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Regulating reproduction is no easy feat. In the past three decades we have witnessed a reproductive revolution and great strides have been made to alleviate the effects of infertility. Reproductive advances such as in-vitro fertilisation (IVF), sex selection, reproductive cloning and embryo selection for the purpose of creating “saviour siblings” have all emerged as part of a rapid and ever-changing branch of medicine, each promising to upset the status quo and transform human reproduction.
Following much activity in this area, the lengthy process of updating the legislation is now complete. The Human Fertilisation and Embryology Act 2008 (HFE Act 2008) received Royal Assent on 13 November 2008. The majority of the HFE Act 2008’s amendments will come into force in October of this year, with the exception of the provisions pertaining to parenthood, which commenced in April 2009. Welcoming Royal Assent, Professor Lisa Jardine, Chair of the Human Fertilisation and Embryology Authority, stated:
“This is a momentous day for the HFEA and for those with fertility problems. The regulatory system that has served us so well has been renewed. Parliament has provided a clear framework for the future and a solid base on which to regulate 21st century practice within 21st century law.”1
However, as scientific endeavours into developments such as artificial gametes, womb transplantation and ectogenesis continue apace, it could be argued that Jardine was perhaps overly optimistic about the achievements of the new legislation. The HFE Act 2008 is an amending statute, and as Jackson2 notes “much of the regulatory architecture” in the 1990 legislation “remains intact”. In retaining the architecture of the 1990 legislation, and merely amending or adding certain provisions, has the government missed an ideal opportunity to consider how to equip the regulatory framework for the next phase/era of assisted reproduction?
The next phase of human reproduction raises a number of possibilities; the first is that of artificial gametes, which can not only assist individuals unable to conceive, but which also raise the possibility that a man could be both the genetic “mother” and “father” to a child.3 4 5 Second, there is the possibility that it will one day be possible not only to fertilise an embryo in vitro, but also to gestate it in vitro—outside the female host and in an artificial womb or ectogenic incubator.6 7 8 9 Finally, scientific endeavours into womb transplantation may enable embryos/fetuses to be implanted and gestated in donated wombs, which could be transplanted into the body of either gender, raising the novel prospect that both men and women may be able to gestate.10 11 12 13
These technologies usher in a different set of legal, ethical and social questions to those raised by IVF. It is worth recalling at this juncture, that the Human Fertilisation and Embryology Act 1990 was initiated in response to IVF, in which fertilisation takes place outside the female host, but is later implanted into her for gestation. With this new phase of human reproduction looming on the horizon, can legislation initially designed to regulate issues arising from IVF accommodate the technologies of this new phase, such as the complete fertilisation and gestation of the fetus outside the human body (ectogenesis), making it possible for the first time that man (and woman) will not be “of woman born” and birth will cease to be a significant milestone.i
In theory at least, the Human Fertilisation and Embryology Authority (HFEA) has the apparatus in place to assist it keep abreast of developments so as not to be caught “off guard” and enable it to meet the challenges raised by novel reproductive technologies. The HFEA has acknowledged “the area of science and medicine regulated by the HFEA is fast-paced and can be controversial”,14 and that because of its involvement in licensing and policy development, the HFEA needs to be aware of new developments. The HFEA now has an Ethics and Law Advisory Group, which meets four times a year to review social, ethical and legal issues arising from, or affecting, activities in which the HFEA has an interest. The HFEA also set up a Horizon Scanning Panel (HSP) to act as an early warning system to identify “new developments that may impact on the field of assisted reproduction or embryo research so that the Authority is aware of potential licence applications and prepared, if necessary, with an Authority policy or position.”15 The internal horizon scanning process is carried out by the HFEA policy team (para 3.2).15 The creation of the HSP was welcomed by the Select Committee on Science and Technology16 and the government, the latter stating that the HSP would allow the HFEA to “make use of the best available data to support its decision making”.17 The importance of being equipped to deal with those reproductive advances looming ahead was explicitly recognised by the HFEA, who commented that although the majority of the techniques discussed by the HSP:
“… are a long way off from being offered to clinics… it is useful for the HFEA to be aware of them so that, as far as possible, we have time to consider the legal, ethical and scientific implications of the use of these techniques, prior to an application being received by a licence committee for their use in research or treatment.
The HSP has the potential to ensure that the HFEA is not caught “off guard” by new developments and that the law is not lagging behind science by scanning those reproductive advances that may be possible in the near future. Yet the HSP is only effective if it is bold and brave enough to deal with such controversial possibilities. Consider for instance womb transplantation to restore fertility to patients with an abnormal, damaged, or absent uterus: this was identified in the 2007/8 Annual Report, but accorded “low priority” and dismissed without further consideration.18 Arguably it was imprudent to dismiss this advance from further consideration in light of scientific interest and the notoriously fast rate of scientific advance. The first human attempt at a womb transplant was conducted in 2000 with limited success.12 Nine years on, Del Priore of New York Downtown Hospital, announced that he and his team are preparing for the world’s second attempt at a human womb transplant.11 19 Dr Del Priore is reported to have identified and interviewed potential recipients and donors10 19 and believes the difficulties encountered by Fageeh et al12 can be overcome through the use of a brain-dead donor. In reality we are one operation away from this becoming a possibility.
Similarly, the issue of artificial gametes as a treatment to assist the many unable to conceive ought to be revisited. Scientists Tsai et al20 state that “alternate sources of gametes are not merely science fiction but already are a concrete fact.” For the many unable to conceive this could be a way forward. Yet the current blanket ban in the legislation to permit the use of artificial gametes to achieve a human pregnancy creates little incentive for scientists to continue with their endeavours in this field. For MP Evan Harris this was one area in which the HFE Bill fell short: he stated:
“This is a good Bill, but the government needs to recognise a few improvements are still needed—such as allowing the use of artificial gametes—before we can say the UK has rational and progressive regulation.”21
As we charge towards a new era of assisted reproduction, it is crucial that we continue to monitor and debate new developments. IVF and the legal and ethical issues it raises have been much debated, and as Deech and Smajdor22 23 note “IVF was just the start of a long procession of technological developments” and “public concern over IVF has waned.” It is imperative that we now move away from the much debated issues that arose from this wave of reproduction and begin to consider the plethora of issues the new era of reproductive technologies is set to usher in.
I end on a note of caution. At present, it is true to state that it is currently unlawful to use artificial gametes to achieve human pregnancy (it would be a criminal offence to assist a single man/woman or a couple to use this technique to reproduce).ii It is also a criminal offence to implant an embryo into a womb located in a male body,iii or into an ectogenic incubator.,iv Yet criminalising reproductive advances is not the solution; it will not abate the problem nor make the possibilities disappear. What it may do, however, is deter scientists from researching such advances and deny some people the ability to exercise their fundamental desire to reproduce. It is worth concluding with the prudent words of Justice Hale:
“The new balances between choice and regulation are all slowly emerging. The law cannot impose a dictatorship however benevolent, which insists that it knows best how people should conduct their private and family lives…. New possibilities are emerging all the time and the law will have to stay alert to develop in response to them.24 25
Acknowledgments
The author gratefully acknowledges the support of the Arts and Humanities Research Council and Wellcome, and would like to thank Professor John Harris and Shaun Pattison for their comments.
Footnotes
Competing interests None.
Provenance and Peer review Commissioned; not externally peer reviewed.
↵i The Offences Against the Person Act 1861 and the Abortion Act 1967 were drafted in the context of pregnancy in a woman and as such do not cover the fetus gestating in an ectogenic incubator.
↵ii Under the HFE Act (as amended), in vitro derived gametes are allowed for research but not treatment.
↵iii Assisting a man to become pregnant does not fall within the specified activities for which a licence can be granted when “bringing about the creation of embryos in vitro”. HFE Act 1990, Schedule 2 lists the activities for which licences may be granted and provides: s1 (1) A licence under this paragraph may authorise any of the following in the course of providing treatment services: (a) bringing about the creation of embryos in vitro; (b) keeping embryos; (c) using gametes; (d) practices designed to secure that embryos are in a suitable condition to be placed in a woman or to determine whether embryos are suitable for that purpose; (e) placing any embryo in a woman; (f) mixing sperm with the egg of a hamster, or other animal specified in directions, for the purpose of testing the fertility or normality of the sperm, but only when anything which forms is destroyed when the test is complete and, in any event, not later than the two cell stage; and (g) such other practices as may be specified in, or determined in accordance with, regulations. The HFE Act 2008, Schedule 2, para 2 amends paragraph 1 of Schedule 2 to the 1990 Act to enable treatment licences to be granted for the use of embryos for training persons in embryo biopsy, embryo storage and other embryological techniques, but only when the HFEA is satisfied that such use is necessary for that purpose.
↵iv The HFE Act 1990, s3(3) prohibits the use of embryos beyond the primitive streak. Section 3(4) states: “For the purposes of subsection (3)(a) above, the primitive streak is to be taken to have appeared in an embryo not later than the end of the period of 14 days beginning with the day when the gametes are mixed, not counting any time during which the embryo is stored.” The HFE Act 2008 retains this prohibition.
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