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Human Fertilisation and Embryology Bill [HL]

I understand the reservation and, perhaps, fears expressed by the noble Lord, but the fact that matters would be discussed by Parliament through the affirmative resolution procedure is the best way that we have found to date. But of course we would be open to discuss this with the noble Lord if he believes that there are better ways forward. I look forward to discussing these matters with him after Committee stage. I turn now to Amendment No. 3 of the noble Lord, Lord Brennan, who I trust is well. It is a delight to see him back in the House. The Bill introduces a wider definition of a human embryo in order to include embryos created in ways other than by fertilisation—for example, by adding genetic material to an egg. New Section 3(2) of the 1990, as inserted by Clause 3, ensures that only permitted embryos, eggs and sperm can be placed in a woman. New Section 3ZA provides definitions of what will be permitted and has the effect that only embryos produced by fertilisation of a natural egg with a natural sperm and natural gametes can be place in a woman. Removing subsection (5), as proposed by Amendment No. 3, would remove that definition. Amendment No. 3 removes subsections (5) and (6) from page 3. This has two principal effects. First, it removes new Section 3ZA, which defines a permitted egg, sperm and embryo for the purposes of the 1990 Act and, secondly, it removes the provision that repeals the Human Reproductive Cloning Act 2001. New Section 3ZA defines a permitted gamete as an egg produced or extracted from the ovary of a woman or sperm produced or extracted from the testes of a man with unaltered nuclear or mitochondrial DNA. A permitted embryo is defined as an embryo created by the fertilisation of a permitted egg by permitted sperm where no nuclear or mitochondrial DNA of any cell of the embryo has been altered and where no additional cells have been added to the embryo. This new subsection also has a provision that will allow Parliament, through regulations, to amend the legislation so that embryos created to avoid the transmission of mitochondrial disease can be replaced in a woman. This regulation-making power would also be removed from the Bill by the amendment tabled by the noble Lord, Lord Walton. I shall return to mitochondrial issues when I respond to that amendment. If the definition of a permitted egg, sperm and embryo in subsection (5) were removed, it would not be clear in the legislation which embryos and gametes could be placed in a woman. That would mean that, for treatment purposes, we would have to rely on a general definition of embryos and gametes similar to that in the 1990 Act. This definition resulted in the Human Reproductive Cloning Act 2001 to prevent embryos created in ways other than by fertilisation to be placed in a woman. The approach under the Bill is to specify precisely what entities can be placed in a woman rather than to list those that cannot, as under the 2001 Act. We believe that this approach gives greater certainty and ensures that only the types of embryos and gametes that Parliament intended could ever be placed in a woman. The Human Reproductive Cloning Act 2001 is repealed by the Bill, but the purpose of this amendment is to remove the provision in the Bill that has that effect. The 2001 Act states that anyone placing in a woman a human embryo that has been created otherwise than by fertilisation will be guilty of an offence. However, the Government remain firmly committed to a ban on reproductive cloning. In this Bill, the provisions have the same effect as the 2001 Act—that is, to prevent anything other than an embryo created by fertilisation of a natural egg with a natural sperm being placed in a woman. Therefore, the 2001 Act is suppressed but it is still an offence to carry out reproductive cloning. The definitions of embryos and gametes in the Bill are drafted to capture a wide range of things that may be created under a research licence. However, we consider it appropriate to separate out embryos and gametes that can be created and used for important research from those that will be used to create a human being. The definition in new Section 3ZA(5) of the Bill clarifies which embryos, eggs and sperm can be placed in a woman, and we think that this clear separation is vital. The noble Lord, Lord Alton, asked whether it would be reproductive cloning if a somatic cell were used in mitochondrial donation. As I said, the Government remain committed to a ban on human reproductive cloning, and the intention of the regulation-making power in new subsection (5) is to use techniques involving fertilisation to prevent the transmission of serious mitochondrial disease, not the use of somatic cells. I turn to Amendment No. 4, tabled by the noble Lord, Lord Walton, who spoke passionately about this issue at Second Reading and this afternoon. As discussed in relation to earlier amendments in this group, Clause 3 introduces the concept of permitted embryos, sperm and eggs. The Bill prohibits placing in a woman any embryo, gametes, eggs or sperm other than permitted embryos or gametes. This essentially prevents placing in a woman anything other than an embryo created by the fertilisation of a naturally occurring egg with a naturally occurring sperm, so, although the legislation covers a much wider spectrum of embryos created through various techniques, only those created through fertilisation can be used to create new life. Clause 3 inserts new Section 3ZA into the 1990 Act to define permitted embryos and gametes. For gametes, this means an egg produced or extracted from the ovaries of a woman or sperm produced or extracted from the testes of a man with unaltered nuclear or mitochondrial DNA. For embryos, this means an embryo created by the fertilisation of a permitted egg with the permitted sperm where no nuclear or mitochondrial DNA of any cell of the embryo has been altered and where no additional cells have been added to the embryo. The noble Lord, Lord Walton, referred to the research group in Newcastle which is trying to find ways to prevent the transmission of mitochondrial disease conditions. If that research develops into a safe and effective treatment, the Bill has a provision that will allow Parliament, through regulations, to amend the legislation so that embryos and eggs created to avoid the transmission of those conditions can be placed in a woman. That regulation-making power, therefore, provides for an egg or an embryo to be brought within the definition of a permitted egg or embryo if it has had applied to it, in prescribed circumstances, a prescribed process designed to prevent the transmission of mitochondrial disease. Clause 3(5), inserting new Section 3ZA(5) into the 1990 Act, is a very specific regulation-making power which would enable such eggs or embryos to be placed in a woman under a treatment licence. Amendment No. 4 moves the provision from secondary legislation and places it in the Bill. The provision was left to secondary legislation not because we believe that the issues relating to mitochondrial disease are, as the noble Lord, Lord Alton, says, to do with technological brutalism, nor because we want to introduce a further layer of bureaucracy, but because we believe that data on safety and efficiency of this technique are not yet available and, therefore, it would seem premature to provide for this technique to be licensed in the Bill. The technique also raises important ethical considerations because it covers the creation of an embryo using three separate genetic contributions. Although we recognise that this research is significant and has the potential to alter significantly the reproductive options for those people who suffer from serious mitochondrial diseases, we feel, at this time, when the safety and efficacy of the technique has yet to be demonstrated, that this provision is most appropriate in secondary legislation with an opportunity for debate in both Houses. Amendment No. 5, tabled by the noble Lord, Lord Patel, raises another important matter. The amendment introduces a regulation-making power which would allow the definition of permitted eggs and sperm to be expanded to eggs and sperm that have been derived from a prescribed process to treat infertility. That relates to research to help those people who are unable to produce gametes naturally to have children that are genetically related to them. It is also possible that in some circumstances that technology could be used for the purpose of enabling same-sex couples to have children who are genetically related to both parents. I note what the noble Lord, Lord Patel, has said about researchers working in this specific area and what the noble Lords, Lord Winston and Lord Wilson, have said. We believe that this research is not yet at a stage when it can be translated into infertility treatments, but Amendment No. 5 provides for the expanded definition of permitted embryos to include artificial gametes to be introduced by secondary legislation. The Bill allows for research into artificial gametes to be carried out but the use of artificial gametes is not permitted in treatment. I understand the arguments that have been put forward from a scientific perspective, but I believe that the amendment raises wider ethical questions, as the noble Earl, Lord Howe, said. Therefore, on balance, the Government have decided that such a significant and potentially wide-ranging development should be subject to full parliamentary debate and consultation as and when further data on these techniques are available. Amendments Nos. 51 and 53 seek to permit the use of cell lines, a tool commonly used in research for the creation of embryos in the laboratory by means of therapeutic cloning without specific consent to this activity. The cell lines may be cultured for many years; some cells found in cell lines were originally donated decades ago. The cells would have been taken from a donor with the person's consent, but that person would be unlikely to have imagined, particularly if the cells were donated many years ago, that they could or would be used for the creation of cloned embryos. Every person has the right to decide whether their cells may be used in the creation of an embryo, and for what purposes that embryo may be used. That was the main reason for the consent regime found in the 1990 Act and the reason behind the proposed changes to the consent requirements found in the Bill today. These changes have been introduced to ensure that a person’s consent is always obtained before the use of their cells or gametes in embryo research. Schedule 3 to the Bill preserves the system of consent under the 1990 Act that makes changes to reflect the fact that human embryos can now be created in more ways than simply mixing human gametes. Additional consent requirements are introduced to ensure that informed consent is obtained before any human material can be used to create an embryo and for the subsequent use and storage of such embryos. These provisions ensure that the same safeguards provided in the 1990 Act for consents relating to embryos are applied to all types of embryo creation. I understand that these cell lines will provide a reliable resource of cells for the creation of cloned embryos, particularly following the advent of cytoplasmic hybrid embryo research, which gives a plentiful supply of animal eggs. I am not convinced that the other use of cells for which proper consent is in place is not just as easy and abundant. The noble Lord, Lord Patel, asked whether ““cell”” included cell lines. Yes, we have proposed that the definition of ““human cell”” that may be used to create a human embryo should include cell lines. The general principle is that consent should be obtained for the creation of embryos. As the Bill stands, this includes where cell lines are used. This huge group of amendments covers some important—