Top News Held the "Meeting of Compliance Managers and Practitioners for 2023
On March 6, 2024, the Pharmaceutical Manufacturers Association of Japan (PMAJ) Code Compliance Promotion Committee held the "FY2023 Meeting of Compliance Managers and Practitioners" in the same online format as in FY2022. The meeting was attended by 155 participants from 71 member companies, including compliance managers and compliance practitioners, and was conducted according to the program shown in Table 1. A summary of the meeting is reported below.
Table 1 Program of the "2023 Meeting of Compliance Managers and Practice Managers"
Opening Remarks
Chika Hirata, Chair, Pharmaceutical Association of Japan Code Compliance Promotion Committee
Mr. Takehiro Yamada from Ono will talk about the establishment of a compliance system and its observance, and Mr. Ryosuke Ishii from ZENTech will talk about the importance of psychological safety in an organization, which is necessary to create an environment in which employees can easily speak up at an early stage. Mr. Ryosuke Ishii of ZENTech will talk about the importance of psychological safety in an organization, which is necessary to make it easier for employees to speak up at an early stage.
The terms "Speak Up," "Compliance," and "Psychological Safety" tend to have a negative image, especially when uttered by compliance officers, but psychological safety is not limited to fraud detection and compliance, but is actually a very important concept for organizational revitalization, He stated that there are various hints and tips that can be used as a reference.
Results of Questionnaire on the Status of Compliance with the "Pharmaceutical Manufacturers Association Compliance Program Guidelines
Chika Hirata, Chairperson, Pharmaceutical Association of Japan Code and Compliance Promotion Committee Chika Hirata , Chairperson, Pharmaceutical Association of Japan Code and Compliance Promotion Committee
First, he reiterated the positioning and purpose of the "Pharmaceutical Manufacturers Association Compliance Program Guidelines" (CPGL), including its purpose of "promoting corporate ethics and thorough legal compliance" and the relationship between the "Pharmaceutical Manufacturers Association Charter of Corporate Behavior" and the "Pharmaceutical Manufacturers Association Code of Practice. He then reconfirmed that the CPGL was revised in March 2023 as a background to the implementation of this survey, and the main contents of the revision.
| ＜Questionnaire items | |
| Q1: | Please select all items in Chapter 2 (Standard Model) of the "Pharmaceutical Association of Japan Compliance Program Guidelines" that are currently covered by your company's internal rules and regulations. |
| Q2: | Of the items not currently covered, are there any items that you plan to reflect in your company rules in the future? |
| Q3: | Of the items already covered, are there any items that you plan to further enhance in the future by revising internal rules, etc.? |
| Q4: | Has your company revised or established internal rules and regulations in response to the March 2023 CPGL revision? |
The survey received responses from all 71 companies, and the general comment was that "it was confirmed that the contents of the CPGL are generally reflected in the internal rules and regulations of each company.
Finally, the survey concluded, "We hope that each company will continue to review its code of conduct and compliance-related regulations, referring to the CPGL as appropriate, in order to adapt to changes in laws and social demands.
Efforts to comply with the Compliance Program Guidelines
Mr. Takehiro Yamada, General Manager, Risk and Compliance Management Department, Ono Pharmaceutical Co.
First, he explained the background of his company's compliance-related efforts, and then introduced the actual efforts in terms of four points.
| ＜Details of Compliance Measures | |
| 1. | Measures for handling scholarship donations, etc. |
| 2. | Measures to strengthen the compliance system and their progress |
| 3. | Employee education |
| 4. | Internal reporting system |
As a result of the efforts, the company has taken measures to ensure independence and impartiality (establishment of a foundation), reviewed its internal screening system, expanded its auditing and compliance systems, and reviewed its code of conduct and whistle-blowing, resulting in the establishment of an internal system, enabling early detection and early response, and improving the work environment. This has led to the improvement of the workplace environment.
He also introduced that the company has designated the three-month period in November of every year, which is the Pharmaceutical Manufacturers Association of Japan's "Month for Promoting Understanding of the Pharmaceutical Manufacturers Association of Japan Code," as the company's own "Month for Strengthening Compliance Promotion" and is conducting activities accordingly.
He concluded by stating that the company has fostered a culture that places the highest priority on compliance, and will continue to work to prevent recurrence and restore trust by ensuring that all employees are aware of the importance of compliance as their own personal matter, and by taking thorough measures internally.
Special Lecture
Psychological safety in the workplace: Fostering a culture of "Speak Up
Mr. Ryosuke Ishii, Representative Director/Chief Scientist, ZENTech
First, he introduced that "psychological safety" is a theme that is attracting a lot of attention and is also required in the field of healthcare, and indicated that the content of this meeting was to understand the importance of psychological safety and to leave with one action to improve psychological safety in one's own workplace, followed by a discussion using the chat function. The lecture was followed by an interactive exchange of information.
| <Topics for understanding psychological safety | |
| 1. | What is psychological safety? |
| 2. | Major Policies of Psychological Safety |
| 3. | Four Factors for Psychological Safety |
| 4. | Reprimand for mistakes and psychological safety |
He explained, with specific examples, that psychological safety is essential for organizations and teams where everyone, regardless of position or experience, can openly express their opinions, and is a leading indicator of future high performance.
Based on the framework of behavior analysis, he also explained that unnecessary punishment and anxiety prevalent in organizations lower psychological safety and make organizations incapable of speaking up.
In addition, he discussed the four factors for increasing psychological safety (ease of talking, mutual help, challenge, and welcoming novelty), including the following points: expressing opinions in an open manner, managers themselves asking for help from others, giving encouragement in the initial stages of challenge, and accepting and digging deeper into opinions.
Regarding reprimand for mistakes and psychological safety, he used specific examples to introduce effective activities.
In closing, he said, "It is you, the participants, who will change your organizations and teams into psychologically safe organizations and teams. We would like you to approach psychological safety on your own, rather than have someone else change it for you. Please try to change your own behavior.
Closing remarks
Mr . Yoshiyuki Ishida, Executive Director, Pharmaceutical Manufacturers Association of Japan
He thanked the compliance managers and compliance practitioners for their participation in the meeting and thanked the speaker speakers, Mr. Yamada and Mr. Ishii.
In light of the current situation where compliance has become an objective due to heightened awareness regarding compliance, he commented that it is one idea to go back to the corporate philosophy and mission in order to spread compliance. He also expressed his hope that going back not only to the corporate philosophy but also to the organization's philosophy and its own objectives will lead to compliance governance, and that incorporating psychological safety in addition to this will lead to further strengthening of the system.
She concluded the meeting with the message, "Compliance is important, but I hope that we can use compliance as a hint to promote corporate activities in a better direction.
( Kazuhiro Shinonaga, Practice Member, Code Compliance Promotion Committee)