APPENDIX 81
Supplementary memorandum from the British
Medical Association
1. What effect has regulation had on clinical
standards? What mechanisms could be used to drive up good practice?
The HFEA sets standards in its code of practice
and carries out inspections to ensure that these standards are
met. The BMA does not have detailed information about how this
has worked in practice and how much the standards set by the HFEA
have changed practice within clinics—this question would
be better directed towards clinics themselves. It is clear, however,
from examples such as the reduction in the number of embryos to
be replaced per cycle that the HFEA's decisions about good practice
clearly impact on the way treatment is provided. The regulatory
mechanism also provides reassurance to patients seeking treatment
that certain minimum standards are adhered to and, for example,
that the treating staff have the appropriate training and expertise.
2. What action could be taken to improve the
inspection and monitoring of clinics?
We are not in a position to respond to this
question as we do not have detailed or practical experience of
the inspection process.
3. Would you like to see a greater role for
the professional bodies in drawing up technical and clinical guidelines?
It is difficult for us to comment on this without
detailed information about the current level of consultation with
professional bodies in drawing up technical and clinical guidelines.
It is clearly important that the HFEA is involved in drawing up
guidance or, in some cases, endorsing that provided by other bodies.
In doing so, views should be sought from all relevant bodies in
order that the HFEA is able to make informed decisions based on
the most up to date information available.
The area in which the BMA has most input into
the HFEA's work is on its ethical policy. In this area the HFEA
frequently seeks the BMA's views to feed into its deliberations,
both formally through public consultations and on a more informal
basis on particular issues. We believe this works well.
4. What ethical issues does reproductive cloning
raise, other than safety?
In 1999 the BMA produced a discussion paper
for the World Medical Association on human "cloning"
(covering both reproductive and "therapeutic" cloning)
calling for a rational and informed debate about the issue. The
document clarified the differences between the range of activities
that had been covered by the general heading of "cloning"
and also set out the ethical arguments in relation to reproductive
cloning. A copy of this paper is attached; part 2 (on pages 2-7)
is directly relevant to this question.
The BMA recognises that many of the arguments
expressed in opposition to human reproductive cloning are based
on common misperceptions (see pages 1-2 of BMA paper) and instinct
rather than clearly articulated robust and logical arguments.
We have argued—for example in Medical Ethics Today—the
BMA's handbook of ethics and law—that if we reached
the stage where it was possible to say with a reasonable degree
of certainty that human cloning was safe, it would be essential
to explore in more detail the motives of those who wish to use
this technology and to consider the benefits, harms and likely
consequences of allowing it. In the absence of concerns about
safety, it would be essential to ensure that continued opposition
to cloning was based on careful analysis rather than relying on
ill-defined notions of "human dignity" and to ensure
that decisions are made on the strength of the arguments rather
than simply on the strength of public opinion.
5. What is your view of the effectiveness
of local ethics committees? Could they take on some of the ethical
oversight currently conducted by the HFEA?
We have only anecdotal information about the
effectiveness of local research ethics committees provided primarily
by individual BMA members in relation to their particular experiences.
Perhaps inevitably, when our members raise issues about ethics
committees with us it tends to be because there is a problem or
because they are unhappy about a decision that has been made or
in relation to some problem connected with their membership of
an ethics committee. Nevertheless, whilst recognising that the
feedback we receive is neither representative nor comprehensive,
our general perception reflects the widely held view that the
quality of ethics committees around the country varies considerably.
We are aware that for some time now, particularly following the
adoption of the Medicines for Human Use (Clinical Trials) Regulations,
work has been in hand to improve the quality and consistency of
ethics committees.
The BMA has, for many years, advocated the use
of clinical ethics committees to help doctors working in assisted
reproduction to consider difficult cases. Their use is now also
supported by the HFEA. Although we are aware that the number of
clinical ethics committees is increasing (and expanding to other
areas of clinical practice) we do not have detailed information
about how they operate although we know that many of our members
find them useful. The Royal College of Physicians has, however,
recently completed a review of ethics support in health care practice,
which includes an assessment of clinical ethics committee. We
understand the report of this work is due to be published shortly.
You might also find it helpful to contact ETHOX (the Oxford Centre
for Ethics and Communication in Health Care Practice—www.ethox.org.uk)
which has undertaken a considerable amount of work in this area.
We see the role of ethics committees in the
area of assisted reproduction as being to provide advice on clinical
cases within the broad framework permitted by the HFEA. We believe
it is appropriate for the HFEA, rather than a local ethics committee,
to consider individual cases where they raise new, or particularly
controversial issues—such as the selection of embryos on
the basis of tissue typing. We would not expect the HFEA to become
involved, however, in individual decisions about whether a particular
post-menopausal woman should be provided with treatment (although
it might, during its inspection process, question the way in which
the decision to treat was made and how the welfare of the child
was assessed in the particular case).
In relation to embryo research we believe that
there is sufficient public concern to justify maintaining the
current practice whereby every research project is considered
and approved by the HFEA.
November 2004
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