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.

--- Later in debate ---

[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.