House of Commons - Science and Technology

Select Committee on Science and Technology Fifth Report

4 Problems with the HFE Act

Definition of embryo and gamete

51. The 1990 HFE Act defines an embryo in Section 1(1) as "a live human embryo where fertilisation is complete". This includes "an egg in the process of fertilisation". Section 1(4) says that the Act's use of the term gamete covers live human eggs or sperm but not eggs in the process of fertilisation. This definition, based on the process of fertilisation, had caused no problems until researchers at the Roslin Institute in Scotland demonstrated that a technique called cell nuclear replacement (CNR), involving the replacement of an egg nucleus with that of an adult cell, could lead to a live birth. The first example of this was the birth of Dolly the sheep. While the HFE Act had foreseen cloning, it had assumed that this would require the replacement of an embryonic nucleus rather than an egg, and had outlawed cloning only in specific terms, which did not include the method used to create Dolly. At the time, the Government held the view that, although fertilisation had not taken place, this process was nonetheless covered by the HFE Act. An initially successful challenge by the Pro-Life Alliance in the High Court that the HFE Act only referred to embryos that were created by fertilisation was subsequently overturned by the Court of Appeal whose judgment was approved by the House of Lords:

This purposive approach to the definition of an embryo could be seen as resolving the definition of the embryo. Nonetheless, in its evidence, the HFEA suggests that the definition contained in the HFE Act is unsatisfactory and proposes that "An amended definition of 'embryo' and 'gametes' might clarify that the remit of the Act also extends to embryos that have been created by other means than 'fertilisation' (CNR, parthenogenesis), and to artificially created gametes".[41] Support for an amended definition comes from Sarah Elliston of Glasgow University: "Given the challenges there have been to them already, I think it is arguable that there are so many different ways of creating something which can develop into a human being that the definitions are not correct".[42] The solicitor James Lawford Davies points out that the HFEA's proposed merger with the Human Tissue Authority means that "there will be a range of definitions which will be quite crucial to phrase carefully in legislation relating to human tissue, human material, embryos, gametes, and the processes by which they are created, used and stored".[43] We will return to this proposed merger later.

52. There are three ways in which the perceived problem of the definition of an embryo can be addressed:

a) By redefining an embryo, at least defining those types of embryo that fall under legislation, according to the way in which they were created. This has the advantage of clarity but it fails to embrace any future technique that might be developed. For example, it might become possible to reprogramme an adult cell to behave like an embryo. Vivian Nathanson from the BMA says: "The question, really, is whether it is possible to find a simple definition that would capture not only all current scientific possibilities but the ones that people speculate might happen within the next 10-15 years […] but if one cannot find an acceptable phrase for that then we would still commend putting in the concept of cell nuclear replacement because it is so important".[44] If this approach were to be adopted, the legislation would need to be sufficiently flexible to allow new forms of embryo to be included. An alternative approach would be to distinguish between fertilised embryos and what Professor Kenyon Mason of Edinburgh Law School termed "laboratory artefacts".[45] Dr Veronica van Heyningen, a geneticist who contributed to our online consultation, also made this distinction: "I would not […] think that laboratory experiments where you transplant a nucleus for entirely laboratory purposes into an oocyte [egg […]] is an embryo".[46] By making this distinction, as the Human Reproductive Cloning Act 2001 does, it would be possible to provide that only embryos for which fertilisation had taken place could be implanted. The disadvantage of this would be that some of these "laboratory artefacts" may have benefits, both for infertility treatment and avoiding genetic diseases.

b) By defining an embryo by its capabilities. For example, it could embrace any diploid cell (two sets of chromosomes) with the potential to differentiate. However, Professor Lee M Silver from Princeton University describes a broader definition: "There's a word biologists use to describe a cell, or group of cells, that by itself can develop into a whole animal or person: That word is 'embryo'. Each random bunch of eight to 10 human ES [embryonic stem] cells is nothing more or less than a 'naked' human embryo - that is, an embryo without its pre-placental 'coat'".[47] This comment illustrates the danger that embryonic stem cells might be swept up by such a definition. This problem might be solved by including the provision that the cell(s) must have the potential to develop in the womb in order to be defined as an embryo. However, the cells' potential might be open to debate and subject to technological advances. The Scottish Council on Human Bioethics cites German legislation in which any totipotent cell (capable of developing into a complete organism or differentiating into any of its cells or tissues), which has been extracted from an embryo which may divide and develop into an individual human being once the necessary further conditions are provided, is considered to be an embryo.[48]

c) A final option would be to avoid any definition, as is the case in the 2001 Human Reproductive Cloning Act. Using this approach, the term "embryo" would cover the normal usage of the word. We understand that this approach has been taken by the French in recent legislation.

53. 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. 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.

Prohibitions

54. The HFE Act contains a number of absolute prohibitions relating to embryos.[49] This inquiry has not just considered whether these or any prohibitions remain appropriate but also whether they should be extended to limit the discretion of the regulator. Beyond stating that the creation or keeping of an embryo requires a licence, the Act prohibits:

a) Placing in a woman a live embryo other than a human embryo;

b) Placing in a woman any live gametes other than human gametes;

c) Keeping or using an embryo after the appearance of the primitive streak (14 days);

d) Placing a human embryo in any animal;

e) Keeping or using an embryo under any circumstances in which regulations prohibit its keeping or use; or

f) 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.[50]

Schedule 2 of the Act outlines those activities for which a licence cannot be awarded and are thus effective prohibitions. Paragraph 1(4) states that a treatment licence "cannot authorise altering the genetic structure of any cell while it forms part of an embryo". It is worth reiterating that placing in a woman an embryo formed by cell nuclear replacement was not prohibited under the Act but put it within the regulatory powers of the HFEA. This situation was later clarified by the Human Reproductive Cloning Act 2001, which states "A person who places in a woman a human embryo which has been created otherwise than by fertilisation is guilty of an offence". The significance of this legislation will be discussed below (see paragraphs 68-78).

TIME LIMITS

Process of fertilisation

55. The HFE Act's definition of an embryo includes one in the process of fertilisation, which is complete at the two cell stage. After fertilisation, two pronuclei are formed, one containing the paternal chromosomes from the sperm and the other the maternal chromosomes. The fully formed embryo nucleus does not appear until the two cell stage. When the HFE Bill was first published it limited the definition of an embryo to one that had completed fertilisation at the two cell stage; however, the Government introduced an amendment at the Report stage to expand the definition to include an egg in the process of fertilisation, particularly for the purposes of research.[51] This has recently caused problems following the application for a research licence by the Newcastle Fertility Centre to study cell nuclear replacement on an early embryo as a technique for treating mitochondrial diseases. This is because the HFE Act prohibits "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".[52] The Newcastle team argues that they wish to replace a pronucleus, not a nucleus, and that their project should be permitted under the Act.[53] This issue of definition does not arise in the case if the embryo does not come under the law's protection until it has completed fertilisation at the two-cell stage. We see little value in regulating the use of an egg in the process of fertilisation. A unique genetic entity is only formed at the union of the male and female pronuclei and this seems the most appropriate point at which to bring the creation under the protection of legislation.

The 14 day rule

56. If the embryo is to be afforded some protection in law it is important to establish criteria for such protection where a gradualist approach is adopted. The HFE Act currently affords protection to an embryo until 14 days, at which point it must either be transferred to a woman or destroyed: the so-called "14 day rule" advocated by the Warnock Committee. After this period of time, an embryo created outside the body must either be implanted, stored for future use or destroyed.[54] This rule is based on selecting as significant the developmental stage of the embryo at which it shows clear signs of differentiation into tissues, and in particular the appearance of the "primitive streak", the precursor to the spinal cord. This developmental approach is widely accepted: other countries that have also adopted a 14-day rule include Australia, Belgium, Japan and Singapore.[55] Despite this, the 14 day rule has not met with universal approval. For example, the Scottish Council on Human Bioethics points out that, "the process of human development is a continuous one in which any demarcation would be arbitrary and merely conventional […] it is indeed impossible to indicate a non-arbitrary point of transition from human non-person to human person".[56]

57. On the other hand, Professor Julian Savulescu suggested in evidence that one could make a distinction on the basis of the embryo's capabilities. He argued that we consider death to be at the point at which the brain is no longer capable of conscious thought, and that at this point we allow the withdrawal of life-prolonging medical treatment. It was therefore logical, he argued, to conclude that life in a morally significant sense started at around 18-20 weeks.[57] Professor Robin Gill countered that "We have to take into consideration not just how that person values themselves or what they think or what they feel but what other people feel about them. It makes me extremely uncomfortable if we only value a person for what goes on inside their head".[58] Having adopted a gradualist approach, the cut-off point at which embryos can no longer be cultured in vitro seems to be uncontroversial outside philosophical or religious discourse. This is largely due to the fact that clinicians and scientists seem to lack the desire or ability at present to culture embryos for longer than 14 days. For IVF, the embryo is typically transferred between days 3 and 5 and, while some centres have attempted to implant slightly later than this (at the blastocyst stage) in an attempt to increase the chances of a pregnancy, the benefits are contested.[59] It has not proved possible for researchers to sustain an embryo in culture for 14 days, although research on artificial wombs is underway.

58. However, as this inquiry has sought to look beyond current medical and scientific practice, we should assume that demands and capabilities will change. Dr Richard Fleming, a contributor to our online consultation, told us, "I imagine that in the future you will have to re-examine it [the 14-day rule]. At the moment there is not much of a call to do so but progress will take us there".[60] We would consider it negligent not to consider the long-term appropriateness of the 14 day rule, which John Polkinghorne has described as "appropriately cautious and conservatively calculated".[61] A starting point should be to establish why we need statutory limits on the culture of embryos. Beyond the point of fertilisation, there is no clear cut-off point and it could be argued that providing discretion to the regulator offers a more pragmatic response. It is conceivable, for example, that research could demonstrate that long-term culture of embryos offers the best chance of a live birth. A BBC drama documentary screened in December speculated that there may be value in deriving stem cells from a 19-day-old cloned embryo. In the story, a doctor was being prosecuted for breaching the 14-day-rule of the HFE Act to provide stem cell therapy to a man suffering spinal cord injury as a result of a climbing accident.[62] It is interesting that viewer polls suggested that 80% of the 11,500 votes cast supported a not guilty verdict against the doctor. We have been told that the 14-day rule is an arbitrary cut off point. For many, even those who support assisted reproduction and embryo research, an extension to the 14-day rule would be unacceptable. We accept that there is no case at present for an extension, or indeed reduction. However, we believe that, if scientists or clinicians were able to provide convincing justification for any change, this should be determined by Parliament.

ANIMALS AND HUMAN CELLS

59. Technical developments since 1990 challenge our notions of what constitutes a human embryo and provide new ways of creating viable embryos. In this context, it is worthwhile to discuss the HFE Act's prohibitions relating to the uses of animal and human embryos.

Placing a human embryo in an animal

60. The placing of a human embryo in an animal raises clear issues of animal welfare but the ethical problems relating to the special status of the embryo are less clear. We are aware of no possible treatment applications that should lead us to question the current prohibition. However, if a spare embryo has been made available for research, then it could be argued that respect for the embryo should prompt us to ensure that it is used for the best possible ends. It has been commented that very little is known about the development of the human embryo in vivo. There have been calls for the application of animal research work to human assisted reproduction.[63] While we are aware of no interest from scientists in extending this work by placing human embryos in animals, it is conceivable that such research could yield valuable insights into the causes of infertility and miscarriage. Such a proposition would make many uncomfortable. Nonetheless, we have set ourselves the task of recommending new legislation that can cope with new technical advances and difficult issues must be taken into account.

61. In the House of Lords debate on stem cell research in 2002, Baroness Warnock said:

Once an embryo has been created but is not required for treatment, it must either be destroyed or used for research. It could be argued that its special status demands that it used for potentially valuable research. It could be argued that if incubation of that embryo in an animal were to yield value information about the causes of infertility, then this is an appropriate use for the embryo and consistent with its status. The Warnock report recommended that placing a human embryo in an animal would be a "cause for concern", but gave no reasoning for its conclusion that undertaking such a procedure should be a criminal offence. If the mixing of animal and human cells raised particular ethical issues, a greater area of concern might be the co-culture of human embryonic stem cells with animal "feeder" cells, which is a well-established technique.

62. As Baroness Warnock's quote demonstrates, the ethical problems concerning the use of embryos surplus to treatment are not clear cut, particularly if no embryo could be incubated in the animal for longer than the statutory maximum duration for in vitro culture. In considering the subject comprehensively we should not shy away from addressing difficult subjects which may widely be considered 'taboo'. In this instance, however, we have heard no evidence which would lead us to conclude that there is any merit in relaxing the HFE Act's prohibition on placing human embryos in an animal for research purposes. Should the government receive expert advice to the contrary, given the ethical issues involved, any such change should be a matter for Parliament and primary legislation.

Placing an animal embryo in a human

63. The HFE Act also prohibits the placing of an animal embryo in a human. We are aware of no scientific benefits arising from such a procedure and there is no virtue in relaxing the current prohibition.

Chimeras and hybrids

64. Consideration of animal-human chimeras and hybrids is made difficult by the lack of legal definitions. However, the Canadian Assisted Human Reproduction Act 2004 usefully defines a number of techniques that result in the formation of hybrids or chimeras, and we shall employ them here (see Box 2). Sarah Elliston from Glasgow School of Law suggested to us that, if we are to consider how to deal with such creations in law, we have to decide why it is that it [the chimera or hybrid] deserves respect: "Is it because of what it is made up of? Is it its DNA composition? Is it its potential to develop into a human being? What do we mean by human being?" She suggests that it is necessary to speculate what status we would give to an animal-human hybrid if it were to be born.[65]

Box 2: Definitions of chimeras and hybrids in Canadian law.

A "chimera" is
i.  an embryo into which a cell of any non-human life form has been introduced; or
ii.  an embryo that consists of cells of more than one embryo, foetus or human being.

A hybrid is:
i.  a human ovum that has been fertilized by a sperm of a non-human life form;
ii.  an ovum of a non-human life form that has been fertilized by a human sperm;
iii.  a human ovum into which the nucleus of a cell of a non-human life form has been introduced;
iv.  an ovum of a non-human life form into which the nucleus of a human cell has been introduced; or
v.  a human ovum or an ovum of a non-human life form that otherwise contains haploid sets of chromosomes from both a human being and a non-human life form.

Clause 5 of the Canadian legislation states that creating a chimera or transplanting it into a human or animal is prohibited. Hybrids can be created but not for the purpose of reproduction or transplanting a hybrid into a human or animal.

65. There is some uncertainty about how hybrids and chimeras are dealt with in UK law. The Centre for Bioethics and Public Policy states that "the creation of new genetic human-animal chimeric embryos and foetuses, do not come under the HFE Act".[66] This uncertainty was shared by some of the researchers who gave evidence to this inquiry.[67] However, a chimera, as defined by the Canadian legislation, might constitute genetic modification of an embryo under Schedule 2(1)(4) (for treatment) or Schedule 2(3)(4). Hybrids formed by the fertilisation of human and non-human gametes are clearly covered by Section 4(1), which demands that such a procedure requires a licence. Schedule 2(1)(f) permits this procedure for the purpose of testing the fertility or normality of the sperm, but only if any embryo formed is destroyed no later than the two cell stage. Hybrids created by the introduction of animal nuclei into a human egg might require a licence if the storage of the eggs is involved. The introduction of a human nucleus into an animal egg would come under the HFE Act if the resulting creation is considered to be a human embryo.

66. While a chimera is unlikely to be able to develop very far, it may have value as a research tool, possibly as a means of testing the ability of stem cell cultures to form all forms of tissue.[68] Similarly, hybrids formed by cell nuclear replacement might have value in deriving embryonic stem cells for research purposes. There have been reports that Chinese scientists have harvested stem cells from embryos created by introducing human cell nuclei into enucleated rabbit eggs. Professor Robin Lovell Badge from the Medical Research Council's National Institute for Medical Research told us that this technique might overcome the shortage of human cell lines, although he told us that some of this work was "to be taken with a pinch of salt".[69] The 2000 Donaldson Report on stem cell research stated that the 1990 Act does not control the mixing of animal eggs with other human cells but that this should be prohibited.[70] The Lords Stem Cell Research Committee expressed some surprise at the conclusion since it could raise fewer ethical questions than would the use of a human embryo created using CNR.[71] It should be remembered that the HFE Act aimed to give protection to the human embryo and not gametes or other forms of embryo. Provisions to protect hybrids would require a different ethical justification . The ethical status of hybrids and chimeras is complex. While there is revulsion in some quarters that such creations appear to blur the distinction between animals and humans, it could be argued that they are less human than, and therefore pose fewer ethical problems for research than fully human embryos. We recognise concerns that hybrids and chimeras could be used for reproductive purposes and recommend that new legislation a) defines the nature of these creations, b) makes their creation legal for research purposes if they are destroyed in line with the current 14-day rule for human embryo cultures, and c) prohibits their implantation in a woman.

EMBRYOS NOT FORMED THROUGH FERTILISATION

67. Embryos not formed through fertilisation are covered by two pieces of legislation: the 1990 HFE Act and the Human Reproductive Cloning Act 2001. The latter was introduced when a case was brought by the Pro-Life Alliance, claiming that embryos formed by cell nuclear replacement were outside the HFE Act since they fell outside the definition of an embryo in Section 1(1)a ("a live human embryo where fertilisation is complete"). The initial success of the Pro-Life Alliance's challenge in the High Court prompted the Government to introduce legislation quickly in order to prevent attempts at reproductive cloning in the UK, although it is debatable whether any attempt was imminent. In the meantime the Government was given leave to appeal to the Court of Appeal, which it did, successfully. Lord Bingham of Cornhill said that the court's task, within the permissible bounds of interpretation, was to give effect to Parliament's purpose, and the court ruled against a literal interpretation of the HFE Act. This decision was upheld in the House of Lords. If the Pro-Life Alliance's challenge had been ultimately successful, the HFEA would not have been able to regulate therapeutic cloning.

Cell nuclear transfer and reproductive cloning

68. While the safety concerns surrounding reproductive cloning are well recognised, we have sought to explore the relevant ethical issues, which have received less attention. Much of the online discussion on cloning focused on the rights and wrongs of therapeutic cloning, often based on beliefs about the status of the embryo or concerns about the commoditisation of human tissue or future persons. There are a number of objections to the idea of creating a human being genetically identical to a person who is living or who has once lived and fears that the technology could be used to create large numbers of identical, genetically modified individuals. A 1998 study of public attitudes commissioned by the Wellcome Trust found that most respondents exhibited a "widespread and often spontaneous reaction" to human cloning with its use "linked to its adoption by malevolent outside influences such as the military, megalomaniac leaders and rogue scientists". Even when the science behind cloning and the influence of environmental factors were explained, respondents continued to reject the idea.[72] In evidence, Dr Tom Shakespeare felt that "being foreshadowed by somebody whose genotype to all intents and purposes is identical to yourself is problematic. […] If you have the same genetic characteristics as one of your parents, then you will see them developing in ways which, to a large extent, you will echo," although this already true to some extent.[73] On the other hand, Dr Sarah Parry from Edinburgh University reported that, while people have concerns about the impact of a clone on family life and what this means in terms of how it feels to be an individual, when people talked about reproductive cloning, "the conclusion, after going through the range of pros and cons around reproductive cloning, tended to be […] that maybe it would not be such a bad thing" and "that people did not necessarily think [cloning] would always been seen as such a taboo".[74]

69. This leaves us with the dilemma as to how far we should extend notions of reproductive liberty to cloning. There are coherent reasons why it would not be desirable to advocate cloning for anything other than therapeutic research, but the conclusion from this that it should be completely outlawed is more difficult to sustain. Writing in New Scientist, Professor Ian Wilmut from the Roslin Institute describes a scenario in which reproductive cloning is used to overcome a genetic disease: an embryo with faulty genes is created through IVF. Stem cells are extracted from the embryo and cultured. The faulty genes are then replaced with healthy ones. The nucleus of a stem cell is then transferred to an enucleated egg and the resultant embryo is then implanted in a womb.[75] In this scenario, a clone has been born but not of an individual who has ever existed. It is not clear that such a child would suffer as a result of its manner of conception. A further example might be the cloning of a still-born child. Patrick Mahon, an identical twin who contributed to our online consultation, argued that this would still not be acceptable since it could only be of benefit to the parents who wanted to clone their dead child. He said "If cloning were in any sense available to help the child then I think there is an ethical issue there and one has to decide what the relative costs and benefits are".[76] The House of Lords Stem Cell Research Committee concluded that there were "familial and child welfare considerations arising from the ambiguity of the cloned child's relationships". Reproductive cloning was not a major element of the Lords Committee's inquiry. It is, therefore, odd that it "unreservedly endorses the legislative prohibition on reproductive cloning now contained in the Human Reproductive Cloning Act 2001" when there are obvious scenarios in which the welfare arguments it employs do not apply.[77] We recognise that human reproductive cloning, if possible at all, is not currently safe and that no clinician could legitimately pursue it under existing professional regulation. In addition, we recognise that research in developing reproductive cloning would very likely involve experimentation that is highly unethical. Nonetheless, the patchy legislation around the world suggests that the research will take place somewhere and someone may be able to demonstrate a technique that is safe, effective and reliable.

70. We were interested to hear the views of the HFEA's Deputy Chairman, ethicist Tom Baldwin. He told us that he had no principled objection to reproductive cloning being a licensable treatment but that "it would need to be tightly regulated because you need to control carefully the kinds of conditions for which you could use the technology".[78] Professor Peter Braude told us that "if you were going to make new legislation, it needs to have a mechanism to be flexible enough to respond, but it is not in the current framework of Parliament; they have outlawed cloning. Reproductive cloning is not allowed and there is no flexibility in that".[79] Interestingly, the view of Professors Baldwin and Braude that cloning should be dealt with by regulation seems to be at odds with the medical and scientific establishment. Dr Vivienne Nathanson from the BMA argued that reproductive cloning should be one of the very few broad prohibitions in a revised HFE Act. The Royal Society is equally hostile. It is a signatory to a statement by the InterAcademy Panel on International Affairs, which states that even if reproductive cloning by somatic (non-reproductive) cell nuclear transfer might be accomplished without undue risk, this would not of itself warrant the lifting of a ban, which would still face "strong ethical, social and economic objections". Its sister organisation in Edinburgh takes a more pragmatic view, noting that while "there is little prospect of developing a satisfactory technique for human cloning, since the experimental stage would not be acceptable [[…] there] may be acceptable reasons for human cloning".[80] The scenario described by Professor Wilmut is one such case - this is only one example of where the technology is not being used to clone an individual with legal rights. However, it is disappointing that both the BMA and the Royal Society of London seem unwilling to countenance the idea that applications of cloning such as this could have a future. In doing so, they have become unlikely advocates of a prohibitively restrictive application of the precautionary principle. We question whether their stance owes more to the protection of the public image of doctors and scientists; that they fear that a more pragmatic approach to reproductive cloning would leave them open to criticism. It would be unfortunate if our most respected scientific bodies felt unable to take a lead on ethical issues of the day. Even Professor John Polkinghorne from the University of Cambridge states that "with only a very few rogue exceptions, […] reproductive human cloning […] is ethically unacceptable". Yet beyond citing safety, his only further stated objection is the "moral propriety of creating a child who was the identical twin of one of its parents".[81]

71. The responsible Minister is equally hostile to reproductive cloning, to the extent that she was unwilling even to discuss the issue with us: "I think it raises all sorts of difficult issues and I think there are people here around this table who do understand very well what those views are. I do not want to go down the path of discussing this because it is not up for discussion, it is illegal, and we have no plans to change it".[82] This is curious since it was the Government's earlier intention that it should remain a legal but licensable activity. It was only the initial success of the Pro-Life Alliance in contesting the status of embryos created using cell nuclear replacement that led to the Government's introduction of the Human Reproductive Cloning Bill in 2001 and an outright ban. Evidence to our predecessor Committee in 1998 during its inquiry into The Cloning of Animals from Adult Cells from John Battle, the then Minister for Science, Energy and Industry, states that "cloning involving embryo splitting or nuclear replacement in eggs cannot take place because the HFEA has made clear its decision that it will not license any treatment involving such techniques or any research to develop cloning for such treatment purposes".[83] This is not the same as a ban. Even if human reproductive cloning were shown to be safe, effective and reliable we would still have grave concerns about many of its applications . However, there are clear examples where the situation is not so clear cut and the ethical debate is highly complex. Professor Ian Wilmut has described a scenario in which the aims are therapeutic and no clone is created of an individual who has ever been born. If there is to be a total prohibition of any form of reproductive cloning, it is important that it is supported by principled arguments why such a technique should be banned even if it were shown to be safe, effective and reliable. Without such arguments, an indefinite absolute ban could not be considered rational. The Minister's refusal to enter into any discussion of reproductive cloning is not an encouraging starting point for an open-minded review of the adequacy of existing legislation.

Therapeutic cloning

72. As part of this inquiry, we have received a number of written submissions on the subject of therapeutic cloning and the derivation of embryonic stem cells. Indeed, many of the contributions to our online consultation on the subject of human cloning and written submissions to this inquiry have sought to address this issue rather than that of reproductive cloning.[84] It has never been the intention of this inquiry to weigh up the merits of adult and embryonic stem cells. The issues have been comprehensively addressed by the House of Lords Stem Cell Research Committee in 2001 and we are unaware of any new evidence that would require a reassessment of that Committee's conclusions, which we respect. Our interest in therapeutic cloning relates to the adequacy of the 2001 Regulations, which extended the purposes for which embryo research could be undertaken to include the study and treatment of disease; and to the ability of the HFEA to take an informed view as to whether a research project for which a licence was sought could have been undertaken using adult stem cells. We will consider these elsewhere in this report.[85]

Embryo splitting

73. Embryo splitting is a natural process that gives rise to identical twins. However, there are concerns that this could also be achieved deliberately in vitro, for example by dividing an eight cell embryo. In our online consultation, there were objections that this amounted to cloning and, if the resulting embryos were implanted separately, could violate the bonds enjoyed by identical twins. The HFEA considered embryo splitting in 1994 following reports that an American research team had succeeding in growing a split human in Petri dish for several days in 1993. The HFEA concluded that it would consider research applications but not if the intention was to increase the number of embryos for transfer.[86]

74. Under the HFE Act, therefore, embryo splitting is a licensable activity. However, it could be argued that an embryo formed as a result of splitting had been formed by means other than by fertilisation and therefore that implanting the embryo would breach the Human Reproductive Cloning Act 2001. There are reasons why someone would wish to undertake embryo splitting, other than to create identical twins. The parents might carry the gene for a late onset condition for which preimplantation genetic diagnosis was not permitted. While one of the split embryos would be allowed to develop into a fully formed person, the other could be kept in deep freeze. The frozen embryo could then be used to provide a source of embryonic stem cells to treat the "twin" later in life. A second therapeutic application, which could be undertaken under an HFEA licence, would be to split a cloned embryo to increase the chances of deriving a cloned stem cell culture.

75. While a rhesus monkey was born following embryo splitting in 1999, it was one of only four embryos created by splitting an eight cell embryo, suggesting that the technique is far from being safe and efficacious As with cell nuclear replacement, the risks of implanting a split embryo are high, but a distinction needs to be made between safety of the treatment and the fundamental ethical principles. If embryo splitting for treatment purposes is to be prevented, as with reproductive cloning, this should be based on coherent ethical argument, such as the right not to be purposefully created with a specific genetic identity.

Parthenogenesis

76. Parthenogenesis can be defined as a form of reproduction in which an unfertilised egg develops into a new individual. It is common among invertebrates and plants, and present in some fish, amphibians, and reptiles. It does not, however, occur naturally in mammals although researchers have been able to stimulate artificially unfertilised mammalian eggs by chemical or electronic means into starting embryo development. This is currently the subject of an HFEA licensed research project by the Newcastle Fertility Centre to derive embryonic stem cells. The lay summary of its application says that the technique may have value in deriving stem cell lines for therapeutic use that are genetically similar to the recipient and so will not be rejected.[87] An advantage of this technique is that it could eliminate the need to destroy potentially viable embryos in order to derive stem cells. While research projects can be licensed by the HFEA, parthenogenetic embryos cannot be placed in a woman under the terms of the Human Reproductive Cloning Act 2001.

77. The Centre for Bioethics and Public Policy has complained that "parthenogenesis raises fundamental questions of what it means to be human and of how humans should be treated. Yet there has been no public debate in this country on this procedure, on the safety and medical issues raised, on the ultimate purpose and outcome of this type of research, nor on the ethical considerations".[88] The Church of Scotland Society, Religion and Technology Project takes the view that the "moral status of parthenogenetic creations is not clear. […] If they are not viable because certain crucial factors in their development does not follow the pattern of normal sperm plus egg embryos, are these defective human embryos, or are they not real embryos at all? If they are defective then this suggests that, as with cow-human hybrids, the route may pose at least as many ethical problems as other methods, including nuclear transfer embryos".[89] The status of an embryo is often said to depend on its potential, yet it is highly unlikely that a parthenogenetic embryo has any more chance of being born than has a gamete. We regret that the use of parthenogenesis to derive stem cells was not considered by either the Donaldson report or the House of Lords Stem Research Committee. This gives the impression that inadequate consideration has been given to these ethical issues before research projects were licensed by the HFEA.[90] Nevertheless, we are pleased that this line of research is possible under the current legislation as we take the view that parthenogenesis raises fewer ethical issues than creating an embryo created using CNR, provided that it is not cultured for longer than 14 days.

GENETIC MODIFICATION

78. The HFE Act's restrictions on the genetic modification of embryos are set out in Schedule 2. Paragraph 1(4) states that a treatment licence "cannot authorise altering the genetic structure of any cell while it forms part of an embryo". Paragraph 3(4) states that a research licence "cannot authorise altering the genetic structure of any cell while it forms part of an embryo, except in such circumstances (if any) as may be specified in or determined in pursuance of regulations", thus enabling this prohibition to be relaxed through a statutory instrument. The alteration of the genetic composition of an embryo can be achieved by modifying the gametes or the early embryo. This is termed germline therapy. It would appear that genetic modification of gametes would lie outside the HFE Act if no storage of the gametes was involved before modification. If the desired gene is chromosomal rather than mitichondrial then a version of gene therapy would be used to introduce the gene using a virus. If the intention is to correct defective mitochondrial DNA then cell nuclear replacement can be used to insert the nucleus of the egg that contains the faulty mitochondria into an enucleated donate egg, or it is plausible that healthy mitochondria could be injected into the affected egg. The same technique could also be employed to boost the likelihood of fertilisation for women for whom IVF has failed repeatedly, although Richard Fleming, in contributing to our online consultation, said that early results were disappointing.

79. Defects in the mitochondrial DNA cause more than 50 different inherited metabolic diseases.[91] The Chief Medical Officer considered the treatment as part of his Expert Group review of stem cell research in 2000. He recommended that the technique "would require considerable research before its possible use in treatment could be contemplated. However, subject to the feasibility and safety of the technique being established, the Expert Group concluded that such research appeared to offer the long term prospect of a healthy child for affected families".[92] Because the technique is applied to the egg rather than the embryo, the HFEA is able to license this research under the HFE Act. The use of this technique has attracted the media's attention as, in theory, the resulting child would have three genetic parents, although the genetic proportion of mitochondrial DNA in the human genome is tiny.[93] Most of the 20 genes in the mitochondrial DNA code for proteins are part of the inner mitochondrial membrane and therefore contribute nothing to a person's individuality. Since mitochondrial DNA is passed unchanged down the maternal line (except for rare mutations), the egg donor would no more be the child's genetic mother than the donor's great great grandmother.

80. If the technique was applied to the embryo rather than the egg it is less clear that the HFEA could license a research application; indeed, an application from the Newcastle Fertility Centre to undertake such a study has been rejected on the grounds that it would constitute an alteration of the genetic structure of the embryo.[94] Even if the appeal against this decision is successful, modified embryos could not be implanted in a woman under the Human Reproductive Cloning Act 2001, despite the fact that no cloning had taken place unless the mitochondrial genome had been eliminated from the germline by injected unaffected mitochondria into the embryo. Regardless of whether cell nuclear replacement is undertaken on eggs or embryos for the purposes of research on mitochondrial diseases, the aim of the research is the same. Given that we permit experimentation on embryos to investigate heritable diseases, we see no need to distinguish between the techniques in law.

81. The use of germline therapy on chromosomal DNA is more contentious. In theory the technique could be used to modify any number of human genes; to create designer babies in a very real sense. Equally, it could be used to achieve exactly the same aims as preimplantation genetic diagnosis (PGD). John Polkinghorne asks "If we could eliminate the propagation of Huntington's by genetic engineering, should we not do so? That would be seen as remedying a defect by restoration to the norm".[95] In some ways it could be considered less ethically problematic since PGD involves the rejection of "faulty" embryos. In genetic conditions with more than one defective gene, the chances of identifying an unaffected embryo diminish and in many cases may prove impossible. Gene therapy would seek to correct rather than eliminate and, if consistently successful, would involve less wastage. Dr Simon Fishel from the Park Hospital in Nottingham told us "If the technology could be safe and you could introduce to subsequent generations health from what would be a disease position, that, to my way of thinking, is positive medicine, a one-step PGD process, if you like, to ensure that a particular devastating disorder would no longer continue through the family line".[96] The Centre for Bioethics and Public Policy argues that "Germline engineering is not permitted in this country and most other countries for very good reason - it is risky, has unpredictable results and any errors or unforeseen results would be passed down future generations. The effects could be devastating and irreversible".[97] Professor Peter Braude told us that, "Every child would be an experiment".[98] However, if we wish new legislation to be robust, we need to assume that the technology will one day arrive. Absence of imminence is not a reason for inaction. As the Christian charity CARE points out, "introduction of a new technology often follows a common path - first its development behind closed doors, then the winning over of the public with predictions of life-saving advances, then finally, a regulatory regime to fit the already completed package. Clearly it is much better to have regulatory regimes set up earlier in the process".[99] Effective and safe germline therapy to treat serious genetic diseases would result in reduced child mortality and morbidity and fewer abortions and destroyed embryos.

82. The Gene Therapy Advisory Committee (GTAC) is a non-statutory regulatory body set up in 1993. Its principal term of reference is "To consider and advise on the acceptability of proposals for gene therapy research on human subjects, on ethical grounds, taking account of the scientific merits of the proposals and the potential benefits and risks".[100] However, GTAC considers applications for clinical trials. We conclude that the absolute prohibition on genetic modification of the pre-14 day human embryo be removed for research purposes and recommend that future legislation, while prohibiting the modification of chromosomal DNA for reproductive purposes, should provide for regulations to be made to relax this ban under tightly controlled circumstances if and when the technology is further advanced.

Fresh gametes

GIFT and IUI

83. The HFE Act only brings stored and donated gametes within a regulatory framework. Thus, gamete intrafallopian transfer (GIFT) and intrauterine insemination (IUI) can be undertaken in unlicensed premises if these involve the partner's sperm. The British Fertility Society is keen for these "outlying treatments" to be brought within the Act as they have "the potential for many of the risks and consequences of IVF".[101] This is based on the fact that in both cases the woman is likely to be given ovarian stimulation drugs, bringing with them the small but significant risk of ovarian hyperstimulation syndrome (OHSS). Recent technological developments have arguably increased the claims to bring fresh gametes within regulation. Up to a point this will happen anyway with the transposition of the EU Tissue Directive into UK law in April 2006, but the Directive only demands that certain standards are met and does not require the competent authority (currently the HFEA) to provide guidance on the purposes for which fresh gametes can be used. However, as we have already noted, the law permits people to accept even risky therapy. If the purpose of regulation in assisted reproduction is to protect patients, there is no justification for exempting GIFT and IUI with partner sperm from the legislative framework. However, given our acceptance of the position that the state should intervene only in carefully defined and justified circumstances, where there are specific harms, in reproductive decisions, the common law rules of consent are sufficient to protect patients in the face of these risks. It is consistent with our ethical approach that, rather than adding to the list of regulated fertility treatments, we should be decreasing the level of state intervention. We accept that GIFT and IUI pose similar risks to IVF, but we have already concluded that these risks lie within accepted legal boundaries on what people can consent to. We have not been persuaded, therefore, that regulation should demand anything more than that the highest technical standards are observed.

INTERNET SERVICES

84. The advent of the internet and the worldwide web has raised novel issues in assisted reproduction services. The Man Not Included website was set up in 2002 and claims to provide "a non-discriminatory, confidential and totally anonymous sperm donation service available to any woman wishing to conceive, regardless of sexual orientation or marital status".[102] The service circumvents the HFE Act as the gametes are not stored.[103] Having signed up and paid, a woman will receive, by courier, a flask containing sperm with which she can inseminate herself.[104] The service is aimed at single women and lesbians and would appear to have obvious appeal to these groups (see Table 4). However, the response from Pink Parents UK was not favourable. Lisa Saffron, its Founder and Executive Director, told us that "Because they are outside the HFEA regulation, they are never inspected. They do not have to show their procedures to anyone. […] They are not offering a service for lesbians, they are exploiting us".[105]Table 4: Advantages and disadvantages of forms of sperm donation.

Regulated gamete donation ManNotIncluded Known donor insemination Sex with a stranger

Fresh sperm - + + +

Anonymity[106] - + - +

Convenience - + + +

Safety + +/- + -

Legal protection + - - -

Cost - - + +

Legal Protection for sperm donor + - - -

85. While many single women and lesbians will attach different weights to each of the criteria in Table 4, regulated services do not obviously provide a significant excess of advantages compared to unregulated approaches. Therefore, it appears unlikely that regulating internet services will result in potential customers opting for regulated services as opposed to other unregulated approaches. At the same time, arguments of principle for regulating internet services on the basis that the use of fresh as opposed to frozen sperm does not vitiate the need for regulation would also apply to known donor insemination and sex with a stranger. Regulation of these latter approaches would, however, never be practical. The principal concern to us is that purchasers of this service can be assured of the safety and viability of this service. The HFEA's position is that, since the sperm is not frozen, it has not been stored. This is based on the fact that sperm lose viability rapidly. While the service screens donors every 12 weeks, this does not apply to each donation. We therefore share concerns of Pink Parents that the service is not subject to statutory safety standards. The risks to users and their offspring from an internet sperm donation service need to be established. There is a case for regulating such services to ensure their quality. It is not clear whether they would be covered by the EU Tissue Directive. If not, we conclude that revised legislation should ensure that such commercial services are subject to the highest technical and safety standards. We would also consider it anomalous if gamete donation that is undertaken in a clinical setting required identifying information to be held in a central database but did not if the donor and recipient were "introduced" over the internet. Our concern is to ensure that the safety and quality standards expected of all assisted reproduction technologies are equivalent.

SPERM SORTING

86. A technique for separating sperm on the basis of whether they carry the X or Y chromosome was first developed in the veterinary field by scientists at the United States Department of Agriculture. It works on the basis that the X chromosome is substantially larger than the Y chromosome. The technique was subsequently developed for human use in collaboration with the Genetics and IVF Institute in Fairfax Virginia as a patented technology called MicroSort.[107] Having isolated either X or Y chromosome-carrying sperm, these are then used to inseminate the woman using IUI. MicroSort claims that attempts to achieve a female pregnancy are 91% successful and that attempts to establish a male pregnancy are 76% successful. The EU Tissue Directive would apply to any institution offering this service in the UK. Sex selection can be sought for medical reasons, to avoid a sex-linked genetic condition; and for social reasons, for example "family balancing". The issue of sex selection will be considered further later.

87. For the moment, the HFEA's report on sex selection, while recognising that the risks do not appear to be higher than for other, licensed, assisted techniques, argues that the long term risks are unknown. As of January 2004, fewer than 500 babies had been born using this technique.[108] The report further points out that the technique, while better than previous sperm sorting techniques, is still far from being 100% successful and that there are issues that arise if the "wrong" sex is born.[109] While sperm sorting raises many of the same issues as sex selection using PGD, it differs in one important respect. Since no embryos are discarded by virtue of their sex, sperm sorting might be considered as less ethically problematic if concerns about its safety and efficacy have been successfully addressed We consider the controversial issue of sex selection in more detail below in paragraphs 132-143.

REGULATION OF FRESH GAMETES

88. The inclusion of fresh gametes in legislation goes to the heart of the arguments about the purpose of regulation. If the HFE Act is about the special status of the embryo then there are no grounds for intervention in the use of fresh gametes. If regulation aims to provide a safe environment for the use of reproductive technologies, then the EU Tissue Directive, in specifying standards for the handling of human tissue and cells, may be all that is required. However, if regulation has a legitimate role in reproductive decision-making and if existing professional medical codes of practice are insufficient in ensuring the welfare of children born using these outlying technologies, then it is reasonable to ensure that legislation and regulation are consistent, regardless of whether they involve the in-vitro manipulation of embryos. Currently, the HFE Act demands that data on embryo and gamete donations are kept by the HFEA (see paragraph 147). It would be anomalous for one form of gamete donation, where the gametes have been frozen, to require this data to be maintained when another does not, when both forms have involved a third party. We conclude that while it is appropriate that commercial services involving fresh gametes should be subject to regulation, this should not extend beyond seeking to ensure that there are as few anomalies as possible between different options for donor insemination.

ARTIFICIAL GAMETES

89. Current legislation is further challenged by new techniques in which gametes can be created by a process called haploidisation.[110] The technique could be used to help infertile men or women but it could also allow lesbian couples to have a child (daughter) without a donor. The process could involve stem cells, some of which have the capacity to form gametes, which raises issues regarding their regulation. This scenario was employed during our online consultation. In favour of the use of the technology we heard that "If we do not judge heterosexual couples before we allow them to have children (often without thought or even planning) because it is seen as their 'right' then how can we make a decision that affects almost 10% of our population simply based on the fact they have a different kind of fertility issue which is no fault of their own?" However, there was criticism that lesbian parenting could have adverse effects and that the technique further amounted to the commodification of life. For example: "If artificial reproductive technologies are available merely to satisfy the desires of adults (not all of which I acknowledge are frivolous) then we are on a very slippery slope".

90. These issues are problems are compounded by safety concerns. Research is still at an early stage and any introduction to clinical practice must be rigorously overseen. Subject to their safety, we recognise that artificial gametes have potential to treat infertility and reduce the need for gamete donors. It is important that, in the use of any cell cultures for reproductive purposes, the original donors must be traceable and their informed consent obtained.

Welfare of the child

91. The welfare of the child provision is one of the more contentious elements of the HFE Act and prompted widespread concerns of principle and practicality. The provision allows the HFEA and clinicians to make decisions on the reproductive rights of people seeking infertility treatment. Section 13(5) of the HFE Act requires that:

"A woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for a father), and of any other child who may be affected by the birth."

It has been argued that this discriminates against certain people and undermines their liberty. There are also questions about how to enforce the provision and whether, in doing so, there is any effective protection of the welfare of the child to be born. The welfare of the child debate encapsulates arguments on the limits of reproductive freedom.

92. The issue of the welfare of the child issue has taken centre stage in many of the HFEA's policy decisions. Most recently in its review of preimplantation tissue typing (saviour siblings), it concluded that the benefits of preimplantation tissue typing - to the sick sibling, the new baby and the family as a whole - needed to be balanced against a better understanding of the "possible physical and psychological risks to the child to be born".[111] The Authority concluded that preimplantation tissue typing should be available, subject to appropriate safeguards, in cases in which there is a genuine need for potentially life-saving tissue and a likelihood of therapeutic benefit for an affected child.[112]

There has been a misconception in some quarters that the HFE Act demands that the welfare of the child should be paramount (rather than taken into consideration), in line with adoption law, which states that "The paramount consideration of the court or adoption agency must be the child's welfare, throughout his life".[113] Indeed, Melanie Johnson, the Parliamentary Under Secretary for Public Health, came very close to adopting this position in suggesting that the "welfare of the child has to be the overriding main concern of anybody working in this area" and that "the single most important factor is the welfare of the child".[114] Further support has come from Dr Alexina McWhinnie and Professor Alastair Bissett-Johnson from Dundee University, who describe the current legislation as "too weak to offer any real consideration of the long term implications and consequences for those created by the programmes" and advocate the approach by the Victoria State Government in Australia. Its legislation states that "The welfare and interests of any person born or to be born as a result of a treatment procedure are paramount".[115] The example of adoption law is often cited in support of the welfare of the child provision, but in our view this approach is not valid. With adoption the state has assumed responsibility for the future of an existing child. With assisted reproduction, the child is only theoretical. At the time at which such assessments are made, there is not even an embryo. Moreover, a wealth of expertise is available to assess and evaluate the needs of an existing child, particularly in light of their own individual vulnerabilities. This evidence has no bearing on the non-existent embryo. In reality, this provision is more akin to a 'fitness for parenting' requirement, which was historically used to prevent certain 'undesirable' groups from reproducing and is now widely rejected.

PRACTICAL ISSUES AND THE CODE OF PRACTICE

94. The HFEA's Code of Practice contains detailed guidelines for clinics on how to take account of the welfare of the child. The principles which guide the Authority are:

a) The respect which is due to human life at all stages of its development;

b) The right of people seeking assisted reproductive treatment to proper consideration of their request;

c) A concern for the welfare of the children, which cannot always be adequately protected by concern for the interests of the adults involved; and

d) A recognition of the benefits, both to individuals and to society, which can flow from the responsible pursuit of medical and scientific knowledge.

95. The HFEA has issued a consultation document, grandly entitled Tomorrow's Children, on how the application of the welfare of the child could be improved in recognition of the fact that current guidance is 10 years old.[116] A number of problems have been identified. One is the inconsistency with which each clinic approaches the welfare of the child assessment. Sarah Elliston of the University of Glasgow told us that "this provision is notoriously open to wide variation in interpretation. The extent to which it allows arbitrary judgments to be made suggests that serious reconsideration of its retention, or at least a reconsideration of its scope and practical application, is required".[117] The difficulty here is that, in overcoming this problem, the guidance would have to be extremely specific and possibly inflexible, unless the assessment is made on a very simplistic basis, such as checking whether the parents appear on police registers of violent offenders. Clinics have reported that it is difficult to get GPs to respond to the welfare of the child assessment form and many GPs are uncomfortable with having to perform this function. The Progress Educational Trust said that "Whilst maximising the psychological and social welfare of children is clearly, and rightly, a societal priority, this aspect of the welfare of putative children is in many ways an impossible assessment to make […] Clinicians should act in their patients' best interests. However they should not be asked to second-guess those of their patients' putative children, whilst of course doing all they can do to ensure the physical health of future generations".[118]

96. The HFEA reported other concerns that the time and cost of carrying out the welfare of the child assessment is disproportionate to any benefit gained. Professor Allan Templeton of the Royal College of Obstetricians and Gynaecologists told us that "It has been a distortion of clinical practice; it has been absolutely beyond any effect at all in terms of trying to enhance the welfare of the child". He argues that there is no need for specific welfare of the child issues within any act as "it is good medical practice".[119] Witnesses from the British Fertility Society and the Association of Clinical Embryologists told us that they had compared notes in advance of the session. Of the four clinics they represented, they said that their "hit rate" for stopping treatment based on welfare of the child was between 0% and 0.3%.[120] This suggests that if the welfare of the child provision were abolished, we would, in theory, be exposing around 10 children a year to potential harm, even then there are different ways of dealing with potential harm. It is possible, however, that the provision has had a deterrent effect or that patients have withdrawn from treatment when it became clear that inquiries were being made about their background. The HFEA reports that while clinics sometimes make further enquiries to other agencies, they very rarely turn patients down for treatment. When they do, the most common reasons are medical (because the patient has an infectious disease or they are being treated for cancer), psychiatric (because the patient has a mental illness or a drug or alcohol problem) or, occasionally, social (because the couple lives apart).[121] The consultation document sets out a range of approaches to the implementation of the HFE Act's provision:

a) The maximum welfare principle, which considers a child's welfare to be of paramount importance and places the burden of proof upon the prospective parents to demonstrate their competence;

b) The minimum threshold principle, which places great importance upon the autonomy of the prospective parents and seeks to override their wishes only when their child would be at high risk of serious harm; and

c) The reasonable welfare principle, which reflects a compromise position.

97. The application of the welfare of the child provision in the HFE Act has been highly unsatisfactory. We welcome the HFEA's attempts to improve the application of the welfare of the child provision. Ultimately, however, if the welfare of the child provision is to be retained in any revised legislation should be based on the principle that the state has a role in determining who can have fertility based on their personal history and circumstances.

DISCRIMINATION

98. The welfare of the child provision has been seen as seen as discriminatory for two reasons. First, as the Royal College of Obstetricians and Gynaecologists argues, it "discriminates between those wishing to use licensed treatment to conceive and those who can conceive naturally". Mr Tony Gilland, a contributor to our online consultation describes this as "tantamount to licensing parenthood".[122] Others, while conceding that there is discrimination, suggest that this is reasonable, citing, for example, analogies with adoption procedures, in which the background of prospective adoptive parents is carefully scrutinised. The welfare of the child provision is also defended using the same justification for regulation in this field; namely that the intervention of a third party justifies the assessment of the parents. Alistair Campbell argues that "when the state and the professions are involved in parenting decisions (as they are in AHR [assisted human reproduction] and adoption), there is an obligation to avoid harm wherever possible. By preventing a pregnancy through regulation, no child is harmed (unless we believe in pre-existing souls!). Refusing to select parents could result in complicity in clear harm to children".[123] On the other hand, potential parents are themselves harmed when they are denied the chance to conceive a child and/or are asked intrusive questions as to their suitability as parents. This is particularly the case when they these individuals are not being treated on the NHS. When any third party, such as a doctor, is involved, it is inevitable that patients surrender an element of reproductive autonomy. An important issue is whether the state has a stake and, if so, whether this justifies discrimination against some sectors of society.

Need for a father

99. A possible further area of discrimination is provided by Section 13(5)'s demand that the welfare of the child should embrace the consideration of the need for a father, which was introduced as an amendment in the HFE Bill. This has provoked controversy in that it seems to impose an official view of an ideal family and was clearly intended to restrict the provision of IVF to lesbian and single women. The Royal College of Obstetricians and Gynaecologists (RCOG) argues that "The requirement for a father does not square with the current view of what constitutes a family, and discriminates against single women who may have the financial and emotional facilities to cope with a child on their own or with other support systems, who may need to use donor insemination to conceive safely".[124] PROGAR (Project Group on Assisted Reproduction), a multidisciplinary body under the auspices of the British Association of Social Workers, recommends that "the child's 'need for a father' in the Act, be replaced by 'the need for a family'".[125] In evidence the Minister maintained that the consideration of the "need for a father" was important and should be retained because "as a general rule it is better for the children to be born into a two parent family with both father and mother".[126]

100. One could argue that requiring only the consideration of the need for a father is not discriminatory, since the HFE Act does not actually demand that there is an identifiable father. The solicitor James Lawford Davies told us, considered in isolation, that "on the face of it, the act is not discriminatory. It does not prevent the treatment of single women or same-sex couples".[127] Pink Parents has undertaken a survey of clinics' policy on lesbian and single women, which demonstrates that, while some will refuse to treat, many others will not.[128] Lisa Saffron told us that "In practice there are some clinics which accept lesbians and others do not. They interpret the need for a father clause in completely different ways. It is basically a meaningless clause".[129] The difficulties of the "need for a father" issue are, however, compounded by the HFE Act's "meaning of a 'father'" in Section 28. Mr Lawford Davies pointed out that "You can read into it ['the need for a father'] a degree of discrimination because, elsewhere in the act [Section 28], children born to single women will essentially be legally fatherless, so it does in some way point to the desirability of being born in anything other than a heterosexual couple. I think the inclusion of the term 'including the need of a child for a father' then changes the basic premise. That does introduce an element of discrimination, although, again, clinics are quite free to take that into account and to reject it".[130]

101. As we stated above, the Minister clearly wishes to retain the requirement to consider the need for a father. However, the HFEA has pointed out that, in doing so, her view is contrary to the wishes of Parliament, which passed the Civil Partnerships Act in 2004 and the Adoption of Children Act in 2002. The HFEA's Chair was reported in January 2004 as saying that "It is absolutely clear if you think about the changes in society and the different ways that families can be constituted that it is anachronistic for the law to include the statement about a child's need for a father[…]It seems to me a bit of nonsense to have that still in the legislation".[131] The research of Professor Susan Golombok from City University supports this position. She told us that while there had been little research on the psychological outcomes for children born to single heterosexual mothers through donor insemination, there was "a considerable body of research" on lesbian mother families suggesting that there were no adverse outcomes for their children born using assisted reproduction.[132] The requirement to consider whether a child born as a result of assisted reproduction needs a father is too open to interpretation and unjustifiably offensive to many. It is wrong for legislation to imply that unjustified discrimination against "unconventional families" is acceptable.

Parental age

102. In the course of our inquiry, it was reported that a 66-year-old Romanian woman had given birth to a daughter to become the oldest known new mother. There are no upper limits set out in the HFEA's Code of Practice, merely the guidance that, in considering the welfare of the child, clinics should assess "The age, health and ability to provide for the needs of a child/children".[133] It is widely recognised that as they approach the menopause women's chances of achieving a live birth using IVF substantially reduce. Postmenopausal women must rely on donor eggs unless they have some of their own that have been previously frozen. While any welfare assessment would logically seek to determine the ability of the parents to look after the child in the long term, there seems to be hostility to older women having children that cannot simply be based on concerns for the welfare of the resulting child. It seems more likely that this stems from a deep-seated feeling that it is unnatural. Women of natural child-bearing age may have a significant risk of dying before their children reach adulthood, for example from a predisposition to breast cancer or diabetes. These are not absolute contraindications to assisted reproduction, nor should they be. Given that men's life expectancy is lower than women's, it might be logical to suggest that if there is an upper limit, the father's age would be of greater concern. Tracey Sainsbury, who formed part of a panel assembled by Infertility Network UK, identified concerns about the health of the mother - "If she has a life-threatening illness and you know she is not going to be around for much longer, then you do look at who is going to be left to care for the child?"[134] On the same panel, Sheena Young told us "there has to be a cut-off somewhere. Within society, we do know that there is a cut-off. In the UK, because of the legislation we have here, in general you will not find older women being treated. It is very rare that you see that happening here. It is not very rare to see that happening in other countries".[135] If judgements are to be made about the health or age of parents, they should be applied equally to both parents (where there are two) and based on evidence of risk of significant harm. The reaction to the Romanian case seems to be based on ageism and sexism, neither of which is a good basis for legislation.

Human rights

103. Article 12 of the Convention for the Protection of Human Rights states that "Men and women of marriageable age have the right to marry and to found a family, according to the national laws governing the exercise of this right". What the Convention does not say is that men and women have the right to parental responsibility. This distinction is important since it means that, while the State should not prevent a someone having a child - by assisted reproduction or other means - it can intervene following birth, through, for example, social services, if it has reasons to believe that child is at risk of harm. In many ways social services are at an advantage since a couple undergoing IVF has entered the healthcare environment and any concerns there that any child born to that couple might be at risk can be relayed at an early stage. To some, it seems foolish to help someone to have a child if it is likely to place a burden on social services. However, most would consider it an infringement of liberty for the State to prevent fertile individuals from having a child in similar circumstances. There is also a danger that social services are lulled into a false sense of security under the impression that couples who have undergone IVF have somehow been screened and there is less need for vigilance. The State employs social services to protect children from harm. If it has reason to believe that children born as a result of assisted reproduction are at increased risk then healthcare professionals can alert social services at an early stage. Indeed, the law has declined to intervene to protect the welfare of a child not yet born, being satisfied that the foetus in utero cannot be made a ward of court, and that appropriate action could be taken if required following live birth.[136]

104. The HFE Act could also be considered to conflict with Article 8 of the Convention for the Protection of Human Rights, which states that:

"Everyone has the right to respect for his private and family life, his home and his correspondence".

"There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others."

If third party intervention is necessary to enable a couple to have a child, then the nature of that intervention could be considered irrelevant in categorising it as private or public. So, there is no qualitative difference between seeking to assist in establishing a pregnancy by reversing a vasectomy or unblocking fallopian tubes (which require third party intervention but no evaluation of the welfare of future children—including no upper age limit for the intending parent(s)) and using assisted reproductive technologies. Further, unless having a child is seen as a threat to public health or public morals, it is not clear that any of the permitted derogations to Article 8 would apply.

Inconsistency

105. If one accepts that the welfare of the child provision is important and that the involvement of healthcare professionals justifies an erosion of liberty, logic would dictate that any professional intervention to overcome infertility or subfertility should be subject to the same standards. IVF is just one of a number of techniques that include ovulation induction, tubal and uterine surgery, surgical management of endometriosis, IUI and GIFT. Only with the last two is a welfare of the child assessment required, and only if donor sperm is being used. The exclusive requirement to consider the welfare of the child for fertility treatments where fertilisation takes place outside the woman or involves donated sperm is illogical. If the legislation aims to regulate the treatment of infertility or subfertility then it should cover all forms of interventions. If it wishes to do both then this needs to be clearly stated and justified.

Explicit requirement

106. Professor Brenda Almond, a former member of the HFEA told us that "there should be no question at all of removing the 'welfare of the child' provision […] New procedures in reproductive medicine mean that the rights and welfare of children can be violated at a stage of vulnerability which it has not previously been necessary to recognise".[137] However, it does not inevitably not follow that because one values the welfare of children that this should be explicitly enshrined in legislation and thereby compromise liberty. For example, the requirement for quality management systems and technical accreditation should lead to higher standards, which one would expect to have a positive impact on the welfare of children born. Dr Alexina McWhinnie and Professor Alastair Bissett-Johnson from Dundee University cite the example of the increased risk of multiple pregnancies as a justification for the welfare of the child provision. As we discuss below in paragraph 268, this issue is of great concern to us, but the welfare of the child provision has noticeably failed to solve the problem. Dr McWhinnie and Professor Bissett-Johnson use the possibility of multiple pregnancies to argue that the welfare of the child provision be strengthened. A better solution would be to ensure that doctors consider the impact of the treatments they provide on other areas of health services in general and, in neonatal care in particular.[138] Given that a major known threat to the welfare of the embryo/foetus and any subsequent child is associated with multiple pregnancies, it might be more desirable for legislation to specify that a regulator impose limits on the numbers of multiple births on licensed clinics. Dr McWhinnie and Professor Bissett-Johnson also use the example of the donation of third-party gametes, where they draw attention to the psychological problems experienced by donor conceived adolescents and as adults when "seeking a resolution of this 50% gap in their biological/genetic and self identity".[139] These concerns can be met by banning the process entirely, as is the case in a number of countries, or by making specific provision in legislation, for example by enabling the children born to identify their genetic parents.

107. The welfare of the child provision discriminates against the infertile and some sections of society, is impossible to implement and is of questionable practical value in protecting the interests of children born as a result of assisted reproduction. We recognise that there will be difficult cases but these should be resolved by recourse to local clinical ethics committees. The welfare of the child provision has enabled the HFEA and clinics to make judgements that are more properly made by patients in consultation with their doctor. It should be abolished in its current from. The minimum threshold principle should apply but should specify that this threshold should be the risk of unpreventable and significant harm. Doctors should minimise the risks to any child conceived from treatment within the constraints of available knowledge but this should be encouraged through the promotion of good medical practice not legislation.

Selection and screening

108. Part of the process of IVF involves identifying the most suitable embryos before implantation. This generally involves an assessment by a skilled eye to establish those most likely to implant and develop. The advent of preimplantation genetic diagnosis opened up many new issues, as the use of embryo biopsy provided the opportunity to select an embryo with the desired genetic or chromosomal composition (see Box 3). The HFEA's jurisdiction over the selection of embryos is provided in Schedule 2 1(d) which enables it to license "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".

Box 3: Techniques for preimplantation genetic diagnosis.

Polar body biopsy

A mature oocyte is characterised by the presence of a first polar body that contains a complement
of 23 bivalent maternal chromosomes. This structure can be removed and used for genetic
testing or for aneuploidy screening of the oocyte before fertilization.

Cleavage stage biopsy

Individual cells of the cleaving embryo are distinct and discernible until around the 8-16-cell stage (day 3). One or two cells can be removed and the choice is controversial. Removing two cells
reduces the cellular mass of the embryo and, therefore, might reduce its developmental capacity. The accuracy of the diagnosis, however, is likely to be enhanced if embryos are replaced only when the results from both are concordant.

Blastocyst biopsy

Biopsy of the embryo at the blastocyst stage (normally on day five or six after fertilization) has advantages in that the embryo can contain up to 300 cells so more cells can be removed without apparent detrimental effect. So far, blastocyst biopsy has not been extensively used in humans because of the difficulty in culturing embryos to the blastocyst stage.
Source: Peter Braude et al, 2002, Nature Reviews Genetics, 3: 941-943

ETHICAL BASIS FOR PGD

109. The reasons for which PGD is licensed, if at all, are some of the most challenging facing the review of the HFE Act, despite the fact that PGD is not common. Professor Peter Braude of Guy's and St Thomas' Hospital told us that in the UK there had only been 500 cases involving PGD since the 1990 Act was passed yet there are around 25,000 IVF cycles each year.[140] Many of the debates focus on the ethical issues we discussed in Chapter 3 of this Report, namely the status of the embryo and the balance between reproductive freedom and the interests of the state and society.

110. Any form of embryo selection is wrong according to some people since it involves the destruction of those embryos that are considered unsuitable. This view was expressed by Alison Davis, a contributor to our online consultation who has spina bifida, hydrocephalus, osteoporosis and emphysema: "I think that both PGD and abortion kill a living human individual. The age at which they are killed is of no significance. If you killed a five year old child or a 30 year old person the fact that you had killed would be significant and not the age of the individual killed. So I see the moral argument as the same in both".[141] This position is reflected in the recent Italian legislation in which up to three embryos can be fertilised, but all must be transferred. Further opposition to any form of selection came from Mr John Ford, a contributor to our online consultation, who argued on philosophical grounds that "every single individual is unique and valued and has an intrinsic value as a person and I believe that this selection on genetic criteria reduces that degree of individuality".[142] It is difficult to see these arguments being made from anything other than a perspective which specifies that full human rights begin at conception as opposed to the gradualist approach in which we have found much to commend.

111. The Nuffield Council on Bioethics's (NCB) 2002 report on genetics and human behaviour describes the libertarian view of selection. It states that "The main argument in favour of the permissibility of selection is that this is a legitimate exercise of individual liberty. There is, quite generally, a strong presumption in favour of the exercise of individual liberty wherever its exercise does not conflict, directly or indirectly, with the legitimate interests of others".[143]

112. The NCB also articulates the dignitarian perspective that the "intuitive objection to prenatal selection is that it is 'interfering with nature'".[144] This view has been expressed by several of our witnesses. Human Genetics Alert comments that our industrial market society brings with it a "tendency is to subject natural processes to the criteria of industrial production: efficiency, uniformity and quality control, and thereby to create objects/commodities that can be sold to consumers.".[145] It argues that "With the ability to select the characteristics of and even genetically engineer children according to consumers' desires comes the concern that human beings are becoming just another designed object/commodity within the industrial market system". The term "designer babies" is often employed to described any child that has been born as a result of PGD, although in our view this term is highly misleading since they are no more designed than a child who has been born following a negative genetic test during pregnancy. Professor Alastair Campbell from the University of Bristol expresses similar sentiments: "we should view children as gifts, not as products. On this basis, I argue against conceptions (and pregnancies using PND (pre-natal diagnosis) or PGD (pre-implantation genetic diagnosis)), when these are based on social reasons (gender, height, intelligence, physical appearance, etc). These are all examples of treating the child, not as a person in her own right, but as a product, designed by parental wishes".[146] However, natural conceptions are very much the product of selection—partner selection, often very powerful. Even strong ethical arguments that there should be constraints on reproductive choice do not necessarily mean that legislation should provide that check. As Tony Gilland, a contributor to our online consultation pointed out, there is an important difference between disapproving and disallowing.[147]

Eugenics

113. It is sometimes argued that the intention behind selection—particularly to avoid the birth of children with disabilities—is essentially eugenic in its most negative sense. Our relatively recent history of the abuse of technical expertise reminds us of the need for caution. Tim Lewens from the University of Cambridge has described how "The ghost of eugenics haunts much contemporary discussion of the rights and wrongs of genetic screening".[148] It is also, however, worth reminding ourselves of what eugenics is. Eugenics is defined by the Concise Oxford Dictionary as "the science of using controlled breeding to increase the occurrence of desirable heritable characteristics in a population". Negatively, eugenics can also be defined as the deliberate policy of preventing the birth of those whose characteristics are thought to be undesirable, and it is with this practice at a state level that the term is most commonly associated. The Office of the Chief Rabbi uses the term to describe the selecting in of a characteristic, e.g gender, as opposed to screening out for genetic disease.[149]

114. Human Genetics Alert states that "Many disabled people view the medical surveillance of reproduction, and, in particular, prenatal screening, as a continuation of the eugenic practices of the early 20th century. It coins the term "consumer eugenics". Its director, Dr David King, who contributed to the online consultation, told us that "I do not blame any parents for [avoiding having a child with a disability], it is perfectly understandable, but it does, I think, harm our society in terms of the elimination of diversity".[150] Dr Calum McKellar was concerned that "we are starting to hear in bioethical conferences more and more about eugenics. […] We do not even talk about, it is a sort of taboo topic, but it is resurfacing and it is something that has to be looked at".[151] The problem, as John Gillott of the Genetic Interest Group has pointed out, stems from "whether or not these procedures [genetic screening] are thought to be 'eugenic' will depend on what that emotive term is taken to mean".[152]

115. The real fear of routine prejudice or discrimination is linked with the enforcement of policies which overtly declare the lack of worth of certain individuals. The kinds of choice to which Dr King refers are qualitatively different. Professor Julian Savulescu from the University of Oxford argued that "What was wrong with the Nazi eugenic programme was that the State imposed a blueprint of perfection on couples seeking to have children by forcing sterilisation of the 'unfit' and removed their reproductive freedom".[153] Professor Robert Edwards told the Committee that what could be termed eugenic practices were being undertaken in Cyprus, where the government has signed a deal with US scientists to screen all the embryos of people carrying the gene for â-thalassaemia and transfer unaffected embryos in an attempt to eradicate the disease.[154]

116. Equally, it could be suggested that the Genetics White Paper, Our Inheritance, Our Future, published in June 2003, which outlines the Government's strategy for future screening programmes and proposes specific antenatal and neonatal screening tests that are to be made available either immediately or in the near future, has a eugenic intent, even although it does not seek to impose screening.[155] It proposes that "all pregnant women are offered antenatal screening for Down's syndrome and are then counselled by midwives to help them make an informed choice" by the end of 2004-05. It also states that "An antenatal screening programme for sickle cell and thalassaemia will be in place aiming to offer screening to around 200,000 pregnant women a year, initially targeting areas of high prevalence for these diseases".[156] If ensuring that your child is less likely to face a debilitating disease in the course of their life can be termed eugenics, we have no problem with its use. State programmes that impose a genetic blueprint are another matter. They should be outlawed as part of any regulation of assisted reproduction. Use of the word eugenics must not be used as an emotive term of abuse to obscure rational debate.

PGD and abortion

117. The HFEA states in its Code of Practice that indications for the use of PGD are expected to be consistent with current practice in the use of (post-implantation) prenatal diagnosis (PND).[157] There are concerns over whether this is an appropriate benchmark. Prenatal diagnosis embraces a range of tests, including ultrasonography, amniocentesis, chorionic villus sampling, foetal blood tests and maternal serum tests, none of which would be undertaken before 9 weeks. The application of the gradualist approach to the status of the embryo would suggest that a 5-day old embryo should be accorded fewer rights (or less respect) than a 9-week foetus, although this does not consider the rights or welfare of the pregnant woman; although where she consent to the proposed action in each case, her rights do not provide a confounding factor, in deciding the balance. Professor John Polkinghorne states: "I recognise that embryo research and abortion cannot simply be equated, for the latter involves the ethical interests of a highly relevant third party, the woman carrying the foetus. Yet the difference between these two time limits is very great. The discrepancy suggests to me that we have some more work to do in the search for a consistent understanding of moral truth and its application to medical ethics".[158]

118. The basis for the comparison is that both PGD and PND have at the least theoretical risks attached to them but to apply the same clinical indications to both is only justified if these risks are equivalent. The HFEA surveyed the scientific literature on the risks associated with embryo biopsy in relation to its policy review on preimplantation tissue typing. It cited two studies and reported that "These studies showed consistently that the sample of children studied did not show a significant increase in incidence of serious abnormalities at birth, or, where information was available, at 1 and 2 years of age. Nevertheless, there are as yet no long-term follow-up studies of PGD offspring available".[159]

119. Jayson Whitaker told us "when we first suggested PGD to our consultant, we were told, 'You can't do that here but what you can do is get pregnant, you can have amniocentesis, you can have a test and then you can terminate.' I am not anti-abortion, I am not pro-life, people can do what they want to do, but the human and emotional and ethical cost for my wife of being pregnant, carrying a child and then terminating was the unethical question. That was actually suggested to us as an alternative, a legal NHS approved alternative that could be done here. That, to me, was disgusting".[160] The Royal Society of Edinburgh agrees that "restricting PGD to serious conditions might mean that the (arguably) ethically less troubling option of non-implantation would be subject to more rigorous controls than the (arguably) more troubling ethical option of pregnancy termination with prenatal diagnosis".[161] It is possible to sex a child using ultrasound and seek a termination and if PGD reduces the demand for abortion then this is a good thing. While we recognise that abortion legislation recognises the right of the woman, our gradualist approach to the status of the embryo leads us to conclude that there is a mismatch between the protection afforded an embryo created in vitro before it is implanted and one at a later stage of development in a woman's uterus.

REASONS TO UNDERTAKE PGD

120. There are essentially four reasons for undertaking preimplantation genetic doagnosis:

a) To select an embryo which is more likely to implant and develop;

b) To select an embryo unaffected by an inherited genetic disease;

c) To select an embryo which is a tissue match for an existing person who would benefit from a transplant of (probably) umbilical cord stem cells; or

d) To select an embryo with a desired characteristic for non-medical reasons.

121. The HFEA's Code of Practice sets out the criteria for which PGD can be licensed. First, PGD will be available only where there is a significant risk of a serious genetic condition being present in the embryo (see Table 5). The HFEA says that in any particular situation the following factors are expected to be considered when deciding the appropriateness of PGD:

i. The view of the people seeking treatment of the condition to be avoided;

ii. Their previous reproductive experience;

iii. The likely degree of suffering associated with the condition;

iv. The availability of effective therapy, now and in the future;

v. The speed of degeneration in progressive disorders;

vi. The extent of any intellectual impairment;

vii. The extent of social support available; and

viii. The family circumstances of the people seeking treatment.Table 5: Examples of conditions licensed for PGD in the UK.

Condition Category

Cancer predisposition (eg Familial Adenomatous polyposis coli (FAP), Li-Fraumeni syndrome, Neurofibromatosis type 2) Specific diagnosis

Autosomal dominant disorders (eg Crouzon Syndrome, Huntington's disease, myotonic dystrophy) Specific diagnosis

Autosomal recessive diseases (eg sensorineural deafness, Cystic Fibrosis, Spinal muscular atrophy, ectodermal dysplasia) Specific diagnosis

Haemoglobinopathies (eg Beta thalassaemia, Sickle Cell Disease) Specific diagnosis

Chromosomal reciprocal translocations, deletions and insertions, Robertsonian translocations, gonadal mosaicism Specific diagnosis

Chromosome 13, 16, 18, 21, 22, X, Y Aneuploidy screening using fluorescent in situ hybridization (FISH)

X-linked conditions( eg Adrenoleukodystrophy, Hunters, Haemophilias, Lesch Nyhan syndrome, Wiskott-Aldrich, Duchenne and Becker muscular dystrophy, lymphoproliferative syndrome, Fragile X mental retardation) Sexing and specific diagnoses

Selecting the "best" embryo

122. The selection of the most viable embryo for implantation is largely uncontentious in that it is an extension of what has been undertaken with the naked eye, although there are concerns that some of the screening techniques are expensive and do not necessarily increase the chances of a live birth.[162] This process is termed preimplantation genetic screening since it does not give a diagnosis but identifies, for patients thought to be at a higher than average risk of conceiving abnormal embryos, whether their embryos have certain abnormalities present. It is unfortunate that the NICE guidelines did not cover selection issues apart from recommending that there should be further research to improve the use of single embryo transfer.[163]

Avoiding a genetic disease

123. The option of selecting out single gene disorders such as cystic fibrosis, Duchenne's muscular dystrophy and Huntington's disease is generally welcomed by patient groups, but there are concerns expressed by some disability campaigners that this sends out signals that disability is unacceptable or that disabled people are inferior. This argument is reinforced by the contemporary adoption of the perspective that disability is a social and not a medical phenomenon. Using this argument, broadly speaking, what renders a person's life of limited quality is not the fact of their condition (physical or mental) but rather society's failure adequately to accommodate them. However, many within the disability rights lobby would in fact concede that intending parents may have a legitimate interest in avoiding the birth of a child with a condition that they believe will not be in its future interests. Indeed, the Government's policy, as espoused in Our Inheritance, Our Future, is to make screening for certain conditions more, rather than less, available; implicitly, therefore, to provide people with the capacity to terminate affected pregnancies.[164] It is at least arguable that selection at the pre-implantation stage is less morally weighty than is the termination of an affected pregnancy: the plausible outcome of pre-natal screening.

124. The application of selection becomes more problematic when the expression of the gene is not 100% and when there are available cures. The use of PGD for cancer predispositions and to eliminate carriers of genetic conditions is likely to remain controversial. We took evidence from Dr Maureen McHugh, a contributor to our online consultation who has Parkinson's disease. She stated that "If it were possible to deselect an embryo at the very early pre-implantation stage to exclude the possibility of Parkinson's disease, then I think it would be morally wrong to allow that embryo to develop further. […] This is not discriminating against disabled people and it is not murder. It is simply trying to prevent disability, pain and misery".[165] We have concerns about the criteria imposed by the HFEA. PGD is limited in that it can only be used to screen out disorders and thus it cannot be used to create "designer babies" . We see no reason why a regulator should seek to determine which disorders can be screened out using PGD. Nevertheless, clinical decisions should operate within clear boundaries set by Parliament and informed by ethical judgements.

Preimplantation tissue typing

125. There are a number of genetic conditions that result in blood disorders. Techniques for treating these include transplants of haemopoietic stem cells (precursors of blood cells) from a tissue-matched donor. Sources of such stem cells are the bone marrow and the umbilical cord blood. In recent years it has become possible to screen embryos to establish whether the pregnancy could provide a source of stem cells, ideally from the cord blood but potentially from the bone marrow of the born child (the "saviour sibling"). The technique has proved controversial in the UK and elsewhere, often on the basis that children are being "designed" to meet the needs of an existing person. Although some groups object to preimplantation tissue-typing (PTT) in principle, for others the argument has hinged on whether or not the child born as a result of the test was at risk of developing the condition. These situations have arisen in the UK in the notable cases of the Hashmi and Whitaker families (see Boxes 4 and 5).

Box 4: The Hashmi case
Mr and Mrs Hashmi have five children. The fourth, a son Zain, was born with a blood disorder known as beta thalassaemia major. By the time that he was 2½ years old he had to take a daily cocktail of drugs and to submit to regular blood transfusions in hospital. Mrs Hashmi had been aware that she had a genetic predisposition to producing children with this disorder and, when pregnant with Zain, had undergone prenatal testing to see whether he would be born with the disorder. The test failed to disclose that this was indeed the position.
Zain's condition might be cured by a transplant of stem cells from someone with matching tissue. The stem cells could be supplied from blood taken from the umbilical cord of a new born child, or from bone marrow. The most likely source of matching tissue would be a sibling. Statistically, Mrs Hashmi has one chance in four of producing a child with matching tissue, although the odds are somewhat longer of producing such a child who is not affected with beta thalassaemia major. None of Zain's three elder siblings have tissue that matches his.
Mrs Hashmi decided to have another child, in the hope that it would have matching tissue. She conceived, but prenatal testing showed that the child would have beta thalassaemia major, so she underwent an abortion. She conceived again, and a healthy son was born, but unfortunately his tissue did not match that of Zain. At this point Mrs Hashmi met Dr Simon Fishel from the Park Hospital in Nottingham to ask him whether it would be possible for her to be impregnated in this country with an embryo selected as a tissue macth for Zain. Dr Fishel applied to the HFEA for a ruling as to whether an IVF clinic could properly apply for a licence to administer treatment including tissue typing. On 22 February 2002, the HFEA granted a licence to carry out the treatment. Mr and Mrs Hashmi made two attempts to produce a child by IVF treatment involving PGD and tissue typing. In the first, 15 embryos were produced. Only one proved to have an exact tissue match, but it carried the beta thalassaemia disease. In the second, 10 embryos were produced. Two of these proved disease free and to have a tissue match with Zain. One was implanted in Mrs Hashmi, but no pregnancy resulted. [166]

Box 5: The Whitaker case
Charlie Whitaker suffers from a rare form of anaemia called Diamond Blackfan syndrome. Diamond Blackfan syndrome is rare and it can be inherited, but Charlie's parents, Jason and Michelle Whitaker, have been tested and they are not carriers. A stem cell transfusion from a tissue matched individual, would, as in the case of Zain Hashmi, cure Charlie of the disease.
The Whitakers have a daughter whose tissue does not match Charlie's and so they approached Mohamed Taranissi of the Assisted Reproduction and Gynaecology Centre in London. He applied for a licence from the HFEA to have their embryos screened and tissue typed in a procedure which could have produced a baby that could have provided a cure for their son.
In August 2001 the HFEA were refused permission on the basis that, unlike Zain Hashmi, Charlie's disease was not inherited but arose from a spontaneous genetic mutation. This means that the chances of Mr and Mrs Whitaker having another baby with the same condition are negligible.
The couple travelled to the US to have the biopsy undertaken there. The process was successful and Jamie Whitaker was born in June 2003 in Sheffield. Blood tests confirmed that Jamie was a tissue match, so stem cells from his umbilical cord can be used to treat Charlie. This has now been undertaken and it is understood that the treatment has been successful.

126. There is clearly a distinction in many people's mind between PGD and PTT where the born child is not at risk of a genetic condition. Some concerns are based on principles of human dignity: using PTT the child is not born for its own sake, i.e. is solely a means to an end. Professor John Harris has criticised this argument, stating that "it's difficult […] to find evidence or even persuasive anecdotes that if people are treated as means, they are necessarily treated as mere means, or exclusively as means or solely as means. […] even if this were to be the case, even if we could make sense of this idea, the children would be so unloved and treated so unacceptably badly that it would cause psychological damage is a piece of reckless speculation for which there is no evidence".[167]

127. Welfare arguments stem from suggestions that the use of the technique would have an impact on the relationships in the family. The Christian Medical Fellowship raises important issues for the families seeking PTT, yet these are matters for doctors to explain clearly in advance and not for regulation or legislation. Mr and Mrs Whitaker initially hoped that their second child, conceived naturally, would be a tissue match for Charlie.[168] There was nothing to prevent them from producing a child for this purpose, yet the resulting child is now having, in theory, to deal with having been a failed donor.

128. There are concerns about the safety of the biopsy process, which become more acute when the embryo has nothing to benefit from the process. The HFEA reviewed literature on the impacts on families of sibling bone marrow and cord blood donation and found that no relevant, transferable problems had been identified. It also found little to prompt concerns about the long-term effects of biopsy.[169] It has been argued that no embryo has an interest in being biopsied since it does nothing but reduce the chances of it being implanted. It has also been suggested by the Christian Medical Fellowship that PTT should not be permitted because of the degree of stress on the mother; low success rate; the need for many eggs; the expense; and the technically demanding nature of the laboratory work.[170]

129. The term "saviour sibling" has been coined, yet little attention has been given to the prospect of saviour sons or daughters, or even nephews and nieces. The HFEA ethics committee, while supporting the use of PTT for siblings, drew the line at the use of the technology to benefit other members of the family. To make this distinction implies that there is evidence to suggest the psychological impact on the child, and the nature of the family's relationship, would be different if the recipient of the stem cells were not a sibling. The HFEA's review of its policy acknowledged this issue but stated merely that it raised "distinct and significant issues" and should be the subject of further consideration.[171] We conclude that there are no compelling reasons for a statutory authority to make judgements on whether or not a family can seek preimplantation tissue typing, provided they fall within parameters set by Parliament.

Non-medical reasons

130. There is nothing in the HFE Act that indicates that selection for non-medical reasons should not be permitted; however, HFEA's guidance makes it clear that PGD should only be used for serious genetic conditions. We have commented above that developments in the technology will mean that there will be complex issues to resolve concerning genetic predispositions for diseases and genetic carriers.[172] An even more controversial area would be the use of PGD for social reasons. .

Sex selection

131. Sex selection has become widely accepted as a legitimate route for the avoidance of sex-linked disorders, although as we have already noted this is not completely uncontroversial. Pressure, albeit from a limited number of individuals, to obtain access to sex selection using pre-implantation genetic diagnosis for non-medical reasons ultimately led the HFEA to issue a consultation document and report on this area.[173] The HFEA identified three means by which the sex of a child could be determined:

a) PGD;

b) Sperm sorting; and

c) Selective termination of pregnancy.

132. Each raises distinct issues but in this discussion we will focus solely on the implications of sex selection and how this should be reflected in legislation and regulation. While PGD is covered by the HFE Act, sperm sorting is not and would require the scope of the Act to be widened to include fresh and not stored gametes only (see paragraph 89). Termination is regulated by the Abortion Act 1967.

133. There are three reasons why a family might wish to choose the sex of a child for non-medical reasons:

a) To have a family that includes children of both sexes (known as 'family balancing');

b) To rebuild a family after the death of a child with another of the same sex; and

c) To fulfil a general preference for children of one sex over another. This could be related to economic, cultural or social reasons.[174]

134. There are a number of objections to sex selection:

a) Demographic impacts;

b) International implications;

c) Psychosocial impacts;

d) Ethical considerations; and

e) Sex discrimination.

135. In giving evidence to the US President's Council on Bioethics, Nicholas Eberstadt from the American Enterprise Institute said that there were a number of countries around the world where the ratio of boys to girls being born was 107:100, which, he argued, could not happen naturally.[175] China and India are popularly cited examples. However, it cannot be assumed that this would happen in the UK. First, it makes the assumption that people would all choose the same way; that is all, or at least a significant majority, would chose either boys or girls, leading to a socially destructive shortage of one sex or the other. Second, sufficient numbers of people would need to utilise sex selection for their choices to contribute to this "demographic disaster". A team of researchers from the University of Giessen in Germany looked at sex preferences in Germany and in the UK (see Table 6). These showed that only a small proportion had a preference for all or mostly one sex, and that these were similar for both sexes. Table 6: Gender preferences in the UK and Germany.

UK (excluding the small percentage of undecided) Germany (excluding the small percentage of undecided)

16% said they did not care about the sex of their children,
68% said they wanted an equal number of boys and girls,
6% would like more boys than girls,
4% would like more girls than boys,
3% would prefer only boys,
2% would prefer only girls,
16% would prefer a first born boy,
10% would prefer a first born girl
73% had no preference for their first born
58% said they did not care about the sex of their children,
30% said they wanted an equal number of boys and girls,
4% would like more boys than girls,
3% would like more girls than boys,
1% would prefer only boys,
1% would prefer only girls,
14.2% would prefer a first born boy
10.2% would prefer a first born girl:
75.6% had no preference for their first born

Source: Human Reproduction. Vol 18. No 10 pp2231-2234, 2238-2239

136. Some communities within the UK do have a decided preference for boys over girls, and permitting such choices leads to increased opportunities for reinforcing sexist attitudes. Research at De Monfort University on attitudes to infertility among south Asian communities in the UK shows that a social need for male children is widespread and that the failure to produce a male child could almost be regarded as a form of infertility in some families. Culturally, the birth of male children is reported as a cause for celebration in a way that is not the case for female children.[176] While the data for the UK as a whole suggests that there would be few demographic implications resulting from any relaxation of limits on sex selection, there may be communities where this would be the case. Further research is required to establish these impacts.

137. Even if there are those who have a strong preference for children of one sex, this is not necessarily a reason for banning sex selection since it could be restricted to those families who wished to have a balance of both sexes, i.e. family balancing. Professor Martin Richards from Cambridge University reports that research suggests that "were sex selection to be made available in the UK very few would use it and its use is unlikely to have any significant effect on the overall sex ratio of children born".[177] He told us that in the US sex selection based on sorting the sex determining Y or X sperm and artificial insemination has been commercially available since 1995 for family balancing but has only been used by some 2,000 couples.[178]

138. The most high profile case in the UK has been that of the Masterton family (see Box 6), whose desire to have a girl falls into category b) in paragraph 134. In their letter to the HFEA in January 2000, they suggest that the birth of a daughter could alleviate Louise Masterton's depression and cite the opinion of a clinical psychologist to that effect.[179]

Box 6: The Masterton case
Alan and Louise Masterton from Monifieth near Dundee lost their youngest child, a three year old daughter Nicole, in 1999, in a domestic accident. The Mastertons, who have four sons, campaigned for the right to rebuild their family with a daughter.
Louise Masterton had been sterilised after the birth of Nicole and so sperm sorting followed by artificial insemination, which is available and unregulated in the UK, was not an option. The Mastertons wanted the Human Fertilisation and Embryology Authority (HFEA) to allow them to undergo IVF treatment and select a female embryo using pre-implantation genetic diagnosis (PGD). They argued that their family had a psychological need for a daughter. However, the HFEA
will only consider an issue if a clinic applies to them for a licence. The Mastertons could not find a UK clinic that was prepared to take up the case on their behalf and so sought treatment in Italy instead. However, only one male embryo was produced, which was donated to an infertile couple.

139. The HFEA has drawn on theoretical psychosocial harms in formulating policy on sex selection, invoking the precautionary principle. It concerns us that the potential for harm is often quoted without recourse to a growing body of evidence of its absence. Ms Philippa Taylor, a contributor to our online consultation, told us that while she would not oppose sex selection for social reasons if evidence of lack of harm could be found, she remained confident that "you will not find there is no psychological impact on children from sex selection". She used in support of her view an anecdote of a man whose failing marriage could be traced back to the fact that his parents had wished him to be a girl.[180] Others might use this as evidence to support the use of technologies to determine sex. If sex selection had been available to the man's parents then the daughter would not have had to face the same intolerable feeling of rejection. Also, if this takes place in the normal course of events, what justification is there for citing psychological problems when technology has been involved?

140. It has been suggested that sex selection would sanction sex discrimination. This argument has been employed by Baroness Kennedy of the Shaws, at the launch of our online consultation. The available data suggest that most people in the UK want a "balanced" family which suggests that any sexist attitudes are not being expressed in the choice of gender. It could be argued, as Josephine Quintavalle did at the launch of our online consultation, that the UK should consider the impact on other countries resulting from a relaxation of guidelines on sex selection. It could be argued that by permitting people to choose the sex of their child in this country we are legitimising the choices among cultures where boys are preferred. A difficulty here is that the practice of selecting boys is widespread, as we reported in paragraph 136, yet often this takes place in countries where the law prohibits this and where the use PGD or sperm sorting is unlikely to be a significant factor in gender imbalances. It is important, however, that the United Kingdom, does not take a purely insular view. What is allowed here will, of course, be cited as a precedent by other countries. It may also make it harder for the UK to criticise sex selection in other countries, however, abominably it is presently carried out, for instance by the murder of baby girls in some countries or by abortion. In terms of future-proofing, it is also important to consider that PGD may through scientific advance become much more widely available in the future in other countries, for instance for sex selection in China or India, the countries most cited as having demographic imbalance. The UK should carefully consider the current evidence there available now about such imbalances and harms before allowing blanket changes our laws and regulations on sex selection.

141. In paragraph 113, we discussed the objection to the selection of embryos on that this undermines the status of children as gifts rather than products. We find this an unsatisfactory argument when it is applied to the screening out of genetic disorders but believe that it has more merit when it is applied to desired characteristics such as sex and tissue type.

142. Doubts have been cast over the validity of the data gathered by the HFEA in support of its conclusions on sex selection. However, even if the HFEA exaggerates the public's hostility to sex selection for social reasons, we have little reason to doubt that a majority of the British public oppose it. Professor Tom Shakespeare from Newcastle University has provided confirmation of this from his own research.[181] Nevertheless, we do not see this as adequate grounds for prohibition. In paragraph 46, we stated that while reproductive freedom needed to be balanced against harms to individuals and society, these claims of harm needed to be based on evidence. In 2001, the Ethics Committee of the American Society of Reproductive Medicine concluded that:

182

The onus should be on those who oppose sex selection for social reasons using PGD to show harm from its use. However, the use and destruction of embryos does raise ethical issues and there are grounds for caution. The issue requires greater analysis than has been afforded it by the HFEA and we urge greater efforts to establish the demographic impacts across all sectors of society and the implications for the creation and destruction of embryos in vitro before new legislation is introduced. On balance we find no adequate justification for prohibiting the use of sex selection for family balancing.

Other desired characteristics

143. As sex has a simple genetic basis, sex selection is available now and is, as the HFEA has recognised, a pressing policy issue. The selection of physical and mental characteristics is further away, partly because of the lack of interest from the medical community and the fact that the genetic basis of many desirable characteristics is less well understood and likely to involve multiple genes. As Professor John Robertson, Chair of the Ethics Committee of the American Society for Reproductive Medicine has stated, "popular accounts of PGD assume that it will eventually be used to select for such non-medical traits as intelligence, height, sexual orientation, beauty, hair and eye colour, memory, and other factors. Because the genetic basis of those traits is unknown, and in any case is likely to involve many different genes, […] it is unrealistic to think that non-medical screening […], with the possible exception of perfect pitch, will occur anytime soon".[183] A limitation of PGD is that it can only work using the available raw material. Even in single gene disorders, it is not always possible to identify a suitable embryo for implantation. If more than one gene is involved the chances shrink still further. Consequently, the debate has been more philosophical than practical and generally our witnesses have stressed a significant difference between the use of selection for social rather than medical reasons. Jayson Whitaker, who has sought to use PTT to select a child who is a tissue match for an existing sibling (see Box 4), told us that "There is a big difference between a child who can run fast and one that has difficulty running".[184] A contrary view is held by Professor Julian Savulescu, who told us that parents had a moral duty to do the best for their children. He argued that it was therefore illogical to prevent the use of a technology if the benefits outweighed the risk.[185] As we have stated, the argument is largely an academic one, but we have been keen in preparing this Report not to become mired in what is currently possible and what is not. We should use the current impracticality of screening for desirable social characteristics to engage in a rational debate on the subject. One danger is that the pursuit of the desired embryo might require the creation of a large number of embryos, which raises ethical issues concerning the destruction of embryos (unless they were donated) and health concerns if this required repeated cycles of hormone treatment to stimulate egg production. We are aware that the Human Genetics Commission is holding its own inquiry into reproductive decision-making and we look forward to reading their conclusions.

"Undesirable" characteristics

144. While the selecting out of serious genetic conditions has been generally supported by our witnesses, the issue as to whether families should be allowed to choose what some might consider to be a negative trait has proved to be more complicated. For the most part these discussions have been theoretical rather than based on real cases. The most high profile example so far did not involve assisted reproduction. A deaf lesbian couple in the United States deliberately created a deaf child by using as a sperm donor a deaf friend with five generations of deafness in his family. The couple do not see deafness as a disability but as a defining part of their cultural identity and see signing as a sophisticated, unique form of communication.[186] We employed a similar scenario as part of our online consultation, in which a married, fertile achondroplastic dwarf couple wish to have a achondroplastic child on the basis that a child of normal height would cause practical problems in their home. Many of the comments opposed this idea, although many did so based on their opposition to any form of selection. A view expressed was that just because we should not discriminate against the disabled, it did not necessarily follow that disability was a good thing.

145. Cases such as these have split those who otherwise are attracted by notions of reproductive freedom. Len Doyal, Professor of Medical Ethics at Queen Mary, University of London, argues that "procreative freedom should be maximised in relation to reproductive technologies" with one exception; "the use of reproductive technology to produce rather than to prevent children who are physically harmed" on the grounds that "when serious physical harm is foreseeable with certainty and it can be avoided, it should be".[187] In slight contrast Julian Savulescu from Oxford University argues that there should be "strong presumption in favour of procreative autonomy" but that, while a decision to have a child with worse life opportunities than another child is wrong, any interference in the decision is only justified if there is a significant interest of that particular child in not being born at all or a public interest.[188] We can imagine that many clinicians would baulk at the idea of selecting, for example, a deaf child using PGD, but we do not feel that the creation of a child with reduced life opportunities is sufficient grounds for regulatory intervention, else we might logically deny poor people IVF. Professor Tom Shakespeare told us that PGD should not be allowed to select out "minor or trivial" conditions such as restricted growth or deafness.[189] On this basis, it is difficult to argue that they should not be selected rather than deselected. A more challenging but unlikely scenario would be the desire to select a child who would suffer obvious discomfort (rather than disadvantage), or worse. In this area there needs to be further debate.

Donation of gametes and embryos

146. Since the HFEA register was set up in 1991 over 25,000 children have been born as a result of donated sperm, eggs or embryos. Around 13,000 donor insemination cycles are carried out annually and the Department of Health estimates that 12,000 donor conceived people were born before the HFEA register was set up.[190] The use of donation as a form of fertility treatment raises many issues and our inquiry has been conducted against the backdrop of a Department of Health review of the provision of information to children born through donor insemination (the anonymity issue) and an HFEA review of the regulation of gamete and embryo donation.

ANONYMITY

147. The 1990 Act demanded greater levels of confidentiality than is the case in other areas of medical practice. Section 31 of the Act provides for the setting up of a Register, containing information on "(a) the provision of treatment services for any identifiable individual, or (b) the keeping or use of the gametes of any identifiable individual or of an embryo taken from any identifiable woman, or if it shows that any identifiable individual was, or may have been, born in consequence of treatment services". Under the original regulations, when these children reach 18 they could ask the HFEA to confirm that they were born as a result of donated sperm, eggs or embryos. Those intending to marry, including those who plan to do so before their 18th birthday, may also ask whether the HFEA Register shows that they are related to the person they intend to marry.

148. The Department of Health issued a consultation on the provision of information to people born as a result of sperm, egg or embryo donation in December 2001. On 21 January 2004, the Public Health Minister announced that the Government would be introducing legislation that will lift anonymity from future sperm, egg and embryo donors and allow donor conceived children to access the identity of their donor when they reach the age of 18. This was achieved through the Human Fertilisation and Embryology Authority (Disclosure of Donor Information) Regulations 2004, which were passed on 18 May 2004. The new rules will allow children conceived from future sperm, egg and embryo donations to access more information about their genetic origins.

149. There are many arguments for and against the lifting of donor anonymity presented to us in evidence. These are summarised in Table 7.Table 7: Arguments for and against the lifting of gamete and embryo donor anonymity.

For Against

Information about the circumstances of one's conception can play an important role in the formation of an individual's personal identity.

Information about a donor's medical and family history would have potential value in informing the donor offspring's lifestyle choices.

It is unethical for the State to hold information on someone that is unavailable to that person.

Older, more mature, donors with a strong sense of altruism can be recruited.

Consistent with ruling on Rose case, which demonstrated that the Human Rights Act was engaged (see Table 3), although it did not go on to rule on the merits of the case which would involve a balance of rights.
It would create a major disincentive for people to donate.

There can be no absolute right to know one's parents; otherwise we parents would be required by law to inform children who their genetic parents are.

Prospective parents may travel overseas to get anonymous donation.

Prospective parents wishing to retain anonymity, may switch to unregulated forms of gamete donation, such as man not included or sex with strangers.

Parents may be less likely to tell their children that they were born through donor insemination for fear of "losing" them to their genetic parent, thereby negating the possibility of benefit from any of the first two listed advantages.

150. The new regulations will not be retrospective. People donating sperm, eggs or embryos before April 2005 will not be identifiable. When the new regulations do come into force, they will not impact on a donor's responsibilities to any child born as a result of their donation. As now, they will have no financial or legal obligations towards the child. However, PROGAR is concerned that the HFE Act "omitted to provide 'amnesty' for people who donated gametes prior to the Act's implementation. This has left these donors uncertain as to whether they might have any legal responsibility towards their donor offspring, and fearful as to whether any offspring might have a financial claim on them. We have no evidence from donor-conceived people that they would make any such claim but there is research in progress which has revealed that the possibility of it is very troubling for some past donors. PROGAR believes that that is unjust and that it may be hindering past donors from registering with UK Donorlink".[191] Walter Merricks from the Donor Conception Network also expressed concerns to us about pre-1991 donations, in that there is no legislation or guidance concerning the records of such donations. He told us that "There is nothing to prevent the destruction of those records at the moment. I know of one doctor who was responsible for a number of treatments […] and there are some records in his house, and who knows whether or not he is going to destroy those or his wife may do so".[192] We recommend that the Government clarify the position relating to any financial obligations of donors before 1990. It would be regrettable if such donors did not come forward under the mistaken impression that they would become financially liable for the upbringing of children born as a result of an altruistic donation.

151. It has been argued that the changes in the law regarding the anonymity of donors will have limited impact because of the limited number of parents who tell their children the nature of their conception. The Donation Conception Network argues that the "welfare of donor conceived children demands that only those who are clearly committed to telling their children should be offered donor treatment" and uses the example of adoption, where proposed adopters are required to undertake to tell their children the facts about their adoption and are not accepted as adoptive parents unless this had been agreed to.[193] The Government has decided against forcing parents to tell their children the fact of their donor insemination and does not propose to volunteer the information. Either of these approaches would seem more sensible than proposing to treat only those who promise to tell. It recognises that this provision could not be enforced and indeed we can see no way in which clinics could make any meaningful attempt at determining the intentions of parents. We have discussed above (see paragraph 94) that the analogies with adoption are limited. While we recognise the value of openness, interfering with the relationship between the child and its parents seems an unwarranted intrusion. The Donor Conception Network further argues that the right to know, embodied in the new regulations, should be conferred on both child and donor. It suggests that donors should be entitled to know whether children have been born as a result of their donation and if any offspring have expressed a request for their donor's identity, rather than being contacted direct without warning.[194] We have sympathy with the view that if children born following donor insemination have a right to know their genetic parents, donors have some the rights to non-identifying information about any children born as a result of their donation. We recommend that the Government address this anomaly in its review of the HFE Act.

Supply of donors

152. The major contentious issue involving the ending of anonymity is its effect on the supply of donors. Dr Simon Thornton of the Park Hospital in Nottingham told us that since the Department of Health published its consultation on donor anonymity in December 2001, there had been "a large drop in the number of donors coming forward" and that a number of sperm banks had closed down.[195] Mrs Liz Corrigan from the Bristol Centre for Reproductive Medicine told us that her clinic's donor programme was among those that had closed down since all its current and recent donors refused to donate if anonymity were lifted.[196]

153. The Parliamentary Under Secretary for Public Health told the First Standing Committee on Delegated Legislation during the debate on the Draft Human Fertilisation and Embryology Authority (Disclosure of Donor Information) Regulations 2004 on 18 May 2004 that "In certain other countries, donor-conceived people have access to identifying information about their donor. I understand that patient organisations in Sweden, the Netherlands and the state of Victoria in Australia value the changes that have been made. I also understand that there are indications in Sweden that, although donor numbers dropped initially, they rose again".[197] The Minister has announced a publicity campaign to encourage new donors and will be appointing a PR agency. Currently around 250 men donate sperm each year (as anonymous donors) and 1,100 women donate eggs (again anonymously).

154. During our visit to Stockholm we were told that, in the 1980s, 250 children were born by donor insemination each year. We heard that, after the law ending anonymity was passed in 1985, the number of inseminations declined but that the practice did not end. Currently, around 60 children are born each year by donor insemination and it was estimated that another 200 are conceived abroad. We understand that the waiting list for donors is several years' long.[198] The Department of Health said that the Minister's statement about the Swedish case was based largely on a report commissioned from Professor Eric Blyth at the University of Huddersfield. He reported that the change in legislation in Sweden resulted in a decline in donor recruitment, but that it was not possible to ascertain the scale of the reduction. He provided anecdotal data that recruitment had recovered following the change in legislation.[199] It is difficult to reconcile the Department's statements with the comments we heard first hand in Stockholm. A possible solution is that the Department's evidence related to the number of donors rather than the number of children born through donation. A flaw in their approach is that it relied on input from existing clinics that offer donor insemination. We have heard that in the UK some clinics have ceased operating the service. In Sweden the same effect was observed, with five of the 10 clinics closing.[200] Those that continued the service may have managed to maintain their own supplies despite an overall drop in the number of donors. This may seem a minor point but this has been used to provide a misleading picture of donation post-anonymity. We regret the Department's poor use of evidence in policy-making and its failure to commission and have published the necessary research underpinning its decision on the removal of donor anonymity.

155. Victoria's Infertility Treatment Act 1995, came into force on 1 January 1998, requiring all donors to be identifiable to any offspring when they turn 18. The Infertility Treatment Act superseded the Infertility (Medical Procedures) Act 1984, which had been in force since June 1988. The 1984 Act had established a donor registry and, while it enabled a donor to remain anonymous, it provided donor offspring with the right to access non-identifying information and, with the donor's consent, access to his identity. It has been reported that since 1998, sperm stocks have become depleted and the BBC website reported on 14 January 2005 that Monash IVF clinic in Melbourne has written to all male politicians under the age of 45, appealing for them to set an example by donating sperm. According to the clinic's medical director, Prof Gab Kovacs, before the law changed, Monash IVF clinic had around 20 new donors a year, while only five men signed up last year. The BBC website has reported that, in December 2004, an Australian fertility clinic in Albury, south-west of Sydney, offered students in Canada a free two-week holiday in Australia in return for sperm.

156. One solution to the problem of supply following the removal of anonymity is to introduce a twin-track approach, which would discourage anonymity but not prevent it. This raises a number of issues. The HFEA commented that "this would seem to give a determining role to the decisions of the parents, who would be able to choose whether to use donated gametes where there was no identifying information".[201] Also, Professor Golombok told us that "those children whose parents have opted for a non-identifiable donor who then found out would be at a disadvantage and might be even more concerned about it because they would know that their parents had the choice and then opted for the non-identifiable donor".[202] This is, however, speculation based on surmise founded on anecdote, as it is not clear that there would be any such children, suffering any such harm and if there were that would not outweighed by increased secrecy with the ending of donor anonymity. Discovery of non-paternity is far more common a problem and it is not clear that anyone is arguing a child's right to know.

157. Much of the argument in favour of ending donor anonymity has depended on anecdotal (perforce) testimonies from the off-spring of gamete donation who describe the painful experience of either not being able to trace their biological parents, or not being told that they were donor-conceived or both. In many of these cases it is the keeping of the secret that has caused the pain or undermined family relationships rather than the fact of donor-conception per se or the consequent inability to trace the donor. The major drawback of ending donor anonymity on the basis of these experiences is that there is a powerful argument that the ending of such anonymity would result in a greater likelihood of parents not telling the child because the fear (rational or not) of rejection in favour of an identifiable biological parent outweighs the advantage of having identifying information to transmit.. Even were such children given a right to know at age 18 that they are donor conceived and therefore can obtain identifiable information should they wish - which the Government has noticeably not provided for - this may simply result in the increased use of unregulated services where anonymity is provided. The experience of Sweden and use of Danish clinics provides strong evidence for this. As a result of these unintended consequences there may be more secrecy and possibly more harm caused. Given the threat to donor supply, it would have been better to have attempted to conduct research on parental attitudes to secrecy in the context of anonymity versus identifiable donors before changing the system entirely to one where anonymity is ended.

158. While the arguments for and against changing the status of donors are complex, opinions seem to centre on the relative weight given to the pain of infertility and the welfare of the offspring. Despite this, most would agree that, in principle, openness is a good thing. The task is to promote as much openness as possible without sacrificing the availability of donated gametes. In our view the benefits from the removal of anonymity are not such that the change justifies the likely impact on the number of donors. We therefore favour a twin track approach. While patients and donors should be aware of the benefits of openness and the regulator should provide for those who wish to adopt this strategy.

159. The new Regulations will enable children born from donation to trace their biological parent(s) when they reach 18 years. There is evidence that if the children were told of their status when they are young, between 3 and 5 years, their reaction was generally one either of curiosity or disinterest.[203] We were told by Marilyn Crawshaw from PROGAR that one of their concerns was unplanned or accidental disclosure of information at a later age anyway.[204] If openness is a good thing, it seems also that early openness is even better, yet the law currently make children wait a decade or more before they can find out who the donor in their case is. When he was 12, David Gollancz discovered the fact that he was born following donor insemination. He told us that he would have liked to have known the donor's identity then: "It would have meant that the figure in my imagination which occupied that space was a real person with a name and a history. Even if I could not meet them, they would be a real person as opposed to a ghostly insubstantial figure".[205] We understand that Swedish law that children born as a result of donor conception are entitled to identifying information about the donor when they are "sufficiently mature".[206] We have been told that, the earlier the child is told that they were born from donor gametes the better, yet parents wishing to tell their child that he or she was born using donor gametes may wish to avoid telling them if they then are unable to know anything about the donor. We recommend that certain non-identifying information is available to the child so that they can request it upon being told by their legal parents that they were conceived using donor insemination.

160. Having entered statute in June 2004, the Government is unlikely to want to reopen the issue again, although we welcome the Minister's apparently open mind.[207] The original HFE Bill was given a free vote, as were the research purposes regulations in 2001. However, there was no free vote on the donor anonymity regulations in standing committee. In recognition of concerns about the supply of donors, the Department of Health has launched a PR campaign to recruit new donors. By the time revised legislation is placed before Parliament, data should be available that give an indication as to whether the removal of anonymity will have a long-lasting effect on the supply of donors. With this information, Parliament can decide to what extent the removal of anonymity is a price worth paying.

REGULATION OF EMBRYO AND GAMETE DONATION

161. In November 2004 the HFEA issued a more general consultation document on the Regulation of Donor-Assisted Conception, which sought views on screening and selection of donors, the number of children per donor, compensation and remuneration, supply and distribution of gametes and embryos, storage and recruitment.

162. The issue of the remuneration of donors has been subject to a long-running discussion. Section 12(e) of the HFE Act states that "no money or other benefit shall be given or received in respect of any supply of gametes or embryos unless authorised by directions", i.e. the HFEA has discretion. The HFEA issued a consultation document in February 1998 on the Implementation of Withdrawal of Payment to Donors, following a "decision in principle to phase out payment to gamete donors".[208] At present, the HFEA's Code of Practice states that "Gamete donors must be paid no more than £15 for each donation plus reasonable expenses".[209] We look forward to the results of the HFEA's consultation on the remuneration of embryo and gamete donors. We are concerned that the HFEA should be placed in a position in which it is forced to make decisions that could provide an incentive or disincentive to donors. This is a political decision best left to Parliament .

Counselling

163. The HFE Act states that "A woman shall not be provided with any treatment services […] unless the woman being treated and, where she is being treated together with a man, the man have been given a suitable opportunity to receive proper counselling about the implications of taking the proposed steps, and have been provided with such relevant information as is proper".[210] The HFEA's Code of Practice says that treatment centres are expected to ensure that at least one member of staff is appointed to fulfil the roles of counsellor and must:

a) Hold either a recognised counselling, clinical psychology, counselling psychology or psychotherapy qualification to diploma of higher education level or above; or

b) Hold an Infertility Counselling Award; or

c) Hold a professional social work qualification recognised by one of the UK social care councils; or

d) Be able to provide evidence of working towards accreditation through the British Infertility Counselling Association/British Fertility Society Infertility Counselling Award; or

e) Be able to provide evidence of membership of a recognised professional counselling body with a complaints/disciplinary procedure and has agreed to abide by an appropriate code of conduct or ethics.

164. In addition the HFEA demands that treatment centres provide a private and comfortable room for counselling and maintain good relationships with independent counselling organisations so that patients can obtain counselling, in addition, or as an alternative, to the centre's resources. Despite these quite detailed requirements, it is evident that the availability of counselling is a thorny issue in clinics. In its written evidence the British Infertility Counselling Association (BICA) stated that it wished to see mandatory implications counselling for all regulated procedures: "BICA considers that implications counselling for all donor-assisted conception should be mandatory and that consideration should also be given to mandatory implications counselling for all prospective recipients of ART procedures". It suggests that this is in line with international trends (e.g. in Australia and Canada).[211]

165. The demand for mandatory counselling is radical and raises several issues. First, whether the potential psychosocial implications of assisted reproduction are so serious that patients should be counselled whether they like it or not; second, why we should single out regulated treatments when non-regulated treatments may present similar problems; and third, do we have any evidence that counselling brings about the desired effects.

166. On the first point, there are obvious concerns. Forcing people to be counselled could easily be considered an infringement of liberties and might be counterproductive if the parents felt that it had been forced on them. However, we must recognise that, while standard IVF has come a long way since 1978, there is still only a 50% chance of taking home a baby. It is not difficult to imagine the distress of couples who have failed in their attempt, possibly expensive and drawn out, to have a child. Professor Susan Golombok told us that "It is important to differentiate between those who are successful in treatment and those who are not. For those who are not, the evidence seems to be that […] it is very difficult and distressing but, over time, this diminishes, albeit there is a small minority left with long-lasting problems. I do not think it is right to assume that everybody who has unsuccessful treatment will then be plagued by all kinds of psychological problems for years to come".[212] Dr Jim Monach of BICA told us that studies had shown that "infertility and childlessness generate the second highest levels of anxiety and depression of all medical conditions".[213] Dr Monach told us that, while evidence for the efficacy and effectiveness of counselling in a range of other circumstances is strong, it seems that there have been few attempts to determine its effectiveness in assisted reproduction.[214] Professor Golombok told us that "I do not think […] that there is a great deal of evidence that it is beneficial, but that does not mean that, were good studies to be carried out, that benefits would not be found".[215] In its supplementary evidence, BICA provided supporting references for the effectiveness of infertility counselling. The Department of Health has stated that "[there is] evidence of counselling effectiveness in mixed anxiety or depression; most effective when used with specific client groups […] psychological therapies have benefit in a range of somatic complaints including gynaecological problems".[216]

167. There are examples elsewhere in the world where counselling is mandatory.[217] In Canada, the 2004 legislation requires licensees "to the extent required by the regulations, make counselling services available to the person and ensure that the person receives them".[218] However, we are unwilling to make recommendations to that effect. Indeed, the wording of the current legislation seems perfectly adequate. We were surprised that, when we challenged BICA on the wording, Sheila Pike told us "Perhaps the term 'mandatory counselling' is not the best way to describe it. I do not believe that you can impose counselling on anybody but I do believe that you can offer a realistic opportunity to people".[219] Her concern was on the interpretation of "suitable opportunity" in the Act and that counselling should become a "routine procedure, just as routine as an initial clinical consultation".[220]

168. We were pleased that, in its supplementary evidence, BICA moderated its demands, suggesting that "perhaps [it would be] more helpful to see this as a matter of clinics strongly encouraging certain groups of patients to seek counselling", although it maintains that counselling might be a requirement in the case of those embarking on donor gamete treatment, surrogacy or egg sharing.[221] In our view the interpretation of the Act in the Code of Practice is acceptable as there are limits to how regulation can force the routine use of counselling on health care professionals. It has been apparent during this inquiry that the value of counselling is not fully appreciated by clinicians, and indeed some seem to regard it with thinly disguised contempt. This is, in our view, at the heart of the problem, not the legislation or regulation: this needs to be resolved at a professional level. The Draft Standards for Assisted Conception Units, compiled by ACE and BFS on the instigation of the HFEA, do contain standards relating to the role of counselling within a treatment centre: "The management shall, with the aid of organisational charts […] define the organisation and management of the clinical, laboratory and counselling services and their place in a parent organisation". If implemented, this should provide a framework for all professionals working in, and in association with, treatment centres to develop a constructive working relationship. While assisted reproduction is a relatively new area of clinical practice, the emphasis on the drive to improve treatment services has, not surprisingly, been on improving clinical practice and, along with an established research culture, a substantial body of data has built up providing evidence, or otherwise, for the efficacy of different procedures. This has not been the case with counselling. While we believe that clinicians should adopt a more sympathetic attitude to infertility counselling, counsellors must work harder to develop an evidence base to support their practice. Only in this way can they hope or deserve to receive the respect of their clinical colleagues. We see no role for legislation or regulation in facilitating this process.

Research

169. The Human Fertilisation and Embryology Act 1990 requires the HFEA to regulate the creation, storage and use of embryos for research throughout the UK. The purposes for which research is licensable are outlined in Schedule 2, Section 3 of the HFE Act. Initially, research was permitted for five purposes:

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; or

e) developing methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation.

170. The HFE Act was amended in 2001 through the Human Fertilisation and Embryology (Research Purposes) Regulations 2001, which added the following three purposes:

a) increasing knowledge about the development of embryos;

b) increasing knowledge about serious disease; or

c) enabling any such knowledge to be applied in developing treatments for serious disease.

171. These regulations allow the use of embryos for therapeutic research, including that using embryonic stem cells. The HFEA has received over 150 applications for human embryo research licences since it was established in 1991.

FERTILITY RESEARCH

172. There are a number of concerns about Schedule 2(3) of the Act. The demand for clinical trials licences reflects a concern that the HFEA has had no way of allowing the introduction of new techniques in a controlled manner. The Peckham Report comments that "Before a new treatment covered by the Act can be used it must have an HFEA licence, which is not approved until expert review has satisfied the HFEA that the treatment is safe. However, as things stand, there is no legal requirement for clinical testing and/or trials to rigorously assess new treatments before they are introduced".[222] When ICSI became available, having been initially successful following a laboratory mistake, the HFEA could only prohibit or allow the technique to be undertaken.[223] Its only tool was to demand stricter licensing requirements. A problem has been that the HFEA has been unable to license a clinical trial; it can issue a licence for a treatment or research purposes only. It cannot issue a treatment licence unless it is satisfied either that it is for "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" and the activity is "necessary or desirable for the purpose of providing treatment services".[224] The HFEA suggests that Schedule 2 (3) of the HFE Act needs consideration. It says that the ability to issue clinical trials licences might give greater control over the introduction of new techniques and technologies into clinical practice. This is disputed by Professor Alison Murdoch. She argues that "If I wanted to introduce a new drug into my clinical practice, there are various processes that I go through. If it is a drug that has been tried and tested, I would go to my Trust, I would go to the Drugs and Therapeutics Committee; I would give them the evidence to show that it was better than the existing [drug] and was cost effective and would be introduced into clinical practice. If it were a new drug, I would go through phase one, phase two and phase three so as to do it; it would go to Ethics Committee and patients would be informed and it would be appropriately funded. In terms of introducing clinical trials, I do not see any need to introduce any different model".[225] The HFEA is able to attach conditions to any licence that it awards and it could already use its existing licensing system to ensure that certain techniques were only used as part of a clinical trial. We recognise that powers to award a clinical trials licence might have advantages for the HFEA but we would be nervous about the creation of any further bureaucratic hurdle introduced to the setting up of clinical trials.

173. A further problem with the HFE Act, identified by the HFEA itself, relates to training in techniques for assisted reproduction and embryo biopsy. Individuals can currently only receive training under a research licence, whereas the introduction of training licences would allow the proper regulation of training. This move would have obvious benefits. Currently, new staff can only be trained if they are working in centres where research is being undertaken. This limits the ability of smaller centres to develop the necessary expertise. Problems may arise in seeking consent to use embryos in this way, which would be compounded by the poor supply of "spare" embryos. It is not appropriate that embryos donated for research should be used to train staff and it could be argued that the HFEA is acting illegally by awarding research licences in the knowledge that the primary purpose is training. Furthermore, training in the handling of embryos should not be limited to those centres that are undertaking research. Training staff to handle embryos for the purposes of providing treatment should be possible under treatment licences as long as it is made clear to donors of embryos what they will be used for.

THERAPEUTIC RESEARCH

174. The 2001 Research Purposes Regulations were intended to clear the way for human embryonic stem cell research, including research using cells from derived embryos. To a great extent this has been the case now that the status of the embryo has been resolved at the Court of Appeal. The issues surrounding such research were addressed by the House of Lords Select Committee on Stem Cell Research in 2001. It reached the following conclusions:

a) If the full therapeutic potential of all forms of stem cell are to be realised, fundamental research on ES cells is necessary, particularly to understand the processes of cell differentiation and dedifferentiation;

b) The Government should take an active part in any move to negotiate an international ban on human reproductive cloning;

c) The Department of Health should examine with the HFEA the possibility of drawing up indicative guidance as to what constitutes serious disease for the purposes of the Regulations;

d) When the Government brings forward legislation it should consider making express provision for such basic research as is necessary as a precursor for the development of cell-based therapies;

e) A regulatory body to regulate clinical research using stem cells would become necessary;

f) A stem cell bank should be set up and, before granting any new licence to establish human ES cell lines, the HFEA should satisfy itself that there are no existing ES cell lines in the bank suitable for the proposed research.

175. Eleven research projects relating to embryonic stem cells have now been licensed. Two licences- one to the Newcastle Fertility Centre at Life, and one jointly to the Roslin Institute and King's College, London - have been awarded for therapeutic cloning.[226] Nevertheless, there are some outstanding issues concerning the adequacy of the drafting of the research purposes regulations. The House of Lords Stem Cell Research Committee expressed concern about the new regulations' ability to provide for this basic research:

227

The derivation of embryonic stem cell lines is not a straightforward matter, as researchers from Newcastle and King's College London explained at the HFEA's Research Conference in November 2005, nor is the process of cell nuclear replacement. Professor Alison Murdoch estimates that it takes 100 "spare" embryos to create a single stem cell line.[228] Valuable basic research could be undertaken in perfecting these techniques yet it would yield no information on serious disease, nor arguably increase knowledge about the development of embryos.

Stem cell bank

176. The HFEA makes it a condition of licences for research on stem cells that "Applicants will be required to place a sample of all cell lines in the UK Stem Cell Bank".[229] There are concerns, expressed by the Wellcome Trust and others, that the guidelines for the UK Stem Cell Bank will impose restrictions on the purposes for which cell lines can be used.[230] Professor Alison Murdoch told us "We should not have regulations for the sake of it, we should look at the risks and what we are trying to protect against and I think the risk of what you are doing in the lab helping to learn how stem cells grow is actually very small".[231] Professor Peter Andrews from Sheffield University agrees that regulation of stem cell lines should be kept to a minimum, since "Once a line of hES [human embryonic stem] cells has been established in culture, it is just that - namely a group of cells, and it is no longer an embryo. […] At this stage, the major ethical milestone, namely whether or not to use an embryo to derive an ES cell line, has been passed".[232]

177. The UK Stem Cell Bank's Code of Practice has no legal force; however, its draft Code states that embryonic stem cell lines may be used only for:

a) Research which has the long term goal of helping to increase knowledge about serious diseases and their treatment;

b) Basic cell research which underpins these aims; and

c) Development of cell-based therapies for clinical trials in respect of serious human diseases.

178. The first criterion reflects the wording of the research purpose regulations. The second takes into account the concerns of the Lords Stem Cell Research Committee. However, in combination, the two criteria are inconsistent with Professor Andrews's hope that further limits on the use of the cell lines should not be imposed. The Steering Committee has clearly stated its desire to be consistent with the will of Parliament and the Lords Stem Cell Research Committee but we are unconvinced that consistency in this case has much merit. On ethical grounds there is little basis for providing such protection for a cell culture, and on scientific grounds it is unfortunate that researchers cannot use the cell lines to tackle a wide range of diseases that are causing great discomfort and impose a huge burden on the NHS.

179. The inconsistencies highlighted above expose the illogicality of the regulations passed in 2001. If a research team wished to derive stem cells to research therapies for a "trivial" disease, these would be deposited in the stem cell bank and there is every likelihood that another research team would use the cell line to research a "serious" disease. We believe that the creation of a stem cell line should be grounds in itself for awarding a licence.

Stem cells and clinical trials

180. The House of Lords Stem Cell Research Committee noted that, when the prospect of clinical studies involving gene therapy emerged, the Gene Therapy Advisory Committee (GTAC), was established by the Department of Health to provide further oversight of such studies from scientific, medical, safety and ethical standpoints. It identified a need for a body to regulate clinical trials involving embryonic stem cells when this stage was reached and recommended either the creation of a body like GTAC or the extension of its remit. While this has merits, we believe that given its expertise the Government should give consideration to extending the role of the stem cell bank include the regulation of clinical trials.

Stem cell research funding

181. We have not sought to investigate the funding of stem cell research; however, in the course of this inquiry, our attention has been drawn to some funding issues. We are aware that one of the Roslin Institute's Dolly team, Alan Colman, left to continue his research in Singapore because of the greater financial support there. In a Californian referendum, known as Proposition 71, researchers in California are now eligible for $295 million a year for 10 years to work on embryonic stem cell lines, despite the ban on federal US funding being used for this purpose. Although there may be practical problems in California (the research must be carried out in facilities without federal funding), we have concerns that the UK's position as a "world leader in embryonic stem cell research" is under threat.[233] We have noted with great interest Sir Chris Evans's plans to set up a £100 million stem cell research foundation. The Research Councils have recently begun a £40 million two year cross-Council programme for stem cell research, which will fund projects running over several years.[234] The budget allocations for the 2004 Spending Review were published in March 2005 without any specific reference to stem cell research. We recognise that the Research Councils have no interest in investing in research teams if they have no interest in sustaining them in the medium term. However, we recommend that they monitor the success of applications in this area made in open competition and bid for ring-fenced funds in future Spending Reviews if funding in stem cell research projects declines.

CONCLUSION

182. When the HFE Act was passed, the five allowed research purposes all related to fertility. However, it could be argued that, when the research purposes were extended to embrace therapeutic research, this covered all the reasonable grounds for which embryo research could be undertaken. An alternative approach would be to remove research purposes from legislation but ensure that there is rigorous peer review of any proposal involving embryos. Professor Murdoch told us "one possibility of restructuring the Act is that you actually avoid putting these dogmatic statements in primary legislation and maybe devolve that to a secondary body of the good and great […] That will give us the flexibility to move on much more quickly than having to do it as we did with nuclear transfer, go back to primary legislation and actually change the Act to do it".[235] Baroness Warnock has regretted that her report employed the term "respect" with regard to the embryo but said, in 2002, that the word was used to mean that "the early embryo should never be used frivolously for research purposes".[236] It is debatable whether the MRC would fund frivolous research. A problem here is that the MRC is by no means the only funder of embryo research. The Warnock Committee made it clear that research applications received by the HFEA should have been scientifically peer reviewed.[237] We discuss the research licensing process in relation to ethical oversight and make recommendations for a new approval system for embryo research in paragraph 331-342.

Criminality and compliance

BREACHES OF THE HFE ACT

183. Section 41 sets out the offences for breaching the provisions of the HFE Act or contravening licence conditions. In the cases of placing in a woman a live embryo other than a human embryo or any live gametes other than human gametes, mixing animal and human gametes, placing a human embryo in an animal or keeping or using an embryo after 14 days, the penalty is up to 10 years in prison. We have commented on the various prohibitions in the HFE Act and concluded that legislation should be more flexible, particularly with regard to research (see paragraphs 331-342). We are also concerned by the size of the maximum sentence. That the embryo only gradually acquires human rights is a widely accepted view. In this light, the maximum sentence of 10 years for breaching some of the prohibitions in the HFE Act seem unduly harsh.

Person responsible

184. The HFE Act (Section 17) demands that centres conducting licensable procedures nominate a person responsible "under whose supervision the activities authorised by a licence are carried on". The legal status of this person was tested recently in a case of an embryologist at two clinics in Hampshire at which women were deceived into mistakenly believing that embryos had been implanted. In a key judgement it was concluded that the person responsible was not criminally liable. However, the embryologist was found liable and sentenced to 18 months in jail. This is the only prosecution under the HFE Act. The Royal College of Obstetricians and Gynaecologists says that "The role of the 'person responsible' is unclear when a misdemeanour extends beyond their immediate practical remit[…] It seems inappropriate that sanctions should apply specifically to one person and that these sanctions are only within the Criminal law".[238] The British Fertility Society argues that implementation of the NICE guidelines will shift provision to the public sector and that, since NHS governance is robust, "the role of the 'person responsible', unique in the health care setting, should be replaced by the more conventional model of lead clinician, clinical director or lead scientist. Accountability for compliance with the regulatory requirements must fall to the Chief Executive (in the NHS model, or similar functionality in the private sector) as it does with all other aspects of health care".[239] The legal role of the person responsible is outdated. While the law did not confer liability on the person responsible for the misdemeanours of a member of staff, it still seems sensible to separate responsibility in respect of compliance with the HFE Act and compliance with technical standards. Standards would become the responsibility of the Trust Chief Executive (or equivalent in the private sector) while responsibility for compliance with the provisions of the HFE Act would be retained by a senior member of the clinic.

BREACHES OF REGULATION

185. Non-compliance with the Code of Practice, conditions of licences and directions is not an offence under the HFE Act but the HFEA is given the powers to consider any breaches when renewing licences. The HFEA has suggested that it needs a wider armoury of sanctions to "give the Authority more teeth in addressing situations which might require a firm response, but where suspension or revocation of the licences could not be justified".[240] Dr Simon Thornton of the Park Hospital in Nottingham agrees that, while the HFEA can impose conditions on a licence, the only available penalty is the removal of the licence, which he describes as "a fairly blunt instrument".[241] However, Section 22 of the HFE Act allows the Authority to suspend a licence with immediate effect for up to three months where it believes it has grounds for revocation of a licence, thus enabling clinics to sort out something that is potentially very serious but appears remediable. The clinic is able to keep the stored gametes but can address risks identified in the provision of treatment that have not been addressed.

186. The Epalan management consultancy highlights the conflict between the HFEA's role in promoting risk management in centres and its ability to revoke licences: "the body which is responsible for the alert system is also the body that is responsible for holding licensed centres to account for their failings and imposing sanctions where they see fit. There is an inherent conflict between these two roles and this is certain to impact upon centres' openness and willingness in reporting incidents or near misses where they believe it could have an adverse impact upon their licensing".[242] We agree that the regulator needs a wider range of sanctions but we are concerned that the emphasis is on penalty and not on improving standards and systems. The incompetent and the unethical needs to be closed down but the vast majority in the middle need to operate in a regulatory environment which encourages them to improve. There should be no deterrent to self-reporting.

187. According to Sarah Elliston from Glasgow University, standards of practice might be thought to be most appropriately dealt with by professionally-led bodies with relevant expertise in issuing evidence-based guidelines. She suggests that non-compliance might be dealt with by the common law or by regulatory bodies such as the General Medical Council (GMC) in terms of failure to meet standards of professional practice. Alternatively it could be dealt with by legal regulation that requires practitioners to comply with professional practice guidelines, although this would be an unusual step. A further option would be for an independent body, such as the present HFEA, to itself issue guidelines on acceptable standards and to make compliance with them a condition of treatment, under a scheme such as licensing.

PROFESSIONAL DISCIPLINE

188. There is a large number of professional bodies regulating the conduct of healthcare professionals. In April 2003, on the basis of the report of the Bristol Royal Infirmary Inquiry chaired by Sir Ian Kennedy, the Government established the Council for the Regulation of Healthcare Professionals (now the Council for Healthcare Regulatory Excellence, CHRE) under the NHS Reform and Health Care Professions Act 2002.[243]The CHRE is a statutory overarching body, covering all of the UK and separate from Government. It promotes best practice and consistency in the regulation of healthcare professionals by nine regulatory bodies, including the GMC. The CHRE can appeal against unduly lenient judgements by the regulatory bodies. A notable example is the referral of the GMC's decision in the case of Professor David Southall, a consultant paediatrician who had accused a father of murdering his two babies after watching a television documentary. He was found guilty of professional misconduct but was not struck-off.

189. The law gives the GMC four main functions:

a) Keeping up to date registers of qualified doctors;

b) Fostering good medical practice;

c) Promoting high standards of medical education; and

d) Dealing firmly and fairly with doctors whose fitness to practise has been questioned.

190. The GMC has set out the duties of a doctor and issued guidelines on Good Medical Practice (see Box 7). To our knowledge, no doctor engaged in IVF has been subject to GMC sanction, although, in April 2002, the GMC decided not to proceed with its case against Professor Ian Craft, director of the London Fertility Centre. He had faced charges of serious professional misconduct for ignoring medical guidelines in treating a woman in her forties and for mistakenly implanting gametes in a faulty fallopian tube.[244]

Box 7:

Duties of a doctor

§ Make the care of your patient your first concern;

§ Treat every patient politely and considerately;

§ Respect patients' dignity and privacy;

§ Listen to patients and respect their views;

§ Give patients information in a way they can understand;

§ Respect the rights of patients to be fully involved in decisions about their care;

§ Keep your professional knowledge and skills up to date;

§ Recognise the limits of your professional competence;

§ Be honest and trustworthy;

§ Respect and protect confidential information;

§ Make sure that your personal beliefs do not prejudice your patients' care;

§ Act quickly to protect patients from risk if you have good reason to believe that you or a colleague may not be fit to practise;

§ Avoid abusing your position as a doctor; and

§ Work with colleagues in the ways that best serve patients' interests.

In all these matters you must never discriminate unfairly against your patients or colleagues. And you must always be prepared to justify your actions to them.

Good Medical Practice

The third edition of the GMC's Good Medical Practice covers:

§ Good clinical care;

§ Maintaining good medical practice;

§ Teaching and training, appraising and assessing;

§ Relationships with patients;

§ Working with colleagues;

§ Probity; and

§ Health.

191. The HFEA and the GMC have a memorandum of understanding setting out cooperation and collaboration in relation to licensed assisted conception services. In terms of this, the HFEA may identify for the GMC in the course of an inspection or licence application an issue that might raise a question about an individual doctor's fitness to practise.[245] The multiple murders carried out by Manchester GP Harold Shipman prompted the Shipman Inquiry to consider the role of the GMC in regulating the medical profession. Dame Janet Smith, Chairman of the Inquiry, concluded in its fifth report that "I have been driven to the conclusion that the GMC has not, in the past, succeeded in its primary purpose of protecting patients. Instead it has, to a very significant degree, acted in the interests of doctors".[246] In response to the Shipman Inquiry the Secretary of State for Health, John Reid, asked Liam Donaldson, the Chief Medical Officer, in January 2005 to conduct a review into patient safety to report later in 2005. The review will identify measures to:

a) Strengthen procedures for assuring the safety of patients in situations where a doctor's performance or conduct poses a risk to patient safety or the effective functioning of services;

b) Ensure the operation of an effective system of revalidation; and

c) Modify the role, structure and functions of the GMC.[247]

192. The primary aim of healthcare regulation should be to protect patients. We believe that this can best be achieved by creating a culture in which good practice is encouraged rather than the focus being on penalising poor service. If individual practitioners have performed below acceptable standards, the professional regulators should act in a manner that protects patients. We recognise the Government's efforts to improve professional regulation through the creation of the Council of Healthcare Regulatory Excellence. While these changes need to "bed down", we welcome the commitment to strengthen regulation.

40 Lord Bingham of Cornhill, House of Lords, Session 2002-03, 13 March 2003[2003] UKHL13 Regina v. Secretary of State for Health (Respondent)exparte Quintavalle (on behalf of Prof-Life Alliance)(Appellant) Back

41 Ev 323 Back

42 Q 888 Back

43 See paragraphs 376-377 Back

44 Q 881 Back

45 Q 888 Back

46 Q 202 Back

47 Lee M Silver, Watch What You Are Calling an Embryo; And Other Subtleties That Define the Debate, The Washington Post, 19 August 2001 Back

48 Ev 262 Back

49 Section 3 Back

50 The Act specifies the replacement of an embryo's nucleus and therefore does not cover the cloning technique developed at the Roslin Institute which used an enucleated egg. Back

51 HL Deb, 6 March 1990, col 1055 Back