Public Bodies Bill [HL]

Lord Warner Excerpts

Wednesday 9th March 2011 Lords Chamber

[Baroness Thornton]

My Lords, I shall speak also to Amendments 93, 150 and 151. On Second Reading, many noble Lords expressed their disquiet at the inclusion in the Bill of the HFEA and the HTA. At the time, I wondered if they were included because the Minister’s department insisted that the Department of Health had to offer something up to the Bill, so the poor old HFEA and HTA were the sacrificial lambs. Indeed, in its own review of the arm’s-length bodies, the Department of Health gives a much more measured suggestion of the deliberation and consultation before decisions were taken about the HFEA and HTA over a timescale that is the life of this Parliament. Unless something has changed about the expected length of this Parliament, it seems precipitate and unnecessary to include these bodies in the Bill.

In a meeting convened by the Minister—the noble Earl, Lord Howe—to discuss this important matter with interested parties, which I was pleased to attend, he was concerned to reassure us about the consultation and discussion to take place before decisions were reached. We can add to those reassurances the proposal, as I understand it, that in the next Session—in other words, after May 2012—primary legislation will be introduced to establish a new science regulator in the department. If that is the case, the passage of that legislation would allow proper consultation and scrutiny across the field including the work of the HFEA and the HTA, which is the way in which such reforms should be carried out. So I ask again: why is it necessary for these bodies to be included in the Bill?

The HFEA and the HTA almost symbolise the concerns that noble Lords have expressed in relation to the constitutional propriety of the Bill in giving Ministers powers to amend primary legislation. Both organisations would have their work and their regulation fragmented unnecessarily when they need to be left alone to get on with the jobs that they do very well—although there is always room for improvement—until a proper period of consultation and pre-legislative scrutiny, which I am sure the noble Earl would wish to have, can precede the introduction of the science regulator Bill or whatever it will be called. That is the way to proceed.

What do these bodies do? The HTA licenses and inspects organisations that store and use human tissue for purposes such as research, patient treatment and post-mortem examination, teaching and public exhibitions. It also gives approval for organ and bone marrow donations from living people, including anatomy and stem cells and cord blood; public display—that is, the public display of any human body parts in various forms—post mortems; coroners; and transplants.

The advances made by science throw up new and sometimes complex ethical issues for the HTA to address. The cavalier use of body parts for research without the knowledge or consent of patients and their families was a huge scandal, leading to public indignation. Many in your Lordships’ House will recall the time and the thought given to the creation of a regulatory framework that would command public confidence. I fail to see what has changed that can allow any slackening off of the responsibility that the HTA bears for the use of human tissue.

The HFEA is the UK’s independent regulator of treatment using eggs and sperm and of treatment and research involving human embryos. It sets standards for and issues licences to centres and provides authoritative information for the public, particularly for people seeking treatment, donor-conceived people and donors. Very importantly, it also determined a policy framework for fertility issues which are sometimes ethically and clinically complex. The HFEA Act 2008 includes provisions for research on different types of embryos and changes the definition of legal parenthood for cases involving assisted reproduction. Therefore, the work of both bodies is of enormous scientific importance apart from anything else.

The arm’s-length body review in July 2010 concluded that the HFEA carries out essential functions which satisfy,

“the criteria for being undertaken by an arm’s-length body”.

The review states that the HFEA,

“deals with issues that are judicially and ethically complex and contentious”.

The HFEA is a world-respected model which has been used by other jurisdictions to deal with extremely technical and legally complex areas of practice. We have to ask what will happen to the high level of expertise and experience in both organisations and whether it will be in the public interest to transfer regulatory functions to other organisations where this knowledge may be lost to the detriment of patient safety.

I know that some noble Lords, particularly some of our very respected medics, for sometimes differing reasons have expressed the view that time has moved on since the original reason was established for setting up these bodies, human fertilisation is not the novelty that it once was, these medical procedures no longer need the attention of their own regulator and therefore change is necessary. That is a powerful argument but I disagree with it, or at least I have yet to be convinced. It seems to me that the powerful reasons that brought these two bodies into existence, and the reason we in Parliament paid such close attention to establishing their duties, responsibilities and independence, are still as potent today as they were when they were founded. These are not primarily medical or scientific reasons but concern the need to maintain public confidence in the uses to which human tissue is put, and sometimes in the very controversial issues arising out of human fertility and procreation.

Time and consideration need to be given to the contribution to scientific research made by the HTA and the HFEA, and, of course, they should carry out their respective functions in a cost-effective and efficient manner with appropriate public accountability. We may wish to see change in the way that the HTA and the HFEA functions are carried out but I believe many of the changes needed could be achieved without their inclusion in the Bill. Change should be helpful in achieving the broader stated aims of reducing bureaucracy and saving money rather than simply focusing on a reduction in the number of arm’s-length bodies. By and large, by the way, I believe that both bodies have sought to make and have succeeded in making improvements in their work and functions in recent times. I believe that more now even than at Second Reading, given the Government’s proposals on research. As the proposals for the reorganisation of the NHS are discussed it seems to me that the future of the HTA and the HFEA need more time and much more consideration. Apart from anything else, the CQC, which it is proposed should become the healthcare regulator for the HTA and fertility treatment, will have neither the time nor the expertise to carry out this function until it has swallowed the regulation of the whole of the rest of medical and social care. One might imagine that if a scandal arises in four or five years’ time regarding either fertility regulation or the use of human tissues, the excuse will be given that the CQC was too preoccupied with the rest of its enormous brief to give these matters the important attention that they warrant. I beg to move.

[Lord Warner]

My Lords, I have added my name to Amendments 92 and 93 in part in a spirit of helpfulness—I hope that is the case—to the Minister as I have traversed the same ground as him on Department of Health arm’s-length bodies. In 2003-04, I was the Minister who reviewed DH arm’s-length bodies and halved their number. Therefore, I cannot claim to be against reducing the number of Department of Health arm’s-length bodies. Indeed, my sins are fully catalogued by this Government in annexe B of their document on the arm’s-length body review, which was published last year. Therefore, I own up fully to these past misdemeanours. However, as I have previously said about the Government’s own arm’s-length body review, although I do not necessarily agree with every aspect of it, it comprises a serious, comprehensive, clear and coherent set of proposals, unlike some of the things which emerged from other departments under this Bill. Therefore, I do not in any way wish to argue that it was not a thorough piece of work.

--- Later in debate ---

[Lord Warner]

I am sorry to interrupt the Minister. I have been listening intently to what he has said. I am extremely confused about the order in which things are going to be done. As I understood what he was saying, we are going to get a series of orders that transfer functions through a process of consultation, which I welcome, but we may or may not know at that point what the Government are going to do about setting up a health research agency, either by statute or otherwise. As I understood him, we could be in the position of being asked to agree those orders before we know what the final endgame is. It would be helpful if, before the next stage of the Bill, the Minister could set this out more clearly for us in writing so that we can understand the sequence. I found it rather difficult to understand.

[Earl Howe]

I must apologise to the Committee if I was not sufficiently clear and I will be happy to write to those who have participated in this debate to make the position clearer. I was seeking to say that we do not wish to take a disjointed, piecemeal approach. There is a natural flow of process that, if Parliament agrees, can lead us to a position where we are able in one move, so to speak, to transfer the various functions more or less simultaneously—although I would not wish to undertake that the whole thing would be done on the same day—so as to arrive at that point.

In our view it is desirable to consult during the late summer of this year. We will then set about the process of designing statutory instruments based on that consultation and go out to consultation on them. All being well, we will then introduce a second-Session health Bill that will have within it the provisions to establish a single research regulator, assuming that that is what we decide to do. Therefore, the whole process should work in a seamless way. However, I shall be very happy to write to noble Lords setting that out.

I return to the point at which I left off, which is to express the hope that the noble Baroness will not press her amendment this evening. I hope that she will accept our assurance that we have a clear intention to consult on the proposed transfers of functions and that she will be willing to withdraw the amendment.