Held the "FY2024 Meeting for Persons Responsible for Compliance Management and Practitioners".
The Pharmaceutical Manufacturers Association of Japan (PMAJ) Code Compliance Promotion Committee held the "2024 Meeting of Compliance Managers and Practitioners" in online format on March 17, 2025. The meeting was attended by 159 persons/69 companies from member companies, including compliance managers and compliance practitioners, and was conducted in accordance with the program shown in Table 1. A summary of the meeting is reported below.
Conference
Table 1: Program of the "FY2024 Meeting of Compliance Managers and Practitioners
| Moderator: | Takashi Tamada, Practice Committee Member, Pharmaceutical Association of Japan Code Compliance Promotion Committee |
|---|---|
| (1) Opening remarks | Chika Hirata, Chairperson of the Committee |
| (2) Business Ethics initiatives in the global pharmaceutical industry and
Business Ethics Initiatives in the Global Pharmaceutical Industry and the Contribution of the Pharmaceutical Association of Japan (PAC) Code Compliance Promotion Committee | Mr. Go Matsumura, Chairperson of the Practice Committee |
| (3) Globalization and Compliance | Takeda Pharmaceutical Company Limited
Associate Director, Ethics & Compliance, Japan Pharma Business Unit Kaori Taniguchi |
| (4) Special Lecture
AI Governance - Toward Trustworthy Use of AI | IBM Japan, Ltd.
Atsushi Yamada, Technical Director, Consulting Business Unit, IBM Japan, Ltd. Ms. Tomoka Miho, Trust & Compliance Officer, Legal, IP & Compliance Counsel |
| (5) Closing remarks | Mr. Yoshiyuki Ishida, Executive Director, Pharmaceutical Manufacturers Association of Japan |
Opening Remarks
Chika Hirata, Chairperson, Pharmaceutical Association of Japan Code Compliance Promotion Committee
Chika Hirata, Chairperson of the Pharmaceutical Association of Japan (PAK) Code and Compliance Promotion Committee, opened the meeting by discussing the issues of global expansion, such as "What is the global standard? and "Where should we start? She introduced the discussion on corporate ethics of globally operating companies by Practice Committee Chairperson Goh Matsumura, and Kaori Taniguchi of Takeda Pharmaceutical Company, Limited, who introduced their globalization and compliance efforts.
She also expressed her opinion that the pharmaceutical industry is one of the industries that are greatly benefiting from AI on a global scale, while at the same time handling highly sensitive data such as patients' personal information, and that domestic pharmaceutical companies are not keeping up in various aspects with the use of AI technology that global pharmaceutical companies are advancing ahead of their counterparts. He expressed the view that domestic pharmaceutical companies may not be able to keep up with the use of AI technology that global pharmaceutical companies are advancing. In order to bridge the gap between the reality of AI and data use globally, we expected to get hints from the special presentations on AI governance by Mr. Atsushi Yamada and Mr. Tomoga Miho of IBM Japan on where to seek opportunities and at the same time how to guarantee the risk aspects.
Business Ethics Initiatives in the Global Pharmaceutical Industry and the Contribution of the Pharmaceutical Cooperative Code and Compliance Promotion Committee
Pharmaceutical Association of Japan Code Compliance Promotion Committee Go Matsumura, Practice Committee Chairman
He introduced the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which has 53 pharmaceutical associations and 38 pharmaceutical companies as its members worldwide. The Pharmaceutical Manufacturers Association of Japan (PMAJ)
He then introduced the involvement of the Pharmaceutical Manufacturers Association of Japan (PMAJ) in IFPMA as follows
- The IFPMA has two Ethics and Business Integrity committees: the Chief Ethics & Compliance Officer Round Table (CECORT) and the Ethics & Business Integrity Committee (eBIC). eBIC).
- CECORT includes the chief ethics and compliance officers from each member organization and company to discuss ethics and business integrity priorities and strategies. The eBIC, on the other hand, is responsible for implementing CECORT's decisions. The Pharmaceutical Cooperative Code and Compliance Promotion Committee participates and works with the eBIC.
In addition, the Pharmaceutical Association's involvement in Asia-Pacific Economic Cooperation (APEC) includes IFPMA and APEC's strong tag-team efforts to lay the foundation for business ethics in the global pharmaceutical and medical device markets, APEC's focus on promoting the Mexico City Principles and the Consensus Framework for the The Pharmaceutical Association of Japan's efforts to promote the establishment and application of the Mexico City Principles and the Consensus Framework, which APEC is focusing on, were also introduced.
Finally, as other activities, Practice Committee Chair Matsumura conducted a workshop on the IFPMA Code for South African healthcare professionals at the Ethics & Business Integrity Day in South Africa held in November 2024 as a member of the trainers. In addition, APEC participants from the Pharmaceutical Association of Japan, including Executive Director Yoshiyuki Ishida and Chairperson Hirata, visited the Japanese embassies of each APEC host country in 2023 and 2024 to share the contribution of the Pharmaceutical Association of Japan to APEC, and also visited PhRMA in 2023 to discuss mutual cooperation in the field of business ethics, They also visited PhRMA in 2023 to discuss mutual cooperation in the field of business ethics.
Globalization and Compliance
Takeda Pharmaceutical Company Limited
Japan Pharma Business Unit Ethics & Compliance
Kaori Taniguchi, Associate Director, Ethics & Compliance, Japan Pharma Business Unit, Takeda Pharmaceutical Company Limited
At the outset, she introduced Takeda's global expansion, which began with its full-scale entry into overseas markets, starting with North and Central America and Asia in 1951, with the acquisition of Shire in 2019 serving as a major turning point.
Next, he introduced Takeda's efforts to strengthen compliance in advancing globalization, as follows
Takeda's employees follow "P-T-R-B" (Patient-Trust-Reputation-Business) as their daily guiding principle, with the common value of Takeda-ism as the guiding principle.
- First, is it right for patients?
- Second, will it help build trust with people?
- Third, can Takeda's social reputation be enhanced?
- Finally, will it help develop sustainable business?
We ask ourselves the above four questions in turn, and if the answer is "Yes" to all of them, we make the decision to implement them. Every year around June 12, the anniversary of Takeda's founding, we hold a "Values Day" event to reflect on and verbalize Takeda's corporate philosophy. The purpose of the event is to ensure that the corporate philosophy is shared by employees in different countries, and for Takeda Japan, to remember past mistakes.
In addition, the "Takeda Compliance Program" was introduced as follows.
Takeda encourages continuous improvement through a cycle of eight items such as Culture & Values. The key to this cycle is internal company regulations such as the Global Policy. With the Code of Conduct, the highest level policy, as a foundation, there are individual policies such as the Global Policy on Interactions with Healthcare Professionals and Patients, the Conflict of Interest Policy, and the Anti-Bribery and Corrupt Practices Policy. In particular, the Anti-Bribery and Corrupt Practices Policy is positioned as the most important policy when conducting business globally.
Lastly, he introduced the following information on how to respond to the ever-evolving technology.
Recently, technology has evolved at an alarming rate and AI has become an integral part of each company's operations. In the past few years, generative AI has emerged and begun to be used in various fields, and while it has enjoyed a lot of value in increasing productivity, reducing costs, and supporting creative work, it has also created new risks. As risks become more diverse and complex, many companies are considering the establishment of AI governance. Takeda is also promoting the use of AI and working on the establishment of governance. In addition, Takeda publishes a position paper on its website that expresses its views on key issues arising from the use of AI and health data in creating Takeda's raison d'etre and values. Takeda is working with its global and Japan teams to promote the use of technology and build governance. The global team creates and publishes high-level internal rules that are common worldwide, while the Japan team adds and translates additional information on Japanese laws and regulations, disseminates it to employees in Japan, and provides training.
Special Lecture "AI Governance - Toward reliable use of AI
IBM Japan, Ltd.
Atsushi Yamada, Technical Director, Consulting Business Division
Mr. Tomoka Miho, Trust & Compliance Officer, Legal, IP & Compliance Counsel
The two speakers gave an easy-to-understand explanation of AI governance. The main points are summarized as follows
- In the past, AI required time-consuming preparation of a huge amount of data for each application, but recent AI has already learned basic knowledge, and if specific knowledge is taught on top of it, it can be used immediately as AI for each application. Three factors are behind the recent evolution of AI: increased computing power, accumulation of big data, and new neural network structures.
- She introduced the survey on the actual utilization of generative AI in the healthcare industry published in the spring of 2024 and the comparative survey between the U.S. and Japan in all industries.
- There is no single definition of AI governance, but it is the structure (people, technology, and processes) that an organization should have in place to promote the use of AI. They are not brakes to control AI utilization, but rather guardrails to move it forward. They are built according to the manufacturing methodology, which involves iterations of conception, requirements definition, design/implementation, and testing. Of course, they can also be incorporated into existing risk management frameworks.
- At IBM, we have established principles on AI and the basic characteristics that support them, and have published them both internally and externally. This becomes a common language for employees and clarifies what to do and what not to do, in other words, risks that can be taken and risks that should be avoided.
- Also connecting those principles to practice is the AI Ethics Committee, an organization led by a technology and legal two-top. it is important that organizations involved in AI governance be composed of a diverse cross-organizational group of people. This is because it needs to be a forum for constructive discussion with different expertise, experience, knowledge or ethics.
- For individual AI projects, there is a process to undergo a risk review by the AI Ethics Committee, and a Japanese AI Ethics Section representative is in charge of the primary evaluation of Japanese projects. For high-risk projects, the global AI Ethics Committee (or its PMO) is responsible for the final decision.
- The speed of technological evolution, including AI, is exponential. By acquiring the right knowledge now, we can turn the dramatic wave of change into an opportunity. It will be imperative for each of us to improve our literacy and we should also focus on educating our employees.
- The design thinking workshop method should be used in employee training. Through the process of using hypothetical cases, organizing the people involved, identifying risks from the perspective of those who feel disadvantaged, and considering countermeasures, it is possible to identify risks without being an expert and make them feel as if they are personal matters.
Tomoga Miho, IBM Japan, Ltd.
E-mail address:tomoka.miho@ibm.com
Closing remarks
Yoshiyuki Ishida, Executive Director, Pharmaceutical Manufacturers Association of Japan
At the beginning of his greeting, Managing Director Ishida expressed his appreciation for the participation of compliance managers and compliance practitioners in this meeting and thanked Mr. Matsumura, Chairperson of the Working Committee, Mr. Taniguchi, Mr. Yamada, and Mr. Miho for their participation.
Next, he made a special presentation on AI, saying, "While some people feel threatened by AI as a non-living agent, young businessmen are using ChatGPT and Copilot to improve their business efficiency. Today, we have been introduced to the governance and ethical checks in implementing new ideas using AI. The ethics governing AI can change, but how compliance officers and management will view it is the homework for the future. He concluded his presentation with the following words.
He concluded the meeting by saying, "Based on the practical discussion of AI governance that you have presented today, I hope that all member companies will devote themselves to making more and more use of AI in their business and to controlling it well. The meeting concluded with the following words.
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(Naoyuki Masuda, Practice Member, Code Compliance Promotion Committee)
