The Pharmaceutical Manufacturers Association of Japan (PMAJ) Media Forum: Initiatives for Priority Infectious Diseases (including AMR) -Introduction of the Revised Government Action Plan for H1N1 Influenza, etc., and Future Responses
The Pharmaceutical Manufacturers Association of Japan (PMAJ) Media Forum was held on October 2, 2024. In addition to measures to be taken in the event of an infectious disease crisis caused by new strains of influenza or new coronaviruses, drug-resistant (AMR) organisms must also be addressed as a priority infectious disease. In addition to countermeasures against infectious disease crises caused by new strains of influenza and new coronaviruses, drug-resistant (AMR) bacteria also need to be addressed as a priority infectious disease. Through this forum, the current status of countermeasures against priority infectious diseases (including AMR) during normal times was introduced from the standpoints of industry, government, and academia, and the need for industry, academia, and government to cooperate in taking countermeasures in case of emergency was deepened in the media's understanding.
Scene of the forum
Lecture 1
Preparation and contingency planning of medical countermeasures for infectious diseases in Japan
Dr. Eiji Kusaka, Deputy Director-General, Cabinet Office, Infectious Disease Control and Prevention
In this lecture, the revised contents of the "Government Action Plan for H1N1 Influenza" were explained. Former Prime Minister Fumio Kishida pointed out the need for a command post function for infectious diseases, and he introduced the background and role of the establishment of the Cabinet Office for the Control of Infectious Disease Crisis Management. He also explained that the organization of the Agency differs between normal times and emergencies, and that in emergencies, a considerable number of additional staff members are assigned to the Agency to take countermeasures.
Next, the revised "Government Action Plan for Pandemic Influenza" was introduced (Figure 1). Based on the experience of the recent new coronavirus infection (COVID-19), the plan has been fundamentally revised to enable more effective measures to be taken against a wide range of infectious diseases.
In particular, the revision includes the expansion of the target diseases from new strains of influenza, the division of normal preparation into three phases (preparation phase, initial response phase, and response phase), an increase in the number of countermeasure items to 13, and the inclusion of cross-cutting perspectives such as human resource development, support for research and development, collaboration with local governments, and international collaboration. It was also introduced that, in consideration of the need to cope with multiple infectious diseases, the revised regulation was specified to be revised approximately every six years.
Figure 1: Key Points of Revision of the Government Action Plan for Countermeasures against Influenza Pandemic
Lecture 2
Preparation and contingency planning of medical countermeasures for infectious diseases in Japan
Director, Center for Global Infectious Diseases, National Center for Global Health and Medicine
Dr. Takao Omagari, Director, AMR Clinical Reference Center, National Center for Global Health and Medicine
In this lecture, he discussed medical preparedness and emergency response plans for infectious diseases in Japan from the R&D and clinical perspectives.
In the COVID-19 REGISTRY JAPAN (COVIREGI-JP), which was conducted during the COVID-19 epidemic in Japan, a registry was established to collect clinical information and specimens of COVID-19 patients by applying protocols for patients with Middle East respiratory syndrome (MERS), The efficacy and safety of treatment with plasma from COVID-19 recovering patients was studied. As a learning from this experience, he stated that preparation is very important and that what has been prepared can be implemented. He also stated that preparation for infectious disease drug R&D in Japan must be based on a plan, and presented the following seven points that need to be strengthened (Figures 2 and 3).
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Promotion of R&D in normal times based on the national R&D plan
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Coordination and strengthening of basic and practical research
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Promotion of data utilization
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Strengthening human resource development
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Expansion of support for drug discovery ventures
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Establish a system for international joint clinical trials
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Regulatory Development
Figure 2: Points in Japan where R&D on infectious disease drugs needs to be strengthened (1)
Figure 3: Points in Need of Strengthening Infectious Disease Drug R&D in Japan (2)
Regarding preparations being made in the clinical field in Japan, various initiatives were mentioned, including the establishment of a clinical research network for infectious diseases, as exemplified by the National Repository for Emerging and Re-emerging Infectious Diseases Data Bank Project (REBIND), and the Emerging and Re-emerging Infectious Diseases Research Platform Creation Project, which has established bases overseas and conducts basic research. The UN High-Level Meeting on Infectious Diseases (UNHIDS) The Political Declaration on AMR, which was resolved at a high-level meeting of the United Nations, introduced the need to promote research and development to deliver antimicrobial agents to people from various walks of life in all countries and the need for financial support for this purpose.
Lecture 3
Initiatives for Priority Infectious Diseases - Focusing on AMR Initiatives
From a pharmaceutical company's viewpoint
Nobuo Murakami, Chairman, International Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
In this lecture, Mr. Murakami explained the efforts being made by the Pharmaceutical Manufacturers Association of Japan (PMAJ) to address priority infectious diseases in the field of infectious diseases where the market environment is severe. He stated that drug-resistant (AMR) organisms are positioned in Group C in the classification of priority infectious diseases, and that they are aware of the need to be prepared for them from normal times. In the research and development related to AMR, he stated that a drug discovery ecosystem must be promoted, but he also pointed out the following problems: although strict proper use of antimicrobial agents is recommended, the proper use of antimicrobial agents is not yet widespread enough, and in cases where there is a negative business impact due to drug prices, companies are less willing to invest in research and development. In addition, the willingness of companies to invest in research and development is decreasing in cases where drug prices have a negative impact on their business.
The AMR Action Fund, established under the leadership of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), has collected a total of more than US$1 billion from volunteer pharmaceutical companies to invest in biotech companies developing drugs for infectious diseases. The AMR Action Fund is investing in biotech, which has attracted more than US$1 billion in total from the world's leading pharmaceutical companies to develop drugs for the treatment of infectious diseases.
Regarding priority infectious diseases, it was mentioned that in addition to push-type incentives, pull-type incentives are important to promote research and development, and that it is necessary to expand awareness of the importance of strict proper use to the public through AMR awareness activities (Figure 4).
Figure 4: Summary of today's presentation
Conclusion
In this media forum, the "Government Action Plan for Pandemic Influenza" was revised based on the experience of COVID-19, aiming for a society that can respond to a wide range of infectious diseases, and it was stated that in addition to countermeasures in case of infectious disease crisis caused by novel influenza or novel coronavirus, drug-resistant (AMR) organisms must also be addressed as a priority infectious disease. In addition to countermeasures against infectious disease crises caused by new strains of influenza and new coronaviruses, it was also introduced that drug-resistant (AMR) bacteria must be addressed as a priority infectious disease.
In addition, the speakers from industry, academia, and government reported on the current status of countermeasures against priority infectious diseases (including AMR) during normal times from their respective standpoints, and we believe that the media gained a broad understanding of the wide range of issues involved in countermeasures against priority infectious diseases.
In particular, from the standpoint of the pharmaceutical industry, he introduced the need to foster researchers who will be the key players and the need for pull-type incentives in order to establish an ecosystem for the research and development of infectious disease drugs. The International Committee of the Pharmaceutical Consortium of Japan (PPCJ) will continue to promote various activities in cooperation with industry, academia, and government, while maintaining a global perspective.
The End
(Responsibility: Takeshi Watanabe and Toshiaki Sakai, International Committee)