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The Department of Health has launched a three-month consultation on the draft regulations for a radical procedure that aims to prevent mothers from passing on serious genetic diseases to their children, a controversial technique because it leads to babies with DNA from three people.
Mitochondrial transfer has never been tried in humans and is prohibited in Britain under laws that ban the placing of an egg or embyro into a woman if the DNA has been altered. But scientists working on the technique said it offered hope of preventing life-threatening diseases for which there were no cures.
The government announced last June that it intends to allow the procedure, but the regulations must be finalised, debated and approved by parliament before the Human Fertilisation and Embryology Authority (HFEA) can allow clinics to offer the treatment.
About one in 200 children born in the UK have some form of mitochondrial disorder. The most serious affect the heart, brain, muscles and liver. Under the procedure, the nucleus is removed from an affected woman's egg or from a cell in an embryo and transferred to a donor egg or embryo that has healthy mitochondria.
As a result, a baby will have DNA from the biological parents and a female donor who provides healthy mitochondria, the tiny biological batteries that power most cells in the body. The fraction of a cell's DNA that is in mitochondria is minuscule and affects only how cells are powered. It does not influence the child's physical appearance or personality.
Another reason the procedure is controversial is that it would be the first to introduce genetic changes that are passed on not only to the intended child, but to all subsequent generations. One concern is that any harmful and unexpected side-effects might then damage the health of people born long into the future.
Launching the consultation, Dame Sally Davies, the chief medical officer, 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."
She added: "I want to encourage contributions to this consultation so that we have as many views as possible before introducing our final regulations."
Under the draft regulations, donors of mitochondrial DNA would remain anonymous, but could request details from the HFEA of the number and sex of any children born from their material. If someone aged 16 or over asked the HFEA if they were born after mitochondrial transfer, the authority would be required to tell them.
Doug Turnbull, a neurologist at Newcastle University and the leader of mitochondrial transfer research in Britain, welcomed 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," he said.
Last year, the HFEA published results of a national consultation on mitochondrial transfer, which found broad public support for the procedure. Tests in monkeys suggest that the procedure is safe, but research to perfect the technique is ongoing.
Mitochondrial diseases can affect single or multiple organs and tend to worsen with age. One disorder, called Leigh syndrome, usually develops in babies before the age of two, and causes progressive degeneration of the brain and nervous system.
Jeremy Farrar, director of the Wellcome Trust, encouraged the government to bring the regulations before parliament as soon as the consultation period finished in May. "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," he said.
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