APPENDIX 33
Memorandum from the Progress Educational
Trust
Progress Educational Trust continues its work
as the interface between clinicians, academics and lawyers, the
public and policymakers, a function established from its beginnings
as The Progress Campaign for Research into Human Reproduction,
in 1985.
We provide information and debate in the area
of assisted reproduction and human genetics, through our educational
work on the BioNews web and email service (www.Bionews.org.uk),
our conferences and public debates (www.progress.org.uk/Events/Index.html)
and our science packs for schools in the "Jeans for Genes"
campaign. These approaches have all contributed to the great advances
in public confidence in current clinical practice and future research
needs and techniques, seen in recent years.
PRESERVING THE
STRENGTHS OF
THE HUMAN
FERTILISATION AND
EMBRYOLOGY ACT
The HFE Act has enormous strengths, which should
not be abandoned. The fundamental principle that research using
human embryos should be allowed to continue must be preserved
and protected. To this end, Progress Educational Trust is working
to increase public understanding of embryonic stem cell research,
to give but one example.
We feel that public support is vital to the
promotion of important research work in the future—which
we can see clearly if we draw a comparison with other European
countries, such as Germany and Italy, where there is less public
education and more restrictive regulation.
The value of this kind of informative work is
evident in the now-widespread public and media support for the
provision of in vitro fertilisation—a technique that
was once a source of great disquiet and misinformation.
POSSIBLE CHANGES
TO REGULATING
PREIMPLANTATION GENETIC
DIAGNOSIS
Treating patients' needs for PGD on a "case
by case" licensing basis with the HFEA is an unsatisfactory
way to proceed. The HFEA regulates the processes involved in PGD,
under the Interim Licensing Arrangements, because PGD necessarily
involves the IVF process. However the HFEA have no expertise in
the genetic testing of embryonic cells.
For each new disorder that the practitioner
wishes to diagnose by PGD, a separate application must be made
to the HFEA to vary their clinic's license. This application informs
the HFEA of the details of the genetic condition, the laboratory
protocols to be used and details of how these were developed,
amongst other information. The requirements of this system often
repeat previously published data, since the strategies for carrying
out PGD are well established in the literature.
Strict adherence to HFEA requirements means
that in effect, virtually every case for treatment requires a
new, and necessarily time consuming application. This application
can only be made once the preparatory work at the clinic has been
done, which could be from three months to a year's work. This
work is done without any certainty that the HFEA will approve
treatment in each case using PGD.
Progress Educational Trust has also had reports
from clinics of up to a six months' wait for a response to applications
submitted to the HFEA. Couples waiting for PGD treatment have
already had uncertainty and delays as a result of this application
procedure, and to add to those delays unnecessarily is unacceptable,
particularly where an older female patient is concerned about
her waning fertility.
We would like to see a review into the way PGD
is regulated, and to recommend that amendments are made. These
could be such that where a clinic in the UK is found to be competent
to carry out PGD for a particular type of genetic disorder over
a three year period, then the application to the HFEA should only
be a letter stating the nature of the disorder intended to be
treated. The HFEA could be thus be confident that PGD is not being
offered for any trivial purpose. It does seem to us incongruous
that PGD is more tightly regulated than prenatal diagnosis, which
may result in the termination of a pregnancy and the death of
a fetus.
THE ISSUE
OF THE
WELFARE OF
THE CHILD
As many commentators, speaking from within and
outside of clinical practice have observed since 1990 that s 13(5)
of the HFE Act, the "welfare of the child" clause, is
a difficult section to commend.
Whilst maximising the psychological and social
welfare of children is clearly, and rightly, a societal priority,
this aspect of the welfare of putative children is in many ways
an impossible assessment to make. Progress Educational Trust would
also question whether it is appropriate for this predictive responsibility
to be shouldered by medical and other fertility clinic staff,
in any case.
Clinicians should act in their patients' best
interests. However they should not be asked to second-guess those
of their patients' putative children, whilst of course doing all
they can do to ensure the physical health of future generations.
Progress Educational Trust would recommend that
section 13.5 be amended, so as to reflect achievable priorities
for clinicians treating patients, as stated above.
June 2004
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