Promoting practical application of novel therapies and expanding the drug discovery ecosystem: Cabinet approves Healthcare Policy Phase III

On February 18, 2025, the government approved Phase III of its Healthcare Policy. This covers the 5-year period beginning this April. The Headquarters for Healthcare Policy met before the Cabinet meeting. In addition to the Policy, the Headquarters approved the Plan for Promotion of Medical Research and Development Phase III.

Phase III of the Policy will strengthen efforts to promote the practical application of pharmaceuticals, medical devices, and novel therapies. This is in addition to conventional R&D, which mainly involves the Japan Agency for Medical Research and Development (AMED).

Prime Minister Shigeru Ishiba said, "When it comes to a strategy, what matters is its implementation. I request Minister Kiuchi and other relevant ministers to make concerted efforts to advance initiatives under the new strategy."

Previous phases of the Healthcare Policy have improved Japan's drug discovery capabilities. Phase I of the strategy promoted disease-specific R&D. Modality-specific R&D was promoted in Phase II. However, concerns have often been raised that government R&D alone does not lead to actual products. Therefore, in addition to strengthening R&D, Phase III of the strategy will involve strengthening various other initiatives, including efforts to expand the drug discovery ecosystem through R&D and promote R&D that contributes to solving social issues. Systems required to prepare for new infectious disease emergencies will also be established.

First, AMED's integrated projects will be reorganized from the current six-project structure to eight projects: pharmaceuticals; medical devices and healthcare; regenerative medicine and cell and gene therapies; infectious disease control; data utilization and life course; seeds development and basic medical research; translational and clinical research acceleration; and innovative ecosystem. In particular, a pairing and matching system will be introduced to link basic research to applied research and non-clinical research to clinical research/clinical trials.

Pairing will be done when basic-stage research projects are selected assuming that continued support will be required for the next stage. Upon completion, the content will be reviewed, and support will be provided for the next project.

Matching will be done before the basic stage of a project has been completed. The aim is to determine whether or not to proceed to the next phase. Seamless support will be provided if the project gets the approval.

Furthermore, some of the Coordination Funds for the medical field will be allocated as AMED operating grants. These will enable complementary support to be provided when projects are being linked. Additionally, the ecosystem will be expanded to expand R&D results. For example, there are plans to attract foreign companies and foreign funds through the Public-Private Council. Domestic and overseas universities and startups will be matched with pharmaceutical companies and venture-capital firms.

The following initiatives will be promoted: development of drug discovery clusters; establishment of a stable and continuous support framework for strengthening the drug discovery infrastructure; support for collaboration between domestic medical device start-ups and existing companies; support for the development of an environment for evidence-building (e.g., enhancement of medical device industry promotion centers); review of pharmaceutical regulations (e.g., clarification of the concept of Phase I for Japanese patients in international clinical trials); and development of a consultation and support system for the promotion of the practical application of new modalities.

There are also plans to promote R&D that contributes to solving social issues. For this purpose, new, internationally competitive first-in-human (FIH) trial facilities will be established. These facilities will be able to handle innovative modalities and attract international joint FIH trials. Human resources will be developed to raise the level of Japan's clinical development capabilities. These will include doctors, nurses, and administrative staff. Furthermore, the approval requirements for clinical research core hospitals will be revised. The contribution of these hospitals to drug discovery and medical device creation will be evaluated more highly than at present.

Phase III will involve strengthening the clinical trial network, primarily in Asia. Stronger cooperation is also planned between clinical research core hospitals, the Japan Health Research Promotion Bureau, the Japan Institute for Health Security (JIHS), the National Hospital Organization, etc. Cooperation is expected in areas such as knowledge-sharing, exchanging personnel, and conducting joint clinical trials. The aim is to strengthen the domestic network for clinical trials, including FIH trials. A one-stop service center will be established to provide advice and support for conducting clinical trials in Japan. It will serve overseas start-ups and pharmaceutical companies that do not have development bases in Japan. Currently, in multi-center clinical trials, review by a single institutional review board (single IRB) is possible, but this will become the norm.

In the area of infectious disease countermeasures, the government and JIHS will cooperate with universities and other research institutions. They will train human resources in basic research on infectious diseases and in clinical research such as clinical trials. The aim is to secure R&D leaders for vaccines, diagnostic, and therapeutic agents. The government will further support research entities, such as universities, through cooperation with municipal government organizations.

In addition, the national and prefectural governments will actively use the human resources trained through career development support, etc. They will support the strengthening of R&D systems at clinical research core hospitals and designated medical institutions for infectious diseases that participate in collaborative networks with medical institutions and research institutions that promote research. R&D that contributes to the development of domestically produced vaccines in normal times will be promoted. This will be done in collaboration with the Strategic Center of Biomedical Advanced Vaccine Research and Development for Preparedness and Response (SCARDA).