To ask Her Majesty's Government whether the activities authorised by Human Fertilisation and Embryology Authority research licence R0152 include the use of donor nuclei from diabetic patients; and whether research licence R0152 specifically covers the use of donor nuclei from adults with a serious mitochondrial disease. [HL3059]

The Human Fertilisation and Embryology Authority (HFEA) has advised that the research licence R0152 includes the derivation of stem cell lines from embryos created by cell nuclear replacement using nuclei taken from a patient with type 1 diabetes. The licence was authorised by the HFEA licence committee, 16 March 2005.

The HFEA has advised that R0152 does not specifically cover the use of donor nuclei from adults with a serious mitochondrial disease.

To ask Her Majesty's Government why the most recent progress report for Human Fertilisation and Embryology Authority licence R0145 (pertaining to an inspection on 15 May 2008) made no reference to mitochondria; why it stated on page 4 that there were no proposed licence variations; when the lay summary for licence R0145 was revised to “also study the mitochondria”; whether the centre had requested to incorporate any new activities in that licence between 15 May 2008 and 28 September 2009; and how the three lay summaries on the Human Fertilisation and Embryology Authority's website constitutes consolidation of project aims. [HL3062]

The Human Fertilisation and Embryology Authority (HFEA) has advised that a progress report on research project R0145 received from the licensed centre in April 2009 informed the HFEA of a change to the project's objectives: determining how mitochondrial DNA mutations segregate between blastomeres and the derivation of human embryonic stem cell lines from embryos donated by couples in which the female partner carried mitochondrial mutations. The HFEA advises that the updated objectives did not change the licensed activities of the research project, and that the project continued to meet the statutory tests for the grant of a licence.

Following receipt of a renewal application in July 2009, the lay summary for R0145 was revised to reflect the change of objective, by adding the phrase “also study the mitochondria”. A consolidated lay summary is on the HFEA website at www. hfea.gov.uk

The centre did not request the incorporation of new activities to licence R0145 between 15 May 2008 and 28 September 2009.

To ask Her Majesty's Government further to the remarks by the then Minister of State at the Department of Health, Dawn Primarolo, on 22 October 2008 (Official Report, Commons, col. 387), which scientific authorities indicated that the nucleus in a cell should be considered to be cytoplasm; how restricting regulating powers to prevent the transmission of serious mitochondrial diseases via the cytoplasm would not necessarily exclude transmission via the cell's nucleus; and whether cloning involves the transfer of a nucleus rather than the cytoplasm. [HL3061]

To ask Her Majesty's Government further to the remarks by the then Minister of State at the Department of Health, Dawn Primarolo, in the Public Bill Committee on the Human Fertilisation and Embryology Bill on 3 June 2008 (col. 28), whether it remains their intention to ban any alteration to nuclear DNA being permitted under regulations; whether the Human Fertilisation and Embryology Act 2008 provides a regulation-making power for embryos to be used in treatment if they have been processed in a manner allowing the avoidance of serious mitochondrial diseases; and how the definition of such treatments precludes the transfer of an adult somatic cell nucleus into an enucleated egg. [HL3063]

The remarks made by the then Minister for State on 22 October 2008 (Official Report, Commons, col. 387) were a response to an amendment tabled to the Human Fertilisation and Embryology Bill. The proposed amendment was to a provision intended to prevent the transmission of serious mitochondrial diseases. The point being made by the Minister was that the proposed amendment could introduce uncertainty around definitions of cell structures, and could therefore potentially render the provision ineffective. The Minister asked that the amendment be withdrawn, which it was.

The Government, and Parliament, have made it clear that they are not prepared to countenance human reproductive cloning. The Human Fertilisation and Embryology Act 1990 (as amended) does so by prohibiting the placing in a woman of an embryo, egg or sperm that has had its nuclear or mitochondrial DNA altered.

The Human Fertilisation and Embryology Act 1990 (as amended) contains a regulation-making power to allow the use of embryos in treatment which have had applied to them a prescribed process designed for the very specific purpose of preventing the transfer of serious mitochondrial disease. It is not clear precisely what that process might be. Before any regulations concerning this were made there would be a full public consultation and debates in both Houses of Parliament.