Select Committee on Stem Cell Research Report


13 February 2002

By the Select Committee appointed to consider and report on the issues connected with human cloning and stem cell research arising from the Human Fertilisation (Research Purposes) Regulations 2001




1.1 The regulation of research on human embryos is governed by the Human Fertilisation and Embryology Act 1990. This legislation was enacted primarily to regulate the practice of in vitro fertilisation (IVF)[1] and the creation, use, storage and disposal of embryos formed by this means.

1.2 The regulatory authority established by the Act is the Human Fertilisation and Embryology Authority (HFEA), which is also empowered to issue licences, under strict conditions, for research on human embryos. The Act followed widespread discussion, both inside and outside Parliament, stimulated by the report of the Committee of Inquiry into Human Fertilisation and Embryology chaired by Baroness Warnock, which was set up in 1982 and reported in 1984.[2] The Act largely implemented the recommendations of the Warnock Committee.

1.3 Under the Act research on embryos older than fourteen days (or when the "primitive streak"[3] has appeared, if earlier) is prohibited. Research may not be undertaken except under a licence issued by the HFEA. Under Schedule 2 to the Act such a licence may not be granted "unless the Authority is satisfied that any proposed use of embryos is necessary for the purposes of the research;"[4] and "cannot authorise any activity unless it appears to the Authority to be necessary or desirable for the purposes of:

    (a)  promoting advances in the treatment of infertility,

    (b)  increasing knowledge about the causes of congenital disease,

    (c)  increasing knowledge about the causes of miscarriages,

    (d)  developing more effective techniques for contraception,

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

or for such other purposes as may be specified in regulations".[5]

1.4 The Act limits these "other purposes" to projects of research "which increase knowledge about the creation and development of embryos, or about disease, or enable such knowledge to be applied".[6]

1.5 Licence applications therefore have to meet two tests: first that the use of embryos is necessary for the purposes of the research and they cannot be achieved by other means, such as work on animals; and, secondly—and only if the first test is satisfied—that the research is necessary or desirable for one of the specified purposes.

1.6 Since the Act was passed there have been a number of important developments—this is a very fast-moving area of science—which were not and could not have been foreseen at the time. The most significant was the cloning[7] in 1996 (by cell nuclear replacement—CNR[8]) of Dolly the sheep, which led to widespread concern that the same technique might be used to produce a baby. At the same time the cloning of Dolly enhanced interest in the feasibility of using CNR to develop treatment therapies.

1.7 The issues arising from these developments were looked at in 1998 jointly by the HFEA and the Human Genetics Advisory Commission (HGAC), which undertook a public consultation on human cloning. Their report recommended, among other things, that the Secretary of State for Health should consider specifying in regulations two further purposes for which the HFEA might issue licences for research: the development of methods of therapy for mitochondrial disease;[9] and the development of therapeutic treatments for diseased or damaged tissues or organs.[10]

1.8 In September 1999, following this report, the Government set up an expert group under the chairmanship of the Chief Medical Officer, Professor Sir Liam Donaldson, to undertake an assessment of the anticipated benefits of new areas of research using human embryos, the risks, and the alternatives; and to advise whether these new areas of research should be permitted and whether regulations needed to be made under the 1990 Act to extend the purposes for which the HFEA might issue licences for research involving human embryos.

1.9 In its report the expert group reviewed the scientific evidence. Its principal recommendation was that research using embryos (whether created by IVF or CNR) to increase understanding about human disease and disorders and their cell-based treatments should be permitted, subject to the controls in the 1990 Act.[11]

The Regulations

1.10 In the light of the expert group's report, the Government brought forward draft regulations extending the purposes for which research on human embryos could be lawfully undertaken (subject to licensing by the HFEA). What became the Human Fertilisation and Embryology (Research Purposes) Regulations 2001[12] were debated and passed by the House of Commons on 19 December 2000 and by the House of Lords on 22 January 2001. The Regulations added three new purposes to the five in the Act:

    (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.

1.11 Two points about the wording of the Regulations are worth noting. First, they refer to "serious" disease, whereas the Act itself refers simply to disease, and there is no definition of what constitutes serious disease. Secondly, they do not include among the purposes increasing knowledge about the creation of embryos, even though the Act invites an extension of the purposes in these terms. We comment on the drafting of the Regulations in Chapter 8.

1.12 In the debates on the Regulations particular concern was expressed about the prospect of the use of the CNR procedure to produce cloned human embryos, albeit for research rather than reproductive purposes. In the Lords an amendment was tabled by Lord Alton of Liverpool inviting the House to decline to approve the draft regulations until a Select Committee had reported on the issues connected with human cloning and stem cell research. This amendment was rejected (by 212 votes to 92). An alternative amendment was then proposed by Lord Walton of Detchant calling on the Government to support the appointment of a Select Committee to report on the issues connected with human cloning and stem cell research, and to undertake to review the Regulations following the report of that Committee. This amendment was passed without a division, and the Regulations duly came into effect on 31 January 2001.

1.13 Before the Regulations were made the Pro-Life Alliance applied for judicial review of them on two grounds. It submitted that they were ultra vires the 1990 Act (this claim was not pursued) and sought a declaration that an embryo created by CNR does not fall within the definition of embryo in the Act. The case was heard on 31 October and 1 November 2001. [13] Judgment was given in the High Court on 15 November 2001 granting a declaration in the terms sought.

1.14 The effect of the judgment was to remove embryos created by CNR from the controls imposed by the 1990 Act and regulation by the HFEA. The Government immediately announced that it would introduce legislation to prohibit reproductive cloning.[14] The Human Reproductive Cloning Bill was introduced on 21 November and became law on 4 December 2001. At the same time the Government appealed against the judgment to try to bring the use of CNR for research back within the scope of the Act. The appeal was heard on 16 January 2002 and judgment was given on 18 January: the Court of Appeal allowed the appeal and refused leave to petition the House of Lords. [15] The Pro-Life Alliance indicated that it would apply directly to the House of Lords for leave.

The establishment of the Committee and the scope of its remit

1.15 On 7 March 2001 the House of Lords agreed a motion appointing the Committee "to consider and report on the issues connected with human cloning and stem cell research arising from the Human Fertilisation and Embryology (Research Purposes) Regulations". The membership of the Committee is at Appendix 1, together with a list of the interests that the Members declared.

1.16 Sadly one member of the Committee, the Earl of Carnarvon, died during our inquiry, on 11 September 2001. He made a distinguished contribution in the many areas of public life in which he participated, and his work on the Committee was no exception: we have missed his sense of humour, his robust common-sense, and his unerring ability to get to the heart of the matter.

1.17 Our terms of reference focus on issues connected with the Regulations. We were clear from the outset that it was not our task to review the whole range of issues studied by the Warnock Committee. At the same time it is 17 years since the Committee reported, and we did not think that it would have been satisfactory simply to take that Committee's recommendations as given. We have therefore taken a fresh look at those aspects of its report relevant to our remit: in particular the fundamental question of the status of the embryo, which is central to the issues of stem cell research and cloning; and the creation of embryos for research, an issue on which the Warnock Committee was divided.

1.18 In reviewing the Regulations we have sought to take account of relevant developments in the field of reproductive technology and to assess whether the 1990 Act and the Regulations are still apt to cover them. We have looked very closely at the scientific issues—and have had the benefit of scientific advice—but we are not a scientific committee and we have seen our role as being to conduct a broadly-based examination of the ethical, legal and commercial as well as the scientific aspects of stem cell research.

1.19 The central question underlying the appointment of the Committee is whether the extension of the purposes in the 2001 Regulations is justified. In addressing this question the main issues we have considered are:


1.20 We issued a call for evidence on 5 April 2001 (reproduced at Appendix 2). We distributed it widely—not only to scientific and research organisations, the churches, medical charities, patients' support groups, pro-life groups and others with a close interest in the issues—but also to organisations representing sections of the general public, such as the National Association of Citizens Advice Bureaux, the Townswomen's Guild, the Trades Union Congress and the National Federation of Women's Institutes. These are profound issues which touch many people very deeply and we wanted to hear from as broad a cross section of society as possible.

1.21 We were also concerned to get as broad a view of the scientific issues as possible. We invited the major scientific and medical research organisations to give evidence, and their representatives included people working on both "adult" stem cells[18] and embryonic stem (ES) cells derived from animals; we wrote to scientists and medical practitioners cited as supporting the view that advances in work on adult stem cells made research on ES cells unnecessary and invited them to give evidence; and we made a special effort to obtain the views of some of the leading adult stem cell researchers around the world on the relative merits of adult and ES cells.

1.22 We received 52 submissions from representative organisations and 57 from individuals (listed in Appendix 3). We held 12 sessions of oral evidence at which 42 people representing 17 organisations (or in some cases giving evidence on their own account) appeared before us. In order to reach a broader range of opinion we also commissioned the Hansard Society to conduct on our behalf an internet debate over a period of four weeks in September and October 2001. One hundred and ninety six people registered to take part in the debate, 110 users logged on to the site and 330 messages were posted. A summary of the debate is included in the volume of evidence (pp 450-469). The nature of the submissions we received varied considerably, consisting of both technical evidence about scientific developments and expressions of opinion and argument on the ethical aspects. We received much valuable material of both kinds and are very grateful to all those who helped us by contributing their views.

1.23 We undertook two visits, one to the Medical Research Council's Clinical Sciences Centre at Hammersmith to gain a better understanding of the science involved, and the other to Durham University for an informal discussion with members of the multidisciplinary Policy, Ethics and Life Sciences Institute of the Universities of Durham and Newcastle. We followed the debates in other countries, particularly in the rest of Europe and in the United States. Some of us met members of the German Bundestag Commission of Inquiry on Law and Ethics in Modern Medicine and the European Parliament's Temporary Committee on Human Genetics, which were examining related issues, in the course of visits that they were making to the United Kingdom. We also obtained information from embassies here and from our diplomatic posts abroad about the situation in other countries; and we had a useful briefing from a number of the scientific attachés at British posts abroad.

Specialist advisers

1.24 We appointed two specialist advisers, Professor Roger Brownsword, Professor of Law at Sheffield University, and Professor Christopher Higgins, Director of the Medical Research Council's Clinical Sciences Centre, Imperial College Faculty of Medicine.[19] We are greatly indebted to both for the careful and impartial way in which they elucidated the complex scientific and legal issues with which we are concerned. The Members of the Committee are, of course, solely responsible for the conclusions of this report.

1   The fertilisation of a human egg by a human sperm outside the body. Back

2   Cmnd 9314. Back

3   A collection of cells from which the central nervous system eventually develops. Back

4   Paragraph 3(6). Back

5   Paragraph 3(2). Back

6   Schedule 2, paragraph 3(3). Back

7   The derivation from a cell or organism of another cell or organism genetically identical to it. Back

8   The procedure of replacing the cell nucleus of an egg with the nucleus from another cell. Back

9   The mitochondria are energy-producing structures in the cytoplasm (the jelly-like substance, which together with the nucleus it surrounds, forms the cell. Back

10   Cloning Issues in Reproduction, Science and Medicine, December 1998. Back

11   Stem Cell Research: Medical Progress with Responsibility, Department of Health, June 2000. Back

12   S1 2001 No. 188. Back

13   R v. Secretary of State for Health, ex parte Bruno Quintavalle (on behalf of Pro-Life Alliance) [2001], 15 November 2001. Back

14   The implantation in a woman of an embryo created by CNR. Back

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

16   We use the term "early embryo" to describe the stage of embryonic development up to the appearance of the primitive streak-see paragraph 4.2(c). Back

17   Stem cells cultured in the laboratory, which are able to reproduce themselves, in principle indefinitely. Back

18   Stem cells obtained from the human body, rather than from an early embryo-see Chapters 2 and 3. Back

19   See Appendix 1 for further details. Back

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