Dáil Éireann debate -
Tuesday, 22 May 2001

Vol. 536 No. 5

Written Answers. - Birth Control Products.

Jan O'Sullivan

Question:

109 Ms O'Sullivan asked the Minister for Health and Children his views on the continuing ban on the Levonelle morning after pill by the Irish Medicines Board; the steps he intends to take to make this safe medication available to women; and if he will make a statement on the matter. [14801/01]

Minister for Health and Children (Mr. Martin)

I have been informed by the Irish Medicines Board, which is the national competent authority on the regulation of medicinal products, that an application for authorization was received for this medicinal product in June 2000 under the European mutual recognition licensing procedure. The proposed indication was: "Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method".

One of the mechanisms of action of this product isvia the inhibition of implantation of a ferti lised egg. This mode of action is interpreted by some as abortifacient. No products with this mode of action or with this indication have ever been licensed in Ireland.

The Irish Medicines Board's understanding at the time was, and remains, that under the Constitution, and law, it would not be legally permissable for it to authorize the product for that type of indication. It decided to consult its legal advisers to seek counsel opinion on the board's behalf. As there are strict timelines to the European mutual recognition licensing procedure, the Irish Medicines Board informed the company of its understanding of the legal position in Ireland.

The company had the option of amending the requested indication, challenging the position as set out by the board, withdrawing the application from Ireland. It voluntarily withdrew the application on July 27 2000.

I understand that counsel opinion is expected to be available to the Irish Medicines Board in the near future.