Italy's Senate has passed a law on assisted reproduction that makes it a crime to freeze or destroy human embryos or to use donated sperm and eggs.
The new rules—which will need an additional, formal approval by the lower house but are expected to come into effect in early 2004—limit the number of oocytes that can be fertilised to three. They also state that all the embryos created must be transferred into the woman's womb.
Additionally they restrict the use of assisted reproduction techniques to sterile heterosexual couples in a stable relationship and ban all forms of pre-implantation genetic testing.
Antonio Lanzone, head of the centre for assisted reproduction at the Catholic University, Rome, said, “The principle of safeguarding the embryo from fertilisation, which I subscribe to, is the main goal of this law, which pays a price in terms of loss of efficiency and increase of risks.”
However, Arne Sunde, chairman of the European Society of Human Reproduction and Embryology, said it was a “disaster for women” and expressed his fear of consequences all around Europe.
Most Italian experts on assisted reproduction agree with Professor Sunde. Luca Gianaroli, scientific director of the Italian Society for the Study of Reproductive Medicine, Bologna, said the law was in sharp contrast to the guidelines of the World Health Organization. He said, “According to an analysis we conducted on the medical charts of 100 successful pregnancies, fertilising just three oocytes will cut the success rates by about two thirds. This translates to unneeded treatments, expenses, and risks for women.” Because sterility is not considered an illness the costs of the treatments will no longer be reimbursed, meaning that many couples will go abroad. “Some couples are already bringing their frozen embryos home, maybe fearing that they might be seized,” said Dr Gianaroli.
The law was passed by a strong majority in the Senate because part of the opposition (mostly Catholics) sided with the centre right government. But some legal experts have already questioned the law, saying it conflicts with Italy's constitution, which explicitly protects the health of its citizens.
“We expect a strong mobilisation to call for a referendum to repeal the law,” predicts Giovanni Monni, a member of the board of the European Association of Perinatal Medicine and a specialist in genetic testing in Cagliari, Sardinia. “Around 13% of Sardinians carry the gene for thalassaemia. We have performed around 40 pre-implantation genetic tests so far, and we were planning to perform 300 in 2004. Our previous experience of 6500 prenatal tests for thalassaemia tells us that out of the 1600 fetuses found to be ill, all except 20 were aborted.”