Draft rules allowing the introduction of a pioneering IVF treatment developed in the region have been announced by Government.
Regulations for the new treatments that could see the creation of babies with three genetic parents could come into force by the end of this year following a period of public consultation.
Ministers have agreed to amend fertility law in order to prevent a range of inherited diseases caused by faulty mitochondria, tiny energy-generating powerhouses in cells that have their own DNA.
A team of researchers at Newcastle University have led the development of the technique in humans.
Doug Turnbull, Professor of Neurology at Newcastle University, said: “I am delighted that the Government has published 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.”
Under the new rules, IVF clinics will be able to replace a baby’s defective mitochondrial DNA with healthy DNA from a female donor’s egg. Controversially, it would result in babies having DNA from two parents plus a tiny amount of extra DNA from a second “mother”.
While many doctors and scientists agree with the move, pointing out that it could eliminate devastating diseases, critics argue “mitochondrial transfer” could be a step towards designer babies.
Dr David King, director of the pressure group Human Genetics Alert, said: “The techniques are unethical according to basic medical ethics, since their only advantage over standard and safe egg donation is that the mother is genetically related to her child. This cannot justify the unknown risks to the child or the social consequences of allowing human genome modification.”
Around one in every 6,500 babies born in the UK has a severe mitochondrial disease. Although rare, the disorders can be passed to future generations through the maternal line.
Defects in mitochondrial DNA give rise to a range of potentially life-threatening diseases, including a form of muscular dystrophy and conditions leading to the loss of hearing and vision, heart problems and bowel disorders.
Robert Meadowcroft, chief executive of the Muscular Dystrophy Campaign, said: “News that the wait for proposed amendments to genetic research regulations to be shared with the public is over will be welcomed by many families living with mitochondrial disease.
“We have supported the Government’s review of the mitochondrial transfer IVF technique throughout, in the firm belief that open, thorough and transparent dialogue is critical. However, it will soon be two years since the initial consultation with the public was announced and three since the review began.
“There have been lengthy waits at every stage, and we now call on the Government to ensure that regulations are passed before the next general election, so that the technique can be moved towards clinical trials.”
The new consultation is not to debate whether mitochondrial transfer should be allowed, but how it should be implemented. Once the rules are brought in, it will be up to the regulator, the Human Fertilisation and Embryology Authority to decide on a case-by-case basis.