Topics Held the "FY2021 Meeting of Compliance Managers and Practitioners

Prior to the meeting, Satoshi Tanaka, Chairperson of the Pharmaceutical Association of Japan Code Compliance Promotion Committee, explained the basic policy and key issues of the Committee for FY2021: "Support for member companies' compliance promotion," "Promotion of appropriate information disclosure based on transparency guidelines," "Response to guidelines on sales information provision activities for ethical drugs," and "Support for administrative and regulatory compliance. The Committee also outlined its basic policies and priority issues for the year 2021: "Supporting member companies in promoting compliance," "Promoting appropriate information disclosure based on transparency guidelines," "Responding to guidelines for the provision of information on the marketing of prescription drugs," and "Collaborating with the government, JFMA, JFTC, IFPMA, and other related domestic and foreign organizations, collecting and disseminating information and providing feedback.

He also reported that the revision of the Transparency Guidelines was approved in January 2022, and that member companies shared their efforts for the Guidelines for Marketing Information Provision Activities, and stated that they will collect and disseminate information on global trends in the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and Asia-Pacific Economic Cooperation (APEC). Chugai will continue to collect and disseminate information on global trends in IFPMA and APEC.

Hitoshi Aikawa of Chugai's Sustainability Promotion Department gave a presentation titled "Status of Efforts Concerning the Whistleblower System.

He then introduced the "Chugai Group Code of Conduct (CCC)" and related guidelines and regulations as part of Chugai's efforts to develop guidelines and regulations related to whistleblowing. He then introduced the "Chugai Group Code of Conduct (CCC)" and related guidelines and regulations.

He introduced that Chugai has established multiple contact points for reporting and consultation, and has a system for easy consultation whereby the person consulting can choose which contact point to use. In addition, he stated that employees in charge of these consultation services are making efforts to acquire knowledge and skills by attending internal and external training sessions so that they can respond appropriately.

In addition, he stated that the company strives to create an environment that facilitates reporting and consultation, and as part of its educational activities to enable timely and appropriate reporting and consultation, the company uses posters and introduces the person in charge with a photograph. In addition, he introduced that a compliance awareness survey is conducted every year, and that a Q&A is prepared to eliminate concerns and questions of consultants identified in the survey, and that past consultation cases are posted on the website. He reported that these activities have been successful, with some consultants commenting that they consulted with the company after seeing the posters or because similar cases were introduced.

Ms. Ikuko Yamane, Chief Researcher, Organizational Behavior Division, Japan Management Association Research Institute, gave a lecture titled "Compliance Survey with Specific Figures.

Ms. Yamane stated that the purpose of her presentation was to reconfirm the significance and purpose of quantifying employee awareness by conducting a compliance survey, and to discuss with everyone how to utilize the survey results. He also emphasized that it is important not to be happy or sad about the results of the compliance survey, but to analyze the reasons why the score is high (or low), and to "put it into practice" by developing measures and improving the workplace culture based on the survey results.

In the prerequisite section, we stated that the definition of compliance is not only legal compliance, but also behavior that takes into account legal, internal, and social norms, and that the purpose of compliance is to improve corporate value and business continuity as a voluntary activity, and to gain the trust of stakeholders.

He further discussed the "whistle-blowing system" and "checklist" as similar to the compliance survey and explained the difference in significance and purpose.

Mr. Tokuo Tanaka, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), thanked the speakers, Mr. Aikawa and Mr. Yamane, and expressed his appreciation for the participation of compliance managers and compliance practitioners in this meeting and their daily activities.

He emphasized that the pharmaceutical industry, which handles life-related products, has been working on thorough compliance since earlier than other industries, and that the occurrence of noncompliance by a single company could cause a major loss of public trust in the pharmaceutical industry as a whole. Referring to the recent cases of GMP violations that have even affected the stable supply of pharmaceuticals, he said that it is too late to "thoroughly inspect the industry at that time," and that it will take more than twice as much time to regain the lost trust as it has taken to build it up.

Unfortunately, the number of compliance violations has not yet reached zero. He explained that the major cause of the problems that develop from whistleblowing, etc., as mentioned in today's lecture, is poor initial response, and that it is important for the company to take it seriously, take appropriate action, and convey the message to the whistleblower and to the entire company that the company has changed. The training was enthusiastically conducted by each company, and although the participants had the knowledge, would they be able to respond appropriately in an actual situation? He emphasized that ethical standards can be said to have been demonstrated only when accompanied by actions.