The "FY2024 General Meeting of the Drug Evaluation Committee" was held. Patient and Public Involvement" - For Whom We Work
The 146th Annual Meeting of the Pharmaceutical Evaluation Committee was held on November 15, 2024 at Muromachi Mitsui Hall & Conference (Chuo-ku, Tokyo). As a general meeting open to all employees of member companies of the Drug Evaluation Committee, the meeting was held in a hybrid format with both on-site and YouTube streaming, with more than 1,300 participants including those who attended online.
Patient and Public Involvement (PPI), which started in the U.K. and is defined as "research conducted with or by patients and the public," has spread to major countries in the U.S. and Europe. In Japan, patient groups for rare diseases and cancer are developing activities, and pharmaceutical companies are also involved in related initiatives. The Pharmaceutical Manufacturers Association of Japan (PMAJ) issued "Guidelines for Collaboration with Patient Groups" in 2013, and a task force on "Drug Development Based on Patients' Voices" was established in the Drug Evaluation Committee in 2016, and many related efforts are now being made in various subcommittees. Recently, the importance of PPI has been reaffirmed in the wake of the drug lag/loss issue. However, committee members had few opportunities to be exposed to activities and overall initiatives outside their subcommittees, and there were no opportunities to discuss the difference between Patient Centricity and PPI.
At the beginning of the meeting, Takayuki Imaeda, Vice Chairperson of the Drug Evaluation Committee, explained the purpose of the meeting as the moderator, followed by opening remarks by Shigeru Nakaji, Chairperson of the Drug Evaluation Committee. In the second part, the activities of the Patient Organization Collaboration Promotion Committee, the Drug Evaluation Committee, the Clinical Evaluation Committee, the Pharmacovigilance Committee, and the Medical Affairs Committee were introduced. In the third part of the general discussion, the participants discussed future activity policies based on the new insights gained from the first and second parts of the meeting, and the four-hour meeting was concluded with a Closing Remark by Yoshiyuki Ishida, Executive Director of the Pharmaceutical Manufacturers Association of Japan.
Part I (Special Lecture)
To look for "hope" together
Ms. Yoko Matsumoto, President, Ehime Cancer Support Orenji no Kai (NPO)
Dr. Matsumoto, who also serves as the president of Ehime Cancer Patients and Families Association "Orenji no Kai" and the vice president of National Federation of Cancer Patients' Associations, gave a lecture from the perspective of having experienced anti-cancer drug treatment for cervical cancer herself.
During the lecture, Mr. Matsumoto asked the audience whether pharmaceutical companies are focusing on "what" to communicate in providing information. He also stated that the most important thing is to "show" rather than "make" information be read, and to provide information based on scientific evidence in plain language so that patients can think of it as their own problem and make an appropriate choice. The patient should be able to think of it as "my" problem and make an appropriate choice.
Who are Patients? The lecture provided an opportunity for each participant to think deeply about the message that "Patients are not a number that can be rounded up, but are different for each individual," the difficulty of reaching correct information under the different circumstances of readers, and the importance of presenting information in a way that takes readers' emotions into consideration.
Pharmaceuticals and the Importance of Patient and Public Involvement
Professor Kaori Muto, Department of Public Policy Research, Institute of Medical Science, University of Tokyo
Dr. Muto gave a thought-provoking lecture on the theme of pharmaceuticals and patient/citizen participation from an academic perspective.
At the beginning of the panel discussion, the latest findings on how to describe patient and public involvement were explained, and the view that patient and public involvement in research and development should be described as "Patient and Public Involvement and Engagement (PPIE)" was presented.
The PPIE presented the idea that it is important for patients and researchers to cooperate at all stages of the drug development process, to have "Meaningful: meaningful" discussions that do not end with "Thank you for your valuable input," and to ensure that patients' voices are reflected in drug development and the realization of better medical service delivery. He also expressed his thoughts on the importance of having "Meaningful" discussions and ensuring that patients' voices are reflected in the development of drugs and the provision of better medical services. He concluded his lecture with the message that it is important to continue to accumulate good examples of patient and citizen participation and to aim for the realization of medical care that patients want in the development and use of pharmaceutical products.
Part 2 (Lecture) Introduction of initiatives by the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Initiatives to promote PPI by the Committee for Promotion of Cooperation among Patient Organizations
Kenji Misawa, Patient Group Collaboration Promotion Committee, Chair
The Patient Organization Collaboration Promotion Committee was established in 2012, but its base efforts date back to 1999. Currently, the committee aims to work with patient groups to realize "patient-participatory medicine.
In his speech, Chair Misawa first gave an overview of the committee, including the ideal state of the committee by the end of FY2025 and its organizational structure. Then, he introduced specific initiatives to achieve the ideal state. Specifically, the committee is developing "Guidelines for Collaboration with Patient Groups" and "Guidelines for Transparency of Relationship between Corporate Activities and Patient Groups," conducting surveys on the awareness and activities of patient groups, establishing an advisory board, holding seminars for patient groups, providing information on the website, and providing operational support for the "Society for Creating Accessible Clinical Trials for All. The committee introduced a very wide range of activities, including support for the operation of the "Association for Creating a Society with Easy Access to Clinical Trials," and support for the operation of the Pharmaceutical Visionary Conference.
Through his presentation, Dr. Kato's message was that collaboration among various stakeholders, including patient groups and pharmaceutical companies, will play an important role in realizing a better healthcare environment.
Initiatives by the Drug Evaluation Committee
Shigeru Nakaji, Chair, Drug Evaluation Committee
As an introduction to the activities and policies for FY2024, Chair Nakaji outlined the PPI activities of the Drug Evaluation Committee and explained the results of the surveys and questionnaires conducted on citizens and patients. The results of the survey showed that there are issues related to access to information (not being able to access reliable information, low usability of information websites) and information content (insufficient amount of information, information is difficult to understand). Next, he explained about the efforts of regulatory authorities, drug discovery ecosystem, the website of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and information disclosure using social networking services (SNS).
Finally, the results of the survey to date indicate that there are issues with access to clinical trial information and the quality of its content, and the panel indicated that they will continue to emphasize dialogue with patients and the public and improve the provision of information, with the aim of promoting participation in clinical trials and improving drug literacy. He also concluded his presentation by expressing his hope that the committee will contribute to the national effort to strengthen drug discovery and eliminate drug lag/loss.
PPI in the activities of the Clinical Evaluation Subcommittee
Hiroshi Matsuzawa, Chairman, Clinical Evaluation Subcommittee, Drug Evaluation Committee
Mr. Matsuzawa, Chairperson of the Committee, explained that the Clinical Evaluation Committee has established "Vision 2025" as its activity policy, and is working on it with the goal of promoting drug development together with patients, and explained the action plan and task force activities toward that goal. According to the results of a questionnaire survey of member companies of the Clinical Evaluation Subcommittee of the Pharmaceutical Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan, data on the status of PPI efforts by each company over time showed that efforts are progressing, but are still insufficient. Specific actions include the use of DX (Digital Transformation) overseas, DCT (Decentralized Clinical Trial) for patient-oriented clinical trials, ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the new topic E22 "General Guidelines for Patient Preference Trials.
Finally, he declared that we will continue our activities with PPI in mind in order to deliver innovative and highly useful medicines to patients, healthcare professionals, and people around the world more quickly.
Efforts of the Pharmacovigilance Subcommittee and promotion of patient safety
Makoto Miyazaki, Chairman, Pharmacovigilance Subcommittee, Drug Evaluation Committee
Section Chair Miyazaki began the session by introducing the activities of writing textbooks for students and medical professionals as part of efforts to raise awareness of pharmacovigilance activities. Next, after explaining the status of preparation of the Risk Management Plan (RMP) for pharmaceuticals, the question was raised as to whether the information provided to patients is sufficient only by providing information as stipulated by regulations. The results of the analysis of how patients, physicians, and pharmacists obtain safety information and the gap between patient needs and the actual explanations given by physicians and pharmacists were also presented, He also mentioned the need to review whether the medium (digital or paper) is appropriate and whether the information is provided in a way that is appropriate for IT literacy and disease.
Initiatives of the Medical Affairs Subcommittee
Mr. Koji Aoyama, Chairman, Medical Affairs Subcommittee, Drug Evaluation Committee
Mr. Aoyama, Chairperson of the committee, introduced the overall activities of the Medical Affairs Committee and its initiatives on Patient Centricity. According to a questionnaire survey of member companies of the Medical Affairs Subcommittee of the Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), many pharmaceutical companies are engaged in Patient Centricity activities, but some issues such as lack of experience in implementation and lack of internal rules have been highlighted. In response to this, the Medical Affairs Committee has compiled a collection of case studies on "points to note when the medical affairs department conducts disease awareness activities targeting patients.
The results of interviews with patient groups also suggested the importance of continuity in information dissemination and the creation of materials that reflect the voices of patients. He also presented the activities of the task force that is studying disease awareness activities targeting patients and others.
As for future efforts, the Medical Affairs Subcommittee concluded with a declaration that it aims to create an environment in which patients can obtain correct information and realize a society in which they can receive treatment with conviction.
Part III (General Discussion)
Chairperson Kazuhiko Mori, Executive Director, Pharmaceutical Manufacturers Association of Japan (PMAJ); Ken Kaiabe, Vice-Chairman, Drug Evaluation Committee
Panelists The speakers from Parts I and II were: Dr. Yoko Matsumoto, President, Ehime Cancer Support Orenji no Kai (NPO); Dr. Kaori Muto, Professor of Public Policy Research, Institute of Medical Science, University of Tokyo; Dr. Hiroshi Matsuzawa, Chairman, Clinical Evaluation Committee; Dr. Makoto Miyazaki, Chairman, Pharmacovigilance Committee; Dr. Koji Aoyama, Chairman, Medical Affairs Committee; Dr. Shoji Aoyama, Chairman, Medical Affairs Committee; Dr. Shoji Aoyama, Chairman, Medical Affairs Committee; and Dr. Yoshiaki Nakamura, Chairman, Pharmaceutical Affairs Committee. Five members
Panel Discussion Chairperson
Activities of the Pharmaceutical Manufacturers Association of Japan (following the presentations in Part II)
At the beginning of the session, Yoko Matsumoto and Kaori Muto commented on the activities of the Pharmaceutical Manufacturers Association of Japan (PMAJ) in the second part of the session, expressing surprise at the wide range of activities being conducted by all organizations related to PPI and commending their activities. On the other hand, they pointed out that the activities are not well known to the public and that there is a lack of appeal, including ways to publicize the activities.
Organizing Terminology
Executive Director Kazuhiko Mori raised the issue that the term "Patient Centricity" may be uncomfortable from the patients' perspective, such as "it is not something to be fêted. Ms. Yoko Matsumoto and Ms. Kaori Muto felt that "Patient Centricity" makes patients feel as if they are being kept away from discussions on drug development. They also commented that they felt uncomfortable because they had the impression that all opinions had to be taken into account, even though not all of what patients say is correct. On the other hand, some commented that pharmaceutical companies have a history of operating as "Physician Centers," and if the term "Patient Centricity" is used as a contrast to this, or as an admonition to act with the mindset of "Patient Center," then there is nothing wrong with using the term. The committee believes that the use of "Patient Centricity" is not out of place. He then suggested that since these ideas and PPI are two different things, we should use different words if we want to express our commitment to patient and citizen participation.
Future PPI initiatives and issues to be prioritized by the Drug Evaluation Committee
Regarding future PPI initiatives, there were proposals to spread new concepts such as "co-creation" and "making together: Co-creation," as well as a discussion on the balance between PPI initiatives and the role of medical professionals.
As activities to be prioritized in the future from the viewpoints of the Drug Evaluation Committee and each subcommittee, he mentioned the necessity of PPI initiatives with clear objectives and targets, the way of providing information that is more patient-oriented and leads to consideration of treatment options, the importance of continuous and genuine collaboration with patients, the reflection of patients' viewpoints in the design of clinical trials, and the importance of communication within the Pharmaceutical Manufacturers' Association and the role of the Pharmaceutical Manufacturers' Association in the design of clinical trials. The need to reflect the patient perspective in the design of clinical trials, and the need to promote communication and collaboration within the Pharmaceutical Cooperative Association were also discussed.
Communication between pharmaceutical companies and patients
The question of how pharmaceutical companies should communicate with patients continues to be an issue. In this regard, it was mentioned that it is important to build a seamless relationship between companies and patients, while recognizing the differences in their positions, and that two-way communication, rather than one-way provision of information, is necessary. It was suggested that a forum for open discussion (e.g., in a round-table setting) be established within the scope of the regulations. In order for pharmaceutical companies to listen to patients' opinions and plan for development, it is important for pharmaceutical companies and patients to have an ongoing dialogue on a regular basis. In addition, there is a need for a better understanding of the drug development process on the part of patients, and a need to establish contact with a wider patient base in addition to communication with patient groups The committee discussed the need to develop a better understanding of the drug development process on the part of patients. As measures to resolve these issues, the participants proposed the use of Artificial Intelligence (AI), the development of a venue for matching individual patients with pharmaceutical companies, the establishment of a permanent panel, and the use of patients' opinions within companies.
Provision of information from the pharmaceutical company side
Regarding the provision of information from the pharmaceutical companies' side, it was confirmed that improvements are needed based on the issues mentioned at the beginning of the lecture, such as the lack of sufficient recognition of the activities of the Pharmaceutical Manufacturers Association and the need to provide information from diverse perspectives in order to respond to various patient needs.
The hour-long general discussion ended with many insights that should be applied to the future activities of the Drug Evaluation Committee.
Panel Discussion
(Responsibility: Ayako Okayasu, Secretary of the Steering Committee for Drug Evaluation)
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