asked Her Majesty's Government:

What was the date of the publication of the draft Human Tissue and Embryos Bill; and what is the closing date for public response to the draft; and [HL4210]

In publishing the draft Human Tissue and Embryos Bill, what account they took of the recommendations of the Select Committee on the Draft Freedom of Information Bill (HL Paper 97, 1998-99) with regard to the need for adequate public consultation on Bills subject to pre-legislative scrutiny; and how consideration of the Bill is likely to meet the recommendation of the Joint Committee on the Draft Legal Services Bill (HL Paper 232-1, 2005-06) that such committees should allow sufficient time for adequate scrutiny of such Bills. [HL4211]

The draft Human Tissue and Embryos Bill was published on 17 May 2007. Its provisions were drawn up based on the White Paper Review of the Human Fertilisation and Embryology Act: Proposals for Revised Legislation (Including Establishment of the Regulatory Authority for Tissue and Embryos), published on 14 December 2006. The policy proposals in the White Paper represented the outcome of the Government’s review of the law, which included a public consultation exercise that ran from 16 August to 25 November 2005. The review also took account of an extensive inquiry during 2004-05 by the House of Commons Science and Technology Committee and its report Human Reproductive Technologies and the Law.

The Bill has been published for pre-legislative scrutiny by a Joint Committee of both Houses, with the scrutiny process due to end on 25 July 2007 and a report due to be available in early August. The committee has published its call for evidence and is currently examining a range of witnesses. Representations from members of the public may be made to the committee. It is open to the committee to consider whether sufficient time has been made available for scrutiny.

Given the considerable public and parliamentary debate to date on the policy proposals that comprise the draft Bill, the Government decided not to undertake a further formal public consultation outwith the parliamentary pre-legislative scrutiny process. However, persons wishing to make representations to the department may do so; contact details are included in the draft Bill and on the department’s website at www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publications Legislation/DH_074718.

asked Her Majesty's Government:

Further to the Written Answer by Lord Hunt of Kings Heath on 7 June (WA 203-04), how their stated commitment to a ban on reproductive cloning is reflected in the Human Tissue and Embryos (Draft) Bill, particularly in light of the repeal of the Human Reproductive Cloning Act 2001, proposed on page 88 of the draft Bill, and proposal 22 on page 146 of the draft Bill, which indicates their intention to remove the restriction on reproductive cloning in order to encourage an increase in research licence applications; and [HL4252]

Whether, in light of the proposed removal of relevant prohibitions, the Human Tissue and Embryos (Draft) Bill is intended to permit reproductive cloning; and [HL4253]

How regulations will automatically or necessarily preclude reproductive cloning given that the Human Tissue and Embryos (Draft) Bill will permit eggs or embryos to be placed in a woman, including those as described in Section 3ZA(5), which have had applied to them a process designed to prevent the transmission of mitochondrial disease; and [HL4254]

From whom they received representations suggesting that a change in the law relating to nuclear transfer might be warranted; and whether any such individuals or groups are currently engaged in or otherwise connected with research involving nuclear transfer. [HL4255]

The Government are committed to a ban on human reproductive cloning and the draft Human Tissue and Embryos Bill does not permit human reproductive cloning. Clause 16(2) in the draft Bill allows only “permitted” embryos to be placed in a woman. An embryo is a permitted embryo if:

it has been created by fertilisation of a permitted egg by a permitted sperm; and

no nuclear or mitochondrial DNA of any cell of the embryo has been altered.

This would not include an embryo created by cell nuclear replacement. As these provisions supersede the requirements for the Human Cloning Act 2001, it is accordingly revoked by Clause 16(6).

The draft Bill introduces a regulation-making power in new Section 3ZA(5) of the amended Act, which, if exercised, will allow an embryo that has had applied to it a process in circumstances prescribed by regulations designed to prevent the transmission of serious mitochondrial disease to be included within the category of “permitted” embryos. Regulations to allow this would be subject to affirmative resolution.

While retaining the ban on reproductive cloning by specifying only those embryos that can be placed in a woman, the draft Bill removes the prohibition on replacing the nucleus of a cell of an embryo with a nucleus of any person or embryo, or subsequent development of an embryo for research purposes only. Licences for the purposes of a project of research involving human embryos cannot authorise any activity unless it appears to the regulator to be necessary or desirable for one or more of the purposes specified in the Act.

In 2005, the department undertook a public consultation on the review of the Human Fertilisation and Embryology Act. Responses were received from stakeholders including members of the scientific community and professional bodies. Among those that supported the removal of the prohibition on “replacing the cell of an embryo with the nucleus from a cell of any person” for research purposes only were the British Medical Association, the Royal College of Obstetricians and Gynaecologists and the Association of Clinical Embryologists. These groups are not directly involved in cell nuclear replacement research but members represented by those groups could be.