The Irish Medicines Board has given its approval for the "morning-after" pill, declaring it to be a contraceptive rather than an abortifacient.
The board's decision contrasts with its position of just a year and a half ago when a pharmaceutical company made an application to license a morning-after pill. The IMB said at that time there was a question over the drug's "abortive nature". The move is consistent with the Government's new proposals stating that since the morning-after pill is intended to prevent pregnancy, it does not come within the definition of abortion set out in the Protection of Human Life in Pregnancy Bill currently at second stage before the Dβil.
Last month the Cabinet sub-committee on abortion recommended that any legal uncertainties that might exist in relation to emergency contraception should be removed.
The board said yesterday in a statement that it had now finished its deliberations and "in consultation with legal and expert medical advisers has deemed Levonelle to be classed as a contraceptive". "This process followed queries and possible concerns in relation to Levonelle acting as a abortifacient," it said.
An IMB spokeswoman said the decision had been made "in consultation with" the Institute of Obstetricians and Gynaecolgists and a senior counsel who had examined the matter for the board.
The drug has been licensed in 13 EU states under contraception regulations rather than abortion. The company seeking licencing approval, Schering, had made an EU-wide application but withdrew it in Ireland once difficulties arose so as not to cause problems in other countries. The drug is on sale over the counter in British pharmacies.
Mr Eugene O'Connor, Female Health business manager for Schering in Ireland, said the company had not been officially informed of the IMB's decision. "But if and when we do, we would like to bring Levonelle onto the market here."
Mr Tony O'Brien, chief executive of the Irish Family Planning Association said they welcomed the decision. "We regret that it has taken the IMB so long to realise that they completely misunderstood the nature and function of Levonelle and inappropriately described it as an abortifacient."
He said the decision demonstrated the Government was "playing politics" by claiming it needed legislation to protect emergency contraception. "It is dishonest of the Government to mix it in with its flawed abortion proposals. The Abortion Bill has not concluded second stage in the Dβil and the IMB feel able to proceed with this," he said.