Public Bodies Bill [HL]

Lord Willis of Knaresborough Excerpts

Monday 28th March 2011 Lords Chamber

[Baroness Thornton]

My Lords, we turn to Amendments 49 and 50 and the subject of the HFEA and the HTA somewhat late in the evening again. We have now had time to reflect on what the Minister said on 9 March, to read the letter to my noble friend Lord Warner, which the noble Lord thoughtfully copied to me and others, and to compare the two. In reading the debate on 9 March, I realised it had centred on the issues that arise out of the siting of the HFEA rather than on the proposals for the HTA, so I shall start by raising a few issues that are particularly pertinent to the HTA.

Since the previous debate, the Government have announced that the HTA has been appointed as the competent authority to regulate the quality and safety of organs under the EU organ donation directive. The HTA is now the competent authority for two EU directives. I would be grateful if the Minister will explain where this competence will sit under the various options he outlined in his letter to my noble friend Lord Warner. In addition, the HTA’s responsibilities with respect to EU legislation extend across the UK, but the Care Quality Commission’s remit extends to England only. The Minister can see where I am leading with this question because of the statutory implications that such a move might involve. For example, have the Government consulted the Welsh Administration about this matter or would they divide the legislation or extend the geographical remit of the CQC? Indeed, what if the Welsh said no to such matters regulated by the CQC?

We also need to look at the context in which these changes are being proposed. There are loopholes between coroners legislation, the Human Tissue Act and the Police and Criminal Justice Act which the HTA is addressing at the moment. I think it is right to be concerned with the Government’s continued determination to abandon the idea of establishing a chief coroner’s officer, the abolition of the National Policing Improvement Agency combined with proposals to break up the HTA’s functions. Added to the squeeze on resources in the central government’s resource, one should ask what guarantees will continue to be there and where they will be concerning human tissue not being retained without consent.

When the Minister answered this debate on 9 March, he took the trouble to explain in some detail the Government’s thinking about the future of the HFEA and the HTA and spoke about the possible creation of a new health research agency, which I think largely met with a great deal of approval across the House, and I shall return to that matter in a moment. His letter to my noble friend explores the various options that the Government might take with the powers that the Bill will grant them. I know my noble friend Lord Warner will want to explore the contents of that letter, so I shall limit myself to two issues that are still outstanding and need to be addressed before Parliament grants such powers with regard to these two bodies.

The first is the nature of the pick-and-mix proposals for the future of the HFEA and HTA, which the Minister suggested in his reply to the House on 9 March and in his letter to my noble friend, because I do not think it is acceptable to ask for powers fundamentally to change these organisations and not to know at this stage how those changes might be achieved and what they will do. The Minister spoke about this being a road of travel. Roads of travel are fine when one is developing policy but they are more difficult when one is putting into legislation things which will have a direct effect—in this case, on these two organisations.

Secondly, I return to public confidence, which I raised in Committee. I have read the Minister’s reply on the importance of keeping public confidence in the functions of the HFEA and the HTA. It centres around the fact that he is keen to assure the House that the legislation, and the ethics that underpin that legislation creating the HFEA and HTA would not be fundamentally changed. But I am puzzled: I do not see how, as regards the options outlined by the Minister—the orders that would need to be consulted on—he would intend to stop those ethical issues that lie at the heart of that legislation being discussed at length because of the public confidence that resides in them. When change is being proposed, that reassurance and the assurance that the new arrangements will do their job is obviously very important. Option papers do not usually provide the necessary assurance about people’s jobs or functions and, in this case, about where the ethical issues that underpin that legislation would lie.

I feel that the Government have the opportunity to move forward with the creation of a new science body, and the future of the HFEA and the HTA, with a great deal of agreement across the House and with a great deal of good will to make that happen. I do not think that this Bill is the place to start that, which probably is the heart of the problem.

[Lord Willis of Knaresborough]

Before the noble Baroness leaves the issue of ethics, if the agency model is developed, which would have a separate ethics committee that I think most of us would accept, does she agree that it is not just simply the ethics of research that is important, it is also the ethnical decisions about developing clinical practice? The need for those to be kept together within the new agency is of paramount importance in order that there is public confidence. Without the setting up of the agency, there will be a huge gap that needs to be filled.

[Baroness Thornton]

The noble Lord, Lord Willis, makes the point extremely well and much more eloquently than I was able to. It underlines the point that I have been trying to make. Taking the powers to break up the HFEA and the HTA, as it were, is not the way to start that process. The noble Lord makes exactly the right point. The Minister should recognise that there is a great deal of good will to make this happen across the House but not starting here. I beg to move.

[Baroness Warwick of Undercliffe]

My Lords, I declare my interest as chair of the Human Tissue Authority. I and my authority remain concerned about the impact of the Bill on public and professional confidence in the safe and ethical use of human tissue, as has already been raised by my noble friend. My first question to the Minister is to seek reassurance that the HTA’s functions will not be divided. A division of our functions into three or possibly four different parcels would, in my view, risk undermining the legislation that the HTA was set up to implement, increase the regulatory burden on the sectors we regulate and damage public confidence that has been so hard won.

We must not forget that the HTA was established as a result of scandals at Alder Hey and Bristol Royal Infirmary. Those events caused profound grief among affected families, outrage amongst the public and a crisis of confidence. Those events are still recent. The Human Tissue Act, which set up the HTA and was subject to more than 100 of hours of parliamentary scrutiny, was passed in 2004. The HTA began regulating as recently as 2006. In a relatively short period, it has successfully turned around that crisis of confidence. When people know there is effective regulation, they are more confident in donating their tissue for medical research, their organs for transplant and their bodies for medical education and training. Increased public confidence should mean more donation; more donation should increase professional confidence, thereby creating a virtuous circle beneficial for all. More lives are saved; more people are given back their quality of life; and there is more research and surgical skills training for the benefit of the public.

The Government’s arm’s-length bodies review sets out proposals for transferring the HTA’s functions across three or four different organisations. I fear that separating the HTA’s functions would risk undermining the progress that has been made in building public and professional confidence. Leading thinkers have voiced profound concerns about dismantling the HTA. Senior legal academics have said in the Sunday Times:

“The proposals to abolish the Human Tissue Authority—HTA and the divisions of its functions among larger, non-specialist regulators—risk confusion and error in the implementation of the Human Tissue Act 2004, which in turn will erode public confidence”.

In addition, earlier this month, senior consultant surgeons writing in the Guardian said that moves to break up the HTA would,

“undermine professional and public confidence in the area of medical consent”,

and urged,

“the government to think again and stop trying to operate on things that aren't broken”.

I hope that the Minister will listen to these voices.

The Minister has said that the HTA’s health-related functions should transfer to the Care Quality Commission. I am still not clear about the fate of the HTA’s organ donation and research functions. The ALB review does not suggest a home for its organ donation approvals and suggests that its research functions should transfer to a single research regulator.

With regard to organs, the Human Tissue Act requires board approval of highly sensitive and ethically complex cases of organ donation from living people. If this were to be placed with the CQC, how would the Minister meet the statutory requirement that at least three authority board members who are specifically trained in this area review such cases?

With regard to research, the new regulator for health research will provide a potentially helpful way forward for streamlining medical research in the UK, simplifying life for researchers and increasing the quantity and quality of research. The Minister stated at Second Reading that the purpose of this Bill was to streamline the process of regulation and to reduce costs and bureaucracy. I do not see how the proposal to transfer the HTA's research functions to this new regulator would achieve simplification; nor do I believe the proposals would save money. The sectors that the HTA regulates are interrelated and interdependent, and although it regulates a separate research sector, the licensing framework also allows establishments in the post-mortem, patient treatment and anatomy sectors to store tissue for research as well as for other purposes.

I take the post-mortem sector as an example. The proposal would result in at least one-third of post-mortem establishments needing to be licensed by an additional regulator if they wished to store material for research. A similar proportion of establishments storing tissue for patient treatment would also need to be licensed by an additional regulator. The regulatory burden on an estimated 200 establishments would therefore increase, not decrease. So can the Minister explain what impact this proposal will have on the regulatory burden on these establishments? Can he explain who would be responsible for producing the statutory code of practice on consent and who would be responsible for ensuring consistently high standards if the HTA’s functions were divided?

My noble friend Lady Thornton raised concerns about the ethical dimensions of the work being lost in the rush to amend the mechanical processes. I share these concerns. This is a complex ethical landscape. The HTA has the professional expertise to respond to emerging forms of communication such as Facebook and Twitter. These are now being used as conduits for patients looking for organ donors. We are launching consultation on this very issue in May, and this is a good example of how agile and sensitive the authority can be. Can the Minister assure me that the credibility that lay and professional board members bring to the HTA will not be lost in the Care Quality Commission, when the CQC has only a small number of commissioners? An advisory group has been mentioned. If that model is proposed, can the Minister say what guarantee there will be of its independence?

I apologise for raising so many issues at this late hour but there are many issues still to be resolved. In summing up, I say only that the reason the HTA was established has not gone away and there is still work to be done. My argument is not against the Government’s intention to simplify the regulatory landscape; rather, I want to avoid putting at risk the substantial gains that the HTA has made by splitting its functions across a number of different organisations and losing the overall coherent approach which has been so successful in supporting public and professional confidence and ensuring that tissues and organs are used safely and ethically and with proper consent.

I have one final plea. David Thewlis and Stuart Taylor, both parents affected by the events at Alder Hey, brought it all home to me recently when they said:

“All the effort and soul searching that went into the establishing of the Human Tissue Authority cannot afford to be overthrown by abolishing the HTA and splitting its functions”.

I urge noble Lords to take this on board when deliberating the future of the HTA.

[Lord Willis of Knaresborough]

My Lords, I apologise to the noble Baroness, Lady Thornton, for missing her opening remarks in introducing the amendment.

The fact that so many noble Lords wish to speak to the amendment at this hour indicates that this is an issue of significance to your Lordships’ House. In Committee, my noble and learned friend Lord Mackay ended his remarks by saying that he had helped to give birth to the baby that was the Human Fertilisation and Embryology Authority but that perhaps it was now time to let the child move out, or words to that effect. Before a child moves out into the world, it is important that a responsible parent—and I think that the House should regard itself as a responsible parent—knows that it is safe to do so. However, the reality is that during the passage of the Bill, and in particular during the Committee stage and in the clarification given since then, many questions asked on behalf of the HFEA and the HTA, as the noble Baroness has just indicated, have not been answered. That is regrettable. I think that the House accepts that what the Government are trying to do has a great deal of merit; it is just that it requires organisations to be properly set up before the functions are transferred.

As I have said on two previous occasions, I am not against what the Government are ultimately trying to do. However, before we get rid of two organisations in which the public have great confidence and whose operation is tried and tested, we should be absolutely clear about what will happen to their functions. Although the Minister has made tremendous attempts to satisfy inquiries from noble Lords on all sides of the House, I think that his letter of 22 March to the noble Lord, Lord Warner, raises more issues than it resolves. I am sure that the noble Lord will go through that letter in great detail and therefore I do not intend to do so. However, some of the comments in it indicate that two organisations appear to be in the running to inherit most of the functions of the Human Tissue Authority and the Human Fertilisation and Embryology Authority —the Medical Research Agency and the Care Quality Commission. I was delighted that the Chancellor made it clear in his Statement last week that the Medical Research Agency is going to be set up but, as many noble Lords have said, that announcement was made literally only a week ago. We know nothing about the way in which the organisation will work, other than the report of the Academy of Medical Sciences suggesting that an agency overlooking the whole of medical research would be a good thing.

As for the Care Quality Commission, it is itself an organisation in its infancy and learning how to do its business. Indeed, there are significant complaints about the Care Quality Commission. That is not an overarching criticism. It is inevitable that when a new organisation sets itself up, particularly one that inherited so many problems from its predecessors, there will be difficulties, yet here we are, saying that we will lump another major piece of work with it.

In Committee, the Minister made it clear that the existing personnel would be transferred en bloc into the new organisations, yet in the letter to the noble Lord, Lord Warner, there is no mention of key personnel being transferred into the Care Quality Commission. I understand that staff are seeking posts elsewhere. They will move out of the organisation. If we are not careful, there will be nothing to transfer and we will be looking for new personnel in these key posts. Will the Minister clarify that issue?

The new Medical Research Agency will not be set up until the latter part of this Parliament at the earliest. The Minister floated the idea that some of its functions could be transferred early using the Public Bodies Act—regulation and inspection of clinical services could go to the Care Quality Commission, for example. There is a further suggestion that all but the research functions of both the HTA and the HFEA could be transferred under the Public Bodies Act, as it will then be, with the final process completed following the setting up of the Medical Research Agency. Such hypothetical and confusing scenarios to break up two well-respected and well-worked regulators will do little for public confidence in either of these two areas. It will do little for clinician confidence and will certainly do nothing for research community confidence either. It is important that the agency is set up, properly staffed and has clear terms of reference agreed with both Houses of Parliament before we transfer these key functions to it.

One function that has been set out by the Academy of Medical Sciences, which is a clear pathway, is an ethical structure. We argued when we were looking at the draft Bill and your Lordships in this House argued during the passage of the Human Fertilisation and Embryology Act that we ought to have some form of parliamentary ethics committee. At least the Academy of Medical Sciences has said that there ought to be an overarching ethics committee to look at both areas. But if clinical ethics are not dealt with by that organisation, who will deal with them? Where within the Care Quality Commission are the sort of important ethical considerations that are necessary if we are to transfer all these functions to that body?

I can see the attraction of a method of transfer of functions to avoid primary legislation. I understand why the Minister would want to go down that road, particularly given the enormously strong public scrutiny over legislation concerning the Human Tissue Authority and embryology and stem cells over the past five years, but the idea that if the scrutiny is only in both Houses of Parliament it will be less severe does not hold up. There are 200 new MPs in the other place who were not party to any of this legislation when it went through. It is highly optimistic to believe that there will not be very detailed scrutiny of any new arrangements. I suggest to the Minister in all humility that he accepts the amendment before us tonight or makes some provision to satisfy our concerns. He should seek a comprehensive solution to the problem that the Government have created for themselves. I for one—and, I suspect, many of your Lordships—would agree that there is a way forward from this. The Medical Research Agency is a good idea. There is a possibility of transferring some of the functions to the Care Quality Commission, but it needs to be done en bloc, rather than piecemeal, so that there is a danger of undermining two excellent regulators, which have public confidence, the confidence of most clinicians and the confidence of the research community.

[Baroness Deech]

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.

--- Later in debate ---

[Earl Howe]

My Lords, I do not think that I am chancing my arm by saying that that is my understanding of what the impact assessment ought to look like in that a typical impact assessment will have within it several alternatives so that it is possible to compare different options. I would be happy to come back to the noble and right reverend Lord with a definite answer on that but my understanding from previous impact assessments is that that kind of benchmarking ought to be possible.

The noble Baroness, Lady Thornton, has previously raised her concerns about where the ethical framework for any new arrangements will sit. Ethical safeguards, for example concerning the embryos and gametes 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 continue to remain firmly in place and will underpin the regulation of treatment and research as currently, by whoever is responsible for regulating. Where there are specific ethical issues surrounding new treatments, the department will consider how best to commission expert advice on an individual basis, as is currently being done for mitochondrial transfer, for example.

A number of noble Lords have shown interest in and support for the Government’s announcement last week, as part of the growth review, about streamlining research regulation and governance. The Government announced in the Plan for Growth on 23 March that they will create a health research regulatory agency to combine and streamline approvals for health research which are at present scattered across many organisations. As a first step, the Government will establish this year a special health authority with the National Research Ethics Service as its core. When established, the new agency will work closely with the Medicines and Healthcare Products Regulatory Agency to create a unified approval process and promote proportionate standards for compliance and inspection within a consistent national system of research governance.

This will reduce the regulatory burden on firms and improve the timeliness of decisions about clinical trials and hence the cost-effectiveness of their delivery in the UK, and has clear support from the Academy of Medical Sciences review of medical research regulation and governance.

In this context, it is important for me to remind the House of a key point. Here I refer particularly to the question posed by the noble and right reverend Lord, Lord Harries. The AMS report recognised at paragraph 9.5.1 that there are significant benefits in bringing all medical research regulation, including embryo research currently undertaken by the HFEA, within the remit of a single health research regulatory agency. Indeed, remarks made by Sir Michael Rawlins in the Guardian on 11 January firmly backed up that view. We agree with that proposition but again the consultation will invite views on it.

My noble friend Lord Willis expressed his fears about the Government adopting a piecemeal approach to reorganisation, as did some other noble Lords. I accept that our approach to the HFEA and the HTA may indeed seem rather complex. The powers of the Public Bodies Bill will enable us to transfer some of the functions of the HFEA and HTA to other bodies but they do not enable us to do everything that we have set out in the arm’s-length body review. In order to abolish the HFEA and HTA, or to transfer their research-related functions to any new research agency, we will require powers under future primary legislation.

It might help if I provided a rough outline of how and when we could take this forward. We intend publicly to consult on proposals to transfer all the HFEA and HTA functions to other bodies in the late summer of this year. During 2012-13, under the provisions of the Bill, we will prepare draft orders for formal consultation dealing with the transfer of functions, other than research functions. If appropriate, we would then be able to lay the orders before Parliament. This process would enable noble Lords and other interested parties to see, comment on and debate the proposals, as they progress.

Without the inclusion of these bodies in Schedule 5, we would have to provide for the transfer of their functions entirely within future primary legislation. I simply say again, particularly to the noble Lord, Lord Warner, that not including these bodies would significantly increase the risk that the underlying ethical provisions of the Human Fertilisation and Embryology Act and the Human Tissue Act were reopened for debate.

[Lord Willis of Knaresborough]

Would it not be possible to include a new clause in the Health and Social Care Bill to set up the new medical research agency and leave to consultation and secondary legislation the details that would follow? That would at least give certainty to that organisation and, with a new Bill in the second part of the Parliament, put it into the parliamentary timetable much earlier than envisaged.

[Earl Howe]

In theory, my noble friend makes a constructive suggestion. We have considered that option and, I am afraid, rejected it on the grounds that the Health and Social Care Bill is big enough as it is, and contains a substantial programme of modernisation. It would be possible to Christmas-tree that Bill almost ad infinitum, and we have decided that that would not be helpful. With the Health and Social Care Bill, we seek to focus on the modernisation agenda, pure and simple. I am sorry to disappoint my noble friend, who makes a perfectly sound point, but I am afraid that we are not going to do that.

As I made clear earlier, I confirm to my noble friend that the CQC will have staff transferred into it. The intention is that expertise in staff and advice will follow the functions. Unfortunately, we cannot be definite about exactly which functions will be transferred to the CQC or elsewhere until after the summer consultation. If, standing here, I were to say exactly how that would work, I would be pre-empting the results of that consultation. I agree on the desirability of having clarity and certainty, and our aim is that there should be more clarity and certainty for HFEA and HTA staff after the consultation.

The noble Baroness, Lady Warwick, asked a number of detailed questions about the effect of our proposals on bodies regulated by the HTA and the way that its functions are performed. The case that she put eloquently was an argument in favour of keeping the HTA’s functions together. I understand her point of view; however, I reassure her that we will consult on the option of keeping the HTA’s functions together. We will not consult simply on one model, let alone pre-empt the results of the consultation.