practice and other voluntary codes, and that they fulfill their social responsibilities as members of life-related industries with high ethical standards. 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 the Transparency Guideline," "respond to guidelines regarding activities to provide sales information on ethical drugs," "cooperate with the government, the JFMA, the Japan Fair Trade Association, IFPMA and other related domestic and foreign organizations," "collect information," and "promote the development of new products. 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 on August 18, 2021 of the "FY2020 Report on the Monitoring of Sales Information Provision Activities," the Committee issued a letter of notification to each member company on August 24, 2009, titled "Compliance with the JPMA Code," and requested that each member company 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.
Satoshi Tanaka, Chairperson, JPMA Code Compliance Committee
JPMA Code of Practice Violation Cases
Mr. Hiroaki Mizoguchi, Deputy Practice Chairperson of the Code Compliance Committee, stated that he hoped that the Code Compliance Committee would have a good understanding of the concept of the "Measures" as a request for voluntary improvement by the violating companies. He then explained the viewpoints of the measures taken with regard to the two new cases added after September 2020: "Inappropriate Handling of Drug Product Samples" and "Inappropriate Promotional Activities Including Recommendation of Unapproved and Off-label Drugs".
He pointed out that the violations were long-term and widespread, that the weaknesses in governance were taken particularly seriously, and that although the violations had already been stopped, the measures to prevent recurrence lacked specificity and could not be said to have been fully implemented. He explained in detail the criteria for determining whether the violation was "minor or not minor," and whether "the violation was stopped and appropriate measures to prevent recurrence were taken. Finally, he explained past cases of inappropriate information provision activities, especially "cases where off-label cases were included in briefing slides," "promotional activities before marketing approval using IR information," and "promotional materials using real-world data including in-house drugs not yet approved in Japan, He concluded his presentation with the hope that it will serve as a reference for each company's code compliance promotion.
JPMA Code Compliance
Promotion Committee Hiroaki Mizoguchi, Deputy Chairperson
Measures for the Code Understanding Promotion Month
Mr. Toshiyuki Yamano, Chairperson of the Code Compliance Committee, explained the measures to be taken during the Code Compliance 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 in the poster as a sign of unity as a JPMA in order to meet the expectations of society.
JPMA Code Compliance
Promotion Committee Toshiyuki Yamano Chairperson
Mr. Tanaka concluded his presentation by introducing the transition of the Month for Promotion of Understanding, stating that the Month for Promotion of Understanding of the Code, which started in 2001 as "the Month for Promotion of Understanding of the Promotion Code," marked its 20th anniversary in 2021.
Special Lecture
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 also 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 are not included in the monitoring project report, so that they can make use of 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.
Ministry of Health, Labour and Welfare, Pharmaceuticals and Consumer Health Bureau
Advertising Guidance Officer, Supervisory Guidance and Narcotics Control Division
Mr. Shota Nohara
Finally, he explained the "surcharge system," "measure orders," and "establishment of a legal compliance system" in relation to advertising under the revised Pharmaceuticals and Medical Devices Law (Pharmaceutical Affairs Agency Law), which went into effect on August 1, 2021.
Closing remarks
JPMA Executive Director Tokuo Tanaka expressed his appreciation for the participation in this meeting of code administration managers and code practitioners, and thanked the special speaker, Advertising Advisor Katuta Nohara. He then reported on the following three points.
First, he mentioned the "FY 2020 Report on the Monitoring of Sales Information Provision Activities" issued on August 18, and reported that the quality of information provision had 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.
Second, he reported that two member companies were disciplined at the September 16 meeting of the JPMA's standing members' Assembly and that, in response, the JPMA was asked to re-enforce the JPMA's 2014 notice, "Basic Idea on the Way of Supporting Clinical Research by Pharmaceutical Companies".
Mr. Tokuo Tanaka, Executive Director, JPMA
Third, in his opening remarks at the "2021 MR Forum" held by the MR Certification Center on August 26, he reported that he proposed that MR be translated as "proper use promoter" (a person in charge of providing information to promote the proper use of the company's pharmaceutical products) instead of "pharmaceutical information officer.
He concluded by expressing his sincere gratitude to the steering committee members of each company for their dedication in organizing this meeting.
( Naoyuki Masuda, Practice Committee Member, Code Compliance Committee)