Joint Committee on the Human Tissue and Embryos (Draft) Bill Minutes of Evidence

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 regulator—a 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" version.

  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 BAS—this group should oversee all aspects of policy on Treatment/Research and Training.

  6.  The HFEA should deal only with issues relating to:

    (a)  Collection and collation of outcome statistics (very important—but what they collect needs to be reviewed). Collection of data now is much easier due to "EDI".

    (b)  Reviewing, with PAC, the appropriateness of personnel—so the Person Responsible role could still be maintained.

    (c)  Receive and collate data on incidents and publish Alerts.

    (d)  Repository of public/patient complaints.

    (e)  Maintenance of Register.

    (f)  Licensing—which could now be trimmed right down, especially as the HCC too inspect units.

    (g)  NOT to determine social policy etc—the 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 gained—quite the converse in terms of increased costs, professional time away from patients and considerable anguish; for arguably no measurable benefit to patients, practitioners or public).

  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, but less.

  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 area—regulation, research or treatment. There is some considerable merit in what we do, but less so in how we do it and what has been achieved—for 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 Utopia—just a much worse situation for many patients and their future offspring alike

  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 donation—how 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 into again!

  I could go on with other examples ... (BTW—I 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" for Media!....

  "...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!"

June 2007

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