Public Bodies Bill [HL]

My Lords, in a nutshell what I and others are calling for is that the HFEA and the HTA should remain untouched until a new research regulatory body is in place with its own statute ready to receive those functions, and that in the mean time there should be a wholly independent external review of the HFEA. The HFEA is like no other quango. Its work touches deeply on the intimate lives of the one in six couples who cannot conceive naturally, the health of babies, scientific research, cures for diseases now and in the future, the profits of scientific companies, and public morality. It is unique, has an international reputation and was a British first. I am seeking to preserve it from being shattered and to prevent lasting damage being caused to that area. The HFEA and the Human Tissue Authority, to which similar considerations apply, are both listed in Schedule 5 as bodies that may have their functions transferred or modified under Clause 5. In Committee and at Report, amendments were tabled to remove the HFEA and the HCA from that schedule but, for various reasons, the proposal was not voted on but withdrawn to give the Government a further chance to reflect on the damage that it seems to us will be done, which we were convinced would persuade the Government to change their minds. This did not occur. Indeed, it seems that the Government are developing policy in this area as they go along. I sometimes suspect that behind closed doors there would be relief if the amendments being looked at by the House today were to succeed. The first two amendments in the group are set down in my name and those of the noble Baroness, Lady Warwick, the noble Lord, Lord Walton, and the noble and right reverend Lord, Lord Harries, who cannot be in his place today because he has an unbreakable prior commitment but is giving his full support. The amendments seek to rectify an omission—the need for an independent review—and to prove a point that change in the organisations will be for the worse. We have the support of the key organisations in this field—the Association of Clinical Embryologists, the British Fertility Society, the British Infertility Counselling Association, the BMA, the RCN, the RCOG and the Infertility Network UK. They do not consider that the HFEA should remain in the Bill because there has been no full and impartial public review of the risks and benefits of the new proposals, including the financial costs of all the options. However, as I have said, the removal of the two bodies from the schedule is not now a possibility. There is agreement that there are some elements of its remit that the HFEA could do better. Therefore, there should be an independent external review of the HFEA, with the aim of reducing bureaucracy, increasing accountability and saving money—albeit that the cost to the public purse is only £2 million and can be reduced. Even those who are most critical of the HFEA cannot oppose these two amendments, which call for just such a review. The consultation proposed by the Government is not at all the same. No doubt the HFEA’s working practices could be streamlined with other regulators. Efficiencies could be found in the back offices and research regulation could be improved. However, there was no need to include the HTA and the HFEA in this Bill. No matter how irritating the HFEA may have been found to be by clinicians, they must surely welcome a review, for if they accept the Government’s way forward the irritations will no doubt increase and there will be no improvement of those functions. I wish to say a few words about the third amendment, Amendment 9. Just shifting the HFEA into the Care Quality Commission will not achieve money savings or efficiency. The shift will not meet the objections of the professionals to some of the ways in which the HFEA works. I am saying: do not take it apart but make it better, with an impartial review by, for example, the King’s Fund, the Nuffield Foundation or the Wellcome Trust. Indeed, the proposed overarching regulatory body could work with the HFEA to achieve the aims desired by the Government. By splitting away the research functions of the HFEA as the Government propose, there is the risk of creating additional bureaucracy and increasing, rather than diminishing, the burden of regulation. The HFEA and HTA functions will be transferred to the Care Quality Commission, and research will go to a new body that has not yet been created. There is to be consultation about that reallocation of functions, even about the database—perhaps the most important feature to be concerned with in dismembering the HFEA—but in the mean time, the shadow of destruction hangs over the HFEA. That will affect staff morale and retention, and the confidence of scientists and clinicians, who rely on it for legitimacy and guidance, not to mention international respectability. I submit that the CQC does not have the experience or expertise in the complex areas governed by the HFEA and the HTA, and there is the danger of losing the corporate knowledge developed over the past 20 years, along with the relationship built up between the HFEA and the clinics. There is no practical benefit in abolishing the HFEA and handing its responsibilities over to the Care Quality Commission. More members of staff will have to be recruited and trained to replace the existing ones. Rearrangement of all external relations will have to be accomplished. The efficiency and cost-effectiveness of that has not been tested. Nobody can understand why that is being done, when other countries such as Canada are trying to emulate what has been done so successfully here over the years to regulate infertility practice and embryology while staying ahead of the field in maintaining safety and patient confidence. If ever there was a time to protect consumers in this field, it is now. Patients are used to having a single port of call for information and complaints. To disband the HFEA and the HTA sends the message that the Government do not trust the way that tissue, infertility and embryology is handled in this country. It is a message that will go right around the world. I fear that there will be fragmentation in an illogical way. The latest government proposal is that the licensing of embryo research, the release of identifying treatment data to researchers where it is not practicable to obtain consent, and the provision of guidance to researchers will be hived off to a new research regulatory body. Those things are in fact inseparable from the maintenance of the database, which is of enormous significance in itself, and advice to patients, all of which is HFEA-based now. There is no definite timetable for the establishment of a new, overarching research regulatory body, on which the architecture depends. It depends on new primary legislation, likely to be after 2012. In the mean time, it is proposed that there be an interim special health authority in 2011-12 to bridge the gap until the hoped-for primary legislation in the second Session of this Parliament. It will need more funding from the Department of Health budget. If noble Lords think that that is incomprehensible and confusing, they are right. The cost of a bridging research agency will no doubt far outweigh any savings—not that we have been told what they might be—that could be envisaged in the transfer of HFEA and HTA functions. That is why the third amendment has been tabled. Our preference, of course, is that your Lordships should vote for the first amendment, which calls for a review, but even so, if there is to be transfer, the Government's intentions have not yet been made plain in detail. Why is a bridging authority necessary? How much will it cost? How can an interim body deal effectively and authoritatively with ethical questions—those specific to the sensitive functions of the two existing bodies? That is why the third amendment is here, for it covers newly revealed policies not hitherto debated or explained in sufficient detail. Can the Minister guarantee that the HFEA and the HTA will remain untouched until legislation is in place and all is set to receive their functions into a new body? Of course we do not know what the other place will do in this area. Some have said that IVF is routine and does not need special attention. That is not the Government's view, for they rightly propose to stick to the primary legislation. The Human Fertilisation and Embryology Acts will stay in place; they will not go. The demands that they place on laboratories and clinicians will stay, every word of them. Nor do the public think that IVF is routine. Their emotions and intelligence are engaged by every new development—for example, as recently reported, in treating mitochondrial disease, set out in some of the tabloids as having three mothers; in screening embryos; and in protecting the patents on stem cell work. All those who hope for cures for terrible diseases are involved in this debate. The uniting of eggs and sperm, and the resultant possibilities, can never be routine unless one is very hard-boiled. This is what commentators have said. The Guardian said: "““The abolition of the HFEA will leave a major policy vacuum in biotech ethics. Without intervention, it’ll be filled by the Daily Mail””." The New Statesman said: "““The regulation of fertility and embryology … will now be hidden within the remit of the Care Quality Commission … There will be repercussions … Without a distinct, visible body to oversee reproductive ethics, scientists in the field stand to lose public trust””." I should have said that I declare an interest, in that I was chairman of the HFEA years ago, and my heart is engaged in this topic for the sake of the patients and because of the whole enormously enriching field that was opened up to me and to many others. I urge your Lordships to do the right thing—to call for a review before committing this pointless transfer, which will save no money and damage British interests. I beg to move.