To ask Her Majesty’s Government, further to the Written Statement by the Parliamentary Under-Secretary of State for Public Health, Jane Ellison, on 17 December 2014 (HC Deb, cols 96–7WS) and the Written Answer by Earl Howe on 5 January (HL3754), why the draft Regulations laid before Parliament do not mention the regulatory process that would involve analysis of the POLG gene; whether they still consider Leigh syndrome to be one of "the most serious disorders that can arise from unhealthy mitochondria"; and whether certain patients presenting with Leigh syndrome might therefore be contraindicated as candidates for pronuclear transfer or spindle-chromosomal complex transfer due to heterozygosity for POLG mutations as reported in the Journal of Pediatrics (May 2007, Volume 150, Issue 5, pages 531–534), Human Mutation (February 2009, Volume 30, Issue 2, pages 248–254), Biochimica et Biophysica Acta (May 2009, Volume 1787, Issue 5, pages 484–490) and the European Journal of Paediatric Neurology (September 2012, Volume 16, Issue 5, pages 542–548).
Answered on
20 January 2015
The Human Fertilisation and Embryology Authority has advised that it will design the regulatory process following the passage of any regulations to allow mitochondrial donation. Should Parliament pass the mitochondrial donation regulations, the technique could only be licensed for the avoidance of serious diseases caused by inherited mutations in mitochondrial DNA, not nuclear DNA. It is anticipated that the regulatory process would require case by case approval of each application relating to each particular patient.