Public Bodies Bill [HL]

My Lords, I declare an interest as a former chair of the HFEA. My name is on this amendment, and I support every word of what previous speakers have said. Those who oppose this amendment consist largely of those who are impatient about the shackles that regulation imposes and wish to be free of them. They will not be if this government scheme goes ahead. As researchers and clinicians, they will have to deal with at least two departments or bodies in place of one, which can be guaranteed to be no quicker or cheaper. Criticisms have been made of the style or overlap of inspections, but that is not the point. Those faults can be remedied. Inspection can be delegated or contracted out. What is at issue is the continued existence and symbolism of one integrated body—the HFEA and the HTA—representing lay and clinical interests, accountable to patients through consultations and to Parliament, speaking with one voice to government and to the world. The HFEA may be alone among the many bodies listed in this Bill that has an international significance and symbolism. Google it, and you will see twice as many thousands of references internationally as in the UK. It has achieved a presence in the world that has helped to give UK science a good reputation and has enabled this country to be the first legally to embrace embryo research for stem cells and as the object of study around the world. Other advanced countries have national ethics committees, such as the United States and France, or HFEA-type regulators, such as Canada, California and parts of Australia. They will be aghast that where the UK led the way it is now abandoning its respected structure. Now we have to look at the unanswered questions—indeed, there are more unanswered questions at this stage of the Bill relating to these two bodies than there were a few months ago. Noble Lords have referred to them. There is a failure of governance in the plans put forward in the Bill. Plans is too positive a word for an outline of future options which may or may not involve primary legislation and may or may not be predicated on the establishment of an unknown new body—a general medical research regulator—about which we know next to nothing. The notion of an all-purpose regulatory body for medical research is a possibility mentioned in a letter kindly sent by the Minister to those interested in this amendment and available in the Library. However, there is no information in that letter as to when and whether it will be created and how much will be in its scope. There are no powers in this Bill to set it up; it will have to be provided for in separate primary legislation when time allows. But the new body is a linchpin of the planned dismembering of the HFEA and the shifting of embryo research away from it. How much confidence can UK and overseas researchers who may come here have in our system, while years may go by before it is reconsidered? It will be like the familiar experience of being forced into a single lane on the motorway with a coned-off section indicating improvements but with absolutely nobody working inside the coned-off section and no end in sight. If this amendment is not passed, the attractiveness of the UK research environment may plummet immediately. Just as staff may drift away, so will researchers. As others have said, the future division of functions has not yet been settled, but we know that there is already a risk that the CQC will be overburdened. If there is an overlap between the CQC and the HFEA in licensing, the CQC should be relieved by dropping HFEA-type inspections. In the mean time, the welfare of patients and children will be at risk. It is not clear what functions will go to the CQC and we do not know where the all important database will go. In a few years’ time, children will be entitled to ask how about their parentage. Who will safeguard the answers? Who will enable researchers to carry out anonymised research from that database? The future governance and organisation of IVF and related matters has been cast into even greater doubt than before in this latest attempt to sort out the detail, which goes to show what a bad idea it was to unpick the HFEA in the first place. If the Government will accept this amendment, however, the criteria that should inform the establishment and general shape of regulation will be met. That is: we must keep independence in this sensitive, ethical area. It must be free from government. As a freestanding organisation, the HFEA is much more accountable and transparent than the new proposals for structure would be. It has a global name, which has done this country nothing but good, and provides a one-stop fount for those who wish to know about IVF and research here or who seek guidance as patients. It commands public confidence. There can be no argument about saving costs and preserving efficiency except by leaving it alone. To fail to accept this amendment means a loss of respect and trust in the UK IVF world, a failure to keep these issues at arm’s length from government, more control over funding when it is taken up by the Government and, possibly, an end to hopes of parity of infertility treatment in the NHS. The Government have not settled these concerns. Other countries have copied us. Why would the proposed submerging improve regulation? Why put integration and efficiency at risk? Why is there a need for a structural change at all? We have not been told, but these questions must be answered before Third Reading or we will have to continue to put them. We need the outcome of the promised consultations. Finally, in summary, the concern is that the starting point for changing these two bodies, the HFEA and the HTA, has been tackled upside down. If it is considered that there is a need for a different HFEA, the starting point should be to look at what, if anything, is wrong with it and what is the best way to overcome those problems rather than starting with a decision to abolish and split up its functions that has been reached not by an analysis of the HFEA but, quite simply, to meet a political target to reduce arm’s-length bodies. We should not tie ourselves to an outcome before we undertake a review. I believe that the fear of many professional bodies and patient groups is that by disassembling the HFEA, we could end up with something much worse. It would seem prudent to do the review and the consultations before we determine the outcome. There is no hurry; one can wait until the new, all-purpose medical regulatory authority is established, and then decide what to do. If not, there is great risk so I hope that the Government will accept this amendment and believe that they would be greatly relieved if they did.