We have today laid regulations to allow mitochondrial donation to prevent the transmission of serious mitochondrial disease from mother to child.
Mitochondrial disease is passed from mother to child through faults in the mitochondrial DNA. It is estimated that one in 6,500 children are born every year in the UK with a serious mitochondrial DNA disorder. Serious mitochondrial disease can have a profound effect on families, including the premature death of children; and causes painful, debilitating and disabling suffering, long-term ill health and low quality of life. There is no cure. British scientists are leading the world in the development of mitochondrial donation techniques which can prevent the transmission of this devastating disease.
The Government have run a comprehensive and transparent process over the lifetime of this Parliament to review the public acceptability of mitochondrial donation and the ongoing evidence of safety and efficacy of the new techniques involved. In developing the draft regulations, we have taken extensive advice from the scientific and research community and the United Kingdom’s regulator, the Human Fertilisation and Embryology Authority (HFEA). Should the regulations be approved by Parliament these mitochondrial donation techniques would form part of the HFEA’s regulatory framework. Any prospective provider would have to demonstrate that it could perform the technique both safely and effectively in order to obtain a licence, putting mitochondrial donation on the same footing as other fertility treatments.
The consultative process has included: a public dialogue and consultation about public acceptability run by the HFEA in 2012-13; three separate reports about the safety and efficacy of the techniques by an expert panel convened by the HFEA in 2011, 2013 and 2014; and a consultation by the Department of Health in 2014 about the detail of draft regulations that would allow these techniques. The HFEA published “Mitochondrial Donation: an introductory briefing” on 22 October, which provides a very helpful summary about the expert panel review process and outcome.
In addition the Nuffield Council on Bioethics ran a public consultation about the ethics of allowing the new techniques in 2012. Most recently, the House of Commons’ Science and Technology committee took evidence and considered the science of the new techniques, subsequently writing to the Government urging them to proceed.
Taking into account this cumulative consideration and consultation, the Government consider that the time is now right to give Parliament the opportunity to consider and vote on these regulations.