Examination of Witnesses (Questions 820
- 839)
WEDNESDAY 27 OCTOBER 2004
DR MICHAEL
WILKS AND
DR VIVIENNE
NATHANSON
Q820 Dr Turner: Your evidence also
highlights the possibility of vulnerable people being exploited
or abused by, shall we say, less scrupulous practitioners. To
the best of our knowledge there has been no recorded incidence
of this since 1990. Do you think this is proof of the effectiveness
of the regulation?
Dr Wilks: I am not sure that we
would necessarily say that just because there has been no reported
evidence it has not happened. I think this is another issue around
earlier questions around reproductive freedom. Unless we are going
to suggest—and I doubt whether you are—that there
should be some restrictions on those normal reproductive freedom
rights (and I presume you are not) then we have to ask why we
would want to regulate and control various forms of assisted reproduction.
I think it comes back to the basic principles that we set out
before. Particularly, I think, we do have to have some concern
for the safety of those procedures, and if a service is being
offered to the public which has dubious safety, is completely
unregulated and uncontrolled and can be sold, as it were, as a
service to patients without any medical assessment then we have
to ask whether that does not, actually, have the potential for
creating vulnerable groups of people. So we would argue that anything
in which the technology involves the creation of an embryo, or
a child, in any artificial way, where there is a question about
the safety and competence of that process, then we think it should
come within a regulatory framework.
Dr Nathanson: Just to say we would
also be concerned, in terms of vulnerability, about donated gametes,
particularly donated eggs, because a woman who either cannot produce
her own eggs—or, for other reasons, hers cannot be used—is
particularly vulnerable at a time when we know that in society
generally that internationally there is a shortage of eggs and
egg donors, and at the same time we have groups of women who can
produce eggs but who may not have financial access to the treatment.
So, for example, one of the groups of particularly vulnerable
people we are concerned about is women being persuaded against
an offer of free treatment to give eggs, and I think we do need
to look at those because there are risks associated with the treatment
and because, in a sense, those individuals have difficulty in
making a truly free choice at a time when they are under considerable
emotional, financial and other pressures.
Q821 Geraldine Smith: Does the HFEA
need to change? Would you favour the establishment of a national
bioethics committee to undertake ethical decision making?
Dr Nathanson: If we can start
with that last one, we think a national bioethics committee is
a good thing but not to take the decisions on behalf of the Human
Fertilisation and Embryology Authority. I think there are different
issues about whether a national bioethics committee would be useful
to contribute to the ethics debate on a very broad set of fronts,
but in terms of the HFEA one of the things it does is it does
not just look at ethical principles, it also looks at clinical
practice and it makes an interesting and careful balance between
principle and pragmatism, and I do not think a national bioethics
committee would be able to encompass that area. So that a national
bioethics committee would lose some of the interpretations that
put it into a practical context, and I think that would mean that
the ability of clinics to carry things forward would be compromised
in a way that would be unacceptable to most of us.
Dr Wilks: I think that is absolutely
right. There is a huge difference between bioethical advice at
that sort of level and the actual regulation, and the balance,
as Vivienne says, between good ethical principles and how they
work in practice through an actual practical process of licensing
is very important. We support this process of review not because
of some concern about the efficiency and the balance that the
current HFEA Structure creates but more because it is right to
review this whole area of regulation when the technology has changed
so much. We have great confidence, historically, that the majority
of decisions that the HFEA have made have been well-balanced;
they have balanced the interests of the children to be born with
the interests of society generally, they have addressed safety
issues through licensing, and we think that system has actually,
basically, worked well. We have said that in our evidence, but
that is a very strong point we would like to make.
Q822 Geraldine Smith: Who should
make the ethical decisions at the end of the day?
Dr Wilks: Ethical decisions in
terms of what actually happens at the moment—
Q823 Geraldine Smith: At the moment,
the majority of the HFEA are lay people and they have a lay chairman.
On the HFEA, at the moment, if you are opposed to embryo research
you cannot take part, you cannot be a member. So is it not a bit
one-sided and should we not have a more open debate about some
of these ethical considerations rather than just leaving it to
people with a certain view?
Dr Nathanson: Firstly, the law
allows for embryo research, so it is not that the HFEA is making
a decision on whether embryo research is allowed, it is whether
they will license an individual or an individual clinic or organisation
to carry out research that is covered by the law. So they are
not looking at, if you like, the fundamental ethics underneath
whether we should allow embryo research. It is, in fact, a matter
on which Parliament has made the decision, but if there were to
be further debate on it then, by all means, a national bioethics
committee—
Q824 Geraldine Smith: I guess at
times we make decisions on how far research should go. It is where
you actually draw the line, surely.
Dr Wilks: It is making decisions
about how far things should go and, obviously, things like decisions
about preimplantation genetic diagnosis may change within the
HFEA in terms of who regulates that activity because it is then
convinced it is more safe (that is what the recent decision of
the HFEA has been). The HFEA works within existing legislation,
so it can license embryo research. If there is a concern about
the ethics of that then the debate needs to be much wider about
what is regulated. We would hope that a regulatory body that made
these kinds of decisions would be sensible enough to have the
right make- up and the right advice given to it so that it knew
what clinical and scientific research ethical boundaries were
around that work. So I would hope it would take that sort of advice.
We would not have much confidence if it was not set up in that
way or did not operate in that way.
Q825 Geraldine Smith: What about
the fact that people are barred from being on the HFEA if they
are opposed to embryo research? Does that really help constructive
debate? Should we not have all views represented?
Dr Nathanson: The difficulty is
that if you have those views represented then every time that
an application for a licence to carry out research which was entirely
legitimate and entirely within the legislation came forward then
the chances are that that could be barred, which would effectively
mean that that person's membership of the HFEA could actually
turn back what Parliament has decided to allow in the legislation.
I think that is the difficult balance that you have when you have
a regulatory body of this sort. I think it is extremely important
that the bigger debate carries on and informs both any changes
to the legislation and, separately, that the bigger debate carries
on and, when the HFEA is considering individual licences, that
broader debate is considered as part of their policy making, as
part of their licensing, but not within the actual committee structure
because the danger there is that you stop all licences being granted,
and I do not think that is what Parliament wanted when it passed
legislation to allow embryo research.
Q826 Bob Spink: Could I just step
in here, Geraldine? Is it not the case that the HFEA has actually
gone further than Parliament expected them to go in the legislation
on procedures and in giving certain licences? They have gone further
not just than legislation allowed them to go but they have gone
further than public opinion would suggest they should have gone.
Dr Nathanson: One of the difficulties
when the technology and the science is moving so quickly is that
the way in which the current legislation is written leaves areas
where you can argue that they are silent on or that there is no
law either prohibiting or allowing the HFEA to make decisions.
Q827 Bob Spink: In that circumstance
would you expect, therefore, the HFEA—this, we have already
heard from you, biased body that does not represent society as
a whole—to make these decisions and to push it forward,
or would you expect them to be precautionary and to take the view
of society and to consult and to go through Parliament to seek
guidance?
Dr Nathanson: I would expect them
to consult widely, to engage in ethical debate, to encourage ethical
debate and to encourage the participation in that debate by the
widest possible group of stakeholders. That means people with
an interest, both as ordinary members of society, as potential
parents, as people who can benefit as scientists and, indeed,
as opponents and to listen to those debates. However, in an ideal
world they would not have to step into areas on which Parliament
has not legislated because they are meant to be working within
the legislative framework.
Bob Spink: Thank you, Geraldine.
Q828 Geraldine Smith: The majority
of these people are lay people, so they are not even experts.
Should there be a greater proportion of experts? I think, perhaps,
that the role should be split. I do think it is important to have
some sort of bioethical committee that could debate the wider
ethical issues and then you need some sort of expert body.
Dr Wilks: That may be a way forward,
but I would illustrate it by the way, for instance, that my medical
ethics committee works at the BMA. We have experts, we have doctors
who are experts in some things and we have experts who are experts
in other fields. What we do is we have debates based on ethical
principles which are then translated into ethical procedure so
that we can advise members of the BMA how they should practically
approach a particular dilemma in a very practical way. So we do
actually go through that process of what are the basic principles,
what are the issues, how is society changing, what is public opinion
(and we do consult if we do not know the answer), how might things
change in the future, what is the balance of risk on this particular
technology and then what is best to do in terms of advice to doctors?
Obviously, we are not going to regulate that treatment but we
do give very strong advice about it. I think it is difficult to
separate the ethical principles, particularly as those change
with the technology. As I say, one of the reasons we are here
today is because things have changed so much in little more than
ten years. Unless you actually work within the very broad principles
that Parliament has established, I think a regulatory body has
got to be given the freedom to advance the boundaries, as long
as it is within the basic principles that are set out.
Q829 Dr Iddon: The majority of the
population, at some time in their lives, have had almost complete
reproductive freedom. Why then do we impose a "welfare of
the child" provision on the infertile?
Dr Nathanson: There are a variety
of answers to that, including the fact that we always have, in
the sense that if you want to adopt or foster we actually assess
your suitability to be parents but we do not assess people who
produce children naturally, as it were, without any help. I suppose
the answer is that, in the same way, when we are looking at assisted
reproductive technology, there is the question of the harm to
any child that might be created using that technology. However
I would emphasise that we do not believe in blanket exclusions
and we do not believe in idealised family concepts; we believe
that every individual should be looked at separately and every
individual case or every individual person involved, and that
the exclusions should be truly exceptional, where there is very
good evidence that there would be a serious risk to the welfare
of any child created to that individual. So it would be truly
exceptional. It is different in that society does have a role,
as society is encouraging and supporting in some way the use of
this technology and, therefore, the creation of a child in a way
which is different to natural reproduction.
Q830 Dr Iddon: Is it not a dangerous
precedent to enshrine a moral question under the law?
Dr Nathanson: I think the law
enshrines moral questions a lot of the time. It says things are
wrong and very often the reasons why we consider them wrong have
a moral basis.
Q831 Geraldine Smith: Can I come
back on the inspections? I would like to ask about the inspections
of clinics under the HFEA. Do you think people that are actually
carrying out the inspections are suitably qualified to do that?
Do you think it would be better if, perhaps, that was undertaken
by experts?
Dr Nathanson: We do not have the
expertise on that element of it. That is for the clinics and for
the people who actually do inspections to say.
Dr Wilks: May I come back to Dr
Iddon's point about the issue of reproductive freedom? Obviously,
on the face of it, it seems odd that we create these hoops that
people have to go through to get what most of us will have obtained
naturally. I think the issue of the safety of the techniques used
and the future techniques that may need to be assessed in terms
of their safety and their clinical effectiveness is something
that does put a responsibility on a regulatory body to allow it
to happen or not to allow it to happen, or to allow research on
it until they are confident that it is safe. I think society obviously
moves in terms of, for instance, what it sees as an ideal family
in which this child will be brought up in, so the best interests
of the child might vary according to society's view of a family.
For instance, we have taken a view in the last few weeks that
our view on being opposed to the posthumous use of gametes should
change towards favouring posthumous use of gametes where explicit
consent has been given before death for use after death, simply
because we have looked at evidence about the welfare of children
brought up in different types of family and we certainly have
some scepticism that the "family unit" as many people
might define it is the only environment in which a child can be
brought up, loved and nurtured. That is why we have a little bit
of concern about this maintenance of this "need for a father"
that legislation has and whether that should be reviewed.
Q832 Dr Iddon: We have a dilemma
as a Committee because, obviously, you support the retention of
"welfare of the child" and that is clear from the evidence
today and especially from the written evidence you have given
us. However, the Royal College of Obstetricians and Gynaecologists
have given us in evidence the following quote. They believe that
the "welfare of the child" provision, "has proved
unworkable and may be considered discriminatory". So we have
a dispute between two organisations working in the same area.
How do we resolve that dispute, as a Committee?
Dr Nathanson: I would suggest
that we need to look very carefully at what they mean by discriminatory
and why it does not work. We would suggest that people are, perhaps,
trying to draw rigid rules from the "welfare of the child"
rather than looking at each individual case on its merits and
that there are in some people's minds assumptions that the welfare
of the child requires these rather formalised, particular types
of family setting, rather than an assumption that most people
who are seeking infertility treatment are just normal people in
a range of family and other circumstances who just happen to need
medical help to produce pregnancy. In the majority of those cases
their children will enjoy all the benefits that other children
enjoy, and it is only in rare and exceptional cases that the welfare
of the child is genuinely at risk. I think that is the key; some
people saw the "welfare of the child" issue in this
part of the process as being a common reason, as it were, for
excluding people—that you would frequently see children
who were at very great risk. Obviously, the potential for children
to be at great risk we would see as an exceptional circumstance,
and I think that in itself becomes non-discriminatory. I think
on discrimination we have to be careful. If we are discriminating
against people on the grounds of the welfare of the child and
there is a serious risk I do not see that as a negative form of
discrimination; it would be very negative if we were discriminating
on the grounds of the race, or sexuality or whatever else of the
potential parents, and that is where we are absolutely firm that
we should not be making decisions; that is not an issue that would
affect the welfare of the child.
Dr Wilks: It would also be discriminatory
if people seeking treatment felt that they had to prove they were
going to be good parents. That would be ludicrous. Presumably
one could make the assumption generally that people who are seeking
this type of assistance desperately want to be parents and be
good parents and one could make the assumption that a child so
produced would be loved in a happy environment. However, I do
not think you can get away entirely from the issue of the safety
of the technology and I think that is why we argue, particularly,
for flexibility of approach—each case considered on its
merits—and a very wide view of what a "family"
actually is.
Q833 Dr Iddon: The safety of the
technique cannot be influenced by the suitability of the prospective
parents, surely?
Dr Wilks: No, no, I was arguing
for a process of regulatory inquiry that included the welfare
of the child as well as the assessment of safety. I was arguing
for the overall construction.
Q834 Dr Iddon: My final question
is the BMA does, therefore, believe that there are measurable
benefits from having this provision in the Act. Is that correct?
If so, what are they?
Dr Nathanson: I think it is extremely
difficult to measure them because the nature of measurement would
be, in a sense, trying to measure a negative, because the assessment
would be whether the potential child has been saved from disbenefit,
as it were, or harm by not being created, and it is extremely
difficult to prove that kind of negative.
Dr Turner: We have, in fact, got minus
time to finish this session. We have two important areas still
to cover, so please can I ask my colleagues to be very brief and
you to be as succinct as possible in your answers?
Q835 Dr Harris: Can I just remind
colleagues on the Committee that I am a member of BMA Medical
Ethics Committee but I did not take part in the formulation of
this evidence, otherwise I would seem to be arguing against myself—which
I am more than capable of doing. I just wanted to pursue this
important point. Can you give me examples of circumstances where
you think that the welfare of the child requires that a couple,
say, or a patient, cannot be treated?
Dr Nathanson: I suppose the most
obvious example is where the potential parent has recent convictions
for child abuse.
Q836 Dr Harris: So in those circumstances
would you go out and make infertile such couples who were not
already infertile? Would you use castration?
Dr Nathanson: Of course not.
Q837 Dr Harris: So, in those circumstances,
we rely on social services and the "at risk" register
to intervene. Do you feel that those social services are incapable
of acting even when there is prospective notice that such a couple
may have a child? Indeed, where there may be greater ability of
social services to intervene, why do you use the withholding of
medical treatment to do something that social services could do?
Dr Nathanson: Because you are
asking doctors to interfere to use powerful technology to create
a child into a situation of risk where you know that the management
of that risk is very far from perfect.
Q838 Dr Harris: Can you think of
any other circumstances where the "welfare of the child"
provision should be used in this way? Otherwise you could just
draw into the regulation that people with recent convictions should
not be treated, and then we would not have to have this "welfare
of the child" which serves, we have heard, to discriminate—as
you have said yourself—potentially against classes of people
who may actively be denied treatment or may feel that they will
be given a rough time on the basis of their sexuality or their
age or their disability.
Dr Nathanson: I would not want
to start to create a specific category and an absolute set of
rules to say that in these circumstances or these individuals
should always be denied access to technology. Our thesis throughout
is that every individual must be considered on their own merits
and that you have to look in a holistic sense at the potential
child and its welfare—looking at the potential parents,
looking at the circumstances and so on. I do not want to start
trying to create a list of specifics that would say "This
group of people should not be allowed access to this technology".
Q839 Dr Harris: You have said that
before. Dr Wilks, can you think of any circumstances where the
"welfare of the child" provision should be used to prevent
a child because their life would be so terrible that it would
be better that they were not born?
Dr Wilks: No, I think it is very
difficult to do that but, I suppose, what I would be concerned
about would be if it were to be suggested that the "welfare
of the child" provision was of no value whatsoever and that,
therefore, it should be completely removed and that, therefore,
it was to be of no concern to either the HFEA or individual clinicians
about the welfare of a potential child, in the sense that the
rest of society takes a very strong interest in the welfare of
the child at all sorts of levels of education and social services.
So I do not think it is inconsistent that a regulatory authority
should also do that.
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