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Dangerous laws that compromise patient safety

16 December 2003
By Juliet Tizzard
Director, Progress Educational Trust
Appeared in BioNews 238
This week's BioNews reports a vote in the European Parliament today which will result in a new EU Directive on the use of human tissues and cells in treatment. The good news is that, after lengthy discussions between the decision-making bodies within the European Union, a compromise deal has been struck which removes a series of previous amendments designed to ban the creation of cloned embryos for research and impose heavy restrictions upon embryonic stem cell (ES cell) research. As we reported in November, if these ES cell and cloning amendments had been kept in the tissue directive, research in the UK and in other member states would have been severely constrained. However, with the compromise deal, the decision about whether to permit such research remains with member states.

Of course, there are a number of European member states which do not take the same relatively liberal view of ES cell and cloning research as the United Kingdom does. As we report elsewhere in BioNews, the French parliament has just passed draft legislation banning cloning for research purposes. Meanwhile, the Italian Senate has passed a bill which will prohibit ES cell and cloning research, as well as a long list of assisted reproductive and genetic technologies.

Sovereign states are entitled to legally prohibit research which they find morally problematic, just as the UK is entitled to permit it. But when states like Italy take it one step further by banning particular clinical treatments, leaving patients with less safe and less effective techniques as their only options, they are surely shirking their responsibilities to patients. The new Italian law on assisted reproductive technology seeks to prohibit not only embryo and ES cell research, but also the donation of eggs and sperm, embryo freezing and the destruction of surplus embryos. A maximum of three eggs can be collected from a women undergoing IVF in Italy and all resulting embryos must be replaced in her womb, regardless of the risks this might entail. This legal requirement will reduce the chance of success of an IVF cycle, because there will be fewer embryos from which to select those most likely to result in a pregnancy. It also puts the woman and her potential children at greater risk because it increases the likelihood of a multiple pregnancy occurring and may mean the transfer of abnormal embryos. Finally, with no embryo freezing permitted, the law obliges women to undergo a fresh cycle of IVF treatment - with the ovarian stimulation drugs it entails - each time, instead of using spare embryos that could have been frozen after a previous cycle.

Given these circumstances, it is tempting to say that it would be better for Italian infertile couples to forego treatment or to travel abroad for it, than to subject themselves to the treatment that will now be permitted in Italy. But no doubt, many couples will undergo IVF treatment within these draconian rules because they have no other way of trying to become parents. The message from the Italian government, however, is that the survival of all human embryos is more important than the safety and wellbeing of its infertile citizens.

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