Hum. Reprod. Advance Access originally published online on June 30, 2006
Human Reproduction 2006 21(11):2756-2765; doi:10.1093/humrep/del248
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OPINION |
Escaping the tyranny of the embryo? A new approach to ART regulation based on UK and Australian experiences
Department of Anatomy, University of Cambridge, Downing Street, Cambridge, UK
To whom correspondence should be addressed at: Department of Anatomy, Downing Street, Cambridge CB2 3DY, UK. E-mail: mhj21{at}cam.ac.uk
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Abstract |
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Top
Abstract
IntroductionThe early legislative responses to fertilization of human oocytes in vitro exaggerated the protection of the embryo at the expense of the interests of other parties. Although more recent legislative changes have lessened this embryonic grip, it nonetheless still distorts legal thinking and is fundamentally in conflict with biological understanding. Drawing largely on experiences in the UK and Australia, a proposal is explored that reframes the legislative approach to the regulation of assisted reproductive technology (ART) with the following objectives: (i) to align more closely the legal and biological understandings of the earliest stages of human development; (ii) to place the legislative focus on objective, intent and outcome; and in the process (iii) to disentangle legally and conceptually the status of the embryo from that of the potential child. Experiences in the UK and Australia are drawn on, because these two jurisdictions have a common legal heritage and were among the earliest players both scientifically and legally but have pursued very different legal routes to their current legislative practices.
Key words: ART/embryo/legislation/regulation
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Introduction |
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The regulation of assisted reproductive technologies (ARTs) has been an issue for nearly 40 years, since the first successful fertilization of a human oocyte in vitro (Edwards et al., 1969
). The first IVF births [Louise Brown in the UK (Steptoe and Edwards, 1978), followed over the next 4 years by births in Australia, USA, France and Sweden (Cohen et al., 2005)] increased the pressure on Governments to legislate, and the State of Victoria was among the first to respond [Infertility (Medical Procedures) Act, 1984], the UK following more cautiously [Human Fertilisation and Embryology (HFE) Act, 1990]. Around the world, a range of regulatory regimes now operates from free market-based self-regulation [e.g. much of the USA (Adamson, 2002; Robertson, 2004b)] to highly restrictive criminal law [e.g. Germany and Italy (Robertson, 2004a,b)]. The UK and Australia lie somewhere between having systems for licensing certain activities subject to conditions backed by criminal sanctions. In what follows, the arguments for and against regulation in general are not considered (Johnson, 1998, 2002, 2006): the assumption is made that regulation will continue to be either desirable or inevitable in many jurisdictions. It is with the framework for and objectives of that regulation that this article is concerned. The objectives of different ART regulatory regimes have sometimes been explicit but are often simply implicit. However, five core common objectives can be identified, namely to protect the interests of
- the embryo in vitro;
- children deriving from these embryos;
- patients (especially women, but also partners, donors and surrogates);
- society (the public interest) and
- the health team (doctors, counsellors, nurses and biomedical scientists)
The priority given to each objective has varied with country, the influence of the different constituencies within it and the time at which legislation was approved [both calendrical and political (Robertson, 2004b; Johnson, 2006)]. However, because the initial stimulus to legislation was the creation of the human embryo in vitro, it is not surprising that in the UK (Warnock, 1984) and Australia (Waller, 1984), initially most press and parliamentary time was concerned with the status of that embryo in vitro and what might, could or should be done or not done to it [(i) above]. The question was: how can we best protect the embryo? This is captured in the opening of the long title to the HFE Act (1990): ‘An Act to make provision in connection with human embryos and any subsequent development of such embryos; to prohibit certain practices in connection with embryos and gametes; ....’. Likewise, even as recently as 2002, the State and Commonwealth Governments of Australia were able to reach an agreement regarding the national regulation of human embryo research (Prohibition of Human Cloning Act, 2002; Research Involving Human Embryos Act, 2002), something not achieved for treatment services using ARTs, which remain disparately regulated at State level, despite the fact that patients and children, not just embryos, are involved (Szoke et al., 2006).
In the early days, there was also, especially amongst the public at large, a strong underlying concern about the (ab)uses to which human embryos might be put in creating children [(ii) above]. A strong sense of the inevitability of the in vitro embryo becoming a child permeated discussions in the 1980s in the UK. There was confusion between the embryo per se and the embryo as child-to-be, and these two interconnected strands of thinking were often not separated effectively. This confusion was a consequence of the ways in which those originally opposed to embryo research vividly equated embryos with babies [and researched embryos with monsters: e.g. Unborn Child (Protection) Bill, 1984]. Responsively, those supporting embryo research then related embryo research to the wanted and bouncing babies that would derive from it (Mulkay, 1997). This conflation of two different regulatory objectives led to the primary regulatory emphasis being placed on the status of the embryo itself and thereby distorted the way in which legislation has addressed the other four objectives. More recently, there has been a move to disentangle the legal status of the embryo itself from that of the potential child. In the UK, this has been seen not so much in law as in the rhetoric and decisions of the Human Fertilisation and Embryology Authority (HFEA) itself and in a recent report from the House of Commons Committee on Science Technology (Inquiry into Human Reproductive Technologies and the Law, 2004–2005). In the Australian State of Victoria, a replacement Act (Infertility Treatment Act, 1995) explicitly articulated and changed the priorities for protection in that Commonwealth State, reducing the priority given to the embryo over that given to the child to be born. Thus:
Infertility Treatment Act 1995 (Victoria)S5. Guiding principles
(1) It is Parliament’s intention that the following principles be given effect in administering this Act, carrying out functions under this Act, and in the carrying out of activities regulated by this Act -
(a) The welfare and interests of any person born or to be born as a result of a treatment procedure are paramount;
(b) human life should be preserved and protected;
(c) the interests of the family should be considered;
(d) infertile couples should be assisted in fulfilling their desire to have children.
(2) These principles are listed in descending order of importance and must be applied in that order.
Contrast the priority in 1995 with that in 1984 in the preceding Infertility (Medical Procedures) Act 1984
S29 (7). In the exercise of its functions, the (Standing Review and Advisory) Committee:
shall have regard to the principle that childless couples should be assisted in fulfilling their desire to have children; shall ensure that the highest regard is given to the principle that human life shall be protected at all times; and shall have regard to the spirit and intent of the several provisions of this Act.
However, the framing of even this later Act remains influenced strongly by the earlier dominance of the embryo in legal discourse.
This exploratory discussion paper examines whether it might be timely to reframe fundamentally the legislative approach away from its focus on the embryo. First, the problems raised by trying to define an embryo biologically and legally are examined, and it is concluded that these problems will persist. Then, an approach to legislation is explored that places less emphasis on the processes of ARTs and more on the intended outcomes of those treatments. As part of this exploration, a way of more closely aligning the legal and biological understandings of the earliest stages of human development is suggested. Evidence is drawn primarily from legislative experiences in the UK and Australia, because these two jurisdictions have a common legal heritage, were among the earliest players both scientifically and legally and have systems of licensing in place. Despite these similarities, they have pursued different routes to legislation, in part because of the federal structure of Australia (Petersen, 2002; Szoke, 2004; Petersen et al., 2005; Szoke et al., 2006).
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The problem of defining the embryo: biology |
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To regulate embryos in vitro, it has proved necessary to define them in law. The legal definition of the embryo in the two jurisdictions differs:
Australia: ‘Human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro-nuclei or the initiation of its development by other means. For the purposes of the definition of human embryo ... in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.’ [Section 3, Infertility Treatment Act (1995)UK: ‘...except where otherwise stated embryo means a live human embryo where fertilisation is complete, and references to an embryo include an egg in the process of fertilisation, and, for this purpose, fertilisation is not complete until the appearance of a two cell zygote .... This Act, so far as it governs bringing about the creation of an embryo, applies only to bringing about the creation of an embryo outside the human body....[in a later section, it is not permitted to]... keep or use an embryo after the appearance of the primitive streak, ...[where]... 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.’ (Section 1, HFE Act, 1990).
Although in both jurisdictions the definitions have relied substantially on biological information, they differ strikingly in content and emphasis, despite that fact that in both cases the protection of the embryo was a central issue driving regulation. The difficulties that legal definition brings are illustrated by the fact that both legislatures are currently exploring whether and how to revise their definitions [in the UK, the Department of Health Consultation on the Human Fertilisation and Embryology Act (2005), Questions 5 and 6; in Australia, a Commonwealth Review Committee chaired by Lockhart (2005), and a scientific response to it: NHMRC (2006)]. That the lawyers have had difficulties is no surprise, because scientists do not themselves agree practically, semantically and conceptually on the meaning of the term embryo (Hauskeller, 2005). There are three types of confusion.
First, an embryo is understood generally to refer to that biological entity (or group of cells) that gives rise to a fetus, which then grows and matures to develop into a baby. Embryonic stem (ES) cells are so called because they have exactly this capacity to produce an entire fetus and baby. However, they can only do so if ‘carried’ inside a placental support system, which they themselves cannot generate. Thus, in mammals, early development is complicated by the requirement to elaborate this system of ‘extra’-embryonic tissues that contributes, with maternal uterine tissues, to the developing placenta. ‘Extra’ here means ‘outside of’, in this case ‘outside of the embryo’. These extra-embryonic tissues comprise the major part of the whole conceptus by the time it is implanted in the uterus. Because the early period of mammalian development after fertilization is concerned with the elaboration of both embryonic and extra-embryonic cell populations, it is often called the ‘embryogenic’ stage of development, an adjectival qualification that means literally ‘generating the embryo’. It is not therefore strictly correct to call these early stages ‘embryos’. Notwithstanding the general awareness of this mistaken use of terminology, many scientists do call them embryos, and then when the real embryonic cells can be identified, they call these the ‘embryo-proper’ (a tacit admission of the impropriety of their earlier use of embryo). More appropriate terms used for these embryogenic stages include conceptus, pre-embryo [pre-embryo has also entered legal use in certain jurisdictions (e.g. Davis v. Davis, 1992) (842 S.W.2d 588, 597; Tenn. 1992], pro-embryo, embryogen and even oocyte or ovum [which is also confusing, as these last two terms can be used for the prefertilization oocyte (Johnson and Selwood, 1996; Selwood and Johnson, 2006)]. This tangled confusion of terminology is captured in the legal definitions above. Thus, in the UK, it is largely the zygotic and embryogenic periods that are captured in the definition, whereas in Australia, the embryogenic and embryonic periods are captured.
Second, and more important, in the above discussion, ‘embryo’ is used as a categorical description, but development is a continuous process. Thus, the production of oocytes and spermatozoa (the gametes) and their maturation and coming together (summarized as the gametogenic stage of development) lead up to fertilization and the embryogenic stage, which in turn leads to the embryonic, fetal and neonatal stages. Giving ‘stage names’ to these different elements in a continuous process can easily confuse us into thinking that each stage is discreet—semantics distorts concepts. Of necessity, in a continuous biological process, the beginning and the end of each stage (including the embryogenic and embryonic stages) is fuzzy and imprecise, simply because the stage does not exist biologically (Johnson, 2001a). The defining of ‘Beginnings and Endings’ depends on biologists agreeing, and they do not. This dilemma is captured in the two different legal definitions above, where both the ‘beginnings’ and the ‘endings’ of the regulated ‘embryo’ differ significantly. The problem posed by the continuity of development is illustrated clearly in an important operational problem identified in the Lockhart Report (Lockhart, 2005) (p. xv):
...the Committee has recommended that the prohibition on the creation of an embryo by the fertilisation of a human egg by human sperm for any purpose apart from ART treatment of a woman should continue. However, the Committee was concerned to hear that this provision, combined with the current definition of a human embryo as starting from the appearance of two pronuclei—a very early stage in fertilisation before the male and female genetic material combine—has had the apparently unintended consequence of impeding valuable research and clinical practice in ART clinics. In particular, the legislation has stopped research on culture and maturation of immature eggs (called ‘in vitro maturation of oocytes’, or IVM), storage of frozen eggs, various aspects of IVF, and gamete (egg and sperm) development.
This problem of human embryo definition exists because the question asked of biology is not the one that biology can answer. A useful analogy is with human evolution. A biologist does not ask the question ‘on what day did humankind appear on earth?’, because it is a question that would only be asked, and could only be answered, by a creationist. The fact that lawyers ask biologists inappropriate questions is no reason to give unbiological answers.
Third, even if biologists could reach some sort of provisional contemporary agreement on what an embryo is, when it comes into existence and when it ceases to exist, how long would agreement last? Science is not exact but is provisional and so what may or may not be called an embryo can change with further discovery, for example, when ‘entities’ are generated which are plausibly ‘embryos’ but which do not snugly fit an agreed definition. A few examples are given to illustrate this point.
- Should a parthenote be called an embryo at any point? Clearly, in mice (but not in humans; Johnson et al., 1990; Hsu et al., 1994; Zhang et al., 1999; Lin et al., 2003; Rogers et al., 2004), it is possible for parthenogenetically activated oocytes to pass through an embryogenic phase and produce an ‘embryo(-proper)’ and even a fetus, but this fetus cannot produce a neonate. Thus, the form and organization is embryonic, but the potential is not there. But could it become so with the development of centriolar transplantation?
- Are ES cells the equivalent of an embryo when clearly they can do everything an ‘embryo(-proper)’ can? However, they can only do so if carried in placental tissues. Thus, the potential is there, but the organization to support its expression is not. But could it become so with the development of a capacity to induce trophoblast by activating Cdx2 expression in some ES cells (Deb et al., 2006)?
- And what about ‘embryos’ made from oocytes and/or sperm that have themselves been derived from ES cells? Do they qualify as embryos if they have not been through a true gametogenic phase? We do not yet know for sure, but one can envisage that in organization and potential they may be adequate to the task, but in history they differ from a conventional embryo. Moreover, the use of gamete intra-Fallopian transfer (GIFT) could bypass embryo formation in vitro altogether, but would this fit with the spirit of the law in protecting children and patients?
- Finally, what about human genomes transferred to enucleated animal oocytes, or animal mitochondria or even just cytoplasm transferred into human oocytes? Are they human? If they are, for how long—until animal components can no longer be detected?
These four examples serve to illustrate how discoveries and new technologies challenge concepts and understandings (Johnson, 2001b). They illustrate both the provisionality of science and the fact that it deals with probabilities not absolutes. An excellent description of the problems outlined in this section has recently been published (NHMRC, 2006).
These considerations generate problems for biologists and clinicians when trying to communicate clearly with non-scientists about biology and the moral and social issues arising therefrom (Hauskeller, 2005). They therefore pose problems for legislators, who may wish to encapsulate clearly what can and cannot be done to what entity. The interaction between biology and law is complex and interesting. On the one hand, legislators and many clinicians want clear and reliable definitions so ‘they know where they stand’. On the other hand, some clinicians, biologists and indeed lawyers may wish to know these limits so they can push them. The above analysis suggests that attempts to capture in law a definition of embryo based strictly on biological definition will be unlikely of itself to be of enduring value or adequate to the regulatory task. Indeed, given the multiplicity of understandings, both biological and legal, of the word ‘embryo’, hereafter I use in it only in parenthesis. The Lockhart Committee Report (Lockhart, 2005) states:
The Committee also learnt that different people and groups hold differing views about the meaning and use of the term ‘embryo’, both in medical science and as a more general term. The Committee considers that it is essential that the terminology used in the legislation is biologically accurate, clearly understandable by all stakeholders, and unambiguous to regulators, scientists and the public.
This last sentence is probably more optimistic than realistic, and brief reports of two exemplary UK legal cases will be used to illustrate the difficulty that ‘embryo’ definition is likely to bring.
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The problem of defining the embryo: law |
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Biopsy of cells and the issue of developmental potential
In 2002, an application for judicial review of the HFEA brought by Comment on Reproductive Ethics (CORE) was heard in the High Court [R (Quintavalle) v. Human Fertilisation and Embryology Authority, 2002
]. The application challenged the HFEA’s authority to allow tissue typing on an embryo biopsy. Part of the argument advanced in the HFEA’s defence was that the tissue typing was not performed on an embryo but on a biopsy. The implication here is that once removed from the ‘embryo’, the biopsy does not itself have the capacity to generate a child. The biology here is not straightforward. It hinges on the evidence as to the developmental potential of cells removed from an ‘embryo’. There are animal data consistent with a single 4-cell blastomere (1/4) or two 8-cell blastomeres (2/8) being able to produce a pregnancy and an offspring, but not for a single 8-cell blastomere (1/8; Kelly, 1977; Willadsen, 1981; Willadsen and Polge, 1981; Johnson et al., 1995; Chan et al., 2002). One or two 8-cell blastomeres may be removed at biopsy, but, if two are removed, each is tested genetically independently. So, it might be arguable that, where two cells are removed and treated individually, the biopsy was indeed not an embryo. However, the scientific studies are few, the conclusion provisional and statistical—how many studies of 1/8 cell do you have to do till you have proof of no potential? What would the interpretation be if in 1/100 cases a 1/8 cell did produce a baby mouse? What if it became possible to allow a biopsied 1/8 cell to proliferate to produce a group of eight or more cells without differentiating (Johnson, 2000a), then clearly the biopsy could be classifiable as an embryo? What if a 1/4 cell was mistakenly or deliberately biopsied instead of a 1/8 cell? Justice Maurice Kay did not get drawn into this detailed biology but did dismiss the HFEA’s argument in favour of the plaintiff’s on grounds that include the statements:
‘tissue typing involves the testing of an embryonic cell’, and ‘...section 3 is headed "Prohibitions in connection with embryos". The words "in connection with" militate against a narrow construction’.
Both these aspects of the judgement seem to leave open to future legal challenge the idea that the ‘biopsy is an embryo’. However, when the case went to appeal [R (Quintavalle) v. Human Fertilisation and Embryology Authority, 2003, 2005], only Lord Justice Mance addressed this issue (again without considering the detailed biology) and appeared to dismiss this interpretation of biopsy:
An embryo is distinct from embryonic cell material, which is extracted from an embryo leaving the embryo free to continue to develop.
However, one can envisage potential further challenges as the scientific understanding of developmental potency, and our ability to manipulate it, increases.
Diploid somatic nuclear transfer to the oocyte does not involve a sperm or a process of fertilization
With Dolly the sheep came the possibility of human somatic nuclear transfer. In the UK, this was forbidden under the HFE Act (1990) [S(3d) A licence cannot authorise ... (d) replacing a nucleus of a cell of an embryo with a nucleus taken from a cell of any person, embryo or subsequent development of an embryo]. However, the wording of that Act, although clear in its intention, did not literally ban the application of the Dolly technique itself, because that technique involved nuclear replacement in an oocyte, not in an ‘embryo’. Moreover, since the legal definition of an ‘embryo’ incorporated the process of fertilization, was there an ‘embryo’ there at all legally?
Principal terms used"1(1) In this Act, except where otherwise stated—(a) embryo means a live human embryo where fertilisation is complete, and (b) references to an embryo include an egg in the process of fertilisation, and, for this purpose, fertilisation is not complete until the appearance of a two cell zygote.
"(2) This Act, so far as it governs bringing about the creation of an embryo, applies only to bringing about the creation of an embryo outside the human body; and in this Act—(a) references to embryos the creation of which was brought about in vitro (in their application to those where fertilisation is complete) are to those where fertilisation began outside the human body whether or not it was completed there, and (b) references to embryos taken from a woman do not include embryos whose creation was brought about in vitro.
The HFEA determined, nonetheless, on purposive grounds, that this technique did come under its regulation and so prohibited its use for ‘reproductive’ purposes [producing a new human being, using s.1(1) of the HFE Act]. However, the HFEA did agree to consider allowing the technique for research purposes (‘therapeutic’ nuclear transfer), this decision being based on a literal reading of the Act (s.3(3)(d)), something a purposive reading did not allow. This was called by some ‘having your cake and eating it’ and was challenged in the courts [R (Quintavalle) v. Secretary of State for Health, 2002, 2003). The courts upheld the HFEA’s decisions. Interestingly, within the judgement, it was made clear that Parliament intended the protective regulatory system in connection with human embryos to be comprehensive, and that the words ‘where fertilization is complete’ were not intended to form an integral part of the definition of an embryo. Lord Bingham’s judgement illustrates how a less precise description has advantages over a detailed definition:
8. The basic task of the court is to ascertain and give effect to the true meaning of what Parliament has said in the enactment to be construed. But that is not to say that attention should be confined and a literal interpretation given to the particular provisions which give rise to difficulty. Such an approach not only encourages immense prolixity in drafting, since the draftsman will feel obliged to provide expressly for every contingency which may possibly arise. It may also (under the banner of loyalty to the will of Parliament) lead to the frustration of that will, because undue concentration on the minutiae of the enactment may lead the court to neglect the purpose which Parliament intended to achieve when it enacted the statute. Every statute other than a pure consolidating statute is, after all, enacted to make some change, or address some problem, or remove some blemish, or effect some improvement in the national life. The court’s task, within the permissible bounds of interpretation, is to give effect to Parliament’s purpose.9. There is, I think, no inconsistency between the rule that statutory language retains the meaning it had when Parliament used it and the rule that a statute is always speaking. If Parliament, however long ago, passed an Act applicable to dogs, it could not properly be interpreted to apply to cats; but it could properly be held to apply to animals, which were not regarded as dogs when the Act was passed, but are so regarded now.
This judgement is strongly purposive and objective driven. It is of interest to note comparatively in the context of this judgement that the ‘embryo’ is subjected to 15 primary or qualificatory definitions in Section 8 of the Australian Prohibition of Human Cloning Act (2002).
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Does the ‘embryo’ need to be defined in law? |
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The above scientific analysis and judicial experience indicate the difficulty of navigating a legislative route that includes a definition of ‘embryo’ in law, given that disputed territory. One option is to live with whatever definition(s) we have and rely on purposive judicial interpretations such as that described above. This route is certainly attractive, although there are at least two problems with it. First, the interpretative freedom available to the courts is rightly heavily circumscribed. Indeed, in the House of Lords case quoted above, the judicial interpretation had differed in lower court judgements, and even Lord Bingham expressed clearly the limitations of Court authority. Second, for this approach to work, the legislation must have clearly identifiable purpose(s) that must be assumed to remain unchanged by events. Ethical, philosophical and political understanding, like scientific understanding, can change with time, leaving old purposes out of step with current intentions. Perhaps for these reasons, the Australian Lockhart Committee chose not to ‘leave it to purposive interpretation’ and considered an agreed definition of the embryo to be ‘essential’. In contrast, the House of Commons Science and Technology Committee Report (Inquiry into Human Reproductive Technologies and the Law, 2004–2005
, Recommendation 5) says: We are concerned that any legal definitions of the embryo based on the way it was created or its capabilities would either be open to legal challenge or fail to withstand technological advance. The attempt to define an embryo in the HFE Act has proved counter-productive, and we recommend that any future legislation should resist the temptation to redefine it.
The UK Department of Health is consulting on this matter.
This latter approach to legislation is explored further here, together with some of the consequences that might flow from it. The approach formulates a different (more biological) way of embedding early human development in law. In the exploration that follows, a regulatory system that requires licensing of practitioners will be assumed to be operating, much as occurs in the UK through the HFEA (see Johnson, 2000b, for a short description of how this system operates in practice) and in a more constrained way in Australia (Petersen et al., 2005; Szoke et al., 2006).
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An alternative legal approach |
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The starting point is that all regulatory processes have a purpose: i.e. they are implicitly or explicitly objective driven. Second, all meaningful objective-driven processes must have a definable outcome. We start by treating the ‘embryo’ in vitro not purely as an entity in itself, but as a component part of a process that has clear objectives and definable outcomes. After all, that is why the ‘embryo’ is in vitro in the first place. On objective-driven criteria, the two most directly relevant are the birth of healthy children and the protection of the ‘embryo’ in vitro. In principle then, one can also distinguish two classes of ‘embryo’ by the intention lying behind their creation: the ‘embryo’ intended (sooner or later—after storage) for the production of a child and the ‘embryo’ intended for disposal (by death, destruction or research).
This distinction was to some extent captured in the UK when introducing the concepts of ‘reproductive’ and ‘therapeutic’ cloning (discussed earlier). What is being proposed here is a generalizing extension of this concept to reproductive and therapeutic ‘processes in general’ and to reproductive and therapeutic ‘embryos’ in particular. However, even within the phrasing of this approach, the problem of the ‘embryo’ appears to remain, albeit now adjectively qualified and in parenthesis. Whether this is problematic, and if so, how to deal with it, will be discussed after the general approach has been explored further. First, the more straightforward case is considered, in which the sole objective of the process is to produce children—an exclusively reproductive process involving therefore ‘reproductive embryos’. Any clinical intervention is intentionally directed towards this end alone, and the ‘therapeutic embryo’ is not an issue. Could one devise a regulatory regime that operated by specifying the limits that apply to the production of children by certain types of medical intervention?
A possible draft form of words might be: ‘Any medical intervention to assist a woman to establish a pregnancy and have a child shall be prohibited unless licensed. Licenses are issued subject to the following general conditions: ...’. The conditions could then specify prohibitions or requirements by outcome. For example, prohibited outcomes might specify that treatments should not be given such that children born are intentionally genetically identical to others, are intentionally composed in whole or in part of non-human biological elements, result from the intentional manipulation of genetic composition (cytoplasmic or nuclear) or result from intentional negative or positive selection for any genetic characteristic. All or some of these prohibitions could be tempered by the further varying condition ‘unless specified licensing conditions are satisfied’. Such licensing variations might, for example, state that selection for sex of offspring was permissible for the avoidance of defined sex-linked medical conditions only.
Elements of this approach already are appearing in legislation. For example, in the Infertility Treatment Act (Victoria) 1995(1) If a person is carrying out artificial insemination or a treatment procedure, that person must not—
(a) use a gamete or embryo; or
(b) perform the procedure in a particular manner —
with the purpose or a purpose of producing or attempting to produce a child of a particular sex....
(2) Sub-section (1) does not apply if it is necessary for the child to be of a particular sex so as to avoid the risk of transmission of a genetic abnormality or a disease to the child.
Likewise, required outcomes might specify that a maximum of one child should be intended to be born from one pregnancy, that their welfare as children must have been considered in specified ways and that their genetic parenthood must match the social and legal parenthood, again with provision for licensed variation to outcomes to allow for donation. Licensing conditions here might provide for donor sperm use, the use of surrogate mothers etc.
In this system, by specifying the outcome of a medical intervention, and the requirement for intent to reach such an outcome, defining the ‘embryo’ becomes less critical. Rather than trying to prevent an undesirable outcome by attacking the detailed manipulation of the ‘embryo’ itself, one focuses on the intended outcome. Moreover, the provision for licensed exceptions or variation allows for the regulation to meet objectives relating to parental welfare [legislative objective (iii)] and the public interest [legislative objective (iv)]. It also provides a system that can be responsive to changing social attitudes and new technologies. But does such an approach raise more problems than it solves?
Intent
One issue raised is that of intent to do something. The question arises: whose intent? Clearly, there must be joint intent of doctors and parents (consent issues), but the ultimate responsibility lies with the health team that provides the medical intervention to ensure valid consent and to stick to a treatment framework within the law. The notion of intent is firmly embedded in law in relation to health, reproductive and sexual issues and is well understood, e.g. intent to procure a pregnancy termination [Crimes Act (Victoria) 1958 Section 65, Abortion. ‘... and whosoever with intent to procure the miscarriage of any woman whether she is or is not with child unlawfully administers to her or causes to be taken by her any poison or other noxious thing, or unlawfully uses any instrument or other means with the like intent, shall be guilty of an indictable offence....’]. The intention to establish a pregnancy seems likely to be an easier case to prove. Indeed, intent already features in Australian Commonwealth law on ‘embryos’ (see Sections 9–17 and 19–23, Prohibition of Human Cloning Act, 2002). Thus, this issue does not seem to be an impediment.
Medical intervention
A larger issue is how to define a medical intervention. This clearly has implications for legislative objective (v) of regulatory regimes: protecting the health team. However, is this problem so difficult? There is a precedent already within the HFE Act, in which ‘treatment services’ is defined as ‘medical, surgical or obstetric services provided to the public or a section of the public for the purpose of assisting women to carry children’. Medical interventions could be further qualified by universal exclusions from prohibition, e.g. the removal of contraceptive devices, psychotherapeutic counselling and other advisory (non-physical) medical interventions and diagnostic testing for infertility—the list ascertainable by consultation with professional bodies.
Expansion of regulatory reach
A more severe objection, especially from IVF clinics, might be that regulatory reach is expanded to bring more stages of development under control than just ‘embryos’. However, could this actually be helpful rather than problematic? Thus, although the whole impetus for regulation derived initially from the ability to generate ‘embryos’ in vitro, contentious reproductive issues increasingly do not involve ‘embryos’, but, for example, gametes. Thus, in their recent consultation on the operation of the HFE Act, the Department of Health in the UK consulted on whether screening and selection of gametes should be brought under regulatory control (Question 36) and on whether and how to regulate the use of artificial and fresh gametes (Questions 7 and 8; Consultation on the Human Fertilisation and Embryology Act 2005). An objective based on outcomes need not be restricted to IVF and closely related procedures, such as ICSI, that involve ‘embryos’ in vitro. Thus, if genetic selection and/or manipulation are not considered to be an acceptable outcome (other than for specified licensed conditions) and so are subject to regulation, why should it matter whether that selection/manipulation is done on ‘embryos’, on ES cells or on gametes? Yet currently, the HFEA—although it does have the power to prohibit the genetic modification or selection of oocytes or sperm for use in ‘embryo’ creation in vitro—does not have the power to prohibit the use of such gametes for use in GIFT (unregulated in the UK) or partner insemination (unregulated in the UK). In a press release on its submission to the Department of Health review, the HFEA suggests that the regulation of gametes should be brought within the law (http://www.hfea.gov.uk/PressOffice/Archive/1132833178). Likewise, the single biggest welfare problem for children and mothers arising from ART programmes is multiparity. The health professions have been dilatory in tackling this question under the current ‘embryo’-centred regulation (El-Toukhy et al., 2006). Outcome-based regulation might focus clinical minds and also bring GIFT and, if it were thought useful, induced ovulation (with or without artificial insemination) under regulatory scrutiny. In essence, because the original legislation was focused so heavily on protecting the ‘embryo’, the important issues for children became secondary almost by accident. By moving to an objective-based outcome-assessed approach to treatment that clearly prioritizes the child’s interests, outcomes not inputs would determine how reproductive practice is regulated. Moreover, the ability to license exceptional activities provides for flexibility should the clinical case be made. Overall, defining medical interventions and gaining agreement on their definitions should be easier and indeed more useful than trying to define ‘embryos’.
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‘Embryos’ remain? |
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But has the problem of defining ‘embryos’ really been resolved? First, as was pointed out above, a qualified and parenthesized ‘embryo’ still features in the discourse. Second, without a legally defined ‘reproductive embryo’, it might reasonably be asked: how could one specify any process-related conditions relating to the storage or treatment of ‘reproductive embryos’, such as a maximum period of cryo-preserved storage, conditions under which culture must be conducted, whether or not ‘reproductive embryos’ that were visibly defective could be allowed to perish, and indeed how to dispose of any ‘reproductive embryos’ not wanted for treatment and the consent issues involved therein? An answer to this question would be that by focusing on legislative objectives and outcomes, the legal interest has itself expanded beyond the ‘embryo’ itself, however that might be defined, into a conceptual embrace of all developmental ‘stages’ that contribute to the establishment of a pregnancy and the production of a child. Thus, immature and mature gametes, the zygote, the pre-embryo, ES cells and indeed the embryo-proper are all brought within the interest of the law when being used for specific reproductive purposes under licensed treatment conditions. Because each of these players (through their artificially bounded ‘stage names’) forms part of a continuous developmental process, encompassing them all in a single legal concept simply aligns the law with biology. The issues of storage, handling, disposal and consent are just as pertinent for each of these players in the reproductive treatment context. Indeed, in the UK, it seems likely that the incorporation of the provisions under the Human Tissue Act (2004)
with those of the HFE Act will provide an opportunity to do this anyway. The question is how best to capture this legal concept in words.
The HFEA, in the sixth edition of its Code of Practice (Section 9.11(i); 2003), uses the term ‘human genetic material’ as a generic term for the physical totality of what passes between generations (‘oocytes, spermatozoa, embryos’) and so provides a precedent for such a concept, if not a felicitously named one. Human generative material or tissue might be better descriptively, if not much better aesthetically. For the purposes of this discussion, the exact wording is not important, because it could be legally described (i.e. purposive) rather than defined (i.e. literal) along the lines ‘including any human biological material or tissue that contributed directly, in whole or in part, to the establishment of a pregnancy and formation of a new child, and is taken to include gametes, the zygote, the pre-embryo, the embryo and ES cells’. Its qualification might also possibly incorporate interpretive powers for the licensing body within the overall objectives of the regulatory purpose. This issue is returned to when ‘therapeutic embryos’ are discussed. For the moment, with a conservative nod to the HFEA Code of Practice, the term ‘human generative tissue’ (HGT) will be used to capture the concept. In case it should be felt that this term is too nebulous to achieve its purpose, the quotation from Lord Bingham’s judgement in R (Quintavalle) v. Secretary of State for Health (2003) provided earlier illustrated how a less precise description has advantages over a detailed definition. This judgement is strongly purposive and objective driven.
A couple of brief examples are given to illustrate how the use of this terminology might operate. In respect of consent to use, one could then specify that the use of HGT required consent from all parties contributing to it genetically. In respect of cryo-storage, one could specify that storage should be limited to periods considered safe for the tissue in question and should not exceed limits as specified in the Code of Practice, which itself might use landmark descriptive terms to subcategorize.
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Where does this approach leave ‘the non-reproductive embryo’? |
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The concept of the reproductive HGT embeds legally the former ‘embryo’ in its place developmentally. In doing so, it emphasizes its potentiality as one elemental player in the cumulative development of a person. This approach addresses more directly the interests of the intended child. In doing so, it also provides via the conditional licensing system a mechanism for the interests of parents, public and health care team, as well as the potential interest of the reproductive HGT itself, to be addressed. However, given the contested nature of the status of ‘the embryo’ historically and the consequentially privileged position assigned to it in much of the existing regulation, it is essential to examine the effect that this rebalancing of interests has on the protection of ‘the non-reproductive embryo’.
Earlier, two classes of ‘embryo’ were defined by intention: the ‘embryo intended for production of a child’ (whether immediate, after storage or by donation) and the ‘embryo intended for disposal’ (by death, destruction or research). Most of the latter are derived from the former (‘spare embryos’), but not all, because in some jurisdictions ‘embryos’ can be created for research purposes or as part of a research project (e.g. in studies on the fertilization process). Thus, we have three classes of traditional ‘embryo’ to consider in the proposed system.
To those for whom currently ‘the status of the embryo’ is paramount over all other considerations, a legal restriction to the use of reproductive HGTs for reproductive purposes will be the goal. The proposals made here do not prevent that approach being enshrined in law, and so cannot therefore be considered fundamentally ‘anti-embryo’. However, most jurisdictions that restrict the use of reproductive HGTs to reproductive purposes do not specify that all HGTs must ultimately and inevitably be reproductive HGTs. The HGTs are used with intent to establish a pregnancy, but there are going to be HGTs surplus to this reproductive use. These must then be stored in perpetuity or disposed of. For the purposes of regulation, in jurisdictions where research is banned, reproductive HGTs could simply be allowed to perish. Conditions could apply to the circumstances under which they were allowed to perish—e.g. observational non-invasive study of them might be allowed, the use of fixed perished HGTs allowed or time/stage limits imposed after which destruction must occur. Such regulation need not require the redesignation of reproductive HGTs (see e.g. Section 10(2) of the Research Involving Human Embryos Act, 2002; Australia). In principle, given that HGT is an inclusive term, regulations or Codes of Practice could, by refinement, be varied, for example, specifying more or less strict conditions before or after particular descriptive developmental landmarks. Thus, responsive to the graded view of tissue status explicit in Italian and German legislation and implicit in most legislative approaches to human development, the disposal requirements for spermatozoa and/or oocytes before they are mixed might be different from after they are mixed. These refinements could be tailored to the local translation of biology through theology or ethics into law but do not require an ‘embryo’ to be defined as such, relying on descriptive landmarks rather than on conceptualized definitions.
However, if research on HGTs were to be agreed, redesignation to ‘therapeutic or research HGTs’ could occur. [It seems unlikely that the reverse would apply, e.g. research or therapeutic HGT becoming reproductive HGT, but this possibility could be considered.] Most therapeutic HGTs would then arise secondarily from reproductive HGTs. In some cases (few in practice), HGTs will form part of a research project, which could be licensed as such, for example, when studying the process of fertilization, parthenogenetic activation, nuclear transfer, ES cell derived HGTs etc. It will be noted immediately that by using an encompassing definition of HGT, the more controversial processes (parthenogenetic activation, nuclear transfer, ‘artificial’ gametes and developmental potency studies) are no longer problematic, in contrast to the possible ambiguities of inclusion that come with attempts to define ‘embryos’. Moreover, these examples are problematic precisely because they would lead to unacceptable pregnancy and birth outcomes, but, as therapeutic HGTs, they are barred from being reproductive under the above proposal. The separation of reproductive and research strands is clear and unambiguous, and so the use of therapeutic HGTs in research is no longer problematic for a jurisdiction in which research is allowed. Again there may a complaint that this approach extends regulatory reach by bringing all research involving human spermatozoa and oocytes potentially within the regulatory framework. However, the use of descriptive landmarks in Statutes or Codes of Practice could deal with this problem by blanket exclusions of gametes prior to mixing or activation from legislative purview for research purposes.
Does this approach adequately ‘respect the special status of the embryo’ (Warnock, 1984)? Again, the question to ask is: what are the agreed objectives of the research HGT and how can they best be met? In the UK, the legitimate purposes for which human ‘embryo’ research may be undertaken under license were agreed in Parliament and are set out in the HFE Act.
Human Fertilisation Act 1990, Schedule 2 Section 3(2&3) (amended 2001)(2) A licence under this paragraph cannot authorise any activity unless it appears to the Authority to be necessary or desirable for the purpose of—
(a) promoting advances in the treatment of infertility,
(b) increasing knowledge about the causes of congenital disease,
(c) increasing knowledge about the causes of miscarriages,
(d) developing more effective techniques of contraception,
(e) developing methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation,
(f) increasing knowledge about the development of embryos,
(g) increasing knowledge about serious disease, or
(h) enabling such knowledge to be applied in developing treatments for serious disease,
or for such other purposes as may be specified in regulations.
(3) Purposes may only be so specified with a view to the authorisation of projects of research which increase knowledge about the creation and development of embryos, or about disease, or enable such knowledge to be applied.
Such purposes could again be qualified by use in licensing or in primary legislation of particular descriptive developmental landmarks to constrain research HGTs within boundaries considered to be ‘respectful’ in that jurisdiction. Thus, the ethical view of the embryo in any society adopting such a legislative approach can be as adequately incorporated in law as it is at present.
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Conclusions |
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The proposals suggested above offer a different perspective on regulation of human ‘embryos’ than has been traditional in western Judaeo-Christian societies. Traditionally, the ‘embryo’ dominated the discourse and distorted the legal regulation relative to other interested parties. This legacy lingers on, but is gradually being eroded, witness the changed priorities in the 1995 Act from the State of Victoria compared with its 1984 predecessor (discussed earlier). The proposals here suggest a more decisive break by re-evaluating what we are trying to achieve through regulation. It builds on legal judgements that have supported a purposive approach to legislation. It uses strands in regulation that exist or have emerged already through medical and legal practice and/or consultation, such as ‘reproductive’ versus ‘therapeutic’, ‘purposive’ versus ‘literal’, ‘human genetic material’ versus ‘embryo’, ‘provision of treatment services’, balancing the ‘interests’ of various parties and using an approach of ‘regulation by licensing and conditions and codes of practice’. The notion of distinguishing reproductive and therapeutic ‘embryos’/HGTs is embedded deeply in Australia’s Lockhart Report, and in the UK House of Commons Select Committee Report, which itself goes some way towards the proposals contained in this article saying in Recommendation 5: ‘.... The attempt to define an embryo in the HFE Act has proved counter-productive, and we recommend that any future legislation should resist the temptation to redefine it. We consider that a better approach would be to define the forms of embryo that can be implanted and under what circumstances. Using this approach, only those forms of embryo specified by the legislation, such as those created by fertilisation, could be implanted in the womb and thereby used for reproductive purposes. Other forms of embryo would be regulated insofar as they are created and used for research purposes’. It remains to be seen whether this approach will be acceptable to the Parliaments. In both these jurisdictions, the prime motive for these distinctions has been largely practical, couched in terms of health or commercial benefits. Here, I have tried to articulate biological and ethical arguments to not only support this distinction but bring greater coherence to legislation.
I am not a lawyer, and it has not been my intention in this article to create definitive ‘forms of words’ that encapsulate legally the ideas proposed, nor to propose a definitive framework, but to expose the general ideas for wider consideration, and for development. At a time when Government, in both the UK and Australia, is reviewing legislation, it may be time to at least consider a frame-shift in the way we view the ‘embryo’ legislatively, rather then to tinker at the embryonic margins. Moreover, the flexibility of the proposed approach might also be useful in legal jurisdictions that encompass more than one country (EU) or state (Australia), where an overarching regulatory system could nonetheless accommodate local public interest differences through local licensing variations.
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Acknowledgements |
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I thank Kerry Petersen, Peter Braude, Juliet Tizzard, Lynne Selwood and Veronica English for their constructive comments and advice on drafts of this manuscript, and Dennis Warren for his help in locating legal materials. I thank the Institute for Advanced Study (IAS) at La Trobe University, Victoria, Australia, for the award of a Distinguished Visiting Fellowship that made this work possible and the NHMRC of Australia for providing a public forum for discussion of some of these ideas. Finally, my thanks to Julia Anderson at the IAS for so efficiently and warmly facilitating my visit and research in Melbourne.
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