The Department of Health has published a consultation on draft regulations regarding mitochondrial donation. The consultation seeks the views of stakeholders and the wider public about draft regulations to allow newly developed treatment techniques to prevent the transfer of a serious mitochondrial disease from a mother to her child. The techniques would involve the donation of healthy mitochondria.
Mitochondrial disease is caused by unhealthy mitochondria, passed from mother to child through faults in the mitochondrial DNA or by faults in nuclear DNA. It is estimated that 1 in 200 children are born every year in the United Kingdom with some kind of mitochondrial DNA disorder. Serious mitochondrial disease can have a devastating effect on families, including the premature death of children, painful debilitating and disabling suffering, long-term ill-health and low quality of life.
According to BBC health news the Department of Health has already backed the technique and says this consultation is not about whether it should be allowed, but how it is implemented. The regulatory body, the Human Fertilisation and Embryology Authority, will have to decide in each case that there is a “significant risk” of disability or serious illness. It is anticipated that only the most severely affected women – perhaps 10 cases per year – would go ahead.
The regulations suggest treating the donor woman in the same manner as an organ donor. Any resulting children will not be able to discover the identity of the donor, which is the case with other sperm and egg donors.
Prof Doug Turnbull, who has pioneered research in mitochondrial donation at Newcastle University, said: “I am delighted that the government has published the draft regulations. This is very good news for patients with mitochondrial DNA disease and an important step in the prevention of transmission of serious mitochondrial disease”.
The chief medical officer for England, Prof Dame Sally Davies, said: “Allowing mitochondrial donation would give women who carry severe mitochondrial disease the opportunity to have children without passing on devastating genetic disorders. It would also keep the UK at the forefront of scientific development in this area. I want to encourage contributions to this consultation so that we have as many views as possible before introducing our final regulations”.
Dr David King, the director of Human Genetics Alert, said this was a decision of “major historical significance” which had not been debated adequately. “If passed, this will be the first time any government has legalised inheritable human genome modification, something that is banned in all other European countries. The techniques have not passed the necessary safety tests so it is unnecessary and premature to rush ahead with legalisation. The techniques are unethical according to basic medical ethics, since their only advantage over standard and safe egg donation is that the mother is genetically related to her child. This cannot justify the unknown risks to the child or the social consequences of allowing human genome modification”.
Following the consultation, a decision will be made about the regulations to put before Parliament.