ALLEVIATING INFERTILITY
30. Arguably, one of the least controversial uses
of the human embryo is implantation with the intention of establishing
a pregnancy. Despite some (relatively uncommon) residual concerns
about assisted reproduction itself, such services seem to be well
tolerated in UK society and their aim - the birth of a child -
is widely regarded positively. The question here, therefore, revolves
not around the status of the embryo, but rather on the 'rights'
or interests of individuals to have assistance in reproducing.
This raises directly the question of reproductive liberty. This
concept became of increasing importance in the 20th Century, particularly
in the early years when a number of states adopted policies designed
to intervene in the reproductive choices of individuals, by, for
example, instituting policies of non-consensual sterilisation.
Such policies are now widely regarded as objectionable.
31. The philosophical view that individuals should
have the right to make private choices - such as reproductive
decisions - free from the scrutiny of the state can be traced
to John Stuart Mill:
"[…]the only purpose for which power
can be rightfully exercised over any member of a civilised community,
against his will, is to prevent harm to others. The only part
of the conduct of any one, of which he is amenable to society,
is that which concerns others. In the part which merely concerns
himself, his independence is, of right, absolute. Over himself,
over his own body and mind, the individual is sovereign".[27]
Its application to reproduction has been espoused
by Professor Emily Jackson from Queen Mary, University of London.
She has written that "interfering with a particular individual's
decision to conceive a child would usually involve violating their
bodily integrity and sexual privacy. We do not sterilise people
who have been convicted of violent offences against children because,
however gruesome their crime, their person must remain inviolate.
[…] the freedom to decide for oneself whether or not to reproduce
is integral to a person's sense of being the author of their own
life plan".[28]
Professor John Harris from Manchester University has argued that
"There are many arguments from many sides, which purport
to give reasons for limiting access to reproductive technologies
and to gene based reproductive procedures. There is one reason
to reject them all, and that is that they do not point to dangers
or harms of sufficient seriousness or sufficient probability or
proximity to justify the limitation on human freedom that they
require.".[29]
32. This approach emphasises the importance of the
individual, specifically the autonomy of the individual and the
right to make private choices. It has been challenged by Professor
Robin Gill from the University of Kent, who argues that "We
live in the "time of the triumph of autonomy in bioethics"
in which "the law and ethics of medicine are dominated by
one paradigm - the autonomy of the patient". He argues that
"conceptions of individual autonomy cannot provide a sufficient
and convincing starting point for ethics within medical practice".[30]
However, it is worth bearing in mind that legal tradition is that
decisions which fall into the private domain are generally regarded
as not of interest to the state. Certain exceptions to this maxim
do, of course, exist but these generally arise in the sphere of
criminal law. Thus, when the service to be provided is the implantation
of an embryo with the intention of establishing a pregnancy, and
in line with Article 8 of the European Convention on Human Rights
(incorporated into UK law by the Human Rights Act 1998) reproduction
itself would seem to be firmly situated within the private domain.
The primary consequence of this is that the right to private and
family life espoused in Article 8 can be said to apply to reproductive
decisions. Only if one of the possible derogations from that Article
can be established (for example where there is a threat to public
health or morals) would the terms of this Article be inapplicable.
33. Nonetheless, a number of justifications have
been put forward for limiting reproductive freedom in assisted
reproduction. The weight given to these issues and the extent
to which they are dealt with in other forms of regulation are,
we believe, critical in establishing a new framework for regulation.
These arguments, which will be dealt with in turn, are as follows:
a) Protection of the embryo;
b) The procedures result in the creation of a
new life;
c) The intervention of a third party;
d) Concerns for the welfare of children who are
born using assisted reproduction;
e) Concerns that, where embryos and gametes are
donated, a genetic link should be maintained;
f) Concerns that it would expose patients to
excessive levels of risk;
g) Concerns that individual reproductive decisions
may have wider impacts on society; and
h) The need to supervise a morally controversial
aspect of assisted reproduction.
34. The Chair of the HFEA, Suzi Leather, stated to
us that she thought it was the special status of the embryo that
justified regulation However, it is important to draw a distinction
between legislation and regulation and it is not clear that protection
of the special status of the embryo requires oversight beyond
that set out in legislation. It is interesting to note that in
the Warnock report, the idea of protecting the embryo in law arose
from the discussion of embryo research rather than assisted reproduction.
Professor Peter Braude from Guy's Hospital and a former member
of the HFEA felt that it was the creation of a new life that justified
intervention. He told us that "I do not think there is another
area of medical practice that is like assisted conception. There
is no other area I know other than drugs in pregnancy where, in
satisfying the client […] who come along to you and say,
"We desperately want some children", to solve that problem
is a child".[31]
35. The argument that the intervention of a third
party takes reproduction out of the private and into the public
domain may be based on two premises. First, that the involvement
of a third party (the doctor or clinic) imposes additional professional
constraints. For example, Professor Alastair Campbell from Bristol
University states that it is justified to intervene in otherwise
private choices because issues of professional responsibility
arise: "In these cases reproduction ceases to be a purely
private matter between partners and is appropriately a concern
of the state, as well as of the profession". This was the
view expressed by the Minister in giving evidence to us.[32]
However, the two issues can be separated. Certainly, clinicians
are subject to professional constraints imposed by their own professional
bodies, and very rarely, the state, but this is true in all medical
practice and does not in itself justify the intervention of the
state. Second, it might be argued that the mere fact of third
party involvement is enough to render the behaviour in question
public rather than private. However, third party involvement in
reproduction is also present when doctors operate to reverse a
vasectomy operation or unblock fallopian tubes, both of which
are intended to achieve the same outcome as assisted reproduction;
that is, the birth of a child. Although assisted reproduction
is closely regulated, neither of these operations is subject to
the same constraints, arguably leading to inconsistency, and discrimination
against certain groups or individuals based on the cause of their
infertility rather than on any other ethical basis . The Human
Rights Act may also be relevant here. If Article 8 is engaged
by questions of reproductive liberty, then the Article 14 prohibition
on discrimination may also be engaged.
36. Interventions on the grounds of welfare can be
usefully divided into medical and psychosocial. The safety of
assisted reproduction has been a matter of conjecture, since even
the earliest children born using IVF are still only young adults.
Professor Alastair Campbell argues that when the state and the
professions are involved in parenting decisions "there is
an obligation to avoid harm wherever possible. […] Refusing
to select parents could result in complicity in clear harms to
children […] The only ethical issue is what criteria should
be employed". The issue is one of degree since few people
argue that reproductive freedom should be unrestricted. As Professor
Julian Savulescu from Oxford University put it to us, "we
should consider the vulnerable and consider the children by balancing
the risks and benefits" but whereas Professor Harris asks
(in the context of a child conceived using foetal ovarian tissue)
"Will this knowledge be so terrible that it would be better
that no such children had ever been or were ever born?",
Professor Campbell maintains that this view is mistaken because
"By preventing a pregnancy through regulation, no child is
harmed".
37. Professor Peter Braude from Guy's Hospital, London
and a former member of the HFEA, pointed out the effect that the
absence of a regulator had had in the US, where in 66 per cent
of cycles, there were more than three embryos replaced, in 32
per cent, there were more than four embryos replaced and, in 11
per cent, there were more than five embryos replaced. This subjects
pregnant women and children to risks resulting from multiple pregnancies
(see paragraph 268). An issue with this approach is that it could
be applied to other - unregulated -- forms of infertility treatment
such as ovarian stimulation, which also carries with it a high
risk of multiple pregnancy, and various surgical procedures. However,
there are few calls to bring this within the regulation of assisted
reproduction.
38. Concerns about welfare are particularly acute
when they relate to the use of donated gametes and embryos. If
anything these have intensified since the Warnock Report, which
took the view that this would take place in any case and that
it was therefore important that it took place in a regulated environment,
was published. It concluded that "An AID child is a very
much wanted child: a couple may have had to endure many years
of waiting and will consequently cherish the child".[33]
39. The importance of maintaining a genetic link
where embryos and gametes are donated has proved to be a matter
of debate, with no clear consensus emerging as to the weight to
be given to genetic linkage, although the recent regulations permitting
future children to gain identifying information about gamete donors
do seem to emphasise biological over social status.
40. In law there are considered to be levels of risk,
for example where someone is being exposed to unnecessary danger,
at which it is reasonable for the state to intervene, even if
the individual has consented to be exposed to that risk. In terms
of assisted reproduction, it could be argued that the drugs used
stimulate egg production and the risks associated with multiple
pregnancy are such that they justify state regulation. While these
risks are real and significant, however, they do not obviously
fall beyond the level of risk which people are legally permitted
to assume. For example, a valid consent to surgery such as heart
transplantation (which carries a significant risk of harm) or
to involvement in non-therapeutic research projects, is regarded
in law as valid so long as it has been taken by a competent individual.
The state will only go so far to protect people from themselves,
and will intervene only when the risk is deemed unacceptably high
or grave. The risks of assisted reproduction, if explained to
and understood by, the individual concerned seem to us to sit
firmly within those which can be consented to in law.
41. Concerns that individual reproductive decisions
may have wider impacts on society are commonly expressed in relation
to embryo selection. For example, it may be argued that permitting
selection of embryos on the basis of their sex would lead to demographic
disaster or the reinforcement of sexist attitudes, both of which
would be harmful to the wider society.
42. The demand to regulate morally controversial
techniques goes beyond possible harms to individuals or even society.
The concern here is more that the use of the treatment offends
human dignity rather than any harms that might result from it.
This approach argues that any action or technology that involves
comprising human dignity must be rejected. Both the Warnock report
and the 1989 Polkinghorne report on the research use of foetuses
and foetal material accorded some status to the human embryo and
had something akin to 'dignity' in mind. This notion that we should
not treat the embryo of the human species casually is surely one
with which most - if not all - would agree.
43. Witnesses expressing this concern have included
the Scottish Council on Human Bioethics, which argues that "an
acknowledgement of human identity and personhood with, as a consequence,
the protection of human dignity should be the underlying basis
on which to draft new legislation.".[34]
Human Genetics Alert argues that "The insistence by some
commentators on 'reproductive liberty' has become the key ideological
element in the construction of a free market consumerist model
for reproduction, rather than any attempt to free women from patriarchal
control over their bodies.".[35]
Some faith groups have adopted a similar stance. The Catholic
Bishops of England and Wales states that "Increasingly, children
are seen as the object of 'consumer choices', rather than as new
human beings to be accepted unconditionally." The Christian
Medical Fellowship supports the use of science and technology
to prevent, treat and relieve the suffering of infertility but
believes that "this should be guided by sound ethical principles
based on a profound respect for all human life as made in the
image of God".[36]
However, even conceding this point does not inevitably provide
a strong argument against assisted reproduction. The concept of
dignity is difficult to define and would be extremely difficult
to fashion into a foundation for legislation. It is also worth
noting that human rights conventions considering dignity have
in general avoided references to the human embryo. An exception
to this is the Council of Europe's Convention on Biomedicine,
to which the UK is not a signatory. In any event, in this section
we are concerned with the fate of the embryo created for implantation;
it is hard to argue that an embryo's dignity is in any sense negatively
affected by being born. .
44. An alternative perspective to the balance between
reproductive freedom and state intervention is provided by utilitarian
ethics. Here the emphasis is on measuring the benefits over burdens
of particular activities. This approach was rejected by the Warnock
Committee. It said "Moral questions, such as those with which
we have been concerned, are, by definition, questions that involve
not only a calculation of consequences, but also strong sentiments
with regard to the nature of the proposed activities themselves."[37]
Thus, for the Warnock Committee, even if evidence were available
which could establish that the benefits (for example to the infertile)
of unregulated access to assisted reproduction, there were underpinning
moral or ethical considerations which also had to be considered,
at least in some circumstances. However, the Warnock Committee
did not view assisted reproduction in itself as a threshold that
should not be crossed over. Thus, it would appear that both libertarian
and utilitarian ethics would support the view that, in terms of
the embryo intended for implantation, since the creation of the
pregnancy is inherently to be regarded as a good thing, the state
has no right to intervene in the choices of people to procreate
unless evidence of harm can be shown.
45. Of course, IVF generally involves the creation
of a number of embryos, not all of which will be implanted. For
some, this is the essentially problematic aspect of assisted reproduction.
Indeed, for some this is the principal reason for opposing all
assisted reproduction. For others who would not go quite this
far, nonetheless the fate of 'surplus', 'spare' or unselected
embryos demands close regulation. On the other hand, given that
a choice of embryos exists, some have argued that it is either
morally neutral to select one over another, or even that there
may be a positive duty on intending parents to select the embryo
which has the best chance of a 'happy' life.
46. We accept that
a society that is both multi-faith and largely secular, there
is never going to be consensus on the level of protection accorded
to the embryo or the role of the state in reproductive decision-making.
There are no demonstrably "right" answers to the complex
ethical, moral and political equations involved. We respect the
views of all sides on these issues. We recognise the difficulty
of achieving consensus between protagonists in opposing camps
in this debate, for example the pro-life groups and those advocating
an entirely libertarian approach to either assisted reproduction
or research use of the embryo. We believe, however, that to be
effective this Committee's conclusions should seek consensus,
as far as it is possible to achieve. Given the rate of scientific
change and the ethical dilemmas involved, we conclude, therefore,
that we should adopt an approach consistent with the gradualist
approach, of which the Warnock Committee is one important example.
This does not mean that we will shy from criticism of regulation
to date, where we believe it warranted. But it does mean that
we accept that assisted reproduction and research involving the
embryo of the human species both remain legitimate interests of
the state. Reproductive and research freedoms must be balanced
against the interests of society but alleged harms to society,
too, should be based on evidence.
47. Many of the decisions about what to regulate
or to legislate about depend on the approach taken with regard
to the balance of harm and benefit or potential harm and potential
benefit. It has become fashionable to specify that authorities
(whether that be Governments, agencies, industry, watchdogs etc)
should take a "precautionary approach" or adopt the
"precautionary principle". This means different things
to different pressure groups, and to different sides of the argument.
In respect of medical advances it has never meant "proceed
only where there is evidence of no harm". If it did many
of the advances would never be made. In medical research practice
it means proceeding through carefully regulated and tightly overseen
research stages, requiring -among other things - vigilance and
peer review. In clinical practice it means proceed cautiously
and in a manner amenable to ethical oversight and clinical audit
while there is no evidence of sufficiently serious harm or potential
harm to outweigh benefit or potential benefit, while being vigilant
in looking for unintended and otherwise adverse outcomes. We
do not see why the area human reproductive technologies should
do anything other than proceed under a precautionary principle
currently prevalent in scientific, research and clinical practise.
This means - as specified in paragraph 46 above - that alleged
harms to society or to patients need to be demonstrated before
forward progress is unduly impeded.
SPARE EMBRYOS
48. If embryos are to be used for the purposes of
alleviating infertility, there remains the question of what can
or should be done with those considered spare or unsuitable for
implantation. There are a number of options: they can be destroyed,
donated to another individual, stored for later use, or donated
for research. This has been a major stumbling block for some individuals
and groups, and has had a major impact on the recent Italian legislation,
which does not prohibit IVF but demands that only three embryos
are fertilised and that all must be implanted in the woman. This
law attempts to eliminate the destruction of spare embryos, and
donation, storage (except for certain circumstances) and research
are forbidden. It could be argued that there is nothing "respectful"
about the destruction of an embryo and that this therefore gives
it no special status at all, not even that derived from a gradualist
approach. The Church of England has addressed this issue in the
following way:
"The superabundance of embryos, seventy
per cent of which do not implant in the womb, is echoed throughout
nature. Every living thing produces infinitely more seed than
is ever used for reproduction. Only if the seed is implanted in
soil in which it can flourish, as the parable teaches (Mark 4),
can there be any fruit. If it is of God's being to give more than
enough, is it appropriate to regard that which is left over as
waste, or is it meaningful in some other way? Biologically the
generosity of nature is needed for the power of life and species
development to overcome the force of entropy. Seed or eggs which
do not reproduce are frequently sources of food for other creatures.".[38]
It could, of course, be said that what nature does
and what man does are not equivalent, Unlike man, nature cannot
be said to have intention. Thus, it might be argued, even if nature
creates more embryos than survive to live birth, this is no justification
for man to do the same. However, it must be borne in mind also
that in IVF the intention is not create embryos to be spare, although
it would be seen as a good thing to have a reasonable number from
which to select the most viable for implantation. Once created,
then, the question is the extent to which the embryo's status
can or should outweigh the potential benefits to be derived from
its existence, or the extent to which its existence outweighs
the choice of those who do not seek to implant every embryo which
has been created and/or stored. At the simplest level, it can
be argued that the competition here is between the interests that
we have in respecting the human embryo (which is not a legal person)
and the rights of born individuals to have their reproductive
choices respected. While we agree that this decision is not an
easy one, we nonetheless believe that the balance must lie with
the rights of those already in existence but subject to appropriate
ethical oversight and regulation. The outcome of any other conclusion
would be that every embryo created would have to be implanted,
thus potentially forcing individuals to have more children than
they wish or repeated cycles of unsuccessful IVF, as in Italy.
Such a direct invasion of their reproductive rights is hard to
justify. Thus, inevitably, some embryos will perish, unless we
can find a way of creating only as many embryos as it is anticipated
will be implanted. Even then, however, some embryos will not be
selected for implantation because, for example, they carry genetic
conditions incompatible with life, or with a life of quality.
Again, this is a controversial aspect of assisted reproduction,
which we consider in paragraphs 109-146.
RESEARCH
49. The view that the embryo acquires human rights
at conception would preclude any research being undertaken on
it. We have concluded that the embryo should be accorded special
status in common with the Warnock Committee. For research this
means that the respect given to the embryo needs to be considered
in the context of the benefits that might accrue from the research.
The Warnock Committee suggested that research on embryos should
not be permitted if the purposes could be achieved in any other
permissible way or for "frivolous" reasons. This is
reflected in the HFE Act in the list of purposes for which research
on embryos can be conducted. The Warnock report did not specify
what those purposes should be, other than the committee expected
it be mainly for the alleviation of infertility and the prevention
of hereditary disease. Broadly speaking, this continues to represent
the legal position on embryonic research, although additional
provisions have recently been added. These will be considered
in more depth in paragraphs 331-342.
50. As we have seen, IVF procedures often produce
spare embryos. These may either be surplus or of insufficient
quality. While the Warnock committee was unanimous on the use
of embryos in appropriate and ethical research, four of the 16
members felt that there was a "clear moral distinction"
between the use of spare embryos and the creation of embryos specifically
for research.[39] These
views were based on the following arguments:
a) That the creation of an embryo for research
was inconsistent with the idea that it should be afforded special
status.
b) That, unless prohibited, it would lead to
the use of embryos for routine and less valid research.
The majority of the Warnock Committee felt that the
medical benefits from the creation of embryos were such that it
was justified in certain circumstances. We also subscribe to this
view. We believe
that the research on human embryos can be undertaken without compromising
their special status but that this research should have proper
ethical oversight as set out in Chapter 8 and 9. We further conclude
that, where necessary, embryos can be created specifically for
research purposes.
18 Ev 318 Back
19
Q 712 Back
20
Q 697 Back
21
Embryo Research: Some Christian Perspectives, A report
from the Mission and Public Affairs Council, Church of England Back
22
Quaestionum in Hept I II n 80 Back
23
Ev 373 Back
24
JC Polkinghorne, The person, the soul, and genetic engineering,
Journal of Medical Ethics, 2004;30:593-597 Back
25
para 11.5 Back
26
para 11.17 Back
27
JS Mill, 'Utilitarianism & On Liberty'(ed. M. Warnock),
1962, Fontana Press Back
28
Emily Jackson, Fertility treatment: abolish the 'welfare principle',
Spiked Online, 11 June 2003 Back
29
John Harris, Reproductive Liberty, Disease and Disability, unpublished
article, 2004 Back
30
Robin Gill and Gordon Stirrat, Journal of Medical Ethics,
in press Back
31
Q 616 Back
32
Q 1308 Back
33
Department of Health, Report of the Committee of Enquiry
into Human Fertilisation and Embryology (The Warnock Report),
July 1984 Back
34
Ev 247 Back
35
Ev 288 Back
36
Ev 217 Back
37
para 4 Back
38
EmbryoResearch:SomeChristianPerspectives:AreportfromtheMissionandPublicAffairsCouncil Back
39
page94 Back
