World Congress

for freedom of scientific research

The Law 40/2004. Five years of hindrance of assisted reproduction in Italy

04/06/2010

The condition of infertility is defined as the inability to procreate after two years of unprotected sexual intercourse. The problem seems to affect about 12-15% of couples of reproductive age and has not just medical but social dimensions. In Italy, each year about 40,000 new couples may encounter some procreative difficulties. The older the couple when they decide to have a child, the lower their chances of success. Law No. 40 of 2004 on assisted reproduction introduced a number of restrictions in Italy. Thanks to its advocacy role, Luca Coscioni Association obtained that a set of court sentences reduced the harm for infertile couples. Until a sentence by the Italian Constitutional Court of April 2009, law 40 provided that the production limit of embryos per cycle of ovarian stimulation was three and laid that all these embryos were implanted at the same time, since their cryoconservation was prohibited. The Court recognized that those limits strongly hindered the effectiveness of the techniques and compelled women to bear many ovarian stimulation treatments, what represented a violation of the good medical practice. Moreover the forbiddance of cryoconservation implied that all embryos, even the sick ones should be implanted and compelled women to resort to therapeutic abortion, after becoming pregnant. According to law 40 assisted reproduction techniques (ART) are only permitted for those suffering from otherwise incurable sterility or infertility. Only starting from the revision of the guidelines in 2008, challenged by Luca Coscioni Association, in vitro fertilization (IVF) as well as washing of semen are allowed for people suffering from viral diseases, e.g. potentially fertile HIV-positive people, even if they are fertile. In many European countries this is permitted to any couple suffering from genetic or viral diseases in order to prevent them from transmitting such pathologies to their children (and, for HIV positive people, from infecting each other). Couples affected by genetic diseases are still excluded from ART in Italy, if they are fertile. Until 2008 all genetic pre-implantation diagnosis (PGD) was prohibited by the guidelines, i.e. an administrative act integrating law 40. This prohibition openly contradicted the opportunity to make the observation under the microscope, along with the opportunity to make the prenatal diagnosis (like CVS and amniocentesis). A sentence of Latium Regional Administrative Court revoked the act as far as it concerned the restriction of diagnostic methods since these were not limited by the law 40 itself, that is by a superior law. After that sentence, PGD is allowed if requested by the couple according to artt.14 comma 5 and 13 comma 2. Law No. 40 still prohibits assisted reproduction for those without a partner or for homosexual couples, with art. 5 stating that only “adult pairs of heterosexual people, be they married or living together, of a potential fertile age and both alive�? can apply for ART. Law 40 also prohibits heterologous fertilization (involving the donation to the couple of either sperm or eggs from a third party) and research on supernumerary embryos. In 2005 a spring referendum for the abolition of the Law 40 was defeated. This referendum had been demanded by 500,000 people endorsing a petition to support pre-implantation genetic and observational diagnosis, heterologous insemination, assisted reproduction for single people, sick people and genetic and viral disease carriers, as well as the lifting of the ban on research on supernumerary embryos. In the opinion of Luca Coscioni Association, assisted reproduction should be the right of every adult male or female citizen. To this purpose, its website provides information about European centres offering treatments which are otherwise forbidden in Italy, although these are extremely expensive. Moreover, LCA declares its availability to sue, believing that this may help overcoming the prohibition and enable access to rights. Indeed in April 2009 the Italian Constitutional Court recognized the priority of women’s right to health – although without contesting the so-called status of the embryo – and the right of the physician to choose the best therapy for the woman patient in any case. Other writs by some more regional courts in all Italy recognized the rights of couples damaged by law 40. Though the efforts of LCA and the above mentioned court sentences, a constant decrease in success of assisted reproduction rates has been recorded in Italy since the approval of law 40, while the trend in Europe has been opposite. Triplet deliveries have also increased to second-highest rate in Europe (a 2.7% vs. for instance a 0.9% of Germany and 0.2 of Sweden). Please make reference to the study Assisted Reproductive Technology (ART) in Europe, 2005. Results generated from European registers by ESHRE - European Society of Human Reproduction and Embryology, in attachment. Following to this, a boom in reproductive tourism abroad has been noticed, what represents a limit for the poorer and a further risk for the health of women. Please find hereby enclosed some case-stories as narrated by infertile couples. Marina, Thursday 12th May 2005 My name is Marina, I am forty and happily married with F., aged 42. On the 25th of April we celebrated our fifteenth wedding anniversary, which was a mixture of pain and happiness: it was also our fifteenth year of infertility. We have been trying for a baby since 1990, undergoing all possible and imaginable tests, and several cycles of treatment to resolve the problem - to no avail. We made several attempts at in vitro fertilization, and my beta tests came back positive four times; however, the dream only lasted a few weeks, and anyone who has experienced or is experiencing my same situation will truly understand how one feels when menstruation starts again. I lived with this for one hundred and seventy-nine months: each time it feels like a painful wound reopening and bleeding unendingly. In spite of my efforts not to think about it, seeing a pram, someone who is pregnant, or an advertisement featuring mothers and children is enough to start me thinking about my failure to achieve what the majority of couples achieve in the privacy of their bedroom. Since March 2004, Law 40 regulates IVF in Italy: whilst I do not expect everyone to approve of people choosing to undergo IVF, I do ask that those who are infertile be allowed to decide with their doctor on the most appropriate therapies and techniques for them, without being thwarted by laws that result in one having to repeatedly seek risky hormone therapies or expensive treatments abroad. Romina, Thursday 12th May 2005 Every News is different, but it will always involve people who have emotional and financial weaknesses. I have been trying for a baby for ten years, since my husband and I met and married: I was nineteen, and after a year of failed attempts we decided to go to a public centre where tests were carried out. Three, four years went by without answers as to why I was failing to remain pregnant: we made an appointment at the hospital but there were many more couples in our situation, and after so many years the doctors could not remember who we were. Five years later they found that my husband had had an infection, which had made him infertile, so we decided to go private: more money spent, and by now my husband was the only one working because the hormone therapy I had to undergo had some side effects. Artificial insemination after artificial insemination, millions after millions, and nothing happened: we travelled to places outside our city, and more inseminations followed, but still nothing happened. We had to stop for a year because we were broke, having also applied for several loans: we were on the brink of despair. After seven years we tired another private clinic: the good news was that they would use IVF, and even though my husband and I are religious, we had no choice and we had the courage to let ourselves be convinced to go ahead. Sure, we may be Catholic but having a baby this way did not go against that: rather, it meant putting oneself in the hands not only of God but of the doctors. More misfortune, more money thrown away: I decided that the only way must be to use a sperm donor. After many years, and having talked about this with my husband, we came to agree that if it were be a child born unto me, and which would live with my husband from birth, and which we both saw being born, it could not be thought of as illegitimate. But, suddenly, it was not lawful any more; what about all the money we spent, and all the loans we still had to repay? Some people play with the wellbeing of others: one cannot just decide on the spare of the moment to ruin people’s life when they are trying to deal with it. These politicians are too busy counting money, because I doubt that even one out of those who endorsed this law has infertility issues! It is I who has to rethink my life, and summarise with unease my last ten years of failure: my husband and I poured our whole beings into everything we had to do. I am speechless, and disappointed with the way things have turned out in my life, and with the way in which other people manipulated our lives on our behalf leaving us to just pay our way through life without anything in return. I am thirty years old, young enough to become a mother in some way. What saddens me is that other people will suffer too: I wonder how many couples will have affairs, will run out of tears and of faith with their doctors, and how many will lose all hope to regain a normal life. That’s it, I am done talking, just like I am done with everything else. Eleonora, 26th May 2005 Seven years ago I found out that I needed to undergo artificial insemination to conceive: after the hardship of five years’ worth of medical tests, I finally had my first ICSI (intracytoplasmic sperm injection), for which I had to pay. Having obtained five embryos I thought I could have some frozen, but already in 2003 the clinic where I was could not freeze embryos because there was already knowledge of Law 40 coming into being. Therefore, in February of that year I had all five embryos implanted, but it was a failure; still, I didn’t give up, and in May of the same year I had another five embryos implanted. Again, nothing happened; by then, the hormonal upheaval had caused me to menstruate for fifty-five days in a row. In February 2005 I had another ICSI and five more embryos implanted: this time I was in pain throughout the process, but I did become pregnant. Unfortunately, the dream was short-lived: after only seven weeks, my little one died. The pain continued and my period just did not seem to stop: I had to take a break because I became concerned at the serious side effects caused by the process, and I wished with all my heart that the law were revoked lest I should have so many implants all together, and because I could not travel abroad for this. These are choices that should be made by neither Parliament nor the Church, but by each couple: some people want to make shameful the quest for bringing a new child into the world, which should be the most wonderful thing in the world. We ought to protect our right to wellbeing more than that of a four-cell embryo. (Translated into English by Francesco Sani)

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