Select Committee on Stem Cell Research Report


CHAPTER 8: LEGISLATION AND REGULATION

The existing regulatory regime

8.1 The regulatory system established by the 1990 Act has worked well. The lynchpin of the system is the HFEA. Its work is highly regarded, both at home and abroad. It appeared from the evidence we received that it has the full confidence of the scientific and medical research community, and we believe that it has also been instrumental in reassuring the public that regulation in a particularly emotive area of public policy is carried out effectively and sensitively. It is striking that there have been few legal challenges to the HFEA's rulings and that media criticism has often been on the ground that the Authority is too strict rather than too lax.

8.2 Those opposed in principle to the 1990 Act are understandably unsympathetic to the work of the HFEA, and a few of our witnesses commented on aspects of its work which are outside our terms of reference. Within the field of research on early embryos we received no evidence of any instance where the HFEA's handling of applications under the Act had been the subject of criticism. Some witnesses expressed the fear that, in reviewing applications for research on embryonic stem cells, insufficient attention would be paid to alternatives using adult stem cells (or animals). One witness drew attention to the risk of research applications being peer-reviewed by experts sympathetic to the methodology proposed.[54] We have not received any evidence to support this criticism. The HFEA uses the most distinguished people in the field, from other countries if necessary, to peer-review applications and it is very conscious of its statutory duty to be satisfied that any proposed use of embryos is necessary for the purposes of the research, and that they cannot be achieved by other means.[55] Its approach has not been subject to legal challenge.

8.3 Nevertheless, as the HFEA is very well aware, the 2001 Regulations require it to take a view of areas of scientific enquiry that it did not previously need to consider. The purposes in the 1990 Act are all related, one way or another, to reproductive medicine, whereas applications under the Regulations will be for research relevant to a range of serious diseases and for fundamental research that underlies it. In its evidence to us the HFEA fully recognised the need to call upon a much wider range of experts to advise it on applications under the Regulations.

8.4 As explained in Chapter 2, developments in research on adult stem cells have been proceeding at a great pace. It is possible that at some stage in the future research on adult stem cells will make further research on ES cells unnecessary. It is therefore important that the HFEA also keeps these developments under continuous review. The 1990 Act provides an in-built legislative brake on research on human embryos, since each proposal must be reviewed to ensure that the same results could not be achieved by other research, including research on animals or on adult stem cells. However, we believe that, in addition to this safeguard, a more strategic examination of the potential of adult stem cells is required in the not too distant future. At an appropriate time, perhaps towards the end of the decade, the Government should undertake a further review of scientific developments, particularly of the progress of adult stem cell research and therapies, and of the development of stem cell banks, with a view to determining whether research on human embryos is still necessary.

8.5 The Regulations have the potential to extend the HFEA's area of responsibility quite substantially. To maintain its effective regulation of research on human embryos, and to maintain public confidence, it is essential that it should be properly resourced for these additional functions. It is too early to judge the effect of the Regulations on the HFEA's future workload (so far only two applications have been made under them). But the Government should keep the funding of the HFEA under review and ensure that it is commensurate with its increased responsibilities.

Review of outcomes of research undertaken under the 1990 Act

8.6 The existing regulatory regime works well in ensuring that applications for licences are carefully considered against the requirements of the Act and that researchers comply with the conditions of their licences. That is, rightly, its main focus. But it is also important to assess whether the research achieves its objectives and realises the benefits claimed for it in the licence application. We believe that there should be a greater focus on outcomes. The public is entitled to know whether the claims made for human embryo research have been realised. The HFEA is probably best placed to undertake a review of this kind since it will have approved the original licence applications and can best judge whether they achieved the purposes in the Act and the Regulations. We invite the HFEA and the Department of Health to consider how a review of the outcomes of research licensed under the Act might be undertaken and updated on a regular basis.

The drafting of the Regulations

"SERIOUS DISEASE"

8.7 We looked at two aspects of the drafting of the Regulations in some detail. The first was the use of the term "serious disease". The 1990 Act itself refers to increasing knowledge of disease, without qualification. It was clear from the debates on the Regulations that Ministers expected the HFEA to adopt a common-sense approach, but they only offered very general guidance by reference to examples of diseases that they would regard as serious.

8.8 "Serious disease" is not a term that is defined in other statutes (although in other contexts there are references to "serious disability") and we believe that it would be helpful to have a clearer indication of what it is intended to cover. It is uncertain whether it means serious for the individual or serious for society (the debates suggested that Ministers had the former in mind); and whether it is wide enough to encompass serious injury (to the spinal cord, for example) as well as disease. Moreover, if research properly directed at serious disease later proves to have a useful secondary application for "non-serious" disease, that application should not be ruled out by the fact that the initial research must be relevant to serious disease. We accept that an exhaustive list of serious diseases would be difficult to frame satisfactorily and might involve making invidious distinctions. It would be less difficult to include in the Regulations an indicative list which gave some central examples while making clear that it was not exhaustive. A further possibility would be for the Department of Health or the HFEA to issue non-statutory guidance on the matter. We consider that this last possibility would be the most flexible and would meet the need best. We invite the Department of Health to examine with the HFEA the possibility of drawing up indicative guidance as to what constitutes serious disease for the purposes of the Regulations.

APPLICATION OF THE NEW PURPOSES TO BASIC RESEARCH

8.9 Secondly, it was suggested to the Committee by several witnesses that the Regulations are ultra vires the 1990 Act. On the face of it this is a puzzling suggestion because the Regulations reproduce almost verbatim the terms of the principal enabling provision in the 1990 Act, and this claim was not pursued in the judicial review. However, we did look at the drafting of the Regulations in the light of the way the 1990 Act is framed and the current focus of stem cell research.

8.10 ES cell research and CNR were not in prospect when the Act was passed and we have considered how applications to undertake them would relate to the purposes in the Regulations (the wording of which, as mentioned above, follows closely the terms of the Act). As described in Chapter 2, work on stem cells is at a very early stage and a good deal of basic research is required before the stage of more applied research is reached. Whilst it may be possible to justify basic research as (eventually) leading to a treatment for serious disease, it is not altogether clear how such research is to be connected strictly to the new purposes. For example, if research is directed at increasing understanding of how cells behave and, in particular, of the mechanisms by which they differentiate and dedifferentiate, it is not immediately obvious how this increases knowledge about the development of embryos, or about serious disease, or about the application of such knowledge to the development of treatments.

8.11 We asked the HFEA how it proposed to consider such applications. The Authority told us that it had received counsel's opinion to the effect that, where an application is directed at understanding how human stem cells behave and differentiate, such research "may be appropriately described" as being concerned with increasing knowledge about the development of the embryo (purpose (a) in the Regulations). In the same opinion, the Authority has been advised that, where such basic research moves beyond purpose (a), consideration will need to be given to whether it falls under purpose (b) (increasing knowledge about serious disease) or (c) (development of treatments for serious disease). Further, counsel has advised that, whilst purpose (b) is confined to "research that may reasonably be anticipated to advance knowledge of the [serious] disease, not the treatment of the disease", purpose (c) may be relevant because it allows for research to be licensed where the purpose is to apply knowledge about the development of embryos with a view to developing treatments for serious disease. On this reading of the Regulations basic research on human embryonic stem cells might be authorised initially under purpose (a), with further applications being subsequently made under purpose (c) when understanding of cell differentiation has reached a point at which treatments for serious disease might be developed.

8.12 An alternative approach, permitting the language of the Regulations to take account of the background legislative purpose (underlying the 1990 Act and the 2001 Regulations), might be encouraged by the Master of the Rolls' judgment in the Pro-Life Alliance case.[56]

8.13 In that case the Master of the Rolls' approach to statutory interpretation draws on guidance given by Lord Wilberforce in Royal College of Nursing of the United Kingdom v Department of Health and Social Security.[57] Lord Wilberforce addressed the question of how far the courts can go in judging that new developments (concerning prostaglandin induction methods of carrying out abortions) fall within Parliament's intention (in the Abortion Act 1967). According to Lord Wilberforce, new developments may be held to come within the legislative intention "if they fall within the same genus of facts as those to which the expressed policy has been formulated…[or] if there can be detected a clear purpose in the legislation which can only be fulfilled if the extension is made."[58] However, he emphasised that these principles are to be applied in a way that is sensitive to the legislative context:

    "How liberally these principles may be applied must depend upon the nature of the enactment, and the strictness or otherwise of the words in which it has been expressed. The courts should be less willing to extend expressed meanings if it is clear that he Act in question was designed to be restrictive or circumscribed in its operation rather than liberal or permissive."[59]

He made it clear, however, that gap-filling as such is strictly prohibited:

    In any event there is one course which the courts cannot take, under the law of this country; they cannot fill gaps, they cannot by asking the question 'What would Parliament have done in this current case—not being one in contemplation—if the facts had been before it?' attempt themselves to supply the answer, if the answer is not to be found in the terms of the Act itself.[60]

Significantly, having laid down these guidelines, Lord Wilberforce judged that the extension to the Abortion Act argued for by the Department involved a radical reconstruction of the legislation and was a matter calling for Parliamentary rather than judicial attention.[61]

8.14 Applying Lord Wilberforce's principle in the present context, the key question would be whether the legislative policy was judged to encompass basic research on human embryos (at any rate, where such research is a necessary precursor to the development of therapies for serious diseases). If the legislative purpose were to be so judged, then it would not matter that the particular line of research (involving ES cells or CNR, for example) had neither been specifically foreseen by Parliament nor expressly provided for in the legislation. And, provided that the particular basic research activity was sufficiently closely connected to recognised therapeutic objectives, it would be covered by the Regulations.[62]

8.15 It is not for us to express an authoritative view on the interpretation of the Regulations. However, it is in the nature of the science that, before research into ES as well as adult stem cells can lead to therapeutic applications, there must be basic research; and, given that the Regulations explicitly recognise the development of treatments for serious diseases as one of the new purposes, it would be perverse if basic research were not implicitly incorporated. The Committee confidently believes that Parliament cannot have intended to will the therapeutic end without also willing the necessary means to that end and has no doubt that the HFEA should consider applications made under the Regulations in accordance with the legal advice it has received. Nevertheless, to put the matter beyond any possible doubt, when the Government bring forward legislation they should consider making express provision for such basic research as is necessary as a precursor for the development of cell-based therapies.

Future legislation

8.16 Under the Human Reproductive Cloning Act 2001 placing a CNR embryo in a woman is a criminal offence. Following the Court of Appeal judgment of 18 January 2001, research on CNR embryos is subject to direct regulation by the HFEA. There is an argument that, irrespective of the final outcome of the case, the HFEA retains an indirect form of control over CNR. This is because CNR requires a supply of eggs, and because the storage of eggs is regulated by the HFEA, then to the extent that it involves the storage of eggs CNR falls within the regulatory ambit of the HFEA.

8.17 If the case were to go to the House of Lords and the Government lost the final appeal, there would be a need, as Ministers have acknowledged, for urgent legislation. Even if the Court of Appeal's judgment stands, it is likely that there will be a need for further legislation at a fairly early date to take account of developments that have taken place since 1990.

8.18 The Donaldson report identified a gap in the 1990 Act in that it did not control the mixing of animal eggs with other human cells. It recommended that the mixing of adult (somatic) cells with the live eggs of any animal species should not be permitted, although it did not discuss the thinking behind this recommendation.[63] We are aware of reports of experiments in other countries involving the replacement of a nucleus of an animal egg with the nucleus of an adult human cell. These developments raise important issues. It would clearly be totally unacceptable to implant such an entity in a woman with a view to bringing it to term—and that would be prohibited by the Human Reproductive Cloning Act 2001. For any possible therapeutic applications there would also be significant concerns relating to safety, on which reassurance would be needed. However, if placing a human nucleus in an animal egg provided a way of creating human ES cells for research, some might argue that it was more acceptable to use such an entity for research, the creation of which involves no human gametes, than an embryo created by CNR.

8.19 More generally, the Committee is aware of the very rapid pace at which scientific advances are being made in this field. Only a few years ago the procedure of cell nuclear replacement would hardly have been given credence. It is likely that in the not very distant future there will be further new developments. Some of these possibilities have already been brought to our attention, although publication in reputable journals has not yet occurred in all cases.[64] For example, with greater scientific understanding it may prove possible to:

    (a)  dedifferentiate an adult stem cell to generate the equivalent of a zygote by growing it in the right conditions, circumventing the need for cell nuclear replacement;

    (b)  generate an embryo from an oocyte without the need for fertilisation by sperm;

    (c)  induce the processes of differentiation and redifferentiation more easily using animal rather than human material, for example materials from an animal egg rather than a human egg. Doctors frequently use animal materials in human therapies, but using materials from animal gametes raises separate questions;

    (d)  induce ES cells to develop into an early embryo (blastocyst) in the laboratory.

8.20 These possible developments raise issues that are beyond our remit. But they clearly need to be kept under review and a separate study of the scientific and ethical implications of using such methods for research in preference to early human embryos may be called for.

Informed consent

8.21 Informed consent is especially important in all research on tissues of human origin. From the evidence we have received, and the people we have talked to informally on our visits, we are satisfied that it is, quite properly, taken very seriously indeed by researchers and by the HFEA. For example, every effort is made to ensure that people undergoing IVF treatment who are invited to donate surplus eggs or embryos for research understand fully what is involved, and that they are given relevant information and the time to consider it. Wherever possible, steps are taken to ensure that the person providing the IVF treatment is not the same as the prospective researcher, to avoid the risk—real or perceived—of moral pressure being brought to bear on potential donors. In the United States people may be paid large amounts of money for gametes, particularly eggs, which makes it much more difficult to ensure that consent is genuinely freely given. We recommend that the separation of clinical and research roles be standard practice for donation of eggs or embryos. The prohibition in the United Kingdom of payment to donors for gametes has been an important element in preventing undesirable commercialisation of this aspect of assisted reproduction and should be strictly maintained.

Custody and regulation of stem cell lines

8.22 As explained in Chapter 2, ES cell lines can be grown in culture in principle indefinitely. Three applications have been approved under the 1990 Act which could lead to the development of human ES cell lines in the United Kingdom. Applications under the Regulations will almost certainly lead to more ES cell lines being developed in the United Kingdom and lines developed overseas have already been imported. At present responsibility for research using human embryos rests with the HFEA. However, ES cells are not embryos and the HFEA is not responsible under the 1990 Act for ES cell lines. There is consequently considerable urgency in deciding how these lines should be maintained and what degree of regulation, if any, they require.

8.23 We distinguish here between ES cell lines to be used for research and ES cell lines which, may, ultimately, be used for therapeutic purposes. Therapeutic application of ES cells or cells/tissues derived from them is still some way off. If and when it does happen, existing controls will come into operation, including those operated by the Medicines Control Agency.[65] 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. The Committee invites the Department of Health to consider either establishing a similar body with oversight of clinical studies involving stem cells, or extending the membership and remit of GTAC to achieve the same ends. The Committee sees no other special need at present for additional regulation of the use of stem cells in the treatment of patients.

8.24 A more pressing question is what, if any, arrangements are necessary for the oversight of ES cell lines used for research purposes once they have been derived from the embryo. In considering this issue we have been especially concerned to minimise the need to generate new ES cell lines (and consequently minimise the use of embryos for research) while not impeding scientific and medical progress. The Department of Health submitted a supplementary memorandum on the regulation of the use of ES cells.[66]

8.25 The starting point of the Committee's analysis is (as with human embryos themselves) the status of the ES cell lines. They are a human tissue and need to be treated on a similar basis to other human tissues used for research. The sensitivity of using different human tissues varies according to their nature and source. Particular sensitivities attach to certain types of tissue, for example human foetal and embryonic material. However, ES cells once established as a line, are not embryos, and the Committee does not see a need for special arrangements to be made beyond those, such as informed consent (see below), applying to the use of other human material. The logic of this analysis is that the use of established ES cell lines does not require the sort of regulation to which human embryo research is currently subject by the HFEA.

8.26 The Department of Health has asked the Medical Research Council (MRC) to take the lead in considering the establishment of an ES cell bank. Following discussions between the MRC, the Department of Health, the HFEA and other agencies, there is a measure of agreement on the need for such a bank and that the MRC should be responsible for it. The bank would provide scientists with ready access to ES cell lines of guaranteed purity and provenance, and from sources which operate ethically-approved standards. The Department of Health proposes that rules governing what can be deposited in and withdrawn from the bank should be established by a steering committee. Among the matters the rules would cover would be knowledge of the source of the stem cells, obtaining the consent of the donor, and establishing a full history of their storage and handling under good laboratory conditions.

8.27 The Committee believes that the steering committee should also take responsibility for establishing codes of conduct for the use of ES cells, whether obtained from the bank or imported from elsewhere. The bank, should use its best endeavours to ensure that, in addition to ES cells generated in the United Kingdom, it includes ES cell lines of appropriate provenance that have been generated overseas, although we acknowledge that it will not be possible (or even appropriate) to obtain all such ES cell lines. Moreover, it would not be practicable, even if it were desirable, to regulate the import by individual scientists of ES cell lines generated overseas, some of which are already in laboratories in the United Kingdom. Such a bank would undoubtedly become the preferred source of ES cells for British scientists. It could also facilitate the distribution of ES cell lines to overseas scientists operating under approved ethical guidelines. It should have the effect of facilitating research and minimising the need both to import ES cells from overseas and to derive new ES cell lines. Above and beyond the proposed steering committee for the stem cell bank, the Committee sees no need for additional levels of regulation.

8.28 If in the future it becomes possible to develop adult stem cell lines, it would be desirable for those lines to be placed in such a bank. In that way stem cell lines could be made available to the widest possible range of reputable researchers and an overview maintained of their use. However, no special consideration needs to be given to regulations for adult stem cells above and beyond those of informed consent (see below).

8.29 The Committee endorses the Department of Health's proposals to establish a stem cell bank overseen by a steering committee, responsible for the custody of stem cell lines, ensuring their purity and provenance and monitoring their use. As a condition of granting a research licence, the HFEA should require that any ES cell line generated in the United Kingdom in the course of that research is deposited in the bank. 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.

INFORMED CONSENT

8.30 Since ES cell lines are potentially "immortal", obtaining informed consent, from those who donate the embryos from which they are derived raises distinctive problems.

8.31 In English law there is no property in live or dead human bodies, with the exception of long dead remains in museums. English law has also hesitated to recognise property in removed body parts: recent case-law does allow for the possibility of B having property rights in A's removed body parts, but it does not directly challenge the orthodox view that A can have no property rights in A's own body parts.[67] Despite this, the principle of respect for persons clearly requires that no human tissue should be taken or used without the informed consent of the donor, or where the tissue is obtained post mortem, of the next of kin.

8.32 The culturing of cells and stem cell lines means that a person's genetic identity may be reproduced indefinitely. It has been suggested that those who donate an embryo for stem cell research might subsequently expect a share in any benefits accruing from commercial exploitation of research on stem cell lines derived from it. In our view it would be undesirable for legislation to permit such claims: any commercial benefits will have come about as a result of the research and subsequent development rather than any intrinsic quality of a particular embryo donated. However, it makes it even more important that potential donors should fully understand the implications if embryos they are donating may be used for the production of stem cell lines, and in particular that the material donated may be used for a purpose other than the immediate one. [68]

8.33 The Committee recommends that the HFEA ensures that the implications arising from the "immortality" of stem cell lines are fully covered in obtaining informed consent from donors giving embryos for the potential establishment of ES cell lines for research. To prevent future restrictions in using ES cell lines (and therefore minimise the need to generate new ES cell lines) the HFEA should not permit ES cell lines to be generated from donated embryos unless informed consent places no specific constraint on their future use. Where parents wish to restrict the type of research which can be undertaken, for example specifically for reproductive purposes, the embryos donated should be used for purposes other than the generation of ES cell lines.


54   Dr Helen Watt (Q 213). Back

55   Paragraph 3 (b) of Schedule 2 to the Act. Back

56   R (Quintavalle) v Secretary of State for Health [2002] EWCA, 18 January 2002. Back

57   [1981] AC 800. Back

58   [1981] AC 800, 822. Back

59   Ibid. Back

60   Ibid. Back

61   More recently, Lord Wilberforce's guidance was approved by three of the Law Lords (including Lord Slynn of Hadley giving the leading majority speech) in Fitzpatrick v Sterling Housing Association Ltd. [2001] I AC 27. The point at issue in this case was whether the word "family" in the Rent Act 1977 should be extended to cover a same sex partner with regard to enjoying succession rights in relation to statutory tenancies. Back

62   In our analysis of this issue we have given "understanding how human stem cells behave and differentiate" as an example of basic research. However, there are other aspects of basic research (for instance, the development and improvement of techniques for extracting ES cells) which can be presented as an essential part of a programme with therapeutic objectives but which are at some (arguably greater) distance from the achievement of these objectives. Back

63   Recommendation 6, page 47. Back

64   They are discussed in detail by Dr Elizabeth Allan in her written evidence (pp 342-350). Back

65   Described in the Agency's evidence, pp 256-257. Back

66   pp 469-471. Back

67   Notably R v Kelly [1998] 3 All ER 741. Back

68   Three licences have been granted under the Act which could, potentially result in the generation of ES cells. In these cases informed consent would not have been given for purposes other than research into reproduction as this was all that was permitted at the time. The HFEA may wish to work with the scientists involved, and the original embryo donors, to establish whether the donors would give informed consent for use of any ES cells in research permitted under the new purposes. Back


 
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