¹Centro Cellule Staminali e Terapia Cellulare, Ospedale San Martino, Largo R Benzi 19, 16132 Genova, Italy.

Correspondence: F Frassoni, E-mail: francesco.frassoni@hsanmartino.it

In recent years, the debate over the various possible uses of the embryos resulting from in vitro fertilization has often been prominent in the press and in television programs. In Italy, the so-called law number 40 (Legge 19 febbraio 2004, no. 40) concerning in vitro fertilization and research on embryos created much dissension among concerned members of the public, although in the last few months discussion seems to have abated. Briefly, the law states that no more than three embryos can be created and all three must be implanted into the uterus of the mother (to avoid a situation where a given embryo has no possible chance to give rise to an individual). Incidentally, it is curious that the wording used is 'create' and not 'generate'; the Nicene Creed (a prayer that contains statements of catholic faith established in Nicea in the year 325 AD) reads 'Génitum, nonfactum', that is begotten, not made.

Moreover, the law forbids any attempt to select a embryo on the basis of a genetic defect it may or may not carry. This contrasts with the fact that prenatal diagnosis is legal in Italy and parents can opt for termination of pregnancy if deemed appropriate. Furthermore, no extra embryos can be generated for research purposes. The law also forbids the use of research on any of the embryos that already exist in freezers – and it is thought that there must be about 30 000 stored embryos in Italy. A referendum was organized to challenge this law. In Italy, for a referendum to be valid more than 50% of the population must actually vote, so supporters of the law encouraged people not to vote. In the event the voter turn-out on 13, June 2005 was less than 30%, so the law holds. It will exclude Italian scientists from research on human embryos. It leaves a complex scenario for infertile couples.

It must be conceded that the Catholic Church should get credit for raising issues of paramount importance. For example, although the prenatal diagnosis of thalassemia and sometimes termination of pregnancy are accepted practice in Italy, the church challenges the concept that only human beings who are going to be fully 'fit' have the right to exist. But this line of reasoning will take us too far from the focus of this commentary.

In most of the debates in the media, the experts spend hours debating when life really begins, when precisely we can consider that a given number of cells is already a human being, and so on. I believe that no agreement can ever be reached in this debate.

Before law no. 40 was enacted, in vitro fertilization in Italy involved production in vitro of several embryos. Those not implanted were cryopreserved and could be thawed and used at a later date if the first attempt did not result in a successful pregnancy. Thus, following a given in vitro fertilization procedure a number of cryopreserved embryos were stored; if not used for later implantation and if the couple decided not to have more children, they could be used for scientific purposes. This is approved practice in many countries. However, there is no disputing the fact that these embryos do represent potential human beings; even more important – each embryo could engender a unique and unrepeatable human being. When Karol Wojtila said 'every human being is unrepeatable and should be loved because of his/her uniqueness' he conferred poetry and deep religiousness to the specific recombination of DNA that is the basis of this uniqueness for each individual. Thus law no. 40, inspired by the convictions of the Vatican and unquestionably supported by a proportion of the Italian population, forbids production of any embryos in excess of those that will actually be implanted. The principles of the Catholic Church go further. It is worth noting that Pope Paul VI in the Encyclical Humanae Vitae (1968) addressed the issue when he prohibited use of the contraceptive pill because it may prevent development of a new human being. Thus we can see that the Catholic Church has views on the creation of embryos but focuses also on earlier events in the attempt to ensure that the chance of conception can in no way be impaired.

This brings us, however, to an even more fundamental problem quite apart from the precise time of onset of human life. It is: Who is going to exist and who is not? Put more succinctly: 'To be or not to be: that is the question...'. In practice, under normal circumstances only one spermatozoon among many millions will fertilize an egg. For the remaining millions of potential individuals, each probably unique, there will never be any further chance to exist for the entire life of the universe. This is a remarkable fact that should be contemplated at some level by every human being regardless of his or her religious or ethical background.

So who is to decide which human being results when a human oocyte is fertilized by just one of the millions of spermatoazoa, each of which could theoretically give rise to a unique individual? Until the technology of in vitro fertilization was developed, the choice among the millions of possible individuals must have been based purely on chance or guided by God. If one also believes in eternal life, one can readily see how important it is not to stop the development of any individual who has been chosen to exist.

However, the situation has now changed profoundly. Science has overcome many barriers. It is now possible to generate in vitro many embryos. The person supervising the coalescence of egg and spermatozoon in effect chooses from many possibilities. Who guides the hand of the operator? It is perhaps interesting to point out that, in probabilistic terms, as a result of in vitro fertilization, one can generate embryos which, according to the rules of nature, would never have had any chance to exist. In other words, there is some analogy between the natural system and the results of in vitro fertilization: in the generation of a new human being by normal mechanisms only one human being among millions of other possible individuals will eventually exist; similarly as a result of in vitro fertilization one or very few 'possibles' will actually achieve existence. The vast majority will not.

It is evident that the problem is of enormous complexity. Here, I propose that men and women should be permitted to make their own decisions in accordance with their ethical and religious convictions. What about the law? The solution should not be legislation which imposes on citizens just one narrow view of the problem. The compromise should be 'broadly based legislation' which establishes some firm boundaries (i.e. no cloning of individuals) but allows great freedom within these boundaries.

After surveying the worldwide situation, I have asked myself several times whether defenders of law no. 40 believe that the governments and citizens of the vast majority of the Western World are totally devoid of moral principles. The majority of European countries and now some states in the United States have approved therapeutic cloning (better named nuclear transfer technology) and large amounts of money are being invested in this research. In the United States research on embryos can proceed, provided it is privately funded. I have difficulty in understanding how supporters of law no. 40 are happy that their views should prevail in Italy whereas most of other countries are moving in another direction.

If the prohibition on production of and research on embryonic cells is not reversed in Italy, the scenario will be as follows. In some parts of the world, treatment for diabetes, cardiac failure and other conditions based on the use of embryonic cells will be established in the foreseeable future. Italian patients (including those who have supported the present law) will want to profit from these therapeutic opportunities and will seek authorization from their Health Authorities to go to those centres (abroad) where the relevant treatment is available. They will seek not only permission, but also reimbursement of their expenses. If the Health Authority says 'yes', the economic load will be unsustainable. If the Health Authority says 'no', only wealthy people will have the chance of profiting from the new treatment. By that time, the arguments discussed here will seem much less important. I am optimistic enough to think that eventually (in a few years, perhaps) the law will be adjusted to make it more reasonable. I might accept the views of those who wish to discourage the generation of extra embryos with the sole purpose of research, but for the cryopreserved embryos already in existence some sensible compromise solution should be found.

I should add that in these 'prohibitionist' times there is always the risk of monopolistic temptations. Thus, it is important that the research on embryos, as for any type of relevant biomedical research, remains under the governance of the national health service and academic institutions.

Finally, at a time when the precise moment when life in embryos begins is argued so forcefully, one cannot ignore the paradox that mankind spends an enormous amount of money in making weapons and that hundreds of thousands of human beings have been killed only recently in Iraq and Sudan, just to give two examples. How is it possible that we are so much concerned with the potential survival of a few embryos and so little disturbed by the many existing human lives that are lost every day?