Regulation and Oversight of A.R.T. in Australia : Lessons Learned Robert Jansen Invited address to a special conference sponsored by NABER: The National Advisory Board on Ethics in Reproduction RESOLVE INC. and the Centers for Disease Control and Prevention (CDC), Atlanta Washington DC, February 12-13, 1998   Ladies and Gentlemen: In the days of anarchy, it was freedom to. The author Margaret Atwood is writing in her book, The Handmaid’s Tale. She writes: There is more than one kind of freedom. Freedom to and freedom from. In the days of anarchy, it was freedom to. Now you are being given freedom from. Atwood, a Canadian, is writing of the fictional north American Republic of Gilead. In her book, written in 1986 and set in what then was the near-future, nuclear war has wreaked havoc with sperm counts. Don’t follow the biology too closely, but there’s wide-spread male sterility, and there’s a premium on female fertility to compensate. Political upheaval has occurred, and there’s a totalitarian regime in place, a conservative regime of a sort of neo-Old Testament kind. The controllers of society share a revulsion against artificial reproductive technology as being contrary to God’s will. Instead, young, extremely fertile women are recruited to be surrogate mothers for the elders; but they’re impregnated by conventional sexual intercourse (you could call it ‘coitus classic’) … coitus delivered by patriarchs … well-connected patriarchs. The heroine of the book, if you can call the luckless young woman a heroine, is reflecting on her past life. Before the upheaval she was free to pick her mate; she was free to have sex; she was free to get pregnant; she was free to have a baby; and she was free to keep it. Now sex is forbidden - except for sex with a patriarch, sex supervised by the state - now that sex is forbidden she has freedoms from. This is how the state sells it. She’s fortunate because she’s free from having to pick her mate. She is free from having to make difficult choices. The English newspaper The Economist gives a similar example of the difference between a freedom to and a freedom from. At Schiphol airport, in Amsterdam, prices in all the airport stores are apparently set by the Schiphol Airport Authority. There’s no price competition. This is in the interests of consumers, the Authority explains. We fix prices so that consumers will know they don’t have to compare them. Shoppers are free from having to shop around. It does not require me to explain to citizens of the United States that a libertarian society maximizes freedoms to – freedom to get the best price, freedom to have sex, freedom to get pregnant, freedom to seek reproductive technology – … that a libertarian society keeps the freedoms from to a minimum, a freedom from truly harmful consequences, as in freedom from hunger, freedom from war, freedom from disease, freedom from being randomly assaulted on the streets, and, yes, freedom from being too crassly swindled. Most thinking people accept regulation: drug and device testing for safety; truth in labeling; truth in advertising; liability for professional negligence; the need for proper consent. These are not issues in any of our countries. Liberty requires these regulatory constraints: they are not issues special or novel to reproductive technology and nor is reproductive technology immune from these regulations. The question, today and tomorrow, is deciding what aspects of reproductive technology U.S. citizens should be free to enjoy the benefits of, and free to run the personal risks of when they have choices, and what dangers … what real dangers … what "evidence-based" dangers … what dangers are truly dangerous enough that U.S. citizens should be free from risking them. My invitation is to use an Australian paradigm to illustrate these particular freedoms and how they’ve worked. The subjects I’ll be touching on are three, each of which is today unresolved in the U.S.: embryo research; third party reproduction; and cloning. Like the U.S., Australia is a federation of states … states among which there’s substantial independence in some matters of social policy. And we do have a state, the state of Victoria which, like Atwood’s Republic, back in 1984 took a proscriptive approach to reproductive technology, attempting to keep its citizens free from the ravages of this new-fangled, value-threatening in vitro fertilization technology …. And on the other hand we have the state of New South Wales, which took a minimal legislative approach, on paper at least leaving its citizens free to make their reproductive technology choices and, in principle, free to make their mistakes. So one lesson will come from figuring out which state’s citizens are best off now, more than a decade later. Before I contrast the Victorian and New South Wales legislative approaches, let me point out that there’s no society that regards getting pregnant and having children to be a wholly personal matter … we have no society that takes the total view that "they’re your children to do with what you will". On the contrary. We have laws and conventions on who can marry whom; we have laws against incest; we enforce parental responsibility; we have requirements for child maintenance; we have the crime of child neglect. Infanticide (once upon a time a legitimate family planning device) … infanticide is now always a crime; we limit feticide and abortion; some societies still limit contraception. In the United States, a country many outsiders regard as one of the freer societies in the world … in the United States you have all these rules and more. And far from being free here to pursue reproductive technology research, you have in place, still, a comprehensive ban on federally funded pre-embryo experimentation: there’s an indefinite suspension here [FAST] on funding the kind of research infertile couples have the same expectation of that any suffering patient expects of the medical research establishment. You pay a harsh penalty if federal money finds its way into a human embryo study. So we’re not here today to work out if the U.S. should limit reproductive technology through regulatory oversight. It already does. Yet in other ways the U.S. is extraordinarily laisser faire. I draw attention to the essentially unfettered commerce that takes place here in human sperm and human eggs. Genetic future is sold on the Internet for a credit card number: this in a country where there are forces, forces wary of the unknown, forces that want a permanent ban on gene therapy that affects the germ line. What kind of biological fundamentalism is this, which could ban whatever uncertainty there might be in reconstructing a single faulty gene destined for a new individual yet permit an incalculable number of children to be conceived … conceived from anonymously sold sperm or eggs … children conceived who have fully half their genes from a person they will never know, half their genes from a person they can never meet? We have a disconnect here. The question of course is not if there should be regulatory oversight in the U.S. but rather what oversight might be best. 1984 long ago became famous as a fictional beacon for the notion of state control. It was in 1984 too that the Government of the state of Victoria enacted its Medical Procedures (Infertility) Bill. Australia today has a system of hierarchical control over the reproductive technologies. In 1982 - well before I was actively involved in IVF research myself, a year or two prior to George Orwell’s showdown date of 1984 - in 1982 I was a member of the Australian Government’s Medical Research Ethics Committee. Our job was to rewrite national guidelines for the ethical conduct of medical research. The National Health and Medical Research Council - our equivalent to your NIH – the NHMRC had taken the view that IVF technology was novel enough to warrant the tag of research, and the research guidelines we formulated became a de facto standard for ethical practice in reproductive medicine - a standard, studies have shown, has for one reason and another been widely adhered to in Australia. The Guidelines are federal. The various states are free to legislate tighter control, and a number of states have done so, as you’ll see in the case of Victoria. The states are not free to loosen control; they can only tighten it, like a ratchet. As well, local communities – hospital-based communities or individual institutions – can tighten control further through their institutional review boards or ethics committees. Catholic hospital reproductive medicine programs, for example, might permit gamete intrafallopian transfer but not in vitro fertilization. Institutions can tighten control but they can’t loosen it. It’s a ratchet. The NHMRC Guidelines themselves are not that tough, but nor are they trivial. They form the ethical backbone of a voluntary but universal system that accredits reproductive medicine programs in Australia known as R-TAC, that Sandra Dill will be speaking about. First: A register has to be kept of all treatment attempts – suitable for collation by a national body. The national body that collates IVF statistics in Australia has been the National Perinatal Statistics Unit, a federally funded body set up to record birth defects nation-wide. Second: The technology is to be for the treatment of infertility within "accepted family relationships". Third party donors can be a part of this relationship, provided that there’s no element of commerce. Commerce in human tissues is illegal in Australia under federal law. Whether homosexual couples or single mothers are to qualify as "accepted family relationships" was left for society to work out for itself … and this is a debate that’s really only now getting underway. Likewise, debate is hot in Australia right now over what constitutes the narrow condition of infertility, compared with the wider, social condition of childlessness. Third: Gestational surrogacy – this is a third party form of reproduction where a woman gets pregnant for another woman then later hands over the baby … gestational surrogacy was in 1982 put on the backburner as "not yet capable of resolution". Surrogacy’s not illegal in Australia federally and has since been sanctioned by a national committee that’s the descendant of the MREC we were then. ( But this is one area where most states have ratcheted down, enacting state legislation to make it a crime for medical practitioners to take part in surrogacy arrangements. ) Fourth: Research involving sperm, eggs and fertilized eggs (biologically they’re ‘pre-embryos’ but we loosely call it embryo research) … I quote from the Guideline…[ SLOW ] "research has been and remains inseparable from the development of safe and effective in vitro fertilization and embryo transfer technology", and … "as part of this research other important scientific information concerning human reproductive biology may emerge" (and, by implication, is to be encouraged). Oh boy! That libertarian freedom to conduct embryo research really put the cat among the conservative state pigeons! Moral fundamentalists are as busy in Australia as they are in the U.S., and a lot of energy was expended in a lot of states to get the ratchet down onto embryo research and to ban it. I’ll come back to it. Fifth: Property in sperm and eggs (and the embryos that resulted) … ownership … was vested in their providers, basically in perpetuity. Ascendancy was given, if you like, to the owners of the genetic potential sperm, eggs and embryos represent. No independent life was envisaged federally for a fertilized egg without a uterus. Sixth: Storage – cryostorage, low temperature freezing of fertilized eggs - was, in 1982, thought to be capable still of causing biological hazard (since dispelled) as well as a possible social hazard (which is not today as hot a topic as it has been). A time limit for embryo storage was thought then to be important. This was set at about 10 years and to be "not beyond the time of conventional reproductive need or competence of the female donor". ( I think it’s fair to say that this ethical imperative is susceptible to ongoing review. ) Seventh: Cloning to intentionally produce multiple genetically identical offspring was and is unacceptable. Lastly: People employed in public institutions who conscientiously object to reproductive technology on moral grounds could opt out of them without jeopardy to their jobs. The guidelines remained unchanged for 14 years, a time during which in Australia in vitro technology became accepted into routine – and reimbursable – medical practice. In 1996 they were refined in detail, with added prohibitions on using gametes from cadavers or from fetuses. In 1996 there was also one new and striking provision: that third party donors of sperm or eggs should only be accepted as donors if they are prepared one day to be made known to their offspring. In my state, New South Wales, these guidelines have been deemed to be enough, at least inside the ordinary bounds of medical practice set by statute and regulation, and by the torts of injury and consent. In New South Wales we can – and do: use sperm from men who are dead if they provided sperm before they died, if this is what they would have wanted, and if this is what their partner still wants carry out gestational surrogacy where the surrogate mother helps for altruistic reasons and not for commercial reasons and we help achieve pregnancies for women in a variety of relationships Back in 1984, the state of Victoria took a different approach. The Medical Procedures (Infertility) Bill was drafted under the direction of the then chairman of the Victorian Law Reform Commission, Professor Louis Waller, who today heads the Victorian Infertility Treatment Authority, which is funded by charging reproductive medicine clinics in Victoria a licensing fee. The legislation in 1984 recognized the inevitability of this new reproductive technology, but, implicitly and explicitly, it set out to contain it – to contain it morally, and to contain it practically. The Bill defined life as starting with fertilization (so putting out into the cold those thoughtful protestants and humanists who had a different, but arguably equally moral, perspective on the sanctity of early human life; it isolated anglican moral theorists who would confer a step-wise (but still rapid) increase … who would confer a step-wise need for increasing protection through the stages of implantation, embryonic plate formation, neural differentiation, and so on) The Bill mandated a two year wait for commencement of in vitro fertilization treatment unless both fallopian tubes were demonstrably blocked (so it contravened Section 2 of the 1975 World Medical Association Declaration of Helsinki, which, condensed down slightly, states that "in the treatment of the sick person, the doctor must be free to use a new diagnostic and therapeutic measure, if in his or her judgement it offers hope of re-establishing health or alleviating suffering …( and infertile patients do suffer )…. and it completely failed to anticipate the clinical movement of the field into low sperm count and mixed-cause infertility, which as it has turned out, are no less in need of reproductive technology and in fact do better outcome-wise than lumped-together fallopian tube problems. The Bill sought to make compulsory a second medical opinion on the advisability of in vitro technology, by punishing a doctor - with penalties that could include imprisonment - if he or she were both the doctor who recommended in vitro technology and then also the doctor who carried it out (this introduced the nonsense that the smart patient who was intent on seeing the best doctor for in vitro fertilization should first seek out the second best one to get the OK for the treatment) I need hardly point out that this provision in the Act was and is breached daily; that it’s only ever been observed accidentally; and that not a single instance has even been discussed with a prosecuting attorney. And the Bill made marriage compulsory before a couple could gain access to reproductive technology (and this has duly led to a successful suit against a state-law abiding in vitro program Melbourne being successfully sued for unlawful discrimination under federal antidiscrimination law) The scientific research into in vitro fertilization in Victoria that had put Australia into a position of prominence, became unstuck. A statutory committee was established under the legislation to foster debate in the community on the new technologies and to protect Victorians from the effects of uncontrollable embryo research. It accomplished neither. Far from promoting debate in the community it hijacked it. Quintessentially well balanced in its composition, the Victorian committee represented the two main protagonist groups – the fundamentalists and the moral gradualists. They reached decisions on nothing. And research stopped. What then happened is a story that deserves a detailed re-telling, because it touches right at the heart of what’s important in the regulation of research using human fertilized eggs – "embryo research", as it’s popularly known. By 1989 the new technique of sperm injection into eggs had led to a pregnancy in Singapore – and in Victoria Alan Trounson was hot to trot with this revolutionary new technique for treating seriously low sperm counts. But Trounson, working in Victoria, first wanted to be sure that having a scientist place a sperm into the immediate environment of the egg was not going to cause gross genetic problems. After all, Nature was being deprived here of yet another barrier that might be screening out bad sperm. Trounson (and his colleague Ismail Kola) had developed a way of looking at the chromosome count of fertilized eggs. Before copying the Singapore clinicians, who had just pressed on regardless of clinical unknowns and produced a baby, Trounson wanted to do what he could to establish that sperm injection was safe with an in vitro research study of genetic consequences before moving to clinical practice. The problem was, you could only look at the fertilized egg’s chromosomes by destroying the fertilized egg – exactly the kind of research that in the U.S. today is still under the cloud of an indefinite freeze on federal funding. Ladies and Gentlemen, this is embryo research. This, if you want to verbalize it plainly … this is what the moral critics of IVF mean when they say "non-therapeutic, destructive embryo experimentation". This is what NIH is banned from funding and this, in Victoria, was and is illegal. But it’s not contrary to our NHMRC guidelines and there’s no prohibitory legislation in New South Wales. The NHMRC guidelines recognize that this is exactly the kind of research that had permitted the development of IVF in the first place; this is exactly the kind of research that’s essential to advance the field responsibly. Step 1 for us at Sydney IVF was to secure institutional review board approval. They agreed we could recruit up to 20 couples who’d been unsuccessful with IVF because of low sperm count-fertilization failure. I had 16 couples who volunteered to have an IVF cycle in which eggs would be fertilized by microinjection of sperm, but all fertilized eggs would be examined to see if the chromosomes were normal or abnormal. As controls, we examined unused fertilized eggs from other people. We also compared the chromosome abnormality rate with that reported for normally fertilized eggs (which is quite high). The rest is history. In a two week effort that saw the entire Victorian research team 600 miles north and bunked at Sydney IVF, we showed the chromosome abnormality rate was actually lower for microinjected eggs than for conventionally in vitro fertilized eggs; we also showed that microinjection IVF and ordinary IVF both had lower rates of abnormalities than eggs fertilized naturally. IRB approval for clinical sperm injection soon followed, and the world’s second and third sperm microinjection babies came from among these 16 couples. Laboriously, the Victorian Government amended its Act to define life as starting 24 hours later – a compromise maybe to allow some research. But inside a few years the same sorry story repeated itself. In 1993 research on fertilized egg genetic status was proposed for the new sperm injection procedure called "ICSI" – intracytoplasmic sperm injection, in which the single sperm is actually injected into the heart of the egg itself. This time Trounson wanted to see if fertilized eggs would divide without genetic errors. Again the Victorian standing committee said "No". This time the Victorian embryologists just said "To hell with it!" and, like the Belgians, the British, the Americans, the Italians and everyone else, just went ahead anyhow and did it clinically. So much for morality and the ethical, research-based practice of medicine. Remember I said that the Victorian Government wanted to contain IVF practically as well as morally. Well ……. as it’s turned out, on a population basis …. …. Victoria has the highest IVF usage rate in Australia, and there’s not the slightest evidence that Victorians enjoy any particular practical ethical safeguard that New South Welshmen do not. As I mentioned, citizens of New South Wales are also free to get pregnant before they formally marry; a woman in New South Wales is free to be inseminated with her dead husband’s sperm if that’s the way she wants to complete her family; she’s free to donate an egg to a friend or a sister; and she’s free as a surrogate to carry a baby for someone else if that’s what she wants and if an ethics committee determines that everyone will most probably be better off; and I’m free, with IRB approval, to look at the mitochondrial DNA of fertilized eggs and see how it correlates with the ability to form a pre-embryo. Victorians are free from making these difficult choices, but they’re not free from paying an extra charge per IVF treatment cycle to cover their clinic’s licensing fee, to keep their Infertility Treatment Authority properly funded. The different approach taken by Victoria and by New South Wales has many lessons. The important lesson for us today, I believe, is not that a zero legislative approach is necessarily best. There’s a role for legislation in some circumstances and I’ll get to it shortly. The important point is that cautious experiment is no less important to the advance of consequential ethics than it is to advances in medical practice and scientific knowledge. There’s value in a heterogeneous approach during fledgling days in any field. Far from insisting on a uniform regulatory approach too early, there’s been value in variety. The disparate experience of Victoria and New South Wales is important in its very disparity. If their approach had not been different, there would not have been lessons to learn. We need differences to highlight mistakes. The mistakes need to be observable endpoints. We need to use these endpoints as evidence. And so we ought to base our codes of practice –as guidelines, regulations or laws … we ought to base our administrative best practice, or ethical best practice, on evidence … the evidence that comes from controlled trials, controlled social trials. Such evidence was lacking in 1984 when the Victorian Government tried to anticipate the future and set its code of practice into the concrete of legislation. Such evidence is not lacking today. But too often, still, evidence – evidence of actual harm done, or evidence that harm is not done - is being ignored, sacrificed to moral prejudice. Not the proper, legitimate moral imperative of a total human conviction, such as the moral imperative "thou shall not kill", but the moral prejudice voiced in otherwise plural societies by the few who are loud or powerful or quick, so that in many countries today ethics or morals-based decisions affecting individuals’ reproductive behavior are being taken by - have been hijacked by - small groups of people close to government and then given government imprimatur on the excuse of, at best, guessed-at harm. Regulations and laws in many European countries today are being based not on a search for harm done or harm not done - evidence that in one form or another is now plentiful for reproductive technology outcomes - … rather, European and perhaps Canadian regulations and laws are, like in the Australian state of Victoria, … regulations and laws are still being based on faith and moral intuition when such faith and moral opinion falls well short of a universal morality. It’s true that one does not need evidence, for example, to justify the universal moral imperative "thou shall not kill"; the reason is that it’s an article of faith, of intuition, that’s held by virtually everyone in society. But the commandment, "Thou shall not be an egg donor for thy friend", is an entirely different matter. Surely there are circumstances where no harm is done by it. Surely there are circumstances when everyone will be better off: the infertile woman, who’s not entirely disenfranchised from a genetic legacy; the husband, who’s a father just the same; the child, with an aunt who’s literally part of the family; a child with three parents instead of just two. Is this question – Should you be an egg donor for your friend? …. is this a moral question we should vote on? Should an opinion poll determine collective regulatory action? An opinion poll that tests faith and intuition rather than direct experience? Aren’t we turning the clock back to use an opinion poll or a vote to determine what a couple might and might not do to reproduce in an open society? Isn’t this the same as determining best medical practice by polling today’s doctors on what they think is best practice? If evidence-based medicine is the yardstick for Canada’s reproductive technology application why isn’t evidence-based ethics the yardstick for social policy? Where’s the evidence that says it should be compulsory in Canada and in the United Kingdom for sperm and egg donors to be anonymous? It’s utterly curious! Here we have a national ethics committee in one Anglo-Saxon country decreeing that an ethical matter must be dealt with one way. And we have a national ethics committee in another Anglo-Saxon country decreeing exactly the opposite. And they’re both convinced not only that they’re right, but that their judgement should now be beyond more debate and that there’s to be only one way of doing it. Full stop. I can’t make a better case for evidence-based ethics. We ought to look for evidence of harm done – and we ought to look for evidence that harm is not done - before in a plural democracy we set regulations and legislation in stone. And this, then, is the case for not regulating and for not legislating too early. You need experience to take an evidence-based approach, and our different experience in New South Wales is what’s enabled us to reveal the mistaken legislative approach adopted by our neighboring state of Victoria. But I am not making a case for a laisser faire approach; I’m not making a case for a free-for-all, for zero regulation. Certainly I’m not making a case for the current situation in the U.S. today …. a situation that I’ve said is an odd mixture of open commerce in eggs and sperm hand-in-hand with a morals-based federal freeze on IVF research funding … an odd mixture of an open market in anonymous gene bucket-loads and a possible ban on altering a single gene in the germ line. In my talk so far, I’ve dwelled rather substantially on the question of third party reproduction, the donation – or the selling - of sperm, of eggs, of embryos perhaps, and of gestational capacity in the form of surrogacy. In the words of the philosopher Karl Popper, an open society – a truly libertarian society - is a society that allows or enables the greatest number of individuals to reach their fullest potential. Margaret Atwood might say: A society that creates the greatest number of freedoms to and the fewest number of freedoms from. In this respect there’s important evidence coming from donor sperm programs in Australia. Evidence of harm done. Like elsewhere in the world, sperm banks in Australia sprang up in the 1970s to help couples form families when the husband was sterile. Well, nothing succeeded like success and there’s been evidence in abundance that the donor insemination program on the whole has been successful. I won’t go into the outcome measures in detail, but for a start it’s evident that couples who were treated this way have a significantly lower risk of divorce compared with couples who rejected donor insemination as an option, and heaps lower than couples who have no trouble with fertility at all. But the gold is in the details. Evidence is emerging that the families that did – and do – do best …. the families that do best as coherent, stabile, resilient families, are those who explained to their children, the children who resulted from donor insemination … the families who have done best are those who explained to their children at the first opportunity how an outsider, a donor, "helped mommy and daddy". The evidence of harm done by keeping donor sperm a secret has been slow to arrive. But it’s now compelling and it’s substantial. The older a child is when they learn of their missing genetic father – and compounded considerably if they find out by accident - the worse it is. The more that their parents have been keeping it a secret, the greater the loss of trust, and the more indelible the effect on the child, ... on the adolescent, … on the adult. We have here that classic dichotomy between risk and hazard. The risk of the child finding out by accident might be small (although in this age of genetic information it can only rise) … the risk of the child finding out by accident might be small, but the hazard, the penalty you pay if that small risk is realized, is now on all evidence a devastation. A collection of experiences from donor sperm offspring to whom this has happened has recently been published in Australia and it’s the most moving book you can read in the field of experiencing infertility. Donor insemination was bred in an age, the 1970s, when nurture had it over nature in schools of sociology. It was meant not to make a difference who your genetic father was. Nurture and the social father was everything. Commentators were even drawn to noting how much sons could look like their social fathers! But the children have grown up in a society that has about-faced completely. Your genes are now everything. Your DNA is to blame for your social behavior, your personality and everything else. Yet donor sperm banks remain overwhelmingly anonymous and, in the U.S., donors of eggs are generally equally so. And we have several societies seeking to make this anonymity compulsory. In my opinion this is not a matter of mere controversy. This is a matter of considerable folly. This is creating children who are free from knowing their genetic origins. This is not liberty, which surely means the freedom to know where you came from, the freedom to have two, three parents, whatever. If I feel restraint in forcing your attention – your potential regulatory attention – to this issue, this issue of genetically anonymous childhood …. if I feel restraint it’s my point that it’s evidence – evidence-based ethics and not some special intuition that should lie behind regulation in this area, and it’s evidence of harm done through anonymous reproduction that should carry the day rather than any clumsy prophecy of doom based on personal intuition. I’m glad that, in Australia at least, that evidence is beginning to surface, so we can act on it. To finish, I want to say that there will be areas in which our field – the field of assisted reproductive technology – … there will be areas where the field moves too fast to be sure that evidence can be gathered rapidly enough to direct the field sensibly. And a good example today is cloning. Most thinking people recognize that the lab techniques that will soon enable cloning have too much promise for betterment of the human condition than for them to be banned outright – embryonic stem cell research is what I’m thinking of. Yet there’s a special unease about human cloning - about the replication of a person. Except for the lucky few who have moral certitude unaffected by experience, we simply do not know when a judicious clone might be a compassionate thing and when it could be a recipe for human suffering on a colossal scale. Meanwhile, quite apart from a legitimate fear of yet unknown harm, there’s a real and very practical danger in not putting a freeze on human cloning. And that danger is this: The field of human reproductive technology, as you know, is a very competitive commercial business. Fame is an important part of commercial success. The competition and need for fame is such that there’s a disproportionate advantage for a third-rate A.R.T. program to risk all in being the first to achieve a human clone: through the notoriety, they have nothing to lose and everything to gain. But if cloning is to happen, this is not where it should be done. If it is to be done, it’s in the best programs, not the worst programs, where it should be. So it’s this – stopping this badly placed incentive – it’s making sure you don’t reward the third-raters - but rather, in due course, making sure that the research is done responsibly - that’s the reason for slowing the field down with a statutory moratorium on (in this instance) cloning. If the Victorian Government, worried in 1984 that its embryologists were out of control, had passed the legislation they did but had had the foresight to pin a 5-year sunset clause to it, they would have had the best of two worlds. They would have slowed the advance of reproductive technology enough to take the heat out of it, to enable the community to catch up with developments, yet they would not have crippled medical practice in an expensive way that has permanently stopped research there and has not demonstrably helped a single Victorian. So I conclude by saying that there is a place for pre-emptive legislation in ensuring a libertarian approach to reproductive technology. The still abstract reason for the legislation needs to be a substantial one – a possible harm that’s plausibly real enough and plausibly serious enough, and with a real risk that it will be cowboys instead of the nation’s best that will be leaping into it - that "breathing space" needs to be created. Remember that in recent history A.R.T. developments once scary to some people - scary things such as IVF itself, sperm microinjection, embryo flushing, sex pre-selection, gestational surrogacy - experience in these other things have either lessened their feared impact or anyhow seen the techniques drop out of clinical practice. So pre-emptive legislation, with a real breathing-space-role to play, ought to be accompanied by a sunset clause, a time clause, limiting the effect of the legislation to say 5 years or 10 years, during which evidence can be gathered that will eventually provide an outcomes-base – an evidence-base – to those regulations and legislation that are to endure.