Human Fertilisation and Embryology Bill [HL]
Baroness Royall of Blaisdon (Chief Whip (House of Lords), HM Household; Labour)
My Lords, I am grateful to the noble Lord, Lord Walton, and the noble Lord, Lord Patel—who is not in his place, and I quite understand why—for the further discussions that we have had on this issue after previous debates.
The noble Lord referred to the letter from my noble friend Lord Darzi, which covered a number of the issues raised during the passage of the Bill, including a considerable contribution on this subject, and copies have been placed in the Library. I am happy to repeat the salient points for all noble Lords present.
The Government have consistently supported the use of cells derived from embryos for the treatment of human disease and medical conditions, and have therefore given the issue very serious consideration. On the basis of advice and discussions we have had following Report, the Government are of the view that the licensing framework which would be in place following the introduction of the Bill would allow the derivation of embryonic stem cells. Furthermore, it would allow the development of those cells into a therapeutic product without the need for further amendment. Any embryonic stem cell line intended for therapeutic use will need to be subjected to considerable research activity, including rigorous safety assessment, before entering into preclinical and clinical studies. As each cell used would be different, significant investigation would be required in each case prior to, and during, preclinical and clinical study.
Regulatory oversight by the HFEA finishes once a stem cell line is derived. This means that once embryonic stem cell lines have been developed, the HFEA regulatory framework under which the embryo was produced is not relevant to any further use of that cell line, whether for further research or for therapy.
There are a number of ethical and safety issues regarding the use of stem cells in patients that go wider than the regulatory remit of the HFEA. They include the regulation of clinical trials using stem cells, of the widespread therapeutic use of stem cells and of the standards against which the use of such stem cells would be regulated.
These are questions which a working group of regulators comprising the HFEA, the Human Tissue Authority and the Medicines and Healthcare Products Regulatory Agency are considering. This work will inform the research community about the steps to be taken to enable cell-based therapies to be introduced into clinical practice. The issue will be informed by the work of the stem cell bank steering committee, chaired by the noble Lord, Lord Patel, and the Medical Research Council.
The Government remain committed to developing an enabling regulatory system as part of the 10-year UK stem cell initiative. We look forward to engaging with all relevant stakeholders to ensure that the overall regulatory framework is effective and proportionate at all stages of the research pathway from laboratory to clinic. We are of the firm belief that there is no legal impediment to current research being developed into clinical application. As such, I hope that the noble Lord will feel able to withdraw his amendment.