Dáil Éireann díospóireacht -
Wednesday, 30 Jan 2002

Vol. 547 No. 1

Written Answers. - Licensing of Drug.

Denis Naughten

Ceist:

532 Mr. Naughten asked the Minister for Health and Children the grounds on which the Irish Medicines Board changed their opinion on the licensing of the morning after pill; and if he will make a statement on the matter. [1538/02]

Minister for Health and Children (Mr. Martin)

The background to this issue is that the Irish Medicines Board received an application for authorisation 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.

No products with this indication have ever been licensed in Ireland. The precise mechanisms of action of this product were unclear and one of the suggestions was that it could act as an abortifacient.

As there are strict timelines to the European mutual recognition licensing procedure, the Irish Medicines Board informed the company of difficulties in assessing the product in that timeframe from the legal and medical aspects, and the company subsequently withdrew its application.

Over the past year the Irish Medicines Board has discussed this product with medical experts and with the Institute of Obstetrics and Gynaecology. Legal advice was obtained and the issue was also discussed at the IMB's clinical expert group, the advisory committee on human medicines and subsequently at an IMB board meeting.

Based on all the advice available the board, at its October 2001 meeting, classified this product as a contraceptive.