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Italy's guidelines on ART law change little

16 August 2004
By BioNews
Appeared in BioNews 271

Italy's restrictive fertility laws, passed in February this year, are making it harder for couples to receive fertility treatment in the country, as well as causing a decline in the success rate of the treatments that do take place. Since the law was passed, the success rate for fertility treatments has fallen from 25 per cent to about 11 per cent. Another consequence of the new law is an increase in 'reproductive tourism' out of Italy - some clinics in Spain, Austria and Switzerland are already reporting a 20 per cent increase in Italian patients, reports the BBC, and some Italian fertility doctors have relocated their practices outside the country's borders.

The law limits the use of ARTs (assisted reproductive technologies) to 'stable heterosexual couples who live together and are of childbearing age', as well as being 'clinically infertile'. Research using human embryos is prohibited, as well as embryo freezing, gamete donation, surrogacy and the provision of any ARTs for single women or same-sex couples. The law also says that no more than three eggs can be fertilised at any one time, and that any eggs fertilised must all be transferred to the uterus simultaneously. PGD (pre-implantation genetic diagnosis) and prenatal screening for genetic disorders have also been banned.

The Italian legislation has gained 'worldwide condemnation by scientists' and has been called 'mediaeval' by female parliamentarians. However, it was hoped that new guidelines on how to implement the law would 'soften' its implications. But, when health minister Girolamo Sirchia announced the guidelines at the end of last month, they reinforced the ban on embryo research and said that any PGD 'with eugenic purposes' was prohibited.

The guidelines were also meant to prevent the continuation of controversial cases caused by the law. In June an infertile couple were told by a court that they had to transfer all their IVF embryos, even though they knew that they both carry the thalassaemia gene, and that some of their embryos were possibly affected; the woman later miscarried. In July, a woman underwent a selective termination of a triplet pregnancy in order to protect her health after all three of her IVF embryos successfully implanted. The 26-year old woman had to apply to a court for permission for the termination procedure, which ruled that if her 11-week triple pregnancy continued, the mother's life would be put at risk.

Now, Sirchia said, implantation 'will not be compulsory' if observational diagnosis shows 'irreversible defects' in an embryo. In that case, the embryo will have to be kept in culture until it naturally 'dies out'. However, some clinicians question how easy it will be to establish whether an embryo is defective if they are only allowed to undertake 'observational diagnosis' rather than PGD. Franco Cuccurullo, who resigned as president of the National Health Institute section in charge of the guidelines, said that the guidelines could still have 'terrible' implications, adding 'abortion might be the only solution when one or more defective embryos are implanted'. Sirchia said that the guidelines will be revisited every three years, so in the future PGD might be possible. But, reports the Scientist, it might not be necessary to wait that long, as signatures for a referendum to abolish the law are being collected across the country.

Fertility laws frustrate Italians
BBC News Online |  9 August 2004
Outrage over Italian law
The Scientist |  2 August 2004
14 December 2009 - by Antony Starza-Allen 
A group of Italian scientists have lost an appeal to challenge a research funding call that excludes embryonic stem celln (ES cell) research even though the technique is lawful in the country, Nature reports. The Italian health ministry put together an expert committee to produce a set of proposals to attract funding, after the previous stem cell research fund was marred in controversy following allegations that funds were being distributed in a non-transparent and arbitrary manner. ..
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The results are in on the Italian referendum on its fertility laws. A low turnout of voters on Sunday 12 June - fewer than 19 per cent - made it doubtful that the 50 per cent turnout rate necessary would be reached, even though the polls were opened for a second day...
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The new Italian law regulating assisted reproduction technology restricts the provision of fertility treatments to 'stable heterosexual couples' who are shown to be clinically infertile. The law, passed in 2004, states that no more than three oocytes (eggs) can be fertilised in an IVF cycle, and that all embryos obtained...
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13 July 2004 - by Juliet Tizzard 
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Restrictive Italian fertility laws, passed in February this year, have been shown to be 'mediaeval' and are again under debate, reports the British Medical Journal (BMJ). The law on IVF procedures requires that no more than three eggs can be fertilised at once, and that all eggs fertilised must be...
4 June 2004 - by BioNews 
An infertile Italian couple has been told by a court that they must transplant all embryos they created during IVF treatment, even though it is known that they both carry the gene for thalassaemia, a recessive genetic condition, and that some of their embryos may be affected. The decision of...
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Italian lawmakers are campaigning for stricter national regulation of the field of assisted reproductive technology. In a debate on new fertility laws that took place in the Senate last week, legislators from a variety of political backgrounds called Italy the 'Wild West of assisted reproduction', because people can travel to...
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