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A controversial technique involving three-parent embryos, designed to prevent incurable genetic diseases, could be ready within two years but unless the government changes the law, prospective parents will be prevented from using it, scientists say.
Mitochondrial disease afflicts around 100 babies born in the UK every year. It is incurable and passed from mother to child. Symptoms include heart, liver and kidney disease, blindness and deafness, neurological problems and dementia.
The experimental treatment, known as mitochondrial replacement, involves taking the genetic material from a man and a woman and cellular material from a third person to create an embryo. It exchanges the faulty mitochondria from the mother with those from a healthy donor. It is controversial because mitochondria carry a small amount of DNA, and the law currently rules out all treatments on humans that require changing their DNA.
A report published today by the Human Fertilisation and Embryology Authority (HFEA), commissioned by the government, found that academic research into mitochondrial replacement was progressing well and that providing a number of critical experiments prove successful, the technique could be ready for clinical trials within 18 to 24 months.
The report is the third such review in as many years. On 27 February 2014 the government launched a parallel consultation on the draft regulations for legalising the treatment. This consultation closed on 21 May 2014.
The timescale is now tight for any change in the law that would allow the trials to take place at their earliest possible opportunity. There is also the concern that the legislative process could be delayed further by next year's general election.
Peter Thompson, chief executive of the HFEA, does not think the government has been dragging its heels. "In this case the government has been very thoughtful. It has taken a long time but government... can still resolve this in the remaining parliament."
The issue has been challenged on ethical grounds. The campaign group Human Genetics Alert, a secular charity, has spoken out against the legalisation of mitochondrial replacement, arguing that it crosses a line and could make it more difficult to oppose other forms of genetic modification. It warns that this could lead to "the risk of a consumer eugenic market in 'enhanced designer babies'."
"This will not lead to cloning or eugenics," said Professor Robin Lovell-Badge of the National Institute for Medical Research in Mill Hill, at a briefing held at the Science Media Centre, London, on the morning of the report's publication. Lovell-Badge has been a panel member for all three reviews.
Although the resulting embryos carry genetic material from a mother, father, and a mitochondrial donor, proponents of the technique say that a person's characteristics do not come from the mitochondrial DNA but from the DNA found in the cell nucleus.
The government must now decide whether to ask parliament for its approval to change the law and allow the trials to go ahead.
Even if the law is changed, trials will not automatically start. Clinics seeking to offer the treatment will have to gain approval from the HFEA, and that will be based upon the results of ongoing scientific experiments into the treatment's safety and efficacy.
The report recommends that any children born using this technique, and their subsequent children, are monitored for ill effects for the rest of their lives.
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