Italy's guidelines on ART law change little

Dr. Kirsty Horsey

Progress Educational Trust

16 August 2004

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[BioNews, London] 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 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. Pre-implantation genetic diagnosis (PGD) 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.

Reproduced with permission from BioNews, an email and online sources of news, information and comment on assisted reproduction and genetics.