Topics FY2020 Meeting of Code Administration Managers and Practitioners

Prior to the meeting, Makoto Hatano, Chairperson of the JPMA Code Compliance Committee, stated the basic policy of the Committee for FY2020: "The Code Compliance Committee is committed to ensuring that member companies comply not only with relevant laws and regulations but also with voluntary codes, including the JPMA Code of Practice, and that they fulfill their social responsibilities as members of the life-related industry 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 priority issues are to "support member companies in promoting compliance," "promote appropriate information disclosure based on Transparency Guideline," "respond to guidelines regarding sales information provision activities for ethical pharmaceuticals," and "promote the development and implementation of compliance activities in cooperation with the government, JFMA, JFTC, IFPMA, and other relevant domestic and foreign organizations, The presentation outlined "cooperation, collection and dissemination of information, and feedback with the government and related domestic and international organizations such as JFMA, JFTC, IFPMA, etc.".

He also stated that the JPMA will participate in international compliance promotion activities, such as the APEC Business Ethics Forum 2020 to be held in October, to gather global trends and disseminate information on the JPMA's efforts.

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 "Monitoring Project for Sales Information Provision Activities".

Mr. Nohara gave an overview of the "Fiscal Year 2022 Sales Information Provision Activity Monitoring Project," and also highlighted major cases of questionable reports, explaining the main points of the project. He stated that "inappropriate sales information provision activities are still being conducted in the "closed" environment where pharmaceutical company representatives visit medical institutions to explain products and provide information to on-site physicians and pharmacists," and that "pharmaceutical companies should take the following actions to ensure that medical professionals properly verify and ultimately use pharmaceutical products appropriately. Pharmaceutical companies need to provide information requested by healthcare professionals so that healthcare professionals can properly verify and consequently use pharmaceuticals appropriately.

He also called for "the appropriate and accurate provision of information, both positive and negative, for the safe and proper use of pharmaceuticals," and for "the inappropriate provision of information to be an opportunity to review the company's overall system and education, rather than a problem for MRs and other front-line workers.

He concluded by saying, "I hope that MRs and others will devise ways to provide balanced explanations of efficacy and safety even in the face of the new coronavirus disaster, reduced opportunities and time to visit medical institutions, and limited provision of information. He concluded by saying, "I would like to keep a close eye on the way information is provided through the Web and other means.

Dr. Shinichi Watanabe, Professor of the Pharmaceutical Affairs and Informatics Unit, Teikyo Heisei University Faculty of Pharmaceutical Sciences, gave a lecture titled "Research and Study on Guidelines for Activities to Provide Information on the Sale of Ethical Drugs".

Mr. Watanabe gave an overview of the "Survey Research on the Actual Situation of Companies in Relation to the Enforcement of the Guidelines for Provision of Information on the Sale of Ethical Drugs," which has been conducted to date, and stated that "This research is scheduled to be conducted as a three-year MHLW Science Research project from FY 2005 to FY 2021," and that "The survey on the status of response to the establishment of internal systems conducted in the previous fiscal year was conducted by each company. The purpose of this study is to promote the development of internal systems at each company, and is not intended to provide administrative guidance.

Then, from the results of the survey conducted in FY2019, he introduced the status of responses of the four surveyed organizations and pharmaceutical companies regarding "establishment and membership of supervisory departments and examination and supervision committees," "examination of materials for sales information provision activities," "evaluation and education," "implementation of monitoring and guidance such as monitoring," "response to inappropriate sales information provision activities," "complaints desk," etc. The status of response by the four organizations surveyed and member companies of the Pharmaceutical Manufacturers Association of Japan (PMAJ) was presented.

In closing, he stated that he hoped that the results of this survey would be used as a reference to check their own systems and that the provision of information by manufacturers and distributors to healthcare professionals is essential for appropriate drug treatment, and that they should continue to provide appropriate information for patients who need pharmaceutical products.

JPMA Executive Director Tokuo Tanaka thanked the special speakers, Mr. Keita Nohara and Mr. Shinichi Watanabe, and expressed his gratitude to the code administrators and code practitioners for their participation in the meeting.

He also noted that while the number of violations of the JPMA Code has not decreased, there is no doubt that the attitude of those responsible for code management and in charge of code practices who are watching closely is a major deterrent, and he requested that they continue their activities in the future.

Regarding the disclosure of information under the Transparency Guideline, which is the cornerstone of "trust," the JPMA member companies have continued to disclose information for the past seven years without missing a single company, despite the fact that the disclosure has been voluntary since it started in 2013, and many member companies have also continued to disclose items required by the Clinical Research Act (principle method, printable and searchable These facts were reflected in the "Results of the Survey on the Enforcement Status of the Clinical Research Act in the Fiscal Year 2028" issued by the Economic Affairs Division, Medical Affairs Bureau, Ministry of Health, Labour and Welfare.

Regarding the monitoring of sales information provision activities, he requested that if the person to whom the information was provided felt that the information was inappropriate, we must improve our activities, and that we should take this opportunity to share the report with all employees and reflect on our own actions, rather than thinking that the fact that our company was not pointed out to us was someone else's problem.

He concluded by saying that "research and development of new drugs" and "compliance" are two wheels that go hand in hand, and that unless everyone involved in the pharmaceutical industry fully understands and practices compliance on a daily basis, they will not be able to gain the trust of society, and asked for further understanding and cooperation.