Examination of Witnesses (Questions 804
- 819)
WEDNESDAY 27 OCTOBER 2004
DR MICHAEL
WILKS AND
DR VIVIENNE
NATHANSON
Q804 Dr Turner: My apologies to Dr
Nathanson and Dr Wilks, our first witnesses, for starting late;
we will try and get on as quickly as we possibly can. Welcome
to this latest session in our long-running saga of an inquiry
into human reproductive technologies. As members of the BMA's
Medical Ethics Committee and Professional Activities Director
we want to hear your angle on human reproductive technologies.
Your evidence mentions five ethical principles implicit in the
1990 HFE Act. Do you think clinicians would be helped if these
were explicitly stated?
Dr Nathanson: Yes, we believe
that these principles are very helpful and that if explicitly
stated they would actually help the debate about how the rules,
the law itself, needs to be interpreted, because very often when
individuals are looking at specific, individual cases—and
the nature of human fertilisation is that it is about individual
cases as well as being about the global body of regulation—then
it does help people to interpret and to look at those and to say,
"When I am making judgments about whether this person fits
within what the law allows or not then the overarching principles
help to frame the way in which that consideration is done".
Dr Wilks: Yes, I agree with that
entirely. Obviously the point is that we are here looking at a
possible review of an Act that is relatively young, and it is
amazing to think how far technology has moved on beyond the initial
purposes of the HFEA. So general principles are very important
and have to encapsulate possible changes that are completely unknown
over probably a relatively short period of time, and I think things
like the special status of the embryo and the welfare of the child
and access to treatment being based on individual treatment are
three very important principles that we think would apply to a
great deal of potential future therapeutic and reproductive technologies
and treatments.
Q805 Dr Turner: Technology has moved
on very considerably in the last 15 years since the Act was first
drawn up as a Bill. During that time other issues have arisen,
and if you were setting out a list of basic ethical principles
now would you wish to add to that five?
Dr Nathanson: I think not. I think
we would actually say that those five principles encompass the
things that it is easy to state as principles. Whether there would
be other specific clauses is a different matter but as a set of
general principles we think those encompass the background upon
which both the legislation and, indeed, the considerations under
the legislation are framed.
Q806 Dr Turner: How would you wish
to deal with the issue of reproductive freedom?
Dr Harris: It seems like a good principle.
Dr Nathanson: When we are thinking
about reproductive freedom we need to consider what we mean by
that. Are we saying that individuals have the right to reproduce
if they do not need help, and whether because they need medical
help we are looking at things differently? We would look at reproductive
freedom and say that the state, in general, does not and should
not interfere with the decisions people make. However, there is
a difference when you are looking at assisted reproductive technology
because in these circumstances you are looking at the use of medical
and scientific expertise, and the question then is: is it legitimate
to interfere with people's freedom or—to put it another
way—can people require that this technology be made available
to them? We believe that the key issue here is that you are asking
doctors and scientists to help create a potential child, but to
think about that in terms of looking at each individual case separately
and to have a firm focus on the welfare of the child, so we would
not want to make a general, very broad prohibition with one or
two exceptions—such as reproductive cloning. The point about
looking at the welfare of the child and to make decisions when
you are talking about the potential for very serious harm to the
child rather than only giving people reproductive freedom if they
fit some kind of idealised family which we do not think to be
appropriate.
Q807 Dr Turner: How would you frame
that in an Act?
Dr Nathanson: I think it is about
the principles which talk about the need to take account of the
welfare of the child and to talk about that in terms of not making
these global assumptions that there is an idealised family and
that only people that fit within that idealised family concept
should be allowed access to the technology. That is one of the
key issues.
Q808 Bob Spink: I am going to look
at the embryo and research on the embryo, if I may, please. Many
people in the public are deeply concerned about the fate and status
of embryos, and therefore society, one could say, is deeply concerned
about that. Do you think Parliament should reflect that?
Dr Nathanson: We believe that
the current provisions in the legislation on embryo research are
appropriate and right. One of the problems with some of the concerns
that are expressed is that there is a mixture of both misunderstanding
and, also, a concern about what could happen in the future. So
I think the key issue here is to have reassurance that the fact
is that the law is unlikely to be changed to allow more to be
done, to allow research to continue until a much later date. Indeed
that medical science continues despite—or indeed perhaps
because of—all the developments, makes the 14-day limit
that was set entirely appropriate. I think one of the concerns
that people have expressed relates to people's perception that
perhaps we did not understand enough about embryonic development
at the time the law was set. I think we did and the limit was
set well below the time at which there was the possibility of
pain and so on, which is one of the public's concerns.
Q809 Bob Spink: We are talking now
about very early embryos. Do you think, therefore, there is in
principle a difference in status between a one-day old embryo
and a 14-day old or 28-day old embryo?
Dr Nathanson: I think the embryo
always has a special status; it is not the same as any other tissue.
However, the key factors that were taken into account accepting
that special status at the time at which research was allowed
seemed to be based upon two things: one was that the research
could not be carried out on any other form of tissue to get the
medical gains and benefits that were essential and, secondly,
that the stage of embryonic development was before the stage at
which there was any possibility of pain or of sentience. I think
those were both important reassurances for the public.
Q810 Bob Spink: Do you see any value
in redefining the term "embryo", say, to embrace stem
cells?
Dr Wilks: I am not sure necessarily
that we would. It is not a thing that we have specifically considered.
I think in terms of the place of the embryo, we have in our evidence
suggested that the overarching statements on the face of the Bill
reflect a special status of the embryo. That then begs the question,
what is that special status and how do you define it? Unless you
believe deeply—and some people do believe deeply—that
life begins at that moment of conception then I think we are forced
into some consideration of a sort of graduated series of rights
which we have to reflect as duties to that embryo. It is also
unsatisfactory[1],
I think, that the law gives no legal right to a foetus, but we
believe a moral duty is owed to that embryo/foetus. So I think
the idea of graduated rights may, to some people, seem a convenience
but I think it is a reality in terms of framing legislation. I
think, when it comes to stem cells, there are problems in that
although we are very interested in the work that may be useful
in future stem cell treatment using adult stem cells, nevertheless
we are absolutely convinced that the need exists to continue with
work on embryonic stem cells. However, that technology is going
to vary so much that to frame a right according to an embryonic
right, I think, would be very complicated and would probably rapidly
become out of date.
Dr Nathanson: The other part of
that question, I think, is whether putting that within this legislation
with the revised authority regulating it flows into the same areas
of research. For people doing stem cell research it is very often
somewhat very different and the question is how is it best to
regulate it? I think that we certainly need regulation of stem
cell research to get public confidence that it is appropriately
controlled, but we have not considered whether it would be appropriate
under this legislation. It needs to be clear to everyone how it
is regulated and appropriately limited.
Q811 Bob Spink: You have suggested
in your evidence to us that the definition of an embryo should
be extended to include cell nuclear replacement embryos. Should
we try to define an embryo by its capabilities rather than by
the process by which it was formed?
Dr Nathanson: That is a very tempting
suggestion. The question, really, is whether it is possible to
find a simple definition that would capture not only all current
scientific possibilities but the ones that people speculate might
happen within the next 10-15 years, because one assumes that you
do not want to change the legislation on a very regular basis.
I think that if it were possible to find a definition of embryo
that does not actually have to define the scientific or non-scientific
method of its creation that would be useful because it might capture
all those things that we cannot yet currently specifically pin
down as scientific possibilities, but if one cannot find an acceptable
phrase for that then we would still commend putting in the concept
of cell nuclear replacement because it is so important.
Q812 Bob Spink: Could I ask you three
very quick questions? How should the status of human-animal hybrids
or chimeras be resolved?
Dr Nathanson: I am sorry—in
terms of regulation?
Q813 Bob Spink: Yes.
Dr Nathanson: That is not something
we have considered. It could be under the Human Fertilisation
and Embryology Authority but that would be unusual or odd because,
again, they are unlikely to be being created in the same types
of facilities that are doing work on assisted reproductive technology.
So the question is whether this is the best body to be regulating
that, or whether we need, along with stem cells, perhaps, a group
looking at stem cells which would fit more naturally into that,
because it is about the creation of cells, human tissue, not with
the intention of producing reproductive ends but for other scientific
experimental ends. I would see those two fitting closer together
than it does with assisted reproductive technology.
Q814 Bob Spink: Are there any special
or different ethical issues surrounding the creation of human
embryos by parthenogenesis?
Dr Nathanson: I do not think there
are any extra special issues.
Dr Wilks: No.
Q815 Bob Spink: Finally, then, does
the creation of artificial gametes raise any new ethical issues?
Dr Nathanson: Again, I do not
think it raises any new issues that are not considered under the
general tenor.
Bob Spink: Thank you very much.
Q816 Dr Turner: In your evidence
you say that despite the fact that IVF is now a standard medical
procedure the current level of regulation should remain in place.
Yet your colleagues in the British Fertility Society would argue
that that level of constant regulation is unnecessary and that
spot regulation to look for trouble spots would be adequate. Do
you have a view on this? Why are you more cautious?
Dr Wilks: I think caution is a
good principle when we have uncertainty about the way the technology
will take us, both at a research level and at treatment level.
Although I think it would be unwise to be too obsessive about
the issue of safety at a stage when, of course, clinical trials
need to be done to establish the safety of the technology when
it becomes a treatment, I think the idea of a kind of spot safety
check would actually, probably, be an inadequate level of control.
Dr Nathanson: The other thing
is that we would have concerns about whether there would be sufficient
public trust in that, and we have to recognise that there remain
people who are cautious about the whole concept of assisted reproductive
technology. I think the fact that there is a strong regulatory
framework helps to encourage public support for people who would
otherwise, perhaps, sit on the fence.
Q817 Dr Harris: On that basis, if
there was a loss of public trust in the medical profession generally,
would the BMA argue that professional self-regulation was no longer
sufficient and there ought to be external majority lay regulation?
In other words, is the principle that you need to maintain public
trust and, therefore, have regulation something that you think
is extendable to other areas of medical practice or medical practice
generally? If not, why do you say it is necessary in this area
specifically?
Dr Nathanson: I think you have
to look at every single area separately. We say it in this area
for two reasons: one is because we are looking at the human embryo,
its special status and people's emotional and other connections
with that concept. Secondly, if you like, part of the bargain
that was made with society, from the Warnock report onwards through
the passage of the legislation, was that this technology would
be legislated for and controlled and regulated in a particular
way. Moving away from that at a time when there remains some public
disquiet would cause us some concern. Having said that, we also
recognise that, of course, we are not looking at this on behalf
of clinics which are inspected, regulated, visited and so on,
so we are not commenting in that sense upon whether that is a
tremendous burden on them; we are commenting purely from the point
of view of the view we have of the public confidence this helps
to support.
Q818 Dr Turner: IVF is relatively
straightforward, yet it is totally regulated, whereas there are
other more complex procedures which are outside regulation designed
to have the same effect. Do you see any moral or ethical difference?
Dr Wilks: What sort of procedures
are you thinking of?
Q819 Dr Turner: You know better than
me.
Dr Wilks: I see, within the technology.
Dr Nathanson: I think that we
see advantages in having, in general, the majority of these technologies
covered within the legislation, but there is always that fine
balance of how much those technologies are innovative, potentially
risky, and so on, that you need to balance before including more
things into the legislation. We would not want the regulatory
system to be so complex and so costly that its effect became to
deny access to increasingly safe and common procedures to people
who need these procedures. So it is a fine balance.
1 Note by the witness: Dr Michael Wilks has
subsequently stated that he should have used the word "strange"
rather than "unsatisfactory". Back
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