Public Bodies Bill [HL]

Lord Patel Excerpts

Wednesday 9th March 2011 Lords Chamber

The difficulty here is partly ethical. It is interesting that, for the patient herself, those fertilised eggs are her babies and she may, not unreasonably, insist on having two of them back even though she has been advised to have a single-embryo transfer. That problem needs to be thought about. At the moment, as we have dealt with this it has not been well addressed. It is an extremely difficult issue. So I hope that my noble friend Lady Thornton does not push this measure to a Division as I would find it difficult to support the amendment under its present form.

[Lord Patel]

Briefly, I find myself in support of what was said by the noble and learned Lord, Lord Mackay of Clashfern, and also by my friend in the professional sense, the noble Lord, Lord Winston. I was involved as an officer when the Royal College of Obstetricians and Gynaecologists, together with the Medical Research Council, set up the voluntary licensing authority because it was felt that there was a need to reassure the public that the new science of in vitro fertilisation was not going to lead, as the newspapers then had it, to creating monsters in a Petri dish. Fortunately, two years after that, the noble and learned Lord, Lord Mackay of Clashfern, led the Bill that became the Act that established the Human Fertilisation and Embryology Authority. For the reason already rehearsed, it was necessary to make sure that the public could be reassured. More importantly, it was set up to make sure that clinical practice followed strict rules about what should be good practice and about people engaged in in vitro fertilisation and fertility.

I was not a specialist in in vitro fertilisation, but as an obstetrician I saw the results of the initial practices of multiple pregnancies, to which the noble Lord, Lord Winston, just referred. Every obstetrician in the land was crying out that there should be some kind of advice or regulation from the HFEA that would control the number of embryos that were inserted. The evidence existed that putting more and more embryos in might result in more pregnancies but also in multiple births that resulted in handicapped babies.

We have two issues here. First was the responsibility of the HFEA in making sure that clinical practices were improved to improve the outcome for both the parents and the babies. Second is the regulation related to research practices, especially in embryo research. I have no doubt whatever that the research regulation aspect of the HFEA needs to be maintained.

I go further in saying that there is a great need to bring some co-ordination in the whole area of the medical research regulatory framework; it is very fragmented. In my previous role as a National Patient Safety Agency chairman, while I was responsible for running the National Research Ethics Service for England and Wales, I found that there were issues relating to ethics for some of the medical research that, because it was fragmented, we had to address, as it was not being addressed by any of the existing regulatory authorities. The report from the Academy of Medical Sciences gives us an opportunity, which I hope the Government will grasp soon, to produce a national medical research regulatory authority that brings in all the regulation that is required. As the noble Lord, Lord Warner, said, the report did not say that it should include the HFEA and the Human Tissue Authority. In his consultation, he also said that they were not addressing the issue of the HFEA and the HTA because they were awaiting the results of the debate that we are now having, and the Bill that we will have relating to National Health Service reform and social care.

I accept that we need a research regulatory authority. Now the issue is whether we need, particularly with the HFEA, to regulate clinical practice related to in vitro fertilisation. If NICE is going to have the new role of setting standards in all areas of clinical practice that will deliver better outcomes, and if we have a regulatory authority—the CQC, which may need to improve its performance and may need resources to be able to do so—we have to ask why we would have a regulation confined to one area, sensitive though it might be. Given the performance of the authority hitherto, we have to ask whether we are going to throw out something so precious; I accept that some of the aspects that the HFEA has been awarded are very precious. I accept that we were the first country in the world to bring about regulation for in vitro fertilisation, which others followed, because it was then necessary. It laid down the template of how clinical practice in a sensitive area such as in vitro fertilisation should be handled. However, as the noble and learned Lord, Lord Mackay of Clashfern, said, we have moved on. I think we might be at a stage where we need a more overarching regulation that promotes good clinical practices and therefore good clinical outcomes.

[Baroness Deech]

My Lords, on a factual point, may I correct the impression—it may have been a mistake— that the previous speakers have given that any number of embryos can be implanted in a patient? The HFEA brought down the number of embryos from three to two and is working towards one. That was in the face of relentless resistance from patients, who wanted the best chance of becoming pregnant, and indeed many—but not all—of the clinicians and embryologists, who said, “We know what’s best for our patients”. The impression should not be given that an unlimited number of embryos are implanted. The number is two and they are working towards one.

[Lord Winston]

Forgive me for correcting that impression. Many units limited the number of embryos well before the HFEA did. At Hammersmith Hospital, we limited the number of embryos two years before the HFEA did. We were not alone; a number of units did that because we were very concerned. The idea that medical practitioners do not feel responsible for the pregnancy that is induced is, I think, a dangerous precedent. It is just not true. Of course there is a problem when patients put you under pressure, and it is a very difficult ethical issue that needs to be resolved.

[Lord Patel]

My Lords, I think I have lost my thread, but I have said what I wanted to say.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, I begin by expressing my thanks to all noble Lords for the opportunity to debate these amendments. As the noble Baroness, Lady Thornton, pointed out at the beginning of her remarks, following the Government’s concession in withdrawing Schedule 7 in its entirety, these amendments would have the effect of putting the Human Tissue Authority and Human Fertilisation and Embryology Authority out of scope of the Bill.

Our starting point in approaching these issues is a clear objective to streamline the process of regulation and, consequently, reduce costs and the administrative burden on establishments while continuing to offer the necessary protection for the public. The Bill presents us with an opportunity to achieve that. Our aim is to streamline healthcare and medical research regulation and so reduce bureaucracy. That approach is supported by leading assisted reproduction clinicians and their professional bodies and by the Academy of Medical Sciences.

The scope for streamlining is clear. We estimate that around 80 per cent of the centres currently licensed by the HFEA are also either regulated by the Care Quality Commission or are in premises that the commission regulates. Some 60 per cent of the centres licensed by the HTA are similarly covered by the CQC. It therefore seems unsustainable to continue to have these regulatory systems running in parallel. The question posed by my noble friend Lord Newton of Braintree as to whether the CQC wants to take on this work can best be answered by reference to the regulatory activity that it already performs. In any event, as regards the pace at which we take this, we intend to develop arrangements for the transfer of functions in consultation with the CQC over the next few years, and no transfer of functions will take place until that process is complete. However, the Government recognise that there are number of noble Lords with concerns about the proposal to transfer the functions of these two bodies, and not for a minute would I wish to minimise the nature of those concerns.

Let me be clear—both the HFEA and the HTA are models of regulatory authority that were right for the times in which they were created and which have done an admirable job in meeting the demands placed on them. However, as my noble and learned friend Lord Mackay of Clashfern pointed out, times change, and most pertinently so has the way in which we regulate the delivery of healthcare. With the establishment of the CQC along with the possibility—and I put it no stronger than that at the moment—of the creation of a new regulatory body for medical research, alternative structures are becoming available to ensure a more joined-up system. This provides, as I have said, the opportunity to streamline the process of regulation and reduce costs.

The powers in Clause 5 would allow us to achieve that without disturbing the underlying legislation, which captures the ethical safeguards that Parliament has so carefully set in place. Any future proposals to abolish these two bodies will be provided for in future primary legislation. I am happy to reiterate my assurance that there is no intention to revisit the provisions in either the Human Tissue Act or the Human Fertilisation and Embryology Act that provide the important ethical safeguards necessary to maintain public confidence in these sensitive areas. I would say to my noble friend Lord Willis and to the noble and learned Baroness, Lady Butler-Sloss, and the noble Baroness, Lady Deech, that means that future arrangements to regulate tissue and embryos must adhere strictly to the provisions of the two relevant Acts.

Noble Lords have raised particular concerns about the need to preserve the expertise these bodies have built up in the ethically sensitive subjects they deal with and the need to preserve the confidence of both professionals and the public in the way that these regulatory functions are carried out. The Government recognise the genuine nature of these concerns and we are determined that changes will not be at the expense of regulatory rigour or expertise.

I say to my noble friend Lord Willis that expertise will not be lost. It is envisaged that expertise will follow functions; for instance, through staff transfers and expert reference groups. Noble Lords have questioned the capacity of the CQC to assume these responsibilities. It will be given the capacity and the resources to carry out any widened functions. The CQC already has a proven track record of taking on the oversight of a specialist area. It took on the Mental Health Act Commission functions and I believe has successfully maintained oversight and focus on that area.

The noble Baroness, Lady Thornton, expressed concern that our whole approach in this area seemed unnecessarily complex. The powers that we are debating today 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 ALB 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 may help if I try to provide a rough outline as to how and when we expect things to happen. We intend publically to consult on proposals to transfer all of the HFEA and HTA functions to other bodies in the late summer of 2011. Then during 2012-13 we would prepare draft orders for formal consultation under the provisions of this Bill dealing with the transfer of functions other than research functions. If appropriate we would then be able to lay the orders before Parliament. The process would enable noble Lords and other interested parties to see, comment on and debate the proposals as they progress. In order to avoid the piecemeal transfer of functions we would intend to ensure that the timetables for necessary future primary legislation and the commencement date of orders made under this Bill are aligned so that they come into force at the same time.

Without the inclusion of these bodies in Schedule 5 to the Public Bodies Bill we would have to provide for the transfer of their functions entirely within future primary legislation and this would significantly increase the risk that the underlying ethical provisions of the Human Fertilisation and Embryology Act and the Human Tissue Act could be reopened for debate and would afford less time for consideration and comment than the progressive approach which I have just outlined. I seek to impress upon noble Lords that that is a very powerful reason for wishing to grant the Government the powers we are seeking as regards these two bodies.

The noble Lord, Lord Warner, indicated that, in his view, the report by the Academy of Medical Sciences does not give sufficient backing to the idea that embryo research should be covered by the new research regulator. I would simply point him, if I may, towards paragraph 9.5.1 of the report which explicitly refers to the new body, if it is set up, having responsibility,

“for ‘specialist’ approvals and licences within the HRA around data, tissue and embryos, gene therapy and exposure to radiation”.

I think, as I read that, it was very much in the minds of the authors of the report that the research functions of the HFEA should be brought within the scope of a health research regulatory agency.

The noble and learned Baroness, Lady Butler-Sloss, expressed her worries about the information functions of the HFEA and the absence of a clear plan by the Government for what should happen to those functions. She is right, we have not fully made up our minds about where those functions should best sit, but that is one of the main reasons why we wish to consult on this. We need to ask the public and interested parties where these functions should sit, and there will be an impact assessment with the consultation.

My noble friend Lord Willis asked about the possibility of setting up a single research agency without primary legislation. He is technically right; we could do that. I should emphasise that we have not decided whether to accept the AMS recommendation to establish a single research agency—we think that there are merits in the proposal and we will be making an announcement shortly—but if we were to propose setting up such an agency we could do so initially by creating a special health authority. However, we could not legally transfer the research-related functions of either the HTA or the HFEA to that body. We could not make a transfer of functions to a special health authority without amending the 2006 Act.

The case was simply put by my noble and learned friend Lord Mackay of Clashfern. Essentially, we are asking the Committee to agree to grant the Government permission to consult on these matters. I hope that the noble Baroness will not seek to press her amendment today but instead will consider that a good purpose will be served by reflecting on the comments that I have made in response. In view of our concessions—