Topics ICHAA held the "Meeting of Code Administration Managers and Practitioners in 2019
The "FY2019 Meeting of Code Administration Managers and Practitioners" was held on September 26, 2019 at Nomura Conference Plaza Nihonbashi (Chuo-ku, Tokyo). A total of 125 code administration managers and code practice managers (including proxy attendance) from 72 member companies (as of the date of the meeting) attended the meeting, which was a meaningful gathering with information sharing in Part 1 and group discussions in Part 2 according to the program in Table 1. The following is a summary of the meeting.
Panoramic view of the venue
Table 1: Program of the "2019 Meeting of Code Administration Managers and Practitioners"
Opening remarks
Prior to the meeting, Mr. Makoto Hatano, Chairperson of the Pharmaceutical Association of Japan (PAK) Code Compliance Promotion Committee, stated the basic policy of the Committee for FY2019: "We support our member companies to comply with not only relevant laws and regulations but also with the PAK Code and other voluntary codes and to fulfill their social responsibilities with high ethical standards as a member of life-related industries. The Committee also introduced its key issues: "Supporting member companies to promote compliance," "Promoting appropriate information disclosure based on transparency guidelines," "Responding to guidelines on activities for providing sales information on ethical drugs," and "Collaborating with the government, JFMA, JFTC, IFPMA and other related domestic and international organizations, collecting and disseminating information, and providing feedback. and feedback" were introduced. He also introduced a report from the Pharmaceutical Association on its activities to raise awareness and disseminate the Consensus Framework agreed and signed in Japan in 2018 at the APEC Business Ethics Forum 2019, held in Chile in September 2019.
Pharmaceutical Association of Japan Code Compliance
Code and Compliance Promotion Committee Chairman
Makoto Hatano, Chair of the Practice Committee
Code Revision Report
Mr. Hatano, Chairperson of the Working Committee, reported on the status of member companies' response to the Pharmaceutical Manufacturers Association Code of Practice ("Pharmaceutical Manufacturers Association Code"), which was revised in November 2018 (results of a survey conducted on member companies in June 2019). He then reported that the Pharmaceutical Association Code was revised as of September 19, 2019, in response to the "Guidelines on Activities for Providing Marketing Information on Prescription Drugs" (hereinafter referred to as the "Guidelines") notified in September 2018, and in response to the creation of the Code by related organizations based on the Guidelines. He explained that the three points of the revision of the Pharmaceutical Cooperative Association Code are (1) addition of the requirement to comply with the Guidelines, (2) addition of the provisions of the Guidelines in the commentary, and (3) specification of the Code Compliance Promotion Committee as the committee in charge of the Guidelines, which will be implemented on October 1, 2019.
He also introduced a questionnaire survey scheduled for October 2019 to ascertain member companies' compliance with the guidelines as a future activity of the Committee in charge of the guidelines, and asked for cooperation.
Code of Practice Measures Case Study
Mr. Hiroaki Mizoguchi, Deputy Practice Chair of the Code and Compliance Promotion Committee, stated that it should be well understood that "action" is a request by the Code and Compliance Promotion Committee for voluntary improvement by the violating company, which is different from imposing a punishment or penalty. He then explained the viewpoints of the measures and other aspects of the reference cases of "promotional activities prior to marketing authorization using IR information" and "promotional materials using real-world data including in-house drugs not yet approved in Japan".
He pointed out the weak governance in the process of instructions, orders, and execution by the Sales Division, and the continued use of promotional materials in violation of the guidelines while being aware of the violation. The presentation included concrete explanations of the perspectives of the measures to be taken. Finally, he concluded by suggesting that the collection of case studies of actions taken be used as a reference for promoting code compliance at each company.
The Pharmaceutical Manufacturers Association of Japan Code Compliance
Compliance Promotion Committee
Hiroaki Mizoguchi Deputy Practice Committee Chair
(5) Measures for the Month to Promote Understanding of the Code
Code and Compliance Promotion Committee Working Member Hiroyuki Yoshimine explained the measures for the 2019 Code Understanding Promotion Month, including a review of the 2018 fiscal year.
First, he reported on the results of the questionnaire survey of member companies regarding the 2018 Code Understanding Promotion Month. 96% of the respondents said that understanding of "integrity," the theme for fiscal 2018, was spreading, such as "the word integrity has taken root" and "people are getting into the habit of thinking about what they say and do, etc." The survey also showed that "Our workplace inspections have been conducted with a high degree of accuracy. Also, 84% of the respondents said that the "Inspection Items for Our Workplace" were meaningful, such as "We can expect to increase our commitment to compliance" and "We can pick up problems in our own workplace and have a greater sense of participation in making improvements. We have decided to continue the program in FY2019.
Next, he explained that the theme for fiscal 2019 is "Trust" because trust from society is essential for a life-related company. As background, he explained that the Charter of Corporate Behavior of the Pharmaceutical Manufacturers Association of Japan clearly states that the mission of pharmaceutical companies is to "communicate sincerely with medical professionals and patients to gain their satisfaction and trust," and that the Pharmaceutical Manufacturers Association of Japan Code also states that "member companies shall, based on appropriate industry-academia collaboration, build relationships of mutual trust with researchers, medical professionals, patient groups, and others. The Pharmaceutical Manufacturers Association Code also states that "member companies are required to build relationships of mutual trust with researchers, medical professionals, patient groups, etc., based on appropriate industry-academia collaboration, and strive to provide optimal medical care in an ethical and patient-oriented manner.
Pharmaceutical Manufacturers Association of Japan Code Compliance
Compliance Promotion Committee
Hiroyuki Yoshimine Practice Member
Special Lecture
Mr. Tomoyuki Ishii, Advertising Specialist, Supervisory Guidance and Narcotics Control Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare, and Mr. Takamasa Horio, Legal Advisor, gave a lecture titled "Recent Regulations on Pharmaceutical Advertising".
In the lecture, Mr. Ishii first introduced an overview of the results of the "Monitoring Project for Monitoring Advertising Activities of Ethical Drugs in Fiscal Year 2008" and, in relation to the status of the Monitoring Project for Sales Information Provision Activities being implemented in fiscal year 2019, it is planned to start accepting reports from all medical institutions other than monitored medical institutions in the near future The report will be accepted from all medical institutions other than the monitored medical institutions in the near future. The Office Communication "Q&A on Guidelines for Marketing Information Provision Activities for Prescription Drugs (Part 3)" dated September 6 was then introduced, stating that information on drug stability, etc., which is helpful when performing simple suspension, crushing, etc., at the discretion of medical institutions according to the patient's condition, should be provided in an interview form in accordance with certain common rules and that the information should be provided in a timely manner. The information is acceptable to be provided in the interview form in accordance with certain common rules. In addition, in relation to the Q&A, it was explained that although data on the stability of bare tablets when packaged in a single package and on changes in formulation when multiple drugs are mixed are not confirmed by the approval review, they are different from so-called "off-label" data and can be provided without a request if firm evidence is provided. Mr. Horio explained that the data is not the same as the so-called "off-label" data.
Ministry of Health, Labour and Welfare
Pharmaceuticals and Public Health Bureau, Ministry of Health, Labour and Welfare
Tomoyuki Ishii, Advertising Specialist
Mr. Horio introduced the proposed amendment to the Pharmaceuticals and Medical Devices Law, which is scheduled for deliberation in the Diet this fall, the history of the review of the law, and the introduction of a surcharge system for false and exaggerated advertising of pharmaceuticals and other products. He also explained that the purpose of the surcharge is to deter violations and ensure a fair competitive environment by collecting economic gains from false or exaggerated advertising, which is prohibited by the Pharmaceuticals and Medical Devices Act, and preventing violators from retaining such gains.
Ministry of Health, Labour and Welfare
Ministry of Health, Labour and Welfare, Pharmaceuticals and Consumer Health Bureau
Mr. Takamasa Horio, Legal Guidance Officer
Group Discussion
In the second part of the meeting for Code Administration Managers and Practitioners, code administrators from 68 member companies who participated in the meeting were divided into nine groups for group discussions on the theme of "Initiatives for Appropriate Sales Information Provision Activities" to "resolve questions and concerns about the guidelines in their work". In the group discussions, participants were able to discuss and share their specific efforts, concerns, and issues on such topics as monitoring, material review, education (content and structure), evaluation, and creation and management of business records. The information obtained from this discussion will be useful for each company's response to the guidelines.
Group Discussion
Acknowledgements and Closing Remarks
In his acknowledgement of the special lecture, Tokuo Tanaka, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), made the following request to the member companies.
In spite of numerous lectures and guidance by the Monitoring and Guidance and Narcotics Control Division of the Ministry of Health, Labour and Welfare's Pharmaceuticals and Consumer Health Bureau, inappropriate information provision activities have not decreased. Most of the information provision activities using new materials and by MRs are carried out by the 72 member companies of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and it is important that these 72 companies take firm action and make efforts to address this issue. Based on today's special lecture, I hope that you will take the initiative to change your actions from now on.
In his closing remarks, he also thanked the code administrators and code practitioners for their participation in the meeting and their daily activities, and concluded the meeting as follows
Mr. Norio Tanaka, Executive Director, Pharmaceutical Manufacturers Association of Japan
The Pharmaceutical Manufacturers Association Code was revised in 2018 in line with the IFPMA Code revision, and was also revised in September 2019 in line with the full application of the Guidelines for Activities to Provide Sales Information. Member companies are requested to understand the purpose of these revisions and respond to the revisions to their own codes. The revision is based on the strong desire to protect the health of patients and people in need by providing correct information on excellent pharmaceutical products. In addition, transparency is essential to maintain the trust of society. As a pharmaceutical association, we would like to take transparency one step further, so we would like to request that the method of disclosure be reviewed after further internal discussion.
( Yoshiki Ozawa, Practice Member, Code Compliance Promotion Committee, Understanding Promotion Subcommittee)