ROME (AP) – Italy has approved the use of the abortion drug RU-486, capping years of debate and defying opposition from the Vatican, which warned of immediate excommunication for doctors prescribing the pill and for women who use it.

The pill is already available in a number of other European countries. Its approval by Italy’s drug regulation authorities was praised by women’s groups and pro-choice organizations, which say the pill will provide women with an additional, noninvasive procedure.

It drew the immediate protest of the Catholic Church, which opposes abortion and contraception.

“That’s not how you alleviate human suffering, that’s not how you help women, that’s not how you help mankind,” Monsignor Elio Sgreccia, a senior church bioethicist, said in an interview Friday with Associated Press Television News.

The Italian Drug Agency ruled after a meeting that ended late Thursday that the drug, which terminates pregnancy by causing the embryo to detach from the uterine wall, cannot be sold in pharmacies but can only be administered by doctors in a hospital.

The agency said in a statement that the pill can only be taken up to the seventh week of pregnancy, and not up to the ninth as is the case in other countries. Women who used the pill between the seventh and the ninth week of pregnancy incurred more risks and had often needed surgery, it said.

The decision is expected to be effective in about two months, the agency said.

In a nod to the ethical implications associated with the decision and the controversy surrounding it, the agency noted that “the task of protecting the well-being of citizens … must take precedence over personal convictions.”

The 4-1 vote at the agency’s executive branch comes about two years after the agency first started looking at the issue. The pill became available in some parts of Italy on an experimental basis in 2006.

For the Catholic Church, the agency’s decision was the latest defeat in its efforts to ban or restrict abortion in the nation that hosts the Vatican.

Italy legalized abortion on demand through the end of the third month of pregnancy in 1978, after a long battle between secular forces and the church. Abortion after three months is allowed when the pregnancy is deemed a grave danger to the woman’s mental or physical health.

Three years later, Italians voted in a referendum to keep the law, again defying a church-backed campaign.

Archbishop Rino Fisichella, who heads the Vatican’s Pontifical Academy for Life, issued a strong condemnation of abortion and the RU-486 pill in a front-page article in Vatican newspaper L’Osservatore Romano on Friday. He said the church cannot passively sit back, and insisted the ethical implications of the pill could not be overlooked.

“An embryo is not a bunch of cells,” Fisichella wrote. “It’s real and full human life. Suppressing it is a responsibility nobody can take without fully knowing the consequences.”

Sgreccia, who called the RU-486 “not a drug, but poison,” said that women taking the pill or doctors administering are automatically excommunicated under church law.

There were about 121,000 abortions on demand in Italy in 2008, according to figures provided by Italy’s health authorities. That number was down 48 percent from 1982 – the year when the number peaked after the referendum upholding the abortion law – and down 4 percent compared to the previous year.

But critics of RU-486 say that taking a pill might reverse that trend because it would make interrupting a pregnancy easier. They also fear that it would be possible to avert a mandatory hospitalization policy and effectively go back to the pre-legislation days of clandestine abortions performed at home without medical supervision.

“The apparent ease of this pharmacological method will inevitably lower the level of caution and responsibility,” Romano Colozzi, the only member of the agency to vote against the use of the pill, told the ANSA news agency.

Supporters say it has no significant side effects and is safe.

Gabriella Pacini, a doctor with the Woman’s Life group that provides medical counseling to women, said that RU-486 “has been used for years in Europe, on millions of women and is considered safe and effective.”

“Why not give Italian women a choice between pharmacological abortion and surgical abortion?” she said.

The RU-486 pill, first introduced in France two decades ago, is known chemically as mifepristone and causes an embryo to detach from the uterine wall. A second pill, misoprostol, is used afterward to cause contractions and push the embryo out of the uterus.

Doctors can declare themselves conscientious objectors and refuse to carry out abortions.

Since 2000, Italy also allows the so-called morning-after pill, which prevents a fertilized egg from implanting in the uterine wall and growing into an embryo.

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