Medical Innovation Bill [HL]
Baroness Butler-Sloss Excerpts(10 years, 3 months ago)
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Lord Turnberg
My Lords, I strongly support Amendment 2 in the name of the noble Lord, Lord Pannick, for inserting the word “reasonable” for all the cogent reasons that he has given. Amendment 3 follows on from my earlier Amendment 1, which defines “relevant condition” and does not need further discussion here. I am very pleased to see that we have the agreement of the noble Lord, Lord Saatchi, that the word “reckless” will disappear from the Bill.
Baroness Butler-Sloss (CB)
My Lords, I strongly support the Bill as it is drafted. I am relieved that the noble Lord, Lord Saatchi, produced a short Bill; I hope that the House does not think that it was a bad idea to suggest that a short Bill might be more attractive than a longer one. For that reason I am not at all happy about the various amendments that were in the first part of our discussions today.
I do have reservations about the words in brackets in Clause 1(1), and I take the view that the noble Lord, Lord Pannick, is probably right to say that they should be excluded.
Baroness Finlay of Llandaff
My Lords, I added my name to the amendment deleting “reckless” because I felt quite strongly that it detracted from the overall intention of the Bill. This is not about reckless innovation; it certainly must deter irresponsible innovation, but it is about encouraging responsible innovation. I also added my name to Amendment 3, on treatment for the “relevant conditions”, because many of these patients who are seriously ill will have multiple co-morbidities and may have many things happening to them. This Bill is aimed, as far as I have understood, at the principal condition—the condition for which patients are often desperate for some innovative treatment. It should not inadvertently allow lots of other strange things to be presented to patients to cope with many of the other co-morbidities that they may have.
My feeling about that comes particularly from my own specialty, which the House knows is palliative medicine, where we see time and again patients who are very emotionally vulnerable, psychologically fragile and potentially in despair, so they are unable to make sense of what is going on. In that state, they are quite vulnerable to people presenting all kinds of strange treatments with false claims. I will give a specific example from my own practice. We came across a group of patients on a ward who all had small crystals by their bed, and we discovered that a member of staff strongly believed that holding on to these crystals would shrink the patients’ cancers. The evidence for it was absolutely zilch; I think that the patients had paid to have the crystals given to them. That type of so-called experimentation is completely outside the scope of the Bill—and must be outside its scope. That is why it struck me that the wording about the relevant medical condition should feature in the Bill, because of the potential for exploitation otherwise.
Baroness Butler-Sloss
It seems to me that if one is going to have Amendment 6, instead of saying that it “means”, it should say that it “includes”. That would then leave open everything else that might come in as medical innovation.
Earl Howe
This group of amendments seeks to define innovation and the scope of the Bill. This is a uniquely difficult task as innovation is, in essence, about constant improvement, change and progression. It is essential that in the act of defining we do not inadvertently limit responsible innovation. I ask the Committee to take on board the point neatly made by my noble and learned friend Lord Mackay.
Amendment 8 to Clause 1(2) in the name of my noble friend Lord Saatchi limits the scope of the Bill to situations where a doctor departs from,
“the existing range of accepted”,
medical treatments for a condition. This will be well understood by doctors, who are best placed to know whether they are following accepted treatments. This amendment also ensures that the Bill applies only to medical treatment.
A further provision, Clause 1(4)(a), ensures that the Bill applies not to research but only to the care of individuals. This exclusion of research is sufficient to achieve the same effect as Amendment 6 in the name of the noble Lord, Lord Winston. I hope that that clarifies that point for the noble Baroness, Lady Wheeler.
The Bill’s definition of innovation allows for situations in which doctors choose to carry out no treatment in the best interests of the patient. The definition of innovation in medical treatment proposed by the noble Lord, Lord Winston, would exclude that. I hope that that point, if no other, will give him pause when he decides what to do with Amendment 6.
There is another basic point to make here. Defining innovation on the face of the Bill would restrict the application of the Bill and could risk uncertainty for doctors as to whether the protection offered by the Bill would extend to the treatment that they are proposing. It is important that the scope of the Bill is clear to the medical profession.
Moving on to Amendment 28, the Government do not believe this to be necessary. The Government are already fully committed to promoting innovation which can save and improve lives. The Committee may be aware that NHS England has a full programme of initiatives to unblock innovation and disseminate the benefits to the NHS and beyond—something that the Government fully support. These include Innovation Connect, a programme to help innovators in the health service and industry to realise their ideas, embed them into clinical practice and exploit new opportunities in international markets, NHS innovation challenge prizes to encourage, recognise and reward front-line innovation and drive the spread and adoption of these innovations across the NHS, and the NICE Implementation Collaborative, which supports work streams by providing essential support to overcome identified barriers to innovation. Those are just some examples.
My noble friend Lord Blencathra asked in particular about off-label treatments. Without repeating the answer that I gave earlier to the noble Baroness, Lady Masham, on a similar issue, the Bill sets out a series of steps which doctors can choose to take when innovating to give them confidence that they have acted responsibly and with the intention of reducing the risk to doctors of successful claims of clinical negligence. With that threat diminished, the intended effect is that doctors will be confident to innovate appropriately and responsibly. That applies in full measure to off-label treatments. I would say as an aside that the cancer drugs fund, which has enabled access to a number of novel medicines, including off-label treatments, has benefited more than 55,000 patients since September 2010. So the decision on whether to prescribe unlicensed or off-label medicines will remain a matter for the doctor or prescriber who has clinical responsibility for the patient’s care, taking into account their individual clinical circumstances.
In response to the noble Baroness, Lady Masham, about funding, I should make the simple point that the Bill does not add any extra funding for drugs. Funding may be a consideration in certain circumstances, but the Bill does not affect the situation one way or the other.
I hope that noble Lords will take into account the Government’s view that innovation is best defined as a departure from the standard range of existing medical treatments, and that on reflection the Committee will not accept Amendments 6 and 28.
Health: Transition to Adult Health Services
Baroness Butler-Sloss Excerpts(10 years, 7 months ago)
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Earl Howe
I think that I can reassure the noble Lord on this point. NHS England is currently developing service specifications across the range of commissioning models: specialised commissioning, CCG secondary and primary care commissioning, adolescent mental health and special educational needs, and learning disability. Those will translate examples of best practice and published outcomes into specifications for commissioning to hold providers to account for the delivery of robust transition services with measurable quality standards attached to them.
Baroness Butler-Sloss (CB)
My Lords, there is a particular problem with young people who have not only physical problems but very considerable mental health problems. Is a priority being given to help that group of children?
Earl Howe
The noble and learned Baroness is quite right, and as she well knows, this has been a long-standing issue. Our document, Closing the Gap: Priorities for Essential Change in Mental Health, which we published recently, identifies the transition from child and adolescent mental health services into adult services as a priority for action. We are supporting the work of NHS England to develop the service specification which I have just referred to. CCGs and local authorities will be able to use that specification to build excellent person-centred services that take into account the developmental needs of the young person, as well as the need for age-appropriate services.
Female Genital Mutilation
Baroness Butler-Sloss Excerpts(11 years, 3 months ago)
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The Chancellor of the Duchy of Lancaster (Lord Hill of Oareford) (Con)
My Lords, the noble Lord, Lord West, could not see that a Cross-Bencher behind him wanted to speak.
Baroness Butler-Sloss
My Lords, will the Minister ensure that the police and the Crown Prosecution Service put forward far more appropriate prosecutions?
Earl Howe
My Lords, the Government are as frustrated as I am sure the noble and learned Baroness is by the lack of prosecutions. We welcome the Crown Prosecution Service action plan, published last year with a view to bringing successful prosecutions. The CPS guidance on FGM prosecutions provides a useful framework for prosecutors to understand how to build stronger cases with the police to bring to court. It explains how they need to be aware of the fact that where there is a victim of FGM, the local authority or social services may well have material or information to support that.
Health and Social Care Bill
Baroness Butler-Sloss Excerpts(12 years, 10 months ago)
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Baroness Butler-Sloss
My Lords, I have not yet spoken on this Bill. Could I ask the Minister a very practical question? If the amendment of the noble Baroness, Lady Thornton, is passed, what on earth will happen to this Bill? What I understand might happen is that in due course it would be passed by the Commons but without the amendments of this House. The result of that would mean that the enormous amount of work done by everybody in this House to improve this Bill would be totally lost, and the Bill as it left the Commons would be the same Bill that went through it. Is that what we want?
Earl Howe
My Lords, the noble Baroness, Lady Thornton, made some very complimentary comments about me at the beginning of her remarks and I thank her for those. Therefore, it is a cause for sadness to me that we have reached this final stage of the Bill in a climate of antagonism rather than of the mutual good will that typically characterises the end of a long parliamentary process in this House. That good will is still present, but it has perhaps been temporarily overshadowed.
I am sorry that the noble Baroness, for whom I have enormous respect, has taken the unusual step of tabling this Motion. It will not surprise her to hear that I disagree utterly with her summary of what this Bill will achieve, but it is not my intention to rehearse the arguments for it all over again. I did that at Second Reading and throughout subsequent stages of the Bill, when we debated at length and in depth the detailed provisions within it.
It is disappointing, too, that this Motion, so negative in its tone and content, is the only amendment which the Official Opposition have seen fit to table on our final day of debate. It stands in marked contrast to the highly constructive approach taken to Third Reading by Peers on all Benches, and indeed to the approach of thoughtful testing and challenge to the Government which the Labour Front Bench has adopted hitherto. I believe that we have used today’s Third Reading to good and positive effect. The noble Baroness, on the other hand, has chosen today to stand aside from that approach.
Public Bodies Bill [HL]
Baroness Butler-Sloss Excerpts(13 years, 11 months ago)
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Lord Willis of Knaresborough
My Lords, I added my name to Amendments 92 and 93. I congratulate the noble Baroness, Lady Thornton, on presenting a reasoned case for both amendments. I also congratulate the noble Lord, Lord Warner, on being able as a Minister to say that we should get rid of the HFEA and the HTA and now arguing that we should retain them. That is quite a trick—I am sorry; I should not use “trick” in East Anglia references.
I support the amendments not because I believe that the Government have got it wrong, but because in presenting Schedules 5 and 7, and in the Explanatory Notes to the Bill, they have failed to present a convincing argument for changing from two well respected regulators to something that has not been explained well and clearly leaves a lot of questions to be answered. There is a need for an equivalent of the Human Tissue Authority. Sometimes we overplay the organ retention scandal. It happened in one hospital in one area. The practice was not rife through the whole research base; it is important to state that. Nevertheless, there is a need for a regulator. In the case of the Human Fertilisation and Embryology Authority, despite the fact that so much time has elapsed since the original regulator was put in place, science is changing dramatically and the research, particularly on cytoplasmic hybrid embryos—admixed embryos—was something that the HFEA rightly referred back to government to ask for a view, whereupon the legislation was updated.
I had the pleasure in 2007, when I was in the other place, of chairing a Joint Committee on the Human Tissue and Embryos Bill. When the noble Lord, Lord Warner, presented the idea of a regulatory authority for tissues and embryos, I was hugely in support. It made good sense to bring everything together; it was efficient; and the less unnecessary regulation we have, the better. However, while I was initially supportive, I was staggered by the response from a host of organisations that supported two regulatory bodies. I remember a consultative session one evening in Portcullis House when all the organisations that were opposed to any research on embryos, or any use of the embryo other than for its God-ordained purpose, came together and argued for the regulators to stay on the ground that this would protect the embryo. I left with a clear understanding that the principled, ethical and moral stance on the special relationship of the embryo taken by the noble Baroness, Lady Warnock, was something that the Human Fertilisation and Embryology Authority had taken to heart and incorporated into its regulatory function. To be fair, the Government listened to the Joint Committee and dropped their proposals, which is why we are where we are today. The Minister has made it clear in several forums that this is not a rerun of RATE, and I fully accept that. However, he must today make absolutely clear how tissue and embryos will be protected in the new regulatory and research environment. If you throw out the current organisations, it is clearly necessary for the Minister to clarify what will replace them.
The HFEA was far from perfect but it commands huge support from the research and clinical communities and, in particular, from the public. Ultimately, we regulate to protect the public and not simply to ensure efficient and effective clinical practice. However, the Government have now given us some clarification and we should at least examine the proposals that they are making.
In terms of research, I strongly support the report of the Academy of Medical Sciences. It makes good sense to establish a health research agency and to try to bring all medical research together under one body. Indeed, as the Health and Social Care Bill is almost totally devoid of any reference to medical research, at least there would be a regulatory body, run by clinicians and scientists, with some clear understanding about the way that medical research is carried out. Therefore, I believe that the proposal for bringing all medical research together is excellent. It certainly gives me confidence that, provided the Government accept the recommendation of the Academy of Medical Sciences for a new health research agency, their proposals will take us forward in a much more positive sense.
Will the Minister assure the Committee that regulation regarding research and research techniques will also reside with the health research agency? The idea of placing research under the new agency but putting the regulation of research techniques under a different agency is totally unacceptable. Will the Minister also confirm that the new health research agency does not require primary legislation and that it can be established relatively quickly without such legislation? If he is able to confirm that, can he assure the Committee that when the Bill goes to the other place there will be a clear timetable for setting up the agency? That will provide some clarity about the path ahead regarding research.
Where clinicians have a strong case is that there is a sense that techniques approved for clinical application should come within the regulatory framework of NICE or the CQC. I have some clear reservations about the CQC and I recognise that the Government will have to make the case. My qualification is that the CQC is untried, and there is a huge difference between inspecting care homes and inspecting clinics which use the most advanced techniques of assisted conception, PGD, the use of saviour siblings and so on.
In closing, will the Minister assure the Committee that the current team of specialists dealing with clinical application in the HFEA and the HTA will be transferred en bloc and kept together within the new organisation so that we do not lose impetus or, more worryingly, make mistakes? There is, I believe, a coming together in terms of what the Government want and preserving the best of what the HTA and the HFEA have to offer. I think that the Minister has to make the case but I believe that the Committee is listening.
Baroness Butler-Sloss
My Lords, I have been looking with interest at the very helpful parliamentary briefing, particularly on the HFEA and the statutory functions that fall into four main groups. I am very concerned about each area. If licensing is to go into the Care Quality Commission, as has already been mentioned, will that commission have the same level of expertise to deal with the really difficult cases that may come up? I speak as a former judge who had a case where semen was put into the wrong eggs. Two families found that the non-white semen had been put into white eggs, and the children born to the white family were not white. It was the most appalling story. It caused grief to two families and, of course, to the twin children. It became public knowledge. It was a case that I tried. What is needed is careful regulation of the clinics and expertise in what the clinics are doing.
Another matter I would like to raise in particular with the Minister, and one which has not yet been raised in this evening’s debate, is the collection of data, the division of information, and the maintenance of a register. What is happening, according to the Government, is that the licensing and regulating will go to the Care Quality Commission but the provision of the information, the data collection, will go somewhere else.
What rather shocked me was the last paragraph of the helpful briefing saying that the arrangements for the transfer of the information-related functions will be based on assessments, and functions will be integrated into the most appropriate body. We do not know where the data functions will be going, which I find extremely disturbing. It leads me to the view that this plan to abolish both the HFEA and the HTA, whose functions are going to be divided, has not been given the sufficient thought or impact assessment one would have hoped for. We have not yet been given good reasons why these two functioning bodies should be got rid of.
I entirely support the wise words of the noble Lord, Lord Warner. It may very well be that each of these bodies could be streamlined, pared to the bone, have less back-up staff and cost less money. However, having asked in another debate on this Public Bodies Bill, “If something works, why break it?”, I say that these two organisations appear to work and so it is premature, at least, to be abolishing them now.
Lord Walton of Detchant
My Lords, when I came into this House almost 22 years ago, my baptism of fire was the consideration of the Human Fertilisation and Embryology Bill. I spent a great deal of time considering its provisions, based upon that splendid report produced by the noble Baroness, Lady Warnock.
The purpose of the Act, as it became, was to license experiments on the human embryo up to 14 days after fertilisation, first, for improvement of the management of infertility and, secondly, to help in the prevention of the birth of children with fatal and seriously damaging disease.
Those objectives were, very largely, fulfilled. We got to a stage of being able, through licences from the HFEA, to embark upon a programme of pre-implantation diagnosis of some of the severest diseases like cystic fibrosis and muscular dystrophy. It did a wonderful job.
It became quite clear, however, that, because of the developments in human embryology and the enormous advances in research, it was necessary that the Act should be further amended, not only in order to prevent the birth of people with severe diseases but also to be able to use human embryo material and the stem cells derived from it for the treatment of human disease. That resulted in a number of other amendments and regulations being introduced.
We then went even further with additional developments. As many in this House will know, one of the great developments recently under a licence from the HFEA has been the ability to prevent the birth of children—not yet feasible but on the verge of becoming so—with a devastating form of mitochondrial disease. I will not go into the scientific detail because it is extremely complex.
I mention the word complexity because I cannot conceive that the role and responsibility of the HFEA—I entirely agree that it is not perfect; it may be slimmed down, streamlined or modified—could possibly be carried out by the Care Quality Commission, which is, under its major new responsibilities, required to inspect hospitals, care homes, general practices and all bodies concerned with the supervision of health work of all kinds. To try to carry out those responsibilities under the Care Quality Commission is simply not feasible.
Last week, as the noble Earl will remember, we debated a Question on the role of the Academy of Medical Science’s report on the governance of medical research. I agree entirely with what the noble Lord, Lord Warner, said: this is a very exciting and important development, particularly in the conduct of clinical trials and the supervision of research in general. It certainly does not cover the responsibility which the HFEA is carrying out, and I therefore cannot accept the Government's proposals to put that body within the Care Quality Commission.
I move on to the HTA for a moment. When I was a medical student in the early 1940s, on the top floor of my medical school there was a museum which was full of organs held in formalin in plastic bottles. They were a wonderful teaching resource, because they were organs showing the signs of disease and, for the teaching of medical students, they fulfilled a major responsibility. No one had asked the patients involved before those organs were retained for teaching purposes.
The problem of the Alder Hey so-called scandal was that the permission of the individuals from whom the organs were removed had not been taken. What nobody recognised at the time was that if you were to carry out a post-mortem examination to try to determine the nature and causation of the disease from which the individual had died, there was no way in which the simple carrying out of the post mortem and visual inspection of the organs could give you the answer. The organs had to be removed; they had to be pickled in formalin; they had to be studied under the microscope, to give the answers which everyone wanted to know as the outcome of that post-mortem examination.
Where members of my profession were mistaken was that it became almost accepted by doctors, pathologists and clinicians that once permission for a post mortem had been given they could assume that permission had been granted to retain the organs for such an examination. They were wrong. Hence, the Human Tissue Authority was created to control that process. It has been very successful not only in that regard but also in issues related to the retention of tissues obtained for diagnostic purposes by biopsy. It has also been extremely successful in controlling the use of anatomical material for teaching purposes. It has fulfilled a whole series of other functions. My view is that it is so necessary that that function should be continued that I do not believe, for the same reasons, that the Care Quality Commission could feasibly absorb that task. It could do so only if it took on board the scientific experts on human fertilisation and embryology on the one hand, to deal with the responsibilities of the HFEA, and the scientific experts in pathology, anatomy, molecular biology and other branches of medicine, to look at the human tissue issues and also to be able to deal with issues relating to the donation of organs for transplantation. Those complex issues are so broad in their responsibility that I do not believe that the Care Quality Commission could conceivably handle them all. That is why I give warm support to the amendments.