Topics FY2020 Meeting of Code Administration Managers and Practitioners" held

Prior to the meeting, Makoto Hatano, Chairperson of the JPCPA Code Compliance Promotion Committee, stated the basic policy of the Committee for FY2020: "The Code Compliance Promotion Committee is committed to ensuring that member companies comply not only with relevant laws and regulations but also with voluntary codes, including the JPCPA Code of Practice, and that they conduct themselves in a socially responsible manner as members of the life-related industry with high ethical standards. Supporting the fulfillment of social responsibility with high ethical standards as a member」 and Priority Tasks「 Support member companies in promoting compliance」「 Promotion of appropriate information disclosure based on transparency guidelines」「 Compliance with guidelines on activities to provide sales information on ethical drugs」「 Government and JFPA、 JFTC、 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 committee 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 efforts of the Pharmaceutical Manufacturers Association of Japan (PMAJ).

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 Surveillance Project," and explained the main points of the project, highlighting the main cases of questionable reports. 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 in-house 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 members of the supervisory department and the examination and supervision committee," "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," "complaint window," 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.

Tokuo Tanaka, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), thanked special speakers Mr. Keita Nohara and Mr. Shinichi Watanabe, and expressed his appreciation for the participation of code administrators and code practitioners in this meeting.

He also stated that although the number of violations of the Pharmaceutical Association Code has not decreased, there is no doubt that the attitude of code administrators and code practitioners to show that they are paying close attention is a major deterrent, and 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 meeting noted that although the disclosure has been voluntary since it started in 2013, not a single member company of the Pharmaceutical Manufacturers Association of Japan (PMAJ) has continued to disclose information for the past seven years without missing any 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 earn the trust of society.