On 15 December 2016, following a scientific report into the efficacy and safety of the procedure (see BioNews 880), the Human Fertilisation and Embryology Authority (HFEA) ruled that the therapy should be approved for 'cautious clinical use'. The UK government legalised mitochondrial replacement therapy (MRT) in 2015.
Fertility clinics can now apply for a licence to carry out MRT to prevent mitochondrial disease, meaning that the first babies could potentially be born around this time next year.
'Today's historic decision means that parents at very high risk of having a child with a life-threatening mitochondrial disease may soon have the chance of a healthy, genetically related child. This is life-changing for those families,' said Sally Cheshire, chair of the HFEA. 'We feel now is the right time to carefully introduce this new treatment in the limited circumstances recommended by the panel.'
Mitochondrial diseases are caused by faulty mitochondria that cause incurable, progressive failure in tissues such as the brain, heart and muscles. As mitochondria are passed on solely from the mother via the cytoplasm of the egg cell, MRT involves replacing the faulty mitochondria of the egg with healthy mitochondria from a donor egg.
A team of specialists at Newcastle University, where the technique was pioneered, is expected to be the first to be granted a licence. They hope to treat up to 25 women per year. The NHS has said it will provide £8 million in funding for a five-year clinical trial.
Mary Herbert, Professor of Reproductive Biology at Newcastle University, said: 'We welcome today's decision from the HFEA, and it is enormously gratifying that our many years of research in this area can finally be applied to help families affected by these devastating diseases.'
After applying for a licence to carry out the procedure, a second licence will need to be obtained for each patient, who will be reviewed on a case-by-case basis.
Professor Sir Mark Walport, the government's Chief Scientific Adviser, said: 'I welcome this careful and considered assessment by the HFEA. The UK leads the world in the development of new medical technologies. This decision demonstrates that, thanks to organisations like the HFEA, we also lead the world in our ability to have a rigorous public debate around their adoption.'
The world's first mitochondrial donation baby was born in a clinic in Mexico earlier this year, where no national laws currently exist to regulate the practice (see BioNews 871). The medical director of the clinic, Dr Alejandro Chávez Badiola, has recently announced plans to treat 20 more women in the first half of 2017.