Japan introduces 'selected medical treatment' for long-listed products — patients who ask for the originator drug pay a 'special fee' for part of the price gap (in force 1 October 2024)
Source material is a Japanese government announcement (in Japanese); this page is a summary.
From 1 October 2024 Japan operates 'selected medical treatment' (選定療養), under which a patient who asks for an originator drug that has a generic version (a long-listed product) without a medical need pays part of the price gap between the originator and the generic as a 'special fee' outside insurance cover.
Key facts
| In force from | 1 October 2024 (Reiwa 6, 1 October) |
|---|---|
| Responsible body | Health Insurance Bureau, Ministry of Health, Labour and Welfare (厚生労働省) |
| What it covers | Originator drugs that have a generic version = long-listed products (長期収載品). Cases where there is a recognised medical need, and certain other cases, are excluded |
| Special fee (at the start) | One quarter of the price gap between the originator and the generic (the remaining three quarters stays covered by insurance as before). The special fee is taxable, so consumption tax is added separately |
| Special fee (revised) | Raised to one half of the gap from 1 June 2026 (令和8年6月1日) (Ministry of Health, Labour and Welfare Notification No. 116 of 2026) |
| Exemptions | A medical need (difference in efficacy or effect, safety concerns, recommendation in an academic society guideline, reasons relating to the dosage form), or where the generic is hard to supply, for example because of stock shortages |
| How it is calculated | Where there are several generics, the gap is calculated against the generic with the highest drug price |
Last checked:
From 1 October 2024, when a patient asks for an originator drug that has a generic version (a long-listed product), and there is no recognised medical need or other exemption, Japan treats it as 'selected medical treatment' and the patient pays part of the price gap between the originator drug and the generic as a 'special fee' outside insurance cover. When the scheme started, the special fee was one quarter of the gap, with the remaining three quarters still covered by insurance as before, and the special fee is taxable, so consumption tax is added on top. Where there are several generics, the gap is calculated against the generic with the highest drug price. A notification issued on 27 March 2026 (Ministry of Health, Labour and Welfare Notification No. 116 of 2026) then raised the special fee to one half of the gap from 1 June 2026.
Background — why this change
The Japanese government introduced the scheme with the stated aim of improving health insurance finances so that universal health insurance can be maintained into the future. Where a lower-priced generic with the same ingredient is available but the originator drug is chosen, the patient bears part of the difference.
Summaries below are factual notes based on government announcements and primary sources — not evaluations or opinions.
Summaries reflect national-level programs. Municipal (city/ward/town) programs may differ — confirm with the official desk before applying.
FAQ
Does the special fee apply to every originator drug?
No. It applies to originator drugs that have a generic version — that is, long-listed products (長期収載品). Cases with a recognised medical need (difference in efficacy or effect, safety concerns, recommendation in an academic society guideline, reasons relating to the dosage form), or where the generic is hard to supply because of stock shortages and the like, are excluded.
How much is the special fee?
When the scheme started (1 October 2024) it was one quarter of the price gap between the originator drug and the generic, with the remaining three quarters still covered by insurance as before. From 1 June 2026 it was raised to one half of the gap. The special fee is taxable, so consumption tax is added on top.
If there are several generics, which price is used?
The gap is calculated against the generic with the highest drug price.