In Vitro Fertilisation

Department of Health written question – answered on 4th February 2015.

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Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

To ask Her Majesty’s Government, further to the Written Answers by Viscount Younger of Leckie on 23 January 2014 (WA 153–4) and by Earl Howe on 20 October 2014 (HL1962), how the provider of any novel intervention to prevent mitochondrial disease would be expected to demonstrate in advance that they could carry out the procedure safely and effectively; to what extent the safety of each proposed technique would be evaluated primarily by means of preclinical studies with animal models or by Phase 1 clinical trials; whether the initial application of the proposed techniques in a clinical context would be undertaken for any investigative purposes; and how informed consent would be obtained for investigations into how mutations are passed down from mother to child and vary in different cells of the resulting children, as described in paragraph 1.11 of their February 2014 consultation document entitled "Mitochondrial Donation".

Photo of Earl Howe Earl Howe The Parliamentary Under-Secretary of State for Health

It will be for the national regulator, the Human Fertilisation and Embryology Authority (HFEA), to determine its procedures for assessing applications to provide mitochondrial donation treatment for a named patient. The HFEA has advised that it will design the regulatory process, following the passage of any regulations to allow mitochondrial donation, on which it will seek views.

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