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A cord blood bank is potentially positive for any child having to undergo a bone marrow transplant but the specific nature of the disorder of Fanconi Anaemia, the commonest inherited bone marrow failure condition, is that a related sibling match will always have significantly less mortality and morbidity than an unrelated donor match irrespective
from an unrelated adult donor or unrelated cord blood.
Mr. Burrowes: I am grateful, particularly for the hon. Gentlemans reference to cord blood. It is the 20th anniversary of the first cord blood transplant specifically for fanconi anaemia; it was performed in France by Professor Elaine Gluckman, the major pioneer in the field. Should we not move heaven and earth, to cite the Ministers words, to ensure that we do not just throw away 98 per cent. of cord blood and so that we can use it as a resource to provide cures for fanconi anaemia without going down the ethically perilous route of saviour siblings?
Tom Levitt: I am sure that there is a role for cord blood banks. In this particular case, however, Davids is one of the six families who have been licensed for the saviour sibling technique precisely on the grounds that there is no alternative treatment. Were David to have a sibling-saviour transplant, there would be a 95 per cent. chance of success in the short term. He would spend just three weeks in hospital and live the rest of his life as normal.
Conditions such as fanconi anaemia are very rare, and that may be why only six families are licensed for the treatment at present. Davids father has explained why his family have embarked on the process:
We would like to save his life. We would also like to have an unaffected child that will outlive us and that can give us hope in our lives...For most people who choose to have an opinion, this Bill will fortunately never affect them. This Bill is for families like us...Other families worry about what choice of secondary school they will send their child to, we worry about whether our child will be alive next year. Our son already asks about bone marrow, transplantation, and death...we are waiting with trepidation for the day he asks us to explain his condition.
My hon. Friend was present when the hon. and learned Member for Torridge and West Devon (Mr. Cox) questioned the suitability of parents engagement in decisions about the matters under discussion. Does my hon. Friend not agree that the
process through which his constituents have gonethe counselling and expert advice that they have receivedplaces them in a stronger position than most people will ever be in for taking an informed decision?
Tom Levitt: My hon. Friend anticipates what I was just about to say about Davids parents. They are both doctors and are very well informed about what they are asking of their future child. It is also interesting that they are both Catholics. They are concerned that if they go ahead with the technique, they will be stigmatised among some of their friends.
Judy Mallaber: Did my hon. Friend hear his constituent speaking on the news at lunch time? Anyone else in the Committee who heard him will have had no doubt about the rationality of his decision, his love for his existing child and the love that he would give a second child. The decisions were taken in a very rounded way and were reached in difficult ethical circumstances, given the personal beliefs with which the parents had to contest. My hon. Friends constituent should be a welcome example for anybody in the House.
Tom Levitt: My hon. Friend is right. I knew that the interview was taking place, although I did not hear it. However, I have been in e-mail correspondence with my constituent about this issue in the past few days.
Davids parents are desperate that their child and others with similar conditions should be able to live. They have asked me to beg the Committee to let David live, accept the proposals for savour siblings outlined in the Bill and ensure that when that choice is the right and only way forward, it is not ruled out for families such as Davids.
Dr. Evan Harris: This excellent debate has gone far and wide, well beyond the issue of saviour siblings. In fact, I am surprised that the debate has ended somewhat earlier than planned. Nevertheless, I should like to offer the following comments to the Minister and the Committee about my amendments.
Amendments Nos. 24 to 30 question whether abnormality is the right term to use for the genetic characteristic to be tested in pre-implantation genetic diagnosis. I accept that, as the Minister said, my amendments go further than the provisions of the Bill. But I am concerned that the Bill may not go far enough to capture all the conditions that are not single-gene mutations, and therefore abnormalities, that one might legitimately want to test for with the same threshold of seriousness. The Minister says that we would need to provide examples in order to persuade her that the existing wording was not sufficient, and that is the challenge. If, for example, one could identify two normal variantscausing a life-threatening diseasethat could not be called abnormalities, perhaps the Government would look at the matter again. I shall ask the clinical advisers whom I have been hearing fromincluding Professor Martin Bobrow, who chaired the Academy of Medical Sciences working group into another aspect of the Billwhether they can provide some specific examples.
The second area is that of licences for therapy, which is dealt with by amendment No. 30 and associated amendments. I listened carefully to the Minister, who
made it clear that the Bill allows embryos to be created and used for research, which in itself should be sufficient to cover any therapeutic use. She gave a second reason, which I accept, that the therapeutic use of cells will be covered by the Medicines and Healthcare products Regulatory Agency, the Human Tissue Authority and not the Human Fertilisation and Embryology Authority.
Moreover, any embryos from which stem cells are derived will inevitably have research associated with them, and therefore could be covered by a research licence. But I question whether that is the case in every situation. Briefly, I want to mention four scenarios and see whether the Minister recognises that there might be a problem.
There might be an organisation that is a specialist in the derivation of embryonic stem-cell lines in other jurisdictions, which applies to the HFEA for a licence to use embryos to create stem-cell lines that it intends to pass on to another organisation to use for research or therapy. How would such an applicant be able to specify what research was done if it is not doing the research? The current Bill requires the people producing the embryos to be the people associated with the research licences, which may stifle innovation, investment and the production of stem cells.
Secondly, cell-based therapy might be so well established in the future that only quality assurance need be carried out, without a research protocol, prior to therapy. In such a scenario, the embryo would be created and then used for therapy without a research step. The same distinction between quality assurance and audit on the one hand, and research on the other, is already made in the Human Tissue Act 2004 for the use of tissue. The Ministers argument depends on there being no possible therapeutic use that did not require a form of clinical or pre-clinical research on those cells, and I am not convinced that that is certain.
The assumption that the therapeutic use of ES cells will always follow formal research during the lifetime of the legislation is dangerous because if phase 1 and phase 2 trials are successful, there will be clinical pressure to use ES cells as experimental treatment, albeit licensed by the MHRA, outside of the phase 3 research protocol. Alternatively, phase 3 trials might be successful, and it would be questionable whether one could identify a proper research application, beyond quality assurance, within the subsequent use of the newly derived ES cell lines created under research licence. The Minister may say that that is dealt with, and if she agrees to put a summary of the legal advice in the Library, I shall look at it.
Finally, if therapeutic cloning works, it might be possible to provide autologous stem-cell therapy for a patient using their own somatic cells. That would be experimental therapy, not research, if it were used, and such a situation might apply in the lifetime of the Bill. I am concerned that the Government are not adequately future-proofing the Bill by accepting the relevant amendment, and we shall have to examine that question in the weeks to come. It is not my intention, however, to press it to a Division now.
I turn to amendment No. 15, in the name of the hon. Member for Boston and Skegness (Mark Simmonds), which I did not address in my earlier comments. It proposes to change the definition of serious disease to
a disease that causes a serious impairment of quality of life. He defended that on the basis that his definition was tighter and less open to interpretation. I questioned that in interventions. To be fair, he kindly accepted that he was not sure that it was tighter.
Dr. Harris: I question whether the definition is tighter, but I do not believe that it should be because the decision should be left to doctors and patients, under the regulators guidance. It is difficult for us to decide at the outset that something is not serious when the regulator, the doctor and the patient might consider it serious. When pre-natal diagnosis is done through amniocentesis, with an indication for termination of pregnancy, not at an embryonic but a foetal stage, weeks into the pregnancy, there are no criteria for seriousness. It is illogical to have a high threshold for embryonic steps to avoid illness when amniocentesis and pre-natal diagnosis in an established pregnancy require no such threshold. Doctors have written to me saying that they do not understand that distinction: why one can terminate a pregnancy without a seriousness thresholdthe doctors and patients decidewhen we set such a threshold for embryo testing, before a pregnancy is established.
Let me consider the important speech of the hon. Member for South Derbyshire (Mr. Todd) about the extent to which it is appropriate to conduct invasive procedures on a child to derive tissue for transplant to a sibling. I am a member of the BMA Medical Ethics Committee. The BMA wrote that it is not worried about that ethical problem because there is already provision for taking the childs best interests into account. In the case of disagreement by doctors and parents or between parents, a court must be involved. Paragraph 44 of the Human Tissue Authority code of practice states clearly, if briefly:
Courts have identified certain important decisions which require court approval where one person with parental responsibility consents against the wishes of another. If there is any dispute between persons with parental responsibility or any doubt as to the childs best interest, the matter should be referred to court for approval.
Invasive procedure could be sanctioned only when there is no doubt that it is in the childs best interests. Of course, that is relevant to every sibling, not only the small minority of saviour siblings, who may be a match for an affected child. It is wrong to suggest, in the few cases that the Bill covers, that there is a problem with common law, medical ethics and the guidance to doctors about the best interests of a child for invasive procedures if we do not extend those provisions to the many more children in that position. The Bill strikes the right balance on saviour siblings and I urge hon. Members to bear that in mind.
I respect the commitment of the hon. Member for Enfield, Southgate (Mr. Burrowes) and the way in which he presented amendment No. 4, on which I am sure the Committee will divide. However, it is clear
from advisers on cord blood banking that, however much one expands cord banks, it will not remove the need in a minority of cases for saviour siblings. I hope that he accepts that I can find no medical opinion, including from those who run the banks, to support the view that expansion would do away with the need for legislation on saviour siblings in a minority of cases.
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