Report on the Pharmaceutical Manufacturers Association of Japan Media Forum "Two Major Issues in Countermeasures against Infectious Diseases: Consideration of Countermeasures against Drug-Resistant Bacteria and Proper Understanding of Immunization
On September 3, 2025, the Pharmaceutical Manufacturers Association of Japan (PMAJ) held a media forum titled "Two Major Issues in Countermeasures against Infectious Diseases: Consideration of Countermeasures against Drug Resistant Bacteria and Proper Understanding of Immunization". At this forum, the latest findings were introduced to the media through a deep dive into the efforts of industry-academia-government collaboration under the themes of "countermeasures against drug-resistant (AMR) bacteria" and "correct understanding of vaccinations," which are two urgent issues in the fight against infectious diseases. The forum provided a valuable opportunity to understand the current situation and consider future countermeasures together with the media in order to protect the future of infectious diseases.
The forum was divided into two parts, with the first part focusing on the latest trends in AMR countermeasures and the second part on creating a system to visualize and deliver accurate information on immunization. This paper reports on the "Introduction" and the content of the first part, which was organized by the International Committee.
Introduction: "Significance and Purpose of the Establishment of the National Institutes for Health Risk Management (JIHS)"
Dr. Manabu Sumi, Director, Infectious Disease Control Division, Health and Welfare Bureau, Ministry of Health, Labour and Welfare
In this lecture, he introduced the significance and purpose of the establishment of the National Institutes of Health Risk Management (JIHS), which was established in April 2025.
Mr. Sumi began by explaining that through the experience of the new coronavirus pandemic, there was a deepening recognition that it is essential to develop a command post function in the government and to strengthen the expert organization that supports policy decisions based on scientific findings. This is due to the recommendations made in the June 2022 Expert Group Report, which called for strengthening the role of the expert organizations in data collection, analysis, and recommendations to the government. In response, in September 2022, the "Headquarters for Countermeasures to Combat Infectious Diseases of New Coronaviruses" decided to establish the Cabinet Office for Infectious Disease Crisis Management and Control, and at the same time, the Department of Infectious Disease Control was newly established within the Ministry of Health, Labor and Welfare. Furthermore, the National Institute of Infectious Diseases (NIID) and the National Center for Global Medical Research (NCGM) were merged to create the JIHS as a new expert organization.
The main objectives of the JIHS are to build a nationwide information infrastructure, which will be strengthened by the revision of the Law Concerning Prevention of Infectious Diseases and Medical Care for Patients of Infectious Diseases (Infectious Diseases Control Law), and an integrated research infrastructure from basic to clinical research, and to acquire high-quality scientific knowledge through collaboration with external organizations, which will be promptly provided to the Directorate General and the MHLW's This organization is to provide the information to the National Health Service and the Ministry of Health, Labour and Welfare. This organization is fully funded by the government under a special law (National Institutes of Health Crisis Control and Research Act), and will prepare a mid-term plan and promote its operations based on the mid-term goals set by the Minister of Health, Labour and Welfare.
The JIHS is the result of the merger of the former National Institute of Infectious Diseases (originally the National Institute of Infectious Diseases, of which Dr. Shibasaburo Kitasato was the first director) and the former National Center for International Medical Research (formerly an army hospital), and has a wide range of purposes and functions. Of particular importance is the strengthening of the intelligence base for infectious diseases, providing information to the government through information collection, analysis, and risk assessment. It also promotes basic, clinical, and epidemiological research in an integrated manner and strengthens collaboration with the private sector (industry) and academia to support the rapid development of a three-part "weapon" set of infectious diseases: therapeutic drugs, testing methods, and vaccines. Collaboration with regional health institutes and international partnerships will also be emphasized, and the Center is expected to serve as a cross-border infectious disease control hub. The mid-term goals include strengthening initial response to emergencies (e.g., collection of First Few Hundred findings), strengthening research and development capabilities, clinical functions, human resource development, and international cooperation, and quantitative targets have also been set. He concluded his lecture by expressing his hope that the synergy effect of the integration of the National Center for Global Health and the National Institute of Infectious Diseases will produce groundbreaking research results in the future.
Lecture 1: "The Role of JIHS in AMR Control
Dr. Hiroshi Yotsuyanagi, Director, National Institute of Health Risk Management
In this lecture, titled "The Role of JIHS in AMR Countermeasures," Dr. Shiryanagi explained from multiple perspectives the infectious disease intelligence function for the government, medical institutions, and the public in the fight against drug-resistant AMR.
Functions of Infectious Disease Intelligence for the Government and Medical Institutions
First, Dr. Shiryanagi introduced several surveillance systems in operation in Japan for AMR control as the importance of information collection and surveillance in AMR control. The National Epidemiological Surveillance of Infectious Diseases (NESID), an all-inclusive notification system based on the Infectious Diseases Control Law, is the foundation for the government to comprehensively grasp the outbreak status of designated infectious diseases. On the other hand, the Japan Nosocomial Infection Surveillance (JANIS), in which medical institutions voluntarily participate, is a system for reporting information on drug-resistant organisms, and the number of participating institutions is increasing due to additional reimbursement. In addition, the Joint Platform for Infection Control (J-SIPHE), which collects data on antimicrobial use and nosocomial infections, contributes to the promotion of appropriate use of antimicrobial agents by providing feedback to medical institutions. In addition, the system to support the appropriate use of antimicrobials in clinics (OASIS) will be launched in April 2024, and many clinics are participating. These systems are helping to strengthen the intelligence base for understanding the status of AMR in healthcare settings from multiple perspectives and for appropriate intervention.
As for trends in AMR, while the isolation rate of methicillin-resistant Staphylococcus aureus (MRSA) has been decreasing, drug resistance among Gram-negative rods (especially E. coli) has emerged as a new challenge in recent years, and the existence of multidrug-resistant E. coli such as broad spectrum β-lactamase (ESBL)-producing bacteria is a global problem. The presence of multidrug-resistant E. coli such as broad-spectrum β-lactamase (ESBL)-producing bacteria is a global problem. In response, JIHS is promoting a one-health approach that includes not only humans but also animals and the environment, in collaboration with international trends led by the World Health Organization (WHO), and is also providing technical assistance such as genome analysis to Malaysia and Indonesia, he said.
Functions of infectious disease intelligence to the public
The JIHS aims to provide the public with easy-to-understand information on AMR and promote correct understanding.
In his presentation, he introduced examples of how the company provides opportunities for both children and adults to learn about AMR through the creation of easy-to-understand websites and the use of educational tools such as friendly characters and backgammon games. The purpose of this is to help people acquire knowledge of antimicrobial agents and deepen their understanding of AMR through play. The program also educates healthcare professionals on the importance of AMR measures to improve patient prognosis. It was emphasized that we recognize that communication with the media is also very important in accurately communicating information to the public.
Part I: Lecture 2 "Sustainable Development of Antimicrobial Agents and AMR Control
Mr. Kazuhiko Mori, Executive Director, Japan Pharmaceutical Manufacturers Association (at the time of the event)
In this lecture, the challenges of sustainable development of antimicrobial agents and AMR countermeasures were explained from the perspective of pharmaceutical companies.
Infectious diseases are often overshadowed by cancer and lifestyle-related diseases, but they are a constant threat to humanity. The pandemic of new coronavirus infections in 2020 reminded us that it is essential to develop therapeutic agents, diagnostic methods, and vaccines to combat infectious diseases.
On the other hand, the development of new antimicrobial agents is extremely difficult for pharmaceutical companies to commercialize due to low profitability, and there has been a string of withdrawals from this disease area worldwide. In Japan, the Action Plan for AMR Countermeasures has also led to a reduction in the use of antimicrobial agents, which has resulted in a shrinking market, further dampening companies' motivation to develop new antimicrobial agents. In addition, the aging of the population is making it difficult to achieve the goal of reducing the use of antimicrobial agents for severely ill patients.
In this context, the Pharmaceutical Manufacturers Association of Japan (PMAJ) made a recommendation on the need for business improvement in the area of infectious diseases at the government's Council on Infectious Diseases held on September 2, 2025. In this recommendation, the Council stressed that it is essential to improve the environment in which companies can develop and manufacture antimicrobial agents and other products in a sustainable manner in order to maintain a stable supply of such products amid the ever-increasing threat of AMR.
In his presentation, Dr. Mori referred to the following three key issues in the development and manufacture of antimicrobial agents, which were presented at the Infectious Disease Conference.
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Improvement and expansion of clinical trial environment
There is an urgent need to strengthen the clinical trial system during normal times and to secure capacity at medical institutions in the event of a contingency, especially the formation of an international joint clinical trial network in Asia (such as the NCGM initiative, which has now been taken over by the JIHS), which must be continued.
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Securing manufacturing capacity
It is important to strengthen domestic manufacturing capacity to meet the rapidly increasing demand during a pandemic. In addition to this, supplementation through collaboration with neighboring countries is one effective way to address issues such as unstable raw material supply and increased costs due to environmental regulations.
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Fostering and promotion of industry
Sustainable development of antimicrobial agents is difficult based on market principles alone. In addition to support in the research and development stage (push-type support), purchase and incentives after commercialization (pull-type incentives) are essential. There is a case in the U.S. where push-type support alone did not prevent a company from going bankrupt, so it is necessary to improve marketability through policy measures.
He added that although there is a growing understanding of these issues within the government, financial resources and other issues still exist, making it difficult to solve these problems.
He concluded his presentation by reemphasizing the importance of strengthening the industrial base for drug development and production in the field of infectious diseases as a national policy, and the necessity of cooperation and collaboration among the medical field, academia, and pharmaceutical companies.
The "Introduction" and the first part of this media forum clearly indicated that the establishment of the JIHS is part of the government-wide effort to resolve the issues of infectious disease control exposed by the coronary disaster, and that the JIHS is expected to serve as a core institution to provide scientific knowledge, AMR control, and promote private sector collaboration. The JIHS is expected to be a core institution for providing scientific knowledge, AMR measures, and promoting private sector collaboration. In addition, the importance of an elaborate surveillance system and a one-health approach in AMR control was emphasized, and it was reaffirmed that international collaboration and the understanding of each and every citizen are indispensable in dealing with the borderless threat of infectious diseases. On the other hand, from the standpoint of pharmaceutical companies, the low business feasibility of antimicrobial drug development lies as a fundamental issue, and it was strongly emphasized that government policy support (especially pull-type incentives) is essential to rebuild the ecosystem from research and development to stable supply.
The forum demonstrated a common understanding that, in order to protect our future from the threat of infectious diseases, it is extremely important for industry, academia, and government to work closely together while fulfilling their respective roles in addressing these diverse issues.
(Shinichiro Awamura, Toshiaki Sakai, Atsushi Nakamura, International Committee)