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Italian scientists had been hoping that new guidelines for how to implement the country's controversial assisted reproduction law would soften the ban on embryo research. But those hopes were dashed last week (July 26) as health minister Girolamo Sirchia revealed the main points of the rules.
Approved by the Italian legislature last December, the law upon which the guidelines are based bans a range of activities on ethical grounds, including any testing of embryos for research and experimental purposes. It also establishes that no more than three cells may be fertilized in vitro and that they must be transferred into the womb simultaneously.
The strict rules governing the use of human embryos have gained worldwide condemnation by scientists and have been called "medieval" by women parliamentarians of many moderate political shades in Italy.
"The Italian law is the end of any progress. It is the world's worst law ever seen, except for Costa Rica, where the constitution forbids IVF [in vitro fertilization]," Paul Devroey, clinical director of the Center for Reproductive Medicine in Belgium, told The Scientist.
The guidelines, approved by part of the National Health Institute, reinforce the ban on embryo research and establish that "any preimplantation diagnosis with eugenic purposes" is forbidden. Basically, any investigation on formed embryos will be limited to "an observational nature," Sirchia said in a statement.
"These guidelines go beyond the law and make it even more rigid. How can they say that a diagnosis is eugenic? The action resulting from the diagnosis may be eugenic, if anything. I believe that parents have the right to know whether the implanted embryos are defective," Franco Cuccurullo told The Scientist. Cuccurullo resigned as president of the National Health Institute section that approved the guidelines.
If observational diagnosis shows irreversible defects for embryo development, implantation "will not be compulsory," Sirchia said. In that case, the in vitro culture "will have to be kept until it dies out." If the woman is temporarily unable to undergo implantation, embryos can be frozen but "the implant will have to occur as soon as possible," Sirchia said.
Many argue that establishing whether an embryo is defective will be a hard task when researchers are only allowed to carry out "observational investigations."
"These guidelines have terrible relapses. Abortion might be the only solution when one or more defective embryos are implanted," Cuccurullo said.
Sirchia remarked that the law does not ban the possibility of preimplantation screening, as it authorizes embryo manipulations with diagnostic and therapeutic purposes.
"At present, there is no way in vitro to manipulate the embryo's genetic patrimony, but in the future this could be possible," Sirchia said. For this reason, the guidelines will be updated every 3 years, he said.
But it might not be necessary to wait for new rules in 2007. Signatures for a referendum to abolish the controversial law are being collected across the country.
"It is a battle to free our country from a law that prevents thousands of couples from having children. But most of all, it halts the scientific research by forbidding embryo stem cell research," Luca Coscioni, president of the political party who launched the referendum campaign, told reporters.
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