Skip to main content

In Vitro Fertilisation

Question for Department of Health

UIN HL4327, tabled on 21 January 2015

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".

Answered on

4 February 2015

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.

Answered by

Department of Health and Social Care