Human Fertilisation and Embryology Bill [Lords]

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 variants—causing a life-threatening disease—that 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 from—including Professor Martin Bobrow, who chaired the Academy of Medical Sciences working group into another aspect of the Bill—whether 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 Minister's 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.