15:33 - Division on Amendment 1 - Ayes: 179 / Noes: 185 - Amendment 1 disagreed.
16:11 - Division on Amendment 6 - Ayes: 172 / Noes: 215 - Amendment 6 disagreed.
18:00 - Division on Amendment 7 - Ayes: 199 / Noes: 209 - Amendment 7 disagreed.
Baroness Thornton
My Lords, I thank the noble Baroness, Lady Deech, my noble friend Lady Warwick and other noble Lords for their determination to have the future work of the HFEA and the HTA clarified during the course of the Bill. I join others in thanking the Minister for his patience and accessibility in discussing the different aspects of the issue.
We have had another excellent debate that has illustrated why it was necessary to bring the issue back to the Floor of the House for further discussion. The House needs to heed the voices raised across the Chamber—as well as the pleas contained in the letters that we have received from some of the parents of Alder Hey children, the letter in the Times this morning signed by a galaxy of medical experts and the briefing from the BMA on behalf of several organisations—as a sign of increasing concern.
Since Report, the Minister has kindly written to me explaining further the Government’s proposals for the HFEA and the HTA and the staged break-up that seems to be the Government’s preferred option at the moment. In brief, the break-up involves HFEA and HTA functions being transferred to the CQC except for research-related functions, which will be transferred to the health research regulatory agency, presumably covering what have been broadly referred to as the ethical issues. To facilitate this, as the noble Baroness, Lady Deech, explained, a special health authority will be created in 2011-12 and there will be primary legislation to establish the agency proper in the second Session of this Parliament. Presumably, the ethical issues will therefore be dealt with by the interim body in that process. Notwithstanding the proposals of the noble Lord, Lord Willis, regarding the Health and Social Care Bill when—indeed, if—it reaches us, it is clear that there will be primary legislation to establish the new research body.
I am further grateful to the Minister for his explanatory letter because it served to strengthen my view that these bodies should never have been in the Bill in the first place. It also illustrated for me the question that I want to put to him: why go through such disruption, risk, lack of stability, potential loss of expertise and expense for the next two years prior to the introduction of primary legislation to establish the new health research agency, which will address all of these issues? Why not agree the amendment that establishes an independent assessment of the work of both bodies? That could feed into the pre-legislative process and consultation, which will include all the questions that need to be asked, leading to primary legislation in about two years’ time. If the Government go down the route that the Minister is proposing, they intend to launch a consultation this summer, as outlined in the Minister’s letter to me, and then presumably will break up the agencies at some point towards the end of this year and the beginning of next. That means that at the beginning of 2012 the agencies would be broken up and then, by the end of 2012, we would start the pre-legislative programme to set up the new research agency.
That is why we on these Benches will be supporting all these amendments. It is not that either the HTA or the HFEA should be preserved for ever; indeed, it is clear that my noble friend Lord Winston and the noble Lord, Lord Patel, have grave problems with the HFEA. I make the point to the noble Lords, which I have also done outside the Chamber, that that is not the point of the Bill. Passing the amendments would actually be more likely to address their concerns than would leaving the situation as it is. In other words, there is no guarantee that their concerns about the HFEA, which I am sure are legitimate, would be addressed if we left the Bill as it is without the reassurances.
The one thing that we know is that there is going to be a health research agency. It is an idea of merit. It is also a proposal that is ideally suited to the expertise and inclination of this House; the Select Committee, the pre-legislative scrutiny, the draft Bill and, if I may say, the skills that the Minister brought to bear when he helped to create both these agencies make this the place where that process should start. I am certain that that would ensure a good outcome.
The amendments are different from the simple deletion amendments that we tabled in Committee and on Report, particularly the third amendment, because it accepts the principle that the Minister may transfer or modify the functions under Clause 5 in respect of these bodies but would require the Minister to have first established the Government’s new regulatory body with a separate ethics committee. It would ensure that there were no gaps between what is happening now with the current bodies and the Government’s intended independent regulatory body in future, a point that many noble Lords have made. However, it would not preclude an examination and independent assessment of the work of both these bodies. It would ensure that the critically important ethical functions performed by these bodies were recognised and catered for, which, in a way, is where we came in at the first stage of the Bill.
Earl Howe
My Lords, I thank noble Lords who have moved or spoken to these amendments. I recognise and understand the sentiments underlying them. I do not in the least wish to argue against or downplay the importance of cost-effectiveness in any legislative changes that we propose, or of ensuring that the right successor arrangements are in place for discharging the relevant functions of the HFEA and HTA. I therefore hope that what I am about to say will satisfy noble Lords that in most key respects I am in the same place as they are regarding the points at issue.
Since our debate on Report I have written to the noble Baroness, Lady Thornton, to set out my reflections on the points that she and others have made. There were common themes: a desire for greater clarity on where the Government intend to transfer the functions of the HFEA and HTA to; concern that the dispersal of functions across a range of bodies would risk fragmenting regulation; and concern over loss of expertise. I have considered these concerns carefully. As I have made clear, we intend to consult in the late summer on the options as to where certain functions would be most appropriately transferred. That remains our aim. However, having taken into account the strength of feeling about keeping functions together, we now intend to proceed on the basis that our preferred option is for all HFEA and HTA functions to be transferred to the Care Quality Commission, except for certain research-related functions that will transfer to the proposed health research regulatory agency. We shall therefore consult on this basis but, at the same time, remain open to receiving views on the way forward from all stakeholders through the consultation process. I hope noble Lords will agree that this preferred option will address concerns about the potential impact of fragmentation.
The noble Baroness, Lady Deech, expressed the fear that the Government’s proposals would lead to a vacuum as regards the ethical focus of these bodies—in the decision-making process for research and treatment involving embryos in particular. Let me explain what we intend. Ethical safeguards—for example, the type of embryo and gamete that can be used in treatment, the need to consider the welfare of the child, and the need for consent in respect of human tissue—are clearly enshrined in legislation in accordance with the wishes of Parliament. These safeguards will remain firmly in place.
In keeping an integrated approach to HFEA functions, the CQC would be the focal point for ethical considerations of treatment licensing that arise from the Human Fertilisation and Embryology Act. There is no reason whatever to suppose that it is not up to fulfilling that role. I say to my noble friend Lord Newton that my department’s officials have had discussions with the CQC senior managers about the proposed transfer of functions. The CQC is confident that these can be taken on effectively. The health research agency will provide a focal point for the ethical consideration of research using embryos. It will draw on expert advice, as the HFEA does now. The aim is to simplify and rationalise the ethical approvals process for all kinds of research. Far from the ethical focus for each type of activity being lost, it will be actively preserved.
My noble friend Lord Willis suggested that we might use the Health and Social Care Bill, now in another place, as the vehicle for the proposed changes, rather than this Bill. I recognise the force of his proposal. He will know why we have chosen not to go down that road. We do not want to add to what is already a substantial Bill. It is important, too, that the Government retain momentum for their planned changes across the ALB sector. The ALB review process has already garnered significant rationalisation across the health sector and we do not want that rolled back. By keeping the HTA and the HFEA within the Public Bodies Bill, we can deal discretely with complex issues and undertake detailed consultation and impact assessments in a timely and considered way. We also, as I have indicated on several earlier occasions, wish to avoid reopening the Human Tissue Act and the Human Fertilisation and Embryology Act, which command widespread agreement. Our desire to maintain momentum is why we plan to establish a special health authority to continue and strengthen the work of the National Research Ethics Service and to be a starting point for the simplification of research approval processes. That special health authority would be the platform on which we would build the fully fledged research regulator.
Lord Willis of Knaresborough
Does the Minister not understand the incredulity of many of us? This is a Bill that deals with getting rid of quangos, yet the Minister’s solution is to set up a quango to create time in order to set up a bona fide agency. Surely the Minister sees that by simply delaying the whole process until the agency is in place, everything can be transferred either to the CQC or to the new agency, all at once, without an interim body.
Earl Howe
I ask my noble friend to wait a few minutes; I hope I will tell him something that he will welcome.
I turn to the amendments. On Amendments 7 and 8 the issue is not so much the end point that they seek to achieve as the practical implications that they would carry if they were accepted. Let me set out what we plan to do. There will be a full public consultation on our proposals this summer. Alongside that, we will publish an impact assessment, which will include a view about the cost-effectiveness of options for transferring functions. I assure the House that the key comparison for the purposes of the assessment will be between our preferred option and the organisations’ own plans for rationalisation. I hope noble Lords will endorse the idea of a formal impact assessment as the vehicle for doing this. It is a process that, until now, has been accepted by Parliament for general legislative and policy changes. There does not seem to be any obvious reason why that should not be an appropriate way to proceed in this case.
In addition, as I have said previously, there will be a further consultation on the proposed regulations in due course before these are laid. Taken together, these three safeguards should be sufficient to meet the aspirations of noble Lords for achieving a robust evaluation. The approach that we propose on consultation and impact assessment will, I suggest, produce a result that is thorough, transparent, balanced and, therefore, fit for purpose. The amendments, taken literally, would have us go further by suggesting a formal process of independent assessment of cost-effectiveness. This would be neither necessary nor desirable. With the best will in the world, any such assessment would be costly to the public purse, highly subjective—as any assessment of cost-effectiveness is bound to be—and very difficult to measure definitively. Practically, it would get us no further forward than a standard impact assessment. In any issue of this kind, we need to take care that legislation does not set conditions that are impossible to meet. That is why I hope the assurances that I have given will be enough to persuade the noble Baroness not to press these amendments.
In turning to Amendment 9, I will address the question posed by my noble friend Lord Willis. The amendment seeks to ensure that no HFEA or HTA functions would be transferred using the powers in this Bill until the health research regulatory agency has been established. I fully appreciate the reasoning behind this. It very much accords with the Government’s wish to avoid a piecemeal approach to the transfer of functions. In my letter of 27 April to the noble Baroness, Lady Thornton, I said that,
“in principle our preference would be to consult on the draft secondary legislation during 2012 and to commence it after the primary legislation is place that will give the health research regulatory agency the necessary legal basis. In that way, transfer could take place as a single and clear exercise, and in a co-ordinated and least disruptive way”.
In the light of this amendment and the points made today in support of it, I am prepared to go further and give a firm commitment that, subject to the will and views of Parliament, the Government will proceed on the basis of transferring functions from the HFEA and HTA only once the research regulatory agency is established in legislation. I hope that this commitment will satisfy the House. There are problems with including the amendment in the Bill from a legal perspective. It is difficult to envisage how, within this Bill, we could describe with the necessary level of legal certainty the new research body that would need to be established. The detail of what a new regulator will look like and the functions it should hold is a matter for Parliament to debate and determine as and when the relevant legislation comes before it. To make provision for a future body in this Bill risks both describing it in a way that is not accurate, thus making the power to transfer functions redundant, and attempting to limit the discretion of Parliament in relation to future legislation.
The amendment also seeks to provide in this Bill that the research agency,
“must have a separate ethics committee to undertake … ethical consideration functions”
transferred to it from the HFEA and HTA. I fully appreciate the need for assurance that the research regulatory agency will have access to the relevant expertise to deal with the licensing of embryo research and any research-related functions that may transfer to it from the HTA. Therefore, I repeat the assurance that we have consistently given that expertise will follow function, and that we expect that the research agency will have access to expert peer reviewers and others in the relevant fields that are currently available to the HFEA and HTA. However, I suggest that the level of detail on matters such as expert committees is again more appropriate for consideration by Parliament in relation to any legislation that will seek to establish the research regulatory agency rather than attempting to include it prematurely in this Bill.
Although, for the reasons I have given, I cannot accept the amendment, as I indicated at the beginning of my remarks, I would like to believe that noble Lords who have spoken will not now be too far removed from the Government’s own position on these matters. In view of our developed approach to the transfer of functions and our clear intention to consult on our proposals in an open and transparent way, I hope that the noble Baroness will feel able to withdraw the amendment.