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Italy Approves Embryo Law ... Strict Rules Will Mean A Disaster For Italian Research, Say Scientists
By Rossella Lorenzi - [log in to unmask]

December 12, 2003

In a move designed to end the perception of Italy as the “Wild West of assisted reproduction,”
http://www.biomedcentral.com/news/20031205/06/ the Italian Senate approved on Thursday (December 11) strict rules on
the use of human embryos, which have been judged “unacceptable and immoral” by some of Italy's leading scientists.

Senators confirmed all 18 articles of the controversial law on assisted fertility approved by the lower House of the
Italian Parliament last June. The new law will govern the field of reproductive technology with a series of bioethical
bans focusing on the rights of “all subjects involved in the assisted reproduction process, including those of the
conceived.”

Embryos will be untouchable: the law bans any testing of embryos for research and experimental purposes, freezing
embryos or embryo suppression, and forbids preimplantation diagnosis for preventing genetically transmitted diseases.

Further, the law prohibits donor insemination, denies access to artificial reproductive techniques for single women,
and establishes that no more than three cells may be fertilized in vitro and that they must be transferred into the
womb simultaneously. Once couples agree on the treatment, they will not be allowed to withdraw.

“Under this insane law, we will be obliged to implant a defective embryo in the womb,” said Nino Guglielmino, head of
the Hera Medical Centre, who specializes in preimplant genetic diagnosis.

It also includes prison terms of up to 20 years, fines up to €1 million, and the end of the individual's career for
“anyone who realizes a project which aims to obtain a human being from one starting cell, genetically identical to
another human being, alive or dead.”

Doctors attempting to use donor sperm or eggs will face fines from €300,000 to €600,000 and the suspension of their
career for a period up to 3 years.

“Some of these bans, such as that of the preimplantation diagnosis with the obligations of transferring all the formed
embryos in the womb, are astonishing from a scientific point of view and disgusting from a moral point of view,” some
of Italy's top researchers, including geneticist Alberto Piazza, fertility expert Carlo Flamigni, and Nobel Laureate
Rita Levi-Montalcini, wrote in a statement. http://www.nobel.se/medicine/laureates/1986/index.html

According to Montalcini, the new law “doesn't have any scientific justification” and represents “a step backwards of a
century.”

The new rules could call into question the country's 1978 abortion law, according to Senator for Life Giulio Andreotti.
“This law recognized that an embryo is life and that the rights of the conceived must be respected. I don't understand
why it can be killed for up to 4 months,” he told reporters.

According to Health Minister Girolamo Sirchia, the law is a “good starting point.” Under the new regulation, he will
have to decide over the fate of 27,000 frozen embryos stored so far in the next 3 months. “We are thinking to store
them at Milan's Polyclinic. They will remain available for the couples who have conceived them. The unidentified ones
could be adopted by other couples. In this case, donor insemination is an extreme solution,“ Sirchia told Corriere
della Sera.

He strongly dismissed the possibility of utilizing the stored embryos for research—“research should be carried out on
animals, not on Christians”—and agreed on the ban for preimplant diagnosis. “It would have paved the way to research,”
he concluded.

Cryopreserving human eggs may be the only practicable way for Italian infertile couples that can't afford to go abroad
to conceive, said Ermanno Greco of the Center for Reproductive Medicine of Rome's European Hospital. “Freezing
fertilized eggs should not raise any ethical problem,” he told The Scientist.

The new legislation has gained worldwide condemnation by scientists.

“It will be disastrous for Italian research and clinical practice in the field of reproductive medicine,” Arne Sunde,
chairman of the European Society of Human Reproduction and Embryology, http://www.eshre.com/ told The Scientist.

“Italy hosts many good research centers which will have to move their projects outside Italy. Clinical practice in
Italy will become less efficient and will have an increased frequency of negative side effects, such as multiple
pregnancies, compared to other European countries,” he said.

Links for this article

R. Lorenzi, “Italy faces strict embryo rules,” The Scientist, December 5, 2003.
http://www.biomedcentral.com/news/20031205/06/

Rita Levi-Motalcini
http://www.nobel.se/medicine/laureates/1986/index.html

European Society of Human Reproduction and Embryology
http://www.eshre.com

SOURCE: The Scientist / BioMed Central News
http://www.biomedcentral.com/news/20031212/04

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