From the original proposal, to the moment of approval, there were numerous protests against drafts of the law, protests within and outside the Parliament, organised and supported by, amongst others, the political parties, unofficial groupings of diverse political interests, experts in the field of assisted reproduction and bio-ethics and by various non profit associations, chief among them CECOS Italia (Centre for the study and conservation of human eggs and sperm).
The CECOS self-regulation Statute, incidentally, has been subscribed to by various scientific associations and societies and, up until the passing of the law 40/2004, represented the set of scientific and ethical rules the people operating in this field took inspiration from, when dealing with ART.
On his website, Professor Flamigni argues that the law 40/2004 is unenforceable for a number of reasons. One of these is precisely in the application field of the law itself: according to the law (article 4) recourse to ART &ldquois proscribed in cases of inexplicable infertility medically documented, as well as to those cases of sterility or infertility with certified medical explanations”. Putting it another way, only couples with a verified form of sterility can avail of assisted reproduction, while couples with idiopathic infertility (or that 10% whose tests appear normal but still can not conceive) could, it seems, be excluded. The question also concerns those couples who have genetic illnesses, which can be transmitted to the foetus. These people can no longer, as in the past, take advantage of ART, to benefit from a pre-implantation genetic diagnosis. This recently caused a sensation, with the judgement from Catanese Judge Felice Lima, who forbade the pre-implantation diagnosis for a couple with thalassaemia. [Editor's note: a genetic disorder affecting the blood. The couple was undergoing IVF-ET and the embryos obtained presented, during the pre-implantation testing phase signs of the disease.] The judge simply applied the new law, and declared that 'the fertilised ova must be implanted, even if there is a risk that it may carry a genetic illness', highlighting one of the crueller aspects of 40/2004.
The same article 4 of the law makes reference to a progression up to techniques considered 'invasive', as for example IVF-ET, and recommends that first other techniques are used such as inducing ovulation and aimed sexual relations. This procedure though, while having sense for a young woman, can represent for older women a dangerous 'setback' in the case of failure, in so far as the female fertility diminishes, after a certain age, from month to month, weighing heavily against the success of an eventual IVF-ET.
Among the clauses that appear to have been inserted on purely moral basis (and Catholic morality at that) are those in article 5 (Subject's requirements), that in practice prohibit access to ART to couples in which one of the partners is irremediably sterile, homosexual couples, those in which the woman enters into premature menopause, various singles (for example widows): the law infact forbids ART with donor's sperm or ovum. It's not clear if actual couples, of opposite sex, that don't however live together under the same roof have the right to access ART.
The State has obviously taken heed of the recommendations of the Catholic Church, and as a result does not hold these cathegories suitable or capable to love and parent a child. At the same time though it allows parents that, as is the case in life, become divorced, widowed, bisexual to raise children born naturally during marriage, or anyway within a stable couple. One can only hope that the Government has neither the intention nor the chance to further limit the freedom or the rights of people in these categories…
One of the points that has created, and continues to create, euphemistically' the liveliest' debate, is the ban on the freezing and elimination of embryos, specified by article 14 of 40/2004. The same article specifies that the maximum number of embryos that can be created is three, and that, because of the ban on cryoconservation, all the embryos must be transferred into the uterus. In the light of the aforementioned impossibility to predict the number of fertilisable follicles, and of implantable embryos, this article in substance obliges doctor and patient to voluntarily hamper the success of the ART (only a maximum of three ova may be fertilised and in the worst case scenario it's possible that no implantable embryos will be produced), the health of the woman (because there is the doubt as to whether cryoconservation is safe for the female gametes, in the case of failure of the ART cycle, the woman has to subject herself to who knows how many cycles of ovarian stimulation, with psychological and physical risks attached) and the birth of a healthy baby (because not being enough that there's the risk of multiple births, with all the dangers and malformations that those carry, the law obliges the transfer of ALL embryos, including those malformed).
Many have interpreted, in the ban on the embryos elimination, a clear indication that there is a desire on the part of the Government to make moves against law 194 or the law that sanctioned legalised abortion. What seems evident is that 40/2004 and 194/78 are in opposition, in terms of a legal definition of the conceived.
Articles 14 and 13, the latest is the one that prohibits the clinical research and experimentation on embryos if the embryo itself is not the beneficiary of such research, put in place a clear limit on a particular type of research, that on stem cells, that nowadays is seen as fundamental to the battle against illnesses such as Alzheimer's, Parkinson's, and diabetes. This certainly remains a delicate and complex ethical argument, on which there's an ongoing debate in scientific circles.