---

Human Fertilisation and Embryology Bill [HL]

moved Amendment No. 1: 1: Clause 1, page 2, line 5, leave out from second ““eggs”” to ““but”” in line 6 The noble Lord said: I shall speak also to Amendments Nos. 2, 10, 11, 13 to 15, 17, 18 and 52. The purpose of these amendments relates to the Bill’s extension of the definition of ““gametes”” under the 1990 Act to include germ-line cells at any stage of maturity. It is not clear to me why this is necessary or desirable. The extended definition is out of line with the ordinary scientific meaning of the term. Biologically, a diploid germ cell, with a full complement of 46 chromosomes, needs to undergo DNA replication before the DNA divides to become a haploid gamete, with 23 chromosomes. Gametes are germ lines that have at least initiated meiosis—the process of halving the number of chromosomes to create a haploid cell. Therefore, the definition under the Bill extends ““gametes”” to cover germ lines in the early stage of development which have not reached the stage of becoming gametes. This creates considerable confusion, but with no obvious rationale for treating early-stage germ-line cells in the same way as gametes. Extending the definition of gametes brings immature germ cells under the remit of the Bill and presumably out of the Human Tissue Act. Why is that required? The first two amendments would remove the extension to early germ cells from the definition of gametes, reverting to the terminology used in the current Human Fertilisation and Embryology Act and Human Tissue Act. That is in keeping with the scientific understanding of the term and keeps those two Acts in line in this respect. The next seven amendments are consequential, ensuring consistency of approach in the definitions of, and division between, gametes and other cellular tissue. The changes to the definition of gametes and the consequential amendments to the interpretation of cells in new Section 4A(6) will affect the interpretation of the definition of interspecies embryo in new Section 4A(5); for example, some creations such as cytoplasmic hybrids, created by replacing the nucleus of an animal egg with the nucleus of a human germ cell, will now be covered under paragraph (b) of the definition rather than paragraph (a). However, I do not believe that the changes will alter the scope; rather, in my view they will enable a more natural reading of that definition. That covers Amendments Nos. 10, 11, 13 to 15, 17 and 18. Finally, I turn to Amendment No. 5, which is also in my name. The background to this amendment is that eggs are naturally formed in the ovary and sperm in the testes. Developments in stem cell biology indicate that it is possible to make sperm from embryonic or other stem cells. These are being called artificial gametes, and early studies in mice confirm the reproductive potential of these cells. They are thus seen as a potential cure for some forms of infertility; for example, in cases where the testes no longer function as a result of cancer treatment or where sperm production is defective. Although it may be several years before the use of artificial gametes in clinical trials can be initiated, it is most likely that this will happen within the next five to 10 years. The Bill must take account of this likely development, and I am told that the UK is now leading the international field in this respect. The 1990 Act makes no mention of artificial gametes but, in the 2005 consultation on the review of the Act, the Government state: "““The Government believes that the potential use of artificial gametes raises safety issues and that some uses may also raise ethical concerns. Therefore the Government proposes that the use of artificial gametes in assisted reproduction treatment should not be permitted but that the HFE Act should contain a regulation-making power giving Parliament more flexibility to allow the use of artificial gametes in future should it wish to do so””." However, in the White Paper, the Government proposed a ban on the use of artificial gametes—a view which they stated was well supported by the responses received to their consultation. As it stands, the Bill prohibits the use or treatment of gametes other than those that originate from the ovary or testes. The Government also considered introducing a regulation-making power to permit the future use of gametes. The White Paper stated: "““The Government has decided, on balance, not to recommend such a power, proposing instead that this would be a matter requiring primary legislation””." The problem is that the Bill does not permit the use of gametes which do not originate from testes or ovaries for the purpose of creating a permitted embryo under a treatment licence from the HFEA. Furthermore, there is no regulation-making power in the Bill to enable such treatment to be permitted in the future as there is, for example, for the use of mitochondrial transplant embryos, which we shall discuss later under the amendment of my noble friend Lord Walton of Detchant. Several leading researchers are already working in this area in the United Kingdom. In fact, the United Kingdom has managed to recruit scientists from overseas because of our legislative support. If we do not allow that to continue, research in this area will stop. The following consequences will flow from the current position under the Bill. UK researchers are pursuing research projects to develop treatments for infertility which will become illegal in primary legislation and require further primary legislation to permit them in the future. That could have inevitable consequences such as difficulty in obtaining funding for such research and consequences for the future of clinical trials and for infertile patients who wish to have their own children. It must also be remembered that artificial gametes could be derived from bone marrow stem cells, other adult stem cells or adult cells in which pluripotency has been induced. Therefore, it does not refer only to embryonic stem cells. That makes the potential use in therapy even less controversial, especially in the case of derivation from adult stem cells where no genes are inserted to reprogram the nucleus. If such treatment were not banned—and this is important—several safeguards remain. First, the use of such gametes for fertility treatment would require a licence. Secondly, the HFEA has powers to ensure that the procedure used for the creation and use of embryos for fertility treatment takes account of the welfare of any child that may result. The Bill thus requires that safety issues are the priority consideration of any treatment licence application that would use artificial gametes for fertility purposes. If regulation-making powers were included in the Bill, as the noble Lord, Lord Walton, suggests, additional oversight by Parliament would be available. I do not suggest that a therapeutic application of this technology is imminent, but it is likely to emerge at some point in the foreseeable future. A clinical trial may be proposed and Parliament needs to be in a position to permit the HFEA to licence at that point—hence my amendments. These amendments, on which the noble Lord, Lord Winston, may wish to comment, are supported by those who work in the clinical infertility area, such as the British Fertility Society and the British Medical Association. I turn to Amendments Nos. 51 and 53. The Bill as introduced uses the term ““human cell”” throughout Schedule 3 but does not fully clarify its meaning in that context. This creates ambiguity as to its scope, and as to the meaning of the phrases in which it is used in the schedule, including ““a person’s human cells”” and ““a person providing human cells””. It is unclear to me whether the term refers to cells from an individual, in line with the approach taken in the Human Tissue Act 2004, or to cells artificially created in vitro; that is, cell lines. By extension, it is unclear whether references to ““a person’s human cells”” are to cells from the body of a person or cells, such as cell lines, that may be personal property and are owned by the person who generated them in vitro. In my view, clarification of that definition is pivotal to the consent provision in Schedule 3. Cell lines created in vitro are currently outside the scope of the 1990 Act. They are also outside the scope of the Human Tissue Act 2004. This approach is entirely logical and sensible. If the consent requirements of the 1990 Act were extended by the Bill to cell lines, vast stores of valuable cell lines currently held in public, charitable and commercial collections of cell lines would become unusable for the purposes set out in Schedule 3, contrary to the interests of patients and public. The approach adopted to cell lines to date has significant support and we see no reason to change it. I presume that that is not the Government’s intention. The amendment would make it clear that a ““human cell”” in Schedule 3 is a cell from the body of a person and that references to a person in the phrase ““a person’s human cells”” are to the person from whose body the cell has come. The amendment also makes it clear that the requirements of Schedule 3 do not apply to cell lines generated in vitro from human cells. Briefly, on the other amendments in this group, I support the amendment of my noble friend Lord Walton and Amendment No. 5, which would clearly define a permitted egg, sperm and embryo. I shall reserve my comments on Amendment No. 2A, tabled by my noble friend Lord Alton. I beg to move.