Topics The "2022 Meeting of Code Administration Managers and Practitioners" was held.

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The Pharmaceutical Manufacturers Association of Japan (PMAJ) Code Compliance Promotion Committee held the "FY2022 Meeting of Code Administration Managers and Practitioners" on September 20, 2022. 2022, as in 2021, was held in an online format from the perspective of the spread and prevention of new coronavirus infection. Code management managers and code practitioners from 71 member companies participated in the meeting, which was conducted in accordance with 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 "2022 Meeting for Code Administration Managers and Practitioners"
Table1 「2022 Fiscal Year Code Administrative Officer・ Board of Practitioners」 Program

 

Opening remarks

Prior to the meeting, Satoshi Tanaka, Chairperson of the Pharmaceutical Association of Japan (PAC) Code Compliance Promotion Committee, introduced the basic policy of the Committee for FY 2022 and an overview of the four key issues. He also explained that, following the release of the "Report on the Monitoring of Sales Information Provision Activities in FY2022" on July 29, 2022, the Committee issued a notice to its member companies on August 24, "Ensuring Compliance with the Pharmaceutical Manufacturers Association Code" and requested that each member company carefully read the report and the notice and comply with the Code, The committee requested each member company to read the report and this letter carefully and comply with the Code.

<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.

 Satoshi Tanaka, Chairman, Code Compliance Promotion Committee, Pharmaceutical Manufacturers Association of Japan Chairman, Code Compliance Promotion Committee, Pharmaceutical Manufacturers Association of Japan (PMAJ)
Satoshi Tanaka, Chair, Pharmaceutical Manufacturers Association of Japan (PMAJ) Code Compliance Promotion Committee

<Four Key Tasks

  1. The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.
    Supporting member companies in promoting compliance
  2. The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.
    Promotion of appropriate information disclosure based on transparency guidelines
  3. The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.
    Compliance with guidelines for activities related to the provision of sales information on ethical drugs
  4. The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.
    Collaboration, information collection, dissemination, and feedback with the government and related domestic and international organizations such as the Federation of Pharmaceutical Manufacturers' Associations of Japan (JFPMA), the Fair Trade Council of the Ethical Drug Manufacturers and Distributors Association (JFTC), and the International Federation of Pharmaceutical Manufacturers' Associations (IFPMA)

Notification and communication issued by the Pharmaceutical Manufacturers Association of Japan (PMAJ)

Mr. Toshiyuki Yamano, Chairperson of the Code Compliance Promotion Committee, explained that the "Guidelines for Posting Contents on Websites" established in July 2016 were revised to improve the description of the main text of the guidelines and add Q&A in light of subsequent environmental changes.


Cases of Pharmaceutical Association Code of Practice Violation Actions

 Mr. Toshiyuki Yamano, Chairperson of the Pharmaceutical Manufacturers Association of Japan (PMAJ) Code Compliance Promotion Committee Chairman of the Pharmaceutical Manufacturers Association of Japan (PMAJ) Code Compliance Promotion Committee Toshiyuki Yamano
Chairperson: Toshiyuki Yamano Practice Committee Chairperson: Toshiyuki Yamano

Mr. Hiroaki Mizoguchi, Deputy Practice Committee Chairperson of the Code Compliance Promotion Committee, gave an overview of the definition of "measures" (the term "measures" in the JCIA refers to requests for voluntary improvements from member companies), levels of measures, criteria for determining the level of measures, and other information.

He also stated that the "Measures Casebook" prepared by the Measures Review Subcommittee should be utilized for internal inspections, etc., and explained the outline of the two newly added cases and the viewpoints of the measures taken.

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.

 Hiroaki Mizoguchi, Deputy Practice Committee Chair, Pharmaceutical Association of Japan (PAK) Code Compliance Promotion Committee Toshiaki Yamano, Chairperson of the Code Compliance Promotion Committee, Pharmaceutical Manufacturers Association of Japan (PMAJ)
Compliance Promotion Committee, Pharmaceutical Manufacturers Association of Japan (PMAJ)

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

Mr. Naoyuki Masuda, a member of the Code Compliance Promotion Committee, explained the measures to be taken during the Code Understanding Promotion Month in FY2022.

He began by explaining that the theme for FY2022 was decided to be "Meeting Society's Expectations through Sincere Actions," the same as in FY2021, and that the subtitle was set to "Each one of us is responsible" to reiterate the importance of awareness and consciousness on the part of each individual.

Regarding the intention of the poster design for the Month to Promote Understanding of the Code, he explained that the illustrations depicted the various occupations and situations of people working for pharmaceutical companies, and that the poster was meant to convey the importance of each individual's awareness and consciousness as a responsible person in order to meet society's expectations through sincere actions.

The presentation was followed by an explanation of poster display and inspection items and electronic media for posters, as well as an introduction of the Pharmaceutical Manufacturers Association Code of Practice explanatory materials.

 Naoyuki Masuda, Practice Committee Member, Code Compliance Promotion Committee, Pharmaceutical Manufacturers Association of Japan (PMAJ) Hiroaki Mizoguchi, Deputy Practice Committee Chair
Naoyuki Masuda Practice Committee Member

Special Lecture

Mr. Michiaki Furue, Chief, Supervisory Guidance and Narcotics Control Division, Pharmaceutical and Life Sanitation Bureau, Ministry of Health, Labour and Welfare, gave a lecture titled "The 'Sales Information Provision Activity Monitoring Project'".

After explaining the background and overview of the "Monitoring of Sales Information Provision Activities of Ethical Drugs" in FY2021, Mr. Furue gave an overview of the results of the FY2021 project, stating that both the number of suspected violations and the number of cases had increased compared to FY2020; however, with the Corona disaster, it was difficult to evaluate the size of the number of cases. He stated that it is difficult to evaluate the size of the number of cases. Next, he discussed the main cases of questionable reports and explained the key points.

He also mentioned other cases that are included in the report and those that are not included but require attention. Regarding the latter, he explained about cases that lack explanation in terms of safety and cases that need attention as slanderous expressions of other companies.

 Michiaki Furue, Chief, Supervisory Guidance and Narcotics Control Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare Ministry of Health, Labour and Welfare
Michiaki Furue, Chief, Monitoring, Guidance and Narcotics Control Division, Pharmaceuticals and Public Health Bureau, Ministry of Health, Labour and Welfare

In addition, as a summary of the surveillance project in FY2021, Mr. Furue discussed the main results, requests to pharmaceutical companies and industry associations, and future issues. As a request to pharmaceutical companies and industry associations, he stated that the lack of timely and appropriate provision of information needed by medical professionals is a problem in itself, and that they should conduct sales information provision activities so as not to impede medical treatment. He also explained that MRs should be trained as an organization, that compliance should be further enforced, and that pharmaceutical companies themselves should confirm the content of slides and other information provided to medical professionals at company-sponsored seminars to ensure that such activities do not lead to inappropriate provision of sales information.

Finally, he explained the surcharge payment system for transactions of pharmaceuticals with false or exaggerated advertising, which is part of the revised Pharmaceutical Affairs Law that went into effect on August 1, 2021. He concluded his presentation by requesting that although there have been no cases subject to the surcharge payment system to date, the participants should continue to provide appropriate sales information.

Acknowledgments

Tokuo Tanaka, then Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), expressed his appreciation for the participation in the meeting by code administration managers and code practitioners, and thanked Mr. Furue, the speaker of the special lecture.

He also thanked Mr. Furue, the special lecturer, for his presentation. He then stated that the project to monitor sales information provision activities has already been in place for seven years, and that it is necessary to promptly stop any inappropriate activities by having MRs act as if all the doctors in front of them are monitors, and by posting the direct contact information of the sponsoring pharmaceutical company at the end of slides used at lectures and information meetings, etc. He also stated that it is necessary to stop any inappropriate activities as soon as they occur. Furthermore, he asked member companies to politely explain to those who play a role in the lectures that, from the pharmaceutical companies' point of view, the lectures are for promoting proper use of drugs when requesting lectures.

Finally, he thanked the members for allowing him to serve in his current position since 2013. He concluded his message by saying that he hopes that from now on he will lead the company cheerfully with a focus on the compliance department, including code management officers and practical affairs officers; that he hopes MRs will be educated to demonstrate ethics in the field; and that the industry will continue to be transparent and trustworthy, rather than just thinking that it is good enough for their own company. He concluded his message by saying that he hopes the industry will continue to be transparent and trustworthy.

 Mr. Tokuo Tanaka, then Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ) Mr. Tokuo Tanaka, then Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

( Momoko Mori, Practice Committee Member, Code Compliance Promotion Committee)

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