Public Bodies Bill [HL]

Baroness Thornton Excerpts

Monday 28th March 2011 Lords Chamber

Moved by

[Baroness Thornton]

49: Schedule 5, page 18, line 15, leave out “Human Fertilisation and Embryology Authority.”

[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.

--- Later in debate ---

[Earl Howe]

The direction of travel for the HFEA is one that we have mapped out. I am not aware that we are considering consulting on keeping the HFEA together. If I am incorrect about that, I will write to the noble Baroness. I understand why she wishes to press me on the point. However, I have not heard this option put forward, and it was not contained in the arm's-length bodies review.

I can assure the noble Baroness that the consultation will give an opportunity to all those with an interest to express their views on where would be the best place to transfer the functions, and on the merits of keeping functions together where appropriate. I recognise that the expertise of the HTA, and the extent to which this will be carried forward, is a key issue. The consultation that we plan will, as I mentioned, give an opportunity for interested parties to express their views on the point.

The noble Baroness, Lady Thornton, asked who would take over the role of competent authority for the EU tissue and organ directives from the HTA. That role will be considered for transfer to other bodies, as with other functions. It involves regulating according to quality and safety standards. We will consult on the most appropriate body for those functions to be transferred to.

My noble friend Lord Willis made clear his view that we should not split research functions. I can tell him that we envisage that the health research agency will cover what is now covered by the approval of research licences. In the context of human embryo research, the legislative requirements that the research is necessary or desirable, and that the use of embryos is necessary, will remain firmly in place. If that consideration includes an assessment of the research technique proposed, it will remain so in future.

The noble Baroness, Lady Thornton, and the noble and right reverend Lord, Lord Harries, asked how we would deal with the devolved Administrations. The intention of the proposals is to reduce both the cost of regulation and the bureaucracy for regulated establishments. It is important that a workable solution is found for the devolved Administrations, while recognising that the subject matter of the legislation is reserved. The Human Fertilisation and Embryology Act extends to the whole of the UK, and the Human Tissue Act extends to England, Wales and Northern Ireland. We hope to agree a way forward with the devolved Administrations that avoids any unnecessary duplication of effort in order to keep costs and bureaucracy for regulated establishments to a minimum. We have had constructive discussions already at official level, and these will continue. The CQC is at present an England-only body. If reserved functions were transferred to the CQC, we would extend its territorial remit in respect of those functions alone.

I will return to where I began. It is surely right that the Government and Parliament should look for opportunities to streamline regulatory mechanisms, as long as this is done in a way that preserves the legal functions, and the ethical underpinning of those functions that Parliament has put in place. The Bill provides us with the means to do that in respect of the HFEA and the HTA. In view of the Government's broader concessions on the Bill, and our intentions to consult widely on the proposed transfers of functions and to protect existing ethical and legislative safeguards, I hope that noble Lords will not press their amendments.

[Baroness Thornton]

I thank the Minister for another detailed response. I also thank the noble Lord, Lord Willis, the noble Baroness, Lady Deech, the noble and right reverend Lord, Lord Harries, and my noble friends Lady Warwick and Lord Warner. I counted 17 to 20 questions that the Minister was asked. He gave us a great deal of information, some of which was useful and very interesting. However, I do not think that he answered all the questions.

The Minister raised the issue of us not being convinced. We are not being perversely unconvinced. The problem is that there are still too many unknowns about this part of the Bill. Extensive consultation in the summer, to which the noble Earl has referred on many occasions, is after the decision has been taken and after the powers have been taken.

For example, the Minister was pressed on the concern about registers and databases. His answer was that the decision would be part of the consultation, that they would not be dissipated and that there would be options put in the consultation. That is not a satisfactory answer at this point. The same goes for the impact assessment, which will be carried out in the context that the Government will have already taken the powers to do what they want to do.

On the ethical issues that I raised, the Minister suggested that those would go with whoever it seemed appropriate to be the responsible body. Frankly, at this stage of the Bill, an answer that has “whoever” in it is not satisfactory. There is widespread agreement that the medical research agency proposals sound promising, but that simply underlines the point that we should not proceed with including these two bodies in the Bill at this point.

The Minister has said several times that it is a complex process. We agree, and indeed the noble Lord, Lord Willis, made an extremely good suggestion about one way to simplify the process by using forthcoming legislation. Having been the Minister responsible for several Bills that might have been called Christmas-tree Bills, I am not sure that he does not have a very good point.

That begs the question: what is the hurry? If streamlining can be achieved without powers being taken in this Bill, money can be saved—as several noble Lords have said—without taking such powers, and a much larger discussion will be taking place as we move forward. It seems to me that those points remain outstanding.

At this point in our consideration, I do not think that we have reached a satisfactory and conclusive point in our discussions about the HFEA and HTA. I hope that we can resolve and clarify the remaining and outstanding uncertainties on this issue before Third Reading, and I very much welcome the fact that the Minister has said that he will be responding to certain points. I am sure that he is prepared to continue those discussions and I hope that we can resolve them before Third Reading. Otherwise, I fear that we may have to return to this issue. I beg leave to withdraw the amendment.

Amendment 49 withdrawn.