Taiwan might partially authorize emergency contraceptives, also known as morning-after pills, to be sold over the counter following an ongoing regulatory experiment in Japan, the Food and Drug Administration (FDA) said yesterday.
The agency last week initiated the legal process for conducting medical trials by convening the first of the several public opinion gathering conferences required by law, Medicinal Product Division deputy head Lin Yi-chu (林意筑) told a news conference.
The FDA would amend its proposal based on the public input and submit it to the Ministry of Health and Welfare’s Human Research Ethics Review Board for approval, Lin said.
Photo: CNA
The agency hopes the trial could start as soon as possible, she added.
The Japanese Ministry of Health, Labor and Welfare, and Japan Pharmaceutical Association are jointly conducting a trial on which the FDA proposal is based, she said.
In the Japanese trial, women or girls aged 16 or above may buy a dosage of drugs that are intended to prevent pregnancy without a prescription from an authorized pharmacy, Lin said.
The woman must take the drug in the presence of the pharmacist and visit a gynecologist appointed by the clinic three weeks after that, she said
The Japanese program has 340 collaborating pharmacies, and a clinic is designated for every two or three pharmacies to increase availability, she said.
Taiwanese law classifies contraceptive medicine as prescription drugs, meaning the sale of such substances without a prescription is an offense punishable by a fine of up to NT$2 million (US$62,467), Lin said.
The FDA said it has been planning to allow over-the-counter contraceptives since 2016.
Doctors, pharmacists, women and children’s welfare groups, and parental rights groups in Taiwan broadly agree that the drug should be made available to protect women’s health, but disagreed on distribution methods, it said.
Morning-after pills are a class of contraceptive medicine that should be taken within the first 72 hours after unprotected sexual intercourse, National Taiwan University Hospital Department of Genetic Medicine doctor Tai Yi-yun (戴怡芸) said.
Morning-after pills typically contain synthetic progesterone that suppresses or delays ovulation, so they are not recommended for long-term use, Tai said.
Contrary to widespread belief, especially among men, the withdrawal method does not reliably prevent pregnancy, as sperm is present in prostatic fluids, she said, adding that menstrual tracking is also unreliable due to natural variances and irregularities in the cycle.
Concerns that oral contraceptives could permanently inhibit fertility have no scientific basis, and it takes about three months for menstrual cycles and fertility to return to normal after stopping taking oral contraceptives, she said.
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