asked Her Majesty's Government:
Further to the Written Answer by Lord Hunt of Kings Heath on 17 April (WA 42–43), whether they will explain the feasibility of proposals to allow research activities that involve alteration of the genetic structure of human embryos in order to understand how specific gene defects lead to failure of embryo implantation, whilst maintaining a specific prohibition against transferral of such embryos to the womb of either a woman or an animal; and [HL3401]
Further to the Written Answer by Lord Hunt of Kings Heath on 17 April (WA 42–43), bearing in mind that the other suggested aims of research on embryos might include understanding how specific gene defects lead to symptoms of disease, why embryonic stem cells would not be sufficient for such purposes; and to what extent organismal development might be required to establish the appearance of symptoms consistent with disease onset, especially in light of the current 14-day rule; and [HL3402]
Further to the Written Answer by Lord Hunt of Kings Heath on 17 April (WA 42–43), whether the continuation of licensing controls on research projects involving human embryos allows specific prohibitions in the Human Fertilisation and Embryology Act 1990 to be reinterpreted without recourse to Parliament; and whether such prohibitions were breached by the regulatory authority when granting HFEA research licence R0153. [HL3403]
The need to use embryos is a key consideration during the Human Fertilisation and Embryology Authority's licensing process for embryo research. The regulatory framework requires the use of alternatives to embryos—for example, established embryonic stem cell lines—where suitable ones exist. Schedule 2 to the Human Fertilisation and Embryology Act 1990 sets out the activities for which licences may be granted. Licences for the purposes of a project of research involving human embryos cannot authorise any activity unless it appears to the HFEA to be necessary or desirable for one or more of the purposes specified. The law also makes it clear that no licence shall be granted unless the authority is satisfied that any proposed use of embryos is necessary for the purposes of the particular research project.
The Government recently published a White Paper, Review of the Human Fertilisation and Embryology Act, and will shortly be publishing a draft Bill for pre-legislative scrutiny. The revised legislation will continue to permit the creation and use of embryos for research within limits and subject to regulatory oversight. It will continue to be the responsibility of the regulator to consider licence applications within the parameters set out in legislation. The Act currently prohibits culturing embryos for more than 14 days in vitro, and the Government do not intend to change the 14-day limit.
For research purposes only, the Government intend to remove the restriction on altering the genetic structure of a cell while it forms part of an embryo. This could aid understanding of genetic pathways involved in implantation and the mutations resulting in failure of implantation. For example, modifying a specific gene thought to affect the ability of an embryo to implant will allow scientists to learn about its function by looking at the effects on other genes in the early embryo. This approach could identify potential targets for treatment without the need to place the modified embryo in a woman.
A HFEA appeals committee licensed application R0153 on 1 September 2005. Following consideration of the overall intentions of Parliament and of the definition of genetic structure, the appeals committee concluded that none of the activities proposed in the application was prohibited, that they were necessary or desirable for specified research purposes and that the use of embryos was necessary for the purpose of the proposed research project.