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Policy Watch

Japan Drafts 25% Surcharge on 1,100 Prescription Drugs That Mirror OTC Medicines

From March 2027, patients filling prescriptions for 77 active ingredients also sold over the counter will pay an extra quarter of the drug cost, unless they are children, cancer patients, or otherwise exempted.

Aug 6, 20263 min read
Close-up of a pharmacy counter with two rows of unlabeled medicine boxes and a receipt showing one highlighted charge line, representing a prescription-drug cost surcharge.

Japan's health ministry wants patients to pay more when a doctor prescribes something that is, in practical terms, the same drug sold a few aisles over in the pharmacy. The Ministry of Health, Labour and Welfare has opened a public comment period, running August 6 to August 20, 2026, on an interim report that lays out how a new partial exclusion from insurance coverage will work starting in March 2027.

The mechanism is narrow but not small. It targets 77 active ingredients, spanning roughly 1,100 prescription products, that share the same ingredient, administration route and maximum daily dose as an over-the-counter equivalent. Patients who receive one of these prescription drugs will generally pay an additional 25% of the drug's cost out of pocket, on top of normal cost-sharing, under a legal category the ministry calls "partial non-insurance care." The surcharge falls away, though, when the drug treats a condition the OTC version is not approved to address, since the two products are then no longer functionally interchangeable. The framework rests on a law amending the Health Insurance Act and related statutes (Act No. 31 of 2026), promulgated June 5, 2026.

Who avoids the surcharge, and why it gets complicated

The idea that patients should not be charged extra just for visiting a doctor instead of a drugstore comes with a long list of carve-outs, and the interim report spends most of its length trying to draw firm lines around them. A technical advisory committee of physicians and pharmacists, formed in June 2026, produced the August 5 interim report specifically to define who qualifies.

Who avoids the 25% surcharge
Based on the technical committee's August 5, 2026 interim report; final scope subject to further review and public comment.
Patient categoryExemption condition
ChildrenExempt from the surcharge; ministry is still deciding whether the cutoff extends through high-school age
Cancer patientsExempt only for drugs treating the cancer or its treatment side effects, not unrelated symptoms
Designated intractable disease patientsExempt for the designated disease and conditions arising from it
Low-income patientsExempt, per the ministry's stated policy
Hospitalized patientsExempt for drugs prescribed during a hospital stay, including at discharge
Physician-certified long-term needExempt when a doctor certifies medically necessary long-term use, roughly 50 weeks of annual prescriptions for oral medicines
Pregnant or breastfeeding womenExempt for drugs whose OTC labeling warns against use during pregnancy or breastfeeding

The cancer exemption shows how granular the ministry has gotten: a patient actively being treated for cancer avoids the surcharge for drugs addressing the cancer itself or its treatment side effects, such as anti-nausea medication during chemotherapy, but not for an unrelated complaint like hay fever or a common cold picked up during treatment. For long-term users of oral medicines, the committee settled on a rough proxy: roughly 50 weeks of prescriptions filled in a year, drawn from pharmacy records or medication notebooks, counts as evidence of genuine chronic need. Topical pain relievers get a narrower, temporary exemption tied to imaging-confirmed severity, such as Kellgren-Lawrence Grade 4 knee arthritis, running through the fiscal year ending March 2029, after which the ministry says it will revisit the evidence. Moisturizers, skin protectants and keratosis treatments get a separate temporary exemption over the same period, judged differently: because skin severity is often assessed by exam rather than imaging, the committee proposes covering patients whose symptoms have not sufficiently improved despite systemic treatment, such as immunosuppressants, within the past year.

The committee frames the exercise as balancing two goals that pull in opposite directions: trimming the cost burden on an insurance pool largely funded by working-age premiums, while not scaring patients away from care they actually need. It flags a risk of its own making, too: the rules could push doctors and patients toward switching prescriptions rather than simply absorbing the extra charge. The ministry says it will monitor that behavior once the policy takes effect and will require insurers to record, through claims documentation, why a particular patient was exempted.

For now, the document remains a draft. The ministry plans to report the findings to the Social Security Council's health insurance panel and continue the necessary work toward implementing the partial exclusion system, with the surcharge slated to start in March 2027.