Aska Pharmaceutical has applied to sell its emergency contraceptive pill Norlevo without a prescription, according to a recent announcement by the company, marking a potential shift in Japan’s approach to reproductive health care.

The application, which was originally submitted in June 2024, is progressing after amendments to an act on pharmaceutical and medical devices passed on Wednesday. The amendments are set to take effect in 2027.

The government began examining the switch to over-the-counter use for such medications in 2021, with a trial run beginning in 2023 that offers them at some pharmacies without a prescription. Aska filed the application in 2024 to be able to respond to potential demand should it be approved, the company said in a news release.

As a result of the legal revisions, Norlevo could fall under the new classification of "specific guidance-required drug," meaning that it can be sold over the counter under the supervision of pharmacists, but not online.

Designed to prevent pregnancy when taken within 72 hours of sexual intercourse, Norlevo is most effective when used promptly and can prevent pregnancy in about 81% of cases. But access in Japan remains limited due to the drug’s classification as a prescription-only pharmaceutical.

In most cases, women must undergo a medical examination and obtain a prescription to access emergency contraceptive pills — an added burden that can pose logistical and emotional barriers particularly over weekends and on national holidays, when clinics are unlikely to be open, or in cases involving sexual violence.

Another barrier for some is cost. National health insurance does not cover emergency contraceptive pills, and they typically cost between ¥10,000 and ¥20,000 ($69 to $138) for a single course, including clinic and consultation fees.

However, since November 2023, Norlevo has been available without a doctor’s prescription at a few pharmacies under the government-backed trial program, where those 16 and over can purchase the pill following a mandatory in-person consultation with a pharmacist.

Initially rolled out across 145 pharmacies, the program expanded to 339 locations by Jan. 31 this year. The trial was originally scheduled to conclude in March 2024 but was extended to March 2025 and later through March 2026.

Between the launch of the trial and the end of January 2025, a total of 6,813 units were sold, according to data released by the health ministry on Wednesday. Sales were highest in Tokyo, followed by Kanagawa, Osaka, Okinawa and Aichi prefectures. Pills provided under the trial range in cost from ¥7,000 to ¥9,000.

If approved, Norlevo’s reclassification will greatly expand access to the pill outside of the small number of pharmacies participating in the trial.

The move would also bring Japan closer to international standards. Emergency contraceptives are available without a prescription in roughly 90 countries and regions across the globe, according to the European Consortium for Emergency Contraception, often at about half the cost seen in Japan.