JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
ple, packaging and product labelling – and the explanatory written material provided with the products (such explanatory information is usually available online) – must be provided in Japanese and satisfy the requirements under the Pharma- ceuticals Law. Changing 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 As of January 2025, Japan has signed 21 eco- nomic partnership agreements/free trade agree- ments with other countries. Among others, Japan is a signatory to the Comprehensive and Progressive Agreement for Trans-Pacific Part- nership (TPP) and the Regional Comprehensive Economic Partnership (RCEP), as well as eco- nomic partnership agreements with such coun- tries as the United States, the United Kingdom, Singapore, Mexico, India, Peru, Switzerland, Thailand and Indonesia. a manufacturing business licence. 7.5 Trade Blocs and Free Trade Agreements 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Prices for the substantial majority of medical ser- vices 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 nation- al 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 Insur- ance Act and is a separate procedure from the marketing authorisation procedure provided under the Pharmaceuticals Law. The profit mar- gin of the hospitals and the pharmacies is usu- ally the difference between the prices for the rel- evant 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 medi- cal services provided using the medical devices, that are reimbursable under the Japanese health insurance. However, certain medical device products that are designated by the MHLW are reimbursable under the Japanese health insur- ance. 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 phar- maceuticals listed are determined by the MHLW after reviewing the applications submitted by the market authorisation-holders of such pharma- ceuticals. The price of the same product in other countries is one element of background infor- mation considered when determining the listing price. The drug tariff is reviewed and updated 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.
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