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
