Topics Meeting of Code Administration Managers and Practitioners for FY2022

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The JPMA Code Compliance 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, Mr. Satoshi Tanaka, Chairperson of the JPMA Code Compliance 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 on July 29, 2022 of the "Report on the Monitoring of Sales Information Provision Activities in Fiscal Year 2022," the JPMA issued a letter of notification on August 24, 2022 to its member companies, asking them to carefully read the report and this letter and to comply with the JPMA 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 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.

 Satoshi Tanaka Chairperson, Code Compliance Committee, JPMA JPMA Code Compliance
Satoshi Tanaka, Chairperson, Pharmaceutical Manufacturers Association of Japan (PMAJ) Code Compliance Promotion Committee

<Four Priority Tasks

  1. Support for member companies to promote compliance
  2. Promotion of appropriate information disclosure based on Transparency Guideline
  3. Compliance with guidelines on activities to provide information on sales of ethical drugs
  4. Collaboration, collection, dissemination of information, and feedback with the government and related domestic and international organizations such as the Federation of Pharmaceutical Manufacturers and Associations of Japan (JPMA), the Fair Trade Council of Ethical Drug Manufacturers and Distributors (JFTC), and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

Notices and communications issued by the JPMA

Mr. Toshiyuki Yamano, Chairperson of the Code Compliance 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 changes in the environment.


JPMA Code of Practice Violation Cases

 JPMA Code Compliance Committee Toshiyuki Yamano, Chairperson of the Practice Committee JPMA Code Compliance Promotion Committee
Chairperson of the Code Compliance Promotion Committee

Mr. Hiroaki Mizoguchi, Deputy Chairperson of the Code Compliance Committee, gave an overview of the definition of measures ("measures" in JPMA means to request voluntary improvements from member companies), the levels of measures, and the criteria for determining the level of measures.

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 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.

 Hiroaki Mizoguchi, Deputy Chairperson, JPMA Code Compliance Committee JPMA Code Compliance Promotion Committee
Chairperson (at that time) Mr. Hiroaki Mizoguchi, Deputy Chairperson, Code Compliance Promotion Committee, Pharmaceutical Manufacturers Association of Japan (PMAJ)

Measures for the Code Understanding Promotion Month

Mr. Naoyuki Masuda, a member of the Code Compliance Committee, explained the measures to be taken during the Code Compliance 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 designed to express 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 to the JPMA Code of Practice Explanation materials.

 Naoyuki Masuda, JPMA Code Compliance Committee, Practice Committee Member JPMA Code Compliance Promotion Committee
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 highlighted the main cases of questionable reports and explained the key points of the reports.

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, we provided Explanation of the main results, requests to pharmaceutical companies and industry associations, and future tasks. As a request to pharmaceutical companies and industry associations, he stated that it is a problem that information needed by medical professionals is not provided in a timely and appropriate manner, 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.

Lastly, among the revisions to the Pharmaceutical Affairs Law that went into effect on August 1, 2021, Explanation was given on the surcharge payment system for transactions of pharmaceuticals due to false or exaggerated advertisements. Although there have been no cases subject to the surcharge payment system to date, he concluded his presentation with a request for continued efforts to provide appropriate sales information.

Acknowledgements

Mr. Tokuo Tanaka, then Executive Director of the JPMA, 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, for his presentation.

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 MRs should act as if all the doctors in front of them were monitors, and that any inappropriate activities should be stopped immediately 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 being good enough for their own companies. He concluded his message by saying that he hopes the industry will continue to be transparent and trustworthy.

 Mr. Tokuo Tanaka, then Executive Director, JPMA Mr. Tokuo Tanaka, then Executive Director, JPMA

( Momoko Mori, Practice Member, Code Compliance Committee)

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