Public Bodies Bill [HL]

Baroness Deech Excerpts

Monday 28th March 2011 Lords Chamber

[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.

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[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.

[Baroness Deech]

Will that same option in the consultation apply to the HFEA, whereby its functions can be kept together?

Public Bodies Bill [HL]

Baroness Deech Excerpts

Wednesday 9th March 2011 Lords Chamber

[Lord Newton of Braintree]

My Lords, my reason for not pressing my case earlier was that I knew I was going to be out-gunned by the noble Lord, Lord Walton. He has demonstrated that conclusively, and I am certainly not going to try to compete with him. I ought in passing to declare an interest I had at the time of the passage of the Human Tissue Act: I was then chairman of the Royal Brompton and Harefield, a major transplant centre which clearly had an interest in this matter.

I ought to confess, in what is going to be a brief intervention, that I am getting to be rather worried about the number of occasions on which I find myself in some sympathy with the noble Lord, Lord Warner. He indicated earlier that he had hopes of enticing me to a different part of the Chamber, if I understood his remarks correctly—but his hopes will be frustrated. I want to make some simple remarks from what I call the coal face, as I am chair of another health trust in the mental health field, on the issue of the CQC. The CQC was asked to do a huge new task by the previous Government, and is doing it valiantly, not least in the mental health area that I know. However, it is struggling to fulfil in the originally intended timescale the jobs that were put upon it. I wonder whether the CQC actually wants yet more tasks, whatever the argument might be in an intellectual sense. Even if we agree in the end to go down this path, and that is some way ahead yet, I hope it will not be too quick and that the CQC will be in a position to digest the meals it is being asked to take in before being asked to consume them. As a specific question: does the CQC actually want this work?

[Baroness Deech]

I support this amendment, and I declare an interest as a former chair of the HFEA. In other words, I was a gamekeeper, and there were poachers on the other side, if I may use that term in respect of some very eminent clinicians and embryologists in this country. They may tell you that IVF reproductive work embryology is now routine. Yet at the same time, they will say—or at least not deny—that the work they are doing is ground-breaking. So it remains: every day brings something new.

I have spoken about this topic many times in this Chamber and elsewhere, and I will not repeat myself, save to say that my admiration for the Minister is such that I share his pain on each occasion when I feel that he is trying to defend the indefensible. He would be grateful, I think, if we could somehow get him off the hook. One of the ways of doing that is cost. The principle underlying the abolition and retention of various quangos in this Bill is, of course, streamlining, efficiency and cost. The HFEA currently costs £7 million, of which all but £2 million comes from the patients. No one who cares about the patients could possibly imagine that they will be charged any less—or not charged at all—if these functions are absorbed into an existing or new body. The poachers, who are very keen to get rid of the HFEA, seem to think, when you listen to them, that there will be no regulation, that there will be a free-for-all. They are under the misapprehension that if this amendment fails, which I hope very much it will not, a merger of the HFEA will mean no regulation; as I say, a free-for-all. But that is not so. Primary legislation remains and no one has suggested that we would cease to have regulation for which this country is world renowned, having followed the lead of the noble Baroness, Lady Warnock, in her esteemed report written more than 20 years ago, which remains to this day the very best report on the issue.

Those who really dislike the whole concept of embryology and in vitro fertilisation because of their religious beliefs have, as others have said, still shown respect for the HFEA because they regard it as something of a shield against the wholesale misuse of embryos, as has happened in some other countries. Before it had regulation, Italy was the place everyone went to if they could not get what they wanted elsewhere. It was where you would go if you were white and wanted a black baby or vice versa, or if you were 64 or 70 and wanted a baby. Italy now has regulation, albeit in my view too strict. America has a patchwork of regulation, but has seen more scandals than we have. As my noble and learned friend Lady Butler-Sloss said, things go wrong sometimes as a result of simple human error, which in the end is probably not preventable. But at least we do not have the birth of octuplets, as has happened in the United States. We do not have those websites which noble Lords may enjoy googling one evening. They can look up “California Cryobank” and see lists of apparently brilliant Californian PhD students, all of them six foot six and sporty with IQs to match, offering their sperm for sale, and indeed the female equivalents their eggs. This is not the route that we wish to go down. We wish to retain regulation.

If we are going to keep regulation, there is absolutely no reason for dismembering the HFEA and putting functions that are plainly closely linked together and of utmost importance to parents, babies and sick people into different bodies, some of which are untried. Again, I echo my noble and learned friend Lady Butler-Sloss in saying, “If it ain’t broke, don’t fix it”.

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[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.

Human Fertilisation and Embryology Authority/Human Tissue Authority

Baroness Deech Excerpts

Tuesday 1st February 2011 Grand Committee

[Baroness Deech]

My Lords, I declare an interest as the former chair of the HFEA. For most of my tenure I was paid the princely sum of £8,000 per annum, but it was a burden—nearly a full-time burden—that I undertook with pride and viewed as a privilege, grateful that infertility had not affected me. I wished to help others safely and with respect for their dignity, avoiding exploitation, and I remained in awe of the achievement of the scientists.

This debate, for which I am grateful, is about public confidence. It is not about confident, or self-confident, doctors; nor is it about how wonderful and trustworthy our doctors and embryologists are. If that were the issue, we would not need regulation in many walks of professional life and the controversy surrounding the Public Bodies Bill would fade away. It is easy in these surroundings or among researchers and specialists to forget how sensitive the issues of IVF and embryos are, and how very concerned the public are. The most vivid event during the passage of the Human Fertilisation and Embryology Bill three years ago was the hundreds of members of the public protesting outside this Palace about the possible extension of embryo research to animal hybrids. If your name, like mine, is associated with embryo research, you are the recipient of hundreds of letters about it, and not always peaceful or unthreatening ones. As the noble Baroness, Lady Warnock, said in her esteemed report of 1984, the public want to know that some principles are involved. It is also not to be forgotten that most of the treatment in this country is private, and therefore a great deal of money is involved and the need for protection is all the greater. European law, as referred to by the noble Lord, Lord Winston, is a weakness in that protection but unavoidable.

Any analogy with the progress of science in the US, which is largely unregulated, is false. The US has been home to some of the scandals that have echoed around the world, whether it was a clinician using his own sperm, octuplets or the sale of eggs and sperm by needy college students for large sums of money. That is not a road that we wish to risk going down, but we are not risking it under the Government’s proposal. Those who want to see the HFEA abolished seem to think that there will then be no regulation and that they will be free to do what they want, and quickly. But no—the law will be the same; consent will be needed exactly as before, and so will licences. Taking the processes into other organisations can be guaranteed to be no faster, no less bureaucratic and no cheaper; just worse. IVF is not routine because, although it is practised very often, any one treatment can throw up not only ethical issues that are known to us, such as saviour siblings, but also new ones, as the science progresses every day. One cannot separate the collection of embryos and eggs from patients from their storage, their storage from donation for research, donation for research from new research and stem cell work, and none of that from the great database, patient guidance and reliable statistics and health screening of donors. The risks will be too great and the gains from the government proposal nil, and our international reputation will suffer.

We are talking about an annual expenditure of £7 million, of which only £1.5 million to £2 million comes from the Government, and even this, I am told, could be reduced. Certainly patients will still have to pay for regulation if the tasks of the HFEA are dismembered, so it will be no cheaper for them either. Placing the regulation with the CQC is misguided. This is a new organisation. There have already been hints that it is overburdened and its operations have not always been met with praise. There is no improvement in public confidence there; nor will the public be persuaded that embryos will be treated with respect and that there will be bounds on embryo research if it is handed over to unknowns and not the accountable and expert figures of the HFEA. Review, yes; reversal, no.

Department of Health: Arm’s-length Bodies

Baroness Deech Excerpts

Tuesday 16th November 2010 Lords Chamber

[Earl Howe]

My Lords, the key point to make about our proposals around the HFEA and the HTA is that we are not proposing to change the functions or alter the provisions of the underlying statutes. All we are doing is proposing to transfer various functions in different directions. As for the independence of the advice, I see no reason at all why the current independence should not be maintained under the new arrangements.

[Baroness Deech]

My Lords, is the Minister aware that a pre-legislative scrutiny committee gave an opinion two or three years ago that there was not a read-across between the HTA and the HFEA and that they had different skill sets? It accepted evidence that there was no money to be saved and that there would be a considerable loss of experience and probably money in bringing the two together. Does the Minister agree that we cannot keep revisiting this issue, which has been so thoroughly looked at?

[Earl Howe]

They are different skill sets, but I am not aware that Parliament has visited these issues, let alone revisited them. As I said, we will have the opportunity to do that, but the proposals we have outlined will ensure that the teams that are currently involved in inspection activities will be kept together. I see no reason why they should not be.

Human Fertilisation and Embryology: Regulation

Baroness Deech Excerpts

Wednesday 13th October 2010 Lords Chamber

Asked By

[Baroness Deech]

To ask Her Majesty’s Government what are their plans for the future regulation of human fertilisation and embryology.

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

My Lords, the Government fully recognise the work of the Human Fertilisation and Embryology Authority since 1991. However, as a result of the Department of Health’s review of its arm’s-length bodies, the Government believe that there is scope to streamline healthcare regulation. The HFEA will continue for the time being but we propose that its functions will transfer to other bodies by the end of this Parliament.

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[Baroness Deech]

My Lords, I thank the Minister for that Answer. Will he assure the House that he will stand by the report of the pre-legislative scrutiny committee of three years ago and not endanger the statutory functions of the HFEA, including the all-important database and the guidance to patients, by splitting up the functions between five other committees, thereby saving no money at all and endangering the worldwide reputation of this model of regulation?

[Earl Howe]

My Lords, I recognise the experience of the noble Baroness and I pay tribute to her time as chair of the HFEA. The review that we have conducted has been based on a close examination of the functions of every arm’s-length body. Whereas some 20 years ago it may have made sense to look at a single body for carrying out the functions undertaken by the HFEA, she will agree that the functions concerned are very different. Times have moved on and we think that there is a more logical way to parcel out those functions which does not dilute in the slightest the efficacy or the efficiency of the regulatory action.

Health: Cancer

Baroness Deech Excerpts

Monday 21st June 2010 Lords Chamber

[Earl Howe]

The noble Baroness is quite right. This is a partnership effort, and she may know that a systematic review of PDT has been undertaken as part of the Health Technology Assessment programme, which is an element of the National Institute for Health Research. The final report on that will be published in August, but the institute has already identified that there are not enough high-quality research studies in this area. We know from experts in the field that there are at least three or four areas where further research should be prioritised.

[Baroness Deech]

Is the Minister aware that this month is the 50th anniversary of the invention of the laser? At that time its use in medicine could not have been foreseen. Does he therefore accept how important it is to enable universities to continue to do research in this field, in the hope that there will be future inventions, and not to cut them back in this area?

[Earl Howe]

The noble Baroness makes a crucial point. I am sure she will agree that neither basic research nor translational research should be neglected when we look at the research effort. Indeed, my own department is looking carefully at how the barriers to clinical research can be reduced. Therefore, she is absolutely right to focus our attention on the importance of continuing research.