The Ministry of Health, Labor, and Welfare (MHLW) budget for the 2024 fiscal year in Japan includes substantial funding aimed at promoting pharmaceutical and healthcare innovation and addressing clinical priorities. The cabinet has approved a budget of ¥33.8 trillion ($237.5 billion) for the general account.
A significant portion of this budget, ¥61.7 billion ($433.3 million), has been designated to establish an infrastructure for pharmaceutical innovation. This includes initiatives such as whole genome sequencing for cancer and incurable diseases, the creation of a clinical innovation network to accelerate the utilization of disease-specific registries in drug and medical device development, and the promotion of AI-based drug development.
Furthermore, ¥1.9 billion ($13.3 million) will be invested in efforts to encourage the use of drugs and medical devices, enhance the security of the supply system, and build public trust in generic medications. Specific measures include expediting the designation of orphan drugs and pediatric medicines to address drug lag, strengthening Asian bases for clinical development, harmonizing pharmaceutical regulations, and promoting the utilization of real-world data in regulatory affairs.
Japan’s Healthcare Innovation Strategy for 2024: Drug Promotion and Clinical Priorities
The budget also allocates substantial resources to address various clinical areas:
- Promoting measures against intractable diseases and specific chronic pediatric diseases: ¥164.2 billion ($1.154 billion).
- Preventing severe hepatitis, promoting the treatment of liver cancer and severe cirrhosis, and providing benefits for hepatitis B patients: ¥123.2 billion ($865.9 million).
- Countermeasures against cancer, cardiovascular disease, and chronic diseases, including initiatives like cervical cancer screening, HPV vaccination, building comprehensive support for stroke/heart disease patients, addressing immune/inflammatory disorders, and tackling chronic kidney disease: ¥40.6 billion ($285.3 million).
- Early detection and treatment of dementia, prevention of its progression, improved nursing and social care, and the appropriate use of new therapies in medical centers: ¥13.4 billion ($94.1 million).
While the life sciences industry welcomes the infrastructure support for pharmaceutical innovation, the budget allocation of ¥1.9 billion ($13.3 million) for promoting drug and medical device use, enhancing supply security, and building trust in generics may prove insufficient.
The funding distribution across different disease areas sheds light on the government’s healthcare priorities. Notably, intractable and pediatric diseases, followed by hepatitis, liver cancer, and cirrhosis, receive the most substantial funding. However, given the increasing prevalence of dementia and the introduction of potentially disease-modifying treatments, the ¥13.4 billion ($94.1 million) allocated for dementia-related efforts may be insufficient. It remains to be seen how the “appropriate” use of new therapies will be defined in practice.
Resource: Neil Grubert, December 27, 2023
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