Supplementary Memorandum by Professor
Simon Fishel (Ev 85)
On this particular issue [regulation] I believe
that the future structure should be the following:
1. NOT a new regulatora retrograde
step, especially if the HCC keeps its IVF remit **.
2. Keep the HFEA (why not use the what we
have and their experience)but a "honed-down"
3. In relation to costs I believe a "single-office"
regulator is all that is required, with the right structure.
4. My view for the structure would be a
Professional Advisory Commission (PAC) and/or a National Bioethics
Commission working alongside the (restructured) HFEA.
5. The Professional Advisory Commission
should be made up from the RCOG, BFS, ACE and BASthis group
should oversee all aspects of policy on Treatment/Research and
6. The HFEA should deal only with issues
(a) Collection and collation of outcome statistics
(very importantbut what they collect needs to be reviewed).
Collection of data now is much easier due to "EDI".
(b) Reviewing, with PAC, the appropriateness
of personnelso the Person Responsible role could still
(c) Receive and collate data on incidents
and publish Alerts.
(d) Repository of public/patient complaints.
(e) Maintenance of Register.
(f) Licensingwhich could now be trimmed
right down, especially as the HCC too inspect units.
(g) NOT to determine social policy etcthe
necessary administration function.
The HCC will obviously continue to review premises/estates
and other areas.
I am sure your learned Committee members well
understand the current overlap between the HFEA and HCC (and it
is enormously burdensome)but I have taken the liberty to
attach a document that shows just what areas the HCC already cover,
independent of the HFEA, and in addition to (so adding this regulatory
body in recent years has only complicated matters and no efficiencies
have been gainedquite the converse in terms of increased
costs, professional time away from patients and considerable anguish;
for arguably no measurable benefit to patients, practitioners
Ethical (and this is an interesting, complex
and dubious area in a pluralistic society), Clinical, Training
and Research should be removed from the ambit, as said above.
This should exist by necessity with, hopefully, a more liberal
Act, as implied from the deliberations of the Parliamentary Science
and Technology Committee (23 March 2005).
If we care about our patients, our international
standing in the field and costs we do not need more of the same,
We have a British habit of being self-congratulatory
and creating an illusion. The fact is we are NOT "the envy
of the world" in this arearegulation, research or
treatment. There is some considerable merit in what we do, but
less so in how we do it and what has been achievedfor patients
and in contributing to the field. I am a supporter for regulation
though, as I said yesterday (I have expounded my reasons elsewhere
but there is a peculiarity to IVF and human reproduction that
justifies regulation)but it is time to change! We were
(pre HFEA) "the envy of the world" and could be again,
but the quality of our research and its contribution to the clinical
imperative has been eroded over the years. And, some of the social
decisions and the reasons for their existence are highly dubious
(the "next door neighbour's" views v a real clinical
imperative, for example); the known donation only policy is calamitous,
and will never achieve the hoped for social Utopiajust
a much worse situation for many patients and their future offspring
I speak as one who, by way of just some examples
1. developed the sperm injection procedure
here but was forced abroad to perfect it for clinical use.
2. in the mid 1980's did the first known
egg donation case in the UK only to be pilloried for it and a
moratorium was introduced to ban known donationhow ironic
20 years on it is the only donation we can do.
3. Fifteen years ago I used a new procedure
called "vitrification"which had considerable
benefits to clinical practice and patients. The first baby born
is today a normal, healthy fourteen year old. But at the time
the regulator said it was "too new" created a moratorium,
and only today (with 15 years wasted) is vitrification being looked
I could go on with other examples ... (BTWI
was on the original team of Steptoe and Edwards and was working
with Robert Edwards since before the birth of Louise Brown in
1978, so have been privileged to be part of virtually all the
IVF breakthroughs since that time).
** with regard to regulation I'd like to use
Tony Blair's very own words in his "Politics and the Media
in the 21st Century" talk on 12th June, but I have taken
the liberty to change just one word"Regulation"
"...outside of the really major decisions
[for us this is of course the patients, their condition and their
hoped-for unborn child] is coping with "regulation",
its sheer scale, weight and constant hyperactivity. At points
it literally overwhelms!"