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Draft regulations on mitochondrial donation published

3 March 2014
Appeared in BioNews 744

The UK Department of Health has published draft guidelines for the use of new techniques to prevent mothers passing on serious mitochondrial diseases to their children. The guidelines will be the subject of a three-month consultation.

The techniques, for use in IVF, use a small amount of DNA from a female donor which is passed on to the child and have been referred to as 'three-person IVF' by the press and 'mitochondrial transfer' or 'mitochondrial donation' by specialists. They are currently being evaluated by researchers and are not yet allowed to be used in humans.

A public consultation by the Human Fertilisation and Embryology Authority (HFEA) last year found that overall, the British public supports mitochondrial donation treatments being used, although that approval is not universal (see BioNews 698).

The techniques are controversial because they involve three people having genetic links to any baby. Also the donated DNA that would be passed to the child would also be passed on to subsequent generations.

One in 200 babies in Britain is born with a serious mitochondrial disease. These conditions can affect many organ systems and can be fatal. They arise due to mutations in the small amount of DNA contained in the mitochondria, the cell's 'batteries' that provide energy.

Mitochondrial donation techniques seek to replace all the mitochondrial DNA with that from a donor. As mitochondrial DNA is separate from nuclear DNA and principally controls energy generation in cells it is thought that any child born via mitochondrial transfer would not inherit any of the donor's physical or psychological characteristics.

Dame Sally Davies, chief medical officer for England, 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 Britain at the forefront of scientific development in this area'.

Senior biomedical researchers have voiced support for the Government's decision to move towards regulation of the technique. Professor Jeremy Farrar, director of the Wellcome Trust, told the Telegraph: 'Once further public consultation on the detail of these regulations is complete, we urge the Government to move swiftly so that Parliament can debate the regulations at the earliest opportunity and families affected by these devastating disorders can begin to benefit'.

However, Dr David King, director of the pressure group Human Genetics Alert and a critic of the techniques, told the newspaper: 'The techniques have not passed the necessary safety tests so it is unnecessary and premature to rush ahead with legalisation'.

Under the draft regulations, donors would remain anonymous; however, if a 16-year-old or older asks the HFEA if they were born after mitochondrial transfer, the authority is required to inform them.

Mitochondrial transfer would only be allowed when there is a 'significant risk' of disability or serious illness.

The consultation will end on 21 May 2014.

Consultation on babies with three people's DNA
The Guardian |  27 February 2014
Mitochondrial Donation - A consultation on draft regulations (pdf)
Department of Health |  27 February 2014
Mitochondrial donation consultation launched
Department of Health (press release) |  27 February 2014
Plans for three-parent babies outlined
ITV News |  27 February 2014
'Three-parent babies' could be born in Britain next year
Daily Telegraph |  27 February 2014
4 August 2014 - by Siobhan Chan 
The UK Government has been accused of deliberately misleading the public in order to win approval over its plans to implement mitochondrial replacement techniques in IVF...
21 July 2014 - by Professor Vardit Ravitsky, Dr John Appleby, Professor Stephen Wilkinson, Dr Anthony Wrigley and Dr Annelien Bredenoord 
Ethical dimensions of the emerging technology of mitochondrial replacement were the focus of a symposium that took place on 25 June at the 12th World Congress of Bioethics in Mexico City....
16 June 2014 - by Professor Marcus Pembrey 
When the Progress Educational Trust - the UK charity that publishes BioNews - emerged from the Progress Campaign for Research into Human Reproduction in 1992, I had no idea that I would end up chairing the Trustees for 20 of the last 22 years!...
9 June 2014 - by Alice Plein 
Two experimental IVF techniques that could prevent certain types of incurable genetic disease are 'not unsafe', a report from the UK's Human Fertilisation and Embryology Authority has found....
24 March 2014 - by Professor Janna Thompson 
MP Jacob Rees-Mogg recently implied that mitochondrial transfer is akin to eugenics, but it is a way of combating debilitating ailments rather than producing 'perfect' human beings...
21 October 2013 - by Ruth Saunders 
The health regulator in the USA is considering whether clinical trials of mitochondrial replacement techniques should go ahead....
14 October 2013 - by Dr Rosie Morley 
A group of European parliamentarians has criticised UK proposals to legislate for mitochondrial replacement therapy, calling it 'a eugenic practice'...
1 July 2013 - by Dr Rosie Morley 
The UK Government is to support the introduction of mitochondrial replacement therapy. The IVF-based procedure could allow women with mitochondrial disease the opportunity to have healthy children, by replacing their own, faulty, mitochondria with healthy mitochondria from a donor....
21 March 2013 - by Sandy Starr 
Mitochondrial replacement therapy, where a small amount of a mother's genetic material is swapped with material from a donor during IVF to avoid passing on heritable illnesses, enjoys the 'general support' of the public, the UK's fertility regulator says...
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