JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
ceuticals or medical devices, it may be necessary to change the product’s packaging to conform to prod- uct description and information requirements pro- vided under the Pharmaceuticals Law. By way of an example, packaging and product labelling – and the explanatory written material provided with the prod- ucts (such explanatory information is usually available online) – must be provided in Japanese and satisfy the requirements under the Pharmaceuticals Law. Chang- ing a product’s packaging is considered part of the manufacturing of the product and, as such, the entity responsible for performing such changes is required to possess a manufacturing business licence. 7.5 Trade Blocs and Free Trade Agreements As of February 2026, Japan has signed 21 economic partnership agreements/free trade agreements with other countries. Among others, Japan is a signatory to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (TPP) and the Regional Comprehensive Economic Partnership (RCEP), as well as economic partnership agreements with such countries as the United States, the United Kingdom, Singapore, Mexico, India, Peru, Switzerland, Thailand and Indonesia. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Prices for the substantial majority of medical servic- es provided and prescription pharmaceuticals sold in Japan are reimbursed by the Japanese universal healthcare system, and the substantial majority of legal residents of Japan participate in and are covered by Japan’s national health insurance system. The cost of prescription pharmaceuticals to be paid through the national health insurance system corresponds to the prices for the relevant pharmaceuticals listed on the drug tariff. Listing of a prescription pharmaceutical’s price on the drug tariff is based on the Health Insurance Act and is a separate procedure from the marketing authorisa- tion procedure provided under the Pharmaceuticals Law. The profit margin of the hospitals and the phar-
macies is usually the difference between the prices for the relevant pharmaceuticals listed on the drug tariff and the prices at which the pharmaceuticals are purchased by the hospitals and the pharmacies (such price is usually lower than the price listed on the drug tariff). In the case of medical devices, typically, it is not the medical devices themselves, but the medical services provided using the medical devices, that are reimburs- able under the Japanese health insurance. However, certain medical device products that are designated by the MHLW are reimbursable under the Japanese health insurance. 8.2 Price Levels of Pharmaceuticals or Medical Devices The listing of pharmaceuticals on the drug tariff and the price designated for each of the pharmaceuticals listed are determined by the MHLW after reviewing the applications submitted by the market authorisa- tion-holders of such pharmaceuticals. The price of the same product in other countries is one element of background information considered when determining the listing price. The drug tariff is reviewed and updat- ed basically every two years. Recently, an “interim” review and update of the drug tariff is conducted after one year, which essentially means that the drug tariff is generally reviewed and updated every year. 8.3 Reimbursement From Public Funds A substantial part of the costs of pharmaceuticals 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 The MHLW considers cost-benefit analysis as a key factor when evaluating new pharmaceuticals. Whether or not pharmaceuticals, medical devices and medi- cal treatments are reimbursed by the Japanese health insurance, and the reimbursement price of such prod- ucts and services under Japanese health insurance, are determined and reviewed periodically by the MHLW, upon taking into consideration various fac- tors including cost-benefit analyses.
177 CHAMBERS.COM
Powered by FlippingBook