What’s happening to the HFEA?

Posted on October 14, 2010 by

0


We still don’t know exactly how the government plans to reorganise the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA). As we wait for more details, yesterday in the Lords, Baroness Deech, a former chair of the HFEA, posed a question on the government’s plans for its future to the health minister Earl Howe.

The discussion includes reference to some of the concerns across the science community. Peers involved include Lord Willis who was very involved in the recent Human Fertilisation and Embyrology Act 2008, the most recent legislation covering research using human embryos, and Lord Harries who has served as a member and briefly an interim chair of the HFEA.

Background

In July, the government announced they are planning to get rid of the Human Fertilisation and Embryology Authority (HFEA) and Human Tissue Authority (HTA) – both of which play a role in regulating medical research using embryos and human tissue. This is part of a wholescale reorganisation of all the arms-length bodies (also known as quangoes) associated with the Department of Health.

The regulating jobs they do will still need to be done. Who exactly will do this is yet to be determined – the government is awaiting the outcome of the Academy of Medical Sciences Review of the regulation and governance of medical research in the UK before it makes a more detailed announcement of its plans. It is likely their responsibilities will be split across a new system of four regulators – focused on quality, economics, medicines & devices and research.

Asked By Baroness Deech – Wednesday 13 October 2010
To ask Her Majesty’s Government what are their plans for the future regulation of human fertilisation and embryology.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe): My Lords, the Government fully recognise the work of the Human Fertilisation and Embryology Authority since 1991. However, as a result of the Department of Health’s review of its arm’s-length bodies, the Government believe that there is scope to streamline healthcare regulation. The HFEA will continue for the time being but we propose that its functions will transfer to other bodies by the end of this Parliament.
Baroness Deech: My Lords, I thank the Minister for that Answer. Will he assure the House that he will stand by the report of the pre-legislative scrutiny committee of three years ago and not endanger the statutory functions of the HFEA, including the all-important database and the guidance to patients, by splitting up the functions between five other committees, thereby saving no money at all and endangering the worldwide reputation of this model of regulation?
Earl Howe: My Lords, I recognise the experience of the noble Baroness and I pay tribute to her time as chair of the HFEA. The review that we have conducted has been based on a close examination of the functions of every arm’s-length body. Whereas some 20 years ago it may have made sense to look at a single body for carrying out the functions undertaken by the HFEA, she will agree that the functions concerned are very different. Times have moved on and we think that there is a more logical way to parcel out those functions which does not dilute in the slightest the efficacy or the efficiency of the regulatory action.
Lord Willis of Knaresborough: My Lords, I beg to disagree with my noble friend. What remains the same, as the noble Baroness, Lady Warnock, said, is the fact that we must enshrine in legislation and through regulation the very special status of the embryo. Since 1991, the HFEA has carried out that function very effectively indeed and it has done so because it has the support of the British people. As regards bringing these regulations in house, will the Minister say why the public should have more confidence in him as the Minister than in an independent regulator?
Earl Howe: My Lords, I need to make it clear that our proposal is not to bring the regulation in house; it is to distribute the regulatory function between several different bodies. I also emphasise that there is absolutely no suggestion that we are changing the special status of the embryo. We have no plans to re-examine those parts of the legislation which recognise that status. We fully recognise the role which the HFEA has played in establishing the UK as a world leader in this area, but times change and so has the way in which we regulate the delivery of healthcare. That is the basis on which we have looked at this.
Baroness Thornton: My Lords, when I was a government Minister and the BMA, the Royal College of Obstetricians and Gynaecologists, the Royal College of Pathologists and the Royal College of Nursing ganged up on me, I always thought it was wise to listen. All those bodies have expressed very serious concerns about the government proposal. Has the Minister had meetings with the royal colleges and the BMA about their concerns? Has he discussed in particular the real risk to loss of specialist expertise and public confidence and the risk to patient safety?
Earl Howe: My Lords, we intend to engage fully with all interested parties on this matter but it is early days. The noble Baroness quite rightly raises the specialist expertise available to the HFEA. We fully recognise that. We are very keen that the expertise is not lost but is made available to the CQC or to the new research regulator, if we set up one. I understand that, where a
function of one organisation transfers to another organisation, it is customary for the relevant staff to transfer as well. I emphasise that matters are at a very early stage.
Lord Harries of Pentregarth: My Lords, given the special ethical status of the early embryo, does the Minister agree that the integrated function of the HFEA, whereby the licensing of the clinics, the licensing of research and the extensive database are held together, minimises the risk of unfortunate incidents? If the HFEA is dismembered, the likelihood of such unfortunate incidents is likely to increase.
Earl Howe: My Lords, I recognise, as will the House, the noble and right reverend Lord’s experience in these matters. At this early stage, we will look very carefully at the design of systems to ensure that the expertise and the scrutiny functions, which we associate so well with the HFEA, are not diluted or lost in any moves that we make in this area.
Baroness Warwick of Undercliffe: My Lords, I declare my interest as chair of the Human Tissue Authority. Just as with the HFEA, the HTA works efficiently and effectively to ensure public and professional confidence in the regulation of human tissue, and to ensure that it is used safely and ethnically and with proper consent. Does the Minister agree that it is crucial in any transfer of functions that the confidence of both the public and professionals is maintained; that consent, respect and dignity are maintained; and that any disruption to well-regarded regulation is kept to a minimum?
Earl Howe: My Lords, again, I thank the noble Baroness for the work that she does with the HTA. The answer is yes in every case.
Earl Ferrers: My Lords, in his Answer, my noble friend referred to an arm’s-length body. What does that look like?
Earl Howe: My Lords, my noble friend will be pleased to learn that it is a sort of portmanteau term that can apply to a quango, a non-departmental public body, an advisory committee and bodies of that ilk.

Posted in: Policy