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 late yesterday 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 in Ireland, Portugal and hitherto Italy.
Used to terminate pregnancies of up to 49 days, the drug is marketed in the United States by Danco Laboratories as Mifeprex and outside the US by French firm Exelgyn as Mifegyne.
Its supporters in Italy say there is no contradiction with current Italian law.
"If a woman can't be convinced to avoid an abortion, we should accept a less invasive and painful method,"
Youth minister Giorgia Meloni (32) said, adding however that she personally "would never have an abortion".
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 said authorisation of the RU-486 pill had been "heavily sponsored by politicians" and questioned its safety record.
After five women died in the United States and Canada from a rare bacterial infection after taking the abortion pill in 2005, US researchers recently reported that giving it orally rather than vaginally, with antibiotics, reduced the risk of infection.
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," said 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 told reporters.
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 per cent of Italian doctors are "conscientious objectors" who refuse to carry out abortions in their clinics or hospitals.
Italy has a low abortion rate compared to Britain, France and the United States and it has fallen steadily for decades.
In 2008 there were 121,406 terminations, down 4.1 per cent on the previous year and 48.3 per cent less than the 1982 peak.
Silvio Viale, a Turin gynaecologist who has campaigned for the pill to be authorised, said the AIFA decision was "a victory for Italian women, who from today have more freedom and choice".
"But I am sorry it has come 20 years late. If such there had been such an innovative drug for something like the prostate I doubt we would have had to wait so long," said Dr Viale.
Reuters