The UK Government has announced that regulations around the use of mitochondrial replacement techniques will be presented to Parliament in the next few months.
Defects in mitochondria cause severe, incurable diseases in one in 6,500 UK babies each year. Many of these diseases are fatal in infancy. However, mitochondrial replacement techniques to avoid diseases caused by defective mitochondria, which are only inherited from the mother, are being developed with a centre based at Newcastle University carrying out further work on the procedures.
The techniques involve removing the nuclear material from a donor egg - containing healthy mitochondria - and replacing it with the nuclear material from the mother's egg, either before fertilisation or after both eggs have been fertilised. The resulting embryo will then be implanted. The techniques have been called 'three-person IVF', as children will inherit nuclear DNA from both parents, but also have approximately 0.1 percent genetic contribution from the donor since the mitochondria carry their own mitochondrial DNA. This constitutes a change to the germline that would be passed on to future generations.
A three-month public consultation on draft regulations for the techniques conducted by the Department of Health indicated that a majority of the respondents were supportive of the proposals, and the Government has stated that its decision to proceed further is the result of four years of 'detailed consideration' (see BioNews 711).
Opponents of the techniques argue that they are still experimental, and could be the start of a slippery slope to designer babies. Dr David King of Human Genetics Alert, said, 'Looking back, 15 years from now in the midst of a eugenic designer baby marketplace, people will see this as the moment when the crucial ethical line was crossed'.
Meanwhile, supporters are keen for the Government to push through legislation before the general election next May. Professor Jeremy Farrar, director of the Wellcome Trust, said: 'There is broad public support for making mitochondrial replacement therapy available to patients'.
'There is now no excuse for the Government not to table regulations for debate as soon as Parliament returns this autumn, so that the Human Fertilisation and Embryology Authority can license clinics to treat affected families without delay once it is satisfied that any risks are acceptable'.
The HFEA has also conducted a number of reviews into the safety and efficacy of mitochondrial replacement techniques. Its third review reported no evidence that the procedure is unsafe, although did request a number of further investigations to be carried out before the treatment is offered (see BioNews 757).
Dr Andy Greenfield, chair of the HFEA's expert panel of scientists who conducted the review, said: 'Our understanding of mitochondria has developed significantly over recent years, and scientists in the UK and the US are now close to providing new treatment options for a range of serious conditions that are inherited through the mothers' mitochondria'.
'In three years' study the expert panel has seen no evidence which suggests that these new mitochondrial replacement therapies are unsafe'.
Under the proposed regulations, children born by the technique will not be able to know the identity of the donor, but could access 'non-identifiable' information at the age of 16. Mitochondrial replacement techniques will also be under the regulation of the HFEA, who will approve each application on a case-by-case basis.
Sarah Norcross, director of the Progress Educational Trust, which publishes BioNews, said: 'While we welcome the Government's decisions, we are disappointed by the time it has taken to reach this point in the process'.
'A year ago, the Government promised a consultation in autumn 2013 which ultimately took place in March 2014. We note that the Government now aims to provide an update by early autumn 2014 - we hope that this is not similarly delayed.'