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Mitochondrial donation gets go ahead in England

NHS England announces it will fund ground-breaking clinical trial of the technique

Ingrid Torjesen

Friday, 16 December 2016

NHS England has today announced it will make up to £8 million available over five years to fund the treatment costs of a five-year clinical trial of mitochondrial donation – a form of IVF in which the future baby’s mitochondrial DNA comes from a donor egg, to avoid passing on inherited mitochondrial diseases.

The decision follows the announcement by the Human Fertilisation and Embryology Authority (HFEA) this week to start accepting applications for licences to carry out the procedure.

NHS England Chief Executive, Simon Stevens, said: “The NHS has given the world medical innovations ranging from modern cataract surgery, new vaccines and hip replacements, and today we take a world-leading next step to harness ground-breaking science for the benefit of our children.”

James Palmer, Clinical Director of Specialised Services at NHS England said: “Mitochondrial diseases can be devastating and life limiting as well as hugely costly to the NHS to treat. This trial will, for the first time, give women living with mitochondrial disease the option of having a baby without passing on their condition and is a shining example of how the NHS is leading the world in developing cutting-edge innovative new medical interventions.”

Mitochondrial donation involves the nuclear DNA from the affected mother being transferred into a donor embryo from which the nuclear DNA has been removed but in which the healthy donor mitochondrial DNA has been left. The procedure became legal in the UK on in October 2015, is commissioning responsibility of NHS England.

However, mitochondrial donation is subject to regulation by HFEA, so requires both the accreditation of the centre(s) carrying out the procedure and the approval of individual cases in which the technique would be used.

Since the technique has not yet been tested in humans, it is not yet possible for NHS England to develop an evidence-based clinical commissioning policy.  Instead, Wellcome has agreed – subject to a successful license application – to fund a five-year research programme at Newcastle University and Newcastle upon Tyne NHS Foundation Trust to study the long-term follow up of any children born following mitochondrial donation. A total of 125 patients can be enrolled, with an estimated 25 progressing to treatment annually.

Wellcome Director Dr Jeremy Farrar said: “This is a landmark day for people living with mitochondrial disease. For over 10 years Wellcome has supported brilliant researchers at Newcastle University pioneering mitochondrial donation. It’s right there’s been such a thorough process to get to this stage.”

NHS England has agreed to fund the treatments costs associated with the trial for those women who meet the HFEA criteria and agree to the long-term follow up of children born.

Mitochondrial diseases cause very significant morbidity and often early mortality. The impact of disease can include: blindness, blocked heart, muscle wastage and weakness, learning disabilities, deafness and diabetes. An estimated 2,473 women of child bearing age are at risk for transmitting mitochondrial DNA disease nationally and the lifetime treatment cost for a patient with serious mitochondrial disease is around £1.3 million.

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