Italy's drug regulation agency has authorised the use of the abortion pill despite protests from the Roman Catholic church which threatens to excommunicate doctors who prescribe the drug and patients who use it.
The Italian Pharmaceuticals Agency (AIFA) announced its decision after a long meeting during which it was lobbied intensely by the church and Catholic politicians, including many from Silvio Berlusconi's centre-right government.
Since 1978 abortion has been legal in Italy on demand in the first 90 days of pregnancy and until the 24th week if the life of the mother is at risk or the foetus is malformed.
By law, all abortions must take place in a hospital.
Developed in the early 1980s in France mifepristone, or RU-486, is approved as a prescription drug in the United States and almost all the European Union except some of the most Catholic countries like Portugal, Ireland and hitherto Italy.
Its supporters in Italy say there is no contradiction with current Italian law.
Critics say that, despite the AIFA stipulating that the pill could only be given in hospital in accordance with the law, some women were bound to abort at home without medical assistance.
"It intrinsically means women will have abortions at home, because the moment of expulsion is not predictable," said senior health ministry official Eugenia Roccella, presenting an annual report on abortion this week ahead of the AIFA's decision.
She says authorisation of the RU-486 pill has been "heavily sponsored by politicians" and questions its safety record.
Question of conscience
The Vatican, which opposes all forms of abortion in the belief that human life is sacred from the point of conception, says the pill is no different from surgical abortion.
"There will be excommunication for the doctor, the woman and anyone who encourages its use," says Monsignor Elio Sgreccia, emeritus president of the Pontifical Academy for Life and the pope's top expert on bioethical issues.
"First abortion was legalised to stop it being clandestine, but now doctors are washing their hands of it and transferring the burden of conscience to women," he says.
The abortion pill has already been given experimentally in some Italian regions but the AIFA ruling means it will now be legally available throughout the country.
It remains to be seen how many doctors will prescribe it since, according to the health ministry report, about 70 percent of Italian doctors are "conscientious objectors" who refuse to carry out abortions in their clinics or hospitals.
