STEM CELL RESEARCH
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
ORDERED TO
REPORT
CHAPTER
1: INTRODUCTION
Background
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:
(a) the potential benefits of stem
cell research;
(b) whether, in the current state of scientific
knowledge, there are satisfactory alternatives to research on
human embryos;
(c) the status of the early embryo;[16]
(d) the distinctions to be drawn, if any, between
the use for research of "surplus" embryos (i.e. embryos
left over from IVF treatment), of embryos created by IVF, and
of embryos created by CNR;
(e) the commercial interests involved;
(f) the international context to the debate;
(g) the possible need for further legislation;
and
(h) the possible need for further provision for
the custody and regulation of stem cell "lines" derived
from early embryos.[17]
Evidence
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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