asked Her Majesty's Government:
Further to the Written Answers by Lord Darzi of Denham on 21 April (WA 234), 2 May (WA 109–10), 19 June (WA 177–78), 24 June (WA 227 and 1 July (WA 27–8) regarding the evidence available to the Human Fertilisation and Embryology Authority (HFEA), to what extent the scientific consensus referred to was based (1) on personal opinions and (2) an objective analysis of all published data; and whether they will provide references for all scientific papers considered by the HFEA which demonstrate (a) the potential of currently licensed cytoplasmic hybrids to develop into a human being if implanted in a woman; and (b) the intrinsic lack of potential in any embryo cultured on a layer of feeder cells for more than 14 days, despite the ability of mouse embryos to develop contractions resembling a heart beat after cultivation in vitro. [HL4647]
We have been advised by the Human Fertilisation and Embryology Authority (HFEA) that the scientific consensus formed was largely based on an extensive review of published literature on the scientific context and biological issues surrounding the creation of human-animal embryos for research, including nuclear reprogramming, the interaction of the nuclear and mitochondrial genome and the mixing of human and animal mitochondria.
The literature review also analysed alternative avenues of research and alternative sources of stem cells. In addition, the HFEA consulted a small number of stakeholders on specific scientific questions concerned with human-animal embryos. Responses were gathered from the HFEA's Scientific and Clinical Advances Group, the HFEA Horizon Scanning Panel and external stakeholders including the British Fertility Society, Human Genetics Alert and the Motor Neurone Disease Association.
No research has been published specifically on the potential of cytoplasmic hybrids to develop if implanted in a woman. This is because cytoplasmic hybrids cannot be transferred into a woman, as this activity is prohibited by the Reproductive Cloning Act 2001. The HFEA therefore did not consider any specific studies on this as part of their consultation. However, the HFEA did consider published literature on the development of cytoplasmic hybrid embryos in vitro and on the interaction between mitochondria and nuclear DNA. This included:
Illmensee K, Levanduski M & Zavos P (2006) “Evaluation of the embryonic preimplantation potential of human adult somatic cells via an embryo interspecies bioassay using bovine oocytes”. Fertility and Sterility 85(Suppl 1): 1248-60;
Chen Y et al. (2003) “Embryonic stem cells generated by nuclear transfer of human somatic nuclei into rabbit oocytes”. Cell Res. 13(4): 251-63;
Chang K H et al.(2003) “Blastocyst formation, karyotype, and mitochondrial DNA of interspecies embryos derived from nuclear transfer of human cord fibroblasts into enucleated bovine oocytes”. Fertility and Sterility 80: 1380-87;
Bowles E J, Campbell K & St. John J (2007) Chapter 10, “Nuclear Transfer: Preservation of a Nuclear Genome at the Expense of Its Associated mtDNA. Genome(s)” Current Topics in Developmental Biology 77: 251-90; and
St John & Lovell-Badge (2007) “Human-animal cytoplasmic hybrid embryos, mitochondria, and an energetic debate” Nature Cell Biology 9: 988-92.
No published data on the potential of embryos cultured on feeder cells beyond 14 days were considered. This is because embryos are not permitted to be cultured in vitro beyond 14 days. This issue was therefore not considered to be relevant to the consultation.
asked Her Majesty's Government:
Further to the Written Answer by Lord Darzi of Denham on 1 July (WA 28) regarding Clause 4 of the Human Fertilisation and Embryology Bill, to what extent the quantitative criterion underlying that clause (whereby it has been stressed that animal DNA does not predominate in the resulting embryos) reflects the mixing of human sperm with eggs of Mesocricetus auratus, in light of what is known about the nuclear genome size (in base pairs) of each respective species and the total mass (in picograms) of mitochondrial DNA typically found in mammalian eggs. [HL4648]
Provision regarding the mixing of human gametes with the gametes of an animal for research purposes is provided for under new Section 4A(6)(b) of the Human Fertilisation and Embryology Act, as introduced by Clause 4 of the Human Fertilisation and Embryology Bill (HFE). The “hamster test” is also provided for separately in the HFE Bill through provisions in Schedule 2 to the HFE Bill. The “predominantly human” provision is only a specific requirement of new Section 4A(6)(e).