6.0.1 The Select Committee has set out certain questions to which we here respond. However, we are not thereby endorsing these as the most pertinent questions which could be asked, and our answers cannot be taken as a summary of this Submission (a summary is provided before the Introduction, S.1 7).
6.1 Do the additional purposes in the 2001 Regulations raise issues of principle different from the purposes specified in the 1990 Act?
6.1.1 Yes, destroying human embryos in stem-cell research leads to new questions of conscience (4.5.1-5; 5.3.4); furthermore, the interpretation of these regulations as allowing cloning for research raises the question of the ethical legitimacy of cloning (4.4.1-2; 4.6.1-6), and also the question of whether and how to promote alternative avenues of research (5.2.1-5). However, the most important issue of principle is one already compromised in the 1990 Act and which urgently needs to be reviewed; i.e. the legitimacy of producing and using human embryos for destructive research (4.1.1-4.3.3).
6.2 There is a range of different views world-wide on the acceptability of research on embryonic stem cells. What considerations underlie these differences? Do changes in the law here have implications for practice overseas and vice versa?
6.2.1 Those who accept embryonic stem-cell research either see no ethical objection to what seems to be a beneficial technical advance or else they have accepted the overriding necessity of this form of research.
6.2.2 Those who object do so for many different reasons. What they have in common is that they are unconvinced by claims of the imminence of the prospective benefits and/or by claims of the necessity of research using these means (2.1.1-2.2.5). Many also hold that there are ethical objections in principle to this kind of research (4.1.1-5.1.9; 5.3.1-4).
6.3 Have increased globalisation and other international commercial developments, in relation, for example, to e-commerce and patenting, changed the context of the debate in the UK? Would issues relating to research on embryos benefit from more attention at international level?
6.3.1 Yes scientific research and development is now an international endeavour and effective regulation and maintenance of ethical standards requires international co-operation. If one country allows unethical research then it will quickly attract those wishing to avoid restrictions placed on research in their own countries. Such international research tourism is already apparent with some fertility treatments, and cloning would surely follow this pattern. As international co-operation is essential, it is important to pay close attention to the concerns of international partners when framing domestic legislation in this area (5.3.1-2).
6.4 What are the potential medical benefits of stem cell research? What is the most likely time-scale for realising them? What are the potential risks?
6.4.1 There are great potential benefits from stem-cell research for a range of diseases. Some patients are already benefiting from (adult) stem cell research; however, for other conditions it will take many years before we see results at the clinical level.
6.5 There are differing views on the extent to which potential treatments could be developed from non-embryonic stem cells, such as adult and umbilical cord stem cells. What are the advantages and disadvantages of working with these alternative sources of stem cells?
6.5.1 Treatments using adult and umbilical cord stem cells are already being carried out for some conditions (2.1.1-2.2.5). It is clearly best if the patient's own cells can be used to avoid rejection problems. Cloning has been mooted as a way to avoid these problems; however, the high rate of genetic abnormality found in animal clones casts doubt over the safety of cloning for transplantation (2.4.1).
6.5.2 Another advantage of adult stem cell research is that human ova (already a scarce resource in fertility treatment) are not required to generate adult stem cells.
6.5.3 Adult stem cells are also more stable and less inclined to produce cancer or disorganized growths (2.2.1-4; 2.4.1).
6.6 What are the commercial interests involved in research in this area? Does increased commercial involvement create additional ethical difficulties?
6.6.1 Biotechnology companies have invested heavily in cloning and embryonic stem cell patents. Commercial interests endanger the clarity of the ethical discussion as commercial benefits may distort the fair presentation of the medical benefits.
6.7 Human reproductive cloning (the transfer of an embryo created by cell nuclear replacement into a woman's uterus) is unlawful in the UK, and the Government has announced its intention of reinforcing this ban by specific primary legislation. Is there likely to be any pressure to resist such a ban? What are the principal ethical (and scientific) arguments against human reproductive cloning?
6.7.1 If it has proven politically difficult to block research on cloned embryos, even though this is unnecessary and unethical, it may also prove difficult to block requests that some clones be allowed to come to term to fulfill the desire of an infertile couple for a child.
6.7.2 Cloning for birth is objectionable: first, as it would involve the creation of hundreds of damaged embryos, most of whom would miscarry; second, as it would impose significant risks on the gestating mother; and third, as the clone would be produced asexually and according to a predetermined genetic plan. Cloning would deprive the child of natural parentage and genetic novelty and subject him or her unfairly to the desires of the commissioning parents (4.6.1-7).
6.7.3 All cloning, including “therapeutic cloning”, is reproductive in the sense that it generates a new embryonic individual (1.3.2-4). In any primary legislation, human reproductive cloning should be defined as “cloning for the purpose of implantation'. It is the initial generation of the clone embryo which should be prohibited, not the implanting of a clone embryo who already exists.
6.8 Does the extension of embryonic stem cell research, and, in particular, the technique of cell nuclear replacement therapy (therapeutic cloning) - designed to grow tissue for therapeutic purposes - increase the likelihood of human reproductive cloning in the future?
6.8.1 Yes it is clear to everyone that cloning for research facilitates cloning for birth both technically and politically (4.4.2).
6.8.2 It should, however, be made clear that generating clones who will then be destroyed in the course of “harvesting” their cells is itself seriously wrong irrespective of the fact that it might lead to cloning for birth. Indeed, in its treatment of the clone embryo, “therapeutic cloning” is a greater injustice than “reproductive cloning” (3.3b.6-7).
6.9 Has the regulatory framework established by the 1990 Act operated effectively? Is it likely to remain adequate for the foreseeable future? Have any gaps appeared in the regime as a result of developments since 1990?
6.9.1 The 1990 Act presumed the legitimacy of creating embryos in the course of fertility treatment who would not be implanted, and even of creating embryos purely for the sake of destructive research. As these procedures are both unethical, the regulatory framework could never have “operated effectively” in any ethical sense.
6.9.2 The intention of the statutory instrument seems to presuppose the existence of a significant gap, in that the 1990 Act forbade one technique of human cloning but did not envisage cloning by the “Dolly” technique. It is remarkable that this gap should be thought a sufficient basis for the regulation of such an ethically contentious issue as the creation and use of cloned human embryos.
6.10 Do additional guidelines need to be developed to assist the Human Fertilisation and Embryology Authority in issuing licences in accordance with the new Regulations? If so, what should the guidelines contain?
6.10.1 If fundamental ethical principles have already been compromised in the framing of the Regulations themselves, it is difficult to see what could be the ethical basis of any further guidelines. Additional specification could perform only a cosmetic or a rhetorical function, not the function of specifying in greater detail valid ethical principles.
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