To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 14 October (WA 63–4), which physical and mental characteristics they consider to differ from those representative of health; what are the definitions of health and disease employed by the Human Fertilisation and Embryology Authority (HFEA) when making regulatory decisions; and whether the HFEA’s distinction between health and disease depends on presentation of symptoms or, if not, how mitochondrial disease is defined.
To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 14 October (WA 63–4), whether germline mitochondrial DNA mutations that aggravate ageing and impair brain development, as described in the journal Nature (Volume 501, pages 412-15), would be recognised by the Human Fertilisation and Embryology Authority as mitochondrial disease.
Mitochondrial diseases have some unique characteristics, both because of the way the disease is inherited from the mother and because mitochondria are so critical to cell and tissue function. Each individual affected will have different severity of symptoms because of different levels of functioning mitochondria within each cell and their location within the body. For that reason, it would be inappropriate to attempt to generalise on what conditions might be considered to differ from those representative of health.
The Human Fertilisation and Embryology Authority (HFEA) has advised that when making regulatory decisions the definitions it refers to are those contained in the Human Fertilisation and Embryology Act 1990, as amended. The HFEA has also advised that it has not made a distinction between health and disease.
The Government is currently developing draft regulations, which will describe in more detail the proposed approach for regulating mitochondria donation treatment. The Government is planning to publish these, as part of a public consultation, shortly.