tokyo

The Japanese government is expected soon to lift its ban on the contraceptive pill, almost nine years after the first application for its use. The approval of the drug will come almost 40 years after its release in the West.

According to the Central Pharmaceutical Affairs Council, which advises the health minister, approval will probably be recommended during a council meeting in June, with a view to having the drug on the market by the autumn.

The move comes after public criticism of the speed with which the Ministry of Health and Welfare approved Viagra, the male impotence treatment, just six months after the first application.

In contrast, the contraceptive pill has been entangled in a debate over its possible risks to human health. However, as far back as 1985 legalization seemed on the horizon, and the Japan Obstetrics and Gynaecology Society and the Japan Motherhood Protection Medical Association were asking the Ministry of Health and Welfare to allow clinical tests (see Nature 317, 760–761; 1985). Although the government came close to approving it in 1992, they backed down at the last moment amid fears that the release could lead to an increase in AIDS and other sexually transmitted diseases.

The government has since cited concerns about the contraceptive pill being an endocrine disruptor — the man-made chemicals suspected of affecting human reproductive functions — but such claims have so far been brushed aside by scientists.

The government's reluctance to legalize the pill is said to result from a powerful medical lobby that opposes threats to its lucrative abortion business. According to the ministry, one in five unwanted pregnancies ends in abortion, with more than 340,000 such operations performed each year.

There is also speculation that conservative politicians concerned about the low birth rate in Japan are strongly opposed to approval of the pill.

Approximately 200,000 women are taking the high-dose pill — available in Japan as a treatment for menstrual disorders — for contraceptive purposes.

A spokesman from Schering, the German pharmaceutical company that is one of the nine drug firms awaiting approval of their oral contraceptive, says they are “crossing their fingers” that the health ministry will keep its promise and not reverse its decision at the last moment again.