Question
To ask Her Majesty's Government, further to the Written Answers by Baroness Blackwood of North Oxford on 20 January (HL277) and Lord Bethell on 5 March (HL1701) and 18 March (HL2406), what outcomes the Human Fertilisation and Embryology Authority consider to be adverse following mitochondrial donation treatment; whether such outcomes include (1) implantation failure, (2) spontaneous miscarriage, and (3) the termination of a pregnancy following the detection of unanticipated abnormalities; and what assessment they have made of the reason for the lack of live births pursuant to the application of such treatments.
Answer
The Human Fertilisation and Embryology Authority (HFEA) have advised that this information is set out in its Code of Practice at section 33.35, which states:
“If a centre becomes aware that a child born following mitochondrial donation has been born with a mitochondrial disease, birth defect, or genetic abnormality, or if there has been some other adverse outcome (including but not limited to failed or no embryo development, miscarriage or premature birth) following treatment involving mitochondrial donation, the centre must regard this as an adverse incident and report this to the HFEA in line with the requirements on adverse incidents set out in guidance note 27. This is to capture information about any abnormalities that may occur as a result of carrying out the MST (maternal spindle transfer) or PNT (pro-nuclear transfer) treatment, to inform any regulatory or licensing action that the HFEA may wish to take and to inform the scientific sector.”
The HFEA has made no assessment of the efficacy of mitochondrial treatment to date as the number of treatments is so low, at this stage.