Life Sciences 2025

JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu

8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds A substantial part of the costs of pharmaceu- ticals and medical treatments is covered by the health insurance scheme. For the majority of Japanese residents, 70% of these costs are covered by health insurance. 8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices The MHLW considers cost-benefit analysis as a key factor when evaluating new pharmaceuti- cals. Whether or not pharmaceuticals, medical devices and medical treatments are reimbursed by the Japanese health insurance, and the reim- bursement price of such products and services under the Japanese health insurance, are deter- mined and reviewed periodically by the MHLW, upon taking into consideration various factors including cost-benefit analyses.

8.5 Regulation of Prescriptions and Dispensing by Pharmacies Historically, Japanese hospitals prescribed and dispensed pharmaceuticals themselves. Howev- er, in an effort to address excessive pharmaceu- tical-related spending, the MHLW began incenti- vising hospitals to separate the prescription and dispensing of pharmaceuticals functions so that pharmaceuticals are not prescribed unneces- sarily. Furthermore, under the Japanese health insurance regulations, Japanese hospitals are prohibited from instructing patients to purchase prescription drugs at a specific pharmacy.

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