Japanese government drafts new strategy to strengthen medical countermeasures for public health emergencies

The Infectious Disease Committee of the Headquarters for Healthcare and Medical Strategy Promotion has released draft recommendations that revise the country's vaccine strategy. The proposal consolidates specific policies aimed at strengthening development and production systems not only for vaccines but also for therapeutics and diagnostics, in response to infectious disease emergencies. Minister of State for Science and Technology Policy Kimi Onoda stated: "The outcomes of research and development for MCMs (medical countermeasures) will have a significant impact on the health, medical care, and security of the public in the next infectious disease crisis. The recommendations from the Infectious Disease Committee are expected to be finalized after the new year, and, going forward, we intend to develop a national strategy based on these recommendations."

The Healthcare Policy approved by Cabinet decision in February last year outlined efforts to cope with infectious disease emergencies, including strengthening the research infrastructure for infectious diseases and promoting support for the research and development of vaccines, diagnostics, and therapeutics. In response, the Infectious Disease Committee has been holding meetings with experts from industry, academia, and government since June, consolidating opinions on MCM research and development, production, and related matters.

The draft recommendations suggest the following measures: expanding the scope of strengthened research and development support to include therapeutics and diagnostics for infectious diseases, in addition to vaccines; conducting training exercises and simulations to improve the effectiveness of the response to infectious disease emergencies; revising response schemes and regulation based on issues identified through these activities; and expanding direct funding at the research and development stage (push-type R&D support) while also considering mechanisms to continuously maintain manufacturing environments after commercialization. This last approach, known as pull-type R&D support, is intended to build fiscal incentive mechanisms such as government procurement and stockpiling, to expedite pharmaceutical screening, and promote market entry, thereby building an MCM ecosystem.

Director Yoshihiro Kawaoka of the International Virus Infectious Disease Research Center at the National Institute of Global Health and Medicine, pointed out: "In the development of therapeutics, even when academia can reach Phase 1, there are cases where no company steps forward to take on subsequent stages due to lack of economic viability, and promising seeds are cut off. Pull-type support such as government procurement is important for addressing this. At the same time, we should go further with a national policy of establishing a public drug discovery and manufacturing infrastructure that directly takes on the development and manufacturing processes."

Vice Chairman Isao Teshirogi of the Japan Pharmaceutical Manufacturers Association (Shionogi & Co., Ltd.), called for concrete pull-type support measures, stating: "The domestic vaccine manufacturing infrastructure developed with national funding through programs such as the Emergency Development Project for Vaccine Production Systems may, in some cases, be extremely difficult for individual companies to maintain on their own due to cost factors and uncertainty in demand. To maintain a system capable of responding swiftly to the next infectious disease crisis over the long term, I urge consideration of mechanisms for sustainable long-term government support for production systems."