Lord Alton of Liverpool – 2016 Parliamentary Question to the Department of Health

The below Parliamentary question was asked by Lord Alton of Liverpool on 2016-01-26.

To ask Her Majesty’s Government what are the proposed protocols for (1) detection of aneuploidy in embryos following application of the proposed Augment technique, and (2) demonstrating that injected mitochondria either disperse so as to be equally inherited by each blastomere of any resulting embryos or are concentrated in the inner cell mass, in the recent application received by the Human Fertilisation and Embryology Authority (HFEA) for a pilot trial in the UK; what estimate the HFEA has been provided regarding (1) the likely financial costs to patients undergoing the proposed Augment procedure, and (2) the potential impact on clinical pregnancy rates of any assessments deemed to be scientifically necessary; and what assessment the HFEA has made of the ruling by the US Food and Drugs Administration in 2013 that Augment is a novel drug in need of extensive and expensive safety testing.

Lord Prior of Brampton

The Human Fertilisation and Embryology Authority (HFEA) advises that it does not hold data from clinics on the incidence of aneuploidy in oocytes over time, nor has it received evidence from OvaScience, Professor Simon Fishel or other sources that mitochondrial defects are primarily responsible for age-related increases in oocyte chromosomal aneuploidy.

The HFEA also advises that it has not been made aware of any published randomised trials regarding the Augment technique and has not made an assessment of the credibility of claims by OvaScience and those previously made by Clonaid, in the light of data available in peer-reviewed journals. It is currently considering whether techniques, which involve addition of autologous mitochondria to eggs, would be legal in the United Kingdom (under the framework of the Human Fertilisation and Embryology Act 1990, as amended). Part of this consideration involves considering the claims made for Augment by Ovascience.

The HFEA has not received any formal applications for clinical use of the Augment technique, and has not made an assessment of the ruling by the US Food and Drugs Administration to which the Noble Lord refers.