Prospects For OCs Market Opening In Japan Delayed

Hopes of an early approval of oral contraceptives in Japan - where despite their availability in almost all countries of the world for nearly 30 years, they are still banned - appear to have been dashed by recent worries on the safety of several low-dose combination products (Marketletters passim).

Reform of Japanese legislation on OCs was expected after a Ministry of Health and Welfare advisory panel concluded that such products were both effective and safe, but then nothing happened. However, according to a report in the Financial Times, the 12 or so companies planning to launch their OC products in Japan when the law permitted, called for a meeting with the Ministry for clarification of the position, only to be told that no decision would be made until the latest safety data could be thoroughly evaluated.

To date, Japanese women have relied on abortion as a major means of birth control, with an estimated 400,000 pregnancy terminations a year. Given this, the FT suggests that gynecologists, reckoned to earn some 50 billion yen ($493 million) a year from performing abortions, have lobbied against reform.